42 CFR 436.832 Post-eligibility treatment of income and resources of
institutionalized individuals: Application of patient income to the
cost of care.
(a) Basic rules. (1) The agency must reduce its payment to an
institution, for services provided to an individual specified in
paragraph (b) of this section, by the amount that remains after
deducting the amounts specified in paragraphs (c) and (d) of this
section from the individual's total income.
(2) The individual's income must be determined in accordance with
paragraph (e) of this section.
(3) Medical expenses must be determined in accordance with paragraph
(f) of this section.
(b) Applicability. This section applies to medically needy
individuals in medical institutions and intermediate care facilities.
(c) Required deductions. The agency must deduct the following
amounts, in the following order, from the individual's total income as
determined under paragraph (e) of this section. Income that was
disregarded in determining eligibility must be considered in this
process.
(1) Personal needs allowance. A personal needs allowance that is
reasonable in amount for clothing and other personal needs of the
individual while in the institution. This protected personal needs
allowance must be at least --
(i) $30 a month for an aged, blind, or disabled individual, including
a child applying for Medicaid on the basis of blindness or disability;
(ii) $60 a month for an institutionalized couple if both spouses are
aged, blind, or disabled and their income is considered available to
each other in determining eligibility; and
(iii) For other individuals, a reasonable amount set by the agency,
based on a reasonable difference in their personal needs from those of
the aged, blind, or disabled.
(2) Maintenance needs of spouse. For an individual with only a
spouse at home, an additional amount for the maintenance needs of the
spouse. This amount must be based on a reasonable assessment of need
but must not exceed the higher of --
(i) The amount of the highest need standard for an individual without
income and resources under the State's approved plan for OAA, AFDC, AB,
APTD, or AABD; or
(ii) The amount of the highest medically needy income standard for
one person established under 436.814.
(3) Maintenance needs of family. For an individual with a family at
home, an additional amount for the maintenance needs of the family.
This amount must --
(i) Be based on a reasonable assessment of their financial need;
(ii) Be adjusted for the number of family members living in the home;
and
(iii) Not exceed the highest of the following need standards for a
family of the same size:
(A) The standard used to determine eligibility under the State's
Medicaid plan, as provided for in 436.814.
(B) The standard used to determine eligibility under the State's
approved AFDC plan.
(4) Expenses not subject to third party payment. Amounts for
incurred expenses for medical or remedial care that are not subject to
payment by a third party, including --
(i) Medicare and other health insurance premiums, deductibles, or
coinsurance charges; and
(ii) Necessary medical or remedial care recognized under State law
but not covered under the State's Medicaid plan, subject to reasonable
limits the agency may establish on amounts of these expenses.
(d) Optional deduction: Allowance for home maintenance. For single
individuals and couples, an amount (in addition to the personal needs
allowance) for maintenance of the individual's or couple's home if --
(1) The amount is deducted for not more than a 6-month period; and
(2) A physician has certified that either of the individuals is
likely to return to the home within that period.
(e) Determination of income -- (1) Option. In determining the amount
of an individual's income to be used to reduce the agency's payment to
the institution, the agency may use total income received or it may
project total monthly income for a prospective period not to exceed 6
months.
(2) Basis for projection. The agency must base the projection on
income received in the preceding period, not to exceed 6 months, and on
income expected to be received.
(3) Adjustments. At the end of the prospective period specified in
paragraph (e)(1) of this section, or when any significant change occurs,
the agency must reconcile estimates with income received.
(f) Determination of medical expenses -- (1) Option. In determining
the amount of medical expenses to be deducted from an individual's
income, the agency may deduct incurred medical expenses, or it may
project medical expenses for a prospective period not to exceed 6
months.
(2) Basis for projection. The agency must base the estimate on
medical expenses incurred in the preceding period, not to exceed 6
months, and medical expenses expected to be incurred.
(3) Adjustments. At the end of the prospective period specified in
paragraph (f)(1) of this section, or when any significant change occurs,
the agency must reconcile estimates with incurred medical expenses.
(45 FR 24888, Apr. 11, 1980, as amended at 46 FR 47991, Sept. 30,
1981; 48 FR 5735, Feb. 8, 1983; 53 FR 3597, Feb. 8, 1988; 56 FR 8851,
8854, Mar. 1, 1991)
42 CFR 436.832 Medically Needy Resource Standards
42 CFR 436.840 Medically needy resource standards: General
requirements.
To determine eligibility of medically needy individuals, the Medicaid
agency must use a resource standard under this subpart that is --
(a) Based on family size;
(b) Uniform for all individuals in a group; and
(c) Reasonable (See 436.841).
(46 FR 47992, Sept. 30, 1981; 46 FR 54744, Nov. 4, 1981)
42 CFR 436.841 Medically needy resource standards: Reasonableness.
(a) The agency must use a medically needy resource standard that is
reasonable, according to the provisions of this section.
(b) The following medically needy resource standards are presumed to
be reasonable:
(1) The agency provides one medically needy resource standard for all
covered medically needy groups. The standard must at least equal the
highest resource standard used on or after January 1, 1966, to determine
eligibility for the OAA, AFDC, AB, APTD, and AABD programs that are
related to the covered medically needy groups.
(2) The agency provides for a different medically needy resource
standard for each covered medically needy group. The standard for each
covered group must at least equal the highest resource standard used on
or after January 1, 1966, to determine eligibility for the OAA, AFDC,
AB, APTD, or AABD program that is related to that covered medically
needy group.
(c) If the agency provides for a medically needy resource standard
not specified in paragraph (b) of this section --
(1) That standard is not presumed to be reasonable; and
(2) HCFA must approve the standard.
(46 FR 47992, Sept. 30, 1981; 46 FR 54744, Nov. 4, 1981)
42 CFR 436.843 Medically needy resource standards: State plan
requirements.
(a) The State plan must specify the resource standard for each
covered medically needy group.
(b) If the agency provides for a resource standard that is not
presumed reasonable under 436.841, the State plan must describe that
standard.
(46 FR 47992, Sept. 30, 1981; 46 FR 54744, Nov. 4, 1981)
42 CFR 436.843 Determining Eligibility on the Basis of Resources
42 CFR 436.845 Medically needy resource eligibility.
To determine eligibility on the basis of resources for medically
needy individuals, the agency must --
(a) Consider only the individual's resources and those that are
considered available to him under the financial responsibility
requirements for relatives under 436.821;
(b) Consider only resources available during the period for which
income is computed under 436.831(a);
(c) Deduct the value of resources that would be deducted in
determining eligibility under the State's plan for OAA, AFDC, AB, APTD,
or AABD; and
(d) Apply the resource standards established under 436.843.
(43 FR 45218, Sept. 29, 1978, as amended at 46 FR 47992, Sept. 30,
1981)
42 CFR 436.845 Treatment of Income and Resources
42 CFR 436.850 Treatment of income and resources: General
requirements.
To determine eligibility of medically needy individuals, a Medicaid
agency must use a methodology for the treatment of income and resources
that is --
(a) Uniform for all individuals in a covered group; and
(b) Reasonable (see 436.851).
(46 FR 47992, Sept. 30, 1981)
42 CFR 436.851 Treatment of income and resources: Reasonableness.
(a) The agency must use a methodology for the treatment of income and
resources, to determine eligibility of the medically needy, that is
reasonable.
(b) The methodology used to determine eligibility of cash assistance
program related to the covered medically needy group is presumed to be
reasonable.
(c) If the agency uses a methodology not described in paragraph (b)
of this section --
(1) The methodology is not presumed to be reasonable; and
(2) HCFA must approve that methodology.
(46 FR 47992, Sept. 30, 1981)
42 CFR 436.852 Treatment of income and resources: State plan
requirements.
(a) The State plan must specify the methodology used to treat the
income and resources for each covered medically needy group.
(b) If the agency uses a methodology that is not presumed to be
reasonable under 436.851, the State plan must describe that
methodology.
(46 FR 47992, Sept. 30, 1981)
42 CFR 436.852 Subpart J -- Eligibility in Guam, Puerto Rico, and the
Virgin Islands
Source: 44 FR 17939, Mar. 23, 1979, unless otherwise noted.
42 CFR 436.900 Scope.
This subpart sets forth requirements for processing applications,
determining eligibility, and furnishing Medicaid.
42 CFR 436.901 General requirements.
The Medicaid agency must comply with all the requirements of part
435, subpart J, of this subchapter, except those specified in 435.909.
42 CFR 436.909 Automatic entitlement to Medicaid following a
determination of eligibility under other programs.
The agency may not require a separate application for Medicaid from
an individual if the individual receives cash assistance under a State
plan for OAA, AFDC, AB, APTD, or AABD.
42 CFR 436.909 Subpart K -- Federal Financial Participation (FFP)
42 CFR 436.1000 Scope.
This subpart specifies when, and the extent to which, FFP is
available in expenditures for determining eligibility and for Medicaid
services to individuals determined eligible under this part, and
prescribes limitations and conditions on FFP for those expenditures.
42 CFR 436.1000 FFP for Expenditures for Determining Eligibility and Providing Services
42 CFR 436.1001 FFP for administration.
(a) FFP is available in the necessary administrative costs the State
incurs in determining and redetermining Medicaid eligibility and in
providing Medicaid to eligible individuals.
(b) Administrative costs include any costs incident to an eye
examination or medical examination to determine whether an individual is
blind or disabled.
42 CFR 436.1002 FFP for services.
(a) FFP is available in expenditures for Medicaid services for all
recipients whose coverage is required or allowed under this part.
(b) FFP is available in expenditures for services provided to
recipients who were eligible for Medicaid in the month in which the
medical care or services were provided, except that, for recipients who
establish eligibility for Medicaid by deducting incurred medical
expenses from income, FFP is not available for expenses that are the
recipient's liability.
(43 FR 45218, Sept. 29, 1978, as amended at 44 FR 17940, Mar. 23,
1979)
42 CFR 436.1003 Recipients overcoming certain conditions of
eligibility.
FFP is available for a temporary period specified in the State plan
in expenditures for services provided to recipients who are overcoming
certain eligibility conditions, including blindness, disability,
continued absence or incapacity of a parent, or unemployment of a
parent.
(45 FR 24888, Apr. 11, 1980)
42 CFR 436.1004 Institutionalized individuals.
(a) FFP is not available in expenditures for services provided to --
(1) Individuals who are inmates of public institutions as defined in
435.1009; or
(2) Individuals under age 65 who are patients in an institution for
mental diseases unless they are under age 22 and are receiving inpatient
psychiatric services under 440.160 of this subchapter.
(b) The exclusion of FFP described in paragraph (a) of this section
does not apply during that part of the month in which the individual is
not an inmate of a public institution or a patient in an institution for
mental diseases.
(c) An individual on conditional release or convalescent leave from
an institution for mental diseases is not considered to be a patient in
that institution. However, such an individual who is under age 22 and
has been receiving inpatient pyschiatric services under 440.160 of this
subchapter is considered to be a patient in the institution until he is
unconditionally released or, if earlier, the date he reaches age 22.
(43 FR 45204, Sept. 29, 1978, as amended at 50 FR 13200, Apr. 3,
1985; 50 FR 38811, Sept. 25, 1985)
42 CFR 436.1005 Definitions relating to institutional status.
For purposes of FFP, the definitions in 435.1009 of this subchapter
apply to this part.
42 CFR 436.1005 Pt. 440
42 CFR 436.1005 PART 440 -- SERVICES: GENERAL PROVISIONS
42 CFR 436.1005 Subpart A -- Definitions
Sec.
440.1 Basis and purpose.
440.2 Specific definitions; definitions of services for FFP
purposes.
440.10 Inpatient hospital services, other than services in an
institution for mental diseases.
440.20 Outpatient hospital services and rural health clinic services.
440.30 Other laboratory and X-ray services.
440.40 Skilled nursing facility services for individuals age 21 or
older (other than services in an institution for mental diseases).
EPSDT, and family planning services and supplies.
440.50 Physicians' services and medical and surgical services of a
dentist.
440.60 Medical or other remedial care provided by licensed
practitioners.
440.70 Home health services.
440.80 Private duty nursing services.
440.90 Clinic services.
440.100 Dental services.
440.110 Physical therapy, occupational therapy, and services for
individuals with speech, hearing, and language disorders.
440.120 Prescribed drugs, dentures, prosthetic devices, and
eyeglasses.
440.130 Diagnostic, screening, preventive, and rehabilitative
services.
440.140 Inpatient hospital services, skilled nursing facility
services, and intermediate care facility services for individuals age 65
or older in institutions for mental diseases.
440.150 Intermediate care facility services, other than in
institutions for mental diseases.
440.160 Inpatient pyschiatric services for individuals under age 21.
440.165 Nurse-midwife services.
440.170 Any other medical or remedial care recognized under State law
and specified by the Secretary.
440.180 Home or community-based services.
440.181 Home and community-based services for individuals age 65 or
older.
42 CFR 436.1005 Subpart B -- Requirements and Limits Applicable to All
Services
440.200 Basis, purpose, and scope.
440.210 Required services for the categorically needy.
440.220 Required services for the medically needy.
440.230 Sufficiency of amount, duration, and scope.
440.240 Comparability of services for groups.
440.250 Limits on comparability of services.
440.255 Limited services available to certain aliens.
440.260 Methods and standards to assure quality of services.
440.270 Religious objections.
Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
Source: 43 FR 45224, Sept. 29, 1978, unless otherwise noted.
42 CFR 436.1005 Subpart A -- Definitions
42 CFR 440.1 Basis and purpose.
This subpart interprets and implements the following sections of the
Act:
1902(a)(43) Laboratory services. (See also 447.10 and 447.342 for
related provisions on laboratory services.)
1905(a) Services included in the term ''medical assistance.''
1905 (c), (d), (f) through (i), (l), and (m) Definitions of
institutions and services that are included in the term ''medical
assistance.''
1913 ''Swing-bed'' services. (See 447.280 and 482.66 of this
chapter for related provisions on ''swing-bed'' services.)
1915(c) Home and community-based services listed as ''medical
assistance'' and furnished under waivers under that section to
individuals who would otherwise require the level of care furnished in a
hospital, NF, or ICF/MR.
1915(d) Home and community-based services listed as ''medical
assistance'' and furnished under waivers under that section to
individuals age 65 or older who would otherwise require the level of
care furnished in a NF.
(57 FR 29155, June 30, 1992)
42 CFR 440.2 Specific definitions; definitions of services for FFP
purposes.
(a) Specific definitions.
Inpatient means a patient who has been admitted to a medical
institution as an inpatient on recommendation of a physician or dentist
and who --
(1) Receives room, board and professional services in the institution
for a 24 hour period or longer, or
(2) Is expected by the institution to receive room, board and
professional services in the institution for a 24 hour period or longer
even though it later develops that the patient dies, is discharged or is
transferred to another facility and does not actually stay in the
institution for 24 hours.
Outpatient means a patient of an organized medical facility, or
distinct part of that facility who is expected by the facility to
receive and who does receive professional services for less than a
24-hour period regardless of the hour of admission, whether or not a bed
is used, or whether or not the patient remains in the facility past
midnight.
Patient means an individual who is receiving needed professional
services that are directed by a licensed practitioner of the healing
arts toward the maintenance, improvement, or protection of health, or
lessening of illness, disability, or pain. (See also 435.1009 of this
subchapter for definitions relating to institutional care.)
(b) Definitions of services for FFP purposes. Except as limited in
part 441, FFP is available in expenditures under the State plan for
medical or remedial care and services as defined in this subpart.
(43 FR 45224, Sept. 29, 1978, as amended at 52 FR 47934, Dec. 17,
1987)
42 CFR 440.10 Inpatient hospital services, other than services in an
institution for mental diseases.
(a) Inpatient hospital services means services that --
(1) Are ordinarily furnished in a hospital for the care and treatment
of inpatients;
(2) Except in the case of nurse-midwife services, as specified in
440.165, are furnished under the direction of a physician or dentist;
and
(3) Are furnished in an institution that --
(i) Is maintained primarily for the care and treatment of patients
with disorders other than mental diseases;
(ii) Is licensed or formally approved as a hospital by an officially
designated authority for State standard-setting;
(iii) Except in the case of medical supervision of nurse-midwife
services, as specified in 440.165, meets the requirements for
participation in Medicare as a hospital; and
(iv) Has in effect a utilization review plan, applicable to all
Medicaid patients, that meets the requirements of 482.30 of this
chapter, unless a waiver has been granted by the Secretary.
(b) Inpatient hospital services do not include SNF and ICF services
furnished by a hospital with a swing-bed approval.
(47 FR 21050, May 17, 1982, as amended at 47 FR 31532, July 20, 1982;
51 FR 22041, June 17, 1986, 52 FR 47934, Dec. 17, 1987)
42 CFR 440.20 Outpatient hospital services and rural health clinic
services.
(a)Outpatient hospital services means preventive, diagnostic,
therapeutic, rehabilitative, or palliative services that --
(1) Are furnished to outpatients;
(2) Except in the case of nurse-midwife services, as specified in
440.165, are furnished by or under the direction of a physician or
dentist; and
(3) Are furnished by an institution that --
(i) Is licensed or formally approved as a hospital by an officially
designated authority for State standard-setting; and
(ii) Except in the case of medical supervision of nurse-midwife
services, as specified in 440.165, meets the requirements for
participation in Medicare as a hospital; and
(4) May be limited by a Medicaid agency in the following manner: A
Medicaid agency may exclude from the definition of ''outpatient hospital
services'' those types of items and services that are not generally
furnished by most hospitals in the State.
(b) Rural health clinic services. If nurse practitioners or
physician assistants (as defined in 481.1 of this chapter) are not
prohibited by State law from furnishing primary health care, ''rural
health clinic services'' means the following services when furnished by
a rural health clinic that has been certified in accordance with part
491 of this chapter.
(1) Services furnished by a physician within the scope of practice of
his profession under State law, if the physician performs the services
in the clinic or the services are furnished away from the clinic and the
physician has an agreement with the clinic providing that he will be
paid by it for such services.
(2) Services furnished by a physician assistant, nurse practitioner,
nurse midwife or other specialized nurse practitioner (as defined in
405.2401 and 491.2 of this chapter) if the services are furnished in
accordance with the requirements specified in 405.2414(a) of this
chapter.
(3) Services and supplies that are furnished as an incident to
professional services furnished by a physician, physician assistant,
nurse practitioner, nurse midwife, or specialized nurse practitioner.
(See 405.2413 and 405.2415 of this chapter for the criteria for
determining whether services and supplies are included under this
paragraph.)
(4) Part-time or intermittent visiting nurse care and related medical
supplies (other than drugs and biologicals) if:
(i) The clinic is located in an area in which the Secretary has
determined that there is a shortage of home health agencies (see
405.2417 of this chapter):
(ii) The services are furnished by a registered nurse or licensed
practical nurse or a licensed vocational nurse employed by, or otherwise
compensated for the services by, the clinic;
(iii) The services are furnished under a written plan of treatment
that is established and reviewed at least every 60 days by a supervising
physician of the clinic or that is established by a physician, physician
assistant, nurse practitioner, nurse midwife, or specialized nurse
practitioner and reviewed and approved at least every 60 days by a
supervising physician of the clinic; and
(iv) The services are furnished to a homebound recipient. For
purposes of visiting nurse care, a ''homebound'' recipient means one who
is permanently or temporarily confined to his place of residence because
of a medical or health condition. He may be considered homebound if he
leaves the place of residence infrequently. For this purpose, ''place
of residence'' does not include a hospital or a skilled nursing
facility.
(c) Other ambulatory services furnished by a rural health clinic. If
the State plan covers rural health clinic services, other ambulatory
services means ambulatory services other than rural health clinic
services, as defined in paragraph (b) of this section, that are
otherwise included in the plan and meet specific State plan requirements
for furnishing those services. Other ambulatory services furnishd by a
rural health clinic are not subject to the physician supervision
requirements specified in 491.8(b) of this chapter, unless required by
State law or the State plan.
(43 FR 45224, Sept. 29, 1978, as amended at 47 FR 21050, May 17,
1982; 52 FR 47934, Dec. 17, 1987)
42 CFR 440.30 Other laboratory and X-ray services.
Other laboratory and X-ray services means professional and technical
laboratory and radiological services --
(a) Ordered and provided by or under the direction of a physician or
other licensed practioner of the healing arts within the scope of his
practice as defined by State law or ordered by a physician but provided
by referral laboratory;
(b) Provided in an office or similar facility other than a hospital
outpatient department or clinic; and
(c) Furnished by a laboratory that meets the requirements of part 493
of this chapter.
(46 FR 42672, Aug. 24, 1981, as amended at 57 FR 7135, Feb. 28, 1992)
42 CFR 440.40 Skilled nursing facility services for individuals age 21
or older (other than services in an institution for mental diseases).
EPSDT, and family planning services and supplies.
(a) Skilled nursing facility services. (1) ''Skilled nursing
facility services for individuals age 21 or older, other than services
in an institution for mental diseases'', means services that are --
(i) Needed on a daily basis and required to be provided on an
inpatient basis under 409.31 through 409.35 of this chapter.
(ii) Provided by (A) a facility or distinct part of a facility that
is certified to meet the requirements for participation under subpart C
of part 442 of this subchapter, as evidenced by a valid agreement
between the Medicaid agency and the facility for providing skilled
nursing facility services and making payments for services under the
plan; or (B) if specified in the State plan, a swing-bed hospital that
has an approval from HCFA to furnish skilled nursing facility services
in the Medicare program; and
(iii) Ordered by and provided under the direction of a physician.
(2) Skilled nursing facility services includes services provided by
any facility located on an Indian reservation and certified by the
Secretary as meeting the requirements of subpart K of part 405 of this
chapter.
(b) EPSDT. ''Early and periodic screening and diagnosis and
treatment'' means --
(1) Screening and diagnostic services to determine physical or mental
defects in recipients under age 21; and
(2) Health care, treatment, and other measures to correct or
ameliorate any defects and chronic conditions discovered. (See subpart
B of part 441 of this subchapter.)
(c) Family planning services and supplies for individuals of
child-bearing age. (Reserved)
(43 FR 45224, Sept. 29, 1978, as amended at 47 FR 31532, July 20,
1982; 48 FR 12551, Mar. 25, 1983; 51 FR 22041, June 17, 1986)
42 CFR 440.50 Physicians' services and medical and surgical services of
a dentist.
(a) ''Physicians' services,'' whether furnished in the office, the
recipient's home, a hospital, a skilled nursing facility, or elsewhere,
means services furnished by a physician --
(1) Within the scope of practice of medicine or osteopathy as defined
by State law; and
(2) By or under the personal supervision of an individual licensed
under State law to practice medicine or osteopathy.
(b) ''Medical and surgical services of a dentist'' means medical and
surgical services furnished, on or after January 1, 1988, by a doctor of
dental medicine or dental surgery if the services are services that --
(1) If furnished by a physician, would be considered physician's
services.
(2) Under the law of the State where they are furnished, may be
furnished either by a physician or by a doctor of dental medicine or
dental surgery; and
(3) Are furnished by a doctor of dental medicine or dental surgery
who is authorized to furnish those services in the State in which he or
she furnished the services.
(56 FR 8851, Mar. 1, 1991)
42 CFR 440.60 Medical or other remedial care provided by licensed
practitioners.
(a) ''Medical care or any other type remedial care provided by
licensed practitioners'' means any medical or remedial care or services,
other than physicians' services, provided by licensed practitioners
within the scope of practice as defined under State law.
(b) Chiropractors' services include only services that --
(1) Are provided by a chiropractor who is licensed by the State and
meets standards issued by the Secretary under 405.232(b) of this
chapter; and
(2) Consists of treatment by means of manual manipulation of the
spine that the chiropractor is legally authorized by the State to
perform.
42 CFR 440.70 Home health services.
(a) ''Home health services'' means the services in paragraph (b) of
this section that are provided to a recipient --
(1) At his place of residence, as specified in paragraph (c) of this
section; and
(2) On his physician's orders as part of a written plan of care that
the physician reviews every 60 days.
(b) Home health services include the following services and items.
Those listed in paragraphs (b) (1), (2) and (3) of this section are
required services; those in paragraph (b)(4) of this section are
optional.
(1) Nursing service, as defined in the State Nurse Practice Act, that
is provided on a part-time or intermittent basis by a home health agency
as defined in paragraph (d) of this section, or if there is no agency in
the area, a registered nurse who --
(i) Is currently licensed to practice in the State;
(ii) Receives written orders from the patient's physician;
(iii) Documents the care and services provided; and
(iv) Has had orientation to acceptable clinical and administrative
recordkeeping from a health department nurse.
(2) Home health aide service provided by a home health agency,
(3) Medical supplies, equipment, and appliances suitable for use in
the home, and
(4) Physical therapy, occupational therapy, or speech pathology and
audiology services, provided by a home health agency or by a facility
licensed by the State to provide medical rehabilitation services. (See
441.15 of this subchapter.)
(c) A recipient's place of residence, for home health services, does
not include a hospital, skilled nursing facility, or intermediate care
facility except for home health services in an intermediate care
facility that are not required to be provided by the facility under
subparts F and G of part 442 of this subchapter. For example, a
registered nurse may provide short-term care for a recipient in an
intermediate care facility during an acute illness to avoid the
recipient's transfer to a skilled nursing facility.
(d) ''Home health agency'' means a public or private agency or
organization, or part of an agency or organization, that meets
requirements for participation in Medicare.
(e) A ''facility licensed by the State to provide medical
rehabilitation services'' means a facility that --
(1) Provides therapy services for the primary purpose of assisting in
the rehabilitation of disabled individuals through an integrated program
of --
(i) Medical evaluation and services; and
(ii) Psychological, social, or vocational evaluation and services;
and
(2) Is operated under competent medical supervision either --
(i) In connection with a hospital; or
(ii) As a facility in which all medical and related health services
are prescribed by or under the direction of individuals licensed to
practice medicine or surgery in the State.
(43 FR 45224, Sept. 29, 1978, as amended at 45 FR 24888, Apr. 11,
1980)
42 CFR 440.80 Private duty nursing services.
Private duty nursing services means nursing services for recipients
who require more individual and continuous care than is available from a
visiting nurse or routinely provided by the nursing staff of the
hospital or skilled nursing facility. These services are provided --
(a) By a registered nurse or a licensed practical nurse;
(b) Under the direction of the recipient's physician; and
(c) To a recipient in one or more of the following locations at the
option of the State --
(1) His or her own home;
(2) A hospital; or
(3) A skilled nursing facility.
(52 FR 47934, Dec. 17, 1987)
42 CFR 440.90 Clinic services.
Clinic services means preventive, diagnostic, therapeutic,
rehabilitative, or palliative services that are furnished by a facility
that is not part of a hospital but is organized and operated to provide
medical care to outpatients. The term includes the following services
furnished to outpatients:
(a) Services furnished at the clinic by or under the direction of a
physician or dentist.
(b) Services furnished outside the clinic, by clinic personnel under
the direction of a physician, to an eligible individual who does not
reside in a permanent dwelling or does not have a fixed home or mailing
address.
(c) Services furnished at the clinic that are nurse-midwife services,
as defined in 440.165.
(56 FR 8851, Mar. 1, 1991)
42 CFR 440.100 Dental services.
(a) ''Dental services'' means diagnostic, preventive, or corrective
procedures provided by or under the supervision of a dentist in the
practice of his profession, including treatment of --
(1) The teeth and associated structures of the oral cavity; and
(2) Disease, injury, or impairment that may affect the oral or
general health of the recipient.
(b) ''Dentist'' means an individual licensed to practice dentistry or
dental surgery.
(43 FR 45224, Sept. 29, 1978, as amended at 45 FR 24888, Apr. 11,
1980)
42 CFR 440.110 Physical therapy, occupational therapy, and services for
individuals with speech, hearing, and language disorders.
(a) Physical therapy. (1) ''Physical therapy'' means services
prescribed by a physician and provided to a recipient by or under the
direction of a qualified physical therapist. It includes any necessary
supplies and equipment.
(2) A ''qualified physical therapist'' is an individual who is --
(i) A graduate of a program of physical therapy approved by both the
Committee on Allied Health Education and Accreditation of the American
Medical Association and the American Physical Therapy Association or its
equivalent; and
(ii) Where applicable, licensed by the State.
(b) Occupational therapy. (1) ''Occupational therapy'' means
services prescribed by a physician and provided to a recipient by or
under the direction of a qualified occupational therapist. It includes
any necessary supplies and equipment.
(2) A ''qualified occupation therapist'' is an individual who is --
(i) Registered by the American Occupational Therapy Association; or
(ii) A graduate of a program in occupational therapy approved by the
Committee on Allied Health Education and Accreditation of the American
Medical Association and engaged in the supplemental clinical experience
required before registration by the American Occupational Therapy
Association.
(c) Services for individuals with speech, hearing, and language
disorders. (1) ''Services for individuals with speech, hearing, and
language disorders'' means diagnostic, screening, preventive, or
corrective services provided by or under the direction of a speech
pathologist or audiologist, for which a patient is referred by a
physician. It includes any necessary supplies and equipment.
(2) A ''speech pathologist or audiologist'' is an individual who --
(i) Has a certificate of clinical competence from the American Speech
and Hearing Association;
(ii) Has completed the equivalent educational requirements and work
experience necessary for the certificate; or
(iii) Has completed the academic program and is acquiring supervised
work experience to qualify for the certificate.
(43 FR 45224, Sept. 29, 1978, as amended at 45 FR 24888, Apr. 11,
1980; 56 FR 8854, Mar. 1, 1991)
42 CFR 440.120 Prescribed drugs, dentures, prosthetic devices, and
eyeglasses.
(a) ''Prescribed drugs'' means simple or compound substances or
mixtures of substances prescribed for the cure, mitigation, or
prevention of disease, or for health maintenance that are --
(1) Prescribed by a physician or other licensed practitioner of the
healing arts within the scope of this professional practice as defined
and limited by Federal and State law;
(2) Dispensed by licensed pharmacists and licensed authorized
practitioners in accordance with the State Medical Practice Act; and
(3) Dispensed by the licensed pharmacist or practitioner on a written
prescription that is recorded and maintained in the pharmacist's or
practitioner's records.
(b) ''Dentures'' are artificial structures made by or under the
direction of a dentist to replace a full or partial set of teeth.
(c) ''Prosthetic devices'' means replacement, corrective, or
supportive devices prescribed by a physician or other licensed
practitioner of the healing arts within the scope of his practice as
defined by State law to --
(1) Artificially replace a missing portion of the body;
(2) Prevent or correct physical deformity or malfunction; or
(3) Support a weak or deformed portion of the body.
(d) ''Eyeglasses'' means lenses, including frames, and other aids to
vision prescribed by a physician skilled in diseases of the eye or an
optometrist.
42 CFR 440.130 Diagnostic, screening, preventive, and rehabilitative
services.
(a) ''Diagnostic services,'' except as otherwise provided under this
subpart, includes any medical procedures or supplies recommended by a
physician or other licensed practitioner of the healing arts, within the
scope of his practice under State law, to enable him to identify the
existence, nature, or extent of illness, injury, or other health
deviation in a recipient.
(b) ''Screening services'' means the use of standardized tests given
under medical direction in the mass examination of a designated
population to detect the existence of one or more particular diseases or
health deviations or to identify for more definitive studies individuals
suspected of having certain diseases.
(c) ''Preventive services'' means services provided by a physician or
other licensed practitioner of the healing arts within the scope of his
practice under State law to --
(1) Prevent disease, disability, and other health conditions or their
progression;
(2) Prolong life; and
(3) Promote physical and mental health and efficiency.
(d) ''Rehabilitative services,'' except as otherwise provided under
this subpart, includes any medical or remedial services recommended by a
physician or other licensed practitioner of the healing arts, within the
scope of his practice under State law, for maximum reduction of physical
or mental disability and restoration of a recipient to his best possible
functional level.
42 CFR 440.140 Inpatient hospital services, skilled nursing facility
services, and intermediate care facility services for individuals age 65
or older in institutions for mental diseases.
(a) Inpatient hospital services. (1) ''Inpatient hospital services
for individuals age 65 or older in institutions for mental diseases''
means services provided under the direction of a physician for the care
and treatment of recipients in an institution for mental diseases that
meets the requirements specified in 482.60(b), (c), and (e) of this
chapter and --
(i) Meets the requirements for utilization review in 482.30(a), (b),
(d), and (e) of this chapter; or
(ii) Has been granted a waiver of those utilization review
requirements under section 1903(i)(4) and subpart H of part 456 of this
subchapter.
(2) ''Institution for mental diseases'' means a hospital, nursing
facility, or other institution of more than 16 beds that is primarily
engaged in providing diagnosis, treatment, or care of individuals with
mental diseases, including medical care, nursing care, and related
services.
(b) Skilled nursing facility services. ''Skilled nursing facility
services for individuals age 65 or older in institutions for mental
diseases'' means skilled nursing facility services as defined in 440.40
that are provided in institutions for mental diseases, as defined in
paragraph (a) of this section.
(c) Intermediate care facility services. ''Intermediate care
facility services for individuals age 65 or older in institutions for
mental diseases'' means intermediate care facility services as defined
in 440.150 of this subpart, that are provided to recipients who are --
(1) Determined under 456.360 through 456.372 of this subchapter to
be in need of services; and
(2) In institutions for mental diseases, as defined in paragraph (a)
of this section.
(51 FR 22041, June 17, 1986, as amended at 56 FR 8854, Mar. 1, 1991)
42 CFR 440.150 Intermediate care facility services, other than in
institutions for mental diseases.
(a) ''Intermediate care facility services, other than in an
institution for mental diseases'' means services provided in a facility
that --
(1) Fully meets the requirements for a State license to provide, on a
regular basis, health-related services to individuals who do not require
hospital or skilled nursing facility care, but whose mental or physical
condition requires services that --
(i) Are above the level of room and board; and
(ii) Can be made available only through institutional facilities;
(2) Has been certified to meet the requirements of subpart C of part
442 of this subchapter as evidenced by a valid agreement between the
Medicaid agency and the facility for providing intermediate care
facility services and making payments for services under the plan; and
(3) Meets the conditions of subpart E of part 442 of this subchapter.
(b) ''Intermediate care facility services'' include services --
(1) Considered appropriate by the State and provided by a Christian
Science sanatorium operated, or listed and certified, by the First
Church of Christ, Scientist, Boston, Mass.; or
(2) Provided by a facility located on an Indian reservation that --
(i) Furnishes, on a regular basis, health-related services; and
(ii) Is certified by the Secretary to meet the standards in subpart E
of part 442 of this subchapter.
(c) ''Intermediate care facility services'' may include services in
an institution for the mentally retarded or persons with related
conditions if --
(1) The primary purpose of the institution is to provide health or
rehabilitative services for mentally retarded individuals or persons
with related conditions;
(2) The institution meets the standards in subpart E of part 442 of
this subchapter; and
(3) The mentally retarded recipient for whom payment is requested is
receiving active treatment as specified in 483.440.
(d) ''Intermediate care facility services'' may include services
provided in a distinct part of a facility other than an intermediate
care facility if the distinct part --
(1) Meets all requirements for an intermediate care facility;
(2) Is an identifiable unit, such as an entire ward or contiguous
ward, a wing, floor, or building;
(3) Consists of all beds and related facilities in the unit;
(4) Houses all recipients for whom payment is being made for
intermediate care facility services, except as provided in paragraph (e)
of this section;
(5) Is clearly identified; and
(6) Is approved in writing by the survey agency.
(e) If a State includes as intermediate care facility services those
services provided by a distinct part of a facility other than an
intermediate care facility, it may not require transfer of a recipient
within or between facilities if, in the opinion of the attending
physician, it might be harmful to the physical or mental health of the
recipient.
(f) Intermediate care facility services may include services provided
in a swing-bed hospital that has an approval to furnish intermediate
care services.
(43 FR 45224, Sept. 29, 1978, as amended at 47 FR 31532, July 20,
1982; 51 FR 22041, June 17, 1986; 53 FR 20495, June 3, 1988)
42 CFR 440.160 Inpatient psychiatric services for individuals under age
21.
''Inpatient psychiatric services for individuals under age 21'' means
services that --
(a) Are provided under the direction of a physician;
(b) Are provided in a facility or program accredited by the Joint
Commission on Accreditation of Hospitals; and
(c) Meet the requirements in subpart D of part 441.
42 CFR 440.165 Nurse-midwife service.
(a) ''Nurse-midwife services'' means services that --
(1) Are concerned with management of the care of mothers and newborns
throughout the maternity cycle;
(2) Are furnished by a nurse-midwife within the scope of practice
authorized by State law or regulation and, in the case of inpatient or
outpatient hospital services or clinic services, are furnished by or
under the direction of a nurse-midwife to the extent permitted by the
facility; and
(3) Unless required by State law or regulations or a facility, are
reimbursed without regard to whether the nurse-midwife is under the
supervision of, or associated with, a physician or other health care
provider. (See 441.21 of this chapter for provisions on independent
provider agreements for nurse-midwives.)
(b) ''Nurse-midwife'' means a registered professional nurse who meets
the following requirements:
(1) Is currently licensed to practice in the State as a registered
professional nurse.
(2) Is legally authorized under State law or regulations to practice
as a nurse-midwife.
(3) Except as provided in paragraph (b)(4) of this section, has
completed a program of study and clinical experience for nurse-midwives,
as specified by the State.
(4) If the State does not specify a program of study and clinical
experience that nurse-midwives must complete to practice in that State,
meets one of the following conditions:
(i) Is currently certified as a nurse-midwife by the American College
of Nurse-Midwives.
(ii) Has satisfactorily completed a formal educational program (of at
least one academic year) that, upon completion, qualifies the nurse to
take the certification examination offered by the American College of
Nurse-Midwives.
(iii) Has successfully completed a formal educational program for
preparing registered nurses to furnish gynecological and obstetrical
care to women during pregnancy, delivery, and the postpartum period, and
care to normal newborns, and was practicing as a nurse-midwife for a
total of 12 months during any 18-month period from August 8, 1976 to
July 16, 1982.
(c) ''Maternity cycle'' means a period limited to --
(1) Pregnancy;
(2) Labor;
(3) Birth; and
(4) The immediate postpartum period which begins on the last day of
pregnancy and extends through the end of the month in which the 60-day
period following termination of pregnancy ends.
(47 FR 21050, May 17, 1982; 47 FR 23448, May 28, 1982, as amended at
55 FR 48611, Nov. 21, 1990)
42 CFR 440.170 Any other medical care or remedial care recognized under
State law and specified by the Secretary.
(a) Transportation. (1) ''Transportation'' includes expenses for
transportation and other related travel expenses determined to be
necessary by the agency to secure medical examinations and treatment for
a recipient.
(2) Transportation, as defined in this section, is furnished only by
a provider to whom a direct vendor payment can appropriately be made by
the agency. If other arrangements are made to assure transportation
under 431.53 of this subchapter, FFP is available as an administrative
cost.
(3) ''Travel expenses'' include --
(i) The cost of transportation for the recipient by ambulance,
taxicab, common carrier, or other appropriate means;
(ii) The cost of meals and lodging en route to and from medical care,
and while receiving medical care; and
(iii) The cost of an attendant to accompany the recipient, if
necessary, and the cost of the attendant's transportation, meals,
lodging, and, if the attendant is not a member of the recipient's
family, salary.
(b) Services of Christian Science nurses. ''Services of Christian
Science nurses'' mean services provided by nurses who are listed and
certified by the First Church of Christ, Scientist, Boston, Mass., if --
(1) The services have been requested by the recipient; and
(2) The services are provided --
(i) By or under the supervision of a Christian Science visiting nurse
organization listed and certified by the First Church of Christ,
Scientist, Boston, Mass.; or
(ii) As private duty services to a recipient in his own home or in a
Christian Science sanatorium operated, or listed and certified, by the
First Church of Christ, Scientist, Boston, Mass., if the recipient
requires individual and continuous care beyond that available from a
visiting nurse or that routinely provided by the nursing staff of the
sanatorium.
(c) Services in Christian Science sanatoriums. ''Services in
Christian Science sanatoriums'' means services provided in Christian
Science sanatoriums that are operated by, or listed and certified by,
the First Church of Christ, Scientist, Boston, Mass.
(d) Skilled nursing facility services for individuals under age 21.
''Skilled nursing facility services for individuals under 21'' means
those services specified in 440.40 that are provided to recipients
under 21 years of age.
(e) Emergency hospital services. ''Emergency hospital services''
means services that --
(1) Are necessary to prevent the death or serious impairment of the
health of a recipient; and
(2) Because of the threat to the life or health of the recipient
necessitate the use of the most accessible hospital available that is
equipped to furnish the services, even if the hospital does not
currently meet --
(i) The conditions for participation under Medicare; or
(ii) The definitions of inpatient or outpatient hospital services
under 440.10 and 440.20.
(f) Personal care services in a recipient's home. Unless defined
differently by a State agency for purposes of a waiver granted under
part 441, subpart G of this chapter, ''personal care services in a
recipient's home'' means services prescribed by a physician in
accordance with the recipient's plan of treatment and provided by an
individual who is --
(1) Qualified to provide the services;
(2) Supervised by a registered nurse; and
(3) Not a member of the recipient's family.
(43 FR 45224, Sept. 29, 1978, as amended at 45 FR 24889, Apr. 11,
1980; 46 FR 48540, Oct. 1, 1981)
42 CFR 440.180 Home or community-based services.
''Home or community-based services'' means services, not otherwise
furnished under the State's Medicaid plan, that are furnished under a
waiver granted under the provisions of part 441, subpart G of this
subchapter. Except as provided in 441.310 the services may consist of
any of the following services as defined by the agency that meet the
standards specified in 441.302(a):
(a) Case management services;
(b) Homemaker services;
(c) Home health aide services;
(d) Personal care services;
(e) Adult day health services;
(f) Habilitation services;
(g) Respite care services;
(h) Other services requested by the Medicaid agency and approved by
HCFA as cost-effective.
(50 FR 10026, Mar. 13, 1985)
42 CFR 440.181 Home and community-based services for individuals age 65
or older.
(a) Description of services. -- Home and community-based services for
individuals age 65 or older means services, not otherwise furnished
under the State's Medicaid plan, or services already furnished under the
State's Medicaid plan but in expanded amount, duration, or scope, which
are furnished to individuals age 65 or older under a waiver granted
under the provisions of part 441, subpart H of this subchapter. Except
as provided in 441.310, the services may consist of any of the services
listed in paragraph (b) of this section that are requested by the State,
approved by HCFA, and furnished to eligible recipients. Service
definitions for each service in paragraph (b) of this section must be
approved by HCFA.
(b) Included services. (1) Case management services.
(2) Homemaker services.
(3) Home health aide services.
(4) Personal care services.
(5) Adult day health services.
(6) Respite care services.
(7) Other medical and social services requested by the Medicaid
agency and approved by HCFA, which will contribute to the health and
well-being of individuals and their ability to reside in a
community-based care setting.
(57 FR 29156, June 30, 1992)
42 CFR 440.181 Subpart B -- Requirements and Limits Applicable to All Services
42 CFR 440.200 Basis, purpose, and scope.
(a) This subpart implements the following statutory requirements --
(1) Section 1902(a)(10), regarding comparability of services for
groups of recipients, and the amount, duration, and scope of services
described in section 1905(a) of the Act that the State plan must provide
for recipients;
(2) Section 1902(a)(22)(D), which provides for standards and methods
to assure quality of services;
(3) Section 1903(v)(1), which provides that no payment may be made to
a State under this section for medical assistance furnished to an alien
who is not lawfully admitted for permanent residence or otherwise
permanently residing in the United States under color of law;
(4) Section 1903(v)(2) which provides that FFP will be available for
services necessary to treat an emergency medical condition of an alien
not described in paragraph (a)(3) of this section if that alien
otherwise meets the eligibility requirements of the State plan;
(5) Section 1907 on observance of religious beliefs;
(6) Section 1915 on exceptions to section 1902(a)(10) and waivers of
other requirements of section 1902 of the Act; and
(7) Sections 245A(h), 210 and 210A of the Immigration and Nationality
Act which provide that certain aliens who are legalized may be eligible
for Medicaid.
(b) The requirements and limits of this subpart apply for all
services defined in subpart A of this part.
(55 FR 36822, Sept. 7, 1990)
42 CFR 440.210 Required services for the categorically needy.
(a) A State plan must specify that, as a minimum, categorically needy
recipients are provided the following services:
(1) The services as specified in 440.10 through 440.50, 440.70 and
(to the extent nurse-midwives are authorized to practice under State law
or regulation), 440.165;
(2) Pregnancy-related services and services for other conditions that
might complicate the pregnancy.
(i) Pregnancy-related services are those services that are necessary
for the health of the pregnant woman and fetus, or that have become
necessary as a result of the woman having been pregnant. These include,
but are not limited to, prenatal care, delivery, postpartum care, and
family planning services.
(ii) Services for other conditions that might complicate the
pregnancy include those for diagnoses, illnesses, or medical conditions
which might threaten the carrying of the fetus to full term or the safe
delivery of the fetus; and
(3) For women who, while pregnant, applied for, were eligible for,
and received Medicaid services under the plan, all services under the
plan that are pregnancy-related for an extended postpartum period. The
postpartum period begins on the last day of pregnancy and extends
through the end of the month in which the 60-day period following
termination of pregnancy ends.
(b) A State plan must specify that eligible aliens as defined in
435.406(a) and 436.406(a) of this subchapter will receive at least the
services provided in paragraph (a) of this section.
(c) A State plan must specify that aliens not defined in 435.406(a)
and 436.406(a) of this subchapter will only be provided the limited
services specified in 440.255.
(56 FR 24010, May 28, 1991)
42 CFR 440.220 Required services for the medically needy.
(a) A State plan that includes the medically needy must specify that
the medically needy are provided, as a minimum, the following services:
(1) Prenatal care and delivery services for pregnant women.
(2) Ambulatory services, as defined in the State plan, for --
(i) Individuals under age 18; and
(ii) Individuals entitled to institutional services.
(3) Home health services ( 440.70) to any individual entitled to
skilled nursing facility services.
(4) If the State plan includes services in an institution for mental
diseases ( 440.140 or 440.160) or in an intermediate care facility for
the mentally retarded ( 440.150(c)) for any group of medically needy,
either of the following sets of services to each of the medically needy
groups:
(i) The services contained in 440.10 through 440.50 and (to the
extent nurse-midwives are authorized to practice under State law or
regulation) 440.165; or
(ii) The services contained in any seven of the sections in 440.10
through 440.165.
(5) For women who, while pregnant, applied for, were eligible as
medically needy for, and received Medicaid services under the plan,
services under the plan that are pregnancy-related (as defined in
440.210(a)(2)(i) of this subpart) for an extended postpartum period.
The postpartum period begins on the last day of pregnancy and extends
through the end of the month in which the 60-day period following
termination of pregnancy ends.
(b) A State plan must specify that eligible aliens as defined in
435.406(a) and 436.406(a) of this subchapter will receive at least the
services provided in paragraphs (a)(4) (i) and (ii) of this section.
(c) A State plan must specify that aliens defined in 435.406(b),
435.406(c), 436.406(b) and 436.406(c) of this subchapter will only be
provided the limited services specified in 440.255.
(56 FR 24011, May 28, 1991)
42 CFR 440.230 Sufficiency of amount, duration, and scope.
(a) The plan must specify the amount, duration, and scope of each
service that it provides for --
(1) The categorically needy; and
(2) Each covered group of medically needy.
(b) Each service must be sufficient in amount, duration, and scope to
reasonably achieve its purpose.
(c) The Medicaid agency may not arbitrarily deny or reduce the
amount, duration, or scope of a required service under 440.210 and
440.220 to an otherwise eligible recipient solely because of the
diagnosis, type of illness, or condition.
(d) The agency may place appropriate limits on a service based on
such criteria as medical necessity or on utilization control procedures.
(46 FR 47993, Sept. 30, 1981)
42 CFR 440.240 Comparability of services for groups.
Except as limited in 440.250 --
(a) The plan must provide that the services available to any
categorically needy recipient under the plan are not less in amount,
duration, and scope than those services available to a medically needy
recipient; and
(b) The plan must provide that the services available to any
individual in the following groups are equal in amount, duration, and
scope for all recipients within the group:
(1) The categorically needy.
(2) A covered medically needy group.
(46 FR 47993, Sept. 30, 1981)
42 CFR 440.250 Limits on comparability of services.
(a) Skilled nursing facility services ( 440.40(a)) may be limited to
recipients age 21 or older.
(b) Early and periodic screening, diagnosis, and treatment (
440.40(b)) must be limited to recipients under age 21.
(c) Family planning services and supplies must be limited to
recipients of childbearing age, including minors who can be considered
sexually active and who desire the services and supplies.
(d) If covered under the plan, services to recipients in institutions
for mental diseases ( 440.140) must be limited to those age 65 or older.
(e) If covered under the plan, inpatient psychiatric services (
440.160) must be limited to recipients under age 22 as specified in
441.151(c) of this subchapter.
(f) If Medicare benefits under Part B of title XVIII are made
available to recipients through a buy-in agreement or payment of
premiums, or part or all of the deductibles, cost sharing or similar
charges, they may be limited to recipients who are covered by the
agreement or payment.
(g) If services in addition to those offered under the plan are made
available under a contract between the agency or political subdivision
and an organization providing comprehensive health services, those
additional services may be limited to recipients who reside in the
geographic area served by the contracting organization and who elect to
receive services from it.
(h) Ambulatory services for the medically needy ( 440.220(a)(2)) may
be limited to --
(1) Individuals under age 18; and
(2) Individuals entitled to institutional services.
(i) Services provided under an exception to requirements allowed
under 431.54 may be limited as provided under that exception.
(j) If HCFA has approved a waiver of Medicaid requirements under
431.55, services may be limited as provided by the waiver.
(k) If the agency has been granted a waiver of the requirements of
440.240 (Comparability of services) in order to provide for home or
community-based services under 440.180 or 440.181, the services
provided under the waiver need not be comparable for all individuals
within a group.
(l) If the agency imposes cost sharing on recipients in accordance
with 447.53, the imposition of cost sharing on an individual who is not
exempted by one of the conditions in section 447.53(b) shall not require
the State to impose copayments on an individual who is eligible for such
exemption.
(m) Eligible legalized aliens who are not in the exempt groups
described in 435.406(a) and 436.406(a), and considered categorically
needy or medically needy must be furnished only emergency services (as
defined in 440.255), and services for pregnant women as defined in
section 1916(a)(2)(B) of the Social Security Act for 5 years from the
date the alien is granted lawful temporary resident status.
(n) Aliens who are not lawful permanent residents, permanently
residing in the United States under color of law, or granted lawful
status under section 245A, 210 or 210A of the Immigration and
Nationality Act, who, otherwise meet the eligibility requirements of the
State plan (except for receipt of AFDC, SSI or a State Supplementary
payment) must be furnished only those services necessary to treat an
emergency medical condition of the alien as defined in 440.255(c).
(o) (Reserved)
(p) A State may provide a greater amount, duration, or scope of
services to pregnant women than it provides under its plan to other
individuals who are eligible for Medicaid, under the following
conditions:
(1) These services must be pregnancy-related or related to any other
condition which may complicate pregnancy, as defined in 440.210(a)(2)
of this subpart; and
(2) These services must be provided in equal amount, duration, and
scope to all pregnant women covered under the State plan.
(43 FR 45224, Sept. 29, 1978, as amended at 45 FR 24889, Apr. 11,
1980; 46 FR 48541, Oct. 1, 1981; 48 FR 5735, Jan. 8, 1983; 51 FR
22041, June 17, 1986; 55 FR 36822, Sept. 7, 1990; 56 FR 24011, May 28,
1991; 57 FR 29156, June 30, 1992)
42 CFR 440.255 Limited services available to certain aliens.
(a) FFP for services. FFP is available for services provided to
aliens described in this section which are necessary to treat an
emergency medical condition as defined in paragraphs (b)(1) and (c) or
services for pregnant women described in paragraph (b)(2).
(b) Legalized aliens eligible only for emergency services and
services for pregnant women. Aliens granted lawful temporary resident
status, or lawful permanent resident status under sections 245A, 210 or
210A of the Immigration and Nationality Act, who are not in one of the
exempt groups described in 435.406(a)(3) and 436.406(a)(3) and who
meet all other requirements for Medicaid will be eligible for the
following services --
(1) Emergency services required after the sudden onset of a medical
condition manifesting itself by acute symptoms of sufficient severity
(including severe pain) such that the absence of immediate medical
attention could reasonably be expected to result in:
(i) Placing the patient's health in serious jeopardy;
(ii) Serious impairment to bodily functions; or
(iii) Serious dysfunction of any bodily organ or part.
(2) Services for pregnant women which are included in the approved
State plan. These services include routine prenatal care, labor and
delivery, and routine post-partum care. States, at their option, may
provide additional plan services for the treatment of conditions which
may complicate the pregnancy or delivery.
(c) Effective January 1, 1987, aliens who are not lawfully admitted
for permanent residence in the United States or permanently residing in
the United States under the color of law must receive the services
necessary to treat the condition defined in paragraph (1) of this
section if --
(1) The alien has, after sudden onset, a medical condition (including
emergency labor and delivery) manifesting itself by acute symptoms of
sufficient severity (including severe pain) such that the absence of
immediate medical attention could reasonably be expected to result in:
(i) Placing the patient's health in serious jeopardy;
(ii) Serious impairment to bodily functions; or
(iii) Serious dysfunction of any bodily organ or part, and
(2) The alien otherwise meets the requirements in 435.406(c) and
436.406(c) of this subpart.
(55 FR 36823, Sept. 7, 1990; 56 FR 10807, Mar. 14, 1991)
42 CFR 440.260 Methods and standards to assure quality of services.
The plan must include a description of methods and standards used to
assure that services are of high quality.
42 CFR 440.270 Religious objections.
(a) Except as specified in paragraph (b) of this section, the agency
may not require any individual to undergo any medical service,
diagnosis, or treatment or to accept any other health service provided
under the plan if the individual objects, or in the case of a child, a
parent or guardian objects, on religious grounds.
(b) If a physical examination is necessary to establish eligibility
based on disability or blindness, the agency may not find an individual
eligible for Medicaid unless he undergoes the examination.
42 CFR 440.270 Pt. 441
42 CFR 440.270 PART 441 -- SERVICES: REQUIREMENTS AND LIMITS
APPLICABLE TO SPECIFIC SERVICES
Sec.
441.1 Purpose.
42 CFR 440.270 Subpart A -- General Provisions
441.10 Basis.
441.11 Continuation of FFP for institutional services.
441.12 Inpatient hospital tests.
441.13 Prohibitions on FFP.
441.15 Home health services.
441.16 Laboratory services.
441.20 Family planning services.
441.21 Nurse-midwife services.
441.25 Prohibition on FFP for certain prescribed drugs.
441.30 Optometric services.
441.35 Organ transplants.
441.40 End-stage renal disease.
42 CFR 440.270 Subpart B -- Early and Periodic Screening, Diagnosis,
and Treatment (EPSDT) of Individuals Under Age 21
441.50 Basis and purpose.
441.55 State plan requirements.
441.56 Required activities.
441.57 Discretionary services.
441.58 Periodicity schedule.
441.59 Treatment of requests for EPSDT screening services.
441.60 Continuing care.
441.61 Utilization of providers and coordination with related
programs.
441.62 Transportation and scheduling assistance.
42 CFR 440.270 Subpart C -- Medicaid for Individuals Age 65 or Over in
Institutions for Mental Diseases
441.100 Basis and purpose.
441.101 State plan requirements.
441.102 Plan of care for institutionalized recipients.
441.103 Alternate plans of care.
441.105 Methods of administration.
441.106 Comprehensive mental health program.
42 CFR 440.270 Subpart D -- Inpatient Psychiatric Services for
Individuals Under Age 21 in Psychiatric Facilities or Programs
441.150 Basis and purpose.
441.151 General requirements.
441.152 Certification of need for services.
441.153 Team certifying need for services.
441.154 Active treatment.
441.155 Individual plan of care.
441.156 Team developing individual plan of care.
441.180 Maintenance of effort: General rule.
441.181 Maintenance of effort: Explanation of terms and
requirements.
441.182 Maintenance of effort: Computation.
42 CFR 440.270 Subpart E -- Abortions
441.200 Basis and purpose.
441.201 Definition.
441.202 General rule.
441.203 Life of the mother would be endangered.
441.204 -- 441.205 (Reserved)
441.206 Documentation needed by the Medicaid agency.
441.207 Drugs and devices and termination of ectopic pregnancies.
441.208 Recordkeeping requirements.
42 CFR 440.270 Subpart F -- Sterilizations
441.250 Applicability.
441.251 Definitions.
441.252 State plan requirements.
441.253 Sterilization of a mentally competent individual aged 21 or
older.
441.254 Mentally incompetent or instititionalized individuals.
441.255 Sterilization by hysterectomy.
441.256 Additional condition for Federal financial participation
(FFP).
441.257 Informed consent.
441.258 Consent form requirements.
441.259 Review of regulations.
42 CFR 440.270 Subpart G -- Home and Community-Based Services: Waiver
Requirements
441.300 Basis and purpose.
441.301 Contents of request for a waiver.
441.302 State assurances.
441.303 Supporting documentation required.
441.304 Duration of a waiver.
441.305 Notification of a waiver termination.
441.306 Hearings procedures for waiver terminations.
441.310 Limits on Federal financial participation (FFP).
42 CFR 440.270 Subpart H -- Home and Community-Based Services Waivers
for Individuals Age 65 or Older: Waiver Requirements
441.350 Basis and purpose.
441.351 Contents of a request for a waiver.
441.352 State assurances.
441.353 Supporting documentation required.
441.354 Aggregate projected expenditure limit (APEL).
441.355 Duration, extension, and amendment of a waiver.
441.356 Waiver termination.
441.357 Hearing procedures for waiver denials.
441.360 Limits on Federal financial participation (FFP).
441.365 Periodic evaluation, assessment, and review.
42 CFR 440.270 Subpart I -- Community Supported Living Arrangements
Services
441.400 Basis and purpose.
441.402 State plan requirements.
441.404 Required minimum protections.
Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
Source: 43 FR 45229, Sept. 29, 1978, unless otherwise noted.
42 CFR 441.1 Purpose.
This part sets forth State plan requirements and limits on FFP for
specific services defined in part 440 of this subchapter. Standards for
payments for services provided in intermediate care facilities and
skilled nursing facilities are set forth in part 442 of this subchapter.
42 CFR 441.1 Subpart A -- General Provisions
42 CFR 441.10 Basis.
This subpart is based on the following sections of the Act which
state requirements and limits on the services specified or provide
Secretarial authority to prescribe regulations relating to services:
(a) Sections 1902(a)(10)(D) and 1905(a)(7) for home health services (
441.15).
(b) Section 1905(a)(4)(C) for family planning ( 441.20).
(c) Section 1905(a)(12) and (e) for optometric services ( 441.30).
(d) Section 1102 for end-stage renal disease ( 441.40).
(e) Section 1905(a) (following (a)(18)), which prohibits FFP in
expenditures for certain services ( 441.13).
(f) Section 1903(i)(1) for organ transplant procedures, and
1903(i)(5) for certain prescribed drugs ( 441.35 and 441.25).
(g) Section 1903(i)(6) which prohibits (except in emergency
situations) FFP in expenditures for inpatient hospital tests that are
not ordered by the attending physician or other licensed practitioner (
441.12).
(h) Section 1905 (a)(17) and (m) for nurse-midwife services (
441.21).
(i) Section 1138(b) for organ procurement organization services (
441.13(c)).
(43 FR 45229, Sept. 29, 1978, as amended at 45 FR 24889, Apr. 11,
1980; 46 FR 47993, Sept. 30, 1981; 46 FR 48554, Oct. 1, 1981; 47 FR
21051, May 17, 1982; 47 FR 31878, July 23, 1982; 53 FR 6549, March 1,
1988; 56 FR 8851, Mar. 1, 1991; 56 FR 23022, May 20, 1991)
42 CFR 441.11 Continuation of FFP for institutional services.
(a) Basic conditions for continuation of FFP. FFP may be continued
for up to 30 days after the effective date of termination or expiration
of a provider agreement, or after an administrative hearing decision
that upholds the agency's termination or nonrenewal action, if the
following conditions are met:
(1) The Medicaid payments are for recipients admitted to the facility
before the effective date of termination or expiration.
(2) The Medicaid agency is making reasonable efforts to transfer
those recipients to other facilities or to alternate care.
(b) When the 30-day period begins. The 30-day period begins on
either of the following:
(1) The effective date of termination or nonrenewal of the facility's
Medicare provider agreement by HCFA, or of its Medicaid provider
agreement as instructed by HCFA.
(2) The later of --
(i) The effective date of termination or nonrenewal of the facility's
Medicaid provider agreement by the Medicaid agency on is own volition;
or
(ii) The date of issuance of an administrative hearing decision that
upholds the agency's termination or nonrenewal action.
(c) Services for which FFP may be continued. FFP may be continued
for any of the following services, as defined in subpart A of part 440
of this chapter:
(1) Inpatient hospital services.
(2) Inpatient hospital services for individuals age 65 or older in an
institution for mental diseases.
(3) Skilled nursing facility services for individuals age 21 or
older.
(4) Skilled nursing facility services for individuals age 65 or older
in an institution for mental diseases.
(5) Intermediate care facility services.
(6) Intermediate care facility services for individuals age 65 or
over in an institution for mental diseases.
(7) Inpatient psychiatric services for individuals under age 21.
(8) Skilled nursing facility services for individuals under 21.
(52 FR 32550, Aug. 28, 1987, as amended at 54 FR 4027, Jan. 27, 1989)
42 CFR 441.12 Inpatient hospital tests.
Except in an emergency situation (see 440.170(e)(1) of this chapter
for definition), FFP is not available in expenditures for inpatient
hospital tests unless the tests are specifically ordered by the
attending physician or other licensed practitioner, acting within the
scope of practice as defined under State law, who is responsible for the
diagnosis or treatment of a particular patient's condition.
(46 FR 48554, Oct. 1, 1981)
42 CFR 441.13 Prohibitions on FFP.
(a) FFP is not available in expenditures for services for --
(1) Any individual who is in a public institution, as defined in
435.1009 of this subchapter; or
(2) Any individual who is under age 65 and is in an institution for
mental diseases, except an individual who is under age 22 and receiving
inpatient psychiatric services under subpart D of this part.
(b) Payments to institutions for the mentally retarded or persons
with related conditions and to psychiatric facilities or programs
providing inpatient psychiatric services to individuals under age 21 may
not include reimbursement for vocational training and educational
activities.
(c) FFP is not available in expenditures for services furnished by an
organ procurement organization on or after April 1, 1988, that does not
meet the requirements of part 485, subpart D of this chapter.
(43 FR 45229, Sept. 29, 1978, as amended at 51 FR 22041, June 17,
1986; 53 FR 6549, March 1, 1988)
42 CFR 441.15 Home health services.
With respect to the services defined in 440.70 of this subchapter, a
State plan must provide that --
(a) Home health services include, as a minimum --
(1) Nursing services;
(2) Home health aide services; and
(3) Medical supplies, equipment, and appliances.
(b) The agency provides home health services to --
(1) Categorically needy recipients age 21 or over;
(2) Categorically needy recipients under age 21, if the plan provides
skilled nursing facility services for them; individuals; and
(3) Medically needy recipients to whom skilled nursing facility
services are provided under the plan.
(c) The eligibility of a recipient to receive home health services
does not depend on his need for or discharge from institutional care.
(43 FR 45229, Sept. 29, 1978, as amended at 45 FR 24889, Apr. 11,
1980)
42 CFR 441.16 Laboratory services.
(a) The plan must provide for payment of laboratory services as
defined in 440.30 of this subchapter if provided by --
(1) An independent laboratory that meets the requirements for
participation in the Medicare program found in 405.1316 of this
chapter;
(2) A hospital-based laboratory that meets the requirements for
participation in the Medicare program found in 482.27 of this chapter;
(3) A rural health clinic, as defined in 491.9 of this chapter; or
(4) A skilled nursing facility -- based clinical laboratory, as
defined in 405.1128(a) of this chapter.
(b) Except as provided under paragraph (c), if a laboratory or other
entity is requesting payment under Medicaid for testing for the presence
of the human immunodeficiency virus (HIV) antibody or for the isolation
and identification of the HIV causative agent as described in
405.1316(f) (2) and (3) of this chapter, the laboratory records must
contain the name and other identification of the person from whom the
specimen was taken.
(c) An agency may choose to approve the use of alternative
identifiers, in place of the requirement for patient's name, in
paragraph (b) of this section for HIV antibody or causative agent
testing of Medicaid recipients.
(54 FR 48647, Dec. 2, 1988)
42 CFR 441.20 Family planning services.
For recipients eligible under the plan for family planning services,
the plan must provide that each recipient is free from coercion or
mental pressure and free to choose the method of family planning to be
used.
42 CFR 441.21 Nurse-midwife services.
If a State plan, under 440.210 or 440.220 of this subchapter,
provides for nurse-midwife services, as defined in 440.165, the plan
must provide that the nurse-midwife may enter into an independent
provider agreement, without regard to whether the nurse-midwife is under
the supervision of, or associated with, a physician or other health care
provider.
(47 FR 21051, May 17, 1982)
42 CFR 441.25 Prohibition on FFP for certain prescribed drugs.
(a) FFP is not available in expenditures for the purchase or
administration of any drug product that meets all of the following
conditions:
(1) The drug product was approved by the Food and Drug Administration
(FDA) before October 10, 1962.
(2) The drug product is available only through prescription.
(3) The drug product is the subject of a notice of opportunity for
hearing issued under section 505(e) of the Federal Food, Drug, and
Cosmetic Act and published in the Federal Register on a proposed order
of FDA to withdraw its approval for the drug product because it has
determined that the product is less than effective for all its labeled
indications.
(4) The drug product is presently not subject to a determination by
FDA, made under its efficacy review program (see 21 CFR 310.6 for an
explanation of this program), that there is a compelling justification
of the drug product's medical need.
(b) FFP is not available in expenditures for the purchase or
administration of any drug product that is identical, related, or
similar, as defined in 21 CFR 310.6, to a drug product that meets the
conditions of paragraph (a) of this section.
(46 FR 48554, Oct. 1, 1981)
42 CFR 441.30 Optometric services.
The plan must provide for payment of optometric services as physician
services, whether furnished by an optometrist or a physician, if --
(a) The plan does not provide for payment for services provided by an
optometrist, except for eligibility determinations under 435.531 and
436.531 of this subchapter, but did provide for those services at an
earlier period; and
(b) The plan specifically provides that physicians' services include
services an optometrist is legally authorized to perform.
42 CFR 441.35 Organ transplants.
(a) FFP is available in expenditures for services furnished in
connection with organ transplant procedures only if the State plan
includes written standards for the coverage of those procedures, and
those standards provide that --
(1) Similarly situated individuals are treated alike; and
(2) Any restriction on the practitioners or facilities that may
provide organ transplant procedures is consistent with the accessibility
of high quality care to individuals eligible for the procedures under
the plan.
(b) Nothing in paragraph (a) permits a State to provide, under its
plan, services that are not reasonable in amount, duration, and scope to
achieve their purpose.
(56 FR 8851, Mar. 1, 1991)
42 CFR 441.40 End-stage renal disease.
FFP in expenditures for services described in subpart A of part 440
is available for facility treatment of end-stage renal disease only if
the facility has been approved by the Secretary to furnish those
services under Medicare. This requirement for approval of the facility
does not apply under emergency conditions permitted under Medicare (see
482.2 of this chapter).
(43 FR 45229, Sept. 29, 1978, as amended at 51 FR 22041, June 17,
1986)
42 CFR 441.40 Subpart B -- Early and Periodic Screening, Diagnosis, and
Treatment (EPSDT) of Individuals Under Age 21
Source: 49 FR 43666, Oct. 31, 1984, unless otherwise noted.
42 CFR 441.50 Basis and purpose.
This subpart implements sections 1902(a)(43) and 1905(a)(4)(B) of the
Social Security Act, by prescribing State plan requirements for
providing early and periodic screening and diagnosis of eligible
Medicaid recipients under age 21 to ascertain physical and mental
defects, and providing treatment to correct or ameliorate defects and
chronic conditions found.
42 CFR 441.55 State plan requirements.
A State plan must provide that the Medicaid agency meets the
requirements of 441.56-441.62, with respect to EPSDT services, as
defined in 440.40(b) of this subchapter.
42 CFR 441.56 Required activities.
(a) Informing. The agency must --
(1) Provide for a combination of written and oral methods designed to
inform effectively all EPSDT eligible individuals (or their families)
about the EPSDT program.
(2) Using clear and nontechnical language, provide information about
the following --
(i) The benefits of preventive health care;
(ii) The services available under the EPSDT program and where and how
to obtain those services;
(iii) That the services provided under the EPSDT program are without
cost to eligible individuals under 18 years of age, and if the agency
chooses, to those 18 or older, up to age 21, except for any enrollment
fee, premium, or similar charge that may be imposed on medically needy
recipients; and
(iv) That necessary transportation and scheduling assistance
described in 441.62 of this subpart is available to the EPSDT eligible
individual upon request.
(3) Effectively inform those individuals who are blind or deaf, or
who cannot read or understand the English language.
(4) Provide assurance to HCFA that processes are in place to
effectively inform individuals as required under this paragraph,
generally, within 60 days of the individual's initial Medicaid
eligibility determination and in the case of families which have not
utilized EPSDT services, annually thereafter.
(b) Screening. (1) The agency must provide to eligible EPSDT
recipients who request it, screening (periodic comprehensive child
health assessments); that is, regularly scheduled examinations and
evaluations of the general physical and mental health, growth,
development, and nutritional status of infants, children, and youth.
(See paragraph (c)(3) of this section for requirements relating to
provision of immunization at the time of screening.) As a minimum, these
screenings must include, but are not limited to:
(i) Comprehensive health and developmental history.
(ii) Comprehensive unclothed physical examination.
(iii) Appropriate vision testing.
(iv) Appropriate hearing testing.
(v) Appropriate laboratory tests.
(vi) Dental screening services furnished by direct referral to a
dentist for children beginning at 3 years of age. An agency may request
from HCFA an exception from this age requirement (within an outer limit
of age 5) for a two year period and may request additional two year
exceptions. If an agency requests an exception, it must demonstrate to
HCFA's satisfaction that there is a shortage of dentists that prevents
the agency from meeting the age 3 requirement.
(2) Screening services in paragraph (b)(1) of this section must be
provided in accordance with reasonable standards of medical and dental
practice determined by the agency after consultation with recognized
medical and dental organizations involved in child health care.
(c) Diagnosis and treatment. In addition to any diagnostic and
treatment services included in the plan, the agency must provide to
eligible EPSDT recipients, the following services, the need for which is
indicated by screening, even if the services are not included in the
plan --
(1) Diagnosis of and treatment for defects in vision and hearing,
including eyeglasses and hearing aids;
(2) Dental care, at as early an age as necessary, needed for relief
of pain and infections, restoration of teeth and maintenance of dental
health; and
(3) Appropriate immunizations. (If it is determined at the time of
screening that immunization is needed and appropriate to provide at the
time of screening, then immunization treatment must be provided at that
time.)
(d) Accountability. The agency must maintain as required by 431.17
and 431.18 --
(1) Records and program manuals;
(2) A description of its screening package under paragraph (b) of
this section; and
(3) Copies of rules and policies describing the methods used to
assure that the informing requirement of paragraph (a)(1) of this
section is met.
(e) Timeliness. With the exception of the informing requirements
specified in paragraph (a) of this section, the agency must set
standards for the timely provision of EPSDT services which meet
reasonable standards of medical and dental practice, as determined by
the agency after consultation with recognized medical and dental
organizations involved in child health care, and must employ processes
to ensure timely initiation of treatment, if required, generally within
an outer limit of 6 months after the request for screening services.
(49 FR 43666, Oct. 31, 1984; 49 FR 45431, Nov. 16, 1984)
42 CFR 441.57 Discretionary services.
Under the EPSDT program, the agency may provide for any other medical
or remedial care specified in part 440 of this subchapter, even if the
agency does not otherwise provide for these services to other recipients
or provides for them in a lesser amount, duration, or scope.
42 CFR 441.58 Periodicity schedule.
The agency must implement a periodicity schedule for screening
services that --
(a) Meets reasonable standards of medical and dental practice
determined by the agency after consultation with recognized medical and
dental organizations involved in child health care;
(b) Specifies screening services applicable at each stage of the
recipient's life, beginning with a neonatal examination, up to the age
at which an individual is no longer eligible for EPSDT services; and
(c) At the agency's option, provides for needed screening services as
determined by the agency, in addition to the otherwise applicable
screening services specified under paragraph (b) of this section.
42 CFR 441.59 Treatment of requests for EPSDT screening services.
(a) The agency must provide the screening services described in
441.56(b) upon the request of an eligible recipient.
(b) To avoid duplicate screening services, the agency need not
provide requested screening services to an EPSDT eligible if written
verification exists that the most recent age-appropriate screening
services, due under the agency's periodicity schedule, have already been
provided to the eligible.
42 CFR 441.60 Continuing care.
(a) Continuing care provider. For purposes of this subpart, a
continuing care provider means a provider who has an agreement with the
Medicaid agency to provide reports as required under paragraph (b) of
this section and to provide at least the following services to eligible
EPSDT recipients formally enrolled with the provider:
(1) With the exception of dental services required under 441.56,
screening, diagnosis, treatment, and referral for follow-up services as
required under this subpart.
(2) Maintenance of the recipient's consolidated health history,
including information received from other providers.
(3) Physicians' services as needed by the recipient for acute,
episodic or chronic illnesses or conditions.
(4) At the provider's option, provision of dental services required
under 441.56 or direct referral to a dentist to provide dental services
required under 441.56(b)(1)(vi). The provider must specify in the
agreement whether dental services or referral for dental services are
provided. If the provider does not choose to provide either service,
then the provider must refer recipients to the agency to obtain those
dental services required under 441.56.
(5) At the provider's option, provision of all or part of the
transportation and scheduling assistance as required under 441.62. The
provider must specify in the agreement the transportation and scheduling
assistance to be furnished. If the provider does not choose to provide
some or all of the assistance, then the provider must refer recipients
to the agency to obtain the transportation and scheduling assistance
required under 441.62.
(b) Reports. A continuing care provider must provide to the agency
any reports that the agency may reasonably require.
(c) State monitoring. If the State plan provides for agreements with
continuing care providers, the agency must employ methods described in
the State plan to assure the providers' compliance with their
agreements.
(d) Effect of agreement with continuing care providers. Subject to
the requirements of paragraphs (a), (b), and (c) of this section, HCFA
will deem the agency to meet the requirements of this subpart with
respect to all EPSDT eligible recipients formally enrolled with the
continuing care provider. To be formally enrolled, a recipient or
recipient's family agrees to use one continuing care provider to be a
regular source of the described set of services for a stated period of
time. Both the recipient and the provider must sign statements that
reflect their obligations under the continuing care arrangement.
(e) If the agreement in paragraph (a) of this section does not
provide for all or part of the transportation and scheduling assistance
required under 441.62, or for dental service under 441.56, the agency
must provide for those services to the extent they are not provided for
in the agreement.
42 CFR 441.61 Utilization of providers and coordination with related
programs.
(a) The agency must provide referral assistance for treatment not
covered by the plan, but found to be needed as a result of conditions
disclosed during screening and diagnosis. This referral assistance must
include giving the family or recipient the names, addresses, and
telephone numbers of providers who have expressed a willingness to
furnish uncovered services at little or no expense to the family.
(b) The agency must make available a variety of individual and group
providers qualified and willing to provide EPSDT services.
(c) The agency must make appropriate use of State health agencies,
State vocational rehabilitation agencies, and Title V grantees (Maternal
and Child Health/Crippled Children's Services). Further, the agency
should make use of other public health, mental health, and education
programs and related programs, such as Head Start, Title XX (Social
Services) programs, and the Special Supplemental Food Program for Women,
Infants and Children (WIC), to ensure an effective child health program.
42 CFR 441.62 Transportation and scheduling assistance.
The agency must offer to the family or recipient, and provide if the
recipient requests --
(a) Necessary assistance with transportation as required under
431.53 of this chapter; and
(b) Necessary assistance with scheduling appointments for services.
42 CFR 441.62 Subpart C -- Medicaid for Individuals Age 65 or Over in
Institutions for Mental Diseases
Source: 44 FR 17940, Mar. 23, 1979, unless otherwise noted.
42 CFR 441.100 Basis and purpose.
This subpart implements section 1905(a)(14) of the Act, which
authorizes State plans to provide for inpatient hospital services,
skilled nursing services, and intermediate care facility services for
individuals age 65 or older in an institution for mental diseases, and
sections 1902(a)(20)(B) and (C) and 1902(a)(21), which prescribe the
conditions a State must meet to offer these services. (See 431.620 of
this subchapter for regulations implementing section 1902(a)(20)(A),
which prescribe interagency requirements related to these services.)
42 CFR 441.101 State plan requirements.
A State plan that includes Medicaid for individuals age 65 or older
in institutions for mental diseases must provide that the requirements
of this subpart are met.
42 CFR 441.102 Plan of care for institutionalized recipients.
(a) The Medicaid agency must provide for a recorded individual plan
of treatment and care to ensure that institutional care maintains the
recipient at, or restores him to, the greatest possible degree of health
and independent functioning.
(b) The plan must include --
(1) An initial review of the recipient's medical, psychiatric, and
social needs --
(i) Within 90 days after approval of the State plan provision for
services in institutions for mental disease; and
(ii) After that period, within 30 days after the date payments are
initiated for services provided a recipient.
(2) Periodic review of the recipient's medical, psychiatric, and
social needs;
(3) A determination, at least quarterly, of the recipient's need for
continued institutional care and for alternative care arrangements;
(4) Appropriate medical treatment in the institution; and
(5) Appropriate social services.
42 CFR 441.103 Alternate plans of care.
(a) The agency must develop alternate plans of care for each
recipient age 65 or older who would otherwise need care in an
institution for mental diseases.
(b) These alternate plans of care must --
(1) Make maximum use of available resources to meet the recipient's
medical, social, and financial needs; and
(2) In Guam, Puerto Rico, and the Virgin Islands, make available
appropriate social services authorized under sections 3(a)(4) (i) and
(ii) or 1603(a)(4)(A) (i) and (ii) of the Act.
42 CFR 441.105 Methods of administration.
The agency must have methods of administration to ensure that its
responsibilities under this subpart are met.
42 CFR 441.106 Comprehensive mental health program.
(a) If the plan includes services in public institutions for mental
diseases, the agency must show that the State is making satisfactory
progress in developing and implementing a comprehensive mental health
program.
(b) The program must --
(1) Cover all ages;
(2) Use mental health and public welfare resources; including --
(i) Community mental health centers;
(ii) Nursing homes; and
(iii) Other alternatives to public institutional care; and
(3) Include joint planning with State authorities.
(c) The agency must submit annual progress reports within 3 months
after the end of each fiscal year in which Medicaid is provided under
this subpart.
42 CFR 441.106 Subpart D -- Inpatient Psychiatric Services for Individuals Under Age 21 in Psychiatric Facilities or Programs
42 CFR 441.150 Basis and purpose.
This subpart specifies requirements applicable if a State provides
inpatient psychiatric services to individuals under age 21, as defined
in 440.160 of this subchapter and authorized under section 1905 (a)(16)
and (h) of the Act.
42 CFR 441.151 General requirements.
Inpatient psychiatric services for recipients under age 21 must be
provided --
(a) Under the direction of a physician;
(b) By a psychiatric facility or an inpatient program in a
psychiatric facility, either of which is accredited by the Joint
Commission on Accreditation of Hospitals; and
(c) Before the recipient reaches age 21 or, if the recipient was
receiving the services immediately before he reached age 21, before the
earlier of the following --
(1) The date he no longer requires the services; or
(2) The date he reaches age 22.
42 CFR 441.152 Certification of need for services.
(a) A team specified in 441.154 must certify that --
(1) Ambulatory care resources available in the community do not meet
the treatment needs of the recipient;
(2) Proper treatment of the recipient's psychiatric condition
requires services on an inpatient basis under the direction of a
physician; and
(3) The services can reasonably be expected to improve the
recipient's condition or prevent further regression so that the services
will no longer be needed.
(b) The certification specified in this section and in 441.153
satisfies the utilization control requirement for physician
certification in 456.60, 456.160, 456.260, and 456.360 of this
subchapter.
42 CFR 441.153 Team certifying need for services.
Certification under 441.152 must be made by terms specified as
follows:
(a) For an individual who is a recipient when admitted to a facility
or program, certification must be made by an independent team that --
(1) Includes a physician;
(2) Has competence in diagnosis and treatment of mental illness,
preferably in child psychiatry; and
(3) Has knowledge of the individual's situation.
(b) For an individual who applies for Medicaid while in the facility
of program, the certification must be --
(1) Made by the team responsible for the plan of care as specified in
441.156; and
(2) Cover any period before application for which claims are made.
(c) For emergency admissions, the certification must be made by the
team responsible for the plan of care ( 441.156) within 14 days after
admission.
42 CFR 441.154 Active treatment.
Inpatient psychiatric services must involve ''active treatment'',
which means implementation of a professionally developed and supervised
individual plan of care, described in 441.155 that is --
(a) Developed and implemented no later than 14 days after admission;
and
(b) Designed to achieve the recipient's discharge from inpatient
status at the earliest possible time.
42 CFR 441.155 Individual plan of care.
(a) ''Individual plan of care'' means a written plan developed for
each recipient in accordance with 456.180-456.181, and 456.280-456.281
of this subchapter, to improve his condition to the extent that
inpatient care is no longer necessary.
(b) The plan of care must --
(1) Be based on a diagnostic evaluation that includes examination of
the medical, psychological, social, behavioral and developmental aspects
of the recipient's situation and reflects the need for inpatient
psychiatric care;
(2) Be developed by a team of professionals specified under 441.156
in consultation with the recipient; and his parents, legal guardians,
or others in whose care he will be released after discharge;
(3) State treatment objectives;
(4) Prescribe an integrated program of therapies, activities, and
experiences designed to meet the objectives; and
(5) Include, at an appropriate time, post-discharge plans and
coordination of inpatient services with partial discharge plans and
related community services to ensure continuity of care with the
recipient's family, school, and community upon discharge.
(c) The plan must be reviewed every 30 days by the team specified in
441.156 to --
(1) Determine that services being provided are or were required on an
inpatient basis, and
(2) Recommend changes in the plan as indicated by the recipient's
overall adjustment as an inpatient.
(d) The development and review of the plan of care as specified in
this section satisfies the utilization control requirements for --
(1) Recertification under 456.60(b), 456.160(b), 456.260(b), and
456.360(b) of this subchapter; and
(2) Establishment and periodic review of the plan of care under
456.80, 456.180, 456.280, and 456.380 of this subchapter.
(43 FR 45229, Sept. 29, 1978, as amended at 46 FR 48560, Oct. 1,
1981)
42 CFR 441.156 Team developing individual plan of care.
(a) The individual plan of care under 441.155 must be developed by
an interdisciplinary team of physicians and other personnel who are
employed by, or provide services to patients in, the facility.
(b) Based on education and experience, preferably including
competence in child psychiatry, the team must be capable of --
(1) Assessing the recipient's immediate and long-range therapeutic
needs, developmental priorities, and personal strengths and liabilities;
(2) Assessing the potential resources of the recipient's family;
(3) Setting treatment objectives; and
(4) Prescribing therapeutic modalities to achieve the plan's
objectives.
(c) The team must include, as a minimum, either --
(1) A Board-eligible or Board-certified psychiatrist;
(2) A clinical psychologist who has a doctoral degree and a physician
licensed to practice medicine or osteopathy; or
(3) A physician licensed to practice medicine or osteopathy with
specialized training and experience in the diagnosis and treatment of
mental diseases, and a psychologist who has a master's degree in
clinical psychology or who has been certified by the State or by the
State psychological association.
(d) The team must also include one of the following:
(1) A psychiatric social worker.
(2) A registered nurse with specialized training or one year's
experience in treating mentally ill individuals.
(3) An occupational therapist who is licensed, if required by the
State, and who has specialized training or one year of experience in
treating mentally ill individuals.
(4) A psychologist who has a master's degree in clinical psychology
or who has been certified by the State or by the State psychological
association.
42 CFR 441.180 Maintenance of effort: General rule.
FFP is available only if the State maintains fiscal effort as
prescribed under this subpart.
42 CFR 441.181 Maintenance of effort: Explanation of terms and
requirements.
(a) For purposes of 441.182:
(1) The base year is the 4-quarter period ending December 31, 1971.
(2) Quarterly per capita non-Federal expenditures are expenditures
for inpatient psychiatric services determined by reimbursement
principles under Medicare. (See part 405, subpart D.)
(3) The number of individuals receiving inpatient psychiatric
services in the current quarter means --
(i) The number of individuals receiving services for the full
quarter; plus
(ii) The full quarter composite number of individuals receiving
services for less than a full quarter.
(4) In determining the per capita expenditures for the base year, the
Medicaid agency must compute the number of individuals receiving
services in a manner similar to that in paragraph (a)(3) of this
section.
(5) Non-Federal expenditures means the total amount of funds expended
by the State and its political subdivisions, excluding Federal funds
received directly or indirectly from any source.
(6) Expenditures for the current calendar quarter exclude Federal
funds received directly or indirectly from any source.
(b) As a basis for determining the correct amount of Federal
payments, each State must submit estimated and actual cost data and
other information necessary for this purpose in the form and at the
times specified in this subchapter and by HCFA guidelines.
(c) The agency must have on file adequate records to substantiate
compliance with the requirements of 441.182 and to ensure that all
necessary adjustments have been made.
(d) Facilities that did not meet the requirements of
441.151-441.156 in the base year, but are providing inpatient
psychiatric services under those sections in the current quarter, must
be included in the maintenance of effort computation if, during the base
year, they were --
(1) Providing inpatient psychiatric services for individuals under
age 21; and
(2) Receiving State aid.
42 CFR 441.182 Maintenance of effort: Computation.
(a) For expenditures for inpatient psychiatric services for
individuals under age 21, in any calendar quarter, FFP is available only
to the extent that the total State Medicaid expenditures in the current
quarter for inpatient psychiatric services and outpatient psychiatric
treatment for individuals under age 21 exceed the sum of the following:
(1) The total number of individuals receiving inpatient psychiatric
services in the current quarter times the average quarterly per capita
non-Federal expenditures for the base year; and
(2) The average non-Federal quarterly expenditures for the base year
for outpatient psychiatric services for individuals under age 21.
(b) FFP is available for 100 percent of the increase in expenditures
over the base year period, but may not exceed the Federal medical
assistance percentage times the expenditures under this subpart for
inpatient psychiatric services for individuals under age 21.
42 CFR 441.182 Subpart E -- Abortions
42 CFR 441.200 Basis and purpose.
This subpart implements section 402 of Pub. L. 97-12, and subsequent
laws that appropriate funds for the Medicaid program, including section
204 of Pub. L. 98-619. All of these laws prohibit the use of Federal
funds to pay for abortions except when continuation of the pregnancy
would endanger the mother's life.
(52 FR 47935, Dec. 17, 1987)
42 CFR 441.201 Definition.
As used in this subpart, ''physician'' means a doctor of medicine or
osteopathy who is licensed to practice in the State.
(52 FR 47935, Dec. 17, 1987)
42 CFR 441.202 General rule.
FFP is not available in expenditures for an abortion unless the
conditions specified in 441.203 and 441.206 are met.
(52 FR 47935, Dec. 17, 1987)
42 CFR 441.203 Life of the mother would be endangered.
FFP is available in expenditures for an abortion when a physician has
found, and certified in writing to the Medicaid agency, that on the
basis of his professional judgment, the life of the mother would be
endangered if the fetus were carried to term. The certification must
contain the name and address of the patient.
441.204 -- 441.205 (Reserved)
42 CFR 441.206 Documentation needed by the Medicaid agency.
FFP is not available in any expenditures for abortions or other
medical procedures otherwise provided for under 441.203 if the Medicaid
agency has paid without first having received the certifications and
documentation specified in that section.
(52 FR 47935, Dec. 17, 1987)
42 CFR 441.207 Drugs and devices and termination of ectopic
pregnancies.
FFP is available in expenditures for drugs or devices to prevent
implantation of the fertilized ovum and for medical procedures necessary
for the termination of an ectopic pregnancy.
42 CFR 441.208 Recordkeeping requirements.
Medicaid agencies must maintain copies of the certifications and
documentation specified in 441.203 for 3 years under the recordkeeping
requirements at 45 CFR 74.20.
(52 FR 47935, Dec. 17, 1987)
42 CFR 441.208 Subpart F -- Sterilizations
Source: 43 FR 52171, Nov. 8, 1978, unless otherwise noted.
42 CFR 441.250 Applicability.
This subpart applies to sterilizations and hysterectomies reimbursed
under Medicaid.
42 CFR 441.251 Definitions.
As used in this subpart:
Hysterectomy means a medical procedure or operation for the purpose
of removing the uterus.
Institutionalized individual means an individual who is (a)
involuntarily confined or detained, under a civil or criminal statute,
in a correctional or rehabilitative facility, including a mental
hospital or other facility for the care and treatment of mental illness;
or (b) confined, under a voluntary commitment, in a mental hospital or
other facility for the care and treatment of mental illness.
Mentally incompetent individual means an individual who has been
declared mentally incompetent by a Federal, State, or local court of
competent jurisdiction for any purpose, unless the individual has been
declared competent for purposes which include the ability to consent to
sterilization.
Sterilization means any medical procedure, treatment, or operation
for the purpose of rendering an individual permanently incapable of
reproducing.
42 CFR 441.252 State plan requirements.
A State plan must provide that the Medicaid agency will make payment
under the plan for sterilization procedures and hysterectomies only if
all the requirements of this subpart were met.
42 CFR 441.253 Sterilization of a mentally competent individual aged 21
or older.
FFP is available in expenditures for the sterilization of an
individual only if --
(a) The individual is at least 21 years old at the time consent is
obtained;
(b) The individual is not a mentally incompetent individual;
(c) The individual has voluntarily given informed consent in
accordance with all the requirements precribed in 441.257 and 441.258;
and
(d) At least 30 days, but not more than 180 days, have passed between
the date of informed consent and the date of the sterilization, except
in the case of premature delivery or emergency abdominal surgery. An
individual may consent to be sterilized at the time of a premature
delivery or emergency abdominal surgery, if at least 72 hours have
passed since he or she gave informed consent for the sterilization. In
the case of premature delivery, the informed consent must have been
given at least 30 days before the expected date of delivery.
42 CFR 441.254 Mentally incompetent or institutionalized individuals.
FFP is not available for the sterilization of a mentally incompetent
or institutionalized individual.
42 CFR 441.255 Sterilization by hysterectomy.
(a) FFP is not available in expenditures for a hysterectomy if --
(1) It was performed solely for the purpose of rendering an
individual permanently incapable of reproducing; or
(2) If there was more than one purpose to the procedure, it would not
have been performed but for the purpose of rendering the individual
permanently incapable of reproducing.
(b) FFP is available in expenditures for a hysterectomy not covered
by paragraph (a) of this section only under the conditions specified in
paragraph (c), (d), or (e) of this section.
(c) FFP is available if --
(1) The person who secured authorization to perform the hysterectomy
has informed the individual and her representative, if any, orally and
in writing, that the hysterectomy will make the individual permanently
incapable of reproducing; and
(2) The individual or her representative, if any, has signed a
written acknowledgment of receipt of that information.
(d) Effective on March 8, 1979 or any date thereafter through the
date of publication of these regulations at the option of the State, FFP
is available if --
(1) The individual --
(i) Was already sterile before the hysterectomy; or
(ii) Requires a hysterectomy because of a life-threatening emergency
situation in which the physician determines that prior acknowledgment is
not possible; and
(2) The physician who performs the hysterectomy --
(i) Certifies in writing that the individual was already sterile at
the time of the hysterectomy, and states the cause of the sterility; or
(ii) Certifies in writing that the hysterectomy was performed under a
life-threatening emergency situation in which he or she determined prior
acknowledgment was not possible. He or she must also include a
description of the nature of the emergency.
(e) Effective March 8, 1979, or any date thereafter through the date
of publication of these regulations at the option of the State, FFP is
available for hysterectomies performed during a period of an
individual's retroactive Medicaid eligibility if the physician who
performed the hysterectomy certifies in writing that --
(1) The individual was informed before the operation that the
hysterectomy would make her permanently incapable of reproducing; or
(2) One of the conditions in paragraph (d)(1) of this section was
met. The physician must supply the information specified in paragraph
(d)(2) of this section.
(47 FR 33702, Aug. 4, 1982)
42 CFR 441.256 Additional condition for Federal financial participation
(FFP).
(a) FFP is not available in expenditures for any sterilization or
hysterectomy unless the Medicaid agency, before making payment, obtained
documentation showing that the requirements of this subpart were met.
This documentation must include a consent from, an acknowledgement of
receipt of hysterectomy information or a physician's certification under
441.255(d)(2), as applicable.
(b) With regard to the requirements of 441.255(d) for hysterectomies
performed from March 8, 1979 through November 2, 1982, FFP is available
in expenditures for those services if the documentation showing that the
requirements of that paragraph were met is obtained by the Medicaid
agency before submitting a claim for FFP for that procedure.
(47 FR 33702, Aug. 4, 1982)
42 CFR 441.257 Informed consent.
(a) Informing the individual. For purposes of this subpart, an
individual has given informed consent only if --
(1) The person who obtained consent for the sterilization procedure
offered to answer any questions the individual to be sterilized may have
concerning the procedure, provided a copy of the consent form and
provided orally all of the following information or advice to the
individual to be sterilized:
(i) Advice that the individual is free to withhold or withdraw
consent to the procedure at any time before the sterilization without
affecting the right to future care or treatment and without loss or
withdrawal of any federally funded program benefits to which the
individual might be otherwise entitled.
(ii) A description of available alternative methods of family
planning and birth control.
(iii) Advice that the sterilization procedure is considered to be
irreversible.
(iv) A thorough explanation of the specific sterilization procedure
to be performed.
(v) A full description of the discomforts and risks that may
accompany or follow the performing of the procedure, including an
explanation of the type and possible effects of any anesthetic to be
used.
(vi) A full description of the benefits or advantages that may be
expected as a result of the sterilization.
(vii) Advice that the sterilization will not be performed for at
least 30 days, except under the circumstances specified in 441.253(c).
(2) Suitable arrangements were made to insure that the information
specified in paragraph (a)(1) of this section was effectively
communicated to any individual who is blind, deaf, or otherwise
handicapped;
(3) An interpreter was provided if the individual to be sterilized
did not understand the language used on the consent form or the language
used by the person obtaining consent;
(4) The individual to be sterilized was permitted to have a witness
of his or her choice present when consent was obtained;
(5) The consent form requirements of 441.258 were met; and
(6) Any additional requirement of State or local law for obtaining
consent, except a requirement for spousal consent, was followed.
(b) When informed consent may not be obtained. Informed consent may
not be obtained while the individual to be sterilized is --
(1) In labor or childbirth;
(2) Seeking to obtain or obtaining an abortion; or
(3) Under the influence of alcohol or other substances that affect
the individual's state of awareness.
42 CFR 441.258 Consent form requirements.
(a) Content of consent form. The consent form must be a copy of the
form appended to this subpart or another form approved by the Secretary.
(b) Required signatures. The consent form must be signed and dated
by --
(1) The individual to be sterilized;
(2) The interpreter, if one was provided;
(3) The person who obtained the consent; and
(4) The physician who performed the sterilization procedure.
(c) Required certifications. (1) The person securing the consent
must certify, by signing the consent form, that
(i) Before the individual to be sterilized signed the consent form,
he or she advised the individual to be sterilized that no Federal
benefits may be withdrawn because of the decision not to be sterilized;
(ii) He or she explained orally the requirements for informed consent
as set forth on the consent form; and
(iii) To the best of his or her knowledge and belief, the individual
to be sterilized appeared mentally competent and knowingly and
voluntarily consented to be sterilized.
(2) The physician performing the sterilization must certify, by
signing the consent form, that:
(i) Shortly before the performance of sterilization, he or she
advised the individual to be sterilized that no Federal benefits may be
withdrawn because of the decision not to be sterilized;
(ii) He or she explained orally the requirements for informed consent
as set forth on the consent form; and
(iii) To the best of his or her knowledge and belief, the individual
appeared mentally competent and knowingly and voluntarily consented to
be sterilized.
Except in the case of premature delivery or emergency abdominal
surgery, the physician must further certify that at least 30 days have
passed between the date of the individual's signature on the consent
form and the date upon which the sterilization was performed.
(3) In the case of premature delivery or emergency abdominal surgery
performed within 30 days of consent, the physician must certify that the
sterilization was performed less than 30 days, but not less than 72
hours after informed consent was obtained because of premature delivery
or emergency abdominal surgery and --
(i) In the case of premature delivery, must state the expected date
of delivery; or
(ii) In the case of abdominal surgery, must describe the emergency.
(4) If an interpreter is provided, the interpreter must certify that
he or she translated the information and advice presented orally and
read the consent form and explained its contents to the individual to be
sterilized and that, to the best of the interpreter's knowledge and
belief, the individual understood what the interpreter told him or her.
42 CFR 441.259 Review of regulations.
The Secretary will request public comment on the operation of this
subpart not later than 3 years after its effective date.
42 CFR 441.259 Appendix to Subpart F -- Required Consent Form
42 CFR 441.259 Pt. 441, Subpt. F, App.
Notice: Your decision at any time not to be sterilized will not
result in the withdrawal or withholding of any benefits provided by
programs or projects receiving Federal funds.
I have asked for and received information about sterilization from
(doctor or clinic). When I first asked for the information, I was told
that the decision to be sterilized is completely up to me. I was told
that I could decide not to be sterilized. If I decide not to be
sterilized, my decision will not affect my right to future care or
treatment. I will not lose any help or benefits from programs receiving
Federal funds, such as A.F.D.C. or Medicaid that I am now getting or for
which I may become eligible.
I understand that the sterilization must be considered permanent and
not reversible. I have decided that I do not want to become pregnant,
bear children or father children.
I was told about those temporary methods of birth control that are
available and could be provided to me which will allow me to bear or
father a child in the future. I have rejected these alternatives and
chosen to be sterilized.
I understand that I will be sterilized by an operation known as a
------------ . The discomforts, risks and benefits associated with the
operation have been explained to me. All my questions have been
answered to my satisfaction.
I understand that the operation will not be done until at least 30
days after I sign this form. I understand that I can change my mind at
any time and that my decision at any time not to be sterilized will not
result in the withholding of any benefits or medical services provided
by Federally funded programs.
I am at least 21 years of age and was born on (Day) (Month) (Year).
I, ------------ , hereby consent of my own free will to be sterilized
by ------------ by a method called ------------ . My consent expires
180 days from the date of my signature below.
I also consent to the release of this form and other medical records
about the operation to:
Representatives of the Department of Health and Human Services or
Employees of programs or projects funded by that Department but only
for determining if Federal laws were observed.
I have received a copy of this form. (Signature) (Date) (Month)
(Day) (Year).
You are requested to supply the following information, but it is not
required: (Race and ethnicity designation (please check)) Black (not of
Hispanic origin); Hispanic; Asian or Pacific Islander; American
Indian or Alaskan native; or White (not of Hispanic origin).
If an interpreter is provided to assist the individual to be
sterilized:
I have translated the information and advice presented orally to the
individual to be sterilized by the person obtaining this consent. I
have also read him/her the consent form in ------------ ------------
language and explained its contents to him/her. To the best of my
knowledge and belief he/she understood this explanation. (Interpreter)
(Date).
Before (name of individual) signed the consent form, I explained to
him/her the nature of the sterilization operation ------------ , the
fact that it is intended to be a final and irreversible procedure and
the discomforts, risks and benefits associated with it.
I counseled the individual to be sterilized that alternative methods
of birth control are available which are temporary. I explained that
sterilization is different because it is permanent.
I informed the individual to be sterilized that his/her consent can
be withdrawn at any time and that he/she will not lose any health
services or any benefits provided by Federal funds.
To the best of my knowledge and belief the individual to be
sterilized is at least 21 years old and appears mentally competent.
He/She knowingly and voluntarily requested to be sterilized and appears
to understand the nature and consequence of the procedure. (Signature
of person obtaining consent) (Date) (Facility) (Address).
Shortly before I performed a sterilization operation upon (Name of
individual to be sterilized) on (Date of sterilization) (operation), I
explained to him/her the nature of the sterilization operation (specify
type of operation), the fact that it is intended to be a final and
irreversible procedure and the discomforts, risks and benefits
associated with it.
I counseled the individual to be sterilized that alternative methods
of birth control are available which are temporary. I explained that
sterilization is different because it is permanent.
I informed the individual to be sterilized that his/her consent can
be withdrawn at any time and that he/she will not lose any health
services or benefits provided by Federal funds.
To the best of my knowledge and belief the individual to be
sterilized is at least 21 years old and appears mentally competent.
He/She knowingly and voluntarily requested to be sterilized and appeared
to understand the nature and consequences of the procedure.
(Instructions for use of alternative final paragraphs: Use the first
paragraph below except in the case of premature delivery or emergency
abdominal surgery where the sterilization is performed less than 30 days
after the date of the individual's signature on the consent form. In
those cases, the second paragraph below must be used. Cross out the
paragraph which is not used.)
(1) At least 30 days have passed between the date of the individual's
signature on this consent form and the date the sterilization was
performed.
(2) This sterilization was performed less than 30 days but more than
72 hours after the date of the individual's signature on this consent
form because of the following circumstances (check applicable box and
fill in information requested): Premature delivery.
Individual's expected date of delivery: ------------
Emergency abdominal surgery: (describe circumstances): ------------
(Physician) (Date).
42 CFR 441.259 Subpart G -- Home and Community-Based Services: Waiver
Requirements
Source: 46 FR 48541, Oct. 1, 1981, unless otherwise noted.
42 CFR 441.300 Basis and purpose.
Section 1915(c) of the Act permits States to offer, under a waiver of
statutory requirements, an array of home and community-based services
that an individual needs to avoid institutionalization. Those services
are defined in 440.180 of this subchapter. This subpart describes what
the Medicaid agency must do to obtain a waiver.
42 CFR 441.301 Contents of request for a waiver.
(a) A request for a waiver under this section must consist of --
(1) The assurances required by 441.302 and the supporting
documentation required by 441.303;
(2) When applicable, requests for waivers of the requirements of
section 1902(a) (1) or (10) of the Act; and
(3) A statement as to whether the agency will refuse to offer home or
community-based services to any recipient because it can reasonably
expect that the cost of the home or community-based services furnished
to that recipient would exceed the cost of the level of care provided in
an SNF or ICF (or ICF/MR if applicable).
(b) If the agency furnishes home and community-based services, as
defined in 440.180 of this subchapter, under a waiver granted under
this subpart, the waiver request must --
(1) Provide that the services are furnished --
(i) Under a written plan of care subject to approval by the Medicaid
agency;
(ii) Only to recipients who are not inpatients of a hospital, SNF,
ICF, or ICF/MR, and who the agency determines would require the level of
care provided in an SNF or ICF (or ICF/MR, if applicable) under Medicaid
(as defined in 440.40 and 440.150) if not furnished these services;
(2) Describe the qualifications of the individual or individuals who
will be responsible for developing the individual plan of care;
(3) Describe the group or groups of individuals to whom the services
will be offered;
(4) Describe the services to be furnished;
(5) Provide that the documentation requirements regarding individual
evaluation, specified in 441.303(c), will be met; and
(6) Be limited to one of the following target groups or any subgroup
thereof that the State may define:
(i) Aged or disabled, or both.
(ii) Mentally retarded or developmentally disabled, or both.
(iii) Mentally ill.
(46 FR 48541, Oct. 1, 1981, as amended at 50 FR 10026, Mar. 13, 1985)
42 CFR 441.302 State assurances.
HCFA will not grant a waiver under this subpart and may terminate a
waiver unless the Medicaid agency provides the following satisfactory
assurances to HCFA:
(a) Health and Welfare -- Assurance that necessary safeguards have
been taken to protect the health and welfare of the recipients of the
services. Those safeguards must include --
(1) Adequate standards for all types of providers that provide
services under the waiver;
(2) Assurance that the standards of any State licensure or
certification requirements are met for services or for individuals
furnishing services that are provided under the waiver; and
(3) Assurance that all facilities covered by section 1616(e) of the
Act, in which home and community-based services will be provided, are in
compliance with applicable State standards that meet the requirements of
45 CFR Part 1397 for board and care facilities.
(b) Financial accountability. -- The agency will assure financial
accountability for funds expended for home and community-based services,
provide for an independent audit of its waiver program (except as HCFA
may otherwise specify for particular waivers), and it will maintain and
make available to HHS, the Comptroller General, or other designees,
appropriate financial records documenting the cost of services provided
under the waiver, including reports of any independent audits conducted.
(c) Evaluation of need. -- Assurance that the agency will provide for
an evaluation (and periodic reevaluations) of the need for the level of
care provided in an SNF, ICF, or ICF/MR, as defined by 440.40 and
440.150, respectively, when there is a reasonable indication that
individuals might need such services in the near future but for the
availability of home and community-based services.
(d) Alternatives -- Assurance that when a recipient is determined to
be likely to require the level of care provided in an SNF, ICF, or
ICF/MR, the recipient or his or her legal representative will be --
(1) Informed of any feasible alternatives available under the waiver;
and
(2) Given the choice of either institutional or home and
community-based services.
(e) Expenditures. Assurance that -- (1) The average per capita
fiscal year expenditures under the waiver will not exceed the average
per capita expenditures for the level of care provided in an SNF, ICF,
or ICF/MR under the State plan that would have been made in that fiscal
year had the waiver not been granted. (i) These expenditures must be
reasonably estimated by the agency; and (ii) The estimates must be
annualized and must cover each year of the waiver period.
(2) The agency's actual total expenditures for home and
community-based services under the waiver and its claim for FFP in
expenditures for the services will not exceed the agency's approved
estimates for these services, expressed as the product of (C D) in the
supporting documentation required under 441.303(f), for each year of
the waiver period.
(3) The agency's actual total expenditures for home and
community-based and other Medicaid services provided to individuals
under the waiver will not, in any year of the waiver period, exceed the
amount that would be incurred by Medicaid for these individuals in an
SNF, ICF, or ICF/MR, in the absence of a waiver.
(f) Reporting. Assurance that annually, the agency will provide HCFA
with information on the waiver's impact. The information must be
consistent with a data collection plan designed by HCFA and must address
the waiver's impact on --
(1) The type, amount, and cost of services provided under the State
plan; and
(2) The health and welfare of recipients.
(50 FR 10026, Mar. 13, 1985)
42 CFR 441.303 Supporting documentation required.
The agency must furnish HCFA with sufficient information to support
the assurances required by 441.302. Except as HCFA may otherwise
specify for particular waivers, the information must consist of the
following, at a minimum:
(a) A description of the safeguards necessary to protect the health
and welfare of recipients. This information must include a copy of the
standards established by the State for facilities that are covered by
section 1616(e) of the Act.
(b) A description of the records and information that will be
maintained to support financial accountability.
(c) A description of the agency's plan for the evaluation and
reevaluation of recipients, including -- (1) A description of who will
make these evaluations and how they will be made; (2) A copy of the
evaluation instrument to be used; (3) The agency's procedure to ensure
the maintenance of written documentation on all evaluations and
reevaluations; and (4) The agency's procedure to ensure reevaluations
of need at regular intervals.
(d) A description of the agency's plan for informing eligible
recipients of the feasible alternatives available under the waiver and
allowing recipients to choose either institutional services or home and
community-based services.
(e) An explanation of how the agency will apply the applicable
provisions regarding the post-eligibility treatment of income and
resources of those individuals receiving home and community-based
services who are eligible under a special income level (included in
435.217 of this chapter).
(f) An explanation with supporting documentation satisfactory to HCFA
of how the agency estimated the per capita expenditures for services.
This information must include but is not limited to the estimated
utilization rates and costs for services included in the plan, the
number of actual and projected beds in Medicaid certified SNFs, ICFs,
and ICF/MRs by type, and evidence of the need for additional bed
capacity in the absence of the waiver.
(1) The annual average per capita expenditure estimate of the cost of
home and community-based and other Medicaid services under the waiver
must not exceed the annual average per capita expenditures of the cost
of services in the absence of a waiver. The estimates are to be based
on the following equation:
where:
A=the estimated annual number of beneficiaries who would receive the
level of care provided in an SNF, ICF, or ICF/MR with the waiver.
B=the estimated annual Medicaid expenditure for SNF, ICF, or ICF/MR
care per eligible Medicaid user with the waiver.
C=the estimated annual number of beneficiaries who would receive home
and community-based services under the waiver.
D=the estimated annual Medicaid expenditure for home and
community-based services per eligible Medicaid user.
F=the estimated annual number of beneficiaries who would likely
receive the level of care provided in an SNF, ICF, or ICF/MR in the
absence of the waiver.
G=the estimated annual Medicaid expenditure per eligible Medicaid
user of such institutional care in the absence of the waiver.
H=the estimated annual number of beneficiaries who would receive any
of the noninstitutional, long-term care services otherwise provided
under the State plan as an alternative to institutional care.
I=the estimated annual Medicaid expenditure per eligible Medicaid
user of the noninstitutional services referred to in H.
The symbol '': '' is intended to mean that the result of the left
side of the equation must be less than or equal to the result of the
right side of the equation.
A'=the estimated annual number of beneficiaries referred to in A who
would receive any of the acute care services otherwise provided under
the State plan.
B'=the estimated annual Medicaid expenditure per eligible Medicaid
user of the acute care services referred to in A'.
C'=the estimated annual number of beneficiaries referred to in C who
would receive any of the acute care services otherwise provided under
the State plan.
D'=the estimated annual Medicaid expenditure per eligible Medicaid
user of the acute care services referred to in C'.
F'=the estimated annual number of beneficiaries referred to in F who
would receive any of the acute care services otherwise provided under
the State plan.
G' = the estimated annual Medicaid expenditure per eligible Medicaid
user of the acute care services referred to in F'.
(2) For purposes of the equation, acute care services means all
services otherwise provided under the State plan that are neither SNF,
ICF, or ICF/MR services, nor the noninstitutional, long-term care
services referred to in H.
(3) Data on the estimated annual number of beneficiaries and
expenditures for those who would otherwise receive an SNF, ICF, or
ICF/MR level of care is required for all three types of institutions
only if the waiver request provides that each of these groups will be
offered home and community-based services. For example, if the request
does not include persons who would otherwise receive an ICF/MR level of
care, the State is not required to furnish data on that group.
(4) The data must show the estimated annual number of beneficiaries
who will be deinstitutionalized from certified SNFs, ICFs and ICF/MRs
because they would receive home and community-based services under the
waiver, and the estimated annual number of beneficiaries whose admission
to such institutions would be diverted or deflected because of the
waiver services. For the latter group, the State's evaluation process
required by 441.303(c) must provide for a more detailed description of
their evaluation and screening procedures for recipients to assure that
waiver services will be limited to persons who would otherwise receive
the level of care provided in an SNF, ICF, or ICF/MR.
(g) Except as HCFA may otherwise specify for particular waivers, the
agency must provide for an independent assessment of its waiver that
evaluates the quality of care provided, access to care, and
cost-effectiveness. The results of the assessment must be submitted to
HCFA at least 90 days prior to the third anniversary of the approved
waiver period and cover at least the first 24 months of the waiver.
(46 FR 48532, Oct. 1, 1981, as amended at 50 FR 10027, Mar. 13, 1985;
50 FR 25080, June 17, 1985)
42 CFR 441.304 Duration of a waiver.
(a) The effective date for a waiver of Medicaid requirements to
provide home and community-based services approved under this subpart is
established by HCFA prospectively on or after the date of approval and
after consultation with the State agency. The waiver continues for a
three-year period from the effective date. If the agency requests it,
the waiver may be extended for additional three-year periods, if HCFA's
review of the prior three-year period shows that the assurances required
by 441.302 of this subpart were met.
(b) HCFA will determine whether a request for extension of an
existing waiver is actually an extension request or a request for a new
waiver.
(1) Generally, if a State's extension request proposes a change in
services provided, eligible population, service area, or statutory
sections waived, HCFA will consider it a new waiver request.
(2) If a State submits an extension request that would add a new
group to the existing group of beneficiaries covered under the waiver,
HCFA will consider it to be two requests; one as an extension request
for the existing group, and the other as a new waiver request for the
new group.
(c) HCFA may grant a State an extension of its existing waiver for up
to 90 days to permit the State to document more fully the satisfaction
of statutory and regulatory requirements needed to approve a new waiver
request. HCFA will consider this option when it requests additional
information on a new waiver request submitted by a State to extend its
existing waiver or when HCFA disapproves a State's request for
extension.
(d) If HCFA finds that an agency is not meeting any of the
requirements for a waiver contained in this subpart, the agency will be
given a notice of HCFA's findings and an opportunity for a hearing to
rebut the findings. If HCFA determines that the agency is not in
compliance with this subpart after the notice and any hearing, HCFA may
terminate the waiver. For example:
(1) If HCFA finds that the agency's actual total expenditures for
home and community-based services under the waiver exceed the agency's
approved estimates for these services, expressed as the product of (C
D) in the supporting documentation required under 441.303(f), for any
year of the waiver period, the waiver may be terminated; or
(2) The waiver may be terminated if HCFA finds that the agency's
actual total expenditures for home and community-based and other
Medicaid services provided to individuals under the waiver exceed, for
any year of the waiver period, the amount that would be incurred by
Medicaid for these individuals in an SNF, ICF, or ICF/MR, in the absence
of a waiver.
(50 FR 10028, Mar. 13, 1985; 50 FR 25080, June 17, 1985)
42 CFR 441.305 Notification of a waiver termination.
(a) If a State chooses to terminate its waiver before the three-year
period is up, it must notify HCFA in writing 30 days before terminating
services to recipients.
(b) If HCFA or the State terminates the waiver, the State must notify
recipients of services under the waiver in accordance with 431.210 of
this subchapter and notify them 30 days before terminating services.
42 CFR 441.306 Hearings procedures for waiver terminations.
The procedures specified in subpart D of part 430 of this chapter are
applicable to State requests for hearings on terminations.
(50 FR 10028, Mar. 13, 1985)
42 CFR 441.310 Limits on Federal financial participation (FFP).
(a) FFP for home and community-based services listed in 440.180 of
this chapter is not available in expenditures for --
(1) Services provided in a facility subject to the health and welfare
requirements described in 441.302(a) during any period in which the
facility is found not to be in compliance with the applicable State
standards described in that section;
(2) Home and community-based services that exceed the agency's
approved estimated total expenditures for these services, expressed as
the product of (C D) in the supporting documentation required under
441.303(f) for each year of the waiver period; and
(3) The cost of room and board except when provided as part of
respite care in a facility approved by the State that is not a private
residence. For purposes of this provision, ''board'' means three meals
a day or any other full nutritional regimen and does not include meals
provided as part of a program of adult day health services.
(b) On or after June 11, 1985, the limits specified in paragraphs
(a)(1) and (a)(2) of this section are applicable to all existing and
future waiver programs under this part.
(50 FR 10028, Mar. 13, 1985)
42 CFR 441.310 Subpart H -- Home and Community-Based Services Waivers
for Individuals Age 65 or Older: Waiver Requirements
Source: 57 FR 29156, June 30, 1992, unless otherwise noted.
42 CFR 441.350 Basis and purpose.
Section 1915(d) of the Act permits States to offer, under a waiver of
statutory requirements, home and community-based services not otherwise
available under Medicaid to individuals age 65 or older, in exchange for
accepting an aggregate limit on the amount of expenditures for which
they claim FFP for certain services furnished to these individuals. The
home and community-based services that may be furnished are listed in
440.181 of this subchapter. This subpart describes the procedures the
Medicaid agency must follow to request a waiver.
42 CFR 441.351 Contents of a request for a waiver.
A request for a waiver under this section must meet the following
requirements:
(a) Required signatures. The request must be signed by the Governor,
the Director of the Medicaid agency or the Director of the larger State
agency of which the Medicaid agency is a component or any official of
the Medicaid agency to whom this authority has been delegated. A
request from any other agency of State government will not be accepted.
(b) Assurances and supporting documentation. The request must
provide the assurances required by 441.352 of this part and the
supporting documentation required by 441.353.
(c) Statement for sections of the Act. The request must provide a
statement as to whether waiver of section 1902(a)(1), 1902(a)(10)(B), or
1902(a)(10)(C)(i)(III) of the Act is requested. If the State requests a
waiver of section 1902(a)(1) of the Act, the waiver must clearly specify
the geographic areas or political subdivisions in which the services
will be offered. The State must indicate whether it is requesting a
waiver of one or all of these sections. The State may request a waiver
of any one of the sections cited above.
(d) Identification of services. The request must identify all
services available under the approved State plan, which are also
included in the APEL and which are identified under 440.181, and any
limitations that the State has imposed on the provision of any service.
The request must also identify and describe each service specified in
440.181 of this subchapter to be furnished under the waiver, and any
additional services to be furnished under the authority of
440.181(b)(7). Descriptions of additional services must explain how each
additional service included under 440.181(b)(7) will contribute to the
health and well-being of the recipients and to their ability to reside
in a community-based setting.
(e) Recipients served. The request must provide that the home and
community-based services described in 440.181 of this subchapter, are
furnished only to individuals who --
(1) Are age 65 or older;
(2) Are not inpatients of a hospital, NF, or ICF/MR; and
(3) The agency determines would be likely to require the care
furnished in a NF under Medicaid.
(f) Plan of care. The request must provide that the home and
community-based services described in 440.181 of this subchapter, are
furnished under a written plan of care based on an assessment of the
individual's health and welfare needs and developed by qualified
individuals for each recipient under the waiver. The qualifications of
the individual or individuals who will be responsible for developing the
individual plan of care must be described. Each plan of care must
contain, at a minimum, the medical and other services to be provided,
their frequency, and the type of provider to furnish them. Plans of
care must be subject to the approval of the Medicaid agency.
(g) Medicaid agency review. The request must assure that the State
agency maintain and exercise its authority to review (at a minimum) a
valid statistical sample of each month's plans of care. When the
services in a plan do not comport with the stated disabilities and needs
of the recipient, the agency must implement immediate corrective action
procedures to ensure that the needs of the recipient are adequately
addressed.
(h) Groups served. The request must describe the group or groups of
individuals to whom the services will be offered.
(i) Assurances regarding amount expended. The request must assure
that the total amount expended by the State under the plan for
individuals age 65 or older during a waiver year for medical assistance
with respect to NF, home health, private duty nursing, personal care,
and home and community-based services described in 440.180 and 440.181
of this subchapter and furnished as an alternative to NF care will not
exceed the aggregate projected expenditure limit (APEL) defined in
441.354.
Effective Date Note: At 57 FR 29156, June 30, 1992, 441.351 was
added. This section contains information collection and recordkeeping
requirements and will not become effective until approval has been given
by the Office of Management and Budget. A notice will be published in
the Federal Register once approval has been obtained.
42 CFR 441.352 State assurances.
Unless the Medicaid agency provides the following satisfactory
assurances to HCFA, HCFA will not grant a waiver under this subpart and
may terminate a waiver already granted.
(a) Health and welfare. The agency must assure that necessary
safeguards have been taken to protect the health and welfare of the
recipients of services by assuring that the following conditions are
met:
(1) Adequate standards for all types of providers that furnish
services under the waiver are met. (These standards must be reasonably
related to the requirements of the waiver service to be furnished.)
(2) The standards of any State licensure or certification
requirements are met for services or for individuals furnishing services
under the waiver.
(3) All facilities covered by section 1616(e) of the Act, in which
home and community-based services are furnished, are in compliance with
applicable State standards that meet the requirements of 45 CFR part
1397 for board and care facilities.
(4) Physician reviews of prescribed psychotropic drugs (when
prescribed for purposes of behavior control of waiver recipients) occur
at least every 30 days.
(b) Financial accountability. The agency must assure financial
accountability for funds expended for home and community-based services.
The State must provide for an independent audit of its waiver program.
The performance of a single financial audit, in accordance with the
Single Audit Act of 1984 (Pub. L. 98-502, enacted on October 19, 1984),
is deemed to satisfy the requirement for an independent audit. The
agency must maintain and make available to HHS, the Comptroller General,
or other designees, appropriate financial records documenting the cost
of services furnished to individuals age 65 or older under the waiver
and the State plan, including reports of any independent audits
conducted.
(c) Evaluation of need. The agency must provide for an initial
evaluation (and periodic reevaluations) of the need for the level of
care furnished in a NF when there is a reasonable indication that
individuals age 65 or older might need those services in the near
future, but for the availability of home and community-based services.
The procedures used to assess level of care for a potential waiver
recipient must be at least as stringent as any existing State procedures
applicable to individuals entering a NF. The qualifications of
individuals performing the waiver assessment must be as high as those of
individuals assessing the need for NF care, and the assessment
instrument itself must be the same as any assessment instrument used to
establish level of care of prospective inpatients in NFs. A periodic
reevaluation of the level of care must be performed. The period of
reevaluation of level of care cannot extend beyond 1 year.
(d) Expenditures. The agency must assure that the total amount
expended by the State for medical assistance with respect to NF, home
health, private duty nursing, personal care services, home and
community-based services furnished under a section 1915(c) waiver
granted under Subpart G of this part to individuals age 65 or older, and
the home and community-based services approved and furnished under a
section 1915(d) waiver for individuals age 65 or older during a waiver
year will not exceed the APEL, calculated in accordance with 441.354.
(e) Reporting. The agency must assure that it will provide HCFA
annually with information on the waiver's impact. The information must
be consistent with a reasonable data collection plan designed by HCFA
and must address the waiver's impact on --
(1) The type, amount, and cost of services furnished under the State
plan; and
(2) The health and welfare of recipients of the services described in
440.181 of this chapter.
Effective Date Note: At 57 FR 29156, June 30, 1992, 441.352 was
added. This section contains information collection and recordkeeping
requirements and will not become effective until approval has been given
by the Office of Management and Budget. A notice will be published in
the Federal Register once approval has been obtained.
42 CFR 441.353 Supporting documentation required.
The agency must furnish HCFA with sufficient information to support
the assurances required under 441.352, in order to meet the requirement
that the assurances are satisfactory. At a minimum, this information
must consist of the following:
(a) Safeguards. A description of the safeguards necessary to protect
the health and welfare of recipients.
This information must include:
(1) A copy of the standards established by the State for facilities
(in which services will be furnished) that are covered by section
1616(e) of the Act.
(2) The minimum educational or professional qualifications of the
providers of the services.
(3) A description of the administrative oversight mechanisms
established by the State to ensure quality of care.
(b) Records. A description of the records and information that are
maintained by the agency and by providers of services to support
financial accountability, information regarding how the State meets the
requirement for financial accountability, and an explanation of how the
State assures that there is an audit trail for State and Federal funds
expended for section 1915(d) home and community-based waiver services.
If the State has an approved Medicaid Management Information System
(MMIS), this system must be used to process individual claims data and
account for funds expended for services furnished under the waiver.
(c) Evaluation and reevaluation of recipients. A description of the
agency's plan for the evaluation and reevaluation of recipients' level
of care, including the following:
(1) A description of who makes these evaluations and how they are
made.
(2) A copy of the evaluation instrument.
(3) The agency's procedure to assure the maintenance of written
documentation on all evaluations and reevaluations and copies of the
forms. In accordance with regulations at 45 CFR part 74, written
documentation of all evaluations and reevaluations must be maintained
for a minimum period of 3 years.
(4) The agency's procedure to assure reevaluations of need at regular
intervals.
(5) The intervals at which reevaluations occur, which may be no less
frequent than for institutionalized individuals at comparable levels of
care.
(6) The procedures and criteria used for evaluation and reevaluation
of waiver recipients must be the same or more stringent than those used
for individuals served in NFs.
(d) Alternatives available. A description of the agency's plan for
informing eligible recipients of the feasible alternatives available
under the waiver and allowing recipients to choose either institutional
or home and community-based services must be submitted to HCFA. A copy
of the forms or documentation used by the agency to verify that this
choice has been offered and that recipients of waiver services, or their
legal representatives, have been given the free choice of the providers
of both waiver and State plan services must also be available for HCFA
review. The Medicaid agency must provide an opportunity for a fair
hearing, under 42 CFR part 431, subpart E, to recipients who are not
given the choice of home or community-based services as an alternative
to institutional care in a NF or who are denied the service(s) or the
providers of their choice.
(e) Post-eligibility of income. An explanation of how the agency
applies the applicable provisions regarding the post-eligibility
treatment of income and resources of those individuals receiving home
and community-based services who are eligible under a special income
level (included in 435.217 of this subchapter).
Effective Date Note: At 57 FR 29156, June 30, 1992, 441.353 was
added. This section contains information collection and recordkeeping
requirements and will not become effective until approval has been given
by the Office of Management and Budget. A notice will be published in
the Federal Register once approval has been obtained.
42 CFR 441.354 Aggregate projected expenditure limit (APEL).
(a) Definitions. For purposes of this section, the term base year
means --
(1) Federal fiscal year (FFY) 1987 (that is, October 1, 1986 through
September 30, 1987); or
(2) In the case of a State which did not report expenditures on the
basis of age categories during FFY 1987, the base year means FFY 1989
(that is, October 1, 1988 through September 30, 1989).
(b) General. (1) The total amount expended by the State for medical
assistance with respect to NF, home and community-based services under
the waiver, home health services, personal care services, private duty
nursing services, and services furnished under a waiver under subpart G
of this part to individuals age 65 or older furnished as an alternative
to care in an SNF or ICF (NF effective October 1, 1990), may not exceed
the APEL calculated in accordance with paragraph (c) of this section.
(2) In applying for a waiver under this subpart, the agency must
clearly identify the base year it intends to use.
(3) The State may make a preliminary calculation of the expenditure
limit at the time of the waiver approval; however, HCFA makes final
calculations of the aggregate limit after base data have been verified
and accepted.
(4) All base year and waiver year data are subject to final cost
settlement within 2 years from the end of the base or waiver year
involved.
(c) Formula for calculating APEL. Except as provided in paragraph
(d) of this section, the formula for calculating the APEL follows:
APEL=P (1+Y) + V (1+Z), where
P=The aggregate amount of the State's medical assistance under title
XIX for SNF and ICF (NF effective October 1, 1990) services furnished to
individuals who have reached age 65, defined as the total medical
assistance payments (Federal and State) reported on line 6 of form HCFA
64 (as adjusted) for SNF services, ICF-other services, and mental health
facility services for the base year, multiplied by the ratio of
expenditures for SNF and ICF-other services for the aged to total
expenditures for these services as reported on form HCFA 2082 for the
base year.
Q=The market basket index for SNF and ICF (NF effective October 1,
1990) services for the waiver year involved, defined as the total SNF
Input Price Index used in the Medicare program, identified as the third
quarter data available from HCFA's Office of National Cost Estimates in
August preceding the start of the fiscal year.
R=The SNF Input Price Index for the base year.
S=The number of residents in the State in the waiver year involved
who have reached age 65, defined as the number of aged Medicare
beneficiaries in the State, equal to the Mid-Period Enrollment in HI or
SMI in that State on July 1 preceding the start of the fiscal year.
T=The number of aged Medicare beneficiaries in the State who are
enrolled in either the HI or SMI programs in the base year, as defined
in S, above.
U=The number of years beginning after the base year and ending on the
last day of the waiver year involved.
V=The aggregate amount of the State's medical assistance under title
XIX in the base year for home and community-based services for
individuals who have reached age 65, defined as the total medical
assistance payments (Federal and State) reported on line 6 of form HCFA
64 (as adjusted) for home health, personal care, and home and
community-based services waivers, which provide services as an
alternative to care in a SNF or ICF (NF effective October 1, 1990),
increased by an estimate (acceptable to HCFA) of expenditures for
private duty nursing services, multiplied by the ratio of expenditures
for home health services for the aged to total expenditures for home
health services, as reported on form HCFA 2082, for the base year.
W=The market basket index for home and community-based services for
the waiver year involved, defined as the Home Agency Input Price Index,
used in the Medicare program identified as the third quarter data
available from HCFA's Office of National Cost Estimates in August
preceding the start of the fiscal year.
X=The Home Health Agency Input Price Index for the base year.
Y=The greater of --
(U .07), or (Q/R)-1+(S/T)-1+(U .02).
Z=The greater of --
(U .07), or (W/X)-1+(S/T)-1+(U .02).
(d) Amendment of the APEL. The State may request amendment of its
APEL to reflect an increase in the aggregate amount of medical
assistance for NF services and for services included in the calculation
of the APEL as required by paragraph (c) of this section when the
increase is directly attributable to legislation enacted on or after
December 22, 1987, which amends title XIX of the Act. Costs
attributable to laws enacted before December 22, 1987 will not be
considered. Because the APEL for each year of the waiver is computed
separately from the APEL for any other waiver year, a separate amendment
must be submitted for each year in which the State chooses to raise its
APEL. Documentation specific to the waiver year involved must be
submitted to HCFA.
42 CFR 441.355 Duration, extension, and amendment of a waiver.
(a) Effective dates and extension periods. (1) The effective date
for a waiver of Medicaid requirements to furnish home and
community-based services to individuals age 65 or older under this
subpart is established by HCFA prospectively on the first day of the FFY
following the date on which the waiver is approved.
(2) The initial waiver is approved for a 3-year period from the
effective date. Subsequent renewals are approved for 5-year periods.
(3) If the agency requests it, the waiver may be extended for an
additional 5-year period if HCFA's review of the prior period shows that
the assurances required by 441.352 were met.
(4) The agency may request that waiver modifications be made
effective retroactive to the first day of the waiver year in which the
amendment is submitted, unless the amendment involves substantive
change. Substantive changes may include, but are not limited to,
addition of services under the waiver, a change in the qualifications of
service providers, or a change in the eligible population.
(5) A request for an amendment that involves a substantive change is
given a prospective effective date, but this date need not coincide with
the start of the next FFY.
(b) Extension or new waiver request. HCFA determines whether a
request for extension of an existing waiver is actually an extension
request, or a request for a new waiver. Generally, if a State's
extension request proposes a substantive change in services furnished,
eligible population, service area, statutory sections waived, or
qualifications of service providers, HCFA considers it a new waiver
request.
(c) Reconsideration of denial. A determination of HCFA to deny a
request for a waiver (or for extension of a waiver) under this subpart
may be reconsidered in accordance with 441.357.
(d) Existing waiver effectiveness after denial. If HCFA denies a
request for an extension of an existing waiver under this subpart:
(1) The existing waiver remains in effect for a period of not less
than 90 days after the date on which HCFA denies the request, or, if the
State seeks reconsideration in accordance with 441.357, the date on
which a final determination is made with respect to that review.
(2) HCFA calculates an APEL for the period for which the waiver
remains in effect, and this calculation is used to pro-rate the limit
according to the number of days to which it applies.
42 CFR 441.356 Waiver termination.
(a) Termination by the State. If a State chooses to terminate its
waiver before an approved program is due to expire, the following
conditions apply:
(1) The State must notify HCFA in writing at least 30 days before
terminating services to recipients.
(2) The State must notify recipients of services under the waiver at
least 30 days before terminating services in accordance with 431.210 of
this chapter.
(3) HCFA continues to apply the APEL described in 441.354 through
the end of the waiver year, but this limit is not applied in subsequent
years.
(4) The State may not decrease the services available under the
approved State plan to individuals age 65 or older by an amount that
violates the comparability of service requirements set forth in 440.240
of this chapter.
(b) Termination by HCFA. (1) If HCFA finds, during an approved
waiver period, that an agency is not meeting one or more of the
requirements for a waiver contained in this subpart, HCFA notifies the
agency in writing of its findings and grants an opportunity for a
hearing in accordance with 441.357. If HCFA determines that the agency
is not in compliance with this subpart after the notice and any hearing,
HCFA may terminate the waiver.
(2) If HCFA terminates the waiver, the following conditions apply:
(i) The State must notify recipients of services under the waiver at
least 30 days before terminating services in accordance with 431.210 of
this chapter.
(ii) HCFA continues to apply the APEL in 441.354 of this subpart,
but the limit is prorated according to the number of days in the fiscal
year during which waiver services were offered. The limit expires
concurrently with the termination of home and community-based services
under the waiver.
Effective Date Note: At 57 FR 29156, June 30, 1992, 441.356 was
added. This section contains information collection and recordkeeping
requirements and will not become effective until approval has been given
by the Office of Management and Budget. A notice will be published in
the Federal Register once approval has been obtained.
42 CFR 441.357 Hearing procedures for waiver denials.
The procedures specified in 430.18 of this subchapter apply to State
requests for hearings on denials, renewals, or amendments of waivers for
home and community-based services for individuals age 65 or older.
42 CFR 441.360 Limits on Federal financial participation (FFP).
FFP for home and community-based services listed in 440.181 of this
subchapter is not available in expenditures for the following:
(a) Services furnished in a facility subject to the health and
welfare requirements described in 441.352(a) during any period in which
the facility is found not to be in compliance with the applicable State
requirements described in that section.
(b) The cost of room and board except when furnished as part of
respite care services in a facility, approved by the State, that is not
a private residence. For purposes of this subpart, ''board'' means
three meals a day or any other full nutritional regimen. ''Board'' does
not include meals, which do not comprise a full nutritional regimen,
furnished as part of adult day health services.
(c) The portion of the cost of room and board attributed to
unrelated, live-in personal caregivers when the waiver recipient lives
in the caregiver's home or a residence owned or leased by the provider
of the Medicaid services (the caregiver).
(d) Services that are not included in the approved State plan and not
approved as waiver services by HCFA.
(e) Services furnished to recipients who are ineligible under the
terms of the approved waiver.
(f) Services furnished by a provider when either the services or the
provider do not meet the standards that are set by the State and
included in the approved waiver.
(g) Services furnished to a recipient by his or her spouse.
42 CFR 441.365 Periodic evaluation, assessment, and review.
(a) Purpose. This section prescribes requirements for periodic
evaluation, assessment, and review of the care and services furnished to
individuals receiving home and community-based waiver services under
this subpart.
(b) Evaluation and assessment review team. (1) A review team, as
described in paragraphs (b)(2) and (c) of this section, must
periodically evaluate and assess the care and services furnished to
recipients under this subpart. The review team must be created by the
State agency directly, or (through interagency agreement) by other
departments of State government (such as the Department of Health or the
Agency on Aging).
(2) Each review team must consist of at least one physician or
registered nurse, and at least one other individual with health and
social service credentials who the State believes is qualified to
properly evaluate and assess the care and services provided under the
waiver. If there is no physician on the review team, the Medicaid
agency must ensure that a physician is available to provide consultation
to the review team.
(3) For waiver services furnished to individuals who have been found
to be likely to require the level of care furnished in a NF that is also
an IMD, each review team must have a psychiatrist or physician and other
appropriate mental health or social service personnel who are
knowledgeable about geriatric mental illness.
(c) Financial interests and employment of review team members. (1)
No member of a review team may have a financial interest in or be
employed by any entity that furnishes care and services under the waiver
to a recipient whose care is under review.
(2) No physician member of a review team may evaluate or assess the
care of a recipient for whom he or she is the attending physician.
(3) No individual who serves as case manager, caseworker, benefit
authorizer, or any similar position, may serve as member of a review
team that evaluates and assesses care furnished to a recipient with whom
he or she has had a professional relationship.
(d) Number and location of review teams. A sufficient number of
teams must be located within the State so that onsite inspections can be
made at appropriate intervals at sites where waiver recipients receive
care and services.
(e) Frequency of periodic evaluations and assessments. Periodic
evaluations and assessments must be conducted at least annually for each
recipient under the waiver. The review team and the agency have the
option to determine the frequency of further periodic evaluations and
assessments, based on the quality of services and access to care being
furnished under the waiver and the condition of patients receiving care
and services.
(f) Notification before inspection. No provider of care and services
under the waiver may be notified in advance of a periodic evaluation,
assessment, and review. However, when a recipient receives services in
his own home or the home of a relative, notification must be provided to
the residents of the household at least 48 hours in advance. The
recipient must have an opportunity to decline access to the home. If
the recipient declines access to his or her own home, or the home of a
relative, the review is limited solely to the review of the provider's
records. If the recipient is incompetent, the head of the household has
the authority to decline access to the home.
(g) Personal contact with and observation of recipients and review of
records. (1) For recipients of care and services under a waiver, the
review team's evaluation and assessment must include --
(i) A review of each recipient's medical record, the evaluation and
reevaluation required by 441.353(c), and the plan of care under which
the waiver and other services are furnished; and
(ii) If the records described in paragraph (g)(1)(i) of this section
are inadequate or incomplete, personal contact and observation of each
recipient.
(2) The review team may personally contact and observe any recipient
whose care the team evaluates and assesses.
(3) The review team may consult with both formal and informal
caregivers when the recipient's records are inadequate or incomplete and
when any apparent discrepancy exists between services required by the
recipient and services furnished under the waiver.
(h) Determinations by the review team. The review team must
determine in its evaluation and assessment whether --
(1) The services included in the plan of care are adequate to meet
the health and welfare needs of each recipient;
(2) The services included in the plan of care have been furnished to
the recipient as planned;
(3) It is necessary and in the interest of the recipient to continue
receiving services through the waiver program; and
(4) It is feasible to meet the recipient's health and welfare needs
through the waiver program.
(i) Other information considered by review team. When making
determinations, under paragraph (h) of this section, for each recipient,
the review team must consider the following information and may consider
other information as it deems necessary:
(1) Whether the medical record, the determination of level of care,
and the plan of care are consistent, and whether all ordered services
have been furnished and properly recorded.
(2) Whether physician review of prescribed psychotropic medications
(when required for behavior control) has occurred at least every 30
days.
(3) Whether tests or observations of each recipient indicated by his
or her medical record are made at appropriate times and properly
recorded.
(4) Whether progress notes entered in the record by formal and
informal caregivers are made as required and appear to be consistent
with the observed condition of the recipient.
(5) Whether reevaluations of the recipient's level of care have
occurred at least as frequently as would be required if that individual
were served in a NF.
(6) Whether the recipient receives adequate care and services, based,
at a minimum, on the following when observations are necessary (the
requirements for the necessity of observations are set forth in new
441.365(g)(3)):
(i) Cleanliness.
(ii) Absence of bedsores.
(iii) Absence of signs of malnutrition or dehydration.
(7) Whether the recipient needs any service that is not included in
the plan of care, or if included, is not being furnished by formal or
informal caregivers under the waiver or through arrangements with
another public or private source of assistance.
(8) Determination as to whether continued home and community-based
services are required by the recipient to avoid the likelihood of
placement in a NF.
(j) Submission of review team's results. The review team must submit
to the Medicaid agency the results of its periodic evaluation,
assessment and review of the care of the recipient:
(1) Within 1 month of the completion of the review.
(2) Immediately upon its determination that conditions exist that may
constitute a threat to the life or health of a recipient.
(k) Agency's action. The Medicaid agency must establish and adhere
to procedures for taking appropriate action in response to the findings
reported by the review team. These procedures must provide for
immediate response to any finding that the life or health of a recipient
may be jeopardized.
Effective Date Note: At 57 FR 29156, June 30, 1992, 441.365 was
added. This section contains information collection and recordkeeping
requirements and will not become effective until approval has been given
by the Office of Management and Budget. A notice will be published in
the Federal Register once approval has been obtained.
42 CFR 441.365 Subpart I -- Community Supported Living Arrangements
Services
Source: 56 FR 48114, Sept. 24, 1991, unless otherwise noted.
42 CFR 441.400 Basis and purpose.
This subpart implements section 1905(a)(24) of the Act, which adds
community supported living arrangements services to the list of services
that States may provide as medical assistance under title XIX (to the
extent and as defined in section 1930 of the Act), and section
1930(h)(1)(B) of the Act, which specifies minimum protection
requirements that a State which provides community supported living
arrangements services as an optional Medicaid service to developmentally
disabled individuals must meet to ensure the health, safety and welfare
of those individuals.
42 CFR 441.402 State plan requirements.
If a State that is eligible to provide community supported living
arrangements services as an optional Medicaid service to developmentally
disabled individuals provides such services, the State plan must specify
that it complies with the minimum protection requirements in 441.404.
42 CFR 441.404 Minimum protection requirements.
To be eligible to provide community supported living arrangements
services to developmentally disabled individuals, a State must assure,
through methods other than reliance on State licensure processes or the
State quality assurance programs described under section 1930(d) of the
Act, that:
(a) Individuals receiving community supported living arrangements
services are protected from neglect, physical and sexual abuse, and
financial exploitation;
(b) Providers of community supported living arrangements services --
(1) Do not use individuals who have been convicted of child or client
abuse, neglect, or mistreatment, or of a felony involving physical harm
to an individual; and
(2) Take all reasonable steps to determine whether applicants for
employment by the provider have histories indicating involvement in
child or client abuse, neglect, or mistreatment, or a criminal record
involving physical harm to an individual;
(c) Providers of community supported living arrangements services are
not unjustly enriched as a result of abusive financial arrangements
(such as owner lease-backs) with developmentally disabled clients; and
(d) Providers of community supported living arrangements services, or
the relatives of such providers, are not named beneficiaries of life
insurance policies purchased by or on behalf of developmentally disabled
clients.
42 CFR 441.404 PART 442 -- STANDARDS FOR PAYMENT FOR SKILLED NURSING AND INTERMEDIATE CARE FACILITY SERVICES
42 CFR 441.404 Subpart A -- General Provisions
Sec.
442.1 Basis and purpose.
442.2 Terms.
42 CFR 441.404 Subpart B -- Provider Agreements
442.10 State plan requirement.
442.12 Provider agreement: General requirements.
442.13 Effective date of agreement.
442.14 Effect of change of ownership.
442.15 Duration of agreement.
442.16 Extension of agreement.
442.30 Agreement as evidence of certification.
442.40 Availability of FFP during appeals.
442.42 FFP under a retroactive provider agreement following appeal.
42 CFR 441.404 Subpart C -- Certification of NFs and ICFs/MR
442.100 State plan requirements.
442.101 Obtaining certification.
442.105 Certification with deficiencies: General provisions.
442.109 Certification period: General provisions.
442.110 Certification period: Facilities with deficiencies.
442.116 Reduction plans for ICFs/MR.
442.117 Termination of certification for NFs and ICFs/MR whose
deficiencies pose immediate jeopardy.
442.118 Denial of payments for new admissions.
442.119 Duration of denial of payments and subsequent termination.
42 CFR 441.404 Subparts D-F -- (Reserved)
Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302),
unless otherwise noted.
Source: 43 FR 45233, Sept. 29, 1978, unless otherwise noted.
42 CFR 441.404 Subpart A -- General Provisions
42 CFR 442.1 Basis and purpose.
(a) This part states requirements for provider agreements and
facility certification relating to the provision of services furnished
by nursing facilities and intermediate care facilities for the mentally
retarded. This part is based on the following sections of the Act:
Section 1902(a)(4), administrative methods for proper and efficient
operation of the State plan;
Section 1902(a)(27), provider agreements;
Section 1902(a)(28), skilled nursing facility standards;
Section 1902(a)(33)(B), State survey agency functions;
Section 1902(i), circumstances and procedures for denial of payment
and termination of provider agreements in certain cases;
Section 1905(c), definition of nursing facility; Section 1905(d),
definition of intermediate care facility for the mentally retarded;
Section 1905 (f) and (i), definition of skilled nursing facility
services;
Section 1910, certification and approval of SNFs and of RHCs;
Section 1913, hospital providers of nursing facility services; and
Section 1922, correction and reduction plans for intermediate care
facilities for the mentally retarded.
(b) Section 431.610 of this subchapter contains requirements for
designating the State licensing agency to survey these facilities and
for certain survey agency responsibilities.
(43 FR 45233, Sept. 29, 1978, as amended at 47 FR 31533, July 20,
1982; 51 FR 24490, July 3, 1986; 53 FR 1993, Jan. 25, 1988; 53 FR
20495, June 3, 1988; 56 FR 48865, Sept. 26, 1991; 57 FR 43924, Sept.
23, 1992)
42 CFR 442.2 Terms.
In this part --
Facility refers to a nursing facility, and an intermediate care
facility for the mentally retarded or persons with related conditions
(ICF/MR).
Facility, and any specific type of facility referred to, may include
a distinct part of a facility as specified in 440.40 or 440.150 of
this subchapter.
Immediate jeopardy or immediate threat for Medicaid certified
facilities means a situation in which a facility's noncompliance with
one or more conditions of participation (for ICFs/MR) or level A
requirements (for SNFs and ICFs) poses a serious threat to patients' or
clients' health or safety such that immediate corrective action is
necessary. There is no substantive difference between immediate
jeopardy and immediate threat.
New admission means the admission of a Medicaid recipient who has
never been in the facility or, if previously admitted, had been
discharged or had voluntarily left the facility. The term does not
include the following:
(a) Individuals who were in the facility before the effective date of
denial of payment for new admissions, even if they become eligible for
Medicaid after that date.
(b) If the approved State plan includes payments for reserved beds,
individuals who, after a temporary absence from the facility, are
readmitted to beds reserved for them in accordance with 447.40(a) of
this chapter.
(43 FR 45233, Sept. 29, 1978, as amended at 51 FR 24491, July 3,
1986; 53 FR 1993, Jan. 25, 1988; 54 FR 5358, Feb. 2, 1989; 56 FR
48865, Sept. 26, 1991)
42 CFR 442.2 Subpart B -- Provider Agreements
42 CFR 442.10 State plan requirement.
A State plan must provide that requirements of this subpart are met.
42 CFR 442.12 Provider agreement: General requirements.
(a) Certification and recertification. Except as provided in
paragraph (b) of this section, a Medicaid agency may not execute a
provider agreement with a facility for nursing facility services nor
make Medicaid payments to a facility for those services unless the
Secretary or the State survey agency has certified the facility under
this part to provide those services. (See 442.101 for certification by
the Secretary or by the State survey agency).
(b) Exception. The certification requirement of paragraph (a) of
this section does not apply with respect to Christian Science sanitoria
operated, or listed and certified, by the First Church of Christ
Scientist, Boston, Mass.
(c) Conformance with certification condition. An agreement must be
in accordance with the certification provisions set by the Secretary or
the survey agency under subpart C of this part.
(d) Denial for good cause. (1) If the Medicaid agency has adequate
documentation showing good cause, it may refuse to execute an agreement,
or may cancel an agreement, with a certified facility.
(2) A provider agreement is not a valid agreement for purposes of
this part even though certified by the State survey agency, if the
facility fails to meet the civil rights requirements set forth in 45 CFR
parts 80, 84, and 90.
(45 FR 22936, Apr. 4, 1980, as amended at 56 FR 48865, Sept. 26,
1991)
42 CFR 442.13 Effective date of agreement.
(a) Basic requirements. If the Medicaid agency enters into a
provider agreement, the effective date must be in accordance with this
section.
(b) All Federal requirements are met on the date of the survey. The
agreement must be effective on the date the onsite survey is completed
(or on the day following the expiration of a current agreement) if, on
the date of the survey the provider meets all Federal requirements and
any other requirements imposed by the Medicaid agency.
(c) All Federal requirements are not met on the date of the survey.
If the provider fails to meet any of the requirements specified in
paragraph (b) of this section, the agreement must be effective on the
earlier of the following dates:
(1) The date on which the provider meets all requirements.
(2) The date on which a NF is found to meet the applicable
requirements or an ICF/MR is found to meet all conditions of
participation, and the facility submits an acceptable correction plan
for lower level deficiencies, or an approvable waiver request, or both.
(45 FR 22936, Apr. 4, 1980; as amended at 53 FR 20495, June 3, 1988;
54 FR 5358, Feb. 2, 1989; 54 FR 37466, Sept. 11, 1989; 56 FR 48865,
Sept. 26, 1991; 57 FR 43924, Sept. 23, 1992)
42 CFR 442.14 Effect of change of ownership.
(a) Assignment of agreement. When there is a change of ownership,
the Medicaid agency must automatically assign the agreement to the new
owner.
(b) Conditions that apply to assigned agreements. An assigned
agreement is subject to all applicable statutes and regulations and to
the terms and conditions under which it was originally issued,
including, but not limited to, the following:
(1) Any existing plan of correction.
(2) Any expiration date.
(3) Compliance with applicable health and safety requirements.
(4) Compliance with the ownership and financial interest disclosure
requirements of 455.104 and 455.105 of this chapter.
(5) Compliance with civil rights requirements set forth in 45 CFR
parts 80, 84, and 90.
(6) Compliance with any additional requirements imposed by the
Medicaid agency.
(45 FR 22936, Apr. 4, 1980, as amended at 53 FR 20495, June 3, 1988)
42 CFR 442.15 Duration of agreement.
(a) Except as specified under 442.16, the duration of an agreement
may not exceed 12 months.
(b) The agreement must be for the same duration as the certification
period set by the survey agency. However, if the Medicaid agency has
adequate documentation showing good cause, it may make an agreement for
less than this period.
(c) FFP is available for services provided by a facility for up to 30
days after its agreement expires or terminates under the conditions
specified in 441.11 of this subchapter.
(d) The limitation specified in paragraph (a) of this section does
not apply to hospitals with a swing-bed approval.
(43 FR 45233, Sept. 29, 1978, as amended at 47 FR 31532, July 20,
1982)
42 CFR 442.16 Extension of agreement.
A Medicaid agency may extend a provider agreement for a single period
of up to 2 months beyond the original expiration date specified in the
agreement if it receives written notice from the survey agency, before
the expiration date of the agreement, that extension will not jeopardize
the patients' health and safety, and --
(a) Is needed to prevent irreparable harm to the facility or hardship
to the recipients in the facility; or
(b) Is needed because it is impracticable to determine, before the
expiration date, whether the facility meets certification requirements.
(43 FR 45233, Sept. 29, 1978, as amended at 52 FR 32551, Aug. 28,
1987; 53 FR 20495, June 3, 1988)
42 CFR 442.30 Agreement as evidence of certification.
(a) Under 440.40(a) and 440.150 of this chapter, FFP is available
in expenditures for NF and ICF/MR services only if the facility has been
certified as meeting the requirements for Medicaid participation, as
evidenced by a provider agreement executed under this part. An
agreement is not valid evidence that a facility has met those
requirements if HCFA determines that --
(1) The survey agency failed to apply the applicable requirements
under part 483 for NFs or subpart D of part 483 of this chapter, which
sets forth the conditions of participation for ICFs/MR.
(2) The survey agency failed to follow the rules and procedures for
certification set forth in subpart C of this part and 431.610 of this
subchapter;
(3) The survey agency failed to perform any of the functions
specified in 431.610(g) of this subchapter relating to evaluating and
acting on information about the facility and inspecting the facility;
(4) The survey agency failed to use the Federal standards, and the
forms, methods and procedures prescribed by HCFA as required under
431.610(f)(1) of this chapter, for determining the qualifications of
providers; or
(5) The survey agency failed to adhere to the following principles in
determining compliance:
(i) The survey process is the means to assess compliance with Federal
health, safety and quality standards;
(ii) The survey process uses resident outcomes as the primary means
to establish the compliance status of facilities. Specifically,
surveyors will directly observe the actual provision of care and
services to residents, and the effects of that care, to assess whether
the care provided meets the needs of individual residents;
(iii) Surveyors are professionals who use their judgment, in concert
with Federal forms and procedures, to determine compliance;
(iv) Federal procedures are used by all surveyors to ensure uniform
and consistent application and interpretation of Federal requirements;
(v) Federal forms are used by all surveyors to ensure proper
recording of findings and to document the basis for the findings.
(6) The survey agency failed to assess in a systematic manner a
facility's actual provision of care and services to residents and
effects of that care on residents.
(7) Required elements of the SNF or ICF survey process include all of
the following:
(i) An entrance conference;
(ii) A resident-centered tour of facility;
(iii) An in-depth review of a sample of residents including
observation, interview and record review;
(iv) Observation of the preparation and administration of drugs for a
sample of residents;
(v) Evaluation of a facility's meals, dining areas and eating
assistance procedures;
(vi) Formulation of a deficiency statement based on the incorporation
of all appropriate findings onto the survey report form;
(vii) An exit conference; and
(viii) Follow-up surveys as appropriate.
(8) The agreement's terms and conditions do not meet the requirements
of this subpart.
(b) The Administrator will make the determination under paragraph (a)
of this section through onsite surveys, other Federal reviews, State
certification records, or reports he may require from the Medicaid or
survey agency.
(c) If the Administrator disallows a State's claim for FFP because of
a determination under paragraph (a) of this section, the State is
entitled upon request to reconsideration of the disallowance under 45
CFR part 16.
(43 FR 45233, Sept. 29, 1978, as amended at 51 FR 21558, June 13,
1986; 53 FR 20495, June 3, 1988; 53 FR 23101, June 17, 1988; 54 FR
5358, Feb. 2, 1989; 54 FR 37467, Sept. 11, 1989; 56 FR 48865, Sept.
26, 1991)
42 CFR 442.40 Availability of FFP during appeals.
(a) Definitions. As used in this section --
Effective date of expiration means the date of expiration originally
specified in the provider agreement, or the later date specified if the
agreement is extended under 442.16; and
Effective date of termination means a date earlier than the
expiration date, set by the Medicaid agency when continuing
participation until the expiration date is not justified, because the
facility no longer meets the requirements for participation.
(b) Scope, applicability, and effective date -- (1) Scope. This
section sets forth the extent of FFP in State Medicaid payments to a NF
or an ICF/MR after its provider agreement has been terminated or has
expired and not been renewed.
(2) Applicability. (i) This section and 442.42 apply only when the
Medicaid agency, of its own volition, terminates or does not a renew a
provider agreement, and only when the survey agency certifies that there
is no jeopardy to recipient health and safety. When the survey agency
certifies that there is jeopardy to recipient health and safety, or when
it fails to certify that there is no jeopardy, FFP ends on the effective
date of termination or expiration.
(ii) When the State acts under instructions from HCFA, FFP ends on
the date specified by HCFA (HCFA instructs the State to terminate the
Medicaid provider agreement when HCFA in validating a State survey
agency certification, determines that a NF or an ICF/MR does not meet
the requirements for participation.)
(3) Effective date. This section and 442.42 apply to terminations
or expirations that are effective on or after September 28, 1987. For
terminations or nonrenewals that were effective before that date, FFP
may continue for up to 120 days from September 28, 1987, or 12 months
from the effective date of termination or nonrenewal, whichever is
earlier.
(c) Basic rules. (1) Except as provided in paragraphs (d) and (e) of
this section, FFP in payments to a NF or an ICF/MR ends on the effective
date of termination of the facility's provider agreement, or if the
agreement is not terminated, on the effective date of expiration.
(2) If State law, or a Federal or State court order or injunction,
requires the agency to extend the provider agreement or continue
payments to a facility after the dates specified in paragraph (d) of
this section, FFP is not available in those payments.
(d) Exception: Continuation of FFP after termination or expiration
of provider agreement -- (1) Conditions for continuation. FFP is
available after the effective date of termination or expiration only if
--
(i) The evidentiary hearing required under 431.153 of this chapter
is provided by the State agency after the effective date of termination
or expiration (or, if begun before termination or expiration, is not
completed until after that date); and
(ii) Termination or nonrenewal action is based on a survey agency
certification that there is no jeopardy to recipients' health and
safety.
(2) Extent of continuation. FFP is available only through the
earlier of the following:
(i) The date of issuance of an administrative hearing decision that
upholds the agency's termination or nonrenewal action.
(ii) The 120th day after the effective date of termination of the
facility's provider agreement or, if the agreement is not terminated,
the 120th day after the effective date of expiration. (If a hearing
decision that upholds the facility is issued after the end of the
120-day period, when FFP has already been discontinued, the rules of
442.42 on retroactive agreements apply).
(e) Applicability of 441.11. If FFP is continued during appeal under
paragraph (d) of this section, the 30-day period provided by 441.11 of
this chapter would not begin to run until issuance of a hearing decision
that upholds the agency's termination or nonrenewal action.
(52 FR 32551, Aug. 28, 1987, as amended at 56 FR 48865, Sept. 26,
1991; 57 FR 43924, Sept. 23, 1992)
42 CFR 442.42 FFP under a retroactive provider agreement following
appeal.
(a) Basic rule. Except as specified in paragraph (b) of this
section, if a NF or an ICF/MR is upheld on appeal from termination or
nonrenewal of a provider agreement, and the State issues a retroactive
agreement, FFP is available beginning with the retroactive effective
date, which must be determined in accordance with 442.13.
(b) Exception. This rule does not apply if HCFA determines, under
442.30, that the agreement is not valid evidence that the facility meets
the requirements for participation. This exclusion applies even if the
State issues the new agreement as the result of an administrative
hearing decision favorable to the facility or under a Federal or State
court order.
(52 FR 32551, Aug. 28, 1987, as amended at 56 FR 48866, Sept. 26,
1991)
42 CFR 442.42 Subpart C -- Certification of NFs and ICFs/MR
42 CFR 442.100 State plan requirements.
A State plan must provide that the requirements of this subpart and
part 483 are met.
(53 FR 20495, June 3, 1988)
42 CFR 442.101 Obtaining certification.
(a) This section states the requirements for obtaining notice of an
ICF/MR's certification before a Medicaid agency executes a provider
agreement under 442.12.
(b) The agency must obtain notice of certification from the Secretary
for an ICF/MR located on an Indian reservation.
(c) The agency must obtain notice of certification from the survey
agency for all other ICFs/MR.
(d) The notice must indicate that one of the following provisions
pertains to the ICF/MR:
(1) An ICF/MR meets the conditions of participation set forth in
subpart D of part 483 of this chapter.
(2) The ICF/MR has been granted a waiver or variance by HCFA or the
survey agency under subpart D.
(3) An ICF/MR has been certified with standard-level deficiencies and
(i) All conditions of participation are found met; and
(ii) The facility submits an acceptable plan of correction covering
the remaining deficiencies, subject to other limitations specified in
442.105.
(e) The failure to meet one or more of the applicable conditions of
participation is cause for termination or non-renewal of the ICF/MR
provider agreement.
(56 FR 48866, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23,
1992)
42 CFR 442.105 Certification with deficiencies: General provisions.
If a survey agency finds a facility deficient in meeting the
requirements for NFs or the standards (for ICFs/MR), as specified under
subparts B and D of part 483 of this chapter, the agency may certify the
facility for Medicaid purposes under the following conditions:
(a) The agency finds that the facility's deficiencies, individually
or in combination, do not jeopardize the patient's health and safety,
nor seriously limit the facility's capacity to give adequate care. The
agency must maintain a written justification of these findings.
(b) The agency finds acceptable the facility's written plan for
correcting the deficiencies.
(c) If a facility was previously certified with a deficiency and has
a different deficiency at the time of the next survey, the agency
documents that the facility --
(1) Was unable to stay in compliance with the standard (for ICFs/MR)
or requirements (for NFs) for reasons beyond its control, or despite
intensive efforts to comply; and
(2) Is making the best use of its resources to furnish adequate care.
(d) If a facility has the same deficiency it had under the prior
certification, the agency documents that the facility --
(1) Did achieve compliance with the standard (for ICFs/MR) or
requirements (for NFs) at some time during the prior certification
period;
(2) Made a good faith effort, as judged by the survey agency, to stay
in compliance; and
(3) Again became out of compliance for reasons beyond its control.
(56 FR 48866, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23,
1992)
42 CFR 442.109 Certification period: General provisions.
(a) A survey agency may certify a facility that fully meets
applicable requirements for up to 12 months.
(b) The survey agency may notify the Medicaid agency that the term of
a provider agreement may be extended up to 2 months after the expiration
date of the agreement under the conditions specified in 442.16.
(43 FR 45233, Sept. 29, 1978. Redesignated at 53 FR 1993, Jan. 25,
1988)
42 CFR 442.110 Certification period: Facilities with deficiencies.
(a) Facilities with deficiencies may be certified under 442.105 for
the period specified in either paragraph (b) or (c) of this section.
(b) The survey agency may certify a facility for a period that ends
no later than 60 days after the last day specified in the plan for
correcting deficiencies. The certification period must not exceed 12
months, including the period allowed for corrections.
(c) The survey agency may certify a facility for up to 12 months with
a condition that the certification will be automatically canceled on a
specified date within the certification period unless --
(1) The survey agency finds that all deficiencies have been
satisfactorily corrected; or
(2) The survey agency finds and notifies the Medicaid agency that the
facility has made substantial progress in correcting the deficiencies
and has a new plan for correction that is acceptable.
The automatic cancellation date must be no later than 60 days after
the last day specified in the plan for correction of deficiencies under
442.105.
(43 FR 45233, Sept. 29, 1978. Redesignated and amended at 53 FR 1993,
Jan. 25, 1988; 53 FR 20496, June 3, 1988; 56 FR 48866, Sept. 26,
1991; 57 FR 43924, Sept. 23, 1992)
42 CFR 442.116 Reduction plans for ICFs/MR.
(a) Basis and scope. Under section 1922 of the Act, a Medicaid
agency could have chosen to submit reduction plans for ICFs/MR that were
found to have substantial deficiencies that did not pose an immediate
threat to the health and safety of its clients. States that elected to
submit reduction plans must reduce permanently the number of beds in
certified units and correct deficiencies within 36 months of the
approval date of the reduction plan. The section 1922 requirements
apply to reduction plans that HCFA approved by January 1, 1990.
(b) Failure to meet requirements. If, at the conclusion of any
6-month period of the reduction plan, HCFA determines that the Medicaid
agency has substantially failed to meet the requirements of the
reduction plan, HCFA proceeds with one of the following actions:
(1) Termination of the ICF/MR's participation in the Medicaid program
in accordance with section 1910(b) of the Act.
(2) Disallowance of FFP equal to 5 percent of the cost of care for
all eligible clients for each month for which the agency failed to meet
the requirements despite good faith efforts it may have made.
(56 FR 30698, July 5, 1991)
42 CFR 442.117 Termination of certification for NFs and ICFs/MR whose
deficiencies pose immediate jeopardy.
(a) A survey agency must terminate a facility's certification if it
determines that --
(1) The facility no longer meets applicable requirements for NFs or
conditions of participation for ICFs/MR as specified in subpart B or D
of part 483 of this chapter.
(2) The facility's deficiencies pose immediate jeopardy to patients'
health and safety.
(b) Subsequent to a certification of a facility's noncompliance, the
Medicaid agency must, in terminating the provider agreement, follow the
appeals process specified in part 431, subpart D of this chapter.
(51 FR 24491, July 3, 1986, as amended at 53 FR 20496, June 3, 1988;
54 FR 5358, Feb. 2, 1989; 54 FR 37467, Sept. 11, 1989; 56 FR 48866,
Sept. 26, 1991)
42 CFR 442.118 Denial of payments for new admissions.
(a) Basis for denial of payments.
The Medicaid agency may deny payment for new admissions to a NF or an
ICF/MR that no longer meets the applicable conditions of participation
specified under subpart B or D of part 483 of this chapter.
(b) Agency procedures. Before denying payments for new admissions,
the Medicaid agency must comply with the following requirements:
(1) Provide the facility up to 60 days to correct the cited
deficiencies and comply with the requirements (for NFs) or conditions of
participation (for ICFs/MR).
(2) If at the end of the specified period the facility has not
achieved compliance, give the facility notice of intent to deny payment
for new admissions, and opportunity for an informal hearing.
(3) If the facility requests a hearing, provide an informal hearing
that includes --
(i) The opportunity for the facility to present, before a State
Medicaid official who was not involved in making the initial
determination, evidence or documentation, in writing or in person, to
refute the decision that the facility is out of compliance with the
applicable requirements (for NFs) or conditions of participation (for
ICFs/MR).
(ii) A written decision setting forth the factual and legal bases
pertinent to a resolution of the dispute.
(4) If the decision of the informal hearing is to deny payments for
new admissions, provide the facility and the public, at least 15 days
before the effective date of the sanction, with a notice that includes
the effective date and the reasons for the denial of payments.
(c) Effect of denial of Medicare payment -- (1) Period of denial. If
HCFA denies Medicare payments for new admissions to a SNF that also
participates in Medicaid, the Medicaid agency must deny Medicaid
payments for new admissions, effective for the same time period that
Medicare payments are denied.
(2) Informal hearing. Only one informal hearing is available to a
SNF that participates in both programs. It would be provided by HCFA in
accordance with 489.62(c) of this chapter.
(51 FR 24491, July 3, 1986, as amended at 53 FR 20496, June 3, 1988;
54 FR 5358, Feb. 2, 1989; 54 FR 37467, Sept. 11, 1989; 56 FR 48866,
Sept. 26, 1991)
42 CFR 442.119 Duration of denial of payments and subsequent
termination.
(a) Period of denial. The denial of payments for new admissions will
continue for 11 months after the month it was imposed unless, before the
end of that period, the Medicaid agency finds that --
(1) The facility has corrected the deficiencies or is making a good
faith effort to achieve compliance with the level A requirements (for
SNFs and ICFs) and conditions of participation (for ICFs/MR); or
(2) The deficiencies are such that it is necessary to terminate the
facility's provider agreement.
(b) Subsequent termination. The Medicaid agency must terminate a
facility's provider agreement --
(1) Upon the agency's finding that the facility has been unable to
achieve compliance with the level A requirements (for SNFs and ICFs) and
conditions of participation (for ICFs/MR) during the period that
payments for new admissions have been denied;
(2) Effective the day following the last day of the denial of
payments period; and
(3) In accordance with the procedures for appeal of terminations set
forth in subpart D of part 431 of this chapter.
(51 FR 24491, July 3, 1986, as amended at 53 FR 20496, June 3, 1988;
54 FR 5359, Feb. 2, 1989)
42 CFR 442.119 Subparts D-F -- (Reserved)
42 CFR 442.119 PART 447 -- PAYMENTS FOR SERVICES
42 CFR 442.119 Pt. 447
42 CFR 442.119 Subpart A -- Payments: General Provisions
Sec.
447.1 Purpose.
447.10 Prohibition against reassignment of provider claims.
447.15 Acceptance of State payment as payment in full.
447.20 Provider restrictions: State plan requirements.
447.21 Reduction of payments to providers.
447.25 Direct payments to certain recipients for physicians' or
dentists' services.
447.30 Withholding the Federal share of payments to Medicaid
providers to recover Medicare overpayments.
447.31 Withholding Medicare payments to recover Medicaid
overpayments.
447.40 Payments for reserving beds in institutions.
447.45 Timely claims payment.
447.50 Cost sharing: Basis and purpose.
447.51 Requirements and options.
447.52 Minimum and maximum income-related charges.
447.53 Applicability; specification; multiple charges.
447.54 Maximum allowable charges.
447.55 Standard co-payment.
447.56 Income-related charges.
447.57 Restrictions on payments to providers.
447.58 Payments to prepaid capitation organizations.
447.59 FFP: Conditions relating to cost-sharing.
42 CFR 442.119 Subpart B -- Payment Methods: General Provisions
447.200 Basis and purpose.
447.201 State plan requirements.
447.202 Audits.
447.203 Documentation of payment rates.
447.204 Encouragement of provider participation.
447.205 Public notice of changes in Statewide methods and standards
for setting payment rates.
42 CFR 442.119 Subpart C -- Payment For Inpatient Hospital and
Long-Term Care Facility Services
447.250 Basis and purpose.
447.251 Definitions.
447.252 State plan requirements.
447.253 Other requirements.
447.255 Related information.
447.256 Procedures for HCFA action on assurances and State plan
amendments.
447.257 FFP: Conditions relating to institutional reimbursement.
447.271 Upper limits based on customary charges.
447.272 Application of upper payment limits.
447.280 Hospital providers of SNF and ICF services (swing-bed
hospitals).
42 CFR 442.119 Subpart D -- Payment Methods for Other Institutional and
Noninstitutional Services
447.300 Basis and purpose.
447.301 Definitions.
447.302 State plan requirements.
447.304 Adherence to upper limits; FFP.
447.321 Outpatient hospital services and clinic services: Upper
limits of payment.
447.325 Other inpatient and outpatient facility services: Upper
limits of payment.
447.331 Drugs: Aggregate upper limits of payment.
447.332 Upper limits for multiple source drugs.
447.333 State plan requirements, findings and assurances.
447.334 Upper limits for drugs furnished as part of services.
447.342 Physician billing for clinical laboratory services.
447.361 Upper limits of payment: Risk contract.
447.362 Upper limits of payment: Nonrisk contract.
447.371 Services furnished by rural health clinics.
Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
Source: 43 FR 45253, Sept. 29, 1978, unless otherwise noted.
42 CFR 442.119 Subpart A -- Payments: General Provisions
42 CFR 447.1 Purpose.
This subpart prescribes State plan requirements, FFP limitations and
procedures concerning payments made by State Medicaid agencies for
Medicaid services.
42 CFR 447.10 Prohibition against reassignment of provider claims.
(a) Basis and purpose. This section implements section 1902(a)(32)
of the Act which prohibits State payments for Medicaid services to
anyone other than a provider or recipient, except in specified
circumstances; and implements, in part, section 1902(a)(43) concerning
payments to physicians for laboratory services (see also 447.342).
(b) Definitions. For purposes of this section:
Facility means an institution that furnishes health care services to
inpatients.
Factor means an individual or an organization, such as a collection
agency or service bureau, that advances money to a provider for accounts
receivable that the provider has assigned, sold or transferred to the
individual organization for an added fee or a deduction of a portion of
the accounts receivable. Factor does not include a business
representative as described in paragraph (f) of this section.
Organized health care delivery system means a public or private
organization for delivering health services. It includes, but is not
limited to, a clinic, a group practice prepaid capitation plan, and a
health maintenance organization.
(c) State plan requirements. A State plan must provide that the
requirements of paragraphs (d) through (h) of this section are met.
(d) Who may receive payment. Payment may be made only --
(1) To the provider; or
(2) To the recipient if he is a noncash recipient eligible to receive
the payment under 447.25; or
(3) In accordance with paragraphs (e), (f), and (g) of this section.
(e) Reassignments. Payment may be made in accordance with a
reassignment from the provider to a government agency or reassignment by
a court order.
(f) Business agents. Payment may be made to a business agent, such
as a billing service or an accounting firm, that furnishes statements
and receives payments in the name of the provider, if the agent's
compensation for this service is --
(1) Related to the cost of processing the billing;
(2) Not related on a percentage or other basis to the amount that is
billed or collected; and
(3) Not dependent upon the collection of the payment.
(g) Individual practitioners. Payment may be made to --
(1) A physician who bills for outside laboratory services that the
physician orders and pays for, but that he or she did not personally
perform or supervise, or which were not performed or supervised by
another physician with whom he or she shares a practice.
(2) The employer of the practitioner, if the practitioner is required
as a condition of employment to turn over his fees to the employer;
(3) The facility in which the service is provided, if the
practitioner has a contract under which the facility submits the claim;
or
(4) A foundation, plan, or similar organization operating an
organized health care delivery system, if the practitioner has a
contract under which the organization submits the claim.
(h) Prohibition of payment to factors. Payment for any service
furnished to a recipient by a provider may not be made to or through a
factor, either directly or by power of attorney.
(43 FR 45253, Sept. 29, 1978, as amended at 46 FR 42672, Aug. 24,
1981)
42 CFR 447.15 Acceptance of State payment as payment in full.
A State plan must provide that the Medicaid agency must limit
participation in the Medicaid program to providers who accept, as
payment in full, the amounts paid by the agency plus any deductible,
coinsurance or copayment required by the plan to be paid by the
individual. However, the provider may not deny services to any eligible
individual on account of the individual's inability to pay the cost
sharing amount imposed by the plan in accordance with 431.55(g) or
447.53. The previous sentence does not apply to an individual who is
able to pay. An individual's inability to pay does not eliminate his or
her liability for the cost sharing charge.
(50 FR 23013, May 30, 1985)
42 CFR 447.20 Provider restrictions: State plan requirements.
A State plan must provide for the following:
(a) In the case of an individual who is eligible for medical
assistance under the plan for service(s) for which a third party or
parties is liable for payment, if the total amount of the established
liability of the third party or parties for the service is --
(1) Equal to or greater than the amount payable under the State plan
(which includes, when applicable, cost-sharing payments provided for in
447.53 through 447.56), the provider furnishing the service to the
individual may not seek to collect from the individual (or any
financially responsible relative or representative of that individual)
any payment amount for that service; or
(2) Less than the amount payable under the State plan (including cost
sharing payments set forth in 447.53 through 447.56), the provider
furnishing the service to that individual may collect from the
individual (or any financially responsible relative or representative of
the individual) an amount which is the lesser of --
(i) Any cost-sharing payment amount imposed upon the individual under
447.53 through 447.56; or
(ii) An amount which represents the difference between the amount
payable under the State plan (which includes, where applicable,
cost-sharing payments provided for in 447.53 through 447.56) and the
total of the established third party liability for the services.
(b) A provider may not refuse to furnish services covered under the
plan to an individual who is eligible for medical assistance under the
plan on account of a third party's potential liability for the
service(s).
(55 FR 1433, Jan. 16, 1990)
42 CFR 447.21 Reduction of payments to providers.
If a provider seeks to collect from an individual (or any financially
responsible relative or representative of that individual) an amount
that exceeds an amount specified under 447.20(a) --
(a) The Medicaid agency may provide for a reduction of any payment
amount otherwise due to the provider in addition to any other sanction
available to the agency; and
(b) The reduction may be equal to up to three times the amount that
the provider sought to collect in violation of 447.20(a).
(55 FR 1433, Jan. 16, 1990)
42 CFR 447.25 Direct payments to certain recipients for physicians' or
dentists' services.
(a) Basis and purpose. This section implements section 1905(a) of
the Act by prescribing requirements applicable to States making direct
payments to certain recipients for physicians' or dentists' services.
(b) State plan requirements. Except for groups specified in
paragraph (c) of this section, a State may make direct payments to
recipients for physicians' or dentists' services. If it does so, the
State plan must --
(1) Provide for direct payments; and
(2) Specify the conditions under which payments are made.
(c) Federal financial participation. No FFP is available in
expenditures for direct payment for physicians' or dentists' services to
any recipient --
(1) Who is receiving assistance under the State's approved plan under
title I, IV-A, X, XIV or XVI (AABD) of the Act; or
(2) To whom supplemental security benefits are being paid under title
XVI of the Act; or
(3) Who is receiving or eligible for a State supplementary payment or
would be eligible if he were not in a medical institution, and who is
eligible for Medicaid as a categorically needy recipient.
(d) Federal requirements. (1) Direct payments to recipients under
this section are an alternative to payments directly to providers and
are subject to the same conditions; for example, the State's reasonable
charge schedules are applicable.
(2) Direct payments must be supported by providers' bills for
services.
42 CFR 447.30 Withholding the Federal share of payments to Medicaid
providers to recover Medicare overpayments.
(a) Basis and purpose. This section implements section 1914 of the
Act, which provides for withholding the Federal share of Medicaid
payments to a provider if the provider has not arranged to repay
Medicare overpayments or has failed to provide information to determine
the amount of the overpayments. The intent of the statute and
regulations is to facilitate the recovery of Medicare overpayments. The
provision enables recovery of overpayments when institutions have
reduced participation in Medicare or when physicians and suppliers have
submitted few or no claims under Medicare, thus not receiving enough in
Medicare reimbursement to permit offset of the overpayment.
(b) When withholding occurs. The Federal share of Medicaid payments
may be withheld from any provider specified in paragraph (c) of this
section to recover Medicare overpayments that HCFA has been unable to
collect if the provider participates in Medicaid and --
(1) The provider has not made arrangements satisfactory to HCFA to
repay the Medicare overpayment; or
(2) HCFA has been unable to collect information from the provider to
determine the existence or amount of Medicare overpayment.
(c) The Federal share of Medicaid payments may be withheld with
respect to the following providers:
(1) An institutional provider that has or previously had in effect a
Medicare provider agreement under section 1866 of the Act; and
(2) A Medicaid provider who has previously accepted Medicare payment
on the basis of an assignment under section 1842(b)(3)(B)(ii) of the
Act; and during the 12 month period preceding the quarter in which the
Federal share is to be withheld for a Medicare overpayment, submitted no
claims under Medicare or submitted claims which total less than the
amount of overpayment.
(d) Order to reduce State payment.
(1) HCFA may, at its discretion, issue an order to the Medicaid
agency of any State that is using the provider's services, to reduce its
payment to the provider by the amount specified in paragraph (f) of this
section.
(2) The order to reduce payment to the provider will remain in effect
until --
(i) The Medicaid agency determines that the overpayment has been
completely recovered; or
(ii) HCFA terminates the order.
(3) HCFA may withhold FFP from any State that does not comply with
the order specified in paragraph (d)(1) of this section to reduce
payment to the provider and claims FFP for the expenditure on its
quarterly expenditure report.
(e) Notice of withholding. (1) Before the Federal share of payments
may be withheld under this section, HCFA will notify the provider and
the Medicaid agency of each State that HCFA believes may use the
overpaid provider's services under Medicaid.
(2) The notice will include the instruction to reduce State payments,
as provided under paragraph (d) of this section.
(3) HCFA will send the notice referred to in paragraph (e)(1) by
certified mail, return receipt requested.
(4) Each Medicaid agency must identify the amount of payment due the
provider under Medicaid and give that information to HCFA in the next
quarterly expenditure report.
(5) The Medicaid agency may appeal any disallowance of FFP resulting
from the withholding decision to the Grant Appeals Board, in accordance
with 45 CFR part 16.
(f) Amount to be withheld. HCFA may require the Medicaid agency to
reduce the Federal share of its payment to the provider by the lesser of
the following amounts.
(1) The Federal matching share of payments to the provider, or
(2) The total Medicare overpayment to the provider.
(g) Effective date of withholding. Withholding of payment will
become effective no less than 60 days after the day on which the agency
receives notice of withholding.
(h) Duration of withholding. No Federal funds are available in
expenditures for services that are furnished by a provider specified in
paragraph (c) of this section from the date on which the withholding
becomes effective until the termination of withholding under paragraph
(i) of this section.
(i) Termination of withholding.
(1) HCFA will terminate the order to reduce State payment if it
determines that any of the following has occurred:
(i) The Medicare overpayment is completely recovered:
(ii) The institution or person makes an agreement satisfactory to
HCFA to repay the overpayment; or
(iii) HCFA determines that there is no overpayment based on newly
acquired evidence or a subsequent audit.
(2) HCFA will notify each State that previously received a notice
ordering the withholding that the withholding has been terminated.
(j) Procedures for restoring excess withholding. If an amount
ultimately determined to be in excess of the Medicare overpayment is
withheld, HCFA will restore any excess funds withheld.
(k) Recovery of funds from Medicaid agency. A provider is not
entitled to recover from the Medicaid agency the amount of payment
withheld by the agency in accordance with a HCFA order issued under
paragraph (d) of this section.
(50 FR 19688, May 10, 1985; 50 FR 23307, June 3, 1985)
42 CFR 447.31 Withholding Medicare payments to recover Medicaid
overpayments.
(a) Basis and purpose. Section 1885 of the Act provides authority
for HCFA to withhold Medicare payments to a Medicaid provider in order
to recover Medicaid overpayments to the provider. Section 405.375 of
this chapter sets forth the Medicare rules implementing section 1885,
and specifies under what circumstances withholding will occur and the
providers that are subject to withholding. This section establishes the
procedures that the Medicaid agency must follow when requesting that
HCFA withhold Medicare payments.
(b) Agency notice to providers. (1) Before the agency requests
recovery of a Medicaid overpayment through Medicare, the agency must
send either or both of the following notices, in addition to that
required under paragraph (b)(2) of this section, to the provider.
(i) Notice that --
(A) There has been an overpayment;
(B) Repayment is required; and
(C) The overpayment determination is subject to agency appeal
procedures, but we may withhold Medicare payments while an appeal is in
progress.
(ii) Notice that --
(A) Information is needed to determine the amount of overpayment if
any; and
(B) The provider has at least 30 days in which to supply the
information to the agency.
(2) Notice that, 30 days or later from the date of the notice, the
agency intends to refer the case to HCFA for withholding of Medicare
payments.
(3) The agency must send all notices to providers by certified mail,
return receipt requested.
(c) Documentation to be submitted to HCFA. The agency must submit
the following information or documentation to HCFA (unless otherwise
specified) with the request for withholding of Medicare payments.
(1) A statement of the reason that withholding is requested.
(2) The amount of overpayment, type of overpayment, date the
overpayment was determined, and the closing date of the pertinent cost
reporting period (if applicable).
(3) The quarter in which the overpayment was reported on the
quarterly expenditure report (Form HCFA 64).
(4) As needed, and upon request from HCFA, the names and addresses of
the provider's officers and owners for each period that there is an
outstanding overpayment.
(5) A statement of assurance that the State agency has met the notice
requirements under paragraph (b) of this section.
(6) As needed, and upon request for HCFA, copies of notices (under
paragraph (b) of this section), and reports of contact or attempted
contact with the provider concerning the overpayment, including any
reduction or suspension of Medicaid payments made with respect to that
overpayment.
(7) A copy of the provider's agreement with the agency under 431.107
of this chapter.
(d) Notification to terminate withholding. (1) If an agency has
requested withholding under this section, it must notify HCFA if any of
the following occurs:
(i) The Medicaid provider makes an agreement satisfactory to the
agency to repay the overpayment;
(ii) The Medicaid overpayment is completely recovered; or
(iii) The agency determines that there is no overpayment, based on
newly acquired evidence or subsequent audit.
(2) Upon receipt of notification from the State agency, HCFA will
terminate withholding.
(e) Accounting for returned overpayment. The agency must treat as a
recovered overpayment the amounts received from HCFA to offset Medicaid
overpayments.
(f) Procedures for restoring excess withholding. The agency must
establish procedures satisfactory to HCFA to assure the return to the
provider of amounts withheld under this section that are ultimately
determined to be in excess of overpayments. Those procedures are
subject to HCFA review.
(50 FR 19689, May 10, 1985)
42 CFR 447.40 Payments for reserving beds in institutions.
(a) The Medicaid agency may make payments to reserve a bed during a
recipient's temporary absence from an inpatient facility, if --
(1) The State plan provides for such payments and specifies any
limitations on the policy; and
(2) Absences for purposes other than required hospitalization (which
cannot be anticipated and planned) are included in the patient's plan of
care.
(b) An agency that pays for reserved beds in an inpatient facility
may pay less for a reserved bed than an occupied bed if there is a cost
differential between the two beds. (Section 1102 of the Act.)
(43 FR 45253, Sept. 29, 1978, as amended at 51 FR 24491, July 3,
1986)
42 CFR 447.45 Timely claims payment.
(a) Basis and purpose. This section implements section 1902(a)(37)
of the Act by specifying --
(1) State plan requirements for --
(i) Timely processing of claims for payment;
(ii) Prepayment and postpayment claims reviews; and
(2) Conditions under which the Administrator may grant waivers of the
time requirements.
(b) Definitions. Claim means (1) a bill for services, (2) a line
item of service, or (3) all services for one recipient within a bill.
Clean claim means one that can be processed without obtaining
additional information from the provider of the service or from a third
party. It includes a claim with errors originating in a State's claims
system. It does not include a claim from a provider who is under
investigation for fraud or abuse, or a claim under review for medical
necessity.
A shared health facility means any arrangement in which --
(1) Two or more health care practitioners practice their professions
at a common physical location;
(2) The practitioners share common waiting areas, examining rooms,
treatment rooms, or other space, the services of supporting staff, or
equipment;
(3) The practitioners have a person (who may himself be a
practitioner) --
(i) Who is in charge of, controls, manages, or supervises substantial
aspects of the arrangement or operation for the delivery of health or
medical services at the common physical location other than the direct
furnishing of professional health care services by the practitioners to
their patients; or
(ii) Who makes available to the practitioners the services of
supporting staff who are not employees of the practitioners; and
(iii) Who is compensated in whole or in part, for the use of the
common physical location or related support services, on a basis related
to amounts charged or collected for the services rendered or ordered at
the location or on any basis clearly unrelated to the value of the
services provided by the person; and
(4) At least one of the practitioners received payments on a
fee-for-service basis under titles V, XVIII, and XIX in an amount
exceeding $5,000 for any one month during the preceding 12 months or in
an aggregate amount exceeding $40,000 during the preceding 12 months.
The term does not include a provider of services (as specified in
489.2(b) of this chapter), a health maintenance organization (as defined
in section 1301(a) of the Public Health Service Act), a hospital
cooperative shared services organization meeting the requirements of
section 501(e) of the Internal Revenue Code of 1954, or any public
entity.
Third party is defined in 433.135 of this chapter.
(c) State plan requirements. A State plan must (1) provide that the
requirements of paragraphs (d), (e)(2), (f) and (g) of this section are
met; and
(2) Specify the definition of a claim, as provided in paragraph (b)
of this section, to be used in meeting the requirements for timely
claims payment. The definition may vary by type of service (e.g.,
physician service, hospital service).
(d) Timely processing of claims. (1) The Medicaid agency must
require providers to submit all claims no later than 12 months from the
date of service.
(2) The agency must pay 90 percent of all clean claims from
practitioners, who are in individual or group practice or who practice
in shared health facilities, within 30 days of the date of receipt.
(3) The agency must pay 99 percent of all clean claims from
practitioners, who are in individual or group practice or who practice
in shared health facilities, within 90 days of the date of receipt.
(4) The agency must pay all other claims within 12 months of the date
of receipt, except in the following circumstances:
(i) This time limitation does not apply to retroactive adjustments
paid to providers who are reimbursed under a retrospective payment
system, as defined in 447.272 of this part.
(ii) If a claim for payment under Medicare has been filed in a timely
manner, the agency may pay a Medicaid claim relating to the same
services within 6 months after the agency or the provider receives
notice of the disposition of the Medicare claim.
(iii) The time limitation does not apply to claims from providers
under investigation for fraud or abuse.
(iv) The agency may make payments at any time in accordance with a
court order, to carry out hearing decisions or agency corrective actions
taken to resolve a dispute, or to extend the benefits of a hearing
decision, corrective action, or court order to others in the same
situation as those directly affected by it.
(5) The date of receipt is the date the agency receives the claim, as
indicated by its date stamp on the claim.
(6) The date of payment is the date of the check or other form of
payment.
(e) Waivers. (1) The Administrator may waive the requirements of
paragraphs (d) (2) and (3) of this section upon request by an agency if
he finds that the agency has shown good faith in trying to meet them.
In deciding whether the agency has shown good faith, the Administrator
will consider whether the agency has received an unusually high volume
of claims which are not clean claims, and whether the agency is making
diligent efforts to implement an automated claims processing and
information retrieval system.
(2) The agency's request for a waiver must contain a written plan of
correction specifying all steps it will take to meet the requirements of
this section.
(3) The Administrator will review each case and if he approves a
waiver, will specify its expiration date, based on the State's
capability and efforts to meet the requirements of this section.
(f) Prepayment and postpayment claims review. (1) For all claims,
the agency must conduct prepayment claims review consisting of --
(i) Verification that the recipient was included in the eligibility
file and that the provider was authorized to furnish the service at the
time the service was furnished;
(ii) Checks that the number of visits and services delivered are
logically consistent with the recipient's characteristics and
circumstances, such as type of illness, age, sex, service location;
(iii) Verification that the claim does not duplicate or conflict with
one reviewed previously or currently being reviewed;
(iv) Verification that a payment does not exceed any reimbursement
rates or limits in the State plan; and
(v) Checks for third party liability within the requirements of
433.137 of this chapter.
(2) The agency must conduct post-payment claims review that meets the
requirements of parts 455 and 456 of this chapter, dealing with fraud
and utilization control.
(g) Reports. The agency must provide any reports and documentation
on compliance with this section that the Administrator may require.
(Secs. 1102 and 1902(a)(37) of the Social Security Act (42 U.S.C.
1302, 1396a(a)(37)))
(44 FR 30344, May 25, 1979, as amended at 55 FR 1434, Jan. 16, 1990)
42 CFR 447.45 Cost Sharing
42 CFR 447.50 Cost sharing: Basis and purpose.
(a) Section 1902(a)(14) of the Act permits States to require certain
recipients to share some of the costs of Medicaid by imposing upon them
such payments as enrollment fees, premiums, deductibles, coinsurance,
co-payments, or similar cost sharing charges. For States that impose
cost sharing payments, 447.51 through 447.59 prescribe State plan
requirements and options for cost sharing, specify the standards and
conditions under which States may impose cost sharing, set forth minimum
amounts and the methods for determining maximum amounts, and prescribe
conditions for FFP that relate to cost sharing requirements.
42 CFR 447.50 enrollment fee, premium or similar cost sharing charge
42 CFR 447.51 Requirements and options.
(a) The plan must provide that the Medicaid agency does not impose
any enrollment fee, premium, or similar charge upon categorically needy
individuals, as defined in 435.4 and 436.3 of this subchapter, for any
services available under the plan.
(b) The plan may impose an enrollment fee, premium, or similar charge
on medically needy individuals, as defined in 435.4 and 436.3 of this
subchapter, for any services available under the plan.
(c) For each charge imposed under paragraph (b) of this section, the
plan must specify --
(1) The amount of the charge;
(2) The period of liability for the charge; and
(3) The consequences for an individual who does not pay.
(d) The plan must provide that any charge imposed under paragraph (b)
of this section is related to total gross family income as set forth
under 447.52.
42 CFR 447.52 Minimum and maximum income-related charges.
For the purpose of relating the amount of an enrollment fee, premium,
or similar charge to total gross family income, as required under
447.51(d), the following rules apply:
(a) Minimum charge. A charge of at least $1.00 per month is imposed
on each --
(1) One- or two-person family with monthly gross income of $150 or
less;
(2) Three- or four-person family with monthly gross income of $300 or
less; and
(3) Five- or more-person family with monthly gross income of $350 or
less.
(b) Maximum charge. Any charge related to gross family income that
is above the minimum listed in paragraph (a) of this section may not
exceed the standards shown in the following table:
(c) Income-related charges. The agency must impose an appropriately
higher charge for each higher level of family income, within the maximum
amounts specified in paragraph (b) of this section.
(43 FR 45253, Sept. 29, 1978, as amended at 45 FR 24889, Apr. 11,
1980)
42 CFR 447.52 deductible, coinsurance, co-payment or similar cost-sharing charge
42 CFR 447.53 Applicability; specification; multiple charges.
(a) Basic requirements. Except as specified in paragraph (b) of this
section, the plan may impose a nominal deductible, coinsurance,
copayment, or similar charge upon categorically and medically needy
individuals for any service under the plan.
(b) Exclusions from cost sharing. The plan may not provide for
impositions of a deductible, coinsurance, copayment, or similar charge
upon categorically or medically needy individuals (except as specified
in paragraph (b)(6) of this section) for the following:
(1) Children. Services furnished to individuals under 18 years of
age (and, at the option of the State, individuals under 21, 20, or 19
years of age, or any reasonable category of individuals 18 years of age
or over but under 21) are excluded from cost sharing.
(2) Pregnant women. Services furnished to pregnant women if such
services related to the pregnancy, or to any other medical condition
which may complicate the pregnancy are excluded from cost sharing
obligations. These services include routine prenatal care, labor and
delivery, routine post-partum care, family planning services,
complications of pregnancy or delivery likely to affect the pregnancy,
such as hypertension, diabetes, urinary tract infection, and services
furnished during the postpartum period for conditions or complications
related to the pregnancy. The postpartum period is the immediate
postpartum period which begins on the last day of pregnancy and extends
through the end of the month in which the 60-day period following
termination of pregnancy ends. States may further exclude from cost
sharing all services furnished to pregnant women if they desire.
(3) Institutionalized individuals. Services furnished to any
individual who is an inpatient in a hospital, long-term care facility,
or other medical institution if the individual is required (pursuant to
435.725, 435,733, 435.832, or 436.832), as a condition of receiving
services in the institution, to spend all but a minimal amount of his
income required for personal needs, for medical care costs are excluded
from cost sharing.
(4) Emergency services. Services provided in a hospital, clinic,
office, or other facility that is equipped to furnish the required care,
after the sudden onset of a medical condition manifesting itself by
acute symptoms of sufficient severity (including severe pain) that the
absence of immediate medical attention could reasonably be expected to
result in --
(i) Placing the patient's health in serious jeopardy;
(ii) Serious impairment to bodily functions; or
(iii) Serious dysfunction of any bodily organ or part.
(5) Family planning. Family planning services and supplies furnished
to individuals of child-bearing age are excluded from cost sharing.
(6) HMO Enrollees. Services furnished by a health maintenance
organization (HMO) to categorically needy individuals enrolled in the
HMO are excluded from cost sharing. States may further exclude
copayment charges for HMO services furnished to medically needy
individuals.
(c) Prohibition against multiple charges. For any service, the plan
may not impose more than one type of charge referred to in paragraph (a)
of this section.
(d) State plan specifications. For each charge imposed under this
section, the plan must specify --
(1) The service for which the charge is made;
(2) The amount of the charge;
(3) The basis for determining the charge;
(4) The basis for determining whether an individual is unable to pay
the charge and the means by which such an individual will be identified
to providers; and
(5) The procedures for implementing and enforcing the exclusions from
cost sharing found in paragraph (b) of this section.
(43 FR 45253, Sept. 29, 1978, as amended at 47 FR 21051, May 17,
1982; 48 FR 5736, Jan. 8, 1983; 50 FR 23013, May 30, 1985; 55 FR
48611, Nov. 21, 1990; 55 FR 52130, Dec. 19, 1990)
42 CFR 447.54 Maximum allowable charges.
(a) Non-institutional services. Except as specified in paragraph
(b), for non-institutional services, the plan must provide that --
(1) Any deductible it imposes does not exceed $2.00 per month per
family for each period of Medicaid eligibility. For example, if
Medicaid eligibility is certified for a 3-month period, the maximum
deductible which may be imposed on a family for that period of
eligibility is $6.00;
(2) Any coinsurance rate it imposes does not exceed 5 percent of the
payment the agency makes for the services; and
(3) Any co-payments it imposes do not exceed the amounts shown in the
following table:
(b) Waiver of the requirement that cost sharing amounts be nominal.
Upon approval from HCFA, the requirement that cost sharing charges must
be nominal may be waived, in accordance with section 431.55(g) for
nonemergency services furnished in a hospital emergency room.
(c) Institutional services. For institutional services, the plan
must provide that the maximum deductible, coinsurance or co-payment
charge for each admission does not exceed 50 percent of the payment the
agency makes for the first day of care in the institution.
(d) Cumulative maximum. The plan may provide for a cumulative
maximum amount for all deductible, coinsurance or co-payment charges
that it imposes on any family during a specified period of time.
(48 FR 5736, Jan. 8, 1983)
42 CFR 447.55 Standard co-payment.
(a) The plan may provide for a standard, or fixed, co-payment amount
for any service.
(b) This standard copayment amount for any service may be determined
by applying the maximum co-payment amounts specified in 447.54 (a) and
(b) to the agency's average or typical payment for that service. For
example, if the agency's typical payment for prescribed drugs is $4 to
$5 per prescription, the agency might set a standard copayment of $0.50
per prescription.
42 CFR 447.56 Income-related charges.
Subject to the maximum allowable charges specified in 447.54 (a) and
(b), the plan may provide for income-related deductible, coinsurance or
co-payment charges. For example, an agency may impose a higher charge
on medically needy recipients than it imposes upon categorically needy
recipients.
42 CFR 447.57 Restrictions on payments to providers.
(a) The plan must provide that the agency does not increase the
payment it makes to any provider to offset uncollected amounts for
deductibles, coinsurance, copayments or similar charges that the
provider has waived or are uncollectable, except as permitted under
paragraph (b) of this section.
(b) For those providers that the agency reimburses under Medicare
reasonable cost reimbursement principles, in accordance with subpart B
of this part, an agency may increase its payment to offset uncollected
deductible, coinsurance, copayment, or similar charges that are bad
debts of providers.
42 CFR 447.58 Payments to prepaid capitation organizations.
Except for HMO services subject to the co-payment exclusion in
447.53(b)(6), if the agency contracts with a prepaid capitation
organization that does not impose the agency's deductibles, coinsurance,
co-payments or similar charges on its recipient members, the plan must
provide that the agency calculates its payments to the organization as
if those cost sharing charges were collected.
(48 FR 5736, Jan. 8, 1983)
42 CFR 447.58 federal financial participation
42 CFR 447.59 FFP: Conditions relating to cost sharing.
No FFP in the State's expenditures for services is available for --
(a) Any cost sharing amounts that recipients should have paid as
enrollment fees, premiums, deductibles, coinsurance, copayments, or
similar charges under 447.50 through 447.58 (except for amounts that
the agency pays as bad debts of providers under 447.57); and
(b) Any amounts paid by the agency on behalf of ineligible
individuals, whether or not the individual had paid any required premium
or enrollment fee.
42 CFR 447.59 Subpart B -- Payment Methods: General Provisions
42 CFR 447.200 Basis and purpose.
This subpart prescribes State plan requirements for setting payment
rates to implement, in part, section 1902(a)(30) of the Act, which
requires that payments for services be consistent with efficiency,
economy, and quality of care.
(46 FR 48560, Oct. 1, 1981)
42 CFR 447.201 State plan requirements.
(a) A State plan must provide that the requirements in this subpart
are met.
(b) The plan must describe the policy and the methods to be used in
setting payment rates for each type of service included in the State's
Medicaid program.
42 CFR 447.202 Audits.
The Medicaid agency must assure appropriate audit of records if
payment is based on costs of services or on a fee plus cost of
materials.
42 CFR 447.203 Documentation of payment rates.
(a) The agency must maintain documentation of payment rates and make
it available to HHS upon request.
(b) The agency must record, in State manuals or other official files,
the following information for increases in payment rates for individual
practitioner services:
(1) An estimate of the percentile of the range of customary charges
to which the revised payment structure equates and a description of the
methods used to make the estimate.
(2) An estimate of the composite average percentage increase of the
revised payment rates over the preceding rates.
42 CFR 447.204 Encouragement of provider participation.
The agency's payments must be sufficient to enlist enough providers
so that services under the plan are available to recipients at least to
the extent that those services are available to the general population.
42 CFR 447.205 Public notice of changes in Statewide methods and
standards for setting payment rates.
(a) When notice is required. Except as specified in paragraph (b) of
this section, the agency must provide public notice of any significant
proposed change in its methods and standards for setting payment rates
for services.
(b) When notice is not required. Notice is not required if --
(1) The change is being made to conform to Medicare methods or levels
of reimbursement;
(2) The change is required by court order; or
(3) The change is based on changes in wholesalers' or manufacturers'
prices of drugs or materials, if the agency's reimbursement system is
based on material cost plus a professional fee.
(c) Content of notice. The notice must --
(1) Describe the proposed change in methods and standards;
(2) Give an estimate of any expected increase or decrease in annual
aggregate expenditures;
(3) Explain why the agency is changing its methods and standards;
(4) Identify a local agency in each county (such as the social
services agency or health department) where copies of the proposed
changes are available for public review;
(5) Give an address where written comments may be sent and reviewed
by the public; and
(6) If there are public hearings, give the location, date and time
for hearings or tell how this information may be obtained.
(d) Publication of notice. The notice must --
(1) Be published before the proposed effective date of the change;
and
(2) Appear as a public announcement in one of the following
publications:
(i) A State register similar to the Federal Register.
(ii) The newspaper of widest circulation in each city with a
population of 50,000 or more.
(iii) The newspaper of widest circulation in the State, if there is
no city with a population of 50,000 or more.
(46 FR 58680, Dec. 3, 1981; 47 FR 8567, Mar. 1, 1982, as amended at
48 FR 56057, Dec. 19, 1983)
42 CFR 447.205 Subpart C -- Payment for Inpatient Hospital and
Long-Term Care Facility Services
Source: 46 FR 47971, Sept. 30, 1981, unless otherwise noted.
42 CFR 447.250 Basis and purpose.
(a) This subpart implements section 1902(a)(13)(A) of the Act, which
requires that the State plan provide for payment for hospital and
long-term care facility services through the use of rates that the State
finds, and makes assurances satisfactory to the Secretary, are
reasonable and adequate to meet the costs that must be incurred by
efficiently and economically operated facilities to provide services in
conformity with State and Federal laws, regulations, and quality and
safety standards.
(b) Section 447.253(a)(2) implements section 1902(a)(30) of the Act,
which requires that payments be consistent with efficiency, economy, and
quality of care;
(c) Sections 447.253 (c) and (d) implement sections 1902(a)(13)(B)
and 1902(a)(13)(C) of the Act, which require a State Medicaid agency to
make certain assurances to the Secretary regarding increases in payments
resulting solely from changes in ownerships of hospitals, NFs, and
ICFs/MR.
(d) Section 447.271 implements section 1903(i)(3) of the Act, which
requires that payments for inpatient hospital services not exceed the
hospital's customary charges.
(e) Section 447.280 implements section 1913(b) of the Act, which
concerns reimbursement for long-term care services furnished by
swing-bed hospitals.
(48 FR 56057, Dec. 19, 1983, as amended at 57 FR 43921, Sept. 23,
1992)
Effective Date Note: At 57 FR 43921, Sept. 23, 1992, in 447.250,
paragraphs (c) and (d) were redesignated as (d) and (e) and a new (c)
added, effective October 23, 1992.
42 CFR 447.250 Payment Rates
42 CFR 447.251 Definitions.
For the purposes of this subpart --
Long-term care facility services means intermediate care facility
services for the mentally retarded (ICF/MR) and nursing facility (NF)
services.
Provider means an institution that furnishes inpatient hospital
services or an institution that furnishes long-term care facility
services.
(46 FR 47971, Sept. 30, 1981, as amended at 54 FR 5359, Feb. 2, 1989;
56 FR 48867, Sept. 26, 1991)
42 CFR 447.252 State plan requirements.
(a) The plan must provide that the requirements of this subpart are
met.
(b) The plan must specify comprehensively the methods and standards
used by the agency to set payment rates in a manner consistent with
430.10 of this chapter.
(c) If the agency chooses to apply the cost limits established under
Medicare (see 413.30 of this chapter) on an individual provider basis,
the plan must specify this requirement.
(Approved by the Office of Management and Budget under control number
0938-0193)
(48 FR 56058, Dec. 19, 1983, as amended at 51 FR 34833, Sept. 30,
1986)
42 CFR 447.253 Other requirements.
(a) State assurances. In order to receive HCFA approval of a State
plan change in payment methods and standards, the Medicaid agency must
make assurances satisfactory to HCFA that the requirements set forth in
paragraphs (b) through (i) of this section are being met, must submit
the related information required by 447.255 of this subpart, and must
comply with all other requirements of this subpart.
(b) Findings. Whenever the Medicaid agency makes a change in its
methods and standards, but not less often than annually, the agency must
make the following findings:
(1) Payment rates. (i) The Medicaid agency pays for inpatient
hospital services and long-term care facility services through the use
of rates that are reasonable and adequate to meet the costs that must be
incurred by efficiently and economically operated providers to provide
services in conformity with applicable State and Federal laws,
regulations, and quality and safety standards.
(ii) With respect to inpatient hospital services --
(A) The methods and standards used to determine payment rates take
into account the situation of hospitals which serve a disproportionate
number of low income patients with special needs;
(B) If a State elects in its State plan to cover inappropriate level
of care services (that is, services furnished to hospital inpatients who
require a lower covered level of care such as skilled nursing or
intermediate care services) under conditions similar to those described
in section 1861(v)(1)(G) of the Act, the methods and standards used to
determine payment rates must specify that the payments for this type of
care must be made at rates lower than those for inpatient hospital level
of care services, reflecting the level of care actually received, in a
manner consistent with section 1861(v)(1)(G) of the Act; and
(C) The payment rates are adequate to assure that recipients have
reasonable access, taking into account geographic location and
reasonable travel time, to inpatient hospital services of adequate
quality.
(iii) With respect to nursing facility services --
(A) Except for preadmission screening for individuals with mental
illness and mental retardation under 483.20(f) of this Chapter, the
methods and standards used to determine payment rates take into account
the costs of complying with the requirements of part 483 subpart B of
this chapter;
(B) The methods and standards used to determine payment rates provide
for an appropriate reduction to take into account the lower costs (if
any) of the facility for nursing care under a waiver of the requirement
in 483.30(c) of this Chapter to provide licensed nurses on a 24-hour
basis;
(C) The State establishes procedures under which the data and
methodology used in establishing payment rates are made available to the
public.
(2) Upper payment limits. The agency's proposed payment rate will
not exceed the upper payment limits as specified in 447.272.
(c) Changes in ownership of hospitals. In determining payment when
there has been a sale or transfer of the assets of a hospital, the
State's methods and standards must provide that payment rates can
reasonably be expected not to increase in the aggregate solely as a
result of changes of ownership, more than the payments would increase
under Medicare under 413.130, 413.134, 413.153, and 413.157 of this
chapter, insofar as these sections affect payments for depreciation,
interest on capital indebtedness, return on equity capital (if
applicable), acquisition costs for which payments were previously made
to prior owners, and the recapture of depreciation.
(d) Changes in ownership of NFs and ICFs/MR. In determining payment
when there has been a sale or transfer of assets of an NF or ICF/MR, the
State's methods and standards must provide the following depending upon
the date of the transfer.
(1) For transfers on or after July 18, 1984 but before October 1,
1985, the State's methods and standards must provide that payment rates
can reasonably be expected not to increase in the aggregate, solely as
the result of a change in ownership, more than payments would increase
under Medicare under 413.130, 413.134, 413.153 and 413.157 of this
chapter, insofar as these sections affect payment for depreciation,
interest on capital indebtedness, return on equity capital (if
applicable), acquisition costs for which payments were previously made
to prior owners, and the recapture of depreciation.
(2) For transfers on or after October 1, 1985, the State's methods
and standards must provide that the valuation of capital assets for
purposes of determining payment rates for NFs and ICFs/MR is not to
increase (as measured from the date of acquisition by the seller to the
date of the change of ownership) solely as a result of a change of
ownership, by more than the lesser of --
(i) One-half of the percentage increase (as measured from the date of
acquisition by the seller to the date of the change of ownership, or, if
necessary, as extrapolated retrospectively by the Secretary) in the
Dodge construction index applied in the aggregate with respect to those
facilities that have undergone a change of ownership during the fiscal
year; or
(ii) One-half of the percentage increase (as measured from the date
of acquisition by the seller to the date of the change of ownership) in
the Consumer Price Index for All Urban Consumers (CPI-U) (United States
city average) applied in the aggregate with respect to those facilities
that have undergone a change of ownership during the fiscal year.
(e) Provider appeals. The Medicaid agency must provide an appeals or
exception procedure that allows individual providers an opportunity to
submit additional evidence and receive prompt administrative review,
with respect to such issues as the agency determines appropriate, of
payment rates.
(f) Uniform cost reporting. The Medicaid agency must provide for the
filing of uniform cost reports by each participating provider.
(g) Audit requirements. The Medicaid agency must provide for
periodic audits of the financial and statistical records of
participating providers.
(h) Public notice. The Medicaid agency must provide that it has
complied with the public notice requirements in 447.205 of this part
when it is proposing significant changes to its methods or standards for
setting payment rates for inpatient hospital or LTC facility services.
(i) Rates paid. The Medicaid agency must pay for inpatient hospital
and long term care services using rates determined in accordance with
methods and standards specified in an approved State plan.
(48 FR 56057, Dec. 19, 1983, as amended at 52 FR 28147, July 28,
1987; 54 FR 5359, Feb. 2, 1989; 57 FR 43921, Sept. 23, 1992)
Editorial Note: At 52 FR 28147, July 28, 1987, 447.253 was amended,
paragraph (b) contains information collection requirements which will
not become effective until approval has been obtained from the Office of
Management and Budget. HCFA will publish a notice in the Federal
Register once approval has been obtained.
Effective Date Note: At 57 FR 43921, Sept. 23, 1992, in 447.253
paragraph (a) was amended by changing the phrase ''paragraphs (b)
through (g)'' to read ''paragraphs (b) through (i)'', paragraphs (c)
through (g) were redesignated as (e) through (i), respectively, and new
paragraphs (c) and (d) were added, effective October 23, 1992.
42 CFR 447.255 Related information.
The Medicaid agency must submit, with the assurances described in
447.253(a), the following information:
(a) The amount of the estimated average proposed payment rate for
each type of provider (hospital, ICF/MR, or nursing facility), and the
amount by which that estimated average rate increased or decreased
relative to the average payment rate in effect for each type of provider
for the immediately preceding rate period;
(b) An estimate of the short-term and, to the extent feasible,
long-term effect the change in the estimated average rate will have on
--
(1) The availability of services on a Statewide and geographic area
basis;
(2) The type of care furnished;
(3) The extent of provider participation; and
(4) The degree to which costs are covered in hospitals that serve a
disproportionate number of low income patients with special needs.
(48 FR 56058, Dec. 19, 1983, as amended at 54 FR 5359, Feb. 2, 1989;
56 FR 48867, Sept. 26, 1991; 57 FR 43924, Sept. 23, 1992)
42 CFR 447.256 Procedures for HCFA action on assurances and State plan
amendments.
(a) Criteria for approval. (1) HCFA approval action on State plans
and State plan amendments, is taken in accordance with subpart B of part
430 of this chapter and sections 1116, 1902(b) and 1915(f) of the Act.
(2) In the case of State plan and plan amendment changes in payment
methods and standards, HCFA bases its approval on the acceptability of
the Medicaid agency's assurances that the requirements of 447.253 have
been met, and the State's compliance with the other requirements of this
subpart.
(b) Time limit. HCFA will send a notice to the agency of its
determination as to whether the assurances regarding a State plan
amendment are acceptable within 90 days of the date HCFA receives the
assurances described in 447.253, and the related information described
in 447.255 of this subpart. If HCFA does not send a notice to the
agency of its determination within this time limit and the provisions in
paragraph (a) of this section are met, the assurances and/or the State
plan amendment will be deemed accepted and approved.
(c) Effective date. A State plan amendment that is approved will
become effective not earlier than the first day of the calendar quarter
in which an approvable amendment is submitted in accordance with 430.20
of this chapter and 447.253.
(48 FR 56058, Dec. 19, 1983, as amended at 52 FR 28147, July 28,
1987)
42 CFR 447.256 Federal Financial Participation
42 CFR 447.257 FFP: Conditions relating to institutional
reimbursement.
FFP is not available for a State's expenditures for hospital
inpatient or long-term care facility services that are in excess of the
amounts allowable under this subpart.
(52 FR 28147, July 28, 1987)
42 CFR 447.257 Upper Limits
42 CFR 447.271 Upper limits based on customary charges.
(a) Except as provided in paragraph (b) of this section, the agency
may not pay a provider more for inpatient hospital services under
Medicaid than the provider's customary charges to the general public for
the services.
(b) The agency may pay a public provider that provides services free
or at a nominal charge at the same rate that would be used if the
provider's charges were equal to or greater than its costs.
42 CFR 447.272 Application of upper payment limits.
(a) General rule. Except as provided in paragraph (c) of this
section, aggregate payments by an agency to each group of health care
facilities (that is, hospitals, nursing facilities and ICFs for the
mentally retarded (ICFs/MR)), may not exceed the amount that can
reasonably be estimated would have been paid for those services under
Medicare payment principles.
(b) State operated facilities. In addition to meeting the
requirement of paragraph (a) of this section, aggregate payments to each
group of State-operated facilities (that is, hospitals, nursing
facilities and ICFs/MR) may not exceed the amount that can reasonably be
estimated would have been paid under Medicare payment principles.
(c) Exception. The upper payment limitation established under
paragraphs (a) and (b) of this section does not apply to payment
adjustments made under a State plan to hospitals found to serve a
disproportionate number of low income patients with special needs, as
provided in 447.253(b)(1)(ii)(A).
(52 FR 28147, July 28, 1987, as amended at 54 FR 5359, Feb. 2, 1989;
56 FR 48867, Sept. 26, 1991; 57 FR 43924, Sept. 23, 1992)
42 CFR 447.272 Swing-Bed Hospitals
42 CFR 447.280 Hospital providers of SNF and ICF services (swing-bed
hospitals).
(a) General rule. If the State plan provides for SNF or ICF services
furnished by a swing-bed hospital, as specified in 440.40(a) and
440.150(f) of this chapter, the methods and standards used to determine
payment rates for routine SNF or ICF services must --
(1) Provide for payment at the average rate per patient day paid to
SNFs or ICFs, other than ICFs/MR, as applicable, for routine services
furnished during the previous calendar year; or
(2) Meet the State plan and payment requirements described in this
subpart, as applicable.
(b) Application of the rule. The payment methodology used by a State
to set payment rates for routine SNF or ICF services must apply to all
swing-bed hospitals in the State.
(52 FR 28148, July 28, 1987)
42 CFR 447.280 Subpart D -- Payment Methods for Other Institutional and
Noninstitutional Services
Source: 43 FR 45253, Sept. 29, 1978, unless otherwise noted.
Redesignated at 46 FR 47973, Sept. 30, 1981.
42 CFR 447.300 Basis and purpose.
In this subpart, 447.302 through 447.334 and 447.361 implement
section 1902(a)(30) of the Act, which requires that payments be
consistent with efficiency, economy and quality of care. Section
447.342 of this subpart implements section 1902(a)(43) of the Act, which
permits the State plan to provide for payment to a physician for
laboratory services which the physician did not personally perform or
supervise. Section 447.371 implements section 1902(a)(13)(F) of the
Act, which requires that the State plan provide for payment for rural
health clinic services in accordance with regulations prescribed by the
Secretary.
(46 FR 48560, Oct. 1, 1981)
42 CFR 447.301 Definitions.
For the purposes of this subpart --
Brand name means any registered trade name commonly used to identify
a drug.
Estimated acquisition cost means the agency's best estimate of the
price generally and currently paid by providers for a drug marketed or
sold by a particular manufacturer or labeler in the package size of drug
most frequently purchased by providers.
Multiple source drug means a drug marketed or sold by two or more
manufacturers or labelers or a drug marketed or sold by the same
manufacturer or labeler under two or more different proprietary names or
both under a proprietary name and without such a name.
(52 FR 28657, July 31, 1987)
42 CFR 447.302 State plan requirements.
A State plan must provide that the requirements of this subpart are
met.
(46 FR 48560, Oct. 1, 1981)
42 CFR 447.304 Adherence to upper limits; FFP.
(a) The Medicaid agency must not pay more than the upper limits
described in this subpart.
(b) In the case of payments made under the plan for deductibles and
coinsurance payable on an assigned Medicare claim for noninstitutional
services, those payments may be made only up to the reasonable charge
under Medicare.
(c) FFP is available in expenditures for payments for services that
do not exceed the upper limits.
Note: The Secretary may waive any limitation on reimbursement
imposed by Subpart D of this part for experiments conducted under
section 402 of Pub. L. 90-428, Incentives for Economy Experimentation,
as amended by section 222(b) of Pub. L. 92-603, and under section
222(a) of Pub. L. 92-603.
(46 FR 48560, Oct. 1, 1981; 46 FR 54744, Nov. 4, 1981)
42 CFR 447.304 Outpatient Hospital and Clinic Services
42 CFR 447.321 Outpatient hospital services and clinic services: Upper
limits of payment.
(a) General rule. FFP is not available for any payment that exceeds
the amount that would be payable to providers under comparable
circumstances under Medicare.
(b) Application of the rule. Payments by an agency for outpatient
hospital services may not exceed the total payments received by all
providers from beneficiaries and carriers or intermediaries for
providing comparable services under comparable circumstances under
Medicare.
(52 FR 28148, July 28, 1987)
42 CFR 447.321 Other Inpatient and Outpatient Facilities
42 CFR 447.325 Other inpatient and outpatient facility services: Upper
limits of payment.
The agency may pay the customary charges of the provider but must not
pay more than the prevailing charges in the locality for comparable
services under comparable circumstances.
42 CFR 447.325 Drugs
42 CFR 447.331 Drugs: Aggregate upper limits of payment.
(a) Multiple source drugs. Except for brand name drugs that are
certified in accordance with paragraph (c) of this section, the agency
payment for multiple source drugs must not exceed, the amount that would
result from the application of the specific limits established in
accordance with 447.332. If a specific limit has not been established
under 447.332, then the rule for ''other drugs'' set forth in paragraph
(b) applies.
(b) Other drugs. The agency payments for brand name drugs certified
in accordance with paragraph (c) of this section and drugs other than
multiple source drugs for which a specific limit has been established
under 447.332 must not exceed in the aggregate, payment levels that the
agency has determined by applying the lower of the --
(1) Estimated acquisition costs plus reasonable dispensing fees
established by the agency; or
(2) Providers' usual and customary charges to the general public.
(c) Certification of brand name drugs. (1) The upper limit for
payment for multiple source drugs for which a specific limit has been
established under 447.332 does not apply if a physician certifies in
his or her own handwriting that a specific brand is medically necessary
for a particular recipient.
(2) The agency must decide what certification form and procedure are
used.
(3) A checkoff box on a form is not acceptable but a notation like
''brand necessary'' is allowable.
(4) The agency may allow providers to keep the certification forms if
the forms will be available for inspection by the agency or HHS.
(52 FR 28657, July 31, 1987)
42 CFR 447.332 Upper limits for multiple source drugs.
(a) Establishment and issuance of a listing. (1) HCFA will establish
listings that identify and set upper limits for multiple source drugs
that meet the following requirements:
(i) All of the formulations of the drug approved by the Food and Drug
Administration (FDA) have been evaluated as therapeutically equivalent
in the most current edition of their publication, Approved Drug Products
with Therapeutic Equivalence Evaluations (including supplements or in
successor publications).
(ii) At least three suppliers list the drug (which has been
classified by the FDA as category ''A'' in its publication, Approved
Drug Products with Therapeutic Equivalence Evaluations, including
supplements or in successor publications) based on all listings
contained in current editions (or updates) of published compendia of
cost information for drugs available for sale nationally.
(2) HCFA publishes the list of multiple source drugs for which upper
limits have been established and any revisions to the list in Medicaid
program instructions.
(3) HCFA will identify the sources used in compiling these lists.
(b) Specific upper limits. The agency's payments for multiple source
drugs identified and listed in accordance with paragraph (a) of this
section must not exceed, in the aggregate, payment levels determined by
applying for each drug entity a reasonable dispensing fee established by
the agency plus an amount established by HCFA that is equal to 150
percent of the published price for the least costly therapeutic
equivalent (using all available national compendia) that can be
purchased by pharmacists in quantities of 100 tablets or capsules (or,
if the drug is not commonly available in quantities of 100, the package
size commonly listed) or, in the case of liquids, the commonly listed
size.
(52 FR 28658, July 31, 1987)
42 CFR 447.333 State plan requirements, findings and assurances.
(a) State plan. The State plan must describe comprehensively the
agency's payment methodology for prescription drugs.
(b) Findings and assurances. Upon proposing significant State plan
changes in payments for prescription drugs, and at least annually for
multiple source drugs and triennially for all other drugs, the agency
must make the following findings and assurances:
(1) Findings. The agency must make the following separate and
distinct findings:
(i) In the aggregate, its Medicaid expenditures for multiple source
drugs, identified and listed in accordance with 447.332(a) of this
subpart, are in accordance with the upper limits specified in
447.332(b) of this subpart; and
(ii) In the aggregate, its Medicaid expenditures for all other drugs
are in accordance with 447.331 of this subpart.
(2) Assurances. The agency must make assurances satisfactory to HCFA
that the requirements set forth in 447.331 and 447.332 concerning
upper limits and in paragraph (b)(1) of this section concerning agency
findings are met.
(c) Recordkeeping. The agency must maintain and make available to
HCFA, upon request, data, mathematical or statistical computations,
comparisons, and any other pertinent records to support its findings and
assurances.
(52 FR 28658, July 31, 1987)
42 CFR 447.334 Upper limits for drugs furnished as part of services.
The upper limits for payment for prescribed drugs in this subpart
also apply to payment for drugs provided as part of skilled nursing
facility services and intermediate care facility services and under
prepaid capitation arrangements.
42 CFR 447.334 Clinical Laboratory Services
42 CFR 447.342 Physician billing for clinical laboratory services.
(a) This section applies when a State plan provides for payments to
physicians for clinical laboratory services.
(b) (Reserved)
(c) A state plan may provide for payment to a physician who bills for
clinical laboratory services performed by an outside laboratory. Under
these circumstances, the plan must provide that the agency will not pay
the physician more than the amount that would be authorized under
Medicare in accordance with 405.515 (b), (c), and (d) of this chapter.
(46 FR 48560, Oct. 1, 1981)
42 CFR 447.342 Prepaid Capitation Plans
42 CFR 447.361 Upper limits of payment: Risk contract.
Under a risk contract, Medicaid payments to the contractor, for a
defined scope of services to be furnished to a defined number of
recipients, may not exceed the cost to the agency of providing those
same services on a fee-for-service basis, to an actuarially equivalent
nonenrolled population group.
(48 FR 54025, Nov. 30, 1983)
42 CFR 447.362 Upper limits of payment: Nonrisk contract.
Under a nonrisk contract, Medicaid payments to the contractor may not
exceed --
(a) What Medicaid would have paid, on a fee-for-service basis, for
the services actually furnished to recipients: plus
(b) The net savings of administrative costs the Medicaid agency
achieves by contracting with the plan instead of purchasing the services
on a fee-for-service basis.
(48 FR 54025, Nov. 30, 1983)
42 CFR 447.362 Rural Health Clinic Services
42 CFR 447.371 Services furnished by rural health clinics.
The agency must pay for rural health clinic services, as defined in
440.20(b) of this subchapter, and for other ambulatory services
furnished by a rural health clinic, as defined in 440.20(c) of this
subchapter, as follows:
(a) For provider clinics, the agency must pay the reasonable cost of
rural health clinic services and other ambulatory services on the basis
of the cost reimbursement principles in part 413 of this chapter. For
purposes of this section, a provider clinic is an integral part of a
hospital, skilled nursing facility, or home health agency that is
participating in Medicare and is licensed, governed, and supervised with
other departments of the facility.
(b) For clinics other than provider clinics that do not offer any
ambulatory services other than rural health clinic services, the agency
must pay for rural health clinic services at the reasonable cost rate
per visit determined by a Medicare carrier under 405.2426 through
405.2429 of this chapter.
(c) For clinics other than provider clinics that do offer ambulatory
services other than rural health clinic services, the agency must pay
for the other ambulatory services by one of the following methods:
(1) The agency may pay for other ambulatory services and rural health
clinic services at a single rate per visit that is based on the cost of
all services furnished by the clinic. The rate must be determined by a
Medicare carrier under 405.2426 through 405.2429 of this chapter.
(2) The agency may pay for other ambulatory services at a rate set
for each service by the agency. The rate must not exceed the upper
limits in this subpart. The agency must pay for rural health clinic
services at the Medicare reimbursement rate per visit, as specified in
405.2426 of this chapter.
(3) The agency may pay for dental services at a rate per visit that
is based on the cost of dental services furnished by the clinic. The
rate must be determined by a Medicare carrier under 405.2426 through
405.2429 of this chapter. The agency must pay for ambulatory services
other than dental services under paragraph (c) (1) or (2) of this
section.
(d) For purposes of paragraph (c) (1) and (3) of this section,
''visit'' means a face-to-face encounter between a clinic patient and
any health professional whose services are reimbursed under the State
plan. Encounters with more than one health professional, and multiple
encounters with the same health professional, that take place on the
same day and at a single location constitute a single visit, except when
the patient, after the first encounter, suffers illness or injury
requiring additional diagnosis or treatment.
(43 FR 45253, Sept. 29, 1978, as amended at 51 FR 34833, Sept. 30,
1986)
42 CFR 447.371 Pt. 455
42 CFR 447.371 PART 455 -- PROGRAM INTEGRITY: MEDICAID
Sec.
455.1 Basis and scope.
455.2 Definitions.
455.3 Other applicable regulations.
42 CFR 447.371 Subpart A -- Medicaid Agency Fraud Detection and
Investigation Program
455.12 State plan requirement.
455.13 Methods for identification, investigation, and referral.
455.14 Preliminary investigation.
455.15 Full investigation.
455.16 Resolution of full investigation.
455.17 Reporting requirements.
455.18 Provider's statements on claims forms.
455.19 Provider's statement on check.
455.20 Recipient verification procedure.
455.21 Cooperation with State Medicaid fraud control units.
455.23 Withholding of payments in cases of fraud or willful
misrepresentation.
42 CFR 447.371 Subpart B -- Disclosure of Information by Providers and
Fiscal Agents
455.100 Purpose.
455.101 Definitions.
455.102 Determination of ownership or control percentages.
455.103 State plan requirement.
455.104 Disclosure by providers and fiscal agents: Information on
ownership and control.
455.105 Disclosure by providers: Information related to business
transactions.
455.106 Disclosure by providers: Information on persons convicted of
crimes.
Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
Source: 43 FR 45262, Sept. 29, 1978, unless otherwise noted.
42 CFR 455.1 Basis and scope.
This part sets forth requirements for a State fraud detection and
investigation program, and for disclosure of information on ownership
and control.
(a) Under the authority of sections 1902(a)(4), 1903(i)(2), and 1909
of the Social Security Act, Subpart A provides State plan requirements
for the identification, investigation, and referral of suspected fraud
and abuse cases. In addition, the subpart requires that the State --
(1) Report fraud and abuse information to the Department; and
(2) Have a method to verify whether services reimbursed by Medicaid
were actually furnished to recipients.
(b) Subpart B implements sections 1124, 1126, 1902(a)(36),
1903(i)(2), and 1903(n) of the Act. It requires that providers and
fiscal agents must agree to disclose ownership and control information
to the Medicaid State agency.
(51 FR 34787, Sept. 30, 1986)
42 CFR 455.2 Definitions.
As used in this part unless the context indicates otherwise --
Abuse means provider practices that are inconsistent with sound
fiscal, business, or medical practices, and result in an unnecessary
cost to the Medicaid program, or in reimbursement for services that are
not medically necessary or that fail to meet professionally recognized
standards for health care. It also includes recipient practices that
result in unnecessary cost to the Medicaid program.
Conviction or Convicted means that a judgment of conviction has been
entered by a Federal, State, or local court, regardless of whether an
appeal from that judgment is pending.
Exclusion means that items or services furnished by a specific
provider who has defrauded or abused the Medicaid program will not be
reimbursed under Medicaid.
Fraud means an intentional deception or misrepresentation made by a
person with the knowledge that the deception could result in some
unauthorized benefit to himself or some other person. It includes any
act that constitutes fraud under applicable Federal or State law.
Furnished refers to items and services provided directly by, or under
the direct supervision of, or ordered by, a practitioner or other
individual (either as an employee or in his or her own capacity), a
provider, or other supplier of services. (For purposes of denial of
reimbursement within this part, it does not refer to services ordered by
one party but billed for and provided by or under the supervision of
another.)
Practitioner means a physician or other individual licensed under
State law to practice his or her profession.
Suspension means that items or services furnished by a specified
provider who has been convicted of a program-related offense in a
Federal, State, or local court will not be reimbursed under Medicaid.
(48 FR 3755, Jan. 27, 1983, as amended at 50 FR 37375, Sept. 13,
1985; 51 FR 34788, Sept. 30, 1986)
42 CFR 455.3 Other applicable regulations.
Part 1002 of this title sets forth the following:
(a) State plan requirements for excluding providers for fraud and
abuse, and suspending practitioners convicted of program-related crimes.
(b) The limitations on FFP for services furnished by excluded
providers or suspended practitioners.
(c) The requirements and procedures for reinstatement after exclusion
or suspension.
(d) Requirements for the establishment and operation of State
Medicaid fraud control units and the rates of FFP for their fraud
control activities.
(51 FR 34788, Sept. 30, 1986)
42 CFR 455.3 Subpart A -- Medicaid Agency Fraud Detection and Investigation Program
42 CFR 455.12 State plan requirement.
A State plan must meet the requirements of 455.13 through 455.23.
(52 FR 48817, Dec. 28, 1987)
42 CFR 455.13 Methods for identification, investigation, and referral.
The Medicaid agency must have --
(a) Methods and criteria for identifying suspected fraud cases;
(b) Methods for investigating these cases that --
(1) Do not infringe on the legal rights of persons involved; and
(2) Afford due process of law; and
(c) Procedures, developed in cooperation with State legal
authorities, for referring suspected fraud cases to law enforcement
officials.
(43 FR 45262, Sept. 29, 1978, as amended at 48 FR 3755, Jan. 27,
1983)
42 CFR 455.14 Preliminary investigation.
If the agency receives a complaint of Medicaid fraud or abuse from
any source or identifies any questionable practices, it must conduct a
preliminary investigation to determine whether there is sufficient basis
to warrant a full investigation.
(48 FR 3756, Jan. 27, 1983)
42 CFR 455.15 Full investigation.
If the findings of a preliminary investigation give the agency reason
to believe that an incident of fraud or abuse has occurred in the
Medicaid program, the agency must take the following action, as
appropriate:
(a) If a provider is suspected of fraud or abuse, the agency must --
(1) In States with a State Medicaid fraud control unit certified
under subpart C of part 1002 of this title , refer the case to the unit
under the terms of its agreement with the unit entered into under
1002.309 of this title; or
(2) In States with no certified Medicaid fraud control unit, or in
cases where no referral to the State Medicaid fraud control unit is
required under paragraph (a)(1) of this section, conduct a full
investigation or refer the case to the appropriate law enforcement
agency.
(b) If there is reason to believe that a recipient has defrauded the
Medicaid program, the agency must refer the case to an appropriate law
enforcement agency.
(c) If there is reason to believe that a recipient has abused the
Medicaid program, the agency must conduct a full investigation of the
abuse.
(48 FR 3756, Jan. 27, 1983, as amended at 51 FR 34788, Sept. 30,
1986)
42 CFR 455.16 Resolution of full investigation.
A full investigation must continue until --
(a) Appropriate legal action is initiated;
(b) The case is closed or dropped because of insufficient evidence to
support the allegations of fraud or abuse; or
(c) The matter is resolved between the agency and the provider or
recipient. This resolution may include but is not limited to --
(1) Sending a warning letter to the provider or recipient, giving
notice that continuation of the activity in question will result in
further action;
(2) Suspending or terminating the provider from participation in the
Medicaid program;
(3) Seeking recovery of payments made to the provider; or
(4) Imposing other sanctions provided under the State plan.
(43 FR 45262, Sept. 29, 1978, as amended at 48 FR 3756, Jan. 27,
1983)
42 CFR 455.17 Reporting requirements.
The agency must report the following fraud or abuse information to
the appropriate Department officials at intervals prescribed in
instructions.
(a) The number of complaints of fraud and abuse made to the agency
that warrant preliminary investigation.
(b) For each case of suspected provider fraud and abuse that warrants
a full investigation --
(1) The provider's name and number;
(2) The source of the complaint;
(3) The type of provider;
(4) The nature of the complaint;
(5) The approximate range of dollars involved; and
(6) The legal and administrative disposition of the case, including
actions taken by law enforcement officials to whom the case has been
referred.
(Approved by the Office of Management and Budget under control number
0938-0076)
(43 FR 45262, Sept. 29, 1978, as amended at 48 FR 3756, Jan. 27,
1983)
42 CFR 455.18 Provider's statements on claims forms.
(a) Except as provided in 455.19, the agency must provide that all
provider claims forms be imprinted in boldface type with the following
statements, or with alternate wording that is approved by the Regional
HCFA Administrator:
(1) ''This is to certify that the foregoing information is true,
accurate, and complete.''
(2) ''I understand that payment of this claim will be from Federal
and State funds, and that any falsification, or concealment of a
material fact, may be prosecuted under Federal and State laws.''
(b) The statements may be printed above the claimant's signature or,
if they are printed on the reverse of the form, a reference to the
statements must appear immediately preceding the claimant's signature.
42 CFR 455.19 Provider's statement on check.
As an alternative to the statements required in 455.18, the agency
may print the following wording above the claimant's endorsement on the
reverse of checks or warrants payable to each provider: ''I understand
in endorsing or depositing this check that payment will be from Federal
and State funds and that any falsification, or concealment of a material
fact, may be prosecuted under Federal and State laws.''
42 CFR 455.20 Recipient verification procedure.
(a) The agency must have a method for verifying with recipients
whether services billed by providers were received.
(b) In States receiving Federal matching funds for a mechanized
claims processing and information retrieval system under part 433,
subpart C, of this subchapter, the agency must provide prompt written
notice as required by 433.116 (e) and (f).
(48 FR 3756, Jan. 27, 1983, as amended at 56 FR 8854, Mar. 1, 1991)
42 CFR 455.21 Cooperation with State Medicaid fraud control units.
In a State with a Medicaid fraud control unit established and
certified under subpart C of this part,
(a) The agency must --
(1) Refer all cases of suspected provider fraud to the unit;
(2) If the unit determines that it may be useful in carrying out the
unit's responsibilities, promptly comply with a request from the unit
for --
(i) Access to, and free copies of, any records or information kept by
the agency or its contractors;
(ii) Computerized data stored by the agency or its contractors.
These data must be supplied without charge and in the form requested by
the unit; and
(iii) Access to any information kept by providers to which the agency
is authorized access by section 1902(a)(27) of the Act and 431.107 of
this subchapter. In using this information, the unit must protect the
privacy rights of recipients; and
(3) On referral from the unit, initiate any available administrative
or judicial action to recover improper payments to a provider.
(b) The agency need not comply with specific requirements under this
subpart that are the same as the responsibilities placed on the unit
under subpart D of this part.
42 CFR 455.23 Withholding of payments in cases of fraud or willful
misrepresentation.
(a) Basis for withholding. The State Medicaid agency may withhold
Medicaid payments, in whole or in part, to a provider upon receipt of
reliable evidence that the circumstances giving rise to the need for a
withholding of payments involve fraud or willful misrepresentation under
the Medicaid program. The State Medicaid agency may withhold payments
without first notifying the provider of its intention to withhold such
payments. A provider may request, and must be granted, administrative
review where State law so requires.
(b) Notice of withholding. The State agency must send notice of its
withholding of program payments within 5 days of taking such action.
The notice must set forth the general allegations as to the nature of
the withholding action, but need not disclose any specific information
concerning its ongoing investigation. The notice must:
(1) State that payments are being withheld in accordance with this
provision;
(2) State that the withholding is for a temporary period, as stated
in paragraph (c) of this section, and cite the circumstances under which
withholding will be terminated;
(3) Specify, when appropriate, to which type or types of Medicaid
claims withholding is effective; and
(4) Inform the provider of the right to submit written evidence for
consideration by the agency.
(c) Duration of withholding. All withholding of payment actions
under this section will be temporary and will not continue after:
(1) The agency or the prosecuting authorities determine that there is
insufficient evidence of fraud or willful misrepresentation by the
provider; or
(2) Legal proceedings related to the provider's alleged fraud or
willful misrepresentation are completed.
(52 FR 48817, Dec. 28, 1987)
42 CFR 455.23 Subpart B -- Disclosure of Information by Providers and
Fiscal Agents
Source: 44 FR 41644, July 17, 1979, unless otherwise noted.
42 CFR 455.100 Purpose.
This subpart implements sections 1124, 1126, 1902(a)(38), 1903(i)(2),
and 1903(n) of the Social Security Act. It sets forth State plan
requirements regarding --
(a) Disclosure by providers and fiscal agents of ownership and
control information; and
(b) Disclosure of information on a provider's owners and other
persons convicted of criminal offenses against Medicare, Medicaid, or
the title XX services program.
The subpart also specifies conditions under which the Administrator
will deny Federal financial participation for services furnished by
providers or fiscal agents who fail to comply with the disclosure
requirements.
42 CFR 455.101 Definitions.
Agent means any person who has been delegated the authority to
obligate or act on behalf of a provider.
Disclosing entity means a Medicaid provider (other than an individual
practitioner or group of practitioners), or a fiscal agent.
Other disclosing entity means any other Medicaid disclosing entity
and any entity that does not participate in Medicaid, but is required to
disclose certain ownership and control information because of
participation in any of the programs established under title V, XVIII,
or XX of the Act. This includes:
(a) Any hospital, skilled nursing facility, home health agency,
independent clinical laboratory, renal disease facility, rural health
clinic, or health maintenance organization that participates in Medicare
(title XVIII);
(b) Any Medicare intermediary or carrier; and
(c) Any entity (other than an individual practitioner or group of
practitioners) that furnishes, or arranges for the furnishing of,
health-related services for which it claims payment under any plan or
program established under title V or title XX of the Act.
Fiscal agent means a contractor that processes or pays vendor claims
on behalf of the Medicaid agency.
Group of practitioners means two or more health care practitioners
who practice their profession at a common location (whether or not they
share common facilities, common supporting staff, or common equipment).
Indirect ownership interest means an ownership interest in an entity
that has an ownership interest in the disclosing entity. This term
includes an ownership interest in any entity that has an indirect
ownership interest in the disclosing entity.
Managing employee means a general manager, business manager,
administrator, director, or other individual who exercises operational
or managerial control over, or who directly or indirectly conducts the
day-to-day operation of an institution, organization, or agency.
Ownership interest means the possession of equity in the capital, the
stock, or the profits of the disclosing entity.
Person with an ownership or control interest means a person or
corporation that --
(a) Has an ownership interest totaling 5 percent or more in a
disclosing entity;
(b) Has an indirect ownership interest equal to 5 percent or more in
a disclosing entity;
(c) Has a combination of direct and indirect ownership interests
equal to 5 percent or more in a disclosing entity;
(d) Owns an interest of 5 percent or more in any mortgage, deed of
trust, note, or other obligation secured by the disclosing entity if
that interest equals at least 5 percent of the value of the property or
assets of the disclosing entity;
(e) Is an officer or director of a disclosing entity that is
organized as a corporation; or
(f) Is a partner in a disclosing entity that is organized as a
partnership.
Significant business transaction means any business transaction or
series of transactions that, during any one fiscal year, exceed the
lesser of $25,000 and 5 percent of a provider's total operating
expenses.
Subcontractor means --
(a) An individual, agency, or organization to which a disclosing
entity has contracted or delegated some of its management functions or
responsibilities of providing medical care to its patients; or
(b) An individual, agency, or organization with which a fiscal agent
has entered into a contract, agreement, purchase order, or lease (or
leases of real property) to obtain space, supplies, equipment, or
services provided under the Medicaid agreeement.
Supplier means an individual, agency, or organization from which a
provider purchases goods and services used in carrying out its
responsibilities under Medicaid (e.g., a commercial laundry, a
manufacturer of hospital beds, or a pharmaceutical firm).
Wholly owned supplier means a supplier whose total ownership interest
is held by a provider or by a person, persons, or other entity with an
ownership or control interest in a provider.
(44 FR 41644, July 17, 1979, as amended at 51 FR 34788, Sept. 30,
1986)
42 CFR 455.102 Determination of ownership or control percentages.
(a) Indirect ownership interest. The amount of indirect ownership
interest is determined by multiplying the percentages of ownership in
each entity. For example, if A owns 10 percent of the stock in a
corporation which owns 80 percent of the stock of the disclosing entity,
A's interest equates to an 8 percent indirect ownership interest in the
disclosing entity and must be reported. Conversely, if B owns 80
percent of the stock of a corporation which owns 5 percent of the stock
of the disclosing entity, B's interest equates to a 4 percent indirect
ownership interest in the disclosing entity and need not be reported.
(b) Person with an ownership or control interest. In order to
determine percentage of ownership, mortgage, deed of trust, note, or
other obligation, the percentage of interest owned in the obligation is
multiplied by the percentage of the disclosing entity's assets used to
secure the obligation. For example, if A owns 10 percent of a note
secured by 60 percent of the provider's assets, A's interest in the
provider's assets equates to 6 percent and must be reported.
Conversely, if B owns 40 percent of a note secured by 10 percent of the
provider's assets, B's interest in the provider's assets equates to 4
percent and need not be reported.
42 CFR 455.103 State plan requirement.
A State plan must provide that the requirements of 455.104 through
455.106 are met.
42 CFR 455.104 Disclosure by providers and fiscal agents: Information
on ownership and control.
(a) Information that must be disclosed. The Medicaid agency must
require each disclosing entity to disclose the following information in
accordance with paragraph (b) of this section:
(1) The name and address of each person with an ownership or control
interest in the disclosing entity or in any subcontractor in which the
disclosing entity has direct or indirect ownership of 5 percent or more;
(2) Whether any of the persons named, in compliance with paragraph
(a)(1) of this section, is related to another as spouse, parent, child,
or sibling.
(3) The name of any other disclosing entity in which a person with an
ownership or control interest in the disclosing entity also has an
ownership or control interest. This requirement applies to the extent
that the disclosing entity can obtain this information by requesting it
in writing from the person. The disclosing entity must --
(i) Keep copies of all these requests and the responses to them;
(ii) Make them available to the Secretary or the Medicaid agency upon
request; and
(iii) Advise the Medicaid agency when there is no response to a
request.
(b) Time and manner of disclosure. (1) Any disclosing entity that is
subject to periodic survey and certification of its compliance with
Medicaid standards must supply the information specified in paragraph
(a) of this section to the State survey agency at the time it is
surveyed. The survey agency must promptly furnish the information to
the Secretary and the Medicaid agency.
(2) Any disclosing entity that is not subject to periodic survey and
certification and has not supplied the information specified in
paragraph (a) of this section to the Secretary within the prior 12-month
period, must submit the information to the Medicaid agency before
entering into a contract or agreement to participate in the program.
The Medicaid agency must promptly furnish the information to the
Secretary.
(3) Updated information must be furnished to the Secretary or the
State survey or Medicaid agency at intervals between recertification or
contract renewals, within 35 days of a written request.
(c) Provider agreements and fiscal agent contracts. A Medicaid
agency shall not approve a provider agreement or a contract with a
fiscal agent, and must terminate an existing agreement or contract, if
the provider or fiscal agent fails to disclose ownership or control
information as required by this section.
(d) Denial of Federal financial participation (FFP). FFP is not
available in payments made to a provider or fiscal agent that fails to
disclose ownership or control information as required by this section.
42 CFR 455.105 Disclosure by providers: Information related to
business transactions.
(a) Provider agreements. A Medicaid agency must enter into an
agreement with each provider under which the provider agrees to furnish
to it or to the Secretary on request, information related to business
transactions in accordance with paragraph (b) of this section.
(b) Information that must be submitted. A provider must submit,
within 35 days of the date on a request by the Secretary or the Medicaid
agency, full and complete information about --
(1) The ownership of any subcontractor with whom the provider has had
business transactions totaling more than $25,000 during the 12-month
period ending on the date of the request; and
(2) Any significant business transactions between the provider and
any wholly owned supplier, or between the provider and any
subcontractor, during the 5-year period ending on the date of the
request.
(c) Denial of Federal financial participation (FFP). (1) FFP is not
available in expenditures for services furnished by providers who fail
to comply with a request made by the Secretary or the Medicaid agency
under paragraph (b) of this section or under 420.205 of this chapter
(Medicare requirements for disclosure).
(2) FFP will be denied in expenditures for services furnished during
the period beginning on the day following the date the information was
due to the Secretary or the Medicaid agency and ending on the day before
the date on which the information was supplied.
42 CFR 455.106 Disclosure by providers: Information on persons
convicted of crimes.
(a) Information that must be disclosed. Before the Medicaid agency
enters into or renews a provider agreement, or at any time upon written
request by the Medicaid agency, the provider must disclose to the
Medicaid agency the identity of any person who:
(1) Has ownership or control interest in the provider, or is an agent
or managing employee of the provider; and
(2) Has been convicted of a criminal offense related to that person's
involvement in any program under Medicare, Medicaid, or the title XX
services program since the inception of those programs.
(b) Notification to Inspector General. (1) The Medicaid agency must
notify the Inspector General of the Department of any disclosures made
under paragraph (a) of this section within 20 working days from the date
it receives the information.
(2) The agency must also promptly notify the Inspector General of the
Department of any action it takes on the provider's application for
participation in the program.
(c) Denial or termination of provider participation. (1) The
Medicaid agency may refuse to enter into or renew an agreement with a
provider if any person who has an ownership or control interest in the
provider, or who is an agent or managing employee of the provider, has
been convicted of a criminal offense related to that person's
involvement in any program established under Medicare, Medicaid or the
title XX Services Program.
(2) The Medicaid agency may refuse to enter into or may terminate a
provider agreement if it determines that the provider did not fully and
accurately make any disclosure required under paragraph (a) of this
section.
42 CFR 455.106 Pt. 456
42 CFR 455.106 PART 456 -- UTILIZATION CONTROL
42 CFR 455.106 Subpart A -- General Provisions
Sec.
456.1 Basis and purpose of part.
456.2 State plan requirements.
456.3 Statewide surveillance and utilization control program.
456.4 Responsibility for monitoring the utilization control program.
456.5 Evaluation criteria.
456.6 Review by State medical agency of appropriateness and quality
of services.
42 CFR 455.106 Subpart B -- Utilization Control: All Medicaid Services
456.21 Scope.
456.22 Sample basis evaluation of services.
456.23 Post-payment review process.
42 CFR 455.106 Subpart C -- Utilization Control: Hospitals
456.50 Scope.
456.51 Definitions.
456.60 Certification and recertification of need for inpatient care.
456.80 Individual written plan of care.
456.100 Scope.
456.101 UR plan required for inpatient hospital services.
456.105 UR committee required.
456.106 Organization and composition of UR committee;
disqualification from UR committee membership.
456.111 Recipient information required for UR.
456.112 Records and reports.
456.113 Confidentiality.
456.121 Admission review required.
456.122 Evaluation criteria for admission review.
456.123 Admission review process.
456.124 Notification of adverse decision.
456.125 Time limits for admission review.
456.126 Time limits for final decision and notification of adverse
decision.
456.127 Pre-admission review.
456.128 Initial continued stay review date.
456.129 Description of methods and criteria: Initial continued stay
review date; close professional scrutiny; length of stay modification.
456.131 Continued stay review required.
456.132 Evaluation criteria for continued stay.
456.133 Subsequent continued stay review dates.
456.134 Description of methods and criteria: Subsequent continued
stay review dates; length of stay modification.
456.135 Continued stay review process.
456.136 Notification of adverse decision.
456.137 Time limits for final decision and notification of adverse
decision.
456.141 Purpose and general description.
456.142 UR plan requirements for medical care evaluation studies.
456.143 Content of medical care evaluation studies.
456.144 Data sources for studies.
456.145 Number of studies required to be performed.
42 CFR 455.106 Subpart D -- Utilization Control: Mental Hospitals
456.150 Scope.
456.151 Definitions.
456.160 Certification and recertification of need for inpatient care.
456.170 Medical, psychiatric, and social evaluations.
456.171 Medicaid agency review of need for admission.
456.180 Individual written plan of care.
456.181 Reports of evaluations and plans of care.
456.200 Scope.
456.201 UR plan required for inpatient mental hospital services.
456.205 UR committee required.
456.206 Organization and composition of UR committee;
disqualification from UR committee membership.
456.211 Recipient information required for UR.
456.212 Records and reports.
456.213 Confidentiality.
456.231 Continued stay review required.
456.232 Evaluation criteria for continued stay.
456.233 Initial continued stay review date.
456.234 Subsequent continued stay review dates.
456.235 Description of methods and criteria: Continued stay review
dates; length of stay modification.
456.236 Continued stay review process.
456.237 Notification of adverse decision.
456.238 Time limits for final decision and notification of adverse
decision.
456.241 Purpose and general description.
456.242 UR plan requirements for medical care evaluation studies.
456.243 Content of medical care evaluation studies.
456.244 Data sources for studies.
456.245 Number of studies required to be performed.
42 CFR 455.106 Subpart E -- Utilization Control: Skilled Nursing
Facilities
456.250 Scope.
456.251 Definitions.
456.260 Certification and recertification of need for inpatient care.
456.270 Medical, psychiatric, and social evaluations.
456.271 Medicaid agency review of need for admission.
456.280 Individual written plan of care.
456.281 Reports of evaluations and plans of care.
456.300 Scope.
456.301 UR plan required for skilled nursing facility services.
456.305 UR committee required.
456.306 Organization and composition of UR committee;
disqualification from UR committee membership.
456.311 Recipient information required for UR.
456.312 Records and reports.
456.313 Confidentiality.
456.331 Continued stay review required.
456.332 Evaluation criteria for continued stay.
456.333 Initial continued stay review date.
456.334 Subsequent continued stay review dates.
456.335 Description of methods and criteria: Continued stay review
dates; length of stay modification.
456.336 Continued stay review process.
456.337 Notification of adverse decision.
456.338 Time limits for final decision and notification of adverse
decision.
456.341 Purpose and general description.
456.342 UR plan requirement for medical care evaluation studies.
456.343 Content of medical care evaluation studies.
456.344 Data sources for studies.
456.345 Number of studies required to be performed.
456.346 Discharge plan.
456.347 Discharge planning procedures.
456.348 Information about discharged recipients.
42 CFR 455.106 Subpart F -- Utilization Control: Intermediate Care
Facilities
456.350 Scope.
456.351 Definition.
456.360 Certification and recertification of need for inpatient care.
456.370 Medical, psychological, and social evaluations.
456.371 Exploration of alternative services.
456.372 Medicaid agency review of need for admission.
456.380 Individual written plan of care.
456.381 Reports of evaluations and plans of care.
456.400 Scope.
456.401 State plan UR requirements and options; UR plan required for
intermediate care facility services.
456.405 Description of UR review function: How and when.
456.406 Description of UR review function: Who performs UR;
disqualification from performing UR.
456.407 UR responsibilities of administrative staff.
456.411 Recipient informtion required for UR.
456.412 Records and reports.
456.413 Confidentiality.
456.431 Continued stay review required.
456.432 Evaluation criteria for continued stay.
456.433 Initial continued stay review date.
456.434 Subsequent continued stay review dates.
456.435 Description of methods and criteria: Continued stay review
dates.
456.436 Continued stay review process.
456.437 Notification of adverse decision.
456.438 Time limits for notification of adverse decision.
42 CFR 455.106 Subpart G -- Inpatient Psychiatric Services for
Individuals Under Age 21: Admission and Plan of Care Requirements
456.480 Scope.
456.481 Admission certification and plan of care.
456.482 Medical, psychiatric, and social evaluations.
42 CFR 455.106 Subpart H -- Utilization Review Plans: FFP, Waivers,
and Variances for Hospitals, Mental Hospitals, and Skilled Nursing
Facilities
456.500 Purpose.
456.501 UR plans as a condition for FFP.
456.505 Applicability of waiver.
456.506 Waiver options for Medicaid agency.
456.507 Review and granting of waiver requests.
456.508 Withdrawal of waiver.
Requirements
456.520 Definitions.
456.521 Conditions for granting variance requests.
456.522 Content of request for variance.
456.523 Revised UR plan.
456.524 Notification of Administrator's action and duration of
variance.
456.525 Request for renewal of variance.
42 CFR 455.106 Subpart I -- Inspections of Care in Skilled Nursing and
Intermediate Care Facilities and Institutions for Mental Diseases
456.600 Purpose.
456.601 Definitions.
456.602 Inspection team.
456.603 Financial interests and employment of team members.
456.604 Physician team member inspecting care of recipients.
456.605 Number and location of teams.
456.606 Frequency of inspections.
456.607 Notification before inspection.
456.608 Personal contact with and observation of recipients and
review of records.
456.609 Determinations by team.
456.610 Basis for determinations.
456.611 Reports on inspections.
456.612 Copies of reports.
456.613 Action on reports.
456.614 Inspections by utilization review committee.
42 CFR 455.106 Subpart J -- Penalty for Failure To Make a Satisfactory
Showing of An Effective Institutional Utilization Control Program
456.650 Basis, purpose, and scope.
456.651 Definitions.
456.652 Requirements for an effective utilization control program.
456.653 Acceptable reasons for not meeting requirements for annual
on-site review.
456.654 Requirements for content of showings and procedures for
submittal.
456.655 Validation of showings.
456.656 Reductions in FFP.
456.657 Computation of reductions in FFP.
Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302),
unless otherwise noted.
Source: 43 FR 45266, Sept. 29, 1978, unless otherwise noted.
42 CFR 455.106 Subpart A -- General Provisions
42 CFR 456.1 Basis and purpose of part.
(a) This part prescribes requirements concerning control of the
utilization of Medicaid services including --
(1) A statewide program of control of the utilization of all Medicaid
services; and
(2) Specific requirements for the control of the utilization of
Medicaid services in institutions.
(b) The requirements in this part are based on the following sections
of the Act. Table 1 shows the relationship between these sections of
the Act and the requirements in this part.
(1) Methods and procedures to safeguard against unnecessary
utilization of care and services. Section 1902(a)(30) requires that the
State plan provide methods and procedures to safeguard against
unnecessary utilization of care and services.
(2) Penalty for failure to have an effective program to control
utilization of institutional services. Section 1903(g)(1) provides for
a reduction in the amount of Federal Medicaid funds paid to a State for
long-stay inpatient services if the State does not make a showing
satisfactory to the Secretary that it has an effective program of
control over utilization of those services. This penalty provision
applies to inpatient services in hospitals, mental hospitals, skilled
nursing facilities (SNF's), and intermediate care facilities (ICF's).
Specific requirements are:
(i) Under section 1903(g)(1)(A), a physician must certify at
admission, and a physician (or physician assistant or nurse practitioner
under the supervision of a physician) must periodically recertify, the
individual's need for inpatient care.
(ii) Under section 1903(g)(1)(B), services must be furnished under a
plan established and periodically evaluated by a physician.
(iii) Under section 1903(g)(1)(C), the State must have in effect a
continuous program of review of utilization of care and services under
section 1902(a)(30) whereby each admission is reviewed or screened in
accordance with criteria established by medical and other professional
personnel.
(iv) Under section 1903(g)(1)(D), the State must have an effective
program under sections 1902(a) (26) and (31) of review of care in
skilled nursing and intermediate care facilities and mental hospitals.
This must include evaluation at least annually of the professional
management of each case.
(3) Medical review in skilled nursing facilities and mental
hospitals. Section 1902(a)(26)(A) requires that the plan provide for a
program of medical review that includes a medical evaluation of each
individual's need for care in a SNF or mental hospital, a plan of care,
and, where applicable, a plan of rehabilitation.
(4) Independent professional review in intermediate care facilities.
Section 1902(a)(31)(A) requires that the plan provide for a program of
independent professional review that includes a medical evaluation of
each individual's need for intermediate care and a written plan of
service.
(5) Inspection of care and services in institutions. Sections
1902(a)(26) (B) and (C) and 1902(a)(31) (B) and (C) require that the
plan provide for periodic inspections and reports, by a team of
professional persons, of the care being provided to each recipient in
SNF's, institutions for mental diseases (IMD's), and ICF's participating
in Medicaid.
(6) Denial of FFP for failure to have specified utilization review
procedures. Section 1903(i)(4) provides that FFP is not available in a
State's expenditures for hospital, mental hospital, or SNF services
unless the institution has in effect a utilization review plan that
meets Medicare requirements. However, the Secretary may waive this
requirement if the Medicaid agency demonstrates to his satisfaction that
it has utilization review procedures superior in effectiveness to the
Medicare procedures.
(7) State health agency guidance on quality and appropriateness of
care and services. Section 1902(a)(33)(A) requires that the plan
provide that the State health or other appropriate medical agency
establish a plan for review, by professional health personnel, of the
appropriateness and quality of Medicaid services to provide guidance to
the Medicaid agency and the State licensing agency in administering the
Medicaid program.
(43 FR 45266, Sept. 29, 1978, as amended at 46 FR 48561, Oct. 1,
1981)
42 CFR 456.2 State plan requirements.
(a) A State plan must provide that the requirements of this part are
met.
(b) These requirements may be met by the agency by:
(1) Assuming direct responsibility for assuring that the requirements
of this part are met; or
(2) Deeming of medical and utilization review requirements if the
agency contracts with a PRO to perform that review, which in the case of
inpatient acute care review will also serve as the initial determination
for PRO medical necessity and appropriateness review for patients who
are dually entitled to benefits under Medicare and Medicaid.
(c) In accordance with 431.15 of this subchapter, FFP will be
available for expenses incurred in meeting the requirements of this
part.
(46 FR 48566, Oct. 1, 1981, as amended at 50 FR 15327, Apr. 17, 1985;
51 FR 43198, Dec. 1, 1986)
42 CFR 456.3 Statewide surveillance and utilization control program.
The Medicaid agency must implement a statewide surveillance and
utilization control program that --
(a) Safeguards against unnecessary or inappropriate use of Medicaid
services and against excess payments;
(b) Assesses the quality of those services;
(c) Provides for the control of the utilization of all services
provided under the plan in accordance with subpart B of this part; and
(d) Provides for the control of the utilization of inpatient services
in accordance with subparts C through I of this part.
42 CFR 456.4 Responsibility for monitoring the utilization control
program.
(a) The agency must --
(1) Monitor the statewide utilization control program;
(2) Take all necessary corrective action to ensure the effectiveness
of the program;
(3) Establish methods and procedures to implement this section;
(4) Keep copies of these methods and procedures on file; and
(5) Give copies of these methods and procedures to all staff involved
in carrying out the utilization control program.
42 CFR 456.5 Evaluation criteria.
The agency must establish and use written criteria for evaluating the
appropriateness and quality of Medicaid services. This section does not
apply to services in hospitals, mental hospitals, and SNFs. For these
facilities, see the following sections: 456.122 and 456.132 of
subpart C; 456.232 of subpart D; and 456.332 of subpart E.
42 CFR 456.6 Review by State medical agency of appropriateness and
quality of services.
(a) The Medicaid agency must have an agreement with the State health
agency or other appropriate State medical agency, under which the health
or medical agency is responsible for establishing a plan for the review
by professional health personnel of the appropriateness and quality of
Medicaid services.
(b) The purpose of this review plan is to provide guidance to the
Medicaid agency in the administration of the State plan and, where
applicable, to the State licensing agency described in 431.610.
42 CFR 456.6 Subpart B -- Utilization Control: All Medicaid Services
42 CFR 456.21 Scope.
This subpart prescribes utilization control requirements applicable
to all services provided under a State plan.
42 CFR 456.22 Sample basis evaluation of services.
To promote the most effective and appropriate use of available
services and facilities the Medicaid agency must have procedures for the
on-going evaluation, on a sample basis, of the need for and the quality
and timeliness of Medicaid services.
42 CFR 456.23 Post-payment review process.
The agency must have a post-payment review process that --
(a) Allows State personnel to develop and review --
(1) Recipient utilization profiles;
(2) Provider service profiles; and
(3) Exceptions criteria; and
(b) Identifies exceptions so that the agency can correct
misutilization practices of recipients and providers.
42 CFR 456.23 Subpart C -- Utilization Control: Hospitals
42 CFR 456.50 Scope.
This subpart prescribes requirements for control of utilization of
inpatient hospital services, including requirements concerning --
(a) Certification of need for care;
(b) Plan of care; and
(c) Utilization review plans.
42 CFR 456.51 Definitions.
As used in this subpart:
Inpatient hospital services --
(a) Include --
(1) Services provided in an institution other than an institution for
mental disease, as defined in 440.10;
(2) (Reserved)
(3) Services provided in specialty hospitals and
(b) Exclude services provided in mental hospitals. Utilization
control requirements for mental hospitals appear in subpart D.
Medical care appraisal norms or norms means numerical or statistical
measures of usually observed performance.
Medical care criteria or criteria means predetermined elements
against which aspects of the quality of a medical service may be
compared. These criteria are developed by health professionals relying
on their expertise and the professional health care literature.
(43 FR 45266, Sept. 29, 1978, as amended at 51 FR 22041, June 17,
1986)
42 CFR 456.51 Certification of Need for Care
42 CFR 456.60 Certification and recertification of need for inpatient
care.
(a) Certification. (1) A physician must certify for each applicant
or recipient that inpatient services in a hospital are or were needed.
(2) The certification must be made at the time of admission or, if an
individual applies for assistance while in a hospital, before the
Medicaid agency authorizes payment.
(b) Recertification. (1) A physician, or physician assistant or
nurse practitioner (as defined in 491.2 of this chapter) acting within
the scope of practice as defined by State law and under the supervision
of a physician, must recertify for each applicant or recipient that
inpatient services in a hospital are needed.
(2) Recertifications must be made at least every 60 days after
certification.
(46 FR 48561, Oct. 1, 1981)
42 CFR 456.60 Plan of Care
42 CFR 456.80 Individual written plan of care.
(a) Before admission to a hospital or before authorization for
payment, a physician and other personnel involved in the care of the
individual must establish a written plan of care for each applicant or
recipient.
(b) The plan of care must include --
(1) Diagnoses, symptoms, complaints, and complications indicating the
need for admission;
(2) A description of the functional level of the individual;
(3) Any orders for --
(i) Medications;
(ii) Treatments;
(iii) Restorative and rehabilitative services;
(iv) Activities;
(v) Social services;
(vi) Diet;
(4) Plans for continuing care, as appropriate; and
(5) Plans for discharge, as appropriate.
(c) Orders and activities must be developed in accordance with
physician's instructions.
(d) Orders and activities must be reviewed and revised as appropriate
by all personnel involved in the care of an individual.
(e) A physician and other personnel involved in the recipient's case
must review each plan of care at least every 60 days.
42 CFR 456.80 Utilization Review (UR) Plan: General Requirement
42 CFR 456.100 Scope.
Sections 456.101 through 456.145 of this subpart prescribe
requirements for a written utilization review (UR) plan for each
hospital providing Medicaid services. Sections 456.105 and 456.106
prescribe administrative requirements: 456.111 through 456.113
prescribe informational requirements; 456.121 through 456.129
prescribe requirements for admission review; 456.131 through 456.137
prescribe requirements for continued stay review; and 456.141 through
456.145 prescribe requirements for medical care evaluation studies.
42 CFR 456.101 UR plan required for inpatient hospital services.
(a) A State plan must provide that each hospital furnishing inpatient
services under the plan has in effect a written UR plan that provides
for review of each recipient's need for the services that the hospital
furnishes him.
(b) Each written hospital UR plan must meet the requirements under
456.101 through 456.145.
42 CFR 456.101 UR Plan: Administrative Requirements
42 CFR 456.105 UR committee required.
The UR plan must --
(a) Provide for a committee to perform UR required under this
subpart;
(b) Describe the organization, composition, and functions of this
committee; and
(c) Specify the frequency of meetings of the committee.
42 CFR 456.106 Organization and composition of UR committee;
disqualification from UR committee membership.
(a) For the purpose of this subpart, ''UR committee'' includes any
group organized under paragraphs (b) and (c) of this section.
(b) The UR committee must be composed of two or more physicians, and
assisted by other professional personnel.
(c) The UR committee must be constituted as --
(1) A committee of the hospital staff;
(2) A group outside the hospital staff, established by the local
medical or osteopathic society and at least some of the hospitals and
SNFs in the locality;
(3) A group capable of performing utilization review, established and
organized in a manner approved by the Secretary.
(d) The UR committee may not include any individual who --
(1) Is directly responsible for the care of the patient whose care is
being reviewed; or
(2) Has a financial interest in any hospital.
42 CFR 456.106 UR Plan: Informational Requirements
42 CFR 456.111 Recipient information required for UR.
The UR plan must provide that each recipient's record includes
information needed for the UR committee to perform UR required under
this subpart. This information must include, at least, the following:
(a) Identification of the recipient.
(b) The name of the recipient's physician.
(c) Date of admission, and dates of application for and authorization
of Medicaid benefits if application is made after admission.
(d) The plan of care required under 456.70.
(e) Initial and subsequent continued stay review dates described
under 456.128 and 456.133.
(f) Date of operating room reservation, if applicable.
(g) Justification of emergency admission, if applicable.
(h) Reasons and plan for continued stay, if the attending physician
believes continued stay is necessary.
(i) Other supporting material that the committee believes appropriate
to be included in the record.
42 CFR 456.112 Records and reports.
The UR plan must describe --
(a) The types of records that are kept by the committee; and
(b) The type and frequency of committee reports and arrangements for
their distribution to appropriate individuals.
42 CFR 456.113 Confidentiality.
The UR plan must provide that the identities of individual recipients
in all UR records and reports are kept confidential.
42 CFR 456.113 UR Plan: Review of Need for Admission1
1The Department was enjoined in 1975 in the case of American Medical
Assn. et al. v. Weinberger, 395 F. Supp. 515 (N.D. Ill., 1975),
aff'd., 522 F2d 921 (7th cir., 1975) from implementing the admission
review requirements contained in 456.121-456.127. This case was
dismissed on the condition that these requirements be revised. They are
presently being revised, and will not be in force until that revision is
completed.
42 CFR 456.121 Admission review required.
The UR plan must provide for a review of each recipient's admission
to the hospital to decide whether it is needed, in accordance with the
requirements of 456.122 through 456.129.
42 CFR 456.122 Evaluation criteria for admission review.
The UR plan must provide that --
(a) The committee develops written medical care criteria to assess
the need for admission; and
(b) The committee develops more extensive written criteria for cases
that its experience shows are --
(1) Associated with high costs;
(2) Associated with the frequent furnishing of excessive services;
or
(3) Attended by physicians whose patterns of care are frequently
found to be questionable.
42 CFR 456.123 Admission review process.
The UR plan must provide that --
(a) Admission review is conducted by --
(1) The UR committee;
(2) A subgroup of the UR committee; or
(3) A designee of the UR committee;
(b) The committee, subgroup, or designee evaluates the admission
against the criteria developed under 456.122 and applies close
professional scrutiny to cases selected under 456.129(b);
(c) If the committee, subgroup, or designee finds that the admission
is needed, the committee assigns an initial continued stay review date
in accordance with 456.128;
(d) If the committee, subgroup, or designee finds that the admission
does not meet the criteria, the committee or a subgroup that includes at
least one physician reviews the case to decide the need for admission;
(e) If the committee or subgroup making the review under paragraph
(d) of this section finds that the admission is not needed, it notifies
the recipient's attending physician and gives him an opportunity to
present his views before it makes a final decision on the need for the
continued stay;
(f) If the attending physician does not present additional
information or clarification of the need for the admission, the decision
of the committee or subgroup is final; and
(g) If the attending physician presents additional information or
clarification, at least two physician members of the committee review
the need for the admission. If they find that the admission is not
needed, their decision if final.
42 CFR 456.124 Notification of adverse decision.
The UR plan must provide that written notice of any adverse final
decision on the need for admission under 456.123 (e) through (g) is
sent to --
(a) The hospital administrator;
(b) The attending physician;
(c) The Medicaid agency;
(d) The recipient; and
(e) If possible, the next of kin or sponsor.
42 CFR 456.125 Time limits for admission review.
Except as required under 456.127, the UR plan must provide that
review of each recipient's admission to the hospital is conducted --
(a) Within one working day after admission, for an individual who is
receiving Medicaid at that time; or
(b) Within one working day after the hospital is notified of the
application for Medicaid, for an individual who applies while in the
hospital.
42 CFR 456.126 Time limits for final decision and notification of
adverse decision.
Except as required under 456.127, the UR plan must provide that the
committee makes a final decision on a recipient's need for admission and
gives notice of an adverse final decision --
(a) Within two working days after admission, for an individual who is
receiving Medicaid at that time; or
(b) Within two working days after the hospital is notified of the
application for Medicaid, for an individual who applies while in the
hospital.
42 CFR 456.127 Pre-admission review.
The UR plan must provide for review and final decision prior to
admission for certain providers or categories of admissions that the UR
committee designates under 456.142(b) (4)(iii) to receive pre-admission
review.
42 CFR 456.128 Initial continued stay review date.
The UR plan must provide that --
(a) When a recipient is admitted to the hospital under the admission
review requirements of this subpart, the committee assigns a specified
date by which the need for his continued stay will be reviewed;
(b) The committee bases its assignment of the initial continued stay
review date on --
(1) The methods and criteria required to be described under 456.129;
(2) The individual's condition; and
(3) The individual's projected discharge date;
(c)(1) The committee uses any available appropriate regional medical
care appraisal norms, such as those developed by abstracting services or
third party payors, to assign the initial continued stay review date;
(2) These regional norms are based on current and statistically valid
data on duration of stay in hospitals for patients whose
characteristics, such as age and diagnosis, are similar to those of the
individual whose case is being reviewed;
(3) If the committee uses norms to assign the initial continued stay
review date, the number of days between the individual's admission and
the initial continued stay review date is no greater than the number of
days reflected in the 50th percentile of the norms. However, the
committee may assign a later review date if it documents that the later
date is more appropriate; and
(d) The committee ensures that the initial continued stay review date
is recorded in the individual's record.
42 CFR 456.129 Description of methods and criteria: Initial continued
stay review date; close professional scrutiny; length of stay
modification.
The UR plan must describe --
(a) The methods and criteria, including norms if used, that the
committee uses to assign the initial continued stay review date under
456.128.
(b) The methods that the committee uses to select categories of
admission to receive close professional scrutiny under 456.123(b); and
(c) The methods that the committee uses to modify an approved length
of stay when the recipient's condition or treatment schedule changes.
42 CFR 456.129 UR Plan: Review of Need for Continued Stay
42 CFR 456.131 Continued stay review required.
The UR plan must provide for a review of each recipient's continued
stay in the hospital to decide whether it is needed, in accordance with
the requirements of 456.132 through 456.137.
42 CFR 456.132 Evaluation criteria for continued stay.
The UR plan must provide that --
(a) The committee develops written medical care criteria to assess
the need for continued stay.
(b) The committee develops more extensive written criteria for cases
that its experience shows are --
(1) Associated with high costs;
(2) Associated with the frequent furnishing of excessive services;
or
(3) Attended by physicians whose patterns of care are frequently
found to be questionable.
42 CFR 456.133 Subsequent continued stay review dates.
The UR plan must provide that --
(a) The committee assigns subsequent continued stay review dates in
accordance with 456.128 and 456.134(a);
(b) The committee assigns a subsequent review date each time it
decides under 456.135 that the continued stay is needed; and
(c) The committee ensures that each continued stay review date it
assigns is recorded in the recipient's record.
42 CFR 456.134 Description of methods and criteria: Subsequent
continued stay review dates; length of stay modification.
The UR plan must describe --
(a) The methods and criteria, including norms if used, that the
committee uses to assign subsequent continued stay review dates under
456.133; and
(b) The methods that the committee uses to modify an approved length
of stay when the recipient's condition or treatment schedule changes.
42 CFR 456.135 Continued stay review process.
The UR plan must provide that --
(a) Review of continued stay cases is conducted by --
(1) The UR committee;
(2) A subgroup of the UR committee; or
(3) A designee of the UR committee;
(b) The committee, subgroup or designee reviews a recipient's
continued stay on or before the expiration of each assigned continued
stay review date;
(c) For each continued stay of a recipient in the hospital, the
committee, subgroup or designee reviews and evaluates the documentation
described under 456.111 against the criteria developed under 456.132
and applies close professional scrutiny to cases selected under
456.129(b);
(d) If the committee, subgroup, or designee finds that a recipient's
continued stay in the hospital is needed, the committee assigns a new
continued stay review date in accordance with 456.133;
(e) If the committee, subgroup, or designee finds that a continued
stay case does not meet the criteria, the committee or a subgroup that
includes at least one physician reviews the case to decide the need for
continued stay;
(f) If the committee or subgroup making the review under paragraph
(e) of this section finds that a continued stay is not needed, it
notifies the recipient's attending physician and gives him an
opportunity to present his reviews before it makes a final decision on
the need for the continued stay;
(g) If the attending physician does not present additional
information or clarification of the need for the continued stay, the
decision of the committee or subgroup is final; and
(h) If the attending physician presents additional information or
clarification, at least two physician members of the committee review
the need for the continued stay. If they find that the recipient no
longer needs inpatient hospital services, their decision is final.
42 CFR 456.136 Notification of adverse decision.
The UR plan must provide that written notice of any adverse final
decision on the need for continued stay under 456.135 (f) through (h)
is sent to --
(a) The hospital administrator;
(b) The attending physician;
(c) The Medicaid agency;
(d) The recipient; and
(e) If possible, the next of kin or sponsor.
42 CFR 456.137 Time limits for final decision and notification of
adverse decision.
The UR plan must provide that --
(a) The committee makes a final decision on a recipient's need for
continued stay and gives notice under 456.136 of an adverse final
decision within 2 working days after the assigned continued stay review
dates, except as required under paragraph (b) of this section.
(b) If the committee makes an adverse final decision on a recipient's
need for continued stay before the assigned review date, the committee
gives notice under 456.136 within 2 working days after the date of the
final decision.
42 CFR 456.137 UR Plan: Medical Care Evaluation Studies
42 CFR 456.141 Purpose and general description.
(a) The purpose of medical care evaluation studies is to promote the
most effective and efficient use of available health facilities and
services consistent with patient needs and professionally recognized
standards of health care.
(b) Medical care evaluation studies --
(1) Emphasize identification and analysis of patterns of patient
care; and
(2) Suggest appropriate changes needed to maintain consistently high
quality patient care and effective and efficient use of services.
42 CFR 456.142 UR plan requirements for medical care evaluation
studies.
(a) The UR plan must describe the methods that the committee uses to
select and conduct medical care evaluation studies under paragraph
(b)(1) of this section.
(b) The UR plan must provide that the UR committee --
(1) Determines the methods to be used in selecting and conducting
medical care evaluation studies in the hospital;
(2) Documents for each study --
(i) Its results; and
(ii) How the results have been used to make changes to improve the
quality of care and promote more effective and efficient use of
facilities and services;
(3) Analyzes its findings for each study; and
(4) Takes action as needed to --
(i) Correct or investigate further any deficiencies or problems in
the review process for admissions or continued stay cases;
(ii) Recommend more effective and efficient hospital care procedures;
or
(iii) Designate certain providers or categories of admissions for
review prior to admission.
42 CFR 456.143 Content of medical care evaluation studies.
Each medical care evaluation study must --
(a) Identify and analyze medical or administrative factors related to
the hospital's patient care;
(b) Include analysis of at least the following:
(1) Admissions;
(2) Durations of stay;
(3) Ancillary services furnished, including drugs and biologicals;
(4) Professional services performed in the hospital; and
(c) If indicated, contain recommendations for changes beneficial to
patients, staff, the hospital, and the community.
42 CFR 456.144 Data sources for studies.
Data that the committee uses to perform studies must be obtained from
one or more of the following sources:
(a) Medical records or other appropriate hospital data;
(b) External organizations that compile statistics, design profiles,
and produce other comparative data;
(c) Cooperative endeavors with --
(1) PROs;
(2) Fiscal agents;
(3) Other service providers; or
(4) Other appropriate agencies.
(43 FR 45266, Sept. 29, 1978, as amended at 51 FR 43198, Dec. 1,
1986)
42 CFR 456.145 Number of studies required to be performed.
The hospital must, at least, have one study in progress at any time
and complete one study each calendar year.
42 CFR 456.145 Subpart D -- Utilization Control: Mental Hospitals
42 CFR 456.150 Scope.
This subpart prescribes requirements for control of utilization of
inpatient services in mental hospitals, including requirements
concerning --
(a) Certification of need for care;
(b) Medical evaluation and admission review;
(c) Plan of care; and
(d) Utilization review plans.
42 CFR 456.151 Definitions.
As used in this subpart:
Medical care appraisal norms or norms means numerical or statistical
measures of usually observed performance.
Medical care criteria or criteria means predetermined elements
against which aspects of the quality of a medical service may be
compared. These criteria are developed by health professionals relying
on their expertise and the professional health care literature.
42 CFR 456.151 Certification of Need for Care
42 CFR 456.160 Certification and recertification of need for inpatient
care.
(a) Certification. (1) A physician must certify for each applicant
or recipient that inpatient services in a mental hospital are or were
needed.
(2) The certification must be made at the time of admission or, if an
individual applies for assistance while in a mental hospital, before the
Medicaid agency authorizes payment.
(b) Recertification. (1) A physician, or physician assistant or
nurse practitioner (as defined in 491.2 of this chapter) acting within
the scope of practice as defined by State law and under the supervision
of a physician, must recertify for each applicant or recipient that
inpatient services in a mental hospital are needed.
(2) Recertification must be made at least every 60 days after
certification.
(46 FR 48561, Oct. 1, 1981)
42 CFR 456.160 Medical, Psychiatric, and Social Evaluations and Admission Review
42 CFR 456.170 Medical, psychiatric, and social evaluations.
(a) Before admission to a mental hospital or before authorization for
payment, the attending physician or staff physician must make a medical
evaluation of each applicant's or recipient's need for care in the
hospital; and appropriate professional personnel must make a
psychiatric and social evaluation.
(b) Each medical evaluation must include --
(1) Diagnoses;
(2) Summary of present medical findings;
(3) Medical history;
(4) Mental and physical functional capacity;
(5) Prognoses; and
(6) A recommendation by a physician concerning --
(i) Admission to the mental hospital; or
(ii) Continued care in the mental hospital for individuals who apply
for Medicaid while in the mental hospital.
42 CFR 456.171 Medicaid agency review of need for admission.
Medical and other professional personnel of the Medicaid agency or
its designees must evaluate each applicant's or recipient's need for
admission by reviewing and assessing the evaluations required by
456.170.
42 CFR 456.171 Plan of Care
42 CFR 456.180 Individual written plan of care.
(a) Before admission to a mental hospital or before authorization for
payment, the attending physician or staff physician must establish a
written plan of care for each applicant or recipient.
(b) The plan of care must include --
(1) Diagnoses, symptoms, complaints, and complications indicating the
need for admission;
(2) A description of the functional level of the individual;
(3) Objectives;
(4) Any orders for --
(i) Medications;
(ii) Treatments;
(iii) Restorative and rehabilitative services;
(iv) Activities;
(v) Therapies;
(vi) Social services;
(vii) Diet; and
(viii) Special procedures recommended for the health and safety of
the patient;
(5) Plans for continuing care, including review and modification to
the plan of care; and
(6) Plans for discharge.
(c) The attending or staff physician and other personnel involved in
the recipient's care must review each plan of care at least every 90
days.
42 CFR 456.181 Reports of evaluations and plans of care.
A written report of each evaluation and plan of care must be entered
in the applicant's or recipient's record --
(a) At the time of admission; or
(b) If the individual is already in the facility, immediately upon
completion of the evaluation or plan.
42 CFR 456.181 Utilization Review (UR) Plan: General Requirements
42 CFR 456.200 Scope.
Sections 456.201 through 456.245 of this subpart prescribe
requirements for a written utilization review (UR) plan for each mental
hospital providing Medicaid services. Sections 456.205 and 456.206
prescribe administrative requirements; 456.211 through 456.213
prescribe informational requirements; 456.231 through 456.238
prescribe requirements for continued stay review; and 456.241 through
456.245 prescribe requirements for medical care evaluation studies.
42 CFR 456.201 UR plan required for inpatient mental hospital services.
(a) The State plan must provide that each mental hospital furnishing
inpatient services under the plan has in effect a written UR plan that
provides for review of each recipient's need for the services that the
mental hospital furnishes him.
(b) Each written mental hospital UR plan must meet the requirements
under 456.201 through 456.245.
42 CFR 456.201 UR Plan: Administrative Requirements
42 CFR 456.205 UR committee required.
The UR plan must --
(a) Provide for a committee to perform UR required under this
subpart;
(b) Describe the organization, composition, and functions of this
committee; and
(c) Specify the frequency of meetings of the committee.
42 CFR 456.206 Organization and composition of UR committee;
disqualification from UR committee membership.
(a) For the purpose of this subpart, ''UR committee'' includes any
group organized under paragraphs (b) and (c) of this section.
(b) The UR committee must be composed of two or more physicians, one
of whom is knowledgeable in the diagnosis and treatment of mental
diseases, and assisted by other professional personnel.
(c) The UR committee must be constituted as --
(1) A committee of the mental hospital staff;
(2) A group outside the mental hospital staff, established by the
local medical or osteopathic society and at least some of the hospitals
and SNFs in the locality; or
(3) A group capable of performing utilization review, established and
organized in a manner approved by the Secretary.
(d) The UR committee may not include any individual who --
(1) Is directly responsible for the care of patients whose care is
being reviewed; or
(2) Has a financial interest in any mental hospital.
42 CFR 456.206 UR Plan: Informational Requirements
42 CFR 456.211 Recipient information required for UR.
The UR plan must provide that each recipient's record includes
information needed to perform UR required under this subpart. This
information must include, at least, the following:
(a) Identification of the recipient.
(b) The name of the recipient's physician.
(c) Date of admission, and dates of application for and authorization
of Medicaid benefits if application is made after admission.
(d) The plan of care required under 456.172.
(e) Initial and subsequent continued stay review dates described
under 456.233 and 456.234.
(f) Reasons and plan for continued stay, if the attending physician
believes continued stay is necessary.
(g) Other supporting material that the committee believes appropriate
to be included in the record.
42 CFR 456.212 Records and reports.
The UR plan must describe --
(a) The types of records that are kept by the committee; and
(b) The type and frequency of committee reports and arrangements for
their distribution to appropriate individuals.
42 CFR 456.213 Confidentiality.
The UR plan must provide that the identities of individual recipients
in all UR records and reports are kept confidential.
42 CFR 456.213 UR Plan: Review of Need for Continued Stay
42 CFR 456.231 Continued stay review required.
The UR plan must provide for a review of each recipient's continued
stay in the mental hospital to decide whether it is needed, in
accordance with the requirements of 456.232 through 456.238.
42 CFR 456.232 Evaluation criteria for continued stay.
The UR plan must provide that --
(a) The committee develops written medical care criteria to assess
the need for continued stay.
(b) The committee develops more extensive written criteria for cases
that its experience shows are --
(1) Associated with high costs;
(2) Associated with the frequent furnishing of excessive services;
or
(3) Attended by physicians whose patterns of care are frequently
found to be questionable.
42 CFR 456.233 Initial continued stay review date.
The UR plan must provide that --
(a) When a recipient is admitted to the mental hospital under
admission review requirements of this subpart, the committee assigns a
specified date by which the need for his continued stay will be
reviewed;
(b) If an individual applies for Medicaid while in the mental
hospital, the committee assigns the initial continued stay review date
within 1 working day after the mental hospital is notified of the
application for Medicaid;
(c) The committee bases its assignment of the initial continued stay
review date on --
(1) The methods and criteria required to be described under
456.235(a);
(2) The individual's condition; and
(3) The individual's projected discharge date;
(d)(1) The committee uses any available appropriate regional medical
care appraisal norms, such as those developed by abstracting services or
third party payors, to assign the initial continued stay review date;
(2) These norms are based on current and statistically valid data on
duration of stay in mental hospitals for patients whose characteristics,
such as age and diagnosis, are similar to those of the individual whose
need for continued stay is being reviewed;
(3) If the committee uses norms to assign the initial continued stay
review date, the number of days between the individual's admission and
the initial continued stay review date is no greater than the number of
days reflected in the 50th percentile of the norms. However, the
committee may assign a later review date if it documents that the later
date is more appropriate;
(e) The initial continued stay review date is not in any case later
than 30 days after admission of the individual or notice to the mental
hospital of his application for Medicaid; and
(f) The committee insures that the initial continued stay review date
is recorded in the individual's record.
42 CFR 456.234 Subsequent continued stay review dates.
The UR plan must provide that --
(a) The committee assigns subsequent continued stay review dates in
accordance with 456.235(a) and 456.233;
(b) The committee assigns a subsequent continued stay review date at
least every 90 days each time it decides under 456.236 that the
continued stay is needed; and
(c) The committee insures that each continued stay review date it
assigns is recorded in the recipient's record.
42 CFR 456.235 Description of methods and criteria: Continued stay
review dates; length of stay modification.
The UR plan must describe --
(a) The methods and criteria, including norms if used, that the
committee uses to assign initial and subsequent continued stay review
dates under 456.233 and 456.234 of this subpart; and
(b) The methods that the committee uses to modify an approved length
of stay when the recipient's condition or treatment schedule changes.
42 CFR 456.236 Continued stay review process.
The UR plan must provide that --
(a) Review of continued stay cases is conducted by --
(1) The UR committee;
(2) A subgroup of the UR committee; or
(3) A designee of the UR committee;
(b) The committee, subgroup or designee reviews a recipient's
continued stay on or before the expiration of each assigned continued
stay review date;
(c) For each continued stay of a recipient in the mental hospital,
the committee, subgroup or designee reviews and evaluates the
documentation described under 456.211 against the criteria developed
under 456.232 and applies close professional scrutiny to cases
described under 456.232(b).
(d) If the committee, subgroup or designee finds that a recipient's
continued stay in the mental hospital is needed, the committee assigns a
new continued stay review date in accordance with 456.234;
(e) If the committee, subgroup or designee finds that a continued
stay case does not meet the criteria, the committee or a subgroup that
includes at least one physician reviews the case to decide the need for
continued stay;
(f) If the committee or subgroup making the review under paragraph
(e) of this section finds that a continued stay is not needed, it
notifies the recipient's attending or staff physician and gives him an
opportunity to present his views before it makes a final decision on the
need for the continued stay;
(g) If the attending or staff physician does not present additional
information or clarification of the need for the continued stay, the
decision of the committee or subgroup is final; and
(h) If the attending or staff physician presents additional
information or clarification, at least two physician members of the
committee, one of whom is knowledgeable in the treatment of mental
diseases, review the need for the continued stay. If they find that the
recipient no longer needs inpatient mental hospital services, their
decision is final.
42 CFR 456.237 Notification of adverse decision.
The UR plan must provide that written notice of any adverse final
decision on the need for continued stay under 456.236 (f) through (h)
is sent to --
(a) The hospital administrator;
(b) The attending or staff physician;
(c) The Medicaid agency;
(d) The recipient; and
(e) If possible, the next of kin or sponsor.
42 CFR 456.238 Time limits for final decision and notification of
adverse decision.
The UR plan must provide that --
(a) The committee makes a final decision on a recipient's need for
continued stay and gives notice under 456.237 of an adverse decision
within 2 working days after the assigned continued stay review date,
except as required under paragraph (b) of this section.
(b) If the committee makes an adverse final decision on a recipient's
need for continued stay before the assigned review date, the committee
gives notice under 456.237 within 2 working days after the date of the
final decision.
42 CFR 456.238 UR Plan: Medical Care Evaluation Studies
42 CFR 456.241 Purpose and general description.
(a) The purpose of medical care evaluation studies is to promote the
most effective and efficient use of available health facilities and
services consistent with patient needs and professionally recognized
standards of health care.
(b) Medical care evaluation studies --
(1) Emphasize identification and analysis of patterns of patient
care; and
(2) Suggest appropriate changes needed to maintain consistently high
quality patient care and effective and efficient use of services.
42 CFR 456.242 UR plan requirements for medical care evaluation
studies.
(a) The UR plan must describe the methods that the committee uses to
select and conduct medical care evaluation studies under paragraph
(b)(1) of this section.
(b) The UR plan must provide that the UR committee --
(1) Determines the methods to be used in selecting and conducting
medical care evaluation studies in the mental hospital;
(2) Documents for each study --
(i) Its results; and
(ii) How the results have been used to make changes to improve the
quality of care and promote more effective and efficient use of
facilities and services;
(3) Analyzes its findings for each study; and
(4) Takes action as needed to --
(i) Correct or investigate further any deficiencies or problems in
the review process; or
(ii) Recommend more effective and efficient hospital care procedures.
42 CFR 456.243 Content of medical care evaluation studies.
Each medical care evaluation study must --
(a) Identify and analyze medical or administrative factors related to
the mental hospital's patient care;
(b) Include analysis of at least the following:
(1) Admissions.
(2) Durations of stay.
(3) Ancillary services furnished, including drugs and biologicals.
(4) Professional services performed in the hospital; and
(c) If indicated, contain recommendations for change beneficial to
patients, staff, the hospital, and the community.
42 CFR 456.244 Data sources for studies.
Data that the committee uses to perform studies must be obtained from
one or more of the following sources:
(a) Medical records or other appropriate hospital data.
(b) External organizations that compile statistics, design profiles,
and produce other comparative data.
(c) Cooperative endeavors with --
(1) PROs;
(2) Fiscal agents;
(3) Other service providers; or
(4) Other appropriate agencies.
(43 FR 45266, Sept. 29, 1978, as amended at 51 FR 43198, Dec. 1,
1986)
42 CFR 456.245 Number of studies required to be performed.
The mental hospital must, at least, have one study in progress at any
time and complete one study each calendar year.
42 CFR 456.245 Subpart E -- Utilization Control: Skilled Nursing Facilities
42 CFR 456.250 Scope.
(a) This subpart prescribes requirements for control of utilization
of skilled nursing facility (SNF) services including requirements
concerning --
(1) Certification of need for care;
(2) Medical evaluation and admission review;
(3) Plan of care;
(4) Utilization review plans; and
(5) Discharge plans.
42 CFR 456.251 Definitions.
Skilled nursing facility services means those items and services
defined in 440.40 and 440.140 of this subchapter, but excludes those
services if they are provided in Christian Science sanitoria.
Medical care criteria means predetermined elements against which
aspects of the quality of a medical service may be compared. These
criteria are developed by health professionals relying on their
expertise and the professional health care literature.
42 CFR 456.251 Certification of Need for Care
42 CFR 456.260 Certification and recertification of need for inpatient
care.
(a) Certification. (1) A physician must certify for each applicant
or recipient that SNF services are or were needed.
(2) The certification must be made at the time of admission or, if an
individual applies for assistance while in a SNF, before the Medicaid
agency authorizes payment.
(b) Recertification. (1) A physician, or physician assistant or
nurse practitioner (as defined in 491.2 of this chapter) acting within
the scope of practice as defined by State law and under the supervision
of a physician, must recertify for each applicant or recipient that SNF
services are needed.
(2) Recertification must be made at least every 60 days after
certification.
(46 FR 48561, Oct. 1, 1981; 46 FR 54744, Nov. 4, 1981)
42 CFR 456.260 Medical, Psychiatric, and Social Evaluations, and Admission Review
42 CFR 456.270 Medical, psychiatric, and social evaluations.
(a) Before admission to a SNF or before authorization for payment,
the attending physician must make --
(1) A medical evaluation of each applicant's or recipient's need for
care in the SNF; and
(2) A plan of rehabilitation, where applicable.
(b) In a SNF that cares primarily for mental patients, appropriate
professional personnel must make a psychiatric and a social evaluation
of need for care.
(c) Each medical evaluation must include --
(1) Diagnoses;
(2) Summary of present medical findings;
(3) Medical history;
(4) Mental and physical functional capacity;
(5) Prognoses; and
(6) A recommendation by a physician concerning --
(i) Admission to the SNF; or
(ii) Continued care in the SNF for individuals who apply for Medicaid
while in the facility.
42 CFR 456.271 Medicaid agency review of need for admission.
Medical and other professional personnel of the Medicaid agency or
its designees must evaluate each applicant's or recipient's need for
admission by reviewing and assessing the evaluations required by
456.270.
42 CFR 456.271 Plan of Care
42 CFR 456.280 Individual written plan of care.
(a) Before admission to a SNF or before authorization for payment,
the attending physician must establish a written plan of care for each
applicant or recipient in a SNF.
(b) The plan of care must include --
(1) Diagnoses, symptoms, complaints and complications indicating the
need for admission;
(2) A description of the functional level of the individual;
(3) Objectives;
(4) Any orders for --
(i) Medications;
(ii) Treatments;
(iii) Restorative and rehabilitative services;
(iv) Activities;
(v) Therapies;
(vi) Social services;
(vii) Diet; and
(viii) Special procedures recommended for the health and safety of
the patient;
(5) Plans for continuing care, including review and modification to
the plan of care; and
(6) Plans for discharge.
(c) The attending or staff physician and other personnel involved in
the recipient's care must review each plan of care at least every 60
days.
42 CFR 456.281 Reports of evaluations and plans of care.
A written report of each evaluation and plan of care must be entered
in the applicant's or recipient's record --
(a) At the time of admission; or
(b) If the individual is already in the SNF, immediately upon
completion of the evaluation or plan.
42 CFR 456.281 Utilization Review (UR) Plan: General Requirement
42 CFR 456.300 Scope.
Sections 456.301 through 456.345 of this subpart prescribe
requirements for a written utilization review (UR) plan for each SNF
providing Medicaid services. Sections 456.305 and 456.306 prescribe
administrative requirements; 456.311 through 456.313 prescribe
informational requirements; 456.331 through 456.338 prescribe
requirements for continued stay review; and 456.341 through 456.345
prescribe requirements for medical care evaluation studies.
42 CFR 456.301 UR plan required for skilled nursing facility services.
(a) The State plan must provide that each SNF furnishing inpatient
services under the plan has in effect a written UR plan that provides
for review of each recipient's need for the services that the SNF
furnishes him.
(b) Each written SNF UR plan must meet the requirements under
456.301 through 456.345.
42 CFR 456.301 UR Plan: Administrative Requirements
42 CFR 456.305 UR committee required.
The UR plan must --
(a) Provide for a committee to perform UR required under this
subpart;
(b) Describe the organization, composition, and functions of this
committee; and
(c) Specify the frequency of meetings of the committee.
42 CFR 456.306 Organization and composition of UR committee;
disqualification from UR committee membership.
(a) For the purpose of this subpart, ''UR committee'' includes any
group organized under paragraphs (b) and (c) of this section.
(b) The UR committee must be composed of two or more physicians and
assisted by other professional personnel and, in a SNF that cares
primarily for mental patients, include at least one physician member who
is knowledgeable in the diagnosis and treatment of mental diseases.
(c) The UR committee must be constituted as --
(1) A committee of individuals with SNF staff privileges;
(2) A group outside the SNF established by the local medical or
osteopathic society and at least some of the hospitals and SNFs in the
locality; or
(3) A group capable of performing utilization review and established
and organized in a manner approved by the Secretary.
(d) The UR committee may not include any individual who --
(1) Is directly responsible for the care of patients whose care is
being reviewed;
(2) Is employed by the SNF; or
(3) Has a financial interest in any SNF.
42 CFR 456.306 UR Plan: Informational Requirements
42 CFR 456.311 Recipient information required for UR.
The UR plan must provide that each recipient's record includes
information needed to perform UR required under this subpart. This
information must include, at least, the following:
(a) Identification of the recipient.
(b) The name of the recipient's physician.
(c) Date of admission and dates of application for and authorization
of Medicaid benefits if application is made after admission.
(d) The plan of care required under 456.272.
(e) Initial and subsequent continued stay review dates described
under 456.333 and 456.334.
(f) Reasons and plan for continued stay if the attending physician
believes continued stay is necessary.
(g) Other supporting material that the committee believes appropriate
to be included in the record.
42 CFR 456.312 Records and reports.
The UR plan must describe --
(a) The types of records that are kept by the committee; and
(b) The type and frequency of committee reports, and arrangements for
their distribution to appropriate individuals.
42 CFR 456.313 Confidentiality.
The UR plan must provide that the identities of individual recipients
in all UR records and reports are kept confidential.
42 CFR 456.313 UR Plan: Review of Need for Continued Stay
42 CFR 456.331 Continued stay review required.
The UR plan must provide for a review of each recipient's continued
stay in the SNF to decide whether it is needed, in accordance with the
requirements of 456.332-456.338.
42 CFR 456.332 Evaluation criteria for continued stay.
The UR plan must provide that --
(a) The committee develops written medical care criteria to assess
the need for continued stay; and
(b) The committee develops more extensive written criteria for cases
that its experience shows are --
(1) Associated with high costs;
(2) Associated with the frequent furnishing of excessive services;
or
(3) Attended by physicians whose patterns of care are frequently
found to be questionable.
42 CFR 456.333 Initial continued stay review date.
The UR plan must provide that --
(a) When a recipient is admitted to the SNF under admission review
requirements of this subpart, the committee assigns a specified date by
which the need for his continued stay will be reviewed;
(b) If an individual applies for Medicaid while in the SNF, the
committee assigns the initial continued stay review date within one
working day after the SNF is notified of the application for Medicaid;
(c) The committee bases its assignment of the initial continued stay
review date on the methods and criteria required to be described under
456.335(a);
(d) The initial continued stay review date is either --
(1) Not later than 90 days after the date of the individual's
admission or notice to the SNF of his application for Medicaid, if the
date is established using specific periods for diagnostic categories or
categories based on functional capabilities; or
(2) Not later than 30 days after the date of the individual's
admission or notice of application, if the date is established by
another method; and
(e) The committee ensures that the initial continued stay review date
is recorded in the individual's record.
42 CFR 456.334 Subsequent continued stay review dates.
The UR plan must provide that --
(a) The committee assigns subsequent continued stay review dates in
accordance with 456.333 and 456.335(a).
(b) The committee assigns subsequent continued stay review dates each
time it decides under 456.336 that the continued stay is needed --
(1) At least every 90 days if the dates are established using
specific periods for diagnostic categories based on functional
capabilities; or
(2) At least every 30 days for the first 90 days and at least every
90 days thereafter if the dates are established by another method; and
(c) The committee ensures that each continued stay review date that
it assigns is recorded in the recipient's record.
42 CFR 456.335 Description of methods and criteria: Continued stay
review dates; length of stay modification.
The UR plan must describe --
(a) The methods and criteria that the committee uses to assign
initial and subsequent continued stay review dates under 456.333 and
456.334; and
(b) The methods used by the committee to modify an approved length of
stay when the recipient's condition or treatment schedule changes.
42 CFR 456.336 Continued stay review process.
The UR plan must provide that --
(a) Review of continued stay cases is conducted by --
(1) The UR committee;
(2) A subgroup of the UR committee; or
(3) A designee of the UR committee;
(b) The committee, subgroup or designee reviews a recipient's
continued stay on or before the expiration of each assigned continued
stay review date;
(c) For each continued stay of a recipient in the SNF, the committee,
subgroup or designee reviews and evaluates the documentation described
under 456.311 against the criteria developed under 456.332 and applies
close professional scrutiny to cases described under 456.332(b);
(d) If the committee, subgroup or designee finds that the recipient's
continued stay in the SNF is needed, the committee assigns a new
continued stay review date in accordance with 456.334;
(e) If the committee, subgroup or designee finds that a continued
stay does not meet the criteria, the committee or a subgroup that
includes at least one physician reviews the case to decide the need for
continued stay;
(f) If the committee or subgroup making the review under paragraph
(e) of this section finds that a continued stay is not needed, it
notifies the recipient's attending physician and gives him an
opportunity to present his views before it makes a final decision on the
need for the continued stay;
(g) If the attending physician does not present additional
information or clarification of the need for the continued stay, the
decision of the committee of subgroup is final; and
(h) If the attending physician presents additional information or
clarification, at least two physician members of the committee review
the need for the continued stay. In a SNF that cares primarily for
mental patients, one of these two physicians must be knowledgeable in
the treatment of mental diseases. If they find that the recipient no
longer needs SNF services, their decision is final.
42 CFR 456.337 Notification of adverse decision.
The UR plan must provide that written notice of any adverse final
decision on the need for continued stay under 456.336 (f) through (h)
is sent to --
(a) The SNF administrator;
(b) The attending physician;
(c) The Medicaid agency;
(d) The recipient; and
(e) If possible, the next of kin or sponsor.
42 CFR 456.338 Time limits for final decision and notification of
adverse decision.
The UR plan must provide that --
(a) The committee makes a final decision on a recipient's need for
continued stay and gives notice under 456.337 of an adverse decision
within three working days after the assigned review date, except as
required under paragraph (b) of the section.
(b) If the committee makes an adverse final decision on a recipient's
need for continued stay before the assigned review date, the committee
gives notice under 456.337 within 2 working days after the date of the
final decision.
42 CFR 456.338 UR Plan: Medical Care Evaluation Studies
42 CFR 456.341 Purpose and general description.
(a) The purpose of medical care evaluation studies is to promote the
most effective and efficient use of available health facilities and
services consistent with patient needs and professionally recognized
standards of health care.
(b) Medical care evaluation studies --
(1) Emphasize identification and analyses of patterns of patient
care; and
(2) Suggest appropriate changes needed to maintain consistently high
quality patient care and effective and efficient use of services.
42 CFR 456.342 UR plan requirement for medical care evaluation studies.
(a) The UR plan must describe the methods that the committee uses to
select and conduct medical care evaluation studies under paragraph
(b)(1) of this section.
(b) The UR plan must provide that the UR committee --
(1) Determines the methods to be used in selecting and conducting
medical care evaluation studies in the SNF;
(2) Documents for each study --
(i) Its results; and
(ii) How the results have been used to make changes to improve the
quality of care and promote more effective and efficient use of
facilities and services;
(3) Analyzes its findings for each study; and
(4) Takes action as needed to --
(i) Correct or investigate further any deficiencies or problems in
the review process; or
(ii) Recommend more effective and efficient skilled nursing care
procedures.
42 CFR 456.343 Content of medical care evaluation studies.
Each medical care evaluation study must --
(a) Identify and analyze medical or administrative factors related to
the SNFs patient care;
(b) Include analysis of at least the following:
(1) Admissions.
(2) Durations of stay.
(3) Ancillary services furnished, including drugs and biologicals.
(4) Professional services performed in the SNF; and
(c) If indicated, contain recommendations for change beneficial to
patients, staff, the SNF and the community.
42 CFR 456.344 Data sources for studies.
Data that the committee uses to perform studies must be obtained from
one or more of the following sources:
(a) Medical records or other appropriate data.
(b) External organizations that compile statistics, design profiles,
and produce other comparative data.
(c) Cooperative endeavors with --
(1) PROs;
(2) Fiscal agents;
(3) Other providers of services; or
(4) Other appropriate agencies.
(43 FR 45266, Sept. 29, 1978, as amended at 51 FR 43198, Dec. 1,
1986)
42 CFR 456.345 Number of studies required to be performed.
The SNF must, at least, have one study in progress at any time and
complete one study each calendar year.
42 CFR 456.345 Discharge Plan
42 CFR 456.346 Discharge plan.
(a) The UR committee must review each recipient's discharge plan.
(b) Each discharge plan must insure that the recipient has a planned
program of post-discharge continuing care that takes his needs into
account.
42 CFR 456.347 Discharge planning procedures.
Each SNF must maintain discharge planning procedures that describe
the following:
(a) The staff member of the SNF or the health, social, or welfare
agency responsible for discharge planning.
(b) The authority of the member or agency, and the methods used in
discharge planning, including the relationship with the SNF's staff.
(c) The time allowed for determining each recipient's need for
discharge planning. The period must not be longer than 7 days after the
day of admission.
(d) The period after which each recipient's discharge plan will be
reevaluated.
(e) The local resources available to the SNF, the recipient, and the
attending physician to assist in developing and implementing discharge
plans.
(f) The provisions for periodic review and reevaluation of the SNF's
discharge planning program.
42 CFR 456.348 Information about discharged recipients.
(a) When a recipient is discharged, the SNF must provide information
that will insure the optimal continuity of care, such as --
(1) Current information relative to diagnoses;
(2) Prior treatment;
(3) Rehabilitation potential;
(4) Physician advice concerning immediate care; and
(5) Pertinent social information.
(b) This information must be provided to those persons who are
responsible for the recipient's post-discharge care.
42 CFR 456.348 Subpart F -- Utilization Control: Intermediate Care Facilities
42 CFR 456.350 Scope.
This subpart prescribes requirements for control of utilization of
intermediate care facility (ICF) services including requirements
concerning --
(a) Certification of need for care;
(b) Medical evaluation and admission review;
(c) Plan of care; and
(d) Utilization review plans.
42 CFR 456.351 Definition.
As used in this subpart:
Intermediate care facility services means those items and services
furnished in an intermediate care facility as defined in 440.140 and
440.150 of this subchapter, but excludes those services if they are
provided in Christian Science sanitoria.
42 CFR 456.351 Certification of Need for Care
42 CFR 456.360 Certification and recertification of need for inpatient
care.
(a) Certification. (1) A physician must certify for each applicant
or recipient that ICF services are or were needed.
(2) The certification must be made at the time of admission or, if an
individual applies for assistance while in an ICF, before the Medicaid
agency authorizes payment.
(b) Recertification. (1) A physician, or physician assistant or
nurse practitioner (as defined in 491.2 of this chapter) acting within
the scope of practice as defined by State law and under the supervision
of a physician, must recertify for each applicant or recipient that ICF
services are needed.
(2) Recertification must be made at least --
(i) Every 12 months after certification in an institution for the
mentally retarded or persons with related conditions; and
(ii) Every 60 days after certification in an ICF other than an
institution for the mentally retarded or persons with related
conditions.
(46 FR 48561, Oct. 1, 1981, as amended at 50 FR 33034, Aug. 16, 1985)
42 CFR 456.360 Medical, Psychological, and Social Evaluations and Admission Review
42 CFR 456.370 Medical, psychological, and social evaluations.
(a) Before admission to an ICF or before authorization for payment,
an interdisciplinary team of health professionals must make a
comprehensive medical and social evaluation and, where appropriate, a
psychological evaluation of each applicant's or recipient's need for
care in the ICF.
(b) In an institution for the mentally retarded or persons with
related conditions, the team must also make a psychological evaluation
of need for care. The psychological evaluation must be made before
admission or authorization of payment, but not more than three months
before admission.
(c) Each evaluation must include --
(1) Diagnoses;
(2) Summary of present medical, social, and where appropriate,
developmental findings;
(3) Medical and social family history;
(4) Mental and physical functional capacity;
(5) Prognoses;
(6) Kinds of services needed;
(7) Evaluation by an agency worker of the resources available in the
home, family and community; and
(8) A recommendation concerning --
(i) Admission to the ICF; or
(ii) Continued care in the ICF for individuals who apply for Medicaid
while in the ICF.
42 CFR 456.371 Exploration of alternative services.
If the comprehensive evaluation recommends ICF services for an
applicant or recipient whose needs could be met by alternative services
that are currently unavailable, the facility must enter this fact in the
recipient's record and begin to look for alternative services.
42 CFR 456.372 Medicaid agency review of need for admission.
Medical and other professional personnel of the Medicaid agency or
its designees must evaluate each applicant's or recipient's need for
admission by reviewing and assessing the evaluations required by
456.370.
42 CFR 456.372 Plan of Care
42 CFR 456.380 Individual written plan of care.
(a) Before admission to an ICF or before authorization for payment, a
physician must establish a written plan of care for each applicant or
recipient.
(b) The plan of care must include --
(1) Diagnoses, symptoms, complaints, and complications indicating the
need for admission;
(2) A description of the functional level of the individual;
(3) Objectives;
(4) Any orders for --
(i) Medications;
(ii) Treatments;
(iii) Restorative and rehabilitative services;
(iv) Activities;
(v) Therapies;
(vi) Social services;
(vii) Diet; and
(viii) Special procedures designed to meet the objectives of the plan
of care;
(5) Plans for continuing care, including review and modification of
the plan of care; and
(6) Plans for discharge.
(c) The team must review each plan of care at least every 90 days.
42 CFR 456.381 Reports of evaluations and plans of care.
A written report of each evaluation and plan of care must be entered
in the applicant's or recipient's record --
(a) At the time of admission; or
(b) If the individual is already in the ICF, immediately upon
completion of the evaluation or plan.
42 CFR 456.381 Utilization Review (UR) Plan: General Requirement
42 CFR 456.400 Scope.
Sections 456.401 through 456.438 of this subpart prescribe
requirements for a written utilization review (UR) plan for each ICF
providing Medicaid services. Sections 456.405 through 456.407 prescribe
administrative requirements; 456.411 through 456.413 prescribe
informational requirements; and 456.431 through 456.438 prescribe
requirements for continued stay review.
42 CFR 456.401 State plan UR requirements and options; UR plan
required for intermediate care facility services.
(a) The State plan must provide that --
(1) UR is performed for each ICF that furnishes inpatient services
under the plan;
(2) Each ICF has on file a written UR plan that provides for review
of each recipient's need for the services that the ICF furnishes him;
and
(3) Each written ICF UR plan meets requirements under 456.401
through 456.438.
(b) The State plan must specify the method used to perform UR, which
may be --
(1) Review conducted by the facility;
(2) Direct review in the facility by individuals --
(i) Employed by the medical assistance unit of the Medicaid agency;
or
(ii) Under contract to the Medicaid agency; or
(3) Any other method.
42 CFR 456.401 UR Plan: Administrative Requirements
42 CFR 456.405 Description of UR review function: How and when.
The UR plan must include a written description of --
(a) How UR is performed in the ICF; and
(b) When UR is performed.
42 CFR 456.406 Description of UR review function: Who performs UR;
disqualification from performing UR.
(a) The UR plan must include a written description of who performs UR
in the ICF.
(b) UR must be performed using a method specified under 456.401(b)
by a group of professional personnel that includes --
(1) At least one physician;
(2) In an ICF that cares primarily for mental patients, at least one
individual knowledgeable in the treatment of mental diseases; and
(3) In an institution for the mentally retarded, a least one
individual knowledgeable in the treatment of mental retardation.
(c) The group performing UR may not include any individual who --
(1) Is directly responsible for the care of the recipient whose care
is being reviewed;
(2) Is employed by the ICF; or
(3) Has a financial interest in any ICF.
42 CFR 456.407 UR responsibilities of administrative staff.
The UR plan must describe --
(a) The UR support responsibilities of the ICF's administrative
staff; and
(b) Procedures used by the staff for taking needed corrective action.
42 CFR 456.407 UR Plan: Informational Requirements
42 CFR 456.411 Recipient information required for UR.
The UR plan must provide that each recipient's record include
information needed to perform UR required under this subpart. This
information must include, at least, the following:
(a) Identification of the recipient.
(b) The name of the recipient's physician.
(c) The name of the qualified mental retardation professional (as
defined under 442.401 of this subchapter), if applicable.
(d) Date of admission, and dates of application for and authorization
of Medicaid benefits if application is made after admission.
(e) The plan of care required under 456.372;
(f) Initial and subsequent continued stay review dates described
under 456.433 and 456.434.
(g) Reasons and plan for continued stay, if the attending physician
or qualified mental retardation professional believes continued stay is
necessary.
(h) Other supporting material that the UR group believes appropriate
to be included in the record.
42 CFR 456.412 Records and reports.
The UR plan must describe --
(a) The types of records that are kept by the group performing UR;
and
(b) The type and frequency of reports made by the UR group, and
arrangements for distribution of the reports to appropriate individuals.
42 CFR 456.413 Confidentiality.
The UR plan must provide that the identities of individual recipients
in all UR records and reports are kept confidential.
42 CFR 456.413 UR Plan: Review of Need for Continued Stay
42 CFR 456.431 Continued stay review required.
(a) The UR plan must provide for a review of each recipients
continued stay in the ICF at least every 6 months to decide whether it
is needed.
(b) The UR plan requirement for continued stay review may be met by
--
(1) Reviews that are performed in accordance with the requirements of
456.432 through 456.437; or
(2) Reviews that meet on-site inspection requirements under subpart I
if --
(i) The composition of the independent professional review team under
subpart I meets the requirements of 456.406; and
(ii) Reviews are conducted as frequently as required under 456.433
and 456.434.
42 CFR 456.432 Evaluation criteria for continued stay.
The UR plan must provide that --
(a) The group performing UR develops written criteria to assess the
need for continued stay.
(b) The group develops more extensive written criteria for cases that
its experience shows are --
(1) Associated with high costs;
(2) Associated with the frequent furnishing of excessive services;
or
(3) Attended by physicians whose patterns of care are frequently
found to be questionable.
42 CFR 456.433 Initial continued stay review date.
The UR plan must provide that --
(a) When a recipient is admitted to the ICF under admission review
requirements of this subpart, the group performing UR assigns a
specified date by which the need for his continued stay will be
reviewed;
(b) The group performing UR bases its assignment of the initial
continued stay review date on the methods and criteria required to be
described under 456.435(a);
(c) The initial continued stay review date is --
(1) Not later than 6 months after admission; or
(2) Earlier than 6 months after admission, if indicated at the time
of admission; and
(d) The group performing UR insures that the initial continued stay
review date is recorded in the recipient's record.
42 CFR 456.434 Subsequent continued stay review dates.
The UR plan must provide that --
(a) The group performing UR assigns subsequent continued stay review
dates in accordance with 456.435.
(b) The group assigns a subsequent continued stay review date each
time it decides under 456.436 that the continued stay is needed --
(1) At least every 6 months; or
(2) More frequently than every six months if indicated at the time of
continued stay review; and
(c) The group insures that each continued stay review date it assigns
is recorded in the recipient's record.
42 CFR 456.435 Description of methods and criteria: Continued stay
review dates.
The UR plan must describe the methods and criteria that the group
performing UR uses to assign initial and subsequent continued stay
review dates under 456.433 and 456.434.
42 CFR 456.436 Continued stay review process.
The UR plan must provide that --
(a) Review of continued stay cases is conducted by --
(1) The group performing UR; or
(2) A designee of the UR group;
(b) The group or its designee reviews a recipient's continued stay on
or before the expiration of each assigned continued stay review date.
(c) For each continued stay of a recipient in the ICF, the group or
its designee reviews and evaluates the documentation described under
456.411 against the criteria developed under 456.432 and applies close
professional scrutiny to cases described under 456.432(b);
(d) If the group or its designee finds that a recipient's continued
stay in the ICF is needed, the group assigns a new continued stay review
date in accordance with 456.434;
(e) If the group or its designee finds that a continued stay case
does not meet the criteria, the group or a subgroup that includes at
least one physician reviews the case to decide the need for continued
stay;
(f) If the group or subgroup making the review under paragraph (e) of
this section finds that a continued stay is not needed, it notifies the
recipient's attending physician or, in institutions for the mentally
retarded, the recipient's qualified mental retardation professional,
within 1 working day of its decision, and gives him 2 working days from
the notification date to present his views before it makes a final
decision on the need for the continued stay;
(g) If the attending physician or qualified mental retardation
professional does not present additional information or clarification of
the need for the continued stay, the decision of the UR group is final;
(h) If the attending physician or qualified mental retardation
professional presents additional information or clarification, the need
for continued stay is reviewed by --
(1) The physician member(s) of the UR group, in cases involving a
medical determination; or
(2) The UR group, in cases not involving a medical determination;
and
(i) If the individuals performing the review under paragraph (h) of
this section find that the recipient no longer needs ICF services, their
decision is final.
42 CFR 456.437 Notification of adverse decision.
The UR plan must provide that written notice of any adverse final
decision on the need for continued stay under 456.436 (g) through (i)
is sent to --
(a) The ICF administrator;
(b) The attending physician;
(c) The qualified mental retardation professional, if applicable;
(d) The Medicaid agency;
(e) The recipient; and
(f) If possible, the next of kin or sponsor.
42 CFR 456.438 Time limits for notification of adverse decision.
The UR plan must provide that the group gives notice under 456.437
of an adverse decision not later than 2 days after the date of the final
decision.
42 CFR 456.438 Subpart G -- Inpatient Psychiatric Services for Individuals Under Age 21: Admission and Plan of Care Requirements
42 CFR 456.480 Scope.
This subpart concerns admission and plan of care requirements that
apply to inpatient psychiatric services for individuals under age 21 in
hospitals, mental hospitals, skilled nursing facilities, and
intermediate care facilities.
42 CFR 456.481 Admission certification and plan of care.
If a facility provides inpatient psychiatric services to a recipient
under age 21 --
(a) The admission certification by the review team required in
441.152 satisfies the requirement for physician certification of need
for care in 456.60, 456.160, 456.260, and 456.360; and
(b) The development and review of the plan of care required in
441.154 satisfies the requirement for physician recertification of need
for care in the sections cited in paragraph (a) and the requirement for
establishment and periodic review of the plan of care in 456.80,
456.180, 456.280, and 456.380.
(c) The plan of care must be established by the team described in
441.156.
42 CFR 456.482 Medical, psychiatric, and social evaluations.
If a facility provides inpatient psychiatric services to a recipient
under age 21, the medical, psychiatric, and social evaluations required
by 456.170, 456.270, and 456.370 must be made by the team described in
441.153.
42 CFR 456.482 Subpart H -- Utilization Review Plans: FFP, Waivers, and Variances for Hospitals, Mental Hospitals, and Skilled Nursing Facilities
42 CFR 456.500 Purpose.
For hospitals, mental hospitals and SNFs, this subpart --
(a) Prescribes conditions for the availability of FFP relating to UR
plans;
(b) Prescribes conditions for granting a waiver of UR plan
requirements; and
(c) Prescribes conditions for granting a variance in UR plan
requirements for remote facilities.
42 CFR 456.501 UR plans as a condition for FFP.
(a) Except when waived under 456.505 through 456.508, FFP is not
available in expenditures for Medicaid services furnished by a hospital,
mental hospital, or SNF unless the facility has in effect a UR plan that
meets the utilization review requirements for Medicare under section
1861(k) of the Act.
(b) A facility that participates in Medicare and Medicaid must use
the same UR standards and procedures and review committee for Medicaid
as it uses for Medicare.
(c) A facility that does not participate in Medicare must meet the UR
plan requirements in subpart C, D, or E of this part, which are
equivalent to the Medicare UR plan requirements in 405.1137, 482.30,
and 482.60 of this chapter.
(43 FR 45266, Sept. 29, 1978, as amended at 51 FR 22042, June 17,
1986)
42 CFR 456.501 UR Plan: Waiver of Requirements
42 CFR 456.505 Applicability of waiver.
The Administrator may waive the UR plan requirements of subparts C,
D, or E of this part, except for provisions relating to disqualification
of UR committee members under 456.106 of subpart C, 456.206 of subpart
D, and 456.306 of subpart E, if the Medicaid agency --
(a) Applies for a waiver; and
(b) Demonstrates to the Administrator's satisfaction that it has in
operation specific UR procedures that are superior in their
effectiveness to the UR plan requirements under subparts C, D, or E.
42 CFR 456.506 Waiver options for Medicaid agency.
(a) The agency may apply for a waiver at any time it has the
procedures referred to under 456.505(b) in operation at least --
(1) On a demonstration basis; or
(2) In any part of the State.
(b) Any hospital, mental hospital, or SNF participating under the
plan that is not covered by a waiver must continue to meet all the UR
plan requirements under subpart C, D, or E of this part.
42 CFR 456.507 Review and granting of waiver requests.
(a) When the agency applies for a waiver, the Administrator will
assess the agency's UR procedures and grant the waiver if he determines
that the procedures meet criteria he establishes.
(b) The Administrator will review and evaluate each waiver between 1
and 2 years after he has granted it and between 1 and 2 years
periodically thereafter.
42 CFR 456.508 Withdrawal of waiver.
(a) The Administrator will withdraw a waiver if he determines that
State procedures are no longer superior in their effectiveness to the
procedures required for UR plans under subparts C, D, or E.
(b) If a waiver is withdrawn by the Administrator, each hospital,
mental hospital, or SNF covered by the waiver must meet all the UR plan
requirements under subparts C, D, or E of this part.
42 CFR 456.508 UR Plan: Remote Facility Variances from Time Requirements
42 CFR 456.520 Definitions.
As used in 456.521 through 456.525 of this subpart:
Available physician or other professional personnel means an
individual who --
(a) Is professionally qualified;
(b) Is not precluded from participating in UR under 456.107 of
subpart C; 456.207 of subpart D; or 456.307 of subpart E; and
(c) Is not precluded from effective participation in UR because he
requires more than approximately 1 hour to travel between the remote
facility and his place of work.
Remote facility means a facility located in an area that does not
have enough available physicians or other professional personnel to
perform UR as required under subparts C, D, or E of this part, and for
which the State requests a variance.
Variance means permission granted by the Administrator to the
Medicaid agency for a specific remote facility to use time periods
different from those specified for the start and completion of reviews
of all cases under the following sections: 456.125, 456.126, 456.136,
and 456.137 of subpart C; 456.238 of subpart D; and 456.333,
456.334, and 456.336 of subpart E.
42 CFR 456.521 Conditions for granting variance requests.
(a) Except as described under paragraph (b) of this section, the
administrator may grant a variance for a specific remote facility if the
agency submits concurrently --
(1) A request for the variance that documents to his satisfaction
that the facility is unable to meet the time requirements for which the
variance is requested; and
(2) A revised UR plan for the facility.
(b) The Administrator will not grant a variance if the remote
facility is operating under a UR plan waiver that the Secretary has
granted or is considering under 456.505 through 456.508.
42 CFR 456.522 Content of request for variance.
The agency's request for a variance must include --
(a) The name, location, and type of the remote facility;
(b) The number of total patient admissions and the average daily
patient census at the facility in the 6 months preceding the request;
(c) The number of Medicare and Medicaid patient admissions and the
average daily Medicare and Medicaid patient census at the facility in
the 6 months preceding the request;
(d) The name and location of each hospital, mental hospital, SNF, and
ICF located within a 50-mile radius of the facility;
(e) The distance and average travel time between the remote facility
and each facility listed in paragraph (e) of this section;
(f) Documentation by the facility of its attempts to obtain the
services of available physicians or other professional personnel, or
both;
(g) The names of all physicians on the active staff, and the names of
all other professional personnel on the staff whose availability is
relevant to the request;
(h) The practice locations of available physicians and the estimated
number of available professional personnel whose availability is
relevant to the request;
(i) Documentation by the facility of its inability to perform UR
within the time requirements for which the variance is requested and its
good faith efforts to comply with the UR plan requirements of subparts
C, D, or E of this part;
(j) An assurance by the facility that it will continue its good faith
efforts to meet the UR plan requirements of subpart C, D, or E of this
part; and
(k) A statement of whether a planning or conditional PSRO exists in
the area where the facility is located.
42 CFR 456.523 Revised UR plan.
(a) The revised UR plan for the remote facility must specify the
methods and procedures that the facility will use if a variance is
granted to insure that it --
(1) Maintains effective and timely control over the utilization of
services; and
(2) Conducts reviews in a way that improves the quality of care
provided to patients.
(b) The revised UR plan for the remote facility is the basis for
validation of UR under sec. 1903(g)(2) of the Act for the period when a
variance is in effect.
42 CFR 456.524 Notification of Administrator's action and duration of
variance.
(a) The Administrator --
(1) Will notify the agency of the action he takes on its request for
a variance; and
(2) Will specify the period of time, not to exceed 1 year, for which
the variance may be granted.
(b) When it receives the Administrator's notification, the agency
must promptly notify the remote facility of his action.
42 CFR 456.525 Request for renewal of variance.
(a) The agency must submit a request for renewal of a variance to the
Administrator at least 30 days before the variance expires.
(b) The renewal request must contain the information required under
456.522.
(c) The renewal request must show, to the Administrator's
satisfaction, that the remote facility continues to meet the
requirements of 456.521 through 456.523.
42 CFR 456.525 Subpart I -- Inspections of Care in Skilled Nursing and Intermediate Care Facilities and Institutions for Mental Diseases
42 CFR 456.600 Purpose.
This subpart prescribes requirements for periodic inspections of care
and services in skilled nursing facilities (SNF's), intermediate care
facilities (ICF's), and institutions for mental diseases (IMD's).
42 CFR 456.601 Definitions.
For purposes of this subpart --
Facility means a skilled nursing facility, an institution for mental
diseases, or an intermediate care facility.
Intermediate care facility includes institutions for the mentally
retarded or persons with related conditions but excludes Christian
Science sanatoria operated, or listed and certified, by the First Church
of Christ Scientist, Boston, Mass.
Institution for mental diseases includes a mental hospital, a
psychiatric facility, and a skilled nursing or intermediate care
facility that primarily cares for mental patients.
Psychiatric facility includes a facility or program that provides
inpatient psychiatric services for individuals under 21, as specified in
441.151 of this chapter, but does not include psychiatric wards in
acute care hospitals.
(44 FR 56337, Oct. 1, 1979)
42 CFR 456.602 Inspection team.
(a) A team, as described in this section and 456.603 must
periodically inspect the care and services provided to recipients in
each facility.
(b) Each team conducting periodic inspections must have a least one
member who is at physician or registered nurse and other appropriate
health and social service personnel.
(c) For an IMD other than an ICF, each team must have a psychiatrist
or physician knowledgeable about mental institutions and other
appropriate mental health and social service personnel.
(d) For an ICF that primarily cares for mental patients, each team
must have at least one member who knows the problems and needs of
mentally retarded individuals.
(e) For an institution for the mentally retarded or persons with
related conditions, each team must have at least one member who knows
the problems and needs of mentally retarded individuals.
(f) For ICFs primarily serving individuals 65 years of age or older,
each team must have at least one member who knows the problems and needs
of those individuals.
(g) If there is no physician on the team, the Medicaid agency must
insure that a physician is available to provide consultation to the
team.
(h) If a team has one or more physicians, it must be supervised by a
physician.
42 CFR 456.603 Financial interests and employment of team members.
(a) Except as provided in paragraph (b) of this section --
(1) No member of a team that reviews care in a SNF may have a
financial interest in or be employed by any SNF; and
(2) No member of a team that reviews care in an ICF may have a
financial interest in or be employed by any ICF.
(b) A member of a team that reviews care in an IMD or an institution
for the mentally retarded or persons with related conditions --
(1) May not have a financial interest in any institution of that same
type but may have a financial interest in other facilities or
institutions; and
(2) May not review care in an institution where he is employed but
may review care in any other facility or institution.
42 CFR 456.604 Physician team member inspecting care of recipients.
No physician member of a team may inspect the care of a recipient for
whom he is the attending physician.
42 CFR 456.605 Number and location of teams.
There must be a sufficient number of teams so located within the
State that onsite inspections can be made at appropriate intervals in
each facility caring for recipients.
42 CFR 456.606 Frequency of inspections.
The team and the agency must determine, based on the quality of care
and services being provided in a facility and the condition of
recipients in the facility, at what intervals inspections will be made.
However, the team must inspect the care and services provided to each
recipient in the facility at least annually.
42 CFR 456.607 Notification before inspection.
No facility may be notified of the time of inspection more than 48
hours before the scheduled arrival of the team.
42 CFR 456.608 Personal contact with and observation of recipients and
review of records.
(a) For recipients under age 21 in psychiatric facilities and
recipients in SNFs and ICFs, other than those described in paragraph (b)
of this section, the team's inspection must include --
(1) Personal contact with and observation of each recipient; and
(2) Review of each recipient's medical record.
(b) For recipients age 65 or older in IMDs, the team's inspection
must include --
(1) Review of each recipient's medical record; and
(2) If the record does not contain complete reports of periodic
assessments required by 441.102 of this subchapter or, if such reports
are inadequate, personal contact with and observation of each recipient
(43 FR 45266, Sept. 29, 1978, as amended at 44 FR 17940, Mar. 23,
1979)
42 CFR 456.609 Determinations by team.
The team must determine in its inspection whether --
(a) The services available in the facility are adequate to --
(1) Meet the health needs of each recipient, and the rehabilitative
and social needs of each recipient in an ICF; and
(2) Promote his maximum physical, mental, and psychosocial
functioning.
(b) It is necessary and desirable for the recipient to remain in the
facility;
(c) It is feasible to meet the recipient's health needs and, in an
ICF, the recipient's rehabilitative needs, through alternative
institutional or noninstitutional services; and
(d) Each recipient under age 21 in a psychiatric facility and each
recipient in an institution for the mentally retarded or persons with
related conditions is receiving active treatment as defined in 441.154
of this subchapter.
42 CFR 456.610 Basis for determinations.
In making the determinations on adequacy of services and related
matters under 456.609 for each recipient, the team may consider such
items as whether --
(a) The medical evaluation, any required social and psychological
evaluations, and the plan of care are complete and current; the plan of
care and, where required, the plan of rehabilitation are followed; and
all ordered services, including dietary orders, are provided and
properly recorded;
(b) The attending physician reviews prescribed medications --
(1) At least every 30 days in SNFs, psychiatric facilities, and
mental hospitals; and
(2) At least quarterly in ICFs;
(c) Tests or observations of each recipient indicated by his
medication regimen are made at appropriate times and properly recorded;
(d) Physician, nurse, and other professional progress notes are made
as required and appear to be consistent with the observed condition of
the recipient;
(e) The recipient receives adequate services, based on such
observations as --
(1) Cleanliness;
(2) Absence of bedsores;
(3) Absence of signs of malnutrition or dehydration; and
(4) Apparent maintenance of maximum physical, mental, and
psychosocial funtion;
(f) In an ICF, the recipient receives adequate rehabilitative
services, as evidenced by --
(1) A planned program of activities to prevent regression; and
(2) Progress toward meeting objectives of the plan of care;
(g) The recipient needs any service that is not furnished by the
facility or through arrangements with others; and
(h) The recipient needs continued placement in the facility or there
is an appropriate plan to transfer the recipient to an alternate method
of care.
42 CFR 456.611 Reports on inspections.
(a) The team must submit a report promptly to the agency on each
inspection.
(b) The report must contain the observations, conclusions, and
recommendations of the team concerning --
(1) The adequacy, appropriateness, and quality of all services
provided in the facility or through other arrangements, including
physician services to recipients; and
(2) Specific findings about individual recipients in the facility.
(c) The report must include the dates of the inspection and the names
and qualifications of the members of the team.
(43 FR 45266, Sept. 29, 1978, as amended at 44 FR 56337, Oct. 1,
1979)
42 CFR 456.612 Copies of reports.
The agency must send a copy of each inspection report to --
(a) The facility inspected;
(b) The facility's utilization review committee;
(c) The agency responsible for licensing, certification, or approval
of the facility for purposes of Medicare and Medicaid; and
(d) Other State agencies that use the information in the reports to
perform their official function, including, if inspection reports
concern IMD's, the appropriate State mental health authorities.
42 CFR 456.613 Action on reports.
The agency must take corrective action as needed based on the report
and recommendations of the team submitted under this subpart.
42 CFR 456.614 Inspections by utilization review committee.
A utilization review committee under subparts C through F of this
part may conduct the periodic inspections required by this subpart if --
(a) The committee is not based in the facility being reviewed; and
(b) The composition of the committee meets the requirements of this
subpart.
42 CFR 456.614 Subpart J -- Penalty for Failure To Make a Satisfactory
Showing of an Effective Institutional Utilization Control Program
Authority: Secs. 1102 and 1903(g) of the Social Security Act (42
U.S.C. 1302 and 1396 b(g)).
Source: 44 FR 56338, Oct. 1, 1979, unless otherwise noted.
42 CFR 456.650 Basis, purpose and scope.
(a) Basis. Section 1903(g) of the Act requires that FFP for
long-stay inpatient services at a level of care be reduced, by a
specified formula, for any quarter in which a State fails to make a
satisfactory showing that it has an effective program of utilization
control for that level of care.
(b) Purpose. This subpart specifies --
(1) What States must do to make a satisfactory showing;
(2) How the Administrator will determine whether reductions will be
imposed; and
(3) How the required reductions will be implemented.
(c) Scope. The reductions required by this subpart do not apply to
--
(1) Services provided under a contract with a health maintenance
organization; or
(2) Facilities in which a PRO is performing medical and utilization
reviews under contract with the Medicaid agency in accordance with
431.630 of this chapter.
(44 FR 56338, Oct. 1, 1979, as amended at 50 FR 15327, Apr. 17, 1985;
51 FR 43198, Dec. 1, 1986)
42 CFR 456.651 Definitions.
For purposes of this subpart --
Facility, with respect to inpatient psychiatric services for
individuals under 21, includes a psychiatric program as specified in
441.151 of this chapter.
Level of care means one of the following types of inpatient services:
hospital, mental hospital, skilled nursing facility, intermediate care
facility, or psychiatric services for individuals under 21.
Long-stay services means services provided to a recipient after a
total of 60 days of inpatient stay (90 in the case of mental hospital
services) during a 12-month period beginning July 1, not counting days
of stay paid for wholly or in part by Medicare.
42 CFR 456.652 Requirements for an effective utilization control
program.
(a) General requirements. In order to avoid a reduction in FFP, the
Medicaid agency must make a satisfactory showing to the Administrator,
in each quarter, that it has met the following requirements for each
recipient:
(1) Certification and recertification of the need for inpatient care,
as specified in 456.60, 456.160, 456.260, 456.360 and 456.481.
(2) A plan of care established and periodically reviewed and
evaluated by a physician, as specified in 456.80, 456.180, 456.280,
456.380 and 456.481.
(3) A continuous program of utilization review under which the
admission of each recipient is reviewed or screened in accordance with
section 1903(g)(1)(C) of the Act; and
(4) A regular program of reviews, including medical evaluations, and
annual on-site reviews of the care of each recipient, as specified in
456.170, 456.270, 456.370, and 456.482 and subpart I of this part.
(b) Annual on-site review requirements. (1) An agency meets the
quarterly on-site review requirements of paragraph (a)(4) of this
section for a quarter if it completes on-site reviews of each recipient
in every facility in the State, and in every State-owned facility
regardless of location, by the end of the quarter in which a review is
required under paragraph (b)(2) of this section.
(2) An on-site review is required in a facility by the end of a
quarter if the facility entered the Medicaid program during the same
calendar quarter 1 year earlier or has not been reviewed since the same
calendar quarter 1 year earlier. If there is no Medicaid recipient in
the facility on the day a review is scheduled, the review is not
required until the next quarter in which there is a Medicaid recipient
in the facility.
(3) If a facility is not reviewed in the quarter in which it is
required to be reviewed under paragraph (b)(2) of this section, it will
continue to require a review in each subsequent quarter until the review
is performed.
(4) The requirement for an on-site review in a given quarter is not
affected by the addition or deletion of a level of care in a facility's
provider agreement.
(c) Facilities without valid provider agreements. The requirements
of paragraphs (a) and (b) of this section apply with respect to
recipients for whose care the agency intends to claim FFP even if the
recipients receive care in a facility whose provider agreement has
expired or been terminated.
(44 FR 56338, Oct. 1, 1979, as amended at 46 FR 48561, Oct. 1, 1981)
42 CFR 456.653 Acceptable reasons for not meeting requirements for
annual on-site review.
The Administrator will find an agency's showing satisfactory, even if
it failed to meet the annual review requirements of 456.652(a)(4), if
--
(a) The agency demonstrates that --
(1) It completed reviews by the end of the quarter in at least 98
percent of all facilities requiring review by the end of the quarter;
(2) It completed reviews by the end of the quarter in all facilities
with 200 or more certified Medicaid beds requiring review by the end of
the quarter; and
(3) With respect to all unreviewed facilities, the agency exercised
good faith and due diligence by attempting to review those facilities
and would have succeeded but for events beyond its control which it
could not have reasonably anticipated; or
(b) The agency demonstrates that it failed to meet the standard in
paragraph (a) (1) and (2) of this section by the close of the quarter
for technical reasons, but met the standard within 30 days after the
close of the quarter. Technical reasons are circumstances within the
agency's control.
(c) Facilities that are reviewed under paragraph (b) of this section,
after the quarter in which they were due for review, retain their
original anniversary quarter due date for purposes of subsequent
reviews.
42 CFR 456.654 Requirements for content of showings and procedures for
submittal.
(a) An agency's showing for a quarter must --
(1) Include a certification by the agency that the requirements of
456.652(a) (1) through (4) were met during the quarter for each level of
care or, if applicable, a certification of the reasons the annual
on-site review requirements of 456.652(a)(4) were not met in any
facilities;
(2) For all mental hospitals, skilled nursing facilities,
intermediate care facilities, and facilities providing inpatient
psychiatric services for individuals under 21, participating in Medicaid
any time during the 12-month period ending on the last day of the
quarter, list each facility by level of care, name, address and provider
number;
(3) For each facility entering or leaving the program during the
12-month period ending on the last day of the quarter, list the
beginning or ending dates of the provider agreement and supply a copy of
the provider agreement;
(4) If review has been contracted to a PRO under 431.630 of this
chapter, list the date the PRO contracted for review.
(5) List all dates of on-site reviews completed by review teams
anytime during the 12-month period ending on the last day of the
quarter;
(6) For all facilities in which an on-site review was required but
not conducted, list the facility by name, address and provider number;
(7) For each on-site review in a mental hospital, skilled nursing or
intermediate care facility that primarily cares for mental patients, or
inpatient psychiatric facility, list the name and qualifications of one
team member who is a physician; and
(8) For each on-site review in an intermediate care facility or
skilled nursing facility that does not primarily care for mental
patients, list the name and qualifications of one team member who is
either a physician or registered nurse.
(b) The quarterly showing must be in the form prescribed by the
Administrator.
(c) The quarterly showing must be postmarked or received within 30
days after the close of the quarter for which it is made, unless the
agency demonstrates good cause for later submittal and the showing is
postmarked or received within 45 days after the close of the quarter.
Good cause means unanticipated circumstances beyond the agency's
control.
(44 FR 56338, Oct. 1, 1979, as amended at 50 FR 15327, Apr. 17, 1985;
51 FR 43198, Dec. 1, 1986)
42 CFR 456.655 Validation of showings.
(a) The Administrator will periodically validate showings submitted
under 456.654. Validation procedures will include on-site sample
surveys of institutions and surveys at the Medicaid agencies.
(b) The Administrator will not find an agency's showing satisfactory
if the information obtained through his validation procedures
demonstrates, that any of the requirements of 456.652(a) (1) through
(4) were not met during the quarter for which the showing was made.
42 CFR 456.656 Reductions in FFP.
(a) If the Administrator determines an agency's showing does not meet
each of the requirements of this sub-part, he will give the agency 30
days notice before making the required reduction.
(b) If the Administrator determines that a showing for any quarter is
unsatisfactory on its face, he will make the required reduction in the
grant award based on the Quarterly Medicaid Statement of Expenditures
for the Medical Assistance Program for that quarter. (This form HCFA-64
is described in 430.30(c) of this chapter.)
(c) If the Administrator finds a showing satisfactory on its face,
but after validation determines the showing to be unsatisfactory, he
will notify the agency of any required reduction in FFP no later than
the first day of the fourth calendar quarter following the calendar
quarter for which the showing was made. Any required reduction will be
made by amending or adjusting the agency's grant award.
(d) The agency may request reconsideration of a reduction in
accordance with the procedures specified in 45 CFR part 16.
42 CFR 456.657 Computation of reductions in FFP.
(a) For each level of care specified in a provider agreement, and for
each quarter for which a satisfactory showing is not made, the amount of
the reduction in FFP is computed as follows:
(1) For each level of care, the number of recipients who received
services in facilities that did not meet the requirements of this
subpart is divided by the total number of recipients who received
services in facilities for which a showing was required under this
subpart. If any of the requirements specified in 456.652(a)(1) through
(4) were not met for any recipient in a facility, the reduction will be
computed on the total number of recipients in that facility at the level
of care in question.
(2) The fraction obtained in paragraph (a)(1) of this section is
multiplied by one-third.
(3) The product obtained in paragraph (a)(2) of this section is
multiplied by the Federal Medical Assistance Percentage (FMAP).
(4) The product obtained in paragraph (a)(3) of this section is
multiplied by the agency payments for longstay services furnished during
the quarter at that level of care.
(b) If any of the data required to compute the amount of the
reduction in FFP are unavailable, the Administrator will substitute an
estimate. If the agency determines the exact data to the satisfaction
of the Administrator, the estimate may later be adjusted. If the number
of recipients in individual facilities is not available, the fraction
specified in paragraph (a)(1) of this section will be estimated, for
each level of care, by dividing the number of facilities in which the
requirements were not met by the total number of facilities for which a
showing is required under this subpart.
42 CFR 456.657 SUBCHAPTER D -- PEER REVIEW ORGANIZATIONS
42 CFR 456.657 PART 462 -- PEER REVIEW ORGANIZATIONS
42 CFR 456.657 Subpart A -- General Provisions
Sec.
462.1 Definitions.
42 CFR 456.657 Subpart B -- (Reserved)
42 CFR 456.657 Subpart C -- Utilization and Quality Control Peer Review
Organizations
462.100 Scope and applicability.
462.101 Eligibility requirements for PRO contracts.
462.102 Eligibility of physician-sponsored organizations.
462.103 Eligibility of physician-access organizations.
462.104 Requirements for demonstrating ability to perform review.
462.105 Prohibition against contracting with health care facilities.
462.106 Prohibition against contracting with payor organizations.
462.107 PRO contract award.
Authority: Secs. 1102, 1152, and 1153 of the Social Security Act (42
U.S.C. 1302, 1320c-1 and 1320-2).
42 CFR 456.657 Subpart A -- General Provisions
42 CFR 462.1 Definitions.
For purposes of this part:
Five percent or more owner means a person (including, where
appropriate, a corporation) who:
(a) Has an ownership interest of 5 percent or more;
(b) Has an indirect ownership interest equal to 5 percent or more;
(c) Has a combination of direct and indirect ownership interests (the
possession of equity in the capital, the stock, or the profits of an
entity) equal to 5 percent or more; or
(d) Is the owner of an interest of 5 percent or more in any
obligation secured by an entity, if the interest equals at least 5
percent of the value of the property or assets of the entity.
Health care facility means an institution that directly provides or
supplies health care services for which payment may be made in whole or
in part under Title XVIII of the Act. A health care facility may be a
hospital, skilled nursing facility, home health agency, free-standing
ambulatory surgical center, or outpatient facility or any other entity
which provides or supplies direct care to Medicare beneficiaries.
Managing employee means a general manager, business manager,
administrator, director or other individual who exercises operational or
managerial control over the entity or organization, or who, directly or
indirectly, conducts the day-to-day operations of the entity or
organization.
Payor organization means any organization, other than a self-insured
employer, which makes payments directly or indirectly to health care
practitioners or providers whose health care services are reviewed by
the organization or would be reviewed by the organization if it entered
into a PRO contract. ''Payor organization'' also means any organization
which is affiliated with any entity which makes payments as described
above, by virtue of the organization having two or more governing body
members who are also either governing body members, officers, partners,
5 percent or more owners or managing employees in a health maintenance
organization or competitive medical plan.
Physician means:
(1) A doctor of medicine or osteopathy licensed under State law to
practice medicine, surgery, or osteopathy in the State in which the PRO
is located;
(2) An intern, resident, or Federal Government employee authorized
under State or Federal law to practice medicine, surgery, or osteopathy
in the PRO area; and
(3) An individual licensed to practice medicine in American Samoa,
the Northern Mariana Islands, and the Trust Territory of the Pacific
Islands.
(43 FR 32085, July 24, 1978, as amended at 49 FR 7206, Feb. 27, 1984.
Redesignated at 50 FR 15327, Apr. 17, 1985, and amended at 50 FR 15328,
Apr. 17, 1985; 51 FR 43197, Dec. 1, 1986)
42 CFR 462.1 Subpart B -- (Reserved)
42 CFR 462.1 Subpart C -- Utilization and Quality Control Peer Review
Organizations
Source: 49 FR 7207, Feb. 27, 1984, unless otherwise noted.
Redesignated at 50 FR 15327, Apr. 17, 1985.
42 CFR 462.100 Scope and applicability.
This subpart implements sections 1152 and 1153(b) of the Social
Security Act as amended by the Peer Review Improvement Act of 1982 (Pub.
L. 97-248). It defines the types of organizations eligible to become
PROs and establishes certain limitations and priorities regarding PRO
contracting.
42 CFR 462.101 Eligibility requirements for PRO contracts.
In order to be eligible for a PRO contract an organization must --
(a) Be either a physician-sponsored organization as described in
462.102; or a physician-access organization as described in 462.103;
and
(b) Demonstrate its ability to perform review as set forth in
462.104.
42 CFR 462.102 Eligibility of physician-sponsored organizations.
(a) In order to be eligible for designation as a physician-sponsored
PRO, an organization must meet the following conditions:
(1) Be composed of a substantial number of the licensed doctors of
medicine and osteopathy practicing medicine or surgery in the review
area and who are representative of the physicians practicing in the
area.
(2) Not be a health care facility, health care facility association,
or health care facility affiliate, as specified in 462.105.
(b) In order to meet the requirements of paragraph (a)(1) of this
section, an organization must state and have documentation in its files
showing that it is composed of at least 10 percent of the licensed
doctors of medicine and osteopathy practicing medicine or surgery in the
review area.
(c) In order to meet the requirements or paragraph (a)(2) of this
section, an organization must --
(1) State and have documentation in its files demonstrating that it
is composed of at least 20 percent of the licensed doctors of medicine
and osteopathy practicing medicine or surgery in the review area; or
(2) If the organization is not composed of at least 20 percent of the
licensed doctors of medicine and osteopathy practicing medicine or
surgery in the review area, then the organization must demonstrate in
its contract proposal, through letters of support from physicians or
physician organizations, or through other means, that it is
representative of the area physicians.
(d) Organizations that meet the requirements in paragraph (a) of this
section will receive, during the contract evaluation process, a set
number of bonus points.
(49 FR 7207, Feb. 27, 1984. Redesignated at 50 FR 15327, Apr. 17,
1985 and amended at 50 FR 15328, Apr. 17, 1985)
42 CFR 462.103 Eligibility of physician-access organizations.
(a) In order to be eligible for designation as a physician-access
PRO, an organization must meet the following conditions:
(1) Have available to it, by arrangement or otherwise, the services
of a sufficient number of licensed doctors of medicine or osteopathy
practicing medicine or surgery in the review area to assure adequate
peer review of the services provided by the various medical specialties
and subspecialties.
(2) Not be a health care facility, health care facility association,
or health care facility affiliate, as specified in 462.105.
(b) An organization meets the requirements of paragraph (a)(1) of
this section if it demonstrates --
(1) That it has available to it at least one physician in every
generally recognized specialty; and
(2) The existence of an arrangement or arrangements with physicians
under which the physicians would conduct review for the organization.
(50 FR 15328, Apr. 17, 1985)
42 CFR 462.104 Requirements for demonstrating ability to perform
review.
(a) A physician-sponsored or physician-access organization will be
found capable of conducting review if HCFA determines that the
organization is able to set quantifiable performance objectives and
perform the utilization and quality review functions established under
section 1154 of the Social Security Act in an efficient and effective
manner.
(b) HCFA will determine that the organization is capable of
conducting utilization and quality review if --
(1) The organization's proposed review system is adequate; and
(2) The organization has available sufficient resources (including
access to medical review skills) to implement that system; and
(3) The organization's quantifiable objectives are acceptable.
(c) HCFA may consider prior similar review experience in making
determinations under paragraph (b) of this section.
(d) A State government that operates a Medicaid program will be
considered incapable of performing utilization and quality review
functions in an effective manner, unless the State demonstrates to the
satisfaction of HCFA that it will act with complete independence and
objectivity.
42 CFR 462.105 Prohibition against contracting with health care
facilities.
(a) Basic rule. Except as permitted under paragraph (b) of this
section, the following are not eligible for PRO contracts:
(1) A health care facility in the PRO area.
(2) An association of health care facilities in the PRO area.
(3) A health care facility affiliate; that is, an organization in
which more than 20 percent of the members of the governing body are also
either a governing body member, officer, partner, five percent or more
owner, or managing employee in a health care facility or association of
health care facilities in the PRO area.
(b) Exceptions. Effective November 15, 1984, the prohibition stated
in paragraph (a) of this section will not apply to a payor organization
if HCFA determines under 462.106 that there is no other eligible
organization available.
(c) Subcontracting. A PRO must not subcontract with a facility to
conduct any review activities except for the review of the quality of
care.
(50 FR 15328, Apr. 17, 1985)
42 CFR 462.106 Prohibition against contracting with payor
organizations.
Payor organizations are not eligible to become PROs for the area in
which they make payments until November 15, 1984. If no PRO contract
for an area is awarded before November 15, 1984, a payor organization
will be determined eligible by HCFA, if an eligible organization that is
not a payor organization is unavailable at that time. HCFA may
determine the unavailability of nonpayor organizations based on the lack
of response to an appropriate Request for Proposal.
(50 FR 15328, Apr. 17, 1985)
42 CFR 462.107 PRO contract award.
HCFA, in awarding PRO contracts, will take the following actions --
(a) Identify from among all proposals submitted in response to an RFP
for a given PRO area all proposals submitted by organizations that meet
the requirements of 462.102 or 462.103;
(b) Identify from among all proposals identified in paragraph (a) of
this section all proposals that set forth minimally acceptable plans in
accordance with the requirements of 462.104 and the RFPs;
(c) Assign bonus points not to exceed 10% of the total points
available to all physician-sponsored organizations identified in
paragraph (b) of this section, consistent with statute; and
(d) Subject to the limitations established by 462.105 and 462.106,
award the contract for the given PRO area to the selected organization
for a period of two years.
(49 FR 7207, Feb. 27, 1984. Redesignated and amended at 50 FR 15327,
15328, Apr. 17, 1985)
42 CFR 462.107 Pt. 466
42 CFR 462.107 PART 466 -- UTILIZATION AND QUALITY CONTROL REVIEW
42 CFR 462.107 Subpart A -- General Provisions
Sec.
466.1 Definitions.
42 CFR 462.107 Subpart B -- (Reserved)
42 CFR 462.107 Subpart C -- Review Responsibilities of Utilization and
Quality Control Peer Review Organizations (PROs)
466.70 Statutory bases and applicability.
466.71 PRO review requirements.
466.72 Review of the quality of care of risk-basis health maintenance
organizations and competitive medical plans.
466.73 Notification of PRO designation and implementation of review.
466.74 General requirements for the assumption of review.
466.76 Cooperation with health care facilities.
466.78 Responsibilities of health care facilities.
466.80 Coordination with Medicare fiscal intermediaries and carriers.
466.82 Continuation of functions not assumed by PROs.
466.83 Initial denial determinations.
466.84 Changes as a result of DRG validation.
466.85 Conclusive effect of PRO initial denial determinations and
changes as a result of DRG validations.
466.86 Correlation of Title XI functions with Title XVIII functions.
466.88 Examination of the operations and records of health care
facilities and practitioners.
466.90 Lack of cooperation by a health care facility or practitioner.
466.93 Opportunity to discuss proposed initial denial determination
and changes as a result of a DRG validation.
466.94 Notice of PRO initial denial determination and changes as a
result of a DRG validation.
466.96 Review period and reopening of initial denial determinations
and changes as a result of DRG validations.
466.98 Reviewer qualifications and participation.
466.100 Use of norms and criteria.
466.102 Involvement of health care practitioners other than
physicians.
466.104 Coordination of activities.
Authority: Secs. 1102, 1154, and 1871 of the Social Security Act (42
U.S.C. 1302, 1320c-3 and 1395hh).
Source: 44 FR 32081, June 4, 1979, unless otherwise noted.
42 CFR 462.107 Subpart A -- General Provisions
42 CFR 466.1 Definitions.
As used in this part, unless the context indicates otherwise:
Active staff privileges means: (a) That a physician is authorized on
a regular, rather than infrequent or courtesy, basis: (1) to order the
admission of patients to a facility; (2) to perform diagnostic services
in a facility; or (3) to care for and treat patients in a facility; or
(b) that a health care practitioner other than a physician is authorized
on a regular, rather than infrequent or courtesy, basis to order the
admission of patients to a facility.
Admission review means a review and determination by a PRO of the
medical necessity and appropriateness of a patient's admission to a
specific facility.
Continued stay review means PRO review that is performed after
admission review and during a patient's hospitalization to determine the
medical necessity and appropriateness of continuing the patient's stay
at a hospital level of care.
Criteria means predetermined elements of health care, developed by
health professionals relying on professional expertise, prior
experience, and the professional literature, with which aspects of the
quality, medical necessity, and appropriateness of a health care service
may be compared.
Diagnosis related group (DRG) means a system for classifying
inpatient hospital discharges. DRGs are used for purposes of
determining payment to hospitals for inpatient hospital services under
the Medicare prospective payment system.
DRG validation means a part of the prospective payment system in
which a PRO validates that DRG assignments are based on the correct
diagnostic and procedural information.
Elective, when applied to admission or to a health care service,
means an admission or a service that can be delayed without substantial
risk to the health of the individual.
Five percent or more owner means a person (including, where
appropriate, a corporation) who:
(a) Has an ownership interest of 5 percent or more;
(b) Has an indirect ownership interest equal to 5 percent or more;
(c) Has a combination of direct and indirect ownership interests (the
possession of equity in the capital, the stock, or the profits of an
entity) equal to five percent or more; or
(d) Is the owner of an interest of five percent or more in any
obligation secured by an entity, if the interest equals at least five
percent of the value of the property or assets of the entity.
Health care facility or facility means an organization involved in
the delivery of health care services for which reimbursement may be made
in whole or in part under Title XVIII of the Act.
Health care practitioners other than physicians means those health
professionals who do not hold a doctor of medicine or doctor of
osteopathy degree, who meet all applicable State or Federal requirements
for practice of their professions, and who are in active practice.
Hospital means a health care institution or distinct part of a health
care institution, as defined in Section 1861(e)-(g) of the Act, other
than a Christian Science sanatorium operated, or listed and certified,
by the First Church of Christ, Scientist, Boston, Massachusetts.
Initial denial determination means an initial negative decision by a
PRO, regarding the medical necessity, quality, or appropriateness of
health care services furnished, or proposed to be furnished, to a
patient.
Major clinical area means medicine, surgery, pediatrics, obstetrics
and gynecology, or psychiatry.
Major procedure means a diagnostic or therapeutic procedure which
involves a surgical or anesthetic risk or requires highly trained
personnel or special facilities or equipment.
Non-facility organization means a corporate entity that (1) is not a
health care facility; (2) is not a 5 percent or more owner of a
facility; and (3) is not owned by one or more health care facilities or
association of facilities in the PRO area.
Norm means a pattern of performance in the delivery of health care
services that is typical for a specified group.
Norms means numerical or statistical measures of average observed
performance in the delivery of health care services.
Outliers means those cases that have either an extremely long length
of stay or extraordinarily high costs when compared to most discharges
classified in the same DRG.
Peer review means review by health care practitioners of services
ordered or furnished by other practitioners in the same professional
field.
Physician means a doctor of medicine or osteopathy or another
individual who is authorized under State or Federal law to practice
medicine and surgery, or osteopathy. This includes medical officers in
American Samoa, the Northern Mariana Islands, and the Trust Territory of
the Pacific Islands.
Practitioner means an individual credentialed within a recognized
health care discipline and involved in providing the services of that
discipline to patients.
Preadmission certification means a favorable determination,
transmitted to the hospital and the fiscal intermediary, approving the
patient's admission for payment purposes.
Preadmission review means review prior to a patient's admission to a
hospital to determine, for payment purposes, the reasonableness, medical
necessity and appropriateness of placement at an acute level of care.
Preprocedure review means review of a surgical or other invasive
procedure prior to the conduct of the procedure.
PRO review means review performed in fulfillment of a contract with
HCFA, either by the PRO or its subcontractors.
Profile means aggregated data in formats that display patterns of
health care services over a defined period of time.
Profile analysis means review and analysis of profiles to identify
and consider patterns of health care services.
Quality review study means an assessment conducted by or for a PRO of
a patient care problem for the purpose of improving patient care through
peer analysis, intervention, resolution of the problem and follow-up.
Regional norms, criteria, and standards means norms, criteria, and
standards that apply to a geographic division which is larger than a PRO
area.
Retrospective review means review that is conducted after services
are provided to a patient. The review is focused on determining the
appropriateness, necessity, quality, and reasonableness of health care
services provided.
Review responsibility means (1) the responsibility of the PRO to
perform review functions prescribed under Part B of Title XI of the Act
and the Social Security Amendments of 1983 (Pub. L. No. 98-21) and the
regulations of this part; (2) the responsibility to fulfill the terms
and meet the objectives set forth in the negotiated contract between
HCFA and the PRO; and (3) the authority of a PRO to make conclusive
initial denial determinations regarding the medical necessity and
appropriateness of health care and changes as a result of DRG
validations.
Skilled nursing facility (SNF) means a health care institution or
distinct part of an institution that (a) is primarily engaged in
providing skilled nursing care or rehabilitative services to injured,
disabled, or sick persons, and (b) has an agreement to participate in
Medicare or Medicaid or both, and (c) is not a Christian Science
sanatorium operated or listed and certified by the First Church of
Christ Scientist, Boston, Massachusetts.
Standards means professionally developed expressions of the range of
acceptable variation from a norm or criterion.
Subcontractor means a facility or a non-facility organization under
contract with a PRO to perform PRO review functions.
Working day means any one of at least five days of each week
(excluding, at the option of each PRO, legal holidays) on which the
necessary personnel are available to perform review.
(44 FR 32081, June 4, 1979, as amended at 45 FR 67545, Oct. 10, 1980;
46 FR 48569, Oct. 1, 1981. Redesignated and amended at 50 FR 15328,
15329, Apr. 17, 1985; 51 FR 43197, Dec. 1, 1986)
42 CFR 466.1 Subpart B -- (Reserved)
42 CFR 466.1 Subpart C -- Review Responsibilities of Utilization and
Quality Control Peer Review Organizations (PROs)
Source: 50 FR 15330, Apr. 17, 1985, unless otherwise noted.
42 CFR 466.1 General Provisions
42 CFR 466.70 Statutory bases and applicability.
(a) Statutory basis. Sections 1154, 1866(a)(1)(F) and 1886(f)(2) of
the Act require that a PRO review those services furnished by
physicians, other health care professionals, providers and suppliers as
specified in its contract with the Secretary. Section 1154(a)(4) of the
Act requires PROs, or, in certain circumstances, non-PRO entities, to
perform quality of care reviews of services furnished under risk-basis
contracts by health maintenance organizations (HMOs) and competitive
medical plans (CMPs) that are covered under subpart C of part 417 of
this chapter.
(b) Applicability. The regulations in this subpart apply to review
conducted by a PRO and its subcontractors. Section 466.72 of this part
also applies, for purposes of quality of care reviews under section
1154(a)(4) of the Act, to non-PRO entities that enter into contracts to
perform reviews of services furnished under risk-basis contracts by HMOs
and CMPs under subpart C of part 417 of this chapter.
(52 FR 37457, Oct. 7, 1987)
42 CFR 466.71 PRO review requirements.
(a) Scope of PRO review. In its review, the PRO must determine (in
accordance with the terms of its contract) --
(1) Whether the services are or were reasonable and medically
necessary for the diagnosis and treatment of illness or injury or to
improve functioning of a malformed body member, or (with respect to
pneumococcal vaccine) for prevention of illness or (in the case of
hospice care) for the palliation and management of terminal illness;
(2) Whether the quality of the services meets professionally
recognized standards of health care;
(3) Whether those services furnished or proposed to be furnished on
an inpatient basis could, consistent with the provisions of appropriate
medical care, be effectively furnished more economically on an
outpatient basis or in an inpatient health care facility of a different
type;
(4) Through DRG validation, the validity of diagnostic and procedural
information supplied by the hospital;
(5) The completeness, adequacy and quality of hospital care provided;
(6) The medical necessity, reasonableness and appropriateness of
hospital admissions and discharges;
(7) The medical necessity, reasonableness and appropriateness of
inpatient hospital care for which additional payment is sought under the
outlier provisions of 412.82 and 412.84 of this chapter; and
(8) Whether a hospital has misrepresented admission or discharge
information or has taken an action that results in --
(i) The unnecessary admission of an individual entitled to benefits
under part A;
(ii) Unnecessary multiple admissions of an individual; or
(iii) Other inappropriate medical or other practices with respect to
beneficiaries or billing for services furnished to beneficiaries.
(b) Payment determinations. On the basis of the review specified
under paragraphs (a) (1), (3), (6), (7), and (8) of this section, the
PRO must determine whether payment may be made for these services. A
PRO may grant a period of not more than two days (grace days) for the
purpose of arranging post discharge care when the provider did not know
or could not reasonably be expected to have known that payment for the
service(s) would not be made under the Medicare program as specified in
405.330(b).
(c) Other duties and functions. (1) The PRO must review at least a
random sample of hospital discharges each quarter and submit new
diagnostic and procedural information to the Medicare fiscal
intermediary or carrier if it determines that the information submitted
by the hospital was incorrect.
(2) The PRO must review every change in a DRG assignment that is a
result of a review made under the provisions of 412.60 (d) if the
change results in the assignment of a higher-weighted DRG and the PRO
has not previously reviewed the case. The PRO must verify that the
diagnostic and procedural information supplied by the hospital is
substantiated by the information in the medical record.
(d) Coordination of sanction activities. The PRO must carry out the
responsibilities specified in subpart C of part 1004 of this title
regarding imposition of sanctions on providers and practitioners who
violate their statutory obligations under section 1156 of the Act.
(52 FR 37457, Oct. 7, 1987; 52 FR 47003, Dec. 11, 1987)
42 CFR 466.72 Review of the quality of care of risk-basis health
maintenance organizations and competitive medical plans.
(a) (1) For purposes of a review under section 1154(a)(4) of the Act,
a PRO must determine whether the quality of services (including both
inpatient and outpatient services) provided by an HMO or CMP meets
professionally recognized standards of health care, including whether
appropriate health care services have not been provided or have been
provided in inappropriate settings.
(2) Paragraph (a)(1) of this section will not apply with respect to a
contract year if another entity has been awarded a contract to perform
those reviews under section 1154(a)(4)(C) of the Act.
(b) For purposes of reviews under this section, non-PRO entities
selected to perform these reviews under section 1154(a)(4)(C) of the Act
are subject to the requirements of paragraph (a)(1) of this section and
--
(1) Part 476 of this chapter regarding acquisition, protection, and
disclosure of peer review information; and
(2) Part 1004 of Chapter V regarding a PRO's responsibilities, and
sanctions on health care practitioners and providers.
(52 FR 37457, Oct. 7, 1987)
42 CFR 466.73 Notification of PRO designation and implementation of
review.
(a) Notice of HCFA's decision. HCFA sends written notification of a
PRO contract award to the State survey agency and Medicare fiscal
intermediaries and carriers. The notification includes the effective
dates of the PRO contract and specifies the area and types of health
care facilities to be reviewed by the PRO. The PRO must make a similar
notification when review responsibilities are subcontracted.
(b) Notification to health care facilities and the public. As
specified in its contract with HCFA, the PRO must --
(1) Provide, to each health care facility scheduled to come under
review, a timely written notice that specifies the date and manner in
which the PRO proposes to implement review, and the information to be
furnished by the facility to each Medicare beneficiary upon admission as
specified in 466.78(b)(3) of this part.
(2) Publish, in at least one local newspaper of general circulation
in the PRO area, a notice that states the date the PRO will assume
review responsibilities and lists each area health care facility to be
under review. The PRO must indicate that its plan for the review of
health care services as approved in its contract with HCFA is available
for public inspection in the PRO's business office and give the address,
telephone number and usual hours of business.
(50 FR 15330, Apr. 17, 1985. Redesignated at 52 FR 37457, Oct. 7,
1987)
42 CFR 466.74 General requirements for the assumption of review.
(a) A PRO must assume review responsibility in accordance with the
schedule, functions and negotiated objectives specified in its contract
with HCFA.
(b) A PRO must notify the appropriate Medicare fiscal intermediary or
carrier of its assumption of review in specific health care facilities
no later than five working days after the day that review is assumed in
the facility.
(c) A PRO must maintain and make available for public inspection at
its principal business office --
(1) A copy of each agreement with Medicare fiscal intermediaries and
carriers;
(2) A copy of its currently approved review plan that includes the
PRO's method for implementing review; and
(3) Copies of all subcontracts for the conduct of review.
(d) A PRO must not subcontract with a facility to conduct any review
activities except for the review of the quality of care. The PRO may
subcontract with a non-facility organization to conduct review in a
facility.
(e) If required by HCFA, a PRO is responsible for compiling
statistics based on the criteria contained in 405.332 of this chapter
and making limitation of liability determinations on excluded coverage
of certain services that are made under section 1879 of the Act. If
required by HCFA, PROs must also notify a provider of these
determinations. These determinations and further appeals are governed
by the reconsideration and appeals procedures in part 405, subpart G of
this chapter for Medicare Part A related determinations and part 405,
subpart H of this chapter for Medicare Part B related determinations.
(f) A PRO must make its responsibilities under its contract with
HCFA, primary to all other interests and activities that the PRO
undertakes.
42 CFR 466.76 Cooperation with health care facilities.
Before implementation of review, a PRO must make a good faith effort
to discuss the PRO's administrative and review procedures with each
involved health care facility.
42 CFR 466.78 Responsibilities of health care facilities.
(a) Beginning November 15, 1984, every hospital seeking payment for
services provided to Medicare beneficiaries must maintain a written
agreement with a PRO operating in the area in which the hospital is
located. These agreements must provide for the PRO review specified in
466.70(c).
(b) Cooperation with PROs. Health care facilities that submit
Medicare claims must cooperate in the assumption and conduct of PRO
review. Facilities must --
(1) Allocate adequate space to the PRO for its conduct of review at
the times the PRO is conducting review.
(2) Provide patient care data and other pertinent data to the PRO at
the time the PRO is collecting review information that is required for
the PRO to make its determinations. When review is performed away from
the facility, the facility must photocopy and deliver to the PRO,
without charge, all required information within 30 days of a request.
When the PRO does post-admission, preprocedure review, the facility must
provide the necessary information before the procedure is performed,
unless it must be performed on an emergency basis.
(3) Inform Medicare beneficiaries at the time of admission, in
writing, that the care for which Medicare payment is sought will be
subject to PRO review and indicate the potential outcomes of that
review. Furnishing this information to the patient does not constitute
notice, under 405.332(a) of this chapter, that can support a finding
that the beneficiary knew the services were not covered.
(4) When the facility has issued a written determination in
accordance with 412.42(c)(3) of this chapter that a beneficiary no
longer requries inpatient hospital care, it must submit a copy of its
determination to the PRO within 3 working days.
(5) Assure, in accordance with the provisions of its agreement with
the PRO, that each case subject to preadmission review has been reviewed
and approved by the PRO before admission to the hospital or a timely
request has been made for PRO review.
(6)(i) Agree to accept financial liability for any admission subject
to preadmission review that was not reviewed by the PRO and is
subsequently determined to be inappropriate or not medically necessary.
(ii) The provisions of paragraph (b)(6)(i) of this section do not
apply if a facility, in accordance with its agreement with a PRO, makes
a timely request for preadmission review and the PRO does not review the
case timely. Cases of this type are subject to retrospective prepayment
review under paragraph (b)(7) of this section.
(7) Agree that, if the hospital admits a case subject to preadmission
review without certification, the case must receive retrospective
prepayment review, according to the review priority established by the
PRO.
42 CFR 466.80 Coordination with Medicare fiscal intermediaries and
carriers.
(a) Procedures for agreements. The Medicare fiscal intermediary or
carrier must have a written agreement with the PRO. The PRO must take
the initiative with the fiscal intermediary or carrier in developing the
agreement. The following steps must be taken in developing the
agreement.
(1) The PRO and the fiscal intermediary or carrier must negotiate in
good faith in an effort to reach written agreement. If they cannot
reach agreement, HCFA will assist them in resolving matters in dispute.
(2) The PRO must incorporate its administrative procedures into an
agreement with the fiscal intermediary or carrier and obtain approval
from HCFA, before it makes conclusive determinations for the Medicare
program, unless HCFA finds that the fiscal intermediary or carrier has
--
(i) Refused to negotiate in good faith or in a timely manner, or
(ii) Insisted on including in the agreement, provisions that are
outside the scope of its authority under the Act.
(b) Content of agreement. The agreement must include procedures for
--
(1) Informing the appropriate Medicare fiscal intermediaries and
carriers of --
(i) Changes as a result of DRG validations and revisions as a result
of the review of these changes; and
(ii) Initial denial determinations and revisions of these
determinations as a result of reconsideration, or reopening all
approvals and denials with respect to cases subject to preadmission
review, and outlier claims in hospitals under a prospective payment
system for health care services and items;
(2) Exchanging data or information;
(3) Modifying the procedures when additional review responsibility is
authorized by HCFA; and
(4) Any other matters that are necessary for the coordination of
functions.
(c) Action by HCFA. (1) Within the time specified in its contract,
the PRO must submit to HCFA for approval its agreement with the Medicare
fiscal intermediaries and carriers, or if an agreement has not been
established, the PRO's proposed administrative procedures, including any
comments by the Medicare fiscal intermediaries and carriers.
(2) If HCFA approves the agreement or the administrative procedures
(after a finding by HCFA as specified in paragraph (a)(2) of this
section), the PRO may begin to make determinations under its contract
with HCFA.
(3) If HCFA disapproves the agreement or procedures, it will --
(i) Notify the PRO and the appropriate fiscal agents in writing,
stating the reasons for disapproval; and
(ii) Require the PRO and fiscal intermediary or carrier to revise its
agreements or procedures.
(d) Modification of agreements. Agreements or procedures may be
modified, with HCFA's approval --
(1) Through a revised agreement with the fiscal intermediary or
carrier, or
(2) In the case of procedures, by the PRO, after providing
opportunity for comment by the fiscal intermediary or carrier.
(e) Role of the fiscal intermediary. (1) The fiscal intermediary
will not pay any claims for those cases which are subject to
preadmission review by the PRO, until it receives notice that the PRO
has approved the admission after preadmission or retrospective review.
(2) A PRO's determination that an admission is medically necessary is
not a guarantee of payment by the fiscal intermediary. Medicare
coverage requirements must also be applied.
(50 FR 15330, Apr. 17, 1985; 50 FR 41886, Oct. 16, 1985)
42 CFR 466.82 Continuation of functions not assumed by PROs.
Any of the duties and functions under Part B of Title XI of the Act
for which a PRO has not assumed responsibility under its contract with
HCFA must be performed in the manner and to the extent otherwise
provided for under the Act or in regulations.
42 CFR 466.82 PRO Review Functions
42 CFR 466.83 Initial denial determinations.
A determination by a PRO that the health care services furnished or
proposed to be furnished to a patient are not medically necessary, are
not reasonable, or are not at the appropriate level of care, is an
initial denial determination and is appealable under part 473 of this
chapter.
42 CFR 466.84 Changes as a result of DRG validation.
A provider or practitioner may obtain a review by a PRO under part
473 of this chapter for changes in diagnostic and procedural coding that
resulted in a change in DRG assignment as a result of PRO validation
activities.
42 CFR 466.85 Conclusive effect of PRO initial denial determinations
and changes as a result of DRG validations.
A PRO initial denial determination or change as a result of DRG
validation is final and binding unless, in accordance with the
procedures in part 473 --
(a) The initial denial determination is reconsidered and revised; or
(b) The change as a result of DRG validation is reviewed and revised.
42 CFR 466.86 Correlation of Title XI functions with Title XVIII
functions.
(a) Payment determinations. (1) PRO initial denial determinations
under this part with regard to the reasonableness, medical necessity,
and appropriateness of placement at an acute level of patient care as
are also conclusive for payment purposes with regard to the following
medical issues:
(i) Whether inpatient care furnished in a psychiatric hospital meets
the requirements of 424.14 of this chapter.
(ii) Whether payment for inpatient hospital or SNF care beyond 20
consecutive days is precluded under 489.50 of this chapter because of
failure to perform review of long-stay cases.
(iii) Whether the care furnished was custodial care or care not
reasonable and necessary and, as such, excluded under 405.310(g) or
405.310(k) of this chapter.
(iv) Whether the care was appropriately furnished in the inpatient or
outpatient setting.
(2) Reviews with respect to determinations listed in paragraph (a)(1)
of this section must not be conducted, for purposes of payment, by
Medicare fiscal intermediaries or carriers except as outlined in
paragraph (c) of this section.
(3) PROs make determinations as to the appropriateness of the
location in which procedures are performed. A procedure may be
medically necessary but denied if the PRO determines that it could,
consistent with the provision of appropriate medical care, be
effectively provided more economically on an outpatient basis or in an
inpatient health care facility of a different type.
(4) PRO determinations as to whether the provider and the beneficiary
knew or could reasonably be expected to have known that the services
described in paragraph (a)(1) of this section were excluded are also
conclusive for payment purposes.
(b) Utilization review activities. PRO review activities to
determine whether inpatient hospital or SNF care services are reasonable
and medically necessary and are furnished at the appropriate level of
care fulfill the utilization review requirements set forth in
405.1035, 405.1042, and 405.1137 of this chapter.
(c) Coverage. Nothing in paragraphs (a) (1) and (3) of this section
will be construed as precluding HCFA or a Medicare fiscal intermediary
or carrier, in the proper exercise of its duties and functions, from
reviewing claims to determine:
(1) In the case of items or services not reviewed by a PRO, whether
they meet coverage requirements of Title XVIII relating to medical
necessity, reasonableness, or appropriateness of placement at an acute
level of patient care. However, if a coverage determination pertains to
medical necessity, reasonableness, or appropriateness of placement at an
acute level of patient care, the fiscal intermediary or carrier must use
a PRO to make a determination on those issues if a PRO is conducting
review in the area and must abide by the PRO's determination.
(2) Whether any claim meets coverage requirements of Title XVIII
relating to issues other than medical necessity, reasonableness or
appropriateness of placement at an acute level of patient care.
(d) Payment. Medicare fiscal intermediaries and carriers are not
precluded from making payment determinations with regard to coverage
determinations made under paragraph (c) of this section.
(e) Survey, compliance and assistance activities. PRO review and
monitoring activities fulfill the requirements for compliance and
assistance activities of State survey agencies under section 1864(a)
with respect to sections 1861(e)(6), 1861(j)(8), 1861(j)(12), and
1861(k) of the Act, and activities required of intermediaries and
carriers under 421.100(d) and 421.200(f) of this chapter.
(f) Appeals. The requirements and procedures for PRO review of
changes as a result of DRG validation and the reconsideration, hearing
and judicial review of PRO initial denial determinations are set forth
in part 473 of this chapter.
(50 FR 15330, Apr. 17, 1985; 50 FR 41886, Oct. 16, 1985, as amended
at 53 FR 6648, Mar. 2, 1988)
42 CFR 466.88 Examination of the operations and records of health care
facilities and practitioners.
(a) Authorization to examine records. A facility claiming Medicare
payment must permit a PRO or its subcontractor to examine its operation
and records (including information on charges) that are pertinent to
health care services furnished to Medicare beneficiaries and are
necessary for the PRO or its subcontractor to --
(1) Perform review functions including, but not limited to --
(i) DRG validation;
(ii) Outlier review in facilities under a prospective payment system;
and
(iii) Implementation of corrective action and fraud and abuse
prevention activities;
(2) Evaluate cases that have been identified as deviating from the
PRO norms and criteria, or standards; and
(3) Evaluate the capability of the facility to perform quality review
functions under a subcontract with the PRO.
(b) Limitations on access to records. A PRO has access to the
records of non-Medicare patients if --
(1) The records relate to review performed under a non-Medicare PRO
contract and if authorized by those patients in accordance with State
law; or
(2) The PRO needs the records to perform its quality review
responsibilities under the Act and receives authorization from the
facility or practitioner.
(c) Conditions of examination. When examining a facility's operation
or records the PRO must --
(1) Examine only those operations and records (including information
on charges) required to fulfill the purposes of paragraph (a) of this
section;
(2) Cooperate with agencies responsible for other examination
functions under Federal or Federally assisted programs in order to
minimize duplication of effort;
(3) Conduct the examinations during reasonable hours; and
(4) Maintain in its principal office written records of the results
of the examination of the facility.
42 CFR 466.90 Lack of cooperation by a health care facility or
practitioner.
(a) If a health care facility or practitioner refuses to allow a PRO
to enter and perform the duties and functions required under its
contract with HCFA, the PRO may --
(1) Determine that the health care facility or practitioner has
failed to comply with the requirements of 474.30(c) of this chapter and
report the matter to the HHS Inspector General; or
(2) Issue initial denial determinations for those claims it is unable
to review, make the determination that financial liability will be
assigned to the health care facility, and report the matter to the HHS
Inspector General.
(b) If a PRO provides a facility with sufficient notice and a
reasonable amount of time to respond to a request for information about
a claim, and if the facility does not respond in a timely manner, the
PRO will deny the claim.
42 CFR 466.93 Opportunity to discuss proposed initial denial
determination and changes as a result of a DRG validation.
Before a PRO reaches an initial denial determination or makes a
change as a result of a DRG validation, it must --
(a) Promptly notify the provider or supplier and the patient's
attending physician (or other attending health care practitioner) of the
proposed determination or DRG change; and
(b) Afford an opportunity for the provider or supplier and the
physician (or other attending health care practitioner) to discuss the
matter with the PRO physician advisor and to explain the nature of the
patient's need for health care services, including all factors which
preclude treatment of the patient as an outpatient or in an alternative
level of inpatient care.
42 CFR 466.94 Notice of PRO initial denial determination and changes as
a result of a DRG validation.
(a) Notice of initial denial determination -- (1) Parties to be
notified. A PRO must provide written notice of an initial denial
determination to --
(i) The patient, or if the patient is expected to be unable to
comprehend the notice, the patient's next of kin, guardian or other
representative or sponsor;
(ii) The attending physician, or other attending health care
practitioner;
(iii) The facility; and
(iv) The fiscal intermediary or carrier.
(2) Timing of the notice. The notice must be delivered to
beneficiaries in the facility or mailed to those no longer in the
facility, within the following time periods --
(i) For admission, on the first working day after the initial denial
determination;
(ii) For continued stay (e.g., outliers in facilities under a
prospective payment system), by the first working day after the initial
denial determination if the beneficiary is still in the facility, and
within 3 working days if the beneficiary has been discharged;
(iii) For preprocedure review, before the procedure is performed;
(iv) For preadmission review, before admission;
(v) If identification as a Medicare program patient has been delayed,
within three working days of identification;
(vi) For retrospective review, (excluding DRG validation and post
procedure review), within 3 working days of the initial denial
determination; and
(vii) For post-procedure review, within 3 working days of the initial
denial determination.
(3) Preadmission review. In the case of preadmission review, the PRO
must document that the patient and the facility received notice of the
initial denial determination.
(b) Notice of changes as a result of a DRG validation. The PRO must
notify the provider and practitioner of changes to procedural and
diagnostic information that result in a change of DRG assignment, within
30 days of the PRO's decision.
(c) Content of the notice. The notice must be understandable and
written in plain English and must contain --
(1) The reason for the initial denial determination or change as a
result of the DRG validation;
(2) For day outliers in hospitals, the date on which the stay or
services in the facility will not be approved as being reasonable and
medically necessary or appropriate to the patients' health care needs;
(3) A statement informing each party or his or her representative of
the right to request in accordance with the provisions of part 473,
subpart B of this chapter --
(i) Review of a change resulting from DRG validation; or
(ii) Reconsideration of the initial denial determination;
(4) The locations for filing a request for reconsideration or review
and the time period within which a request must be filed;
(5) A statement about who is liable for payment of the denied
services under section 1879 of the Act; and
(6) A statement concerning the duties and functions of the PRO under
the Act.
(d) Notice to payers. The PRO must provide prompt written notice of
an initial denial determination or changes as a result of a DRG
validation to the Medicare fiscal intermediary or carrier within the
same time periods as the notices to the other parties.
(e) Record of initial denial determination and changes as a result of
a DRG validation. (1) The PRO must document and preserve a record of
all initial denial determinations and changes as a result of DRG
validations for six years from the date the services in question were
provided.
(2) The documentary record must include --
(i) The detailed basis for the initial denial determination or
changes as a result of a DRG validation; and
(ii) A copy of the determination or change in DRG notices sent to all
parties and identification of each party and the date on which the
notice was mailed or delivered.
42 CFR 466.96 Review period and reopening of initial denial
determinations and changes as a result of DRG validations.
(a) General timeframe. A PRO or its subcontractor --
(1) Within one year of the date of the claim containing the service
in question, may review and deny payment; and
(2) Within one year of the date of its decision, may reopen an
initial denial determination or a change as a result of a DRG
validation.
(b) Extended timeframes. (1) An initial denial determination or
change as a result of a DRG validation may be made after one year but
within four years of the date of the claim containing the service in
question, if HCFA approves.
(2) A reopening of an initial denial determination or change as a
result of a DRG validation may be made after one year but within four
years of the date of the PRO's decision if --
(i) Additional information is received on the patient's condition;
(ii) Reviewer error occurred in interpretation or application of
Medicare coverage policy or review criteria;
(iii) There is an error apparent on the face of the evidence upon
which the initial denial or DRG validation was based; or
(iv) There is a clerical error in the statement of the initial denial
determination or change as a result of a DRG validation.
(c) Fraud and abuse. (1) A PRO or its subcontractor may review and
deny payment anytime there is a finding that the claim for service
involves fraud or a similar abusive practice that does not support a
finding of fraud.
(2) An initial denial determination or change as a result of a DRG
validation may be reopened and revised anytime there is a finding that
it was obtained through fraud or a similar abusive practice that does
not support a finding of fraud.
42 CFR 466.98 Reviewer qualifications and participation.
(a) Peer review by physician. (1) Except as provided in paragraph
(a)(2) of this section, each person who makes an initial denial
determination about services furnished or proposed to be furnished by a
licensed doctor of medicine or osteopathy or by a doctor of dentistry
must be respectively another licensed doctor of medicine or osteopathy
or of dentistry with active staff privileges in one or more hospitals in
the PRO area.
(2) If a PRO determines that peers are not available to make initial
denial determinations, a doctor of medicine or osteopathy may make
denial determinations for services ordered or performed by a doctor in
any of the three specialties.
(3) For purposes of paragraph (a)(1) of this section, individuals
authorized to practice medicine in American Samoa, the Northern Mariana
Islands, and the Trust Territory of the Pacific Islands as ''medical
officers'' may make determinations on care ordered or furnished by their
peers but not on care ordered or furnished by licensed doctors of
medicine or osteopathy.
(b) Peer review by health care practitioners other than physicians.
Health care practitioners other than physicians may review services
furnished by other practitioners in the same professional field.
(c) DRG validation review. Decisions about procedural and diagnostic
information must be made by physicians. Technical coding issues must be
reviewed by individuals with training and experience in ICD-9-CM coding.
(d) Persons excluded from review. (1) A person may not review health
care services or make initial denial determinations or changes as a
result of DRG validations if he or she, or a member of his or her family
--
(i) Participated in developing or executing the beneficiary's
treatment plan;
(ii) Is a member of the beneficiary's family; or
(iii) Is a governing body member, officer, partner, 5 percent or more
owner, or managing employee in the health care facility where the
services were or are to be furnished.
(2) A member of a reviewer's family is a spouse (other than a spouse
who is legally separated under a decree of divorce or separate
maintenance), child (including a legally adopted child), grandchild,
parent, or grandparent.
42 CFR 466.100 Use of norms and criteria.
(a) Use of norms. As specified in its contract, a PRO must use
national, or where appropriate, regional norms in conducting review to
achieve PRO contract objectives. However, with regard to determining
the number of procedures selected for preadmission review, a PRO must
use national admission norms.
(b) Use of criteria. In assessing the need for and appropriateness
of an inpatient health care facility stay, a PRO must apply criteria to
determine --
(1) The necessity for facility admission and continued stay (in cases
of day outliers in hospitals under prospective payment);
(2) The necessity for surgery and other invasive diagnostic and
therapeutic procedures; or
(3) The appropriateness of providing services at a particular health
care facility or at a particular level of care. The PRO must determine
whether the beneficiary requires the level of care received or whether a
lower and less costly level of care would be equally effective.
(c) Establishment of criteria and standards. For the conduct of
review a PRO must --
(1) Establish written criteria based upon typical patterns of
practice in the PRO area, or use national criteria where appropriate;
and
(2) Establish written criteria and standards to be used in conducting
quality review studies.
(d) Variant criteria and standards. A PRO may establish specific
criteria and standards to be applied to certain locations and facilities
in the PRO area if the PRO determines that --
(1) The patterns of practice in those locations and facilities are
substantially different from patterns in the remainder of the PRO area;
and
(2) There is a reasonable basis for the difference which makes the
variation appropriate.
42 CFR 466.102 Involvement of health care practitioners other than
physicians.
(a) Basic requirement. Except as provided in paragraph (b) of this
section, a PRO must meet the following requirements:
(1) Consult with the peers of the practitioners who furnish the
services under review if the PRO reviews care and services delivered by
health care practitioners other than physicians.
(2) Assure that in determinations regarding medical necessity of
services or the quality of the services they furnish, these
practitioners are involved in --
(i) Developing PRO criteria and standards;
(ii) Selecting norms to be used; and
(iii) Developing review mechanisms for care furnished by their peers.
(3) Ensure that an initial denial determination or a change as a
result of DRG validation of services provided by a health care
practitioner other than a physician is made by a physician only after
consultation with a peer of that practitioner. Initial denial
determinations and changes as a result of DRG validations must be made
only by a physician or dentist.
(b) Exception. The requirements of paragraph (a) of this section do
not apply if --
(1) The PRO has been unable to obtain a roster of peer practitioners
available to perform review; or
(2) The practitioners are precluded from performing review because
they participated in the treatment of the patient, the patient is a
relative, or the practitioners have a financial interest in the health
care facility as described in 466.98(d).
(c) Peer involvement in quality review studies. Practitioners must
be involved in the design of quality review studies, development of
criteria, and actual conduct of studies involving their peers.
(d) Consultation with practitioners other than physicians. To the
extent practicable, a PRO must consult with nurses and other
professional health care practitioners (other than physicians defined in
1861(r) (1) and (2) of the Act) and with representatives of
institutional and noninstitutional providers and suppliers with respect
to the PRO's responsibility for review.
(50 FR 15330, Apr. 17, 1985; 50 FR 41886, Oct. 16, 1985)
42 CFR 466.104 Coordination of activities.
In order to achieve efficient and economical review, a PRO must
coordinate its activities (including information exchanges) with the
activities of --
(a) Medicare fiscal intermediaries and carriers;
(b) Other PROs; and
(c) Other public or private review organizations as may be
appropriate.
42 CFR 466.104 Pt. 473
42 CFR 466.104 PART 473 -- RECONSIDERATIONS AND APPEALS
42 CFR 466.104 Subpart A -- (Reserved)
42 CFR 466.104 Subpart B -- Utilization and Quality Control Peer Review
Organization (PRO) Reconsiderations and Appeals
Sec.
473.10 Scope.
473.12 Statutory basis.
473.14 Applicability.
473.15 PRO review of changes resulting from DRG validation.
473.16 Right to reconsideration.
473.18 Location for submitting requests for reconsideration.
473.20 Time limits for requesting reconsideration.
473.22 Good cause for late filing of a request for a reconsideration
or hearing.
473.24 Opportunity for a party to obtain and submit information.
473.26 Delegation of the reconsideration function.
473.28 Qualifications of a reconsideration reviewer.
473.30 Evidence to be considered by the reconsideration reviewer.
473.32 Time limits for issuance of the reconsidered determination.
473.34 Notice of a reconsidered determination.
473.36 Record of reconsideration.
473.38 Finality of a reconsidered determination.
473.40 Beneficiary's right to a hearing.
473.42 Submitting a request for a hearing.
473.44 Determining the amount in controversy for a hearing.
473.46 Appeals Council and judicial review.
473.48 Reopening and revision of a reconsidered determination or a
hearing decision.
Authority: Secs. 1102, 1154, 1155, 1866, 1871, and 1879 of the
Social Security Act (42 U.S.C. 1302, 1320c-3, 1320c-4, 1395cc, 1395hh,
and 1395pp).
42 CFR 466.104 Subpart A -- (Reserved)
42 CFR 466.104 Subpart B -- Utilization and Quality Control Peer Review
Organization (PRO) Reconsiderations and Appeals
Source: 50 FR 15372, Apr. 17, 1985, unless otherwise noted.
42 CFR 473.10 Scope.
This subpart establishes the requirements and procedures for --
(a) Reconsiderations conducted by a Utilization and Quality Control
Peer Review Organization (PRO) or its subcontractor of initial denial
determinations concerning services furnished or proposed to be furnished
under Medicare;
(b) Hearings and judicial review of reconsidered determinations; and
(c) PRO review of a change in diagnostic and procedural coding
information.
(50 FR 15372, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985)
42 CFR 473.12 Statutory basis.
(a) Under section 1155 of the Act --
(1) A Medicare beneficiary, a provider, or an attending practitioner
who is dissatisfied with a PRO initial denial determination made under
the provisions of section 1154 of the Act, that services furnished or
proposed to be furnished are not reasonable, necessary, or delivered in
the most appropriate setting, is entitled to a reconsideration by the
PRO that made the initial denial determination;
(2) A Medicare beneficiary is entitled to a hearing by an
administrative law judge (ALJ) if $200 or more is still in controversy
after a reconsidered determination; and
(3) A Medicare beneficiary is entitled to judicial review of a final
determination of the Department if $2,000 or more is still in
controversy.
(b) Under section 1866(a)(1)(F) of the Act, a hospital that is
reimbursed by the Medicare program must maintain an agreement with a PRO
under which the PRO will review the validity of diagnostic information
furnished by the hospital.
42 CFR 473.14 Applicability.
(a) Basic provision. This subpart applies to reconsiderations and
hearings of a PRO initial denial determination involving the following
issues:
(1) Reasonableness of services.
(2) Medical necessity of services.
(3) Appropriateness of the inpatient setting in which services were
furnished or are proposed to be furnished.
(b) Concurrent appeal. A reconsideration or hearing provided under
this subpart fulfills the requirements of any other review, hearing, or
appeal under the Act to which a party may be entitled with respect to
the same issues.
(c) Nonapplicability of rules to related determinations. (1) A PRO
may not reconsider its decision whether to grant grace days.
(2) Limitation of liability determinations on excluded coverage of
certain services are made under section 1879 of the Act. Initial
determinations under section 1879 and further appeals are governed by
the reconsideration and appeal procedures in part 405, subpart G of this
chapter for determinations under Medicare Part A, and part 405, subpart
H of this chapter for determinations under Medicare Part B. References
in those subparts to initial and reconsidered determinations made by an
intermediary, carrier or HCFA should be read to mean initial and
reconsidered determinations made by a PRO.
(50 FR 15372, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985)
42 CFR 473.15 PRO review of changes resulting from DRG validation.
(a) General rules. (1) A provider or practitioner dissatisfied with
a change to the diagnostic or procedural coding information made by a
PRO as a result of DRG validation under section 1866(a)(1)(F) of the Act
is entitled to a review of that change if --
(i) The change caused an assignment of a different DRG; and
(ii) Resulted in a lower payment.
(2) A beneficiary may obtain a review of a PRO DRG coding change only
if that change results in noncoverage of a furnished service.
(3) The individual who reviews changes in DRG procedural or
diagnostic information must be a physician, and the individual who
reviews changes in DRG coding must be qualified through training and
experience with ICD-9-CM coding.
(b) Procedures. Procedures described in 473.18 through 473.36, and
473.48 (a) and (c) for a PRO reconsideration or reopening also apply to
PRO review of a DRG coding change.
(c) Finality of review. No additional review or appeal for matters
governed by paragraph (a) of this section is available.
(50 FR 15372, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985)
42 CFR 473.16 Right to reconsideration.
A beneficiary, provider or practitioner who is dissatisfied with a
PRO initial denial determination on one of the issues specified in
473.14(a) has a right to a reconsideration of that determination by the
PRO that made the initial denial determination.
42 CFR 473.18 Location for submitting requests for reconsideration.
(a) Beneficiaries. Except as provided in paragraph (c) of this
section concerning requests for expedited reconsideration, a beneficiary
who wishes to obtain a reconsideration must submit a written request to
one of the following:
(1) The PRO or the PRO subcontractor that made the initial
determination.
(2) An SSA District Office.
(3) A Railroad Retirement Board Office, if the beneficiary is a
railroad retiree.
(b) Others. A provider, physician or other practitioner that wishes
to obtain reconsideration must submit a written request to the PRO or
PRO subcontractor that made the initial determination.
(c) Expedited reconsideration. A request for an expedited
reconsideration of a preadmission denial determination must be submitted
directly to the PRO.
42 CFR 473.20 Time limits for requesting reconsideration.
(a) Basic rules. (1) Except for a request for expedited
reconsideration as provided in paragraph (c) of this section, or a late
request with good cause under 473.22, a dissatisfied party must file a
request for reconsideration within 60 days after receipt of the notice
of an initial determination.
(2) The date of receipt of the notice of the initial determination is
presumed to be five days after the date on the notice, unless there is a
reasonable showing to the contrary.
(3) A request is considered filed on the date it is postmarked.
(b) Late filing of request. A PRO will accept a request filed after
60 days after receipt of the notice of the initial determination if the
PRO finds under the criteria set forth in 473.22 that there was good
cause for the party's failure to file a timely request.
(c) Request for expedited reconsideration. A request for an
expedited reconsideration under 473.18(c) must be submitted within
three days after receipt of the notice of the initial denial
determination.
42 CFR 473.22 Good cause for late filing of a request for a
reconsideration or hearing.
(a) General Rule. In determining whether a party has good cause for
not filing a request for reconsideration or hearing timely, the PRO or
ALJ, respectively, must consider the following:
(1) What circumstances kept the party from making the request on
time.
(2) Whether an action by the PRO misled the party.
(3) Whether the party understood the requirements of the Act as
affected by amendments to the Act, other legislation, or court
decisions.
(b) Examples. Examples of circumstances in which good cause may
exist include, but are not limited to, the following:
(1) A party was seriously ill and was prevented from requesting a
reconsideration in person, through another person, or in writing.
(2) There was a death or serious illness in a party's immediate
family.
(3) Important records were accidentally destoryed or damaged by fire
or other cause.
(4) A party made a diligent effort but could not find or obtain
necessary relevent information within the appropriate time period.
(5) A party requested additional information to further explain the
determination within the time limit, and requested reconsideration
within 60 days of receiving the explanation (or within 30 days for an
Appeals Council hearing).
(6) The PRO gave the party incorrect or incomplete information about
when and how to request a reconsideration or hearing.
(7) A party sent the request to another Government agency in good
faith within the time limit, but the request did not reach an office
authorized to receive the request until after the time period had
expired.
(8) Other unusual or unavoidable circumstances exist that --
(i) Show that a party could not have known of the need to file
timely; or
(ii) Prevented a party from filing timely.
42 CFR 473.24 Opportunity for a party to obtain and submit information.
(a) Subject to the rules concerning disclosure of PRO information in
section 1160 of the Act, at the request of a provider, practitioner or
beneficiary, the PRO must provide an opportunity for examination of the
material upon which the initial denial determination was based. The PRO
may not furnish a provider, practitioner or beneficiary with --
(1) A record of the PRO deliberation; or
(2) The identity of the PRO review coordinators, physician advisors,
or consultants who assisted in the initial denial determination without
their consent.
(b) The PRO may require the requester to pay a reasonable fee for the
reproduction of the material requested.
(c) The PRO must provide a party with an opportunity to submit new
evidence before the reconsidered determination is made.
42 CFR 473.26 Delegation of the reconsideration function.
A PRO may delegate the authority to reconsider an initial
determination to a nonfacility subcontractor, including the organization
that made the initial determination as a PRO subcontractor.
42 CFR 473.28 Qualifications of a reconsideration reviewer.
A reconsideration reviewer must be someone who is --
(a) Qualified under 466.98 of this chapter to make an initial
determination.
(b) Not the individual who made the initial denial determination.
(c) A specialist in the type of services under review, except where
meeting this requirement would compromise the effectiveness or
efficiency of PRO review.
42 CFR 473.30 Evidence to be considered by the reconsideration
reviewer.
A reconsidered determination must be based on --
(a) The information that led to the initial determination;
(b) New information found in the medical records; or
(c) Additional evidence submitted by a party.
42 CFR 473.32 Time limits for issuance of the reconsidered
determination.
(a) Beneficiaries. If a beneficiary files a timely request for
reconsideration of an initial denial determination, the PRO must
complete its reconsidered determination and send written notice to the
beneficiary within the following time limits --
(1) Within three working days after the PRO receives the request for
reconsideration if --
(i) The beneficiary is still an inpatient in a hospital for the stay
in question when the PRO receives the request for reconsideration; or
(ii) The initial determination relates to institutional services for
which admission to the institution is sought, the initial determination
was made before the patient was admitted to the institution; and a
request was submitted timely for an expedited reconsideration.
(2) Within 10 working days after the PRO receives the request for
reconsideration if the beneficiary is still an inpatient in a SNF for
the stay in question when the PRO receives the request for
reconsideration.
(3) Within 30 working days after the PRO receives the request for
reconsideration if --
(i) The initial determination concerns ambulatory or noninstitutional
services;
(ii) The beneficiary is no longer an inpatient in a hospital or SNF
for the stay in question; or
(iii) The beneficiary does not submit a request for expedited
reconsideration timely.
(b) Providers or practitioners. If the provider or practitioner
files a request for reconsideration of an initial determination, the PRO
must complete its reconsidered determination and send written notice to
the provider or practitioner within 30 working days.
42 CFR 473.34 Notice of a reconsidered determination.
(a) Notice to parties. A written notice of a PRO reconsidered
determination must contain the following;
(1) The basis for the reconsidered determination.
(2) A detailed rationale for the reconsidered determination.
(3) A statement explaining the Medicare payment consequences of the
reconsidered determination.
(4) A statement informing the parties of their appeal rights,
including the information concerning what must be included in the
request for hearing, the amount in controversy, locations for submitting
a request for an administrative hearing and the time period for filing a
request.
(b) Notice to payers. (1) A PRO must provide written notice of its
reconsidered determination to the appropriate Medicare intermediary or
carrier within 30 days if the initial determination is modified or
reversed.
(2) This notice must contain adequate information to allow the
intermediary or carrier to locate the claim file. This must include the
name of the beneficiary, the Health Insurance Claim Number, the name of
the provider, date of admission, and dates or services for which
Medicare payment will not be made.
42 CFR 473.36 Record of reconsideration.
(a) PRO requirements. A PRO must maintain the record of its
reconsideration until the later of the following:
(1) Four years after the date on the notice of the PRO's reconsidered
determination.
(2) Completion of litigation and the passage of the time period for
filing all appeals.
(b) Contents of the record. The record of the reconsideration must
include:
(1) The initial determination.
(2) The basis for the initial determination.
(3) Documentation of the date of the receipt of the request for
reconsideration.
(4) The detailed basis for the reconsidered determination.
(5) Evidence submitted by the parties.
(6) A copy of the notice of the reconsidered determination that was
provided to the parties.
(7) Documentation of the delivery or mailing and, if appropriate, the
receipt of the notice of the reconsidered determination by the parties.
(c) Confidentiality. The record of a PRO reconsideration is subject
to prohibitions against disclosure of information as specified in
section 1160 of the Act.
42 CFR 473.38 Finality of a reconsidered determination.
A PRO reconsidered determination is final and binding upon all
parties to the reconsideration unless --
(a) A hearing is requested in accordance with 473.40 and a final
decision rendered; or
(b) The reconsidered determination is later reopened and revised in
accordance with 473.48.
(50 FR 15372, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985)
42 CFR 473.40 Beneficiary's right to a hearing.
(a) Amount in controversy. If the amount in controversy is at least
$200, a beneficiary (but not a provider or practitioner) who is
dissatisfied with a PRO reconsidered determination may obtain a hearing
by an administrative law judge (ALJ) of the Office of Hearings and
Appeals of the SSA.
(b) Subject matter. A beneficiary has a right to a hearing on the
following issues:
(1) Reasonableness of the services.
(2) Medical necessity of the services.
(3) Appropriateness of the setting in which the services were
furnished.
(c) Governing provisions. The provisions of subpart G,
Reconsiderations and Appeals under the Hospital Insurance Program, of
part 405 of this chapter apply to hearings and appeals under this
subpart unless they are inconsistent with specific provisions in this
subpart. References in subpart G to initial and reconsidered
determinations made by an intermediary, carrier, or HCFA should be read
to mean initial and reconsidered determinations made by a PRO.
(50 FR 15372, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985)
42 CFR 473.42 Submitting a request for a hearing.
(a) Where to submit the written request. A beneficiary who wants to
obtain a hearing under 473.40 must submit a written request to one of
the following:
(1) The office of the PRO or PRO subcontractor that made the initial
determination.
(2) A SSA District Office.
(3) An office of the Office of Hearings and Appeals of SSA.
(4) An office of the Railroad Retirement Board, in the case of a
beneficiary who is a railroad retiree.
(b) Time limit for submitting a request for a hearing. (1) The
request for a hearing must be filed within 60 days of receipt of the
notice of the PRO reconsidered determination, unless the time is
extended for good cause as provided in 473.22.
(2) The date of receipt of the notice of the reconsidered
determination is presumed to be five days after the date on the notice,
unless there is a reasonable showing to the contrary.
(3) A request is considered filed on the date it is postmarked.
42 CFR 473.44 Determining the amount in controversy for a hearing.
(a) After a party has submitted a request for a hearing, the ALJ
determines the amount in controversy in accordance with 405.740 of this
chapter.
(b) If the ALJ determines that the amount in controversy is less than
$200, the ALJ, without holding a hearing, notifies the parties to the
hearing that the parties have 15 calendar days to submit additional
evidence to prove that the amount in controversy is at least $200.
(c) At the end of the 15-day period, if the ALJ determines that the
amount in controversy is less than $200, the ALJ, without holding a
hearing, dismisses the request for a hearing without ruling on the
substantive issues involved in the appeal and notifies the parties to
the hearing and the PRO that the PRO reconsidered determination is
conclusive for Medicare payment purposes.
42 CFR 473.46 Appeals Council and judicial review.
(a) The circumstances under which the Appeals Council of the Social
Security Administration will review an ALJ hearing decision or dismissal
are specified in 20 CFR 404.970, Cases the Appeals Council will review.
(b) If $2,000 or more is in controversy, a party may obtain judicial
review of an Appeals Council decision, or an ALJ hearing decision if a
request for review by the Appeals Council was denied, by filing a civil
action under the Federal Rules of Civil Procedure within 60 days after
the date the party received notice of the Appeals Council decision or
denial.
42 CFR 473.48 Reopening and revision of a reconsidered determination or
a hearing decision.
(a) PRO reopenings -- (1) General rule. A PRO or PRO subcontractor
that made a reconsidered determination, or conducted a review of a DRG
change as described in 473.15, that is otherwise final, may reopen and
revise the reconsidered determination or review, either on its own
motion or at the request of a party, within one year from the date of
the reconsidered determination or review.
(2) Extension of time limit. A PRO or PRO subcontractor may reopen
and revise its reconsidered determination, or its review of a DRG change
as described in 473.15, that is otherwise final, after one year but
within four years of the date of the determination or review if --
(i) The PRO receives new material evidence;
(ii) The PRO erred in interpretation or application of Medicare
coverage policy;
(iii) There is an error apparent on the face of the evidence upon
which the reconsidered determination was based; or
(iv) There is a clerical error in the statement of the reconsidered
determination.
(b) ALJ and Appeals Council Reopening -- Applicable procedures. The
ALJ or the Appeals Council, whichever made the final decision, may
reopen and revise the decision in accordance with the procedures set
forth in 405.750(b) of this chapter, which concerns reopenings and
revisions under subpart G of part 405 of this chapter.
(c) Fraud or similar abusive practice. A reconsidered determination,
a review of a DRG change, or a decision of an ALJ or the Appeals Council
may be reopened and revised at any time, if the reconsidered
determination, review, or decision was obtained through fraud or a
similar abusive practice that does not support a formal finding of
fraud.
42 CFR 473.48 Pt. 476
42 CFR 473.48 PART 476 -- ACQUISITION, PROTECTION, AND DISCLOSURE OF PEER REVIEW INFORMATION
42 CFR 473.48 Subpart A -- (Reserved)
42 CFR 473.48 Subpart B -- Utilization and Quality Control Peer Review
Organizations (PROs)
Sec.
476.101 Scope and definitions.
476.102 Statutory bases for acquisition and maintenance of
information.
476.103 Statutory bases for disclosure of information.
476.104 Procedures for disclosure by a PRO.
476.105 Notice of disclosures made by a PRO.
476.106 Exceptions to PRO notice requirements.
476.107 Limitations on redisclosure.
476.108 Penalties for unauthorized disclosure.
476.109 Applicability of other statutes and regulations.
476.111 PRO access to records and information of institutions and
practitioners.
476.112 PRO access to records and information of intermediaries and
carriers.
476.113 PRO access to information collected for PRO purposes.
476.114 Limitations on data collection.
476.115 Requirements for maintaining confidentiality.
476.116 Notice to individuals and institutions under review.
476.120 Information subject to disclosure.
476.121 Optional disclosure of nonconfidential information.
476.130 Disclosure to the Department.
476.131 Access to medical records for the monitoring of PROs.
476.132 Disclosure of information about patients.
476.133 Disclosure of information about practitioners, reviewers and
institutions.
476.134 Verification and amendment of PRO information.
476.135 Disclosure necessary to perform review responsibilities.
476.136 Disclosure to intermediaries and carriers.
476.137 Disclosure to Federal and State enforcement agencies
responsible for the investigation or identification of fraud or abuse of
the Medicare or Medicaid programs.
476.138 Disclosure for other specified purposes.
476.139 Disclosure of PRO deliberations and decisions.
476.140 Disclosure of quality review study information.
476.141 Disclosure of PRO interpretations on the quality of health
care.
476.142 Disclosure of sanction reports.
476.143 PRO involvement in shared health data systems.
Authority: Secs. 1102, 1154(a), 1156(a), and 1160 of the Social
Security Act (42 U.S.C. 1302, 1320c-3(a), 1320c-5(a), and 1320c-9).
42 CFR 473.48 Subpart A -- (Reserved)
42 CFR 473.48 Subpart B -- Utilization and Quality Control Peer Review
Organizations (PROs)
Source: 50 FR 15359, Apr. 17, 1985, unless otherwise noted.
42 CFR 473.48 General Provisions
42 CFR 476.101 Scope and definitions.
(a) Scope. This subpart sets forth the policies and procedures
governing --
(1) Disclosure of information collected, acquired or generated by a
Utilization and Quality Control Peer Review Organization (PRO) (or the
review component of a PRO subcontractor) in performance of its
responsibilities under the Act and these regulations; and
(2) Acquisition and maintenance of information by a PRO to comply
with its responsibilities under the Act.
(b) Definitions. As used in this part:
Abuse means any unlawful conduct relating to items or services for
which payment is sought under Title XVIII of the Act.
Aggregate statistical data means any utilization, admission,
discharge or diagnostic related group (DRG) data arrayed on a
geographic, institutional or other basis in which the volume and
frequency of services are shown without identifying any individual.
Confidential information means any of the following:
(1) Information that explicitly or implicitly identifies an
individual patient, practitioner or reviewer.
(2) Sanction reports and recommendations.
(3) Quality review studies which identify patients, practitioners or
institutions.
(4) PRO deliberations.
Health care facility or facility means an organization involved in
the delivery of health care services or items for which reimbursement
may be made in whole or in part under Title XVIII of the Act.
Implicitly identify(ies) means data so unique or numbers so small so
that identification of an individual patient, practitioners or reviewer
would be obvious.
Non-facility organization means a corporate entity that: (1) Is not
a health care facility; (2) is not a 5 percent or more owner of a
facility; and (3) is not owned by one or more health care facilities in
the PRO area.
Patient representative means -- (1) an individual designated by the
patient, in writing, as authorized to request and receive PRO
information that would otherwise be disclosable to that patient; or (2)
an individual identified by the PRO in accordance with 476.132(c)(3)
when the beneficiary is mentally, physically or legally unable to
designate a representative.
Practitioner means an individual credentialed within a recognized
health care discipline and involved in providing the services of that
discipline to patients.
PRO deliberations means discussions or communications (within a PRO
or between a PRO and a PRO subcontractor) including, but not limited to,
review notes, minutes of meetings and any other records of discussions
and judgments involving review matters regarding PRO review
responsibilities and appeals from PRO determinations, in which the
opinions of, or judgment about, a particular individual or institution
can be discerned.
PRO information means any data or information collected, acquired or
generated by a PRO in the exercise of its duties and functions under
Title XI Part B or Title XVIII of the Act.
PRO interpretations and generalizations on the quality of health care
means an assessment of the quality of care furnished by an individual
provider or group of providers based on the PRO's knowledge of the area
gained from its medical review experience (e.g., quality review studies)
and any other information obtained through the PRO's review activities.
PRO review system means the PRO and those organizations and
individuals who either assist the PRO or are directly responsible for
providing medical care or for making determinations with respect to the
medical necessity, appropriate level and quality of health care services
that may be reimbursed under the Act. The system includes --
(1) The PRO and its officers, members and employees;
(2) PRO subcontractors;
(3) Health care institutions and practitioners whose services are
reviewed;
(4) PRO reviewers and supporting staff; and
(5) Data support organizations.
Public information means information which has been disclosed to the
public.
Quality review study means an assessment, conducted by or for a PRO,
of a patient care problem for the purpose of improving patient care
through peer analysis, intervention, resolution of the problem and
follow-up.
Quality review study information means all documentation related to
the quality review study process.
Reviewer means review coordinator, physician, or other person
authorized to perform PRO review functions.
Sanction report means a report filed pursuant to section 1156 of the
Act and part 474 of this chapter documenting the PRO's determination
that a practitioner or institution has failed to meet obligations
imposed by section 1156 of the Act.
Shared health data system means an agency or other entity authorized
by Federal or State law that is used by the PRO review system to provide
information or to conduct or arrange for the collection, processing, and
dissemination of information on health care services.
Subcontractor means a facility or a non-facility organization under
contract with a PRO to perform PRO review functions.
(50 FR 15359, Apr. 17, 1985; 50 FR 41886, Oct. 16, 1985)
42 CFR 476.102 Statutory bases for acquisition and maintenance of
information.
(a) Section 1154(a)(7)(C) of the Act requires PROs to the extent
necessary and appropriate to examine the pertinent records of any
practitioner or provider of health care services for which payment may
be made under Title XVIII of the Act.
(b) Section 1154(a)(9) of the Act requires PROs to collect and
maintain information necessary to carry out their responsibilities under
the Act.
(c) Section 1156(a)(3) of the Act requires health care practitioners
and providers to maintain evidence of the medical necessity and quality
of health care services they provide to Medicare patients as required by
PROs.
42 CFR 476.103 Statutory bases for disclosure of information.
(a) Section 1154(a)(10) of the Act requires PROs to exchange
information with intermediaries and carriers with contracts under
sections 1816 and 1842 of the Act, other PROs, and other public or
private review organizations as appropriate.
(b) Section 1160 of the Act provides that PRO information must be
held in confidence and not be disclosed except where --
(1) Necessary to carry out the purpose of Title XI Part B of the Act;
(2) Specifically permitted or required under this subpart;
(3) Necessary, and in the manner prescribed under this subpart, to
assist Federal and State agencies recognized by the Secretary as having
responsibility for identifying and investigating cases or patterns of
fraud or abuse;
(4) Necessary, and in the manner prescribed under the subpart to
assist Federal or State agencies recognized by the Secretary as having
responsibility for identifying cases or patterns involving risks to the
public health;
(5) Necessary, and in the manner prescribed under this subpart, to
assist appropriate State agencies having responsibility for licensing or
certification of providers or practitioners; or
(6) Necessary, and in the manner prescribed under this subpart to
assist Federal or State health planning agencies by furnishing them
aggregate statistical data on a geographical, institutional or other
basis.
(50 FR 15359, Apr. 17, 1985; 50 FR 41886, Oct. 16, 1985)
42 CFR 476.104 Procedures for disclosure by a PRO.
(a) Notice to accompany disclosure.
(1) Any disclosure of information under the authority of this subpart
is subject to the requirements in 476.105 relating to the providing of
a notice of the disclosure.
(2) Disclosure of confidential information made under the authority
of this subpart, except as provided in 476.106, must be accompanied by
a written statement informing the recipient that the information may not
be redisclosed except as provided under 476.107 that limits
redisclosure.
(b) PRO interpretations. A PRO may provide a statement of comment,
analysis, or interpretation to guide the recipient in using information
disclosed under this subpart.
(c) Fees. A PRO may charge a fee to cover the cost of providing
information authorized under this subpart. These fees may not exceed
the amount necessary to recover the cost to the PRO for providing the
information.
(d) Format for disclosure of public information. A PRO is required
to disclose public information ( 476.120(a)(6)) only in the form in
which it is acquired by the PRO or in the form in which it is maintained
for PRO use.
(e) Medicare provider number. A PRO must include the provider
identification number assigned by the Medicare program on information
that HCFA requests.
42 CFR 476.105 Notice of disclosures made by a PRO.
(a) Notification of the disclosure of nonconfidential information.
Except as permitted under 476.106, at least 30 calender days before
disclosure of nonconfidential information, the PRO must notify an
identified institution of its intent to disclose information about the
institution (other than reports routinely submitted to HCFA or Medicare
fiscal intermediaries, or to or from PRO subcontractors, or to or from
the institution) and provide the institution with a copy of the
information. The institution may submit comments to the PRO that must
be attached to the information disclosed if received before disclosure,
or forwarded separately if received after disclosure.
(b) Notification of the disclosure of confidential information. (1)
A PRO must notify the practitioner who has treated a patient, of a
request for disclosure to the patient or patient representative in
accordance with the requirements and exceptions to the requirements for
disclosure specified under 476.132.
(2) A PRO must notify a practitioner or institution of the PRO's
intent to disclose information on the practitioner or institution to an
investigative or licensing agency ( 476.137 and 476.138) except for
cases specified in 476.106 involving fraud or abuse or imminent danger
to individuals or the public health. The practitioner or institution
must be notified and provided a copy of the information to be disclosed
at least 30 calendar days before the PRO discloses the identifying
information. The PRO must forward with the information any comments
submitted by the practitioner or institution in response to the PRO
notice if received before disclosure, or forwarded separately if
received after disclosure.
(50 FR 15359, Apr. 17, 1985; 50 FR 41886, Oct. 16, 1985)
42 CFR 476.106 Exceptions to PRO notice requirements.
(a) Imminent danger to individuals or public health. When the PRO
determines that requested information is necessary to protect against an
imminent danger to individuals or the public health, the notification
required in 476.105 may be sent simultaneously with the disclosure.
(b) Fraud or Abuse. The notification requirement in 476.105 does
not apply if --
(1) The disclosure is made in an investigation of fraud or abuse by
the Office of the Inspector General or the General Accounting Office;
or
(2) The disclosure is made in an investigation of fraud or abuse by
any other Federal or State fraud or abuse agency and the investigative
agency specifies in writing that the information is related to a
potentially prosecutable criminal offense.
42 CFR 476.107 Limitations on redisclosure.
Persons or organizations that obtain confidential PRO information
must not further disclose the information to any other person or
organization except --
(a) As directed by the PRO to carry out a disclosure permitted or
required under a particular provision of this part;
(b) As directed by HCFA to carry out specific responsibilities of the
Secretary under the Act;
(c) As necessary for HCFA to carry out its responsibilities for
appeals under section 1155 of the Act or for HCFA to process sanctions
under section 1156 of the Act;
(d) If the health care services furnished to an individual patient
are reimbursed from more than one source, these sources of reimbursement
may exchange confidential information as necessary for the payment of
claims;
(e) If the information is acquired by the PRO from another source and
the receiver of the information is authorized under its own authorities
to acquire the information directly from the source, the receiver may
disclose the information in accordance with the source's redisclosure
rules;
(f) As necessary for the General Accounting Office to carry out its
statutory responsibilities;
(g) Information pertaining to a patient or practitioner may be
disclosed by that individual provided it does not identify any other
patient or practitioner;
(h) An institution may disclose information pertaining to itself
provided it does not identify an individual patient or practitioner;
(i) Governmental fraud or abuse agencies and State licensing or
certification agencies recognized by HCFA may disclose information as
necessary in a judicial, administrative or other formal legal proceeding
resulting from an investigation conducted by the agency;
(j) State and local public health officials to carry out their
responsibilities, as necessary, to protect against a substantial risk to
the public health; or
(k) As necessary for the Office of the Inspector General to carry out
its statutory responsibilities.
(50 FR 15359, Apr. 17, 1985; 50 FR 41886, Oct. 16, 1985)
42 CFR 476.108 Penalties for unauthorized disclosure.
A person who discloses information not authorized under Title XI Part
B of the Act or the regulations of this part will, upon conviction, be
fined no more than $1,000, or be imprisoned for no more than six months,
or both, and will pay the costs of prosecution.
42 CFR 476.109 Applicability of other statutes and regulations.
The provisions of 42 U.S.C. 290dd-3 and 290ee-3 governing
confidentiality of alcohol and drug abuse patients' records, and the
implementing regulations at 42 CFR part 2, are applicable to PRO
information.
(50 FR 15359, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985)
42 CFR 476.109 PRO Access to Information
42 CFR 476.111 PRO access to records and information of institutions
and practitioners.
(a) A PRO is authorized to have access to and obtain records and
information pertinent to the health care services furnished to Medicare
patients, held by any institution or practitioner in the PRO area. The
PRO may require the institution or practitioner to provide copies of
such records or information to the PRO.
(b) A PRO may obtain non-Medicare patient records relating to review
performed under a non-Medicare PRO contract if authorized by those
patients in accordance with State law.
(c) In accordance with its quality review responsibilities under the
Act, a PRO may have access to and obtain information from, the records
of non-Medicare patients if authorized by the institution or
practitioner.
(50 FR 15359, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985)
42 CFR 476.112 PRO access to records and information of intermediaries
and carriers.
A PRO is authorized to have access to and require copies of Medicare
records or information held by intermediaries or carriers if the PRO
determines that the records or information are necessary to carry out
PRO review responsibilities.
42 CFR 476.113 PRO access to information collected for PRO purposes.
(a) Institutions and other entities must disclose to the PRO
information collected by them for PRO purposes.
(b) Information collected or generated by institutions or
practitioners to carry out quality review studies must be disclosed to
the PRO.
42 CFR 476.114 Limitation on data collection.
A PRO or any agent, organization, or institution acting on its
behalf, that is collecting information under authority of this part,
must collect only that information which is necessary to accomplish the
purposes of Title XI Part B of the Act in accordance with 44 U.S.C.
Chapter 35, Coordination of Federal Reporting Services Information
Policy.
42 CFR 476.114 PRO Responsibilities
42 CFR 476.115 Requirements for maintaining confidentiality.
(a) Responsibilities of PRO officers and employees. The PRO must
provide reasonable physical security measures to prevent unauthorized
access to PRO information and to ensure the integrity of the
information, including those measures needed to secure computer files.
Each PRO must instruct its officers and employees and health care
institution employees participating in PRO activities of their
responsibility to maintain the confidentiality of information and of the
legal penalties that may be imposed for unauthorized disclosure of PRO
information.
(b) Responsible individuals within the PRO. The PRO must assign a
single individual the responsibility for maintaining the system for
assuring the confidentiality of information within the PRO review
system. That individual must notify HCFA of any violations of these
regulations.
(c) Training requirements. The PRO must train participants of the
PRO review system in the proper handling of confidential information.
(d) Authorized access. An individual participating in the PRO review
system on a routine or ongoing basis must not have authorized access to
confidential PRO information unless that individual --
(1) Has completed a training program in the handling of PRO
information in accordance with paragraph (c) of this section or has
received comparable training from another source; and
(2) Has signed a statement indicating that he or she is aware of the
legal penalties for unauthorized disclosure.
(e) Purging of personal identifiers. (1) The PRO must purge or
arrange for purging computerized information, patient records and other
noncomputerized files of all personal identifiers as soon as it is
determined by HCFA that those identifiers are no longer necessary.
(2) The PRO must destroy or return to the facility from which it was
collected confidential information generated from computerized
information, patient records and other noncomputerized files when the
PRO determines that the maintenance of hard copy is no longer necessary
to serve the specific purpose for which it was obtained or generated.
(f) Data system procedures. The PRO must assure that organizations
and consultants providing data services to the PRO have established
procedures for maintaining the confidentiality of PRO information in
accordance with requirements defined by the PRO and consistent with
procedures established under this part.
42 CFR 476.116 Notice to individuals and institutions under review.
The PRO must establish and implement procedures to provide patients,
practitioners, and institutions under review with the following
information --
(a) The title and address of the person responsible for maintenance
of PRO information;
(b) The types of information that will be collected and maintained;
(c) The general rules governing disclosure of PRO information; and
(d) The procedures whereby patients, practitioners, and institutions
may obtain access to information about themselves.
42 CFR 476.116 Disclosure of Nonconfidential Information
42 CFR 476.120 Information subject to disclosure.
Subject to the procedures for disclosure and notice of disclosure
specified in 476.104 and 476.105, the PRO must disclose --
(a) Nonconfidential information to any person upon request, including
--
(1) The norms, criteria, and standards it uses for initial screening
of cases, and for other review activities;
(2) Winning technical proposals for contracts from the Department,
and winning technical proposals for subcontracts under those contracts
(except for proprietary or business information);
(3) Copies of documents describing administrative procedures, agreed
to between the PRO and institutions or between a PRO and the Medicare
intermediary or Medicare carrier;
(4) Routine reports submitted by the PRO to HCFA to the extent that
they do not contain confidential information.
(5) Summaries of the proceedings of PRO regular and other meetings of
the governing body and general membership except for those portions of
the summaries involving PRO deliberations, which are confidential
information and subject to the provisions of 476.139;
(6) Public information in its possession;
(7) Aggregate statiscal information that does not implicitly or
explicitly identify individual patients, practitioners or reviewers;
(8) Quality review study information including summaries and
conclusions from which the identification of patients, practitioners and
institutions has been deleted; and
(9) Information describing the characteristics of a quality review
study, including a study design and methodology.
(b) Aggregate statistical information that does not implicitly or
explicitly identify individual patients, practitioners or reviewers, to
Federal or State health planning agencies (including Health Systems
Agencies and State Health Planning and Development Agencies) in carrying
out their health care planning and related activities.
(50 FR 15359, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985)
42 CFR 476.121 Optional disclosure of nonconfidential information.
A PRO may, on its own initiative, subject to the notification
requirements in 476.105, furnish the information available under
476.120 to any person, agency, or organization.
42 CFR 476.121 Disclosure of Confidential Information
42 CFR 476.130 Disclosure to the Department.
Except as limited by 476.139(a) and 476.140 of this subpart, PROs
must disclose all information requested by the Department to it in the
manner and form required.
42 CFR 476.131 Access to medical records for the monitoring of PROs.
HCFA or any person, organization or agency authorized by the
Department or Federal statute to monitor a PRO will have access to
medical records maintained by institutions or health care practitioners
on Medicare patients. The monitor can require copies of the records.
42 CFR 476.132 Disclosure of information about patients.
(a) General requirements for disclosure. Except as specified in
paragraph (b) of this section, a PRO must --
(1) Disclose patient identified information in its possession to the
identified patient or the patient's representative if --
(i) The patient or the patient's representative requests the
information in writing;
(ii) The request by a patient's representative includes the
designation, by the patient, of the representative; and
(iii) All other patient and practitioner identifiers have been
removed.
(2) Seek the advice of the attending practitioner that treated the
patient regarding the appropriateness of direct disclosure to the
patient 15 days before the PRO provides the requested information. If
the attending practitioner states that the released information could
harm the patient, the PRO must act in accordance with paragraph (c)(2)
of this section. The PRO must make disclosure to the patient or
patient's representative within 30 calendar days of receipt of the
request.
(b) Exceptions. (1) If the request is in connection with an initial
denial determination under section 1154(a)(3) of the Act, the PRO --
(i) Need not seek the advice of the practitioner that treated the
patient regarding the appropriateness of direct disclosure to the
patient; and
(ii) Must provide only the information used to support that
determination in accordance with the procedures for disclosure of
information relating to determinations under 473.24.
(2) A PRO must disclose information regarding PRO deliberations only
as specified in 476.139(a).
(3) A PRO must disclose quality review study information only as
specified in 476.140.
(c) Manner of disclosure. (1) The PRO must disclose the patient
information directly to the patient unless knowledge of the information
could harm the patient.
(2) If knowledge of the information could harm the patient, the PRO
must disclose the information to the patient's designated
representative.
(3) If the patient is mentally, physically or legally unable to
designate a representative, the PRO must disclose the information to a
person whom the PRO determines is responsible for the patient.
The PRO must first attempt to make that determination based on the
medical record. If the responsible person is not named in the medical
record, then the PRO may rely on the attending practitioner for the
information. If the practitioner is unable to provide a name, then the
PRO must make a determination based on other reliable information.
(50 FR 15359, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985)
42 CFR 476.133 Disclosure of information about practitioners, reviewers
and institutions.
(a) General requirements for disclosure. Except as specified in
paragraph (b) of this section, the following provisions are required of
the PRO.
(1) Disclosure to the identified individual or institution. A PRO
must disclose, to particular practitioners, reviewers and institutions,
information about themselves, upon request, and may disclose it to them
without a request.
(2) Disclosure to others. (i) A PRO must disclose to an institution,
upon request, information on a practitioner to the extent that the
information displays practice or performance patterns of the
practitioner in that institution.
(ii) In accordance with section 1160 of the Act, a PRO must disclose
information that displays practice or performance patterns of a
practitioner or institution in accordance with the procedures for
disclosures specified in 476.137 and 476.138 to --
(A) Federal and State agencies that are responsible for the
investigation of fraud and abuse of the Medicare or Medicaid programs,
and
(B) Federal and State agencies that are responsible for licensing and
certification of practitioners and providers.
(iii) A PRO may disclose to any person, agency or organization,
information on a particular practitioner or reviewer with the consent of
that practitioner or reviewer provided that the information does not
identify other individuals.
(b) Exceptions. (1) If the request is in connection with an initial
denial determination or a change resulting from a diagnostic related
group (DRG) coding validation under Part 466 of this subchapter, the PRO
must provide only the information used to support that determination in
accordance with the procedures for disclosure of information relating to
determinations under 473.24.
(2) A PRO must disclose information regarding PRO deliberations only
as specified in 476.139(a).
(3) A PRO must disclose quality review study information only as
specified in 476.140.
(50 FR 15359, Apr. 17, 1885, as amended at 52 FR 37458, Oct. 7, 1987;
52 FR 47004, Dec. 11, 1987)
42 CFR 476.134 Verification and amendment of PRO information.
(a) A PRO must verify the accuracy of its information concerning
patients, practitioners, reviewers, and institutions and must permit the
individual or institution to request an amendment of pertinent
information that is in the possession of the PRO.
(b) If the PRO agrees with the request for amendment, the PRO must
correct the information in its possession. If the information being
amended has already been disclosed, the PRO must forward the amended
information to the requester where it may affect decisions about a
particular provider, practitioner or case under review.
(c) If the PRO disagrees with the request for amendment, a notation
of the request, reasons for the request, and the reasons for refusal
must be included with the information and attached to any disclosure of
the information.
(50 FR 15358, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985)
42 CFR 476.135 Disclosure necessary to perform review responsibilities.
(a) Disclosure to conduct review. The PRO must disclose or arrange
for disclosure of information to individuals and institutions within the
PRO review system as necessary to fulfill their particular duties and
functions under Title XI Part B of the Act.
(b) Disclosure to consultants and subcontractors. The PRO must
disclose to consultants or subcontractors the information they need to
provide specified services to the PRO.
(c) Disclosure to other PRO and medical review boards. The PRO must
disclose --
(1) To another PRO, information on patients and practitioners who are
subject to review by the other PRO; and
(2) To medical review boards established under section 1881 of the
Act, confidential information on patients, practitioners and
institutions receiving or furnishing end stage renal disease services.
42 CFR 476.136 Disclosure to intermediaries and carriers.
(a) Required disclosure. Except as specified in 476.139(a) and
476.140 relating to disclosure of PRO deliberations and quality review
study information, a PRO must disclose to intermediaries and carriers
PRO information that relates to, or is necessary for, payment of claims
for Medicare as follows:
(1) Review determinations and claims forms for health care services,
furnished in the manner and form agreed to by the PRO and the
intermediary or carrier.
(2) Upon request, copies of medical records acquired from
practitioners or institutions for review purposes.
(3) PRO information about a particular patient or practitioner if the
PRO and the intermediary or carrier (or HCFA if the PRO and the
intermediary or carrier cannot agree) determine that the information is
necessary for the administration of the Medicare program.
(b) Optional disclosure. The PRO may disclose the information
specified in paragraph (a) of this section to intermediaries and
carriers without a request.
42 CFR 476.137 Disclosure to Federal and State enforcement agencies
responsible for the investigation or identification of fraud or abuse of
the Medicare or Medicaid programs.
(a) Required disclosure. Except as specified in 476.139(a) and
476.140 relating to disclosure of PRO deliberations and quality review
study information, the PRO must disclose confidential information
relevant to an investigation of fraud or abuse of the Medicare or
medicaid programs, including PRO medical necessity determinations and
other information that includes patterns of the practice or performance
of a practitioner or institution, when a written request is received
from a State or Federal enforcement agency responsible for the
investigation or identification of fraud or abuse of the Medicare or
Medicaid programs that --
(1) Identifies the name and title of the individual initiating the
request,
(2) Identifies the physician or institution about which information
is requested, and
(3) States affirmatively that the institution or practitioner is
currently under investigation for fraud or abuse of the Medicare or
Medicaid programs and that the information is needed in furtherance of
that investigation.
(b) Optional disclosure. The PRO may provide the information
specified in paragraph (a) of this section to Federal or State fraud and
abuse enforcement agencies responsible for the investigation or
identification of fraud or abuse of the Medicare or Medicaid programs,
without a request.
(50 FR 15358, Apr. 17, 1985, as amended at 52 FR 37458, Oct. 7, 1987)
42 CFR 476.138 Disclosure for other specified purposes.
(a) General requirements for disclosure. Except as specified in
paragraph (b) of this section, the following provisions are required of
the PRO.
(1) Disclosure to licensing and certification bodies. (i) A PRO must
disclose confidential information upon request, to State or Federal
licensing bodies responsible for the professional licensure of a
practitioner or a particular institution. Confidential information,
including PRO medical necessity determinations that display the practice
or performance patterns of that practitioner, must be disclosed by the
PRO but only to the extent that it is required by the agency to carry
out a function within the jurisdiction of the agency under Federal or
State law.
(ii) A PRO may provide the information specified in paragraph
(a)(1)(i) of this section to the State or Federal licensing body without
request.
(2) Disclosure to State and local public health officials. A PRO
must disclose PRO information to State and local public health officials
whenever the PRO determines that the disclosure of the information is
necessary to protect against a substantial risk to the public health.
(3) Disclosure to the courts. Patient identified records in the
possession of a PRO are not subject to subpoena or discovery in a civil
action, including an administrative, judicial or arbitration proceeding.
(b) Exceptions. (1) The restriction set forth in paragraph (a)(3) of
this section does not apply to HHS, including Inspector General,
administrative subpoenas issued in the course of audits and
investigations of Department programs, in the course of administrative
hearings held under the Social Security Act or to disclosures to the
General Accounting Office as necessary to carry out its statutory
responsibilities.
(2) A PRO must disclose information regarding PRO deliberations and
quality review study information only as specified in 476.139(a) and
476.140.
(50 FR 15359, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985)
42 CFR 476.139 Disclosure of PRO deliberations and decisions.
(a) PRO deliberations. (1) A PRO must not disclose its deliberations
except to --
(i) HCFA, at the PRO office or at a subcontracted organization;
(ii) HCFA, to the extent that the deliberations are incorporated in
sanction and appeals reports; or
(iii) The Office of the Inspector General, and the General Accounting
Office as necessary to carry out statutory responsibilities.
(2) PRO deliberations are not disclosable, either in written form or
through oral testimony, in connection with the administrative hearing or
review of a beneficiary's claim.
(b) Reasons for PRO decisions. (1) A PRO may disclose to those who
have access to PRO information under other provisions of this subpart,
the reasons for PRO decisions pertaining to that information provided
that the opinions or judgements of a particular individual or
practitioner cannot be identified.
(2) A PRO must disclose, if requested in connection with the
administrative hearing or review of a beneficiary's claim, the reasons
for PRO decisions. The PRO must include the detailed facts, findings
and conclusions supporting the PRO's determination. The PRO must insure
that the opinions or judgements of a particular individual or
practitioner cannot be identified through the materials that are
disclosed.
42 CFR 476.140 Disclosure of quality review study information.
(a) A PRO must disclose, onsite, quality review study information
with identifiers of patients, practitioners or institutions to --
(1) Representatives of authorized licensure, accreditation or
certification agencies as is required by the agencies in carrying out
functions which are within the jurisdiction of such agencies under state
law; to federal and state agencies responsible for identifying risks to
the public health when there is substantial risk to the public health;
HCFA; or to Federal and State fraud and abuse enforcement agencies;
(2) An institution or practitioner, if the information is limited to
health care services furnished by the institution or practitioner; and
(3) A medical review board established under section 1881 of the Act
pertaining to end-stage renal disease facilities, if the information is
limited to health care services subject to its review.
(b) A PRO must disclose quality review study information with
identifiers of patients, practitioners or institutions to the Office of
the Inspector General and the General Accounting Office as necessary to
carry out statutory responsibilities.
(c) A PRO may disclose information offsite from a particular quality
review study to any institution or practitioner involved in that study,
provided the disclosed information is limited to that institution or
practitioner.
(d) An institution or group of practitioners may redisclose quality
review study information, if the information is limited to health care
services they provided.
(e) Quality review study information with patient identifiers is not
subject to subpoena or discovery in a civil action, including an
administrative, judicial or arbitration proceeding. This restriction
does not apply to HHS, including Inspector General, administrative
subpoenas issued in the course of audits and investigations of
Department programs, in the course of administrative hearings held under
the Social Security Act, or to disclosures to the General Accounting
Office as necessary to carry out its statutory responsibilities.
42 CFR 476.141 Disclosure of PRO interpretations on the quality of
health care.
Subject to the procedures for disclosure and notice of disclosure
specified in 476.104 and 476.105, a PRO may disclose to the public PRO
interpretations and generalizations on the quality of health care that
identify a particular institution.
42 CFR 476.142 Disclosure of sanction reports.
(a) The PRO must disclose sanction reports directly to the Office of
the Inspector General and, if requested, to HCFA.
(b) The PRO must upon request, and may without a request, disclose
sanction reports to State and Federal agencies responsible for the
identification, investigation or prosecution of cases of fraud or abuse
in accordance with 476.137.
(c) HCFA will disclose sanction determinations in accordance with
part 474 of this chapter.
42 CFR 476.143 PRO involvement in shared health data systems.
(a) Information collected by a PRO. Except as prohibited in
paragraph (b) of this section, information collected by a PRO may be
processed and stored by a cooperative health statistics system
established under the Public Health Service Act (42 U.S.C. 242k) or
other State or Federally authorized shared data system.
(b) PRO participation. A PRO may not participate in a cooperative
health statistics system or other shared health data system if the
disclosure rules of the system would prevent the PRO from complying with
the rules of this part.
(c) Disclosure of PRO information obtained by a shared health data
system. PRO information must not be disclosed by the shared health data
system unless --
(1) The source from which the PRO acquired the information consents
to or requests disclosure; or
(2) The PRO requests the disclosure of the information to carry out a
disclosure permitted under a provision of this part.
42 CFR 476.143 SUBCHAPTER E -- STANDARDS AND CERTIFICATION
42 CFR 476.143 PART 482 -- CONDITIONS OF PARTICIPATION FOR HOSPITALS
42 CFR 476.143 Subpart A -- General Provisions
Sec.
482.1 Basis and scope.
482.2 Provision of emergency services by nonparticipating hospitals.
42 CFR 476.143 Subpart B -- Administration
482.11 Condition of participation: Compliance with Federal, State
and local laws.
482.12 Condition of participation: Governing body.
42 CFR 476.143 Subpart C -- Basic Hospital Functions
482.21 Condition of participation: Quality assurance.
482.22 Condition of participation: Medical staff.
482.23 Condition of participation: Nursing services.
482.24 Condition of participation: Medical record services.
482.25 Condition of participation: Pharmaceutical services.
482.26 Condition of participation: Radiologic services.
482.27 Condition of participation: Laboratory services.
482.28 Condition of participation: Food and dietetic services.
482.30 Condition of participation: Utilization review.
482.41 Condition of participation: Physical environment.
482.42 Condition of participation: Infection control.
42 CFR 476.143 Subpart D -- Optional Hospital Services
482.51 Condition of participation: Surgical services.
482.52 Condition of participation: Anesthesia services.
482.53 Condition of participation: Nuclear medicine services.
482.54 Condition of participation: Outpatient services.
482.55 Condition of participation: Emergency services.
482.56 Condition of participation: Rehabilitation services.
482.57 Condition of participation: Respiratory care services.
42 CFR 476.143 Subpart E -- Requirements for Specialty Hospitals
482.60 Special provisions applying to psychiatric hospitals.
482.61 Condition of participation: Special medical record
requirements for psychiatric hospitals.
482.62 Condition of participation: Special staff requirements for
psychiatric hospitals.
482.66 Special requirements for hospital providers of long-term care
services (''swing-beds'').
Authority: Secs. 1102, 1136, 1138, 1814(a)(6), 1861 (e), (f), (k),
(r), (v)(1)(G), (z), and (ee), 1864, 1871, 1883, 1886, 1902(a)(30), and
1905(a) of the Social Security Act (42 U.S.C. 1302, 1320b-6, 1338,
1395f(a)(6), 1395x (e), (f), (k), (r), (v)(1)(G), (z), and (ee), 1395aa,
1395hh, 1395tt, 1395ww, 1396a(a)(30), and 1396(a)).
Source: 51 FR 22042, June 17, 1986, unless otherwise noted.
42 CFR 476.143 Subpart A -- General Provisions
42 CFR 482.1 Basis and scope.
(a) Basis in legislation. (1) Section 1861(e) of the Act provides
that --
(i) Hospitals participating in Medicare must meet certain specified
requirements; and
(ii) The Secretary may impose additional requirements if they are
found necessary in the interest of the health and safety of the
individuals who are furnished services in hospitals.
(2) Section 1861(f) of the Act provides that an institution
participating in Medicare as a psychiatric hospital must meet certain
specified requirements imposed on hospitals under section 1861(e), must
be primarily engaged in providing, by or under the supervision of a
physician, psychiatric services for the diagnosis and treatment of
mentally ill persons, must maintain clinical records and other records
that the Secretary finds necessary, and must meet staffing requirements
that the Secretary finds necessary to carry out an active program of
treatment for individuals who are furnished services in the hospital. A
distinct part of an institution can participate as a psychiatric
hospital if the institution meets the specified 1861(e) requirements and
is primarily engaged in providing psychiatric services, and if the
distinct part meets the records and staffing requirements that the
Secretary finds necessary.
(3) Section 1905(a) of the Act provides that ''medical assistance''
(Medicaid) payments may be applied to various hospital services.
Regulations interpreting those provisions specify that hospitals
receiving payment under Medicaid must meet the requirements for
participation in Medicare (except in the case of medical supervision of
nurse-midwife services. See 440.10 and 440.165 of this chpater.).
(b) Scope. Except as provided in subpart S of part 405 of this
chapter, the provisions of this part serve as the basis of survey
activities for the purpose of determining whether a hospital qualifies
for a provider agreement under Medicare and Medicaid.
42 CFR 482.2 Provision of emergency services by nonparticipating
hospitals.
(a) The services of an institution that does not have an agreement to
participate in the Medicare program may, nevertheless, be reimbursed
under the program if --
(1) The services are emergency services; and
(2) The institution meets the requirements of section 1861(e) (1)
through (5) and (7) of the Act. Rules applicable to emergency services
furnished by nonparticipating hospitals are set forth in subpart G of
part 424 of this chapter.
(b) Secton 440.170(e) of this chapter defines emergency hospital
services for purposes of Medicaid reimbursement.
(51 FR 22042, June 17, 1986, as amended at 53 FR 6648, Mar. 2, 1988)
42 CFR 482.2 Subpart B -- Administration
42 CFR 482.11 Condition of participation: Compliance with Federal,
State and local laws.
(a) The hospital must be in compliance with applicable Federal laws
related to the health and safety of patients.
(b) The hospital must be --
(1) Licensed; or
(2) Approved as meeting standards for licensing established by the
agency of the State or locality responsible for licensing hospitals.
(c) The hospital must assure that personnel are licensed or meet
other applicable standards that are required by State or local laws.
42 CFR 482.12 Condition of participation: Governing body.
The hospital must have an effective governing body legally
responsible for the conduct of the hospital as an institution. However,
if a hospital does not have an organized governing body, the persons
legally responsible for the conduct of the hospital must carry out the
functions specified in this Part that pertain to the governing body.
(a) Standard: Medical staff. The governing body must:
(1) Determine, in accordance with State law, which categories of
practitioners are eligible candidates for appointment to the medical
staff;
(2) Appoint members of the medical staff after considering the
recommendations of the existing members of the medical staff;
(3) Assure that the medical staff has bylaws;
(4) Approve medical staff bylaws and other medical staff rules and
regulations;
(5) Ensure that the medical staff is accountable to the governing
body for the quality of care provided to patients;
(6) Ensure the criteria for selection are individual character,
competence, training, experience, and judgment; and
(7) Ensure that under no circumstances is the accordance of staff
membership or professional privileges in the hospital dependent solely
upon certification, fellowship, or membership in a specialty body or
society.
(b) Standard: Chief executive officer. The governing body must
appoint a chief executive officer who is responsible for managing the
hospital.
(c) Standard: Care of patients. In accordance with hospital policy,
the governing body must ensure that the following requirements are met:
(1) Every Medicare patient is under the care of:
(i) A doctor of medicine or osteopathy (This provision is not to be
construed to limit the authority of a doctor of medicine or osteopathy
to delegate tasks to other qualified health care personnel to the extent
recognized under State law or a State's regulatory mechanism.);
(ii) A doctor of dental surgery or dental medicine who is legally
authorized to practice dentistry by the State and who is acting within
the scope of his or her license;
(iii) A doctor of podiatric medicine, but only with respect to
functions which he or she is legally authorized by the State to perform;
(iv) A doctor of optometry who is legally authorized to practice
optometry by the State in which he or she practices;
(v) A chiropractor who is licensed by the State or legally authorized
to perform the services of a chiropractor, but only with respect to
treatment by means of manual manipulation of the spine to correct a
subluxation demonstrated by x-ray to exist.
(2) Patients are admitted to the hospital only on the recommendation
of a licensed practitioner permitted by the State to admit patients to a
hospital. If a Medicare patient is admitted by a practitioner not
specified in paragraph (c)(1) of this section, that patient is under the
care of a doctor of medicine or osteopathy.
(3) A doctor of medicine or osteopathy is on duty or on call at all
times.
(4) A doctor of medicine or osteopathy is responsible for the care of
each Medicare patient with respect to any medical or psychiatric problem
that --
(i) is present on admission or develops during hospitalization; and
(ii) Is not specifically within the scope of practice of a doctor of
dental surgery, dental medicine, podiatric medicine or optometry, or a
chiropractor, as that scope is --
(A) Defined by the medical staff;
(B) Permitted by State law; and
(C) Limited, under paragraph (c)(1)(v) of this section, with respect
to chiropractors.
(5)(i) To identify potential organ donors as defined in 485.302 of
this chapter, the hospital has written protocols that --
(A) Assure that the family of each potential organ donor knows of its
option either to donate organs or tissues or to decline to donate;
(B) Encourage discretion and sensitivity with respect to the
circumstances, views and beliefs of the families of potential donors;
and
(C) Require that an organ procurement organization designated by the
Secretary under 485.308 of this chapter be notified of potential organ
donors.
(ii) In the case of a hospital in which organ transplants are
performed, the hospital must be a member of the Organ Procurement and
Transplantation Network established under section 372 of the Public
Health Service Act and abide by its rules and requirements.
(iii) For purposes of this subparagraph, the term ''organ'' means a
human kidney, liver, heart, lung, or pancreas.
(d) Standard: Institutional plan and budget. The institution must
have an overall institutional plan that meets the following conditions:
(1) The plan must include an annual operating budget that is prepared
according to generally accepted accounting principles.
(2) The budget must include all anticipated income and expenses.
This provision does not require that the budget identify item by item
the components of each anticipated income or expense.
(3) The plan must provide for capital expenditures for at least a
3-year period, including the year in which the operating budget
specified in paragraph (d)(2) of this section is applicable.
(4) The plan must include and identify in detail the objective of,
and the anticipated sources of financing for, each anticipated capital
expenditure in excess of $600,000 (or a lesser amount that is
established, in accordance with section 1122(g)(1) of the Act, by the
State in which the hospital is located) that relates to any of the
following:
(i) Acquisition of land;
(ii) Improvement of land, buildings, and equipment; or
(iii) The replacement, modernization, and expansion of buildings and
equipment.
(5) The plan must be submitted for review to the planning agency
designated in accordance with section 1122(b) of the Act, or if an
agency is not designated, to the appropriate health planning agency in
the State. (See part 100 of this title.) A capital expenditure is not
subject to section 1122 review if 75 percent of the health care
facility's patients who are expected to use the service for which the
capital expenditure is made are individuals enrolled in a health
maintenance organization (HMO) or competitive medical plan (CMP) that
meets the requirements of section 1876(b) of the Act, and if the
Department determines that the capital expenditure is for services and
facilities that are needed by the HMO or CMP in order to operate
efficiently and economically and that are not otherwise readily
accessible to the HMO or CMP because --
(i) The facilities do not provide common services at the same site;
(ii) The facilities are not available under a contract of reasonable
duration;
(iii) Full and equal medical staff privileges in the facilities are
not available;
(iv) Arrangements with these facilities are not administratively
feasible; or
(v) The purchase of these services is more costly than if the HMO or
CMP provided the services directly.
(6) The plan must be reviewed and updated annually.
(7) The plan must be prepared --
(i) Under the direction of the governing body; and
(ii) By a committee consisting of representatives of the governing
body, the administrative staff, and the medical staff of the
institution.
(e) Standard: Contracted services. The governing body must be
responsible for services furnished in the hospital whether or not they
are furnished under contracts. The governing body must ensure that a
contractor of services (including one for shared services and joint
ventures) furnishes services that permit the hospital to comply with all
applicable conditions of participation and standards for the contracted
services.
(1) The governing body must ensure that the services performed under
a contract are provided in a safe and effective manner.
(2) The hospital must maintain a list of all contracted services,
including the scope and nature of the services provided.
(f) Standard: Emergency services. (1) If emergency services are
provided at the hospital, the hospital must comply with the requirements
of 482.55.
(2) If emergency services are not provided at the hospital, the
governing body must assure that the medical staff has written policies
and procedures for appraisal of emergencies, initial treatment, and
referral when appropriate.
(51 FR 22042, June 17, 1986; 51 FR 27847, Aug. 4, 1986, as amended
at 53 FR 6549, Mar. 1, 1988; 53 FR 18987, May 26, 1988; 56 FR 8852,
Mar. 1, 1991; 56 FR 23022, May 20, 1991)
42 CFR 482.12 Subpart C -- Basic Hospital Functions
42 CFR 482.21 Condition of participation: Quality assurance.
The governing body must ensure that there is an effective,
hospital-wide quality assurance program to evaluate the provision of
patient care.
(a) Standard: Clinical plan. The organized, hospital-wide quality
assurance program must be ongoing and have a written plan of
implementation.
(1) All organized services related to patient care, including
services furnished by a contractor, must be evaluated.
(2) Nosocomial infections and medication therapy must be evaluated.
(3) All medical and surgical services performed in the hospital must
be evaluated as they relate to appropriateness of diagnosis and
treatment.
(b) Standard: Medically-related patient care services. The hospital
must have an ongoing plan, consistent with available community and
hospital resources, to provide or make available social work,
psychological, and educational services to meet the medically-related
needs of its patients. The hospital also must have an effective,
ongoing discharge planning program that facilitates the provision of
followup care.
(1) Discharge planning must be initiated in a timely manner.
(2) Patients, along with necessary medical information, must be
transferred or referred to appropriate facilities, agencies, or
outpatient services, as needed, for followup or ancillary care.
(c) Standard: Implementation. The hospital must take and document
appropriate remedial action to address deficiencies found through the
quality assurance program. The hospital must document the outcome of
the remedial action.
42 CFR 482.22 Condition of participation: Medical staff.
The hospital must have an organized medical staff that operates under
bylaws approved by the governing body and is responsible for the quality
of medical care provided to patients by the hospital.
(a) Standard: Composition of the medical staff. The medical staff
must be composed of doctors of medicine or osteopathy and, in accordance
with State law, may also be composed of other practitioners appointed by
the governing body.
(1) The medical staff must periodically conduct appraisals of its
members.
(2) The medical staff must examine credentials of candidates for
medical staff membership and make recommendations to the governing body
on the appointment of the candidates.
(b) Standard: Medical staff organization and accountability. The
medical staff must be well organized and accountable to the governing
body for the quality of the medical care provided to patients.
(1) The medical staff must be organized in a manner approved by the
governing body.
(2) If the medical staff has an executive committee, a majority of
the members of the committee must be doctors of medicine or osteopathy.
(3) The responsibility for organization and conduct of the medical
staff must be assigned only to an individual doctor of medicine or
osteopathy.
(c) Standard: Medical staff bylaws. The medical staff must adopt
and enforce bylaws to carry out its responsibilities. The bylaws must:
(1) Be approved by the governing body.
(2) Include a statement of the duties and privileges of each category
of medical staff (e.g., active, courtesy, etc.)
(3) Describe the organization of the medical staff.
(4) Describe the qualifications to be met by a candidate in order for
the medical staff to recommend that the candidate be appointed by the
governing body.
(5) Include a requirement that a physical examination and medical
history be done no more than 7 days before or 48 hours after an
admission for each patient by a doctor of medicine or osteopathy, or,
for patients admitted only for oromaxillofacial surgery, by an
oromaxillofacial surgeon who has been granted such privileges by the
medical staff in accordance with State law.
(6) Include criteria for determining the privileges to be granted to
individual practitioners and a procedure for applying the criteria to
individuals requesting privileges.
(d) Standard: Autopsies. The medical staff should attempt to secure
autopsies in all cases of unusual deaths and of medical-legal and
educational interest. The mechanism for documenting permission to
perform an autopsy must be defined. There must be a system for
notifying the medical staff, and specifically the attending
practitioner, when an autopsy is being performed.
42 CFR 482.23 Condition of participation: Nursing services.
The hospital must have an organized nursing service that provides
24-hour nursing services. The nursing services must be furnished or
supervised by a registered nurse.
(a) Standard: Organization. The hospital must have a well-organized
service with a plan of administrative authority and delineation of
responsibilities for patient care. The director of the nursing service
must be a licensed registered nurse. He or she is responsible for the
operation of the service, including determining the types and numbers of
nursing personnel and staff necessary to provide nursing care for all
areas of the hospital.
(b) Standard: Staffing and delivery of care. The nursing service
must have adequate numbers of licensed registered nurses, licensed
practical (vocational) nurses, and other personnel to provide nursing
care to all patients as needed. There must be supervisory and staff
personnel for each department or nursing unit to ensure, when needed,
the immediate availability of a registered nurse for bedside care of any
patient.
(1) The hospital must provide 24-hour nursing services furnished or
supervised by a registered nurse, and have a licensed practical nurse or
registered nurse on duty at all times, except for rural hospitals that
have in effect a 24-hour nursing waiver granted under 405.1910(c) of
this chapter.
(2) The nursing service must have a procedure to ensure that hospital
nursing personnel for whom licensure is required have valid and current
licensure.
(3) A registered nurse must supervise and evaluate the nursing care
for each patient.
(4) The hospital must ensure that the nursing staff develops, and
keeps current, a nursing care plan for each patient.
(5) A registered nurse must assign the nursing care of each patient
to other nursing personnel in accordance with the patient's needs and
the specialized qualifications and competence of the nursing staff
available.
(6) Non-employee licensed nurses who are working in the hospital must
adhere to the policies and procedures of the hospital. The director of
nursing service must provide for the adequate supervision and evaluation
of the clinical activities of non-employee nursing personnel which occur
within the responsibility of the nursing service.
(c) Standard: Preparation and administration of drugs. Drugs and
biologicals must be prepared and administered in accordance with Federal
and State laws, the orders of the practitioner or practitioners
responsible for the patient's care as specified under 482.12(c), and
accepted standards of practice.
(1) All drugs and biologicals must be administered by, or under
supervision of, nursing or other personnel in accordance with Federal
and State laws and regulations, including applicable licensing
requirements, and in accordance with the approved medical staff policies
and procedures.
(2) All orders for drugs and biologicals must be in writing and
signed by the practitioner or practitioners responsible for the care of
the patient as specified under 482.12(c). When telephone or oral orders
must be used, they must be --
(i) Accepted only by personnel that are authorized to do so by the
medical staff policies and procedures, consistent with Federal and State
law;
(ii) Signed or initialed by the prescribing practitioner as soon as
possible; and
(iii) Used infrequently.
(3) Blood transfusions and intravenous medications must be
administered in accordance with State law and approved medical staff
policies and procedures. If blood transfusions and intravenous
medications are administered by personnel other than doctors of medicine
or osteopathy, the personnel must have special training for this duty.
(4) There must be a hospital procedure for reporting transfusion
reactions, adverse drug reactions, and errors in administration of
drugs.
42 CFR 482.24 Condition of participation: Medical record services.
The hospital must have a medical record service that has
administrative responsibility for medical records. A medical record
must be maintained for every individual evaluated or treated in the
hospital.
(a) Standard: Organization and staffing. The organization of the
medical record service must be appropriate to the scope and complexity
of the services performed. The hospital must employ adequate personnel
to ensure prompt completion, filing, and retrieval of records.
(b) Standard: Form and retention of record. The hospital must
maintain a medical record for each inpatient and outpatient. Medical
records must be accurately written, promptly completed, properly filed
and retained, and accessible. The hospital must use a system of author
identification and record maintenance that ensures the integrity of the
authentification and protects the security of all record entries.
(1) Medical records must be retained in their original or legally
reproduced form for a period of at least 5 years.
(2) The hospital must have a system of coding and indexing medical
records. The system must allow for timely retrieval by diagnosis and
procedure, in order to support medical care evaluation studies.
(3) The hospital must have a procedure for ensuring the
confidentiality of patient records. In-formation from or copies of
records may be released only to authorized individuals, and the hospital
must ensure that unauthorized individuals cannot gain access to or alter
patient records. Original medical records must be released by the
hospital only in accordance with Federal or State laws, court orders, or
subpoenas.
(c) Standard: Content of record. The medical record must contain
information to justify admission and continued hospitalization, support
the diagnosis, and describe the patient's progress and response to
medications and services.
(1) All entries must be legible and complete, and must be
authenticated and dated promptly by the person (identified by name and
discipline) who is responsible for ordering, providing, or evaluating
the service furnished.
(i) The author of each entry must be identifed and must authenticate
his or her entry.
(ii) Authentication may include signatures, written initials or
computer entry.
(2) All records must document the following, as appropriate:
(i) Evidence of a physical examination, including a health history,
performed no more than 7 days prior to admission or within 48 hours
after admission.
(ii) Admitting diagnosis.
(iii) Results of all consultative evaluations of the patient and
appropriate findings by clinical and other staff involved in the care of
the patient.
(iv) Documentation of complications, hospital acquired infections,
and unfavorable reactions to drugs and anesthesia.
(v) Properly executed informed consent forms for procedures and
treatments specified by the medical staff, or by Federal or State law if
applicable, to require written patient consent.
(vi) All practitioners' orders, nursing notes, reports of treatment,
medication records, radiology, and laboratory reports, and vital signs
and other information necessary to monitor the patient's condition.
(vii) Discharge summary with outcome of hospitalization, disposition
of case, and provisions for follow-up care.
(viii) Final diagnosis with completion of medical records within 30
days following discharge.
42 CFR 482.25 Condition of participation: Pharmaceutical services.
The hospital must have pharmaceutical services that meet the needs of
the patients. The institution must have a pharmacy directed by a
registered pharmacist or a drug storage area under competent
supervision. The medical staff is responsible for developing policies
and procedures that minimize drug errors. This function may be
delegated to the hospital's organized pharmaceutical service.
(a) Standard: Pharmacy management and administration. The pharmacy
or drug storage area must be administered in accordance with accepted
professional principles.
(1) A full-time, part-time, or consulting pharmacist must be
responsible for developing, supervising, and coordinating all the
activities of the pharmacy services.
(2) The pharmaceutical service must have an adequate number of
personnel to ensure quality pharmaceutical services, including emergency
services.
(3) Current and accurate records must be kept of the receipt and
disposition of all scheduled drugs.
(b) Standard: Delivery of services. In order to provide patient
safety, drugs and biologicals must be controlled and distributed in
accordance with applicable standards of practice, consistent with
Federal and State law.
(1) All compounding, packaging, and dispensing of drugs and
biologicals must be under the supervision of a pharmacist and performed
consistent with State and Federal laws.
(2) Drugs and biologicals must be kept in a locked storage area.
(3) Outdated, mislabeled, or otherwise unusable drugs and biologicals
must not be available for patient use.
(4) When a pharmacist is not available, drugs and biologicals must be
removed from the pharmacy or storage area only by personnel designated
in the policies of the medical staff and pharmaceutical service, in
accordance with Federal and State law.
(5) Drugs and biologicals not specifically prescribed as to time or
number of doses must automatically be stopped after a reasonable time
that is predetermined by the medical staff.
(6) Drug administration errors, adverse drug reactions, and
incompatibilities must be immediately reported to the attending
physician and, if appropriate, to the hospital-wide quality assurance
program.
(7) Abuses and losses of controlled substances must be reported, in
accordance with applicable Federal and State laws, to the individual
responsible for the pharmaceutical service, and to the chief executive
officer, as appropriate.
(8) Information relating to drug interactions and information of drug
therapy, side effects, toxicology, dosage, indications for use, and
routes of administration must be available to the professional staff.
(9) A formulary system must be established by the medical staff to
assure quality pharmaceuticals at reasonable costs.
(51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986)
42 CFR 482.26 Condition of participation: Radiologic services.
The hospital must maintain, or have available, diagnostic radiologic
services. If therapeutic services are also provided, they, as well as
the diagnostic services, must meet professionally approved standards for
safety and personnel qualifications.
(a) Standard: Radiologic services. The hospital must maintain, or
have available, radiologic services according to needs of the patients.
(b) Standard: Safety for patients and personnel. The radiologic
services, particularly ionizing radiology procedures, must be free from
hazards for patients and personnel.
(1) Proper safety precutions must be maintained against radiation
hazards. This includes adequate shielding for patients, personnel, and
facilities, as well as appropriate storage, use, and disposal of
radioactive materials.
(2) Periodic inspection of equipment must be made and hazards
identified must be promptly corrected.
(3) Radiation workers must be checked periodically, by the use of
exposure meters or badge tests, for amount of radiation exposure.
(4) Radiologic services must be provided only on the order of
practitioners with clinical privileges or, consistent with State law, of
other practitioners authorized by the medical staff and the governing
body to order the services.
(c) Standard: Personnel. (1) A qualified full-time, part-time, or
consulting radiologist must supervise the ionizing radiology services
and must interpret only those radiologic tests that are determined by
the medical staff to require a radiologist's specialized knowledge. For
purposes of this section, a radiologist is a doctor of medicine or
osteopathy who is qualified by education and experience in radiology.
(2) Only personnel designated as qualified by the medical staff may
use the radiologic equipment and administer procedures.
(d) Standard: Records. Records of radiologic services must be
maintained.
(1) The radiologist or other practitioner who performs radiology
services must sign reports of his or her interpretations.
(2) The hospital must maintain the following for at least 5 years:
(i) Copies of reports and printouts.
(ii) Films, scans, and other image records, as appropriate.
(51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986)
42 CFR 482.27 Condition of participation: Laboratory services.
(a) The hospital must maintain, or have available, adequate
laboratory services to meet the needs of its patients. The hospital
must ensure that all laboratory services provided to its patients are
performed in a facility certified in accordance with part 493 of this
chapter.
(b) Standard: Adequacy of laboratory services. The hospital must
have laboratory services available, either directly or through a
contractual agreement with a certified laboratory that meets
requirements of part 493 of this chapter.
(1) Emergency laboratory services must be available 24 hours a day.
(2) A written description of services provided must be available to
the medical staff.
(3) The laboratory must make provision for proper receipt and
reporting of tissue specimens.
(4) The medical staff and a pathologist must determine which tissue
specimens require a macroscopic (gross) examination and which require
both macroscopic and microscopic examinations.
(57 FR 7136, Feb. 28, 1992)
42 CFR 482.28 Condition of participation: Food and dietetic services.
The hospital must have organized dietary services that are directed
and staffed by adequate qualified personnel. However, a hospital that
has a contract with an outside food management company may be found to
meet this Condition of participation if the company has a dietitian who
serves the hospital on a full-time, part-time, or consultant basis, and
if the company maintains at least the minimum standards specified in
this section and provides for constant liaison with the hospital medical
staff for recommendations on dietetic policies affecting patient
treatment.
(a) Standard: Organization. (1) The hospital must have a full-time
employee who --
(i) Serves as director of the food and dietetic service;
(ii) Is responsible for the daily management of the dietary services;
and
(iii) Is qualified by experience or training.
(2) There must be a qualified dietitian, full-time, part-time, or on
a consultant basis.
(3) There must be administrative and technical personnel competent in
their respective duties.
(b) Standard: Diets. Menus must meet the needs of the patients.
(1) Therapeutic diets must be prescribed by the practitioner or
practitioners responsible for the care of the patients.
(2) Nutritional needs must be met in accordance with recognized
dietary practices and in accordance with orders of the practitioner or
practitioners responsible for the care of the patients.
(3) A current therapeutic diet manual approved by the dietitian and
medical staff must be readily available to all medical, nursing, and
food service personnel.
42 CFR 482.30 Condition of participation: Utilization review.
The hospital must have in effect a utilization review (UR) plan that
provides for review of services furnished by the institution and by
members of the medical staff to patients entitled to benefits under the
Medicare and Medicaid programs.
(a) Applicability. The provisions of this section apply except in
either of the following circumstances:
(1) A Utilization and Quality Control Peer Review Organization (PRO)
has assumed binding review for the hospital.
(2) HCFA has determined that the UR procedures established by the
State under title XIX of the Act are superior to the procedures required
in this section, and has required hospitals in that State to meet the UR
plan requirements under 456.50 through 456.245 of this chapter.
(b) Standard: Composition of utilization review committee. A UR
committee consisting of two or more practitioners must carry out the UR
function. At least two of the members of the committee must be doctors
of medicine or osteopathy. The other members may be any of the other
types of practitioners specified in 482.12(c)(1).
(1) Except as specified in paragraphs (b) (2) and (3) of this
section, the UR committee must be one of the following:
(i) A staff committee of the institution;
(ii) A group outside the institution --
(A) Established by the local medical society and some or all of the
hospitals in the locality; or
(B) Established in a manner approved by HCFA.
(2) If, because of the small size of the institution, it is
impracticable to have a properly functioning staff committee, the UR
committee must be established as specified in paragraph (b)(1)(ii) of
this section.
(3) The committee's or group's reviews may not be conducted by any
individual who --
(i) Has a direct financial interest (for example, an ownership
interest) in that hospital; or
(ii) Was professionally involved in the care of the patient whose
case is being reviewed.
(c) Standard: Scope and frequency of review. (1) The UR plan must
provide for review for Medicare and Medicaid patients with respect to
the medical necessity of --
(i) Admissions to the institution;
(ii) The duration of stays; and
(iii) Professional services furnished, including drugs and
biologicals.
(2) Review of admissions may be performed before, at, or after
hospital admission.
(3) Except as specified in paragraph (e) of this section, reviews may
be conducted on a sample basis.
(4) Hospitals that are paid for inpatient hospital services under the
prospective payment system set forth in Part 412 of this chapter must
conduct review of duration of stays and review of professional services
as follows:
(i) For duration of stays, these hospitals need review only cases
that they reasonably assume to be outlier cases based on extended length
of stay, as described in 412.80(a)(1)(i) of this chapter; and
(ii) For professional services, these hospitals need review only
cases that they reasonably assume to be outlier cases based on
extraordinarily high costs, as described in 412.80(a)(1)(ii) of this
chapter.
(d) Standard: Determination regarding admissions or continued stays.
(1) The determination that an admission or continued stay is not
medically necessary --
(i) May be made by one member of the UR committee if the practitioner
or practitioners responsible for the care of the patient, as specified
of 482.12(c), concur with the determination or fail to present their
views when afforded the opportunity; and
(ii) Must be made by at least two members of the UR committee in all
other cases.
(2) Before making a determination that an admission or continued stay
is not medically necessary, the UR committee must consult the
practitioner or practitioners responsible for the care of the patient,
as specified in 482.12(c), and afford the practitioner or practitioners
the opportunity to present their views.
(3) If the committee decides that admission to or continued stay in
the hospital is not medically necessary, written notification must be
given, no later than 2 days after the determination, to the hospital,
the patient, and the practitioner or practitioners responsible for the
care of the patient, as specified in 482.12(c);
(e) Standard: Extended stay review. (1) In hospitals that are not
paid under the prospective payment system, the UR committee must make a
periodic review, as specified in the UR plan, of each current inpatient
receiving hospital services during a continuous period of extended
duration. The scheduling of the periodic reviews may --
(i) Be the same for all cases; or
(ii) Differ for different classes of cases.
(2) In hospitals paid under the prospective payment system, the UR
committee must review all cases reasonably assumed by the hospital to be
outlier cases because the extended length of stay exceeds the threshold
criteria for the diagnosis, as described in 412.80(a)(1)(i). The
hospital is not required to review an extended stay that does not exceed
the outlier threshold for the diagnosis.
(3) The UR committee must make the periodic review no later than 7
days after the day required in the UR plan.
(f) Standard: Review of professional services. The committee must
review professional services provided, to determine medical necessity
and to promote the most efficient use of available health facilities and
services.
42 CFR 482.41 Condition of participation: Physical environment.
The hospital must be constructed, arranged, and maintained to ensure
the safety of the patient, and to provide facilities for diagnosis and
treatment and for special hospital services appropriate to the needs of
the community.
(a) Standard: Buildings. The condition of the physical plant and the
overall hospital environment must be developed and maintained in such a
manner that the safety and well-being of patients are assured.
(1) There must be emergency power and lighting in at least the
operating, recovery, intensive care, and emergency rooms, and
stairwells. In all other areas not serviced by the emergency supply
source, battery lamps and flashlights must be available.
(2) There must be facilities for emergency gas and water supply.
(b) Standard: Life safety from fire. (1) Except as provided in
paragraphs (b)(1)(i) through (b)(1)(iii) of this section, the hospital
must meet the applicable provisions of the 1985 edition of the Life
Safety Code of the National Fire Protection Association (which is
incorporated by reference). /1/
(i) Any hospital that on November 26, 1982, complied, with or without
waivers, with the requirements of the 1967 edition of the Life Safety
Code, or on May 9, 1988, complied with the 1981 edition of the Life
Safety Code, is considered to be in compliance with this standard as
long as the facility continues to remain in compliance with that edition
of the Code.
(ii) After consideration of State survey agency findings, HCFA may
waive specific provisions of the Life Safety Code which, if rigidly
applied, would result in unreasonable hardship upon the facility, but
only if the waiver does not adversely affect the health and safety of
patients.
(iii) The provisions of the Life Safety Code do not apply in a State
where HCFA finds that a fire and safety code imposed by State law
adequately protects patients in hospitals.
(2) The hospital must have procedures for the proper routine storage
and prompt disposal of trash.
(3) The hospital must have written fire control plans that contain
provisions for prompt reporting of fires; extinguishing fires;
protection of patients, personnel and guests; evacuation; and
cooperation with fire fighting authorities.
(4) The hospital must maintain written evidence of regular inspection
and approval by State or local fire control agencies.
(c) Standard: Facilities. The hospital must maintain adequate
facilities for its services.
(1) Diagnostic and therapeutic facilities must be located for the
safety of patients.
(2) Facilities, supplies, and equipment must be maintained to ensure
an acceptable level of safety and quality.
(3) The extent and complexity of facilities must be determined by the
services offered.
(4) There must be proper ventilation, light, and temperature controls
in pharmaceutical, food preparation, and other appropriate areas.
(51 FR 22042, June 17, 1986, as amended at 53 FR 11509, Apr. 7, 1988)
/1/ See footnote to 405.1134(a) of this chapter.
42 CFR 482.42 Condition of participation: Infection control.
The hospital must provide a sanitary environment to avoid sources and
transmission of infections and communicable diseases. There must be an
active program for the prevention, control, and investigation of
infections and communicable diseases.
(a) Standard: Organization and policies. A person or persons must
be designated as infection control officer or officers to develop and
implement policies governing control of infections and communicable
diseases.
(1) The infection control officer or officers must develop a system
for identifying, reporting, investigating, and controlling infections
and communicable diseases of patients and personnel.
(2) The infection control officer or officers must maintain a log of
incidents related to infections and communicable diseases.
(b) Standard: Responsibilities of chief executive officer, medical
staff, and director of nursing services. The chief executive officer,
the medical staff, and the director of nursing services must --
(1) Ensure that the hospital-wide quality assurance program and
training programs address problems identified by the infection control
officer or officers; and
(2) Be responsible for the implementation of successful corrective
action plans in affected problem areas.
42 CFR 482.42 Subpart D -- Optional Hospital Services
42 CFR 482.51 Condition of participation: Surgical services.
If the hospital provides surgical services, the services must be well
organized and provided in accordance with acceptable standards of
practice. If outpatient surgical services are offered the services must
be consistent in quality with inpatient care in accordance with the
complexity of services offered.
(a) Standard: Organization and staffing. The organization of the
surgical services must be appropriate to the scope of the services
offered.
(1) The operating rooms must be supervised by an experienced
registered nurse or a doctor of medicine or osteopathy.
(2) Licensed practical nurses (LPNs) and surgical technologists
(operating room technicians) may serve as ''scrub nurses'' under the
supervision of a registered nurse.
(3) Qualified registered nurses may perform circulating duties in the
operating room. In accordance with applicable State laws and approved
medical staff policies and procedures, LPNs and surgical technologists
may assist in circulatory duties under the surpervision of a qualified
registered nurse who is immediately available to respond to emergencies.
(4) Surgical privileges must be delineated for all practitioners
performing surgery in accordance with the competencies of each
practitioner. The surgical service must maintain a roster of
practitioners specifying the surgical privileges of each practitioner.
(b) Standard: Delivery of service. Surgical services must be
consistent with needs and resources. Policies governing surgical care
must be designed to assure the achievement and maintenance of high
standards of medical practice and patient care.
(1) There must be a complete history and physical work-up in the
chart of every patient prior to surgery, except in emergencies. If this
has been dictated, but not yet recorded in the patient's chart, there
must be a statement to that effect and an admission note in the chart by
the practitioner who admitted the patient.
(2) A properly executed informed consent form for the operation must
be in the patient's chart before surgery, except in emergencies.
(3) The following equipment must be available to the operating room
suites: call-in-system, cardiac monitor, resuscitator, defibrillator,
aspirator, and tracheotomy set.
(4) There must be adequate provisions for immediate post-operative
care.
(5) The operating room register must be complete and up-to-date.
(6) An operative report describing techniques, findings, and tissues
removed or altered must be written or dictated immediately following
surgery and signed by the surgeon.
42 CFR 482.52 Condition of participation; Anesthesia services.
If the hospital furnishes anesthesia services, they must be provided
in a well-organized manner under the direction of a qualified doctor of
medicine or osteopathy. The service is responsible for all anesthesia
administered in the hospital.
(a) Standard: Organization and staffing. The organization of
anesthesia services must be appropriate to the scope of the services
offered. Anesthesia must be administered by only --
(1) A qualified anesthesiologist:
(2) A doctor of medicine or osteopathy (other than an
anesthesiologist);
(3) A dentist, oral surgeon, or podiatrist who is qualified to
administer anesthesia under State law;
(4) A certified registered nurse anesthetist (CRNA), as defined in
410.69(b) of this chapter, who is under the supervision of the operating
practitioner or of an anesthesiologist who is immediately available if
needed; or
(5) An anesthesiologist's assistant, as defined in 410.69(b) of this
chapter, who is under the supervision of an anesthesiologist who is
immediately available if needed.
(b) Standard: Delivery of services. Anesthesia services must be
consistent with needs and resources. Policies on anesthesia procedures
must include the delineation of preanesthesia and post anesthesia
responsibilities. The policies must ensure that the following are
provided for each patient:
(1) A preanesthesia evaluation by an individual qualified to
administer anesthesia under paragraph (a) of this section performed
within 48 hours prior to surgery.
(2) An intraoperative anesthesia record.
(3) With respect to inpatients, a postanesthesia followup report by
the individual who administers the anesthesia that is written within 48
hours after surgery.
(4) With respect to outpatients, a postanesthesia evaluation for
proper anesthesia recovery performed in accordance with policies and
procedures approved by the medical staff.
(51 FR 22042, June 17, 1986 as amended at 57 FR 33900, July 31, 1992)
42 CFR 482.53 Condition of participation: Nuclear medicine services.
If the hospital provides nuclear medicine services, those services
must meet the needs of the patients in accordance with acceptable
standards of practice.
(a) Standard: Organization and staffing. The organization of the
nuclear medicine service must be appropriate to the scope and complexity
of the services offered.
(1) There must be a director who is a doctor of medicine or
osteopathy qualified in nuclear medicine.
(2) The qualifications, training, functions, and responsibilities of
nuclear medicine personnel must be specified by the service director and
approved by the medical staff.
(b) Standard: Delivery of service. Radioactive materials must be
prepared, labeled, used, transported, stored, and disposed of in
accordance with acceptable standards of practice.
(1) In-house preparation of radiopharmaceuticals is by, or under, the
direct supervision of an appropriately trained registered pharmacist or
a doctor of medicine or osteopathy.
(2) There is proper storage and disposal of radioactive material.
(3) If laboratory tests are performed in the nuclear medicine
service, the service must meet the applicable requirement for laboratory
services specified in 482.27.
(c) Standard: Facilities. Equipment and supplies must be appropriate
for the types of nuclear medicine services offered and must be
maintained for safe and efficient performance. The equipment must be --
(1) Maintained in safe operating condition; and
(2) Inspected, tested, and calibrated at least annually by qualified
personnel.
(d) Standard: Records. The hospital must maintain signed and dated
reports of nuclear medicine interpretations, consultations, and
procedures.
(1) The hospital must maintain copies of nuclear medicine reports for
at least 5 years.
(2) The practitioner approved by the medical staff to interpret
diagnostic procedures must sign and date the interpretation of these
tests.
(3) The hospital must maintain records of the receipt and disposition
of radiopharmaceuticals.
(4) Nuclear medicine services must be ordered only by practitioner
whose scope of Federal or State licensure and whose defined staff
privileges allow such referrals.
(51 FR 22042, June 17, 1986, as amended at 57 FR 7136, Feb. 28, 1992)
42 CFR 482.54 Condition of participation: Outpatient services.
If the hospital provides outpatient services, the services must meet
the needs of the patients in accordance with acceptable standards of
practice.
(a) Standard: Organization. Outpatient services must be
appropriately organized and integrated with inpatient services.
(b) Standard: Personnel. The hospitals must --
(1) Assign an individual to be responsible for outpatient services;
and
(2) Have appropriate professional and nonprofessional personnel
available.
42 CFR 482.55 Condition of participation: Emergency services.
The hospital must meet the emergency needs of patients in accordance
with acceptable standards of practice.
(a) Standard: Organization and direction. If emergency services are
provided at the hospital --
(1) The services must be organized under the direction of a qualified
member of the medical staff;
(2) The services must be integrated with other departments of the
hospital;
(3) The policies and procedures governing medical care provided in
the emergency service or department are established by and are a
continuing responsibility of the medical staff.
(b) Standard: Personnel. (1) The emergency services must be
supervised by a qualified member of the medical staff.
(2) There must be adequate medical and nursing personnel qualified in
emergency care to meet the written emergency procedures and needs
anticipated by the facility.
42 CFR 482.56 Condition of participation: Rehabilitation services.
If the hospital provides rehabilitation, physical therapy,
occupational therapy, audiology, or speech pathology services, the
services must be organized and staffed to ensure the health and safety
of patients.
(a) Standard: Organization and staffing. The organization of the
service must be appropriate to the scope of the services offered.
(1) The director of the services must have the necessary knowledge,
experience, and capabilities to properly supervise and administer the
services.
(2) Physical therapy, occupational therapy, or speech therapy, or
audiology services, if provided, must be provided by staff who meet the
qualifications specified by the medical staff, consistent with State
law.
(b) Standard: Delivery of services. Services must be furnished in
accordance with a written plan of treatment. Services must be given in
accordance with orders of practitioners who are authorized by the
medical staff to order the services, and the orders must be incorporated
in the patient's record.
42 CFR 482.57 Condition of participation: Respiratory care services.
The hospital must meet the needs of the patients in accordance with
acceptable standards of practice. The following requirements apply if
the hospital provides respiratory care service.
(a) Standard: Organization and Staffing. The organization of the
respiratory care services must be appropriate to the scope and
complexity of the services offered.
(1) There must be a director of respiratory care services who is a
doctor of medicine or osteopathy with the knowledge experience, and
capabilities to supervise and administer the service properly. The
director may serve on either a full-time or part-time basis.
(2) There must be adequate numbers of respiratory therapists,
respiratory therapy technicians, and other personnel who meet the
qualifications specified by the medical staff, consistent with State
law.
(b) Standard: Delivery of Services. Services must be delivered in
accordance with medical staff directives.
(1) Personnel qualified to perform specific procedures and the amount
of supervision required for personnel to carry out specific procedures
must be designated in writing.
(2) If blood gases or other laboratory tests are performed in the
respiratory care unit, the unit must meet the applicable requirements
for laboratory services specified in 482.27.
(3) Services must be provided only on, and in accordance with, the
orders of a doctor of medicine or osteopathy.
(51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986, as amended
at 57 FR 7136, Feb. 28, 1992)
42 CFR 482.57 Subpart E -- Requirements for Specialty Hospitals
42 CFR 482.60 Special provisions applying to psychiatric hospitals.
Psychiatric hospital must --
(a) Be primarily engaged in providing, by or under the supervision of
a doctor of medicine or osteopathy, psychiatric services for the
diagnosis and treatment of mentally ill persons;
(b) Meet the conditions of participation specified in 482.1 through
482.23 and 482.25 through 482.57;
(c) Maintain clinical records on all patients, including records
sufficient to permit HCFA to determine the degree and intensity of
treatment furnished to Medicare beneficiaries, as specified in 482.61;
and
(d) Meet the staffing requirements specified in 482.62.
(51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986)
42 CFR 482.61 Condition of participation: Special medical record
requirements for psychiatric hospitals.
The medical records maintained by a psychiatric hospital must permit
determination of the degree and intensity of the treatment provided to
individuals who are furnished services in the institution.
(a) Standard: Development of assessment/diagnostic data. Medical
records must stress the psychiatric components of the record, including
history of findings and treatment provided for the psychiatric condition
for which the patient is hospitalized.
(1) The identification data must include the patient's legal status.
(2) A provisional or admitting diagnosis must be made on every
patient at the time of admission, and must include the diagnoses of
intercurrent diseases as well as the psychiatric diagnoses.
(3) The reasons for admission must be clearly documented as stated by
the patient and/or others significantly involved.
(4) The social service records, including reports of interviews with
patients, family members, and others, must provide an assessment of home
plans and family attitudes, and community resource contacts as well as a
social history.
(5) When indicated, a complete neurological examination must be
recorded at the time of the admission physical examination.
(b) Standard: Psychiatric evaluation. Each patient must receive a
psychiatric evaluation that must --
(1) Be completed within 60 hours of admission;
(2) Include a medical history;
(3) Contain a record of mental status;
(4) Note the onset of illness and the circumstances leading to
admission;
(5) Describe attitudes and behavior;
(6) Estimate intellectual functioning, memory functioning, and
orientation; and
(7) Include an inventory of the patient's assets in descriptive, not
interpretative, fashion.
(c) Standard: Treatment plan. (1) Each patient must have an
individual comprehensive treatment plan that must be based on an
inventory of the patient's strengths and disabilities. The written plan
must include --
(i) A substantiated diagnosis;
(ii) Short-term and long-range goals;
(iii) The specific treatment modalities utilized;
(iv) The responsibilities of each member of the treatment team; and
(v) Adequate documentation to justify the diagnosis and the treatment
and rehabilitation activities carried out.
(2) The treatment received by the patient must be documented in such
a way to assure that all active therapeutic efforts are included.
(d) Standard: Recording progress. Progress notes must be recorded
by the doctor of medicine or osteopathy responsible for the care of the
patient as specified in 482.12(c), nurse, social worker and, when
appropriate, others significantly involved in active treatment
modalities. The frequency of progress notes is determined by the
condition of the patient but must be recorded at least weekly for the
first 2 months and at least once a month thereafter and must contain
recommendations for revisions in the treatment plan as indicated as well
as precise assessment of the patient's progress in accordance with the
original or revised treatment plan.
(e) Standard: Discharge planning and discharge summary. The record
of each patient who has been discharged must have a discharge summary
that includes a recapitulation of the patient's hospitalization and
recommendations from appropriate services concerning follow-up or
aftercare as well as a brief summary of the patient's condition on
discharge.
(51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986)
42 CFR 482.62 Condition of participation: Special staff requirements
for psychiatric hospitals.
The hospital must have adequate numbers of qualified professional and
supportive staff to evaluate patients, formulate written, individualized
comprehensive treatment plans, provide active treatment measures, and
engage in discharge planning.
(a) Standard: Personnel. The hospital must employ or undertake to
provide adequate numbers of qualified professional, technical, and
consultative personnel to:
(1) Evaluate patients;
(2) Formulate written individualized, comprehensive treatment plans;
(3) Provide active treatment measures; and
(4) Engage in discharge planning.
(b) Standard: Director of inpatient psychiatric services; medical
staff. Inpatient psychiatric services must be under the supervision of
a clinical director, service chief, or equivalent who is qualified to
provide the leadership required for an intensive treatment program. The
number and qualifications of doctors of medicine and osteopathy must be
adequate to provide essential psychiatric services.
(1) The clinical director, service chief, or equivalent must meet the
training and experience requirements for examination by the American
Board of Psychiatry and Neurology or the American Osteopathic Board of
Neurology and Psychiatry.
(2) The director must monitor and evaluate the quality and
appropriateness of services and treatment provided by the medical staff.
(c) Standard: Availability of medical personnel. Doctors of
medicine or osteopathy and other appropriate professional personnel must
be available to provide necessary medical and surgical diagnostic and
treatment services. If medical and surgical diagnostic and treatment
services are not available within the institution, the institution must
have an agreement with an outside source of these services to ensure
that they are immediately available or a satisfactory agreement must be
established for transferring patients to a general hospital that
participates in the Medicare program.
(d) Standard: Nursing services. The hospital must have a qualified
director of psychiatric nursing services. In addition to the director
of nursing, there must be adequate numbers of registered nurses,
licensed practical nurses, and mental health workers to provide nursing
care necessary under each patient's active treatment program and to
maintain progress notes on each patient.
(1) The director of psychiatric nursing services must be a registered
nurse who has a master's degree in psychiatric or mental health nursing,
or its equivalent from a school of nursing accredited by the National
League for Nursing, or be qualified by education and experience in the
care of the mentally ill. The director must demonstrate competence to
participate in interdisciplinary formulation of individual treatment
plans; to give skilled nursing care and therapy; and to direct,
monitor, and evaluate the nursing care furnished.
(2) The staffing pattern must insure the availability of a registered
professional nurse 24 hours each day. There must be adequate numbers of
registered nurses, licensed practical nurses, and mental health workers
to provide the nursing care necessary under each patient's active
treatment program.
(e) Standard: Psychological services. The hospital must provide or
have available psychological services to meet the needs of the patients.
(f) Standard: Social services. There must be a director of social
services who monitors and evaluates the quality and appropriateness of
social services furnished. The services must be furnished in accordance
with accepted standards of practice and established policies and
procedures.
(1) The director of the social work department or service must have a
master's degree from an accredited school of social work or must be
qualified by education and experience in the social services needs of
the mentally ill. If the director does not hold a masters degree in
social work, at least one staff member must have this qualification.
(2) Social service staff responsibilities must include, but are not
limited to, participating in discharge planning, arranging for follow-up
care, and developing mechanisms for exchange of appropriate, information
with sources outside the hospital.
(g) Standard: Therapeutic activities. The hospital must provide a
therapeutic activities program.
(1) The program must be appropriate to the needs and interests of
patients and be directed toward restoring and maintaining optimal levels
of physical and psychosocial functioning.
(2) The number of qualified therapists, support personnel, and
consultants must be adequate to provide comprehensive therapeutic
activities consistent with each patient's active treatment program.
(51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986)
42 CFR 482.66 Special requirements for hospital providers of long-term
care services (''swing-beds'').
A hospital that has a Medicare provider agreement must meet the
following requirements in order to be granted an approval from HCFA to
provide post-hospital extended care services, as specified in 409.30 of
this chapter, and be reimbursed as a swing-bed hospital, as specified in
413.114 of this chapter:
(a) Eligibility. A hospital must meet the following eligibility
requirements:
(1) The facility has fewer than 100 hospital beds, excluding beds for
newborns and beds in intensive care type inpatient units (for
eligibility of hospitals with distinct parts electing the optional
reimbursement method, see 413.24(d)(5) of this chapter).
(2) The hospital is located in a rural area. This includes all areas
not delineated as ''urbanized'' areas by the Census Bureau, based on the
most recent census.
(3) When required by State in which it is located, the hospital has
been granted a certificate of need for the provision of long-term care
services from the State health planning and development agency
(designated under section 1521 of the Public Health Service Act).
(4) The hospital does not have in effect a 24-hour nursing waiver
granted under 488.54(c) of this chapter.
(5) The hospital has not had a swing-bed approval terminated within
the two years previous to application.
(6) A hospital with more than 49 beds (but fewer than 100) approved
under this section after March 31, 1988, must --
(i) Unless a Medicare-participating SNF is not available or the SNFs
are not willing to enter into an agreement when one is offered, have an
availability agreement with each SNF in its geographic region that
requires the SNF to notify the hospital of the availability of
posthospital SNF care beds and the dates when those beds will be
available; and
(ii) Transfer the extended care patient within 5 days (excluding
weekends and holidays) after learning that a SNF bed is available or in
the case of prospective notification by the SNF, within 5 days of the
date the bed becomes available, unless the patient's physician
certifies, as required under 424.20, that the transfer is not medically
appropriate.
(7) The hospital must provide written assurance to HCFA that the
hospital will not operate over 49 or over 99 beds except in connection
with a catastrophic event. The hospital bed count is determined as
follows:
(i) A hospital bed count is calculated by excluding from the count,
beds that because of their special nature, such as newborn and intensive
care beds, would not be available for swing-bed use. Also excluded from
the bed count are beds in separately certified ''distinct part'' SNFs
and NFs and beds in a distinct part psychiatric or rehabilitation unit
that is excluded from the prospective payment system.
(ii) A hospital licensed for more than 49 or 99 beds, is considered
to have the number of beds that it consistently utilizes and staffs.
Hospitals, at a minimum, document their count by staffing schedules and
census information for the previous 12 months before application to be a
swing-bed hospital.
(b) Skilled nursing facility services. The facility is substantially
in compliance with the following skilled nursing facility requirements
contained in subpart B of part 483 of this chapter.
(1) Resident rights ( 483.10 (b)(3), (b)(4), (b)(5), (b)(6), (d),
(e), (h), (i), (j)(1)(vii), (j)(1)(viii), (l), and (m)).
(2) Admission, transfer, and discharge rights ( 483.12 (a)(1),
(a)(2), (a)(3), (a)(4), (a)(5), (a)(6), and (a)(7)).
(3) Resident behavior and facility practices ( 483.13).
(4) Patient activities ( 483.15(f)).
(5) Social services ( 483.15(g)).
(6) Discharge planning ( 483.20(e)).
(7) Specialized rehabilitative services ( 483.45).
(8) Dental services ( 483.55).
(51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986, as amended
at 51 FR 34833, Sept. 30, 1986; 54 FR 37275, Sept. 7, 1989; 56 FR
54546, Oct. 22, 1991)
42 CFR 482.66 PART 483 -- REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES
42 CFR 482.66 Subpart A -- (Reserved)
42 CFR 482.66 Subpart B -- Requirements for Long Term Care Facilities
Sec.
483.1 Basis and scope.
483.5 Definitions.
483.10 Resident rights.
483.12 Admission, transfer and discharge rights.
483.13 Resident behavior and facility practices.
483.15 Quality of life.
483.20 Resident assessment.
483.25 Quality of care.
483.30 Nursing services.
483.35 Dietary services.
483.40 Physician services.
483.45 Specialized rehabilitative services.
483.55 Dental services.
483.60 Pharmacy services.
483.65 Infection control.
483.70 Physical environment.
483.75 Level A requirement: Administration.
42 CFR 482.66 Subpart C -- (Reserved)
42 CFR 482.66 Subpart D -- Requirements That Must Be Met by States and
State Agencies: Nurse Aide Training and Competency Evaluation
483.150 Deemed meeting of requirements, waiver of requirements.
483.151 State review and approval of nurse aide training and
competency evaluation programs and competency evaluation programs.
483.152 Requirements for approval of a nurse aide training and
competency evaluation program.
483.154 Nurse aide competency evaluation.
483.156 Registry of nurse aides.
483.158 FFP for nurse aide training and competency evaluation.
42 CFR 482.66 Subparts E-H -- (Reserved)
42 CFR 482.66 Subpart I -- Conditions of Participation for Intermediate
Care Facilities for the Mentally Retarded
Sec.
483.400 Basis and purpose.
483.405 Relationship to other HHS regulations.
483.410 Condition of participation: Governing body and management.
483.420 Condition of participation: Client protections.
483.430 Condition of participation: Facility staffing.
483.440 Condition of participation: Active treatment services.
483.450 Condition of participation: Client behavior and facility
practices.
483.460 Condition of participation: Health care services.
483.470 Condition of participation: Physical environment.
483.480 Condition of participation: Dietetic services.
Authority: Sec. 1102, 1819(a)-(f), 1861(j) and (1), 1863, 1871,
1902(a)(28), 1905(a), (c) and (d), and 1919(a)-(f) of the Social
Security Act (42 U.S.C. 1302, 1395(i)(3)(a)-(f), 1395x (j) and (l)
1395hh, 1395z, 1396(a)(a)(28), and 1396d (c) and (d), and 1396r(a)-(f),
unless otherwise noted.
42 CFR 482.66 Subpart A -- (Reserved)
42 CFR 482.66 Subpart B -- Requirements for Long Term Care Facilities
Source: 54 FR 5359, Feb. 2, 1989, unless otherwise noted
42 CFR 483.1 Basis and scope.
(a) Basis in legislation. (1) Sections 1819 (a), (b), (c), and (d)
of the Act provide that --
(i) Skilled nursing facilities participating in Medicare must meet
certain specified requirements; and
(ii) The Secretary may impose additional requirements (see section
1819(d)(4)(B)) if they are necessary for the health and safety of
individuals to whom services are furnished in the facilities.
(2) Sections 1919 (a), (b), (c), and (d) of the Act provide that
nursing facilities participating in Medicaid must meet certain specific
requirements.
(b) Scope. The provisions of this part contain the requirements that
an institution must meet in order to qualify to participate as a SNF in
the Medicare program, and as a nursing facility in the Medicaid program.
They serve as the basis for survey activities for the purpose of
determining whether a facility meets the requirements for participation
in Medicare and Medicaid.
(56 FR 48867, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23,
1992)
42 CFR 483.5 Definitions.
For purposes of this subpart --
Facility means, a skilled nursing facility (SNF) or a nursing
facility (NF) which meets the requirements of sections 1819 or 1919 (a),
(b), (c), and (d) of the Act. ''Facility'' may include a distinct part
of an institution specified in 440.40 of this chapter, but does not
include an institution for the mentally retarded or persons with related
conditions described in 440.150 of this chapter. For Medicare and
Medicaid purposes (including eligibility, coverage, certification, and
payment), the ''facility'' is always the entity which participates in
the program, whether that entity is comprised of all of, or a distinct
part of a larger institution. For Medicare, a SNF (see section
1819(a)(1)), and for Medicaid, a NF (see section 1919(a)(1)) may not be
an institution for mental diseases as defined in 435.1009.
(56 FR 48867, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23,
1992)
42 CFR 483.10 Resident rights.
The resident has a right to a dignified existence,
self-determination, and communication with and access to persons and
services inside and outside the facility. A facility must protect and
promote the rights of each resident, including each of the following
rights:
(a) Exercise of rights.
(1) The resident has the right to exercise his or her rights as a
resident of the facility and as a citizen or resident of the United
States.
(2) The resident has the right to be free of interference, coercion,
discrimination, and reprisal from the facility in exercising his or her
rights.
(3) In the case of a resident adjudged incompetent under the laws of
a State by a court of competent jurisdiction, the rights of the resident
are exercised by the person appointed under State law to act on the
resident's behalf.
(4) In the case of a resident who has not been adjudged incompetent
by the State court, any legal-surrogate designated in accordance with
State law may exercise the resident's rights to the extent provided by
State law.
(b) Notice of rights and services.
(1) The facility must inform the resident both orally and in writing
in a language that the resident understands of his or her rights and all
rules and regulations governing resident conduct and responsibilities
during the stay in the facility. The facility must also provide the
resident with the notice (if any) of the State developed under section
1919(e)(6) of the Act. Such notification must be made prior to or upon
admission and during the resident's stay. Receipt of such information,
and any amendments to it, must be acknowledged in writing;
(2) The resident or his or her legal representative has the right --
(i) Upon an oral or written request, to access all records pertaining
to himself or herself including current clinical records within 24 hours
(excluding weekends and holidays); and
(ii) After receipt of his or her records for inspection, to purchase
at a cost not to exceed the community standard photocopies of the
records or any portions of them upon request and 2 working days advance
notice to the facility.
(3) The resident has the right to be fully informed in language that
he or she can understand of his or her total health status, including
but not limited to, his or her medical condition;
(4) The resident has the right to refuse treatment, to refuse to
participate in experimental research, and to formulate an advance
directive as specified in paragraph (8) of this section; and
(5) The facility must --
(i) Inform each resident who is entitled to Medicaid benefits, in
writing, at the time of admission to the nursing facility or, when the
resident becomes eligible for Medicaid of --
(A) The items and services that are included in nursing facility
services under the State plan and for which the resident may not be
charged;
(B) Those other items and services that the facility offers and for
which the resident may be charged, and the amount of charges for those
services; and
(ii) Inform each resident when changes are made to the items and
services specified in paragraphs (5)(i) (A) and (B) of this section.
(6) The facility must inform each resident before, or at the time of
admission, and periodically during the resident's stay, of services
available in the facility and of charges for those services, including
any charges for services not covered under Medicare or by the facility's
per diem rate.
(7) The facility must furnish a written description of legal rights
which includes --
(i) A description of the manner of protecting personal funds, under
paragraph (c) of this section;
(ii) A description of the requirements and procedures for
establishing eligibility for Medicaid, including the right to request an
assessment under section 1924(c) which determines the extent of a
couple's non-exempt resources at the time of institutionalization and
attributes to the community spouse an equitable share of resources which
cannot be considered available for payment toward the cost of the
institutionalized spouse's medical care in his or her process of
spending down to Medicaid eligibility levels;
(iii) A posting of names, addresses, and telephone numbers of all
pertinent State client advocacy groups such as the State survey and
certification agency, the State licensure office, the State ombudsman
program, the protection and advocacy network, and the Medicaid fraud
control unit; and
(iv) A statement that the resident may file a complaint with the
State survey and certification agency concerning resident abuse,
neglect, and misappropriation of resident property in the facility.
(8) The facility must comply with the requirements specified in
subpart I of part 489 of this chapter relating to maintaining written
policies and procedures regarding advance directives. These
requirements include provisions to inform and provide written
information to all adult residents concerning the right to accept or
refuse medical or surgical treatment and, at the individual's option,
formulate an advance directive. This includes a written description of
the facility's policies to implement advance directives and applicable
State law.
(9) The facility must inform each resident of the name, specialty,
and way of contacting the physician responsible for his or her care.
(10) The facility must prominently display in the facility written
information, and provide to residents and applicants for admission oral
and written information about how to apply for and use Medicare and
Medicaid benefits, and how to receive refunds for previous payments
covered by such benefits.
(11) Notification of changes. (i) A facility must immediately inform
the resident; consult with the resident's physician; and if known,
notify the resident's legal respresentative or an interested family
member when there is --
(A) An accident involving the resident which results in injury and
has the potential for requiring physician intervention;
(B) A significant change in the resident's physical, mental, or
psychosocial status (i.e., a deterioration in health, mental, or
psychosocial status in either life-threatening conditions or clinical
complications);
(C) A need to alter treatment significantly (i.e., a need to
discontinue an existing form of treatment due to adverse consequences,
or to commence a new form of treatment); or
(D) A decision to transfer or discharge the resident from the
facility as specified in 483.12(a).
(ii) The facility must also promptly notify the resident and, if
known, the resident's legal representative or interested family member
when there is --
(A) A change in room or roommate assignment as specified in
483.15(e)(2); or
(B) A change in resident rights under Federal or State law or
regulations as specified in paragraph (b)(1) of this section.
(iii) The facility must record and periodically update the address
and phone number of the resident's legal representative or interested
family member.
(c) Protection of Resident Funds. (1) The resident has the right to
manage his or her financial affairs, and the facility may not require
residents to deposit their personal funds with the facility.
(2) Management of personal funds. Upon written authorization of a
resident, the facility must hold, safeguard, manage, and account for the
personal funds of the resident deposited with the facility, as specified
in paragraphs (c)(3)-(8) of this section.
(3) Deposit of funds. (i) Funds in excess of $50. The facility must
deposit any residents' personal funds in excess of $50 in an interest
bearing account (or accounts) that is separate from any of the
facility's operating accounts, and that credits all interest earned on
resident's funds to that account. (In pooled accounts, there must be a
separate accounting for each resident's share.)
(ii) Funds less than $50. The facility must maintain a resident's
personal funds that do not exceed $50 in a non-interest bearing account,
interest-bearing account, or petty cash fund.
(4) Accounting and records. The facility must establish and maintain
a system that assures a full and complete and separate accounting,
according to generally accepted accounting principles, of each
resident's personal funds entrusted to the facility on the resident's
behalf.
(i) The system must preclude any commingling of resident funds with
facility funds or with the funds of any person other than another
resident.
(ii) The individual financial record must be available through
quarterly statements and on request to the resident or his or her legal
representative.
(5) Notice of certain balances. The facility must notify each
resident that receives Medicaid benefits --
(i) When the amount in the resident's account reaches $200 less than
the SSI resource limit for one person, specified in section
1611(a)(3)(B) of the Act; and
(ii) That, if the amount in the account, in addition to the value of
the resident's other nonexempt resources, reaches the SSI resource limit
for one person, the resident may lose eligibility for Medicaid or SSI.
(6) Conveyance upon death. Upon the death of a resident with a
personal fund deposited with the facility, the facility must convey
within 30 days the resident's funds, and a final accounting of those
funds, to the individual or probate jurisdiction administering the
resident's estate.
(7) Assurance of financial security. The facility must purchase a
surety bond, or otherwise provide assurance satisfactory to the
Secretary, to assure the security of all personal funds of residents
deposited with the facility.
(8) Limitation on charges to personal funds. The facility may not
impose a charge against the personal funds of a resident for any item or
service for which payment is made under Medicaid or Medicare.
(d) Free choice. The resident has the right to --
(1) Choose a personal attending physician;
(2) Be fully informed in advance about care and treatment and of any
changes in that care or treatment that may affect the resident's
well-being; and
(3) Unless adjudged incompetent or otherwise found to be
incapacitated under the laws of the State, participate in planning care
and treatment or changes in care and treatment.
(e) Privacy and confidentiality. The resident has the right to
personal privacy and confidentiality of his or her personal and clinical
records.
(1) Personal privacy includes accommodations, medical treatment,
written and telephone communications, personal care, visits, and
meetings of family and resident groups, but this does not require the
facility to provide a private room for each resident;
(2) Except as provided in paragraph (e)(3) of this section, the
resident may approve or refuse the release of personal and clinical
records to any individual outside the facility;
(3) The resident's right to refuse release of personal and clinical
records does not apply when --
(i) The resident is transferred to another health care institution;
or
(ii) Record release is required by law.
(f) Grievances. A resident has the right to --
(1) Voice grievances without discrimination or reprisal. Such
grievances include those with respect to treatment which has been
furnished as well as that which has not been furnished; and
(2) Prompt efforts by the facility to resolve grievances the resident
may have, including those with respect to the behavior of other
residents.
(g) Examination of survey results. A resident has the right to --
(1) Examine the results of the most recent survey of the facility
conducted by Federal or State surveyors and any plan of correction in
effect with respect to the facility. The facility must make the results
available for examination in a place readily accessible to residents,
and must post a notice of their availability; and
(2) Receive information from agencies acting as client advocates, and
be afforded the opportunity to contact these agencies.
(h) Work. The resident has the right to --
(1) Refuse to perform services for the facility;
(2) Perform services for the facility, if he or she chooses, when --
(i) The facility has documented the need or desire for work in the
plan of care;
(ii) The plan specifies the nature of the services performed and
whether the services are voluntary or paid;
(iii) Compensation for paid services is at or above prevailing rates;
and
(iv) The resident agrees to the work arrangement described in the
plan of care.
(i) Mail. The resident has the right to privacy in written
communications, including the right to --
(1) Send and promptly receive mail that is unopened; and
(2) Have access to stationery, postage, and writing implements at the
resident's own expense.
(j) Access and visitation rights. (1) The resident has the right and
the facility must provide immediate access to any resident by the
following:
(i) Any representative of the Secretary;
(ii) Any representative of the State:
(iii) The resident's individual physician;
(iv) The State long term care ombudsman (established under section
307(a)(12) of the Older Americans Act of 1965);
(v) The agency responsible for the protection and advocacy system for
developmentally disabled individuals (established under part C of the
Developmental Disabilities Assistance and Bill of Rights Act);
(vi) The agency responsible for the protection and advocacy system
for mentally ill individuals (established under the Protection and
Advocacy for Mentally Ill Individuals Act);
(vii) Subject to the resident's right to deny or withdraw consent at
any time, immediate family or other relatives of the resident; and
(viii) Subject to reasonable restrictions and the resident's right to
deny or withdraw consent at any time, others who are visiting with the
consent of the resident.
(2) The facility must provide reasonable access to any resident by
any entity or individual that provides health, social, legal, or other
services to the resident, subject to the resident's right to deny or
withdraw consent at any time.
(3) The facility must allow representatives of the State Ombudsman,
described in paragraph (j)(1)(iv) of this section, to examine a
resident's clinical records with the permission of the resident or the
resident's legal representative, and consistent with State law.
(k) Telephone. The resident has the right to have reasonable access
to the use of a telephone where calls can be made without being
overheard.
(l) Personal property. The resident has the right to retain and use
personal possessions, including some furnishings, and appropriate
clothing, as space permits, unless to do so would infringe upon the
rights or health and safety of other residents.
(m) Married couples. The resident has the right to share a room with
his or her spouse when married residents live in the same facility and
both spouses consent to the arrangement.
(n) Self-Administration of Drugs. An individual resident may
self-administer drugs if the interdisciplinary team, as defined by
483.20(d)(2)(ii), has determined that this practice is safe.
(o) Refusal of certain transfers. (1) An individual has the right to
refuse a transfer to another room within the institution, if the purpose
of the transfer is to relocate --
(i) A resident of a SNF from the distinct part of the institution
that is a SNF to a part of the institution that is not a SNF, or
(ii) A resident of a NF from the distinct part of the institution
that is a NF to a distinct part of the institution that is a SNF.
(2) A resident's exercise of the right to refuse transfer under
paragraph (o)(1) of this section does not affect the individual's
eligibility or entitlement to Medicare or Medicaid benefits.
(56 FR 48867, Sept. 26, 1991, as amended at 57 FR 8202, Mar. 6, 1992;
57 FR 43924, Sept. 23, 1992)
42 CFR 483.12 Admission, transfer and discharge rights.
(a) Transfer and discharge --
(1) Definition: Transfer and discharge includes movement of a
resident to a bed outside of the certified facility whether that bed is
in the same physical plant or not. Transfer and discharge does not
refer to movement of a resident to a bed within the same certified
facility.
(2) Transfer and discharge requirements. The facility must permit
each resident to remain in the facility, and not transfer or discharge
the resident from the facility unless --
(i) The transfer or discharge is necessary for the resident's welfare
and the resident's needs cannot be met in the facility;
(ii) The transfer or discharge is appropriate because the resident's
health has improved sufficiently so the resident no longer needs the
services provided by the facility;
(iii) The safety of individuals in the facility is endangered;
(iv) The health of individuals in the facility would otherwise be
endangered;
(v) The resident has failed, after reasonable and appropriate notice,
to pay for (or to have paid under Medicare or Medicaid) a stay at the
facility. For a resident who becomes eligible for Medicaid after
admission to a facility, the facility may charge a resident only
allowable charges under Medicaid; or
(vi) The facility ceases to operate.
(3) Documentation. When the facility transfers or discharges a
resident under any of the circumstances specified in paragraphs
(a)(2)(i) through (v) of this section, the resident's clinical record
must be documented. The documentation must be made by --
(i) The resident's physician when transfer or discharge is necessary
under paragraph (a)(2)(i) or paragraph (a)(2)(ii) of this section; and
(ii) A physician when transfer or discharge is necessary under
paragraph (a)(2)(iv) of this section.
(4) Notice before transfer. Before a facility transfers or
discharges a resident, the facility must --
(i) Notify the resident and, if known, a family member or legal
representative of the resident of the transfer or discharge and the
reasons for the move in writing and in a language and manner they
understand.
(ii) Record the reasons in the resident's clinical record; and
(iii) Include in the notice the items described in paragraph (a)(6)
of this section.
(5) Timing of the notice. (i) Except when specified in paragraph
(a)(5)(ii) of this section, the notice of transfer or discharge required
under paragraph (a)(4) of this section must be made by the facility at
least 30 days before the resident is transferred or discharged.
(ii) Notice may be made as soon as practicable before transfer or
discharge when --
(A) the safety of individuals in the facility would be endangered
under paragraph (a)(2)(iii) of this section;
(B) The health of individuals in the facility would be endangered,
under paragraph (a)(2)(iv) of this section;
(C) The resident's health improves sufficiently to allow a more
immediate transfer or discharge, under paragraph (a)(2)(ii) of this
section;
(D) An immediate transfer or discharge is required by the resident's
urgent medical needs, under paragraph (a)(2)(i) of this section; or
(E) A resident has not resided in the facility for 30 days.
(6) Contents of the notice. The written notice specified in
paragraph (a)(4) of this section must include the following:
(i) The reason for transfer or discharge;
(ii) The effective date of transfer or discharge;
(iii) The location to which the resident is transferred or
discharged;
(iv) A statement that the resident has the right to appeal the action
to the State;
(v) The name, address and telephone number of the State long term
care ombudsman;
(vi) For nursing facility residents with developmental disabilities,
the mailing address and telephone number of the agency responsible for
the protection and advocacy of developmentally disabled individuals
established under Part C of the Developmental Disabilities Assistance
and Bill of Rights Act; and
(vii) For nursing facility residents who are mentally ill, the
mailing address and telephone number of the agency responsible for the
protection and advocacy of mentally ill individuals established under
the Protection and Advocacy for Mentally Ill Individuals Act.
(7) Orientation for transfer or discharge. A facility must provide
sufficient preparation and orientation to residents to ensure safe and
orderly transfer or discharge from the facility.
(b) Notice of bed-hold policy and readmission -- (1) Notice before
transfer. Before a nursing facility transfers a resident to a hospital
or allows a resident to go on therapeutic leave, the nursing facility
must provide written information to the resident and a family member or
legal representative that specifies --
(i) The duration of the bed-hold policy under the State plan, if any,
during which the resident is permitted to return and resume residence in
the nursing facility; and
(ii) The nursing facility's policies regarding bed-hold periods,
which must be consistent with paragraph (b)(3) of this section,
permitting a resident to return.
(2) Bed-hold notice upon transfer. At the time of transfer of a
resident for hospitalization or therapeutic leave, a nursing facility
must provide to the resident and a family member or legal representative
written notice which specifies the duration of the bed-hold policy
described in paragraph (b)(1) of this section.
(3) Permitting resident to return to facility. A nursing facility
must establish and follow a written policy under which a resident, whose
hospitalization or therapeutic leave exceeds the bed-hold period under
the State plan, is readmitted to the facility immediately upon the first
availability of a bed in a semi-private room if the resident --
(i) Requires the services provided by the facility; and
(ii) Is eligible for Medicaid nursing facility services.
(c) Equal access to quality care.
(1) A facility must establish and maintain identical policies and
practices regarding transfer, discharge, and the provision of services
under the State plan for all individuals regardless of source of
payment;
(2) The facility may charge any amount for services furnished to
non-Medicaid residents consistent with the notice requirement in
483.10(b)(5)(i) and (b)(6) describing the charges; and
(3) The State is not required to offer additional services on behalf
of a resident other than services provided in the State plan.
(d) Admissions policy.
(1) The facility must --
(i) Not require residents or potential residents to waive their
rights to Medicare or Medicaid; and
(ii) Not require oral or written assurance that residents or
potential residents are not eligible for, or will not apply for,
Medicare or Medicaid benefits.
(2) The facility must not require a third party guarantee of payment
to the facility as a condition of admission or expedited admission, or
continued stay in the facility. However, the facility may require an
individual who has legal access to a resident's income or resources
available to pay for facility care to sign a contract, without incurring
personal financial liability, to provide facility payment from the
resident's income or resources.
(3) In the case of a person eligible for Medicaid, a nursing facility
must not charge, solicit, accept, or receive, in addition to any amount
otherwise required to be paid under the State plan, any gift, money,
donation, or other consideration as a precondition of admission,
expedited admission or continued stay in the facility. However, --
(i) A nursing facility may charge a resident who is eligible for
Medicaid for items and services the resident has requested and received,
and that are not specified in the State plan as included in the term
''nursing facility services'' so long as the facility gives proper
notice of the availability and cost of these services to residents and
does not condition the resident's admission or continued stay on the
request for and receipt of such additional services; and
(ii) A nursing facility may solicit, accept, or receive a charitable,
religious, or philanthropic contribution from an organization or from a
person unrelated to a Medicaid eligible resident or potential resident,
but only to the extent that the contribution is not a condition of
admission, expedited admission, or continued stay in the facility for a
Medicaid eligible resident.
(4) States or political subdivisions may apply stricter admissions
standards under State or local laws than are specified in this section,
to prohibit discrimination against individuals entitled to Medicaid.
(56 FR 48869, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23,
1992)
42 CFR 483.13 Resident behavior and facility practices.
(a) Restraints. The resident has the right to be free from any
physical or chemical restraints imposed for purposes of discipline or
convenience, and not required to treat the resident's medical symptoms.
(b) Abuse. The resident has the right to be free from verbal,
sexual, physical, and mental abuse, corporal punishment, and involuntary
seclusion.
(c) Staff treatment of residents. The facility must develop and
implement written policies and procedures that prohibit mistreatment,
neglect, and abuse of residents and misappropriation of resident
property.
(1) The facility must --
(i) Not use verbal, mental, sexual, or physical abuse, corporal
punishment, or involuntary seclusion;
(ii) Not employ individuals who have been --
(A) Found guilty of abusing, neglecting, or mistreating residents by
a court of law; or
(B) Have had a finding entered into the State nurse aide registry
concerning abuse, neglect, mistreatment of residents or misappropriation
of their property; and
(iii) Report any knowledge it has of actions by a court of law
against an employee, which would indicate unfitness for service as a
nurse aide or other facility staff to the State nurse aide registry or
licensing authorities.
(2) The facility must ensure that all alleged violations involving
mistreatment, neglect, or abuse, including injuries of unknown source,
and misappropriation of resident property are reported immediately to
the administrator of the facility and to other officials in accordance
with State law through established procedures (including to the State
survey and certification agency).
(3) The facility must have evidence that all alleged violations are
thoroughly investigated, and must prevent further potential abuse while
the investigation is in progress.
(4) The results of all investigations must be reported to the
administrator or his designated representative and to other officials in
accordance with State law (including to the State survey and
certification agency) within 5 working days of the incident, and if the
alleged violation is verified appropriate corrective action must be
taken.
(56 FR 48870, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23,
1992)
42 CFR 483.15 Quality of life.
A facility must care for its residents in a manner and in an
environment that promotes maintenance or enhancement of each resident's
quality of life.
(a) Dignity. The facility must promote care for residents in a
manner and in an environment that maintains or enhances each resident's
dignity and respect in full recognition of his or her individuality.
(b) Self-determination and participation. The resident has the right
to --
(1) Choose activities, schedules, and health care consistent with his
or her interests, assessments, and plans of care;
(2) Interact with members of the community both inside and outside
the facility; and
(3) Make choices about aspects of his or her life in the facility
that are significant to the resident.
(c) Participation in resident and family groups.
(1) A resident has the right to organize and participate in resident
groups in the facility;
(2) A resident's family has the right to meet in the facility with
the families of other residents in the facility;
(3) The facility must provide a resident or family group, if one
exists, with private space;
(4) Staff or visitors may attend meetings at the group's invitation;
(5) The facility must provide a designated staff person responsible
for providing assistance and responding to written requests that result
from group meetings;
(6) When a resident or family group exists, the facility must listen
to the views and act upon the grievances and recommendations of
residents and families concerning proposed policy and operational
decisions affecting resident care and life in the facility.
(d) Participation in other activities. A resident has the right to
participate in social, religious, and community activities that do not
interfere with the rights of other residents in the facility.
(e) Accommodation of needs. A resident has the right to --
(1) Reside and receive services in the facility with reasonable
accommodation of individual needs and preferences, except when the
health or safety of the individual or other residents would be
endangered; and
(2) Receive notice before the resident's room or roommate in the
facility is changed.
(f) Activities.
(1) The facility must provide for an ongoing program of activities
designed to meet, in accordance with the comprehensive assessment, the
interests and the physical, mental, and psychosocial well-being of each
resident.
(2) The activities program must be directed by a qualified
professional who --
(i) Is a qualified therapeutic recreation specialist or an activities
professional who --
(A) Is licensed or registered, if applicable, by the State in which
practicing; and
(B) Is eligible for certification as a therapeutic recreation
specialist or as an activities professional by a recognized accrediting
body on or after October 1, 1990; or
(ii) Has 2 years of experience in a social or recreational program
within the last 5 years, 1 of which was full-time in a patient
activities program in a health care setting; or
(iii) Is a qualified occupational therapist or occupational therapy
assistant; or
(iv) Has completed a training course approved by the State.
(g) Social Services. (1) -- The facility must provide
medically-related social services to attain or maintain the highest
practicable physical, mental, and psychosocial well-being of each
resident.
(2) A facility with more than 120 beds must employ a qualified social
worker on a full-time basis.
(3) Qualifications of social worker. A qualified social worker is an
individual with --
(i) A bachelor's degree in social work or a bachelor's degree in a
human services field including but not limited to sociology, special
education, rehabilitation counseling, and psychology; and
(ii) One year of supervised social work experience in a health care
setting working directly with individuals.
(h) Environment.
The facility must provide --
(1) A safe, clean, comfortable, and homelike environment, allowing
the resident to use his or her personal belongings to the extent
possible;
(2) Housekeeping and maintenance services necessary to maintain a
sanitary, orderly, and comfortable interior;
(3) Clean bed and bath linens that are in good condition;
(4) Private closet space in each resident room, as specified in
483.70(d)(2)(iv) of this part;
(5) Adequate and comfortable lighting levels in all areas;
(6) Comfortable and safe temperature levels. Facilities initially
certified after October 1, 1990 must maintain a temperature range of
71-81 F; and
(7) For the maintenance of comfortable sound levels.
(56 FR 48871, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23,
1992)
42 CFR 483.20 Resident assessment.
The facility must conduct initially and periodically a comprehensive,
accurate, standardized, reproducible assessment of each resident's
functional capacity.
(a) Admission orders. At the time each resident is admitted, the
facility must have physician orders for the resident's immediate care.
(b) Comprehensive assessments.
(1) The facility must make a comprehensive assessment of a resident's
needs, which --
(i) Is based on a uniform data set specified by the Secretary and
uses an instrument that is specified by the State and approved by the
Secretary; and
(ii) Describes the resident's capability to perform daily life
functions and significant impairments in functional capacity.
(2) The comprehensive assessment must include at least the following
information:
(i) Medically defined conditions and prior medical history;
(ii) Medical status measurement;
(iii) Physical and mental functional status;
(iv) Sensory and physical impairments;
(v) Nutritional status and requirements;
(vi) Special treatments or procedures;
(vii) Mental and psychosocial status;
(viii) Discharge potential;
(ix) Dental condition;
(x) Activities potential;
(xi) Rehabilitation potential;
(xii) Cognitive status; and
(xiii) Drug therapy.
(3) (Reserved)
(4) Frequency. Assessments must be conducted --
(i) No later than 14 days after the date of admission;
(ii) For current NF residents not later than October 1, 1991;
(iii) For current SNF residents not later than January 1, 1991;
(iv) Promptly after a significant change in the resident's physical
or mental condition; and
(v) In no case less often than once every 12 months.
(5) Review of assessments. The nursing facility must examine each
resident no less than once every 3 months, and as appropriate, revise
the resident's assessment to assure the continued accuracy of the
assessment.
(6) Use. The results of the assessment are used to develop, review,
and revise the resident's comprehensive plan of care, under paragraph
(d) of this section.
(7) Coordination. The facility must coordinate assessments with any
State-required preadmission screening program to the maximum extent
practicable to avoid duplicative testing and effort.
(c) Accuracy of assessments. (1) Coordination. (i) Each assessment
must be conducted or coordinated with the appropriate participation of
health professionals.
(ii) Each assessment must be conducted or coordinated by a registered
nurse who signs and certifies the completion of the assessment.
(2) Certification. Each individual who completes a portion of the
assessment must sign and certify the accuracy of that portion of the
assessment.
(3) Penalty for Falsification. An individual who willfully and
knowingly certifies (or causes another individual to certify) a material
and false statement in a resident assessment is subject to civil money
penalties. The implementing regulations for this statutory authority
are located in part 1003 of this chapter.
(4) Use of independent assessors. If a State determines, under a
survey or otherwise, that there has been a knowing and willful
certification of false statements under paragraph (c)(3) of this
section, the State may require (for a period specified by the State)
that resident assessments under this paragraph be conducted and
certified by individuals who are independent of the facility and who are
approved by the State.
(d) Comprehensive care plans. (1) The facility must develop a
comprehensive care plan for each resident that includes measurable
objectives and timetables to meet a resident's medical, nursing, and
mental and psychosocial needs that are identified in the comprehensive
assessment. The care plan must describer the following --
(i) The services that are to be furnished to attain or maintain the
resident's highest practicable physical, mental, and psychosocial
well-being as required under 483.25; and
(ii) Any services that would otherwise be required under 483.25 but
are not provided due to the resident's exercise of rights under 483.10,
including the right to refuse treatment under 483.10(b)(4).
(2) A comprehensive care plan must be --
(i) Developed within 7 days after completion of the comprehensive
assessment;
(ii) Prepared by an interdisciplinary team, that includes the
attending physician, a registered nurse with responsibility for the
resident, and other appropriate staff in disciplines as determined by
the resident's needs, and, to the extent practicable, the participation
of the resident, the resident's family or the resident's legal
representative; and
(iii) Periodically reviewed and revised by a team of qualified
persons after each assessment.
(3) The services provided or arranged by the facility must --
(i) Meet professional standards of quality; and
(ii) Be provided by qualified persons in accordance with each
resident's written plan of care.
(e) Discharge summary. When the facility anticipates discharge a
resident must have a discharge summary that includes --
(1) A recapitulation of the resident's stay;
(2) A final summary of the resident's status to include items in
paragraph (b)(2) of this section, at the time of the discharge that is
available for release to authorized persons and agencies, with the
consent of the resident or legal representative; and
(3) A post-discharge plan of care that is developed with the
participation of the resident and his or her family, which will assist
the resident to adjust to his or her new living environment.
(f) Preadmission screening for mentally ill individuals and
individuals with mental retardation.
(1) A nursing facility must not admit, on or after January 1, 1989,
any new resident with --
(i) Mental illness as defined in paragraph (f)(2)(i) of this section,
unless the State mental health authority has determined, based on an
independent physical and mental evaluation performed by a person or
entity other than the State mental health authority, prior to admission,
(A) That, because of the physical and mental condition of the
individual, the individual requires the level of services provided by a
nursing facility; and
(B) If the individual requires such level of services, whether the
individual requires specialized services; or
(ii) Mental retardation, as defined in paragraph (f)(2)(ii) of this
section, unless the State mental retardation or developmental disability
authority has determined prior to admission --
(A) That, because of the physical and mental condition of the
individual, the individual requires the level of services provided by a
nursing facility; and
(B) If the individual requires such level of services, whether the
individual requires specialized services for mental retardation.
(2) Definition. For purposes of this section --
(i) An individual is considered to have mental illness if the
individual has a serious mental illness as defined in 483.102(b)(1).
(ii) An individual is considered to be mentally retarded if the
individual is mentally retarded as defined in 483.102(b)(3) or is a
person with a related condition as described in 42 CFR 435.1009.
(56 FR 48871, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23,
1992)
42 CFR 483.25 Quality of care.
Each resident must receive and the facility must provide the
necessary care and services to attain or maintain the highest
practicable physical, mental, and psychosocial well-being, in accordance
with the comprehensive assessment and plan of care.
(a) Activities of daily living. Based on the comprehensive
assessment of a resident, the facility must ensure that --
(1) A resident's abilities in activities of daily living do not
diminish unless circumstances of the individual's clinical condition
demonstrate that diminution was unavoidable. This includes the
resident's ability to --
(i) Bathe, dress, and groom;
(ii) Transfer and ambulate;
(iii) Toilet;
(iv) Eat; and
(v) Use speech, language, or other functional communication systems.
(2) A resident is given the appropriate treatment and services to
maintain or improve his or her abilities specified in paragraph (a)(1)
of this section; and
(3) A resident who is unable to carry out activities of daily living
receives the necessary services to maintain good nutrition, grooming,
and personal and oral hygiene.
(b) Vision and hearing. To ensure that residents receive proper
treatment and assistive devices to maintain vision and hearing
abilities, the facility must, if necessary, assist the resident --
(1) In making appointments, and
(2) By arranging for transportation to and from the office of a
practitioner specializing in the treatment of vision or hearing
impairment or the office of a professional specializing in the provision
of vision or hearing assistive devices.
(c) Pressure sores. Based on the comprehensive assessment of a
resident, the facility must ensure that --
(1) A resident who enters the facility without pressure sores does
not develop pressure sores unless the individual's clinical condition
demonstrates that they were unavoidable; and
(2) A resident having pressure sores receives necessary treatment and
services to promote healing, prevent infection and prevent new sores
from developing.
(d) Urinary Incontinence. Based on the resident's comprehensive
assessment, the facility must ensure that --
(1) A resident who enters the facility without an indwelling catheter
is not catheterized unless the resident's clinical condition
demonstrates that catheterization was necessary; and
(2) A resident who is incontinent of bladder receives appropriate
treatment and services to prevent urinary tract infections and to
restore as much normal bladder function as possible.
(e) Range of motion. Based on the comprehensive assessment of a
resident, the facility must ensure that --
(1) A resident who enters the facility without a limited range of
motion does not experience reduction in range of motion unless the
resident's clinical condition demonstrates that a reduction in range of
motion is unavoidable; and
(2) A resident with a limited range of motion receives appropriate
treatment and services to increase range of motion and/or to prevent
further decrease in range of motion.
(f) Mental and Psychosocial functioning. Based on the comprehensive
assessment of a resident, the facility must ensure that --
(1) A resident who displays mental or psychosocial adjustment
difficulty, receives appropriate treatment and services to correct the
assessed problem, and
(2) A resident whose assessment did not reveal a mental or
psychosocial adjustment difficulty does not display a pattern of
decreased social interaction and/or increased withdrawn, angry, or
depressive behaviors, unless the resident's clinical condition
demonstrates that such a pattern was unavoidable.
(g) Naso-gastric tubes. Based on the comprehensive assessment of a
resident, the facility must ensure that --
(1) A resident who has been able to eat enough alone or with
assistance is not fed by naso-gastric tube unless the resident's
clinical condition demonstrates that use of a naso-gastric tube was
unavoidable; and
(2) A resident who is fed by a naso-gastric or gastrostomy tube
receives the appropriate treatment and services to prevent aspiration
pneumonia, diarrhea, vomiting, dehydration, metabolic abnormalities, and
nasal-pharyngeal ulcers and to restore, if possible, normal eating
skills.
(h) Accidents. The facility must ensure that --
(1) The resident environment remains as free of accident hazards as
is possible; and
(2) Each resident receives adequate supervision and assistance
devices to prevent accidents.
(i) Nutrition. Based on a resident's comprehensive assessment, the
facility must ensure that a resident --
(1) Maintains acceptable parameters of nutritional status, such as
body weight and protein levels, unless the resident's clinical condition
demonstrates that this is not possible; and
(2) Receives a therapeutic diet when there is a nutritional problem.
(j) Hydration. The facility must provide each resident with
sufficient fluid intake to maintain proper hydration and health.
(k) Special needs. The facility must ensure that residents receive
proper treatment and care for the following special services:
(1) Injections;
(2) Parenteral and enteral fluids;
(3) Colostomy, ureterostomy, or ileostomy care;
(4) Tracheostomy care;
(5) Tracheal suctioning;
(6) Respiratory care;
(7) Foot care; and
(8) Prostheses.
(l) Unnecessary drugs -- (1) General. Each resident's drug regimen
must be free from unnecessary drugs. An unnecessary drug is any drug
when used:
(i) In excessive dose (including duplicate drug therapy); or
(ii) For excessive duration; or
(iii) Without adequate monitoring; or
(iv) Without adequate indications for its use; or
(v) In the presence of adverse consequences which indicate the dose
should be reduced or discontinued; or
(vi) Any combinations of the reasons above.
(2) Antipsychotic Drugs. Based on a comprehensive assessment of a
resident, the facility must ensure that --
(i) Residents who have not used antipsychotic drugs are not given
these drugs unless antipsychotic drug therapy is necessary to treat a
specific condition as diagnosed and documented in the clinical record;
and
(ii) Residents who use antipsychotic drugs receive gradual dose
reductions, and behavioral interventions, unless clinically
contraindicated, in an effort to discontinue these drugs.
(m) Medication Errors -- The facility must ensure that --
(1) It is free of medication error rates of five percent or greater;
and
(2) Residents are free of any significant medication errors.
(56 FR 48873, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23,
1992)
42 CFR 483.30 Nursing services.
The facility must have sufficient nursing staff to provide nursing
and related services to attain or maintain the highest practicable
physical, mental, and psychosocial well-being of each resident, as
determined by resident assessments and individual plans of care.
(a) Sufficient staff. (1) The facility must provide services by
sufficient numbers of each of the following types of personnel on a
24-hour basis to provide nursing care to all residents in accordance
with resident care plans:
(i) Except when waived under paragraph (c) of this section, licensed
nurses; and
(ii) Other nursing personnel.
(2) Except when waived under paragraph (c) of this section, the
facility must designate a licensed nurse to serve as a charge nurse on
each tour of duty.
(b) Registered nurse. (1) Except when waived under paragraph (c) or
(d) of this section, the facility must use the services of a registered
nurse for at least 8 consecutive hours a day, 7 days a week.
(2) Except when waived under paragraph (c) or (d) of this section,
the facility must designate a registered nurse to serve as the director
of nursing on a full time basis.
(3) The director of nursing may serve as a charge nurse only when the
facility has an average daily occupancy of 60 or fewer residents.
(c) Nursing facilities: Waiver of requirement to provide licensed
nurses on a 24-hour basis. To the extent that a facility is unable to
meet the requirements of paragraphs (a)(2) and (b)(1) of this section, a
State may waive such requirements with respect to the facility if --
(1) The facility demonstrates to the satisfaction of the State that
the facility has been unable, despite diligent efforts (including
offering wages at the community prevailing rate for nursing facilities),
to recruit appropriate personnel;
(2) The State determines that a waiver of the requirement will not
endanger the health or safety of individuals staying in the facility;
(3) The State finds that, for any periods in which licensed nursing
services are not available, a registered nurse or a physician is
obligated to respond immediately to telephone calls from the facility;
(4) A waiver granted under the conditions listed in paragraph (c) of
this section is subject to annual State review;
(5) In granting or renewing a waiver, a facility may be required by
the State to use other qualified, licensed personnel;
(6) The State agency granting a waiver of such requirements provides
notice of the waiver to the State long term care ombudsman (established
under section 307(a)(12) of the Older Americans Act of 1965) and the
protection and advocacy system in the State for the mentally ill and
mentally retarded; and
(7) The nursing facility that is granted such a waiver by a State
notifies residents of the facility (or, where appropriate, the guardians
or legal representatives of such residents) and members of their
immediate families of the waiver.
(d) SNFs: Waiver of the requirement to provide services of a
registered nurse for more than 40 hours a week.
(1) The Secretary may waive the requirement that a SNF provide the
services of a registered nurse for more than 40 hours a week, including
a director of nursing specified in paragraph (b) of this section, if the
Secretary finds that --
(i) The facility is located in a rural area and the supply of skilled
nursing facility services in the area is not sufficient to meet the
needs of individuals residing in the area;
(ii) The facility has one full-time registered nurse who is regularly
on duty at the facility 40 hours a week; and
(iii) The facility either --
(A) Has only patients whose physicians have indicated (through
physicians' orders or admission notes) that they do not require the
services of a registered nurse or a physician for a 48-hours period, or
(B) Has made arrangements for a registered nurse or a physician to
spend time at the facility, as determined necessary by the physician, to
provide necessary skilled nursing services on days when the regular
full-time registered nurse is not on duty;
(iv) The Secretary provides notice of the waiver to the State long
term care ombudsman (established under section 307(a)(12) of the Older
Americans Act of 1965) and the protection and advocacy system in the
State for the mentally ill and mentally retarded; and
(v) The facility that is granted such a waiver notifies residents of
the facility (or, where appropriate, the guardians or legal
representatives of such residents) and members of their immediate
families of the waiver.
(2) A waiver of the registered nurse requirement under paragraph
(d)(1) of this section is subject to annual renewal by the Secretary.
(56 FR 48873, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23,
1992)
42 CFR 483.35 Dietary services.
The facility must provide each resident with a nourishing, palatable,
well-balanced diet that meets the daily nutritional and special dietary
needs of each resident.
(a) Staffing. The facility must employ a qualified dietitian either
full-time, part-time, or on a consultant basis.
(1) If a qualified dietitian is not employed full-time, the facility
must designate a person to serve as the director of food service who
receives frequently scheduled consultation from a qualified dietitian.
(2) A qualified dietitian is one who is qualified based upon either
registration by the Commission on Dietetic Registration of the American
Dietetic Association, or on the basis of education, training, or
experience in identification of dietary needs, planning, and
implementation of dietary programs.
(b) Sufficient staff. The facility must employ sufficient support
personnel competent to carry out the functions of the dietary service.
(c) Menus and nutritional adequacy. Menus must --
(1) Meet the nutritional needs of residents in accordance with the
recommended dietary allowances of the Food and Nutrition Board of the
National Research Council, National Academy of Sciences;
(2) Be prepared in advance; and
(3) Be followed.
(d) Food. Each resident receives and the facility provides --
(1) Food prepared by methods that conserve nutritive value, flavor,
and appearance;
(2) Food that is palatable, attractive, and at the proper
temperature;
(3) Food prepared in a form designed to meet individual needs; and
(4) Substitutes offered of similar nutritive value to residents who
refuse food served.
(e) Therapeutic diets. Therapeutic diets must be prescribed by the
attending physician.
(f) Frequency of meals. (1) Each resident receives and the facility
provides at least three meals daily, at regular times comparable to
normal mealtimes in the community.
(2) There must be no more than 14 hours between a substantial evening
meal and breakfast the following day, except as provided in (4) below.
(3) The facility must offer snacks at bedtime daily.
(4) When a nourishing snack is provided at bedtime, up to 16 hours
may elapse between a substantial evening meal and breakfast the
following day if a resident group agrees to this meal span, and a
nourishing snack is served.
(g) Assistive devices. The facility must provide special eating
equipment and utensils for residents who need them.
(h) Sanitary conditions. The facility must --
(1) Procure food from sources approved or considered satisfactory by
Federal, State, or local authorities;
(2) Store, prepare, distribute, and serve food under sanitary
conditions; and
(3) Dispose of garbage and refuse properly.
(56 FR 48874, Sept. 26, 1991)
42 CFR 483.40 Physician services.
A physician must personally approve in writing a recommendation that
an individual be admitted to a facility. Each resident must remain
under the care of a physician.
(a) Physician supervision. The facility must ensure that --
(1) The medical care of each resident is supervised by a physician;
and
(2) Another physician supervises the medical care of residents when
their attending physician is unavailable.
(b) Physician visits. The physician must --
(1) Review the resident's total program of care, including
medications and treatments, at each visit required by paragraph (c) of
this section;
(2) Write, sign, and date progress notes at each visit; and
(3) Sign and date all orders.
(c) Frequency of physician visits.
(1) The resident must be seen by a physician at least once every 30
days for the first 90 days after admission, and at least once every 60
days thereafter.
(2) A physician visit is considered timely if it occurs not later
than 10 days after the date the visit was required.
(3) Except as provided in paragraphs (c)(4) and (f) of this section,
all required physician visits must be made by the physician personally.
(4) At the option of the physician, required visits in SNFs after the
initial visit may alternate between personal visits by the physician and
visits by a physician assistant, nurse practitioner, or clinical nurse
specialist in accordance with paragraph (e) of this section.
(d) Availability of physicians for emergency care. The facility must
provide or arrange for the provision of physician services 24 hours a
day, in case of an emergency.
(e) Physician delegation of tasks in SNFs. (1) Except as specified
in paragraph (e)(2) of this section, a physician may delegate tasks to a
physician assistant, nurse practitioner, or clinical nurse specialist
who --
(i) Meets the applicable definition in 491.2 of this chapter or, in
the case of a clinical nurse specialist, is licensed as such by the
State;
(ii) Is acting within the scope of practice as defined by State law;
and
(iii) Is under the supervision of the physician.
(2) A physician may not delegate a task when the regulations specify
that the physician must perform it personally, or when the delegation is
prohibited under State law or by the facility's own policies.
(f) Performance of physician tasks in NFs. At the option of the
State, any required physician task in a NF (including tasks which the
regulations specify must be performed personally by the physician) may
also be satisfied when performed by a nurse practitioner, clinical nurse
specialist, or physician assistant who is not an employee of the
facility but who is working in collaboration with a physician.
(56 FR 48875, Sept. 26, 1991)
42 CFR 483.45 Specialized rehabilitative services.
(a) Provision of services. If specialized rehabilitative services
such as but not limited to physical therapy, speech-language pathology,
occupational therapy, and mental health rehabilitative services for
mental illness and mental retardation, are required in the resident's
comprehensive plan of care, the facility must --
(1) Provide the required services; or
(2) Obtain the required services from an outside resource (in
accordance with 483.75(h) of this part) from a provider of specialized
rehabilitative services.
(b) Qualifications. Specialized rehabilitative services must be
provided under the written order of a physician by qualified personnel.
(56 FR 48875, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23,
1992)
42 CFR 483.55 Dental services.
The facility must assist residents in obtaining routine and 24-hour
emergency dental care.
(a) Skilled nursing facilities. A facility (1) Must provide or
obtain from an outside resource, in accordance with 483.75(h) of this
part, routine and emergency dental services to meet the needs of each
resident;
(2) May charge a Medicare resident an additional amount for routine
and emergency dental services;
(3) Must if necessary, assist the resident --
(i) In making appointments; and
(ii) By arranging for transportation to and from the dentist's
office; and
(4) Promptly refer residents with lost or damaged dentures to a
dentist.
(b) Nursing facilities. The facility (1) Must provide or obtain from
an outside resource, in accordance with 483.75(h) of this part, the
following dental services to meet the needs of each resident:
(i) Routine dental services (to the extent covered under the State
plan); and
(ii) Emergency dental services;
(2) Must, if necessary, assist the resident --
(i) In making appointments; and
(ii) By arranging for transportation to and from the dentist's
office; and
(3) Must promptly refer residents with lost or damaged dentures to a
dentist.
(56 FR 48875, Sept. 26, 1991)
42 CFR 483.60 Pharmacy services.
The facility must provide routine and emergency drugs and biologicals
to its residents, or obtain them under an agreement described in
483.75(h) of this part. The facility may permit unlicensed personnel to
administer drugs if State law permits, but only under the general
supervision of a licensed nurse.
(a) Procedures. A facility must provide pharmaceutical services
(including procedures that assure the accurate acquiring, receiving,
dispensing, and administering of all drugs and biologicals) to meet the
needs of each resident.
(b) Service consultation. The facility must employ or obtain the
services of a licensed pharmacist who --
(1) Provides consultation on all aspects of the provision of pharmacy
services in the facility;
(2) Establishes a system of records of receipt and disposition of all
controlled drugs in sufficient detail to enable an accurate
reconciliation; and
(3) Determines that drug records are in order and that an account of
all controlled drugs is maintained and periodically reconciled.
(c) Drug regimen review. (1) The drug regimen of each resident must
be reviewed at least once a month by a licensed pharmacist.
(2) The pharmacist must report any irregularities to the attending
physician and the director of nursing, and these reports must be acted
upon.
(d) Labeling of drugs and biologicals. Drugs and biologicals used in
the facility must be labeled in accordance with currently accepted
professional principles, and include the appropriate accessory and
cautionary instructions, and the expiration date when applicable.
(e) Storage of drugs and biologicals.
(1) In accordance with State and Federal laws, the facility must
store all drugs and biologicals in locked compartments under proper
temperature controls, and permit only authorized personnel to have
access to the keys.
(2) The facility must provide separately locked, permanently affixed
compartments for storage of controlled drugs listed in Schedule II of
the Comprehensive Drug Abuse Prevention and Control Act of 1976 and
other drugs subject to abuse, except when the facility uses single unit
package drug distribution systems in which the quantity stored is
minimal and a missing dose can be readily detected.
(56 FR 48875, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23,
1992)
42 CFR 483.65 Infection control.
The facility must establish and maintain an infection control program
designed to provide a safe, sanitary, and comfortable environment and to
help prevent the development and transmission of disease and infection.
(a) Infection control program. The facility must establish an
infection control program under which it --
(1) Investigates, controls, and prevents infections in the facility;
(2) Decides what procedures, such as isolation, should be applied to
an individual resident; and
(3) Maintains a record of incidents and corrective actions related to
infections.
(b) Preventing spread of infection. (1) When the infection control
program determines that a resident needs isolation to prevent the spread
of infection, the facility must isolate the resident.
(2) The facility must prohibit employees with a communicable disease
or infected skin lesions from direct contact with residents or their
food, if direct contact will transmit the disease.
(3) The facility must require staff to wash their hands after each
direct resident contact for which handwashing is indicated by accepted
professional practice.
(c) Linens. Personnel must handle, store, process, and transport
linens so as to prevent the spread of infection.
(56 FR 48876, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23,
1992)
42 CFR 483.70 Physical environment.
The facility must be designed, constructed, equipped, and maintained
to protect the health and safety of residents, personnel and the public.
(a) Life safety from fire. Except as provided in paragraph (a)(1) or
(a)(3) of this section, the facility must meet the applicable provisions
of the 1985 edition of the Life Safety Code of the National Fire
Protection Association (which is incorporated by reference).
Incorporation of the 1985 edition of the National Fire Protection
Association's Life Safety Code (published February 7, 1985; ANSI/NFPA)
was approved by the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51 that govern the use of incorporations
by reference. /1/
(1) A facility is considered to be in compliance with this
requirement as long as the facility --
(i) On November 26, 1982, complied with or without waivers, with the
requirements of the 1967 or 1973 editions of the Life Safety Code and
continues to remain in compliance with those editions of the Code; or
(ii) On May 9, 1988, complied, with or without waivers, with the 1981
edition of the Life Safety Code and continues to remain in compliance
with that edition of the Code.
(2) After consideration of State survey agency findings, HCFA may
waive specific provisions of the Life Safety Code which, if rigidly
applied would result in unreasonable hardship upon the facility, but
only if the waiver does not adversely affect the health and safety of
residents or personnel.
(3) The provisions of the Life Safety Code do not apply in a State
where HCFA finds, in accordance with applicable provisions of sections
1819(d)(2)(B)(ii) and 1919(d)(2)(B)(ii) of the Act, that a fire and
safety code imposed by State law adequately protects patients, residents
and personnel in long term care facilities.
(b) Emergency power.
(1) An emergency electrical power system must supply power adequate
at least for lighting all entrances and exits; equipment to maintain
the fire detection, alarm, and extinguishing systems; and life support
systems in the event the normal electrical supply is interrupted.
(2) When life support systems are used, the facility must provide
emergency electrical power with an emergency generator (as defined in
NFPA 99, Health Care Facilities) that is located on the premises.
(c) Space and equipment. The facility must --
(1) Provide sufficient space and equipment in dining, health
services, recreation, and program areas to enable staff to provide
residents with needed services as required by these standards and as
identified in each resident's plan of care; and
(2) Maintain all essential mechanical, electrical, and patient care
equipment in safe operating condition.
(d) Resident rooms. Resident rooms must be designed and equipped for
adequate nursing care, comfort, and privacy of residents.
(1) Bedrooms must --
(i) Accommodate no more than four residents;
(ii) Measure at least 80 square feet per resident in multiple
resident bedrooms, and at least 100 square feet in single resident
rooms;
(iii) Have direct access to an exit corridor;
(iv) Be designed or equipped to assure full visual privacy for each
resident;
(v) In facilities initially certified after March 31, 1992, except in
private rooms, each bed must have ceiling suspended curtains, which
extend around the bed to provide total visual privacy in combination
with adjacent walls and curtains;
(vi) Have at least one window to the outside; and
(vii) Have a floor at or above grade level.
(2) The facility must provide each resident with --
(i) A separate bed of proper size and height for the convenience of
the resident;
(ii) A clean, comfortable mattress;
(iii) Bedding appropriate to the weather and climate; and
(iv) Functional furniture appropriate to the resident's needs, and
individual closet space in the resident's bedroom with clothes racks and
shelves accessible to the resident.
(3) HCFA, or in the case of a nursing facility the survey agency, may
permit variations in requirements specified in paragraphs (d)(1) (i) and
(ii) of this section relating to rooms in individual cases when the
facility demonstrates in writing that the variations --
(i) Are in accordance with the special needs of the residents; and
(ii) Will not adversely affect residents' health and safety.
(e) Toilet facilities. Each resident room must be equipped with or
located near toilet and bathing facilities.
(f) Resident call system. The nurse's station must be equipped to
receive resident calls through a communication system from --
(1) Resident rooms; and
(2) Toilet and bathing facilities.
(g) Dining and resident activities. The facility must provide one or
more rooms designated for resident dining and activities. These rooms
must --
(1) Be well lighted;
(2) Be well ventilated, with nonsmoking areas identified;
(3) Be adequately furnished; and
(4) Have sufficient space to accommodate all activities.
(h) Other environmental conditions. The facility must provide a
safe, functional, sanitary, and comfortable environment for the
residents, staff and the public. The facility must --
(1) Establish procedures to ensure that water is available to
essential areas when there is a loss of normal water supply;
(2) Have adequate outside ventilation by means of windows, or
mechanical ventilation, or a combination of the two;
(3) Equip corridors with firmly secured handrails on each side; and
(4) Maintain an effective pest control program so that the facility
is free of pests and rodents.
(56 FR 48876, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23,
1992)
/1/ The Code is available for inspection at the Office of the Federal
Register Information Center, room 8301, 1110 L Street NW., Washington,
DC Copies may be obtained from the National Fire Protection Association,
Batterymarch Park, Quincy, MA 02200. If any changes in this code are
also to be incorporated by reference, a notice to that effect will be
published in the Federal Register.
42 CFR 483.75 Level A requirement: Administration.
A facility must be administered in a manner that enables it to use
its resources effectively and efficiently to attain or maintain the
highest practicable physical, mental, and psychosocial well-being of
each resident.
(a) Licensure. A facility must be licensed under applicable State
and local law.
(b) Compliance with Federal, State, and local laws and professional
standards. The facility must operate and provide services in compliance
with all applicable Federal, State, and local laws, regulations, and
codes, and with accepted professional standards and principles that
apply to professionals providing services in such a facility.
(c) Relationship to other HHS regulations. In addition to compliance
with the regulations set forth in this subpart, facilities are obliged
to meet the applicable provisions of other HHS regulations, including
but not limited to those pertaining to nondiscrimination on the basis of
race, color, or national origin (45 CFR part 80); nondiscrimination on
the basis of handicap (45 CFR part 84); nondiscrimination on the basis
of age (45 CFR part 91); protection of human subjects of research (45
CFR part 46); and fraud and abuse (42 CFR part 455). Although these
regulations are not in themselves considered requirements under this
part, their violation may result in the termination or suspension of, or
the refusal to grant or continue payment with Federal funds.
(d) Governing body. (1) The facility must have a governing body, or
designated persons functioning as a governing body, that is legally
responsible for establishing and implementing policies regarding the
management and operation of the facility; and
(2) The governing body appoints the administrator who is --
(i) Licensed by the State where licensing is required; and
(ii) Responsible for management of the facility.
(e) Required training of nursing aides -- (1) Definitions.
Licensed health professional means a physician; physician assistant;
nurse practitioner; physical, speech, or occupational therapist;
physical or occupational therapy assistant; registered professional
nurse; licensed practical nurse; or licensed or certified social
worker.
Nurse aide means any individual providing nursing or nursing-related
services to residents in a facility who is not a licensed health
professional, a registered dietitian, or someone who volunteers to
provide such services without pay.
(2) General rule. A facility must not use any individual working in
the facility as a nurse aide for more than 4 months, on a full-time
basis, unless:
(i) That individual is competent to provide nursing and nursing
related services; and
(ii)(A) That individual has completed a training and competency
evaluation program, or a competency evaluation program approved by the
State as meeting the requirements of 483.151-483.154 of this part; or
(B) That individual has been deemed or determined competent as
provided in 483.150 (a) and (b).
(3) Non-permanent employees. A facility must not use on a temporary,
per diem, leased, or any basis other than a permanent employee any
individual who does not meet the requirements in paragraphs (e)(2) (i)
and (ii) of this section.
(4) Competency. A facility must not use any individual who has
worked less than 4 months as a nurse aide in that facility unless the
individual --
(i) Is a full-time employee in a State-approved training and
competency evaluation program;
(ii) Has demonstrated competence through satisfactory participation
in a State-approved nurse aide training and competency evaluation
program or competency evaluation program; or
(iii) Has been deemed or determined competent as provided in 483.150
(a) and (b).
(5) Registry verification. Before allowing an individual to serve as
a nurse aide, a facility must receive registry verification that the
individual has met competency evaluation requirements unless --
(i) The individual is a full-time employee in a training and
competency evaluation program approved by the State; or
(ii) The individual can prove that he or she has recently
successfully completed a training and competency evaluation program or
competency evaluation program approved by the State and has not yet been
included in the registry. Facilities must follow up to ensure that such
an individual actually becomes registered.
(6) Multi-State registry verification. Before allowing an individual
to serve as a nurse aide, a facility must seek information from every
State registry established under sections 1819(e)(2)(A) or 1919(e)(2)(A)
of the Act the facility believes will include information on the
individual.
(7) Required retraining. If, since an individual's most recent
completion of a training and competency evaluation program, there has
been a continuous period of 24 consecutive months during none of which
the individual provided nursing or nursing-related services for monetary
compensation, the individual must complete a new training and competency
evaluation program or a new competency evaluation program.
(8) Regular in-service education. The facility must complete a
performance review of every nurse aide at least once every 12 months,
and must provide regular in-service education based on the outcome of
these reviews. The in-service training must --
(i) Be sufficient to ensure the continuing competence of nurse aides,
but must be no less than 12 hours per year;
(ii) Address areas of weakness as determined in nurse aides'
performance reviews and may address the special needs of residents as
determined by the facility staff; and
(iii) For nurse aides providing services to individuals with
cognitive impairments, also address the care of the cognitively
impaired.
(f) Proficiency of Nurse aides. The facility must ensure that nurse
aides are able to demonstrate competency in skills and techniques
necessary to care for residents' needs, as identified through resident
assessments, and described in the plan of care.
(g) Staff qualifications. (1) The facility must employ on a
full-time, part-time or consultant basis those professionals necessary
to carry out the provisions of these requirements.
(2) Professional staff must be licensed, certified, or registered in
accordance with applicable State laws.
(h) Use of outside resources. (1) If the facility does not employ a
qualified professional person to furnish a specific service to be
provided by the facility, the facility must have that service furnished
to residents by a person or agency outside the facility under an
arrangement described in section 1861(w) of the Act or an agreement
described in paragraph (h)(2) of this section.
(2) Arrangements as described in section 1861(w) of the Act or
agreements pertaining to services furnished by outside resources must
specify in writing that the facility assumes responsibility for --
(i) Obtaining services that meet professional standards and
principles that apply to professionals providing services in such a
facility; and
(ii) The timeliness of the services.
(i) Medical director. (1) The facility must designate a physician to
serve as medical director.
(2) The medical director is responsible for --
(i) Implementation of resident care policies; and
(ii) The coordination of medical care in the facility.
(j) Level B requirement: Laboratory services. (1) The facility must
provide or obtain laboratory services to meet the needs of its
residents. The facility is responsible for the quality and timeliness
of the services.
(i) If the facility provides its own laboratory services, the
services must meet the applicable requirements for laboratories
specified in part 493 of this chapter.
(ii) If the facility provides blood bank and transfusion services, it
must meet the applicable requirements for laboratories specified in part
493 of this chapter.
(iii) If the laboratory chooses to refer specimens for testing to
another laboratory, the referral laboratory must be certified in the
appropriate specialties and subspecialties of services in accordance
with the requirements of part 493 of this chapter.
(iv) If the facility does not provide laboratory services on site, it
must have an agreement to obtain these services from a laboratory that
meets the applicable requirements of part 493 of this chapter.
(2) The facility must --
(i) Provide or obtain laboratory services only when ordered by the
attending physician;
(ii) Promptly notify the attending physican of the findings;
(iii) Assist the resident in making transportation arrangements to
and from the source of service, if the resident needs asistance; and
(iv) File in the resident's clinical record laboratory reports that
are dated and contain the name and address of the testing laboratory.
(k) Radiology and other diagnostic services. (1) The facility must
provide or obtain radiology and other diagnostic services to meet the
needs of its residents. The facility is responsible for the quality and
timeliness of the services.
(i) If the facility provides its own diagnostic services, the
services must meet the applicable conditions of participation for
hospitals contained in 482.26 of this subchapter.
(ii) If the facility does not provide its own diagnostic services, it
must have an agreement to obtain these services from a provider or
supplier that is approved to provide these services under Medicare.
(2) The facility must --
(i) Provide or obtain radiology and other diagnostic services only
when ordered by the attending physician;
(ii) Promptly notify the attending physician of the findings;
(iii) Assist the resident in making transportation arrangements to
and from the source of service, if the resident needs assistance; and
(iv) File in the resident's clinical record signed and dated reports
of x-ray and other diagnostic services.
(l) Clinical records. (1) The facility must maintain clinical
records on each resident in accordance with accepted professional
standards and practices that are --
(i) Complete;
(ii) Accurately documented;
(iii) Readily accessible; and
(iv) Systematically organized.
(2) Clinical records must be retained for --
(i) The period of time required by State law; or
(ii) Five years from the date of discharge when there is no
requirement in State law; or
(iii) For a minor, three years after a resident reaches legal age
under State law.
(3) The facility must safeguard clinical record information against
loss, destruction, or unauthorized use;
(4) The facility must keep confidential all information contained in
the resident's records, regardless of the form or storage method of the
records, except when release is required by --
(i) Transfer to another health care institution;
(ii) Law;
(iii) Third party payment contract; or
(iv) The resident.
(5) The clinical record must contain --
(i) Sufficient information to identify the resident;
(ii) A record of the resident's assessments;
(iii) The plan of care and services provided;
(iv) The results of any preadmission screening conducted by the
State; and
(v) Progress notes.
(m) Disaster and emergency preparedness. (1) The facility must have
detailed written plans and procedures to meet all potential emergencies
and disasters, such as fire, severe weather, and missing residents.
(2) The facility must train all employees in emergency procedures
when they begin to work in the facility, periodically review the
procedures with existing staff, and carry out unannounced staff drills
using those procedures.
(n) Transfer agreement. (1) In accordance with section 1861(l) of
the Act, the facility (other than a nursing facility which is located in
a State on an Indian reservation) must have in effect a written transfer
agreement with one or more hospitals approved for participation under
the Medicare and Medicaid programs that reasonably assures that --
(i) Residents will be transferred from the facility to the hospital,
and ensured of timely admission to the hospital when transfer is
medically appropriate as determined by the attending physician; and
(ii) Medical and other information needed for care and treatment of
residents, and, when the transferring facility deems it appropriate, for
determining whether such residents can be adequately cared for in a less
expensive setting than either the facility or the hospital, will be
exchanged between the institutions.
(2) The facility is considered to have a transfer agreement in effect
if the facility has attempted in good faith to enter into an agreement
with a hospital sufficiently close to the facility to make transfer
feasible.
(o) Quality assessment and assurance. (1) A facility must maintain a
quality assessment and assurance committee consisting of --
(i) The director of nursing services;
(ii) A physician designated by the facility; and
(iii) At least 3 other members of the facility's staff.
(2) The quality assessment and assurance committee --
(i) Meets at least quarterly to identify issues with respect to which
quality assessment and assurance activities are necessary; and
(ii) Develops and implements appropriate plans of action to correct
identified quality deficiencies.
(3) A State or the Secretary may not require disclosure of the
records of such committee except in so far as such disclosure is related
to the compliance of such committee with the requirements of this
section.
(4) Good faith attempts by the committee to identify and correct
quality deficiencies will not be used as a basis for sanctions.
(p) Disclosure of ownership.
(1) The facility must comply with the disclosure requirements of
420.206 and 455.104 of this chapter.
(2) The facility must provide written notice to the State agency
responsible for licensing the facility at the time of change, if a
change occurs in --
(i) Persons with an ownership or control interest, as defined in
420.201 and 455.101 of this chapter;
(ii) The officers, directors, agents, or managing employees;
(iii) The corporation, association, or other company responsible for
the management of the facility; or
(iv) The facility's administrator or director of nursing.
(3) The notice specified in paragraph (p)(2) of this section must
include the identity of each new individual or company.
(56 FR 48877, Sept. 26, 1991, as amended at 56 FR 48918, Sept. 26,
1991; 57 FR 7136, Feb. 28, 1992; 57 FR 43925, Sept. 23, 1992)
42 CFR 483.75 Subpart C -- (Reserved)
42 CFR 483.75 Subpart D -- Requirements That Must Be Met by States and
State Agencies: Nurse Aide Training and Competency Evaluation
Source: 56 FR 48919, Sept. 26, 1991, unless otherwise noted.
42 CFR 483.150 Deemed meeting of requirements, waiver of requirements.
(a) A nurse aide is deemed to satisfy the requirement of completing a
training and competency evaluation approved by the State if he or she
successfully completed a training and competency evaluation program
before July 1, 1989 if --
(1) The aide would have satisfied this requirement if --
(i) At least 60 hours were substituted for 75 hours in sections
1819(f)(2) and 1919(f)(2) of the Act, and
(ii) The individual has made up at least the difference in the number
of hours in the program he or she completed and 75 hours in supervised
practical nurse aide training or in regular in-service nurse aide
education;
or
(2) The individual was found to be competent (whether or not by the
State) after the completion of nurse aide training of at least 100 hours
duration.
(b) A State may --
(1) Waive the requirement for an individual to complete a competency
evaluation program approved by the State for any individual who can
demonstrate to the satisfaction of the State that he or she has served
as a nurse aide at one or more facilities of the same employer in the
state for at least 24 consecutive months before December 19, 1989; or
(2) Deem an individual to have completed a nurse aide training and
competency evaluation program approved by the State if the individual
completed, before July 1, 1989, such a program that the State determines
would have met the requirements for approval at the time it was offered.
(56 FR 48919, Sept. 26, 1991; 56 FR 59331, Nov. 25, 1991)
42 CFR 483.151 State review and approval of nurse aide training and
competency evaluation programs and competency evaluation programs.
(a) State review and administration. (1) The State --
(i) Must specify any nurse aide training and competency evaluation
programs that the State approves as meeting the requirements of 483.152
and/or competency evaluations programs that the State approves as
meeting the requirements of 483.154; and
(ii) May choose to offer a nurse aide training and competency
evaluation program that meets the requirements of 483.152 and/or a
competency evaluation program that meets the requirements of 483.154.
(2) If the State does not choose to offer a nurse aide training and
competency evaluation program or competency evaluation program, the
State must review and approve or disapprove nurse aide training and
competency evaluation programs and nurse aide competency evaluation
programs upon request.
(3) The State survey agency must in the course of all surveys,
determine whether the nurse aide training and competency evaluation
requirements of 483.75(e) are met.
(b) Requirements for approval of programs. (1) Before the State
approves a nurse aide training and competency evaluation program or
competency evaluation program, the State must --
(i) Determine whether the nurse aide training and competency
evaluation program meets the course requirements of 483.152:
(ii) Determine whether the nurse aide competency evaluation program
meets the requirements of 483.154; and
(iii) In all reviews other than the initial review, visit the entity
providing the program.
(2) The State may not approve a nurse aide training and competency
evaluation program or competency evaluation program offered by or in a
facility which, in the previous two years --
(i) In the case of a skilled nursing facility, has operated under a
waiver under section 1819(b)(4)(C)(ii)(II) of the Act;
(ii) In the case of a nursing facility, has operated under a waiver
under section 1919(b)(4)(C)(ii) of the Act that was granted on the basis
of a demonstration that the facility is unable to provide nursing care
required under section 1919(b)(4)(C)(i) of the Act for a period in
excess of 48 hours per week;
(iii) Has been subject to an extended (or partial extended) survey
under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act;
(iv) Has been assessed a civil money penalty described in section
1819(h)(2)(B)(ii) of 1919(h)(2)(A)(ii) of the Act of not less than
$5,000; or
(v) Has been subject to a remedy described in sections 1819(h)(2)(B)
(i) or (iii), 1819(h)(4), 1919(h)(1)(B)(i), or 1919(h)(2)(A) (i), (iii)
or (iv) of the Act.
(3) A State may not, until two years since the assessment of the
penalty (or penalties) has elapsed, approve a nurse aide training and
competency evaluation program or competency evaluation program offered
by or in a facility that, within the two-year period beginning October
1, 1988 --
(i) Had its participation terminated under title XVIII of the Act or
under the State plan under title XIX of the Act;
(ii) Was subject to a denial of payment under title XVIII or title
XIX;
(iii) Was assessed a civil money penalty of not less than $5,000 for
deficiencies in nursing facility standards;
(iv) Operated under temporary management appointed to oversee the
operation of the facility and to ensure the health and safety of its
residents; or
(v) Pursuant to State action, was closed or had its residents
transferred.
(c) Time frame for acting on a request for approval. The State must,
within 90 days of the date of a request under paragraph (a)(3) of this
section or receipt of additional information from the requester --
(1) Advise the requester whether or not the program has been
approved; or
(2) Request additional information form the requesting entity.
(d) Duration of approval. The State may not grant approval of a
nurse aide training and competency evaluation program for a period
longer than 2 years. A program must notify the State and the State must
review that program when there are substantive changes made to that
program within the 2-year period.
(e) Withdrawal of approval. (1) The State must withdraw approval of
a nurse aide training and competency evaluation program or nurse aide
competency evaluation program offered by or in a facility described in
paragraph (b)(2) of this section.
(2) The State may withdraw approval of a nurse aide training and
competency evaluation program or nurse aide competency evaluation
program if the State determines that any of the applicable requirements
of 483.152 or 483.154 are not met by the program.
(3) The State must withdraw approval of a nurse aide training and
competency evaluation program or a nurse aide competency evaluation
program if the entity providing the program refuses to permit
unannounced visits by the State.
(4) If a State withdraws approval of a nurse aide training and
competency evaluation program or competency evaluation program --
(i) The State must notify the program in writing, indicating the
reason(s) for withdrawal of approval of the program.
(ii) Students who have started a training and competency evaluation
program from which approval has been withdrawn must be allowed to
complete the course.
42 CFR 483.152 Requirements for approval of a nurse aide training and
competency evaluation program.
(a) For a nurse aide training and competency evaluation program to be
approved by the State, it must, at a minimum --
(1) Consist of no less than 75 clock hours of training;
(2) Include at least the subjects specified in paragraph (b) of this
section;
(3) Include at least 16 hours of supervised practical training.
Supervised practical training means training in a laboratory or other
setting in which the trainee demonstrates knowledge while performing
tasks on an individual under the direct supervision of a registered
nurse or a licensed practical nurse;
(4) Ensure that --
(i) Students do not perform any services for which they have not
trained and been found proficient by the instructor; and
(ii) Students who are providing services to residents are under the
general supervision of a licensed nurse or a registered nurse;
(5) Meet the following requirements for instructors who train nurse
aides;
(i) The training of nurse aides must be performed by or under the
general supervision of a registered nurse who possesses a minimum of 2
years of nursing experience, at least 1 year of which must be in the
provision of long term care facility services;
(ii) Instructors must have completed a course in teaching adults or
have experience in teaching adults or supervising nurse aides;
(iii) In a facility-based program, the training of nurse aides may be
performed under the general supervision of the director of nursing for
the facility who is prohibited from performing the actual training; and
(iv) Other personnel from the health professions may supplement the
instructor, including, but not limited to, registered nurses, licensed
practical/vocational nurses, pharmacists, dietitians, social workers,
sanitarians, fire safety experts, nursing home administrators,
gerontologists, psychologists, physical and occupational therapists,
activities specialists, speech/language/hearing therapists, and resident
rights experts. Supplemental personnel must have at least 1 year of
experience in their fields;
(6) Contain competency evaluation procedures specified in 483.154.
(b) The curriculum of the nurse aide training program must include --
(1) At least a total of 16 hours of training in the following areas
prior to any direct contact with a resident:
(i) Communication and interpersonal skills;
(ii) Infection control;
(iii) Safety/emergency procedures, including the Heimlich maneuver;
(iv) Promoting residents' independence; and
(v) Respecting residents' rights.
(2) Basic nursing skills;
(i) Taking and recording vital signs;
(ii) Measuring and recording height and weight;
(iii) Caring for the residents' environment;
(iv) Recognizing abnormal changes in body functioning and the
importance of reporting such changes to a supervisor; and
(v) Caring for residents when death is imminent.
(3) Personal care skills, including, but not limited to --
(i) Bathing;
(ii) Grooming, including mouth care;
(iii) Dressing;
(iv) Toileting;
(v) Assisting with eating and hydration;
(vi) Proper feeding techniques;
(vii) Skin care; and
(viii) Transfers, positioning, and turning.
(4) Mental health and social service needs:
(i) Modifying aide's behavior in response to residents' behavior;
(ii) Awareness of developmental tasks associated with the aging
process;
(iii) How to respond to resident behavior;
(iv) Allowing the resident to make personal choices, providing and
reinforcing other behavior consistent with the resident's dignity; and
(v) Using the resident's family as a source of emotional support.
(5) Care of cognitively impaired residents:
(i) Techniques for addressing the unique needs and behaviors of
individual with dementia (Alzheimer's and others);
(ii) Communicating with cognitively impaired residents;
(iii) Understanding the behavior of cognitively impaired residents;
(iv) Appropriate responses to the behavior of cognitively impaired
residents; and
(v) Methods of reducing the effects of cognitive impairments.
(6) Basic restorative services:
(i) Training the resident in self care according to the resident's
abilities;
(ii) Use of assistive devices in transferring, ambulation, eating,
and dressing;
(iii) Maintenance of range of motion;
(iv) Proper turning and positioning in bed and chair;
(v) Bowel and bladder training; and
(vi) Care and use of prosthetic and orthotic devices.
(7) Residents' Rights.
(i) Providing privacy and maintenance of confidentiality;
(ii) Promoting the residents' right to make personal choices to
accommodate their needs;
(iii) Giving assistance in resolving grievances and disputes;
(iv) Providing needed assistance in getting to and participating in
resident and family groups and other activities;
(v) Maintaining care and security of residents' personal possessions;
(vi) Promoting the resident's right to be free from abuse,
mistreatment, and neglect and the need to report any instances of such
treatment to appropriate facility staff;
(vii) Avoiding the need for restraints in accordance with current
professional standards.
(c) Prohibition of charges. (1) No nurse aide who is employed by, or
who has received an offer of employment from, a facility on the date on
which the aide begins a nurse aide training and competency evaluation
program may be charged for any portion of the program (including any
fees for textbooks or other required course materials).
(2) If an individual who is not employed, or does not have an offer
to be employed, as a nurse aide becomes employed by, or receives an
offer of employment from, a facility not later than 12 months after
completing a nurse aide training and competency evaluation program, the
State must provide for the reimbursement of costs incurred in completing
the program on a pro rata basis during the period in which the
individual is employed as a nurse aide.
42 CFR 483.154 Nurse aide competency evaluation.
(a) Notification to Individual. The State must advise in advance any
individual who takes the competency evaluation that a record of the
successful completion of the evaluation will be included in the State's
nurse aid registry.
(b) Content of the competency evaluation program -- (1) Written or
oral examinations. The competency evaluation must --
(i) Allow an aide to choose between a written and an oral
examination;
(ii) Address each course requirement specified in 483.152(b);
(iii) Be developed from a pool of test questions, only a portion of
which is used in any one examination;
(iv) Use a system that prevents disclosure of both the pool of
questions and the individual competency evaluations; and
(v) If oral, must be read from a prepared text in a neutral manner.
(2) Demonstration of skills. The skills demonstration must consist
of a demonstration of randomly selected items drawn from a pool
consisting of the tasks generally performed by nurse aides. This pool
of skills must include all of the personal care skills listed in
483.152(b)(3).
(c) Administration of the competency evaluation. (1) The competency
examination must be administered and evaluated only by --
(i) The State directly; or
(ii) A State approved entity which is neither a skilled nursing
facility that participates in Medicare nor a nursing facility that
participates in Medicaid.
(2) No nurse aide who is employed by, or who has received an offer of
employment from, a facility on the date on which the aide begins a nurse
aide competency evaluation program may be charged for any portion of the
program.
(3) If an individual who is not employed, or does not have an offer
to be employed, as a nurse aide becomes employed by, or receives an
offer of employment from, a facility not later than 12 months after
completing a nurse aide competency evaluation program, the State must
provide for the reimbursement of costs incurred in completing the
program on a pro rata basis during the period in which the individual is
employed as a nurse aide.
(4) The skills demonstration part of the evaluation must be --
(i) Performed in a facility or laboratory setting comparable to the
setting in which the individual will function as a nurse aide; and
(ii) Administered and evaluated by a registered nurse with at least
one year's experience in providing care for the elderly or the
chronically ill of any age.
(d) Facility proctoring of the competency evaluation. (1) The
competency evaluation may, at the nurse aide's option, be conducted at
the facility in which the nurse aide is or will be employed unless the
facility is described in 483.151(b)(2).
(2) The State may permit the competency evaluation to be proctored by
facility personnel if the State finds that the procedure adopted by the
facility assures that the competency evaluation program --
(i) Is secure from tampering;
(ii) Is standardized and scored by a testing, educational, or other
organization approved by the State; and
(iii) Requires no scoring by facility personnel.
(3) The State must retract the right to proctor nurse aide competency
evaluations from facilities in which the State finds any evidence of
impropriety, including evidence of tampering by facility staff.
(e) Successful completion of the competency evaluation program. (1)
The State must establish a standard for satisfactory completion of the
competency evaluation. To complete the competency evaluation
successfully an individual must pass both the written or oral
examination and the skills demonstration.
(2) A record of successful completion of the competency evaluation
must be included in the nurse aide registry provided in 483.156 within
30 days of the date if the individual is found to be competent.
(f) Unsuccessful completion of the competency evaluation program.
(1) If the individual does not complete the evaluation satisfactorily,
the individual must be advised --
(i) Of the areas which he or she; did not pass; and
(ii) That he or she has at least three opportunities to take the
evaluation.
(2) The State may impose a maximum upon the number of times an
individual upon the number of times an individual may attempt to
complete the competency evaluation successfully, but the maximum may be
no less than three.
42 CFR 483.156 Registry of nurse aides.
(a) Establishment of registry. The State must establish and maintain
a registry of nurse aides that meets the requirement of this section.
The registry --
(1) Must include as a minimum the information contained in paragraph
(c) of this section:
(2) Must be sufficiently accessible to meet the needs of the public
and health care providers promptly;
(3) May include home health aides who have successfully completed a
home health aide competency evaluation program approved by the State if
home health aides are differentiated from nurse aides; and
(4) Must provide that any response to an inquiry that includes a
finding of abuse, neglect, or misappropriation of property also include
any statement disputing the finding made by the nurse aide, as provided
under paragraph (c)(1)(ix) of this section.
(b) Registry operation. (1) The State may contract the daily
operation and maintenance of the registry to a non-State entity.
However, the State must maintain accountability for overall operation of
the registry and compliance with these regulations.
(2) Only the State survey and certification agency may place on the
registry findings of abuse, neglect, or misappropriation of property.
(3) The State must determine which individuals who (i) have
successfully completed a nurse aide training and competency evaluation
program or nurse aide competency evaluation program; (ii) have been
deemed as meeting these requirements; or (iii) have had these
requirements waived by the State do not qualify to remain on the
registry because they have performed no nursing or nursing-related
services for a period of 24 consecutive months.
(4) The State may not impose any charges related to registration on
individuals listed in the registry.
(5) The State must provide information on the registry promptly.
(c) Registry Content. (1) (The registry must contain at least the
following information on each individual who has successfully completed
a nurse aide training and competency evaluation program which meets the
requirements of 483.152 or a competency evaluation which meets the
requirements of 483.154 and has been found by the State to be competent
to function as a nurse aide or who may function as a nurse aide because
of meeting criteria in 483.150:
(i) The individual's full name.
(ii) Information necessary to identify each individual;
(iii) The date the individual became eligible for placement in the
registry through successfully completing a nurse aide training and
competency evaluation program or competency evaluation program or by
meeting the requirements of 483.150; and
(iv) The following information on any finding by the State survey
agency of abuse, neglect, or misappropriation of property by the
individual:
(A) Documentation of the State's investigation, including the nature
of the allegation and the evidence that led the State to conclude that
the allegation was valid;
(B) The date of the hearing, if the individual chose to have one, and
its outcome; and
(C) A statement by the individual disputing the allegation, if he or
she chooses to make one; and
(D) This information must be included in the registry within 10
working days of the finding and must remain in the registry permanently,
unless the finding was made in error, the individual was found not
guilty in a court of law, or the State is notified of the individual's
death.
(2) The registry must remove entries for individuals who have
performed no nursing or nursing-related services for a period of 24
consecutive months, unless the individual's registry entry includes
documented findings of abuse, neglect, or misappropriation of property.
(d) Disclosure of information. The State must --
(1) Disclose all of the information in 483.156(c)(1) (iii) and (iv)
to all requesters and may disclose additional information it deems
necessary; and
(2) Promptly provide individuals with all information contained in
the registry on them when adverse findings are placed on the registry
and upon request. Individuals on the registry must have sufficient
opportunity to correct any misstatements or inaccuracies contained in
the registry.
(56 FR 48919, Sept. 26, 1991; 56 FR 59331, Nov. 25, 1991)
42 CFR 483.158 FFP for nurse aide training and competency evaluation.
(a) State expenditures for nurse aide training and competency
evaluation programs and competency evaluation programs are
administrative costs. They are matched as indicated in 433.15(b)(8) of
this chapter.
(b) FFP is available for State expenditures associated with nurse
aide training and competency evaluation programs and competency
evaluation programs only for --
(1) Nurse aides employed by a facility;
(2) Nurse aides who have an offer of employment from a facility;
(3) Nurse aides who become employed by a facility not later than 12
months after completing a nurse aide training and competency evaluation
program or competency evaluation program; or
(4) Nurse aides who receive an offer of employment from a facility
not later than 12 months after completing a nurse aide training and
competency evaluation program or competency evaluation program.
42 CFR 483.158 Subparts E-H -- (Reserved)
42 CFR 483.158 Subpart I -- Conditions of Participation for
Intermediate Care Facilities for the Mentally Retarded
Source: 53 FR 20496, June 3, 1988. Redesignated at 56 FR 48918,
Sept. 26, 1991.
42 CFR 483.400 Basis and purpose.
This subpart implements section 1905 (c) and (d) of the Act which
gives the Secretary authority to prescribe regulations for intermediate
care facility services in facilities for the mentally retarded or
persons with related conditions.
42 CFR 483.405 Relationship to other HHS regulations.
In addition to compliance with the regulations set forth in this
subpart, facilities are obliged to meet the applicable provisions of
other HHS regulations, including but not limited to those pertaining to
nondiscrimination on the basis of race, color, or national origin (45
CFR Part 80), nondiscrimination on the basis of handicap (45 CFR Part
84), nondiscrimination on the basis of age (45 CFR Part 91), protection
of human subjects of research (45 CFR Part 46), and fraud and abuse (42
CFR Part 455). Although those regulations are not in themselves
considered conditions of participation under this Part, their violation
may result in the termination or suspension of, or the refusal to grant
or continue, Federal financial assistance.
42 CFR 483.410 Condition of participation: Governing body and
management.
(a) Standard: Governing body. The facility must identify an
individual or individuals to constitute the governing body of the
facility. The governing body must --
(1) Exercise general policy, budget, and operating direction over the
facility;
(2) Set the qualifications (in addition to those already set by State
law, if any) for the administrator of the facility; and
(3) Appoint the administrator of the facility.
(b) Standard: Compliance with Federal, State, and local laws. The
facility must be in compliance with all applicable provisions of
Federal, State and local laws, regulations and codes pertaining to
health, safety, and sanitation.
(c) Standard: Client records.
(1) The facility must develop and maintain a recordkeeping system
that includes a separate record for each client and that documents the
client's health care, active treatment, social information, and
protection of the client's rights.
(2) The facility must keep confidential all information contained in
the clients' records, regardless of the form or storage method of the
records.
(3) The facility must develop and implement policies and procedures
governing the release of any client information, including consents
necessary from the client, or parents (if the client is a minor) or
legal guardian.
(4) Any individual who makes an entry in a client's record must make
it legibly, date it, and sign it.
(5) The facility must provide a legend to explain any symbol or
abbreviation used in a client's record.
(6) The facility must provide each identified residential living unit
with appropriate aspects of each client's record.
(d) Standard: Services provided under agreements with outside
sources.
(1) If a service required under this subpart is not provided
directly, the facility must have a written agreement with an outside
program, resource, or service to furnish the necessary service,
including emergency and other health care.
(2) The agreement must --
(i) Contain the responsibilities, functions, objectives, and other
terms agreed to by both parties; and
(ii) Provide that the facility is responsible for assuring that the
outside services meet the standards for quality of services contained in
this subpart.
(3) The facility must assure that outside services meet the needs of
each client.
(4) If living quarters are not provided in a facility owned by the
ICF/MR, the ICF/MR remains directly responsible for the standards
relating to physical environment that are specified in 483.470 (a)
through (g), (j) and (k).
(e) Standard: Licensure. The facility must be licensed under
applicable State and local law.
(53 FR 20496, June 3, 1988. Redesignated at 56 FR 48918, Sept. 26,
1991, and amended at 57 FR 43925, Sept. 23, 1992)
42 CFR 483.420 Condition of participation: Client protections.
(a) Standard: Protection of clients' rights. The facility must
ensure the rights of all clients. Therefore, the facility must --
(1) Inform each client, parent (if the client is a minor), or legal
guardian, of the client's rights and the rules of the facility;
(2) Inform each client, parent (if the client is a minor), or legal
guardian, of the client's medical condition, developmental and
behavioral status, attendant risks of treatment, and of the right to
refuse treatment;
(3) Allow and encourage individual clients to exercise their rights
as clients of the facility, and as citizens of the United States,
including the right to file complaints, and the right to due process;
(4) Allow individual clients to manage their financial affairs and
teach them to do so to the extent of their capabilities;
(5) Ensure that clients are not subjected to physical, verbal, sexual
or psychological abuse or punishment;
(6) Ensure that clients are free from unnecessary drugs and physical
restraints and are provided active treatment to reduce dependency on
drugs and physical restraints;
(7) Provide each client with the opportunity for personal privacy and
ensure privacy during treatment and care of personal needs;
(8) Ensure that clients are not compelled to perform services for the
facility and ensure that clients who do work for the facility are
compensated for their efforts at prevailing wages and commensurate with
their abilities;
(9) Ensure clients the opportunity to communicate, associate and meet
privately with individuals of their choice, and to send and receive
unopened mail;
(10) Ensure that clients have access to telephones with privacy for
incoming and outgoing local and long distance calls except as
contraindicated by factors identified within their individual program
plans;
(11) Ensure clients the opportunity to participate in social,
religious, and community group activities;
(12) Ensure that clients have the right to retain and use appropriate
personal possessions and clothing, and ensure that each client is
dressed in his or her own clothing each day; and
(13) Permit a husband and wife who both reside in the facility to
share a room.
(b) Standard: Client finances. (1) The facility must establish and
maintain a system that --
(i) Assures a full and complete accounting of clients' personal funds
entrusted to the facility on behalf of clients; and
(ii) Precludes any commingling of client funds with facility funds or
with the funds of any person other than another client.
(2) The client's financial record must be available on request to the
client, parents (if the client is a minor) or legal guardian.
(c) Standard: Communication with clients, parents, and guardians.
The facility must --
(1) Promote participation of parents (if the client is a minor) and
legal guardians in the process of providing active treatment to a client
unless their participation is unobtainable or inappropriate;
(2) Answer communications from clients' families and friends promptly
and appropriately;
(3) Promote visits by individuals with a relationship to the client
(such as family, close friends, legal guardians and advocates) at any
reasonable hour, without prior notice, consistent with the right of that
client's and other clients' privacy, unless the interdisciplinary team
determines that the visit would not be appropriate;
(4) Promote visits by parents or guardians to any area of the
facility that provides direct client care services to the client,
consistent with the right of that client's and other clients' privacy;
(5) Promote frequent and informal leaves from the facility for
visits, trips, or vacations; and
(6) Notify promptly the client's parents or guardian of any
significant incidents, or changes in the client's condition including,
but not limited to, serious illness, accident, death, abuse, or
unauthorized absence.
(d) Standard: Staff treatment of clients. (1) The facility must
develop and implement written policies and procedures that prohibit
mistreatment, neglect or abuse of the client.
(i) Staff of the facility must not use physical, verbal, sexual or
psychological abuse or punishment.
(ii) Staff must not punish a client by withholding food or hydration
that contributes to a nutritionally adequate diet.
(iii) The facility must prohibit the employment of individuals with a
conviction or prior employment history of child or client abuse, neglect
or mistreatment.
(2) The facility must ensure that all allegations of mistreatment,
neglect or abuse, as well as injuries of unknown source, are reported
immediately to the administrator or to other officials in accordance
with State law through established procedures.
(3) The facility must have evidence that all alleged violations are
thoroughly investigated and must prevent further potential abuse while
the investigation is in progress.
(4) The results of all investigations must be reported to the
administrator or designated representative or to other officials in
accordance with State law within five working days of the incident and,
if the alleged violation is verified, appropriate corrective action must
be taken.
42 CFR 483.430 Condition of participation: Facility staffing.
(a) Standard: Qualified mental retardation professional. Each
client's active treatment program must be integrated, coordinated and
monitored by a qualified mental retardation professional who --
(1) Has at least one year of experience working directly with persons
with mental retardation or other developmental disabilities; and
(2) Is one of the following:
(i) A doctor of medicine or osteopathy.
(ii) A registered nurse.
(iii) An individual who holds at least a bachelor's degree in a
professional category specified in paragraph (b)(5) of this section.
(b) Standard: Professional program services. (1) Each client must
receive the professional program services needed to implement the active
treatment program defined by each client's individual program plan.
Professional program staff must work directly with clients and with
paraprofessional, nonprofessional and other professional program staff
who work with clients.
(2) The facility must have available enough qualified professional
staff to carry out and monitor the various professional interventions in
accordance with the stated goals and objectives of every individual
program plan.
(3) Professional program staff must participate as members of the
interdisciplinary team in relevant aspects of the active treatment
process.
(4) Professional program staff must participate in on-going staff
development and training in both formal and informal settings with other
professional, paraprofessional, and nonprofessional staff members.
(5) Professional program staff must be licensed, certified, or
registered, as applicable, to provide professional services by the State
in which he or she practices. Those professional program staff who do
not fall under the jurisdiction of State licensure, certification, or
registration requirements, specified in 483.410(b), must meet the
following qualifications:
(i) To be designated as an occupational therapist, an individual must
be eligible for certification as an occupational therapist by the
American Occupational Therapy Association or another comparable body.
(ii) To be designated as an occupational therapy assistant, an
individual must be eligible for certification as a certified
occupational therapy assistant by the American Occupational Therapy
Association or another comparable body.
(iii) To be designated as a physical therapist, an individual must be
eligible for certification as a physical therapist by the American
Physical Therapy Association or another comparable body.
(iv) To be designated as a physical therapy assistant, an individual
must be eligible for registration by the American Physical Therapy
Association or be a graduate of a two year college-level program
approved by the American Physical Therapy Association or another
comparable body.
(v) To be designated as a psychologist, an individual must have at
least a master's degree in psychology from an accredited school.
(vi) To be designated as a social worker, an individual must --
(A) Hold a graduate degree from a school of social work accredited or
approved by the Council on Social Work Education or another comparable
body; or
(B) Hold a Bachelor of Social Work degree from a college or
university accredited or approved by the Council on Social Work
Education or another comparable body.
(vii) To be designated as a speech-language pathologist or
audiologist, an individual must --
(A) Be eligible for a Certificate of Clinical Competence in
Speech-Language Pathology or Audiology granted by the American
Speech-Language-Hearing Association or another comparable body; or
(B) Meet the educational requirements for certification and be in the
process of accumulating the supervised experience required for
certification.
(viii) To be designated as a professional recreation staff member, an
individual must have a bachelor's degree in recreation or in a specialty
area such as art, dance, music or physical education.
(ix) To be designated as a professional dietitian, an individual must
be eligible for registration by the American Dietetics Association.
(x) To be designated as a human services professional an individual
must have at least a bachelor's degree in a human services field
(including, but not limited to: sociology, special education,
rehabilitation counseling, and psychology).
(xi) If the client's individual program plan is being successfully
implemented by facility staff, professional program staff meeting the
qualifications of paragraph (b)(5) (i) through (x) of this section are
not required --
(A) Except for qualified mental retardation professionals;
(B) Except for the requirements of paragraph (b)(2) of this section
concerning the facility's provision of enough qualified professional
program staff; and
(C) Unless otherwise specified by State licensure and certification
requirements.
(c) Standard: Facility staffing. (1) The facility must not depend
upon clients or volunteers to perform direct care services for the
facility.
(2) There must be responsible direct care staff on duty and awake on
a 24-hour basis, when clients are present, to take prompt, appropriate
action in case of injury, illness, fire or other emergency, in each
defined residential living unit housing --
(i) Clients for whom a physician has ordered a medical care plan;
(ii) Clients who are aggressive, assaultive or security risks;
(iii) More than 16 clients; or
(iv) Fewer than 16 clients within a multi-unit building.
(3) There must be a responsible direct care staff person on duty on a
24 hour basis (when clients are present) to respond to injuries and
symptoms of illness, and to handle emergencies, in each defined
residential living unit housing --
(i) Clients for whom a physician has not ordered a medical care plan;
(ii) Clients who are not aggressive, assaultive or security risks;
and
(iii) Sixteen or fewer clients,
(4) The facility must provide sufficient support staff so that direct
care staff are not required to perform support services to the extent
that these duties interfere with the exercise of their primary direct
client care duties.
(d) Standard: Direct care (residential living unit) staff. (1) The
facility must provide sufficient direct care staff to manage and
supervise clients in accordance with their individual program plans.
(2) Direct care staff are defined as the present on-duty staff
calculated over all shifts in a 24-hour period for each defined
residential living unit.
(3) Direct care staff must be provided by the facility in the
following minimum ratios of direct care staff to clients:
(i) For each defined residential living unit serving children under
the age of 12, severely and profoundly retarded clients, clients with
severe physical disabilities, or clients who are aggressive, assaultive,
or security risks, or who manifest severely hyperactive or
psychotic-like behavior, the staff to client ratio is 1 to 3.2.
(ii) For each defined residential living unit serving moderately
retarded clients, the staff to client ratio is 1 to 4.
(iii) For each defined residential living unit serving clients who
function within the range of mild retardation, the staff to client ratio
is 1 to 6.4.
(4) When there are no clients present in the living unit, a
responsible staff member must be available by telephone.
(e) Standard: Staff training program. (1) The facility must provide
each employee with initial and continuing training that enables the
employee to perform his or her duties effectively, efficiently, and
competently.
(2) For employees who work with clients, training must focus on
skills and competencies directed toward clients' developmental,
behavioral, and health needs.
(3) Staff must be able to demonstrate the skills and techniques
necessary to administer interventions to manage the inappropriate
behavior of clients.
(4) Staff must be able to demonstrate the skills and techniques
necessary to implement the individual program plans for each client for
whom they are responsible.
42 CFR 483.440 Condition of participation: Active treatment services.
(a) Standard: Active treatment. (1) Each client must receive a
continuous active treatment program, which includes aggressive,
consistent implementation of a program of specialized and generic
training, treatment, health services and related services described in
this subpart, that is directed toward --
(i) The acquisition of the behaviors necessary for the client to
function with as much self determination and independence as possible;
and
(ii) The prevention or deceleration of regression or loss of current
optimal functional status.
(2) Active treatment does not include services to maintain generally
independent clients who are able to function with little supervision or
in the absence of a continuous active treatment program.
(b) Standard: Admissions, transfers, and discharge. (1) Clients who
are admitted by the facility must be in need of and receiving active
treatment services.
(2) Admission decisions must be based on a preliminary evaluation of
the client that is conducted or updated by the facility or by outside
sources.
(3) A preliminary evaluation must contain background information as
well as currently valid assessments of functional developmental,
behavioral, social, health and nutritional status to determine if the
facility can provide for the client's needs and if the client is likely
to benefit from placement in the facility.
(4) If a client is to be either transferred or discharged, the
facility must --
(i) Have documentation in the client's record that the client was
transferred or discharged for good cause; and
(ii) Provide a reasonable time to prepare the client and his or her
parents or guardian for the transfer or discharge (except in
emergencies).
(5) At the time of the discharge, the facility must --
(i) Develop a final summary of the client's developmental,
behavioral, social, health and nutritional status and, with the consent
of the client, parents (if the client is a minor) or legal guardian,
provide a copy to authorized persons and agencies; and
(ii) Provide a post-discharge plan of care that will assist the
client to adjust to the new living environment.
(c) Standard: Individual program plan. (1) Each client must have an
individual program plan developed by an interdisciplinary team that
represents the professions, disciplines or service areas that are
relevant to --
(i) Identifying the client's needs, as described by the comprehensive
functional assessments required in paragraph (c)(3) of this section;
and
(ii) Designing programs that meet the client's needs.
(2) Appropriate facility staff must participate in interdisciplinary
team meetings. Participation by other agencies serving the client is
encouraged. Participation by the client, his or her parent (if the
client is a minor), or the client's legal guardian is required unless
that participation is unobtainable or inappropriate.
(3) Within 30 days after admission, the interdisciplinary team must
perform accurate assessments or reassessments as needed to supplement
the preliminary evaluation conducted prior to admission. The
comprehensive functional assessment must take into consideration the
client's age (for example, child, young adult, elderly person) and the
implications for active treatment at each stage, as applicable, and must
--
(i) Identify the presenting problems and disabilities and where
possible, their causes;
(ii) Identify the client's specific developmental strengths;
(iii) Identify the client's specific developmental and behavioral
management needs;
(iv) Identify the client's need for services without regard to the
actual availability of the services needed; and
(v) Include physical development and health, nutritional status,
sensorimotor development, affective development, speech and language
development and auditory functioning, cognitive development, social
development, adaptive behaviors or independent living skills necessary
for the client to be able to function in the community, and as
applicable, vocational skills.
(4) Within 30 days after admission, the interdisciplinary team must
prepare for each client an individual program plan that states the
specific objectives necessary to meet the client's needs, as identified
by the comprehensive assessment required by paragraph (c)(3) of this
section, and the planned sequence for dealing with those objectives.
These objectives must --
(i) Be stated separately, in terms of a single behavioral outcome;
(ii) Be assigned projected completion dates;
(iii) Be expressed in behavioral terms that provide measurable
indices of performance;
(iv) Be organized to reflect a developmental progression appropriate
to the individual; and
(v) Be assigned priorities.
(5) Each written training program designed to implement the
objectives in the individual program plan must specify:
(i) The methods to be used;
(ii) The schedule for use of the method;
(iii) The person responsible for the program;
(iv) The type of data and frequency of data collection necessary to
be able to assess progress toward the desired objectives;
(v) The inappropriate client behavior(s), if applicable; and
(vi) Provision for the appropriate expression of behavior and the
replacement of inappropriate behavior, if applicable, with behavior that
is adaptive or appropriate.
(6) The individual program plan must also:
(i) Describe relevant interventions to support the individual toward
independence.
(ii) Identify the location where program strategy information (which
must be accessible to any person responsible for implementation) can be
found.
(iii) Include, for those clients who lack them, training in personal
skills essential for privacy and independence (including, but not
limited to, toilet training, personal hygiene, dental hygiene,
self-feeding, bathing, dressing, grooming, and communication of basic
needs), until it has been demonstrated that the client is
developmentally incapable of acquiring them.
(iv) Identify mechanical supports, if needed, to achieve proper body
position, balance, or alignment. The plan must specify the reason for
each support, the situations in which each is to be applied, and a
schedule for the use of each support.
(v) Provide that clients who have multiple disabling conditions spend
a major portion of each waking day out of bed and outside the bedroom
area, moving about by various methods and devices whenever possible.
(iv) Include opportunities for client choice and self-management.
(7) A copy of each client's individual program plan must be made
available to all relevant staff, including staff of other agencies who
work with the client, and to the client, parents (if the client is a
minor) or legal guardian.
(d) Standard: Program implementation. (1) As soon as the
interdisciplinary team has formulated a client's individual program
plan, each client must receive a continuous active treatment program
consisting of needed interventions and services in sufficient number and
frequency to support the achievement of the objectives identified in the
individual program plan.
(2) The facility must develop an active treatment schedule that
outlines the current active treatment program and that is readily
available for review by relevant staff.
(3) Except for those facets of the individual program plan that must
be implemented only by licensed personnel, each client's individual
program plan must be implemented by all staff who work with the client,
including professional, paraprofessional and nonprofessional staff.
(e) Standard: Program documentation. (1) Data relative to
accomplishment of the criteria specified in client individual program
plan objectives must be documented in measureable terms.
(2) The facility must document significant events that are related to
the client's individual program plan and assessments and that contribute
to an overall understanding of the client's ongoing level and quality of
functioning.
(f) Standard: Program monitoring and change. (1) The individual
program plan must be reviewed at least by the qualified mental
retardation professional and revised as necessary, including, but not
limited to situations in which the client --
(i) Has successfully completed an objective or objectives identified
in the individual program plan;
(ii) Is regressing or losing skills already gained;
(iii) Is failing to progress toward identified objectives after
reasonable efforts have been made; or
(iv) Is being considered for training towards new objectives.
(2) At least annually, the comprehensive functional assessment of
each client must be reviewed by the interdisciplinary team for relevancy
and updated as needed, and the individual program plan must be revised,
as appropriate, repeating the process set forth in paragraph (c) of this
section.
(3) The facility must designate and use a specially constituted
committee or committees consisting of members of facility staff,
parents, legal guardians, clients (as appropriate), qualified persons
who have either experience or training in contemporary practices to
change inappropriate client behavior, and persons with no ownership or
controlling interest in the facility to --
(i) Review, approve, and monitor individual programs designed to
manage inappropriate behavior and other programs that, in the opinion of
the committee, involve risks to client protection and rights;
(ii) Insure that these programs are conducted only with the written
informed consent of the client, parent (if the client is a minor), or
legal guardian; and
(iii) Review, monitor and make suggestions to the facility about its
practices and programs as they relate to drug usage, physical
restraints, time-out rooms, application of painful or noxious stimuli,
control of inappropriate behavior, protection of client rights and
funds, and any other area that the committee believes need to be
addressed.
(4) The provisions of paragraph (f)(3) of this section may be
modified only if, in the judgment of the State survey agency, Court
decrees, State law or regulations provide for equivalent client
protection and consultation.
42 CFR 483.450 Condition of participation: Client behavior and
facility practices.
(a) Standard: Facility practices -- Conduct toward clients. (1) The
facility must develop and implement written policies and procedures for
the management of conduct between staff and clients. These policies and
procedures must --
(i) Promote the growth, development and independence of the client;
(ii) Address the extent to which client choice will be accommodated
in daily decision-making, emphasizing self-determination and
self-management, to the extent possible;
(iii) Specify client conduct to be allowed or not allowed; and
(iv) Be available to all staff, clients, parents of minor children,
and legal guardians.
(2) To the extent possible, clients must participate in the
formulation of these policies and procedures.
(3) Clients must not discipline other clients, except as part of an
organized system of self-government, as set forth in facility policy.
(b) Standard: Management of inappropriate client behavior. (1) The
facility must develop and implement written policies and procedures that
govern the management of inappropriate client behavior. These policies
and procedures must be consistent with the provisions of paragraph (a)
of this section. These procedures must --
(i) Specify all facility approved interventions to manage
inappropriate client behavior;
(ii) Designate these interventions on a hierarchy to be implemented,
ranging from most positive or least intrusive, to least positive or most
intrusive;
(iii) Insure, prior to the use of more restrictive techniques, that
the client's record documents that programs incorporating the use of
less intrusive or more positive techniques have been tried
systematically and demonstrated to be ineffective; and
(iv) Address the following:
(A) The use of time-out rooms.
(B) The use of physical restraints.
(C) The use of drugs to manage inappropriate behavior.
(D) The application of painful or noxious stimuli.
(E) The staff members who may authorize the use of specified
interventions.
(F) A mechanism for monitoring and controlling the use of such
interventions.
(2) Interventions to manage inappropriate client behavior must be
employed with sufficient safeguards and supervision to ensure that the
safety, welfare and civil and human rights of clients are adequately
protected.
(3) Techniques to manage inappropriate client behavior must never be
used for disciplinary purposes, for the convenience of staff or as a
substitute for an active treatment program.
(4) The use of systematic interventions to manage inappropriate
client behavior must be incorporated into the client's individual
program plan, in accordance with 483.440(c) (4) and (5) of this
subpart.
(5) Standing or as needed programs to control inappropriate behavior
are not permitted.
(c) Standard: Time-out rooms. (1) A client may be placed in a room
from which egress is prevented only if the following conditions are met:
(i) The placement is a part of an approved systematic time-out
program as required by paragraph (b) of this section. (Thus, emergency
placement of a client into a time-out room is not allowed.)
(ii) The client is under the direct constant visual supervision of
designated staff.
(iii) The door to the room is held shut by staff or by a mechanism
requiring constant physical pressure from a staff member to keep the
mechanism engaged.
(2) Placement of a client in a time-out room must not exceed one
hour.
(3) Clients placed in time-out rooms must be protected from hazardous
conditions including, but not limited to, presence of sharp corners and
objects, uncovered light fixtures, unprotected electrical outlets.
(4) A record of time-out activities must be kept.
(d) Standard: Physical restraints. (1) The facility may employ
physical restraint only --
(i) As an integral part of an individual program plan that is
intended to lead to less restrictive means of managing and eliminating
the behavior for which the restraint is applied;
(ii) As an emergency measure, but only if absolutely necessary to
protect the client or others from injury; or
(iii) As a health-related protection prescribed by a physician, but
only if absolutely necessary during the conduct of a specific medical or
surgical procedure, or only if absolutely necessary for client
protection during the time that a medical condition exists.
(2) Authorizations to use or extend restraints as an emergency must
be:
(i) In effect no longer than 12 consecutive hours; and
(ii) Obtained as soon as the client is restrained or stable.
(3) The facility must not issue orders for restraint on a standing or
as needed basis.
(4) A client placed in restraint must be checked at least every 30
minutes by staff trained in the use of restraints, released from the
restraint as quickly as possible, and a record of these checks and usage
must be kept.
(5) Restraints must be designed and used so as not to cause physical
injury to the client and so as to cause the least possible discomfort.
(6) Opportunity for motion and exercise must be provided for a period
of not less than 10 minutes during each two hour period in which
restraint is employed, and a record of such activity must be kept.
(7) Barred enclosures must not be more than three feet in height and
must not have tops.
(e) Standard: Drug usage. (1) The facility must not use drugs in
doses that interfere with the individual client's daily living
activities.
(2) Drugs used for control of inappropriate behavior must be approved
by the interdisciplinary team and be used only as an integral part of
the client's individual program plan that is directed specifically
towards the reduction of and eventual elimination of the behaviors for
which the drugs are employed.
(3) Drugs used for control of inappropriate behavior must not be used
until it can be justified that the harmful effects of the behavior
clearly outweigh the potentially harmful effects of the drugs.
(4) Drugs used for control of inappropriate behavior must be --
(i) Monitored closely, in conjunction with the physician and the drug
regimen review requirement at 483.460(j), for desired responses and
adverse consequences by facility staff; and
(ii) Gradually withdrawn at least annually in a carefully monitored
program conducted in conjunction with the interdisciplinary team, unless
clinical evidence justifies that this is contraindicated.
42 CFR 483.460 Condition of participation: Health care services.
(a) Standard: Physician services.
(1) The facility must ensure the availability of physician services
24 hours a day.
(2) The physician must develop, in coordination with licensed nursing
personnel, a medical care plan of treatment for a client if the
physician determines that an individual client requires 24-hour licensed
nursing care. This plan must be integrated in the individual program
plan.
(3) The facility must provide or obtain preventive and general
medical care as well as annual physical examinations of each client that
at a minimum include the following:
(i) Evaluation of vision and hearing.
(ii) Immunizations, using as a guide the recommendations of the
Public Health Service Advisory Commitee on Immunization Practices or of
the Committee on the Control of Infectious Diseases of the American
Academy of Pediatrics.
(iii) Routine screening laboratory examinations as determined
necessary by the physician, and special studies when needed.
(iv) Tuberculosis control, appropriate to the facility's population,
and in accordance with the recommendations of the American College of
Chest Physicians or the section of diseases of the chest of the American
Academy of Pediatrics, or both.
(4) To the extent permitted by State law, the facility may utilize
physician assistants and nurse practitioners to provide physician
services as described in this section.
(b) Standard: Physician participation in the individual program
plan. A physician must participate in --
(1) The establishment of each newly admitted client's initial
individual program plan as required by 456.380 of this chapter that
specified plan of care requirements for ICFs; and
(2) If appropriate, physicians must participate in the review and
update of an individual program plan as part of the interdisciplinary
team process either in person or through written report to the
interdisciplinary team.
(c) Standard: Nursing services. The facility must provide clients
with nursing services in accordance with their needs. These services
must include --
(1) Participation as appropriate in the development, review, and
update of an individual program plan as part of the interdisciplinary
team process;
(2) The development, with a physician, of a medical care plan of
treatment for a client when the physician has determined that an
individual client requires such a plan;
(3) For those clients certified as not needing a medical care plan, a
review of their health status which must --
(i) Be by a direct physical examination;
(ii) Be by a licensed nurse;
(iii) Be on a quarterly or more frequent basis depending on client
need;
(iv) Be recorded in the client's record; and
(v) Result in any necessary action (including referral to a physician
to address client health problems).
(4) Other nursing care as prescribed by the physician or as
identified by client needs; and
(5) Implementing, with other members of the interdisciplinary team,
appropriate protective and preventive health measures that include, but
are not limited to --
(i) Training clients and staff as needed in appropriate health and
hygiene methods;
(ii) Control of communicable diseases and infections, including the
instruction of other personnel in methods of infection control; and
(iii) Training direct care staff in detecting signs and symptoms of
illness or dysfunction, first aid for accidents or illness, and basic
skills required to meet the health needs of the clients.
(d) Standard: Nursing staff. (1) Nurses providing services in the
facility must have a current license to practice in the State.
(2) The facility must employ or arrange for licensed nursing services
sufficient to care for clients health needs including those clients with
medical care plans.
(3) The facility must utilize registered nurses as appropriate and
required by State law to perform the health services specified in this
section.
(4) If the facility utilizes only licensed practical or vocational
nurses to provide health services, it must have a formal arrangement
with a registered nurse to be available for verbal or onsite
consultation to the licensed practical or vocational nurse.
(5) Non-licensed nursing personnel who work with clients under a
medical care plan must do so under the supervision of licensed persons.
(e) Standard: Dental services. (1) The facility must provide or
make arrangements for comprehensive diagnostic and treatment services
for each client from qualified personnel, including licensed dentists
and dental hygienists either through organized dental services in-house
or through arrangement.
(2) If appropriate, dental professionals must participate, in the
development, review and update of an individual program plan as part of
the interdisciplinary process either in person or through written report
to the interdisciplinary team.
(3) The facility must provide education and training in the
maintenance of oral health.
(f) Standard: Comprehensive dental diagnostic services.
Comprehensive dental diagnostic services include --
(1) A complete extraoral and intraoral examination, using all
diagnostic aids necessary to properly evaluate the client's oral
condition, not later than one month after admission to the facility
(unless the examination was completed within twelve months before
admission);
(2) Periodic examination and diagnosis performed at least annually,
including radiographs when indicated and detection of manifestations of
systemic disease; and
(3) A review of the results of examination and entry of the results
in the client's dental record.
(g) Standard: Comprehensive dental treatment. The facility must
ensure comprehensive dental treatment services that include --
(1) The availability for emergency dental treatment on a
24-hour-a-day basis by a licensed dentist; and
(2) Dental care needed for relief of pain and infections, restoration
of teeth, and maintenance of dental health.
(h) Standard: Documentation of dental services. (1) If the facility
maintains an in-house dental service, the facility must keep a permanent
dental record for each client, with a dental summary maintained in the
client's living unit.
(2) If the facility does not maintain an in-house dental service, the
facility must obtain a dental summary of the results of dental visits
and maintain the summary in the client's living unit.
(i) Standard: Pharmacy services. The facility must provide or make
arrangements for the provision of routine and emergency drugs and
biologicals to its clients. Drugs and biologicals may be obtained from
community or contract pharmacists or the facility may maintain a
licensed pharmacy.
(j) Standard: Drug regimen review. (1) A pharmacist with input from
the interdisciplinary team must review the drug regimen of each client
at least quarterly.
(2) The pharmacist must report any irregularities in clients' drug
regimens to the prescribing physician and interdisciplinary team.
(3) The pharmacist must prepare a record of each client's drug
regimen reviews and the facility must maintain that record.
(4) An individual medication administration record must be maintained
for each client.
(5) As appropriate the pharmacist must participate in the
development, implementation, and review of each client's individual
program plan either in person or through written report to the
interdisciplinary team.
(k) Standard: Drug administration. The facility must have an
organized system for drug administration that identifies each drug up to
the point of administration. The system must assure that --
(1) All drugs are administered in compliance with the physician's
orders;
(2) All drugs, including those that are self-administered, are
administered without error;
(3) Unlicensed personnel are allowed to administer drugs only if
State law permits;
(4) Clients are taught how to administer their own medications if the
interdisciplinary team determines that self administration of
medications is an appropriate objective, and if the physician does not
specify otherwise;
(5) The client's physician is informed of the interdisciplinary
team's decision that self-administration of medications is an objective
for the client;
(6) No client self-administers medications until he or she
demonstrates the competency to do so;
(7) Drugs used by clients while not under the direct care of the
facility are packaged and labeled in accordance with State law; and
(8) Drug administration errors and adverse drug reactions are
recorded and reported immediately to a physician.
(l) Standard: Drug storage and recordkeeping. (1) The facility must
store drugs under proper conditions of sanitation, temperature, light,
humidity, and security.
(2) The facility must keep all drugs and biologicals locked except
when being prepared for administration. Only authorized persons may
have access to the keys to the drug storage area. Clients who have been
trained to self administer drugs in accordance with 483.460(k)(4) may
have access to keys to their individual drug supply.
(3) The facility must maintain records of the receipt and disposition
of all controlled drugs.
(4) The facility must, on a sample basis, periodically reconcile the
receipt and disposition of all controlled drugs in schedules II through
IV (drugs subject to the Comprehensive Drug Abuse Prevention and Control
Act of 1970, 21 U.S.C. 801 et seq., as implemented by 21 CFR part 308).
(5) If the facility maintains a licensed pharmacy, the facility must
comply with the regulations for controlled drugs.
(m) Standard: Drug labeling. (1) Labeling of drugs and biologicals
must --
(i) Be based on currently accepted professional principles and
practices; and
(ii) Include the appropriate accessory and cautionary instructions,
as well as the expiration date, if applicable.
(2) The facility must remove from use --
(i) Outdated drugs; and
(ii) Drug containers with worn, illegible, or missing labels.
(3) Drugs and biologicals packaged in containers designated for a
particular client must be immediately removed from the client's current
medication supply if discontinued by the physician.
(n) Standard: Laboratory services. (1) If a facility chooses to
provide laboratory services, the laboratory must meet the requirements
specified in part 493 of this chapter.
(2) If the laboratory chooses to refer specimens for testing to
another laboratory, the referral laboratory must be certified in the
appropriate specialties and subspecialities of service in accordance
with the requirements of part 493 of this chapter.
(53 FR 20496, June 3, 1988, as amended at 57 FR 7136, Feb. 28, 1992)
42 CFR 483.470 Condition of participation: Physical environment.
(a) Standard: Client living environment. (1) The facility must not
house clients of grossly different ages, developmental levels, and
social needs in close physical or social proximity unless the housing is
planned to promote the growth and development of all those housed
together.
(2) The facility must not segregate clients solely on the basis of
their physical disabilities. It must integrate clients who have
ambulation deficits or who are deaf, blind, or have seizure disorders,
etc., with others of comparable social and intellectual development.
(b) Standard: Client bedrooms. (1) Bedrooms must --
(i) Be rooms that have at least one outside wall;
(ii) Be equipped with or located near toilet and bathing facilities;
(iii) Accommodate no more than four clients unless granted a variance
under paragraph (b)(3) of this section;
(iv) Measure at least 60 square feet per client in multiple client
bedrooms and at least 80 square feet in single client bedrooms; and
(v) In all facilities initially certified, or in buildings
constructed or with major renovations or conversions on or after October
3, 1988, have walls that extend from floor to ceiling.
(2) If a bedroom is below grade level, it must have a window that --
(i) Is usable as a second means of escape by the client(s) occupying
the room; and
(ii) Is no more than 44 inches (measured to the window sill) above
the floor unless the facility is surveyed under the Health Care
Occupancy Chapter of the Life Safety Code, in which case the window must
be no more than 36 inches (measured to the window sill) above the floor.
(3) The survey agency may grant a variance from the limit of four
clients per room only if a physician who is a member of the
interdisciplinary team and who is a qualified mental retardation
professional --
(i) Certifies that each client to be placed in a bedroom housing more
than four persons is so severely medically impaired as to require direct
and continuous monitoring during sleeping hours; and
(ii) Documents the reasons why housing in a room of only four or
fewer persons would not be medically feasible.
(4) The facility must provide each client with --
(i) A separate bed of proper size and height for the convenience of
the client;
(ii) A clean, comfortable, mattress;
(iii) Bedding appropriate to the weather and climate; and
(iv) Functional furniture appropriate to the client's needs, and
individual closet space in the client's bedroom with clothes racks and
shelves accessible to the client.
(c) Standard: Storage space in bedroom. The facility must provide
--
(1) Space and equipment for daily out-of-bed activity for all clients
who are not yet mobile, except those who have a short-term illness or
those few clients for whom out-of-bed activity is a threat to health and
safety; and
(2) Suitable storage space, accessible to clients, for personal
possessions, such as TVs, radios, prosthetic equipment and clothing.
(d) Standard: Client bathrooms. The facility must --
(1) Provide toilet and bathing facilities appropriate in number,
size, and design to meet the needs of the clients;
(2) Provide for individual privacy in toilets, bathtubs, and showers;
and
(3) In areas of the facility where clients who have not been trained
to regulate water temperature are exposed to hot water, ensure that the
temperature of the water does not exceed 110 Fahrenheit.
(e) Standard: Heating and ventilation. (1) Each client bedroom in
the facility must have --
(i) At least one window to the outside; and
(ii) Direct outside ventilation by means of windows, air
conditioning, or mechanical ventilation.
(2) The facility must --
(i) Maintain the temperature and humidity within a normal comfort
range by heating, air conditioning or other means; and
(ii) Ensure that the heating apparatus does not constitute a burn or
smoke hazard to clients.
(f) Standard: Floors. The facility must have --
(1) Floors that have a resilient, nonabrasive, and slip-resistant
surface;
(2) Nonabrasive carpeting, if the area used by clients is carpeted
and serves clients who lie on the floor or ambulate with parts of their
bodies, other than feet, touching the floor; and
(3) Exposed floor surfaces and floor coverings that promote mobility
in areas used by clients, and promote maintenance of sanitary
conditions.
(g) Standard: Space and equipment. The facility must --
(1) Provide sufficient space and equipment in dining, living, health
services, recreation, and program areas (including adequately equipped
and sound treated areas for hearing and other evaluations if they are
conducted in the facility) to enable staff to provide clients with
needed services as required by this subpart and as identified in each
client's individual program plan.
(2) Furnish, maintain in good repair, and teach clients to use and to
make informed choices about the use of dentures, eyeglasses, hearing and
other communications aids, braces, and other devices identified by the
interdisciplinary team as needed by the client.
(3) Provide adequate clean linen and dirty linen storage areas.
(h) Standard: Emergency plan and procedures. (1) The facility must
develop and implement detailed written plans and procedures to meet all
potential emergencies and disasters such as fire, severe weather, and
missing clients.
(2) The facility must communicate, periodically review, make the plan
available, and provide training to the staff.
(i) Standard: Evacuation drills. (1) The facility must hold
evacuation drills at least quarterly for each shift of personnel and
under varied conditions to --
(i) Ensure that all personnel on all shifts are trained to perform
assigned tasks;
(ii) Ensure that all personnel on all shifts are familiar with the
use of the facility's fire protection features; and
(iii) Evaluate the effectiveness of emergency and disaster plans and
procedures.
(2) The facility must --
(i) Actually evacuate clients during at least one drill each year on
each shift;
(ii) Make special provisions for the evacuation of clients with
physical disabilities;
(iii) File a report and evaluation on each evacuation drill;
(iv) Investigate all problems with evacuation drills, including
accidents, and take corrective action; and
(v) During fire drills, clients may be evacuated to a safe area in
facilities certified under the Health Care Occupancies Chapter of the
Life Safety Code.
(3) Facilities must meet the requirements of paragraphs (i)(1) and
(2) of this section for any live-in and relief staff they utilize.
(j) Standard: Fire protection -- (1) General. (i) Except as
specified in paragraph (j)(2) of this section, the facility must meet
the applicable provisions of either the Health Care Occupancies Chapters
or the Residential Board and Care Occupancies Chapter of the Life Safety
Code (LSC) of the National Fire Protection Association, 1985 edition,
which is incorporated by reference. /2/
(ii) The State survey agency may apply a single chapter of the LSC to
the entire facility or may apply different chapters to different
buildings or parts of buildings as permitted by the LSC.
(iii) A facility that meets the LSC definition of a residential board
and care occupancy and that has 16 or fewer beds, must have its
evacuation capability evaluated in accordance with the Evacuation
Difficulty Index of the LSC (appendix F).
(2) Exceptions. (i) For facilities that meet the LSC definition of a
health care occupancy:
(A) The State survey agency may waive, for a period it considers
appropriate, specific provisions of the LSC if --
(1) The waiver would not adversely affect the health and safety of
the clients; and
(2) Rigid application of specific provisions would result in an
unreasonable hardship for the facility.
(B) The State survey agency may apply the State's fire and safety
code instead of the LSC if the Secretary finds that the State has a code
imposed by State law that adequately protects a facility's clients.
(C) Compliance on November 26, 1982 with the 1967 edition of the LSC
or compliance on April 18, 1986 with the 1981 edition of the LSC, with
or without waivers, is considered to be compliance with this standard as
long as the facility continues to remain in compliance with that edition
of the Code.
(ii) For facilities that meet the LSC definition of a residential
board and care occupancy and that have more than 16 beds, the State
survey agency may apply the State's fire and safety code as specified in
paragraph (j)(2)(B) of this section.
(k) Standard: Paint. The facility must --
(1) Use lead-free paint inside the facility; and
(2) Remove or cover interior paint or plaster containing lead so that
it is not accessible to clients.
(l) Standard: Infection control.
(1) The facility must provide a sanitary environment to avoid sources
and transmission of infections. There must be an active program for the
prevention, control, and investigation of infection and communicable
diseases.
(2) The facility must implement successful corrective action in
affected problem areas.
(3) The facility must maintain a record of incidents and corrective
actions related to infections.
(4) The facility must prohibit employees with symptoms or signs of a
communicable disease from direct contact with clients and their food.
/2/ Incorporation of the 1985 edition of the National Fire Protection
Association's Life Safety Code (published February 7, 1985; ANSI/NFPA
101) was approved by the Director of the Federal Register in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51 that govern the use of
incorporations by reference. The Code is available for inspection at
the Office of the Federal Register Information Center, 800 North Capitol
Street, NW., suite 700, Washington, DC. Copies may be obtained from the
National Fire Protection Association, Batterymarch Park, Quincy, Mass.
02269.
If any changes in this Code are also to be incorporated by reference,
a notice to that effect will be published in the Federal Register.
42 CFR 483.480 Condition of participation: Dietetic services.
(a) Standard: Food and nutrition services. (1) Each client must
receive a nourishing, well-balanced diet including modified and
specially-prescribed diets.
(2) A qualified dietitian must be employed either full-time,
part-time, or on a consultant basis at the facility's discretion.
(3) If a qualified dietitian is not employed full-time, the facility
must designate a person to serve as the director of food services.
(4) The client's interdisciplinary team, including a qualified
dietitian and physician, must prescribe all modified and special diets
including those used as a part of a program to manage inappropriate
client behavior.
(5) Foods proposed for use as a primary reinforcement of adaptive
behavior are evaluated in light of the client's nutritional status and
needs.
(6) Unless otherwise specified by medical needs, the diet must be
prepared at least in accordance with the latest edition of the
recommended dietary allowances of the Food and Nutrition Board of the
National Research Council, National Academy of Sciences, adjusted for
age, sex, disability and activity.
(b) Standard: Meal services. (1) Each client must receive at least
three meals daily, at regular times comparable to normal mealtimes in
the community with --
(i) Not more than 14 hours between a substantial evening meal and
breakfast of the following day, except on weekends and holidays when a
nourishing snack is provided at bedtime, 16 hours may elapse between a
substantial evening meal and breakfast; and
(ii) Not less than 10 hours between breakfast and the evening meal of
the same day, except as provided under paragraph (b)(1)(i) of this
section.
(2) Food must be served --
(i) In appropriate quantity;
(ii) At appropriate temperature;
(iii) In a form consistent with the developmental level of the
client; and
(iv) With appropriate utensils.
(3) Food served to clients individually and uneaten must be
discarded.
(c) Standard: Menus. (1) Menus must --
(i) Be prepared in advance;
(ii) Provide a variety of foods at each meal;
(iii) Be different for the same days of each week and adjusted for
seasonal changes; and
(iv) Include the average portion sizes for menu items.
(2) Menus for food actually served must be kept on file for 30 days.
(d) Standard: Dining areas and service.
The facility must --
(1) Serve meals for all clients, including persons with ambulation
deficits, in dining areas, unless otherwise specified by the
interdisciplinary team or a physician;
(2) Provide table service for all clients who can and will eat at a
table, including clients in wheelchairs;
(3) Equip areas with tables, chairs, eating utensils, and dishes
designed to meet the developmental needs of each client;
(4) Supervise and staff dining rooms adequately to direct self-help
dining procedure, to assure that each client receives enough food and to
assure that each client eats in a manner consistent with his or her
developmental level: and
(5) Ensure that each client eats in an upright position, unless
otherwise specified by the interdisciplinary team or a physician.
42 CFR 483.480 PART 484 -- CONDITIONS OF PARTICIPATION: HOME HEALTH AGENCIES
42 CFR 483.480 Subpart A -- General Provisions
Sec.
484.1 Basis and scope.
484.2 Definitions.
484.4 Personnel qualifications.
42 CFR 483.480 Subpart B -- Administration
484.10 Condition of participation: Patient rights.
484.12 Condition of participation: Compliance with Federal, State,
and local laws, disclosure and ownership information, and accepted
professional standards and principles.
484.14 Condition of participation: Organization, services, and
administration.
484.16 Condition of participation: Group of professional personnel.
484.18 Condition of participation: Acceptance of patients, plan of
care, and medical supervision.
42 CFR 483.480 Subpart C -- Furnishing of Services
484.30 Condition of participation: Skilled nursing services.
484.32 Condition of participation: Therapy services.
484.34 Condition of participation: Medical social services.
484.36 Condition of participation: Home health aide services.
484.38 Condition of participation: Qualifying to furnish outpatient
physical therapy or speech pathology services.
484.48 Condition of participation: Clinical records.
484.52 Condition of participation: Evaluation of the agency's
program.
Authority: Sec. 1102, 1861, 1866(a), 1871 and 1891 of the Social
Security Act (42 U.S.C. 1302, 1395x, 1395cc(a), 1395hh, and 1395bbb).
Source: 54 FR 33367, Aug. 14, 1989, unless otherwise noted.
Editorial Note: Nomenclature changes affecting part 484 appear at 56
FR 32973, July 18, 1991.
42 CFR 483.480 Subpart A -- General Provisions
42 CFR 484.1 Basis and scope.
This part implements the requirements of sections 1861(o) and 1891(a)
of the Act for HHA services and also sets forth the additional
requirements considered necessary to ensure the health and safety of
patients.
42 CFR 484.2 Definitions.
As used in this part, unless the context indicates otherwise --
Bylaws or equivalent means a set of rules adopted by an HHA for
governing the agency's operation.
Branch office means a location or site from which a home health
agency provides services within a portion of the total geographic area
served by the parent agency. The branch office is part of the home
health agency and is located sufficiently close to share administration,
supervision, and services in a manner that renders it unnecessary for
the branch independently to meet the conditions of participation as a
home health agency.
Clinical note means a notation of a contact with a patient that is
written and dated by a member of the health team, and that describes
signs and symptoms, treatment and drugs administered and the patient's
reaction, and any changes in physical or emotional condition.
HHA stands for home health agency.
Nonprofit agency means an agency exempt from Federal income taxation
under section 501 of the Internal Revenue Code of 1954.
Parent home health agency means the agency that develops and
maintains administrative controls of subunits and/or branch offices.
Primary home health agency means the agency that is responsible for
the services furnished to patients and for implementation of the plan of
care.
Progress note means a written notation, dated and signed by a member
of the health team, that summarizes facts about care furnished and the
patient's response during a given period of time.
Proprietary agency means a private profit-making agency licensed by
the State.
Public agency means an agency operated by a State or local
government.
Subdivision means a component of a multi-function health agency, such
as the home care department of a hospital or the nursing division of a
health department, which independently meets the conditions of
participation for HHAs. A subdivision that has subunits or branch
offices is considered a parent agency.
Subunit means a semi-autonomous organization that --
(1) Serves patients in a geographic area different from that of the
parent agency; and
(2) Must independently meet the conditions of participation for HHAs
because it is too far from the parent agency to share administration,
supervision, and services on a daily basis.
Summary report means the compilation of the pertinent factors of a
patient's clinical notes and progress notes that is submitted to the
patient's physician.
Supervision means authoritative procedural guidance by a qualified
person for the accomplishment of a function or activity. Unless
otherwise specified in this part, the supervisor must be on the premises
to supervise an individual who does not meet the qualifications
specified in 484.4.
42 CFR 484.4 Personnel qualifications.
Staff required to meet the conditions set forth in this part are
staff who meet the qualifications specified in this section.
Administrator, home health agency. A person who:
(a) Is a licensed physician; or
(b) Is a registered nurse; or
(c) Has training and experience in health service administration and
at least 1 year of supervisory or administrative experience in home
health care or related health programs.
Audiologist. A person who:
(a) Meets the education and experience requirements for a Certificate
of Clinical Competence in audiology granted by the American
Speech-Language-Hearing Association; or
(b) Meets the educational requirements for certification and is in
the process of accumulating the supervised experience required for
certification.
Home health aide. Effective for services furnished after August 14,
1990, a person who has successfully completed a State-established or
other training program that meets the requirements of 484.36(a) and a
competency evaluation program or State licensure program that meets the
requirements of 484.36 (b) or (e), or a competency evaluation program
or State licensure program that meets the requirements of 484.36 (b) or
(e). An individual is not considered to have completed a training and
competency evaluation program, or a competency evaluation program if,
since the individual's most recent completion of this program(s), there
has been a continuous period of 24 consecutive months during none of
which the individual furnished services described in 409.40 of this
chapter for compensation.
Occupational therapist. A person who:
(a) Is a graduate of an occupational therapy curriculum accredited
jointly by the Committee on Allied Health Education and Accreditation of
the American Medical Association and the American Occupational Therapy
Association; or
(b) Is eligible for the National Registration Examination of the
American Occupational Therapy Association; or
(c) Has 2 years of appropriate experience as an occupational
therapist, and has achieved a satisfactory grade on a proficiency
examination conducted, approved, or sponsored by the U.S. Public Health
Service, except that such determinations of proficiency do not apply
with respect to persons initially licensed by a State or seeking initial
qualification as an occupational therapist after December 31, 1977.
Occupational therapy assistant. A person who:
(a) Meets the requirements for certification as an occupational
therapy assistant established by the American Occupational Therapy
Association; or
(b) Has 2 years of appropriate experience as an occupational therapy
assistant, and has achieved a satisfactory grade on a proficiency
examination conducted, approved, or sponsored by the U.S. Public Health
Service, except that such determinations of proficiency do not apply
with respect to persons initially licensed by a State or seeking initial
qualification as an occupational therapy assistant after December 31,
1977.
Physical therapist. A person who is licensed as a physical therapist
by the State in which practicing, and
(a) Has graduated from a physical therapy curriculum approved by:
(1) The American Physical Therapy Association, or
(2) The Committee on Allied Health Education and Accreditation of the
American Medical Association, or
(3) The Council on Medical Education of the American Medical
Association and the American Physical Therapy Association; or
(b) Prior to January 1, 1966,
(1) Was admitted to membership by the American Physical Therapy
Association, or
(2) Was admitted to registration by the American Registry of Physical
Therapist, or
(3) Has graduated from a physical therapy curriculum in a 4-year
college or university approved by a State department of education; or
(c) Has 2 years of appropriate experience as a physical therapist,
and has achieved a satifactory grade on a proficiency examination
conducted, approved, or sponsored by the U.S. Public Health Service
except that such determinations of proficiency do not apply with respect
to persons initially licensed by a State or seeking qualification as a
physical therapist after December 31, 1977; or
(d) Was licensed or registered prior to January 1, 1966, and prior to
January 1, 1970, had 15 years of full-time experience in the treatment
of illness or injury through the practice of physical therapy in which
services were rendered under the order and direction of attending and
referring doctors of medicine or osteopathy; or
(e) If trained outside the United States,
(1) Was graduated since 1928 from a physical therapy curriculum
approved in the country in which the curriculum was located and in which
there is a member organization of the World Confederation for Physical
Therapy.
(2) Meets the requirements for membership in a member organization of
the World Confederation for Physical Therapy,
Physical therapy assistant. A person who is licensed as a physical
therapy assistant, if applicable, by the State in which practicing, and
(1) Has graduated from a 2-year college-level program approved by the
American Physical Therapy Association; or
(2) Has 2 years of appropriate experience as a physical therapy
assistant, and has achieved a satisfactory grade on a proficiency
examination conducted, approved, or sponsored by the U.S. Public Health
Service, except that these determinations of proficiency do not apply
with respect to persons initially licensed by a State or seeking initial
qualification as a physical therapy assistant after December 31, 1977.
Physician. A doctor of medicine, osteophathy or podiatry legally
authorized to practice medicine and surgery by the State in which such
function or action is performed.
Practical (vocational) nurse. A person who is licensed as a
practical (vocational) nurse by the State in which practicing.
Public health nurse. A registered nurse who has completed a
baccalaureate degree program approved by the National League for Nursing
for public health nursing preparation or postregistered nurse study that
includes content aproved by the National League for Nursing for public
health nursing preparation.
Registered nurse (RN). A graduate of an approved school of
professional nursing, who is licensed as a registered nurse by the State
in which practicing.
Social work assistant. A person who:
(1) Has a baccalaureate degree in social work, psychology, sociology,
or other field related to social work, and has had at least 1 year of
social work experience in a health care setting; or
(2) Has 2 years of appropriate experience as a social work assistant,
and has achieved a satisfactory grade on a proficiency examination
conducted, approved, or sponsored by the U.S. Public Health Service,
except that these determinations of proficiency do not apply with
respect to persons initially licensed by a State or seeking initial
qualification as a social work assistant after December 31, 1977.
Social worker. A person who has a master's degree from a school of
social work accredited by the Council on Social Work Education, and has
1 year of social work experience in a health care setting.
Speech-language pathologist. A person who:
(1) Meets the education and experience requirements for a Certificate
of Clinical Competence in (speech pathology or audiology) granted by the
American Speech-Language-Hearing Association; or
(2) Meets the educational requirements for certification and is in
the process of accumulating the supervised experience required for
certification.
(54 FR 33367, August 14, 1989, as amended at 56 FR 32973, July 18,
1991)
42 CFR 484.4 Subpart B -- Administration
42 CFR 484.10 Condition of participation: Patient rights.
The patient has the right to be informed of his or her rights. The
HHA must protect and promote the exercise of these rights.
(a) Standard: Notice of rights. (1) The HHA must provide the
patient with a written notice of the patient's rights in advance of
furnishing care to the patient or during the initial evaluation visit
before the initiation of treatment.
(2) The HHA must maintain documentation showing that it has complied
with the requirements of this section.
(b) Standard: Exercise of rights and respect for property and
person. (1) The patient has the right to exercise his or her rights as
a patient of the HHA.
(2) The patient's family or guardian may exercise the patient's
rights when the patient has been judged incompetent.
(3) The patient has the right to have his or her property treated
with respect.
(4) The patient has the right to voice grievances regarding treatment
or care that is (or fails to be) furnished, or regarding the lack of
respect for property by anyone who is furnishing services on behalf of
the HHA and must not be subjected to discrimination or reprisal for
doing so.
(5) The HHA must investigate complaints made by a patient or the
patient's family or guardian regarding treatment or care that is (or
fails to be) furnished, or regarding the lack of respect for the
patient's property by anyone furnishing services on behalf of the HHA,
and must document both the existence of the complaint and the resolution
of the complaint.
(c) Standard: Right to be informed and to participate in planning
care and treatment. (1) The patient has the right to be informed, in
advance about the care to be furnished, and of any changes in the care
to be furnished.
(i) The HHA must advise the patient in advance of the disciplines
that will furnish care, and the frequency of visits proposed to be
furnished.
(ii) The HHA must advise the patient in advance of any change in the
plan of care before the change is made.
(2) The patient has the right to participate in the planning of the
care.
(i) The HHA must advise the patient in advance of the right to
participate in planning the care or treatment and in planning changes in
the care or treatment.
(ii) The HHA complies with the requirements of subpart I of part 489
of this chapter relating to maintaining written policies and procedures
regarding advance directives. The HHA must inform and distribute
written information to the patient, in advance, concerning its policies
on advance directives, including a description of applicable State law.
(d) Standard: Confidentiality of medical records. The patient has
the right to confidentiality of the clinical records maintained by the
HHA. The HHA must advise the patient of the agency's policies and
procedures regarding disclosure of clinical records.
(e) Standard: Patient liability for payment. (1) The patient has
the right to be advised, before care is initiated, of the extent to
which payment for the HHA services may be expected from Medicare or
other sources, and the extent to which payment may be required from the
patient. Before the care is initiated, the HHA must inform the patient,
orally and in writing, of --
(i) The extent to which payment may be expected from Medicare,
Medicaid, or any other Federally funded or aided program known to the
HHA;
(ii) The charges for services that will not be covered by Medicare;
and
(iii) The charges that the individual may have to pay.
(2) The patient has the right to be advised orally and in writing of
any changes in the information provided in accordance with paragraph
(e)(1) of this section when they occur. The HHA must advise the patient
of these changes orally and in writing as soon as possible, but no later
than 30 calendar days from the date that the HHA becomes aware of a
change.
(f) Standard: Home health hotline. The patient has the right to be
advised of the availability of the toll-free HHA hotline in the State.
When the agency accepts the patient for treatment or care, the HHA must
advise the patient in writing of the telephone number of the home health
hotline established by the State, the hours of its operation, and that
the purpose of the hotline is to receive complaints or questions about
local HHAs.
(54 FR 33367, August 14, 1989, as amended at 56 FR 32973, July 18,
1991; 57 FR 8203, Mar. 6, 1992)
42 CFR 484.12 Condition of participation: Compliance with Federal,
State, and local laws, disclosure and ownership information, and
accepted professional standards and principles.
(a) Standard: Compliance with Federal, State, and local laws and
regulations. The HHA and its staff must operate and furnish services in
compliance with all applicable Federal, State, and local laws and
regulations. If State or applicable local law provides for the
licensure of HHAs, an agency not subject to licensure is approved by the
licensing authority as meeting the standards established for licensure.
(b) Standard: Disclosure of ownership and management information.
The HHA must comply with the requirements of Part 420, Subpart C of this
chapter. The HHA also must disclose the following information to the
State survey agency at the time of the HHA's initial request for
certification, for each survey, and at the time of any change in
ownership or management:
(1) The name and address of all persons with an ownership or control
interest in the HHA as defined in 420.201, 420.202, and 420.206 of
this chapter.
(2) The name and address of each person who is an officer, a
director, an agent or a managing employee of the HHA as defined in
420.201, 420.202, and 420.206 of this chapter.
(3) The name and address of the corporation, association, or other
company that is responsible for the management of the HHA, and the name
and address of the chief executive officer and the chairman of the board
of directors of that corporation, association, or other company
responsible for the management of the HHA.
(c) Standard: Compliance with accepted professional standards and
principles. The HHA and its staff must comply with accepted
professional standards and principles that apply to professionals
furnishing services in an HHA.
42 CFR 484.14 Condition of participation: Organization, services, and
administration.
Organization, services furnished, administrative control, and lines
of authority for the delegation of responsibility down to the patient
care level are clearly set forth in writing and are readily
identifiable. Administrative and supervisory functions are not
delegated to another agency or organization and all services not
furnished directly, including services provided through subunits are
monitored and controlled by the parent agency. If an agency has
subunits, appropriate administrative records are maintained for each
subunit.
(a) Standard: Services furnished. Part-time or intermittent skilled
nursing services and at least one other therapeutic service (physical,
speech, or occupational therapy; medical social services; or home
health aide services) are made available on a visiting basis, in a place
of residence used as a patient's home. An HHA must provide at least one
of the qualifying services directly through agency employees, but may
provide the second qualifying service and additional services under
arrangements with another agency or organization.
(b) Standard: Governing body. A governing body (or designated
persons so functioning) assumes full legal authority and responsibility
for the operation of the agency. The governing body appoints a
qualified administrator, arranges for professional advice as required
under 484.16, adopts and periodically reviews written bylaws or an
acceptable equivalent, and oversees the management and fiscal affairs of
the agency.
(c) Standard: Administrator. The administrator, who may also be the
supervising physician or registered nurse required under paragraph (d)
of this section, organizes and directs the agency's ongoing functions;
maintains ongoing liaison among the governing body, the group of
professional personnel, and the staff; employs qualified personnel and
ensures adequate staff education and evaluations; ensures the accuracy
of public information materials and activities; and implements an
effective budgeting and accounting system. A qualified person is
authorized in writing to act in the absence of the administrator.
(d) Standard: Supervising physician or registered nurse. The
skilled nursing and other therapeutic services furnished are under the
supervision and direction of a physician or a registered nurse (who
preferably has at least 1 year of nursing experience and is a public
health nurse). This person, or similarly qualified alternate, is
available at all times during operating hours and participates in all
activities relevant to the professional services furnished, including
the development of qualifications and the assignment of personnel.
(e) Standard: Personnel policies. Personnel practices and patient
care are supported by appropriate, written personnel policies.
Personnel records include qualifications and licensure that are kept
current.
(f) Standard: Personnel under hourly or per visit contracts. If
personnel under hourly or per visit contracts are used by the HHA, there
is a written contract between those personnel and the agency that
specifies the following:
(1) Patients are accepted for care only by the primary HHA.
(2) The services to be furnished.
(3) The necessity to conform to all applicable agency policies,
including personnel qualifications.
(4) The responsibility for participating in developing plans of care.
(5) The manner in which services will be controlled, coordinated, and
evaluated by the primary HHA.
(6) The procedures for submitting clinical and progress notes,
scheduling of visits, periodic patient evaluation.
(7) The procedures for payment for services furnished under the
contract.
(g) Standard: Coordination of patient services. All personnel
furnishing services maintain liaison to ensure that their efforts are
coordinated effectively and support the objectives outlined in the plan
of care. The clinical record or minutes of case conferences establish
that effective interchange, reporting, and coordination of patient care
does occur. A written summary report for each patient is sent to the
attending physician at least every 62 days.
(h) Standard: Services under arrangements. Services furnished under
arrangements are subject to a written contract conforming with the
requirements specified in paragraph (f) of this section and with the
requirements of section 1861(w) of the Act (42 U.S.C. 1495x(w)).
(i) Standard: Institutional planning. The HHA, under the direction
of the governing body, prepares an overall plan and a budget that
includes an annual operating budget and capital expenditure plan.
(1) Annual operating budget. There is an annual operating budget
that includes all anticipated income and expenses related to items that
would, under generally accepted accounting principles, be considered
income and expense items. However, it is not required that there be
prepared, in connection with any budget, an item by item identification
of the components of each type of anticipated income or expense.
(2) Capital expenditure plan. (i) There is a capital expenditure
plan for at least a 3-year period, including the operating budget year.
The plan includes and identifies in detail the anticipated sources of
financing for, and the objectives of, each anticipated expenditure of
more than $600,000 for items that would under generally accepted
accounting principles, be considered capital items. In determining if a
single capital expenditure exceeds $600,000, the cost of studies,
surveys, designs, plans, working drawings, specifications, and other
activities essential to the acquisition, improvement, modernization,
expansion, or replacement of land, plant, building, and equipment are
included. Expenditures directly or indirectly related to capital
expenditures, such as grading, paving, broker commissions, taxes
assessed during the construction period, and costs involved in
demolishing or razing structures on land are also included.
Transactions that are separated in time, but are components of an
overall plan or patient care objective, are viewed in their entirety
without regard to their timing. Other costs related to capital
expenditures include title fees, permit and license fees, broker
commissions, architect, legal, accounting, and appraisal fees;
interest, finance, or carrying charges on bonds, notes and other costs
incurred for borrowing funds.
(ii) If the anticipated source of financing is, in any part, the
anticipated payment from title V (Maternal and Child Health and Crippled
Children's Services) or title XVIII (Medicare) or title XIX (Medicaid)
of the Social Security Act, the plan specifies the following:
(A) Whether the proposed capital expenditure is required to comform,
or is likely to be required to conform, to current standards, criteria,
or plans developed in accordance with the Public Health Service Act or
the Mental Retardation Facilities and Community Mental Health Centers
Construction Act of 1963.
(B) Whether a capital expenditure proposal has been submitted to the
designated planning agency for approval in accordance with section 1122
of the Act (42 U.S.C. 1320a-1) and implementing regulations.
(C) Whether the designated planning agency has approved or
disapproved the proposed capital expenditure if it was presented to that
agency.
(3) Preparation of plan and budget. The overall plan and budget is
prepared under the direction of the governing body of the HHA by a
committee consisting of representatives of the governing body, the
administrative staff, and the medical staff (if any) of the HHA.
(4) Annual review of plan and budget. The overall plan and budget is
reviewed and updated at least annually by the committee referred to in
paragraph (i)(3) of this section under the direction of the governing
body of the HHA.
(j) Standard: Laboratory services. (1) If the HHA engages in
laboratory testing outside of the context of assisting an individual in
self-administering a test with an appliance that has been cleared for
that purpose by the FDA, such testing must be in compliance with all
applicable requirements of part 493 of this chapter.
(2) If the HHA chooses to refer specimens for laboratory testing to
another laboratory, the referral laboratory must be certified in the
appropriate specialties and subspecialties of services in accordance
with the applicable requirements of part 493 of this chapter.
(54 FR 33367, August 14, 1989, as amended at 56 FR 32973, July 18,
1991; 56 FR 51334, Oct. 11, 1991; 57 FR 7136, Feb. 28, 1992)
42 CFR 484.16 Condition of participation: Group of professional
personnel.
A group of professional personnel, which includes at least one
physician and one registered nurse (preferably a public health nurse),
and with appropriate representation from other professional disciplines,
establishes and annually reviews the agency's policies governing scope
of services offered, admission and discharge policies, medical
supervision and plans of care, emergency care, clinical records,
personnel qualifications, and program evaluation. At least one member
of the group is neither an owner nor an employee of the agency.
(a) Standard: Advisory and evaluation function. The group of
professional personnel meets frequently to advise the agency on
professional issues, to participate in the evaluation of the agency's
program, and to assist the agency in maintaining liaison with other
health care providers in the community and in the agency's community
information program. The meetings are documented by dated minutes.
(54 FR 33367, August 14, 1989, as amended at 56 FR 32974, July 18,
1991)
42 CFR 484.18 Condition of participation: Acceptance of patients, plan
of care, and medical supervision.
Patients are accepted for treatment on the basis of a reasonable
expectation that the patient's medical, nursing, and social needs can be
met adequately by the agency in the patient's place of residence. Care
follows a written plan of care established and periodically reviewed by
a doctor of medicine, osteopathy, or podiatric medicine.
(a) Standard: Plan of care. The plan of care developed in
consultation with the agency staff covers all pertinent diagnoses,
including mental status, types of services and equipment required,
frequency of visits, prognosis, rehabilitation potential, functional
limitations, activities permitted, nutritional requirements, medications
and treatments, any safety measures to protect against injury,
instructions for timely discharge or referral, and any other appropriate
items. If a physician refers a patient under a plan of care that cannot
be completed until after an evaluation visit, the physician is consulted
to approve additions or modifications to the original plan. Orders for
therapy services include the specific procedures and modalities to be
used and the amount, frequency, and duration. The therapist and other
agency personnel participate in developing the plan of care.
(b) Standard: Periodic review of plan of care. The total plan of
care is reviewed by the attending physician and HHA personnel as often
as the severity of the patient's condition requires, but at least once
every 62 days. Agency professional staff promptly alert the physician
to any changes that suggest a need to alter the plan of care.
(c) Standard: Conformance with physician's orders. Drugs and
treatments are administered by agency staff only as ordered by the
physician. The nurse or therapist immediately records and signs oral
orders and obtains the physician's countersignature. Agency staff check
all medicines a patient may be taking to identify possible ineffective
drug therapy or adverse reactions, significant side effects, drug
allergies, and contraindicated medication, and promptly report any
problems to the physician.
(54 FR 33367, August 14, 1989, as amended at 56 FR 32974, July 18,
1991)
42 CFR 484.18 Subpart C -- Furnishing of Services
42 CFR 484.30 Condition of participation: Skilled nursing services.
The HHA furnishes skilled nursing services by or under the
supervision of a registered nurse and in accordance with the plan of
care.
(a) Standard: Duties of the registered nurse. The registered nurse
makes the initial evaluation visit, regularly reevaluates the patient's
nursing needs, initiates the plan of care and necessary revisions,
furnishes those services requiring substantial and specialized nursing
skill, initiates appropriate preventive and rehabilitative nursing
procedures, prepares clinical and progress notes, coordinates services,
informs the physician and other personnel of changes in the patient's
condition and needs, counsels the patient and family in meeting nursing
and related needs, participates in in-service programs, and supervises
and teaches other nursing personnel.
(b) Standard: Duties of the licensed practical nurse. The licensed
practical nurse furnishes services in accordance with agency policies,
prepares clinical and progress notes, assists the physician and
registered nurse in performing specialized procedures, prepares
equipment and materials for treatments observing aseptic technique as
required, and assists the patient in learning appropriate self-care
techniques.
(54 FR 33367, August 14, 1989, as amended at 56 FR 32974, July 18,
1991)
42 CFR 484.32 Condition of participation: Therapy services.
Any therapy services offered by the HHA directly or under arrangement
are given by a qualified therapist or by a qualified therapy assistant
under the supervision of a qualified therapist and in accordance with
the plan of care. The qualified therapist assists the physician in
evaluating level of function, helps develop the plan of care (revising
it as necessary), prepares clinical and progress notes, advises and
consults with the family and other agency personnel, and participates in
in-service programs.
(a) Standard: Supervision of physical therapy assistant and
occupational therapy assistant. Services furnished by a qualified
physical therapy assistant or qualified occupational therapy assistant
may be furnished under the supervision of a qualified physical or
occupational therapist. A physical therapy assistant or occupational
therapy assistant performs services planned, delegated, and supervised
by the therapist, assists in preparing clinical notes and progress
reports, and participates in educating the patient and family, and in
in-service programs.
(b) Standard: Supervision of speech therapy services. Speech
therapy services are furnished only by or under supervision of a
qualified speech pathologist or audiologist.
(54 FR 33367, August 14, 1989, as amended at 56 FR 32974, July 18,
1991)
42 CFR 484.34 Condition of participation: Medical social services.
If the agency furnishes medical social services, those services are
given by a qualified social worker or by a qualified social work
assistant under the supervision of a qualified social worker, and in
accordance with the plan of care. The social worker assists the
physician and other team members in understanding the significant social
and emotional factors related to the health problems, participates in
the development of the plan of care, prepares clinical and progress
notes, works with the family, uses appropriate community resources,
participates in discharge planning and in-service programs, and acts as
a consultant to other agency personnel.
42 CFR 484.36 Condition of participation: Home health aide services.
Home health aides are selected on the basis of such factors as a
sympathetic attitude toward the care of the sick, ability to read,
write, and carry out directions, and maturity and ability to deal
effectively with the demands of the job. They are closely supervised to
ensure their competence in providing care. For home health services
furnished (either directly or through arrangements with other
organizations) after August 14, 1990, the HHA must use individuals who
meet the personnel qualifications specified in 484.4 for ''home health
aide''.
(a) Standard: Home health aide training -- (1) Content and duration
of training. The aide training program must address each of the
following subject areas through classroom and supervised practical
training totalling at least 75 hours, with at least 16 hours devoted to
supervised practical training. The individual being trained must
complete at least 16 hours of classroom training before beginning the
supervisied practical training.
(i) Communications skills.
(ii) Observation, reporting and documentation of patient status and
the care or service furnished.
(iii) Reading and recording temperature, pulse, and respiration.
(iv) Basic infection control procedures.
(v) Basic elements of body functioning and changes in body function
that must be reported to an aide's supervisor.
(vi) Maintenance of a clean, safe, and healthy environment.
(vii) Recognizing emergencies and knowledge of emergency procedures.
(viii) The physical, emotional, and developmental needs of and ways
to work with the populations served by the HHA, including the need for
respect for the patient, his or her privacy and his or her property.
(ix) Appropriate and safe techniques in personal hygiene and grooming
that include --
(A) Bed bath.
(B) Sponge, tub, or shower bath.
(C) Shampoo, sink, tub, or bed.
(D) Nail and skin care.
(E) Oral hygiene.
(F) Toileting and elimination.
(x) Safe transfer techniques and ambulation.
(xi) Normal range of motion and positioning.
(xii) Adequate nutrition and fluid intake.
(xiii) Any other task that the HHA may choose to have the home health
aide perform.
''Supervised practical training'' means training in a laboratory or
other setting in which the trainee demonstrates knowledge while
performing tasks on an individual under the direct supervision of a
registered nurse or licensed practical nurse.
(2) Conduct of training -- (i) Organizations. A home health aide
training program may be offered by any organization except an HHA that,
within the previous 2 years has been found --
(A) Out of compliance with requirements of this paragraph (a) or
paragraph (b) of this section;
(B) To permit an individual that does not meet the definition of
''home health aide'' as specified in 484.4 to furnish home health aide
services (with the exception of licensed health professionals and
volunteers);
(C) Has been subject to an extended (or partial extended) survey as a
result of having been found to have furnished substandard care (or for
other reasons at the discretion of the HCFA or the State);
(D) Has been assessed a civil monetary penalty of not less than
$5,000 as an intermediate sanction;
(E) Has been found to have compliance deficiencies that endanger the
health and safety of the HHA's patients and has had a temporary
management appointed to oversee the management of the HHA;
(F) Has had all or part of its Medicare payments suspended; or
(G) Under any Federal or State law within the 2-year period beginning
on October 1, 1988 --
(1) Has had its participation in the Medicare program terminated;
(2) Has been assessed a penalty of not less than $5,000 for
deficiencies in Federal or State standards for HHAs;
(3) Was subject to a suspension of Medicare payments to which it
otherwise would have been entitled;
(4) Had operated under a temporary management that was appointed to
oversee the operation of the HHA and to ensure the health and safety of
the HHA's patients; or
(5) Was closed or had it's residents transferred by the State.
(ii) Qualifications for instructors. The training of home health
aides and the supervision of home health aides during the supervised
practical portion of the training must be performed by or under the
general supervision of a registered nurse who possesses a minimum of 2
years of nursing experience, at least 1 year of which must be in the
provision of home health care. Other individuals may be used to provide
instruction under the supervision of a qualified registered nurse.
(3) Documentation of training. The HHA must maintain sufficient
documentation to demonstrate that the requirements of this standard are
met.
(b) Standard: Competency evaluation and in-service training -- (1)
Applicability. An individual may furnish home health aide services on
behalf of an HHA only after that individual has successfully completed a
competency evaluation program as described in this paragraph. The HHA
is responsible for ensuring that the individuals who furnish home health
aide services on its behalf meet the competency evaluation requirements
of this section.
(2) Content and frequency of evaluations and amount of in-service
training. (i) The competency evaluation must address each of the
subjects listed in paragraph (a)(1) (ii) through (xiii) of this section.
(ii) The HHA must complete a performance review of each home health
aide no less frequently than every 12 months.
(iii) The home health aide must receive at least 12 hours of
in-service training per calendar year. The in-service training may be
furnished while the aide is furnishing care to patients.
(3) Conduct of evaluation and training -- (i) Organizations. A home
health aide competency evaluation program may be offered by any
organization except as specified in paragraph (a)(2)(i) of this section.
The in-service training may be offered by any organization.
(ii) Evaluators and instructors. The competency evaluation must be
performed by a registered nurse. The in-service training generally must
be supervised by a registered nurse who possesses a minimum of 2 years
of nursing experience at least 1 year of which must be in the provision
of home health care.
(iii) Subject areas. The subject areas listed at paragraphs (a)(1)
(iii), (ix), (x), and (xi) of this section must be evaluated after
observation of the aide's performance of the tasks with a patient. The
other subject areas in paragraph (a)(1) of this section may be evaluated
through written examination, oral examination, or after observation of a
home health aide with a patient.
(4) Competency determination. (i) A home health aide is not
considered competent in any task for which he or she is evaluated as
''unsatisfactory''. The aide must not perform that task without direct
supervision by a licensed nurse until after he or she receives training
in the task for which he or she was evaluated as ''unsatisfactory'' and
passes a subsequent evaluation with ''satisfactory''.
(ii) A home health aide is not considered to have successfully passed
a competency evaluation if the aide has an ''unsatisfactory'' rating in
more than one of the required areas.
(5) Documentation of competency evaluation. The HHA must maintain
documentation which demonstrates that the requirements of this standard
are met.
(6) Effective date. The HHA must implement a competency evaluation
program that meets the requirements of this paragraph before February
14, 1990. The HHA must provide the preparation necessary for the
individual to successfully complete the competency evaluation program.
After August 14, 1990, the HHA may use only those aides that have been
found to be competent in accordance with 484.36(b).
(c) Standard: Assignment and duties of the home health aide. The
home health aide is assigned to a particular patient by a registered
nurse. Written instructions for patient care are prepared by a
registered nurse or therapist as appropriate. Duties include the
performance of simple procedures as an extension of therapy services,
personal care, ambulation and exercise, household services essential to
health care at home, assistance with medications that are ordinarily
self-administered, reporting changes in the patient's conditions and
needs, and completing appropriate records.
(d) Standard: Supervision.
The following requirements for supervision of home health aides
furnishing home health aide services to patients must be met:
(1) Home health aide services only. When only home health aide
services are being furnished to a patient, a registered nurse must make
a supervisory visit to the patient's residence at least once every 60
days. Each supervisory visit must occur when the aide is furnishing
patient care.
(2) Skilled nursing care or physical, speech, or occupational therapy
furnished. When skilled nursing care or physical, speech, or
occupational therapy are also being furnished to a patient, a registered
nurse must make a supervisory visit to the patient's residence at least
every 2 weeks (either when the aide is present to observe and assist, or
when the aide is absent) to assess relationships and determine whether
goals are being met. When only physical, speech, or occupational
therapy are furnished in addition to the home health aide services, a
skilled therapist may make the supervisory visits in place of a
registered nurse.
(e) Personal care attendant: Evaluation requirements.
(1) Applicability. This paragraph applies to individuals who are
employed by HHAs exclusively to furnish personal care attendant services
under a Medicaid personal care benefit.
(2) Rule. An individual may furnish personal care services, as
defined in 440.170 of this chapter, on behalf of an HHA after the
individual has been found competent by the State to furnish those
services for which a competency evaluation is required by paragraph (b)
of this section and which the individual is required to perform. The
individual need not be determined competent in those services listed in
paragraph (a) of this section that the individual is not required to
furnish.
(54 FR 33367, August 14, 1989, as amended at 56 FR 32974, July 18,
1991; 56 FR 51334, Oct. 11, 1991)
42 CFR 484.38 Condition of participation: Qualifying to furnish
outpatient physical therapy or speech pathology services.
An HHA that wishes to furnish outpatient physical therapy or speech
pathology services must meet all the pertinent conditions of this part
and also meet the additional health and safety requirements set forth in
405.1717 through 405.1719, 405.1721, 405.1723, and 405.1725 of this
chapter to implement section 1861(p) of the Act.
42 CFR 484.48 Condition of participation: Clinical records.
A clinical record containing pertinent past and current findings in
accordance with accepted professional standards is maintained for every
patient receiving home health services. In addition to the plan of
care, the record contains appropriate identifying information; name of
physician; drug, dietary, treatment, and activity orders; signed and
dated clinical and progress notes; copies of summary reports sent to
the attending physician; and a discharge summary.
(a) Standards: Retention of records. Clinical records are retained
for 5 years after the month the cost report to which the records apply
is filed with the intermediary, unless State law stipulates a longer
period of time. Policies provide for retention even if the HHA
discontinues operations. If a patient is transferred to another health
facility, a copy of the record or abstract is sent with the patient.
(b) Standards: Protection of records. Clinical record information
is safe-guarded against loss or unauthorized use. Written procedures
govern use and removal of records and the conditions for release of
information. Patient's written consent is required for release of
information not authorized by law.
42 CFR 484.52 Condition of participation: Evaluation of the agency's
program.
The HHA has written policies requiring an overall evaluation of the
agency's total program at least once a year by the group of professional
personnel (or a committee of this group), HHA staff, and consumers, or
by professional people outside the agency working in conjunction with
consumers. The evaluation consists of an overall policy and
administrative review and a clinical record review. The evaluation
assesses the extent to which the agency's program is appropriate,
adequate, effective, and efficient. Results of the evaluation are
reported to and acted upon by those responsible for the operation of the
agency and are maintained separately as administrative records.
(a) Standard: Policy and administrative review. As a part of the
evaluation process the policies and administrative practices of the
agency are reviewed to determine the extent to which they promote
patient care that is appropriate, adequate, effective, and efficient.
Mechanisms are established in writing for the collection of pertinent
data to assist in evaluation.
(b) Standard: Clinical record review. At least quarterly,
appropriate health professionals, representing at least the scope of the
program, review a sample of both active and closed clinical records to
determine whether established policies are followed in furnishing
services directly or under arrangement. There is a continuing review of
clinical records for each 62-day period that a patient receives home
health services to determine adequacy of the plan of care and
appropriateness of continuation of care.
42 CFR 484.52 PART 485 -- CONDITIONS OF PARTICIPATION AND CONDITIONS FOR COVERAGE: SPECIALIZED PROVIDERS
42 CFR 484.52 Subpart A -- (Reserved)
42 CFR 484.52 Subpart B -- Conditions of Participation: Comprehensive
Outpatient Rehabilitation Facilities
Sec.
485.50 Basis and scope.
485.51 Definition.
485.54 Condition of participation: Compliance with State and local
laws.
485.56 Condition of participation: Governing body and
administration.
485.58 Condition of participation: Comprehensive rehabilitation
program.
485.60 Condition of participation: Clinical records.
485.62 Condition of participation: Physical environment.
485.64 Condition of participation: Disaster procedures.
485.66 Condition of participation: Utilization review plan.
485.70 Personnel qualifications.
485.74 Appeal rights.
42 CFR 484.52 Subpart C -- (Reserved)
42 CFR 484.52 Subpart D -- Conditions for Coverage: Organ Procurement
Organizations
485.301 Basis and scope.
485.302 Definitions.
485.303 Condition: Organ procurement organization qualifications --
General.
485.304 Condition: Qualifications required of an organization for it
to be a designated organ procurement organization.
485.305 Condition: Organ Procurement and Transplantation Network
participation.
485.306 Condition: Performance standards for organ procurement
organizations.
485.307 Failure to meet requirements.
485.308 Designation of one OPO for each service area.
Authority: Secs. 1102, 1138, 1861 (aa) and (cc) and 1871 of the
Social Security Act (42 U.S.C. 1302, 1320b-8, 1395x and 1395hh); and
sec. 353 of the Public Health Service Act (U.S.C. 263a).
Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted.
Redesignated at 50 FR 33034, Aug. 16, 1985.
42 CFR 484.52 Subpart A -- (Reserved)
42 CFR 484.52 Subpart B -- Conditions of Participation: Comprehensive Outpatient Rehabilitation Facilities
42 CFR 485.50 Basis and scope.
This subpart sets forth the conditions that facilities must meet to
be certified as comprehensive outpatient rehabilitation facilities
(CORFs) under section 1861(cc)(2) of the Social Security Act and be
accepted for participation in Medicare in accordance with part 489 of
this chapter.
42 CFR 485.51 Definition.
As used in this subpart, unless the context indicates otherwise,
''comprehensive outpatient rehabilitation facility'', ''CORF'', or
''facility'' means a nonresidential facility that --
(a) Is established and operated exclusively for the purpose of
providing diagnostic, therapeutic, and restorative services to
outpatients for the rehabilitation of injured, disabled, or sick
persons, at a single fixed location, by or under the supervision of a
physician; and
(b) Meets all the requirements of this subpart.
42 CFR 485.54 Condition of participation: Compliance with State and
local laws.
The facility and all personnel who provide services must be in
compliance with applicable State and local laws and regulations.
(a) Standard: Licensure of facility. If State or local law provides
for licensing, the facility must be currently licensed or approved as
meeting the standards established for licensure.
(b) Standard: Licensure of personnel. Personnel that provide
service must be licensed, certified, or registered in accordance with
applicable State and local laws.
42 CFR 485.56 Condition of participation: Governing body and
administration.
The facility must have a governing body that assumes full legal
responsibility for establishing and implementing policies regarding the
management and operation of the facility.
(a) Standard: Disclosure of ownership. The facility must comply
with the provisions of part 420, subpart C of this chapter that require
health care providers and fiscal agents to disclose certain information
about ownership and control.
(b) Standard: Administrator. The governing body must appoint an
administrator who --
(1) Is responsible for the overall management of the facility under
the authority delegated by the governing body;
(2) Implements and enforces the facility's policies and procedures;
(3) Designates, in writing, an individual who, in the absence of the
administrator, acts on behalf of the administrator; and
(4) Retains professional and administrative responsibility for all
personnel providing facility services.
(c) Standard: Group of professional personnel. The facility must
have a group of professional personnel associated with the facility that
--
(1) Develops and periodically reviews policies to govern the services
provided by the facility; and
(2) Consists of at least one physician and one professional
representing each of the services provided by the facility.
(d) Standard: Institutional budget plan. The facility must have an
institutional budget plan that meets the following conditions:
(1) It is prepared, under the direction of the governing body, by a
committee consisting of representatives of the governing body and the
administrative staff.
(2) It provides for --
(i) An annual operating budget prepared according to generally
accepted accounting principles;
(ii) A 3-year capital expenditure plan if expenditures in excess of
$100,000 are anticipated, for that period, for the acquisition of land;
the improvement of land, buildings, and equipment; and the replacement,
modernization, and expansion of buildings and equipment; and
(iii) Annual review and updating by the governing body.
(e) Standard: Patient care policies. The facility must have written
patient care policies that govern the services it furnishes. The
patient care policies must include the following:
(1) A description of the services the facility furnishes through
employees and those furnished under arrangements.
(2) Rules for and personnel responsibilities in handling medical
emergencies.
(3) Rules for the storage, handling, and administration of drugs and
biologicals.
(4) Criteria for patient admission, continuing care, and discharge.
(5) Procedures for preparing and maintaining clinical records on all
patients.
(6) A procedure for explaining to the patient and the patient's
family the extent and purpose of the services to be provided.
(7) A procedure to assist the referring physician in locating another
level of care for -- patients whose treatment has terminated and who are
discharged.
(8) A requirement that patients accepted by the facility must be
under the care of a physician.
(9) A requirement that there be a plan of treatment established by a
physician for each patient.
(10) A procedure to ensure that the group of professional personnel
reviews and takes appropriate action on recommendations from the
utilization review committee regarding patient care policies.
(f) Standard: Delegation of authority. The responsibility for
overall administration, management, and operation must be retained by
the facility itself and not delegated to others.
(1) The facility may enter into a contract for purposes of assistance
in financial management and may delegate to others the following and
similar services:
(i) Bookkeeping.
(ii) Assistance in the development of procedures for billing and
accounting systems.
(iii) Assistance in the development of an operating budget.
(iv) Purchase of supplies in bulk form.
(v) The preparation of financial statements.
(2) When the services listed in paragraph (f)(1) of this section are
delegated, a contract must be in effect and:
(i) May not be for a term of more than 5 years;
(ii) Must be subject to termination within 60 days of written notice
by either party;
(iii) Must contain a clause requiring renegotiation of any provision
that HCFA finds to be in contravention to any new, revised or amended
Federal regulation or law;
(iv) Must state that only the facility may bill the Medicare program;
and
(v) May not include clauses that state or imply that the contractor
has power and authority to act on behalf of the facility, or clauses
that give the contractor rights, duties, discretions, or
responsibilities that enable it to dictate the administration,
mangement, or operations of the facility.
42 CFR 485.58 Condition of participation: Comprehensive rehabilitation
program.
The facility must provide a coordinated rehabilitation program that
includes, at a minimum, physicians' services, physical therapy services,
and social or psychological services. The services must be furnished by
personnel that meet the qualifications set forth in 485.70 and must be
consistent with the plan of treatment and the results of comprehensive
patient assessments.
(a) Standard: Physician services. (1) A facility physician must be
present in the facility for a sufficient time to --
(i) Provide, in accordance with accepted principles of medical
practice, medical direction, medical care services, and consultation;
(ii) Establish the plan of treatment in cases where a plan has not
been established by the referring physician;
(iii) Assist in establishing and implementing the facility's patient
care policies; and
(iv) Participate in plan of treatment reviews, patient case review
conferences, comprehensive patient assessment and reassessments, and
utilization review.
(2) The facility must provide for emergency physician services during
the facility operating hours.
(b) Standard: Plan of treatment. For each patient, a physician must
establish a plan of treatment before the facility initiates treatment.
The plan of treatment must meet the following requirements:
(1) It must delineate anticipated goals and specify the type, amount,
frequency and duration of services to be provided.
(2) It must be promptly evaluated after changes in the patient's
condition and revised when necessary.
(3) It must, if appropriate, be developed in consultation with the
facility physician and the appropriate facility professional personnel.
(4) It must be reviewed at least every 60 days by a facility
physician who, when appropriate, consults with the professional
personnel providing services. The results of this review must be
communicated to the patient's referring physician for concurrence before
treatment is continued or discontinued.
(5) It must be revised if the comprehensive reassessment of the
patient's status or the results of the patient case review conference
indicate the need for revision.
(c) Standard: Coordination of services. The facility must
designate, in writing, a qualified professional to ensure that
professional personnel coordinate their related activities and exchange
information about each patient under their care. Mechanisms to assist
in the coordination of services must include --
(1) Providing to all personnel associated with the facility, a
schedule indicating the frequency and type of services provided at the
facility;
(2) A procedure for communicating to all patient care personnel
pertinent information concerning significant changes in the patient's
status;
(3) Periodic clinical record entries, noting at least the patient's
status in relationship to goal attainment; and
(4) Scheduling patient case review conferences for purposes of
determining appropriateness of treatment, when indicated by the results
of the initial comprehensive patient assessment, reassessment(s), the
recommendation of the facility physician (or other physician who
established the plan of treatment), or upon the recommendation of one of
the professionals providing services.
(d) Standard: Provision of services. (1) All patients must be
referred to the facility by a physician who provides the following
information to the facility before treatment is initiated:
(i) The patient's significant medical history.
(ii) Current medical findings.
(iii) Diagnosis(es) and contraindications to any treatment modality.
(iv) Rehabilitation goals, if determined.
(2) Services may be provided by facility employees or by others under
arrangements made by the facility.
(3) The facility must have on its premises the necessary equipment to
implement the plan of treatment and sufficient space to allow adequate
care.
(4) The services must be furnished by personnel that meet the
qualifications of 485.70 and the number of qualified personnel must be
adequate for the volume and diversity of services offered. Personnel
that do not meet the qualifications specified in 485.70 may be used by
the facility in assisting qualified staff. When a qualified individual
is assisted by these personnel, the qualified individual must be on the
premises, and must instruct these personnel in appropriate patient care
service techniques and retain responsibility for their activities.
(5) A qualified professional must initiate and coordinate the
appropriate portions of the plan of treatment, monitor the patient's
progress, and recommend changes, in the plan, if necessary.
(6) A qualified professional representing each service made available
at the facility must be either on the premises of the facility or must
be available through direct telecommunication for consultation and
assistance during the facility's operating hours. At least one
qualified professional must be on the premises during the facility's
operating hours.
(7) All services must be provided consistent with accepted
professional standards and practice.
(e) Standard: Scope and site of services -- (1) Basic requirements.
The facility must provide all the CORF services required in the plan of
treatment and, except as provided in paragraph (e)(2) of this section,
must provide the services on its premises.
(2) Exceptions. Physical therapy, occupational therapy, and speech
pathology services furnished away from the premises of the CORF may be
covered as CORF services if Medicare payment is not otherwise made for
these services. In addition, a single home visit is covered if there is
need to evaluate the potential impact of the home environment on the
rehabilitation goals.
(f) Standard: Patient assessment. Each qualified professional
involved in the patient's care, as specified in the plan of treatment,
must --
(1) Carry out an initial patient assessment; and
(2) In order to identify whether or not the current plan of treatment
is appropriate, perform a patient reassessment after significant changes
in the patient's status.
(g) Standard: Laboratory services. (1) If the facility provides its
own laboratory services, the services must meet the applicable
requirements for laboratories specified in part 493 of this chapter.
(2) If the facility chooses to refer specimens for laboratory
testing, the referral laboratory must be certified in the appropriate
specialties and subspecialties of services in accordance with the
requirements of part 493 of this chapter.
(48 FR 56293, Dec. 15, 1982, as amended at 56 FR 8852, Mar. 1, 1991;
57 FR 7137, Feb. 28, 1992)
42 CFR 485.60 Condition of participation: Clinical records.
The facility must maintain clinical records on all patients in
accordance with accepted professional standards and practice. The
clinical records must be completely, promptly, and accurately
documented, readily accessible, and systematically organized to
facilitate retrieval and compilation of information.
(a) Standard: Content. Each clinical record must contain sufficient
information to identify the patient clearly and to justify the diagnosis
and treatment. Entries in the clinical record must be made as
frequently as is necessary to insure effective treatment and must be
signed by personnel providing services. All entries made by assistant
level personnel must be countersigned by the corresponding professional.
Documentation on each patient must be consolidated into one clinical
record that must contain --
(1) The initial assessment and subsequent reassessments of the
patient's needs;
(2) Current plan of treatment;
(3) Identification data and consent or authorization forms;
(4) Pertinent medical history, past and present;
(5) A report of pertinent physical examinations if any;
(6) Progress notes or other documentation that reflect patient
reaction to treatment, tests, or injury, or the need to change the
established plan of treatment; and
(7) Upon discharge, a discharge summary including patient status
relative to goal achievement, prognosis, and future treatment
considerations.
(b) Standard: Protection of clinical record information. The
facility must safeguard clinical record information against loss,
destruction, or unauthorized use. The facility must have procedures
that govern the use and removal of records and the conditions for
release of information. The facility must obtain the patient's written
consent before releasing information not required to be released by law.
(c) Standard: Retention and preservation. The facility must retain
clinical record information for 5 years after patient discharge and must
make provision for the maintenance of such records in the event that it
is no longer able to treat patients.
42 CFR 485.62 Condition of participation: Physical environment.
The facility must provide a physical environment that protects the
health and safety or patients, personnel, and the public.
(a) Standard: Safety and comfort of patients. The physical premises
of the facility and those areas of its surrounding physical structure
that are used by the patients (including at least all stairwells,
corridors and passageways) must meet the following requirements:
(1) Applicable Federal, State, and local building, fire, and safety
codes must be met.
(2) Fire extinguishers must be easily accessible and fire regulations
must be prominently posted.
(3) A fire alarm system with local (in-house) capability must be
functional, and where power is generated by electricity, an alternate
power source with automatic triggering must be present.
(4) Lights, supported by an emergency power source, must be placed at
exits.
(5) A sufficient number of staff to evacuate patients during a
disaster must be on the premises of the facility whenever patients are
being treated.
(6) Lighting must be sufficient to carry out services safely; room
temperature must be maintained at comfortable levels; and ventilation
through windows, mechanical means, or a combination of both must be
provided.
(7) Safe and sufficient space must be available for the scope of
services offered.
(b) Standard: Sanitary environment. The facility must maintain a
sanitary environment and establish a program to identify, investigate,
prevent, and control the cause of patient infections.
(1) The facility must establish written policies and procedures
designed to control and prevent infection in the facility and to
investigate and identify possible causes of infection.
(2) The facility must monitor the infection control program to ensure
that the staff implement the policies and procedures and that the
policies and procedures are consistent with current practices in the
field.
(3) The facility must make available at all times a quantity of
laundered linen adequate for proper care and comfort of patients.
Linens must be handled, stored, and processed in a mannner that prevents
the spread of infection.
(4) Provisions must be in effect to ensure that the facility's
premises are maintained free of rodent and insect infestation.
(c) Standard: Maintenance of equipment, physical location, and
grounds. The facility must establish a written preventive maintenance
program to ensure that --
(1) All equipment is properly maintained and equipment needing
periodic calibration is calibrated consistent with the manufacturer's
recommendations; and
(2) The interior of the facility, the exterior of the physical
structure housing the facility, and the exterior walkways and parking
areas are clean and orderly and maintained free of any defects that are
a hazard to patients, personnel, and the public.
(d) Standard: Access for the physically impaired. The facility must
ensure the following:
(1) Doorways, stairwells, corridors, and passageways used by patients
are --
(i) Of adequate width to allow for easy movement of all patients
(including those on stretchers or in wheelchairs); and
(ii) In the case of stairwells, equipped with firmly attached
handrails on at least one side.
(2) At least one toilet facility is accessible and constructed to
allow utilization by ambulatory and nonambulatory individuals.
(3) At least one entrance is usable by individuals in wheelchairs.
(4) In multi-story buildings, elevators are accessible to and usable
by the physically impaired on the level that they use to enter the
building and all levels normally used by the patients of the facility.
(5) Parking spaces are large enough and close enough to the facility
to allow safe access by the physically impaired.
42 CFR 485.64 Condition of participation: Disaster procedures.
The facility must have written policies and procedures that
specifically define the handling of patients, personnel, records, and
the public during disasters. All personnel associated with the facility
must be knowledgeable with respect to these procedures, be trained in
their application, and be assigned specific responsibilities.
(a) Standard: Disaster plan. The facility's written disaster plan
must be developed and maintained with assistance of qualified fire,
safety, and other appropriate experts. The plan must include --
(1) Procedures for prompt transfer of casualties and records;
(2) Procedures for notifying community emergency personnel (for
example, fire department, ambulance, etc.);
(3) Instructions regarding the location and use of alarm systems and
signals and fire fighting equipment; and
(4) Specification of evacuation routes and procedures for leaving the
facility.
(b) Standard: Drills and staff training. (1) The facility must
provide ongoing training and drills for all personnel associated with
the facility in all aspects of disaster preparedness.
(2) All new personnel must be oriented and assigned specific
responsibilities regarding the facility's disaster plan within two weeks
of their first workday.
42 CFR 485.66 Condition of participation: Utilization review plan.
The facility must have in effect a written utilization review plan
that is implemented at least each quarter, to assess the necessity of
services and promotes the most efficient use of services provided by the
facility.
(a) Standard: Utilization review committee. The utilization review
committee, consisting of the group of professional personnel specified
in 485.56(c), a committee of this group, or a group of similar
composition, comprised by professional personnel not associated with the
facility, must carry out the utilization review plan.
(b) Standard: Utilization review plan. The utilization review plan
must contain written procedures for evaluating --
(1) Admissions, continued care, and discharges using, at a minimum,
the criteria established in the patient care policies;
(2) The applicability of the plan of treatment to established goals;
and
(3) The adequacy of clinical records with regard to --
(i) Assessing the quality of services provided; and
(ii) Determining whether the facility's policies and clinical
practices are compatible and promote appropriate and efficient
utilization of services.
42 CFR 485.70 Personnel qualifications.
This section sets forth the qualifications that must be met, as a
condition of participation, under 485.58, and as a condition of
coverage of services under 410.100 of this chapter.
(a) A facility physician must be a doctor of medicine or osteopathy
who --
(1) Is licensed under State law to practice medicine or surgery; and
(2) Has had, subsequent to completing a 1-year hospital internship,
at least 1 year of training in the medical management of patients
requiring rehabilitation services; or
(3) Has had at least 1 year of full-time or part-time experience in a
rehabilitation setting providing physicians' services similar to those
required in this subpart.
(b) A licensed practical nurse must be licensed as a practical or
vocational nurse by the State in which practicing, if applicable.
(c) An occupational therapist and an occupational therapist assistant
must meet the qualifications set forth in 405.1202(f) and (g) of this
chapter.
(d) An orthotist must --
(1) Be licensed by the State in which practicing, if applicable;
(2) Have successfully completed a training program in orthotics that
is jointly recognized by the American Council on Education and the
American Board for Certification in Orthotics and Prosthetics; and
(3) Be eligible to take that Board's certification examination in
orthotics.
(e) A physical therapist and a physical therapist assistant must meet
the qualifications set forth in 405.1702 (d) and (e) of this chapter.
(f) A prosthetist must --
(1) Be licensed by the State in which practicing, if applicable;
(2) Have successfully completed a training program in prosthetics
that is jointly recognized by the American Council on Education and the
American Board for Certification in Orthotics and Prosthetics; and
(3) Be eligible to take that Board's certification examination in
prosthetics.
(g) A psychologist must be certified or licensed by the State in
which he or she is practicing, if that State requires certification or
licensing, and must hold a masters degree in psychology from and
educational institution approved by the State in which the institution
is located.
(h) A registered nurse must be a graduate of an approved school of
nursing and be licensed as a registered nurse by the State in which
practicing, if applicable.
(i) A rehabilitation counselor must --
(1) Be licensed by the State in which practicing, if applicable;
(2) Hold at least a bachelor's degree; and
(3) Be eligible to take the certification examination administered by
the Commission on Rehabilitation Counselor Certification.
(j) A respiratory therapist must --
(1) Be licensed by the State in which practicing, if applicable;
(2) Have successfully completed a training program accredited by the
Committee on Allied Health Education and Accreditation (CAHEA) in
collaboration with the Joint Review Committee for Respiratory Therapy
Education; and
(3) Either --
(i) Be eligible to take the registry examination for respiratory
therapists administered by the National Board for Respiratory Therapy,
Inc.; or
(ii) Have equivalent training and experience as determined by the
National Board for Respiratory Therapy, Inc.
(k) A respiratory therapy technician must --
(1) Be licensed by the State in which practicing, if applicable;
(2) Have successfully completed a training program accredited by the
Committees on Allied Health Education and Accreditation (CAHEA) in
collaboration with the Joint Review Committee for Respiratory Therapy
Education; and
(3) Either --
(i) Be eligible to take the certification examination for respiratory
therapy technicians administered by the National Board for Respiratory
Therapy, Inc,; or
(ii) Have equivalent training and experience as determined by the
National Board for Respiratory Therapy, Inc.
(l) A social worker must --
(1) Be licensed by the State in which practicing, if applicable;
(2) Hold at least a bachelor's degree from a school accredited or
approved by the Council on Social Work Education; and
(3) Have 1 year of social work experience in a health care setting.
(m) A speech-language pathologist must meet the qualifications set
forth in 405.1702(j) of this chapter.
(48 FR 56293, Dec. 15, 1982. Redesignated and amended at 50 FR 33034,
Aug. 16, 1985; 51 FR 41352, Nov. 14, 1986)
42 CFR 485.74 Appeal rights.
The appeal provisions set forth in part 498 of this chapter, for
providers, are applicable to any entity that is participating or seeks
to participate in the Medicare program as a CORF.
(48 FR 56293, Dec. 15, 1982, as amended at 52 FR 22454, June 12,
1987)
42 CFR 485.74 Subpart C -- (Reserved)
42 CFR 485.74 Subpart D -- Conditions for Coverage: Organ Procurement
Organizations
Source: 53 FR 6549, March 1, 1988, unless otherwise noted.
42 CFR 485.301 Basis and scope.
The subpart sets forth the qualifications and requirements an organ
procurement organization (OPO) must meet in order for the costs of its
services in procuring organs for hospitals and transplant centers to be
reimbursable under Medicare and Medicaid. Its statutory basis is
section 1138(b) of the Act, as added by section 9318 of Pub. L. 99-509.
42 CFR 485.302 Definitions.
As used in this subpart, the following definitions apply:
Entire standard metropolitan statistical area means a metropolitan
statistical area, a consolidated metropolitan statistical area, or a
primary statistical area listed in the State and Metropolitan Area Data
Book published by the U.S. Bureau of the Census.
Organ means a human kidney, liver, heart, lung, or pancreas.
Organ procurement organization means an organization that performs or
coordinates the performance of retrieving, preserving and transporting
organs and maintains a system of locating prospective recipients for
available organs.
Potential donor means a person who dies in circumstances (causes and
conditions of death, and age at death) that are generally acceptable for
donation of at least one solid organ if the donor can be identified
timely and permission for donation can be obtained.
Service area means a geographical area of sufficient size that
(unless the service area comprises an entire State) includes at least
2.5 million in population or at least fifty potential organ donors each
year and that either includes an entire standard metropolitan
statistical area or does not include any part of such an area.
Transplant center means a hospital certified by Medicare to furnish
directly, for a specific organ(s), transplant and other medical and
surgical specialty services required for the care of transplant
patients.
42 CFR 485.303 Condition: Organ procurement organization
qualifications -- General.
(a) Payment may be made under the Medicare and Medicaid programs for
organ procurement costs attributable to payments made by an OPO only if
the organization has been designated by the Secretary as an OPO, payment
to which may be treated as organ procurement costs for reimbursement of
hospitals under Medicare and Medicaid.
(b) To be initially designated as an OPO, an organization must:
(1) Apply to HCFA in writing using the application form prescribed by
HCFA; and
(2) Meet the requirements in 485.304 and 485.305.
(c) Upon designation, an OPO is certified for two years. To continue
to be designated as the designated OPO as specified in paragraph (b) of
this section, the OPO must be recertified by the Secretary at least
every two years as meeting the performance standards in 485.306 of this
subpart and must continue to meet the requirements in 485.304 and
485.305 of the subpart.
42 CFR 485.304 Condition: Qualifications required of an organization
for it to be a designated organ procurement organization.
To be designated by the Secretary as the OPO for its service area in
accordance with 485.303 of this subpart, an organization must at the
time of application and throughout the period of its designation --
(a) Be a nonprofit entity that is exempt from Federal income taxation
under section 501 of the Internal Revenue Code of 1986;
(b) Have accounting and other fiscal procedures necessary to assure
the fiscal stability of the organization, including procedures to obtain
payment for kidneys and non-renal organs provided to transplant centers;
(c) Have an agreement with the Secretary to be reimbursed under
Medicare for the procurement of covered organs;
(d) Make available to HCFA documentation of its service area. An OPO
in a service area of less than 2.5 million in population must provide to
HCFA quantifiable data showing that the area yields 50 or more potential
donors of solid or vascular organs per year. Documentation that
precisely defines the proposed service area includes the following:
(1) The names of the counties (or parishes in Louisiana) served
unless the service area includes an entire State, in which case only the
name of the State must be included;
(2) Geographic boundaries of the service area for which U.S.
population statistics are available;
(3) Total population in service area; and
(4) The number of and the names of acute care hospitals in the
service area with an operating room and the equipment and personnel to
retrieve organs;
(e) Have a director and such other staff, including an organ donation
coordinator and an organ procurement specialist, necessary to obtain
organs effectively from donors in its service area;
(f) Have a board of directors or an advisory board that has the
authority to recommend policies relating to the donation, procurement,
and distribution of organs. The board of directors or advisory board
must include --
(1) Members who represent hospital administrators, tissue banks,
voluntary health associations in its service area and either intensive
care or emergency room personnel;
(2) Members who represent the public residing in that area;
(3) A physician with knowledge, experience, or skills in the field of
human histocompatability;
(4) A neurosurgeon or another physician with knowledge or skills in
the field of neurology; and
(5) A transplant surgeon from each transplant center in its service
area with which the OPO has arrangements to coordinate its activities;
(g) To identify potential organ donors, have documented evidence that
-- (1) It has a working relationship with at least 75 percent of the
hospitals that participate in the Medicare and Medicaid programs in its
service area and that have an operating room and the equipment and
personnel for retrieving organs; and
(2) It conducts systematic efforts intended to acquire all usable
organs from potential donors;
(h) Arrange for the appropriate tissue typing of donated organs;
(i) Have a system to allocate donated organs among transplant centers
and patients according to established medical criteria;
(j) Provide or arrange for the transportation of donated organs to
transplant centers;
(k) Have arrangements to coordinate its activities with transplant
centers in the area;
(l) Have arrangements to cooperate with tissue banks for the
retrieval, processing, preservation, storage and distribution of tissues
as may be appropriate to assure that all usable tissues are obtained
from potential donors;
(m) Maintain and make available upon request of the Secretary, the
Comptroller General, or their designees data that relate to the
performance standards;
(n) Maintain data in a format that can be readily used by a successor
OPO and agree to turn over to the Secretary copies of all records and
data necessary to assure uninterrupted service by a successor OPO newly
designated by HCFA;
(o) Have a procedure for ensuring the confidentiality of patient
records. Information from or copies of records may be released only to
authorized individuals and the OPO must ensure that unauthorized
individuals cannot gain access to or alter patient records. Original
medical records may be released by the OPO only in accordance with
Federal or State laws, court orders, or subpoenas; and
(p) Conduct and participate in professional education concerning
organ procurement.
(q) Assure appropriate tests consistent with OPTN standards and CDC
guidelines are performed by a laboratory that is certified in the
appropriate specialty or subspecialty of service in accordance with the
requirements of part 493 of this chapter, including tests to prevent the
acquisition of organs that are infected with the etiologic agent for
acquired immune deficiency syndrome.
(53 FR 6550, March 1, 1988; 53 FR 9172, March 21, 1988; 53 FR
18987, May 26, 1988; 57 FR 7137, Feb. 28, 1992)
42 CFR 485.305 Condition: Organ Procurement and Transplantation
Network participation.
In order to be designated as the OPO for its service area, and to
continue to be the designated OPO once designated, an OPO must be a
member of, have a written agreement with, and abide by the rules and
requirements of the Organ Procurement and Transplantation Network
established in accordance with section 372 of the Public Health Service
Act.
(53 FR 6551, March 1, 1988; 53 FR 18987, May 26, 1988)
42 CFR 485.306 Condition: Performance standards for organ procurement
organizations.
(a) HCFA will not recertify any OPO that fails to meet the following
performance standards:
(1) Each OPO must procure within its service area a minimum ratio of
23 cadaveric kidneys per million population of its service area for each
12 month period surveyed.
(2) Each OPO must provide a minimum ratio of cadaveric kidneys
procured in its service area and transplanted (either locally or
exported and transplanted) of 19 cadaveric kidneys per million
population of its service area for each 12 month period surveyed.
(3) Each OPO must enter into a working relationship with any hospital
or transplant center in the OPO's service area that requests a working
relationship.
(b) An OPO designated by HCFA for its service area will be exempt
from meeting these performance standards for two years after initially
being designated as an OPO under 485.303 of this subpart.
(53 FR 6551, March 1, 1988; 53 FR 9172, March 21, 1988; 53 FR
18987, May 26, 1988)
42 CFR 485.307 Failure to meet requirements.
(a) Failure to continue to meet any of the requirements in 485.304
and 485.305 of the subpart or to meet the performance standards in
485.306(a) of this subpart (after two years after designation (see
485.306(b) of this subpart)) may result in suspension of payment for
costs for OPO services. HCFA will notify the OPO of its determination
that the OPO has not met one or more of the requirements and provide a
reasonable opportunity for correction. Continued failure to meet a
requirement may result in termination of the OPO's agreement with the
Secretary.
(b) An OPO whose payment is suspended or whose agreement with the
Secretary is terminated may appeal the action in accordance with Part
498 of this chapter.
42 CFR 485.308 Designation of one OPO for each service area.
(a) The Secretary may designate only one OPO per service area. If
more than one organization applies and substantially meets the
requirements of 485.304 of this subpart in a given service area, the
Secretary will consider other factors in reaching a decision concerning
which organization to designate. These factors are as follows:
(1) Prior performance, including the previous year's experience in
terms of the number of organs retrieved and wasted and the average cost
per organ;
(2) Actual number of donors compared to the number of potential
donors;
(3) The nature of relationships and degree of involvement with
hospitals in the organization's service area;
(4) Bed capacity associated with the hospitals with which the
organizations have a working relationship;
(5) Willingness and ability to place organs within the service area;
and
(6) Proximity of the organization to the donor hospitals.
(b) An organization that applies to HCFA to be the designated OPO for
its service area and that is not designated may appeal its
nondesignation under part 498 of this chapter.
42 CFR 485.308 PART 488 -- SURVEY AND CERTIFICATION PROCEDURES
42 CFR 485.308 Subpart A -- General Provisions
Sec.
488.1 Definitions.
488.3 Conditions of participation: Conditions for coverage and
requirements for SNFs and NFs.
488.5 Effect of JCAHO or AOA accreditation.
488.6 Validation survey.
488.8 Civil rights requirements.
488.10 State survey agency review: Statutory provisions.
488.11 State survey agency functions.
488.12 Effect of survey agency certification.
488.14 Effect of PRO review.
488.18 Documentation of findings.
488.20 Periodic review of compliance and approval.
488.24 Certification of noncompliance.
488.26 Determining compliance.
488.28 Providers of suppliers with deficiencies.
42 CFR 485.308 Subpart B -- Special Requirements
488.50 Special requirements applicable to skilled nursing facilities
with deficiencies.
488.52 (Reserved)
488.54 Temporary waivers applicable to hospitals.
488.56 Temporary waivers applicable to skilled nursing facilities.
488.60 Special procedures for approving end stage renal disease
facilities.
488.64 Remote facility variances for utilization review requirements.
42 CFR 485.308 Subpart C -- Survey Forms and Procedures
488.100 Long term care survey forms, Part A.
488.105 Long term care survey forms, Part B.
488.110 Procedural guidelines.
488.115 Care guidelines.
42 CFR 485.308 Subpart D -- Reconsideration of Adverse Determinations
-- Deeming Authority for Accreditation Organizations and CLIA Exemption
of Laboratories Under State Programs
488.201 Reconsideration.
488.203 Withdrawal of request for reconsideration.
488.205 Right to informal hearing.
488.207 Informal hearing procedures.
488.209 Hearing officer's findings.
488.211 Final reconsideration determination.
Authority: Secs. 1102, 1814, 1861, 1865, 1866, 1871, 1880, 1881,
1883, and 1913 of the Social Security Act (42 U.S.C. 1302, 1395f, 1395x,
1395bb, 1395cc, 1395hh, 1395qq, 1395rr, 1395tt, and 1396l).
Source: At 53 FR 22859, June 17, 1988, unless otherwise noted.
42 CFR 485.308 Subpart A -- General Provisions
42 CFR 488.1 Definitions.
As used in this part --
Accredited hospital means a hospital accredited by the Joint
Commission on Accreditation of Healthcare Organizations or by the
American Osteopathic Association.
Act means the Social Security Act.
AOA stands for the American Osteopathic Association.
Certification is a recommendation made by the State survey agency on
the compliance of providers and suppliers with the conditions of
participation, requirements (for SNFs and NFs), and conditions of
coverage.
Full review means a survey of a hospital for compliance with all
conditions of participation for hospitals.
JCAHO stands for the Joint Commission on Accreditation of Healthcare
Organizations.
Provider of services or provider means a hospital, skilled nursing
facility, nursing facility, home health agency, hospice, comprehensive
outpatient rehabilitation facility, or provider of outpatient physical
therapy or speech pathology services.
State includes the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, Guam, and American Samoa.
State survey agency means the State health agency or other
appropriate State or local agency used by HFCA to perform survey and
review functions for Medicare.
Substantial allegation means a complaint which reflects on the health
and safety of patients and raises doubts as to a hospital's compliance
with the conditions of participation.
Supplier means any of the following: Independent laboratory;
portable X-ray services physical therapist in independent practice;
ESRD facility; rural health clinic; Federally qualified health center;
or chiropractor.
(53 FR 22859, June 17, 1988, as amended at 54 FR 5373, Feb. 2, 1989;
56 FR 48879, Sept. 26, 1991; 57 FR 24982, June 12, 1992)
42 CFR 488.3 Conditions of participation: Conditions for coverage and
requirements for SNFs and NFs.
(a) Basic rules. In order to be approved for participation in or
coverage under the Medicare program, a prospective provider or supplier
must:
(1) Meet the applicable statutory definition in section 1861, section
1819, or section 1919, section 1881 of the Act; and
(2) Be in compliance with the applicable conditions or requirements
(for SNFs and NFs) prescribed in subpart N, Q, or U of part 405, subpart
C of part 418, part 482, or part 483, part 484, subpart A of part 491 or
part 493 of this chapter.
(b) Special Conditions. (1) The Secretary, after consultation with
the JCAHO or AOA, may issue conditions of participation for hospitals
higher or more precise than those of either those accrediting bodies.
(2) The Secretary may, at a State's request, approve health and
safety requirements for providers and suppliers in that State, which are
higher than those otherwise applied in the Medicare program.
(3) If a State or political subdivision imposes higher requirements
on institutions as a condition for the purchase of health services under
a State Medicaid Plan approved under Title XIX of the Act, (or if Guam,
Puerto Rico, or the Virgin Islands does so under a State plan for Old
Age Assistance under Title I of the Act, or for Aid to the Aged, Blind,
and Disabled under the original Title XVI of the Act), the Secretary is
required to impose similar requirements as a condition for payment under
Medicare in that State or political subdivision.
(53 FR 22859, June 17, 1988, as amended at 54 FR 5373, Feb. 2, 1989;
56 FR 48879, Sept. 26, 1991)
42 CFR 488.5 Effect of JCAHO or AOA accreditation.
Institutions accredited as hospitals by the JCAHO or AOA are deemed
to meet all of the Medicare conditions of participation for hospitals,
except:
(a) The requirement for utilization review as specified in section
1861(e)(6) of the Act and in 482.30 of this chapter.
(b) The additional special staffing and medical records requirements
that are considered necessary for the provision of active treatment in
psychiatric hospitals (section 1861(f) of the Act) and implementing
regulations; and
(c) Any requirement under section 1861(e) of the Act and implementing
regulations which the Secretary, after consulting with JCAHO or AOA,
identifies as being higher or more precise than the requirements for
accreditation (section 1865(a)(4) of the Act).
42 CFR 488.6 Validation survey.
(a) Basis for survey. HCFA may require a survey of an accredited
hospital to validate the JCAHO or AOA accreditation process. These
surveys will be conducted on a selective-sample basis, or in response to
substantial allegations of significant deficiencies.
(b) Effect of selection for survey. A hospital selected for a
validation survey must: (1) Authorize its accrediting body to release
to HCFA or the State survey agency (on a confidential basis for JCAHO
hospitals), a copy of the hospital's current accreditation survey. (For
the rules on confidentiality, see 42 CFR 401.126:
(2) Authorize carrying out the validation survey; and
(3) Authorize its accrediting body to release periodic status reports
to HCFA on correction of deficiencies when HCFA and the accrediting body
agree that the latter will monitor the correction deficiences.
(c) Refusal to cooperate with survey. If a hospital selected for a
validation survey fails to comply with the requirements specified in
paragraph (b) of this section, it will no longer be deemed to meet the
Medicare conditions of participation but will be subject to full review
by the State survey agency in accordance with 488.11 and may be subject
to termination of its provider agreement under 489.53 of this chapter.
(d) Consequences of finding of non-compliance. (1) If a validation
survey results in a finding that the hospital is out of compliance with
one or more conditions of participation and a significant deficiency is
determined to exist, the hospital will no longer be deemed to meet the
conditions of participation. Specifically, the hospital will be subject
to the requirements applied to unaccredited hospitals that are found out
of compliance following a State agency survey under 488.28, and to full
review by a State agency survey in accordance with 488.11.
(2) A significant deficiency will be determined not to exist if:
(i) The accrediting body accepts the State survey agency finding of
deficiencies and agrees to monitor the correction of the deficiencies in
accordance with specified time frames; and
(ii) The State survey agency is unable to justify to HCFA the need
for continued full review by the State survey agency to assure
correction of deficiencies; and
(iii) The accrediting body provides HCFA with periodic reports of
progress toward corrections.
(e) Reinstating effect of accreditation. An accredited hospital will
be once again deemed to meet the Medicare conditions of participation in
accordance with this section if:
(1) It withdraws any prior refusal to authorize its accrediting body
to release a copy of the hospital's current accreditation survey;
(2) It withdraws any prior refusal to allow a validation survey;
(3) It withdraws any prior refusal to authorize its accrediting body
to release periodic status reports on correction progress; and
(4) HCFA finds that the hospital meets all the Medicare conditions of
participation.
(f) Informal administrative review. (1) An accredited hospital which
is dissatisfied with a finding that it is not in compliance with a
condition of participation, or a finding that it is no longer deemed to
meet the conditions of participation, is entitled to an informal
administrative review.
(2) The hospital must request informal review in writing within 15
days of the date it received HCFA's notice of the finding.
(3) The request should state why the finding is considered incorrect
and should be accompanied by any supporting evidence and arguments.
42 CFR 488.8 Civil rights requirements.
Providers must meet the requirements of:
(a) Title VI of the Civil Rights act of 1964, as implemented by 45
CFR part 80, which provides that no person in the United States shall,
on the ground of race, color, or national origin, be excluded from
participation in, be denied the benefits of, or the subject to
discrimination under, any program or activity receiving Federal
financial assistance (section 601);
(b) Section 504 of the Rehabilitation Act of 1973, as implemented by
45 CFR part 84, which provides that no qualified handicapped person
shall, on the basis of handicap, be excluded from participation in, be
denied the benefits of, or othrwise be subjected to discrimination under
any program or activity receiving Federal financial assistance; and
(c) Other pertinent requirements made by the Office of Civil Rights
of the Department of Health and Human Services.
42 CFR 488.10 State survey agency review: Statutory provisions.
(a) Section 1864(a) of the Act requires the Secretary to enter into
an agreement with any State that is able and willing to do so, under
which appropriate State or local survey agencies will determine whether:
(1) Providers or prospective providers meet the Medicare conditions
of participation or requirements (for SNFs and NFs);
(2) Suppliers meet the conditions for coverage; and
(3) Rural health clinics meet the conditions of certification.
(b) Section 1865(a) of the Act provides that if an institution is
accredited as a hospital by the JCAHO, it will be deemed to meet the
conditions of participation:
(1) Except those specified in 488.5;
(2) Provided that such hospital, if it is included within a
validation survey, authorizes the JCAHO to release to HCFA (on a
confidential basis) upon request a copy of the most current JCAHO
accreditation survey.
(c) Section 1864(c) of the Act authorizes the Secretary to enter into
agreements with State survey agencies for the purpose of conducting
validation surveys in hospitals accredited by the JCAHO. Section
1865(b) provides that an accredited hospital which is found after a
validation survey to have significant deficiencies related to the health
and safety of patients will no longer be deemed to meet the conditions
of participation.
(d) Section 1865(a) of the Act also provides that if the Secretary
finds that accreditation of an institution or agency by the AOA or any
other national accreditation body provides reasonable assurance that any
or all of the conditions of participation are met, the Secretary may
treat such institution as meeting the conditions of participation. The
Secretary has found that the accreditation of hospitals by the AOA
provides such reasonable assurance, and has extended the same procedures
applicable to JCAHO accredited hospitals to AOA accredited hospitals.
(53 FR 22859, June 17, 1988, as amended at 56 FR 48879, Sept. 26,
1991)
42 CFR 488.11 State survey agency functions.
State and local agencies that have agreements under section 1864(a)
of the Act --
(a) Survey and make recommendations regarding the issues listed in
488.10;
(b) Conduct validation surveys as provided in 488.6; and
(c) Perform other surveys and other appropriate activities and
certify their findings to HCFA.
(56 FR 48879, Sept. 26, 1991)
42 CFR 488.12 Effect of survey agency certification.
Certifications by the State survey agency represent recommendations
to HCFA.
(a) On the basis of these recommendations, HCFA will determine
whether:
(1) A provider or supplier is eligible to participate in or be
covered under the Medicare program; or
(2) An accredited hospital is deemed to meet the Medicare conditions
of participation or is subject to full review by the State survey
agency.
(b) Notice of HCFA's determination will be sent to the provider or
supplier.
42 CFR 488.14 Effect of PRO review.
When a PRO is conducting review activities under section 1154 of the
Act and Part 466 of this chapter, its activities shall be in lieu of the
utilization review and evaluation activities required of health care
institutions under sections 1861(e)(6), 1861(j)(8), 1861(j)(12), and
1861(k) of the Act and will also be in lieu of survey, compliance and
assistance activities required of State survey agencies under section
1864(a) with respect to those sections.
42 CFR 488.18 Documentation of findings.
(a) The findings of the State agency with respect to each of the
conditions of participation or level A requirements (for SNFs and NFs)
or conditions for coverage shall be adequately documented. Where the
State agency certifies to the Secretary that a provider or supplier is
not in compliance with the conditions or requirements (for SNFs and
NFs), and therefore not eligible to participate in the program, such
documentation includes, in addition to the description of the specific
deficiencies which resulted in the agency's recommendation, a report of
all consultation which has been undertaken in an effort to assist the
provider or supplier to comply with the conditions, a report of the
provider's or supplier's responses with respect to the consultation, and
the State agency's assessment of the prospects for such improvements as
to enable the provider or supplier to achieve compliance with the
conditions or requirements (for SNFs and NFs) within a reasonable period
of time. (See 488.28 of this part.)
(b) If a provider or supplier is certified by the State agency as in
compliance with the conditions or level A requirements (for SNFs and
NFs) or as meeting the requirements for special certification (see
488.54 of this part), with deficiencies not adversely affecting the
health and safety of patients, the following information will be
incorporated into the finding:
(1) A statement of the deficiencies which were found, and
(2) A description of further action which is required to remove the
deficiencies, and
(3) A time-phased plan of correction developed by the provider and
supplier and concurred with by the State agency, and
(4) A scheduled time for a resurvey of the institution or agency to
be conducted by the state agency within 90 days following the completion
of the survey.
(c) If, on the basis of the State certification, the Secretary
determines that the provider or supplier is eligible to participate, the
information described in paragraph (b) of this section will be
incorporated into a notice of eligibility to the provider or supplier.
(39 FR 2251, Jan. 17, 1974. Redesignated at 39 FR 11419, Mar. 28,
1974, and further redesignated at 42 FR 52826, Sept. 30, 1977.
Redesignated and amended at 53 FR 23100, June 17, 1988, and further
amended at 54 FR 5373, Feb. 2, 1989; 56 FR 48879, Sept. 26, 1991)
42 CFR 488.20 Periodic review of compliance and approval.
(a) Determinations by HCFA to the effect that a provider or supplier
is in compliance with the conditions of participation or requirements
(for SNFs and NFs) or the conditions for coverage will be for a 12 month
period, except for physical therapists in independent practice and
chiropractors. Determinations for physical therapists in independent
practice and chiropractors will be made as often as HCFA deems necessary
and may be for more or less than a 12-month period. (See 488.50 of
this part for special rules for skilled nursing facilities.)
(b) The responsibilities of State survey agencies in the review and
certification of compliance are as follows:
(1) Resurvey providers or suppliers as frequently as necessary to
ascertain compliance and confirm the correction of deficiencies;
(2) Review reports prepared by a Professional Standards Review
Organization (authorized under Part B Title XI of the Act) or a State
inspection of care team (authorized under Title XIX of the Act)
regarding the quality of a facility's care;
(3) Evaluate reports that may pertain to the health and safety of
patients; and
(4) Take appropriate actions that may be necessary to achieve
compliance or certify noncompliance to HCFA.
(c) A State survey agency certification to HCFA that a provider or
supplier is no longer in compliance with the conditions of participation
or requirements (for SNFs and NFs) or conditions for coverage will
supersede the State survey agency's previous certification.
(Secs. 1102, 1814, 1861, 1863 through 1866, 1871, and 1881; 42
U.S.C. 1302, 1395f, 1395x, 1395z through 1395cc, 1395hh, and 1395rr)
(45 FR 74833, Nov. 12, 1981. Redesignated and amended at 53 FR 23100,
June 17, 1988, and further amended at 54 FR 5373, Feb. 2, 1989; 56 FR
48879, Sept. 26, 1991)
42 CFR 488.24 Certification of noncompliance.
(a) The State agency will certify that a provider or supplier is not
or is no longer in compliance with the conditions of participation or
level A requirements (for SNFs and NFs) or conditions for coverage where
the deficiencies are of such character as to substantially limit the
provider's or supplier's capacity to render adequate care or which
adversely affect the health and safety of patients; or
(b) If HCFA determines that an institution or agency does not qualify
for participation or coverage because it is not in compliance with the
conditions of participation or level A requirements (for SNFs and NFs)
or condition for coverage, or if a provider's agreement is terminated
for that reason, the institution or agency has the right to request that
the determination be reviewed. (Appeals procedures are set forth in
Part 498 of this chapter.)
(Secs. 1102, 1814, 1861, 1863 through 1866, 1871, and 1881; 42
U.S.C. 1302, 1395f, 1395x, 1395z through 1395cc, 1395hh, and 1395rr)
(39 FR 2251, Jan. 17, 1974. Redesignated at 39 FR 11419, Mar. 28,
1974, and further redesignated at 42 FR 52826, Sept. 30, 1977, and
amended at 45 FR 74833, Nov. 12, 1980; 52 FR 22454, June 12, 1987.
Redesignated at 53 FR 23100, June 17, 1988, and amended at 54 FR 5373,
Feb. 2, 1989; 56 FR 48879, Sept. 26, 1991)
42 CFR 488.26 Determining compliance.
(a) The decision as to whether there is compliance with a particular
condition of participation or level A requirements (for SNFs and NFs) or
conditions for coverage will depend upon the manner and degree to which
the provider or supplier satisfies the various standards within each
condition and requirements (for SNFs and NFs). Evaluation of a
provider's performance against these standards will enable the State
survey agency to document the nature and extent of deficiencies, if any,
with respect to a particular function, and to assess the need for
improvement in relation to the prescribed conditions.
(b) The State agency must adhere to the following principles in
determining compliance with participation requirements:
(1) The survey process is the means to assess compliance with Federal
health, safety and quality standards;
(2) The survey process uses resident outcomes as the primary means to
establish the compliance status of facilities. Specifically surveyors
will directly observe the actual provision of care and services to
residents, and the effects of that care, to assess whether the care
provided meets the needs of individual residents;
(3) Surveyors are professionals who use their judgment, in concert
with Federal forms and procedures, to determine compliance;
(4) Federal procedures are used by all surveyors to ensure uniform
and consistent application and interpretation of Federal requirements;
(5) Federal forms are used by all surveyors to ensure proper
recording of findings and to document the basis for the findings.
(c) The State survey agency must use the survey methods, procedures,
and forms that are prescribed by HCFA.
(d) The survey agency must ensure that a facility's actual provision
of care and services to residents and the effects of that care on
residents are assessed in a systematic manner.
(e) A SNF survey must include the following elements:
(1) An entrance conference;
(2) A resident-centered tour of the facility;
(3) An in-depth review of a sample of residents, including
observation, interview and record review;
(4) Observation of the preparation and administration of drugs for a
sample of residents;
(5) Evaluation of a facility's meals, dining areas and eating
assistance procedures;
(6) A description in the survey report of all deficiencies found
during the survey;
(7) An exit conference; and
(8) Follow-up surveys, as appropriate.
(53 FR 23100, June 17, 1988, as amended at 54 FR 5373, Feb. 2, 1989;
56 FR 48879, Sept. 26, 1991)
42 CFR 488.28 Providers or suppliers with deficiencies.
(a) If a provider or supplier is found to be deficient with respect
to one or more of the standards in the conditions of participation or
level B requirements (for SNFs and NFs) or conditions for coverage, it
may participate in or be covered under the Health Insurance for the Aged
and Disabled Program only if the facility has submitted an acceptable
plan of correction for achieving compliance within a reasonable period
of time acceptable to the Secretary. The existing deficiencies noted
either individually or in combination neither jeopardize the health and
safety of patients nor are of such character as to seriously limit the
provider's capacity to render adequate care. (See 488.50 of this part
for special requirements applicable to skilled nursing facilities.)
(b) If it is determined during a survey that a provider or supplier
is not in compliance with one or more of the standards or level B
requirements (for SNFs and NFs), it will be granted a reasonable time to
achieve compliance. The amount of time will depend upon the nature of
the deficiency and the State survey agency's judgment as to the
capabilities of the facility to provide adequate and safe care.
Ordinarily a provider or supplier will be expected to take the steps
needed to achieve compliance within 60 days of being notified of the
deficiencies but the State survey agency may recommend that additional
time be granted by the Secretary in individual situations, if in its
judgment it is not reasonable to expect compliance within 60 days, e.g.,
a facility must obtain the approval of its governing body, or engage in
competitive bidding.
(39 FR 2251, Jan. 17, 1974. Redesignated at 39 FR 11419, Mar. 28,
1974, and further redesignated at 42 FR 52826, Sept. 30, 1977.
Redesignated and amended at 53 FR 23100, June 17, 1988, and further
amended at 54 FR 5373, Feb. 2, 1989; 56 FR 48879, Sept. 26, 1991)
42 CFR 488.28 Subpart B -- Special Requirements
42 CFR 488.50 Special requirements applicable to skilled nursing
facilities with deficiencies.
(a) Where the facility is not in full compliance with the level B
requirements contained in subpart B of part 483, the period of
certification shall:
(1) Be restricted to a period that is no later than the 60th day
following the end of the time period specified for the correction of
deficiencies in a written plan which the Secretary has approved:
Provided, That such period shall not exceed 12 full calendar months,
except as provided in 489.15(d) and 489.16 of this chapter; or
(2) Provide a conditional period of 12 full months, subject to an
automatic cancellation clause, the certification will expire at the
close of a predetermined date which is no later than the 60th day
following the end of the time period specified for the correction of
deficiencies: Provided, That such date will occur within such 12-month
period, unless the Secretary determines that all required corrections
have been satisfactorily completed or that the facility has made
substantial effort and progress in correcting such deficiencies and has
resubmitted in writing a plan of correction acceptable to the Secretary.
(b) If the facility continues to be out of compliance with the same
level B requirement(s) at the end of the term of the agreement, a new
agreement may not be accepted for filing (see 488.20(b) of this part).
(c) When an agreement with a skilled nursing facility is not renewed
at the end of its specified term (including the automatic cancellation
of agreement), see 489.15(d) and 489.16 of this chapter for public
notice and the right to request review.
(d) If the latest survey discloses that a skilled nursing facility
that had level B requirements out of compliance during the last survey
is no longer in compliance with a level B requirement that was
previously met, a new period of certification may be approved only if,
in the judgment of the Secretary, the new deficiency(ies) has occurred:
(1) Despite adequately documented intensive efforts or for reasons
beyond its control, the skilled nursing facility was unable to maintain
compliance, and
(2) Despite the deficiency the facility is making the best use of its
resources to render adequate care.
(e) If a skilled nursing facility can document to the State's
satisfaction that it achieved compliance with a previously unmet level B
requirement during the period of certification but for reasons beyond
its control, e.g., loss of key staff member, was found out of compliance
by the time of the next survey, this may be treated as a new deficiency
instead of a carry-over deficiency unless in the judgment of the
Secretary the facility did not make a good faith effort to maintain
compliance with the level B requirement.
(39 FR 2251, Jan. 17, 1974. Redesignated at 39 FR 11419, Mar. 28,
1974, and further redesignated at 42 FR 52826, Sept. 30, 1977.
Redesignated and amended at 53 FR 23100, June 17, 1988, and further
amended at 54 FR 5373, Feb. 2, 1989; 56 FR 48879, Sept. 26, 1991)
488.52 (Reserved)
42 CFR 488.54 Temporary waivers applicable to hospitals.
(a) General provisions. If a hospital is found to be out of
compliance with one or more conditions of participation for hospitals,
as specified in part 482 of this chapter, a temporary waiver may be
granted by HCFA. HCFA may extend a temporary waiver only if such a
waiver would not jeopardize or adversely affect the health and safety of
patients. The waiver may be issued for any one year period or less
under certain circumstances. The waiver may be withdrawn earlier if
HCFA determines this action is necessary to protect the health and
safety of patients. A waiver may be granted only if:
(1) The hospital is located in a rural area. This includes all areas
not delineated as ''urban'' by the Bureau of the Census, based on the
most recent census;
(2) The hospital has 50 or fewer inpatient hospital beds;
(3) The character and seriousness of the deficiencies do not
adversely affect the health and safety of patients; and
(4) The hospital has made and continues to make a good faith effort
to comply with personnel requirements consistent with any waiver.
(b) Minimum compliance requirements. Each case will have to be
decided on its individual merits, and while the degree and extent of
compliance will vary, the institution must, as a minimum, meet all of
the statutory conditions in section 1861(e)(1)-(8), in addition to
meeting such other requirements as the Secretary finds necessary under
section 1861(e)(9). (For further information relating to the exception
in section 1861(e)(5) of the Act, see paragraph (c) of this section.)
(c) Temporary waiver of 24-hour nursing requirement of 24-hour
registered nurse requirement. HCFA may waive the requirement contained
in section 1861(e)(5) that a hospital must provide 24-hour nursing
service furnished or supervised by a registered nurse. Such a waiver
may be granted when the following criteria are met:
(1) The hospital's failure to comply fully with the 24-hour nursing
requirement is attributable to a temporary shortage of qualified nursing
personnel in the area in which the hospital is located.
(2) A registered nurse is present on the premises to furnish or
supervise the nursing services during at least the daytime shift, 7 days
a week.
(3) The hospital has in charge, on all tours of duty not covered by a
registered nurse, a licensed practical (vocational) nurse.
(4) The hospital complies with all requirements specified in
paragraph (a) of this section.
(d) Temporary waiver for technical personnel. HCFA may waive
technical personnel requirements, issued under section 1861(e)(9) of the
Act, contained in the Conditions of Participation; Hospitals (part 482
of this chapter). Such a waiver must take into account the availability
of technical personnel and the educational opportunities for technical
personnel in the area in which the hospital is located. HCFA may also
limit the scope of services furnished by a hospital in conjunction with
the waiver in order not to adversely affect the health and safety of the
patients. In addition, the hospital must also comply with all
requirements specified in paragraph (a) of this section.
(39 FR 2251, Jan. 17, 1974. Redesignated at 39 FR 11419, Mar. 28,
1974, and amended at 41 FR 27962, July 8, 1976. Further redesignated at
42 FR 52826, Sept. 30, 1977, and amended at 47 FR 31531, July 20, 1982;
51 FR 22041, June 17, 1986. Redesignated at 53 FR 23100, June 17, 1988)
42 CFR 488.56 Temporary waivers applicable to skilled nursing
facilities.
(a) Waiver of 7-day registered nurse requirement. To the extent that
483.30 of this chapter requires any skilled nursing facility to engage
the services of a registered nurse more than 40 hours a week, the
Secretary may waive such requirement for such periods as he deems
appropriate if, based upon documented findings of the State agency, he
determines that:
(1) Such facility is located in a rural area and the supply of
skilled nursing facility services in such area is not sufficient to meet
the needs of individual patients therein,
(2) Such facility has at least one fulltime registered nurse who is
regularly on duty at such facility 40 hours a week, and
(3) Such facility (i) has only patients whose attending physicians
have indicated (through physicians' orders or admission notes) that each
such patient does not require the services of a registered nurse for a
48-hour period, or (ii) has made arrangements for a registered nurse or
a physician to spend such time at the facility as is determined
necessary by the patient's attending physician to provide necessary
services on days when the regular fulltime registered nurse is not on
duty.
(4) Such facility has made and continues to make a good faith effort
to comply with the more than 40-hour registered nurse requirement, but
such compliance is impeded by the unavailability of registered nurses in
the area.
(b) Waiver of medical director requirement. To the extent that
488.75(i) of this chapter requires any skilled nursing facility to
engage the services of a medical director either part-time or full-time,
the Secretary may waive such requirement for such periods as he deems
appropriate if, based upon documented findings of the State agency, he
determines that:
(1) Such facility is located in an area where the supply of
physicians is not sufficient to permit compliance with this requirement
without seriously reducing the availability of physician services within
the area, and
(2) Such facility has made and continues to make a good faith effort
to comply with 488.75(i) of this chapter, but such compliance is
impeded by the unavailability of physicians in the area.
(39 FR 35777, Oct. 3, 1974. Redesignated and amended at 42 FR 52826,
Sept. 30, 1977. Further redesignated and amended at 53 FR 23100, June
17, 1988, and further amended at 56 FR 48879, Sept. 26, 1991; 57 FR
43925, Sept. 23, 1992)
42 CFR 488.60 Special procedures for approving end stage renal disease
facilities.
(a) Considerations for approval. An ESRD facility which wishes to be
approved for coverage, or which wishes any expansion of dialysis
services to be approved for coverage in accordance with subpart U of
part 405, must secure the Secretary's determination thereunder. In
addition to the certification by the State agency referred to in 488.12
of this part, data furnished by network organizations and
recommendations of the Public Health Service, concerning the
contribution of a facility to the furnishing of end-stage renal disease
services in its network and concerning the facility's compliance with
professional norms and standards (see subpart U of part 405), shall be
considered by the Secretary in determining whether to approve a facility
for coverage or for any expansion of services under the End-Stage Renal
Disease Program. The facility will also be required to submit data
pertaining to its qualifications for approval or for any expansion of
services, for consideration in the Secretary's determination.
(b) Determining compliance with minimal utilization rates: Time
limitations -- (1) Unconditional status. A facility which meets minimal
utilization requirements will be assigned this status as long as it
continues to meet these requirements.
(2) Conditional status. A conditional status may be granted to a
facility for not more than four consecutive calendar years and will not
be renewable (see 405.2122(b) of this chapter). Its status may be
examined each calendar year to ascertain its compliance with Subpart U.
(3) Exception status. Under unusual circumstances (see 405.2122 (b)
of this chapter) the Secretary may grant a time-limited exception to a
facility which is not in compliance with the minimal utilization rate(s)
for either unconditional status or conditional status. This exception
status may be granted, and may be renewed on an annual basis, under
circumstances where rigid application of minimal utilization rate
requirements would adversely affect the achievement of ESRD program
objectives.
(c) New applicant. A facility which has not previously participated
in the ESRD program must submit a plan detailing how it expects to meet
the conditional minimal utilization rate status by the end of the second
calendar year of its operation under the program and meet the
unconditional minimal utilization rate status by the end of the fourth
calendar year of its operation under the program.
(d) Notification. The Secretary will notify each facility and its
network coordinating council of its initial and its subsequent minimal
utilization rate classification.
(e) Failure to meet minimal utilization rate. A facility failing to
meet standards for unconditional status or conditional status, or if
applicable, for exception status, will be so notified at the time of
such classification.
(f) Interim regulations participant. A facility previously
participating under the interim regulations will not be approved under
the program established by subpart U until it has demonstrated that it
meets all the applicable requirements of this subpart, including the
appropriate minimal utilization rate. It may continue under the interim
program only for a period not to exceed 1 year from the effective date
of these amendments (see 405.2100(c) of this chapter). During this
period it may demonstrate its ability to meet the appropriate minimal
utilization rate. Failure to qualify under this subpart will
automatically terminate coverage of such facility's services under the
ESRD program at the end of such year.
(41 FR 22510, June 3, 1976. Redesignated at 42 FR 52826, Sept. 30,
1977, and further amended at 45 FR 58124, Sept. 2, 1980. Redesignated
and amended at 53 FR 23100, June 17, 1988)
42 CFR 488.64 Remote facility variances for utilization review
requirements.
(a) As used in this section:
(1) An ''available'' individual is one who:
(i) Possesses the necessary professional qualifications;
(ii) Is not precluded from participating by reason of financial
interest in any such facility or direct responsibility for the care of
the patients being reviewed or, in the case of a skilled nursing
facility, employment by the facility; and
(iii) Is not precluded from effective participation by the distance
between the facility and his residence, office, or other place of work.
An individual whose residence, office, or other place of work is more
than approximately one hour's travel time from the facility shall be
considered precluded from effective participation.
(2) ''Adjacent facility'' means a health care facility located within
a 50-mile radius of the facility which requests a variance.
(b) The Secretary may grant a requesting facility a variance from the
time frames set forth in 405.1137(d) of this chapter and 482.30 as
applicable, within which reviews all of cases must be commenced and
completed, upon a showing satisfactory to the Secretary that the
requesting facility has been unable to meet one or more of the
requirements of 405.1137 of this chapter or 482.30 of this chapter, as
applicable, by reason of insufficient medical and other professional
personnel available to conduct the utilization review required by
405.1137 of this chapter or 482.30 of this chapter, as applicable.
(c) The request for variance shall document the requesting facility's
inability to meet the requirements for which a variance is requested and
the facility's good faith efforts to comply with the requirements
contained in 405.1137 of this chapter or 482.30 of this chapter, as
applicable.
(d) The request shall include an assurance by the requesting facility
that it will continue its good faith efforts to meet the requirements
contained in 405.1137 of this chapter or 482.30 of this chapter, as
applicable.
(e) A revised utilization review plan for the requesting facility
shall be submitted concurrently with the request for a variance. The
revised plan shall specify the methods and procedures which the
requesting facility will use, if a variance is granted, to assure:
(1) That effective and timely control will be maintained over the
utilization of services; and
(2) That reviews will be conducted so as to improve the quality of
care provided to patients.
(f) The request for a variance shall include:
(1) The name, location, and type (e.g., hospital, skilled nursing
facility) of the facility for which the variance is requested;
(2) The total number of patient admissions and average daily patient
census at the facility within the previous six months;
(3) The total number of title XVIII and title XIX patient admissions
and the average daily patient census of title XVIII and title XIX
patients in the facility within the previous six months;
(4) As relevant to the request, the names of all physicians on the
active staff of the facility and the names of all other professional
personnel on the staff of the facility, or both;
(5) The name, location, and type of each adjacent facility (e.g.,
hospital, skilled nursing facility);
(6) The distance and average travel time between the facility and
each adjacent facility;
(7) As relevant to the request, the location of practice of available
physicians and the estimated number of other available professional
personnel, or both (see paragraph (a)(1)(iii) of this section);
(8) Documentation by the facility of its attempt to obtain the
services of available physicians or other professional personnel, or
both; and
(9) A statement of whether a PRO exists in the area where the
facility is located.
(g) The Secretary shall promptly notify the facility of the action
taken on the request. Where a variance is in effect, the validation of
utilization review pursuant to 405.1137 of this chapter or 482.30
shall be made with reference to the revised utilization review plan
submitted with the request for variance.
(h) The Secretary, in granting a variance, will specify the period
for which the variance has been granted; such period will not exceed
one year. A request for a renewal shall be submitted not later than 30
days prior to the expiration of the variance and shall contain all
information required by paragraphs (c), (d), and (f) of this section.
Renewal of the variance will be contingent upon the facility's
continuing to meet the provisions of this section.
(40 FR 30818, July 23, 1975. Redesignated at 42 FR 52826, Sept. 30,
1977; 51 FR 22041, June 17, 1986; 51 FR 27847, Aug. 4, 1986; 51 FR
43197, Dec. 1, 1986. Redesignated and amended at 53 FR 23100, June 17,
1988)
42 CFR 488.64 Subpart C -- Survey Forms and Procedures
42 CFR 488.64 488.100
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42 CFR 488.110 Procedural guidelines.
SNF/ICF Survey Process. The purpose for implementing a new SNF/ICF
survey process is to assess whether the quality of care, as intended by
the law and regulations, and as needed by the resident, is actually
being provided in nursing homes. Although the onsite review procedures
have been changed, facilities must continue to meet all applicable
Conditions/Standards, in order to participate in Medicare/Medicaid
programs. That is, the methods used to compile information about
compliance with law and regulations are changed; the law and
regulations themselves are not changed. The new process differs from
the traditional process, principally in terms of its emphasis on
resident outcomes. In ascertaining whether residents grooming and
personal hygiene needs are met, for example, surveyors will no longer
routinely evaluate a facility's written policies and procedures.
Instead, surveyors will observe residents in order to make that
determination. In addition, surveyors will confirm, through interviews
with residents and staff, that such needs are indeed met on a regular
basis. In most reviews, then, surveyors will ascertain whether the
facility is actually providing the required and needed care and
services, rather than whether the facility is capable of providing the
care and services.
42 CFR 488.110 The Outcome-Oriented Survey Process -- Skilled Nursing
Facilities (SNFs) and Intermediate Care Facilities (ICFs)
(a) General.
(b) The Survey Tasks.
(c) Task 1 -- Entrance Conference.
(d) Task 2 -- Resident Sample -- Selection Methodology.
(e) Task 3 -- Tour of the Facility.
(f) Task 4 -- Observation/Interview/Medical Record Review (including
drug regimen review).
(g) Task 5 -- Drug Pass Observation.
(h) Task 6 -- Dining Area and Eating Assistance Observation.
(i) Task 7 -- Forming the Deficiency Statement.
(j) Task 8 -- Exit Conference.
(k) Plan of Correction.
(l) Followup Surveys.
(m) Role of Surveyor.
(n) Confidentiality and Respect for Resident Privacy.
(o) Team Composition.
(p) Type of Facility-Application of SNF or ICF Regulations.
(q) Use of Part A and Part B of the Survey Report.
(a) General. A complete SNF/ICF facility survey consists of three
components:
Life Safety Code requirements;
Administrative and structural requirements (Part A of the Survey
Report, Form HCFA-525); and
Direct resident care requirements (Part B of the Survey Report, Form
HCFA-519), along with the related worksheets (HCFA-520 through 524).
Use this survey process for all surveys of SNFs and ICFs -- whether
freestanding, distinct parts, or dually certified. Do not use this
process for surveys of Intermediate Care Facilities for Mentally
Retarded (ICFs/MR), swing-bed hospitals or skilled nursing sections of
hospitals that are not separately certified as SNF distinct parts. Do
not announce SNF/ICF surveys ahead of time.
(b) The Survey Tasks. Listed below are the survey tasks for easy
reference:
Task 1. Entrance Conference.
Task 2. Resident Sample -- Selection Methodology.
Task 3. Tour of the Facility. Resident Needs. Physical
Environment. Meeting with Resident Council Representatives. Tour
Summation and Focus of Remaining Survey Activity.
Task 4. Observation/Interview/Medical Record. Review of Each
Individual in the Resident Sample (including drug regimen review).
Task 5. Drug Pass Observation.
Task 6. Dining Area and Eating Assistance Observation.
Task 7. Forming the Deficiency Statement (if necessary).
Task 8. Exit Conference.
(c) Task 1 -- Entrance Conference. Perform these activities during
the entrance conference in every certification and recertification
survey:
Introduce all members of the team to the facility staff, if possible,
even though the whole team may not be present for the entire entrance
conference. (All surveyors wear identification tags.)
Explain the SNF/ICF survey process as resident centered in focus, and
outline the basic steps.
Ask the facility for a list showing names of residents by room number
with each of the following care needs/treatments identified for each
resident to whom they apply:
-- Decubitus care -- Restraints -- Catheters -- Injections --
Parenteral fluids -- Rehabilitation service -- Colostomy/ileostomy
care -- Respiratory care -- Tracheostomy care -- Suctioning --
Tube feeding
Use this list for selecting the resident sample.
Ask the facility to complete page 2 of Form HCFA-519 (Resident
Census) as soon as possible, so that the information can further orient
you to the facility's population. In a survey of a SNF with a distinct
part ICF, you may collect two sets of census data. However, consolidate
the information when submitting it to the regional office. You may
modify the Resident Census Form to include the numbers of licensed and
certified beds, if necessary.
Ask the facility to post signs on readily viewed areas (at least one
on each floor) announcing that State surveyors are in the facility
performing an ''inspection,'' and are available to meet with residents
in private. Also indicate the name and telephone number of the State
agency. Hand-printed signs with legible, large letters are acceptable.
If the facility has a Resident Council, make mutually agreeable
arrangements to meet privately with the president and officers and other
individuals they might invite.
Inform the facility that interviews with residents and Resident
Councils are conducted privately, unless they independently request
otherwise, in order to enhance the development of rapport as well as to
allay any resident anxiety. Tell the facility that information is
gathered from interviews, the tour, observations, discussions, record
review, and facility officials. Point out that the facility will be
given an opportunity to respond to all findings.
(d) Task 2 -- Resident Sample -- Selection Methodology. This
methodology is aimed at formulating a sample that reflects the actual
distribution of care needs/treatments in the facility population.
Primarily performed on a random basis, it also ensures representation
in the sample of certain care needs and treatments that are assessed
during the survey.
(1) Sample Size. Calculate the size of the sample according to the
following guide:
Note that the calculation is based on the resident census, not beds.
After determining the appropriate sample size, select residents for the
sample in a random manner. You may, for example, select every fifth
resident from the resident census, beginning at a random position on the
list. For surveys of dually certified facilities or distinct part
SNFs/ICFs, first use the combined SNF/ICF population to calculate the
size of the sample, and then select a sample that reflects the
proportions of SNF and ICF residents in the facility's overall
population.
(2) Special Care Needs/Treatments. The survey form specifies several
care needs/treatments that must always be reviewed when they apply to
any facility residents. These include:
Decubitus Care
Restraints
Catheters
Injections, Parenteral Fluids, Colostomy/Ileostomy, Respiratory Care,
Tracheostomy Care, Suctioning, Tube Feeding
Rehabilitative Services (physical therapy, speech pathology and
audiology services, occupational therapy)
Due to the relatively low prevalence of these care needs/treatments,
appropriate residents may be either under-represented or entirely
omitted from the sample. Therefore, determine during the tour how many
residents in the random selection fall into each of these care
categories. Then, compare the number of such residents in the random
selection with the total number of residents in the facility with each
specified care need/treatment (based on either the resident census or
other information provided by the facility).
Review no less than 25 percent of the residents in each of these
special care needs/treatments categories. For example, if the facility
has 10 residents with decubitus ulcers, but only one of these residents
is selected randomly, review two more residents with decubitis ulcers
(25% of 10 equals 2.5, so review a total of 3). Or, if the facility has
two residents who require tube feeding, neither of whom is in the random
selection, review the care of at least one of the these residents. This
can be accomplished in the following manner:
Conduct in-depth reviews of the randomly selected residents and then
perform limited reviews of additional residents as needed to cover the
specified care categories. Such reviews are limited to the care and
services related to the pertinent care areas only, e.g., catheters,
restraints, or colostomy. Utilize those worksheets or portions of
worksheets which are appropriate to the limited review. Refer to the
Care Guidelines, as a resource document, when appropriate.
Always keep in mind that neither the random selection approach nor
the review of residents within the specified care categories precludes
investigation of other resident care situations that you believe might
pose a serious threat to a resident's health or safety. Add to the
sample, as appropriate.
(e) Task 3 -- Tour of the Facility. (1) Purpose. Conduct the tour
in order to:
Develop an overall picture of the types and patterns of care delivery
present within the facility;
View the physical environment; and
Ascertain whether randomly selected residents are communicative and
willing to be interviewed.
(2) Protocol. You may tour the entire facility as a team or
separately, as long as all areas of the facility are examined by at
least one team member. Success of the latter approach, however, is
largely dependent on open intra-team communication and the ability of
each team member to identify situations for further review by the team
member of the appropriate discipline. You may conduct the tour with or
without facility staff accompanying you, as you prefer. Facilities,
however, vary in staff member availability. Record your notes on the
Tour Notes Worksheet, Form HCFA-521.
Allow approximately three hours for the tour. Converse with
residents, family members/significant others (if present), and staff,
asking open-ended questions in order to confirm observations, obtain
additional information, or corroborate information, (e.g., accidents,
odors, apparent inappropriate dress, adequacy and appropriateness of
activities). Converse sufficiently with residents selected for in-depth
review to ascertain whether they are willing to be interviewed and are
communicative. Observe staff interactions with other staff members as
well as with residents for insight into matters such as resident rights
and assignments of staff responsibilities.
Always knock and/or get permission before entering a room or
interrupting privacy. If you wish to inspect a resident's skin, observe
a treatment procedure, or observe a resident who is exposed, courteously
ask permission from the resident if she/he comprehends, or ask
permission from the staff nurse if the resident cannot communicate. Do
not do ''hands-on'' monitoring such as removal of dressings; ask staff
to remove a dressing or handle a resident.
(3) Resident Needs. While touring, focus on the residents' needs --
physical, emotional, psychosocial, or spiritual -- and whether those
needs are being met. Refer to the following list as needed:
-- Personal hygiene, grooming, and appropriate dress -- Position
-- Assistive and other restorative devices -- Rehabilitation
issues -- Functional limitations in ADL -- Functional limitations
in gait, balance and coordination -- Hydration and nutritional
status -- Resident rights -- Activity for time of day (appropriate
or inappropriate) -- Emotional status -- Level of orientation --
Awareness of surroundings -- Behaviors -- Cleanliness of immediate
environment (wheelchair, bed, bedside
table, etc.)
-- Odors -- Adequate clothing and care supplies as well as
maintenance and
cleanliness of same
(4) Review of the Physical Environment. As you tour each resident's
room and auxiliary rooms, also examine them in connection with the
physical environment requirements. You need not document physical
environment on the Tour Notes Worksheet. Instead, you may note any
negative findings directly on the Survey Report Form in the remarks
section.
(5) Meeting With Resident Council Representatives. If a facility has
a Resident Council, one or more surveyors meet with the respresentatives
in a private area. Facility staff members do not attend unless
specifically requested by the Council. Explain the purpose of the
survey and briefly outline the steps in the survey process, i.e.,
entrance conference * * * exit conference. Indicate your interest in
learning about the strengths of the facility in addition to any
complaints or shortcomings. State that this meeting is one part of the
information gathering; the findings have not yet been completed nor the
conclusions formulated. Explain further, however, that the official
survey findings are usually available within three months after the
completion of the survey, and give the telephone number of the State
agency office.
Use this meeting to ascertain strengths and/or problems, if any, from
the consumer's perspective, as well as to develop additional information
about aspects of care and services gleaned during the tour that were
possibly substandard.
Conduct the meeting in a manner that allows for comments about any
aspect of the facility. (See the section on Interview Procedures.) Use
open-ended questions such as:
''What is best about this home?''
''What is worst?''
''What would you like to change?''
In order to get more detail, use questions such as:
''Can you be more specific?''
''Can you give me an example?''
''What can anyone else tell me about this?''
If you wish to obtain information about a topic not raised by the
residents, use an approach like the following:
''Tell me what you think about the food/staff/cleanliness here.''
''What would make it better?''
''What don't you like? What do you like?''
(6) Tour Summation and Focus of Remaining Survey Activity. When the
tour is completed, review the resident census data provided by the
facility. Determine if the care categories specified in the section on
Resident Sample are sufficiently represented in the random selection,
make adjustments as needed, and complete the listing of residents on the
worksheet labeled ''Residents Selected for In-depth Review'', Form
HCFA-520.
Transcribe notes of a negative nature onto the SRF in the ''Remarks''
column under the appropriate rule. Findings from a later segment in the
survey or gathered by another surveyor may combine to substantiate a
deficiency. You need not check ''met'' or ''not met'' at this point in
the survey. Discuss significant impressions/conclusions at the
completion of each subsequent survey task, and transfer any negative
findings onto the Survey Report Form in the Remarks section.
(f) Task 4 -- Observation/Interview/Medical Record Review (including
drug regimen review). Perform the in-depth review of each individual in
the resident sample in order to ascertain whether the facility is
meeting resident needs. Evaluate specific indicators for each resident,
utilizing the front and back of the ''Observation/Interview/Record
Review (OIRR)'' worksheet, Form HCFA-524. You may prefer to perform the
record review first, complete resident/staff/family observations and
interviews, and finally, return to the record for any final unresolved
issues. On the other hand, you may prefer to do the interviews first.
Either method is acceptable. Whenever possible, however, complete one
resident's observation/interview/medical record review and document the
OIRR before moving onto another resident. If because of the facility
layout, it is more efficient to do more than one record review at a
time, limit such record review to two or three residents so your
familiarity with the particular resident and continuity of the OIRR are
not compromised.
(1) Observation. Conduct observations concurrently with interviews
of residents, family/significant others, and discussions with direct
care staff (of the various disciplines involved. In multi-facility
operations, whenever possible, observe staff that is regularly assigned
to the facility in order to gain an understanding of the care and
services usually provided.) Maintain respect for resident privacy.
Minimize disruption of the operations of the facility or impositions
upon any resident as much as possible. Based upon your observations of
the residents' needs, gather information about any of the following
areas, as appropriate:
Bowel and bladder training
Catheter care
Restraints
Injections
Parenteral fluids
Tube feeding/gastrostomy
Colostomy/ileostomy
Respiratory therapy
Tracheostomy care
Suctioning
(2) Interviews. Interview each resident in private unless he/she
independently requests that a facility staff member or other individual
be present. Conduct the in-depth interview in a nonthreatening and
noninvasive fashion so as to decrease anxiety and defensiveness. The
open-ended approach described in the section on the Resident Council is
also appropriate for the in-depth interview. While prolonged time
expenditure is not usually a worthwhile use of resources or the
resident's time, do allow time initially to establish rapport.
At each interview:
Introduce yourself.
Address the resident by name.
Explain in simple terms the reason for your visit (e.g., to assure
that the care and services are adequate and appropriate for each
resident).
Briefly outline the process -- entrance conference, tour, interviews,
observations, review of medical records, resident interviews, and exit
conference.
Mention that the selection of a particular resident for an interview
is not meant to imply that his/her care is substandard or that the
facility provides substandard care. Also mention that most of those
interviewed are selected randomly.
Assure that you will strive for anonymity for the resident and that
the interview is used in addition to medical records, observations,
discussions, etc., to capture an accurate picture of the treatment and
care provided by the facility. Explain that the official findings of
the survey are usually available to the public about three months after
completion of the survey, but resident names are not given to the
public.
When residents experience difficulty expressing themselves:
-- Avoid pressuring residents to verbalize -- Accept and respond
to all communication -- Ignore mistakes in word choice -- Allow
time for recollection of words -- Encourage self-expression
through any means available
When interviewing residents with decreased receptive capacity:
-- Speak slowly and distinctly -- Speak at conversational voice
level -- Sit within the resident's line of vision
Listen to all resident information/allegations without judgment.
Information gathered subsequently may substantiate or repudiate an
allegation.
The length of the interview varies, depending on the condition and
wishes of the resident and the amount of information supplied. Expect
the average interview, however, to last approximately 15 minutes.
Courteously terminate an interview whenever the resident is unable or
unwilling to continue, or is too confused or disoriented to continue.
Do, however, perform the other activities of this task (observation and
record review). If, in spite of your conversing during the tour, you
find that less than 40 percent of the residents in your sample are
sufficiently alert and willing to be interviewed, try to select
replacements so that a complete OIRR is performed for a group this size,
if possible. There may be situations, however, where the resident
population has a high percentage of confused individuals and this
percentage is not achievable. Expect that the information from confused
individuals can be, but is not necessarily, less reliable than that from
more alert individuals.
Include the following areas in the interview of each resident in the
sample:
Activities of daily living
Grooming/hygiene
Nutrition/dietary
Restorative/rehabilitation care and services
Activities
Social services
Resident rights
Refer to the Care Guidelines ''evaluation factors'' as a resource for
possible elements to consider when focusing on particular aspects of
care and resident needs.
Document information obtained from the interviews/observations on the
OIRR Worksheet. Record in the ''Notes'' section any additional
information you may need in connection with substandard care or
services. Unless the resident specifically requests that he/she be
identified, do not reveal the source of the information gleaned from the
interview.
(3) Medical Record Review. The medical record review is a three-part
process, which involves first reconciling the observation/interview
findings with the record, then reconciling the record against itself,
and lastly performing the drug regimen review.
Document your findings on the OIRR Worksheet, as appropriate, and
summarize on the Survey Report Form the findings that are indicative of
problematic or substandard care. Be alert for repeated similar
instances of substandard care developing as the number of completed OIRR
Worksheets increases.
Note: The problems related to a particular standard or condition
could range from identical (e.g., meals not in accordance with dietary
plan) to different but related (e.g., nursing services -- lapse in care
provided to residents with catheters, to residents with contractures, to
residents needing assistance for personal hygiene and residents with
improperly applied restraints).
(i) Reconciling the observation/interview findings with the record.
Determine if:
An assessment has been performed.
A plan with goals has been developed.
The interventions have been carried out.
The resident has been evaluated to determine the effectiveness of the
interventions.
For example, if a resident has developed a decubitus ulcer while in
the facility, record review can validate staff and resident interviews
regarding the facility's attempts at prevention. Use your own judgment;
review as much of the record(s) as necessary to evaluate the care
planning. Note that facilities need not establish specific areas in the
record stating ''Assessment,'' ''Plan,'' ''Intervention,'' or
''Evaluation'' in order for the documentation to be considered adequate.
(ii) Reconciling the record with itself. Determine:
If the resident has been properly assessed for all his/her needs.
That normal and routine nursing practices such as periodic weights,
temperatures, blood pressures, etc., are performed as required by the
resident's conditions.
(iii) Performing the drug regimen review. The purpose of the drug
regimen review is to determine if the pharmacist has reviewed the drug
regimen on a monthly basis. Follow the procedures in Part One of
Appendix N, Surveyor Procedures for Pharmaceutical Service Requirements
in Long-Term Care Facilities. Fill in the appropriate boxes on the top
left hand corner of the reverse side of the OIRR Worksheet, Form
HCFA-524. Appendix N lists many irregularities that can occur. Review
at least six different indicators on each survey. However, the same six
indicators need not be reviewed on every survey.
Note: If you detect irregularities and the documentation
demonstrates that the pharmacist has notified the attending physician,
do not cite a deficiency. Do, however, bring the irregularity to the
attention of the medical director or other facility official, and note
the official's name and date of notification on the Survey Report Form.
(g) Task 5 -- Drug Pass Observation. The purpose of the drug pass
observation is to observe the actual preparation and administration of
medications to residents. With this approach, there is no doubt that
the errors detected, if any, are errors in drug administration, not
documentation. Follow the procedure in Part Two of Appendix N, Surveyor
Procedures for Pharmaceutical Service Requirements in Long-Term Care
Facilities, and complete the Drug Pass Worksheet, Form HCFA-522. Be as
neutral and unobtrusive as possible during the drug pass observation.
Whenever possible, select one surveyor, who is a Registered Nurse or a
pharmacist, to observe the drug pass of approximately 20 residents. In
facilities where fewer than 20 residents are receiving medications,
review as many residents receiving medications as possible. Residents
selected for the in-depth review need not be included in the group
chosen for the drug pass; however, their whole or partial inclusion is
acceptable. In order to get a balanced view of a facility's practices,
observe more than one person administering a drug pass, if feasible.
This might involve observing the morning pass one day in Wing A, for
example, and the morning pass the next day in Wing B.
Transfer findings noted on the ''Drug Pass'' worksheet to the SRF
under the appropriate rule. If your team concludes that the facility's
medication error rate is 5 percent or more, cite the deficiency under
Nursing Services/Administration of Drugs. Report the error rate under
F209. If the deficiency is at the standard level, cite it in Nursing
Services, rather than Pharmacy.
(h) Task 6 -- Dining Area and Eating Assistance Observation. The
purpose of this task is to ascertain the extent to which the facility
meets dietary needs, particularly for those who require eating
assistance. This task also yields information about staff interaction
with residents, promptness and appropriateness of assistance, adaptive
equipment usage and availability, as well as appropriateness of dress
and hygiene for meals.
For this task, use the worksheet entitled ''Dining Area and Eating
Assistance Observation'' (Form HCFA-523). Observe two meals; for a
balanced view, try to observe meals at different times of the day. For
example, try to observe a breakfast and a dinner rather than two
breakfasts. Give particular care to performing observations as
unobtrusively as possible. Chatting with residents and sitting down
nearby may help alleviate resident anxiety over the observation process.
Select a minimum of five residents for each meal observation and
include residents who have their meals in their rooms. Residents
selected for the in-depth review need not be included in the dining and
eating assistance observation; however, their whole or partial
inclusion is acceptable. Ascertain the extent to which the facility
assesses, plans, and evaluates the nutritional care of residents and
eating assistance needs by reviewing the sample of 10 or more residents.
If you are unable to determine whether the facility meets the standards
from the sample reviewed, expand the sample and focus on the specific
area(s) in question, until you can formulate a conclusion about the
extent of compliance. As with the other survey tasks, transfer the
findings noted on the ''Dining & Eating Assistance Observation''
worksheet to the Survey Report Form.
(i) Task 7 -- Forming the Deficiency Statement. (1) General. The
Survey Report Form contains information about all of the negative
findings of the survey. Be sure to transfer to the Survey Report Form
data from the tour, drug pass observation, dining area and eating
assistance observation, as well as in-depth review of the sample of
residents. Transfer only those findings which could possibly contribute
to a determination that the facility is deficient in a certain area.
Meet as a group in a pre-exit conference to discuss the findings and
make conclusions about the deficiencies, subject to information provided
by facility officials that may further explain the situation. Review
the summaries/conclusions from each task and decide whether any further
information and/or documentation is necessary to substantiate a
deficiency. As the facility for additional information for
clarification about particular findings, if necessary. Always consider
information provided by the facility. If the facility considers as
acceptable, practices which you believe are not acceptable, ask the
facility to backup its contention with suitable reference material or
sources and submit them for your consideration.
(2) Analysis. Analyze the findings on the Survey Report Form for the
degree of severity, frequency of occurrence and impact on delivery of
care or quality of life. The threshold at which the frequency of
occurrences amounts to a deficiency varies from situation to situation.
One occurrence directly related to a life-threatening or fatal outcome
can be cited as a deficiency. On the other hand, a few sporadic
occurrences may have so slight an impact on delivery of care or quality
of life that they do not warrant a deficiency citation. Review
carefully all the information gathered. What may appear during
observation as a pattern, may or may not be corroborated by records,
staff, and residents. For example, six of the 32 residents in the
sample are dressed in mismatched, poorly buttoned clothes. A few of the
six are wearing slippers without socks. A few others are wearing worn
clothes. Six occurrences might well be indicative of a pattern of
susbstandard care. Close scrutiny of records, discussions with staff,
and interviews reveal, however, that the six residents are participating
in dressing retraining programs. Those residents who are without socks,
chose to do so. The worn clothing items were also chosen -- they are
favorites.
Combinations of substandard care such as poor grooming of a number of
residents, lack of ambulation of a number of residents, lack of
attention to positioning, poor skin care, etc., can yield a deficiency
in nursing services just as 10 out of 10 residents receiving substandard
care for decubiti yields a deficiency.
(3) Deficiencies Alleged by Staff or Residents. If staff or
residents allege deficiencies, but records, interviews, and observation
fail to confirm the situation, it is unlikely that a deficiency exists.
Care and services that are indeed confirmed by the survey to be in
compliance with the regulatory requirements, but considered deficient by
residents or staff, cannot be cited as deficient for certification
purposes. On the other hand, if an allegation is of a very serious
nature (e.g., resident abuse) and the tools of record review and
observation are not effective because the problem is concealed, obtain
as much information as possible or necessary to ascertain compliance,
and cite accordingly. Residents, family, or former employees may be
helpful for information gathering.
(4) Composing the Deficiency Statement. Write the deficiency
statement in terms specific enough to allow a reasonably knowledgeable
person to understand the aspect(s) of the requirement(s) that is (are)
not met. Do not delve into the facility's policies and procedures to
determine or speculate on the root cause of a deficiency, or sift
through various alternatives in an effort to prescribe an acceptable
remedy. Indicate the data prefix tag and regulatory citation, followed
by a summary of the deficiency and supporting findings using resident
identifiers, not resident names, as in the following example.
F102 SNF 405.1123(b). -- Each resident has not had a physician's
visit at least once every 30 days for the first 90 days after admission.
Resident 1602 has not been seen by a physician since she was admitted
50 days ago. Her condition has deteriorated since that time
(formulation of decubiti, infections).
When the data prefix tag does not repeat the regulations, also
include a short phrase that describes the prefix tag (e.g., F117
decubitus ulcer care). List the data tags in numerical order, whenever
possible.
(j) Task 8 -- Exit Conference. The purpose of the exit conference is
to inform the facility of survey findings and to arrange for a plan of
correction, if needed. Keep the tone of the exit conference consistent
with the character of the survey process -- inspection and enforcement.
Tactful, business-like, professional presentation of the findings is of
paramount importance. Recognize that the facility may wish to respond
to various findings. Although deficiency statements continue to depend,
in part, on surveyor professional judgment, support your conclusions
with resident-specific examples (identifiers other than names) whenever
you can do so without compromising confidentiality. Before formally
citing deficiencies, discuss any allegations or findings that could not
be substantiated during earlier tasks in the process. For example, if
information is gathered that suggests a newly hired R.N. is not
currently licensed, ask the facility officials to present current
licensure information for the nurse in question. Identify residents
when the substandard care is readily observed or discerned through
record review. Ensure that the facility improves the care provided to
all affected residents, not only the identified residents. Make clear
to the facility that during a follow-up visit the surveyors may review
residents other than those with significant problems from the original
sample, in order to see that the facility has corrected the problems
overall. Do not disclose the source of information provided during
interviews, unless the resident has specifically requested you to inform
the facility of his/her comments or complaints. In accordance with your
Agency's policy, present the Statement of Deficiencies, form HCFA-2567,
on site or after supervisory review, no later than 10 calendar days
following the survey.
(k) Plan of Correction. Explain to the facility that your role is to
identify care and services which are not consistent with the regulatory
requirements, rather than to ascertain the root causes of deficiencies.
Each facility is expected to review its own care delivery. Subsequent
to the exit conference, each facility is required to submit a plan of
correction that identifies necessary changes in operation that will
assure correction of the cited deficiencies. In reviewing and accepting
a proposed plan of correction, apply these criteria:
Does the facility have a reasonable approach for correcting the
deficiencies?
Is there a high probability that the planned action will result in
compliance?
Is compliance expected timely?
Plans of correction specific to residents identified on the
deficiency statement are acceptable only where the deficiency is
determined to be unique to that resident and not indicative of a
possible systemic problem. For example, as a result of an aide being
absent, two residents are not ambulated three times that day as called
for in their care plans. A plan of correction that says ''Ambulate John
Jones and Mary Smith three times per day,'' is not acceptable. An
acceptable plan of correction would explain changes made to the
facility's staffing and scheduling in order to gurantee that staff is
available to provide all necessary services for all residents.
Acceptance of the plan of correction does not absolve the facility of
the responsibility for compliance should the implementation not result
in correction and compliance. Acceptance indicates the State agency's
acknowledgement that the facility indicated a willingness and ability to
make corrections adequately and timely.
Allow the facility up to 10 days to prepare and submit the plan of
correction to the State agency, however, follow your SA policy if the
timeframe is shorter. Retain the various survey worksheets as well as
the Survey Report Form at the State agency. Forward the deficiency
statement to the HCFA regional office.
(l) Follow-up Surveys. The purpose of the follow-up survey is to
re-evaluate the specific types of care or care delivery patterns that
were cited as deficient during the original survey. Ascertain the
corrective status of all deficiencies cited on the HCFA-2567. Because
this survey process focuses on the actual provision of care and
services, revisits are almost always necessary to ascertain whether the
deficienicies have indeed been corrected. The nature of the
deficiencies dictates the scope of the follow-up visit. Use as many
tasks or portions of the Survey Report Form(s) as needed to ascertain
compliance status. For example, you need not perform another drug pass
if no drug related deficiencies were cited on the initial survey.
Similarly, you need not repeat the dining area and eating assistance
observations if no related problems were identified. All or some of the
aspects of the observation/interview/medical record review, however, are
likely to be appropriate for the follow-up survey.
When selecting the resident sample for the follow-up, determine the
sample size using the same formula as used earlier in the survey, with
the following exceptions:
The maximum sample size is 30 residents, rather than 50.
The minimum sample size of 10 residents does not apply if only one
care category was cited as deficient and the total number of residents
in the facility in that category was less than 10 (e.g., deficiency
cited under catheter care and only five residents have catheters).
Include in the sample those residents who, in your judgment, are
appropriate for reviewing vis-a-vis the cited substandard care. If
possible, include some residents identified as receiving substandard
care during the initial survey. If after completing the follow-up
activities you determine that the cited deficiencies were not corrected,
initiate adverse action procedures, as appropriate.
(m) Role of Surveyor. The survey and certification process is
intended to determine whether providers and suppliers meet program
participation requirements. The primary role of the surveyor, then, is
to assess the quality of care and services and to relate those findings
to statutory and regulatory requirements for program participation.
When you find substandard care or services in the course of a survey,
carefully document your findings. Explain the deficiency in sufficient
detail so that the facility officials understand your rationale. If the
cause of the deficiency is obvious, share the information with the
provider. For example, if you cite a deficiency for restraints (F118),
indicate that restraints were applied backwards on residents 1621, 1634,
1646, etc.
In those instances where the cause is not obvious, do not delve into
the facility's policies and procedures to determine the root cause of
any deficiency. Do not recommend or prescribe an acceptable remedy.
The provider is responsible for deciding on and implementing the
action(s) necessary for achieving compliance. For the restraint
situation in the example above, you would not ascertain whether the
improper application was due to improper training or lack of training,
nor would you attempt to identify the staff member who applied the
restraints. It is the provider's responsibility to make the necessary
changes or corrections to ensure that the restriants are applied
properly.
A secondary role for the surveyor is to provide general consultation
to the provider/consumer community. This includes meeting with
provider/consumer associations and other groups as well as participating
in seminars. It also includes informational activities, whereby you
respond to oral or written inquiries about required outcomes in care and
services.
(n) Confidentiality and Respect for Resident Privacy. Conduct the
survey in a manner that allows for the greatest degree of
confidentiality for residents, particularly regarding the information
gathered during the in-depth interviews. When recording observations
about care and resident conditions, protect the privacy of all
residents. Use a code such as resident identifier number rather than
names on worksheets whenever possible. Never use a resident's name on
the Deficiency Statement, Form HCFA-2567. Block out resident names, if
any, from any document that is disclosed to the facility, individual or
organization.
When communicating to the facility about substandard care, fully
identify the resident(s) by name if the situation was identified through
observation or record review. Improperly applied restraints, expired
medication, cold food, gloves not worn for a sterile procedure, and diet
inconsistent with order, are examples of problems which can be
identified to the facility by resident name. Information about injuries
due to broken equipment, prolonged use of restraints, and opened mail is
less likely to be obtained through observation or record review. Do not
reveal the source of information unless actually observed, discovered in
the record review, or requested by the resident or family.
(o) Team Composition. Whenever possible, use the following survey
team model:
42 CFR 488.110 SNF/ICF Survey Team Model
In facilities with 200 beds or less, the team size may range from 2
to 4 members. If the team size is:
2 members: The team has at least one RN plus another RN or a
dietitian or a pharmacist.
3-4 member: In addition to the composition described above, the team
has one or two members of any discipline such as a social worker,
sanitarian, etc.
If the facility has over 200 beds and the survey will last more than
2 days, the team size may be greater than 4 members. Select additional
disciplines as appropriate to the facility's compliance history.
Average onsite time per survey: 60 person hours (Number of surveyors
multiplied by the number of hours on site)
Preferably, team members have gerontological training and experience.
Any member may serve as the team leader, consistent with State agency
procedures. In followup surveys, select disciplines based on major
areas of correction. Include a social worker, for example, if the
survey revealed major psychosocial problems. This model does not
consider integrated survey and Inspection of Care review teams, which
typically would be larger.
(p) Type of Facility -- Application of SNF or ICF Regulations. Apply
the regulations to the various types of facilities in the following
manner:
(q) Use of Part A and Part B of the Survey Report. (1) Use of Part A
(HCFA-525). -- Use Part A for initial certification surveys only,
except under the following circumstances:
When a terminated facility requests program participation 60 days or
more after termination. Treat this situation as a request for initial
certification and complete Part A of the survey report in addition to
Part B.
If an ICF with a favorable compliance history requests to covert a
number of beds to SNF level, complete both Part A and Part B for
compliance with the SNF requirements. If distinct part status is at
issue, also examine whether it meets the criteria for certification as a
distinct part.
(i) Addendum for Outpatient Physical Therapy (OPT) or Speech
Pathology Services. Use the Outpatient Physical Therapy -- Speech
Pathology SRF (HCFA-1893) as an addendum to Part A.
(ii) Resurvey of Participating Facilities. Do not use Part A for
resurveys of participating SNFs and ICFs. A determination of
compliance, based on documented examination of the written policies and
procedures and other pertinent documents during the initial survey,
establishes the facility's compliance status with Part A requirements.
This does not preclude citing deficiencies if they pertain to
administrative or structural requirements from Part A that are uncovered
incidental to a Part B survey. As an assurance measure, however, each
facility at the time of recertification must complete an affidavit (on
the HCFA-1516) attesting that no substantive changes have occurred that
would affect compliance. Each facility must also agree to notify the
State agency immediately of any upcoming changes in its organization or
management which may affect its compliance status. If a new
administrator is unable to complete the affidavit, proceed with the
survey using the Part B form and worksheets; do not use the Part A
form. The survey cannot be considered complete, however, until the
affidavit is signed. If the facility fails to complete the affidavit,
it cannot participate in the program.
(iii) Substantial Changes in a Facility's Organization and
Management. If you receive such information, review the changes to
ensure compliance with the regulations. Request copies of the
appropriate documents (e.g., written policies and procedures, personnel
qualifications, or agreements) if they were not submitted. If the
changes have made continued compliance seem doubtful, determine through
a Part B survey whether deficiencies have resulted. Cite any
deficiencies on the HCFA-2567 and follow the usual procedures.
(2) Use of Part B (HCFA-519). Use Part B and the worksheets for all
types of SNF and ICF surveys -- initials, recertifications, followup,
complaints, etc.
The worksheets are:
HCFA-520 -- Residents Selected for Indepth Review
HCFA-521 -- Tour Notes Worksheet
HCFA-522 -- Drug Pass Worksheet
HCFA-523 -- Dining Area and Eating Assistance Worksheet
HCFA-5245 -- Observation/Interview/Record Review Worksheet
For complaint investigations, perform a full or partial Part B survey
based on the extent of the allegations. If the complaint alleges
substandard care in a general fashion or in a variety of services and
care areas, perform several tasks or a full Part B survey, as needed.
If the complaint is of a more specific nature, such as an allegation of
improper medications, perform an appropriate partial Part B survey, such
as a drug pass review and a review of selected medical records.
42 CFR 488.110 488.115
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42 CFR 488.110 Subpart D -- Reconsideration of Adverse Determinations
-- Deeming Authority for Accreditation Organizations and CLIA Exemption
of Laboratories Under State Programs
Source: 57 FR 34012, July 31, 1992, unless otherwise noted.
42 CFR 488.201 Reconsideration.
(a) Right to reconsideration. (1) A national accreditation
organization dissatisfied with a determination that its accreditation
requirements do not provide (or do not continue to provide) reasonable
assurance that the entities accredited by the accreditation organization
meet the applicable CLIA requirements is entitled to a reconsideration
as provided in this subpart.
(2) A State dissatisfied with a determination that the requirements
it imposes on laboratories in that State and under the laws of that
State do not provide (or do not continue to provide) reasonable
assurance that laboratories licensed or approved by the State meet
applicable CLIA requirements is entitled to a reconsideration as
provided in this subpart.
(b) Eligibility for reconsideration. HCFA will reconsider any
determination to deny, remove or not renew the approval of deeming
authority to private accreditation organizations, or any determination
to deny, remove or not renew the approval of a State laboratory program
for the purpose of exempting the State's laboratories from CLIA
requirements, if the accreditation organization or State files a written
request for a reconsideration in accordance with paragraphs (c) and (d)
of this section.
(c) Manner and timing of request for reconsideration. (1) A national
accreditation organization or a State laboratory program described in
paragraph (b), dissatisfied with a determination with respect to its
deeming authority, or, in the case of a State, a determination with
respect to the exemption of the laboratories in the State from CLIA
requirements, may request a reconsideration of the determination by
filing a request with HCFA either directly by its authorized officials
or through its legal representative. The request must be filed within
60 days of the receipt of notice of an adverse determination or
nonrenewal as provided in subpart A of part 488 or subpart E of part
493, as applicable.
(2) Reconsideration procedures are available after the effective date
of the decision to deny, remove, or not renew the approval of an
accreditation organization or State laboratory program.
(d) Content of request. The request for reconsideration must specify
the findings or issues with which the accreditation organization or
State disagrees and the reasons for the disagreement.
42 CFR 488.203 Withdrawal of request for reconsideration.
A requestor may withdraw its request for reconsideration at any time
before the issuance of a reconsideration determination.
42 CFR 488.205 Right to informal hearing.
In response to a request for reconsideration, HCFA will provide the
accreditation organization or the State laboratory program the
opportunity for an informal hearing as described in 488.207 that will
--
(a) Be conducted by a hearing officer appointed by the Administrator
of HCFA; and
(b) Provide the accreditation organization or State laboratory
program the opportunity to present, in writing or in person, evidence or
documentation to refute the determination to deny approval, or to
withdraw or not renew deeming authority or the exemption of a State's
laboratories from CLIA requirements.
42 CFR 488.207 Informal hearing procedures.
(a) HCFA will provide written notice of the time and place of the
informal hearing at least 10 days before the scheduled date.
(b) The informal reconsideration hearing will be conducted in
accordance with the following procedures --
(1) The hearing is open to HCFA and the organization requesting the
reconsideration, including --
(i) Authorized representatives;
(ii) Technical advisors (individuals with knowledge of the facts of
the case or presenting interpretation of the facts); and
(iii) Legal counsel;
(2) The hearing is conducted by the hearing officer who receives
testimony and documents related to the proposed action;
(3) Testimony and other evidence may be accepted by the hearing
officer even though it would be inadmissable under the usual rules of
court procedures;
(4) Either party may call witnesses from among those individuals
specified in paragraph (b)(1) of this section; and
(5) The hearing officer does not have the authority to compel by
subpoena the production of witnesses, papers, or other evidence.
42 CFR 488.209 Hearing officer's findings.
(a) Within 30 days of the close of the hearing, the hearing officer
will present the findings and recommendations to the accreditation
organization or State laboratory program that requested the
reconsideration.
(b) The written report of the hearing officer will include --
(1) Separate numbered findings of fact; and
(2) The legal conclusions of the hearing officer.
42 CFR 488.211 Final reconsideration determination.
(a) The hearing officer's decision is final unless the Administrator,
within 30 days of the hearing officer's decision, chooses to review that
decision.
(b) The Administrator may accept, reject or modify the hearing
officer's findings.
(c) Should the Administrator choose to review the hearing officer's
decision, the Administrator will issue a final reconsideration
determination to the accreditation organization or State laboratory
program on the basis of the hearing officer's findings and
recommendations and other relevant information.
(d) The reconsideration determination of the Administrator is final.
(e) A final reconsideration determination against an accreditation
organization or State laboratory program will be published by HCFA in
the Federal Register.
42 CFR 488.211 PART 489 -- PROVIDER AND SUPPLIER AGREEMENTS
42 CFR 488.211 Subpart A -- General Provisions
Sec.
489.1 Statutory basis.
489.2 Scope of part.
489.3 Definitions.
489.10 Basic requirements.
489.11 Acceptance of a provider as a participant.
489.12 Decision to deny an agreement.
489.13 Effective date of agreement.
489.15 Time limits on agreements with skilled nursing facilities
(SNFs).
489.16 Nonrenewal of agreements with SNFs.
489.18 Change of ownership or leasing: Effect on provider agreement.
42 CFR 488.211 Subpart B -- Essentials of Provider Agreements
489.20 Basic commitments.
489.21 Specific limitations on charges.
489.22 Special provisions applicable to prepayment requirements.
42 CFR 488.211 Subpart C -- Allowable Charges
489.30 Allowable charges: Deductibles and coinsurance.
489.31 Allowable charges: Blood.
489.32 Allowable charges: Noncovered and partially covered services.
489.34 Allowable charges: Hospitals participating in State
reimbursement control systems or demonstration projects.
489.35 Notice to intermediary.
42 CFR 488.211 Subpart D -- Handling of Incorrect Collections
489.40 Definition of incorrect collection.
489.41 Timing and methods of handling.
489.42 Payment of offset amounts to beneficiary or other person.
42 CFR 488.211 Subpart E -- Termination of Agreement and Reinstatement
After Termination
489.52 Termination by the provider.
489.53 Termination by HCFA.
489.54 Termination by the OIG.
489.55 Exceptions to effective date of termination.
489.57 Reinstatement after termination.
42 CFR 488.211 Subpart F -- Denial of Payments to SNF's for New
Admissions; Withholding of Payment
489.60 Denial of payments for new admissions.
489.62 Procedures for denial of payments.
489.64 Duration of denial of payments and subsequent termination.
489.66 Withholding of payment for failure to make timely utilization
review.
42 CFR 488.211 Subparts G-H -- (Reserved)
42 CFR 488.211 Subpart I -- Advance Directives
489.100 Definition.
489.102 Requirements for providers.
489.104 Effective dates.
Authority: Secs. 1102, 1861, 1864, 1866, and 1871 of the Social
Security Act (42 U.S.C. 1302, 1395x, 1395aa. 1395cc, and 1395hh).
Source: 45 FR 22937, Apr. 4, 1980, unless otherwise noted.
42 CFR 488.211 Subpart A -- General Provisions
42 CFR 489.1 Statutory basis.
This part implements section 1866 of the Social Security Act.
Section 1866 specifies the terms of provider agreements, the grounds for
terminating a provider agreement, the circumstances under which payment
for new admissions may be denied, and the circumstances under which
payment may be withheld for failure to make timely utilization review.
The following other sections of that Act are also pertinent.
(a) Section 1861 defines the services covered under Medicare and the
providers that may be reimbursed for furnishing those services.
(b) Section 1864 provides for the use of State survey agencies to
ascertain whether certain entities meet the conditions of participation.
(c) Section 1871 authorizes the Secretary to prescribe regulations
for the administration of the Medicare program.
(45 FR 22937, Apr. 4, 1980, as amended at 51 FR 24492, July 3, 1986)
42 CFR 489.2 Scope of part.
(a) Subpart A of this part sets forth the basic requirements for
submittal and acceptance of a provider agreement under Medicare.
Subpart B of this part specifies the basic commitments and limitations
that the provider must agree to as part of an agreement to provide
services. Subpart C specifies the limitations on allowable charges to
beneficiaries for deductibles, coinsurance, copayments, blood, and
services that must be part of the provider agreement. Subpart D of this
part specifies how incorrect collections are to be handled. Subpart F
sets forth the circumstances and procedures for denial of payments for
new admissions and for withholding of payment as an alternative to
termination of a provider agreement.
(b) The following providers are subject to the provisions of this
part:
(1) Hospitals.
(2) Skilled nursing facilities (SNFs).
(3) Home health agencies (HHAs).
(4) Clinics, rehabilitation agencies, and public health agencies.
(5) Comprehensive outpatient rehabilitation facilities (CORFs).
(6) Hospices.
(c) Those listed in paragraph (b)(4) of this section may enter into
provider agreements only for furnishing outpatient physical therapy and
speech pathology services.
(45 FR 22937, Apr. 4, 1980, as amended at 47 FR 56297, Dec. 15, 1982;
48 FR 56036, Dec. 15, 1983; 51 FR 24492, July 3, 1986)
42 CFR 489.3 Definitions.
For purposes of this part --
Immediate jeopardy for Medicare SNFs means a situation in which a
facility's noncompliance with one or more level A requirements poses a
serious threat to patents' health and safety such that immediate
corrective action is necessary.
Provider agreement means an agreement between HCFA and one of the
providers specified in 489.2(b) to provide services to Medicare
beneficiaries and to comply with the requirements of section 1866 of the
Act.
(48 FR 39837, Sept. 1, 1983, as amended at 51 FR 24492, July 3, 1986;
54 FR 5373, Feb. 2, 1989)
42 CFR 489.10 Basic requirements.
(a) Any of the providers specified in 489.2 may request
participation in Medicare. In order to be accepted, it must meet --
(1) The conditions of participation or requirements (for SNFs) set
forth elsewhere in this chapter; and
(2) The civil rights requirements specified in 45 CFR parts 80, 84,
and 90.
(b) In order for a hospital, SNF, HHA, or hospice to be accepted, it
must also meet the advance directives requirements specified in subpart
I of this part.
(c) The State survey agency will ascertain whether the provider meets
the conditions of participation or requirements (for SNFs) and make its
recommendations to HCFA.
(54 FR 5373, Feb. 2, 1989, as amended at 57 FR 8204, Mar. 6, 1992)
42 CFR 489.11 Acceptance of a provider as a participant.
(a) Action by HCFA. If HCFA determines that the provider meets the
requirements, it will send the provider --
(1) Written notice of that determination; and
(2) Two copies of the provider agreement.
(b) Action by provider. If the provider wishes to participate, it
must return both copies of the agreement, duly signed by an authorized
official, to HCFA, together with a written statement indicating whether
it has been adjudged insolvent or bankrupt in any State or Federal
court, or whether any insolvency or bankruptcy actions are pending.
(c) Notice of acceptance. If HCFA accepts the agreement, it will
return one copy to the provider with a written notice that --
(1) Indicates the dates on which it was signed by the provider's
representative and accepted by HCFA;
(2) Specifies the effective date of the agreement; and
(3) If the agreement is with a SNF, specifies the term of the
agreement.
42 CFR 489.12 Decision to deny an agreement.
(a) Bases for denial. HCFA may refuse to enter into or renew an
agreement for any of the following reasons:
(1) Principals of the provider have been convicted of fraud (see
420.204 of this chapter);
(2) The provider has failed to disclose ownership and control
interests in accordance with 420.206 of this chapter; or
(3) The provider or prospective provider is unable to give
satisfactory assurance of compliance with the requirements of title
XVIII of the Act.
(b) (Reserved)
(c) Compliance with civil rights requirements. HCFA will not enter
into a provider agreement if the provider fails to comply with civil
rights requirements set forth in 45 CFR parts 80, 84, and 90.
(45 FR 22937, Apr. 4, 1980, as amended at 51 FR 34833, Sept. 30,
1986; 54 FR 4027, Jan. 27. 1989)
42 CFR 489.13 Effective date of agreement.
(a) All Federal requirements are met on the date of the survey. The
agreement will be effective on the date the onsite survey is completed
(or on the day following the expiration date of a current agreement) if,
on the date of the survey, the provider meets all Federal health and
safety conditions of participation or level A requirements (for SNFs),
and any other requirements imposed by HCFA.
(b) All Federal requirements are not met on the date of the survey.
If the provider fails to meet any of the requirements specified in
paragraph (a) of this section, the agreement will be effective on the
earlier of the following dates:
(1) The date on which the provider meets all requirements.
(2) The date on which the provider submits a correction plan
acceptable to HCFA or an approvable waiver request, or both.
(54 FR 5373, Feb. 2, 1989)
42 CFR 489.15 Time limits on agreements with skilled nursing facilities
(SNFs).
(a) Basic limitation. An agreement with a SNF must be for a
specified term, determined by HCFA in accordance with paragraphs (b) and
(c) of this section.
(b) SNF in full compliance. If the SNF is in full compliance with
the level A requirements specified elsewhere in this chapter, the term
must be 12 calendar months.
(c) SNF not in full compliance -- (1) Alternatives. A SNF that is
not in full compliance may be issued a restricted agreement or a
conditional agreement.
(2) Restricted agreement. This agreement must:
(i) Specify a date by which corrections must be made;
(ii) End no later than the 60th day following the date specified for
correction of deficiencies; and
(iii) Be for a term that, including the 60-day period, is 12 months
or less.
(3) Conditional agreement. This agreement must:
(i) Be for 12 months;
(ii) Specify a date for correction of deficiences that is no later
than the end of the 10th month; and
(iii) Provide for automatic cancellation on the 60th day following
the date specified for correction, unless HCFA determines that all
deficiencies have been corrected or the SNF has made substantial effort
and progress and has submitted an acceptable revised correction plan.
(d) Extention of the agreement. An agreement may be extended for 60
days if --
(1) HCFA determines the extension will not jeopardize the health and
safety of beneficiaries; and
(2) The extension is needed --
(i) To prevent irreparable harm to the SNF or hardship to the
beneficiaries receiving services from the SNF; or
(ii) To enable HCFA to determine whether the SNF is in compliance
with the level A requirements.
(54 FR 5373, Feb. 2, 1989)
42 CFR 489.16 Nonrenewal of agreements with SNFs.
(a) No automatic renewal. Except as provided in 489.15(d), the term
of an agreement may not be extended. The agreement shall terminate at
the close of the last day of its specified term and will not be
automatically renewable from term to term.
(b) Notice of nonrenewal. (1) If HCFA decides not to renew an
agreement with a SNF, it will notify the SNF at least 30 days, and the
public at least 15 days, before the end of the term.
(2) The notice will state the reasons for the determination, the
effective date for the termination of the existing agreement, and the
applicability of the termination to the SNF's services.
(c) Right to hearing. (1) The nonrenewal of an agreement under the
conditions described in this section is a determination that the
facility does not qualify as a provider of services for the period
immediately following the term of the current agreement.
(2) The facility is entitled to a hearing as provided in part 498 of
this chapter.
(45 FR 22937, Apr. 4, 1980, as amended at 52 FR 22454, June 12, 1987)
42 CFR 489.18 Change of ownership or leasing: Effect on provider
agreement.
(a) What constitutes change of ownership -- (1) Partnership. In the
case of a partnership, the removal, addition, or substitution of a
partner, unless the partners expressly agree otherwise, as permitted by
applicable State law, constitutes change of ownership.
(2) Unincorporated sole proprietorship. Transfer of title and
property to another party constitutes change of ownership.
(3) Corporation. The merger of the provider corporation into another
corporation, or the consolidation of two or more corporations, resulting
in the creation of a new corporation constitutes change of ownership.
Transfer of corporate stock or the merger of another corporation into
the provider corporation does not constitute change of ownership.
(4) Leasing. The lease of all or part of a provider facility
constitutes change of ownership of the leased portion.
(b) Notice to HCFA. A provider who is contemplating or negotiating a
change of ownership must notify HCFA.
(c) Assignment of agreement. When there is a change of ownership as
specified in paragraph (a) of this section, the existing provider
agreement will automatically be assigned to the new owner.
(d) Conditions that apply to assigned agreements. An assigned
agreement is subject to all applicable statutes and regulations and to
the terms and conditions under which it was originally issued including,
but not limited to, the following:
(1) Any existing plan of correction.
(2) Any expiration date.
(3) Compliance with applicable health and safety standards.
(4) Compliance with the ownerhsip and financial interest disclosure
requirements of part 420, subpart C, of this chapter.
(5) Compliance with civil rights requirements set forth in 45 CFR
parts 80, 84, and 90.
(e) Effect of leasing. The provider agreement will be assigned to
the lessee only to the extent of the leased portion of the facility.
42 CFR 489.18 Subpart B -- Essentials of Provider Agreements
42 CFR 489.20 Basic commitments.
The provider agrees to the following:
(a) To limit its charges to beneficiaries and to other individuals on
their behalf, in accordance with provisions of subpart C of this part.
(b) To comply with the requirements of subpart D of this part for the
return or other disposition of any amounts incorrectly collected from a
beneficiary or any other person in his or her behalf.
(c) To comply with the requirements of 420.203 of this chapter when
it hires certain former employees of intermediaries.
(d) In the case of a hospital that furnishes inpatient hospital
services to a beneficiary, to either furnish directly or make
arrangements for all items and services (other than physicians' services
as described in 405.550(b) of this chapter and services of an
anesthetist, as defined in 410.69 of this chapter) for which the
beneficiary is entitled to have payment made under Medicare; and
(e) In the case of a hospital that furnishes inpatient hospital
services for which payment may be made under subpart D of part 405 of
this chapter, to maintain an agreement with a utilization and quality
control peer review organization (if there is such an organization for
the area in which the hospital is located, which has a contract with
HCFA under Part B of title XI of the Act) for that organization to
review the admissions, quality, appropriateness, and diagnostic
information related to such inpatient hospital services.
(f) To maintain a system that, during the admission process,
identifies any primary payers other than Medicare, so that incorrect
billing and Medicare overpayments can be prevented.
(g) To bill other primary payers before billing Medicare except when
the primary payer is a liability insurer and except as provided in
paragraph (j) of this section.
(h) If the provider receives payment for the same services from
Medicare and another payer that is primary to Medicare, to reimburse
Medicare any overpaid amount within 60 days.
(i) If the provider receives, from a payer that is primary to
Medicare, a payment that is reduced because the provider failed to file
a proper claim --
(1) To bill Medicare for an amount no greater than would have been
payable as secondary payment if the primary insurer's payment had been
based on a proper claim; and
(2) To charge the beneficiary only: (i) The amount it would have
been entitled to charge if it had filed a proper claim and received
payment based on such a claim; and
(ii) An amount equal to any third party payment reduction
attributable to failure to file a proper claim, but only if the provider
can show that --
(A) It failed to file a proper claim solely because the beneficiary,
for any reason other than mental or physical incapacity, failed to give
the provider the necessary information; or
(B) The beneficiary, who was responsible for filing a proper claim,
failed to do so for any reason other than mental or physical incapacity.
(j) In the State of Oregon, because of a court decision, and in the
absence of a reversal on appeal or a statutory clarification overturning
the decision, hospitals may bill liability insurers first. However, if
the liability insurer does not pay ''promptly'', as defined in 411.50
of this chapter, the hospital must withdraw its claim or lien and bill
Medicare for covered services.
(k) In the case of home health agencies that provide home health
services to Medicare beneficiaries under subpart E of part 409 and
subpart C of part 410 of this chapter, to offer to furnish catheters,
catheter supplies, ostomy bags, and supplies related to ostomy care to
any individual who requires them as part of their furnishing of home
health services.
(45 FR 22937, Apr. 4, 1980, as amended at 48 FR 39837, Sept. 1, 1983;
49 FR 323, Jan. 3, 1984; 54 FR 41747, Oct. 11, 1989; 57 FR 33900,
July 31, 1992; 57 FR 36018, Aug. 12, 1992)
42 CFR 489.21 Specific limitations on charges.
Except as specified in subpart C of this part, the provider agrees
not to charge a beneficiary for any of the following:
(a) Services for which the beneficiary is entitled to have payment
made under Medicare.
(b) Services for which the beneficiary would be entitled to have
payment made if the provider --
(1) Had in its files the required certification and recertification
by a physician relating to the services furnished to the beneficiary;
(2) Had furnished the information required by the intermediary in
order to determine the amount due the provider on behalf of the
individual for the period with respect to which payment is to be made or
any prior period;
(3) Had complied with the provisions requiring timely utilization
review of long stay cases so that a limitation on days of service has
not been imposed under section 1866(d) of the Act (see subpart K of part
405 and part 482 of this chapter for utilization review requirements);
and
(4) Had obtained, from the beneficiary or a person acting on his or
her behalf, a written request for payment to be made to the provider,
and had properly filed that request. (If the beneficiary or person on
his or her behalf refuses to execute a written request, the provider may
charge the beneficiary for all services furnished to him or her.)
(c) Inpatient hospital services furnished to a beneficiary who
exhausted his or her Part A benefits, if HCFA reimburses the provider
for those services.
(d) Custodial care and services not reasonable and necessary for the
diagnosis or treatment of illness or injury, if --
(1) The beneficiary was without fault in incurring the expenses; and
(2) The determination that payment was incorrect was not made until
after the third year following the year in which the payment notice was
sent to the beneficiary.
(e) Inpatient hospital services for which a beneficiary would be
entitled to have payment made under Part A of Medicare but for a denial
or reduction in payments under regulations at 412.48 of this chapter or
under section 1886(f) of the Act.
(f) Items and services furnished to a hospital inpatient (other than
physicians' services as described in 405.550(b) of this chapter or the
services of an anesthetist as described in 405.553(b)(4) of this
chapter) for which Medicare payment would be made if furnished by the
hospital or by other providers or suppliers under arrangements made with
them by the hospital. For this purpose, a charge by another provider or
supplier for such an item or service is treated as a charge by the
hospital for the item or service, and is also prohibited.
(g) Items and services furnished in connection with the implantation
of cardiac pacemakers or pacemaker leads when HCFA denies payment for
those devices under 409.19 or 410.64 of this chapter.
(49 FR 324, Jan. 3, 1984, as amended at 51 FR 22052, June 17, 1986;
52 FR 27765, July 23, 1987)
42 CFR 489.22 Special provisions applicable to prepayment requirements.
(a) A provider may not require an individual entitled to hospital
insurance benefits to prepay in part or in whole for inpatient services
as a condition of admittance as an inpatient, except where it is clear
upon admission that payment under Medicare, Part A cannot be made.
(b) A provider may not deny covered inpatient services to an
individual entitled to have payment made for those services on the
ground of inability or failure to pay a requested amount at or before
admission.
(c) A provider may not evict, or threaten to evict, an individual for
inability to pay a deductible or a coinsurance amount required under
Medicare.
(d) A provider may not charge an individual for (1) its agreement to
admit or readmit the individual on some specified future date for
covered impatient services; or (2) for failure to remain an inpatient
for any agreed-upon length of time or for failure to give advance notice
of departure from the provider's facilities.
42 CFR 489.22 Subpart C -- Allowable Charges
42 CFR 489.30 Allowable charges: Deductibles and coinsurance.
(a) Part A deductible and coinsurance. The provider may charge the
beneficiary or other person on his or her behalf:
(1) The amount of the inpatient hospital deductible or, if less, the
actual charges for the services;
(2) The amount of inpatient hospital coinsurance applicable for each
day the individual is furnished inpatient hospital services after the
60th day, during a benefit period; and
(3) The posthospital SNF care coinsurance amount.
(4) In the case of durable medical equipment (DME) furnished as a
home health service, 20 percent of the customary charge for the service.
(b) Part B deductible and coinsurance. (1) The basic allowable
charges are the $75 deductible and 20 percent of the customary (insofar
as reasonable) charges in excess of that deductible.
(2) For hospital outpatient services, the allowable deductible
charges depend on whether the hospital can determine the beneficiary's
deductible status.
(i) If the hospital is unable to determine the deductible status, it
may charge the beneficiary its full customary charges up to $75.
(ii) If the beneficiary provides official information as to
deductible status, the hospital may charge only the unmet portion of the
deductible.
(3) In either of the cases discussed in paragraph (b)(2) of this
section, the hospital is required to file with the intermediary, on a
form prescribed by HCFA, information as to the services, charges, and
amounts collected.
(4) The intermediary must reimburse the beneficiary if reimbursement
is authorized and credit the expenses to the beneficiary's deductible if
the deductible has not yet been met.
(5) In the case of DME furnished as a home health service under
Medicare Part B, the coinsurance is 20 percent of the customary (insofar
as reasonable) charge for the services, with the following exception:
If the DME is used DME purchased by or on behalf of the beneficiary at a
price at least 25 percent less than the reasonable charge for comparable
new equipment, no coinsurance is required.
(45 FR 22937, Apr. 4, 1980, as amended at 51 FR 41350, Nov. 14, 1986)
42 CFR 489.31 Allowable charges: Blood.
(a) Limitations on charges. (1) A provider may charge the
beneficiary (or other person on his or her behalf) only for the first
three pints of blood or units of packed red cells furnished under
Medicare Part A during a calendar year, or furnished under Medicare Part
B during a calendar year.
(2) The charges may not exceed the provider's customary charges.
(3) The provider may not charge for any whole blood or packed red
cells in any of the circumstances specified in 409.87(c)(2) of this
chapter.
(b) Offset for excessive charges. If the charge exceeds the cost to
the provider, that excess will be deducted from any Medicare payments
due the provider.
(56 FR 23022, May 20, 1991, as amended at 57 FR 36018, Aug. 12, 1992)
42 CFR 489.32 Allowable charges: Noncovered and partially covered
services.
(a) Services requested by beneficiary. If services furnished at the
request of a beneficiary (or his or her representative) are more
expensive than, or in excess of, services covered under Medicare --
(1) A provider may charge the beneficiary an amount that does not
exceed the difference between --
(i) The provider's customary charges for the services furnished; and
(ii) The provider's customary charges for the kinds and amounts of
services that are covered under Medicare.
(2) A provider may not charge for the services unless they have been
requested by the beneficiary (or his or her representative) nor require
a beneficiary to request services as a condition of admission.
(3) To avoid misunderstanding and disputes, a provider must inform
any beneficiary who requests a service for which a charge will be made
that there will be a specified charge for that service.
(b) Services not requested by the beneficiary. For special
provisions that apply when a provider customarily furnishes more
expensive services, see 413.35 of this chapter.
(45 FR 22937, Apr. 4, 1980, as amended at 51 FR 34833, Sept. 30,
1986)
42 CFR 489.34 Allowable charges: Hospitals participating in State
reimbursement control systems or demonstration projects.
A hospital receiving payment for a covered hospital stay under either
a State reimbursement control system approved under 1886(c) of the Act
or a demonstration project authorized under section 402(a) of Pub. L.
90-248 (42 U.S.C. 1395b-1) or section 222(a) of Pub. L. 92-603 (42
U.S.C. 1395b-1 (note)) and that would otherwise be subject to the
prospective payment system set forth in part 412 of this chapter may
charge a beneficiary for noncovered services as follows:
(a) For the custodial care and medically unnecessary services
described in 412.42(c) of this chapter, after the conditions of
412.42(c)(1) through (c)(4) are met; and
(b) For all other services in accordance with the applicable rules of
this subpart C.
(54 FR 41747, Oct. 11, 1989)
42 CFR 489.35 Notice to intermediary.
The provider must inform its intermediary of any amounts collected
from a beneficiary or from other persons on his or her behalf.
42 CFR 489.35 Subpart D -- Handling of Incorrect Collections
42 CFR 489.40 Definition of incorrect collection.
(a) As used in this subpart, ''incorrect collections'' means any
amounts collected from a beneficiary (or someone on his or her behalf)
that are not authorized under subpart C of this part.
(b) A payment properly made to a provider by an individual not
considered entitled to Medicare benefits will be deemed to be an
''incorrect collection'' when the individual is found to be
retroactively entitled to benefits.
42 CFR 489.41 Timing and methods of handling.
(a) Refund. Prompt refund to the beneficiary or other person is the
preferred method of handling incorrect collections.
(b) Setting aside. If the provider cannot refund within 60 days from
the date on the notice of incorrect collection, it must set aside an
amount, equal to the amount incorrectly collected, in a separate account
identified as to the individual to whom the payment is due. This amount
incorrectly collected must be carried on the provider's records in this
manner until final disposition is made in accordance with the applicable
State law.
(c) Notice to, and action by, intermediary. (1) The provider must
notify the intermediary of the refund or setting aside required under
paragraphs (a) and (b) of this section.
(2) If the provider fails to refund or set aside the required
amounts, they may be offset against amounts otherwise due the provider.
42 CFR 489.42 Payment of offset amounts to beneficiary or other person.
(a) In order to carry out the commitment to refund amounts
incorrectly collected, HCFA may determine that amounts offset in
accordance with 489.41 are to be paid directly to the beneficiary or
other person from whom the provider received the incorrect collection,
if:
(1) HCFA finds that the provider has failed, following written
request, to refund the amount of the incorrect collection to the
beneficiary or other person; and
(2) The provider agreement has been terminated in accordance with the
provisions of subpart E of this part.
(b) Before making a determination to make payment under paragraph (a)
of this section, HCFA will give written notice to the provider (1)
explaining that an incorrect collection was made and the amount; (2)
requesting the provider to refund the incorrect collection to the
beneficiary or other person; and (3) advising of HCFA's intention to
make a determination under paragraph (a) of this section.
(c) The notice will afford an authorized official of the provider an
opportunity to submit, within 20 days from the date on the notice,
written statement or evidence with respect to the incorrect collection
and/or offset amounts. HCFA will consider any written statement or
evidence in making a determination.
(d) Payment to a beneficiary or other person under the provisions of
paragraph (a) of this section:
(1) Will not exceed the amount of the incorrect collection; and
(2) May be considered as payment made to the provider.
42 CFR 489.42 Subpart E -- Termination of Agreement and Reinstatement After Termination
42 CFR 489.52 Termination by the provider.
(a) Notice to HCFA. (1) A provider that wishes to terminate its
agreement must send HCFA written notice of its intent.
(2) The notice may state the intended date of termination which must
be the first day of a month.
(b) Termination date. (1) If the notice does not specify a date, or
the date is not acceptable to HCFA, HCFA may set a date that will not be
more than 6 months from the date on the provider's notice of intent.
(2) HCFA may accept a termination date that is less than 6 months
after the date on the provider's notice if it determines that to do so
would not unduly disrupt services to the community or otherwise
interfere with the effective and efficient administration of the
Medicare program.
(3) A cessation of business is deemed to be a termination by the
provider, effective with the date on which it stopped providing services
to the community.
(c) Public notice. (1) The provider must give notice to the public
at least 15 days before the effective date of termination.
(2) The notice must be published in one or more local newspapers and
must --
(i) Specify the termination date; and
(ii) Explain to what extent services may continue after that date, in
accordance with the exceptions set forth in 489.55.
42 CFR 489.53 Termination by HCFA.
(a) Basis for termination of agreement with any provider. HCFA may
terminate the agreement with any provider if HCFA finds that any of the
following failings is attributable to that provider:
(1) It is not complying with the provisions of title XVIII and the
applicable regulations of this chapter or with the provisions of the
agreement.
(2) It places restrictions on the persons it will accept for
treatment and it fails either to exempt Medicare beneficiaries from
those restrictions or to apply them to Medicare beneficiaries the same
as to all other persons seeking care.
(3) It no longer meets the appropriate conditions of participation or
requirements (for SNFs and NFs) set forth elsewhere in this chapter.
(4) It fails to furnish information that HCFA finds necessary for a
determination as to whether payments are or were due under Medicare and
the amounts due.
(5) It refuses to permit examination of its fiscal or other records
by, or on behalf of HCFA, as necessary for verification of information
furnished as a basis for payment under Medicare.
(6) It failed to furnish information on business transactions as
required in 420.205 of this chapter.
(7) It failed at the time the agreement was entered into or renewed
to disclose information on convicted individuals as required in 420.204
of this chapter.
(8) It failed to furnish ownership information as required in
420.206 of this chapter.
(9) It failed to comply with civil rights requirements set forth in
45 CFR parts 80, 84, and 90.
(b) Required termination of agreement with a SNF. HCFA will
terminate a SNF's provider agreement if it determines that --
(1) The SNF no longer meets a level A requirement specified in part
483, subpart B of this chapter; and
(2) The SNF's deficiencies pose immediate jeopardy to patients'
health and safety.
(c) Notice of termination -- (1) Timing: Basic rule. Except as
provided in paragraph (c)(2) of this section, HCFA will give the
provider notice of termination at least 15 days before the effective
date of termination of the provider agreement.
(2) Exception. For a SNF with deficiencies that pose immediate
jeopardy to patients' health and safety, HCFA will give notice of
termination at least 2 days before the effective date of termination of
the provider agreement.
(3) Content of notice. The notice will state the reasons for, and
the effective date of, the termination, and explain the extent to which
services may continue after that date, in accordance with 489.55.
(4) Notice to public. HCFA will concurrently give notice of the
termination to the public.
(d) Appeal by the provider. A provider may appeal the termination of
its provider agreement by HCFA in accordance with part 498 of this
chapter.
(51 FR 24492, July 3, 1986, as amended at 52 FR 22454, June 12, 1987;
54 FR 5373, Feb. 2, 1989; 56 FR 48879, Sept. 26, 1991)
42 CFR 489.54 Termination by the OIG.
(a) Basis for termination. (1) The OIG may terminate the agreement
of any provider if the OIG finds that any of the following failings can
be attributed to that provider.
(i) It has knowingly and willfully made, or caused to be made, any
false statement or representation of a material fact for use in an
application or request for payment under Medicare.
(ii) It has submitted, or caused to be submitted, requests for
Medicare payment of amounts that substantially exceed the costs it
incurred in furnishing the services for which payment is requested.
(iii) It has furnished services that the OIG has determined to be
substantially in excess of the needs of individuals or of a quality that
fails to meet professionally recognized standards of health care. The
OIG will not terminate a provider agreement under paragraph (a) if HCFA
has waived a disallowance with respect to the services in question on
the grounds that the provider and the beneficiary could not reasonably
be expected to know that payment would not be made. (The rules for
determining such lack of knowledge are set forth in 405.330 through
405.334 of this chapter.)
(b) Notice of termination. The OIG will give the provider notice of
termination at least 15 days before the effective date of termination of
the agreement, and will concurrently give notice of termination to the
public.
(c) Appeal by the provider. A provider may appeal a termination of
its agreement by the OIG in accordance with subpart O of part 405 of
this chapter.
(d) Other applicable rules. The termination of a provider agreement
by the OIG is subject to the additional procedures specified in
1001.105 through 1001.109 of this title for notice and appeals.
(51 FR 24492, July 3, 1986, as amended at 51 FR 34788, Sept. 30,
1986)
42 CFR 489.55 Exceptions to effective date of termination.
Payment is available for up to 30 days after the effective date of
termination for --
(a) Inpatient hospital services (including inpatient psychiatric
hospital services) and posthospital extended care services furnished to
a beneficiary who was admitted before the effective date of termination;
and
(b) Home health services and hospice care furnished under a plan
established before the effective date of termination. 1
(50 FR 37376, Sept. 13, 1985)
1For termination before July 18, 1984 payment was available through
the calendar year in which the termination was effective.
42 CFR 489.57 Reinstatement after termination.
When a provider agreement has been terminated by HCFA under 489.53,
or by the OIG under 489.54, a new agreement with that provider will not
be accepted unless HCFA or the OIG, as appropriate, finds --
(a) That the reason for termination of the previous agreement has
been removed and there is reasonable assurance that it will not recur;
and
(b) That the provider has fulfilled, or has made satisfactory
arrangements to fulfill, all of the statutory and regulatory
responsibilities of its previous agreement.
(51 FR 24493, July 3, 1986)
42 CFR 489.57 Subpart F -- Denial of Payments to SNF's for New
Admissions; Withholding of Payment
Source: 51 FR 24493, July 3, 1986, unless otherwise noted.
42 CFR 489.60 Denial of payments for new admissions.
(a) Basis for denial of payments. HCFA may deny Medicare payments
for new admissions to an SNF that no longer meets a level A requirement
specified in subpart B of part 483 of this chapter, in either of the
following circumstances:
(1) Deficiencies do not pose immediate jeopardy. If HCFA finds that
the SNF's deficiencies do not pose immediate jeopardy to patient health
and safety, HCFA may either terminate the SNF's provider agreement or
deny payment for new admissions. In determining which sanction to
impose, HCFA considers factors such as the facility's compliance history
and the number and seriousness of the deficiencies.
(2) Deficiencies do pose immediate jeopardy. If HCFA finds that the
SNF's deficiencies do pose immediate jeopardy to patient health and
safety, and thereby terminates the SNF's provider agreement, HCFA will
additionally seek to deny payment for new admissions.
(b) Effect of Medicare denial on an SNF that also participates in
Medicaid. When HCFA denies payment for new admissions to an SNF that
also participates in Medicaid, HCFA will require the Medicaid agency to
deny Medicaid payments for new admissions for the same period that
Medicare payments are denied.
(54 FR 5373, Feb. 2, 1989, as amended at 56 FR 48879, Sept. 26, 1991)
Effective Date Note: At 56 FR 48879, Sept. 26, 1991, in 489.60,
paragraph (a) introductory text is amended by replacing the phrase
''level A requirement specified in subpart K of part 405'' with ''level
A requirement specified in subpart B of part 483,'' effective April 1,
1992.
42 CFR 489.62 Procedures for denial of payments.
Before denying payments for new admissions, HCFA will fulfill the
following requirements.
(a) Provide the facility up to 60 days to correct the cited
deficiencies and achieve compliance with the SNF requirements.
(b) If at the end of the specified period the facility has not
achieved compliance, give the facility notice of intent to deny payment
for new admissions, and opportunity for an informal hearing.
(c) If the facility requests a hearing, provide an informal hearing
that includes --
(1) The opportunity for the facility to present, before an HCFA
official who was not involved in making the initial determination,
evidence and documentation, in writing or in person, to refute the
decision that the facility is out of compliance with level A and level B
requirements; and
(2) A written decision setting forth the factual and legal bases
pertinent to a resolution of the dispute.
(d) If the decision of the informal hearing is to deny payments for
new admissions, provide the facility and the public, at least 15 days
before the effective date of the sanction, with a notice that includes
the effective date and the reasons for the denial of payments.
(54 FR 5373, Feb. 2, 1989)
42 CFR 489.64 Duration of denial of payments and subsequent
termination.
(a) Period of denial. The denial of payments will continue for 11
months after the month it was imposed unless, before the end of that
period, HCFA finds that --
(1) The SNF has corrected the deficiencies or is making a good faith
effort to achieve compliance with level A requirements; or
(2) The deficiencies are such that it is necessary to terminate the
provider agreement.
(b) Subsequent termination. HCFA will terminate an SNF's provider
agreement --
(1) Upon HCFA's finding that the SNF has been unable to achieve
compliance with level A requirements during the period of denial of
payments for new admissions;
(2) Effective the day following the last day of the denial of
payments period; and
(3) In accordance with the procedures for terminations and
reinstatements set forth in 489.53 through 489.57.
(54 FR 5373, Feb. 2, 1989)
42 CFR 489.66 Withholding of payment for failure to make timely
utilization review.
(a) If HCFA finds that there is a substantial failure to make timely
utilization review of long-stay cases in a hospital or skilled nursing
facility, HCFA may determine that no payment shall be made for inpatient
hospital services (including inpatient psychiatric hospital services) or
for posthospital SNF care furnished an individual after the 20th day of
a continuing period of such services.
(b) Before making a determination to withhold payment, HCFA will
notify the provider of its intention and will afford the institution or
agency an opportunity for a hearing.
(c) The withholding of payment will become effective as of the date
specified in the determination and be applicable to services furnished
to individuals admitted after that date.
(d) The withholding will continue in effect until HCFA finds that:
(1) The reason for the withholding has been removed; and
(2) There is reasonable assurance that it will not recur.
(45 FR 22937, Apr. 4, 1980. Redesignated at 51 FR 24492, July 3,
1986, and amended at 56 FR 8854, Mar. 1, 1991)
42 CFR 489.66 Subparts G and H -- (Reserved)
42 CFR 489.66 Subpart I -- Advance Directives
Source: 57 FR 8203, Mar. 6, 1992, unless otherwise noted.
42 CFR 489.100 Definition.
For purposes of this part, advance directive means a written
instruction, such as a living will or durable power of attorney for
health care, recognized under State law (whether statutory or as
recognized by the courts of the State), relating to the provision of
health care when the individual is incapacitated.
42 CFR 489.102 Requirements for providers.
(a) Hospitals, skilled nursing facilities, nursing facilities, home
health agencies, providers of home health care (and for Medicaid
purposes, providers of personal care services), and hospices must
maintain written policies and procedures concerning advance directives
with respect to all adult individuals receiving medical care by or
through the provider and are required to:
(1) Provide written information to such individuals concerning --
(i) An individual's rights under State law (whether statutory or
recognized by the courts of the State) to make decisions concerning such
medical care, including the right to accept or refuse medical or
surgical treatment and the right to formulate, at the individual's
option, advance directives; and
(ii) The written policies of the provider or organization respecting
the implementation of such rights, including a clear and precise
statement of limitation if the provider cannot implement an advance
directive on the basis of conscience;
(2) Document in the individual's medical record whether or not the
individual has executed the implementation of such rights;
(3) Not condition the provision of care or otherwise discriminate
against an individual based on whether or not the individual has
executed an advance directive;
(4) Ensure compliance with requirements of State law (whether
statutory or recognized by the courts of the State) regarding advance
directives;
(5) Provide for education of staff concerning its policies and
procedures on advance directives; and
(6) Provide for community education regarding advance directives to
include material required in paragraph (a)(1) of this section, either
directly or in concert with other providers and organizations.
(b) The information specified in paragraph (a) of this section is
furnished:
(1) In the case of a hospital, at the time of the individual's
admission as an inpatient.
(2) In the case of a skilled nursing facility at the time of the
individual's admission as a resident.
(3)(i) In the case of a home health agency, in advance of the
individual coming under the care of the agency.
(ii) In the case of personal care services, in advance of the
individual coming under the care of the personal care services provider.
(4) In the case of a hospice program, at the time of initial receipt
of hospice care by the individual from the program.
(c) The providers listed in paragraph (a) of this section --
(1) Are not required to provide care that conflicts with an advance
directive.
(2) Are not required to implement an advance directive if, as a
matter of conscience, the provider cannot implement an advance
directive, and State law allows any health care provider or any agency
of such provider to conscientiously object.
(d) Prepaid or eligible organizations (as specified in sections
1833(a)(1)(A) and 1876(b) of the Act) must meet the requirements
specified in 417.436 of this chapter.
42 CFR 489.104 Effective dates.
These provisions apply to services furnished on or after December 1,
1991 payments made under section 1833(a)(1)(A) of the Act on or after
December 1, 1991, and contracts effective on or after December 1, 1991.
42 CFR 489.104 Pt. 491
42 CFR 489.104 PART 491 -- CERTIFICATION OF CERTAIN HEALTH FACILITIES
42 CFR 489.104 Subpart A -- Rural Health Clinics: Conditions for
Certification; and Federally Qualified Health Centers Conditions for
Coverage
Sec.
491.1 Purpose and scope.
491.2 Definitions.
491.3 Certification procedures.
491.4 Compliance with Federal, State and local laws.
491.5 Location of clinic.
491.6 Physical plant and environment.
491.7 Organizational structure.
491.8 Staffing and staff responsibilities.
491.9 Provision of services.
491.10 Patient health records.
491.11 Program evaluation.
Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302);
and sec. 353 of the Public Health Service Act (42 U.S.C. 263a).
42 CFR 489.104 Subpart A -- Rural Health Clinics: Conditions for Certification; and Federally Qualified Health Centers Conditions for Coverage
42 CFR 491.1 Purpose and scope.
This subpart sets forth the conditions that rural health clinics or
Federally qualified health centers must meet in order to qualify for
reimbursement under Medicare (title XVIII of the Social Security Act)
and that rural health clinics must meet in order to qualify for
reimbursement under Medicaid (title XIX of the Act).
(57 FR 24982, June 12, 1992)
42 CFR 491.2 Definitions.
As used in this subpart, unless the context indicates otherwise:
Direct services means services provided by the clinic's staff.
Federally qualified health center means an entity as defined in
405.2401(b).
Nurse practitioner means a registered professional nurse who is
currently licensed to practice in the State, who meets the State's
requirements governing the qualifications of nurse practitioners, and
who meets one of the following conditions:
(1) Is currently certified as a primary care nurse practitioner by
the American Nurses' Association or by the National Board of Pediatric
Nurse Practitioners and Associates; or
(2) Has satisfactorily completed a formal 1 academic year educational
program that:
(i) Prepares registered nurses to perform an expanded role in the
delivery of primary care;
(ii) Includes at least 4 months (in the aggregate) of classroom
instruction and a component of supervised clinical practice; and
(iii) Awards a degree, diploma, or certificate to persons who
successfully complete the program; or
(3) Has successfully completed a formal educational program (for
preparing registered nurses to perform an expanded role in the delivery
of primary care) that does not meet the requirements of paragraph (b)(2)
of this section, and has been performing an expanded role in the
delivery of primary care for a total of 12 months during the 18-month
period immediately preceding the effective date of this subpart.
Physician means a doctor of medicine or osteopathy legally authorized
to practice medicine or surgery in the State.
Physician assistant means a person who meets the applicable State
requirements governing the qualifications for assistants to primary care
physicians, and who meets at least one of the following conditions:
(1) Is currently certified by the National Commission on
Certification of Physician Assistants to assist primary care physicians;
or
(2) Has satisfactorily completed a program for preparing physician's
assistants that:
(i) Was at least 1 academic year in length;
(ii) Consisted of supervised clinical practice and at least 4 months
(in the aggregate) of classroom instruction directed toward preparing
students to deliver health care; and
(iii) Was accredited by the American Medical Association's Committee
on Allied Health Education and Accreditation; or
(3) Has satisfactorily completed a formal educational program (for
preparing physician assistants) that does not meet the requirements of
paragraph (d)(2) of this section and assisted primary care physicians
for a total of 12 months during the 18-month period that ended on
December 31, 1986.
Rural area means an area that is not delineated as an urbanized area
by the Bureau of the Census.
Rural health clinic or clinic means a clinic that is located in a
rural area designated as a shortage area, is not a rehabilitation agency
or a facility primarily for the care and treatment of mental diseases,
and meets all other requirements of this subpart.
Shortage area means a defined geographic area designated by the
Department as having either a shortage of personal health services
(under section 1302(7) of the Public Health Service Act) or a shortage
of primary medical care manpower (under section 332 of that Act).
Secretary means the Secretary of Health and Human Services, or any
official to whom he has delegated the pertinent authority.
(Secs. 1102, 1833 and 1902(a)(13), Social Security Act: 49 Stat.
647, 91 Stat. 1485 (42 U.S.C. 1302, 1395l and 1396(a)(13)))
(43 FR 5375, Feb. 8, 1978, as amended at 43 FR 30528, July 14, 1978.
Redesignated at 50 FR 33034, Aug. 16, 1985, and further amended at 56 FR
8854, Mar. 1, 1991; 57 FR 24982, June 12, 1992)
42 CFR 491.3 Certification procedures.
A rural health clinic will be certified for participation in Medicare
in accordance with subpart S of 42 CFR part 405. The Secretary will
notify the State Medicaid agency whenever he has certified or denied
certification under Medicare for a prospective rural health clinic in
that State. A clinic certified under Medicare will be deemed to meet
the standards for certification under Medicaid.
42 CFR 491.4 Compliance with Federal, State and local laws.
The rural health clinic or Federally qualified health center and its
staff are in compliance with applicable Federal, State and local laws
and regulations.
(a) Licensure of clinic or center. The clinic or center is licensed
pursuant to applicable State and local law.
(b) Licensure, certification or registration of personnel. Staff of
the clinic or center are licensed, certified or registered in accordance
with applicable State and local laws.
(57 FR 24982, June 12, 1992)
42 CFR 491.5 Location of clinic.
(a) Basic requirement. The clinic is located in a rural area that is
designated as a shortage area. The Federally qualified health center is
located in a rural or urban area that is designated as a shortage area.
Both the clinic and the center may be permanent or mobile units.
(1) Permanent unit. The objects, equipment and supplies necessary
for the provision of the services furnished directly by the clinic or
center are housed in a permanent structure.
(2) Mobile unit. The objects, equipment, and supplies necessary for
the provision of the services furnished directly by the clinic or center
are housed in a mobile structure which has fixed, scheduled location(s).
Under this requirement, if clinic services are furnished at permanent
units in more than one location, each unit will be independently
considered for certification as a rural health clinic or for coverage as
a Federally qualified health center.
(b) Exceptions. (1) A facility certified under this subpart will not
be disqualified if the area in which it is located subsequently fails to
meet the definition of rural, shortage area.
(2) A private, nonprofit facility that meets all other conditions of
this subpart except for location in a shortage area will be certified
if, on July 1, 1977, it was operating in a rural area that is determined
by the Secretary (on the basis of the ratio of primary care physicians
to the general population) to have an insufficient supply of physicians
to meet the needs of the area served.
(3) Determinations on these exceptions will be made by the Secretary
upon application by the facility.
(c) Criteria for designation of rural areas. (1) Rural areas are
areas not delineated as urbanized areas in the last census conducted by
the Census Bureau.
(2) Excluded from the rural area classification are:
(i) Central cities of 50,000 inhabitants or more;
(ii) Cities with at least 25,000 inhabitants which, together with
contiguous areas having stipulated population density, have combined
populations of 50,000 and constitute, for general economic and social
purposes, single communities;
(iii) Closely settled territories surrounding cities and specifically
designated by the Census Bureau as urban.
(3) Included in the rural area classification are those portions of
extended cities that the Census Bureau has determined to be rural.
(d) Criteria for designation of shortage areas. (1) The criteria for
determination of shortage of personal health services (under section
1302(7) of the Public Health Services Act), are:
(i) The ratio of primary care physicians practicing within the area
to the resident population;
(ii) The infant mortality rate;
(iii) The percent of the population 65 years of age or older; and
(iv) The percent of the population with a family income below the
poverty level.
(2) The criteria for determination of shortage of primary medical
care manpower (under section 332(a)(1)(A) of the Public Health Services
Act) are:
(i) The area served is a rational area for the delivery of primary
medical care services;
(ii) The ratio of primary care physicians practicing within the area
to the resident population; and
(iii) The primary medical care manpower in contiguous areas is
overutilized, excessively distant, or inaccessible to the population in
this area.
Cross Reference: See 42 CFR 110.203(g) (41 FR 45718, Oct. 15, 1976)
and 42 CFR Part 5 (42 FR 1586, Jan. 10, 1978).
(43 FR 5375, Feb. 8, 1978. Redesignated at 50 FR 33034, Aug. 16,
1985, and amended at 57 FR 24982, June 12, 1992)
42 CFR 491.6 Physical plant and environment.
(a) Construction. The clinic or center is constructed, arranged, and
maintained to insure access to and safety of patients, and provides
adequate space for the provision of direct services.
(b) Maintenance. The clinic or center has a preventive maintenance
program to ensure that:
(1) All essential mechanical, electrical and patient-care equipment
is maintained in safe operating condition;
(2) Drugs and biologicals are appropriately stored; and
(3) The premises are clean and orderly.
(c) Emergency procedures. The clinic or center assures the safety of
patients in case of non-medical emergencies by:
(1) Training staff in handling emergencies;
(2) Placing exit signs in appropriate locations; and
(3) Taking other appropriate measures that are consistent with the
particular conditions of the area in which the clinic or center is
located.
(57 FR 24983, June 12, 1992)
42 CFR 491.7 Organizational structure.
(a) Basic requirements. (1) The clinic or center is under the
medical direction of a physician, and has a health care staff that meets
the requirements of 491.8.
(2) The organization's policies and its lines of authority and
responsibilities are clearly set forth in writing.
(b) Disclosure. The clinic or center discloses the names and
addresses of:
(1) Its owners, in accordance with section 1124 of the Social
Security Act (42 U.S.C. 132 A-3);
(2) The person principally responsible for directing the operation of
the clinic or center; and
(3) The person responsible for medical direction.
(57 FR 24983, June 12, 1992)
42 CFR 491.8 Staffing and staff responsibilities.
(a) Staffing. (1) The clinic or center has a health care staff that
includes one or more physicians. Rural health clinic staffs must also
include one or more physician's assistants or nurse practitioners.
(2) The physician member of the staff may be the owner of the rural
health clinic, an employee of the clinic or center, or under agreement
with the clinic or center to carry out the responsibilities required
under this section.
(3) The physician's assistant or nurse practitioner member of the
staff may be the owner of the rural health clinic or an employee of the
clinic or center.
(4) The staff may also include ancillary personnel who are supervised
by the professional staff.
(5) The staff is sufficient to provide the services essential to the
operation of the clinic or center.
(6) A physician, nurse practitioner, or physician assistant is
available to furnish patient care services at all times the clinic or
center operates. In addition, for rural health clinics, a nurse
practitioner or a physician assistant is available to furnish patient
care services at least 60 percent of the time the clinic operates.
(b) Physician responsibilities. (1) The physician:
(i) Provides medical direction for the clinic's or center's health
care activities and consultation for, and medical supervision of, the
health care staff.
(ii) In conjunction with the physician's assistant and/or nurse
practitioner member(s), participates in developing, executing, and
periodically reviewing the clinic's or center's written policies and the
services provided to Federal program patients; and
(iii) Periodically reviews the clinic's or center's patient records,
provides medical orders, and provides medical care services to the
patients of the clinic or center.
(2) A physician is present for sufficient periods of time, at least
once in every 2 week period (except in extraordinary circumstances), to
provide the medical direction, medical care services, consultation and
supervision described in paragraph (b)(1) of this section and is
available through direct telecommunication for consultation, assistance
with medical emergencies, or patient referral. The extraordinary
circumstances are documented in the records of the clinic or center.
(c) Physician assistant and nurse practitioner responsibilities. (1)
The physician assistant and the nurse practitioner members of the
clinic's or center's staff:
(i) Participate in the development, execution and periodic review of
the written policies governing the services the clinic or center
furnishes;
(ii) Participate with a physician in a periodic review of the
patients' health records.
(2) The physician assistant or nurse practitioner performs the
following functions, to the extent they are not being performed by a
physician:
(i) Provides services in accordance with the clinic's or center's
policies;
(ii) Arranges for, or refers patients to, needed services that cannot
be provided at the clinic or center; and
(iii) Assures that adequate patient health records are maintained and
transferred as required when patients are referred.
(57 FR 24983, June 12, 1992)
42 CFR 491.9 Provision of services.
(a) Basic requirements. (1) All services offered by the clinic or
center are furnished in accordance with applicable Federal, State, and
local laws; and
(2) The clinic or center is primarily engaged in providing outpatient
health services and meets all other conditions of this subpart.
(3) The laboratory requirements in paragraph (c)(2) of this section
apply to RHCs, but do not apply to FQHCs.
(b) Patient care policies. (1) The clinic's or center's health care
services are furnished in accordance with appropriate written policies
which are consistent with applicable State law.
(2) The policies are developed with the advice of a group of
professional personnel that includes one or more physicians and one or
more physician assistants or nurse practitioners. At least one member
is not a member of the clinic or center staff.
(3) The policies include:
(i) A description of the services the clinic or center furnishes
directly and those furnished through agreement or arrangement.
(ii) Guidelines for the medical management of health problems which
include the conditions requiring medical consultation and/or patient
referral, the maintenance of health care records, and procedures for the
periodic review and evaluation of the services furnished by the clinic
or center.
(iii) Rules for the storage, handling, and administration of drugs
and biologicals.
(4) These policies are reviewed at least annually by the group of
professional personnel required under paragraph (b)(2) of this section
and reviewed as necessary by the clinic or center.
(c) Direct services -- (1) General. The clinic or center staff
furnishes those diagnostic and therapeutic services and supplies that
are commonly furnished in a physician's office or at the entry point
into the health care delivery system. These include medical history,
physical examination, assessment of health status, and treatment for a
variety of medical conditions.
(2) Laboratory. These requirements apply to RHCs, but not to FQHCs.
The RHC provides basic laboratory services essential to the immediate
diagnosis and treatment of the patient, including:
(i) Chemical examinations of urine by stick or tablet methods or both
(including urine ketones);
(ii) Microscopic examinations of urine sediment;
(iii) Hemoglobin or hematocrit;
(iv) Blood sugar;
(v) Gram stain;
(vi) Examination of stool specimens for occult blood;
(vii) Pregnancy tests;
(viii) Primary culturing for transmittal to a certified laboratory;
and
(ix) Test for pinworm.
(3) Emergency. The clinic or center provides medical emergency
procedures as a first response to common life-threatening injuries and
acute illness and has available the drugs and biologicals commonly used
in life saving procedures, such as analgesics, anesthetics (local),
antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids.
(d) Services provided through agreements or arrangements. (1) The
clinic or center has agreements or arrangements with one or more
providers or suppliers participating under Medicare or Medicaid to
furnish other services to its patients, including:
(i) Inpatient hospital care;
(ii) Physician(s) services (whether furnished in the hospital, the
office, the patient's home, a skilled nursing facility, or elsewhere);
and
(iii) Additional and specialized diagnostic and laboratory services
that are not available at the clinic or center.
(2) If the agreements are not in writing, there is evidence that
patients referred by the clinic or center are being accepted and
treated.
(57 FR 24983, June 12, 1992)
42 CFR 491.10 Patient health records.
(a) Records system. (1) The clinic or center maintains a clinical
record system in accordance with written policies and procedures.
(2) A designated member of the professional staff is responsible for
maintaining the records and for insuring that they are completely and
accurately documented, readily accessible, and systematically organized.
(3) For each patient receiving health care services, the clinic or
center maintains a record that includes, as applicable:
(i) Identification and social data, evidence of consent forms,
pertinent medical history, assessment of the health status and health
care needs of the patient, and a brief summary of the episode,
disposition, and instructions to the patient;
(ii) Reports of physical examinations, diagnostic and laboratory test
results, and consultative findings;
(iii) All physician's orders, reports of treatments and medications,
and other pertinent information necessary to monitor the patient's
progress;
(iv) Signatures of the physician or other health care professional.
(b) Protection of record information. (1) The clinic or center
maintains the confidentiality of record information and provides
safeguards against loss, destruction or unauthorized use.
(2) Written policies and procedures govern the use and removal of
records from the clinic or center and the conditions for release of
information.
(3) The patient's written consent is required for release of
information not authorized to be released without such consent.
(c) Retention of records. The records are retained for at least 6
years from date of last entry, and longer if required by State statute.
(Secs. 1102, 1833 and 1902(a)(13), Social Security Act; 49 Stat.
647, 91 Stat. 1485 (42 U.S.C. 1302, 13951 and 1396a(a)(13)))
(43 FR 30529, July 14, 1978. Redesignated at 50 FR 33034, Aug. 16,
1985, as amended at 57 FR 24984, June 12, 1992)
42 CFR 491.11 Program evaluation.
(a) The clinic or center carries out, or arranges for, an annual
evaluation of its total program.
(b) The evaluation includes review of:
(1) The utilization of clinic or center services, including at least
the number of patients served and the volume of services;
(2) A representative sample of both active and closed clinical
records; and
(3) The clinic's or center's health care policies.
(c) The purpose of the evaluation is to determine whether:
(1) The utilization of services was appropriate;
(2) The established policies were followed; and
(3) Any changes are needed.
(d) The clinic or center staff considers the findings of the
evaluation and takes corrective action if necessary.
(57 FR 24984, June 12, 1992)
42 CFR 491.11 Pt. 493
42 CFR 491.11 PART 493 -- LABORATORY REQUIREMENTS
42 CFR 491.11 Subpart A -- General Provisions
Sec.
493.1 Basis and scope.
493.2 Definitions.
493.3 Applicability.
493.10 Categories of tests by complexity.
493.15 Laboratories performing waived tests.
493.17 Test categorization.
493.20 Laboratories performing tests of moderate complexity.
493.25 Laboratories performing tests of high complexity.
42 CFR 491.11 Subpart B -- Certificate of Waiver
493.35 Application for a certificate of waiver.
493.37 Requirements for a certificate of waiver.
493.39 Notification requirements for laboratories issued a
certificate of waiver.
42 CFR 491.11 Subpart C -- Registration Certificate and Certificate
493.43 Application for registration certificate and certificate.
493.45 Requirements for a registration certificate.
493.49 Requirements for a certificate.
493.51 Notification requirements for laboratories issued a
certificate.
42 CFR 491.11 Subpart D -- Certificate of Accreditation
493.55 Application for registration certificate and certificate of
accreditation.
493.57 Requirements for a registration certificate.
493.61 Requirements for a certificate of accreditation.
493.63 Notification requirements for laboratories issued a
certificate of accreditation.
42 CFR 491.11 Subpart E -- Accreditation by a Private, Nonprofit
Accreditation Organization or Exemption Under an Approved State
Laboratory Program
493.501 General requirements for accredited laboratories.
493.503 Proficiency testing requirements of laboratories with deemed
status.
493.504 Revocation of accreditation.
493.506 Federal review and approval of private, nonprofit
accreditation organizations.
493.507 Validation inspections of laboratories with certificates of
accreditation.
493.509 Continuing Federal oversight of private, nonprofit
accreditation organizations.
493.511 Removal of deeming authority and final determination review.
493.513 General requirements for CLIA-exempt laboratories.
493.515 Federal review of laboratory requirements of State laboratory
programs.
493.517 Validation inspections of CLIA-exempt laboratories.
493.519 Continuing Federal oversight of an approved State laboratory
program.
493.521 Removal of CLIA exemption and final determination review.
42 CFR 491.11 Subpart F -- General Administration
493.602 Scope of subpart. (Reserved)
493.606 Applicability of subpart. (Reserved)
493.610 Certificate requirements for laboratories. (Reserved)
493.614 Application procedures. (Reserved)
493.618 Additional application requirements. (Reserved)
493.622 Appeals procedures. (Reserved)
493.626 Registration certificate. (Reserved)
493.630 Certificate. (Reserved)
493.631 Certificate of waiver. (Reserved)
493.632 Certificate of accreditation. (Reserved)
493.633 Applicability of certificate, certificate of waiver, and
certificate of accreditation. (Reserved)
493.634 Notification of changes. (Reserved)
493.638 Registration certificate and certificate fees.
493.639 Fee for revised certificate.
493.643 Fee for determination of program compliance.
493.645 Fee (s) applicable to accredited laboratories/approved State
licensure programs.
493.646 Payment of fees.
493.649 Methodology for determining fee amount.
42 CFR 491.11 Subpart G -- (Reserved)
42 CFR 491.11 Subpart H -- Participation in Proficiency Testing for
Laboratories Performing Tests of Moderate or High Complexity, or Both
493.801 Condition: Enrollment and testing of samples.
493.803 Condition: Successful participation.
493.807 Condition: Reinstatement of laboratories performing tests of
moderate or high complexity, or both, after failure to participate
successfully.
493.821 Condition: Microbiology.
493.823 Standard; Bacteriology.
493.825 Standard; Mycobacteriology.
493.827 Standard; Mycology.
493.829 Standard; Parasitology.
493.831 Standard; Virology.
493.833 Condition: Diagnostic immunology.
493.835 Standard; Syphilis serology.
493.837 Standard; General immunology.
493.839 Condition: Chemistry.
493.841 Standard; Routine chemistry.
493.843 Standard; Endocrinology.
493.845 Standard; Toxicology.
493.849 Condition: Hematology.
493.851 Standard; Hematology.
493.853 Condition: Pathology.
493.855 Standard; Cytology: gynecologic examinations.
493.857 Condition: Immunohematology.
493.859 Standard; ABO group and D (Rho) typing.
493.861 Standard; Unexpected antibody detection.
493.863 Standard; Compatibility testing.
493.865 Standard; Antibody identification.
42 CFR 491.11 Subpart I -- Proficiency Testing Programs for Tests of
Moderate or High Complexity, or Both
493.901 Approval of proficiency testing programs.
493.903 Administrative responsibilities.
493.905 Nonapproved proficiency testing programs.
493.909 Microbiology.
493.911 Bacteriology.
493.913 Mycobacteriology.
493.915 Mycology.
493.917 Parasitology.
493.919 Virology.
493.921 Diagnostic immunology.
493.923 Syphilis serology.
493.927 General immunology.
493.929 Chemistry.
493.931 Routine chemistry.
493.933 Endocrinology.
493.937 Toxicology.
493.941 Hematology (including routine hematology and coagulation).
493.945 Cytology; gynecologic examinations.
493.959 Immunohematology.
42 CFR 491.11 Subpart J -- Patient Test Management for Moderate or High
Complexity Testing, or Both
493.1101 Condition: Patient test management; moderate or high
complexity testing, or both.
493.1103 Standard; Procedures for specimen submission and handling.
493.1105 Standard; Test requisition.
493.1107 Standard; Test records.
493.1109 Standard; Test report.
493.1111 Standard; Referral of specimens.
42 CFR 491.11 Subpart K -- Quality Control for Tests of Moderate or
High Complexity, or Both
493.1201 Condition: General quality control; moderate or high
complexity testing, or both.
493.1202 Standard; Moderate or high complexity testing, or both:
Effective from September 1, 1992 to September 1, 1994.
493.1203 Standard; Facilities (effective until September 1, 1991)
493.1203 Standard; Moderate or high complexity testing, or both:
Effective beginning September 1, 1994.
493.1204 Standard; Facilities.
493.1205 Standard; Test methods, equipment, instrumentation,
reagents, materials, and supplies.
493.1211 Standard; Procedure manual.
493.1213 Standard; Establishment and verification of method
performance specifications.
493.1215 Standard; Equipment maintenance and function checks.
493.1217 Standard; Calibration and calibration verification
procedures.
493.1218 Standard; Control procedures.
493.1219 Standard; Remedial actions.
493.1221 Standard; Quality control records.
493.1223 Condition: Quality control -- specialties and
subspecialties for tests of moderate or high complexity, or both.
493.1225 Condition: Microbiology.
493.1227 Condition: Bacteriology.
493.1229 Condition: Mycobacteriology.
493.1231 Condition: Mycology.
493.1233 Condition: Parasitology.
493.1235 Condition: Virology.
493.1237 Condition: Diagnostic immunology.
493.1239 Condition: Syphilis serology.
493.1241 Condition: General immunology.
493.1243 Condition: Chemistry.
493.1245 Condition: Routine chemistry.
493.1247 Condition: Endocrinology.
493.1249 Condition: Toxicology.
493.1253 Condition: Hematology.
493.1255 Condition: Pathology.
493.1257 Condition: Cytology.
493.1259 Condition: Histopathology.
493.1261 Condition: Oral pathology.
493.1263 Condition: Radiobioassay.
493.1265 Condition: Histocompatibility.
493.1267 Condition: Clinical cytogenetics.
493.1269 Condition: Immunohematology.
493.1271 Condition: Transfusion services and bloodbanking.
493.1273 Standard; Immunohematological collection, processing,
dating periods, labeling and distribution of blood and blood products.
493.1275 Standard; Blood and blood products storage facilities.
493.1277 Standard; Arrangement for services.
493.1279 Standard; Provision of testing.
493.1283 Standard; Retention of samples of transfused blood.
493.1285 Standard; Investigation of transfusion reactions.
42 CFR 491.11 Subpart L -- (Reserved)
42 CFR 491.11 Subpart M -- Personnel for Moderate and High Complexity
Testing
493.1401 General.
493.1403 Condition: Laboratories performing moderate complexity
testing; laboratory director.
493.1405 Standard; Laboratory director qualifications.
493.1407 Standard; Laboratory director responsibilities.
493.1409 Condition: Laboratories performing moderate complexity
testing; technical consultant.
493.1411 Standard; Technical consultant qualifications.
493.1413 Standard; Technical consultant responsibilities.
493.1415 Condition: Laboratories performing moderate complexity
testing; clinical consultant.
493.1417 Standard; Clinical consultant qualifications.
493.1419 Standard; Clinical consultant responsibilities.
493.1421 Condition: Laboratories performing moderate complexity
testing; testing personnel.
493.1423 Standard; Testing personnel qualifications.
493.1425 Standard; Testing personnel responsibilities.
493.1441 Condition: Laboratories performing high complexity testing;
laboratory director.
493.1443 Standard; Laboratory director qualifications.
493.1445 Standard; Laboratory director responsibilities.
493.1447 Condition: Laboratories performing high complexity testing;
technical supervisor.
493.1449 Standard; Technical supervisor qualifications.
493.1451 Standard; Technical supervisor responsibilities.
493.1453 Condition: Laboratories performing high complexity testing;
clinical consultant.
493.1455 Standard; Clinical consultant qualifications.
493.1457 Standard; Clinical consultant responsibilities.
493.1459 Condition: Laboratories performing high complexity testing;
general supervisor.
493.1461 Standard; General supervisor qualifications.
493.1463 Standard; General supervisor responsibilities.
493.1467 Condition: Laboratories performing high complexity testing;
cytology general supervisor.
493.1469 Standard; Cytology general supervisor qualifications.
493.1471 Standard; Cytology general supervisor responsibilities.
493.1481 Condition: Laboratories performing high Complexity testing;
cytotechnologist.
493.1483 Standard; Cytotechnologist qualifications.
493.1485 Standard; Cytotechnologist responsibilities.
493.1487 Condition: Laboratories performing high complexity testing;
testing personnel.
493.1489 Standard; Testing personnel qualifications.
493.1495 Standard; Testing personnel responsibilities.
42 CFR 491.11 Subparts N-O -- (Reserved)
42 CFR 491.11 Subpart P -- Quality Assurance for Moderate or High
Complexity Testing, or Both
493.1701 Condition: Quality assurance; moderate or high complexity
testing, or both.
493.1703 Standard; Patient test management assessment.
493.1705 Standard; Quality control assessment.
493.1707 Standard; Proficiency testing assessment.
493.1709 Standard; Comparison of test results.
493.1711 Standard; Relationship of patient information to patient
test results.
493.1713 Standard; Personnel assessment.
493.1715 Standard; Communications.
493.1717 Standard; Complaint investigations.
493.1719 Standard; Quality assurance review with staff.
493.1721 Standard; Quality assurance records.
42 CFR 491.11 Subpart Q -- Inspection
493.1775 Condition: Inspection of laboratories issued a certificate
of waiver.
493.1777 Condition: Inspection of all laboratories not issued a
certificate of waiver or a certificate of accreditation.
493.1780 Condition: Inspection of accredited and State-exempt
laboratories.
42 CFR 491.11 Subpart R -- Enforcement Procedures
493.1800 Basis and scope.
493.1804 General considerations.
493.1806 Available sanctions: All laboratories.
493.1807 Additional sanctions: Laboratories that participate in
Medicare.
493.1808 Adverse action on any type of CLIA certificate: Effect on
Medicare approval.
493.1809 Limitation on Medicaid payment.
493.1810 Imposition and lifting of alternative sanctions.
493.1812 Action when deficiencies pose immediate jeopardy.
493.1814 Action when deficiencies are at the condition level but do
not pose immediate jeopardy.
493.1816 Action when deficiencies are not at the condition level.
493.1820 Ensuring timely correction of deficiencies.
493.1826 Suspension of part of Medicare payments.
493.1828 Suspension of all Medicare payments.
493.1832 Directed plan of correction and directed portion of a plan
of correction.
493.1834 Civil money penalty.
493.1836 State onsite monitoring.
493.1838 Training and technical assistance for unsuccessful
participation in proficiency testing.
493.1840 Suspension, limitation, or revocation of any type of CLIA
certificate.
493.1842 Cancellation of Medicare approval.
493.1844 Appeals procedures.
493.1846 Civil action.
493.1850 Laboratory registry.
42 CFR 491.11 Subpart S -- (Reserved)
42 CFR 491.11 Subpart T -- Consultations
493.2001 Establishment and function of the Clinical Laboratory
Improvement Advisory Committee.
Authority: Sec. 353 of the Public Health Service Act, secs. 1102,
1861(e), the sentence following 11861(s)(11), 1861(s)(12), 1861(s)(13),
1861(s)(14), 1861(s)(15), and 1861(s)(16) of the Social Security Act (42
U.S.C. 1302, 1395x(e), the sentence following 1395x(s)(11),
1395x(s)(12), 1395x(s)(13), 1395x(s)(14), 1395x(s)(15), and
1395x(s)(16)).
Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.
42 CFR 491.11 Subpart A -- General Provisions
Source: 57 FR 7139, Feb. 28, 1992, unless otherwise noted.
42 CFR 493.1 Basis and scope.
This part sets forth the conditions that all laboratories must meet
to be certified to perform testing on human specimens under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA). It implements
sections 1861 (e) and (j), the sentence following section 1861(s)(13),
and 1902(a)(9) of the Social Security Act, and section 353 of the Public
Health Service Act. This part applies to all laboratories as defined
under ''laboratory'' in 493.2 of this part. This part also applies to
laboratories seeking payment under the Medicare and Medicaid programs.
The requirements are the same for Medicare approval as for CLIA
certification.
42 CFR 493.2 Definitions.
As used in this part, unless the context indicates otherwise --
Accredited institution means a school or program which --
(a) Admits as regular student only persons having a certificate of
graduation from a school providing secondary education, or the
recognized equivalent of such certificate;
(b) Is legally authorized within the State to provide a program of
education beyond secondary education;
(c) Provides an educational program for which it awards a bachelor's
degree or provides not less than a 2-year program which is acceptable
for full credit toward such a degree, or provides an educational program
for which it awards a master's or doctoral degree;
(d) Is accredited by a nationally recognized accrediting agency or
association.
This definition includes any foreign institution of higher education
that HHS or its designee determines meets substantially equivalent
requirements.
Accredited laboratory means a laboratory that has voluntarily applied
for and been accredited by a private, nonprofit accreditation
organization approved by HCFA in accordance with this part;
Adverse action means the imposition of a principal or alternative
sanction by HCFA.
ALJ stands for Administrative Law Judge.
Alternative sanctions means sanctions that may be imposed in lieu of
or in addition to principal sanctions. The term is synonymous with
''intermediate sanctions'' as used in section 1846 of the Act.
Analyte means a substance or constituent for which the laboratory
conducts testing.
Approved accreditation organization for laboratories means a private,
nonprofit accreditation organization that has formally applied for and
received HCFA's approval based on the organization's compliance with
this part.
Approved State laboratory program means a licensure or other
regulatory program for laboratories in a State, the requirements of
which are imposed under State law, and the State laboratory program has
received HCFA approval based on the State's compliance with this part.
Authorized person means an individual authorized under State law to
order tests or receive test results, or both.
Automated means an instrument or test system in which all analytical
processes, including sample and reagent uptake, sample/reagent
interaction, chemical/biological analysis, result calculation and result
readout are mechanized.
Challenge means, for quantitative tests, an assessment of the amount
of substance or analyte present or measured in a sample. For
qualitative tests, a challenge means the determination of the presence
or the absence of an analyte, organism, or substance in a sample.
CLIA means the Clinical Laboratory Improvement Amendments of 1988.
CLIA certificate means any of the following types of certificates
issued by HCFA or its agent:
(1) Certificate means a certificate issued to a laboratory after an
inspection that finds the laboratory to be in compliance with all
condition level requirements, or to be out of compliance with one or
more condition level requirements and has an alternative sanctions
imposed.
(2) Certificate of accreditation means a certificate issued on the
basis of the laboratory's accreditation by an accreditation organization
approved by HCFA, indicating that the laboratory is deemed to meet CLIA
requirements.
(3) Certificate of registration or registration certificate means a
certificate issued to an entity that is not qualified to receive a
certificate of waiver, to enable the entity to conduct laboratory
testing until the entity is determined to be in compliance through an
inspection by HCFA, the State, or a HCFA agent, or is accredited by an
approved accreditation organization.
(4) Certificate of waiver means a certificate issued to a laboratory
to perform only waiver tests, that are described in 493.15(b).
CLIA-exempt laboratory means a laboratory that has been licensed or
approved by a State where HCFA has determined that the State has enacted
laws relating to laboratory requirements that are equal to or more
stringent than CLIA requirements and the State licensure program has
been approved by HCFA in accordance with subpart E of this part.
Condition level deficiency means noncompliance with one or more
condition level requirements.
Condition level requirements means any of the requirements identified
as ''conditions'' in subparts G through Q of this part.
Credible allegation of compliance means a statement or documentation
that --
(1) Is made by a representative of a laboratory that has a history of
having maintained a commitment to compliance and of taking corrective
action when required;
(2) Is realistic in terms of its being possible to accomplish the
required corrective action between the date of the exit conference and
the date of the allegation; and
(3) Indicates that the problem has been resolved.
Equivalency means that an accreditation organization's or a State
laboratory program's requirements, taken as a whole, are equal to or
more stringent than the CLIA requirements established by HCFA, taken as
whole. It is acceptable for an accreditation organization's or State
laboratory program's requirements to be organized differently or
otherwise vary from the CLIA requirements, as long as (1) all of the
requirements taken as a whole would provide at least the same protection
as the CLIA requirements taken as a whole; and (2) a finding of
noncompliance with respect to CLIA requirements taken as a whole would
be matched by a finding of noncompliance with the accreditation or State
requirements taken as a whole.
HCFA agent means an entity with which HCFA arranges to inspect
laboratories and assess laboratory activities against CLIA requirements
and may be a State survey agency, a private, nonprofit organization
other than an approved accreditation organization, a component of HHS,
or any other governmental component HCFA approves for this purpose. In
those instances where all of the laboratories in a State are exempt from
CLIA requirements, based on the approval of a State's exemption request,
the State survey agency is not the HCFA agent.
HCFA's agent means an entity with which HCFA arranges to inspect
laboratories and assess laboratory activities against CLIA conditions,
and which may be a State survey agency, a professional organization, a
component of the Department, or any other group that HCFA approves for
this purpose. The State survey agency may not be HCFA's agent in a
State in which all laboratories are exempt from CLIA requirements
because HCFA has approved the State's licensure program.
HHS means the Department of Health and Human Services, or its
designee.
Immediate jeopardy means a situation in which immediate corrective
action is necessary because the laboratory's noncompliance with one or
more condition level requirements has already caused, is causing, or is
likely to cause, at any time, serious injury or harm, or death, to
individuals served by the laboratory or to the health or safety of the
general public. This term is synonymous with imminent and serious risk
to human health and significant hazard to the public health.
Intentional violation means knowing and willful noncompliance with
any CLIA condition.
Kit means all components of a test that are packaged together.
Laboratory means a facility for the biological, microbiological,
serological, chemical, immunohematological, hematological, biophysical,
cytological, pathological, or other examination of materials derived
from the human body for the purpose of providing information for the
diagnosis, prevention, or treatment of any disease or impairment of, or
the assessment of the health of, human beings. These examinations also
include procedures to determine, measure, or otherwise describe the
presence or absence of various substances or organisms in the body.
Facilities only collecting or preparing specimens (or both) or only
serving as a mailing service and not performing testing are not
considered laboratories.
Operator means the individual or group of individuals who oversee all
facets of the operation of a laboratory and who bear primary
responsibility for the safety and reliability of the results of all
specimen testing performed in that laboratory. The term includes --
(1) A director of the laboratory if he or she meets the stated
criteria; and
(2) The members of the board of directors and the officers of a
laboratory that is a small corporation under subchapter S of the
Internal Revenue Code.
Owner means any person who owns any interest in a laboratory except
for an interest in a laboratory whose stock and/or securities are
publicly traded. (That is e.g., the purchase of shares of stock or
securities on the New York Stock Exchange in a corporation owning a
laboratory would not make a person an owner for the purpose of this
regulation.)
Party means a laboratory affected by any of the enforcement
procedures set forth in this subpart, by HCFA or the OIG, as
appropriate.
Performance characteristic means a property of a test that is used to
describe its quality, e.g., accuracy, precision, analytical sensitivity,
analytical specificity, reportable range, reference range, etc.
Performance specification means a value or range of values for a
performance characteristic, established or verified by the laboratory,
that is used to describe the quality of patient test results.
Principal sanction means the suspension, limitation, or revocation of
any type of CLIA certificate or the cancellation of the laboratory's
approval to receive Medicare payment for its services.
Prospective laboratory means a laboratory that is operating under a
registration certificate or is seeking any of the three other types of
CLIA certificates.
Rate of disparity means the percentage of sample validation
inspections for a specific accreditation organization or State where
HCFA, the State survey agency or other HCFA agent finds noncompliance
with one or more condition level requirements but no comparable
deficiencies were cited by the accreditation organization or the State,
and it is reasonable to conclude that the deficiencies were present at
the time of the most recent accreditation organization or State
licensure inspection.
Example: Assume the State survey agency, HCFA or other HCFA agent
performs 200 sample validation inspections for laboratories accredited
by a single accreditation organization or licensed in an exempt State
during a validation review period and finds that 60 of the 200
laboratories had one or more condition level requirements out of
compliance. HCFA reviews the validation and accreditation
organization's or State's inspections of the validated laboratories and
determines that the State or accreditation organization found comparable
deficiencies in 22 of the 60 laboratories and it is reasonable to
conclude that deficiencies were present in the remaining 38 laboratories
at the time of the accreditation organization's or State's inspection.
Thirty-eight divided by 200 equals a 19 percent rate of disparity.
Referee laboratory means a laboratory currently in compliance with
applicable CLIA requirements, that has had a record of satisfactory
proficiency testing performance for all testing events for at least one
year for a specific test, analyte, subspecialty, or specialty and has
been designated by an HHS approved proficiency testing program as a
referee laboratory for analyzing proficiency testing specimens for the
purpose of determining the correct response for the specimens in a
testing event for that specific test, analyte, subspecialty, or
specialty.
Reference range means the range of test values expected for a
designated population of individuals, e.g., 95 percent of individuals
that are presumed to be healthy (or normal).
Reportable range means the range of test values over which the
relationship between the instrument, kit, or system's measurement
response is shown to be valid.
Sample in proficiency testing means the material contained in a vial,
on a slide, or other unit that contains material to be tested by
proficiency testing program participants. When possible, samples are of
human origin.
Semi-automated means an instrument or system in which some of the
steps in the analytical process are mechanized but others require
operator intervention.
State includes, for purposes of this part, each of the 50 States, the
District of Columbia, the Commonwealth of Puerto Rico, the Virgin
Islands and a political subdivision of a State where the State, acting
pursuant to State law, has expressly delegated powers to the political
subdivision sufficient to authorize the political subdivision to act for
the State in enforcing requirements equal to or more stringent than CLIA
requirements.
State licensure means the issuance of a license to, or the approval
of, a laboratory by a State laboratory program as meeting standards for
licensing or approval established under State law.
State survey agency means the State health agency or other
appropriate State or local agency that has an agreement under section
1864 of the Social Security Act and is used by HCFA to perform surveys
and inspections.
State-exempt laboratory means a laboratory that does not require a
CLIA certificate because it is licensed by a State whose licensure
program has been approved by HCFA.
Substantial allegation of noncompliance means a complaint from any of
a variety of sources (including complaints submitted in person, by
telephone, through written correspondence, or in newspaper or magazine
articles) that, if substantiated, would have an impact on the health and
safety of the general public or of individuals served by a laboratory
and raises doubts as to a laboratory's compliance with any condition
level requirement.
Target value for quantitative tests means either the mean of all
participant responses after removal of outliers (those responses greater
than 3 standard deviations from the original mean) or the mean
established by definitive or reference methods acceptable for use in the
National Reference System for the Clinical Laboratory (NRSCL) by the
National Committee for the Clinical Laboratory Standards (NCCLS). In
instances where definitive or reference methods are not available or a
specific method's results demonstrate bias that is not observed with
actual patient specimens, as determined by a defensible scientific
protocol, a comparative method or a method group (''peer'' group) may be
used. If the method group is less than 10 participants, ''target
value'' means the overall mean after outlier removal (as defined above)
unless acceptable scientific reasons are available to indicate that such
an evaluation is not appropriate.
Unsatisfactory proficiency testing performance means failure to
attain the minimum satisfactory score for an analyte, test,
subspecialty, or specialty for a testing event.
Unsuccessful participation in proficiency testing means any of the
following:
(1) Unsatisfactory performance for the same analyte in two
consecutive or two out of three testing events.
(2) Repeated unsatisfactory overall testing event scores for two
consecutive or two out of three testing events for the same specialty or
subspecialty.
(3) An unsatisfactory testing event score for those subspecialties
not graded by analyte (that is, bacteriology, mycobacteriology,
virology, parasitology, mycology, blood compatibility, immunohematology,
or syphilis serology) for the same subspecialty for two consecutive or
two out of three testing events.
(4) Failure of a laboratory performing gynecologic cytology to meet
the standard at 493.855.
Unsuccessful proficiency testing performance means a failure to
attain the minimum satisfactory score for an analyte, test,
subspecialty, or specialty for two consecutive or two of three
consecutive testing events.
Validation review period means the one year time period during which
HCFA conducts validation inspections and evaluates the results of the
most recent surveys performed by an accreditation organization or State
laboratory program.
(57 FR 7139, Feb. 28, 1992, as amended at 57 FR 7236, Feb. 28, 1992;
57 FR 34013, July 31, 1992; 57 FR 35761, Aug. 11, 1992)
42 CFR 493.3 Applicability.
(a) Basic rule. Except as specified in paragraph (b) of this
section, a laboratory will be cited as out of compliance with section
353 of the Public Health Service Act unless it --
(1) Has a current, unrevoked or unsuspended certificate of waiver, a
registration certificate, a certificate, or a certificate of
accreditation issued by HHS applicable to the category of examinations
or procedures performed by the laboratory; or
(2) Is State exempt.
(b) Exception. These rules do not apply to components or functions
of --
(1) Any facility or component of a facility that only performs
testing for forensic purposes;
(2) Research laboratories that test human specimens but do not report
patient specific results for the diagnosis, prevention or treatment of
any disease or impairment of, or the assessment of the health of
individual patients; or
(3) Laboratories certified by the National Institutes on Drug Abuse
(NIDA), in which drug testing is performed which meets NIDA guidelines
and regulations. However, all other testing conducted by a
NIDA-certified laboratory is subject to this rule.
(c) Federal laboratories. Laboratories under the jurisdiction of an
agency of the Federal Government are subject to the rules of this part,
except that the Secretary may modify the application of such
requirements as appropriate.
42 CFR 493.10 Categories of tests by complexity.
(a) Laboratory tests are categorized as either --
(1) Waived tests;
(2) Tests of moderate complexity; or
(3) Tests of high complexity.
(b) A laboratory may perform only waived tests, only tests of
moderate complexity, only tests of high complexity or any combination.
(c) Each laboratory must be either State-exempt or possess one of the
following, as defined in this part:
(1) Registration certificate;
(2) Certificate of waiver;
(3) Certificate; or
(4) Certificate of accreditation.
42 CFR 493.15 Laboratories performing waived tests.
(a) Requirement. Tests for certificate of waiver must meet the
descriptive criteria specified in paragraph (b) of this section.
(b) Criteria. Test systems are simple laboratory examinations and
procedures which --
(1) Are cleared by FDA for home use;
(2) Employ methodologies that are so simple and accurate as to render
the likelihood of erroneous results negligible; or
(3) Pose no reasonable risk of harm to the patient if the test is
performed incorrectly.
(c) Certificate of waiver tests. A laboratory may qualify for a
certificate of waiver under section 353 of the PHS Act if it restricts
the tests that it performs to one or more of the following tests or
examinations (or additional tests added to this list as provided under
paragraph (c) of this section) and no others:
(1) Dipstick or Tablet Reagent Urinalysis (non- automated) for the
following:
(i) Bilirubin;
(ii) Glucose;
(iii) Hemoglobin;
(iv) Ketone;
(v) Leukocytes;
(vi) Nitrite;
(vii) pH;
(viii) Protein;
(ix) Specific gravity; and
(x) Urobilinogen.
(2) Fecal occult blood;
(3) Ovulation tests -- visual color comparison tests for human
luteinizing hormone;
(4) Urine pregnancy tests -- visual color comparison tests;
(5) Erythrocyte sedimentation rate -- non-automated;
(6) Hemoglobin -- copper sulfate -- non-automated;
(7) Blood glucose by glucose monitoring devices cleared by the FDA
specifically for home use; and
(8) Spun microhematocrit.
(d) Revisions to criteria for test categorization and the list of
waived tests. (1) The Clinical Laboratory Improvement Advisory
Committee, as defined in subpart T, will conduct reviews upon request of
HHS and recommend to HHS revisions to the criteria for categorization of
tests.
(2) HHS will determine whether a laboratory test meets the criteria
listed under paragraph (b) of this section for a waived test. Revisions
to the list of waived tests approved by HHS will be published in the
Federal Register in a notice with opportunity for comment.
(e) Laboratories eligible for a certificate of waiver must --
(1) Follow manufacturers' instructions for performing the test; and
(2) Meet the requirements in subpart B, Certificate of Waiver, of
this part.
42 CFR 493.17 Test categorization.
(a) Categorization by criteria. Notices will be published in the
Federal Register which list each specific test system, assay, and
examination categorized by complexity. Using the seven criteria
specified in this paragraph for categorizing tests of moderate or high
complexity, each specific laboratory test system, assay, and examination
will be graded for level of complexity by assigning scores of 1, 2, or 3
within each criteria. The score of ''1'' indicates the lowest level of
complexity, and the score of ''3'' indicates the highest level. These
scores will be totaled. Test systems, assays or examinations receiving
scores of 12 or less will be categorized as moderate complexity, while
those receiving scores above 12 will be categorized as high complexity.
Note: A score of ''2'' will be assigned to a criteria heading when
the characteristics for a particular test are intermediate between the
descriptions listed for scores of ''1'' and ''3.''
(1) Knowledge. (i) Score 1. (A) Minimal scientific and technical
knowledge is required to perform the test.
(B) Minimal decision-making is required, and knowledge required to
perform the test may be obtained through on-the-job instruction.
(ii) Score 3. (A) Specialized scientific and technical knowledge is
essential to perform the test.
(B) Specialized knowledge is necessary for decision-making relative
to the preanalytic, analytic, or postanalytic phases of testing.
(2) Training and experience. (i) Score 1. (A) Minimal training is
required for preanalytic, analytic and postanalytic phases of the
testing process; and
(B) Limited experience is required to perform the test.
(ii) Score 3. (A) Specialized training is essential to perform the
preanalytic, analytic or postanalytic testing process; and
(B) Substantial experience may be necessary for analytic test
performance.
(3) Reagents and materials preparation. (i) Score 1. (A) Reagents
and materials are generally stable and reliable; and
(B) Reagents and materials are prepackaged, or premeasured, or
require no special handling, precautions or storage conditions.
(ii) Score 3. (A) Reagents and materials may be labile and may
require special handling to assure reliability; and
(B) Reagents and materials preparation may include manual steps such
as gravimetric or volumetric measurements.
(4) Characteristics of operational steps. (i) Score 1. Operational
steps are either automatically executed (such as pipetting, temperature
monitoring, or timing of steps), or are easily controlled.
(ii) Score 3. Operational steps in the testing process require close
monitoring or control, and may require special specimen preparation,
precise temperature control or timing of procedural steps, accurate
pipetting, or extensive calculations.
(5) Calibration, quality control, and proficiency testing materials.
(i) Score 1. (A) Calibration materials are stable and readily
available;
(B) Quality control materials are stable and readily available; and
(C) External proficiency testing materials, when available, are
stable.
(ii) Score 3. (A) Calibration materials, if available, may be
labile;
(B) Quality control materials may be labile, or not available; or
(C) External proficiency testing materials, if available, may be
labile.
(6) Test system troubleshooting and equipment maintenance. (i) Score
1. (A) Test system troubleshooting is automatic or self-correcting, or
clearly described or requires minimal judgment; and
(B) Equipment maintenance is provided by the manufacturer, is seldom
needed, or can easily be performed.
(ii) Score 3. (A) Troubleshooting is not automatic and requires
decision-making and direct intervention to resolve most problems; and
(B) Maintenance requires special knowledge, skills, and abilities.
(7) Interpretation and judgment. (i) Score 1. (A) Minimal
interpretation and judgment are required to perform preanalytic,
analytic and postanalytic processes; and
(B) Resolution of problems requires limited independent
interpretation and judgment; and
(ii) Score 3. (A) Extensive independent interpretation and judgment
are required to perform the preanalytic, analytic or postanalytic
processes; and
(B) Resolution of problems requires extensive interpretation and
judgment.
(b) Revisions to the criteria for categorization. The Clinical
Laboratory Improvement Advisory Committee, as defined in subpart T of
this part, will conduct reviews upon request of HHS and recommend to HHS
revisions to the criteria for categorization of tests.
(c) Process for device/test categorization utilizing the scoring
system under 493.17(a). (1)(i) For new commercial test systems, assays,
or examinations, the manufacturer, as part of its 510(k) and PMA
application to FDA, will submit supporting data for device/test
categorization. FDA will determine the complexity category, notify the
manufacturers directly, and will simultaneously inform both HCFA and CDC
of the device/test category. FDA will consult with CDC concerning test
categorization in the following three situations:
(A) When categorizing previously uncategorized new technology;
(B) When FDA determines it to be necessary in cases involving a
request for a change in categorization; and
(C) If a manufacturer requests review of a categorization decision by
FDA in accordance with 21 CFR 10.75.
(ii) Test categorization will be effective as of the notification to
the applicant.
(2) For test systems, assays, or examinations not commercially
available, a laboratory or professional group may submit a written
request for categorization to PHS. These requests will be forwarded to
CDC for evaluation; CDC will determine complexity category and notify
the applicant, HCFA, and FDA of the categorization decision. In the
case of request for a change of category or for previously uncategorized
new technology, PHS will receive the request application and forward it
to CDC for categorization.
(3) A request for recategorization will be accepted for review if it
is based on new information not previously submitted in a request for
categorization or recategorization by the same applicant and will not be
considered more frequently than once per year.
(4) If a laboratory test system, assay or examination does not appear
on the lists of tests in the Federal Register notices, it is considered
to be a test of high complexity until PHS, upon request, reviews the
matter and notifies the applicant of its decision.
(5) PHS will publish revisions periodically to the list of moderate
and high complexity tests in the Federal Register in a notice with
opportunity for comment.
42 CFR 493.20 Laboratories performing tests of moderate complexity.
(a) A laboratory may qualify for a certificate to perform tests of
moderate complexity provided that it restricts its test performance to
certificate of waiver tests or examinations and one or more tests or
examinations meeting criteria for tests of moderate complexity.
(b) A laboratory that performs tests or examinations of moderate
complexity must meet the applicable requirements in subpart C,
registration certificate and certificate, or if applicable, subpart D,
certificate of accreditation; subpart H, participation in proficiency
testing; subpart J, patient test management; subpart K, quality
control; subpart M, personnel; subpart P, quality assurance; and
subpart Q, inspections, of this part.
(c) If the laboratory also performs certificate of waiver tests
listed in 493.15, compliance with subparts H, J, K, M, P, and Q of this
part for routine inspections are not required for the waived tests.
However, the laboratory must comply with the requirements in 493.15(d)
and 493.1775.
42 CFR 493.25 Laboratories performing tests of high complexity.
(a) A laboratory must obtain a certificate for tests of high
complexity if it performs one or more tests that meet the criteria for
tests of high complexity as specified in 493.17(a).
(b) A laboratory performing one or more tests of high complexity must
meet the applicable requirements of subpart C, registration certificate
and certificate, or if applicable, subpart D, certificate of
accreditation; subpart H, participation in proficiency testing;
subpart J, patient test management; subpart K, quality control;
subpart M, personnel; subpart P, quality assurance; and subpart Q,
inspections, of this part.
(c) If the laboratory also performs certificate of waiver tests, the
requirements of subparts H, J, K, M, P, and Q of this part for routine
inspections are not applicable for the waived tests. However, the
laboratory must comply with the requirements in 493.15(d) and
493.1775.
(d) If the laboratory also performs tests of moderate complexity, the
personnel requirements of subpart M are applicable for the performance
of tests of moderate complexity as well as subparts H, J, K, P, and Q of
this part.
42 CFR 493.25 Subpart B -- Certificate of Waiver
Source: 57 FR 7142, Feb. 28, 1992, unless otherwise noted.
42 CFR 493.35 Application for a certificate of waiver.
(a) Filing of application. Except as specified in paragraph (b) of
this section, a laboratory performing only one or more waived tests
listed in 435.15(b) of this chapter must file a separate application
for each laboratory location.
(b) Exceptions. (1) Each laboratory that is not in a fixed location,
must file an application using the address of the home base, including
--
(i) A laboratory that moves from testing site to testing site or has
a temporary testing location, such as a health screening fair; and
(ii) Each mobile van providing lab services.
(2) Not-for-profit or Federal, State, or local government
laboratories that engage in limited (e.g., few types of tests) public
health testing may file a single application.
(3) Laboratories within a hospital that are located at the same
street address and under common direction may file a single application
or multiple applications for the laboratory sites within the same
physical location or street address.
(c) Application format and contents. The application must --
(1) Be made to HHS or its designee on a form or forms prescribed by
HHS;
(2) Be signed by an owner, or by an authorized representative of the
laboratory who attests that the laboratory will be operated in
accordance with requirements established by the Secretary under section
353 of the PHS Act; and
(3) Describe the characteristics of the laboratory operation and the
examinations and other test procedures performed by the laboratory
including --
(i) The name and the total number of test procedures and examinations
performed annually (excluding tests the laboratory may run for quality
control, quality assurance or proficiency testing purposes;
(ii) The methodologies for each laboratory test procedure or
examination performed, or both; and
(iii) The qualifications (educational background, training, and
experience) of the personnel directing and supervising the laboratory
and performing the laboratory examinations and test procedures.
(d) Access requirements. Laboratories that perform one or more
waived tests listed in 493.15(b) and no other tests must --
(1) Make records available and submit reports to HHS as HHS may
reasonably require to determine compliance with this section and
493.15(d);
(2) Agree to permit unannounced inspections by HHS in accordance with
subpart Q of this part --
(i) When HHS has substantive reason to believe that the laboratory is
being operated in a manner that constitutes an imminent and serious risk
to human health;
(ii) To evaluate complaints from the public;
(iii) On a random basis to determine whether the laboratory is
performing tests not listed in 493.15; and
(iv) To collect information for the addition, deletion, or continued
inclusion of tests listed in 493.15.
(e) Denial of application. If HHS determines that the application
for a certificate of waiver is to be denied, HHS will --
(1) Provide the laboratory with a written statement of the grounds on
which the denial is based and an opportunity for appeal, in accordance
with the procedures set forth in subpart R of this part;
(2) Notify a laboratory that has its application for a certificate of
waiver denied that it cannot operate as a laboratory under the PHS Act
unless the denial is overturned at the conclusion of the administrative
appeals process provided by subpart R; and
(3) Notify the laboratory that it is not eligible for payment under
the Medicare and Medicaid programs.
42 CFR 493.37 Requirements for a certificate of waiver.
(a) HHS will issue a certificate of waiver to a laboratory only if
the laboratory meets the requirements of 493.35.
(b) Laboratories issued a certificate of waiver --
(1) Are subject to the requirements of this subpart and 493.15(d) of
subpart A of this part; and
(2) Must permit unannounced inspections by HHS in accordance with
subpart Q of this part.
(c) Laboratories must remit the certificate of waiver fee specified
in subpart F of this part.
(d) In accordance with subpart R of this part, HHS will suspend or
revoke or limit a laboratory's certificate of waiver for failure to
comply with the requirements of this subpart. In addition, failure to
meet the requirements of this subpart will result in suspension or
denial of payments under Medicare and Medicaid in accordance with
subpart R of this part.
(e)(1) A certificate of waiver issued under this subpart is valid for
no more than 2 years. In the event of a non-compliance determination
resulting in HHS action to revoke, suspend, or limit the laboratory's
certificate of waiver, HHS will provide the laboratory with a statement
of grounds on which the determination of non-compliance is based and
offer an opportunity for appeal as provided in subpart R of this part.
(2) If the laboratory requests a hearing within the time specified by
HHS, it retains its certificate of waiver or reissued certificate of
waiver until a decision is made by an administrative law judge, as
specified in subpart R of this part, except when HHS finds that
conditions at the laboratory pose an imminent and serious risk to human
health.
(3) For laboratories receiving payment from the Medicare or Medicaid
program, such payments will be suspended on the effective date specified
in the notice to the laboratory of a non-compliance determination even
if there has been no appeals decision issued.
(f) A laboratory seeking to renew its certificate of waiver must --
(1) Complete the renewal application prescribed by HHS and return it
to HHS not less than 9 months nor more than 1 year before the expiration
of the certificate; and
(2) Meet the requirements of 493.35 and 493.37.
(g) A laboratory with a certificate of waiver that wishes to perform
examinations of test procedures not listed in the waiver test category
must meet the requirements set forth in subparts C or D of this part.
42 CFR 493.39 Notification requirements for laboratories issued a
certificate of waiver.
Laboratories performing one or more tests listed in 493.15 and no
others must notify HHS or its designee --
(a) Before performing and reporting results for any test or
examination that is not specified under 493.15 for which it does not
have a registration certificate as required in subparts C or D of this
part; and
(b) Within 30 days of any change(s) in --
(1) Ownership;
(2) Name;
(3) Location; or
(4) Director.
42 CFR 493.39 Subpart C -- Registration Certificate and Certificate
Source: 57 FR 7143, Feb. 28, 1992, unless otherwise noted.
42 CFR 493.43 Application for registration certificate and certificate.
(a) Filing of application. Except as specified in paragraph (b) of
this section, all laboratories performing tests of moderate or high
complexity, or both, must file a separate application for each
laboratory location.
(b) Exceptions. (1) Each laboratory that is not in a fixed location,
must file a single application using the address of the home base,
including --
(i) A laboratory that moves from testing site to testing site or uses
a temporary testing location, such as a health screening fair; and
(ii) Each mobile van providing laboratory services.
(2) Not-for-profit or Federal, State, or local government
laboratories that engage in limited (e.g., few types of tests) public
health testing may file a single application.
(3) Laboratories within a hospital that are located at the same
street address and under common direction may file a single application
or multiple applications for the laboratory sites within the same
physical location or street address.
(c) Application format and contents. The application must --
(1) Be made to HHS or its designee on a form or forms prescribed by
HHS;
(2) Be signed by an owner, or by an authorized representative of the
laboratory who attests that the laboratory will be operated in
accordance with requirements established by the Secretary under section
353 of the PHS Act; and
(3) Describe the characteristics of the laboratory operation and the
examinations and other test procedures performed by the laboratory
including --
(i) The name and total number of test procedures and examinations
performed annually (excluding tests for quality control, quality
assurance or proficiency testing purposes);
(ii) The methodologies for each laboratory test procedure or
examination performed, or both; and
(iii) The qualifications (educational background, training, and
experience) of the personnel directing and supervising the laboratory
and performing the laboratory examinations and test procedures.
(d) Access and reporting requirements. All laboratories must make
records available and submit reports to HHS as HHS may reasonably
require to determine compliance with this section.
42 CFR 493.45 Requirements for a registration certificate.
(a) A registration certificate is required --
(1) Initially for all laboratories performing test procedures listed
at 493.17 (b) and (c); and
(2) For all certificate of waiver laboratories that intend to perform
testing in addition to those tests listed in 493.15.
(b) HHS will issue a registration certificate if the laboratory --
(1) Complies with the requirements of 493.43;
(2) Agrees to notify HHS or its designee within 30 days of any
changes in ownership, name, location, director or supervisor
(laboratories performing high complexity testing only);
(3) Agrees to treat proficiency testing samples in the same manner as
it treats patient specimens; and
(4) Remits the fee for the registration certificate, as specified in
subpart F of this part.
(c) Prior to the expiration of the registration certificate, a
laboratory must --
(1) Remit the certificate fee specified in subpart F of this part;
(2) Be inspected by HHS as specified in subpart Q of this part; and
(3) Demonstrate compliance with the applicable requirements of this
subpart and subparts H, J, K, M, P, and Q of this part.
(d) In accordance with subpart R of this part, HHS will initiate
suspension or revocation of a laboratory's registration certificate and
will deny the laboratory's application for a certificate for failure to
comply with the requirements set forth in this subpart. HHS may also
impose certain alternative sanctions. In addition, failure to meet the
requirements of this subpart will result in suspension of payments under
Medicare and Medicaid as specified in subpart R of this part.
(e) A registration certificate is --
(1) Valid for a period of no more than two years or until such time
as an inspection to determine program compliance can be conducted,
whichever is shorter; and
(2) Not renewable; however, the registration certificate may be
reissued if compliance has not been determined by HHS prior to the
expiration date of the registration certificate.
(f) In the event of a non-compliance determination resulting in an
HHS denial of a laboratory's certificate application, HHS will provide
the laboratory with a statement of grounds on which the non-compliance
determination is based and offer an opportunity for appeal as provided
in subpart R.
(g) If the laboratory requests a hearing within the time specified by
HHS, it retains its registration certificate or reissued registration
certificate until a decision is made by an administrative law judge as
provided in subpart R of this part, except when HHS finds that
conditions at the laboratory pose an imminent and serious risk to human
health.
(h) For laboratories receiving payment from the Medicare or Medicaid
program, such payments will be suspended on the effective date specified
in the notice to the laboratory of denial of the certificate application
even if there has been no appeals decision issued.
42 CFR 493.49 Requirements for a certificate.
(a) HHS will issue a certificate to a laboratory only if the
laboratory --
(1) Meets the requirements of 493.43 and 493.45;
(2) Remits the certificate fee specified in subpart F of this part;
and
(3) Meets the applicable requirements of this subpart and subparts H,
J, K, M, P, and Q of this part.
(b) Laboratories issued a certificate --
(1) Are subject to the notification requirements of 493.51 of this
section; and
(2) Must permit unannounced inspections by HHS in accordance with
subpart Q of this part --
(i) To determine compliance with the requirements of this part;
(ii) To evaluate complaints from the public;
(iii) When HHS has substantive reason to believe that any tests are
being performed, or the laboratory is being operated in a manner that
constitutes an imminent and serious risk to human health; and
(iv) To collect information for the addition, deletion, or continued
inclusion of tests listed in 493.15 and 493.17 (b) and (c).
(c) Failure to comply with the requirements of this subpart will
result in --
(1) Suspension, revocation or limitation of a laboratory's
certificate in accordance with subpart R of this part; and
(2) Suspension or denial of payments under Medicare and Medicaid in
accordance with subpart R of this part.
(d) A certificate issued under this subpart is valid for no more than
2 years.
(e) In the event of a non-compliance determination resulting in an
HHS action to revoke, suspend or limit the laboratory's certificate, HHS
will --
(1) Provide the laboratory with a statement of grounds on which the
determination of non-compliance is based; and
(2) Offer an opportunity for appeal as provided in subpart R of this
part. If the laboratory requests a hearing within the time specified by
HHS, it retains its certificate or reissued certificate until a decision
is made by an administrative law judge as provided in subpart R of this
part, except when HHS finds that conditions at the laboratory pose an
imminent and serious risk to human health.
(f) For laboratories receiving payment from the Medicare or Medicaid
program, such payments will be suspended on the effective date specified
in the notice to the laboratory of a non-compliance determination even
if there has been no appeals decision issued.
(g) A laboratory seeking to renew its certificate must --
(1) Complete and return the renewal application to HHS 9 to 12 months
prior to the expiration of the certificate; and
(2) Meet the requirements of 493.43 and paragraphs (a)(2) and (b)(2)
of this section.
(h) If HHS determines that the application for the renewal of a
certificate is to be denied or limited, HHS will notify the laboratory
in writing of the --
(1) Basis for denial of the application; and
(2) Opportunity for appeal as provided in subpart R of this part.
(i) If the laboratory requests a hearing within the time specified by
HHS, it retains its certificate or reissued certificate until a decision
is made by an ALJ as provided in subpart R, except when HHS finds that
conditions at the laboratory pose an imminent and serious risk to human
health.
(j) For laboratories receiving payment from the Medicare or Medicaid
program, such payments will be suspended on the effective date specified
in the notice to the laboratory of nonrenewal of the certificate even if
there has been no appeals decision issued.
42 CFR 493.51 Notification requirements for laboratories issued a
certificate.
Laboratories issued a certificate must:
(a) Notify HHS or its designee within 30 days of any change in --
(1) Ownership;
(2) Name;
(3) Location;
(4) Director; or
(5) Supervisor (laboratories performing high complexity testing
only).
(b) Notify HHS no later than 6 months after performing any test or
examination within a specialty or subspecialty area that is not included
on the laboratory's certificate, so that compliance with requirements
can be determined; and
(c) Notify HHS no later than 6 months after any deletions or changes
in test methodologies for any test or examination included in a
specialty or subspecialty, or both, for which the laboratory has been
issued a certificate.
42 CFR 493.51 Subpart D -- Certificate of Accreditation
Source: 57 FR 7144, Feb. 28, 1992, unless otherwise noted.
42 CFR 493.55 Application for registration certificate and certificate
of accreditation.
(a) Filing of application. A laboratory performing one or more tests
of moderate complexity or high complexity, or both may be issued a
certificate of accreditation in lieu of a certificate provided the
laboratory --
(1) Meets the standards of a private non-profit accreditation program
approved by HHS in accordance with subpart E; and
(2) Files a separate application for each location, except as
specified in paragraph (b) of this section.
(b) Exceptions. (1) Each laboratory that is not in a fixed location
must file an application using the address of the home base, including
--
(i) A laboratory that moves from testing site to testing site or uses
a temporary testing location, such as a health screening fair; and
(ii) Each mobile van providing laboratory testing.
(2) Not-for-profit or Federal, State, or local government
laboratories that engage in limited (e.g., few types of tests) public
health testing may file a single application.
(3) Laboratories within a hospital that are located at the same
street address and under common direction may file a single application
or multiple applications for the laboratory sites within the same
physical location or street address.
(c) Application format and contents. The application must --
(1) Be made to HHS on a form or forms prescribed by HHS;
(2) Be signed by an owner, or by an authorized representative of the
laboratory who attests that the laboratory will be operated in
accordance with requirements established by the Secretary under section
353 of the PHS Act; and
(3) Describe the characteristics of the laboratory operation and the
examinations and other test procedures performed by the laboratory
including --
(i) The name and total number of tests and examinations performed
annually (excluding tests for quality control, quality assurance or
proficiency testing purposes);
(ii) The methodologies for each laboratory test procedure or
examination performed, or both; and
(iii) The qualifications (educational background, training, and
experience) of the personnel directing and supervising the laboratory
and performing the laboratory examinations and test procedures.
(d) Access and reporting requirements. All laboratories must make
records available and submit reports to HHS as HHS may reasonably
require to determine compliance with this section.
42 CFR 493.57 Requirements for a registration certificate.
A registration certificate is required for all laboratories seeking a
certificate of accreditation, unless the laboratory holds a valid
certificate issued by HHS.
(a) HHS will issue a registration certificate if the laboratory --
(1) Complies with the requirements of 493.55;
(2) Agrees to notify HHS within 30 days of any changes in ownership,
name, location, director, or supervisor (laboratories performing high
complexity testing only);
(3) Agrees to treat proficiency testing samples in the same manner as
it treats patient specimens; and
(4) Remits the fee for the registration certificate specified in
subpart F of this part.
(b)(1) The laboratory must provide HHS with proof of accreditation by
an approved accreditation program --
(i) Within 11 months of issuance of the registration certificate; or
(ii) Prior to the expiration of the certificate.
(2) If such proof of accreditation is not supplied within this
timeframe, the laboratory must meet, or continue to meet, the
requirements of subpart C, 493.49 of this part.
(c) In accordance with subpart R of this part, HHS will initiate
suspension, revocation, or limitation of a laboratory's registration
certificate and will deny the laboratory's application for a certificate
of accreditation for failure to comply with the requirements set forth
in this subpart. In addition, failure to meet the requirements of this
subpart will result in suspension or denial of payments under Medicare
and Medicaid as specified in subpart R of this part.
(d) A registration certificate is valid for a period of no more than
2 years. However, it may be reissued if the laboratory is subject to
subpart C of this part, as specified in 493.57(b)(2) and compliance has
not been determined by HHS before the expiration date of the
registration certificate.
(e) In the event that the laboratory does not meet the requirements
of this subpart, HHS will --
(1) Deny a laboratory's request for certificate of accreditation;
(2) Notify the laboratory if it must meet the requirements for a
certificate as defined in subpart C of this part;
(3) Provide the laboratory with a statement of grounds on which the
application denial is based;
(4) Offer an opportunity for appeal on the application denial as
provided in subpart R of this part. If the laboratory requests a
hearing within the time specified by HHS, the laboratory will retain its
registration certificate or reissued registration certificate until a
decision is made by an administrative law judge as provided in subpart
R, unless HHS finds that conditions at the laboratory pose an imminent
and serious risk to human health; and
(5) For those laboratories receiving payment from the Medicare or
Medicaid program, such payments will be suspended on the effective date
specified in the notice to the laboratory of denial of the request even
if there has been no appeals decision issued.
42 CFR 493.61 Requirements for a certificate of accreditation.
(a) HHS will issue a certificate of accreditation to a laboratory if
the laboratory --
(1) Meets the requirements of 493.57 or, if applicable, 493.49 of
subpart C of this part; and
(2) Remits the certificate of accreditation fee specified in subpart
F of this part.
(b) Laboratories issued a certificate of accreditation must --
(1) Treat proficiency testing samples in the same manner as patient
samples;
(2) Meet the requirements of 493.63;
(3) Comply with the requirements of the approved accreditation
program;
(4) Permit random sample validation and complaint inspections as
required in subpart Q of this part;
(5) Permit HHS to monitor the correction of any deficiencies found
through the inspections specified in paragraph (b)(4) of this section;
(6) Authorize the accreditation program to release to HHS the
laboratory's inspection findings whenever HHS conducts random sample or
complaint inspections; and
(7) Authorize its accreditation program to submit to HHS the results
of the laboratory's proficiency testing.
(c) A laboratory failing to meet the requirements of this section --
(1) Will no longer meet the requirements of this part by virtue of
its accreditation in an approved accreditation program;
(2) Will be subject to full determination of compliance by HHS;
(3) May be subject to suspension revocation or limitation of the
laboratory's certificate of accreditation or certain alternative
sanctions; and
(4) May be subject to suspension of payments under Medicare and
Medicaid as specified in subpart R.
(d) A certificate of accreditation issued under this subpart is valid
for no more than 2 years. In the event of a non-compliance
determination as a result of a random sample validation or complaint
inspection, a laboratory will be subject to a full review by HHS in
accordance with 488.11 of this chapter.
(e) Failure to meet the applicable requirements of part 493, will
result in an action by HHS to suspend, revoke or limit the certificate
of accreditation. HHS will --
(1) Provide the laboratory with a statement of grounds on which the
determination of noncompliance is based;
(2) Notify the laboratory if it is eligible to apply for a
certificate as defined in subpart C of this part; and
(3) Offer an opportunity for appeal as provided in subpart R of this
part.
(f) If the laboratory requests a hearing within the time frame
specified by HHS --
(1) It retains its certificate of accreditation or reissued
certificate of accreditation until a decision is made by an
administrative law judge as provided in subpart R of this part, unless
HHS finds that conditions at the laboratory pose an imminent and serious
risk to human health; and
(2) For those laboratories receiving payments from the Medicare or
Medicaid program, such payments will be suspended on the effective date
specified in the notice to the laboratory even if there has been no
appeals decision issued.
(g) In the event the accreditation organization's approval is removed
by HHS, the laboratory will be subject to the applicable requirements of
subpart C of this part or 493.57.
(h) A laboratory seeking to renew its certificate of accreditation
must --
(1) Complete and return the renewal application to HHS 9 to 12 months
prior to the expiration of the certificate of accreditation;
(2) Meet the requirements of this subpart; and
(3) Submit the certificate of accreditation fee specified in subpart
F of this part.
(i) If HHS determines that the renewal application for a certificate
of accreditation is to be denied or limited, HHS will notify the
laboratory in writing of --
(1) The basis for denial of the application;
(2) Whether the laboratory is eligible for a certificate as defined
in subpart C of this part;
(3) The opportunity for appeal on HHS's action to deny the renewal
application for certificate of accreditation as provided in subpart R of
this part. If the laboratory requests a hearing within the time frame
specified by HHS, it retains its certificate of accreditation or
reissued certificate of accreditation until a decision is made by an
administrative law judge as provided in subpart R of this part, unless
HHS finds that conditions at the laboratory pose an imminent and serious
risk to human health; and
(4) Suspension of payments under Medicare or Medicaid for those
laboratories receiving payments under the Medicare or Medicaid programs.
42 CFR 493.63 Notification requirements for laboratories issued a
certificate of accreditation.
Laboratories issued a certificate of accreditation must:
(a) Notify HHS and the approved accreditation program within 30 days
of any changes in --
(1) Ownership;
(2) Name;
(3) Location; or
(4) Director.
(b) Notify the approved accreditation program no later than 6 months
after performing any test or examination within a specialty or
subspecialty area that is not included in the laboratory's
accreditation, so that the accreditation organization can determine
compliance and a new certificate of accreditation can be issued.
(c) Notify the accreditation program no later than 6 months after of
any deletions or changes in test methodologies for any test or
examination included in a specialty or subspecialty, or both, for which
the laboratory has been issued a certificate of accreditation.
42 CFR 493.63 Subpart E -- Accreditation by a Private, Nonprofit
Accreditation Organization or Exemption Under an Approved State
Laboratory Program
Source: 57 FR 34014, July 31, 1992, unless otherwise noted.
42 CFR 493.501 General requirements for accredited laboratories.
(a) Deemed status. HCFA may deem a laboratory to meet all the
applicable CLIA program requirements of this Part if the laboratory is
accredited by a private, nonprofit accreditation organization for
laboratories that --
(1) Provides reasonable assurance to HCFA that it requires the
laboratories it accredits to meet all of the requirements equivalent to
the CLIA condition level requirements specified in this part and would,
therefore, meet condition level requirements if those laboratories had
not been granted deemed status and had been inspected against condition
level requirements; and
(2) Meets the requirements of 493.506 of this subpart.
(b) Laboratory requirements. To be deemed to meet the applicable
CLIA program requirements, a laboratory accredited by a private,
nonprofit accreditation organization must --
(1) Authorize its accreditation organization to release to HCFA all
records and information required by HCFA;
(2) Permit inspections as required by these regulations;
(3) Obtain a certificate of accreditation as required by 493.632 of
this part; and
(4) Pay the applicable fees as required by 493.638 and 493.645 of
this part.
(c) Application and reapplication process for accreditation
organizations. In applying or reapplying to HCFA for deeming authority,
a private nonprofit accreditation organization must provide the
following information to the Administrator of HCFA --
(1) The specialty(ies) or subspecialty(ies) for which the
organization is requesting ''deeming authority'';
(2) A detailed comparison of individual accreditation requirements
with the comparable condition level requirements; i.e., a crosswalk;
(3) A detailed description of the inspection process, including the
frequency of inspections, copies of inspection forms, instructions, and
guidelines, a description of the review and decision-making process of
accreditation inspections and a description of the steps taken to
monitor the correction of deficiencies;
(4) A description of the process for monitoring proficiency testing
(PT) performance, including action to be taken in response to
unsuccessful participation in an approved PT program;
(5) A description of the accreditation organization's data management
and analysis system with respect to its inspection and accreditation
decisions, including the kinds of routine reports and tables generated
by the system;
(6) Detailed information concerning the personnel who perform
accreditation inspections, including but not limited to the size and
composition of individual accreditation inspection teams, education and
experience requirements that those inspectors must meet and the content
and frequency of the training provided to inspection personnel;
(7) Procedures to investigate and respond to complaints against
accredited laboratories;
(8) A list of any currently accredited laboratories and the
expiration date of each laboratory's accreditation;
(9) Procedures for making PT information available, including
explanatory information required to interpret PT results, on a
reasonable basis, upon request of any person;
(10) Procedures for removal or withdrawal of accreditation status for
laboratories that fail to meet the organization's standards;
(11) A proposed agreement between the accreditation organization and
HCFA with respect to the notification requirements specified in
493.506(b)(3) of this subpart; and
(12) Whether accreditation inspections are announced or unannounced.
(d) Application review process. Once HCFA receives an application
for deeming authority from a private nonprofit accreditation
organization --
(1) HCFA will determine if additional information is necessary to
make a determination for approval of the accreditation organization's
application for deeming authority and will so notify the organization
and give it an opportunity to provide the additional information.
(2) HCFA may visit the organization's offices to verify
representations made by the organization in its application, including,
but not limited to, review of documents and interviews with the
organization's staff.
(3) The accreditation organization will receive a formal notice from
HCFA stating whether the request for deeming authority has been approved
or denied and the rationale for any denial.
(4) HCFA may approve an accreditation organization for a period not
to exceed six years.
(5) An accreditation organization may withdraw its application for
approval of deeming authority at any time prior to the official
notification specified in paragraph (d)(3) of this section.
(6) Except as provided in paragraph (d)(8) of this section, any
accreditation organization whose request for approval of deeming
authority is denied may request, within 60 days of the notification of
the denial, that its original application be reconsidered.
(7) Except as provided in paragraph (d)(8) of this section, any
accreditation organization whose request for approval of deeming
authority has been denied may resubmit its application if the
organization --
(i) Has revised its accreditation program to address the rationale
for denial of its previous request;
(ii) Can demonstrate that it can provide reasonable assurance that
its accredited facilities meet condition level requirements; and
(iii) Resubmits the application in its entirety.
(8) If an accreditation organization has requested, in accordance
with part 488, subpart D of this chapter, a reconsideration of HCFA's
determination that its request for deeming approval is denied, it may
not submit a new application for deeming authority until a final
reconsideration determination is issued.
(e) Publication of names of approved accreditation organizations.
HCFA publishes a notice in the Federal Register when it grants deeming
authority to an accreditation organization under paragraph (a) of this
section. The notice --
(1) Names the accreditation organization;
(2) Describes the basis for granting deeming authority to the
accreditation organization;
(3) Describes how the accreditation organization provides reasonable
assurance to HCFA that laboratories accredited by the organization meet
CLIA requirements equivalent to those specified in this part and would,
therefore, meet CLIA requirements if those laboratories had not been
granted deemed status, but had been inspected against condition level
requirements; and
(4) Specifies a term of approval not to exceed six years.
42 CFR 493.503 Proficiency testing requirements of laboratories with
deemed status.
(a) General. A laboratory deemed to meet condition level
requirements must meet the proficiency testing (PT) requirements of this
part.
(b) Release of PT results. (1) A laboratory deemed to meet condition
level requirements must authorize its PT organization to furnish to its
accreditation organization the results of the laboratory's participation
in an approved PT program for the purpose of monitoring a laboratory's
PT and for making the annual PT results, along with explanatory
information required to interpret the PT results, available on a
reasonable basis, upon request of any person.
(2) A laboratory that refuses to authorize the release of its PT
results will no longer be deemed to meet the condition level
requirements and will be subject to full review by HCFA, the State
survey agency, or other HCFA agent in accordance with 493.1777 of this
chapter and may be subject to the suspension or revocation of its
certificate of accreditation under 493.1840 of this part.
(3) A laboratory with deemed status that has failed to achieve
successful participation in an approved PT program must authorize its
accreditation organization to release to HCFA its PT results that
constitute unsuccessful participation in an approved PT program, in
accordance with the definition of ''unsuccessful participation in an
approved PT program'' as specified in this part. Such a laboratory must
also authorize its accreditation organization to release to HCFA a
notification of the actions taken by the organization as a result of the
unsuccessful participation in a PT program within 30 days of the
initiation of such actions.
(4) HCFA may, on the basis of the notification of adverse actions
received from the accreditation organization, take an adverse action
against a laboratory that fails to participate successfully in an
approved PT program.
42 CFR 493.504 Revocation of accreditation.
After a private, nonprofit accreditation organization withdraws or
revokes its accreditation of a laboratory, the certificate of
accreditation required by this part will continue in effect until the
earlier of --
(a) 45 days after the laboratory receives notice of the withdrawal or
revocation of the accreditation; or
(b) The effective date of any action taken by HCFA.
42 CFR 493.506 Federal review and approval of private, nonprofit
accreditation organizations.
(a) An accreditation organization may request and may be granted
''deeming authority'' for all specialties and subspecialties or for
specific specialty or subspecialty areas. In the latter case, the
accreditation organization will be accountable for the monitoring of
compliance with all requirements equivalent to condition level
requirements within the scope of the specialty or subspecialty.
(b) HCFA's review of a private, nonprofit accreditation organization
includes, but is not necessarily limited to, an evaluation of the
following --
(1) Whether the accreditation organization's requirements for
laboratories are equal to or more stringent than the condition level
requirements for laboratories;
(2) The accreditation organization's inspection process to determine
--
(i) The composition of the inspection team, qualifications of the
inspectors, and the ability of the organization to provide continuing
education and training to inspectors;
(ii) The comparability of the organization's full inspection and
complaint inspection requirements to those of HCFA, including but not
limited to inspection frequency, and the ability to investigate and
respond to complaints against accredited laboratories;
(iii) The organization's procedures for monitoring laboratories found
to be out of compliance with its requirements. (These monitoring
procedures are to be used only when the accreditation organization
identifies noncompliance. If noncompliance is identified through
validation inspections, HCFA, the State survey agency, or other HCFA
agent monitors corrections as authorized at 493.507(b)(4) of this
subpart);
(iv) The ability of the organization to provide HCFA with electronic
data and reports, including the crosswalk specified in 493.501(c)(2),
in ASCII-comparable code that are necessary for effective validation and
assessment of the organization's inspection process;
(v) The ability of the organization to provide HCFA with electronic
data in ASCII-comparable code related to the adverse actions resulting
from PT results constituting unsuccessful participation in PT programs
as well as data related to the PT failures, within 30 days of the
initiation of adverse action;
(vi) The ability of the organization to provide HCFA with electronic
data in ASCII-comparable code for all accredited laboratories, including
the area of specialty or subspecialty;
(vii) The adequacy of numbers of staff and other resources; and
(viii) The organization's ability to provide adequate funding for
performing required inspections; and
(3) The organization's agreement with HCFA that requires it to:
(i) Notify HCFA of any laboratory accredited by the organization that
has had its accreditation withdrawn, revoked or limited by the
accreditation organization denied, suspended, withdrawn or revoked or
that has had any other adverse action taken against it by the
accreditation organization within 30 days of the action taken;
(ii) Notify HCFA within 10 days of a deficiency identified in an
accredited laboratory where the deficiency poses an immediate jeopardy
to the laboratory's patients or a hazard to the general public;
(iii) Notify HCFA of all newly accredited laboratories (or
laboratories whose areas of specialty or subspecialty are revised)
within 30 days;
(iv) Notify each laboratory accredited by the organization within 10
days of HCFA's withdrawal of recognition of the organization's deeming
authority;
(v) Provide HCFA with inspection schedules, as requested, for the
purpose of conducting onsite validation inspections;
(vi) Provide HCFA, the State survey agency or other HCFA agent with
any facility-specific data to include, but not be limited to, the
following (upon request):
(A) PT results that constitute unsuccessful participation in an
approved PT program; and
(B) Notification of the adverse actions or corrective actions imposed
by the accreditation organization as a result of unsuccessful PT
participation;
(vii) Provide HCFA written notification at least 30 days in advance
of the effective date of any proposed changes in its requirements; and
(viii) Disclose any laboratory's PT results upon the reasonable
request by any person.
42 CFR 493.507 Validation inspections of laboratories with certificates
of accreditation.
(a) Basis for inspection. HCFA, the State survey agency, or a HCFA
agent may conduct an inspection of an accredited laboratory that has
been issued a certificate of accreditation. The results of these
inspections will be used to validate the accreditation organization's
accreditation process. These inspections may be conducted on a
representative sample basis or in response to substantial allegations of
noncompliance.
(1) When conducted on a representative sample basis, the inspection
is comprehensive, addressing all condition level requirements, or may be
focused on a specific condition level requirement or requirements, and
the number of laboratories sampled is sufficient to allow a reasonable
estimate of the performance of each accreditation organization.
(2) When conducted in response to a substantial allegation of
noncompliance, HCFA, the State survey agency or other HCFA agent
inspects for any condition level requirement or requirements that HCFA
determines to be related to the allegation. If HCFA, the State survey
agency or other HCFA agent substantiates a deficiency and determines
that the laboratory is out of compliance with any condition level
requirement, HCFA, the State survey agency or other HCFA agent will
conduct a full CLIA inspection.
(b) Effect of selection for inspection. A laboratory selected for
inspection must:
(1) Authorize its accreditation organization to release to HCFA, the
State survey agency or other HCFA agent, on a confidential basis, a copy
of the results of the laboratory's most recent full, and any subsequent
partial, accreditation inspection(s);
(2) Authorize the validation inspection to take place;
(3) Provide HCFA, the State survey agency, or other HCFA agent access
to all facilities, equipment, materials, records and information that
HCFA determines have a bearing on whether the laboratory is being
operated in accordance with the requirements of this part, and permit
HCFA, the State survey agency or other HCFA agent to copy any such
material or require it to be submitted; and
(4) Authorize HCFA, the State survey agency or other HCFA agent to
monitor the correction of any deficiencies found through the validation
inspection.
(c) Refusal to cooperate with the inspection. (1) If a laboratory
selected for inspection fails to comply with the requirements specified
in paragraph (b) of this section it --
(i) Will be subject to full review by HCFA, the State survey agency
or other HCFA agent in accordance with this part; and
(ii) May be subject to suspension, revocation, or limitation of its
certificate of accreditation under this part.
(2) An accredited laboratory will be once again deemed to meet the
condition level requirements by virtue of its accreditation when --
(i) It withdraws any prior refusal to authorize its accreditation
organization to release a copy of the laboratory's current accreditation
inspection, PT results, or notification of any adverse actions resulting
from PT failure;
(ii) It withdraws any prior refusal to allow a validation inspection;
and
(iii) HCFA finds that the laboratory meets all the condition level
requirements.
(d) Consequences of a finding of noncompliance. If a validation
inspection results in a finding that the laboratory is out of compliance
with one or more condition level requirements, the laboratory is subject
to the same requirements and survey and enforcement processes applied to
laboratories that are not accredited and that are found out of
compliance following a State agency inspection under this part and to
full review by HCFA, the State survey agency or other HCFA agent in
accordance with this part; i.e., the laboratory will be subject to the
principal and alternative sanctions specified in 493.1806 of this part.
(e) Disclosure of accreditation and validation inspection results.
The accreditation inspection results are disclosable to the public only
if they are related to an enforcement action taken by the Secretary.
The results of all validation inspections conducted by HCFA, the State
survey agency or other HCFA agents are disclosable.
(f) Onsite observation of accreditation organization operations. As
part of the validation review process, HCFA may conduct an onsite
inspection of the accreditation organization's operations and offices to
verify the organization's representations and to assess the
organization's compliance with its own policies and procedures. Such an
onsite inspection may include, but is not limited to, the review of
documents, the auditing of meetings concerning the accreditation
process, the evaluation of accreditation inspection results or the
accreditation decision-making process, and interviews with the
organization's staff.
42 CFR 493.509 Continuing Federal oversight of private, nonprofit
accreditation organizations.
(a) Comparability review. In addition to reviewing the equivalency
of specified accreditation requirements to the comparable condition
level requirements when an accreditation organization initially applies
to HCFA for ''deeming authority'', HCFA reviews the equivalency of
requirements --
(1) When HCFA promulgates new condition level requirements;
(2) When HCFA identifies accreditation organizations whose
requirements do not continue to be equal to or more stringent than
condition level requirements;
(3) When an accreditation organization adopts new requirements;
(4) When an accreditation organization adopts changes to its
inspection process as required by 493.511(b); or
(5) Every six years or sooner if HCFA determines the organization
requires an earlier review.
(b) Validation review. Following the end of a validation review
period, HCFA evaluates the validation inspection results for each
approved accreditation organization.
(c) Reapplication procedures. (1) Every six years, or sooner as
determined by HCFA, an approved accreditation organization must reapply
for continued approval of deeming authority. HCFA will notify the
organization of the materials the organization must submit as part of
the reapplication procedure.
(2) An accreditation organization that is not meeting the
requirements of this subpart, as determined through a comparability or
validation review, must furnish HCFA, upon request and at any time, with
the reapplication materials HCFA requests. HCFA will establish a
deadline by which the materials are to be submitted.
(d) Notice. HCFA provides written notice to the accreditation
organization indicating that its approval may be in jeopardy if a
comparability or validation review reveals that an accreditation
organization is not meeting the requirements of this subpart and that a
deeming authority review is being initiated. The notice contains the
following information --
(1) A statement of the discrepancies that were found as well as other
related documentation;
(2) An explanation of HCFA's review process on which the final
determination will be based and a description of the possible actions as
specified in 493.511 that may be imposed by HCFA based on the findings
from the comparability or validation review;
(3) A description of the procedures available if the accreditation
organization desires an opportunity to explain or justify the findings
made during the comparability or validation review; and
(4) The reapplication materials the organization must submit and the
deadline for that submission.
42 CFR 493.511 Removal of deeming authority and final determination
review.
(a) Deeming authority review. (1) HCFA reviews, as appropriate, the
criteria described in 493.506 to reevaluate whether the accreditation
organization continues to meet all these criteria. HCFA conducts a
deeming authority review of an accreditation organization's program if
the comparability or validation review produces findings as described at
493.509(a) of this subpart.
(2) HCFA conducts, at its discretion, a deeming authority review of
an accreditation organization's program if validation review findings,
irrespective of the rate of disparity, indicate widespread or systematic
problems in the organization's processes that provide evidence that the
organization's requirements, taken as a whole, are no longer equivalent
to CLIA requirements, taken as a whole.
(3) HCFA conducts a deeming authority review whenever validation
inspection results over a one-year period indicate a rate of disparity
of 20 percent or more between the findings of the accreditation
organization and the findings of HCFA, State survey agencies, or other
HCFA agents.
(b) Following the deeming authority review, if HCFA determines that
the accreditation organization has failed to adopt requirements equal to
or more stringent than CLIA requirements, HCFA may give the
accreditation organization a conditional approval effective 30 days
following the date of HCFA's determination of its deeming authority for
a probationary period, not to exceed one year, to adopt comparable
requirements.
(c) Following the deeming authority review, if HCFA determines that
there are widespread systematic problems in the organization's
inspection process, HCFA may give the accreditation organization
conditional approval of its deeming authority during a probationary
period not to exceed one year that is effective 30 days following the
date of HCFA's determination.
(d) Within 60 days after the end of any probationary period, HCFA
will make a final determination as to whether or not an accreditation
organization continues to meet the criteria described at 493.506 of
this subpart and issues an appropriate notice (including reasons for the
determination) to the accreditation organization. This determination is
based on the evaluation of any of the following:
(1) The most recent validation inspection and review findings as
described at 493.509(b) of this subpart. In order for the
accreditation organization to continue to have deeming authority, it
must continue to meet the criteria in 493.506 of this subpart;
(2) Facility-specific data and other related information;
(3) The accreditation organization's surveyors in terms of
qualifications, ongoing education and training, composition of
inspection team, etc.;
(4) The organization's inspection procedures; and
(5) The organization's accreditation requirements.
(e) HCFA may remove recognition of deeming authority effective 30
days from the date that it provides written notice to the accreditation
organization that its deeming authority will be removed if the
accreditation organization has not made improvements acceptable to HCFA
during the probationary period.
(f) The existence of any validation review, deeming authority review,
probationary status, or any other action by HCFA with respect to an
accreditation organization does not affect or limit the conduct of any
validation inspection of its accredited laboratories.
(g) HCFA will publish a notice in the Federal Register containing a
justification of the basis for removing the deeming authority from an
accreditation organization.
(h) After HCFA withdraws approval of an accreditation organization's
deeming authority, the CLIA certificates of accreditation of all
affected laboratories continue in effect for 60 days after the
laboratory receives notification of the withdrawal of approval. HCFA
may extend the period for an additional 60 days for a laboratory if it
determines that the laboratory submitted an application for inspection
to another approved accreditation organization or an application for a
certificate or certificate of waiver to HCFA, the State agency or other
HCFA agent before the initial 60 day period ends.
(i) If at any time HCFA determines that the continued approval of
deeming authority of any accreditation organization poses an immediate
jeopardy to the patients of the laboratories accredited by that
organization, or such continued approval otherwise constitutes a
significant hazard to the public health, HCFA may immediately withdraw
the approval of deeming authority of that accreditation organization.
(j) Any accreditation organization that is dissatisfied with a
determination to withdraw its deeming authority may request a
reconsideration of that determination in accordance with subpart D of
part 488.
42 CFR 493.513 General requirements for CLIA-exempt laboratories.
(a) HCFA may exempt from CLIA program requirements, for a period not
to exceed six years, all State-licensed or approved laboratories in a
State if the State --
(1) Has in effect laws that provide for requirements equal to or more
stringent than condition level requirements;
(2) Has an agency that licenses or approves laboratories that meet
requirements equal to or more stringent than the CLIA condition level
requirements specified in this part and would, therefore, meet condition
level requirements if those laboratories had not been exempted from
CLIA, but rather had been inspected for compliance with condition level
requirements;
(3) Meets the requirements and is approved in accordance with
493.515 of this subpart;
(4) Demonstrates that it has enforcement authority and administrative
structures and resources adequate to enforce its laboratory
requirements;
(5) Permits HCFA or HCFA agents to inspect laboratories in the State;
(6) Requires laboratories in the State to submit to inspections by
HCFA or HCFA agents as a condition of licensure or approval;
(7) Agrees to pay the cost of the validation program administered by
HCFA in that State as specified in 493.645(b) and 493.646 of this
part; and
(8) Takes appropriate enforcement action against laboratories found
by HCFA or HCFA agents not to be in compliance with requirements
equivalent to CLIA requirements.
(b) A laboratory in a State with an approved State laboratory program
must --
(1) Authorize the laboratory program to release to HCFA or HCFA agent
all records and information required by HCFA; and
(2) Permit inspection as required by these regulations.
(c) In applying to HCFA for exemption from the CLIA program, the
State must provide the following information to HCFA --
(1) A detailed comparison of individual licensure or approval
requirements with the comparable condition level requirements; i.e., a
crosswalk;
(2) A detailed description of the inspection process including the
frequency of inspections, copies of inspection forms, instructions and
guidelines, a description of the review and decision-making process of
licensure or approval inspections, whether inspections are announced or
unannounced and a description of the steps taken to monitor the
correction of deficiencies;
(3) A description of the State's enforcement authority,
administrative structure and resources to enforce the State standards;
(4) A description of the process for monitoring proficiency testing
(PT) performance, including action to be taken in response to
unsuccessful participation in a HCFA-approved PT program;
(5) The State's procedures for responding to, and for the
investigation of, complaints against licensed or approved laboratories;
(6) A list of all currently licensed or approved laboratories and the
expiration date of each laboratory's current license or approval;
(7) Procedures under State confidentiality and disclosure
requirements for the release of PT information, including explanatory
information required to interpret PT results; and
(8) For Medicare and Medicaid payment purposes, a list of the
specialties and subspecialties of tests performed by each laboratory.
(d) The State must also submit the following supporting documentation
--
(1) A written presentation that demonstrates the agency's ability to
furnish HCFA with electronic data in ASCII comparable code, including
the crosswalk specified in paragraph (c)(1) of this section;
(2) A statement acknowledging that the State will notify HCFA through
electronic data transmission of --
(i) Any laboratory that has had its licensure or approval revoked or
withdrawn or has been in any way sanctioned by the State within 30 days
of any such action taken;
(ii) Changes in licensure (or approval) or inspection requirements;
and
(iii) Changes in the specialties or subspecialties under which any
laboratory in the State performs testing.
(e) If HCFA determines that additional information is necessary to
make a determination for approval or denial of the application for
exemption, HCFA will notify the State and afford it an opportunity to
provide the additional information.
(f) HCFA may visit the State laboratory program offices to review the
application of the State's policies and procedures and other information
provided by the State. Such review includes, but is not limited to,
examination of documents and interviews with staff.
(g) HCFA will furnish the State a formal notice stating whether the
request for exemption has been approved or denied and the rationale for
any denial.
(h) Except as provided in paragraph (m) of this section, any State
whose application for approval for exemption, or for renewal of that
approval, from CLIA has been denied may resubmit its request as soon as
the State has taken the necessary action to address the rationale for
any previous denial.
(i) A State may withdraw its request for exempt status at any time
prior to the official notification specified in paragraph (g) of this
section.
(j) Any State whose application for approval for exempt status is
denied may request, within 60 days of the notification of the denial,
that its original application or application for renewal be reconsidered
in accordance with part 488, subpart D of this chapter.
(k) HCFA publishes a notice in the Federal Register when it grants
exemption to a State under paragraph (a) of this section. The notice --
(1) Names the State;
(2) Describes the basis for granting the exemption to the State;
(3) Describes how the laboratory requirements of the State are equal
to or more stringent than those specified in this part; and
(4) Specifies a term of approval not to exceed six years.
(l) A State that has received approval for the exemption of its
laboratories from the CLIA program must reapply to HCFA every two years
for renewal of its exemption status and renew its agreement to pay the
cost of the HCFA administered validation program in that State.
(m) If a State has requested a reconsideration of HCFA's
determination that its request for exemption, or for renewal of its
exemption, of its laboratories from CLIA is denied, it may not resubmit
its request until a final reconsideration determination is issued.
42 CFR 493.515 Federal review of laboratory requirements of State
laboratory programs.
(a) HCFA's review of a State laboratory program includes, but is not
necessarily limited to, an evaluation of the following:
(1) Whether the State's requirements for laboratories are equal to or
more stringent than the condition level requirements;
(2) The State's inspection process requirements to determine --
(i) The comparability of the full inspection and complaint inspection
procedures to those of HCFA, including but not limited to inspection
frequency and the ability to investigate and respond to complaints
against licensed or approved laboratories;
(ii) The State's enforcement procedures for laboratories found to be
out of compliance with its requirements;
(iii) The ability of the State to provide HCFA with electronic data
and reports in ASCII-comparable code with the adverse or corrective
actions resulting from PT results that constitute unsuccessful
participation in PT programs and with other data HCFA determines are
necessary for validation and assessment of the State's inspection
process requirements;
(3) The State's agreement with HCFA to --
(i) Notify HCFA within 30 days of the action taken against any
CLIA-exempt laboratory that has had its licensure or approval withdrawn
or revoked or has been in any way sanctioned;
(ii) Notify HCFA within 10 days of any deficiency identified in a
CLIA-exempt laboratory in cases where the deficiency poses an immediate
jeopardy to the laboratory's patients or a hazard to the general public.
(iii) Notify each laboratory licensed by the State within 10 days of
HCFA's withdrawal of the State's exemption;
(iv) Provide HCFA with written notification of any changes in its
licensure (or approved) and inspection requirements;
(v) Disclose any laboratory's PT results in accordance with a State's
confidentiality requirements;
(vi) Take the appropriate enforcement action against laboratories
found by HCFA not to be in compliance with requirements comparable to
condition level requirements and report such enforcement actions to
HCFA;
(vii) Notify HCFA of all newly licensed laboratories, including the
specialties and subspecialties, for which any laboratory performs
testing within 30 days; and subspecialties, for which any laboratory
performs testing within 30 days; and
(viii) Provide HCFA, as requested, inspection schedules for
validation purposes.
42 CFR 493.517 Validation inspections of CLIA-exempt laboratories.
(a) Basis for inspection. HCFA or a HCFA agent other than the State
survey agency may conduct an inspection of any laboratory in a State
with an approved laboratory program. The results of these inspections
will be used to validate the appropriateness of the exemption of that
State's licensed or approved laboratories from CLIA program
requirements. These inspections may be conducted on a representative
sample basis or in response to substantial allegations of noncompliance.
(1) When conducted on a representative sample basis, the inspection
may be comprehensive, addressing all condition level requirements, or
may be focused on a specific requirement or requirements. The number of
laboratories sampled is sufficient to allow a reasonable estimate of the
performance of the State.
(2) When conducted in response to a substantial allegation of
noncompliance, HCFA or a HCFA agent inspects for any condition level
requirement or requirements that HCFA determines to be related to the
allegation. If HCFA substantiates a deficiency and determines that the
laboratory is out of compliance with any condition level requirement,
HCFA or other HCFA agent will conduct a full CLIA inspection.
(b) Effect of selection for inspection. A CLIA-exempt laboratory
selected for a validation inspection must --
(1) Authorize the State to release to HCFA or a HCFA agent, on a
confidential basis, a copy of the results of the laboratory's most
recent full, and any subsequent partial, licensure or approval
inspection(s);
(2) Authorize the validation inspection to take place; and
(3) Provide HCFA or a HCFA agent access to all facilities, equipment,
materials, records and information that HCFA determines have a bearing
on whether the laboratory is being operated in accordance with the
requirements of this part and permit HCFA or a HCFA agent to copy any
such materials or to require such copies to be submitted.
(c) Refusal to cooperate with the inspection. If a laboratory
selected for a validation inspection fails to comply with the
requirements specified in paragraph (b) of this section, HCFA will
notify the State.
(d) Consequences of a finding of noncompliance. If a validation
inspection results in a finding that the laboratory is out of compliance
with one or more condition level requirements, HCFA will direct the
State to take the appropriate enforcement action(s).
(e) Disclosure of State and validation inspection results. The
disclosure of State inspection results will be the responsibility of the
approved State laboratory program, in accordance with State law. The
results of all validation inspections conducted by HCFA or other HCFA
agents are disclosable.
(f) Onsite observation of State laboratory program operations. As
part of the validation review process, HCFA may conduct an onsite
inspection of a State's laboratory program offices and operations to
verify the State's representations and to assess the State's compliance
with its own policies and procedures, including verification of State
enforcement actions taken on the basis of validation inspections
performed by HCFA or HCFA agents. Such an onsite inspection may
include, but is not limited to, the review of documents, auditing
meetings concerning the licensure or approval process, the evaluation of
State inspection results and the licensure or approval decision-making
process, and interviews with State employees.
42 CFR 493.519 Continuing Federal oversight of an approved State
laboratory program.
(a) Comparability review. In addition to reviewing the equivalency
of specified licensure or approval requirements to the comparable
condition level requirements when a State initially applies to HCFA for
exemption of its licensed or approved laboratories from condition level
requirements, HCFA reviews the equivalency of requirements when --
(1) HCFA promulgates new condition level requirements;
(2) HCFA identifies a State whose requirements do not continue to be
equal to or more stringent than condition level requirements;
(3) A State laboratory program adopts new requirements;
(4) A State laboratory program adopts changes to its inspection
process requirements as required by 493.521(b); or
(5) Every six years or sooner if HCFA determines the State laboratory
requires an earlier review.
(b) Validation review. Following the end of a validation review
period, HCFA evaluates the validation inspection results for each
approved State laboratory program.
(c) Reapplication procedures. (1) Every six years, or sooner as
determined by HCFA, an approved State laboratory program must reapply
for continued approval of CLIA exemption. HCFA will notify the State of
the materials the State must submit as part of the reapplication
procedure.
(2) A State that is not meeting the requirements of this subpart as
determined through a comparability or validation review must furnish
HCFA, upon request and at any time, with the reapplication materials
HCFA requests. HCFA will establish a deadline by which the materials
are to be submitted.
(d) Notice. HCFA provides written notice to the State, indicating
that its CLIA exemption may be in jeopardy if a comparability or
validation review reveals that it is not meeting the requirements of
this subpart and that a review is being initiated of the CLIA exemption
of the State's laboratories. The notice contains the following
information --
(1) A statement of the discrepancies that were found, as well as
other related documentation;
(2) An explanation of HCFA's review process on which the final
determination will be based and a description of the possible actions as
specified in 493.521 that may be imposed by HCFA based on the findings
from the validation or comparability review;
(3) A description of the procedures available if the State desires an
opportunity to explain or justify the findings made during the
comparability or validation review; and
(4) The reapplication materials the State laboratory program must
submit and the deadline for the submission of those materials.
42 CFR 493.521 Removal of CLIA exemption and final determination
review.
(a)(1) HCFA conducts a review of a State's laboratory program if the
comparability review produces findings as described at 493.519(a), of
this subpart. HCFA reviews, as appropriate, the criteria described in
493.515 to reevaluate whether the laboratory program continues to meet
all these criteria.
(2) HCFA conducts, at its discretion, an exemption review of an
approved State laboratory program if validation review findings,
irrespective of the rate of disparity, indicate widespread or systematic
problems in the State's licensure or approval processes that provide
evidence that the State's requirements, taken as a whole, are no longer
equivalent to CLIA requirements, taken as a whole.
(3) HCFA conducts a review of an approved State laboratory program
whenever validation inspection results over a two-year period indicate a
rate of disparity of 20 percent or more between the findings of the
State and the findings of HCFA or other HCFA agents.
(b) Following the review, if HCFA determines that the State has
failed to adopt requirements equal to or more stringent than CLIA
requirements, HCFA may give the State, within 30 days of its
determination, a conditional approval of its exempt status for a
probationary period not to exceed one year to afford the State the
opportunity to adopt equal or more stringent requirements.
(c) Following the review, if HCFA determines that there are
widespread or systematic problems in the State's inspection process,
HCFA may give the State conditional approval of the exemption of its
licensed or approved laboratories during a probationary period not to
exceed one year that is effective 30 days. following the date of the
determination;
(d) Within 60 days after the end of any probationary period, HCFA
makes a final determination as to whether or not a State continues to
meet the criteria described at 493.515 of this subpart and issues an
appropriate notice (including reasons for the determination) to the
State. This determination is based on the evaluation of any of the
following --
(1) The most recent validation inspection(s) and review findings. In
order for the State to continue to be exempt, it must meet the criteria
in 493.519 of this subpart;
(2) Facility-specific data, as necessary, as well as other related
information;
(3) Inspection procedures;
(4) Licensure or approval requirements.
(e) HCFA may remove its approval of a State laboratory program
effective 30 days from the date that it provides written notice to the
State of this proposed action if the State has not made improvements
acceptable to HCFA during the probationary period.
(f) The existence of any validation review, probationary status, or
any other action by HCFA does not affect or limit the conducting of any
validation inspection.
(g) HCFA will cancel the approval of a State laboratory program if
the State fails to pay the applicable fees as specified in 493.645 and
493.646.
(h) If HCFA determines at any time that the continued approval of a
State laboratory program poses an immediate jeopardy to the patients of
the laboratories in that State, or such continued approval otherwise
constitutes a significant hazard to the public health, HCFA may
immediately withdraw the approval of that State laboratory program.
(i) HCFA will publish a notice in the Federal Register containing a
justification of the basis for removing its approval of the State
laboratory program.
(j) After HCFA withdraws approval of a State laboratory program, the
exempt status of licensed or approved laboratories in the State
continues in effect for 60 days after the laboratory receives
notification from the State of the withdrawal of HCFA's approval of the
program. HCFA may extend this period for an additional 60 days for a
laboratory if it determines that the laboratory submitted an application
for accreditation to an approved accreditation organization or an
application to HCFA for a certificate or certificate of waiver before
the initial 60 day period ends.
(k) HCFA may withdraw a State laboratory program's approval if the
State refuses to take enforcement action against a laboratory in that
State where HCFA determined it to be necessary. Laboratories that are
in a State where program approval has been removed are subject to the
same requirements and survey and enforcement processes applied to
laboratories that are not exempt from meeting CLIA requirements.
(l) Any State that is dissatisfied with a determination to remove the
approval of its laboratory program may request a reconsideration of that
determination in accordance with part 488, subpart D of this chapter.
42 CFR 493.521 Subpart F -- General Administration
Source: 57 FR 7213, Feb. 28, 1992, unless otherwise noted.
493.602 Scope of subpart. (Reserved)
493.606 Applicability of subpart. (Reserved)
493.610 Certificate requirements for laboratories. (Reserved)
493.614 Application procedures. (Reserved)
493.618 Additional application requirements. (Reserved)
493.622 Appeals procedures. (Reserved)
493.626 Registration certificate. (Reserved)
493.630 Certificate. (Reserved)
493.631 Certificate of waiver. (Reserved)
493.632 Certificate of accreditation. (Reserved)
493.633 Applicability of certificate, certificate of waiver, and
certificate of accreditation. (Reserved)
493.634 Notification of changes. (Reserved)
42 CFR 493.638 Registration certificate and certificate fees.
(a) Basic rule. Laboratories must pay a fee for the issuance of a
registration certificate, certificate of waiver, certificate of
accreditation, or a certificate, as applicable. Laboratories must also
pay a fee to reapply for a certificate of waiver, certificate of
accreditation, or a certificate. The total of fees collected by HHS
under the laboratory program must be sufficient to cover the general
costs of administering the laboratory certification program under
section 353 of the PHS Act. For registration certificates and
certificates, this includes evaluating and monitoring proficiency
testing programs and accreditation bodies and implementing, monitoring,
and enforcing compliance with section 353 of the PHS Act and collection
of fees and issuing registration certificates and certificates. For a
certificate of waiver, this includes the cost of issuing the certificate
of waiver, collection of fees and the administrative costs associated
with evaluating tests to determine if a certificate of waiver should be
issued. For a certificate of accreditation this includes the cost of
issuing the certificate of accreditation, collection of fees and the
administrative costs associated with evaluating programs of accrediting
bodies and the costs to conduct sample validation surveys of accredited
laboratories.
(b) Fee amount. The fee amount is set annually by HHS on a calendar
year basis and is based on schedules, or ranges, of laboratory test
volume (excluding tests performed for quality control, quality
assurance, and proficiency testing purposes) and scope of specialties
tested, with the amounts of the fees in each schedule a function of the
costs for all aspects of general administration of CLIA as set forth in
493.649 (b) and (c). This fee is assessed and payable at least
biennially. The methodology used to determine the amount of the fee is
found in 493.649. The amount of the fee applicable to the issuance of
the registration certificate or the issuance or renewal of the
certificate of waiver, certificate of accreditation, or certificate is
the amount in effect at the time the application is received. Upon
receipt of an application for a registration certificate, certificate of
waiver, certificate of accreditation, or certificate, HHS or its
designee notifies the laboratory of the amount of the required fee. The
amount of the fee is based on whether the laboratory is considered
small, medium, or large (based on the volume and scope of testing
performed by the laboratory).
42 CFR 493.639 Fee for revised certificate.
(a) If, after a laboratory is issued a registration certificate, it
changes its name or location, the laboratory must pay a fee to cover the
cost of issuing a revised registration certificate. The fee for the
revised registration certificate is based on the cost to issue the
revised certificate to the laboratory.
(b) A laboratory must pay a fee to cover the cost of issuing a
revised certificate in any of the circumstances specified in paragraphs
(b) (1) and (2). The fee for issuing an appropriate revised certificate
is based on the cost to issue the revised certificate to the laboratory.
(An additional fee is also required under 493.643(d) if it is
necessary to determine compliance with additional requirements and, if a
laboratory with a certificate of waiver wishes to perform tests not
listed in the waived test category, it must, as set forth in 493.626,
pay an additional fee for a registration certificate to cover the new
testing.)
(1) If after a certificate, certificate of accreditation, or
certificate of waiver is issued, a laboratory changes its name,
location, or its director;
(2) If after a certificate or certificate of waiver is issued, a
laboratory deletes services or wishes to add services and requests that
its certificate be upgraded or that its certificate of waiver be changed
or eliminated.
(57 FR 7213, Feb. 28, 1992; 57 FR 31664, July 17, 1992)
42 CFR 493.643 Fee for determination of program compliance.
(a) Fee requirement. In addition to the fee required under 493.638,
laboratories regulated subject to the requirements of this part must pay
a fee to cover the cost of determining program compliance, unless it is
issued a certificate of waiver or a certificate of accreditation.
(b) Costs included in the fee. Included in the fee for determining
program compliance is the cost of evaluating qualifications of
personnel; monitoring proficiency testing; conducting onsite
inspections; documenting deficiencies; evaluating laboratories' plans
to correct deficiencies; and necessary administrative costs. HHS sets
the fee amounts annually on a calendar year basis. Laboratories are
inspected biennially; therefore, fees are assessed and payable
biennially. If additional expenses are incurred to conduct follow up
visits to verify correction of deficiencies, to impose sanctions, and/or
for surveyor preparation for and attendance at ALJ hearings, HHS
assesses an additional fee to include these costs. The additional fee
is based on the actual resources and time necessary to perform the
activities.
(c) Classification of laboratories that require inspection for
purpose of determining amount of fee. (1) There are ten classifications
(schedules) of laboratories for the purpose of determining the fee
amount a laboratory is assessed. Each laboratory is placed into one of
the ten following schedules based on the laboratory's scope and volume
of testing (excluding tests performed for quality control, quality
assurance, and proficiency testing purposes).
(i) (A) Schedule A Low Volume. The laboratory performs not more than
2,000 laboratory tests annually.
(B) Schedule A. The laboratory performs tests in no more than 3
specialties of service with a total annual volume of more than 2,000 but
not more than 10,000 laboratory tests.
(ii) Schedule B. The laboratory performs tests in at least 4
specialties of service with a total annual volume of not more than
10,000 laboratory tests.
(iii) Schedule C. The laboratory performs tests in no more 3
specialties of service with a total annual volume of more than 10,000
but not more than 25,000 laboratory tests.
(iv) Schedule D. The laboratory performs tests in at least 4
specialties with a total annual volume of more than 10,000 but not more
than 25,000 laboratory tests.
(v) Schedule E. The laboratory performs more than 25,000 but not
more than 50,000 laboratory tests annually.
(vi) Schedule F. The laboratory performs more than 50,000 but not
more than 75,000 laboratory tests annually.
(vii) Schedule G. The laboratory performs more than 75,000 but not
more than 100,000 laboratory tests annually.
(viii) Schedule H. The laboratory performs more than 100,000 but not
more than 500,000 laboratory tests annually.
(ix) Schedule I. The laboratory performs more than 500,000 but not
more than 1,000,000 laboratory tests annually.
(x) Schedule J. The laboratory performs more than 1,000,000
laboratory tests annually.
(2) For purposes of determining a laboratory's classification under
this section, a test is a procedure or examination for a single analyte.
(Tests performed for quality control, quality assurance, and
proficiency testing are excluded from the laboratory's total annual
volume). Each profile (that is, group of tests) is counted as the
number of separate procedures or examinations; for example, a chemistry
profile consisting of 18 tests is counted as 18 separate procedures or
tests.
(3) For purposes of determining a laboratory's classification under
this section, the specialties and subspecialties of service for
inclusion are:
(i) The specialty of Microbiology, which includes one or more of the
following subspecialties:
(A) Bacteriology.
(B) Mycobacteriology.
(C) Mycology.
(D) Parasitology.
(E) Virology.
(ii) The specialty of Serology, which includes one or more of the
following subspecialties:
(A) Syphilis Serology.
(B) General immunology
(iii) The specialty of Chemistry, which includes one or more of the
following subspecialties:
(A) Routine chemistry.
(B) Endocrinology.
(C) Toxicology.
(D) Urinalysis.
(iv) The specialty of Hematology.
(v) The specialty of Immunohematology, which includes one or more of
the following subspecialties:
(A) ABO grouping and Rh typing.
(B) Unexpected antibody detection.
(C) Compatibility testing.
(D) Unexpected antibody identification.
(vi) The specialty of Pathology, which includes the following
subspecialties:
(A) Cytology.
(B) Histopathology.
(C) Oral pathology.
(vii) The specialty of Radiobioassay.
(viii) The specialty of Histocompatibility.
(ix) The specialty of Cytogenetics.
(d) Additional fees. (1) If after a certificate or certificate of
waiver is issued a laboratory adds services and requests that its
certificate be upgraded, the laboratory must pay an additional fee if,
in order to determine compliance with additional requirements, it is
necessary to conduct an inspection, evaluate personnel, or monitor
proficiency testing performance. The additional fee is based on the
actual resources and time necessary to perform the activities. HHS
revokes the laboratory's certificate for failure to pay the compliance
determination fee.
(2) If it is necessary to conduct a complaint investigation, impose
sanctions or conduct a hearing, HHS assesses the laboratory, other than
a State-exempt laboratory, a fee to cover the cost of these activities.
If a complaint investigation results in a complaint being
unsubstantiated, or if an HHS adverse action is overturned at the
conclusion of the administrative appeals process, the government's costs
of these activities are not imposed upon the laboratory. Costs for
these activities are based on the actual resources and time necessary to
perform the activities and are not assessed until after the laboratory
concedes the existence of deficiencies or an ALJ rules in favor of HHS.
HHS revokes the laboratory's certificate for failure to pay the assessed
costs.
42 CFR 493.645 Fee(s) applicable to accredited laboratories/approved
State licensure programs.
(a) Accredited laboratories. (1) In addition to the certificate fee,
a laboratory that is issued a certificate of accreditation is also
assessed a fee to cover the cost of evaluating individual laboratories
to determine overall whether an accreditation organization's standards
and inspection policies are equivalent to the Federal program. All
accredited laboratories share in the cost of these inspections. These
costs are the same as those that are incurred when inspecting
nonaccredited laboratories.
(2) If, in the case of a laboratory that has been issued a
certificate of accreditation, it is necessary to conduct a complaint
investigation, impose sanctions, or conduct a hearing, HHS assesses that
laboratory a fee to cover the cost of these activities. If a complaint
investigation results in a complaint being unsubstantiated, or if an HHS
adverse action is overturned at the conclusion of the administrative
appeals process, the cost of these activities are not imposed upon the
laboratory. Costs are based on the actual resources and time necessary
to perform the activities and are not assessed until after the
laboratory concedes the existence of deficiencies or an ALJ rules in
favor of HHS. HHS revokes the laboratory's certificate for failure to
pay the assessed costs.
(3) If, in the case of a laboratory subject to an inspection under
paragraph (a), followup visits are necessary because of identified
deficiencies, HHS assesses the laboratory a fee to cover the cost of
these visits. The fee is based on the actual resources and time
necessary to perform the followup visits. HHS revokes the laboratory's
certificate of accreditation for failure to pay the assessed fee.
(b) Approved State licensure programs. State licensure programs
approved by HHS are assessed a fee for the following:
(1) Costs of Federal inspections of laboratories in that State (that
is, State-exempt laboratories) to verify that standards are being
enforced in an appropriate manner.
(2) Costs incurred for investigations of complaints against the
State's State-exempt laboratories if the complaint is substantiated.
(3) Costs of the State's prorata share of general overhead to develop
and implement CLIA.
42 CFR 493.646 Payment of fees.
(a) Except for State-exempt laboratories, all laboratories are
notified in writing by HHS or its designee of the appropriate fee(s) and
instructions for submitting the fee(s), including the due date for
payment and where to make payment. Registration certificates,
certificates of waiver, certificates of accreditation, or certificates
are not issued until the applicable fees have been paid.
(b) For State-exempt laboratories, HHS estimates the cost of
conducting validation surveys within the State for a 2-year period. HHS
or its designee notifies the State by mail of the appropriate fees,
including the due date for payment and the address of the United States
Department of Treasury designated commercial bank to which payment must
be made. In addition, if complaint investigations are conducted in
laboratories within these States and are substantiated, HHS bills the
State(s) the costs of the complaint investigations.
42 CFR 493.649 Methodology for determining fee amount.
(a) General rule. The amount of the fee in each schedule for
compliance determination surveys is based on the average hourly rate
(which includes the costs to perform the required activities and
necessary administration costs) multiplied by the average number of
hours required, or if activities are performed by more than one of the
entities listed in paragraph (b) of this section, the sum of the
products of the applicable hourly rates multiplied by the average number
of hours required by the entity to perform the activity. The fee for
issuance of the registration certificate or certificate is based on the
laboratory's scope and volume of testing.
(b) Determining average hourly rates used in fee schedules. Three
different entities perform activities related to the issuance or
reissuance of certificates of waiver, certificates of accreditation, or
certificates and determining program compliance. HHS determines the
average hourly rates for the activities of each of these entities.
(1) State survey agencies. The following costs are included in
determining an average hourly rate for the activities performed by State
survey agencies:
(i) The costs incurred by the State survey agencies in evaluating
personnel qualifications and monitoring each laboratory's participation
in an approved proficiency testing program. The cost of onsite
inspections and monitoring activities is the hourly rate derived as a
result of an annual budget negotiation process with each State. The
hourly rate encompasses salary costs (as determined by each State's
civil service pay scale) and fringe benefit costs to support the
required number of State inspectors, management and direct support
staff.
(ii) Travel costs necessary to comply with each State's
administrative requirements and other direct costs such as equipment,
printing, and supplies. These costs are established based on historical
State requirements.
(iii) Indirect costs as negotiated by HHS.
(2) Federal agencies. The hourly rate for activities performed by
Federal agencies is the most recent average hourly cost to HHS to staff
and support a full time equivalent employee. Included in this cost are
salary and fringe benefit costs, necessary administrative costs, such as
printing, training, postage, express mail, supplies, equipment, computer
system and building service charges associated with support services
provided by organizational components such as a computer center, and any
other oversight activities necessary to support the program.
(3) HHS contractors. The hourly rate for activities performed by HHS
contractors is the average hourly rate established for contractor
assistance based on an independent government cost estimate for the
required workload. This rate includes the cost of contractor support to
provide proficiency testing programs to laboratories that do not
participate in an approved proficiency testing program, provide
specialized assistance in the evaluation of laboratory performance in an
approved proficiency testing program, perform assessments of cytology
testing laboratories, conduct special studies, bill and collect fees,
issue certificates, establish accounting, monitoring and reporting
systems, and assist with necessary surveyor training.
(c) Determining number of hours. The average number of hours used to
determine the overall fee in each schedule is HHS's estimate, based on
historical experience, of the average time needed by each entity to
perform the activities for which it is responsible.
(Catalog of Federal Domestic Assistance Program No. 13.714, Medical
Assistance Program; No. 13.773, Medicare -- Hospital Insurance; and
No. 113.774, Medicare-Supplementary Medical Insurance)
42 CFR 493.649 Subpart G -- (Reserved)
42 CFR 493.649 Subpart H -- Participation in Proficiency Testing for
Laboratories Performing Tests of Moderate or High Complexity, or Both
Source: 57 FR 7146, Feb. 28, 1992, unless otherwise noted.
Effective Date Note: At 57 FR 7146, Feb. 28, 1992, subpart H was
revised. For laboratories not subject to 42 CFR part 493 published at
55 FR 9538, Mar. 14, 1990, prior to September 1, 1992, subpart H is
effective January 1, 1994.
42 CFR 493.801 Condition: Enrollment and testing of samples.
Each laboratory must enroll in a proficiency testing (PT) program
that meets the criteria in subpart I of this part and is approved by
HHS. The laboratory must enroll in an approved program or programs for
each of the specialties and subspecialties for which it seeks
certification. The laboratory must test the samples in the same manner
as patients' specimens. For laboratories subject to 42 CFR part 493
published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the
rules of this subpart are effective on September 1, 1992. For all other
laboratories, the rules of this subpart are effective January 1, 1994.
(a) Standard; Enrollment. The laboratory must --
(1) Notify HHS of the approved program or programs in which it
chooses to participate to meet proficiency testing requirements of this
subpart.
(2)(i) Designate the program(s) to be used for each specialty,
subspecialty, and analyte or test to determine compliance with this
subpart if the laboratory participates in more than one proficiency
testing program approved by HCFA; and
(ii) For those tests performed by the laboratory that are not
included in subpart I of this part, a laboratory must establish and
maintain the accuracy and reliability of its testing procedures, in
accordance with 493.1709.
(3) For each specialty, subspecialty and analyte or test, participate
in one approved proficiency testing program or programs, for one year
before designating a different program and must notify HCFA before any
change in designation; and
(4) Authorize the proficiency testing program to release to HHS all
data required to --
(i) Determine the laboratory's compliance with this subpart; and
(ii) Make PT results available to the public as required in section
353(f)(3)(F) of the Public Health Service Act.
(b) Standard; Testing of proficiency testing samples. The
laboratory must examine or test, as applicable, the proficiency testing
samples it receives from the proficiency testing program in the same
manner as it tests patient specimens.
(1) The samples must be examined or tested with the laboratory's
regular patient workload by personnel who routinely perform the testing
in the laboratory, using the laboratory's routine methods. The
individual testing or examining the samples and the laboratory director
must attest to the routine integration of the samples into the patient
workload using the laboratory's routine methods.
(2) The laboratory must test samples the same number of times that it
routinely tests patient samples.
(3) Laboratories that perform tests on proficiency testing samples
must not engage in any inter-laboratory communications pertaining to the
results of proficiency testing sample(s) until after the date by which
the laboratory must report proficiency testing results to the program
for the testing event in which the samples were sent. Laboratories with
multiple testing sites or separate locations must not participate in any
communications or discussions across sites/locations concerning
proficiency testing sample results until after the date by which the
laboratory must report proficiency testing results to the program.
(4) The laboratory must not send PT samples or portions of samples to
another laboratory for any analysis which they are certified to perform
in their own laboratory. Any laboratory that HCFA determines
intentionally referred its proficiency testing samples to another
laboratory for analysis and submits the other laboratory's results as
their own will have its certification revoked for at least one year.
Any laboratory that receives proficiency testing samples from another
laboratory for testing must notify HCFA of the receipt of those samples.
(5) The laboratory must document the handling, preparation,
processing, examination, and each step in the testing and reporting of
results for all proficiency testing samples. The laboratory must
maintain a copy of all records, including a copy of the proficiency
testing program report forms used by the laboratory to record
proficiency testing results including the attestation statement provided
by the PT program, signed by the analyst and the laboratory director,
documenting that proficiency testing samples were tested in the same
manner as patient specimens, for a minimum of two years from the date of
the proficiency testing event.
(6) PT is required for only the test system, assay, or examination
used as the primary method for patient testing during the PT event.
42 CFR 493.803 Condition: Successful participation.
(a) Each laboratory performing tests of moderate and/or high
complexity must successfully participate in a proficiency testing
program approved by HCFA, if applicable, as described in subpart I of
this part for each specialty, subspecialty, and analyte or test in which
the laboratory is certified under CLIA.
(b) If the laboratory fails to participate successfully in
proficiency testing for a given specialty, subspecialty, analyte or
test, as defined in this section, or fails to take remedial action when
an individual fails gynecologic cytology, sanctions will be taken as
defined in subpart R of this part.
42 CFR 493.807 Condition: Reinstatement of laboratories performing
tests of moderate or high complexity, or both, after failure to
participate successfully.
(a) If a laboratory's certificate is suspended and/or Medicare or
Medicaid approval is terminated because it fails to participate
successfully in proficiency testing for one or more specialties,
subspecialties, analyte or test, or voluntarily withdraws its
certification under CLIA for the failed specialty, subspecialty, or
analyte, the laboratory must then demonstrate sustained satisfactory
performance on two consecutive proficiency testing events, one of which
may be on site, before HCFA will consider it for reinstatement for
certification and Medicare or Medicaid approval in that specialty,
subspecialty, analyte or test.
(b) The termination period for Medicare or Medicaid approval or
period for suspension of certification under CLIA for the failed
specialty, subspecialty, or analyte or test is for a period of not less
than six months from the date of termination or suspension.
(c) If a laboratory's certificate is suspended and/or Medicare or
Medicaid approval is terminated in gynecologic cytology, the laboratory
must take corrective action and reapply for certification.
42 CFR 493.807 Proficiency Testing by Specialty and Subspecialty for Laboratories Performing Tests of Moderate or High Complexity, or Both
42 CFR 493.821 Condition: Microbiology.
The specialty of microbiology includes, for purposes of proficiency
testing, the subspecialties of bacteriology, mycobacteriology, mycology,
parasitology and virology.
42 CFR 493.823 Standard; Bacteriology.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if --
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency
testing program within the time frame for submitting proficiency testing
results of the suspension of patient testing and the circumstances
associated with failure to perform tests on proficiency testing samples;
and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) Remedial action must be taken and documented, and the
documentation must be maintained by the laboratory for two years from
the date of participation in the proficiency testing event.
(e) Failure to achieve an overall testing event score of satisfactory
performance for two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
42 CFR 493.825 Standard; Mycobacteriology.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if --
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency
testing program within the time frame for submitting proficiency testing
results of the suspension of patient testing and the circumstances
associated with failure to perform tests on proficiency testing samples;
and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) Remedial action must be taken and documented, and the
documentation must be maintained by the laboratory for two years from
the date of participation in the proficiency testing event.
(e) Failure to achieve an overall testing event score of satisfactory
performance for two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
42 CFR 493.827 Standard; Mycology.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if --
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency
testing program within the time frame for submitting proficiency testing
results of the suspension of patient testing and the circumstances
associated with failure to perform tests on proficiency testing samples;
and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) Remedial action must be taken and documented, and the
documentation must be maintained by the laboratory for two years from
the date of participation in the proficiency testing event.
(e) Failure to achieve an overall testing event score of satisfactory
performance for two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
42 CFR 493.829 Standard; Parasitology.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if --
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency
testing program within the time frame for submitting proficiency testing
results of the suspension of patient testing and the circumstances
associated with failure to perform tests on proficiency testing samples;
and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) Remedial action must be taken and documented, and the
documentation must be maintained by the laboratory for two years from
the date of participation in the proficiency testing event.
(e) Failure to achieve an overall testing event score of satisfactory
performance for two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
42 CFR 493.831 Standard; Virology.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if --
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency
testing program within the time frame for submitting proficiency testing
results of the suspension of patient testing and the circumstances
associated with failure to perform tests on proficiency testing samples;
and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unsatisfactory testing events, remedial action must be
taken and documented, and the documentation must be maintained by the
laboratory for two years from the date of participation in the
proficiency testing event.
(e) Failure to achieve an overall testing event score of satisfactory
performance for two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
42 CFR 493.833 Condition: Diagnostic immunology.
The specialty of diagnostic immunology includes for purposes of
proficiency testing the subspecialties of syphilis serology and general
immunology.
42 CFR 493.835 Standard; Syphilis serology.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if --
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency
testing program within the time frame for submitting proficiency testing
results of the suspension of patient testing and the circumstances
associated with failure to perform tests on proficiency testing samples;
and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unacceptable testing event score, remedial action must be
taken and documented, and the documentation must be maintained by the
laboratory for two years from the date of participation in the
proficiency testing event.
(e) Failure to achieve an overall testing event score of satisfactory
performance for two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
42 CFR 493.837 Standard; General immunology.
(a) Failure to attain a score of at least 80 percent of acceptable
responses for each analyte in each testing event is unsatisfactory
analyte performance for the testing event.
(b) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(c) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if --
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency
testing program within the time frame for submitting proficiency testing
results of the suspension of patient testing and the circumstances
associated with failure to perform tests on proficiency testing samples;
and
(3) The laboratory participated in the previous two proficiency
testing events.
(d) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(e)(1) For any unsatisfactory analyte or test performance or testing
event for reasons other than a failure to participate, the laboratory
must undertake appropriate training and employ the technical assistance
necessary to correct problems associated with a proficiency testing
failure.
(2) For any unacceptable analyte or testing event score, remedial
action must be taken and documented, and the documentation must be
maintained by the laboratory for two years from the date of
participation in the proficiency testing event.
(f) Failure to achieve satisfactory performance for the same analyte
or test in two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
(g) Failure to achieve an overall testing event score of satisfactory
performance for two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
42 CFR 493.839 Condition: Chemistry.
The specialty of chemistry includes for the purposes of proficiency
testing the subspecialties of routine chemistry, endocrinology, and
toxicology.
42 CFR 493.841 Standard; Routine chemistry.
(a) Failure to attain a score of at least 80 percent of acceptable
responses for each analyte in each testing event is unsatisfactory
analyte performance for the testing event.
(b) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(c) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if --
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency
testing program within the time frame for submitting proficiency testing
results of the suspension of patient testing and the circumstances
associated with failure to perform tests on proficiency testing samples;
and
(3) The laboratory participated in the previous two proficiency
testing events.
(d) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(e)(1) For any unsatisfactory analyte or test performance or testing
event for reasons other than a failure to participate, the laboratory
must undertake appropriate training and employ the technical assistance
necessary to correct problems associated with a proficiency testing
failure.
(2) For any unacceptable analyte or testing event score, remedial
action must be taken and documented, and the documentation must be
maintained by the laboratory for two years from the date of
participation in the proficiency testing event.
(f) Failure to achieve satisfactory performance for the same analyte
or test in two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
(g) Failure to achieve an overall testing event score of satisfactory
performance for two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
42 CFR 493.843 Standard; Endocrinology.
(a) Failure to attain a score of at least 80 percent of acceptable
responses for each analyte in each testing event is unsatisfactory
analyte performance for the testing event.
(b) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(c) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if --
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency
testing program within the time frame for submitting proficiency testing
results of the suspension of patient testing and the circumstances
associated with failure to perform tests on proficiency testing samples;
and
(3) The laboratory participated in the previous two proficiency
testing events.
(d) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(e)(1) For any unsatisfactory analyte or test performance or testing
event for reasons other than a failure to participate, the laboratory
must undertake appropriate training and employ the technical assistance
necessary to correct problems associated with a proficiency testing
failure.
(2) For any unacceptable analyte or testing event score, remedial
action must be taken and documented, and the documentation must be
maintained by the laboratory for two years from the date of
participation in the proficiency testing event.
(f) Failure to achieve satisfactory performance for the same analyte
or test in two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
(g) Failure to achieve an overall testing event score of satisfactory
performance for two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
42 CFR 493.845 Standard; Toxicology.
(a) Failure to attain a score of at least 80 percent of acceptable
responses for each analyte in each testing event is unsatisfactory
analyte performance for the testing event.
(b) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(c) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if --
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency
testing program within the time frame for submitting proficiency testing
results of the suspension of patient testing and the circumstances
associated with failure to perform tests on proficiency testing samples;
and
(3) The laboratory participated in the previous two proficiency
testing events.
(d) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(e)(1) For any unsatisfactory analyte or test performance or testing
event for reasons other than a failure to participate, the laboratory
must undertake appropriate training and employ the technical assistance
necessary to correct problems associated with a proficiency testing
failure.
(2) For any unacceptable analyte or testing event score, remedial
action must be taken and documented, and the documentation must be
maintained by the laboratory for two years from the date of
participation in the proficiency testing event.
(f) Failure to achieve satisfactory performance for the same analyte
or test in two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
(g) Failure to achieve an overall testing event score of satisfactory
performance for two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
42 CFR 493.849 Condition: Hematology.
The specialty of hematology, for the purpose of proficiency testing,
is not subdivided into subspecialties of testing.
42 CFR 493.851 Standard; Hematology.
(a) Failure to attain a score of at least 80 percent of acceptable
responses for each analyte in each testing event is unsatisfactory
analyte performance for the testing event.
(b) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(c) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if --
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency
testing program within the time frame for submitting proficiency testing
results of the suspension of patient testing and the circumstances
associated with failure to perform tests on proficiency testing samples;
and
(3) The laboratory participated in the previous two proficiency
testing events.
(d) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(e)(1) For any unsatisfactory analyte or test performance or testing
event for reasons other than a failure to participate, the laboratory
must undertake appropriate training and employ the technical assistance
necessary to correct problems associated with a proficiency testing
failure.
(2) For any unacceptable analyte or testing event score, remedial
action must be taken and documented, and the documentation must be
maintained by the laboratory for two years from the date of
participation in the proficiency testing event.
(f) Failure to achieve satisfactory performance for the same analyte
in two consecutive events or two out of three consecutive testing events
is unsuccessful performance.
(g) Failure to achieve an overall testing event score of satisfactory
performance for two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
42 CFR 493.853 Condition: Pathology.
The specialty of pathology includes, for purposes of proficiency
testing, the subspecialty of cytology limited to gynecologic
examinations.
42 CFR 493.855 Standard; Cytology: gynecologic examinations.
To participate successfully in a cytology proficiency testing program
for gynecologic examinations (Pap smears), the laboratory must meet the
requirements of paragraphs (a) through (c) of this section.
(a) The laboratory must ensure that each individual engaged in the
examination of gynecologic preparations is enrolled in a proficiency
testing program approved by HCFA by January 1, 1994. The laboratory
must ensure that each individual is tested at least once per year and
obtains a passing score. To ensure this annual testing of individuals,
an announced or unannounced testing event will be conducted on-site in
each laboratory at least once each year. Laboratories will be notified
of the time of each announced on-site testing event at least 30 days
prior to each event. Additional testing events will be conducted as
necessary in each State or region for the purpose of testing individuals
who miss the on-site testing event and for retesting individuals as
described in paragraph (b) of this section.
(b) The laboratory must ensure that each individual participates in
an annual testing event that involves the examination of a 10-slide test
set as described in 493.945. Individuals who fail this testing event
are retested with another 10-slide test set as described in paragraphs
(b)(1) and (b)(2) of this section. Individuals who fail this second
test are subsequently retested with a 20-slide test set as described in
paragraphs (b)(2) and (b)(3) of this section. Individuals are given not
more than 2 hours to complete a 10-slide test and not more than 4 hours
to complete a 20-slide test. Unexcused failure to appear by an
individual for a retest will result in test failure with resulting
remediation and limitations on slide examinations as specified in
(b)(1), (b)(2), and (b)(3) of this section.
(1) An individual is determined to have failed the annual testing
event if he or she scores less than 90 percent on a 10-slide test set.
For an individual who fails an annual proficiency testing event, the
laboratory must schedule a retesting event which must take place not
more than 45 days after receipt of the notification of failure.
(2) An individual is determined to have failed the second testing
event if he or she scores less than 90 percent on a 10-slide test set.
For an individual who fails a second testing event, the laboratory must
provide him or her with documented, remedial training and education in
the area of failure, and must assure that all gynecologic slides
evaluated subsequent to the notice of failure are reexamined until the
individual is again retested with a 20-slide test set and scores at
least 90 percent. Reexamination of slides must be documented.
(3) An individual is determined to have failed the third testing
event if he or she scores less than 90 percent on a 20-slide test set.
An individual who fails the third testing event must cease examining
gynecologic slide preparations immediately upon notification of test
failure and may not resume examining gynecologic slides until the
laboratory assures that the individual obtains at least 35 hours of
documented, formally structured, continuing education in diagnostic
cytopathology that focuses on the examination of gynecologic
preparations, and until he or she is retested with a 20-slide test set
and scores at least 90 percent.
(c) If a laboratory fails to ensure that individuals are tested or
those who fail a testing event are retested, or fails to take required
remedial actions as described in paragraphs (b)(1), (b)(2) or (b)(3) of
this section, HCFA will initiate intermediate sanctions or revoke the
laboratory's certificate for gynecologic cytology testing under CLIA,
and, if applicable, terminate the laboratory's Medicare approval for
gynecologic cytology testing in accordance with subpart R of this part.
42 CFR 493.857 Condition: Immunohematology.
The specialty of immunohematology includes four subspecialties for
the purposes of proficiency testing: ABO group and D (Rho) typing;
unexpected antibody detection; compatibility testing; and antibody
identification.
42 CFR 493.859 Standard; ABO group and D (Rho) typing.
(a) Failure to attain a score of at least 100 percent of acceptable
responses for each analyte or test in each testing event is
unsatisfactory analyte performance for the testing event.
(b) Failure to attain an overall testing event score of at least 100
percent is unsatisfactory performance.
(c) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if --
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency
testing program within the time frame for submitting proficiency testing
results of the suspension of patient testing and the circumstances
associated with failure to perform tests on proficiency testing samples;
and
(3) The laboratory participated in the previous two proficiency
testing events.
(d) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(e)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unacceptable analyte or unsatisfactory testing event
score, remedial action must be taken and documented, and the
documentation must be maintained by the laboratory for two years from
the date of participation in the proficiency testing event.
(f) Failure to achieve satisfactory performance for the same analyte
in two consecutive testing events or two out of three consecutive
testing events is unsuccessful performance.
(g) Failure to achieve an overall testing event score of satisfactory
for two consecutive testing events or two out of three consecutive
testing events is unsuccessful performance.
42 CFR 493.861 Standard; Unexpected antibody detection.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if --
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency
testing program within the time frame for submitting proficiency testing
results of the suspension of patient testing and the circumstances
associated with failure to perform tests on proficiency testing samples;
and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unsatisfactory testing event score, remedial action must
be taken and documented, and the documentation must be maintained by the
laboratory for two years from the date of participation in the
proficiency testing event.
(e) Failure to achieve an overall testing event score of satisfactory
for two consecutive testing events or two out of three consecutive
testing events is unsuccessful performance.
42 CFR 493.863 Standard; Compatibility testing.
(a) Failure to attain an overall testing event score of at least 100
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if --
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency
testing program within the time frame for submitting proficiency testing
results of the suspension of patient testing and the circumstances
associated with failure to perform tests on proficiency testing samples;
and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unsatisfactory testing event score, remedial action must
be taken and documented, and the documentation must be maintained by the
laboratory for two years from the date of participation in the
proficiency testing event.
(e) Failure to achieve an overall testing event score of satisfactory
for two consecutive testing events or two out of three consecutive
testing events is unsuccessful performance.
42 CFR 493.865 Standard; Antibody identification.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if --
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency
testing program within the time frame for submitting proficiency testing
results of the suspension of patient testing and the circumstances
associated with failure to perform tests on proficiency testing samples;
and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unsatisfactory testing event score, remedial action must
be taken and documented, and the documentation must be maintained by the
laboratory for two years from the date of participation in the
proficiency testing event.
(e) Failure to identify the same antibody in two consecutive or two
out of three consecutive testing events is unsuccessful performance.
(f) Failure to achieve an overall testing event score of satisfactory
for two consecutive testing events or two out of three consecutive
testing events is unsuccessful performance.
42 CFR 493.865 Subpart I -- Proficiency Testing Programs for Tests of
Moderate or High Complexity, or Both
Source: 57 FR 7151, Feb. 28, 1992, unless otherwise noted.
42 CFR 493.901 Approval of proficiency testing programs.
In order for a proficiency testing program to receive HHS approval,
the program must be offered by a private nonprofit organization or a
Federal or State agency, or entity acting as a designated agent for the
State. An organization, Federal, or State program seeking approval or
reapproval for its program for the next calendar year must submit an
application providing the required information by July 1 of the current
year. The organization, Federal, or State program must provide
technical assistance to laboratories seeking to qualify under the
program, and must, for each specialty, subspecialty, and analyte or test
for which it provides testing --
(a) Assure the quality of test samples, appropriately evaluate and
score the testing results, and identify performance problems in a timely
manner;
(b) Demonstrate to HHS that it has --
(1) The technical ability required to --
(i) Prepare or purchase samples from manufacturers who prepare the
samples in conformance with the appropriate good manufacturing practices
required in 21 CFR parts 606, 640, and 820; and
(ii) Distribute the samples, using rigorous quality control to assure
that samples mimic actual patient specimens when possible and that
samples are homogeneous, except for specific subspecialties such as
cytology, and will be stable within the time frame for analysis by
proficiency testing participants;
(2) A scientifically defensible process for determining the correct
result for each challenge offered by the program;
(3) A program of sufficient annual challenge and with the frequency
specified in 493.90 through 493.959 to establish that a laboratory has
met minimum performance requirements;
(4) The resources needed to provide Statewide or nationwide reports
to regulatory agencies on individual's performance for gynecologic
cytology and on individual laboratory performance on testing events,
cumulative reports and scores for each laboratory or individual, and
reports of specific laboratory failures using grading criteria
acceptable to HHS. These reports must be provided to HHS on a timely
basis when requested;
(5) Provisions to include on each proficiency testing program report
form used by the laboratory to record testing event results, an
attestation statement that proficiency testing samples were tested in
the same manner as patient specimens with a signature block to be
completed by the individual performing the test as well as by the
laboratory director;
(6) A mechanism for notifying participants of the PT shipping
schedule and for participants to notify the proficiency testing program
within three days of the expected date of receipt of the shipment that
samples have not arrived or are unacceptable for testing. The program
must have provisions for replacement of samples that are lost in transit
or are received in a condition that is unacceptable for testing; and
(7) A process to resolve technical, administrative, and scientific
problems about program operations;
(c) Meet the specific criteria for proficiency testing programs
listed by specialty, subspecialty, and analyte or test contained in
493.901 through 493.959 for initial approval and thereafter provide HHS,
on an annual basis, with the information necessary to assure that the
proficiency testing program meets the criteria required for approval;
and
(d) Comply with all applicable packaging, shipment, and notification
requirements of 42 CFR part 72.
42 CFR 493.903 Administrative responsibilities.
The proficiency testing program must --
(a)(1) Provide HHS or its designees and participating laboratories
with an electronic or a hard copy, or both, of reports of proficiency
testing results and all scores for each laboratory's performance in a
format as required by and approved by HCFA for each CLIA-certified
specialty, subspecialty, and analyte or test within 60 days after the
date by which the laboratory must report proficiency testing results to
the proficiency testing program.
(2) Provide HHS with reports of PT results and scores of individual
performance in cytology and provide copies of reports to participating
individuals, and to all laboratories that employ the individuals, within
15 working days of the testing event;
(b) Furnish to HHS cumulative reports on an individual laboratory's
performance and aggregate data on CLIA-certified laboratories for the
purpose of establishing a system to make the proficiency testing results
available, on a reasonable basis, upon request of any person, and
include such explanatory information as may be appropriate to assist in
the interpretation of the proficiency testing results;
(c) Provide HHS with additional information and data upon request and
submit such information necessary for HHS to conduct an annual
evaluation to determine whether the proficiency testing program
continues to meet the requirements of 493.901 through 493.959;
(d) Maintain records of laboratories' performance for a period of
five years or such time as may be necessary for any legal proceedings;
and
(e) Provide HHS with an annual report and, if needed, an interim
report which identifies any previously unrecognized sources of
variability in kits, instruments, methods, or PT samples, which
adversely affect the programs' ability to evaluate laboratory
performance.
42 CFR 493.905 Nonapproved proficiency testing programs.
If a proficiency testing program is determined by HHS to fail to meet
any criteria contained in 493.901 through 493.959 for approval of the
proficiency testing program, HCFA will notify the program and the
program must notify all laboratories enrolled of the nonapproval and the
reasons for nonapproval within 30 days of the notification.
42 CFR 493.905 Proficiency Testing Programs by Specialty and Subspecialty
42 CFR 493.909 Microbiology.
The subspecialties under the specialty of microbiology for which a
program may offer proficiency testing are bacteriology,
mycobacteriology, mycology, parasitology and virology. Specific
criteria for these subspecialties are found at 493.911 through
493.919.
42 CFR 493.911 Bacteriology.
(a) Types of services offered by laboratories. In bacteriology, for
proficiency testing purposes, there are five types of laboratories:
(1) Those that interpret Gram stains or perform primary inoculation,
or both; and refer cultures to another laboratory appropriately
certified for the subspecialty of bacteriology for identification;
(2) Those that use direct antigen techniques to detect an organism
and may also interpret Gram stains or perform primary inoculation, or
perform any combination of these;
(3) Those that, in addition to interpreting Gram stains, performing
primary inoculations, and using direct antigen tests, also isolate and
identify aerobic bacteria from throat, urine, cervical, or urethral
discharge specimens to the genus level and may also perform
antimicrobial susceptibility tests on selected isolated microorganisms;
(4) Those that perform the services in paragraph (a)(3) of this
section and also isolate and identify aerobic bacteria from any source
to the species level and may also perform antimicrobial susceptibility
tests; and
(5) Those that perform the services in paragraph (a)(4) of this
section and also isolate and identify anaerobic bacteria from any
source.
(b) Program content and frequency of challenge. To be approved for
proficiency testing for bacteriology, the annual program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The samples
may be provided to the laboratory through mailed shipments or, at HHS'
option, may be provided to HHS or its designee for on-site testing. For
the types of laboratories specified in paragraph (a) of this section, an
annual program must include samples that contain organisms that are
representative of the six major groups of bacteria: anaerobes,
Enterobacteriaceae, gram-positive bacilli, gram-positive cocci,
gram-negative cocci, and miscellaneous gram-negative bacteria, as
appropriate. The specific organisms included in the samples may vary
from year to year. The annual program must include samples for
bacterial antigen detection, bacterial isolation and identification,
Gram stain, and antimicrobial susceptibility testing.
(1) An approved program must furnish HHS with a description of
samples that it plans to include in its annual program no later than six
months before each calendar year. At least 50 percent of the samples
must be mixtures of the principal organism and appropriate normal flora.
The program must include other important emerging pathogens (as
determined by HHS) and either organisms commonly occurring in patient
specimens or opportunistic pathogens. The program must include the
following two types of samples; each type of sample must meet the 50
percent mixed culture criterion:
(i) Samples that require laboratories to report only organisms that
the testing laboratory considers to be a principal pathogen that is
clearly responsible for a described illness (excluding
immuno-compromised patients). The program determines the reportable
isolates, including antimicrobial susceptibility for any designated
isolate; and
(ii) Samples that require laboratories to report all organisms
present. Samples must contain multiple organisms frequently found in
specimens such as urine, blood, abscesses, and aspirates where multiple
isolates are clearly significant or where specimens are derived from
immuno-compromised patients. The program determines the reportable
isolates.
(2) An approved program may vary over time. For example, the types
of organisms that might be included in an approved program over time are
--
Anaerobes:
Bacteroides fragilis group
Clostridium perfringens
Peptostreptococcus anaerobius
Enterobacteriaceae:
Citrobacter freundii
Enterobacter aerogenes
Escherichia coli
Klebsiella pneumoniae
Proteus mirabilis
Salmonella typhimurium
Serratia marcescens
Shigella sonnei
Yersinia enterocolitica
Gram-positive bacilli:
Listeria monocytogenes
Corynebacterium species CDC Group JK
Gram-positive cocci:
Staphylococcus aureus
Streptococcus Group A
Streptococcus Group B
Streptococcus Group D (S. bovis and enterococcus)
Streptococcus pneumoniae
Gram-negative cocci:
Branhamella catarrhalis
Neisseria gonorrhoeae
Neisseria meningitidis
Miscellaneous Gram-negative bacteria:
Campylobacter jejuni
Haemophilis influenza, Type B
Pseudomonas aeruginosa
(3) For antimicrobial susceptibility testing, the program must
provide at least one sample per testing event that includes
gram-positive or gram-negative strains that have a predetermined pattern
of sensitivity or resistance to the common antimicrobial agents.
(c) Evaluation of a laboratory's performance. HHS approves only
those programs that assess the accuracy of a laboratory's responses in
accordance with paragraphs (c) (1) through (7) of this section.
(1) The program determines staining characteristics to be interpreted
by Gram stain. The program determines the reportable bacteria to be
detected by direct antigen techniques or isolation. To determine the
accuracy of a laboratory's response for Gram stain interpretation,
direct antigen detection, identification, or antimicrobial
susceptibility testing, the program must compare the laboratory's
response for each sample with the response which reflects agreement of
either 90 percent of ten or more referee laboratories or 90 percent or
more of all participating laboratories.
(2) To evaluate a laboratory's response for a particular sample, the
program must determine a laboratory's type of service in accordance with
paragraph (a) of this section. A laboratory must isolate and identify
the organisms to the same extent it performs these procedures on patient
specimens. A laboratory's performance will be evaluated on the basis of
its final answer, for example, a laboratory specified in paragraph
(a)(3) of this section will be evaluated on the basis of the average of
its scores for paragraphs (c)(3) through (c)(6) as determined in
paragraph (c)(7) of this section.
(3) Since laboratories may incorrectly report the presence of
organisms in addition to the correctly identified principal organism(s),
the grading system must provide a means of deducting credit for
additional erroneous organisms that are reported. Therefore, the total
number of correct responses for organism isolation and identification
submitted by the laboratory divided by the number of organisms present
plus the number of incorrect organisms reported by the laboratory must
be multiplied by 100 to establish a score for each sample in each
testing event. For example, if a sample contained one principal
organism and the laboratory reported it correctly but reported the
presence of an additional organism, which was not considered reportable,
the sample grade would be 1/(1+1) 100=50 percent.
(4) For antimicrobial susceptibility testing, a laboratory must
indicate which drugs are routinely included in its test panel when
testing patient samples. A laboratory's performance will be evaluated
for only those antibiotics for which service is offered. A correct
response for each antibiotic will be determined as described in
493.911(c) (1) using criteria such as the guidelines established by the
National Committee for Clinical Laboratory Standards. Grading is based
on the number of correct susceptibility responses reported by the
laboratory divided by the actual number of correct susceptibility
responses determined by the program, multiplied by 100. For example, if
a laboratory offers susceptibility testing for Enterobacteriaceae using
amikacin, cephalothin, and tobramycin, and the organism in the
proficiency testing sample is an Enterobacteriaceae, and the laboratory
reports correct responses for two of three antimicrobial agents, the
laboratory's grade would be 2/3 100=67 percent.
(5) The performance criterion for qualitative antigen tests is the
presence or absence of the bacterial antigen. The score for antigen
tests is the number of correct responses divided by the number of
samples to be tested for the antigen, multiplied by 100.
(6) The performance criteria for Gram stain is staining reaction,
i.e., gram positive or gram negative. The score for Gram stain is the
number of correct responses divided by the number of samples to be
tested, multiplied by 100.
(7) The score for a testing event in bacteriology is the average of
the scores determined under paragraphs (c)(3) through (c)(6) of this
section kbased on the type of service offered by the laboratory.
42 CFR 493.913 Mycobacteriology.
(a) Types of services offered by laboratories. In mycobacteriology,
there are five types of laboratories for proficiency testing purposes:l
(1) Those that interpret acid-fast stains and refer specimen to
another laboratory appropriately certified in the subspecialty of
mycobacteriology;
(2) Those that interpret acid-fast stains, perform primary
inoculation, and refer cultures to another laboratory appropriately
certified in the subspecialty of mycobacteriology for identification;
(3) Those that interpret acid-fast stains, isolate and perform
identification and/or antimycobacterial susceptibility of Mycobacterium
tuberculosis, but refer other mycobacteria species to another laboratory
appropriately certified in the subspecialty of mycobacteriology for
identification and/or susceptibility tests;
(4) Those that interpret acid-fast stains, isolate and identify all
mycobacteria to the extent required for correct clinical diagnosis, but
refer antimycobacterial susceptibility tests to another laboratory
appropriately certified in the subspecialty of mycobacteriology; and
(5) Those that interpret acid-fast stains, isolate and identify all
mycobacteria to the extent required for correct clinical diagnosis, and
perform antimycobacterial susceptibility tests on the organisms
isolated.
(b) Program content and frequency of challenge. To be approved for
proficiency testing for mycobacteriology, the annual program must
provide a minimum of five samples per testing event. There must be at
least two testing events per year. The samples may be provided through
mailed shipments or, at HHS' option, provided to HHS or its designee for
on-site testing events. For types of laboratories specified in
paragraphs (a)(1) and (a) (3) through (5) of this section, an annual
program must include samples that contain species that are
representative of the 5 major groups (complexes) of mycobacteria
encountered in human specimens. The specific mycobacteria included in
the samples may vary from year to year.
(1) An approved program must furnish HHS and its agents with a
description of samples that it plans to include in its annual program no
later than six months before each calendar year. At least 50 percent of
the samples must be mixtures of the principal mycobacteria and
appropriate normal flora. The program must include mycobacteria
commonly occurring in patient specimens and other important emerging
mycobacteria (as determined by HHS). The program determines the
reportable isolates and correct responses for antimycobacterial
susceptibility for any designated isolate.
(2) An approved program may vary over time. For example, the types
of mycobacteria that might be included in an approved program over time
are --
TB
Mycobacterium tuberculosis
Mycobacterium bovis
Group I
Mycobacterium kansasii
Group II
Mycobacterium szulgai
Group III
Mycobacterium avium-intracellulare
Mycobacterium terrae
Group IV
Mycobacterium fortuitum
(3) For antimycobacterial susceptibility testing, the program must
provide at least one sample per testing event that includes
mycobacterium tuberculosis that has a predetermined pattern of
sensitivity or resistance to the common antimycobacterial agents.
(4) For laboratories specified in paragraphs (a)(1) and (a)(2), the
program must provide at least five samples per testing event that
includes challenges that are acid-fast and challenges which do not
contain acid-fast organisms.
(c) Evaluation of a laboratory's performance. HHS approves only
those programs that assess the accuracy of a laboratory's response in
accordance with paragraphs (c) (1) through (6) of this section.
(1) The program determines the reportable mycobacteria to be detected
by acid-fast stain and for isolation and identification. To determine
the accuracy of a laboratory's response, the program must compare the
laboratory's response for each sample with the response that reflects
agreement of either 90 percent of ten or more referee laboratories or 90
percent or more of all participating laboratories.
(2) To evaluate a laboratory's response for a particular sample, the
program must determine a laboratory's type of service in accordance with
paragraph (a) of this section. A laboratory must interpret acid-fast
stains and isolate and identify the organisms to the same extent it
performs these procedures on patient specimens. A laboratory's
performance will be evaluated on the basis of the average of its scores
as determined in paragraph (c)(6) of this section.
(3) Since laboratories may incorrectly report the presence of
organisms in addition to the correctly identified principal organism(s),
the grading system must provide a means of deducting credit for
additional erroneous organisms reported. Therefore, the total number of
correct responses submitted by the laboratory divided by the number of
organisms present plus the number of incorrect organisms reported by the
laboratory must be multiplied by 100 to establish a score for each
sample in each testing event. For example, if a sample contained one
principal organism and the laboratory reported it correctly but reported
the presence of an additional organism, which was not present, the
sample grade would be
1/(1+1) 100=50 percent
(4) For antimycobacterial susceptibility testing, a laboratory must
indicate which drugs are routinely included in its test panel when
testing patient samples. A laboratory's performance will be evaluated
for only those antibiotics for which susceptibility testing is routinely
performed on patient specimens. A correct response for each antibiotic
will be determined as described in 493.913(c)(1). Grading is based on
the number of correct susceptibility responses reported by the
laboratory divided by the actual number of correct susceptibility
responses as determined by the program, multiplied by 100. For example,
if a laboratory offers susceptibility testing using three
antimycobacterial agents and the laboratory reports correct response for
two of the three antimycobacterial agents, the laboratory's grade would
be 2/3 100=67 percent.
(5) The performance criterion for qualitative tests is the presence
or absence of acid-fast organisms. The score for acid-fast organism
detection is the number of correct responses divided by the number of
samples to be tested, multiplied by 100.
(6) The score for a testing event in mycobacteriology is the average
of the scores determined under paragraphs (c)(3) through (c)(5) of this
section based on the type of service offered by the laboratory.
42 CFR 493.915 Mycology.
(a) Types of services offered by laboratories. In mycology, there
are four types of laboratories for proficiency testing purposes that may
perform different levels of service for yeasts, dimorphic fungi,
dermatophytes, and aerobic actinomycetes:
(1) Those that isolate and identify only yeasts and/or dermatophytes
to the genus level;
(2) Those that isolate and identify yeasts and/or dermatophytes to
the species level;
(3) Those that isolate and perform identification of all organisms to
the genus level; and
(4) Those that isolate and perform identification of all organisms to
the species level.
(b) Program content and frequency of challenge. To be approved for
proficiency testing for mycology, the annual program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The samples
may be provided through mailed shipments or, at HHS' option, may be
provided to HHS or its designee for on-site testing. An annual program
must include samples that contain organisms that are representative of
five major groups of fungi: Yeast or yeast-like fungi; dimorphic
fungi; dematiaceous fungi; dermatophytes; and saprophytes, including
opportunistic fungi. The specific fungi included in the samples may
vary from year to year.
(1) An approved program must, before each calendar year, furnish HHS
with a description of samples that it plans to include in its annual
program no later than six months before each calendar year. At least 50
percent of the samples must be mixtures of the principal organism and
appropriate normal background flora. Other important emerging pathogens
(as determined by HHS) and organisms commonly occurring in patient
specimens must be included periodically in the program.
(2) An approved program may vary over time. As an example, the types
of organisms that might be included in an approved program over time are
--
Candida albicans
Candida (other species)
Cryptococcus neoformans
Sporothrix schenckii
Exophiala jeanselmei
Fonsecaea pedrosoi
Microsporum sp.
Acremonium sp.
Trichophvton sp.
Aspergillus fumigatus
Nocardia sp.
Blastomyces dermatitidis /1/
Zygomycetes sp.
Note: /1/ Provided as a nonviable sample.
(c) Evaluation of a laboratory's performance. HHS approves only
those programs that assess the accuracy of a laboratory's response, in
accordance with paragraphs (c)(1) through (5) of this section.
(1) The program determines the reportable organisms. To determine
the accuracy of a laboratory's response, the program must compare the
laboratory's response for each sample with the response that reflects
agreement of either 90 percent of ten or more referee laboratories or 90
percent or more of all participating laboratories.
(2) To evaluate a laboratory's response for a particular sample, the
program must determine a laboratory's type of service in accordance with
paragraph (a) of this section. A laboratory must isolate and identify
the organisms to the same extent it performs these procedures on patient
specimens.
(3) Since laboratories may incorrectly report the presence of
organisms in addition to the correctly identified principal organism(s),
the grading system must deduct credit for additional erroneous organisms
reported. Therefore, the total number of correct responses submitted by
the laboratory divided by the number of organisms present plus the
number of incorrect organisms reported by the laboratory must be
multiplied by 100 to establish a score for each sample in each shipment
or testing event. For example, if a sample contained one principal
organism and the laboratory reported it correctly but reported the
presence of an additional organism, which was not present, the sample
grade would be 1/(1+1)x100=50 percent.
(4) The score for the antigen tests is the number of correct
responses divided by the number of samples to be tested for the antigen,
multiplied by 100.
(5) The score for a testing event is the average of the sample scores
as determined under paragraph (c)(3) or (c)(4) of this section.
42 CFR 493.917 Parasitology.
(a) Types of services offered by laboratories. In parasitology there
are two types of laboratories for proficiency testing purposes --
(1) Those that determine the presence or absence of parasites by
direct observation (wet mount) and/or pinworm preparations and, if
necessary, refer specimens to another laboratory appropriately certified
in the subspecialty of parasitology for identification;
(2) Those that identify parasites using concentration preparations
and/or permanent stains.
(b) Program content and frequency of challenge. To be approved for
proficiency testing in parasitology, a program must provide a minimum of
five samples per testing event. There must be at least three testing
events at approximately equal intervals per year. The samples may be
provided through mailed shipments or, at HHS's option, may be provided
to HHS or its designee for on-site testing. An annual program must
include samples that contain parasites that are commonly encountered in
the United States as well as those recently introduced into the United
States. Other important emerging pathogens (as determined by HHS) and
parasites commonly occurring in patient specimens must be included
periodically in the program.
(1) An approved program must, before each calendar year furnish HHS
with a description of samples that it plans to include in its annual
program no later than six months before each calendar year. Samples
must include both formalinized specimens and PVA (polyvinyl alcohol)
fixed specimens as well as blood smears, as appropriate for a particular
parasite and stage of the parasite. The majority of samples must
contain protozoa or helminths or a combination of parasites. Some
samples must be devoid of parasites.
(2) An approved program may vary over time. As an example, the types
of parasites that might be included in an approved program over time are
--
Enterobius vermicularis
Entamoeba histolytica
Entamoeba coli
Giardia lamblia
Endolimax nana
Dientamoeba fragilis
Iodamoeba butschli
Chilomastix mesnili
Hookworm
Ascaris lumbricoides
Strongyloides stercoralis
Trichuris trichiura
Diphyllobothrium latum
Cryptosporidium sp.
Plasmodium falciparum
(3) For laboratories specified in paragraph (a)(1) of this section,
the program must provide at least five samples per testing event that
include challenges which contain parasites and challenges that are
devoid of parasites.
(c) Evaluation of a laboratory's performance. HHS approves only
those programs that assess the accuracy of a laboratory's responses in
accordance with paragraphs (c) (1) through (6) of this section.
(1) The program must determine the reportable parasites. It may
elect to establish a minimum number of parasites to be identified in
samples before they are reported. Parasites found in rare numbers by
referee laboratories are not considered in scoring a laboratory's
performance; such findings are neutral. To determine the accuracy of a
laboratory's response, the program must compare the laboratory's
response with the response that reflects agreement of either 90 percent
of ten or more referee laboratories or 90 percent or more of all
participating laboratories.
(2) To evaluate a laboratory's response for a particular sample, the
program must determine a laboratory's type of service in accordance with
paragraph (a) of this section. A laboratory must determine the presence
or absence of a parasite(s) or concentrate and identify the parasites to
the same extent it performs these procedures on patient specimens.
(3) Since laboratories may incorrectly report the presence of
parasites in addition to the correctly identified principal parasite(s),
the grading system must deduct credit for these additional erroneous
parasites reported and not found in rare numbers by the program's
referencing process. Therefore, the total number of correct responses
submitted by the laboratory divided by the number of parasites present
plus the number of incorrect parasites reported by the laboratory must
be multiplied by 100 to establish a score for each sample in each
testing event. For example, if a sample contained one principal
parasite and the laboratory reported it correctly but reported the
presence of an additional parasite, which was not present, the sample
grade would be
1/(1+1) 100=50 percent.
(4) The criterion for acceptable performance for qualitative
parasitology examinations is presence or absence of a parasite(s).
(5) The score for parasitology is the number of correct responses
divided by the number of samples to be tested, multiplied by 100.
(6) The score for a testing event is the average of the sample scores
as determined under paragraphs (c)(3) through (c)(5) of this section.
42 CFR 493.919 Virology.
(a) Types of services offered by laboratories. In virology, there
are two types of laboratories for proficiency testing purposes --
(1) Those that only perform tests that directly detect viral antigens
or structures, either in cells derived from infected tissues or free in
fluid specimens; and
(2) Those that are able to isolate and identify viruses and use
direct antigen techniques.
(b) Program content and frequency of challenge. To be approved for
proficiency testing in virology, a program must provide a minimum of
five samples per testing event. There must be at least three testing
events at approximately equal intervals per year. The samples may be
provided to the laboratory through mailed shipments or, at HHS's option,
may be provided to HHS or its designee for on-site testing. An annual
program must include viral species that are the more commonly identified
viruses. The specific organisms found in the samples may vary from year
to year. The annual program must include samples for viral antigen
detection and viral isolation and identification.
(1) An approved program must furnish HHS with a description of
samples that it plans to include in its annual program no later than six
months before each calendar year. The program must include other
important emerging viruses (as determined by HHS) and viruses commonly
occurring in patient specimens.
(2) An approved program may vary over time. For example, the types
of viruses that might be included in an approved program over time are
the more commonly identified viruses such as Herpes simplex, respiratory
syncytial virus, adenoviruses, enteroviruses, and cytomegaloviruses.
(c) Evaluation of laboratory's performance. HHS approves only those
programs that assess the accuracy of a laboratory's response in
accordance with paragraphs (c) (1) through (5) of this section.
(1) The program determines the reportable viruses to be detected by
direct antigen techniques or isolated by laboratories that perform viral
isolation procedures. To determine the accuracy of a laboratory's
response, the program must compare the laboratory's response for each
sample with the response that reflects agreement of either 90 percent of
ten or more referee laboratories or 90 percent or more of all
participating laboratories.
(2) To evaluate a laboratory's response for a particular sample, the
program must determine a laboratory's type of service in accordance with
paragraph (a) of this section. A laboratory must isolate and identify
the viruses to the same extent it performs these procedures on patient
specimens.
(3) Since laboratories may incorrectly report the presence of viruses
in addition to the correctly identified principal virus, the grading
system must provide a means of deducting credit for additional erroneous
viruses reported. Therefore, the total number of correct responses
determined by virus culture techniques submitted by the laboratory
divided by the number of viruses present plus the number of incorrect
viruses reported by the laboratory must be multiplied by 100 to
establish a score for each sample in each testing event. For example,
if a sample contained one principal virus and the laboratory reported it
correctly but reported the presence of an additional virus, which was
not present, the sample grade would be 1/(1+1) 100=50 percent.
(4) The performance criterion for qualitative antigen tests is
presence or absence of the viral antigen. The score for the antigen
tests is the number of correct responses divided by the number of
samples to be tested for the antigen, multiplied by 100.
(5) The score for a testing event is the average of the sample scores
as determined under paragraph (c)(3) and (c)(4) of this section.
42 CFR 493.921 Diagnostic immunology.
The subspecialties under the specialty of immunology for which a
program may offer proficiency testing are syphilis serology and general
immunology. Specific criteria for these subspecialties are found at
493.923 and 493.927.
42 CFR 493.923 Syphilis serology.
(a) Program content and frequency of challenge. To be approved for
proficiency testing in syphilis serology, a program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The samples
may be provided through mailed shipments or, at HHS' option, may be
provided to HHS or its designee for on-site testing. An annual program
must include samples that cover the full range of reactivity from highly
reactive to non-reactive.
(b) Evaluation of test performance. HHS approves only those programs
that assess the accuracy of a laboratory's responses in accordance with
paragraphs (b) (1) through (4) of this section.
(1) To determine the accuracy of a laboratory's response for
qualitative and quantitative syphilis tests, the program must compare
the laboratory's response with the response that reflects agreement of
either 90 percent of ten or more referee laboratories or 90 percent or
more of all participating laboratories. The proficiency testing program
must indicate the minimum concentration, by method, that will be
considered as indicating a positive response. The score for a sample in
syphilis serology is the average of scores determined under paragraphs
(b)(2) and (b)(3) of this section.
(2) For quantitative syphilis tests, the program must determine the
correct response for each method by the distance of the response from
the target value. After the target value has been established for each
response, the appropriateness of the response must be determined by
using either fixed criteria or the number of standard deviations the
response differs from the target value. The criterion for acceptable
performance for quantitative syphilis serology tests is the target value
+/^ 1 dilution.
(3) The criterion for acceptable performance for qualitative syphilis
serology tests is reactive or nonreactive.
(4) To determine the overall testing event score, the number of
correct responses must be averaged using the following formula:
42 CFR 493.927 General immunology.
(a) Program content and frequency of challenge. To be approved for
proficiency testing for immunology, the annual program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The annual
program must provide samples that cover the full range of reactivity
from highly reactive to nonreactive. The samples may be provided
through mailed shipments or, at HHS' option, may be provided to HHS or
its designee for on-site testing.
(b) Challenges per testing event. The minimum number of challenges
per testing event the program must provide for each analyte or test
procedure is five. Analytes or tests for which laboratory performance
is to be evaluated include:
Alpha-l antitrypsin
Alpha-fetoprotein (tumor marker)
Antinuclear antibody
Antistreptolysin O, quantitative
Anti-human immunodeficiency virus (HIV)
Complement C3
Complement C4
Hepatitis markers (HBsAg, anti-HBc, HBeAg)
IgA
IgG
IgE
IgM
Infectious mononucleosis
Rheumatoid factor
Rubella
(c) Evaluation of a laboratory's analyte or test performance. HHS
approves only those programs that assess the accuracy of a laboratory's
responses in accordance with paragraphs (c) (1) through (5) of this
section.
(1) To determine the accuracy of a laboratory's response for
quantitative and qualitative immunology tests or analytes, the program
must compare the laboratory's response for each analyte with the
response that reflects agreement of either 90 percent of ten or more
referee laboratories or 90 percent or more of all participating
laboratories. The proficiency testing program must indicate the minimum
concentration that will be considered as indicating a positive response.
The score for a sample in general immunology is either the score
determined under paragraph (c) (2) or (3) of this section.
(2) For quantitative immunology analytes or tests, the program must
determine the correct response for each analyte by the distance of the
response from the target value. After the target value has been
established for each response, the appropriateness of the response must
be determined by using either fixed criteria or the number of standard
deviations (SDs) the response differs from the target value.
42 CFR 493.927 Criteria for Acceptable Performance
The criteria for acceptable performance are --
(3) The criterion for acceptable performance for qualitative general
immunology tests is positive or negative.
(4) To determine the analyte testing event score, the number of
acceptable analyte responses must be averaged using the following
formula:
(5) To determine the overall testing event score, the number of
correct responses for all analytes must be averaged using the following
formula:
42 CFR 493.929 Chemistry.
The subspecialties under the specialty of chemistry for which a
proficiency testing program may offer proficiency testing are routine
chemistry, endocrinology, and toxicology. Specific criteria for these
subspecialties are listed in 493.931 through 493.939.
42 CFR 493.931 Routine chemistry.
(a) Program content and frequency of challenge. To be approved for
proficiency testing for routine chemistry, a program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The annual
program must provide samples that cover the clinically relevant range of
values that would be expected in patient specimens. The specimens may
be provided through mailed shipments or, at HHS' option, may be provided
to HHS or its designee for on-site testing.
(b) Challenges per testing event. The minimum number of challenges
per testing event a program must provide for each analyte or test
procedure listed below is five serum, plasma or blood samples.
Alanine aminotransferase (ALT/SGPT)
Albumin
Alkaline phosphatase
Amylase
Aspartate aminotransferase (AST/SGOT)
Bilirubin, total
Blood gas (pH, pO2, and pCO2)
Calcium, total
Chloride
Cholesterol, total
Cholesterol, high density lipoprotein
Creatine kinase
Creatine kinase, isoenzymes
Creatinine
Glucose (Excluding measurements on devices cleared by FDA for home
use)
Iron, total
Lactate dehydrogenase (LDH)
LDH isoenzymes
Magnesium
Potassium
Sodium
Total Protein
Triglycerides
Urea Nitrogen
Uric Acid
(c) Evaluation of a laboratory's analyte or test performance. HHS
approves only those programs that assess the accuracy of a laboratory's
responses in accordance with paragraphs (c)(1) through (5) of this
section.
(1) To determine the accuracy of a laboratory's response for
qualitative and quantitative chemistry tests or analytes, the program
must compare the laboratory's response for each analyte with the
response that reflects agreement of either 90 percent of ten or more
referee laboratories or 90 percent or more of all participating
laboratories. The score for a sample in routine chemistry is either the
score determined under paragraph (c)(2) or (3) of this section.
(2) For quantitative chemistry tests or analytes, the program must
determine the correct response for each analyte by the distance of the
response from the target value. After the target value has been
established for each response, the appropriateness of the response must
be determined by using either fixed criteria based on the percentage
difference from the target value or the number of standard deviations
(SDs) the response differs from the target value.
42 CFR 493.931 Criteria for Acceptable Performance
The criteria for acceptable performance are --
(3) The criterion for acceptable performance for qualitative routine
chemistry tests is positive or negative.
(4) To determine the analyte testing event score, the number of
acceptable analyte responses must be averaged using the following
formula:
(5) To determine the overall testing event score, the number of
correct responses for all analytes must be averaged using the following
formula:
42 CFR 493.933 Endocrinology.
(a) Program content and frequency of challenge. To be approved for
proficiency testing for endocrinology, a program must provide a minimum
of five samples per testing event. There must be at least three testing
events at approximately equal intervals per year. The annual program
must provide samples that cover the clinically relevant range of values
that would be expected in patient specimens. The samples may be
provided through mailed shipments or, at HHS' option, may be provided to
HHS or its designee for on-site testing.
(b) Challenges per testing event. The minimum number of challenges
per testing event a program must provide for each analyte or test
procedure is five serum, plasma, blood, or urine samples.
Cortisol
Free Thyroxine
Human Chorionic Gonadotropin
T3 Uptake
Triiodothyronine
Thyroid-stimulating hormone
Thyroxine
(c) Evaluation of a laboratory's analyte or test performance. HHS
approves only those programs that assess the accuracy of a laboratory's
responses in accordance with paragraphs (c) (1) through (5) of this
section.
(1) To determine the accuracy of a laboratory's response for
qualitative and quantitative endocrinology tests or analytes, a program
must compare the laboratory's response for each analyte with the
response that reflects agreement of either 90 percent of ten or more
referee laboratories or 90 percent or more of all participating
laboratories. The score for a sample in endocrinology is either the
score determined under paragraph (c)(2) or (c)(3) of this section.
(2) For quantitative endocrinology tests or analytes, the program
must determine the correct response for each analyte by the distance of
the response from the target value. After the target value has been
established for each response, the appropriateness of the response must
be determined by using either fixed criteria based on the percentage
difference from the target value or the number of standard deviations
(SDs) the response differs from the target value.
42 CFR 493.933 Criteria for Acceptable Performance
The criteria for acceptable performance are --
(3) The criterion for acceptable performance for qualitative
endocrinology tests is positive or negative.
(4) To determine the analyte testing event score, the number of
acceptable analyte responses must be averaged using the following
formula:
(5) To determine the overall testing event score, the number of
correct responses for all analytes must be averaged using the following
formula:
42 CFR 493.937 Toxicology.
(a) Program content and frequency of challenge. To be approved for
proficiency testing for toxicology, the annual program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The annual
program must provide samples that cover the clinically relevant range of
values that would be expected in specimens of patients on drug therapy
and that cover the level of clinical significance for the particular
drug. The samples may be provided through mailed shipments or, at HHS'
option, may be provided to HHS or its designee for on-site testing.
(b) Challenges per testing event. The minimum number of challenges
per testing event a program must provide for each analyte or test
procedure is five serum, plasma, or blood samples.
Alcohol (blood)
Blood lead
Carbamazepine
Digoxin
Ethosuximide
Gentamicin
Lithium
Phenobarbital
Phenytoin
Primidone
Procainamide
(and metabolite)
Quinidine
Theophylline
Tobramycin
Valproic Acid
(c) Evaluation of a laboratory's analyte or test performance. HHS
approves only those programs that assess the accuracy of a laboratory's
responses in accordance with paragraphs (c)(1) through (4) of this
section.
(1) To determine the accuracy of a laboratory's responses for
quantitative toxicology tests or analytes, the program must compare the
laboratory's response for each analyte with the response that reflects
agreement of either 90 percent of ten or more referee laboratories or 90
percent or more of all participating laboratories. The score for a
sample in toxicology is the score determined under paragraph (c)(2) of
this section.
(2) For quantitative chemistry tests or analytes, the program must
determine the correct response for each analyte by the distance of the
response from the target value. After the target value has been
established for each response, the appropriateness of the response must
be determined by using fixed criteria based on the percentage difference
from the target value
42 CFR 493.937 Criteria for Acceptable Performance
The criteria for acceptable performance are:
(3) To determine the analyte testing event score, the number of
acceptable analyte responses must be averaged using the following
formula:
(4) To determine the overall testing event score, the number of
correct responses for all analytes must be averaged using the following
formula:
42 CFR 493.941 Hematology (including routine hematology and
coagulation).
(a) Program content and frequency of challenge. To be approved for
proficiency testing for hematology, a program must provide a minimum of
five samples per testing event. There must be at least three testing
events at approximately equal intervals per year. The annual program
must provide samples that cover the full range of values that would be
expected in patient specimens. The samples may be provided through
mailed shipments or, at HHS' option, may be provided to HHS and or its
designee for on-site testing.
(b) Challenges per testing event. The minimum number of challenges
per testing event a program must provide for each analyte or test
procedure is five.
Cell identification or white blood cell differential
Erythrocyte count
Hematocrit (excluding spun microhematocrit)
Hemoglobin
Leukocyte count
Platelet count
Fibrinogen
Partial thromboplastin time
Prothrombin time
(1) An approved program for cell identification may vary over time.
The types of cells that might be included in an approved program over
time are --
Neutrophilic granulocytes
Eosinophilic granulocytes
Basophilic granulocytes
Lymphocytes
Monocytes
Major red and white blood cell abnormalities
Immature red and white blood cells
(2) White blood cell differentials should be limited to the
percentage distribution of cellular elements listed above.
(c) Evaluation of a laboratory's analyte or test performance. HHS
approves only those programs that assess the accuracy of a laboratory's
responses in accordance with paragraphs (c) (1) through (5) of this
section.
(1) To determine the accuracy of a laboratory's responses for
qualitative and quantitative hematology tests or analytes, the program
must compare the laboratory's response for each analyte with the
response that reflects agreement of either 90 percent of ten or more
referee laboratories or 90 percent or more of all participating
laboratories. The score for a sample in hematology is either the score
determined under paragraph (c) (2) or (3) of this section.
(2) For quantitative hematology tests or analytes, the program must
determine the correct response for each analyte by the distance of the
response from the target value. After the target value has been
established for each response, the appropriateness of the response is
determined using either fixed criteria based on the percentage
difference from the target value or the number of standard deviations
(SDs) the response differs from the target value.
42 CFR 493.941 Criteria for Acceptable Performance
The criteria for acceptable performance are:
(3) The criterion for acceptable performance for the qualitative
hematology test is correct cell identification.
(4) To determine the analyte testing event score, the number of
acceptable analyte responses must be averaged using the following
formula:
(5) To determine the overall testing event score, the number of
correct responses for all analytes must be averaged using the following
formula:
42 CFR 493.945 Cytology; gynecologic examinations.
(a) Program content and frequency of challenge. (1) To be approved
for proficiency testing for gynecologic examinations (Pap smears) in
cytology, a program must provide test sets composed of 10- and 20-glass
slides. Proficiency testing programs may obtain slides for test sets
from cytology laboratories, provided the slides have been retained by
the laboratory for the required period specified in 493.1257. If slide
preparations are still subject to retention by the laboratory, they may
be loaned to a proficiency testing program if the program provides the
laboratory with documentation of the loan of the slides and ensures that
slides loaned to it are retrievable upon request. Each test set must
include at least one slide representing each of the response categories
described in paragraph (b)(3)(ii)(A) of this section, and test sets
should be comparable so that equitable testing is achieved within and
between proficiency testing providers.
(2) To be approved for proficiency testing in gynecologic cytology, a
program must provide announced and unannounced on-site testing for each
individual at least once per year and must provide an initial retesting
event for each individual within 45 days after notification of test
failure and subsequent retesting events within 45 days after completion
of remedial action described in 493.855.
(b) Evaluation of an individual's performance. HHS approves only
those programs that assess the accuracy of each individual's responses
on both 10- and 20-slide test sets in which the slides have been
referenced as specified in paragraph (b)(1) of this section.
(1) To determine the accuracy of an individual's response on a
particular challenge (slide), the program must compare the individual's
response for each slide preparation with the response that reflects the
predetermined consensus agreement or confirmation on the diagnostic
category, as described in the table in paragraph (b)(3)(ii)(A) of this
section. For all slide preparations, a 100% consensus agreement among a
minimum of three physicians certified in anatomic pathology is required.
In addition, for premalignant and malignant slide preparations,
confirmation by tissue biopsy is required either by comparison of the
reported biopsy results or reevaluation of biopsy slide material by a
physician certified in anatomic pathology.
(2) An individual qualified as a technical supervisor under 493.1449
(b) or (k) who routinely interprets gynecologic slide preparations only
after they have been examined by a cytotechnologist can either be tested
using a test set that has been screened by a cytotechnologist in the
same laboratory or using a test set that has not been screened. A
technical supervisor who screens and interprets slide preparations that
have not been previously examined must be tested using a test set that
has not been previously screened.
(3) The criteria for acceptable performance are determined by using
the scoring system in paragraphs (b)(3) (i) and (ii) of this section.
(i) Each slide set must contain 10 or 20 slides with point values
established for each slide preparation based on the significance of the
relationship of the interpretation of the slide to a clinical condition
and whether the participant in the testing event is a cytotechnologist
qualified under 493.1469 or 493.1483 or functioning as a technical
supervisor in cytology qualified under 493.1449 (b) or (k) of this
part.
(ii) The scoring system rewards or penalizes the participants in
proportion to the distance of their answers from the correct response or
target diagnosis and the penalty or reward is weighted in proportion to
the severity of the lesion.
(A) The four response categories for reporting proficiency testing
results and their descriptions are as follows:
(B) In accordance with the criteria for the scoring system, the
charts in paragraphs (b)(3)(ii)(C) and (D) of this section, for
technical supervisors and cytotechnologists, respectively, provide a
maximum of 10 points for a correct response and a maximum of minus five
(^5) points for an incorrect response on a 10-slide test set. For
example, if the correct response on a slide is ''high grade squamous
intraepithelial lesion'' (category ''D'' on the scoring system chart)
and an examinee calls it ''normal or negative'' (category ''B'' on the
scoring system chart), then the examinee's point value on that slide is
calculated as minus five (^5). Each slide is scored individually in the
same manner. The individual's score for the testing event is determined
by adding the point value achieved for each slide preparation, dividing
by the total points for the testing event and multiplying by 100.
(C) Criteria for scoring system for a 10-slide test set. (See table
at (b)(3)(ii)(A) of this section for a description of the response
categories.) For technical supervisors qualified under 493.1449(b) or
(k):
(D) Criteria for scoring system for a 10-slide test set. (See table
at paragraph (b)(3)(ii)(A) of this section for a description of the
response categories.) For cytotechnologists qualified under 493.1469
or 493.1483:
(E) In accordance with the criteria for the scoring system, the
charts in paragraphs (b)(3)(ii)(F) and (G) of this section, for
technical supervisors and cytotechnologists, respectively, provide
maximums of 5 points for a correct response and minus ten (^10) points
for an incorrect response on a 20-slide test set.
(F) Criteria for scoring system for a 20-slide test set. (See table
at paragraph (b)(3)(ii)(A) of this section for a description of the
response categories.) For technical supervisors qualified under
493.1449(b) or (k):
(G) Criteria for scoring system for a 20-slide test set. (See table
at (b)(3)(ii)(A) of this section for a description of the response
categories.) For cytotechnologists qualified under 493.1469 or
493.1483:
42 CFR 493.959 Immunohematology.
(a) Types of services offered by laboratories. In immunohematology,
there are four types of laboratories for proficiency testing purposes --
(1) Those that perform ABO group and/or D (Rho) typing;
(2) Those that perform ABO group and/or D (Rho) typing, and
unexpected antibody detection;
(3) Those that in addition to paragraph (a)(2) of this section
perform compatibility testing; and
(4) Those that perform in addition to paragraph (a)(3) of this
section antibody identification.
(b) Program content and frequency of challenge. To be approved for
proficiency testing for immunohematology, a program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The annual
program must provide samples that cover the full range of interpretation
that would be expected in patient specimens. The samples may be
provided through mailed shipments or, at HHS' option, may be provided to
HHS or its designee for on-site testing.
(c) Challenges per testing event. The minimum number of challenges
per testing event a program must provide for each analyte or test
procedure is five.
ABO group (excluding subgroups)
D (Rho) typing
Unexpected antibody detection
Compatibility testing
Antibody identification
(d) Evaluation of a laboratory's analyte or test performance. HHS
approves only those programs that assess the accuracy of a laboratory's
response in accordance with paragraphs (d)(1) through (5) of this
section.
(1) To determine the accuracy of a laboratory's response, a program
must compare the laboratory's response for each analyte with the
response that reflects agreement of either 100 percent of ten or more
referee laboratories or 95 percent or more of all participating
laboratories except for unexpected antibody detection and antibody
identification. To determine the accuracy of a laboratory's response
for unexpected antibody detection and antibody identification, a program
must compare the laboratory's response for each analyte with the
response that reflects agreement of either 95 percent of ten or more
referee laboratories or 95 percent or more of all participating
laboratories. The score for a sample in immunohematology is either the
score determined under paragraph (d)(2) or (3) of this section.
(2) Criteria for acceptable performance. The criteria for acceptable
performance are --
(3) The criterion for acceptable performance for qualitative
immunohematology tests is positive or negative.
(4) To determine the analyte testing event score, the number of
acceptable analyte responses must be averaged using the following
formula:
(5) To determine the overall testing event score, the number of
correct responses for all analytes must be averaged using the following
formula:
42 CFR 493.959 Subpart J -- Patient Test Management for Moderate or
High Complexity Testing, or Both
Source: 57 FR 7162, Feb, 28, 1992, unless otherwise noted.
42 CFR 493.1101 Condition: Patient test management; moderate or high
complexity testing, or both.
Each laboratory performing moderate or high complexity testing, or
both, must employ and maintain a system that provides for proper patient
preparation; proper specimen collection, identification, preservation,
transportation, and processing; and accurate result reporting. This
system must assure optimum patient specimen integrity and positive
identification throughout the preanalytic (pre-testing), analytic
(testing), and postanalytic (post-testing) processes and must meet the
standards of this subpart as they apply to the testing performed.
42 CFR 493.1103 Standard; Procedures for specimen submission and
handling.
(a) The laboratory must have available and follow written policies
and procedures for each of the following, if applicable: Methods used
for the preparation of patients; specimen collection; specimen
labeling; specimen preservation; and conditions for specimen
transportation. Such policies and procedures must assure positive
identification and optimum integrity of the patient specimens from the
time the specimen(s) are collected until testing has been completed and
the results reported.
(b) If the laboratory accepts referral specimens, written
instructions must be available to clients and must include, as
appropriate, the information specified in paragraph (a) of this section.
(c) Oral explanation of instructions to patients for specimen
collection, including patient preparation, may be used as a supplement
to written instructions where applicable.
42 CFR 493.1105 Standard; Test requisition.
The laboratory must perform tests only at the written or electronic
request of an authorized person. Oral requests for laboratory tests are
permitted only if the laboratory subsequently obtains written
authorization for testing within 30 days. Records of test requisitions
or test authorizations must be retained for a minimum of two years. The
patient's chart or medical record, if used as the test requisition, must
be retained for a minimum of two years and must be available to the
laboratory at the time of testing and available to HHS upon request.
The laboratory must assure that the requisition or test authorization
includes --
(a) The patient's name or other unique identifier;
(b) The name and address or other suitable identifiers of the
authorized person requesting the test and, if appropriate, the
individual responsible for utilizing the test results or the name and
address of the laboratory submitting the specimen, including, as
applicable, a contact person to enable the reporting of imminent life
threatening laboratory results or panic values;
(c) The test(s) to be performed;
(d) The date of specimen collection;
(e) For Pap smears, the patient's last menstrual period, age or date
of birth, and indication of whether the patient had a previous abnormal
report, treatment or biopsy; and
(f) Any additional information relevant and necessary to a specific
test to assure accurate and timely testing and reporting of results.
42 CFR 493.1107 Standard; Test records.
The laboratory must maintain a record system to ensure reliable
identification of patient specimens as they are processed and tested to
assure that accurate test results are reported. These records must
identify the personnel performing the testing procedure. Records of
patient testing, including, if applicable, instrument printouts, must be
retained for at least two years. Immunohematology records must be
retained for no less than five years in accordance with 21 CFR part 606,
subpart I. The record system must provide documentation of information
specified in 493.1105 (a) through (f) and include --
(a) The patient identification number, accession number, or other
unique identification of the specimen;
(b) The date and time of specimen receipt into the laboratory;
(c) The condition and disposition of specimens that do not meet the
laboratory's criteria for specimen acceptability; and
(d) The records and dates of all specimen testing, including the
identity of the personnel who performed the test(s), which are necessary
to assure proper identification and accurate reporting of patient test
results.
42 CFR 493.1109 Standard; Test report.
The laboratory report must be sent promptly to the authorized person,
the individual responsible for using the test results or laboratory that
initially requested the test. The original report or an exact duplicate
of each test report, including final and preliminary reports, must be
retained by the testing laboratory for a period of at least two years
after the date of reporting. Immunohematology reports must be retained
by the laboratory for a period of no less than five years in accordance
with 21 CFR part 606, subpart I. For pathology, test reports must be
retained for a period of at least ten years after the date of reporting.
This information may be maintained as part of the patient's chart or
medical record which must be readily available to the laboratory and to
HHS upon request.
(a) The laboratory must have adequate systems in place to report
results in a timely, accurate, reliable and confidential manner, and,
ensure patient confidentiality throughout those parts of the total
testing process that are under the laboratory's control.
(b) The test report must indicate the name and address of the
laboratory location at which the test was performed, the test performed,
the test result and, if applicable, the units of measurement.
(c) The laboratory must indicate on the test report any information
regarding the condition and disposition of specimens that do not meet
the laboratory's criteria for acceptability.
(d) Pertinent ''reference'' or ''normal'' ranges, as determined by
the laboratory performing the tests, must be available to the authorized
person who ordered the tests or the individual responsible for utilizing
the test results.
(e) The results or transcripts of laboratory tests or examinations
must be released only to authorized persons or the individual
responsible for utilizing the test results.
(f) The laboratory must develop and follow written procedures for
reporting imminent life-threatening laboratory results or panic values.
In addition, the laboratory must immediately alert the individual or
entity requesting the test or the individual responsible for utilizing
the test results when any test result indicates an imminent
life-threatening condition.
(g) The laboratory must, upon request, make available to clients a
list of test methods employed by the laboratory and, in accordance with
493.1213, as applicable, the performance specifications of each method
used to test patient specimens. In addition, information that may
affect the interpretation of test results, such as test interferences,
must be provided upon request. Pertinent updates on testing information
must be provided to clients whenever changes occur that affect the test
results or interpretation of test results.
(h) The original report or exact duplicates of test reports must be
maintained by the laboratory in a manner that permits ready
identification and timely accessibility.
42 CFR 493.1111 Standard; Referral of specimens.
A laboratory must refer specimens for testing only to a laboratory
possessing a valid certificate authorizing the performance of testing in
the specialty or subspecialty of service for the level of complexity in
which the referred test is categorized.
(a) The referring laboratory must not revise results or information
directly related to the interpretation of results provided by the
testing laboratory.
(b) The referring laboratory may permit each testing laboratory to
send the test result directly to the authorized person who initially
requested the test. The referring laboratory must retain or be able to
produce an exact duplicate of each testing laboratory's report.
(c) The authorized person who orders a test or procedure must be
notified by the referring laboratory of the name and address of each
laboratory location at which a test was performed.
42 CFR 493.1111 Subpart K -- Quality Control for Tests of Moderate or
High Complexity, or Both
Source: 57 FR 7163, Feb. 28, 1992, unless otherwise noted.
42 CFR 493.1201 Condition: General quality control; Moderate or high
complexity testing, or both.
The laboratory must establish and follow written quality control
procedures for monitoring and evaluating the quality of the analytical
testing process of each method to assure the accuracy and reliability of
patient test results and reports. In addition, the laboratory must meet
the applicable standards in 493.1202 through 493.1221 of this subpart,
unless an alternative procedure specified in the manufacturer's protocol
has been cleared by the Food and Drug Administration (FDA) as meeting
the CLIA requirements for general quality control, and the device/test
quality control instructions contain the following statement: ''Unless
this device is modified by a laboratory, compliance with these quality
control instructions satisfies 42 CFR 493.1201 through 493.1221
implementing the Clinical Laboratory Improvement Amendments of 1988,''
or HCFA approves an equivalent procedure specified in appendix C of the
State Operations Manual (HCFA Pub. 7). HCFA Pub. 7 is available from
the Technical Information Service, U.S. Department of Commerce, 5825
Port Royal Road, Springfield, VA 22161, telephone number (703) 487-4630.
42 CFR 493.1202 Standard; Moderate or high complexity testing, or
both: Effective from September 1, 1992 to September 1, 1994.
(a) For each test of high complexity performed, the laboratory must
meet all applicable standards of this subpart.
(b) For each test of moderate complexity performed using a method
developed in-house or using an instrument, kit or test system cleared by
the FDA through the premarket notification (510(k)) or premarket
approval (PMA) process for in-vitro diagnostic use but modified by the
laboratory, the laboratory must meet all applicable standards of this
subpart.
(c) For all other tests of moderate complexity performed using an
instrument, kit or test system cleared by the FDA through the premarket
notification (510(k)) or premarket approval (PMA) process for in-vitro
diagnostic use, the laboratory must --
(1) Follow the manufacturer's instructions for instrument or test
system operation and test performance;
(2) Have a procedure manual describing the processes for testing and
reporting patient test results;
(3) Perform and document calibration procedures at least once every
six months;
(4) Perform and document control procedures using at least two levels
of control materials each day of testing;
(5) Perform and document applicable specialty and subspecialty
control procedures as specified under 493.1223; and
(6) Perform and document that remedial action has been taken when
problems or errors are identified as specified in 493.1219.
42 CFR 493.1203 Standard; Facilities.
The laboratory must be constructed, arranged and maintained to ensure
adequate space, ventilation, facilities and essential utilities for the
performance and reporting of tests.
Effective Date Note: At 57 FR 7163, Feb. 28, 1992, 493.1203 was
revised, effective September 1, 1994. For the convenience of the
reader, the text in effect as of September 1, 1994 is set forth below:
493.1203 Standard; Moderate or high complexity testing, or both:
Effective beginning September 1, 1994.
For each moderate or high complexity test performed, the laboratory
will be in compliance with this section if it:
(a) Meets all applicable quality control requirements specified in
this subpart; or
(b) Follows manufacturer's instructions when using products
(instruments, kits, or test systems) cleared by the FDA as meeting the
CLIA requirements for general quality control located at 493.1213,
493.1215, 493.1217 and applicable parts of 493.1205, 493.1211 and
493.1218. In addition, the laboratory must comply with requirements
within any section of this subpart that are unique to the laboratory
facility and cannot be met by manufacturer's instructions.
42 CFR 493.1204 Standard; Facilities.
The laboratory must provide the space and environmental conditions
necessary for conducting the services offered.
(a) The laboratory must be constructed, arranged, and maintained to
ensure the space, ventilation, and utilities necessary for conducting
all phases of testing, including the preanalytic (pre-testing), analytic
(testing), and postanalytic (post-testing), as appropriate.
(b) Safety precautions must be established, posted, and observed to
ensure protection from physical hazards and biohazardous materials.
42 CFR 493.1205 Standard; Test methods, equipment, instrumentation,
reagents, materials, and supplies.
The laboratory must utilize test methods, equipment, instrumentation,
reagents, materials, and supplies that provide accurate and reliable
test results and test reports.
(a) Test methodologies and equipment must be selected and testing
performed in a manner that provides test results within the laboratory's
stated performance specifications for each test method as determined
under 493.1213.
(b) The laboratory must have appropriate and sufficient equipment and
instruments, reagents, materials, and supplies for the type and volume
of testing performed and for the maintenance of quality during the
preanalytic, analytic, and postanalytic phases of testing.
(c) The laboratory must define criteria for those conditions that are
essential for proper storage of reagents and specimens, and accurate and
reliable test system operation and test result reporting.
(1) These conditions include, if applicable --
(i) Water quality;
(ii) Temperature;
(iii) Humidity; and
(iv) Protection of equipment and instrumentation from fluctuations
and interruptions in electrical current that adversely affect patient
test results and test reports.
(2) Remedial actions taken to correct conditions that fail to meet
the criteria specified in paragraph (c)(1) of this section must be
documented.
(d) Reagents, solutions, culture media, control materials,
calibration materials and other supplies, as appropriate, must be
labeled to indicate --
(1) Identity and, when significant, titer, strength or concentration;
(2) Recommended storage requirements;
(3) Preparation and expiration date; and
(4) Other pertinent information required for proper use.
(e) Reagents, solutions, culture media, control materials,
calibration materials and other supplies must be prepared, stored, and
handled in a manner to ensure that --
(1) Reagents, solutions, culture media, controls, calibration
materials and other supplies are not used when they have exceeded their
expiration date, have deteriorated or are of substandard quality. The
laboratory must comply with the FDA product dating requirements of 21
CFR 610.53 for blood products and other biologicals, and labeling
requirements, as cited in 21 CFR 809.10 for all other in vitro
diagnostics. Any exception to the product dating requirements in 21 CFR
610.53 will be granted by the FDA in the form of an amendment of the
product license, in accordance with 21 CFR 610.53(d). All exceptions
must be documented by the laboratory; and
(2) Components of reagent kits of different lot numbers are not
interchanged unless otherwise specified by the manufacturer.
42 CFR 493.1211 Standard; Procedure manual.
(a) A written procedure manual for the performance of all analytical
methods used by the laboratory must be readily available and followed by
laboratory personnel. Textbooks may be used as supplements to these
written descriptions but may not be used in lieu of the laboratory's
written procedures for testing or examining specimens.
(b) The procedure manual must include, when applicable to the test
procedure:
(1) Requirements for specimen collection and processing, and criteria
for specimen rejection;
(2) Procedures for microscopic examinations, including the detection
of inadequately prepared slides;
(3) Step-by-step performance of the procedure, including test
calculations and interpretation of results;
(4) Preparation of slides, solutions, calibrators, controls,
reagents, stains and other materials used in testing;
(5) Calibration and calibration verification procedures;
(6) The reportable range for patient test results as established or
verified in 493.1213;
(7) Control procedures;
(8) Remedial action to be taken when calibration or control results
fail to meet the laboratory's criteria for acceptability;
(9) Limitations in methodologies, including interfering substances;
(10) Reference range (normal values);
(11) Imminent life-threatening laboratory results or ''panic
values'';
(12) Pertinent literature references;
(13) Appropriate criteria for specimen storage and preservation to
ensure specimen integrity until testing is completed;
(14) The laboratory's system for reporting patient results including,
when appropriate, the protocol for reporting panic values;
(15) Description of the course of action to be taken in the event
that a test system becomes inoperable; and
(16) Criteria for the referral of specimens including procedures for
specimen submission and handling as described in 493.1103.
(c) Manufacturers' package inserts or operator manuals may be used,
when applicable, to meet the requirements of paragraphs (b)(1) through
(b)(13) of this section. Any of the items under paragraphs (b)(1)
through (b)(13) of this section not provided by the manufacturer must be
provided by the laboratory.
(d) Procedures must be approved, signed, and dated by the director.
(e) Procedures must be re-approved, signed and dated if the
directorship of the laboratory changes.
(f) Each change in a procedure must be approved, signed, and dated by
the current director of the laboratory.
(g) The laboratory must maintain a copy of each procedure with the
dates of initial use and discontinuance. These records must be retained
for two years after a procedure has been discontinued.
42 CFR 493.1213 Standard; Establishment and verification of method
performance specifications.
Prior to reporting patient test results, the laboratory must verify
or establish, for each method, the performance specifications for the
following performance characteristics: accuracy; precision;
analytical sensitivity and specificity, if applicable; the reportable
range of patient test results; the reference range(s) (normal values);
and any other applicable performance characteristic.
(a) The provisions of this section are not retroactive. Laboratories
are not required to verify or establish performance specifications for
any test method of moderate or high complexity in use prior to September
1, 1992.
(b) (1) After September 1, 1992, a laboratory that introduces a new
procedure for patient testing using a moderate or high complexity method
(instrument, kit, or test system) cleared by the FDA as meeting the CLIA
requirements for general quality control, must demonstrate that, prior
to reporting patient test results, it can obtain the performance
specifications for accuracy, precision, and reportable range of patient
test results, comparable to those established by the manufacturer. The
laboratory must also verify that the manufacturer's reference range is
appropriate for the laboratory's patient population.
(2) After September 1, 1992, a laboratory that introduces a new
procedure for patient testing using: a method developed in-house; a
modification of the manufacturer's test procedure; or a method
(instrument, kit, or test system) that has not been cleared by the FDA
as meeting the CLIA requirements for general quality control, must,
prior to reporting patient test results --
(i) Verify or establish for each method the performance
specifications for the following performance characteristics, as
applicable:
(A) Accuracy;
(B) Precision;
(C) Analytical sensitivity;
(D) Analytical specificity to include interfering substances;
(E) Reportable range of patient test results;
(F) Reference range(s); and
(G) Any other performance characteristic required for test
performance.
(ii) Based upon the performance specifications verified or
established in accordance with paragraph (b)(2)(i) of this section,
establish calibration and control procedures for patient testing as
required under 493.1217 and 493.1218.
(c) The laboratory must have documentation of the verification or
establishment of all applicable test performance specifications.
42 CFR 493.1215 Standard; Equipment maintenance and function checks.
The laboratory must perform equipment maintenance and function checks
that include electronic, mechanical and operational checks necessary for
the proper test performance and test result reporting of equipment,
instruments and test systems, to assure accurate and reliable test
results and reports.
(a) Maintenance of equipment, instruments, and test systems. (1) For
manufacturers' equipment, instruments or test systems cleared by the FDA
as meeting the CLIA requirements for general quality control, the
laboratory must --
(i) Perform maintenance as defined by the manufacturer and with at
least the frequency specified by the manufacturer; and
(ii) Document all maintenance performed.
(2) For equipment, instruments, or test systems not cleared by the
FDA as meeting the CLIA requirements for general quality control, or
equipment, instruments, or test systems that have been modified or
developed in-house, the laboratory must --
(i) Establish a maintenance protocol that ensures equipment,
instrument, and test system performance necessary for accurate and
reliable test results and test result reporting;
(ii) Perform maintenance with at least the frequency specified in
paragraph (a)(2)(i) of this section; and
(iii) Document all maintenance performed.
(b) Function checks of equipment, instruments, and test systems. (1)
For manufacturers' equipment, instruments, or test systems cleared by
the FDA as meeting the CLIA requirements for general quality control,
the laboratory must --
(i) Perform function checks as defined by the manufacturer and with
at least the frequency specified by the manufacturer; and
(ii) Document all function checks performed.
(2) For equipment, instruments, or test systems not cleared by FDA as
meeting the CLIA requirements for general quality control, or equipment,
instruments, or test systems that have been modified or developed
in-house, the laboratory must --
(i) Define a function check protocol that ensures equipment,
instrument, and test system performance necessary for accurate and
reliable test results and test result reporting;
(ii) Perform function checks including background or baseline checks
specified in paragraph (b)(2)(i) of this section. Function checks must
be within the laboratory's established limits before patient testing is
conducted; and
(iii) Document all function checks performed.
42 CFR 493.1217 Standard; Calibration and calibration verification
procedures.
Calibration and calibration verification procedures are required to
substantiate the continued accuracy of the test method throughout the
laboratory's reportable range for patient test results. Calibration is
the process of testing and adjusting an instrument, kit, or test system
to provide a known relationship between the measurement response and the
value of the substance that is being measured by the test procedure.
Calibration verification is the assaying of calibration materials in the
same manner as patient samples to confirm that the calibration of the
instrument, kit, or test system has remained stable throughout the
laboratory's reportable range for patient test results. The reportable
range is the range of test result values over which the relationship
between the instrument, kit or test system measurement response is shown
to be valid. Calibration and calibration verification must be performed
and documented as required in this section unless otherwise specified in
493.1223 through 493.1285 of this subpart.
(a) For laboratory test procedures that are performed using
instruments, kits, or test systems that have been cleared by the FDA as
meeting CLIA requirements for general quality control, the laboratory
must, at a minimum, follow the manufacturer's instructions for
calibration and calibration verification procedures using calibration
materials specified by the manufacturer.
(b) For each method that is developed in-house, is a modification of
the manufacturer's test procedure, or is an instrument, kit, or test
system that has not been cleared by the FDA as meeting the CLIA
requirements for general quality control, the laboratory must --
(1) Perform calibration procedures --
(i) At a minimum, in accordance with manufacturer's instructions, if
provided, using calibration materials provided or specified, as
appropriate, and with at least the frequency recommended by the
manufacturer;
(ii) In accordance with criteria established by the laboratory --
(A) Including the number, type and concentration of calibration
materials, acceptable limits for calibration, and the frequency of
calibration if manufacturer's instructions are not provided; and
(B) Using calibration materials appropriate for the methodology and,
if possible, traceable to a reference method or reference material of
known value; and
(iii) Whenever calibration verification fails to meet the
laboratory's acceptable limits for calibration verification; and
(2) Perform calibration verification procedures --
(i) In accordance with the manufacturer's calibration verification
instructions when they meet or exceed the requirements specified in
paragraph (b)(2)(ii) of this section; or
(ii) In accordance with criteria established by the laboratory --
(A) Including the number, type, and concentration of calibration
materials, acceptable limits for calibration verification and frequency
of calibration verification; and
(B) Using calibration materials appropriate for --
(1) The methodology and, if possible, traceable to a reference method
or reference material of known value; and
(2) Verifying the laboratory's established reportable range of
patient test results, which must include at least a minimal (or zero)
value, a mid-point value, and a maximum value at the upper limit of that
range; and
(C) At least once every six months and whenever any of the following
occur:
(1) A complete change of reagents for a procedure is introduced,
unless the laboratory can demonstrate that changing reagent lot numbers
does not affect the range used to report patient test results, and
control values are not adversely affected by reagent lot number changes.
Note: If reagents are obtained from a manufacturer and all of the
reagents for a test are packaged together, the laboratory is not
required to perform calibration verification for each package of
reagents, provided the packages of reagents are received in the same
shipment and contain the same lot number;
(2) There is major preventive maintenance or replacement of critical
parts that may influence test performance;
(3) Controls reflect an unusual trend or shift or are outside of the
laboratory's acceptable limits and other means of assessing and
correcting unacceptable control values have failed to identify and
correct the problem; or
(4) The laboratory's established schedule for verifying the
reportable range for patient test results requires more frequent
calibration verification than specified in paragraphs (b)(2)(ii)(C)(1),
(2), or (3) of this section; and
(3) Document all calibration and calibration verification procedures
performed.
42 CFR 493.1218 Standard; Control procedures.
Control procedures are performed on a routine basis to monitor the
stability of the method or test system; control and calibration
materials provide a means to indirectly assess the accuracy and
precision of patient test results. Control procedures must be performed
as defined in this section unless otherwise specified in 493.1223
through 493.1285 of this subpart.
(a) For each method cleared by the FDA as meeting CLIA requirements
for general quality control, the laboratory must, at a minimum, follow
the manufacturer's instructions for control procedures. In addition,
the laboratory must meet the requirements under paragraphs (c) through
(e) of this section and, as applicable, paragraph (f) of this section.
(b) For each method that is developed in-house, is a modification of
the manufacturer's test procedure, or is a method that has not been
cleared by the FDA as meeting the CLIA requirements for general quality
control, the laboratory must evaluate instrument and reagent stability
and operator variance in determining the number, type, and frequency of
testing calibration or control materials and establish criteria for
acceptability used to monitor test performance during a run of patient
specimen(s). A run is an interval within which the accuracy and
precision of a testing system is expected to be stable, but cannot be
greater than 24 hours. For each procedure, the laboratory must monitor
test performance using calibration materials or control materials or a
combination thereof.
(1) For qualitative tests, the laboratory must include a positive and
negative control with each run of patient specimens.
(2) For quantitative tests, the laboratory must include at least two
samples of different concentrations of either calibration materials,
control materials, or a combination thereof with the frequency
determined in 493.1218(b), but not less frequently than once each run
of patient specimens.
(3) For electrophoretic determinations --
(i) At least one control sample must be used in each electrophoretic
cell; and
(ii) The control sample must contain fractions representative of
those routinely reported in patient specimens.
(4) Each day of use, the laboratory must evaluate the detection phase
of direct antigen systems using an appropriate positive and negative
control material (organism or antigen extract). When direct antigen
systems include an extraction phase, the system must be checked each day
of use using a positive organism.
(5) If calibration materials and control materials are not available,
the laboratory must have an alternative mechanism to assure the validity
of patient test results.
(c) Control samples must be tested in the same manner as patient
specimens.
(d) When calibration or control materials are used, statistical
parameters (e.g., mean and standard deviation) for each lot number of
calibration material and each lot of control material must be determined
through repetitive testing.
(1) The stated values of an assayed control material may be used as
the target values provided the stated values correspond to the
methodology and instrumentation employed by the laboratory and are
verified by the laboratory.
(2) Statistical parameters for unassayed materials must be
established over time by the laboratory through concurrent testing with
calibration materials or control materials having previously determined
statistical parameters.
(e) Control results must meet the laboratory's criteria for
acceptability prior to reporting patient test results.
(f) Reagent and supply checks. (1) The laboratory must check each
batch or shipment of reagents, discs, stains, antisera and
identification systems (systems using two or more substrates) when
prepared or opened for positive and negative reactivity, as well as
graded reactivity if applicable.
(2) Each day of use (unless otherwise specified in this subpart), the
laboratory must test staining materials for intended reactivity to
ensure predictable staining characteristics.
(3) The laboratory must check fluorescent stains for positive and
negative reactivity each time of use (unless otherwise specified in this
subpart).
(4) The laboratory must check each batch or shipment of media for
sterility, if it is intended to be sterile, and sterility is required
for testing. Media must also be checked for its ability to support
growth, and as appropriate, selectivity/inhibition and/or biochemical
response. The laboratory may use manufacturer's control checks of media
provided the manufacturer's product insert specifies that the
manufacturer's quality control checks meet the National Committee for
Clinical Laboratory Standards (NCCLS) for media quality control. The
laboratory must document that the physical characteristics of the media
are not compromised and report any deterioration in the media to the
manufacturer. The laboratory must follow the manufacturer's
specifications for using the media and be responsible for the test
results.
Note: A batch of media (solid, semi-solid, or liquid) consists of
all tubes, plates, or containers of the same medium prepared at the same
time and in the same laboratory; or, if received from an outside source
or commercial supplier, consists of all of the plates, tubes or
containers of the same medium that have the same lot numbers and are
received in a single shipment.
42 CFR 493.1219 Standard; Remedial actions.
Remedial action policies and procedures must be established by the
laboratory and applied as necessary to maintain the laboratory's
operation for testing patient specimens in a manner that assures
accurate and reliable patient test results and reports. The laboratory
must document all remedial actions taken when --
(a) Test systems do not meet the laboratory's established performance
specifications, as determined in 493.1213 of this section, which
include but are not limited to --
(1) Equipment or methodologies that perform outside of established
operating parameters or performance specifications;
(2) Patient test values that are outside of the laboratory's
reportable range of patient test results; and
(3) The determination that the laboratory's reference range for a
test procedure is inappropriate for the laboratory's patient population.
(b) Results of control and calibration materials fail to meet the
laboratory's established criteria for acceptability. All patient test
results obtained in the unacceptable test run or since the last
acceptable test run must be evaluated to determine if patient test
results have been adversely affected and the laboratory must take the
remedial action necessary to ensure the reporting of accurate and
reliable patient test results;
(c) The laboratory cannot report patient test results within its
established time frames. The laboratory must determine, based on the
urgency of the patient test(s) requested, the need to notify the
appropriate individual of the delayed testing; and
(d) Errors in the reported patient test results are detected. The
laboratory must --
(1) Promptly notify the authorized person ordering or individual
utilizing the test results of reporting errors;
(2) Issue corrected reports promptly to the authorized person
ordering the test or the individual utilizing the test results; and
(3) Maintain exact duplicates of the original report as well as the
corrected report for two years.
42 CFR 493.1221 Standard; Quality control records.
The laboratory must document and maintain records of all quality
control activities specified in 493.1202 through 493.1285 of this
subpart and retain records for at least two years. Immunohematology
quality control records must be maintained for a period of no less than
five years. In addition, quality control records for blood and blood
products must be maintained for a period not less than five years after
processing records have been completed, or six months after the latest
expiration date, whichever is the later date, in accordance with 21 CFR
606.160(d).
42 CFR 493.1223 Condition: Quality control -- specialties and
subspecialties for tests of moderate or high complexity, or both.
The laboratory must establish and follow written policies and
procedures for an acceptable quality control program that include
verification and assessment of accuracy, measurement of precision and
detection of error for all analyses and procedures performed by the
laboratory. In addition to the general requirements specified in
493.1201 through 493.1221 of this subpart, the laboratory must meet the
applicable requirements of 493.1225 through 493.1285 unless HCFA
approves an equivalent procedure specified in appendix C of the State
Operations Manual (HCFA Pub. 7). However, effective September 1, 1994, a
laboratory that performs tests of moderate or high complexity, or both,
as applicable, will be in compliance with this section if it --
(a) Meets quality control requirements specified in this subpart; or
(b) Follows manufacturer's instructions when using products
(instruments, kits, or test systems) cleared by FDA as meeting the CLIA
requirements for general quality control as well as specialty and
subspecialty quality control.
Failure to meet any of the applicable conditions in 493.1225
through 493.1285 will result in intermediate sanctions, loss of Medicare
or Medicaid approval, and/or revocation of CLIA certification for the
entire specialty or subspecialty to which the condition applies, in
accordance with subpart R of this part.
42 CFR 493.1225 Condition: Microbiology.
The laboratory must meet the applicable quality control requirements
in 493.1201 through 493.1221 and in 493.1227 through 493.1235 of
this subpart for the subspecialties for which it is certified under the
specialty of microbiology.
42 CFR 493.1227 Condition: Bacteriology.
To meet the quality control requirements for bacteriology, the
laboratory must comply with the applicable requirements in 493.1201
through 493.1221 and with paragraphs (a) through (c) of this section.
All quality control activities must be documented.
(a) The laboratory must check positive and negative reactivity with
control organisms --
(1) Each day of use for catalase, coagulase, beta-lactamase, and
oxidase reagents and DNA probes;
(2) Each week of use for Gram and acid-fast stains, bacitracin,
optochin, ONPG, X, and V discs or strips; and
(3) Each month of use for antisera.
(b) Each week of use, the laboratory must check XV discs or strips
with a positive control organism.
(c) For antimicrobial susceptibility tests, the laboratory must check
each new batch of media and each lot of antimicrobial discs before, or
concurrent with, initial use, using approved reference organisms.
(1) The laboratory's zone sizes or minimum inhibitory concentration
for reference organisms must be within established limits before
reporting patient results.
(2) Each day tests are performed, the laboratory must use the
appropriate control organism(s) to check the procedure.
42 CFR 493.1229 Condition: Mycobacteriology.
To meet the quality control requirements for mycobacteriology, the
laboratory must comply with the applicable requirements in 493.1201
through 493.1221 of this subpart and with paragraphs (a) through (d) of
this section. All quality control activities must be documented.
(a) Each day of use, the laboratory must check the iron uptake test
with at least one acid-fast organism that produces a positive reaction
and with an organism that produces a negative reaction and check all
other reagents or test procedures used for mycobacteria identification
with at least one acid-fast organism that produces a positive reaction.
(b) The laboratory must check fluorochrome acid-fast stains for
positive and negative reactivity each week of use.
(c) The laboratory must check acid-fast stains each week of use with
an acid-fast organism that produces a positive reaction.
(d) For susceptibility tests performed on Mycobacterium tuberculosis
isolates, the laboratory must check the procedure each week of use with
a strain of Mycobacterium tuberculosis susceptible to all
antimycobacterial agents tested.
42 CFR 493.1231 Condition: Mycology.
To meet the quality control requirements for mycology, the laboratory
must comply with the applicable requirements in 493.1201 through
493.1221 of this subpart and with paragraphs (a) through (d) of this
section. All quality control activities must be documented.
(a) Each day of use, the laboratory using the auxanographic medium
for nitrate assimilation must check the nitrate reagent with a peptone
control.
(b) Each week of use, the laboratory must check all reagents used
with biochemical tests and other test procedures for mycological
identification with an organism that produces a positive reaction.
(c) Each week of use, the laboratory must check acid-fast stains for
positive and negative reactivity.
(d) For susceptibility tests, the laboratory must test each drug each
day of use with at least one control strain that is susceptible to the
drug. The laboratory must establish control limits. Criteria for
acceptable control results must be met prior to reporting patient
results.
42 CFR 493.1233 Condition: Parasitology.
To meet the quality control requirements for parasitology, the
laboratory must comply with the applicable requirements of 493.1201
through 493.1221 of this subpart and with paragraphs (a) through (c) of
this section. All quality control activities must be documented.
(a) The laboratory must have available a reference collection of
slides or photographs, and, if available, gross specimens for
identification of parasites and use these references in the laboratory
for appropriate comparison with diagnostic specimens.
(b) The laboratory must calibrate and use the calibrated ocular
micrometer for determining the size of ova and parasites, if size is a
critical parameter.
(c) Each month of use, the laboratory must check permanent stains
using a fecal sample control that will demonstrate staining
characteristics.
42 CFR 493.1235 Condition: Virology.
To meet the quality control requirements for virology, the laboratory
must comply with the applicable requirements in 493.1201 through
493.1221 of this subpart and with paragraphs (a) through (c) of this
section. All quality control activities must be documented.
(a) The laboratory must have available host systems for the isolation
of viruses and test methods for the identification of viruses that cover
the entire range of viruses that are etiologically related to clinical
diseases for which services are offered.
(b) The laboratory must maintain records that reflect the systems
used and the reactions observed.
(c) In tests for the identification of viruses, the laboratory must
simultaneously culture uninoculated cells or cell substrate controls as
a negative control to detect erroneous identification results.
42 CFR 493.1237 Condition: Diagnostic immunology.
The laboratory must meet the applicable quality control requirements
in 493.1201 through 493.1221 and 493.1239 through 493.1241 of this
subpart for the subspecialties for which it is certified under the
specialty of diagnostic immunology.
42 CFR 493.1239 Condition: Syphilis serology.
To meet the quality control requirements for syphilis serology, the
laboratory must comply with the applicable requirements in 493.1201
through 493.1221 of this subpart and with paragraphs (a) through (e) of
this section. All quality control activities must be documented.
(a) For laboratories performing syphilis testing, the equipment,
glassware, reagents, controls, and techniques for tests for syphilis
must conform to manufacturers' specifications.
(b) The laboratory must run serologic tests on patient specimens
concurrently with a positive serum control of known titer or controls of
graded reactivity plus a negative control.
(c) The laboratory must employ positive and negative controls that
evaluate all phases of the test system to ensure reactivity and uniform
dosages.
(d) The laboratory may not report test results unless the
predetermined reactivity pattern of the controls is observed.
(e) All facilities manufacturing blood and blood products for
transfusion or serving as referral laboratories for these facilities
must meet the syphilis serology testing requirements of 21 CFR 640.5(a).
42 CFR 493.1241 Condition: General immunology.
To meet the quality control requirements for general immunology, the
laboratory must comply with the applicable requirements in 493.1201
through 493.1221 of this subpart and with paragraphs (a) through (d) of
this section. All quality control activities must be documented.
(a) The laboratory must run serologic tests on patient specimens
concurrently with a positive serum control of known titer or controls of
graded reactivity, if applicable, plus a negative control.
(b) The laboratory must employ controls that evaluate all phases of
the test system (antigens, complement, erythrocyte indicator systems,
etc.) to ensure reactivity and uniform dosages when positive and
negative controls alone are not sufficient.
(c) The laboratory may not report test results unless the
predetermined reactivity pattern of the controls is observed.
(d) All facilities manufacturing blood and blood products for
transfusion or serving as referral laboratories for these facilities
must meet --
(1) The HIV testing requirements of 21 CFR 610.45; and
(2) Hepatitis testing requirements of 21 CFR 610.40.
42 CFR 493.1243 Condition: Chemistry.
The laboratory must meet the applicable quality control requirements
in 493.1201 through 493.1221 and 493.1245 through 493.1249 of this
subpart for the subspecialties for which it is certified under the
specialty of chemistry.
42 CFR 493.1245 Condition: Routine chemistry.
To meet the quality control requirements for routine chemistry, the
laboratory must comply with the applicable requirements in 493.1201
through 493.1221. All quality control activities must be documented. In
addition, for blood gas analyses, the laboratory must --
(a) Calibrate or verify calibration according to the manufacturer's
specifications and with at least the frequency recommended by the
manufacturer;
(b) Test one sample of control material each eight hours of testing;
(c) Use a combination of calibrators and control materials that
include both low and high values on each day of testing; and
(d) Include one sample of calibration material or control material
each time patients are tested unless automated instrumentation
internally verifies calibration at least every thirty minutes.
42 CFR 493.1247 Condition: Endocrinology.
To meet the quality control requirements for endocrinology, the
laboratory must comply with the applicable requirements contained in
493.1201 through 493.1221 of this subpart. All quality control
activities must be documented.
42 CFR 493.1249 Condition: Toxicology.
To meet the quality control requirements for toxicology, the
laboratory must comply with the applicable requirements in 493.1201
through 493.1221 of this subpart. All quality control activities must
be documented. In addition, for drug abuse screening using thin layer
chromatography --
(a) Each plate must be spotted with at least one sample of
calibration material containing all drug groups identified by thin layer
chromatography which the laboratory reports; and
(b) At least one control sample must be included in each chamber, and
the control sample must be processed through each step of patient
testing, including extraction procedures.
42 CFR 493.1253 Condition: Hematology.
To meet the quality control requirements for hematology, the
laboratory must comply with the applicable requirements in 493.1201
through 493.1221 of this subpart and with paragraphs (a) through (d) of
this section. All quality control activities must be documented.
(a) For automated hematology testing systems, excluding coagulation,
the laboratory must include two levels of controls each eight hours of
operation.
(b) Cell counts performed manually using a hemocytometer must be
tested in duplicate. One control is required for each eight hours of
operation.
(c) For all automated coagulation testing systems, the laboratory
must include two levels of control each eight hours of operation and
each time a change in reagents occurs.
(d) For manual coagulation tests --
(1) Each individual performing tests must test two levels of controls
before testing patient samples and each time a change in reagents
occurs; and
(2) Patient and control specimens must be tested in duplicate.
42 CFR 493.1255 Condition: Pathology.
The laboratory must meet the applicable quality control requirements
in 493.1201 through 493.1221 and 493.1257 through 493.1261 of this
subpart for the subspecialties for which it is certified under the
specialty of pathology. All quality control activities must be
documented.
42 CFR 493.1257 Condition: Cytology.
To meet the quality control requirements for cytology, the laboratory
must comply with the applicable requirements in 493.1201 through
493.1221 of this subpart and paragraphs (a) through (g) of this section.
(a) The laboratory must assure that --
(1) All gynecologic smears are stained using a Papanicolaou or
modified Papanicolaou staining method;
(2) Effective measures are taken to prevent cross-contamination
between gynecologic and nongynecologic specimens during the staining
process;
(3) Nongynecologic specimens that have a high potential for
cross-contamination are stained separately from other nongynecologic
specimens, and the stains are filtered or changed following staining;
(4) Diagnostic interpretations are not reported on unsatisfactory
smears; and
(5) All cytology slide preparations are evaluated on the premises.
(b) The laboratory is responsible for ensuring that --
(1) Each individual engaged in the evaluation of cytology
preparations by nonautomated microscopic technique examines no more than
100 slides (gynecologic or nongynecologic, or both) in a 24 hour period,
irrespective of the site or laboratory. This limit represents an
absolute maximum number of slides and is not to be employed as a
performance target for each individual. Previously examined reactive,
reparative, atypical, premalignant or malignant gynecologic cases as
defined in paragraph (c)(1) of this section, previously examined
nongynecologic cytology preparations, and tissue pathology slides
examined by a technical supervisor qualified under 493.1449 (b) or (k)
are not included in the 100 slide limit. (For this section, all
references to technical supervisor refer to individuals qualified under
493.1449 (b) and (k).);
(2) For purposes of workload calculations, each slide preparation
(gynecologic or nongynecologic) made using automated, semi-automated, or
other liquid-based slide preparatory techniques which result in cell
dispersion over one-half or less of the total available slide area and
which is examined by nonautomated microscopic technique counts as
one-half slide.
(3) Records are maintained of the total number of slides examined by
each individual during each 24 hour period, irrespective of the site or
laboratory, and the number of hours each individual spends examining
slides in the 24 hour period;
(i) The maximum number of 100 slides described in paragraph (b)(1) of
this section is examined in no less than an 8 hour workday;
(ii) For the purposes of establishing workload limits for individuals
examining slides by nonautomated microscopic technique on other than an
8 hour workday basis (includes full-time employees with duties other
than slide examination and part-time employees), a period of 8 hours
must be used to prorate the number of slides that may be examined. Use
the formula --
to determine maximum slide volume to be examined.
(c) The individual qualified under 493.1449 (b) or (k) who provides
technical supervision of cytology must ensure that --
(1) All gynecologic smears interpreted to be showing reactive or
reparative changes, atypical squamous or glandular cells of undetermined
significance, or to be in the premalignant (dysplasia, cervical
intraepithelial neoplasia or all squamous intraepithelial lesions
including human papillomavirus-associated changes) or malignant category
are confirmed by a technical supervisor in cytology. The report must be
signed to reflect the review or, if a computer report is generated with
signature, it must reflect an electronic signature authorized by the
technical supervisor in cytology;
(2) All nongynecologic cytologic preparations are reviewed by the
technical supervisor in cytology. The report must be signed to reflect
technical supervisory review or, if a computer report is generated with
signature, it must reflect an electronic signature authorized by the
technical supervisor;
(3) The slide examination performance of each cytotechnologist is
evaluated and documented, including performance evaluation through the
re-examination of normal and negative cases and feedback on the
reactive, reparative, atypical, malignant or premalignant cases as
defined in paragraph (c)(1) of this section; and
(4) A maximum number of slides, not to exceed the maximum workload
limit described in paragraph (b) of this section is established by the
technical supervisor for each individual examining slide preparations by
nonautomated microscopic technique.
(i) The actual workload limit must be documented for each individual
and established in accordance with the individual's capability based on
the performance evaluation as described in paragraph (c)(3) of this
section.
(ii) Records are available to document that each individual's
workload limit is reassessed at least every 6 months and adjusted when
necessary.
(d) The laboratory must establish and follow a program designed to
detect errors in the performance of cytologic examinations and the
reporting of results.
(1) The laboratory must establish a program that includes a review of
slides from at least 10 percent of the gynecologic cases interpreted to
be negative for reactive, reparative, atypical, premalignant or
malignant conditions as defined in paragraph (c)(1) of this section that
are examined by each individual not qualified under 493.1449 (b) or
(k). This review must be done by a technical supervisor in cytology, a
cytology general supervisor qualified under 493.1469, or a
cytotechnologist qualified under 493.1483 who has the experience
specified in 493.1469(b)(2).
(i) The review must include negative cases selected at random from
the total caseload and from patients or groups of patients that are
identified as having a high probability of developing cervical cancer,
based on available patient information;
(ii) Records of initial examinations and rescreening results must be
available; and
(iii) The review must be completed before reporting patient results
on those cases selected.
(2) The laboratory must compare clinical information, when available,
with cytology reports and must compare all malignant and premalignant
(as defined in paragraph (c)(1) of this section) gynecology reports with
the histopathology report, if available in the laboratory (either
on-site or in storage), and determine the causes of any discrepancies.
(3) For each patient with a current high grade or above
intraepithelial lesion (moderate dysplasia or CIN-2 or above), the
laboratory must review all normal or negative gynecologic specimens
received within the previous five years, if available in the laboratory
(either on-site or in storage). If significant discrepancies are found
that would affect patient care, the laboratory must notify the patient's
physician and issue an amended report.
(4) The laboratory must establish and document an annual statistical
evaluation of the number of cytology cases examined, number of specimens
processed by specimen type, volume of patient cases reported by
diagnosis (including the number reported as unsatisfactory for
diagnostic interpretation), number of gynecologic cases where cytology
and available histology are discrepant, the number of gynecologic cases
where any rescreen of a normal or negative specimen results in
reclassification as malignant or premalignant, as defined in paragraph
(c)(1) of the section, and the number of gynecologic cases for which
histology results were unavailable to compare with malignant or
premalignant cytology cases as defined in paragraph (c)(1) of this
section.
(5) The laboratory must evaluate the case reviews of each individual
examining slides against the laboratory's overall statistical values,
document any discrepancies, including reasons for the deviation, and
document corrective action, if appropriate.
(e) The laboratory report must --
(1) Clearly distinguish specimens or smears, or both, that are
unsatisfactory for diagnostic interpretation; and
(2) Contain narrative descriptive nomenclature for all results.
(f) Corrected reports issued by the laboratory must indicate the
basis for correction.
(g) The laboratory must retain all slide preparations for five years
from the date of examination, or slides may be loaned to proficiency
testing programs, in lieu of maintaining them for this time period,
provided the laboratory receives written acknowledgment of the receipt
of slides by the proficiency testing program and maintains the
acknowledgment to document the loan of such slides. Documentation for
slides loaned or referred for purposes other than proficiency testing
must also be maintained. All slides must be retrievable upon request.
42 CFR 493.1259 Condition: Histopathology.
To meet the quality control requirements for histopathology, a
laboratory must comply with the applicable requirements in 493.1201
through 493.1221 of this subpart and paragraphs (a) through (e) of this
section. All quality control activities must be documented.
(a) A control slide of known reactivity must be included with each
slide or group of slides for differential or special stains.
Reaction(s) of the control slide with each special stain must be
documented.
(b) The laboratory must retain stained slides at least ten years from
the date of examination and retain specimen blocks at least two years
from the date of examination.
(c) The laboratory must retain remnants of tissue specimens in a
manner that assures proper preservation of the tissue specimens until
the portions submitted for microscopic examination have been examined
and a diagnosis made by an individual qualified under 493.1449(b) or
493.1449(l)(1) of this part. In addition, an individual who meets the
requirements of 493.1449(b), 493.1449(l)(1) or 493.1449(l)(2), may
examine and provide reports for specimens for skin pathology; an
individual meeting the requirements of 493.1449(b) or 493.1449(l)(3)
may examine and provide reports for ophthalmic pathology; an individual
meeting the requirements of 493.1449(b) or 493.1449(m) may examine and
provide reports for oral pathology specimens.
(d) All tissue pathology reports must be signed by an individual
qualified as specified in paragraph (c) of the section. If a computer
report is generated with an electronic signature, it must be authorized
by the individual qualified as specified in paragraph (c) of this
section.
(e) The laboratory must utilize acceptable terminology of a
recognized system of disease nomenclature in reporting results.
42 CFR 493.1261 Condition: Oral pathology.
To meet the quality control requirements for oral pathology, the
laboratory must comply with the applicable requirements in 493.1201
through 493.1221 and 493.1259 of this subpart. All quality control
activities must be documented.
42 CFR 493.1263 Condition: Radiobioassay.
To meet quality control requirements for radiobioassay, the
laboratory must comply with the applicable requirements of 493.1201
through 493.1221 of this subpart. All quality control activities must
be documented.
42 CFR 493.1265 Condition: Histocompatibility.
In addition to meeting the applicable requirements for general
quality control in 493.1201 through 493.1221, for quality control for
general immunology in 493.1241 of this subpart and for immunohematology
in 493.1269 of this subpart, the laboratory must comply with the
applicable requirements in paragraphs (a) through (d) of this section.
All quality control activities must be documented.
(a) For renal allotransplantation, the laboratory must meet the
following requirements:
(1) The laboratory must have available and follow criteria for --
(i) Selecting appropriate patient serum samples for crossmatching;
(ii) The technique used in crossmatching;
(iii) Preparation of donor lymphocytes for crossmatching; and
(iv) Reporting crossmatch results;
(2) The laboratory must --
(i) Have available results of final crossmatches before an organ or
tissue is transplanted; and
(ii) Make a reasonable attempt and document efforts to have available
serum specimens for all potential transplant recipients at initial
typing, for periodic screening, for pre-transplantation crossmatch and
following sensitizing events, such as transfusion and transplant loss;
(3) The laboratory's storage and maintenance of both recipient sera
and reagents must --
(i) Be at an acceptable temperature range for sera and components;
(ii) Use a temperature alarm system and have an emergency plan for
alternate storage; and
(iii) Ensure that all specimens are properly identified and easily
retrievable;
(4) The laboratory's reagent typing sera inventory (applicable only
to locally constructed trays) must indicate source, bleeding date and
identification number, and volume remaining;
(5) The laboratory must properly label and store cells, complement,
buffer, dyes, etc.;
(6) The laboratory must --
(i) HLA type all potential transplant recipients;
(ii) Type cells from organ donors referred to the laboratory; and
(iii) Have available and follow a policy that establishes when
antigen redefinition and retyping are required;
(7) The laboratory must have available and follow criteria for --
(i) The preparation of lymphocytes for HLA-A, B and DR typing;
(ii) Selecting typing reagents, whether locally or commercially
prepared;
(iii) The assignment of HLA antigens; and
(iv) Assuring that reagents used for typing recipients and donors are
adequate to define all major and International Workshop HLA-A,B and DR
specificities for which reagents are readily available;
(8) The laboratory must --
(i) Screen potential transplant recipient sera for preformed HLA-A
and B antibodies with a suitable lymphocyte panel on sera collected;
(A) At the time of the recipient's initial HLA typing; and
(B) Thereafter, following sensitizing events and upon request; and
(ii) Use a suitable cell panel for screening patient sera (antibody
screen), a screen that contains all the major HLA specificities and
common splits --
(A) If the laboratory does not use commercial panels, it must
maintain a list of individuals for fresh panel bleeding; and
(B) If the laboratory uses frozen panels, it must have a suitable
storage system;
(9) The laboratory must check --
(i) Each typing tray using --
(A) Positive control sera;
(B) Negative control sera; and
(C) Positive controls for specific cell types when applicable (i.e.,
T cells, B cells, and monocytes); and
(ii) Each compatibility test (i.e. mixed lymphocyte cultures,
homozygous typing cells or DNA analysis) and typing for
disease-associated antigens using controls to monitor the test
components and each phase of the test system to ensure an acceptable
performance level;
(10) Compatibility testing for cellularly-defined antigens must
utilize techniques such as the mixed lymphocyte culture test, homozygous
typing cells or DNA analysis;
(11) If the laboratory reports the recipient's or donor's, or both,
ABO blood group and D(Rho) typing, the testing must be performed in
accordance with 493.1269 of this subpart;
(12) If the laboratory utilizes immunologic reagents (such as
antibodies or complement) to remove contaminating cells during the
isolation of lymphocytes or lymphocyte subsets, the efficacy of the
methods must be verified with appropriate quality control procedures;
(13) At least once each month, the laboratory must have each
individual performing tests evaluate a previously tested specimen as an
unknown to verify his or her ability to reproduce test results. Records
of the results for each individual must be maintained; and
(14) The laboratory must participate in at least one national or
regional cell exchange program, if available, or develop an exchange
system with another laboratory in order to validate inter-laboratory
reproducibility.
(b) If the laboratory performs histocompatibility testing for --
(1) Transfusions and other non-renal transplantation, excluding bone
marrow and living transplants, all the requirements specified in this
section, as applicable, except for the performance of mixed lymphocyte
cultures must be met;
(2) Bone marrow transplantation and living transplants, all the
requirements specified in this section, including the performance of
mixed lymphocyte cultures or other augmented testing to evaluate class
II compatibility, must be met; and
(3) Non-renal solid organ transplantation, the results of final
crossmatches must be available before transplantation when the recipient
has demonstrated presensitization by prior serum screening except for
emergency situations. The laboratory must document the circumstances,
if known, under which emergency transplants are performed, and records
must reflect any information concerning the transplant provided to the
laboratory by the patient's physician.
(c) Laboratories performing HLA typing for disease-associated studies
or parentage testing must meet all the requirements specified in this
section except for the performance of mixed lymphocyte cultures,
antibody screening and crossmatching.
(d) For laboratories performing organ donor HIV testing the
requirements of 493.1241 of this subpart for the transfusion of blood
and blood products must be met.
42 CFR 493.1267 Condition: Clinical cytogenetics.
To meet the quality control requirements for clinical cytogenetics,
the laboratory must comply with the applicable requirements of
493.1201 through 493.1221 of this subpart and with paragraphs (a)
through (d) of this section. All quality control activities must be
documented.
(a) When determination of sex is performed by X and Y chromatin
counts, these counts must be based on an examination of an adequate
number of cells. Confirmatory testing such as full chromosome analysis
must be performed for all atypical results.
(b) The laboratory must have records that reflect the media used and
document the reactions observed, number of cells counted, the number of
cells karyotyped, the number of chromosomes counted for each metaphase
spread, and the quality of the banding; that the resolution is
sufficient to support the reported results; and that an adequate number
of karyotypes are prepared for each patient.
(c) The laboratory also must have policies and procedures for
assuring an accurate and reliable patient sample identification during
the process of accessioning, cell preparation, photographing or other
image reproduction technique, and photographic printing, and storage and
reporting of results or photographs.
(d) The laboratory report must include the summary and interpretation
of the observations and number of cells counted and analyzed and the use
of appropriate nomenclature.
42 CFR 493.1269 Condition: Immunohematology.
To meet the quality control requirements for immunohematology, the
laboratory must comply with the applicable requirements in 493.1201
through 493.1221 of this subpart and with paragraphs (a) through (d) of
this section. All quality control activities must be documented.
(a) The laboratory must perform ABO group and D(Rho) typing,
unexpected antibody detection, antibody identification and compatibility
testing in accordance with manufacturer's instructions, if provided, and
as applicable, with 21 CFR part 606 (with the exception of 21 CFR
606.20a, Personnel) and 21 CFR part 640 et seq.
(b) The laboratory must perform ABO group by concurrently testing
unknown red cells with anti-A and anti-B grouping reagents. For
confirmation of ABO group, the unknown serum must be tested with known
A1 and B red cells.
(c) The laboratory must determine the D(Rho) type by testing unknown
red cells with anti-D (anti-Rho) blood grouping reagent.
(d) If required in the manufacturer's package insert for anti-D
reagents, the laboratory must employ a control system capable of
detecting false positive D(Rho) test results.
42 CFR 493.1271 Condition: Transfusion services and bloodbanking.
If a facility provides services for the transfusion of blood and
blood products, the facility must be under the adequate control and
technical supervision of the pathologist or other doctor of medicine or
osteopathy meeting the qualifications in subpart M for technical
supervision in immunohematology. The facility must ensure that there
are facilities for procurement, safekeeping and transfusion of blood and
blood products and that blood products must be available to meet the
needs of the physicians responsible for the diagnosis, management, and
treatment of patients. The facility meets this condition by complying
with the standards in 493.1273 through 493.1285 of this subpart.
42 CFR 493.1273 Standard; Immunohematological collection, processing,
dating periods, labeling and distribution of blood and blood products.
In addition to the requirements in paragraphs (a) through (d) of this
section, the facility must also meet the applicable quality control
requirements in 493.1201 through 493.1221 of this part.
(a) Blood and blood product collection, processing and distribution
must comply with 21 CFR part 640 and 21 CFR part 606, and the testing
laboratory must meet the applicable requirements of part 493.
(b) Dating periods for blood and blood products must conform to 21
CFR 610.53.
(c) Labeling of blood and blood products must conform to 21 CFR part
606, subpart G.
(d) Policies to ensure positive identification of a blood or blood
product recipient must be established, documented, and followed.
42 CFR 493.1275 Standard; Blood and blood products storage facilities.
(a) The blood and blood products must be stored under appropriate
conditions, which include an adequate temperature alarm system that is
regularly inspected.
(1) An audible alarm system must monitor proper blood and blood
product storage temperature over a 24-hour period; and
(2) Inspections of the alarm system must be documented.
(b) If blood is stored or maintained for transfusion outside of a
monitored refrigerator, the facility must ensure and document that
storage conditions, including temperature, are appropriate to prevent
deterioration of the blood or blood product.
42 CFR 493.1277 Standard; Arrangement for services.
In the case of services provided outside the blood bank, the facility
must have an agreement reviewed and approved by the director that
governs the procurement, transfer and availability of blood and blood
products.
42 CFR 493.1279 Standard; Provision of testing.
There must be provision for prompt ABO blood group, D(Rho) type,
unexpected antibody detection and compatibility testing in accordance
with 493.1269 of this subpart and for laboratory investigation of
transfusion reactions, either through the facility or under arrangement
with an approved facility on a continuous basis, under the supervision
of a pathologist or other doctor of medicine or osteopathy meeting the
qualifications of 493.1449(b) or 493.1449(q).
42 CFR 493.1283 Standard; Retention of samples of transfused blood.
According to the facility's established procedures, samples of each
unit of transfused blood must be retained for further testing in the
event of reactions. The facility must promptly dispose of blood not
retained for further testing that has passed its expiration date.
42 CFR 493.1285 Standard; Investigation of transfusion reactions.
The facility, according to its established procedures, must promptly
investigate all transfusion reactions occurring in all facilities for
which it has investigational responsibility and make recommendations to
the medical staff regarding improvements in transfusion procedures. The
facility must document that all necessary remedial actions are taken to
prevent future recurrences of transfusion reactions and that all
policies and procedures are reviewed to assure that they are adequate to
ensure the safety of individuals being transfused within the facility.
42 CFR 493.1285 Subpart L -- (Reserved)
42 CFR 493.1285 Subpart M -- Personnel for Moderate and High Complexity
Testing
Source: 57 FR 7172, Feb. 28, 1992, unless otherwise noted.
42 CFR 493.1401 General.
This subpart consists of the personnel requirements that must be met
by laboratories performing moderate or high complexity testing, or both.
42 CFR 493.1401 Laboratories Performing Moderate Complexity Testing
42 CFR 493.1403 Condition: Laboratories performing moderate complexity
testing; laboratory director.
The laboratory must have a director who meets the qualification
requirements of 493.1405 of this subpart and provides overall
management and direction in accordance with 493.1407 of this subpart.
42 CFR 493.1405 Standard; Laboratory director qualifications.
42 CFR The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of moderate complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R of this part.
The laboratory director must be qualified to manage and direct the labo ratory personnel and the performance of moderate complexity tests and m ust be eligible to be an operator of a laboratory within the requiremen ts of subpart R of this part
42 CFR (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and
(b) The laboratory director must --
(1) (i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and
(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or
(2) (i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and
(ii) Have had laboratory training or experience consisting of:
(A) At least one year directing or supervising non-waived laboratory testing; or
(B) Effective (August 2, 1993) have at least 20 continuing medical education credit hours in laboratory practice commensurate with the director responsibilities defined in 493.1407; or
(C) Laboratory training equivalent to paragraph (b)(2)(ii)(B) of this section obtained during medical residency (For example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or
(3) Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution; and
(i) Be certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or the American Board of Medical Laboratory Immunology; or
(ii) Have had at least one year experience directing or supervising non-waived laboratory testing;
(4) (i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution;
(ii) Have at least one year of laboratory training or experience, or both; and
(iii) In addition, have at least one year of supervisory laboratory experience; or
(5) (i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution;
(ii) Have at least 2 years of laboratory training or experience, or both; and
(iii) In addition, have at least 2 years of supervisory laboratory experience;
(6) Have previously qualified or could have qualified as a laboratory director under 42 CFR 493.1415 published March 14, 1990, (55 FR 9538) on or before February 28, 1992; or
(7) On or before February 28, 1992, qualified under State law to direct a laboratory in the State in which the laboratory is located.
42 CFR 493.1407 Standard; Laboratory director responsibilities.
42 CFR The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations.
The laboratory director is responsible for the overall operation and ad ministration of the laboratory, including the employment of personnel w ho are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring complian ce with the applicable regulations
42 CFR (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively.
(b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed.
(c) The laboratory director must be accessible to the laboratory to provide onsite, telephone or electronic consultation as needed.
(d) Each individual may direct no more than five laboratories.
(e) The laboratory director must --
(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing;
(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazards;
(3) Ensure that --
(i) The test methodologies selected have the capability of providing the quality of results required for patient care;
(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and
(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results;
(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed and that --
(i) The proficiency testing samples are tested as required under subpart H of this part;
(ii) The results are returned within the timeframes established by the proficiency testing program;
(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require corrective action; and
(iv) An approved corrective action plan is followed when any proficiency testing results are found to be unacceptable or unsatisfactory;
(5) Ensure that the quality control and quality assurance programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur;
(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system;
(7) Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified, and that patient test results are reported only when the system is functioning properly;
(8) Ensure that reports of test results include pertinent information required for interpretation;
(9) Ensure that consultation is available to the laboratory's clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions;
(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart;
(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results;
(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills;
(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and
(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results.
42 CFR 493.1409 Condition: Laboratories performing moderate complexity
testing; technical consultant.
The laboratory must have a technical consultant who meets the
qualification requirements of 493.1411 of this subpart and provides
technical oversight in accordance with 493.1413 of this subpart.
42 CFR 493.1411 Standard; Technical consultant qualifications.
The laboratory must employ one or more individuals who are qualified
by education and either training or experience to provide technical
consultation for each of the specialties and subspecialties of service
in which the laboratory performs moderate complexity tests or
procedures. The director of a laboratory performing moderate complexity
testing may function as the technical consultant provided he or she
meets the qualifications specified in this section.
(a) The technical consultant must possess a current license issued by
the State in which the laboratory is located, if such licensing is
required.
(b) The technical consultant must --
(1) (i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in anatomic or clinical pathology, or both, by the
American Board of Pathology or the American Osteopathic Board of
Pathology or possess qualifications that are equivalent to those
required for such certification; or
(2) (i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Have at least one year of laboratory training or experience, or
both, in the designated specialty or subspecialty areas of service for
which the technical consultant is responsible (for example, physicians
certified either in hematology or hematology and medical oncology by the
American Board on Internal Medicine are qualified to serve as the
technical consultant in hematology); or
(3) (i) Hold an earned doctoral or master's degree in a chemical,
physical, biological or clinical laboratory science or medical
technology from an accredited institution; and
(ii) Have at least one year of laboratory training or experience, or
both, in the designated specialty or subspecialty areas of service for
which the technical consultant is responsible; or
(4) (i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 2 years of laboratory training or experience, or
both, in the designated specialty or subspecialty areas of service for
which the technical consultant is responsible.
Note: The technical consultant requirements for ''laboratory
training or experience, or both'' in each specialty or subspecialty may
be acquired concurrently in more than one of the specialties or
subspecialties of service, excluding waived tests. For example, an
individual, who has a bachelor's degree in biology and additionally has
documentation of 2 years of work experience performing tests of moderate
complexity in all specialties and subspecialties of service, would be
qualified as a technical consultant in a laboratory performing moderate
complexity testing in all specialties and subspecialties of service.
42 CFR 493.1413 Standard; Technical consultant responsibilities.
The technical consultant is responsible for the technical and
scientific oversight of the laboratory. The technical consultant is not
required to be onsite at all times testing is performed; however, he or
she must be available to the laboratory on an as needed basis to provide
consultation, as specified in paragraph (a) of this section.
(a) The technical consultant must be accessible to the laboratory to
provide on-site, telephone, or electronic consultation; and
(b) The technical consultant is responsible for --
(1) Selection of test methodology appropriate for the clinical use of
the test results;
(2) Verification of the test procedures performed and the
establishment of the laboratory's test performance characteristics,
including the precision and accuracy of each test and test system;
(3) Enrollment and participation in an HHS approved proficiency
testing program commensurate with the services offered;
(4) Establishing a quality control program appropriate for the
testing performed and establishing the parameters for acceptable levels
of analytic performance and ensuring that these levels are maintained
throughout the entire testing process from the initial receipt of the
specimen, through sample analysis and reporting of test results;
(5) Resolving technical problems and ensuring that remedial actions
are taken whenever test systems deviate from the laboratory's
established performance specifications;
(6) Ensuring that patient test results are not reported until all
corrective actions have been taken and the test system is functioning
properly;
(7) Identifying training needs and assuring that each individual
performing tests receives regular in-service training and education
appropriate for the type and complexity of the laboratory services
performed;
(8) Evaluating the competency of all testing personnel and assuring
that the staff maintain their competency to perform test procedures and
report test results promptly, accurately and proficiently. The
procedures for evaluation of the competency of the staff must include,
but are not limited to --
(i) Direct observations of routine patient test performance,
including patient preparation, if applicable, specimen handling,
processing and testing;
(ii) Monitoring the recording and reporting of test results;
(iii) Review of intermediate test results or worksheets, quality
control records, proficiency testing results, and preventive maintenance
records;
(iv) Direct observation of performance of instrument maintenance and
function checks;
(v) Assessment of test performance through testing previously
analyzed specimens, internal blind testing samples or external
proficiency testing samples; and
(vi) Assessment of problem solving skills; and
(9) Evaluating and documenting the performance of individuals
responsible for moderate complexity testing at least semiannually during
the first year the individual tests patient specimens. Thereafter,
evaluations must be performed at least annually unless test methodology
or instrumentation changes, in which case, prior to reporting patient
test results, the individual's performance must be reevaluated to
include the use of the new test methodology or instrumentation.
42 CFR 493.1415 Condition: Laboratories performing moderate complexity
testing; clinical consultant.
The laboratory must have a clinical consultant who meets the
qualification requirements of 493.1417 of this part and provides
clinical consultation in accordance with 493.1419 of this part.
42 CFR 493.1417 Standard; Clinical consultant qualifications.
The clinical consultant must be qualified to consult with and render
opinions to the laboratory's clients concerning the diagnosis, treatment
and management of patient care. The clinical consultant must --
(a) Be qualified as a laboratory director under 493.1405(b) (1),
(2), or (3)(i); or
(b) Be a doctor of medicine or doctor of osteopathy and possess a
license to practice medicine or osteopathy in the State in which the
laboratory is located.
42 CFR 493.1419 Standard; Clinical consultant responsibilities.
The clinical consultant provides consultation regarding the
appropriateness of the testing ordered and interpretation of test
results. The clinical consultant must --
(a) Be available to provide clinical consultation to the laboratory's
clients;
(b) Be available to assist the laboratory's clients in ensuring that
appropriate tests are ordered to meet the clinical expectations;
(c) Ensure that reports of test results include pertinent information
required for specific patient interpretation; and
(d) Ensure that consultation is available and communicated to the
laboratory's clients on matters related to the quality of the test
results reported and their interpretation concerning specific patient
conditions.
42 CFR 493.1421 Condition: Laboratories performing moderate complexity
testing; testing personnel.
The laboratory must have a sufficient number of individuals who meet
the qualification requirements of 493.1423, to perform the functions
specified in 493.1425 for the volume and complexity of tests performed.
42 CFR 493.1423 Standard; Testing personnel qualifications.
Each individual performing moderate complexity testing must --
(a) Possess a current license issued by the State in which the
laboratory is located, if such licensing is required; and
(b) Meet one of the following requirements:
(1) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located or have earned a doctoral, master's, or bachelor's degree in a
chemical, physical, biological or clinical laboratory science, or
medical technology from an accredited institution; or
(2) Have earned an associate degree in a chemical, physical or
biological science or medical laboratory technology from an accredited
institution; or
(3) Be a high school graduate or equivalent and have successfully
completed an official military medical laboratory procedures course of
at least 50 weeks duration and have held the military enlisted
occupational specialty of Medical Laboratory Specialist (Laboratory
Technician); or
(4)(i) Have earned an academic high school diploma or equivalent;
and
(ii) Have documentation of training appropriate for the testing
performed prior to analyzing patient specimens. Such training must
ensure that the individual has --
(A) The skills required for proper specimen collection, including
patient preparation, if applicable, labeling, handling, preservation or
fixation, processing or preparation, transportation and storage of
specimens;
(B) The skills required for implementing all standard laboratory
procedures;
(C) The skills required for performing each test method and for
proper instrument use;
(D) The skills required for performing preventive maintenance,
troubleshooting and calibration procedures related to each test
performed;
(E) A working knowledge of reagent stability and storage;
(F) The skills required to implement the quality control policies and
procedures of the laboratory;
(G) An awareness of the factors that influence test results; and
(H) The skills required to assess and verify the validity of patient
test results through the evaluation of quality control sample values
prior to reporting patient test results.
42 CFR 493.1425 Standard; Testing personnel responsibilities.
The testing personnel are responsible for specimen processing, test
performance, and for reporting test results.
(a) Each individual performs only those moderate complexity tests
that are authorized by the laboratory director and require a degree of
skill commensurate with the individual's education, training or
experience, and technical abilities.
(b) Each individual performing moderate complexity testing must --
(1) Follow the laboratory's procedures for specimen handling and
processing, test analyses, reporting and maintaining records of patient
test results;
(2) Maintain records that demonstrate that proficiency testing
samples are tested in the same manner as patient samples;
(3) Adhere to the laboratory's quality control policies, document all
quality control activities, instrument and procedural calibrations and
maintenance performed;
(4) Follow the laboratory's established corrective action policies
and procedures whenever test systems are not within the laboratory's
established acceptable levels of performance;
(5) Be capable of identifying problems that may adversely affect test
performance or reporting of test results and either must correct the
problems or immediately notify the technical consultant, clinical
consultant or director; and
(6) Document all corrective actions taken when test systems deviate
from the laboratory's established performance specifications.
42 CFR 493.1425 Laboratories Performing High Complexity Testing
42 CFR 493.1441 Condition: Laboratories performing high complexity
testing; laboratory director.
The laboratory must have a director who meets the qualification
requirements of 493.1443 of this subpart and provides overall
management and direction in accordance with 493.1445 of this subpart.
42 CFR 493.1443 Standard; Laboratory director qualifications.
The laboratory director must be qualified to manage and direct the
laboratory personnel and performance of high complexity tests and must
be eligible to be an operator of a laboratory within the requirements of
subpart R.
(a) The laboratory director must possess a current license as a
laboratory director issued by the State in which the laboratory is
located, if such licensing is required; and
(b) The laboratory director must --
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in anatomic or clinical pathology, or both, by the
American Board of Pathology or the American Osteopathic Board of
Pathology or possess qualifications that are equivalent to those
required for such certification; or
(2) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(i) Have at least one year of laboratory training during medical
residency (for example, physicians certified either in hematology or
hematology and medical oncology by the American Board of Internal
Medicine); or
(ii) Have at least 2 years of experience directing or supervising
high complexity testing; or
(3) Hold an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited institution
and --
(i) Be certified by the American Board of Medical Microbiology, the
American Board of Clinical Chemistry, the American Board of Bioanalysis,
the American Board of Medical Laboratory Immunology or other board
deemed comparable by HHS; or
(ii) Until September 1, 1994 must have at least --
(A) Two years of laboratory training or experience, or both;
(B) Two years of experience directing or supervising high complexity
testing; and
(C) On September 1, 1994, individuals must meet the qualifications
specified in paragraph (b)(3)(i) of this section;
(4) Be serving as a laboratory director and must have previously
qualified or could have qualified as a laboratory director under
regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538,
on or before February 28, 1992; or
(5) On or before February 28, 1992, be qualified under State law to
direct a laboratory in the State in which the laboratory is located.
42 CFR 493.1445 Standard; Laboratory director responsibilities.
The laboratory director is responsible for the overall operation and
administration of the laboratory, including the employment of personnel
who are competent to perform test procedures, record and report test
results promptly, accurately and proficiently, and for assuring
compliance with the applicable regulations.
(a) The laboratory director, if qualified, may perform the duties of
the technical supervisor, clinical consultant, general supervisor, and
testing personnel, or delegate these responsibilities to personnel
meeting the qualifications under 493.1447, 493.1453, 493.1459, and
493.1487, respectively.
(b) If the laboratory director reapportions performance of his or her
responsibilities, he or she remains responsible for ensuring that all
duties are properly performed.
(c) The laboratory director must be accessible to the laboratory to
provide onsite, telephone or electronic consultation as needed.
(d) Each individual may direct no more than five laboratories.
(e) The laboratory director must --
(1) Ensure that testing systems developed and used for each of the
tests performed in the laboratory provide quality laboratory services
for all aspects of test performance, which includes the preanalytic,
analytic, and postanalytic phases of testing;
(2) Ensure that the physical plant and environmental conditions of
the laboratory are appropriate for the testing performed and provide a
safe environment in which employees are protected from physical,
chemical, and biological hazards;
(3) Ensure that --
(i) The test methodologies selected have the capability of providing
the quality of results required for patient care;
(ii) Verification procedures used are adequate to determine the
accuracy, precision, and other pertinent performance characteristics of
the method; and
(iii) Laboratory personnel are performing the test methods as
required for accurate and reliable results;
(4) Ensure that the laboratory is enrolled in an HHS-approved
proficiency testing program for the testing performed and that --
(i) The proficiency testing samples are tested as required under
subpart H of this part;
(ii) The results are returned within the timeframes established by
the proficiency testing program;
(iii) All proficiency testing reports received are reviewed by the
appropriate staff to evaluate the laboratory's performance and to
identify any problems that require corrective action; and
(iv) An approved corrective action plan is followed when any
proficiency testing result is found to be unacceptable or
unsatisfactory;
(5) Ensure that the quality control and quality assurance programs
are established and maintained to assure the quality of laboratory
services provided and to identify failures in quality as they occur;
(6) Ensure the establishment and maintenance of acceptable levels of
analytical performance for each test system;
(7) Ensure that all necessary remedial actions are taken and
documented whenever significant deviations from the laboratory's
established performance characteristics are identified, and that patient
test results are reported only when the system is functioning properly;
(8) Ensure that reports of test results include pertinent information
required for interpretation;
(9) Ensure that consultation is available to the laboratory's clients
on matters relating to the quality of the test results reported and
their interpretation concerning specific patient conditions;
(10) Ensure that a general supervisor provides on-site supervision of
high complexity test performance by testing personnel qualified under
493.1489(b)(4);
(11) Employ a sufficient number of laboratory personnel with the
appropriate education and either experience or training to provide
appropriate consultation, properly supervise and accurately perform
tests and report test results in accordance with the personnel
responsibilities described in this subpart;
(12) Ensure that prior to testing patients' specimens, all personnel
have the appropriate education and experience, receive the appropriate
training for the type and complexity of the services offered, and have
demonstrated that they can perform all testing operations reliably to
provide and report accurate results;
(13) Ensure that policies and procedures are established for
monitoring individuals who conduct preanalytical, analytical, and
postanalytical phases of testing to assure that they are competent and
maintain their competency to process specimens, perform test procedures
and report test results promptly and proficiently, and whenever
necessary, identify needs for remedial training or continuing education
to improve skills;
(14) Ensure that an approved procedure manual is available to all
personnel responsible for any aspect of the testing process; and
(15) Specify, in writing, the responsibilities and duties of each
consultant and each supervisor, as well as each person engaged in the
performance of the preanalytic, analytic, and postanalytic phases of
testing, that identifies which examinations and procedures each
individual is authorized to perform, whether supervision is required for
specimen processing, test performance or result reporting and whether
supervisory or director review is required prior to reporting patient
test results.
42 CFR 493.1447 Condition: Laboratories performing high complexity
testing; technical supervisor.
The laboratory must have a technical supervisor who meets the
qualification requirements of 493.1449 of this subpart and provides
technical supervision in accordance with 493.1451 of this subpart.
42 CFR 493.1449 Standard; Technical supervisor qualifications.
The laboratory must employ one or more individuals who are qualified
by education and either training or experience to provide technical
supervision for each of the specialties and subspecialties of service in
which the laboratory performs high complexity tests or procedures. The
director of a laboratory performing high complexity testing may function
as the technical supervisor provided he or she meets the qualifications
specified in this section.
(a) The technical supervisor must possess a current license issued by
the State in which the laboratory is located, if such licensing is
required; and
(b) The laboratory may perform anatomic and clinical laboratory
procedures and tests in all specialties and subspecialties of services
except histocompatibility and clinical cytogenetics services provided
the individual functioning as the technical supervisor --
(1) Is a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(2) Is certified in both anatomic and clinical pathology by the
American Board of Pathology or the American Osteopathic Board of
Pathology or Possesses qualifications that are equivalent to those
required for such certification.
(c) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of bacteriology,
the individual functioning as the technical supervisor must --
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Have at least one year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of bacteriology; or
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of bacteriology; or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of bacteriology; or
(5)(i) Have earned a bachelor's degree in a chemical, physical, or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of bacteriology.
(d) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of
mycobacteriology, the individual functioning as the technical supervisor
must --
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycobacteriology; or
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycobacteriology; or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycobacteriology; or
(5)(i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycobacteriology.
(e) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of mycology, the
individual functioning as the technical supervisor must --
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycology; or
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both in high complexity testing within the speciality of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycology; or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycology; or
(5)(i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycology.
(f) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of parasitology,
the individual functioning as the technical supervisor must --
(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Have at least one year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of parasitology;
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of parasitology; or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of parasitology; or
(5)(i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of parasitology.
(g) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of virology, the
individual functioning as the technical supervisor must --
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of virology; or
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of virology; or
(4) (i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of virology; or
(5) (i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of virology.
(h) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the specialty of diagnostic
immunology, the individual functioning as the technical supervisor must
--
(1) (i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2) (i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing for the specialty of diagnostic
immunology; or
(3) (i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of diagnostic
immunology; or
(4) (i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing for the specialty of diagnostic
immunology; or
(5) (i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing for the specialty of diagnostic
immunology.
(i) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the specialty of chemistry, the
individual functioning as the technical supervisor must --
(1) (i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2) (i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing for the specialty of chemistry; or
(3) (i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of chemistry; or
(4) (i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing for the specialty of chemistry; or
(5) (i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing for the specialty of chemistry.
(j) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the specialty of hematology, the
individual functioning as the technical supervisor must --
(1) (i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2) (i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Have at least one year of laboratory training or experience, or
both, in high complexity testing for the specialty of hematology (for
example, physicians certified either in hematology or hematology and
medical oncology by the American Board of Internal Medicine); or
(3) (i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of hematology; or
(4) (i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing for the specialty of hematology; or
(5) (i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing for the specialty of hematology.
(k) (1) If the requirements of paragraph (b) of this section are not
met and the laboratory performs tests in the subspecialty of cytology,
the individual functioning as the technical supervisor must --
(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Meet one of the following requirements --
(A) Be certified in anatomic pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(B) Be certified by the American Society of Cytology to practice
cytopathology or possess qualifications that are equivalent to those
required for such certification;
(2) An individual qualified under 493.1449(b) or paragraph (k)(1) of
this section may delegate some of the cytology technical supervisor
responsibilities to an individual who is in the final year of full-time
training leading to certification specified in paragraphs (b) or
(k)(1)(ii)(A) of this section provided the technical supervisor
qualified under 493.1449(b) or paragraph (k)(1) of this section remains
ultimately responsible for ensuring that all of the responsibilities of
the cytology technical supervisor are met.
(l) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of histopathology,
the individual functioning as the technical supervisor must --
(1) Meet one of the following requirements:
(i) (A) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(B) Be certified in anatomic pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification;
(ii) An individual qualified under 493.1449(b) or paragraph (l)(1)
of this section may delegate to an individual who is a resident in a
training program leading to certification specified in paragraph (b) or
(l)(1)(i)(B) of this section, the responsibility for examination and
interpretation of histopathology specimens.
(2) For tests in dermatopathology, meet one of the following
requirements:
(i) (A) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located and --
(B) Meet one of the following requirements:
(1) Be certified in anatomic pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2) Be certified in dermatopathology by the American Board of
Dermatology and the American Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(3) Be certified in dermatology by the American Board of Dermatology
or possess qualifications that are equivalent to those required for such
certification; or
(ii) An individual qualified under 493.1449(b) or paragraph
(l)(2)(i) of this section may delegate to an individual who is a
resident in a training program leading to certification specified in
paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for
examination and interpretation of dermatopathology specimens.
(3) For tests in ophthalmic pathology, meet one of the following
requirements:
(i) (A) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located and --
(B) Must meet one of the following requirements:
(1) Be certified in anatomic pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2) Be certified in ophthalmic pathology by the American Board of
Ophthalmology or possess qualifications that are equivalent to those
required for such certification; or
(ii) An individual qualified under 493.1449(b) or paragraph
(1)(3)(i) of this section may delegate to an individual who is a
resident in a training program leading to certification specified in
paragraphs (b) or (l)(3)(i)(B) of this section, the responsibility for
examination and interpretation of ophthalmic specimens; or
(m) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of oral pathology,
the individual functioning as the technical supervisor must meet one of
the following requirements:
(1) (i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located and --
(ii) Must meet one of the following:
(A) Be certified in anatomic pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(B) Be certified in oral pathology by the American Board of Oral
Pathology or possess qualifications that are equivalent to those
required for such certification; or
(2) An individual qualified under 493.1449(b) or paragraph (m)(1) of
this section may delegate to an individual who is a resident in a
training program leading to certification specified in paragraphs (b) or
(m)(1)(ii) of this section, the responsibility for examination and
interpretation of oral pathology specimens.
(n) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the specialty of radiobioassay, the
individual functioning as the technical supervisor must --
(1) (i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2) (i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing for the specialty of radiobioassay; or
(3) (i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of radiobioassay;
or
(4) (i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing for the specialty of radiobioassay; or
(5) (i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing for the specialty of radiobioassay.
(o) If the laboratory performs tests in the specialty of
histocompatibility, the individual functioning as the technical
supervisor must either --
(1) (i) Be a doctor of medicine or osteopathy licensed to practice
medicine or osteopathy in the State in which the laboratory is located;
and
(ii) Have training or experience that meets one of the following
requirements:
(A) Have 4 years of laboratory training or experience, or both,
within the specialty of histocompatibility; or
(B) (1) Have 2 years of laboratory training or experience, or both,
in the specialty of general immunology; and
(2) Have 2 years of laboratory training or experience, or both, in
the specialty of histocompatibility; or
(2) (i) Have an earned doctoral degree in a biological or clinical
laboratory science from an accredited institution; and
(ii) Have training or experience that meets one of the following
requirements:
(A) Have 4 years of laboratory training or experience, or both,
within the specialty of histocompatibility; or
(B) (1) Have 2 years of laboratory training or experience, or both,
in the specialty of general immunology; and
(2) Have 2 years of laboratory training or experience, or both, in
the specialty of histocompatibility.
(p) If the laboratory performs tests in the specialty of clinical
cytogenetics, the individual functioning as the technical supervisor
must --
(1) (i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Have 4 years of training or experience, or both, in genetics, 2
of which have been in clinical cytogenetics; or
(2) (i) Hold an earned doctoral degree in a biological science,
including biochemistry, or clinical laboratory science from an
accredited institution; and
(ii) Have 4 years of training or experience, or both, in genetics, 2
of which have been in clinical cytogenetics.
(q) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the specialty of immunohematology,
the individual functioning as the technical supervisor must --
(1) (i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2) (i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Have at least one year of laboratory training or experience, or
both, in high complexity testing for the specialty of immunohematology.
Note: The technical supervisor requirements for ''laboratory
training or experience, or both'' in each specialty or subspecialty may
be acquired concurrently in more than one of the specialties or
subspecialties of service. For example, an individual, who has a
doctoral degree in chemistry and additionally has documentation of 1
year of laboratory experience working concurrently in high complexity
testing in the specialties of microbiology and chemistry and 6 months of
that work experience included high complexity testing in bacteriology,
mycology, and mycobacteriology, would qualify as the technical
supervisor for the specialty of chemistry and the subspecialties of
bacteriology, mycology, and mycobacteriology.
42 CFR 493.1451 Standard: Technical supervisor responsibilities.
The technical supervisor is responsible for the technical and
scientific oversight of the laboratory. The technical supervisor is not
required to be on site at all times testing is performed; however, he
or she must be available to the laboratory on an as needed basis to
provide supervision as specified in (a) of this section.
(a) The technical supervisor must be accessible to the laboratory to
provide on-site, telephone, or electronic consultation; and
(b) The technical supervisor is responsible for --
(1) Selection of the test methodology that is appropriate for the
clinical use of the test results;
(2) Verification of the test procedures performed and establishment
of the laboratory's test performance characteristics, including the
precision and accuracy of each test and test system;
(3) Enrollment and participation in an HHS approved proficiency
testing program commensurate with the services offered;
(4) Establishing a quality control program appropriate for the
testing performed and establishing the parameter for acceptable levels
of analytic performance and ensuring that these levels are maintained
throughout the entire testing process from the initial receipt of the
specimen, through sample analysis and reporting of test results;
(5) Resolving technical problems and ensuring that remedial actions
are taken whenever test systems deviate from the laboratory's
established performance specifications;
(6) Ensuring that patient test results are not reported until all
corrective actions have been taken and the test system is functioning
properly;
(7) Identifying training needs and assuring that each individual
performing tests receives regular in-service training and education
appropriate for the type and complexity of the laboratory services
performed;
(8) Evaluating the competency of all testing personnel and assuring
that the staff maintain their competency to perform test procedures and
report test results promptly, accurately and proficiently. The
procedures for evaluation of the competency of the staff must include,
but are not limited to --
(i) Direct observations of routine patient test performance,
including patient preparation, if applicable, specimen handling,
processing and testing;
(ii) Monitoring the recording and reporting of test results;
(iii) Review of intermediate test results or worksheets, quality
control records, proficiency testing results, and preventive maintenance
records;
(iv) Direct observation of performance of instrument maintenance and
function checks;
(v) Assessment of test performance through testing previously
analyzed specimens, internal blind testing samples or external
proficiency testing samples; and
(vi) Assessment of problem solving skills; and
(9) Evaluating and documenting the performance of individuals
responsible for high complexity testing at least semiannually during the
first year the individual tests patient specimens. Thereafter,
evaluations must be performed at least annually unless test methodology
or instrumentation changes, in which case, prior to reporting patient
test results, the individual's performance must be reevaluated to
include the use of the new test methodology or instrumentation.
(c) In cytology, the technical supervisor or the individual qualified
under 493.1449(k)(2) --
(1) May perform the duties of the cytology general supervisor and the
cytotechnologist, as specified in 493.1471 and 493.1485, respectively;
(2) Must establish the workload limit for each individual examining
slides;
(3) Must reassess the workload limit for each individual examining
slides at least every 6 months and adjust as necessary;
(4) Must perform the functions specified in 493.1257(c);
(5) Must ensure that each individual examining gynecologic
preparations participates in an HHS approved cytology proficiency
testing program, as specified in 493.945 and achieves a passing score,
as specified in 493.855; and
(6) If responsible for screening cytology slide preparations, must
document the number of cytology slides screened in 24 hours and the
number of hours devoted during each 24-hour period to screening cytology
slides.
42 CFR 493.1453 Condition: Laboratories performing high complexity
testing; clinical consultant.
The laboratory must have a clinical consultant who meets the
requirements of 493.1455 of this subpart and provides clinical
consultation in accordance with 493.1457 of this subpart.
42 CFR 493.1455 Standard; Clinical consultant qualifications.
The clinical consultant must be qualified to consult with and render
opinions to the laboratory's clients concerning the diagnosis, treatment
and management of patient care. The clinical consultant must --
(a) Be qualified as a laboratory director under 493.1443(b)(1), (2),
or (3)(i); or
(b) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located.
42 CFR 493.1457 Standard; Clinical consultant responsibilities.
The clinical consultant provides consultation regarding the
appropriateness of the testing ordered and interpretation of test
results. The clinical consultant must --
(a) Be available to provide consultation to the laboratory's clients;
(b) Be available to assist the laboratory's clients in ensuring that
appropriate tests are ordered to meet the clinical expectations;
(c) Ensure that reports of test results include pertinent information
required for specific patient interpretation; and
(d) Ensure that consultation is available and communicated to the
laboratory's clients on matters related to the quality of the test
results reported and their interpretation concerning specific patient
conditions.
42 CFR 493.1459 Condition: Laboratories performing high complexity
testing; general supervisor.
The laboratory must have one or more general supervisors who are
qualified under 493.1461 of this subpart to provide general supervision
in accordance with 493.1463 of this subpart.
42 CFR 493.1461 Standard: General supervisor qualifications.
The laboratory must have one or more general supervisors who, under
the direction of the laboratory director and supervision of the
technical supervisor, provides day-to-day supervision of testing
personnel and reporting of test results. In the absence of the director
and technical supervisor, the general supervisor must be responsible for
the proper performance of all laboratory procedures and reporting of
test results.
(a) The general supervisor must possess a current license issued by
the State in which the laboratory is located, if such licensing is
required; and
(b) The general supervisor must be qualified as a --
(1) Laboratory director under 493.1443; or
(2) Technical supervisor under 493.1449.
(c) If the requirements of paragraphs (b)(1) or (b)(2) of this
section are not met, the individual functioning as the general
supervisor must --
(1) (i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located or have earned a doctoral, master's, or bachelor's degree in a
chemical, physical, biological or clinical laboratory science, or
medical technology from an accredited institution; and
(ii) Have at least one year of laboratory training or experience, or
both, in high complexity testing; or
(2) (i) Have earned an associate degree in a laboratory science or
medical laboratory technology from an accredited institution; and
(ii) Have at least two years of laboratory training or experience, or
both, in high complexity testing; or
(3) Have previously qualified or could have qualified as a general
supervisor under 42 CFR 493.1427 of the Federal regulations published
March 14, 1990, (55 FR 9538) on or before February 28, 1992.
(d) For blood gas analysis, the individual providing general
supervision must --
(1) Be qualified under 493.1461(b) (1) or (2), or 493.1461(c); or
(2) (i) Have earned a bachelor's degree in respiratory therapy from
an accredited institution; and
(ii) Have at least one year of laboratory training or experience, or
both, in blood gas analysis; or
(3) (i) Have earned an associate degree related to pulmonary function
from an accredited institution; and
(ii) Have at least two years of training or experience, or both in
blood gas analysis.
(e) The general supervisor requirement is met in histopathology, oral
pathology, dermatopathology, and ophthalmic pathology because all tests
and examinations, must be performed:
(1) In histopathology, by an individual who is qualified as a
technical supervisor under 493.1449(b) or 493.1449(l)(1);
(2) In dermatopathology, by an individual who is qualified as a
technical supervisor under 493.1449(b) or 493.1449(l) or (2);
(3) In ophthalmic pathology, by an individual who is qualified as a
technical supervisor under 493.1449(b) or 493.1449(1)(3); and
(4) In oral pathology, by an individual who is qualified as a
technical supervisor under 493.1449(b) or 493.1449(m).
42 CFR 493.1463 Standard: General supervisor responsibilities.
The general supervisor is responsible for day-to-day supervision or
oversight of the laboratory operation and personnel performing testing
and reporting test results.
(a) The general supervisor --
(1) Must be accessible to testing personnel at all times testing is
performed to provide on-site telephone or electronic consultation to
resolve technical problems in accordance with policies and procedures
established either by the laboratory director or technical supervisor;
(2) Is responsible for providing day-to-day supervision of high
complexity test performance by testing personnel qualified under
493.1489;
(3) Must be onsite to provide direct supervision when high complex
testing is performed by any individuals qualified under 493.1489(b)(4);
and
(4) Is responsible for monitoring test analyses and specimen
examinations to ensure that acceptable levels of analytic performance
are maintained.
(b) The director or technical supervisor may delegate to the general
supervisor the responsibility for --
(1) Assuring that all remedial actions are taken whenever test
systems deviate from the laboratory's established performance
specifications;
(2) Ensuring that patient test results are not reported until all
corrective actions have been taken and the test system is properly
functioning;
(3) Providing orientation to all testing personnel; and
(4) Annually evaluating and documenting the performance of all
testing personnel.
42 CFR 493.1467 Condition: Laboratories performing high complexity
testing; cytology general supervisor.
For the subspecialty of cytology, the laboratory must have a general
supervisor who meets the qualification requirements of 493.1469 of this
subpart, and provides supervision in accordance with 493.1471 of this
subpart.
42 CFR 493.1469 Standard: Cytology general supervisor qualifications.
The cytology general supervisor must be qualified to supervise
cytology services. The general supervisor in cytology must possess a
current license issued by the State in which the laboratory is located,
if such licensing is required, and must --
(a) Be qualified as a technical supervisor under 493.1449 (b) or
(k); or
(b) (1) Be qualified as a cytotechnologist under 493.1483; and
(2) Have at least 3 years of full-time (2,080 hours per year)
experience as a cytotechnologist within the preceding 10 years.
42 CFR 493.1471 Standard: Cytology general supervisor
responsibilities.
The technical supervisor of cytology may perform the duties of the
cytology general supervisor or delegate the responsibilities to an
individual qualified under 493.1469.
(a) The cytology general supervisor is responsible for the day-to-day
supervision or oversight of the laboratory operation and personnel
performing testing and reporting test results.
(b) The cytology general supervisor must --
(1) Be accessible to provide on-site, telephone, or electronic
consultation to resolve technical problems in accordance with policies
and procedures established by the technical supervisor of cytology;
(2) Document the slide interpretation results of each gynecologic and
nongynecologic cytology case he or she examined or reviewed (as
specified under 493.1257(d));
(3) For each 24-hour period, document the total number of slides he
or she examined or reviewed in the laboratory as well as the total
number of slides examined or reviewed in any other laboratory or for any
other employer; and
(4) Document the number of hours spent examining slides in each
24-hour period.
42 CFR 493.1481 Condition: Laboratories performing high complexity
testing; cytotechnologist.
For the subspecialty of cytology, the laboratory must have a
sufficient number of cytotechnologists who meet the qualifications
specified in 493.1483 to perform the functions specified in 493.1485.
42 CFR 493.1483 Standard: Cytotechnologist qualifications.
Each person examining cytology slide preparations must meet the
qualifications of 493.1449 (b) or (k), or --
(a) Possess a current license as a cytotechnologist issued by the
State in which the laboratory is located, if such licensing is required;
and
(b) Meet one of the following requirements:
(1) Have graduated from a school of cytotechnology accredited by the
Committee on Allied Health Education and Accreditation; or
(2) Be certified in cytotechnology by a certifying agency approved by
HHS; or
(3) Before September 1, 1992 --
(i) Have successfully completed 2 years in an accredited institution
with at least 12 semester hours in science, 8 hours of which are in
biology; and
(A) Have had 12 months of training in a school of cytotechnology
accredited by an accrediting agency approved by HHS; or
(B) Have received 6 months of formal training in a school of
cytotechnology accredited by an accrediting agency approved by HHS and 6
months of full-time experience in cytotechnology in a laboratory
acceptable to the pathologist who directed the formal 6 months of
training; or
(ii) Have achieved a satisfactory grade to qualify as a
cytotechnologist in a proficiency examination approved by HHS and
designed to qualify persons as cytotechnologists; or
(4) Before September 1, 1992, have full-time experience of at least 2
years or equivalent within the preceding 5 years examining slide
preparations under the supervision of a physician qualified under
493.1449(b) or (k)(1), and before January 1, 1969, must have --
(i) Graduated from high school;
(ii) Completed 6 months of training in cytotechnology in a laboratory
directed by a pathologist or other physician providing cytology
services; and
(iii) Completed 2 years of full-time supervised experience in
cytotechnology; or
(5) (i) On or before September 1, 1993, have full-time experience of
at least 2 years or equivalent examining cytology slide preparations
within the preceding 5 years in the United States under the supervision
of a physician qualified under 493.1449(b) or (k)(1); and
(ii) On or before September 1, 1994, have met the requirements in
either paragraph (b)(1) or (2) of this section.
42 CFR 493.1485 Standard; Cytotechnologist responsibilities.
The cytotechnologist is responsible for documenting --
(a) The slide interpretation results of each gynecologic and
nongynecologic cytology case he or she examined or reviewed (as
specified in 493.1257(d));
(b) For each 24-hour period, the total number of slides examined or
reviewed in the laboratory as well as the total number of slides
examined or reviewed in any other laboratory or for any other employer;
and
(c) The number of hours spent examining slides in each 24-hour
period.
42 CFR 493.1487 Condition: Laboratories performing high complexity
testing; testing personnel.
The laboratory has a sufficient number of individuals who meet the
qualification requirements of 493.1489 of this subpart to perform the
functions specified in 493.1495 of this subpart for the volume and
complexity of testing performed.
42 CFR 493.1489 Standard; Testing personnel qualifications.
Each individual performing high complexity testing must --
(a) Possess a current license issued by the State in which the
laboratory is located, if such licensing is required; and
(b) Meet one of the following requirements:
(1) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located or have earned a doctoral, master's, or bachelor's degree in a
chemical, physical, biological or clinical laboratory science, or
medical technology from an accredited institution;
(2) Have earned an associate degree in a laboratory science, or
medical laboratory technology from an accredited institution;
(3) Have previously qualified or could have qualified as a
technologist under 42 CFR 493.1433 published in March 14, 1990 (55 FR
9538), on or before February 28, 1992;
(4) Until September 1, 1997 --
(i) Have earned an academic high school diploma or equivalent; and
(ii) Have documentation of training appropriate for the testing
performed prior to analyzing patient specimens. Such training must
ensure that the individual has --
(A) The skills required for proper specimen collection, including
patient preparation, if applicable, labeling, handling, preservation or
fixation, processing or preparation, transportation and storage of
specimens;
(B) The skills required for implementing all standard laboratory
procedures;
(C) The skills required for performing each test method and for
proper instrument use;
(D) The skills required for performing preventive maintenance,
troubleshooting and calibration procedures related to each test
performed;
(E) A working knowledge of reagent stability and storage;
(F) The skills required to implement the quality control policies and
procedures of the laboratory;
(G) An awareness of the factors that influence test results; and
(H) The skills required to assess and verify the validity of patient
test results through the evaluation of quality sample values prior to
reporting patient test results.
On September 1, 1997, must meet the qualifications of 493.1489(b)
(1) or (2);
(5) For blood gas analysis, the individual must --
(i) Be qualified under 493.1489(b) (1), (2), or (3), (4);
(ii) Have earned a bachelor's degree in respiratory therapy from an
accredited institution; or
(iii) Have earned an associate degree related to pulmonary function
from an accredited institution; or
(6) For histopathology, tissue examinations must be performed by an
individual who meets the qualifications of 493.1449 (b) or (l) of this
subpart.
42 CFR 493.1495 Standard; Testing personnel responsibilities.
The testing personnel are responsible for specimen processing, test
performance and for reporting test results.
(a) Each individual performs only those high complexity tests that
are authorized by the laboratory director and require a degree of skill
commensurate with the individual's education, training or experience,
and technical abilities.
(b) Each individual performing high complexity testing must --
(1) Follow the laboratory's procedures for specimen handling and
processing, test analyses, reporting and maintaining records of patient
test results;
(2) Maintain records that demonstrate that proficiency testing
samples are tested in the same manner as patient specimens;
(3) Adhere to the laboratory's quality control policies, document all
quality control activities, instrument and procedural calibrations and
maintenance performed;
(4) Follow the laboratory's established policies and procedures
whenever test systems are not within the laboratory's established
acceptable levels of performance;
(5) Be capable of identifying problems that may adversely affect test
performance or reporting of test results and either must correct the
problems or immediately notify the general supervisor, technical
supervisor, clinical consultant, or director;
(6) Document all corrective actions taken when test systems deviate
from the laboratory's established performance specifications; and
(7) If qualified under 493.1489(b)(4), must perform high complexity
testing only under the onsite, direct supervision of a general
supervisor qualified under 493.1461.
42 CFR 493.1495 Subparts N-O -- (Reserved)
42 CFR 493.1495 Subpart P -- Quality Assurance for Moderate or High
Complexity Testing, or Both
Source: 57 FR 7183, Feb. 28, 1992, unless otherwise noted.
42 CFR 493.1701 Condition: Quality assurance; moderate or high
complexity testing, or both.
Each laboratory performing moderate or high complexity testing, or
both, must establish and follow written policies and procedures for a
comprehensive quality assurance program which is designed to monitor and
evaluate the ongoing and overall quality of the total testing process
(preanalytic, analytic, postanalytic). The laboratory's quality
assurance program must evaluate the effectiveness of its policies and
procedures; identify and correct problems; assure the accurate,
reliable and prompt reporting of test results; and assure the adequacy
and competency of the staff. As necessary, the laboratory must revise
policies and procedures based upon the results of those evaluations.
The laboratory must meet the standards of this subpart as they apply to
the services offered, complexity of testing performed and reported, and
the unique practices of each testing entity. All quality assurance
activities must be documented.
42 CFR 493.1703 Standard; Patient test management assessment.
The laboratory must have an ongoing mechanism for monitoring and
evaluating the systems required under subpart J, Patient Test
Management. The laboratory must monitor, evaluate, and revise, if
necessary, based on the results of its evaluations, the following:
(a) The criteria established for patient preparation, specimen
collection, labeling, preservation and transportation;
(b) The information solicited and obtained on the laboratory's test
requisition for its completeness, relevance, and necessity for the
testing of patient specimens;
(c) The use and appropriateness of the criteria established for
specimen rejection;
(d) The completeness, usefulness, and accuracy of the test report
information necessary for the interpretation or utilization of test
results;
(e) The timely reporting of test results based on testing priorities
(STAT, routine, etc.); and
(f) The accuracy and reliability of test reporting systems,
appropriate storage of records and retrieval of test results.
42 CFR 493.1705 Standard; Quality control assessment.
The laboratory must have an ongoing mechanism to evaluate the
corrective actions taken under 493.1219, Remedial actions. Ineffective
policies and procedures must be revised based on the outcome of the
evaluation. The mechanism must evaluate and review the effectiveness of
corrective actions taken for --
(a) Problems identified during the evaluation of calibration and
control data for each test method;
(b) Problems identified during the evaluation of patient test values
for the purpose of verifying the reference range of a test method; and
(c) Errors detected in reported results.
42 CFR 493.1707 Standard; Proficiency testing assessment.
Under subpart H of this part, Proficiency Testing, the corrective
actions taken for any unacceptable, unsatisfactory, or unsuccessful
proficiency testing result(s) must be evaluated for effectiveness.
42 CFR 493.1709 Standard; Comparison of test results.
If a laboratory performs the same test using different methodologies
or instruments, or performs the same test at multiple testing sites, the
laboratory must have a system that twice a year evaluates and defines
the relationship between test results using different methodologies,
instruments, or testing sites. In addition, if a laboratory performs
tests that are not included under subpart I, Proficiency Testing
Programs, the laboratory must have a system for verifying the accuracy
and reliability of its test results at least twice a year.
42 CFR 493.1711 Standard; Relationship of patient information to
patient test results.
For internal quality assurance, the laboratory must have a mechanism
to identify and evaluate patient test results that appear inconsistent
with relevant criteria such as --
(a) Patient age;
(b) Sex;
(c) Diagnosis or pertinent clinical data, when provided;
(d) Distribution of patient test results when available; and
(e) Relationship with other test parameters, when available within
the laboratory.
42 CFR 493.1713 Standard; Personnel assessment.
The laboratory must have an ongoing mechanism to evaluate the
effectiveness of its policies and procedures for assuring employee
competence and, if applicable, consultant competence.
42 CFR 493.1715 Standard; Communications.
The laboratory must have a system in place to document problems that
occur as a result of breakdowns in communication between the laboratory
and the authorized individual who orders or receives the results of test
procedures or examinations. Corrective actions taken to resolve the
problems and minimize communications breakdowns must be documented.
42 CFR 493.1717 Standard; Complaint investigations.
The laboratory must have a system in place to assure that all
complaints and problems reported to the laboratory are documented.
Investigations of complaints must be made, when appropriate, and, as
necessary, corrective actions are instituted.
42 CFR 493.1719 Standard; Quality assurance review with staff.
The laboratory must have a mechanism for documenting and assessing
problems identified during quality assurance reviews and discussing them
with the staff. The laboratory must take corrective actions that are
necessary to prevent recurrences.
42 CFR 493.1721 Standard; Quality assurance records.
The laboratory must maintain documentation of all quality assurance
activities including problems identified and corrective actions taken.
All quality assurance records must be available to HHS.
42 CFR 493.1721 Subpart Q -- Inspection
Source: 57 FR 7184, Feb. 28, 1992, unless otherwise noted.
42 CFR 493.1775 Condition: Inspection of laboratories issued a
certificate of waiver.
(a) HHS or its designee will conduct unannounced inspections of any
laboratory at any time during its hours of operation to assess
compliance with the applicable requirements of part 493.
(b) The laboratory may be required, as part of this inspection, to --
(1) Permit HHS or its designee to interview all employees of the
laboratory concerning the laboratory's compliance with the applicable
requirements of part 493;
(2) Permit HHS or its designee access to all areas of the facility
including --
(i) Specimen procurement and processing areas;
(ii) Storage facilities for specimens, reagents, supplies, records,
and reports; and
(iii) Testing and reporting areas.
(3) Permit employees to be observed performing tests, data analysis
and reporting;
(4) Permit HHS or its designee upon request to review all information
and data necessary to --
(i) Determine that testing is being performed or the laboratory is
being operated in a manner that does not constitute an imminent and
serious risk to public health;
(ii) Evaluate complaints from the public;
(iii) Determine whether the laboratory is performing tests not listed
in 493.15; and
(iv) Collect information to determine the addition, deletion, or
continued inclusion of tests listed in 493.15; and
(5) Provide copies to HHS or its designee of all records and data
that the agency requires under these regulations.
(c) The laboratory must provide upon reasonable request all
information and data needed by HHS or its designee to make a
determination of compliance with the requirements of part 493.
(d) Failure to permit an inspection under this subsection will result
in the suspension of Medicare and Medicaid payments to the laboratory or
termination of the laboratory's participation in Medicare and Medicaid
for payment, and suspension of or action to revoke laboratory's CLIA
certificate of waiver in accordance with subpart R of this part.
42 CFR 493.1777 Condition: Inspection of all laboratories not issued a
certificate of waiver or a certificate of accreditation.
(a) HHS or its designee will conduct unannounced inspections on at
least a biennial basis of any laboratory at any time during its hours of
operation. To assess compliance with the requirements of part 493, HHS
will inspect a laboratory possessing a registration certificate before
issuance of a certificate.
(b) The laboratory may be required, as part of this inspection, to --
(1) Test samples (including proficiency testing samples) or perform
procedures as HHS or its designee requires;
(2) Allow HHS or its designee to interview all employees of the
laboratory concerning the laboratory's compliance with the applicable
requirements of part 493;
(3) Permit employees to be observed performing tests (including
proficiency testing specimens), data analysis and reporting;
(4) Permit HHS or its designee access to all areas of the facility
including --
(i) Specimen procurement and processing areas;
(ii) Storage facilities for specimens, reagents, supplies, records,
and reports; and
(iii) Testing and reporting areas; and
(5) Provide copies to HHS or its designee of all records and data it
requires.
(c) The laboratory must have all records and data accessible and
retrievable within a reasonable time frame during the course of the
inspection.
(d) The laboratory must retain --
(1) Immunohematology records for a period of not less than 5 years,
in accordance with 21 CFR part 606, subpart I;
(2) Pathology test reports for at least 10 years after the date of
reporting as required in 493.1109; and
(3) All other laboratory records for at least 2 years.
(e) The laboratory must provide upon request all information and data
needed by HHS or its designee to make a determination of the
laboratory's compliance with the applicable requirements of part 493.
(f) HHS or its designee may reinspect a laboratory at any time
necessary to evaluate the ability of the laboratory to provide accurate
and reliable test results.
(g) Failure to permit an inspection under this subsection will result
in the suspension of Medicare and Medicaid payments to the laboratory,
or termination of the laboratory's participation in Medicare and
Medicaid for payment, and suspension of or action to revoke the
laboratory's CLIA certificate in accordance with subpart R.
42 CFR 493.1780 Condition: Inspection of accredited and State-exempt
laboratories.
(a) HHS or its designee will conduct unannounced, random validation
inspections of any accredited or State-exempt laboratory at any time
during its hours of operation.
(b) HHS or its designee will conduct unannounced complaint
inspections of an accredited or State-exempt laboratory at any time
during its hours of operation upon receiving a complaint about that
laboratory.
(c) The laboratory may be required, as part of either of the above
inspections, to --
(1) Test samples (including proficiency testing samples) or perform
procedures as required by HHS or its designee;
(2) Allow HHS or its designee to interview all employees of the
laboratory concerning the laboratory's compliance with the applicable
requirements of part 493;
(3) Permit employees to be observed performing tests (including
proficiency testing specimens), and performing data analysis and
reporting activities; and
(4) Permit HHS or its designee access to all areas of the facility
including --
(i) Specimen procurement and processing areas;
(ii) Storage facilities for specimens reagents, supplies, records,
and reports; and
(iii) Testing and reporting areas; and
(5) Provide copies to HHS of all records and data required under
these requirements.
(d) The laboratory must have all records and data accessible and
retrievable within a reasonable time during the inspection.
(e) The laboratory must retain --
(1) Immunohematology records for a period of not less than 5 years,
in accordance with 21 CFR part 606, subpart I;
(2) Pathology test reports for at least 10 years after the date of
reporting, as required in 493.1109; and
(3) All other laboratory records for at least 2 years unless
otherwise specified in part 493.
(f) The laboratory must provide, upon request, all information and
data needed by HHS to make a determination of compliance or
noncompliance with the applicable requirements of part 493.
(g) Failure to permit an inspection under this subsection will result
in the suspension of Medicare and Medicaid payments to the laboratory or
termination of the laboratory's Medicare and Medicaid approval for
payment; and suspension of or action to revoke the laboratory's CLIA
certificate of accreditation in accordance with subpart R of this part.
42 CFR 493.1780 Subpart R -- Enforcement Procedures
Source: 57 FR 7237, Feb. 28, 1992, unless otherwise noted.
42 CFR 493.1800 Basis and scope.
(a) Statutory basis. (1) Section 1846 of the Act --
(i) Provides for intermediate sanctions that may be imposed on
laboratories that perform clinical diagnostic tests on human specimens
when those laboratories are found to be out of compliance with one or
more of the conditions for Medicare coverage of their services; and
(ii) Requires the Secretary to develop and implement a range of such
sanctions, including four that are specified in the statute.
(2) The Clinical Laboratories Improvement Act of 1967 (section 353 of
the Public Health Service Act) as amended by CLIA '88 --
(i) Establishes requirements for all laboratories that perform
clinical diagnostic tests on human specimens;
(ii) Requires a Federal certification scheme to be applied to all
such laboratories; and
(iii) Grants the Secretary broad enforcement authority, including --
(A) Use of intermediate sanctions;
(B) Suspension, limitation, or revocation of the certificate of a
laboratory that is out of compliance with one or more requirements for a
certificate; and
(C) Civil suit to enjoin any laboratory activity that constitutes a
significant hazard to the public health.
(3) Section 353 also --
(i) Provides for imprisonment or fine for any person convicted of
intentional violation of CLIA requirements;
(ii) Specifies the administrative hearing and judicial review rights
of a laboratory that is sanctioned under CLIA; and
(iii) Requires the Secretary to publish annually a list of all
laboratories that have been sanctioned during the preceding year.
(b) Scope and applicability. This subpart sets forth --
(1) The policies and procedures that HCFA follows to enforce the
requirements applicable to laboratories under CLIA and under section
1846 of the Act; and
(2) The appeal rights of laboratories on which HCFA imposes
sanctions.
42 CFR 493.1804 General considerations.
(a) Purpose. The enforcement mechanisms set forth in this subpart
have the following purposes:
(1) To protect all individuals served by laboratories against
substandard testing of specimens.
(2) To safeguard the general public against health and safety hazards
that might result from laboratory activities.
(3) To motivate laboratories to comply with CLIA requirements so that
they can provide accurate and reliable test results.
(b) Basis for decision to impose sanctions. (1) HCFA's decision to
impose sanctions is based on one or more of the following:
(i) Deficiencies found by HCFA or its agents in the conduct of
inspections to certify or validate compliance with Federal requirements,
or through review of materials submitted by the laboratory (e.g.,
personnel qualifications).
(ii) Unsuccessful participation in proficiency testing.
(2) HCFA imposes one ore more of the alternative or principal
sanctions specified in 493.1806 and 493.1807 when HCFA or HCFA's agent
finds that a laboratory has condition-level deficiencies.
(c) Imposition of alternative sanctions. (1) HCFA may impose
alternative sanctions in lieu of, or in addition to principal sanctions,
(HCFA does not impose alternative sanctions on laboratories that have
certificates of waiver because those laboratories are not inspected for
compliance with condition-level requirements.)
(2) HCFA may impose alternative sanctions other than a civil money
penalty after the laboratory has had an opportunity to respond, but
before the hearing specified in 493.1844.
(d) Choice of sanction: Factors considered. HCFA bases its choice
of sanction or sanctions on consideration of one or more factors that
include, but are not limited to, the following, as assessed by the State
or by HCFA, or its agents:
(1) Whether the deficiencies pose immediate jeopardy.
(2) The nature, incidence, severity, and duration of the deficiencies
or noncompliance.
(3) Whether the same condition level deficiencies have been
identified repeatedly.
(4) The accuracy and extent of laboratory records (e.g., of remedial
action) in regard to the noncompliance, and their availability to the
State, to other HCFA agents, and to HCFA.
(5) The relationship of one deficiency or group of deficiencies to
other deficiencies.
(6) The overall compliance history of the laboratory including but
not limited to any period of noncompliance that occurred between
certifications of compliance.
(7) The corrective and long-term compliance outcomes that HCFA hopes
to achieve through application of the sanction.
(8) Whether the laboratory has made any progress toward improvement
following a reasonable opportunity to correct deficiencies.
(9) Any recommendation by the State agency as to which sanction would
be appropriate.
(e) Number of alternative sanctions. HCFA may impose a separate
sanction for each condition level deficiency or a single sanction for
all condition level deficiencies that are interrelated and subject to
correction by a single course of action.
(f) Appeal rights. The appeal rights of laboratories dissatisfied
with the imposition of a sanction are set forth in 493.1844.
(57 FR 7237, Feb. 28, 1992; 57 FR 35761, Aug. 11, 1992)
42 CFR 493.1806 Available sanctions: All laboratories.
(a) Applicability. HCFA may impose one or more of the sanctions
specified in this section on a laboratory that is out of compliance with
one or more CLIA conditions.
(b) Principal sanction. HCFA may impose any of the three principal
CLIA sanctions, which are suspension, limitation, or revocation of any
type of CLIA certificate.
(c) Alternative sanctions. HCFA may impose one or more of the
following alternative sanctions in lieu of or in addition to imposing a
principal sanction, except on a laboratory that has a certificate of
waiver.
(1) Directed plan of correction, as set forth at 493.1832.
(2) State onsite monitoring as set forth at 493.1836.
(3) Civil money penalty, as set forth at 493.1834.
(d) Civil suit. HCFA may bring suit in the appropriate U.S.
District Court to enjoin continuation of any activity of any laboratory
(including a State-exempt laboratory that has been found with
deficiencies during a validation survey), if HCFA has reason to believe
that continuation of the activity would constitute a significant hazard
to the public health.
(e) Criminal sanctions. Under section 353(1) of the PHS Act, an
individual who is convicted of intentionally violating any CLIA
requirement may be imprisoned or fined.
42 CFR 493.1807 Additional sanctions: Laboratories that participate in
Medicare.
The following additional sanctions are available for laboratories
that are out of compliance with one or more CLIA conditions and that
have approval to receive Medicare payment for their services.
(a) Principal sanction. Cancellation of the laboratory's approval to
receive Medicare payment for its services.
(b) Alternative sanctions. (1) Suspension of payment for tests in
one or more specific specialties or subspecialties, performed on or
after the effective date of sanction.
(2) Suspension of payment for all tests in all specialties and
subspecialties performed on or after the effective date of sanction.
42 CFR 493.1808 Adverse action on any type of CLIA certificate: Effect
on Medicare approval.
(a) Suspension or revocation of any type of CLIA certificate. When
HCFA suspends or revokes any type of CLIA certificate, HCFA concurrently
cancels the laboratory's approval to receive Medicare payment for its
services.
(b) Limitation of any type of CLIA certificate. When HCFA limits any
type of CLIA certificate, HCFA concurrently limits Medicare approval to
only those specialties or subspecialties that are authorized by the
laboratory's limited certificate.
42 CFR 493.1809 Limitation on Medicaid payment.
As provided in section 1902(a)(9)(C) of the Act, payment for
laboratory services may be made under the State plan only if those
services are furnished by a laboratory that has a CLIA certificate or is
licensed by a State whose licensure program has been approved by the
Secretary under this part.
(57 FR 7237, Feb. 28, 1992; 57 FR 35761, Aug. 11, 1992)
42 CFR 493.1810 Imposition and lifting of alternative sanctions.
(a) Notice of noncompliance and of proposed sanction: Content. If
HCFA or its agency identifies condition level noncompliance in a
laboratory, HCFA or its agent gives the laboratory written notice of the
following:
(1) The condition level noncompliance that it has identified.
(2) The sanction or sanctions that HCFA or its agent proposes to
impose against the laboratory.
(3) The rationale for the proposed sanction or sanctions.
(4) The projected effective date and duration of the proposed
sanction or sanctions.
(5) The authority for the proposed sanction or sanctions.
(6) The time allowed (at least 10 days) for the laboratory to respond
to the notice.
(b) Opportunity to respond. During the period specified in paragraph
(a)(6) of this section, the laboratory may submit to HCFA or its agent
written evidence or other information against the imposition of the
proposed sanction or sanctions.
(c) Notice of imposition of sanction -- (1) Content. HCFA gives the
laboratory written notice that acknowledges any evidence or information
received from the laboratory and specifies the following:
(i) The sanction or sanctions to be imposed against the laboratory.
(ii) The authority and rationale for the imposing sanction or
sanctions.
(iii) The effective date and duration of sanction.
(2) Timing. (i) If HCFA or its agent determines that the
deficiencies pose immediate jeopardy, HCFA provides notice at least 5
days before the effective date of sanction.
(ii) If HCFA or its agent determines that the deficiencies do not
pose immediate jeopardy, HCFA provides notice at least 15 days before
the effective date of the sanction.
(d) Duration of alternative sanctions. An alternative sanction
continues until the earlier of the following occurs:
(1) The laboratory corrects all condition level deficiencies.
(2) HCFA's suspension, limitation, or revocation of the laboratory's
CLIA certificate becomes effective.
(e) Lifting of alternative sanctions -- (1) General rule.
Alternative sanctions are not lifted until a laboratory's compliance
with all condition level requirements is verified.
(2) Credible allegation of compliance. When a sanctioned laboratory
submits a credible allegation of compliance, HCFA's agent determines
whether --
(i) It can certify compliance on the basis of the evidence presented
by the laboratory in its allegation; or
(ii) It must revisit to verify whether the laboratory has, in fact,
achieved compliance.
(3) Compliance achieved before the date of revisit. If during a
revisit, the laboratory presents credible evidence (as determined by
HCFA or its agent) that it achieved compliance before the date of
revisit, sanctions are lifted as of that earlier date.
42 CFR 493.1812 Action when deficiencies pose immediate jeopardy.
If a laboratory's deficiencies pose immediate jeopardy, the following
rules apply:
(a) HCFA requires the laboratory to take immediate action to remove
the jeopardy and may impose one or more alternative sanctions to help
bring the laboratory into compliance.
(b) If the findings of a revisit indicate that a laboratory has not
eliminated the jeopardy, HCFA suspends or limits the laboratory's CLIA
certificate no earlier than 5 days after the date of notice of
suspension or limitation. HCFA may later revoke the certificate.
(c) In addition, if HCFA has reason to believe that the continuation
of any activity by any laboratory (either the entire laboratory
operation or any specialty or subspecialty of testing) would constitute
a significant hazard to the public health, HCFA may bring suit and seek
a temporary injunction or restraining order against continuation of that
activity by the laboratory, regardless of the type of CLIA certificate
the laboratory has and of whether it is State-exempt.
42 CFR 493.1814 Action when deficiencies are at the condition level but
do not pose immediate jeopardy.
If a laboratory has condition level deficiencies that do not pose
immediate jeopardy, the following rules apply:
(a) Initial action. (1) HCFA may cancel the laboratory's approval to
receive Medicare payment for its services.
(2) HCFA may suspend, limit, or revoke the laboratory's CLIA
certificate.
(3) If HCFA does not impose a principal sanction under paragraph
(a)(1) or (a)(2) of this section, it imposes one or more alternative
sanctions. In the case of unsuccessful participation in proficiency
testing, HCFA may impose the training and technical assistance
requirement set forth at 493.1838 in lieu of, or in addition to, one or
more alternative sanctions.
(b) Failure to correct condition level deficiencies. If HCFA imposes
alternative sanctions for condition level deficiencies that do not pose
immediate jeopardy, and the laboratory does not correct the condition
level deficiencies within 12 months after the last day of inspection,
HCFA --
(1) Cancels the laboratory's approval to receive Medicare payment for
its services, and discontinues the Medicare payment sanctions as of the
day cancellation is effective.
(2) Following a revisit which indicates that the laboratory has not
corrected its condition level deficiencies, notifies the laboratory that
it proposes to suspend, limit, or revoke the certificate, as specified
in 493.1816(b), and the laboratory's right to hearing; and
(3) May impose (or continue, if already imposed) any alternative
sanctions that do not pertain to Medicare payments. (Sanctions imposed
under the authority of section 353 of the PHS Act may continue for more
than 12 months from the last date of inspection, (while a hearing on the
proposed suspension, limitation, or revocation of the certificate,
registration certificate, or certificate of accreditation is pending.)
(c) Action after hearing. If a hearing decision upholds a proposed
suspension, limitation, or revocation of a laboratory's CLIA
certificate, HCFA discontinues any alternative sanctions as of the day
it makes the suspension, limitation, or revocation effective.
42 CFR 493.1816 Action when deficiencies are not at the condition
level.
If a laboratory has deficiencies, that are not at the condition
level, the following rules apply:
(a) Initial action. The laboratory must submit a plan of correction
that is acceptable to HCFA in content and time frames.
(b) Failure to correct deficiencies. If, on revisit, it is found
that the laboratory has not corrected the deficiencies within 12 months
after the last day of inspection, the following rules apply:
(1) HCFA cancels the laboratory's approval to receive Medicare
payment for its services.
(2) HCFA notifies the laboratory of its intent to suspend, limit, or
revoke the laboratory's CLIA certificate and of the laboratory's right
to a hearing.
42 CFR 493.1820 Ensuring timely correction of deficiencies.
(a) Timing of visits. HCFA, the State survey agency or other HCFA
agent may visit the laboratory at any time to evaluate progress, and at
the end of the period to determine whether all corrections have been
made.
(b) Deficiencies corrected before a visit. If during a visit, a
laboratory produces credible evidence that it achieved compliance before
the visit, the sanctions are lifted as of that earlier date.
(c) Failure to correct deficiencies. If during a visit it is found
that the laboratory has not corrected its deficiencies, HCFA may propose
to suspend, limit, or revoke the laboratory's CLIA certificate.
(d) Additional time for correcting lower level deficiencies not at
the condition level. If at the end of the plan of correction period all
condition level deficiencies have been corrected, and there are
deficiencies, that are not at the condition level, HCFA may request a
revised plan of correction. The revised plan may not extend beyond 12
months from the last day of the inspection that originally identified
the cited deficiencies.
(e) Persistence of deficiencies. If at the end of the period covered
by the plan of correction, the laboratory still has deficiencies, the
rules of 493.1814 and 493.1816 apply.
42 CFR 493.1826 Suspension of part of Medicare payments.
(a) Application. (1) HCFA may impose this sanction if a laboratory
--
(i) Is found to have condition level deficiencies with respect to one
or more specialties or subspecialties of tests; and
(ii) Agrees (in return for not having its Medicare approval cancelled
immediately) not to charge Medicare beneficiaries or their private
insurance carriers for the services for which Medicare payment is
suspended.
(2) HCFA suspends Medicare payment for those specialities or
subspecialties of tests for which the laboratory is out of compliance
with Federal requirements.
(b) Procedures. Before imposing this sanction, HCFA provides notice
of sanction and opportunity to respond in accordance with 493.1810.
(c) Duration and effect of sanction. This sanction continues until
the laboratory corrects the condition level deficiencies or HCFA cancels
the laboratory's approval to receive Medicare payment for its services,
but in no event longer than 12 months.
(1) If the laboratory corrects all condition level deficiencies, HCFA
resumes Medicare payment effective for all services furnished on or
after the date the deficiencies are corrected.
(2) (Reserved)
(57 FR 7237, Feb. 28, 1992; 57 FR 35761, Aug. 11, 1992)
42 CFR 493.1828 Suspension of all Medicare payments.
(a) Application. (1) HCFA may suspend payment for all
Medicare-approved laboratory services when the laboratory has condition
level deficiencies.
(2) HCFA suspends payment for all Medicare covered laboratory
services when the following conditions are met:
(i) Either --
(A) The laboratory has not corrected its condition level deficiencies
included in the plan of correction within 3 months from the last date of
inspection; or
(B) The laboratory has been found to have the same condition level
deficiencies during three consecutive inspections; and
(ii) The laboratory has chosen (in return for not having its Medicare
approval immediately cancelled), to not charge Medicare beneficiaries or
their private insurance carriers for services for which Medicare payment
is suspended.
(3) HCFA suspends payment for services furnished on and after the
effective date of sanction.
(b) Procedures. Before imposing this sanction, HCFA provides notice
of sanction and opportunity to respond in accordance with 493.1810.
(c) Duration and effect of sanction. (1) Suspension of payment
continues until all condition level deficiencies are corrected, but
never beyond twelve months.
(2) If all the deficiencies are not corrected by the end of the 12
month period, HCFA cancels the laboratory's approval to receive Medicare
payment for its services.
42 CFR 493.1832 Directed plan of correction and directed portion of a
plan of correction.
(a) Application. HCFA may impose a directed plan of correction as an
alternative sanction for any laboratory that has condition level
deficiencies. If HCFA does not impose a directed plan of correction as
an alternative sanction for a laboratory that has condition level
deficiencies, it at least imposes a directed portion of a plan of
correction when it imposes any of the following alternative sanctions:
(1) State onsite monitoring.
(2) Civil money penalty.
(3) Suspension of all or part of Medicare payments.
(b) Procedures -- (1) Directed plan of correction. When imposing
this sanction, HCFA --
(i) Gives the laboratory prior notice of the sanction and opportunity
to respond in accordance with 493.1810;
(ii) Directs the laboratory to take specific corrective action within
specific time frames in order to achieve compliance; and
(iii) May direct the laboratory to submit the names of laboratory
clients for notification purposes, as specified in paragraph (b)(3) of
this section.
(2) Directed portion of a plan of correction. HCFA may decide to
notify clients of a sanctioned laboratory, because of the seriousness of
the noncompliance (e.g., the existence of immediate jeopardy) or for
other reasons. When imposing this sanction, HCFA takes the following
steps --
(i) Directs the laboratory to submit to HCFA, the State survey
agency, or other HCFA agent, within 10 calendar days after the notice of
the alternative sanction, a list of names and addresses of all
physicians, providers, suppliers, and other clients who have used some
or all of the services of the laboratory since the last certification
inspection or within any other timeframe specified by HCFA.
(ii) Within 30 calendar days of receipt of the information, may send
to each laboratory client, via the State survey agency, a notice
containing the name and address of the laboratory, the nature of the
laboratory's noncompliance, and the kind and effective date of the
alternative sanction.
(iii) Sends to each laboratory client, via the State survey agency,
notice of the recission of an adverse action within 30 days of the
rescission.
(3) Notice of imposition of a principal sanction following the
imposition of an alternative sanction. If HCFA imposes a principal
sanction following the imposition of an alternative sanction, and for
which HCFA has already obtained a list of laboratory clients, HCFA may
use that list to notify the clients of the imposition of the principal
sanction.
(c) Duration of a directed plan of correction. If HCFA imposes a
directed plan of correction, and on revisit it is found that the
laboratory has not corrected the deficiencies within 12 months from the
last day of inspection, the following rules apply:
(1) HCFA cancels the laboratory's approval for Medicare payment of
its services, and notifies the laboratory of HCFA's intent to suspend,
limit, or revoke the laboratory's CLIA certificate.
(2) The directed plan of correction continues in effect until the day
suspension, limitation, or revocation of the laboratory's CLIA
certificate.
42 CFR 493.1834 Civil money penalty.
(a) Statutory basis. Sections 1846 of the Act and 353(h)(2)(B) of
the PHS Act authorize the Secretary to impose civil money penalties on
laboratories. Section 1846(b)(3) of the Act specifically provides that
incrementally more severe fines may be imposed for repeated or
uncorrected deficiencies.
(b) Scope. This section sets forth the procedures that HCFA follows
to impose a civil money penalty in lieu of, or in addition to
suspending, limiting, or revoking the certificate, registration
certificate or certificate of accreditation of a laboratory that is
found to have condition level deficiencies.
(c) Basis for imposing a civil money penalty. HCFA may impose a
civil money penalty against any laboratory determined to have condition
level deficiencies regardless of whether those deficiencies pose
immediate jeopardy.
(d) Amount of penalty -- (1) Factors considered. In determining the
amount of the penalty, HCFA takes into account the following factors:
(i) The nature, scope, severity, and duration of the noncompliance.
(ii) Whether the same condition level deficiencies have been
identified during three consecutive inspections.
(iii) The laboratory's overall compliance history including but not
limited to any period of noncompliance that occurred between
certifications of compliance.
(iv) The laboratory's intent or reason for noncompliance.
(v) The accuracy and extent of laboratory records and their
availability to HCFA, the State survey agency, or other HCFA agent.
(2) Range of penalty amount.
(i) For a condition level deficiency that poses immediate jeopardy,
the range is $3,050-$10,000 per day of noncompliance or per violation.
(ii) For a condition level deficiency that does not pose immediate
jeopardy, the range is $50-$3,000 per day of noncompliance or per
violation.
(3) Decreased penalty amounts. If the immediate jeopardy is removed,
but the deficiency continues, HCFA shifts the penalty amount to the
lower range.
(4) Increased penalty amounts. HCFA may, before the hearing, propose
to increase the penalty amount for a laboratory that has deficiencies
which, after imposition of a lower level penalty amount, become
sufficiently serious to pose immediate jeopardy.
(e) Procedures for imposition of civil money penalty -- (1) Notice of
intent. (i) HCFA sends the laboratory written notice, of HCFA's intent
to impose a civil money penalty.
(ii) The notice includes the following information:
(A) The statutory basis for the penalty.
(B) The proposed daily or per violation amount of the penalty.
(C) The factors (as described in paragraph (d)(1) of this section)
that HCFA considered.
(D) The opportunity for responding to the notice in accordance with
493.1810(c).
(E) A specific statement regarding the laboratory's appeal rights.
(2) Appeal rights. (i) The laboratory has 60 days from the date of
receipt of the notice of intent to impose a civil money penalty to
request a hearing in accordance with 493.1844(g).
(ii) If the laboratory requests a hearing, all other pertinent
provisions of 493.1844 apply.
(iii) If the laboratory does not request a hearing, HCFA may reduce
the proposed penalty amount by 35 percent.
(f) Accrual and duration of penalty -- (1) Accrual of penalty. The
civil money penalty begins accruing as follows:
(i) 5 days after notice of intent if there is immediate jeopardy.
(ii) 15 days after notice of intent if there is not immediate
jeopardy.
(2) Duration of penalty. The civil money penalty continues to accrue
until the earliest of the following occurs:
(i) The laboratory's compliance with condition level requirements is
verified on the basis of the evidence presented by the laboratory in its
credible allegation of compliance or at the time or revisit.
(ii) Based on credible evidence presented by the laboratory at the
time of revisit, HCFA determines that compliance was achieved before the
revisit. (In this situation, the money penalty stops accruing as of the
date of compliance.)
(iii) HCFA suspends, limits, or revokes the laboratory's CLIA
certificate, registration certificate, or certificate of accreditation.
(g) Computation and notice of total penalty amount -- (1)
Computation. HCFA computes the total penalty amount after the
laboratory's compliance is verified or HCFA suspends, limits, or revokes
the laboratory's CLIA certificate but in no event before --
(i) The 60 day period for requesting a hearing has expired without a
request or the laboratory has explicitly waived its right to a hearing;
or
(ii) Following a hearing requested by the laboratory, the ALJ issues
a decision that upholds imposition of the penalty.
(2) Notice of penalty amount and due date of penalty. The notice
includes the following information:
(i) Daily or per violation penalty amount.
(ii) Number of days or violations for which the penalty is imposed.
(iii) Total penalty amount.
(iv) Due date for payment of the penalty.
(h) Due date for payment of penalty. (1) Payment of a civil money
penalty is due 15 days from the date of the notice specified in
paragraph (g)(2) of this section.
(2) HCFA may approve a plan for a laboratory to pay a civil money
penalty, plus interest, over a period of up to one year from the
original due date.
(i) Collection and settlement -- (1) Collection of penalty amounts.
(i) The determined penalty amount may be deducted from any sums then or
later owing by the United States to the laboratory subject to the
penalty.
(ii) Interest accrues on the unpaid balance of the penalty, beginning
on the due date. Interest is computed at the rate specified in
405.376(d) of this chapter.
(2) Settlement. HCFA has authority to settle any case at any time
before the ALJ issues a hearing decision.
(57 FR 7237, Feb. 28, 1992; 57 FR 35761, Aug. 11, 1992)
42 CFR 493.1836 State onsite monitoring.
(a) Application.
(1) HCFA may require continuous or intermittent monitoring of a plan
of correction by the State survey agency to ensure that the laboratory
makes the improvements necessary to bring it into compliance with the
condition level requirements. (The State monitor does not have
management authority, that is, cannot hire or fire staff, obligate
funds, or otherwise dictate how the laboratory operates. The monitor's
responsibility is to oversee whether corrections are made.)
(2) The laboratory must pay the costs of onsite monitoring by the
State survey agency.
(i) The costs are computed by multiplying the number of hours of
onsite monitoring in the laboratory by the hourly rate negotiated by
HCFA and the State.
(ii) The hourly rate includes salary, fringe benefits, travel, and
other direct and indirect costs approved by HCFA.
(b) Procedures. Before imposing this sanction, HCFA provides notice
of sanction and opportunity to respond in accordance with 493.1810.
(c) Duration of sanction. (1) If HCFA imposes onsite monitoring, the
sanction continues until HCFA determines that the laboratory has the
capability to ensure compliance with all condition level requirements.
(2) If the laboratory does not correct all deficiencies within 12
months, and a revisit indicates that deficiencies remain, HCFA cancels
the laboratory's approval for Medicare payment for its services and
notifies the laboratory of its intent to suspend, limit, or revoke the
laboratory's certificate, registration certificate, or certificate of
accreditation.
(3) If the laboratory still does not correct its deficiencies, the
Medicare sanction continues until the suspension, limitation, or
revocation of the laboratory's certificate, registration certificate, or
certificate of accreditation is effective.
42 CFR 493.1838 Training and technical assistance for unsuccessful
participation in proficiency testing.
If a laboratory's participation in proficiency testing is
unsuccessful, HCFA may require the laboratory to undertake training of
its personnel, or to obtain necessary technical assistance, or both, in
order to meet the requirements of the proficiency testing program. This
requirement is separate from the principal and alternative sanctions set
forth in 493.1806 and 493.1807.
42 CFR 493.1840 Suspension, limitation, or revocation of any type of
CLIA certificate.
(a) Adverse action based on actions of the laboratory's owner,
operator or employees. HCFA may initiate adverse action to suspend,
limit or revoke any CLIA certificate if HCFA finds that a laboratory's
owner or operator or one of its employees has --
(1) Been guilty of misrepresentation in obtaining a CLIA certificate;
(2) Performed, or represented the laboratory as entitled to perform,
a laboratory examination or other procedure that is not within a
category of laboratory examinations or other procedures authorized by
its CLIA certificate;
(3) Failed to comply with the certificate requirements and
performance standards;
(4) Failed to comply with reasonable requests by HCFA for any
information or work on materials that HCFA concludes is necessary to
determine the laboratory's continued eligibility for its CLIA
certificate or continued compliance with performance standards set by
HCFA;
(5) Refused a reasonable request by HCFA or its agent for permission
to inspect the laboratory and its operation and pertinent records during
the hours that the laboratory is in operation;
(6) Violated or aided and abetted in the violation of any provisions
of CLIA and its implementing regulations;
(7) Failed to comply with an alternative sanction imposed under this
subpart; or
(8) Within the preceding two-year period, owned or operated a
laboratory that had its CLIA certificate revoked. (This provision
applies only to the owner or operator, not to all of the laboratory's
employees.)
(b) Adverse action based on improper referrals in proficiency
testing. If HCFA determines that a laboratory has intentionally
referred its proficiency testing samples to another laboratory for
analysis, HCFA revokes the laboratory's CLIA certificate for at least
one year, and may also impose a civil money penalty.
(c) Adverse action based on exclusion from Medicare. If the OIG
excludes a laboratory from participation in Medicare, HCFA suspends the
laboratory's CLIA certificate for the period during which the laboratory
is excluded.
(d) Procedures for suspension or limitation -- (1) Basic rule.
Except as provided in paragraph (d)(2) of this section, HCFA does not
suspend or limit a CLIA certificate until after an ALJ hearing decision
(as provided in 493.1844) that upholds suspension or limitation.
(2) Exceptions. HCFA may suspend or limit a CLIA certificate before
the ALJ hearing in any of the following circumstances:
(i) The laboratory's deficiencies pose immediate jeopardy.
(ii) The laboratory has refused a reasonable request for information
or work on materials.
(iii) The laboratory has refused permission for HCFA or a HCFA agent
to inspect the laboratory or its operation.
(e) Procedures for revocation. (1) HCFA does not revoke any type of
CLIA certificate until after an ALJ hearing that upholds revocation.
(2) HCFA may revoke a CLIA certificate after the hearing decision
even if it had not previously suspended or limited that certificate.
(f) Notice to the OIG. HCFA notifies the OIG of any violations under
paragraphs (a)(1), (a)(2), (a)(6), and (b) of this section within 30
days of the determination of the violation.
42 CFR 493.1842 Cancellation of Medicare approval.
(a) Basis for cancellation. (1) HCFA always cancels a laboratory's
approval to receive Medicare payment for its services if HCFA suspends
or revokes the laboratory's CLIA certificate.
(2) HCFA may cancel the laboratory's approval under any of the
following circumstances:
(i) The laboratory is out of compliance with a condition level
requirement.
(ii) The laboratory fails to submit a plan of correction satisfactory
to HCFA.
(iii) The laboratory fails to correct all its deficiencies within the
time frames specified in the plan of correction.
(b) Notice and opportunity to respond. Before canceling a
laboratory's approval to receive Medicare payment for its services, HCFA
gives the laboratory --
(1) Written notice of the rationale for, effective date, and effect
of, cancellation;
(2) Opportunity to submit written evidence or other information
against cancellation of the laboratory's approval.
This sanction may be imposed before the hearing that may be requested
by a laboratory, in accordance with the appeals procedures set forth in
493.1844.
(c) Effect of cancellation. Cancellation of Medicare approval
terminates any Medicare payment sanctions regardless of the time frames
originally specified.
42 CFR 493.1844 Appeals procedures.
(a) General rules. (1) The provisions of this section apply to all
laboratories and prospective laboratories that are dissatisfied with any
initial determination under paragraph (b) of this section.
(2) Hearings are conducted in accordance with procedures set forth in
subpart D of part 498 of this chapter, except that the authority to
conduct hearings and issue decisions may be exercised by ALJs assigned
to, or detailed to, the Departmental Appeals Board.
(3) Any party dissatisfied with a hearing decision is entitled to
request review of the decision as specified in subpart E of part 498 of
this chapter, except that the authority to review the decision may be
exercised by the Departmental Appeals Board.
(4) When more than one of the actions specified in paragraph (b) of
this section are carried out concurrently, the laboratory has a right to
only one hearing on all matters at issue.
(b) Actions that are initial determinations. The following actions
are initial determinations and therefore are subject to appeal in
accordance with this section:
(1) The suspension, limitation, or revocation of the laboratory's
CLIA certificate by HCFA because of noncompliance with CLIA
requirements.
(2) The denial of a CLIA certificate.
(3) The imposition of alternative sanctions under this subpart (but
not the determination as to which alternative sanction or sanctions to
impose).
(4) The denial or cancellation of the laboratory's approval to
receive Medicare payment for its services.
(c) Actions that are not initial determinations. Actions that are
not listed in paragraph (b) of this section are not initial
determinations and therefore are not subject to appeal under this
section. They include, but are not necessarily limited to, the
following:
(1) The finding that a laboratory accredited by a HCFA-approved
accreditation organization is no longer deemed to meet the conditions
set forth in subparts H, J, K, M, P, and Q of this part. However, the
suspension, limitation or revocation of a certificate of accreditation
is an initial determination and is appealable.
(2) The finding that a laboratory determined to be in compliance with
condition-level requirements but has deficiencies that are not at the
condition level.
(3) The determination not to reinstate a suspended CLIA certificate
because the reason for the suspension has not been removed or there is
insufficient assurance that the reason will not recur.
(4) The determination as to which alternative sanction or sanctions
to impose, including the amount of a civil money penalty to impose per
day or per violation.
(5) The denial of approval for Medicare payment for the services of a
laboratory that does not have in effect a valid CLIA certificate.
(6) The determination that a laboratory's deficiencies pose immediate
jeopardy.
(7) The amount of the civil money penalty assessed per day or for
each violation of Federal requirements.
(d) Effect of pending appeals -- (1) Alternative sanctions. The
effective date of an alternative sanction (other than a civil money
penalty) is not delayed because the laboratory has appealed and the
hearing or the hearing decision is pending.
(2) Suspension, limitation, or revocation of a laboratory's CLIA
certificate -- (i) General rule. Except as provided in paragraph
(d)(2)(ii) of this section, suspension, limitation, or revocation of a
CLIA certificate is not effective until after a hearing decision by an
ALJ is issued.
(ii) Exceptions. (A) If HCFA determines that conditions at a
laboratory pose immediate jeopardy, the effective date of the suspension
or limitation of a CLIA certificate is not delayed because the
laboratory has appealed and the hearing or the hearing decision is
pending.
(B) HCFA may suspend or limit a laboratory's CLIA certificate before
an ALJ hearing or hearing decision if the laboratory has refused a
reasonable request for information (including but not limited to billing
information), or for work on materials, or has refused permission for
HCFA or a HCFA agent to inspect the laboratory or its operation.
(3) Cancellation of Medicare approval. The effective date of the
cancellation of a laboratory's approval to receive Medicare payment for
its services is not delayed because the laboratory has appealed and the
hearing or hearing decision is pending.
(4) Effect of ALJ decision. (i) An ALJ decision is final unless, as
provided in paragraph (a)(3) of this section, one of the parties
requests review by the Departmental Appeals Board within 60 days, and
the Board reviews the case and issues a revised decision.
(ii) If an ALJ decision upholds a suspension imposed because of
immediate jeopardy, that suspension becomes a revocation.
(e) Appeal rights for prospective laboratories -- (1)
Reconsideration. Any prospective laboratory dissatisfied with a denial
of a CLIA certificate, or of approval for Medicare payment for its
services, may initiate the appeals process by requesting reconsideration
in accordance with 498.22 through 498.25 of this chapter.
(2) Notice of reopening. If HCFA reopens an initial or reconsidered
determination, HCFA gives the prospective laboratory notice of the
revised determination in accordance with 498.32 of this chapter.
(3) ALJ hearing. Any prospective laboratory dissatisfied with a
reconsidered determination under paragraph (e)(1) of this section or a
revised reconsidered determination under 498.30 of this chapter is
entitled to a hearing before an ALJ, as specified in paragraph (a)(2) of
this section.
(4) Review of ALJ hearing decisions. Any prospective laboratory that
is dissatisfied with an ALJ's hearing decision or dismissal of a request
for hearing may file a written request for review by the Departmental
Appeals Board as provided in paragraph (a)(3) of this section.
(f) Appeal rights of laboratories -- (1) ALJ hearing. Any laboratory
dissatisfied with the suspension, limitation, or revocation of its CLIA
certificate, with the imposition of an alternative sanction under this
subpart, or with cancellation of the approval to receive Medicare
payment for its services, is entitled to a hearing before an ALJ as
specified in paragraph (a)(2) of this section and has 60 days from the
notice of sanction to request a hearing.
(2) Review of ALJ hearing decisions. Any laboratory that is
dissatisfied with an ALJ's hearing decision or dismissal of a request
for hearing may file a written request for review by the Departmental
Appeals Board, as provided in paragraph (a)(3) of this section.
(3) Judicial review. Any laboratory dissatisfied with the decision
to impose a civil money penalty or to suspend, limit, or revoke its CLIA
certificate may, within 60 days after the decision becomes final, file
with the U.S. Court of Appeals of the circuit in which the laboratory
has its principal place of business, a petition for judicial review.
(g) Notice of adverse action. (1) If HCFA suspends, limits, or
revokes a laboratory's CLIA certificate or cancels the approval to
receive Medicare payment for its services, HCFA gives notice to the
laboratory, and may give notice to physicians, providers, suppliers, and
other laboratory clients, according to the procedures set forth at
493.1832. In addition, HCFA notifies the general public each time one of
these principal sanctions is imposed.
(2) The notice to the laboratory --
(i) Sets forth the reasons for the adverse action, the effective date
and effect of that action, and the appeal rights if any; and
(ii) When the certificate is limited, specifies the specialties or
subspecialties of tests that the laboratory is no longer authorized to
perform, and that are no longer covered under Medicare.
(3) The notice to other entities includes the same information except
the information about the laboratory's appeal rights.
(h) Effective date of adverse action. (1) When the laboratory's
deficiencies pose immediate jeopardy, the effective date of the adverse
action is at least 5 days after the date of the notice.
(2) When HCFA determines that the laboratory's deficiencies do not
pose immediate jeopardy, the effective date of the adverse action is at
least 15 days after the date of the notice.
(57 FR 7237, Feb. 28, 1992; 57 FR 35761, Aug. 11, 1992)
42 CFR 493.1846 Civil action.
If HCFA has reason to believe that continuation of the activities of
any laboratory, including a State-exempt laboratory, would constitute a
significant hazard to the public health, HCFA may bring suit in a U.S.
District Court to enjoin continuation of the specific activity that is
causing the hazard or to enjoin the continued operation of the
laboratory if HCFA deems it necessary. Upon proper showing, the court
shall issue a temporary injunction or restraining order without bond
against continuation of the activity.
42 CFR 493.1850 Laboratory registry.
(a) Once a year HCFA makes available to physicians and to the general
public specific information (including information provided to HCFA by
the OIG) that is useful in evaluating the performance of laboratories,
including the following:
(1) A list of laboratories that have been convicted, under Federal or
State laws relating to fraud and abuse, false billing, or kickbacks.
(2) A list of laboratories that have had their CLIA certificates
suspended, limited, or revoked, and the reason for the adverse actions.
(3) A list of persons who have been convicted of violating CLIA
requirements, as specified in section 353(1) of the PHS Act, together
with the circumstances of each case and the penalties imposed.
(4) A list of laboratories on which alternative sanctions have been
imposed, showing --
(i) The effective date of the sanctions;
(ii) The reasons for imposing them;
(iii) Any corrective action taken by the laboratory; and
(iv) If the laboratory has achieved compliance, the verified date of
compliance.
(5) A list of laboratories whose accreditation has been withdrawn or
revoked and the reasons for the withdrawal or revocation.
(6) All appeals and hearing decisions.
(7) A list of laboratories against which HCFA has brought suit under
493.1846 and the reasons for those actions.
(8) A list of laboratories that have been excluded from participation
in Medicare or Medicaid and the reasons for the exclusion.
(b) The laboratory registry is compiled for the calendar year
preceding the date the information is made available and includes
appropriate explanatory information to aid in the interpretation of the
data. It also contains corrections of any erroneous statements or
information that appeared in the previous registry.
42 CFR 493.1850 Subpart S -- (Reserved)
42 CFR 493.1850 Subpart T -- Consultations
Source: 57 FR 7185, Feb. 28, 1992, unless otherwise noted.
42 CFR 493.2001 Establishment and function of the Clinical Laboratory
Improvement Advisory Committee.
(a) HHS will establish a Clinical Laboratory Improvement Advisory
Committee to advise and make recommendations on technical and scientific
aspects of the provisions of this part 493.
(b) The Clinical Laboratory Improvement Advisory Committee will be
comprised of individuals involved in the provision of laboratory
services, utilization of laboratory services, development of laboratory
testing or methodology, and others as approved by HHS.
(c) HHS will designate specialized subcommittees as necessary.
(d) The Clinical Laboratory Improvement Advisory Committee or any
designated subcommittees will meet as needed, but not less than once
each year.
(e) The Clinical Laboratory Improvement Advisory Committee or
subcommittee, at the request of HHS will review and make recommendations
concerning:
(1) Criteria for categorizing tests and examinations of moderate and
high complexity;
(2) Categorization of waived tests;
(3) Personnel standards;
(4) Patient test management, quality control, quality assurance
standards;
(5) Proficiency testing standards;
(6) Applicability to the standards of new technology; and
(7) Other issues relevant to part 493, if requested by HHS.
(f) HHS will be responsible for providing the data and information,
as necessary, to the members of the Clinical Laboratory Improvement
Advisory Committee.
42 CFR 493.2001 PART 494 -- CONDITIONS FOR COVERAGE OF PARTICULAR SERVICES
42 CFR 493.2001 Subpart A -- (Reserved)
42 CFR 493.2001 Subpart B -- Conditions for Coverage of Screening
Mammography
Sec.
494.50 Condition for coverage: General.
494.51 Conditions for coverage: Compliance with Federal, State, and
local laws and regulations.
494.52 Condition for coverage: Consultation with a qualified
physician.
494.54 Condition for coverage: Interpretation of the results of
screening mammography procedures.
494.56 Condition for coverage: Qualifications and orientation of
technical personnel and retention of employee records.
494.58 Condition for coverage: Obtaining and preserving records.
494.60 Condition for coverage: Equipment standards.
494.62 Condition for coverage: Safety standards.
494.64 Condition for coverage: Quality assurance.
Authority: Secs. 1833(a)(2)(E), 1834, 1861, 1862(a), 1863, 1864(a),
1865(a), 1902(a)(9)(C), and 1915(a)(1)(B)(ii)(I) of the Social Security
Act (42 U.S.C. 13951(a)(2)(E), 1395m, 1395x, 1395y(a), 1395z, 1395aa(a),
1395bb(a), 1396a(a)(9)(C), and 1396n(a)(1)(B)(ii)(I)).
Source: 55 FR 53522, Dec. 31, 1990, unless otherwise noted.
42 CFR 493.2001 Subpart A -- (Reserved)
42 CFR 493.2001 Subpart B -- Conditions for Coverage of Screening Mammography
42 CFR 494.50 Condition for coverage: General.
To be approved for payment for this benefit under the Medicare
program, a supplier of screening mammography services must meet all the
conditions set forth in this subpart with respect to all services
furnished to Medicare beneficiaries.
42 CFR 494.51 Conditions for coverage: Compliance with Federal, State,
and local laws and regulations.
(a) The supplier of screening mammography services must comply with
all applicable Federal, State, and local laws and regulations pertaining
to radiological services and screening mammography services. This
includes --
(1) Licensure or registration of supplier;
(2) Licensure or registration of personnel;
(3) Licensure or registration of equipment; and
(4) Compliance with health and safety requirements.
(b) In addition, if the supplier of screening mammography services
also provides laboratory services, these services must be provided in
accordance with the applicable requirements of part 493 of this chapter.
If the supplier of screening mammography services chooses to refer
specimens for testing to another laboratory, the referral laboratory
must be certified in the appropriate specialties and subspecialties of
services in accordance with the applicable requirements or part 493 of
this chapter.
(57 FR 7185, Feb. 28, 1992)
42 CFR 494.52 Condition for Coverage: Consultation with a qualified
physician.
(a) Standard: Qualifications for the physician consultant. The
supplier has the basic responsibility for the overall quality of the
screening mammography examination conducted in his or her facility. In
meeting this responsibility, the supplier must have available either on
staff or through arrangement a physician consultant who is a licensed
doctor of medicine or a licensed doctor of osteopathy who meets the
requirements for the interpretation of the results of the screening
mammography procedure as specified in 494.54.
(b) Standard: Physician consultant. The physician consultant must
document in writing annually that --
(1) He or she has checked the procedural manuals, has observed at
least monthly the operators' performance, and has determined that both
are adequate.
(2) He or she has verified that equipment and personnel meet
applicable Federal, State, and local licensure and registration
requirements and that they are performing properly;
(3) Safe operating procedures are used; and
(4) All the other requirements of this subpart are being met.
42 CFR 494.54 Condition for coverage: Interpretation of the results of
screening mammography procedures.
The results of all screening mammography procedures must be
interpreted by a physician who meets the following certification,
experience, continuing education, and written report requirements:
(a) Standard: Board certification. The interpreting physician must
--
(1) Be certified by the American Board of Radiology or by the
American Osteopathic Board of Radiology; or
(2) Be certified as qualified to interpret the results of screening
mammography procedures by an appropriate program, as determined by the
Secretary, that assures the qualifications of the individual.
(b) Standard: Experience and continuing education.
The interpreting physician must also --
(1) Have been reading the results of an average of 10 or more
screening or diagnostic mammographies per work week in the 6 months
prior to beginning mammography screening for Medicare beneficiaries;
(2) Have successfully completed or taught a minimum of 40 hours of
postgraduate instruction in mammography interpretation prior to
beginning mammography screening for Medicare beneficiaries;
(3) Have successfully completed or taught a minimum of 15 hours of
postgraduate work in mammography interpretation every 36 months after
beginning mammography screening for Medicare beneficiaries; and
(4) Continue to read the results of an average of 10 or more
screening or diagnostic mammographies per work week while reading
screening mammographies for Medicare beneficiaries.
(c) Standard: Written and signed report. The interpreting physician
must --
(1) Prepare and sign a written report on his or her interpretation of
the results (that is, images or films) of the screening mammography
procedure;
(2) Provide a copy of the written report and the original images or
films to the patient's screening mammography supplier for inclusion in
the patient's medical record; and
(3) Provide a written statement to the patient, either through a
referring physician or his or her designate, or, if a referring
physician is not available, directly to the patient. The statement
should be written in terms easily understood by a lay person. The
statement must describe the test results and the importance of the
screening mammography to her ongoing health (including, if her results
are positive, a description of the next steps), as well as her
responsibility to share with any new physician or supplier of her next
screening mammography the date and place of her previous screening
mammography procedure. The statement must record the date of the
procedure, the name of the facility providing the procedure, the
physician (if any) to whom the woman wants a copy to be sent, and must
indicate that the original images or films are being provided to the
screening mammography supplier, for inclusion in the woman's medical
record.
42 CFR 494.56 Condition for coverage: Qualifications and orientation
of technical personnel and retention of employee records.
(a) Standard: Qualifications of operators of screening mammography
equipment. Anyone operating screening mammography equipment must --
(1) Be licensed by the State to perform radiological procedures, or,
in States that have no licensure requirements, be certified in
radiography by the American Registry of Radiologic Technologists, the
American Registry of Clinical Radiographic Technologists, or possess
equivalent certification qualifications;
(2) Have successfully completed a program of formal training in
radiologic technology in a school that meets the requirements of
appendix A (Standards for Accreditation of Educational Programs for
Radiographers) of 42 CFR part 75 or that is approved by the Council on
Allied Health Education and Accreditation, or has had at least 5 years
experience in performing radiologic procedures, and at least 1 year
experience in performing screening mammography before January 1, 1991;
and
(3) Have completed successfully specialized training in mammographic
positioning, compression, and technique factor settings prior to the
time he or she begins performing screening mammographies for Medicare
beneficiaries, and completes this specialized training every 24 months
thereafter.
(b) Standard: Personnel orientation. The supplier of screening
mammography services must have an orientation program for operators of
mammography equipment based on a procedures manual that is available to
all members of the staff and that incorporates relevant documents, and
instructions concerning the following:
(1) Precautions to protect the operator of the equipment, the patient
and individuals in the surrounding area from unnecessary exposure to
radiation.
(2) Determination of the area that will receive the primary beam
(breast positioning).
(3) Pertinent information on compression, exposure levels,
resolution, contrast, noise, examination identification, artifacts, and
average glandular dose per view.
(4) Employee responsibilities concerning the proper use of personal
radiation monitors.
(5) Proper use and maintenance of equipment, including a discussion
of the image receptors appropriate for use with mammography and the
kV-target-filter combination to be used with each image receptor.
(6) Proper maintenance of records.
(7) Possible technical problems and solutions.
(8) Protection against electrical hazards.
(9) Hazards of excessive exposure to radiation.
(c) Standard: Qualifications of individuals furnishing diagnostic
X-ray physics support. Individuals furnishing diagnostic X-ray physics
support must meet one of the following qualifications.
(1) The individual must be certified by the American Board of
Radiology as a diagnostic medical physicist or possess equivalent
qualifications. Additionally, the individual must meet minimum
training, experience, and continuing education requirements pertinent to
screening mammography.
(2) The individual must be recognized by a State radiation control
agency as qualified to provide oversight of the establishment and
conduct of the quality assurance program in 494.64, which sets forth
the standards of a quality assurance program for screening mammography
required as a condition of coverage.
(d) Standard: Employee records. Records are maintained to show that
each employee is qualified for his or her position by means of
appropriate State licensure, other certification, training, and
experience.
42 CFR 494.58 Condition for coverage: Obtaining and preserving
records.
The supplier of the current examination must make all reasonable
efforts to obtain the beneficiary's recent screening mammography
records, including original images and films, copies of written reports
prepared by interpreting physicians, and other relevant information
pertinent to previous screening mammographies that might be available
from others, for comparison with the current screening mammography
records. Records of previous screening mammographies obtained and of
current and subsequent screening mammographies performed by the supplier
must be properly preserved and made available to other qualified
mammography suppliers or others that submit a written request authorized
by the beneficiary.
(a) Standard: Records of screening mammography services performed by
the supplier. The supplier must make, for each beneficiary, a record of
the screening mammography services it provides, including --
(1) The date the screening mammography procedure was performed and
the date of the interpretation;
(2) The name of the beneficiary;
(3) The name of the operator of the equipment and the name of the
interpreting physician;
(4) A description of the procedures performed;
(5) the name of the referring physician (if any), or other physician
(if any) identified by the beneficiary to receive the interpreting
physician's written report; and
(6) The date the physician's written report was sent to the
appropriate physician or beneficiary.
(b) Standard: Preservation of records. The supplier must provide
satisfactory assurances (as documented in its medical records) that the
images or films of the first and subsequent screening mammography
procedures and the related written reports of the physicians'
interpretations for each beneficiary are either placed in her medical
record kept by the supplier or sent to another person (including the
beneficiary) for placement in the beneficiary's medical record as
directed by her or by her physician. If the records of the examination
must be retained by the supplier, they mut be retained for a period of
at least 60 calendar months following the date of service (or longer if
required by State law). If the supplier should cease to exist before
the end of the 60-month period, the records mut be transferred to the
woman or her primary care provider.
42 CFR 494.60 Condition for coverage: Equipment standards.
The equipment used to perform mammography must meet the following
standards:
(a) Standard: Equipment design. The equipment must be specifically
designed for mammography.
(b) Standard: FDA standards. The equipment must meet the FDA
performance standards for diagnostic X-ray systems and their major
components at 21 CFR 1020.30 and FDA's standards for radiographic
equipment at 21 CFR 1020.31.
(c) Standard: Image receptor systems. The image receptor systems
and all their individual components must be designed appropriately for
mammography.
(d) Standard: Developer temperature. The developer temperature of
the photographic processor is equivalent to that specified in writing by
the film manufacturer for the particular
film-developer-processor-development time combination.
(e) Standard: kV-target-filter combinations. The equipment must be
limited to providing kV-target-filter combinations appropriate to image
receptors meeting the requirements of paragraph (c) of this section.
(f) Standard: Focal spot size. The focal spot size and
source-to-image receptor distance combinations are limited to those
appropriate for mammography.
(g) Standard: Devices to immobilize and compress the breast.
Devices parallel to the imaging plane must be available to immobilize
and compress the breast.
(h) Standard: Anti-scatter grids. The equipment must have the
capability for using anti-scatter grids.
(i) Standard: Automatic exposure control. The equipment must have
the capability of automatic exposure control.
(j) Standard: Control panel indicators. The equipment must have a
control panel that includes a device (usually a milliammeter) or means
for an audible signal to give positive indication of the production of
X-rays whenever the X-ray tube is energized. The control panel must
include appropriate indicators (labeled control settings or meters that
show the physical factors such as kilovoltage potential (kVp),
milliampere seconds (mAs), exposure time, or whether timing is
automatic) used for exposure.
(k) Standard: Recalibration of mobile units. For mobile units and
vans (or other mobile screening units) a phantom image must be made
after each relocation of the mobile unit or van. Equipment must be
recalibrated as necessary to maintain quality of phantom image.
42 CFR 494.62 Condition for coverage: Safety standards.
Screening mammograms must be conducted using equipment and operating
procedures free of unnecessary hazards and providing minimum radiation
exposure to patients, personnel, and other persons in the immediate
environment.
(a) Standard: Safety precautions. Proper safety precautions must be
maintained. This includes adequate shielding for patients, personnel,
and facilities. The equipment must be operable only from a shielded
position.
(b) Standard: Exposure badges. Personnel operating the equipment
must wear badges or other appropriate devices to measure their radiation
exposure.
(c) Standard: Equipment inspection. Periodic inspection of
equipment and room shielding must be made by a staff or consultant
medical physicist, by a physicist approved by an appropriate State or
local government agency as meeting the qualification requirements of
494.56(c), or by a surveyor/inspector from a State or local government
radiation control agency. Identified hazards must be promptly
corrected.
(d) Standard: Protection against electrical hazards. All equipment
must be shockproof and grounded.
42 CFR 494.64 Condition for coverage: Quality assurance.
The supplier must have an equipment quality assurance program
specific to mammography imagery, and covering all components of the
X-ray system, from the X-ray generator to the image developer, to ensure
consistently high-quality images with minimum patient exposure. The
supplier must conduct a general review of the program at least annually
and have available the services of a person qualified to furnish
diagnostic X-ray physics support and capable of establishing and
conducting the program.
(a) Standard: Responsibility for the quality assurance program.
Under the direction of the physician consultant, the person furnishing
diagnostic X-ray physics support has the overall responsibility for
establishing and conducting the ongoing equipment quality assurance
program. That individual's specific duties must include --
(1) Conducting or training others to conduct equipment performance
monitoring functions;
(2) Analyzing the monitoring results to determine if there are any
problems requiring correction; and
(3) Carrying out or arranging for the necessary corrective actions as
well as for the calibrations and other preventive maintenance.
(b) Standard: Calibration of equipment. All variable parameters of
the equipment must be calibrated --
(1) When the equipment is first installed;
(2) After any major changes or replacement of parts;
(3) At least annually during use; and
(4) When quality assurance tests indicate that calibration is needed.
(c) Standard: Performance monitoring. The supplier must routinely
monitor the performance of the mammography system.
(1) At a minimum, the parameters that must be monitored are --
(i) Processor performance (through sensitometric-densitometric
means);
(ii) Half value layer;
(iii) Output reproducibility and linearity;
(iv) Automatic exposure control reproducibility, kVp response, and
thickness response;
(v) Adequacy of film storage (both before use and after exposure if
processing does not occur immediately);
(vi) Availability and use of technique charts that must include an
indication of the kV-target-filter combination to be used with each
image receptor;
(vii) Darkroom integrity;
(viii) Image quality (using a testing device called a ''phantom'',
which simulates the composition of the breast and indicators of disease
conditions, allowing objective analysis of clinical image quality); and
(ix) Dose.
(2) The equipment must be monitored as follows:
(i) Processor performance and the use of a kV-target-filter
combination appropriate to the image receptor must be monitored daily
before patient irradiation.
(ii) Image quality must be monitored with a phantom every time the
unit is moved, altered in any major way including the replacement of
parts, and at least monthly between movements or alterations.
(iii) The frequency of monitoring all other parameters must be
proportional to the expected variability of each parameter, but
monitoring must be conducted at least annually.
(d) Standard: Evaluation of monitoring results. Monitoring must be
evaluated on a regular basis.
(1) Standards of image quality giving acceptable ranges of values for
each of the parameters tested must be established to aid in the
evaluation. The standards of image quality related to dose must include
a requirement that the mean glandular dose for one craniocaudal view of
a 4.5 cm compressed breast (50 percent adipose/50 percent glandular)
must not exceed 100, 300, and 400 mrad (millirad) for film/screen units
without grids, film/screen units with grids, and xerography units,
respectively.
(2) The monitoring results must be compared routinely to the
standards of image quality. If the results fall outside the acceptable
range, the test must be repeated. If the results continue to be
unacceptable, the source of the problem must be identified and corrected
before further examinations are conducted.
(e) Standard: Retake analysis program. A program to analyze retakes
must be established as a further aid in detecting and correcting
problems affecting image quality or exposure.
(f) Standard: Responsible personnel. Responsibility for each
standard, from monitoring through the annual review, must be assigned to
qualified personnel. These assignments must be documented in the
supplier's records.
42 CFR 494.64 PART 498 -- APPEALS PROCEDURES FOR DETERMINATIONS THAT AFFECT PARTICIPATION IN THE MEDICARE PROGRAM
42 CFR 494.64 Subpart A -- General Provisions
Sec.
498.1 Statutory basis.
498.2 Definitions.
498.3 Scope and applicability.
498.5 Appeal rights.
498.10 Appointment of representatives.
498.11 Authority of representatives.
498.13 Fees for services of representatives.
498.15 Charge for transcripts.
498.17 Filing of briefs with the ALJ or Appeals Council and
opportunity for rebuttal.
42 CFR 494.64 Subpart B -- Initial, Reconsidered, and Revised
Determinations
498.20 Notice and effect of initial determinations.
498.22 Reconsideration.
498.23 Withdrawal of request for reconsideration.
498.24 Reconsidered determination.
498.25 Notice and effect of reconsidered determination.
42 CFR 494.64 Subpart C -- Reopening of Initial or Reconsidered
Determinations
498.30 Limitation on reopening.
498.32 Notice and effect of reopening and revision.
42 CFR 494.64 Subpart D -- Hearings
498.40 Request for hearing.
498.42 Parties to the hearing.
498.44 Designation of hearing official.
498.45 Disqualification of Administrative Law Judge.
498.47 Prehearing conference.
498.48 Notice of prehearing conference.
498.49 Conduct of prehearing conference.
498.50 Record, order, and effect of prehearing conference.
498.52 Time and place of hearing.
498.53 Change in time and place of hearing.
498.54 Joint hearings.
498.56 Hearing on new issues.
498.58 Subpoenas.
498.60 Conduct of hearing.
498.61 Evidence.
498.62 Witnesses.
498.63 Oral and written summation.
498.64 Record of hearing.
498.66 Waiver of right to appear and present evidence.
498.68 Dismissal of request for hearing.
498.69 Dismissal for abandonment.
498.70 Dismissal for cause.
498.71 Notice and effect of dismissal and right to request review.
498.72 Vacating a dismissal of request for hearing.
498.74 Administrative Law Judge's decision.
498.76 Removal of hearing to Appeals Council.
498.78 Remand by the Administrative Law Judge.
42 CFR 494.64 Subpart E -- Appeals Council Review
498.80 Right to request Appeals Council review of Administrative Law
Judge's decision or dismissal.
498.82 Request for Appeals Council review.
498.83 Appeals Council action on request for review.
498.85 Procedures before the Appeals Council on review.
498.86 Evidence admissible on review.
498.88 Decision or remand by the Appeals Council.
498.90 Effect of Appeals Council decision.
498.95 Extension of time for seeking judicial review.
42 CFR 494.64 Subpart F -- Reopening of Decisions Made by
Administrative Law Judges or the Appeals Council
498.100 Basis, timing, and authority for reopening an ALJ or Council
decision.
498.102 Revision of reopened decision.
498.103 Notice and effect of revised decision.
Authority: Secs. 205(a), 1102, 1861(aa), 1869(c), 1871, and 1872 of
the Social Security Act (42 U.S.C. 405(a), 1302, 1395x(aa), 1395ff(c),
1395hh and 1395ii), unless otherwise noted.
Source: 52 FR 22446, June 12, 1987, unless otherwise noted.
42 CFR 494.64 Subpart A -- General Provisions
42 CFR 498.1 Statutory basis.
(a) Section 1869(c) of the Act provides for a hearing and for
judicial review of the hearing for any institution or agency
dissatisfied with a determination that it is not a provider, or with any
determination described in section 1866(b)(2) of the Act.
(b) Section 1866(b)(2) of the Act lists determinations that serve as
a basis for termination of a provider agreement.
(c) Section 1128 (a) and (b) of the Act provide for exclusion of
certain individuals or entities because of conviction of crimes related
to their participation in Medicare.
(d) Section 1156 of the Act establishes certain obligations for
practitioners and providers of health care services, and provides
sanctions and penalties for those that fail to meet those obligations.
(e) Section 1862(d) of the Act provides for the exclusion of
individuals or entities that submit false claims, bill excessive charges
or furnish substandard care.
(f) HFCA is responsible for implementing section 1869(c) of the Act,
and section 1866 (b)(2), except subparagraphs (D), (E), and (F). The
OIG is responsible for implementing the other cited sections.
(g) Although sections 1866 and 1869 of the Act are silent regarding
appeal rights for suppliers and practitioners, the rules in this part
include procedures for review of determinations that affect those two
groups.
42 CFR 498.2 Definitions.
As used in this part --
Affected party means a provider, prospective provider, supplier,
prospective supplier, or practitioner that is affected by an initial
determination or by any subsequent determination or decision issued
under this part, and ''party'' means the affected party or HCFA (or the
OIG), as appropriate.
ALJ stands for Administrative Law Judge.
Appeals Council or Council means the Appeals Council of the Office of
Hearings and Appeals of the Social Security Administration.
OHA stands for the Social Security Administration's Office of
Hearings and Appeals.
OIG stands for the Department's Office of the Inspector General.
Provider means a hospital, skilled nursing facility (SNF),
comprehensive outpatient rehabilitation facility (CORF), home health
agency (HHA), or hospice, that has in effect an agreement to participate
in Medicare, or a clinic, rehabilitation agency, or public health agency
that has a similar agreement but only to furnish outpatient physical
therapy or outpatient speech pathology services, and ''prospective
provider'' means any of the listed entities that seeks to participate in
Medicare as a provider.
Prospective supplier means any of the listed entities that seeks to
be approved for coverage of its services under Medicare. However, for
purposes of the sanctions and penalties that may be imposed by the OIG,
the term ''supplier'' has the meaning specified in 1001.2 of this
title.
Supplier means an independent laboratory, supplier of portable X-ray
services, rural health clinic (RHC), Federal qualified health center
(FQHC), ambulatory surgical center (ASC), organ procurement organization
(OPO), or end-stage renal disease (ESRD) treatment facility that is
approved by HCFA as meeting the conditions for coverage of its services,
and
(52 FR 22446, June 12, 1987, as amended at 53 FR 6551, March 1, 1988;
57 FR 24984, June 12, 1992)
42 CFR 498.3 Scope and applicability.
(a) Scope. This part sets forth procedures for reviewing initial
determinations that HCFA makes with respect to the matters specified in
paragraph (b) of this section and that the OIG makes with respect to
matters specified in paragraph (c) of this section.
(b) Initial determinations by HCFA. HCFA makes initial
determinations with respect to the following matters:
(1) Whether a prospective provider qualifies as a provider.
(2) Whether an institution is a hospital qualified to elect to claim
payment for all emergency hospital services furnished in a calendar
year.
(3) Whether an institution continues to remain in compliance with the
qualifications for claiming reimbursement for all emergency services
furnished in a calendar year.
(4) Whether a prospective supplier meets the appropriate conditions
for coverage of its services, as set forth in part 405 (subpart M, N, Q,
or U), part 416, part 485, subpart D, or part 491 of this chapter).
(5) Whether the services of a supplier continue to meet the
conditions for coverage.
(6) Whether a physical therapist in independent practice or a
chiropractor meets the requirements for coverage of his or her services
as set forth in 405.1730 through 405.1737 or in 410.22 of this
chapter, respectively.
(7) the termination of a provider agreement in accordance with
489.53 of this chapter, or the termination of a rural heath clinic
agreement in accordance with 405.2404 this chapter or the termination
of a Federally qualified health center agreement in accordance with
405.2440.
(8) The cancellation of the approval of a Medicaid SNF or NF by HCFA
under section 1910(b) of the Act.
(9) Whether, for purposes of rate setting and reimbursement, an ESRD
treatment facility is considered to be hospital-based or independent.
(10) Whether to deny payment under 409.19 or 409.64 of this
chapter, pertaining to cardiac pacemakers and the pacemaker registry.
(11) Whether a hospital, skilled nursing facility, home health
agency, or hospice program meets or contimues to meet the advance
directives requirements specified in subpart I of part 489 of this
chapter.
(c) Initial determinations by the OIG. The OIG makes initial
determinations with respect to the following matters:
(1) The termination of a provider agreement in accordance with part
1001, subpart C of this title.
(2) The suspension, or exclusion from coverage and the denial of
reimbursement for services furnished by a provider, practitioner, or
supplier, because of fraud or abuse, or conviction of crimes related to
participation in the program, in accordance with part 1001, subpart B of
this title.
(3) The imposition of sanctions in accordance with part 1004 of this
title.
(d) Administrative actions that are not initial determinations.
Administrative actions other than those specified in paragraphs (b) and
(c) of this section are not initial determinations and thus are not
subject to this part.
Administrative actions that are not initial determinations include,
but are not limited to, the following:
(1) The finding that a provider or supplier determined to be in
compliance with the conditions of participation or level A requirements
(for SNFs and NFs) or the conditions for coverage has deficiencies.
(2) The finding that a prospective provider does not meet the
conditions of participation set forth elsewhere in this chapter, if the
prospective provider is, nevertheless, approved for participation in
Medicare on the basis of special access certification, as provided in
subpart B of part 488 of this chapter.
(3) The refusal to enter into a provider agreement because the
prospective provider is unable to give satisfactory assurance of
compliance with the requirements of title XVIII of the Act.
(4) The finding that an entity that had its provider agreement
terminated may not file another agreement because the reasons for
terminating the previous agreement have not been removed or there is
insufficient assurance that the reasons for the exclusion will not
recur.
(5) The determination not to reinstate a suspended or excluded
practitioner, provider, or supplier because the reason for the
suspension or exclusion has not been removed, or there is insufficient
assurance that the reason will not recur.
(6) The finding that the services of a laboratory are covered as
hospital services or as physician's services, rather than as services of
an independent laboratory, because the laboratory is not independent of
the hospital or of the physician's office.
(7) The refusal to accept for filing an election to claim payment for
all emergency hospital services furnished in a calendar year because the
institution --
(i) Had previously charged an individual or other person for services
furnished during that calendar year;
(ii) Submitted the election after the close of that calendar year;
or
(iii) Had previously been notified of its failure to continue to
comply.
(8) The finding that the reason for the revocation of a supplier's
right to accept assignment has not been removed or there is insufficient
assurance that the reason will not recur.
(9) The finding that a hospital accredited by the Joint Commission on
Accreditation of Hospitals or the American Osteopathic Association is
not in compliance with a condition of participation, and a finding that
that hospital is no longer deemed to meet the conditions of
participation.
(10) With respect to a SNF that is not in compliance with a condition
of participation or a level A requirement (for SNFs and NFs) --
(i) The finding that the SNF's deficiencies pose immediate jeopardy
to patients' health and safety; and
(ii) When the SNF's deficiencies do not pose immediate jeopardy, the
decision to deny payment for new admissions.
(11) The determination that the accreditation requirements of a
national accreditation organization do not provide (or do not continue
to provide) reasonable assurance that the entities accredited by the
accreditation organization meet the applicable long-term care
requirements, conditions for coverage, conditions of certification,
conditions of participation, or CLIA condition level requirements.
(12) The determination that requirements imposed on a State's
laboratories under the laws of that State do not provide (or do not
continue to provide) reasonable assurance that laboratories licensed or
approved by the State meet applicable CLIA requirements.
(e) Exclusion of civil rights issues. The procedures in this subpart
do not apply to the adjudication of issues relating to a provider's
compliance with civil rights requirements that are set forth in part 489
of this chapter. Those issues are handled through the Department's
Office of Civil Rights.
(52 FR 22446, June 12, 1987, as amended at 52 FR 27765, July 23,
1987; 53 FR 6551, March 1, 1988; 53 FR 6649, March 2, 1988; 54 FR
5373, Feb. 2, 1989; 56 FR 8854, Mar. 1, 1991; 56 FR 48879, Sept. 26,
1991; 57 FR 8204, Mar. 6, 1992; 57 FR 24984, June 12, 1992; 57 FR
34021, July 31, 1992; 57 FR 43925, Sept. 23, 1992)
42 CFR 498.5 Appeal rights.
(a) Appeal rights of prospective providers. (1) Any prospective
provider dissatisfied with an initial determination or revised initial
determination that it does not qualify as a provider may request
reconsideration in accordance with 498.22(a).
(2) Any prospective provider dissatisfied with a reconsidered
determination under paragraph (a)(1) of this section, or a revised
reconsidered determination under 498.30, is entitled to a hearing
before an ALJ.
(b) Appeal rights of providers. Any provider dissatisfied with an
initial determination to terminate its provider agreement is entitled to
a hearing before an ALJ.
(c) Appeal rights of providers and prospective providers. Any
provider or prospective provider dissatisfied with a hearing decision
may request Appeals Council review and has a right to seek judicial
review of the Council's decision.
(d) Appeal rights of prospective suppliers. (1) Any prospective
supplier dissatisfied with an initial determination or a revised initial
determination that its services do not meet the conditions for coverage
may request reconsideration in accordance with 498.22(a).
(2) Any prospective supplier dissatisfied with a reconsidered
determination under paragraph (d)(1) of this section, or a revised
reconsidered determination under 498.30, is entitled to a hearing
before an ALJ.
(e) Appeal rights of suppliers. Any supplier dissatisfied with an
initial determination that the services subject to the determination no
longer meet the conditions for coverage, is entitled to a hearing before
an ALJ.
(f) Appeal rights of suppliers and prospective suppliers. (1) Any
supplier or prospective supplier dissatisfied with the hearing decision
may request Appeals Council review of the ALJ's decision.
(2) Suppliers and prospective suppliers do not have a right to
judicial review except as provided in paragraph (i) of this section.
(g) Appeal rights for certain practitioners. A physical therapist in
independent practice or a chiropractor dissatisfied with a determination
that he or she does not meet the requirements for coverage of his or her
services has the same appeal rights as suppliers have under paragraphs
(d), (e) and (f) of this section.
(h) Appeal rights for nonparticipating hospitals that furnish
emergency services. A nonparticipating hospital dissatisfied with a
determination or decision that it does not qualify to elect to claim
payment for all emergency services furnished during a calendar year has
the same appeal rights that providers have under paragraph (a), (b), and
(c) of this section.
(i) Appeal rights for suspended or excluded practitioners, providers,
or suppliers. (1) Any practitioner, provider, or supplier who has been
suspended, or whose services have been excluded from coverage in
accordance with 498.3(c)(2), or has been sanctioned in accordance with
498.3(c)(3), is entitled to a hearing before an ALJ.
(2) Any suspended or excluded practitioner, provider, or supplier
dissatisfied with a hearing decision may request Appeals Council review
and has a right to seek judicial review of the Council's decision by
filing an action in Federal district court.
(j) Appeal rights for Medicaid ICFs/MR terminated by HCFA. (1) Any
Medicaid ICF/MR that has had its approval cancelled by HCFA in
accordance with 498.3(b)(8) has a right to a hearing before an ALJ, to
request Appeals Council review of the hearing decision, and to seek
judicial review of the Council's decision.
(2) The Medicaid agreement remains in effect until the period for
requesting a hearing has expired or, if the facility requests a hearing,
until a hearing decision is issued, unless HCFA --
(i) Makes a written determination that continuation of provider
status for the SNF or ICF constitutes an immediate and serious threat to
the health and safety of patients and specifies the reasons for that
determination; and
(ii) Certifies that the facility has been notified of its
deficiencies and has failed to correct them.
(52 FR 22446, June 12, 1987, as amended at 57 FR 43925, Sept. 23,
1992)
42 CFR 498.10 Appointment of representatives.
(a) An affected party may appoint as its representative anyone not
disqualified or suspended from acting as a representative in proceedings
before the Secretary or otherwise prohibited by law.
(b) If the representative appointed is not an attorney, the party
must file written notice of the appointment with HCFA, the ALJ, or the
Appeals Council.
(c) If the representative appointed is an attorney, the attorney's
statement that he or she has the authority to represent the party is
sufficient.
42 CFR 498.11 Authority of representatives.
(a) A representative appointed and qualified in accordance with
498.10 may, on behalf of the represented party --
(1) Give and accept any notice or request pertinent to the
proceedings set forth in this part;
(2) Present evidence and allegations as to facts and law in any
proceedings affecting that party to the same extent as the party; and
(3) Obtain information to the same extent as the party.
(b) A notice or request may be sent to the affected party, to the
party's representative, or to both. A notice or request sent to the
representative has the same force and effect as if it had been sent to
the party.
42 CFR 498.13 Fees for services of representatives.
Fees for any services performed on behalf of an affected party by an
attorney appointed and qualified in accordance with 498.10 are not
subject to the provisions of section 206 of Title II of the Act, which
authorizes the Secretary to specify or limit those fees.
42 CFR 498.15 Charge for transcripts.
A party that requests a transcript of prehearing or hearing
proceedings or Council review must pay the actual or estimated cost of
preparing the transcript unless, for good cause shown by that party, the
payment is waived by the ALJ or the Appeals Council, as appropriate.
42 CFR 498.17 Filing of briefs with the ALJ or Appeals Council, and
opportunity for rebuttal.
(a) Filing of briefs and related documents. If a party files a brief
or related document such as a written argument, contention, suggested
finding of fact, conclusion of law, or any other written statement, it
must submit an original and one copy to the ALJ or the Appeals Council,
as appropriate. The material may be filed by mail or in person and must
include a statement certifying that a copy has been furnished to the
other party.
(b) Opportunity for rebuttal. (1) The other party will have 20 days
from the date of mailing or personal service to submit any rebuttal
statement or additional evidence. If a party submits a rebuttal
statement or additional evidence, it must file an original and one copy
with the ALJ or the Council and furnish a copy to the other party.
(2) The ALJ or the council will grant an opportunity to reply to the
rebuttal statement only if the party shows good cause.
42 CFR 498.17 Subpart B -- Initial, Reconsidered, and Revised Determinations
42 CFR 498.20 Notice and effect of initial determinations.
(a) Notice of initial determination -- (1) General rule. HCFA or the
OIG, as appropriate, mails notice of an initial determination to the
affected party, setting forth the basis or reasons for the
determination, the effect of the determination, and the party's right to
reconsideration, if applicable, or to a hearing.
(2) Special rules: Independent laboratories and suppliers of
portable x-ray services. If HCFA determines that an independent
laboratory or a supplier of portable x-ray services no longer meets the
conditions for coverage of some or all of its services, the notice --
(i) Specifies an effective date of termination of coverage that is at
least 15 days after the date of the notice;
(ii) Is also sent to physicians, hospitals, and other parties that
might use the services of the laboratory or supplier; and
(iii) In the case of laboratories, specifies the categories of
laboratory tests that are no longer covered.
(3) Special rules: Nonparticipating hospitals that elect to claim
payment for emergency services. If HCFA determines that a
nonparticipating hospital no longer qualifies to elect to claim payment
for all emergency services furnished in a calendar year, the notice --
(i) States the calendar year to which the determination applies;
(ii) Specifies an effective date that is at least 5 days after the
date of the notice; and
(iii) Specifies that the determination applies to services furnished,
in the specified calendar year, to patients accepted (as inpatients or
outpatients) on or after the effective date of the determination.
(4) Other special rules. Additional rules pertaining, for example,
to content and timing of notice, notice to the public and to other
entities, and time allowed for submittal of additional information, are
set forth elsewhere in this chapter, as follows:
Part 405 Subpart X -- for rural health clinics.
Part 416 -- for ambulatory surgical centers.
Part 489 -- for providers, when their provider agreements have been
terminated.
Part 1001, Subpart B -- for excluded or suspended providers,
suppliers, physicians, or practitioners.
Part 1001, Subpart C -- for providers, when their provider agreements
are terminated by the OIG.
Part 1004 -- for sanctioned providers and practitioners.
(b) Effect of initial determination. An initial determination is
binding unless it is --
(1) Reconsidered in accordance with 498.24;
(2) Reversed or modified by a hearing decision in accordance with
498.78; or
(3) Revised in accordance with 498.32 or 498.100.
42 CFR 498.22 Reconsideration.
(a) Right to reconsideration. HCFA reconsiders any initial
determination that affects a prospective provider or supplier, or a
hospital seeking to qualify to claim payment for all emergency hospital
services furnished in a calendar year, if the affected party files a
written request in accordance with paragraphs (b) and (c) of this
section. (None of the determinations made by the OIG are subject to
reconsideration.)
(b) Request for reconsideration: Manner and timing. The affected
party specified in paragraph (a) of this section, if dissatisfied with
the initial determination may request reconsideration by filing the
request --
(1) With HCFA or with the State survey agency;
(2) Directly or through its legal representative or other authorized
official; and
(3) Within 60 days from receipt of the notice of initial
determination, unless the time is extended in accordance with paragraph
(d) of this section. The date of receipt will be presumed to be 5 days
after the date on the notice unless there is a showing that it was, in
fact, received earlier or later.
(c) Content of request. The request for reconsideration must state
the issues, or the findings of fact with which the affected party
disagrees, and the reasons for disagreement.
(d) Extension of time to file a request for reconsideration. (1) If
the affected party is unable to file the request within the 60 days
specified in paragraph (b) of this section, it may file a written
request with HCFA, stating the reasons why the request was not filed
timely.
(2) HCFA will extend the time for filing a request for
reconsideration if the affected party shows good cause for missing the
deadline.
42 CFR 498.23 Withdrawal of request for reconsideration.
A request for reconsideration is considered withdrawn if the
requestor files a written withdrawal request before HCFA mails the
notice of reconsidered determination, and HCFA approves the withdrawal
request.
42 CFR 498.24 Reconsidered determination.
When a request for reconsideration has been properly filed in
accordance with 498.22, HCFA --
(a) Receives written evidence and statements that are relevant and
material to the matters at issue and are submitted within a reasonable
time after the request for reconsideration;
(b) Considers the initial determination, the findings on which the
initial determination was based, the evidence considered in making the
initial determination, and any other written evidence submitted under
paragraph (a) of this section, taking into account facts relating to the
status of the prospective provider or supplier subsequent to the initial
determination; and
(c) Makes a reconsidered determination, affirming or modifying the
initial determination and the findings on which it was based.
42 CFR 498.25 Notice and effect of reconsidered determination.
(a) Notice. (1) HCFA mails notice of a reconsidered determination to
the affected party.
(2) The notice gives the reasons for the determination.
(3) If the determination is adverse, the notice specifies the
conditions or requirements of law or regulations that the affected party
fails to meet, and informs the party of its right to a hearing.
(b) Effect. A reconsidered determination is binding unless --
(1) HCFA or the OIG, as appropriate, further revises the revised
determination; or
(2) The revised determination is reversed or modified by a hearing
decision.
42 CFR 498.25 Subpart C -- Reopening of Initial or Reconsidered Determinations
42 CFR 498.30 Limitation on reopening.
An initial or reconsidered determination that a prospective provider
is a provider or that a hospital qualifies to elect to claim payment for
all emergency services furnished in a calendar year may not be reopened.
HCFA or the OIG, as appropriate, may on its own initiative, reopen any
other initial or reconsidered determination, within 12 months after the
date of notice of the initial determination.
42 CFR 498.32 Notice and effect of reopening and revision.
(a) Notice. (1) HCFA or the OIG, as appropriate, gives the affected
party notice of reopening and of any revision of the reopened
determination.
(2) The notice of revised determination states the basis or reason
for the revised determination.
(3) If the determination is that a supplier or prospective supplier
does not meet the conditions for coverage of its services, the notice
specifies the conditions with respect to which the affected party fails
to meet the requirements of law and regulations, and informs the party
of its right to a hearing.
(b) Effect. A revised determination is binding unless
(1) The affected party requests a hearing before an ALJ; or
(2) HCFA or the OIG further revises the revised determination.
42 CFR 498.32 Subpart D -- Hearings
42 CFR 498.40 Request for hearing.
(a) Manner and timing of request. (1) An affected party entitled to
a hearing under 498.5 may file a request for a hearing with HCFA or the
OIG, as appropriate, or with OHA.
(2) The affected party or its legal representative or other
authorized official must file the request in writing within 60 days from
receipt of the notice of initial, reconsidered, or revised determination
unless that period is extended in accordance with paragraph (c) of this
section. (Presumed date of receipt is determined in accordance with
498.22(b)(3)).
(b) Content of request for hearing. The request for hearing must --
(1) Identify the specific issues, and the findings of fact and
conclusions of law with which the affected party disagrees; and
(2) Specify the basis for contending that the findings and
conclusions are incorrect.
(c) Extension of time for filing a request for hearing. If the
request was not filed within 60 days --
(1) The affected party or its legal representative or other
authorized official may file with the ALJ a written request for
extension of time stating the reasons why the request was not filed
timely.
(2) For good cause shown, the ALJ may extend the time for filing the
request for hearing.
42 CFR 498.42 Parties to the hearing.
The parties to the hearing are the affected party and HCFA or the
OIG, as appropriate.
42 CFR 498.44 Designation of hearing official.
(a) The Associate Commissioner for Hearings and Appeals, or his or
her delegate designates an ALJ or a member or members of the Appeals
Council to conduct the hearing.
(b) If appropriate, the Associate Commissioner or the delegate may
substitute another ALJ or another member or other members of the Appeals
Council to conduct the hearing.
(c) As used in this part, ''ALJ'' includes a member or members of the
Appeals Council who are designated to conduct a hearing.
42 CFR 498.45 Disqualification of Administrative Law Judge.
(a) An ALJ may not conduct a hearing in a case in which he or she is
prejudiced or partial to the affected party or has any interest in the
matter pending for decision.
(b) A party that objects to the ALJ designated to conduct the hearing
must give notice of its objections at the earliest opportunity.
(c) The ALJ will consider the objections and decide whether to
withdraw or proceed with the hearing.
(1) If the ALJ withdraws, another will be designated to conduct the
hearing.
(2) If the ALJ does not withdraw, the objecting party may, after the
hearing, present its objections to the Appeals Council as reasons for
changing, modifying, or reversing the ALJ's decision or providing a new
hearing before another ALJ.
42 CFR 498.47 Prehearing conference.
(a) At any time before the hearing, the ALJ may call a prehearing
conference for the purpose of delineating the issues in controversy,
identifying the evidence and witnesses to be presented at the hearing,
and obtaining stipulations accordingly.
(b) On the request of either party or on his or her own motion, the
ALJ may adjourn the prehearing conference and reconvene at a later date.
42 CFR 498.48 Notice of prehearing conference.
(a) Timing of notice. The ALJ will fix a time and place for the
prehearing conference and mail written notice to the parties at least 10
days before the scheduled date.
(b) Content of notice. The notice will inform the parties of the
purpose of the conference and specify what issues are sought to be
resolved, agreed to, or excluded.
(c) Additional issues. Issues other than those set forth in the
notice of determination or the request for hearing may be considered at
the prehearing conference if ----
(1) Either party gives timely notice to that effect to the ALJ and
the other party; or
(2) The ALJ raises the issues in the notice of prehearing conference
or at the conference.
42 CFR 498.49 Conduct of prehearing conference.
(a) The prehearing conference is open to the affected party or its
representative, to the HCFA or OIG representatives and their technical
advisors, and to any other persons whose presence the ALJ considers
necessary or proper.
(b) The ALJ may accept the agreement of the parties as to the
following:
(1) Facts that are not in controversy.
(2) Questions that have been resolved favorably to the affected party
after the determination in dispute.
(3) Remaining issues to be resolved.
(c) The ALJ may request the parties to indicate the following:
(1) The witnesses that will be present to testify at the hearing.
(2) The qualifications of those witnesses.
(3) The nature of other evidence to be submitted.
42 CFR 498.50 Record, order, and effect of prehearing conference.
(a) Record of prehearing conference. (1) A record is made of all
agreements and stipulations entered into at the prehearing conference.
(2) The record may be transcribed at the request of either party or
the ALJ.
(b) Order and opportunity to object. (1) The ALJ issues an order
setting forth the results of the prehearing conference, including the
agreements made by the parties as to facts not in controversy, the
matters to be considered at the hearing, and the issues to be resolved.
(2) Copies of the order are sent to all parties and the parties have
10 days to file objections to the order.
(3) After the 10 days have elapsed, the ALJ settles the order.
(c) Effect of prehearing conference. The agreements and stipulations
entered into at the prehearing conference are binding on all parties,
unless a party presents facts that, in the opinion of the ALJ, would
make an agreement unreasonable or inequitable.
42 CFR 498.52 Time and place of hearing.
(a) The ALJ fixes a time and place for the hearing and gives the
parties written notice at least 10 days before the scheduled date.
(b) The notice informs the parties of the general and specific issues
to be resolved at the hearing.
42 CFR 498.53 Change in time and place of hearing.
(a) The ALJ may change the time and place for the hearing either on
his or her own initiative or at the request of a party for good cause
shown, or may adjourn or postpone the hearing.
(b) The ALJ may reopen the hearing for receipt of new evidence at any
time before mailing the notice of hearing decision.
(c) The ALJ gives the parties reasonable notice of any change in time
or place or any adjournment or reopening of the hearing.
42 CFR 498.54 Joint hearings.
When two or more affected parties have requested hearings and the
same or substantially similar matters are at issue, the ALJ may, if all
parties agree, fix a single time and place for the prehearing conference
or hearing and conduct all proceedings jointly. If joint hearings are
held, a single record of the preceedings is made and a separate decision
issued with respect to each affected party.
42 CFR 498.56 Hearing on new issues.
(a) Basic rules. (1) Within the time limits specified in paragraph
(b) of this section, the ALJ may, at the request of either party, or on
his or her own motion, provide a hearing on new issues that impinge on
the rights of the affected party.
(2) The ALJ may consider new issues even if HCFA or the OIG has not
made initial or reconsidered determinations on them, and even if they
arose after the request for hearing was filed or after a prehearing
conference.
(3) The ALJ may give notice of hearing on new issues at any time
after the hearing request is filed and before the hearing record is
closed.
(b) Time limits. The ALJ will not consider any issue that arose on
or after any of the following dates:
(1) The effective date of the termination of a provider agreement.
(2) The date on which it is determined that a supplier no longer
meets the conditions for coverage of its services.
(3) The effective date of the notice to a hospital of its failure to
remain in compliance with the qualifications for claiming reimbursement
for all emergency services furnished to Medicare beneficiaries during
the calendar year.
(4) The effective date of the suspension, or of the exclusion from
coverage of services furnished by a suspended or excluded practitioner,
provider, or supplier.
(5) With respect to Medicaid SNFs or ICFs surveyed under section
1910(c) of the Act --
(i) The completion date of the survey or resurvey that is the basis
for a proposed cancellation of approval; or
(ii) If approval was cancelled before the hearings, because of
immediate and serious threat to patient health and safety, the effective
date of cancellation.
(c) Notice and conduct of hearing on new issues. (1) Unless the
affected party waives its right to appear and present evidence, notice
of the time and place of hearing on any new issue will be given to the
parties in accordance with 498.52.
(2) After giving notice, the ALJ will, except as provided in
paragraph (d) of this section, proceed to hearing on new issues in the
same manner as on an issue raised in the request for hearing.
(d) Remand to HCFA or the OIG. At the request of either party, or on
his or her own motion, in lieu of a hearing under paragraph (c) of this
section, the ALJ may remand the case to HCFA or the OIG for
consideration of the new issue and, if appropriate, a determination. If
necessary, the ALJ may direct HCFA or the OIG to return the case to the
ALJ for further proceedings.
(52 FR 22446, June 12, 1987, as amended at 53 FR 31335, Aug. 18,
1988)
42 CFR 498.58 Subpoenas.
(a) Basis for issuance. The ALJ, upon his or her own motion or at
the request of a party, may issue subpoenas if they are reasonably
necessary for the full presentation of a case.
(b) Timing of request by a party. The party must file a written
request for a subpoena with the ALJ at least 5 days before the date set
for the hearing.
(c) Content of request. The request must:
(1) Identify the witnesses or documents to be produced;
(2) Describe their addresses or location with sufficient
particularity to permit them to be found; and
(3) Specify the pertinent facts the party expects to establish by the
witnesses or documents, and indicate why those facts could not be
established without use of a subpoena.
(d) Method of issuance. Subpoenas are issued in the name of the
Secretary, who pays the cost of issuance and the fees and mileage of any
subpoenaed witnesses.
42 CFR 498.60 Conduct of hearing.
(a) Participants in the hearing. The hearing is open to the parties
and their representatives and technical advisors, and to any other
persons whose presence the ALJ considers necessary or proper.
(b) Hearing procedures. (1) The ALJ inquires fully into all of the
matters at issue, and receives in evidence the testimony of witnesses
and any documents that are relevant and material.
(2) If the ALJ believes that there is relevant and material evidence
available which has not been presented at the hearing, he may, at any
time before mailing of notice of the decision, reopen the hearing to
receive that evidence.
(3) The ALJ decides the order in which the evidence and the arguments
of the parties are presented and the conduct of the hearing.
42 CFR 498.61 Evidence.
Evidence may be received at the hearing even though inadmissible
under the rules of evidence applicable to court procedure. The ALJ
rules on the admissibility of evidence.
42 CFR 498.62 Witnesses.
Witnesses at the hearing testify under oath or affirmation. The
representative of each party is permitted to examine his or her own
witnesses subject to interrogation by the representative of the other
party. The ALJ may ask any questions that he or she deems necessary.
The ALJ rules upon any objection made by either party as to the
propriety of any question.
42 CFR 498.63 Oral and written summation.
The parties to a hearing are allowed a reasonable time to present
oral summation and to file briefs or other written statements of
proposed findings of fact and conclusions of law. Copies of any briefs
or other written statements must be sent in accordance with 498.17.
42 CFR 498.64 Record of hearing.
A complete record of the proceedings at the hearing is made and
transcribed in all cases.
42 CFR 498.66 Waiver of right to appear and present evidence.
(a) Waiver procedures. (1) If an affected party wishes to waive its
right to appear and present evidence at the hearing, it must file a
written waiver with the ALJ.
(2) If the affected party wishes to withdraw a waiver, it may do so,
for good cause, at any time before the ALJ mails notice of the hearing
decision.
(b) Effect of waiver. If the affected party waives the right to
appear and present evidence, the ALJ need not conduct an oral hearing
except in one of the following circumstances:
(1) The ALJ believes that the testimony of the affected party or its
representatives or other witnesses is necessary to clarify the facts at
issue.
(2) HCFA or the OIG shows good cause for requiring the presentation
of oral evidence.
(c) Dismissal for failure to appear. If, despite the waiver, the ALJ
sends notice of hearing and the affected party fails to appear, or to
show good cause for the failure, the ALJ will dismiss the appeal in
accordance with 498.69.
(d) Hearing without oral testimony. When there is no oral testimony,
the ALJ will --
(1) Make a record of the relevant written evidence that was
considered in making the determination being appealed, and of any
additional evidence submitted by the parties;
(2) Furnish to each party copies of the additional evidence submitted
by the other party; and
(3) Give both parties a reasonable opportunity for rebuttal.
(e) Handling of briefs and related statements. If the parties submit
briefs or other written statements of evidence or proposed findings of
facts or conclusions of law, those documents will be handled in
accordance with 498.17.
42 CFR 498.68 Dismissal of request for hearing.
(a) The ALJ may, at any time before mailing the notice of the
decision, dismiss a hearing request if a party withdraws its request for
a hearing or the affected party asks that its request be dismissed.
(b) An affected party may request a dismissal by filing a written
notice with the ALJ.
42 CFR 498.69 Dismissal for abandonment.
(a) The ALJ may dismiss a request for hearing if it is abandoned by
the party that requested it.
(b) The ALJ may consider a request for hearing to be abandoned if the
party or its representative --
(1) Fails to appear at the prehearing conference or hearing without
having previously shown good cause for not appearing; and
(2) Fails to respond, within 10 days after the ALJ sends a ''show
cause'' notice, with a showing of good cause.
42 CFR 498.70 Dismissal for cause.
On his or her own motion, or on the motion of a party to the hearing,
the ALJ may dismiss a hearing request either entirely or as to any
stated issue, under any of the following circumstances:
(a) Res judicata. There has been a previous determination or
decision with respect to the rights of the same affected party on the
same facts and law pertinent to the same issue or issues which has
become final either by judicial affirmance or, without judicial
consideration, because the affected party did not timely request
reconsideration, hearing, or review, or commence a civil action with
respect to that determination or decision.
(b) No right to hearing. The party requesting a hearing is not a
proper party or does not otherwise have a right to a hearing.
(c) Hearing request not timely filed. The affected party did not
file a hearing request timely and the time for filing has not been
extended.
42 CFR 498.71 Notice and effect of dismissal and right to request
review.
(a) Notice of the ALJ's dismissal action is mailed to the parties.
The notice advises the affected party of its right to request that the
dismissal be vacated as provided in 498.72.
(b) The dismissal of a request for hearing is binding unless it is
vacated by the ALJ or the Appeals Council.
42 CFR 498.72 Vacating a dismissal of request for hearing.
An ALJ may vacate any dismissal of a request for hearing if a party
files a request to that effect within 60 days from receipt of the notice
of dismissal and shows good cause for vacating the dismissal. (Date of
receipt is determined in accordance with 498.22(b)(3).)
42 CFR 498.74 Administrative Law Judge's decision.
(a) Timing, basis and content. As soon as practical after the close
of the hearing, the ALJ issues a written decision in the case. The
decision is based on the evidence of record and contains separate
numbered findings of fact and conclusions of law.
(b) Notice and effect. A copy of the decision is mailed to the
parties and is binding on them unless --
(1) A party requests review by the Appeals Council within the stated
time period, and the Council reviews the case;
(2) The Appeals Council denies the request for review and the party
seeks judicial review by filing an action in a Federal district court;
(3) The decision is revised by an ALJ or the Appeals Council; or
(4) The decision is a recommended decision directed to the Council.
42 CFR 498.76 Removal of hearing to Appeals Council.
(a) At any time before the ALJ receives oral testimony, the Council
may remove to itself any pending request for a hearing.
(b) Notice of removal is mailed to each party.
(c) The Council conducts the hearing in accordance with the rules
that apply to ALJ hearings under this subpart.
42 CFR 498.78 Remand by the Administrative Law Judge.
(a) If HCFA or the OIG requests remand, and the affected party
concurs in writing or on the record, the ALJ may remand any case
properly before him or her to HCFA or the OIG for a determination
satisfactory to the affected party.
(b) The ALJ may remand at any time before notice of hearing decision
is mailed.
42 CFR 498.78 Subpart E -- Appeals Council Review
42 CFR 498.80 Right to request Appeals Council review of Administrative
Law Judge's decision or dismissal.
Either of the parties has a right to request Appeals Council review
of the ALJ's decision or dismissal order, and the parties are so
informed in the notice of the ALJ's action.
42 CFR 498.82 Request for Appeals Council review.
(a) Manner and time of filing. (1) Any party that is dissatisfied
with an ALJ's decision or dismissal of a hearing request, may file a
written request for review by the Appeals Council.
(2) The requesting party or its representative or other authorized
official must file the request with the OHA within 60 days from receipt
of the notice of decision or dismissal, unless the Council, for good
cause shown by the requesting party, extends the time for filing. The
rules set forth in 498.40(c) apply to extension of time for requesting
Appeals Council review. (The date of receipt of notice is determined in
accordance with 498.22(c)(3).)
(b) Content of request for review. A request for review of an ALJ
decision or dismissal must specify the issues, the findings of fact or
conclusions of law with which the party disagrees, and the basis for
contending that the findings and conclusions are incorrect.
42 CFR 498.83 Appeals Council action on request for review.
(a) Request by HCFA or the OIG. The Appeals Council may dismiss,
deny, or grant a request made by HCFA or the OIG for review of an ALJ
decision or dismissal.
(b) Request by the affected party. The Council will grant the
affected party's request for review unless it dismisses the request for
one of the following reasons:
(1) The affected party requests dismissal of its request for review.
(2) The affected party did not file timely or show good cause for
late filing.
(3) The affected party does not have a right to review.
(4) A previous determination or decision, based on the same facts and
law, and regarding the same issue, has become final through judicial
affirmance or because the affected party failed to timely request
reconsideration, hearing, Council review, or judicial review, as
appropriate.
(c) Effect of dismissal. The dismissal of a request for Appeals
Council review is binding and not subject to further review.
(d) Review panel. If the Council grants a request for review of the
ALJ's decision, the review will be conducted by a panel of at least two
members of the Council, designated by the Chairperson or Deputy
Chairperson, and one individual designated by the Secretary from the U.S
Public Health Service.
42 CFR 498.85 Procedures before the Appeals Council on review.
The parties are given, upon request, a reasonable opportunity to file
briefs or other written statements as to fact and law, and to appear
before the Appeals Council to present evidence or oral arguments.
Copies of any brief or other written statement must be sent in
accordance with 498.17.
42 CFR 498.86 Evidence admissible on review.
(a) The Appeals Council may admit evidence into the record in
addition to the evidence introduced at the ALJ hearing, (or the
documents considered by the ALJ if the hearing was waived), if the
Council considers that the additional evidence is relevant and material
to an issue before it.
(b) If it appears to the Council that additional relevant evidence is
available, the Council will require that it be produced.
(c) Before additional evidence is admitted into the record --
(1) Notice is mailed to the parties (unless they have waived notice)
stating that evidence will be received regarding specified issues; and
(2) The parties are given a reasonable time to comment and to present
other evidence pertinent to the specified issues.
(d) If additional evidence is presented orally to the Council, a
transcript is prepared and made available to any party upon request.
42 CFR 498.88 Decision or remand by the Appeals Council.
(a) When the Appeals Council reviews an ALJ's decision or order of
dismissal, or receives a case remanded by a court, the Council may
either issue a decision or remand the case to an ALJ for a hearing and
decision or a recommended decision for final decision by the Council.
(b) In a remanded case, the ALJ initiates additional proceedings and
takes other actions as directed by the Council in its order of remand,
and may take other action not inconsistent with that order.
(c) Upon completion of all action called for by the remand order and
any other consistent action, the ALJ promptly makes a decision or, as
specified by the Council, certifies the case to the Council with a
recommended decision.
(d) The parties have 20 days from the date of a notice of a
recommended decision to submit to the Council any exception, objection,
or comment on the findings of fact, conclusions of law, and recommended
decision.
(e) After the 20-day period, the Council issues its decision
adopting, modifying or rejecting the ALJ's recommended decision.
(f) If the Council does not remand the case to an ALJ, the following
rules apply:
(1) The Council's decision --
(i) Is based upon the evidence in the hearing record and any further
evidence that the Council receives during its review;
(ii) Is in writing and contains separate numbered findings of fact
and conclusions of law; and
(iii) May modify, affirm, or reverse the ALJ's decision.
(2) A copy of the Council's decision is mailed to each party.
42 CFR 498.90 Effect of Appeals Council decision.
(a) The decision of the Appeals Council is binding unless --
(1) The affected party has a right to judicial review and timely
files a civil action in a district court of the United States; or
(2) The Council reopens and revises its decision in accordance with
498.102.
(b) Section 498.5 specifies the circumstances under which an affected
party has a right to seek judicial review.
42 CFR 498.95 Extension of time for seeking judicial review.
(a) Any affected party that is dissatisfied with an Appeals Council
decision and is entitled to judicial review must commence civil action
within 60 days from receipt of the notice of the Council's decision (as
determined under 498.22(c)(3)), unless the Council extends the time in
accordance with paragraph (c) of this section.
(b) The request for extension must be filed in writing with the
Council before the 60-day period ends.
(c) For good cause shown, the Council may extend the time for
commencing civil action.
42 CFR 498.95 Subpart F -- Reopening of Decisions Made by Administrative Law Judges or the Appeals Council
42 CFR 498.100 Basis, timing, and authority for reopening an ALJ or
Council decision.
(a) Basis and timing for reopening. An ALJ of Appeals Council
decision may be reopened, within 60 days from the date of the notice of
decision, upon the motion of the ALJ or the Council or upon the petition
of either party to the hearing.
(b) Authority to reopen. (1) A decision of the Appeals Council may
be reopened only by the Appeals Council.
(2) A decision of an ALJ may be reopened by that ALJ, by another ALJ
if that one is not available, or by the Appeals Council. For purposes
of this paragraph, an ALJ is considered to be unavailable if the ALJ has
died, terminated employment, or been transferred to another duty
station, is on leave of absence, or is unable to conduct a hearing
because of illness.
42 CFR 498.102 Revision of reopened decision.
(a) Revision based on new evidence. If a reopened decision is to be
revised on the basis of new evidence that was not included in the record
of that decision, the ALJ or the Appeals Council --
(1) Notifies the parties of the proposed revision; and
(2) Unless the parties waive their right to hearing or appearance --
(i) Grants a hearing in the case of an ALJ revision; and
(ii) Grants opportunity to appear in the case of a Council revision.
(b) Basis for revised decision and right to review. (1) If a revised
decision is necessary, the ALJ or the Appeals Council, as appropriate,
renders it on the basis of the entire record.
(2) If the decision is revised by an ALJ, the Appeals Council may
review that revised decision at the request of either party or on its
own motion.
42 CFR 498.103 Notice and effect of revised decision.
(a) Notice. The notice mailed to the parties states the basis or
reason for the revised decision and informs them of their right to
Appeals Council review of an ALJ revised decision, or to judicial review
of a Council reviewed decision.
(b) Effect -- (1) ALJ revised decision. An ALJ revised decision is
binding unless it is reviewed by the Appeals Council.
(2) Appeals Council revised decision. A Council revised decision is
binding unless a party files a civil action in a district court of the
United States within the time frames specified in 498.95.
42 CFR 498.103 42 CFR Ch. V (10-1-92 Edition)
42 CFR 498.103 Office of Inspector General -- Health Care, HHS
42 CFR 498.103 CHAPTER V -- OFFICE OF INSPECTOR
42 CFR 498.103 GENERAL -- HEALTH CARE,
42 CFR 498.103 DEPARTMENT OF HEALTH AND
42 CFR 498.103 HUMAN SERVICES
42 CFR 498.103 SUBCHAPTER A -- GENERAL PROVISIONS
Part
Page
1000 Introduction; General definitions
42 CFR 498.103
42 CFR 498.103 SUBCHAPTER B -- OIG AUTHORITIES
1001 Program integrity -- Medicare and State health care programs
1002 Program integrity -- State-initiated exclusions from Medicaid
1003 Civil money penalties, assessments and exclusions
1004 Imposition of sanctions on health care practitioners and
providers of health care services by a Peer Review Organization
1005 Appeals of exclusions, civil money penalties and assessments
1006 Investigational inquiries
1007 State Medicaid fraud control units
42 CFR 498.103 42 CFR Ch. V (10-1-92 Edition)
42 CFR 498.103 Office of Inspector General -- Health Care, HHS
42 CFR 498.103 SUBCHAPTER A -- GENERAL PROVISIONS
42 CFR 498.103 PART 1000 -- INTRODUCTION; GENERAL DEFINITIONS
42 CFR 498.103 Subpart A -- (Reserved)
42 CFR 498.103 Subpart B -- Definitions
Sec.
1000.10 General definitions.
1000.20 Definitions specific to Medicare.
1000.30 Definitions specific to Medicaid.
Authority: 42 U.S.C. 1320 and 1395hh.
Source: 51 FR 34766, Sept. 30, 1986, unless otherwise noted.
42 CFR 498.103 Subpart A -- (Reserved)
42 CFR 498.103 Subpart B -- Definitions
42 CFR 1000.10 General definitions.
In this chapter, unless the context indicates otherwise --
Act means the Social Security Act, and titles referred to are titles
of that Act.
Administrator means the Administrator, Health Care Financing
Administration.
Beneficiary means any individual eligible to have benefits paid to
him or her, or on his or her behalf, under Medicare or any State health
care program.
CFR stands for Code of Federal Regulations.
Department means the Department of Health and Human Services (HHS),
formerly the Department of Health, Education, and Welfare.
ESRD stands for end-stage renal disease.
FR stands for Federal Register.
Furnished refers to items and services provided directly by, or under
the direct supervision of, or ordered by, a practitioner or other
individual, or ordered or prescribed by a physician, (either as an
employee or in his or her own capacity), a provider, or other supplier
of services.
HCFA stands for Health Care Financing Administration.
HHS stands for the Department of Health and Human Services.
HHA stands for home health agency.
HMO stands for health maintenance organization.
ICF stands for intermediate care facility.
Inspector General means the Inspector General for Health and Human
Services.
Medicaid means medical assistance provided under a State plan
approved under Title XIX of the Act.
Medicare means the health insurance program for the aged and disabled
under Title XVIII of the Act.
OIG means the Office of Inspector General within HHS.
PRO stands for Utilization and Quality Control Peer Review
Organization.
Secretary means the Secretary of Health and Human Services.
SNF stands for skilled nursing facility.
Social security benefits means monthly cash benefits payable under
section 202 or 223 of the Act.
SSA stands for Social Security Administration.
United States means the fifty States, the District of Columbia, the
Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa,
and the Northern Mariana Islands.
U.S.C. stands for United States Code.
(51 FR 34766, Sept. 30, 1986 as amended at 57 FR 3329, Jan. 29, 1992)
42 CFR 1000.20 Definitions specific to Medicare.
As used in connection with the Medicare program, unless the context
indicates otherwise --
Carrier means an entity that has a contract with HCFA to determine
and make Medicare payments for Part B benefits payable on a charge basis
and to perform other related functions.
Entitled means that an individual meets all the requirements for
Medicare benefits.
Hospital insurance benefits means payments on behalf of, and in rare
circumstances directly to, an entitled individual for services that are
covered under Part A of Title XVIII of the Act.
Intermediary means an entity that has a contract with HCFA to
determine and make Medicare payments for Part A or Part B benefits
payable on a cost basis and to perform other related functions.
Medicare Part A means the hospital insurance program authorized under
Part A of Title XVIII of the Act.
Medicare Part B means the supplementary medical insurance program
authorized under Part B of Title XVIII of the Act.
Provider means a hospital, a skilled nursing facility, a
comprehensive outpatient rehabilitation facility, a home health agency,
or effective November 1, 1983 through September 30, 1986, a hospice that
has in effect an agreement to participate in Medicare, or a clinic, a
rehabilitation agency, or a public health agency that has a similar
agreement but only to furnish outpatient physical therapy or speech
pathology services.
Railroad retirement benefits means monthly benefits payable to
individuals under the Railroad Retirement Act of 1974 (45 U.S.C.
beginning at section 231).
Services means medical care or services and items, such as medical
diagnosis and treatment, drugs and biologicals, supplies, appliances,
and equipment, medical social services, and use of hospital or SNF
facilities.
Supplementary medical insurance benefits means payment to or on
behalf of an entitled individual for services covered under Part B of
Title XVIII of the Act.
Supplier means a physician or other practitioner, or an entity other
than a provider, that furnishes health care services under Medicare.
(51 FR 34766, Sept. 30, 1986, as amended at 57 FR 3329, Jan. 29,
1992)
42 CFR 1000.30 Definitions specific to Medicaid.
As used in connection with the Medicaid program, unless the context
indicates otherwise --
Applicant means an individual whose written application for Medicaid
has been submitted to the agency determining Medicaid eligibility, but
has not received final action. This includes an individual (who need
not be alive at the time of application) whose application is submitted
through a representative or a person acting responsibly for the
individual.
Federal financial participation (FFP) means the Federal Government's
share of a State's expenditures under the Medicaid program.
FMAP stands for the Federal medical assistance percentage, which is
used to calculate the amount of Federal share of State expenditures for
services.
Medicaid agency or agency means the single State agency administering
or supervising the administration of a State Medicaid plan.
Provider means any individual or entity furnishing Medicaid services
under a provider agreement with the Medicaid agency.
Recipient means an individual who has been determined eligible for
Medicaid.
Services means the types of medical assistance specified in sections
1905(a)(1) through (18) of the Act.
State means the several States, the District of Columbia, the
Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa
and the Northern Mariana Islands.
State plan or the plan means a comprehensive written commitment by a
Medicaid agency, submitted under section 1902(a) of the Act, to
administer or supervise the administration of a Medicaid program in
accordance with Federal requirements.
42 CFR 1000.30 SUBCHAPTER B -- OIG AUTHORITIES
42 CFR 1000.30 PART 1001 -- PROGRAM INTEGRITY -- MEDICARE AND STATE HEALTH CARE PROGRAMS
42 CFR 1000.30 Subpart A -- General Provisions
Sec.
1001.1 Scope and purpose.
1001.2 Definitions.
42 CFR 1000.30 Subpart B -- Mandatory Exclusions
1001.101 Basis for liability.
1001.102 Length of exclusion.
42 CFR 1000.30 Subpart C -- Permissive Exclusions
1001.201 Conviction relating to program or health care fraud.
1001.301 Conviction relating to obstruction of an investigation.
1001.401 Conviction relating to controlled substances.
1001.501 License revocation or suspension.
1001.601 Exclusion or suspension under a Federal or State health care
program.
1001.701 Excessive claims or furnishing of unnecessary or substandard
items and services.
1001.801 Failure of HMOs and CMPs to furnish medically necessary
items and services.
1001.901 False or improper claims.
1001.951 Fraud and kickbacks and other prohibited activities.
1001.952 Exceptions.
1001.953 OIG report on compliance with investment interest safe
harbor.
1001.1001 Exclusion of entities owned or controlled by a sanctioned
person.
1001.1101 Failure to disclose certain information.
1001.1201 Failure to provide payment information.
1001.1301 Failure to grant immediate access.
1001.1401 Violations of PPS corrective action.
1001.1501 Default of health education loan or scholarship
obligations.
1001.1601 Violations of the limitations on physician charges.
1001.1701 Billing for services of assistant at surgery during
cataract operations.
42 CFR 1000.30 Subpart D -- Waivers and Effect of Exclusion
1001.1801 Waivers of exclusions.
1001.1901 Scope and effect of exclusion.
42 CFR 1000.30 Subpart E -- Notice and Appeals
1001.2001 Notice of intent to exclude.
1001.2002 Notice of exclusion.
1001.2003 Notice of proposal to exclude.
1001.2004 Notice to State agencies.
1001.2005 Notice to State licensing agencies.
1001.2006 Notice to others regarding exclusion.
1001.2007 Appeal of exclusions.
42 CFR 1000.30 Subpart F -- Reinstatement into the Programs
1001.3001 Timing and method of request for reinstatement.
1001.3002 Basis for reinstatement.
1001.3003 Approval of request for reinstatement.
1001.3004 Denial of request for reinstatement.
1001.3005 Reversed or vacated decisions.
Authority: 42 U.S.C. 1302, 1320a-7, 1320a-7b, 1395u(j), 1395u(k),
1395y(d), 1395y(e), 1395cc(b)(2) (D), (E) and (F), and 1395hh, and
section 14 of Public Law 100-93 (101 Stat. 697).
Source: 57 FR 3330, Jan. 29, 1992, unless otherwise noted.
42 CFR 1000.30 Subpart A -- General Provisions
42 CFR 1001.1 Scope and purpose.
The regulations in this part specify certain bases upon which
individuals and entities may, or in some cases must, be excluded from
participation in the Medicare and certain State health care programs.
They also state the effect of exclusion, the factors that will be
considered in determining the length of any exclusion, the provisions
governing notices of exclusions, and the process by which an excluded
individual or entity may seek reinstatement into the programs.
42 CFR 1001.2 Definitions.
Controlled substance means a drug or other substance, or immediate
precursor:
(a) Included in schedules I, II, III, IV or V of part B of subchapter
I in 21 U.S.C. chapter 13, or
(b) That is deemed a controlled substance by the law of any State.
Convicted means that --
(a) A judgment of conviction has been entered against an individual
or entity by a Federal, State or local court, regardless of whether:
(1) There is a post-trial motion or an appeal pending, or
(2) The judgment of conviction or other record relating to the
criminal conduct has been expunged or otherwise removed;
(b) A Federal, State or local court has made a finding of guilt
against an individual or entity;
(c) A Federal, State or local court has accepted a plea of guilty or
nolo contendere by an individual or entity; or
(d) An individual or entity has entered into participation in a first
offender, deferred adjudication or other program or arrangement where
judgment of conviction has been withheld.
Exclusion means that items and services furnished by a specified
individual or entity will not be reimbursed under Medicare or the State
health care programs.
HHS means Department of Health and Human Services.
OIG means Office of Inspector General of the Department of Health and
Human Services.
PRO means Utilization and Quality Control Peer Review Organization as
created by the Tax Equity and Fiscal Responsibility Act of 1982 (42
U.S.C. 1320c-3).
Professionally recognized standards of health care are Statewide or
national standards of care, whether in writing or not, that professional
peers of the individual or entity whose provision of care is an issue,
recognize as applying to those peers practicing or providing care within
a State. Where the Food and Drug Administration (FDA), the Health Care
Financing Administration (HCFA) or the Public Health Service (PHS) has
declared a treatment modality not to be safe and effective,
practitioners who employ such a treatment modality will be deemed not to
meet professionally recognized standards of health care. This
definition shall not be construed to mean that all other treatments meet
professionally recognized standards.
Sole community physician means a physician who is the only physician
who provides primary care services to Federal or State health care
program beneficiaries within a defined service area.
Sole source of essential specialized services in the community means
that an individual or entity --
(a) Is the only practitioner, supplier or provider furnishing
specialized services in an area designated by the Public Health Service
as a health manpower shortage area for that medical specialty, as listed
in 42 CFR part 5, appendices B-F;
(b) Is a sole community hospital, as defined in 412.92 of this
title; or
(c) Is the only source for specialized services in a defined service
area where services by a non-specialist could not be substituted for the
source without jeopardizing the health or safety of beneficiaries.
State health care program means:
(a) A State plan approved under title XIX of the Act (Medicaid),
(b) Any program receiving funds under title V of the Act or from an
allotment to a State under such title (Maternal and Child Health
Services Block Grant program), or
(c) Any program receiving funds under title XX of the Act or from any
allotment to a State under such title (Block Grants to States for Social
Services).
State Medicaid Fraud Control Unit means a unit certified by the
Secretary as meeting the criteria of 42 U.S.C. 1396b(q) and 1002.305 of
this chapter.
42 CFR 1001.2 Subpart B -- Mandatory Exclusions
42 CFR 1001.101 Basis for liability.
The OIG will exclude any individual or entity that --
(a) Has been convicted of a criminal offense related to the delivery
of an item or service under Medicare or a State health care program,
including the performance of management or administrative services
relating to the delivery of items or services under any such program, or
(b) Has been convicted, under Federal or State law, of a criminal
offense related to the neglect or abuse of a patient, in connection with
the delivery of a health care item or service, including any offense
that the OIG concludes entailed, or resulted in, neglect or abuse of
patients. The conviction need not relate to a patient who is a program
beneficiary.
42 CFR 1001.102 Length of exclusion.
(a) No exclusion imposed in accordance with 1001.101 will be for
less than 5 years.
(b) Any of the following factors may be considered to be aggravating
and a basis for lengthening the period of exclusion --
(1) The acts resulting in the conviction, or similar acts, resulted
in financial loss to Medicare and the State health care programs of
$1,500 or more. (The entire amount of financial loss to such programs
will be considered, including any amounts resulting from similar acts
not adjudicated, regardless of whether full or partial restitution has
been made to the programs);
(2) The acts that resulted in the conviction, or similar acts, were
committed over a period of one year or more;
(3) The acts that resulted in the conviction, or similar acts, had a
significant adverse physical, mental or financial impact on one or more
program beneficiaries or other individuals;
(4) The sentence imposed by the court included incarceration;
(5) The convicted individual or entity has a prior criminal, civil or
administrative sanction record; or
(6) The individual or entity has at any time been overpaid a total of
$1,500 or more by Medicare or State health care programs as a result of
improper billings.
(c) Only if any of the aggravating factors set forth in paragraph (b)
of this section justifies an exclusion longer than 5 years, may
mitigating factors be considered as a basis for reducing the period of
exclusion to no less than 5 years. Only the following factors may be
considered mitigating --
(1) The individual or entity was convicted of 3 or fewer misdemeanor
offenses, and the entire amount of financial loss to Medicare and the
State health care programs due to the acts that resulted in the
conviction, and similar acts, is less than $1,500;
(2) The record in the criminal proceedings, including sentencing
documents, demonstrates that the court determined that the individual
had a mental, emotional or physical condition before or during the
commission of the offense that reduced the individual's culpability; or
(3) The individual's or entity's cooperation with Federal or State
officials resulted in --
(i) Others being convicted or excluded from Medicare or any of the
State health care programs, or
(ii) The imposition against anyone of a civil money penalty or
assessment under part 1003 of this chapter.
42 CFR 1001.102 Subpart C -- Permissive Exclusions
42 CFR 1001.201 Conviction relating to program or health care fraud.
(a) Circumstance for exclusion. The OIG may exclude an individual or
entity convicted under Federal or State law of a criminal offense
relating to fraud, theft, embezzlement, breach of fiduciary
responsibility, or other financial misconduct --
(1) In connection with the delivery of any health care item or
service, including the performance of management or administrative
services relating to the delivery of such items or services, or
(2) With respect to any act or omission in a program operated by, or
financed in whole or in part by, any Federal, State or local government
agency.
(b) Length of exclusion. (1) An exclusion imposed in accordance with
this section will be for a period of 3 years, unless aggravating or
mitigating factors listed in paragraphs (b)(2) and (b)(3) of this
section form a basis for lengthening or shortening that period.
(2) Any of the following factors may be considered to be aggravating
and a basis for lengthening the period of exclusion --
(i) The acts resulting in the conviction, or similar acts, resulted
in financial loss of $1,500 or more to a government program or to one or
more other entities, or had a significant financial impact on program
beneficiaries or other individuals. (The total amount of financial loss
will be considered, including any amounts resulting from similar acts
not adjudicated, regardless of whether full or partial restitution has
been made.);
(ii) The acts that resulted in the conviction, or similar acts, were
committed over a period of one year or more;
(iii) The acts that resulted in the conviction, or similar acts, had
a significant adverse physical or mental impact on one or more program
beneficiaries or other individuals;
(iv) The sentence imposed by the court included incarceration; or
(v) The convicted individual or entity has a prior criminal, civil or
administrative sanction record.
(3) Only the following factors may be considered as mitigating and a
basis for reducing the period of exclusion --
(i) The individual or entity was convicted of 3 or fewer misdemeanor
offenses, and the entire amount of financial loss to a government
program or to other individuals or entities due to the acts that
resulted in the conviction and similar acts is less than $1,500;
(ii) The record in the criminal proceedings, including sentencing
documents, demonstrates that the court determined that the individual
had a mental, emotional or physical condition, before or during the
commission of the offense, that reduced the individual's culpability;
(iii) The individual's or entity's cooperation with Federal or State
officials resulted in --
(A) Others being convicted or excluded from Medicare or any of the
State health care programs, or
(B) The imposition of a civil money penalty against others; or
(iv) Alternative sources of the type of health care items or services
furnished by the individual or entity are not available.
42 CFR 1001.301 Conviction relating to obstruction of an investigation.
(a) Circumstance for exclusion. The OIG may exclude an individual or
entity that has been convicted, under Federal or State law, in
connection with the interference with or obstruction of any
investigation into any criminal offense described in 1001.101 or
1001.201.
(b) Length of exclusion. (1) An exclusion imposed in accordance with
this section will be for a period of 3 years, unless aggravating or
mitigating factors listed in paragraphs (b)(2) and (b)(3) of this
section form the basis for lengthening or shortening that period.
(2) Any of the following factors may be considered to be aggravating
and a basis for lengthening the period of exclusion --
(i) The interference with, or obstruction of, the investigation
caused the expenditure of significant additional time or resources;
(ii) The interference or obstruction had a significant adverse
mental, physical or financial impact on program beneficiaries or other
individuals or on the Medicare or State health care programs;
(iii) The interference or obstruction also affected a civil or
administrative investigation;
(iv) The sentence imposed by the court included incarceration; or
(v) The convicted individual or entity has a prior criminal, civil or
administrative sanction record.
(3) Only the following factors may be considered as mitigating and a
basis for reducing the period of exclusion --
(i) The record of the criminal proceedings, including sentencing
documents, demonstrates that the court determined that the individual
had a mental, emotional or physical condition, before or during the
commission of the offense, that reduced the individual's culpability;
(ii) The individual's or entity's cooperation with Federal or State
officials resulted in --
(A) Others being convicted or excluded from Medicare or any of the
State health care programs, or
(B) The imposition of a civil money penalty against others; or
(iii) Alternative sources of the type of health care items or
services furnished by the individual or entity are not available.
(57 FR 3329, Jan. 29, 1992; 57 FR 9669, Mar. 20, 1992)
42 CFR 1001.401 Conviction relating to controlled substances.
(a) Circumstance for exclusion. The OIG may exclude an individual or
entity convicted under Federal or State law of a criminal offense
relating to the unlawful manufacture, distribution, prescription or
dispensing of a controlled substance, as defined under Federal or State
law.
(b) For purposes of this section, the definition of controlled
substance will be the definition that applies to the law forming the
basis for the conviction.
(c) Length of exclusion. (1) An exclusion imposed in accordance with
this section will be for a period of 3 years, unless aggravating or
mitigating factors listed in paragraphs (b)(2) and (b)(3) of this
section form a basis for lengthening or shortening that period.
(2) Any of the following factors may be considered to be aggravating
and a basis for lengthening the period of exclusion --
(i) The acts that resulted in the conviction or similar acts were
committed over a period of one year or more;
(ii) The acts that resulted in the conviction or similar acts had a
significant adverse physical, mental or financial impact on program
beneficiaries or other individuals or the Medicare or State health care
programs;
(iii) The sentence imposed by the court included incarceration; or
(iv) The convicted individual or entity has a prior criminal, civil
or administrative sanction record.
(3) Only the following factors may be considered as mitigating and a
basis for shortening the period of exclusion --
(i) The individual's or entity's cooperation with Federal or State
officials resulted in --
(A) Others being convicted or excluded from Medicare or any of the
State health care programs, or
(B) The imposition of a civil money penalty against others; or
(ii) Alternative sources of the type of health care items or services
furnished by the individual or entity are not available.
42 CFR 1001.501 License revocation or suspension.
(a) Circumstance for exclusion. The OIG may exclude an individual or
entity that has --
(1) Had a license to provide health care revoked or suspended by any
State licensing authority, or has otherwise lost such a license
(including the right to apply for or renew such a license), for reasons
bearing on the individual's or entity's professional competence,
professional performance or financial integrity; or
(2) Has surrendered such a license while a formal disciplinary
proceeding concerning the individual's or entity's professional
competence, professional performance or financial integrity was pending
before a State licensing authority.
(b) Length of exclusion. (1) Except as provided in paragraph (c) of
this section, an exclusion imposed in accordance with this section will
never be for a period of time less than the period during which an
individual's or entity's license is revoked, suspended or otherwise not
in effect as a result of, or in connection with, a State licensing
agency action.
(2) Any of the following factors may be considered aggravating and a
basis for lengthening the period of exclusion --
(i) The acts that resulted in the revocation, suspension or loss of
the individual's or entity's license to provide health care had or could
have had a significant adverse physical, emotional or financial impact
on one or more program beneficiaries or other individuals;
(ii) The individual or entity has a prior criminal, civil or
administrative sanction record; or
(iii) The acts (or similar acts) had or could have had a significant
adverse impact on the financial integrity of the programs.
(3) Only if any of the aggravating factors listed in paragraph (b)(2)
of this section justifies a longer exclusion may mitigating factors be
considered as a basis for reducing the period of exclusion to a period
not less than that set forth in paragraph (b)(1) of this section. Only
the following factors may be considered mitigating --
(i) The individual's or entity's cooperation with a State licensing
authority resulted in the sanctioning of other individuals or entities;
or
(ii) Alternative sources of the type of health care items or services
furnished by the individual or entity are not available.
(4) When an individual or entity has been excluded under this
section, the OIG will consider a request for reinstatement in accordance
with 1001.3001 if the individual or entity obtains a valid license in
the State where the license was originally revoked, suspended,
surrendered or otherwise lost.
(c) Exceptions. (1) Length of exclusion. If, prior to the notice of
exclusion by the OIG, the licensing authority of a State (other than the
one in which the individual's or entity's license had been revoked,
suspended, surrendered or otherwise lost), being fully apprised of all
of the circumstances surrounding the prior action by the licensing board
of the first State, grants the individual or entity a license or takes
no significant adverse action as to a currently held license, an
exclusion imposed in accordance with this section may be for a period of
time less than that prescribed by paragraph (b)(1) of this section.
(2) Consideration of early reinstatement. If an individual or entity
that has been excluded in accordance with this section fully and
accurately discloses the circumstances surrounding this action to a
licensing authority of a different State, and that State grants the
individual or entity a new license or takes no significant adverse
action as to a currently held license, the OIG will consider a request
for early reinstatement.
42 CFR 1001.601 Exclusion or suspension under a Federal or State health
care program.
(a) Circumstance for exclusion. (1) The OIG may exclude an
individual or entity suspended or excluded from participation, or
otherwise sanctioned, under --
(i) Any Federal program involving the provision of health care, or
(ii) A State health care program, for reasons bearing on the
individual's or entity's professional competence, professional
performance or financial integrity.
(2) The term ''or otherwise sanctioned'' in paragraph (a)(1) of this
section is intended to cover all actions that limit the ability of a
person to participate in the program at issue regardless of what such an
action is called, and includes situations where an individual or entity
voluntarily withdraws from a program to avoid a formal sanction.
(b) Length of exclusion. (1) An exclusion imposed in accordance with
this section will be for a period of 3 years, unless aggravating or
mitigating factors set forth in paragraphs (b)(2) and (b)(3) of this
section form the basis for lengthening or shortening that period.
(2) Any of the following factors may be considered aggravating and a
basis for lengthening the period of exclusion --
(i) The acts that resulted in the exclusion, suspension or other
sanction under the Federal or State health care program had, or could
have had, a significant adverse impact on Federal or State health care
programs or the beneficiaries of those programs or other individuals;
(ii) The period of exclusion, suspension or other sanction imposed
under the Federal or State health care program is greater than 3 years;
or
(iii) The individual or entity has a prior criminal, civil or
administrative record.
(3) Only the following factors may be considered mitigating and a
basis for shortening the period of exclusion --
(i) The period of exclusion, suspension or other sanction imposed
under the Federal or State health care program is less than 3 years;
(ii) The individual's or entity's cooperation with Federal or State
officials resulted in the sanctioning of other individuals or entities;
or
(iii) Alternative sources of the types of health care items or
services furnished by the individual or entity are not available.
(4) The OIG will normally not consider a request for reinstatement in
accordance with 1001.3001 until the period of exclusion imposed by the
OIG has expired.
42 CFR 1001.701 Excessive claims or furnishing of unnecessary or
substandard items and services.
(a) Circumstance for exclusion. The OIG may exclude an individual or
entity that has --
(1) Submitted, or caused to be submitted, bills or requests for
payments under Medicare or any of the State health care programs
containing charges or costs for items or services furnished that are
substantially in excess of such individual's or entity's usual charges
or costs for such items or services; or
(2) Furnished, or caused to be furnished, to patients (whether or not
covered by Medicare or any of the State health care programs) any items
or services substantially in excess of the patient's needs, or of a
quality that fails to meet professionally recognized standards of health
care.
(b) The OIG's determination under paragraph (a)(2) of this section --
that the items or services furnished were excessive or of unacceptable
quality -- will be made on the basis of information, including sanction
reports, from the following sources:
(1) The PRO for the area served by the individual or entity;
(2) State or local licensing or certification authorities;
(3) Fiscal agents or contractors, or private insurance companies;
(4) State or local professional societies; or
(5) Any other sources deemed appropriate by the OIG.
(c) Exceptions. An individual or entity will not be excluded for --
(1) Submitting, or causing to be submitted, bills or requests for
payment that contain charges or costs substantially in excess of usual
charges or costs when such charges or costs are due to unusual
circumstances or medical complications requiring additional time,
effort, expense or other good cause; or
(2) Furnishing, or causing to be furnished, items or services in
excess of the needs of patients, when the items or services were ordered
by a physician or other authorized individual, and the individual or
entity furnishing the items or services was not in a position to
determine medical necessity or to refuse to comply with the order of the
physician or other authorized individual.
(d) Length of exclusion. (1) An exclusion imposed in accordance with
this section will be for a period of 3 years, unless aggravating or
mitigating factors listed in paragraphs (d)(2) and (d)(3) of this
section form a basis for lengthening or shortening the period.
(2) Any of the following factors may be considered aggravating and a
basis for lengthening the period of exclusion --
(i) The violations were serious in nature, and occurred over a period
of one year or more;
(ii) The violations had a significant adverse physical, mental or
financial impact on program beneficiaries or other individuals;
(iii) The individual or entity has a prior criminal, civil or
administrative sanction record; or
(iv) The violation resulted in financial loss to Medicare or the
State health care programs of $1,500 or more.
(3) Only the following factors may be considered mitigating and a
basis for reducing the period of exclusion --
(i) There were few violations and they occurred over a short period
of time; or
(ii) Alternative sources of the type of health care items or services
furnished by the individual or entity are not available.
42 CFR 1001.801 Failure of HMOs and CMPs to furnish medically necessary
items and services.
(a) Circumstances for exclusion. The OIG may exclude an entity --
(1) That is a --
(i) Health maintenance organization (HMO), as defined in section
1903(m) of the Act, providing items or services under a State Medicaid
Plan;
(ii) Primary care case management system providing services, in
accordance with a waiver approved under section 1915(b)(1) of the Act;
or
(iii) HMO or competitive medical plan providing items or services in
accordance with a risk-sharing contract under section 1876 of the Act;
(2) That has failed substantially to provide medically necessary
items and services that are required under a plan, waiver or contract
described in paragraph (a)(1) of this section to be provided to
individuals covered by such plan, waiver or contract; and
(3) Where such failure has adversely affected or has a substantial
likelihood of adversely affecting covered individuals.
(b) The OIG's determination under paragraph (a)(2) of this section --
that the medically necessary items and services required under law or
contract were not provided -- will be made on the basis of information,
including sanction reports, from the following sources:
(1) The PRO or other quality assurance organization under contract
with a State Medicaid plan for the area served by the HMO or competitive
medical plan;
(2) State or local licensing or certification authorities;
(3) Fiscal agents or contractors, or private insurance companies;
(4) State or local professional societies;
(5) HCFA's HMO compliance office; or
(6) Any other sources deemed appropriate by the OIG.
(c) Length of exclusion. (1) An exclusion imposed in accordance with
this section will be for a period of 3 years, unless aggravating or
mitigating factors listed in paragraphs (c)(2) and (c)(3) of this
section form a basis for lengthening or shortening the period.
(2) Any of the following factors may be considered aggravating and a
basis for lengthening the period of exclusion --
(i) The entity failed to provide a large number or a variety of items
or services;
(ii) The failures occurred over a lengthy period of time;
(iii) The entity's failure to provide a necessary item or service had
or could have had a serious adverse effect; or
(iv) The entity has a criminal, civil or administrative sanction
record.
(3) Only the following factors may be considered as mitigating and a
basis for reducing the period of exclusion --
(i) There were few violations and they occurred over a short period
of time; or
(ii) Alternative sources of the type of health care items or services
furnished by the entity are not available.
(iii) The entity took corrective action upon learning of
impermissible activities by an employee or contractor.
42 CFR 1001.901 False or improper claims.
(a) Circumstance for exclusion. The OIG may exclude any individual
or entity that it determines has committed an act described in section
1128A of the Act. The imposition of a civil money penalty or assessment
is not a prerequisite for an exclusion under this section.
(b) Length of exclusion. In determining the length of an exclusion
imposed in accordance with this section, the OIG will consider the
following factors --
(1) The nature and circumstances surrounding the actions that are the
basis for liability, including the period of time over which the acts
occurred, the number of acts, whether there is evidence of a pattern and
the amount claimed;
(2) The degree of culpability;
(3) The individual's or entity's prior criminal, civil or
administrative sanction record (The lack of any prior record is to be
considered neutral); and
(4) Other matters as justice may require.
42 CFR 1001.951 Fraud and kickbacks and other prohibited activities.
(a) Circumstance for exclusion. (1) Except as provided for in
paragraph (a)(2)(ii) of this section, the OIG may exclude any individual
or entity that it determines has committed an act described in section
1128B(b) of the Act.
(2) With respect to acts described in section 1128B of the Act, the
OIG --
(i) May exclude any individual or entity that it determines has
knowingly and willfully solicited, received, offered or paid any
remuneration in the manner and for the purposes described therein,
irrespective of whether the individual or entity may be able to prove
that the remuneration was also intended for some other purpose; and
(ii) Will not exclude any individual or entity if that individual or
entity can prove that the remuneration that is the subject of the
exclusion is exempted from serving as the basis for an exclusion.
(b) Length of exclusion. (1) The following factors will be
considered in determining the length of exclusion in accordance with
this section --
(i) The nature and circumstances of the acts and other similar acts;
(ii) The nature and extent of any adverse physical, mental, financial
or other impact the conduct had on program beneficiaries or other
individuals or the Medicare or State health programs;
(iii) The excluded individual's or entity's prior criminal, civil or
administrative sanction record (The lack of any prior record is to be
considered neutral); and
(iv) Any other facts bearing on the nature and seriousness of the
individual's or entity's misconduct.
(2) It will be considered a mitigating factor if --
(i) The individual had a documented mental, emotional, or physical
condition before or during the commission of the prohibited act(s) that
reduced the individual's culpability for the acts in question;
(ii) The individual's or entity's cooperation with Federal or State
officials resulted in the --
(A) Sanctioning of other individuals or entities, or
(B) Imposition of a civil money penalty against others; or
(iii) Alternative sources of the type of health care items or
services provided by the individual or entity are not available.
42 CFR 1001.952 Exceptions.
The following payment practices shall not be treated as a criminal
offense under section 1128B of the Act and shall not serve as the basis
for an exclusion:
(a) Investment Interests. As used in section 1128B of the Act,
''remuneration'' does not include any payment that is a return on an
investment interest, such as a dividend or interest income, made to an
investor as long as all of the applicable standards are met within one
of the following two categories of entities:
(1) If, within the previous fiscal year or previous 12 month period,
the entity possesses more than $50,000,000 in undepreciated net tangible
assets (based on the net acquisition cost of purchasing such assets from
an unrelated entity) related to the furnishing of items and services,
all of the following five applicable standards must be met --
(i) With respect to an investment interest that is an equity
security, the equity security must be registered with the Securities and
Exchange Commission under 15 U.S.C. 781 (b) or (g).
(ii) The investment interest of an investor in a position to make or
influence referrals to, furnish items or services to, or otherwise
generate business for the entity must be obtained on terms equally
available to the public through trading on a registered national
securities exchange, such as the New York Stock Exchange or the American
Stock Exchange, or on the National Association of Securities Dealers
Automated Quotation System.
(iii) The entity or any investor must not market or furnish the
entity's items or services (or those of another entity as part of a
cross referral agreement) to passive investors differently than to
non-investors.
(iv) The entity must not loan funds to or guarantee a loan for an
investor who is in a position to make or influence referrals to, furnish
items or services to, or otherwise generate business for the entity if
the investor uses any part of such loan to obtain the investment
interest.
(v) The amount of payment to an investor in return for the investment
interest must be directly proportional to the amount of the capital
investment of that investor.
(2) If the entity possesses investment interests that are held by
either active or passive investors, all of the following eight
applicable standards must be met --
(i) No more than 40 percent of the value of the investment interests
of each class of investments may be held in the previous fiscal year or
previous 12 month period by investors who are in a position to make or
influence referrals to, furnish items or services to, or otherwise
generate business for the entity.
(ii) The terms on which an investment interest is offered to a
passive investor, if any, who is in a position to make or influence
referrals to, furnish items or services to, or otherwise generate
business for the entity must be no different from the terms offered to
other passive investors.
(iii) The terms on which an investment interest is offered to an
investor who is in a position to make or influence referrals to, furnish
items or services to, or otherwise generate business for the entity must
not be related to the previous or expected volume of referrals, items or
services furnished, or the amount of business otherwise generated from
that investor to the entity.
(iv) There is no requirement that a passive investor, if any, make
referrals to, be in a position to make or influence referrals to,
furnish items or services to, or otherwise generate business for the
entity as a condition for remaining as an investor.
(v) The entity or any investor must not market or furnish the
entity's items or services (or those of another entity as part of a
cross referral agreement) to passive investors differently than to
non-investors.
(vi) No more than 40 percent of the gross revenue of the entity in
the previous fiscal year or previous 12 month period may come from
referrals, items or services furnished, or business otherwise generated
from investors.
(vii) The entity must not loan funds to or guarantee a loan for an
investor who is in a position to make or influence referrals to, furnish
items or services to, or otherwise generate business for the entity if
the investor uses any part of such loan to obtain the investment
interest.
(viii) The amount of payment to an investor in return for the
investment interest must be directly proportional to the amount of the
capital investment (including the fair market value of any
pre-operational services rendered) of that investor.
For purposes of paragraph (a) of this section, the following terms
apply. Active investor means an investor either who is responsible for
the day-to-day management of the entity and is a bona fide general
partner in a partnership under the Uniform Partnership Act or who agrees
in writing to undertake liability for the actions of the entity's agents
acting within the scope of their agency. Investment interest means a
security issued by an entity, and may include the following classes of
investments: shares in a corporation, interests or units of a
partnership, bonds, debentures, notes, or other debt instruments.
Investor means an individual or entity either who directly holds an
investment interest in an entity, or who holds such investment interest
indirectly by, including but not limited to, such means as having a
family member hold such investment interest or holding a legal or
beneficial interest in another entity (such as a trust or holding
company) that holds such investment interest. Passive investor means an
investor who is not an active investor, such as a limited partner in a
partnership under the Uniform Partnership Act, a shareholder in a
corporation, or a holder of a debt security.
(b) Space Rental. As used in section 1128B of the Act,
''remuneration'' does not include any payment made by a lessee to a
lessor for the use of premises, as long as all of the following five
standards are met --
(1) The lease agreement is set out in writing and signed by the
parties.
(2) The lease specifies the premises covered by the lease.
(3) If the lease is intended to provide the lessee with access to the
premises for periodic intervals of time, rather than on a full-time
basis for the term of the lease, the lease specifies exactly the
schedule of such intervals, their precise length, and the exact rent for
such intervals.
(4) The term of the lease is for not less than one year.
(5) The aggregate rental charge is set in advance, is consistent with
fair market value in arms-length transactions and is not determined in a
manner that takes into account the volume or value of any referrals or
business otherwise generated between the parties for which payment may
be made in whole or in part under Medicare or a State health care
program.
For purposes of paragraph (b) of this section, the term fair market
value means the value of the rental property for general commercial
purposes, but shall not be adjusted to reflect the additional value that
one party (either the prospective lessee or lessor) would attribute to
the property as a result of its proximity or convenience to sources of
referrals or business otherwise generated for which payment may be made
in whole or in part under Medicare or a State health care program.
(c) Equipment rental. As used in section 1128B of the Act,
''remuneration'' does not include any payment made by a lessee of
equipment to the lessor of the equipment for the use of the equipment,
as long as all of the following five standards are met --
(1) The lease agreement is set out in writing and signed by the
parties.
(2) The lease specifies the equipment covered by the lease.
(3) If the lease is intended to provide the lessee with use of the
equipment for periodic intervals of time, rather than on a full-time
basis for the term of the lease, the lease specifies exactly the
schedule of such intervals, their precise length, and the exact rent for
such interval.
(4) The term of the lease is for not less than one year.
(5) The aggregate rental charge is set in advance, is consistent with
fair market value in arms-length transactions and is not determined in a
manner that takes into account the volume or value of any referrals or
business otherwise generated between the parties for which payment may
be made in whole or in part under Medicare or a State health care
program.
For purposes of paragraph (c) of this section, the term fair market
value means the value of the equipment when obtained from a manufacturer
or professional distributor, but shall not be adjusted to reflect the
additional value one party (either the prospective lessee or lessor)
would attribute to the equipment as a result of its proximity or
convenience to sources of referrals or business otherwise generated for
which payment may be made in whole or in part under Medicare or a State
health care program.
(d) Personal services and management contracts. As used in section
1128B of the Act, ''remuneration'' does not include any payment made by
a principal to an agent as compensation for the services of the agent,
as long as all of the following six standards are met --
(1) The agency agreement is set out in writing and signed by the
parties.
(2) The agency agreement specifies the services to be provided by the
agent.
(3) If the agency agreement is intended to provide for the services
of the agent on a periodic, sporadic or part-time basis, rather than on
a full-time basis for the term of the agreement, the agreement specifies
exactly the schedule of such intervals, their precise length, and the
exact charge for such intervals.
(4) The term of the agreement is for not less than one year.
(5) The aggregate compensation paid to the agent over the term of the
agreement is set in advance, is consistent with fair market value in
arms-length transactions and is not determined in a manner that takes
into account the volume or value of any referrals or business otherwise
generated between the parties for which payment may be made in whole or
in part under Medicare or a State health care program.
(6) The services performed under the agreement do not involve the
counselling or promotion of a business arrangement or other activity
that violates any State or Federal law.
For purposes of paragraph (d) of this section, an agent of a
principal is any person, other than a bona fide employee of the
principal, who has an agreement to perform services for, or on behalf
of, the principal.
(e) Sale of practice. As used in section 1128B of the Act,
''remuneration'' does not include any payment made to a practitioner by
another practitioner where the former practitioner is selling his or her
practice to the latter practitioner, as long as both of the following
two standards are met --
(1) The period from the date of the first agreement pertaining to the
sale to the completion of the sale is not more than one year.
(2) The practitioner who is selling his or her practice will not be
in a professional position to make referrals to, or otherwise generate
business for, the purchasing practitioner for which payment may be made
in whole or in part under Medicare or a State health care program after
one year from the date of the first agreement pertaining to the sale.
(f) Referral services. As used in section 1128B of the Act,
''remuneration'' does not include any payment or exchange of anything of
value between an individual or entity (''participant'') and another
entity serving as a referral service (''referral service''), as long as
all of the following four standards are met --
(1) The referral service does not exclude as a participant in the
referral service any individual or entity who meets the qualifications
for participation.
(2) Any payment the participant makes to the referral service is
assessed equally against and collected equally from all participants,
and is only based on the cost of operating the referral service, and not
on the volume or value of any referrals to or business otherwise
generated by the participants for the referral service for which payment
may be made in whole or in part under Medicare or a State health care
program.
(3) The referral service imposes no requirements on the manner in
which the participant provides services to a referred person, except
that the referral service may require that the participant charge the
person referred at the same rate as it charges other persons not
referred by the referral service, or that these services be furnished
free of charge or at reduced charge.
(4) The referral service makes the following five disclosures to each
person seeking a referral, with each such disclosure maintained by the
referral service in a written record certifying such disclosure and
signed by either such person seeking a referral or by the individual
making the disclosure on behalf of the referral service --
(i) The manner in which it selects the group of participants in the
referral service to which it could make a referral;
(ii) Whether the participant has paid a fee to the referral service;
(iii) The manner in which it selects a particular participant from
this group for that person;
(iv) The nature of the relationship between the referral service and
the group of participants to whom it could make the referral; and
(v) The nature of any restrictions that would exclude such an
individual or entity from continuing as a participant.
(g) Warranties. As used in section 1128B of the Act,
''remuneration'' does not include any payment or exchange of anything of
value under a warranty provided by a manufacturer or supplier of an item
to the buyer (such as a health care provider or beneficiary) of the
item, as long as the buyer complies with all of the following standards
in paragraphs (g)(1) and (g)(2) of this section and the manufacturer or
supplier complies with all of the following standards in paragraphs
(g)(3) and (g)(4) of this section --
(1) The buyer must fully and accurately report any price reduction of
the item (including a free item), which was obtained as part of the
warranty, in the applicable cost reporting mechanism or claim for
payment filed with the Department or a State agency.
(2) The buyer must provide, upon request by the Secretary or a State
agency, information provided by the manufacturer or supplier as
specified in paragraph (g)(3) of this section.
(3) The manufacturer or supplier must comply with either of the
following two standards --
(i) The manufacturer or supplier must fully and accurately report the
price reduction of the item (including a free item), which was obtained
as part of the warranty, on the invoice or statement submitted to the
buyer, and inform the buyer of its obligations under paragraphs (a)(1)
and (a)(2) of this section.
(ii) Where the amount of the price reduction is not known at the time
of sale, the manufacturer or supplier must fully and accurately report
the existence of a warranty on the invoice or statement, inform the
buyer of its obligations under paragraphs (g)(1) and (g)(2) of this
section, and, when the price reduction becomes known, provide the buyer
with documentation of the calculation of the price reduction resulting
from the warranty.
(4) The manufacturer or supplier must not pay any remuneration to any
individual (other than a beneficiary) or entity for any medical,
surgical, or hospital expense incurred by a beneficiary other than for
the cost of the item itself.
For purposes of paragraph (g) of this section, the term warranty
means either an agreement made in accordance with the provisions of 15
U.S.C. 2301(6), or a manufacturer's or supplier's agreement to replace
another manufacturer's or supplier's defective item (which is covered by
an agreement made in accordance with this statutory provision), on terms
equal to the agreement that it replaces.
(h) Discounts. As used in section 1128B of the Act, ''remuneration''
does not include a discount, as defined in paragraph (h)(3) of this
section, on a good or service received by a buyer, which submits a claim
or request for payment for the good or service for which payment may be
made in whole or in part under Medicare or a State health care program,
from a seller as long as the buyer complies with the applicable
standards of paragraph (h)(1) of this section and the seller complies
with the applicable standards of paragraph (h)(2) of this section:
(1) With respect to the following three categories of buyers, the
buyer must comply with all of the applicable standards within each
category --
(i) If the buyer is an entity which reports its costs on a cost
report required by the Department or a State agency, it must comply with
all of the following four standards --
(A) The discount must be earned based on purchases of that same good
or service bought within a single fiscal year of the buyer;
(B) The buyer must claim the benefit of the discount in the fiscal
year in which the discount is earned or the following year;
(C) The buyer must fully and accurately report the discount in the
applicable cost report; and
(D) The buyer must provide, upon request by the Secretary or a State
agency, information provided by the seller as specified in paragraph
(h)(2)(ii) of this section.
(ii) If the buyer is an entity which is a health maintenance
organization or competitive medical plan acting in accordance with a
risk contract under section 1876(g) or 1903(m) of the Act, or under
another State health care program, it need not report the discount
except as otherwise may be required under the risk contract.
(iii) If the buyer is not an entity described in paragraphs (h)(1)(i)
or (h)(1)(ii) of this section, it must comply with all of the following
three standards --
(A) The discount must be made at the time of the original sale of the
good or service;
(B) Where an item or service is separately claimed for payment with
the Department or a State agency, the buyer must fully and accurately
report the discount on that item or service; and
(C) The buyer must provide, upon request by the Secretary or a State
agency, information provided by the seller as specified in paragraph
(h)(2)(ii)(A) of this section.
(2) With respect to either of the following two categories of buyers,
the seller must comply with all of the applicable standards within each
category --
(i) If the buyer is an entity described in paragraph (h)(1)(ii) of
this section, the seller need not report the discount to the buyer for
purposes of this provision.
(ii) If the buyer is any other individual or entity, the seller must
comply with either of the following two standards --
(A) Where a discount is required to be reported to the Department or
a State agency under paragraph (h)(1) of this section, the seller must
fully and accurately report such discount on the invoice or statement
submitted to the buyer, and inform the buyer of its obligations to
report such discount; or
(B) Where the value of the discount is not known at the time of sale,
the seller must fully and accurately report the existence of a discount
program on the invoice or statement submitted to the buyer, inform the
buyer of its obligations under paragraph (h)(1) of this section and,
when the value of the discount becomes known, provide the buyer with
documentation of the calculation of the discount identifying the
specific goods or services purchased to which the discount will be
applied.
(3) For purposes of this paragraph, the term discount means a
reduction in the amount a seller charges a buyer (who buys either
directly or through a wholesaler or a group purchasing organization) for
a good or service based on an arms length transaction. The term
discount may include a rebate check, credit or coupon directly
redeemable from the seller only to the extent that such reductions in
price are attributable to the original good or service that was
purchased or furnished. The term discount does not include --
(i) Cash payment;
(ii) Furnishing one good or service without charge or at a reduced
charge in exchange for any agreement to buy a different good or service;
(iii) A reduction in price applicable to one payor but not to
Medicare or a State health care program;
(iv) A reduction in price offered to a beneficiary (such as a routine
reduction or waiver of any coinsurance or deductible amount owed by a
program beneficiary);
(v) Warranties;
(vi) Services provided in accordance with a personal or management
services contract; or
(vii) Other remuneration in cash or in kind not explicitly described
in this paragraph.
(i) Employees. As used in section 1128B of the Act, ''remuneration''
does not include any amount paid by an employer to an employee, who has
a bona fide employment relationship with the employer, for employment in
the furnishing of any item or service for which payment may be made in
whole or in part under Medicare or a State health care program. For
purposes of paragraph (i) of this section, the term employee has the
same meaning as it does for purposes of 26 U.S.C. 3121(d)(2).
(j) Group purchasing organizations. As used in section 1128B of the
Act, ''remuneration'' does not include any payment by a vendor of goods
or services to a group purchasing organization (GPO), as part of an
agreement to furnish such goods or services to an individual or entity
as long as both of the following two standards are met --
(1) The GPO must have a written agreement with each individual or
entity, for which items or services are furnished, that provides for
either of the following --
(i) The agreement states that participating vendors from which the
individual or entity will purchase goods or services will pay a fee to
the GPO of 3 percent or less of the purchase price of the goods or
services provided by that vendor.
(ii) In the event the fee paid to the GPO is not fixed at 3 percent
or less of the purchase price of the goods or services, the agreement
specifies the amount (or if not known, the maximum amount) the GPO will
be paid by each vendor (where such amount may be a fixed sum or a fixed
percentage of the value of purchases made from the vendor by the members
of the group under the contract between the vendor and the GPO).
(2) Where the entity which receives the goods or service from the
vendor is a health care provider of services, the GPO must disclose in
writing to the entity at least annually, and to the Secretary upon
request, the amount received from each vendor with respect to purchases
made by or on behalf of the entity.
For purposes of paragraph (j) of this section, the term group
purchasing organization (GPO) means an entity authorized to act as a
purchasing agent for a group of individuals or entities who are
furnishing services for which payment may be made in whole or in part
under Medicare or a State health care program, and who are neither
wholly-owned by the GPO nor subsidiaries of a parent corporation that
wholly owns the GPO (either directly or through another wholly-owned
entity).
(k) Waiver of beneficiary coinsurance and deductible amounts. As
used in section 1128B of the Act, ''remuneration'' does not include any
reduction or waiver of a Medicare or a State health care program
beneficiary's obligation to pay coinsurance or deductible amounts as
long as all of the standards are met within either of the following two
categories of health care providers:
(1) If the coinsurance or deductible amounts are owed to a hospital
for inpatient hospital services for which Medicare pays under the
prospective payment system, the hospital must comply with all of the
following three standards --
(i) The hospital must not later claim the amount reduced or waived as
a bad debt for payment purposes under Medicare or otherwise shift the
burden of the reduction or waiver onto Medicare, a State health care
program, other payers, or individuals.
(ii) The hospital must offer to reduce or waive the coinsurance or
deductible amounts without regard to the reason for admission, the
length of stay of the beneficiary, or the diagnostic related group for
which the claim for Medicare reimbursement is filed.
(iii) The hospital's offer to reduce or waive the coinsurance or
deductible amounts must not be made as part of a price reduction
agreement between a hospital and a third-party payor.
(2) If the coinsurance or deductible amounts are owed by an
individual who qualifies for subsidized services under a provision of
the Public Health Services Act or under titles V or XIX of the Act to a
federally qualified health care center or other health care facility
under any Public Health Services Act grant program or under title V of
the Act, the health care center or facility may reduce or waive the
coinsurance or deductible amounts for items or services for which
payment may be made in whole or in part under part B of Medicare or a
State health care program.
42 CFR 1001.953 OIG report on compliance with investment interest safe
harbor.
Within 180 days of the effective date of this subpart, the OIG will
report to the Secretary on the compliance with 1001.952(a)(2)(i) and
1001.952(a)(2)(vi).
42 CFR 1001.1001 Exclusion of entities owned or controlled by a
sanctioned person.
(a) Circumstance for exclusion. (1) The OIG may exclude an entity
if:
(i) A person with a relationship with such entity --
(A) Has been convicted of a criminal offense as described in sections
1128(a) and 1128(b) (1), (2) or (3) of the Act;
(B) Has had civil money penalties or assessments imposed under
section 1128A of the Act; or
(C) Has been excluded from participation in Medicare or any of the
State health care programs, and
(ii) Such a person --
(A) Has a direct or indirect ownership interest (or any combination
thereof) of 5 percent or more in the entity;
(B) Is the owner of a whole or part interest in any mortgage, deed of
trust, note or other obligation secured (in whole or in part) by the
entity or any of the property or assets thereof, in which whole or part
interest is equal to or exceeds 5 percent of the total property and
assets of the entity;
(C) Is an officer or director of the entity, if the entity is
organized as a corporation;
(D) Is a partner in the entity, if the entity is organized as a
partnership;
(E) Is an agent of the entity; or
(F) Is a managing employee, that is, an individual (including a
general manager, business manager, administrator or director) who
exercises operational or managerial control over the entity or part
thereof, or directly or indirectly conducts the day-to-day operations of
the entity or part thereof.
(2) For purposes of this section, the term:
Agent means any person who has express or implied authority to
obligate or act on behalf of an entity.
Indirect ownership interest includes an ownership interest through
any other entities that ultimately have an ownership interest in the
entity in issue. (For example, an individual has a 10 percent ownership
interest in the entity at issue if he or she has a 20 percent ownership
interest in a corporation that wholly owns a subsidiary that is a 50
percent owner of the entity in issue.)
Ownership interest means an interest in:
(i) The capital, the stock or the profits of the entity, or
(ii) Any mortgage, deed, trust or note, or other obligation secured
in whole or in part by the property or assets of the entity.
(b) Length of exclusion. (1) Except as provided in 1001.3002(c),
exclusions under this section will be for the same period as that of the
individual whose relationship with the entity is the basis for this
exclusion, if the individual has been or is being excluded.
(2) If the individual was not excluded, the length of the entity's
exclusion will be determined by considering the factors that would have
been considered if the individual had been excluded.
(3) An entity excluded under this section may apply for reinstatement
at any time in accordance with the procedures set forth in
1001.3001(a)(2).
42 CFR 1001.1101 Failure to disclose certain information.
(a) Circumstance for exclusion. The OIG may exclude any entity that
did not fully and accurately, or completely, make disclosures as
required by section 1124, 1124A or 1126 of the Act, and by part 455,
subpart B and part 420, subpart C of this title.
(b) Length of exclusion. The following factors will be considered in
determining the length of an exclusion under this section --
(1) The number of instances where full and accurate, or complete,
disclosure was not made;
(2) The significance of the undisclosed information;
(3) The entity's prior criminal, civil and administrative sanction
record (The lack of any prior record is to be considered neutral);
(4) Any other facts that bear on the nature or seriousness of the
conduct;
(5) The availability of alternative sources of the type of health
care services provided by the entity; and
(6) The extent to which the entity knew that the disclosures made
were not full or accurate.
42 CFR 1001.1201 Failure to provide payment information.
(a) Circumstance for exclusion. The OIG may exclude any individual
or entity that furnishes items or services for which payment may be made
under Medicare or any of the State health care programs and that:
(1) Fails to provide such information as is necessary to determine
whether such payments are or were due and the amounts thereof, or
(2) Has refused to permit such examination and duplication of its
records as may be necessary to verify such information.
(b) Length of exclusion. The following factors will be considered in
determining the length of an exclusion under this section --
(1) The number of instances where information was not provided;
(2) The circumstances under which such information was not provided;
(3) The amount of the payments at issue;
(4) The individual's or entity's criminal, civil or administrative
sanction record (The lack of any prior record is to be considered
neutral); and
(5) The availability of alternative sources of the type of health
care items or services provided by the individual or entity.
42 CFR 1001.1301 Failure to grant immediate access.
(a) Circumstance for exclusion. (1) The OIG may exclude any
individual or entity that fails to grant immediate access upon
reasonable request to --
(i) The Secretary, a State survey agency or other authorized entity
for the purpose of determining, in accordance with section 1864(a) of
the Act, whether --
(A) An institution is a hospital or skilled nursing facility;
(B) An agency is a home health agency;
(C) An agency is a hospice program;
(D) A facility is a rural health clinic as defined in section
1861(aa)(2) of the Act, or a comprehensive outpatient rehabilitation
facility as defined in section 1861(cc)(2) of the Act;
(E) A laboratory is meeting the requirements of section 1861(s) (15)
and (16) of the Act, and section 353(f) of the Public Health Service
Act;
(F) A clinic, rehabilitation agency or public health agency is
meeting the requirements of section 1861(p)(4) (A) or (B) of the Act;
(G) An ambulatory surgical center is meeting the standards specified
under section 1832(a)(2)(F)(i) of the Act;
(H) A portable x-ray unit is meeting the requirements of section
1861(s)(3) of the Act;
(I) A screening mammography service is meeting the requirements of
section 1834(c)(3) of the Act;
(J) An end-stage renal disease facility is meeting the requirements
of section 1881(b) of the Act;
(K) A physical therapist in independent practice is meeting the
requirements of section 1861(p) of the Act;
(L) An occupational therapist in independent practice is meeting the
requirements of section 1861(g) of the Act;
(M) An organ procurement organization meets the requirements of
section 1138(b) of the Act; or.
(N) A rural primary care hospital meets the requirements of section
1820(i)(2) of the Act;
(ii) The Secretary, a State survey agency or other authorized entity
to perform the reviews and surveys required under State plans in
accordance with sections 1902(a)(26) (relating to inpatient mental
hospital services), 1902(a)(31) (relating to intermediate care
facilities for the mentally retarded), 1919(g) (relating to nursing
facilities), 1929(i) (relating to providers of home and community care
and community care settings), 1902(a)(33) and 1903(g) of the Act;
(iii) The OIG for the purposes of reviewing records, documents and
other data necessary to the performance of the Inspector General's
statutory functions; or
(iv) A State Medicaid fraud control unit for the purpose of
conducting its activities.
(2) For purposes of paragraphs (a)(1)(i) and (a)(1)(ii) of this
section, the term --
Failure to grant immediate access means the failure to grant access
at the time of a reasonable request or to provide a compelling reason
why access may not be granted.
Reasonable request means a written request made by a properly
identified agent of the Secretary, of a State survey agency or of
another authorized entity, during hours that the facility, agency or
institution is open for business.
The request will include a statement of the authority for the
request, the rights of the entity in responding to the request, the
definition of reasonable request and immediate access, and the penalties
for failure to comply, including when the exclusion will take effect.
(3) For purposes of paragraphs (a)(1)(iii) and (a)(1)(iv) of this
section, the term --
Failure to grant immediate access means:
(i) Except where the OIG or State Medicaid fraud control unit
reasonably believes that requested documents are about to be altered or
destroyed, the failure to produce or make available for inspection and
copying requested records upon reasonable request, or to provide a
compelling reason why they cannot be produced, within 24 hours of such
request;
(ii) Where the OIG or State Medicaid fraud control unit has reason to
believe that requested documents are about to be altered or destroyed,
the failure to provide access to requested records at the time the
request is made.
Reasonable request means a written request for documents, signed by
the IG or a delegatee, and made by a properly identified agent of the
OIG or a State Medicaid fraud control unit during reasonable business
hours, where there is information to suggest that the individual or
entity has violated statutory or regulatory requirements under titles V,
XI, XVIII, XIX or XX of the Act. The request will include a statement
of the authority for the request, the rights of the individual or entity
in responding to the request, the definition of reasonable request and
immediate access, and the effective date, length, and scope and effect
of the exclusion that would be imposed for failure to comply with the
request, and the earliest date that a request for reinstatement would be
considered.
(4) Nothing in this section shall in any way limit access otherwise
authorized under State or Federal law.
(b) Length of exclusion. (1) An exclusion of an individual under
this section may be for a period equal to the sum of:
(i) The length of the period during which the immediate access was
not granted, and
(ii) An additional period of up to 90 days.
(2) The exclusion of an entity may be for a longer period than the
period in which immediate access was not granted based on consideration
of the following factors --
(i) The impact of the failure to grant the requested immediate access
on Medicare or any of the State health care programs, beneficiaries or
the public;
(ii) The circumstances under which such access was refused;
(iii) The impact of the exclusion on Medicare or any of the State
health care programs, beneficiaries or the public; and
(iv) The entity's prior criminal, civil or administrative sanction
record (the lack of any prior record is to be considered neutral).
(3) For purposes of paragraphs (b)(1) and (b)(2) of this section, the
length of the period in which immediate access was not granted will be
measured from the time the request is made, or from the time by which
access was required to be granted, whichever is later.
(c) The exclusion will be effective as of the date immediate access
was not granted.
42 CFR 1001.1401 Violations of PPS corrective action.
(a) Circumstance for exclusion. The OIG may exclude any hospital
that HCFA determines has failed substantially to comply with a
corrective action plan required by HCFA under section 1886(f)(2)(B) of
the Act.
(b) Length of exclusion. The following factors will be considered in
determining the length of exclusion under this section --
(1) The impact of the hospital's failure to comply on Medicare or any
of the State health care programs, program beneficiaries or other
individuals;
(2) The circumstances under which the failure occurred;
(3) The nature of the failure to comply;
(4) The impact of the exclusion on Medicare or any of the State
health care programs, beneficiaries or the public; and
(5) The hospital's prior criminal, civil or administrative sanction
record (The lack of any prior record is to be considered neutral).
42 CFR 1001.1501 Default of health education loan or scholarship
obligations.
(a) Circumstance for exclusion. (1) Except as provided in paragraph
(a)(4) of this section, the OIG may exclude any individual that the
Public Health Service (PHS) determines is in default on repayments of
scholarship obligations or loans in connection with health professions
education made or secured in whole or in part by the Secretary.
(2) Before imposing an exclusion in accordance with paragraph (a)(1)
of this section, the OIG must determine that PHS has taken all
reasonable administrative steps to secure repayment of the loans or
obligations. If PHS has offered a Medicare offset arrangement as
required by section 1892 of the Act, the OIG will find that all
reasonable steps have been taken.
(3) The OIG will take into account access of beneficiaries to
physicians' services for which payment may be made under Medicare or
State health care programs in determining whether to impose an
exclusion.
(4) The OIG will not exclude a physician who is the sole community
physician or the sole source of essential specialized services in a
community if a State requests that the physician not be excluded.
(b) Length of exclusion. The individual will be excluded until such
time as PHS notifies the OIG that the default has been cured or the
obligations have been resolved to the PHS's satisfaction. Upon such
notice, the OIG will inform the individual of his or her right to
request reinstatement.
42 CFR 1001.1601 Violations of the limitations on physician charges.
(a) Circumstance for exclusion. (1) The OIG may exclude a physician
whom it determines --
(i) Is a non-participating physician under section 1842(j) of the
Act;
(ii) Furnished services to a beneficiary;
(iii) Knowingly and willfully billed --
(A) On a repeated basis for such services actual charges in excess of
the maximum allowable actual charge determined in accordance with
section 1842(j)(1)(C) of the Act for the period January 1, 1987 through
December 31, 1990, or
(B) Individuals enrolled under part B of title XVIII of the Act
during the statutory freeze for actual charges in excess of such
physician's actual charges determined in accordance with section
1842(j)(1)(A) of the Act for the period July 1, 1984 to December 31,
1986; and''
(iv) Is not the sole community physician or sole source of essential
specialized services in the community.
(2) The OIG will take into account access of beneficiaries to
physicians' services for which Medicare payment may be made in
determining whether to impose an exclusion.
(b) Length of exclusion. (1) In determining the length of an
exclusion in accordance with this section, the OIG will consider the
following factors --
(i) The number of services for which the physician billed in excess
of the maximum allowable charges;
(ii) The number of beneficiaries for whom services were billed in
excess of the maximum allowable charges;
(iii) The amount of the charges that were in excess of the maximum
allowable charges;
(iv) The physician's prior criminal, civil or administrative sanction
record (the lack of any prior record is to be considered neutral); and
(v) The availability of alternative sources of the type of health
care items or services furnished by the physician.
(2) The period of exclusion may not exceed 5 years.
(57 FR 3329, Jan. 29, 1992; 57 FR 9669, Mar. 20, 1992)
42 CFR 1001.1701 Billing for services of assistant at surgery during
cataract operations.
(a) Circumstance for exclusion. The OIG may exclude a physician whom
it determines --
(1) Has knowingly and willfully presented or caused to be presented a
claim, or billed an individual enrolled under Part B of the Medicare
program (or his or her representative) for:
(i) Services of an assistant at surgery during a cataract operation,
or
(ii) Charges that include a charge for an assistant at surgery during
a cataract operation;
(2) Has not obtained prior approval for the use of such assistant
from the appropriate Utilization and Quality Control Peer Review
Organization (PRO) or Medicare carrier; and
(3) Is not the sole community physician or sole source of essential
specialized services in the community.
(b) The OIG will take into account access of beneficiaries to
physicians' services for which Medicare payment may be made in
determining whether to impose an exclusion.
(c) Length of exclusion. (1) In determining the length of an
exclusion in accordance with this section, the OIG will consider the
following factors --
(i) The number of instances for which claims were submitted or
beneficiaries were billed for unapproved use of assistants during
cataract operations;
(ii) The amount of the claims or bills presented;
(iii) The circumstances under which the claims or bills were made,
including whether the services were medically necessary;
(iv) Whether approval for the use of an assistant was requested from
the PRO or carrier;
(v) The physician's criminal, civil or administrative sanction record
(the lack of any prior record is to be considered neutral); and
(vi) The availability of alternative sources of the type of health
care items or services furnished by the physician.
(2) The period of exclusion may not exceed 5 years.
42 CFR 1001.1701 Subpart D -- Waivers and Effect of Exclusion
42 CFR 1001.1801 Waivers of exclusions.
(a) The OIG has the authority to grant or deny a request from a State
health care program that an exclusion from that program be waived with
respect to an individual or entity, except that no waiver may be granted
with respect to an exclusion under 1001.101(b). The request must be in
writing and from an individual directly responsible for administering
the State health care program.
(b) With respect to exclusions under 1001.101(a), a request from a
State health care program for a waiver of the exclusion will only be
considered if the individual or entity is the sole community physician
or the sole source of essential specialized services in a community.
(c) With respect to exclusions imposed under subpart C of this part,
a request for waiver will only be granted if the OIG determines that
imposition of the exclusion would not be in the public interest.
(d) If the basis for the waiver ceases to exist, the waiver will be
rescinded, and the individual or entity will be excluded for the period
remaining on the exclusion, measured from the time the exclusion would
have been imposed if the waiver had not been granted.
(e) In the event a waiver is granted, it is applicable only to the
program(s) for which waiver is requested.
(f) The decision to grant, deny or rescind a request for a waiver is
not subject to administrative or judicial review.
(g) The Inspector General may waive the exclusion of an individual or
entity from participation in the Medicare program in conjunction with
granting a waiver requested by a State health care program. If a State
program waiver is rescinded, the derivative waiver of the exclusion from
Medicare is automatically rescinded.
42 CFR 1001.1901 Scope and effect of exclusion.
(a) Scope of exclusion. Exclusions of individuals and entities under
this title will be from Medicare, State health care programs, and all
other Federal non-procurement programs. The OIG will exclude the
individual or entity from the Medicare program and direct each State
agency administering a State health care program to exclude the
individual or entity for the same period. In the case of an individual
or entity not eligible to participate in Medicare, the exclusion will
still be effective on the date, and for the period, established by the
OIG.
(b) Effect of exclusion on excluded individuals and entities. (1)
Unless and until an individual or entity is reinstated into the Medicare
program in accordance with subpart F of this part, no payment will be
made by Medicare or any of the State health care programs for any item
or service furnished, on or after the effective date specified in the
notice period, by an excluded individual or entity, or at the medical
direction or on the prescription of a physician or other authorized
individual who is excluded when the person furnishing such item or
service knew or had reason to know of the exclusion.
(2) An excluded individual or entity may not take assignment of an
enrollee's claim on or after the effective date of exclusion.
(3) An excluded individual or entity that submits, or causes to be
submitted, claims for items or services furnished during the exclusion
period is subject to civil money penalty liability under section
1128A(a)(1)(D) of the Act, and criminal liability under section
1128B(a)(3) of the Act.
(c) Exceptions to paragraph (b)(1) of this section. (1) If an
enrollee of Part B of Medicare submits an otherwise payable claim for
items or services furnished by an excluded individual or entity, or
under the medical direction or on the prescription of an excluded
physician or other authorized individual after the effective date of
exclusion, HCFA will pay the first claim submitted by the enrollee and
immediately notify the enrollee of the exclusion.
(2) HCFA will not pay an enrollee for items or services furnished by
an excluded individual or entity, or under the medical direction or on
the prescription of an excluded physician or other authorized individual
more than 15 days after the date on the notice to the enrollee, or after
the effective date of the exclusion, whichever is later.
(3) Unless the Secretary determines that the health and safety of
beneficiaries receiving services under Medicare or a State health care
program warrants the exclusion taking effect earlier, payment may be
made under such program for up to 30 days after the effective date of
the exclusion for --
(i) Inpatient institutional services furnished to an individual who
was admitted to an excluded institution before the date of the
exclusion, and
(ii) Home health services and hospice care furnished to an individual
under a plan of care established before the effective date of exclusion.
(4) (i) Notwithstanding the other provisions of this section, payment
may be made under Medicare or a State health care program for certain
emergency items or services furnished by an excluded individual or
entity, or at the medical direction or on the prescription of an
excluded physician or other authorized individual during the period of
exclusion. To be payable, a claim for such emergency items or services
must be accompanied by a sworn statement of the person furnishing the
items or services specifying the nature of the emergency and why the
items or services could not have been furnished by an individual or
entity eligible to furnish or order such items or services.
(ii) Notwithstanding paragraph (c)(4)(i) of this section, no claim
for emergency items or services will be payable if such items or
services were provided by an excluded individual who, through an
employment, contractual or any other arrangement, routinely provides
emergency health care items or services.
42 CFR 1001.1901 Subpart E -- Notice and Appeals
42 CFR 1001.2001 Notice of intent to exclude.
(a) Except as provided in paragraph (c) of this section, if the OIG
proposes to exclude an individual or entity in accordance with subpart C
of this part or in accordance with subpart B of this part where the
exclusion is for a period exceeding 5 years, it will send written notice
of its intent, the basis for the proposed exclusion, and the potential
effect of an exclusion. Within 30 days of receipt of notice, which will
be deemed to be 5 days after the date on the notice, the individual or
entity may submit documentary evidence and written argument concerning
whether the exclusion is warranted and any related issues.
(b) If the OIG proposes to exclude an individual or entity in
accordance with 1001.701 or 1001.801, the individual or entity may
submit, in addition to the information described in paragraph (a) of
this section, a written request to present evidence or argument orally
to an OIG official.
(c) Exception. If the OIG proposes to exclude an individual or
entity under the provisions of 1001.1301, 1001.1401 or 1101.1501,
paragraph (a) of this section will not apply.
(d) If an entity has a provider agreement under section 1866 of the
Act, and the OIG proposes to terminate that agreement in accordance with
section 1866(b)(2)(C) of the Act, the notice provided for in paragraphs
(a) and (b) of this section will so state.
42 CFR 1001.2002 Notice of exclusion.
(a) Except as provided in 1001.2003, if the OIG determines that
exclusion is warranted, it will send a written notice of this decision
to the affected individual or entity.
(b) The exclusion will be effective 20 days from the date of the
notice.
(c) The written notice will state --
(1) The basis for the exclusion;
(2) The length of the exclusion and, where applicable, the factors
considered in setting the length;
(3) The effect of the exclusion;
(4) The earliest date on which the OIG will consider a request for
reinstatement;
(5) The requirements and procedures for reinstatement; and
(6) The appeal rights available to the excluded individual or entity.
(d) Paragraph (b) of this section does not apply to exclusions
imposed in accordance with 1001.1301.
42 CFR 1001.2003 Notice of proposal to exclude.
(a) Except as provided in paragraph (c) of this section, if the OIG
proposes to exclude an individual or entity in accordance with
1001.901, 1001.951, 1001.1601 or 1001.1701, it will send written notice
of this decision to the affected individual or entity. The written
notice will provide the same information set forth in 1001.2002(c). If
an entity has a provider agreement under section 1866 of the Act, and
the OIG also proposes to terminate that agreement in accordance with
section 1866(b)(2)(C) of the Act, the notice will so indicate. The
exclusion will be effective 60 days after the date of the notice unless,
within that period, the individual or entity files a written request for
a hearing in accordance with part 1005 of this chapter. Such request
must set forth --
(1) The specific issues or statements in the notice with which the
individual or entity disagrees;
(2) The basis for that disagreement;
(3) The defenses on which reliance is intended;
(4) Any reasons why the proposed length of exclusion should be
modified; and
(5) Reasons why the health or safety of individuals receiving
services under Medicare or any of the State health care programs does
not warrant the exclusion going into effect prior to the completion of
an administrative law judge (ALJ) proceeding in accordance with part
1005 of this chapter.
(b) (1) If the individual or entity does not make a written request
for a hearing as provided for in paragraph (a) of this section, the OIG
will send a notice of exclusion as described in 1001.2002.
(2) If the individual or entity makes a timely written request for a
hearing and the OIG determines that the health or safety of individuals
receiving services under Medicare or any of the State health care
programs does not warrant an immediate exclusion, an exclusion will not
go into effect unless an ALJ upholds the decision to exclude.
(c) If, prior to issuing a notice of proposal to exclude under
paragraph (a) of this section, the OIG determines that the health or
safety of individuals receiving services under Medicare or any of the
State health care programs warrants the exclusion taking place prior to
the completion of an ALJ proceeding in accordance with part 1005 of this
chapter, the OIG will proceed under 1001.2001 and 1001.2002.
42 CFR 1001.2004 Notice to State agencies.
HHS will promptly notify each appropriate State agency administering
or supervising the administration of each State health care program of:
(a) The facts and circumstances of each exclusion, and
(b) The period for which the State agency is being directed to
exclude the individual or entity.
42 CFR 1001.2005 Notice to State licensing agencies.
(a) HHS will promptly notify the appropriate State(s) or local
agencies or authorities having responsibility for the licensing or
certification of an individual or entity excluded (or directed to be
excluded) from participation of the facts and circumstances of the
exclusion.
(b) HHS will request that appropriate investigations be made and
sanctions invoked in accordance with applicable State law and policy,
and will request that the State or local agency or authority keep the
Secretary and the OIG fully and currently informed with respect to any
actions taken in response to the request.
42 CFR 1001.2006 Notice to others regarding exclusion.
(a) HHS will give notice of the exclusion and the effective date to
the public, to beneficiaries (in accordance with 1001.1901(c)), and, as
appropriate, to --
(1) Any entity in which the excluded individual or entity is known to
be serving as an employee, administrator, operator, or in which the
individual or entity is serving in any other capacity and is receiving
payment for providing services (The lack of this notice will not affect
HCFA's ability to deny payment for services);
(2) State Medicaid Fraud Control Units;
(3) Utilization and Quality Control Peer Review Organizations;
(4) Hospitals, skilled nursing facilities, home health agencies and
health maintenance organizations;
(5) Medical societies and other professional organizations;
(6) Contractors, health care prepayment plans, private insurance
companies and other affected agencies and organizations;
(7) The State and Area Agencies on Aging established under title III
of the Older Americans Act; and
(8) Other Departmental operating divisions, Federal agencies, and
other agencies or organizations, as appropriate.
(b) In the case of an exclusion under 1001.101 of this chapter, if
section 304(a)(5) of the Controlled Substances Act (21 U.S.C.
824(a)(5)) applies, HHS will give notice to the Attorney General of the
United States of the facts and circumstances of the exclusion and the
length of the exclusion.
42 CFR 1001.2007 Appeal of exclusions.
(a)(1) Except as provided in 1001.2003, an individual or entity
excluded under this Part may file a request for a hearing before an ALJ
only on the issues of whether:
(i) The basis for the imposition of the sanction exists, and
(ii) The length of exclusion is unreasonable.
(2) When the OIG imposes an exclusion under subpart B of this part
for a period of 5 years, paragraph (a)(1)(ii) of this section will not
apply.
(3) The request for a hearing should contain the information set
forth in 1005.2(d) of this chapter.
(b) The excluded individual or entity has 60 days from the receipt of
notice of exclusion provided for in 1001.2002 to file a request for
such a hearing.
(c) The standard of proof at a hearing is preponderance of the
evidence.
(d) When the exclusion is based on the existence of a conviction, a
determination by another government agency or any other prior
determination, the basis for the underlying determination is not
reviewable and the individual or entity may not collaterally attack the
underlying determination, either on substantive or procedural grounds,
in this appeal.
(e) The procedures in part 1005 of this chapter will apply to the
appeal.
42 CFR 1001.2007 Subpart F -- Reinstatement into the Programs
42 CFR 1001.3001 Timing and method of request for reinstatement.
(a) (1) Except as provided in paragraph (a)(2) of this section or in
1001.501(b)(4) and (c) and 1001.601(b)(4), an excluded individual or
entity (other than those excluded in accordance with 1001.1001 and
1001.1501) may submit a written request for reinstatement to the OIG
only after the date specified in the notice of exclusion.
(2) An entity under 1001.1001 may apply for reinstatement prior to
the date specified in the notice of exclusion by submitting a written
request for reinstatement that includes documentation demonstrating that
the standards set forth in 1001.3002(c) have been met.
(3) Upon receipt of a written request, the OIG will require the
requestor to furnish specific information and authorization to obtain
information from private health insurers, peer review bodies, probation
officers, professional associates, investigative agencies and such
others as may be necessary to determine whether reinstatement should be
granted.
(4) Failure to furnish the required information or authorization will
result in the continuation of the exclusion.
(b) If a period of exclusion is reduced on appeal (regardless of
whether further appeal is pending), the individual or entity may request
reinstatement once the reduced exclusion period expires.
42 CFR 1001.3002 Basis for reinstatement.
(a) The OIG will authorize reinstatement if it determines that --
(1) The period of exclusion has expired;
(2) There are reasonable assurances that the types of actions that
formed the basis for the original exclusion have not recurred and will
not recur; and
(3) There is no additional basis under sections 1128 (a) or (b) or
1128A of the Act for continuation of the exclusion.
(b) In making the reinstatement determination, the OIG will consider
--
(1) Conduct of the individual or entity occurring prior to the date
of the notice of exclusion, if not known to the OIG at the time of the
exclusion;
(2) Conduct of the individual or entity after the date of the notice
of exclusion;
(3) Whether all fines, and all debts due and owing (including
overpayments) to any Federal, State or local government that relate to
Medicare or any of the State health care programs, have been paid or
satisfactory arrangements have been made to fulfill these obligations;
(4) Whether HCFA has determined that the individual or entity
complies with, or has made satisfactory arrangements to fulfill, all of
the applicable conditions of participation or supplier conditions for
coverage under the statutes and regulations; and
(5) For purposes of individuals or entities excluded under part 1004
of this chapter only, the individual's or entity's willingness and
ability to provide health care that meets professionally recognized
standards.
(c) If the OIG determines that the criteria in paragraphs (a)(2) and
(a)(3) of this section have been met, an entity excluded in accordance
with 1001.1001 will be reinstated upon a determination by the OIG that
the individual whose conviction, exclusion or civil money penalty was
the basis for the entity's exclusion --
(1) Has reduced his or her ownership or control interest in the
entity below 5 percent;
(2) Is no longer an officer, director, agent or managing employee of
the entity; or
(3) Has been reinstated in accordance with paragraph (a) of this
section or 1001.3005.
(d) Reinstatement will not be effective until OIG grants the request
and provides notice under 1001.3003(a)(1). Reinstatement will be
effective as provided in the notice.
(e) A determination with respect to reinstatement is not appealable
or reviewable except as provided in 1001.3004.
(f) An ALJ may not require reinstatement of an individual or entity
in accordance with this chapter.
42 CFR 1001.3003 Approval of request for reinstatement.
(a) If the OIG grants a request for reinstatement, the OIG will --
(1) Notify HCFA of the date of the individual's or entity's
reinstatement in the Medicare program;
(2) Give written notice to the excluded individual or entity
specifying the date when Medicare participation may resume;
(3) Notify State agencies that administer the State health care
programs that the individual or entity has been reinstated into the
Medicare program; and
(4) To the extent applicable, give notice to those agencies, groups,
individuals and others that were originally notified of the exclusion.
(b) If the OIG makes a determination to reinstate an individual or
entity under Medicare, the State health care program upon notification
from the OIG must automatically reinstate the individual or entity under
such program, effective on the date of reinstatement under Medicare,
unless --
(1) Reinstatement is not available to such excluded party under State
law, or
(2) A longer exclusion period was established in accordance with the
State's own authorities and procedures.
42 CFR 1001.3004 Denial of request for reinstatement.
(a) If a request for reinstatement is denied, OIG will give written
notice to the requesting individual or entity. Within 30 days of the
date on the notice, the excluded individual or entity may submit:
(1) Documentary evidence and written argument against the continued
exclusion,
(2) A written request to present written evidence and oral argument
to an OIG official, or
(3) Both documentary evidence and a written request.
(b) After evaluating any additional evidence submitted by the
excluded individual or entity (or at the end of the 30-day period, if
none is submitted), the OIG will send written notice either confirming
the denial, and indicating that a subsequent request for reinstatement
will not be considered until at least one year after the date of denial,
or approving the request consistent with the procedures set forth in
1001.3003(a).
(c) The decision to deny reinstatement will not be subject to
administrative or judicial review.
42 CFR 1001.3005 Reversed or vacated decisions.
(a) An individual or entity will be reinstated into the Medicare
program retroactive to the effective date of the exclusion when such
exclusion is based on --
(1) A conviction that is reversed or vacated on appeal; or
(2) An action by another agency, such as a State agency or licensing
board, that is reversed or vacated on appeal.
(b) If an individual or entity is reinstated in accordance with
paragraph (a) of this section, HCFA will make payment for services
covered under Medicare that were furnished or performed during the
period of exclusion.
(c) The OIG will give notice of a reinstatement under this section in
accordance with 1001.3003(a).
(d) An action taken by OIG under this section will not require any
State health care program to reinstate the individual or entity if it
has imposed an exclusion under its own authority.
42 CFR 1001.3005 PART 1002 -- PROGRAM INTEGRITY -- STATE-INITIATED EXCLUSIONS FROM MEDICAID
42 CFR 1001.3005 Subpart A -- General Provisions
Sec.
1002.1 Scope and purpose.
1002.2 General authority.
1002.3 Disclosure by providers; information on persons convicted of
crimes.
1002.100 State plan requirement.
42 CFR 1001.3005 Subpart B -- Mandatory Exclusion
1002.203 Mandatory exclusion.
42 CFR 1001.3005 Subpart C -- Permissive Exclusions
1002.210 Permissive exclusions; general authority.
1002.211 Effect of exclusion.
1002.212 State agency notifications.
1002.213 Appeals of exclusions.
1002.214 Basis for reinstatement after State agency-initiated
exclusion.
1002.215 Action on request for reinstatement.
42 CFR 1001.3005 Subpart D -- Notification to OIG of State or Local
Convictions of Crimes Against Medicaid
1002.230 Notification of State or local convictions of crimes against
Medicaid.
Authority: 42 U.S.C. 1302, 1320a-3, 1320a-5, 1320a-7, 1396(a)(4)(A),
1396(p)(1), 1396a(30), 1396a(39), 1396b(a)(6), 1396b(b)(3), 1396b(i)(2)
and 1396b(q).
Source: 57 FR 3343, Jan. 29, 1992, unless otherwise noted.
42 CFR 1001.3005 Subpart A -- General Provisions
42 CFR 1002.1 Scope and purpose.
The regulations in this part specify certain bases upon which
individuals and entities may, or in some cases must, be excluded from
participation in the Medicaid program. These regulations specifically
address the authority of State agencies to exclude on their own
initiative, regardless of whether the OIG has excluded an individual or
entity under part 1001 of this chapter. These regulations also
delineate the States' obligation to inform the OIG of certain
Medicaid-related convictions.
42 CFR 1002.2 General authority.
(a) In addition to any other authority it may have, a State may
exclude an individual or entity from participation in the Medicaid
program for any reason for which the Secretary could exclude that
individual or entity from participation in the Medicare program under
sections 1128, 1128A or 1866(b)(2) of the Social Security Act.
(b) Nothing contained in this part should be construed to limit a
State's own authority to exclude an individual or entity from Medicaid
for any reason or period authorized by State law.
42 CFR 1002.3 Disclosure by providers; information on persons
convicted of crimes.
(a) Information that must be disclosed. Before the Medicaid agency
enters into or renews a provider agreement, or at any time upon written
request by the Medicaid agency, the provider must disclose to the
Medicaid agency the identity of any person described in 1001.1001(a)(1)
of this chapter.
(b) Notification to Inspector General. (1) The Medicaid agency must
notify the Inspector General of any disclosures made under paragraph (a)
of this section within 20 working days from the date it receives the
information.
(2) The agency must also promptly notify the Inspector General of any
action it takes on the provider's application for participation in the
program.
(c) Denial or termination of provider participation. (1) The
Medicaid agency may refuse to enter into or renew an agreement with a
provider if any person who has ownership or control interest in the
provider, or who is an agent or managing employee of the provider, has
been convicted of a criminal offense related to that person's
involvement in any program established under Medicare, Medicaid or the
title XX Services program.
(2) The Medicaid agency may refuse to enter into, or terminate, a
provider agreement if it determines that the provider did not fully and
accurately make any disclosure required under paragraph (a) of this
section.
42 CFR 1002.100 State plan requirement.
The plan must provide that the requirements of this subpart are met.
However, the provisions of these regulations are minimum requirements.
The agency may impose broader sanctions if it has the authority to do so
under State law.
42 CFR 1002.100 Subpart B -- Mandatory Exclusion
42 CFR 1002.203 Mandatory exclusion.
(a) The State agency, in order to receive Federal financial
participation (FFP), must provide that it will exclude from
participation any HMO, or entity furnishing services under a Waiver
approved under section 1915(b)(1) of the Act, if such organization or
entity --
(1) Could be excluded under 1001.1001 of this chapter, or
(2) Has, directly or indirectly, a substantial contractual
relationship with an individual or entity that could be excluded under
1001.1001 of this chapter.
(b) As used in this section, the term --
Exclude includes the refusal to enter into or renew a participation
agreement or the termination of such an agreement.
Substantial contractual relationship is one in which the sanctioned
individual described in 1001.1001 of this chapter has direct or
indirect business transactions with the organization or entity that, in
any fiscal year, amount to more than $25,000 or 5 percent of the
organization's or entity's total operating expenses, whichever is less.
Business transactions include, but are not limited to, contracts,
agreements, purchase orders, or leases to obtain services, supplies,
equipment, space or salaried employment.
42 CFR 1002.203 Subpart C -- Permissive Exclusions
42 CFR 1002.210 Permissive exclusions; general authority.
The State agency must have administrative procedures in place that
enable it to exclude an individual or entity for any reason for which
the Secretary could exclude such individual or entity under parts 1001
or 1003 of this chapter. The period of such exclusion is at the
discretion of the State agency.
42 CFR 1002.211 Effect of exclusion.
(a) Denial of payment. Except as provided for in 1001.1901 (c)(3)
and (c)(4)(i) of this chapter, no payment may be made by the State
agency for any item or service furnished on or after the effective date
specified in the notice by an excluded individual or entity, or at the
medical direction or on the prescription of a physician who is excluded
when a person furnishing such item or service knew, or had reason to
know, of the exclusion.
(b) Denial of FFP. FFP is not available where the State agency is
required to deny payment under paragraph (a) of this section. FFP will
be reinstated at such time as the excluded individual or entity is
reinstated in the Medicaid program.
42 CFR 1002.212 State agency notifications.
When the State agency initiates an exclusion under 1002.210, it must
provide to the individual or entity subject to the exclusion
notification consistent with that required in subpart E of part 1001 of
this chapter, and must notify other State agencies, the State medical
licensing board (where applicable), the public, beneficiaries, and
others as provided in 1001.2005 and 1001.2006 of this chapter.
42 CFR 1002.213 Appeals of exclusions.
Before imposing an exclusion under 1002.210, the State agency must
give the individual or entity the opportunity to submit documents and
written argument against the exclusion. The individual or entity must
also be given any additional appeals rights that would otherwise be
available under procedures established by the State.
42 CFR 1002.214 Basis for reinstatement after State agency-initiated
exclusion.
(a) The provisions of this section and 1002.215 apply to the
reinstatement in the Medicaid program of all individuals or entities
excluded in accordance with 1002.210, if a State affords reinstatement
opportunity to those excluded parties.
(b) An individual or entity who has been excluded from Medicaid may
be reinstated only by the Medicaid agency that imposed the exclusion.
(c) An individual or entity may submit to the State agency a request
for reinstatement at any time after the date specified in the notice of
exclusion.
42 CFR 1002.215 Action on request for reinstatement.
(a) The State agency may grant reinstatement only if it is reasonably
certain that the types of actions that formed the basis for the original
exclusion have not recurred and will not recur. In making this
determination, the agency will consider, in addition to any factors set
forth in State law --
(1) The conduct of the individual or entity occurring prior to the
date of the notice of exclusion, if not known to the agency at the time
of the exclusion;
(2) The conduct of the individual or entity after the date of the
notice of exclusion; and
(3) Whether all fines, and all debts due and owing (including
overpayments) to any Federal, State or local government that relate to
Medicare or any of the State health care programs, have been paid, or
satisfactory arrangements have been made, that fulfill these
obligations.
(b) Notice of action on request for reinstatement. (1) If the State
agency approves the request for reinstatement, it must give written
notice to the excluded party, and to all others who were informed of the
exclusion in accordance with 1002.212, specifying the date on which
Medicaid program participation may resume.
(2) If the State agency does not approve the request for
reinstatement, it will notify the excluded party of its decision. Any
appeal of a denial of reinstatement will be in accordance with State
procedures and need not be subject to administrative or judicial review,
unless required by State law.
42 CFR 1002.215 Subpart D -- Notification to OIG of State or Local Convictions of Crimes Against Medicaid
42 CFR 1002.230 Notification of State or local convictions of crimes
against Medicaid.
(a) The State agency must notify the OIG whenever a State or local
court has convicted an individual who is receiving reimbursement under
Medicaid of a criminal offense related to participation in the delivery
of health care items or services under the Medicaid program, except
where the State Medicaid Fraud Control Unit (MFCU) has so notified the
OIG.
(b) If the State agency was involved in the investigation or
prosecution of the case, it must send notice within 15 days after the
conviction.
(c) If the State agency was not so involved, it must give notice
within 15 days after it learns of the conviction.
42 CFR 1002.230 PART 1003 -- CIVIL MONEY PENALTIES, ASSESSMENTS AND
EXCLUSIONS
Sec.
1003.100 Basis and purpose.
1003.101 Definitions.
1003.102 Basis for civil money penalties and assessments.
1003.103 Amount of penalty.
1003.104 Amount of assessment.
1003.105 Exclusion from participation in Medicare or a State health
care program.
1003.106 Determinations regarding the amount of the penalty and
assessment.
1003.107 Determinations regarding exclusion.
1003.108 Penalty not exclusive.
1003.109 Notice of proposed determination.
1003.110 Failure to request a hearing.
1003.114 Collateral estoppel.
1003.126 Settlement.
1003.127 Judicial review.
1003.128 Collection of penalty and assessment.
1003.129 Notice to other agencies.
1003.132 Limitations.
1003.133 Statistical sampling.
1003.134 Effect of exclusion.
1003.135 Reinstatement.
Authority: 42 U.S.C. 1302, 1320a-7, 1320a-7a, 1320b-10, 1395u(j),
1395u(k), 11131(c) and 11137(b)(2).
Source: 51 FR 34777, Sept. 30, 1986, unless otherwise noted.
42 CFR 1003.100 Basis and purpose.
(a) Basis. This part implements sections 1128, 1128A, 1140, 1842(j)
and 1842(k) of the Social Security Act, and sections 421(c) and
427(b)(2) of Public Law 99-660 (42 U.S.C. 1320a-7, 1320a-7a, 1320b-10,
1395u(j) and 1395u(k), 11131(c) and 11137(b)(2)).
(b) Purpose. This part --
(1) Provides for the imposition of civil money penalties and, as
applicable, assessments against persons who --
(i) Have submitted certain prohibited claims under the Medicare,
Medicaid, or the Maternal and Child Health Services or Social Services
Block Grant programs;
(ii) Seek payment in violation of the terms of an assignment
agreement or a limitation on charges or payments under the Medicare
program, or a requirement not to charge in excess of the amount
permitted under the Medicaid program;
(iii) Give false or misleading information that might affect the
decision to discharge a Medicare patient from the hospital;
(iv) Fail to report information concerning medical malpractice
payments or who improperly disclose, use or permit access to information
reported under part B of title IV of Pub.L. 99-660, and regulations
specified in 45 CFR part 60; or
(v) Misuse certain Medicare and Social Security program words,
letters, symbols and emblems;
(2) Provides for the exclusion of persons from the Medicare or State
health care programs against whom a civil money penalty or assessment
has been imposed, and the basis for reinstatement of persons who have
been excluded; and
(3) Sets forth the appeal rights of persons subject to a penalty,
assessment and exclusion.
(57 FR 3345, Jan. 29, 1992)
42 CFR 1003.101 Definitions.
For purposes of this part:
Act means the Social Security Act.
ALJ means an Administrative Law Judge.
Assessment means the amount described in 1003.104, and includes the
plural of that term.
Claim means an application for payment for an item or service for
which payment may be made under the Medicare, Medicaid, Maternal and
Child Health Services Block Grant, or Social Services Block Grant
programs.
(a) An item or service for which payment may be made under Medicare,
or
(b) An item or service for which medical assistance is provided under
a State plan for medical assistance, or
(c) An item or service for which payment may be made under the
Maternal and Child Health Services Block Grant program.
Department means the Department of Health and Human Services.
Exclusion means the temporary or permanent barring of a person from
participation in the Medicare program or in a State health care program,
and that items or services furnished or ordered by such person are not
reimbursed under such programs.
General Counsel means the General Counsel of the Department or his or
her designees.
HCFA means the Health Care Financing Administration.
Inspector General means the Inspector General of the Department or
his or her designees.
Item or service includes (a) any item, device, medical supply or
service claimed to have been provided to a patient and listed in an
itemized claim for program payment or a request for payment, and (b) in
the case of a claim based on costs, any entry or omission in a cost
report, books of account or other documents supporting the claim.
Maternal and Child Health Services Block Grant program means the
program authorized under Title V of the Act.
Medicaid means the program of grants to the States for medical
assistance authorized under title XIX of the Act.
Medical malpractice claim or action means a written complaint or
claim demanding payment based on a physician's, dentist's or other
health care practitioner's provision of, or failure to provide health
care services, and includes the filing of a cause of action based on the
law of tort brought in any State or Federal court or other adjudicative
body.
Medicare means the program of health insurance for the aged and
disabled authorized under Title XVIII of the Act.
Penalty means the amount described in 1003.103 and includes the
plural of that term.
Person means an individual, trust or estate, partnership,
corporation, professional association or corporation, or other entity,
public or private.
Program means the Medicare, Medicaid, Maternal and Child Health
Services Block Grant, and Social Services Block Grant programs.
Request for payment means an application submitted by a person to any
person for payment for an item or service.
Respondent means the person upon whom the Secretary has imposed, or
proposes to impose, a penalty or assessment.
Secretary means the Secretary of the Department or his or her
designees.
Social Services Block Grant program means the program authorized
under title XX of the Social Security Act.
State includes the District of Columbia, Puerto Rico, the Virgin
Islands, Guam, American Samoa, the Northern Mariana Islands, and the
Trust Territory of the Pacific Islands.
State health care program means a State plan approved under title XIX
of the Act, any program receiving funds under title V of the Act or from
an allotment to a State under such title, or any program receiving funds
under title XX of the Act or from an allotment to a State under such
title.
(51 FR 34777, Sept. 30, 1986, as amended at 56 FR 28492, June 21,
1991; 57 FR 3345, Jan. 29, 1992)
42 CFR 1003.102 Basis for civil money penalties and assessments.
(a) The OIG may impose a penalty and assessment against any person
whom it determines in accordance with this part has presented, or caused
to be presented, a claim which is for --
(1) An item or service that the person knew, or should have known,
was not provided as claimed;
(2) An item or service for which the person knew, or should have
known, that the claim was false or fraudulent;
(3) An item or service furnished during a period in which the person
was excluded from participation in the program to which the claim was
made in accordance with a determination made under sections 1128 (42
U.S.C. 1320a-7), 1128A (42 U.S.C. 1320a-7a), 1156 (42 U.S.C. 1320c-5),
1160(b) as in effect on September 2, 1982 (42 U.S.C.
1320c-9(b)),1842(j)(2) (42 U.S.C. 1395u(j), 1862(d) as in effect on
August 18, 1987 (42 U.S.C. 1395y(d)), or 1866(b) (42 U.S.C. 1395cc(b));
or
(4) For a physician's service (or an item or service incident to a
physician's service) for which the person knew, or should have known,
that the individual who furnished (or supervised the furnishing of) the
service --
(i) Was not licensed as a physician;
(ii) Was licensed as a physician, but such license had been obtained
through a misrepresentation of material fact (including cheating on an
examination required for licensing); or
(iii) Represented to the patient at the time the service was
furnished that the physician was certified in a medical specialty board
when he or she was not so certified.
(b) The OIG may impose a penalty, and where authorized, an assessment
against any person (including an insurance company in the case of
paragraphs (b)(5) and (b)(6) of this section) whom it determines in
accordance with this part --
(1) Has presented or caused to be presented a request for payment in
violation of the terms of --
(i) An agreement to accept payments on the basis of an assignment
under section 1842(b)(3)(B)(ii) of the Act;
(ii) An agreement with a State agency or other requirement of a State
Medicaid plan not to charge a person for an item or service in excess of
the amount permitted to be charged;
(iii) An agreement to be a participating physician or supplier under
section 1842(h)(1); or
(iv) An agreement in accordance with section 1866(a)(1)(G) of the Act
not to charge any person for inpatient hospital services for which
payment had been denied or reduced under section 1886(f)(2) of the Act.
(2) Is a non-participating physician under section 1842(j) of the Act
and has knowingly and willfully billed --
(i) On a repeated basis for such services actual charges in excess of
the maximum allowable actual charge determined in accordance with
section 1842(j)(1)(C) of the Act for the period January 1, 1987 through
December 31, 1990, or
(ii) Individuals enrolled under part B of title XVIII of the Act
during the statutory freeze for actual charges in excess of such
physician's actual charges determined in accordance with section
1842(j)(1)(A) of the Act for the period July 1, 1984 to December 31,
1986.
(3) Is a physician who has knowingly and willfully --
(i) Billed for services as an assistant at surgery during a routine
cataract operation, or
(ii) Included in his or her bill the services of an assistant at
surgery during a routine cataract operation, and has not received prior
approval from the appropriate Peer Review Organization or Medicare
carrier for such services based on the existence of a complicating
medical condition; or
(4) Has given to any person, in the case of inpatient hospital
services subject to the provisions of section 1886 of the Act,
information that he or she knew, or should have known, was false or
misleading and that could reasonably have been expected to influence the
decision when to discharge such person or another person from the
hospital.
(5) Fails to report information concerning a payment made under an
insurance policy, self-insurance or otherwise, for the benefit of a
physician, dentist or other health care practitioner in settlement of,
or in satisfaction in whole or in part of, a medical malpractice claim
or action or a judgment against such a physician, dentist or other
health care practitioner in accordance with section 421 of Pub. L.
99-660 (42 U.S.C. 11131) and as required by regulations at 45 CFR part
60.
(6) Improperly discloses, uses or permits access to information
reported in accordance with part B of title IV of Pub. L. 99-660, in
violation of section 427 of Pub. L. 99-660 (42 U.S.C. 11137) or
regulations at 45 CFR part 60. (The disclosure of information reported
in accordance with part B of title IV in response to a subpoena or a
discovery request is considered to be an improper disclosure in
violation of section 427 of Pub. L. 99-660. However, disclosure or
release by an entity of original documents or underlying records from
which the reported information is obtained or derived is not considered
to be an improper disclosure in violation of section 427 of Pub. L.
99-660.)
(7) Has made use of certain words, letters, symbols or emblems in
such a manner that they knew, or should have known, would convey the
false impression that an advertisement or other item was authorized,
approved or endorsed by the Department, the Social Security
Administration (SSA) or HCFA, or that such person or organization has
some connection with, or authorization from, the Department, SSA or
HCFA. Civil money penalties may be imposed for misuse of --
(i) The words ''Social Security,'' ''Social Security Account,''
''Social Security Administration,'' ''Social Security System,''
''Medicare,'' and ''Health Care Financing Administration,'' or any other
combination or variation of such words;
(ii) The letters ''SSA'' or ''HCFA,'' or any other combination or
variation of such letters; or
(iii) A symbol or emblem of the Social Security Administration
(including the design of, or a reasonable facsimile of the design of,
the Social Security card, the check used for payment of benefits under
title II, or envelopes or other stationery used by SSA) or of the Health
Care Financing Administration, or any combination or variation of such
symbols or emblems.
(c) (1) In any case in which it is determined that more than one
person was responsible for presenting or causing to be presented a claim
as described in paragraph (a) of this section, each such person may be
held liable for the penalty prescribed by this part, and an assessment
may be imposed against any one such person or jointly and severally
against two or more such persons, but the aggregate amount of the
assessments collected may not exceed the amount that could be assessed
if only one person was responsible.
(2) In any case in which it is determined that more than one person
was responsible for presenting, or causing to be presented, a request
for payment or for giving false or misleading information as described
in paragraph (b) of this section, each such person may be held liable
for the penalty prescribed by this part.
(3) In any case in which it is determined that more than one person
was responsible for failing to report information that is required to be
reported on a medical malpractice payment, or for improperly disclosing,
using or permitting access to information, as described in paragraphs
(b)(5) and (b)(6) of this section, each such person may be held liable
for the penalty prescribed by this part.
(4) Under this section, a principal is liable for penalties and
assessments for the actions of his or her agent acting within the scope
of the agency.
(57 FR 3345, Jan. 29, 1992; 57 FR 9670, Mar. 20, 1992)
42 CFR 1003.103 Amount of penalty.
(a) Except as provided in paragraphs (b), (c) and (d) of this
section, the OIG may impose a penalty of not more than $2,000 for each
item or service that is subject to a determination under 1003.102.
(b) The OIG may impose a penalty of not more than $15,000 for each
person with respect to whom a determination was made that false or
misleading information was given under 1003.102(b)(4).
(c) The OIG may impose a penalty of not more than $10,000 for each
payment for which there was a failure to report required information in
accordance with 1003.102(b)(5), or for each improper disclosure, use or
access to information that is subject to a determination under
1003.102(b)(6).
(d) (1) The OIG may impose a penalty of not more than $5,000 for each
violation resulting from the misuse of Departmental or program words,
letters, symbols or emblems relating to printed media, and a penalty of
not more than $25,000 in the case of such misuse relating to a broadcast
or telecast, that is subject to a determination under 1003.102(b)(7) of
this part. With respect to multiple violations consisting of
substantially identical communications or productions, total penalties
may not exceed $100,000 per year.
(2) For purposes of this paragraph, a violation is defined as --
(i) In the case of a direct mailing solicitation, each group mailing
of an identical, non-personalized, generic letter or solicitation sent
at the same time on the same day. Each unique or personalized letter or
solicitation, such as with the individual's name and address appearing
in the body of the advertisement or on the mailing envelope or covering,
will be treated as a separate and single violation;
(ii) In the case of a printed advertisement, each advertisement or
solicitation in each publication or issue of a publication in which it
appears. Multiple or separate advertisements will be treated as
separate violations; and
(iii) In the case of a broadcast or telecast, the airing of a single
commercial or solicitation. Each airing will be a separate violation.
(57 FR 3346, Jan. 29, 1992)
42 CFR 1003.104 Amount of assessment.
A person subject to a penalty determined under 1003.102(a) may be
subject, in addition, to an assessment of not more than twice the amount
claimed for each item or service which was a basis for the penalty. The
assessment is in lieu of damages sustained by the Department or a State
agency because of that claim.
42 CFR 1003.105 Exclusion from participation in Medicare or a State
health care program.
(a) A person subject to a penalty or assessment determined under
1003.102 may, in addition, be excluded from participation in Medicare
for a period of time determined under 1003.107. The OlG will also
direct each appropriate State agency to exclude the person from each
State health care program for the same period of time. The OIG may
waive an exclusion from a State health care program upon request of the
State agency in accordance with the following provisions:
(1) The OIG will consider an application from a State agency for a
waiver if the person is --
(i) The sole community physician, or
(ii) The sole source of essential specialized services in a
community.
(2) If a waiver is granted, it is applicable only to the State health
care program for which the State agency requested the waiver.
(3) If the OIG subsequently obtains information that the basis for a
waiver no longer exists, or the State agency submits evidence that the
basis for the waiver no longer exists, the waiver will cease and the
person will be excluded from the State health care program for the
remainder of the period that such person is excluded from Medicare.
(4) The OIG will notify the State agency whether its request for a
waiver has been granted or denied.
(5) The decision to deny a waiver is not subject to administrative or
judicial review.
(b) When the Inspector General proposes to exclude a long-term care
facility from the Medicare and Medicaid programs, he or she will at the
same time he or she notifies the respondent, notify the appropriate
State licensing authority, State Office of Aging, the long-term care
ombudsman, and the State Medicaid agency of the Inspector General's
intention to exclude the facility.
(57 FR 3346, Jan. 29, 1992)
42 CFR 1003.106 Determinations regarding the amount of the penalty and
assessment.
(a) (1) In determining the amount of any penalty or assessment in
1003.102 (a) and (b)(1) to (b)(4), the Department will take into account
--
(i) The nature of the claim, request for payment or information
given, and the circumstances under which it was presented or given;
(ii) The degree of culpability of the person submitting the claim or
request for payment, or giving the information;
(iii) The history of prior offenses of the person submitting the
claim or request for payment, or giving the information;
(iv) The financial condition of the person presenting the claim or
request for payment, or giving the information; and
(v) Such other matters as justice may require.
(2) In determining the amount of any penalty in accordance with
1003.102 (b)(5) and (b)(6), the Department will take into account --
(i) The nature and circumstances resulting in the failure to report
medical malpractice payments or the improper disclosure of information;
(ii) The degree of culpability of the person in failing to provide
timely and complete malpractice payment data or in improperly
disclosing, using or permitting access to information;
(iii) The materiality, or significance of omission, of the
information to be reported with regard to medical malpractice judgments
or settlements, or the materiality of the improper disclosure of, or use
of, or access to information;
(iv) Any prior history of the person with respect to violations of
these provisions; and
(v) Such other matters as justice may require.
(3) In determining the amount of any penalty in accordance with
1003.102(b)(7), the OIG will take into account --
(i) The nature and objective of the solicitation or other
communication, and the degree to which the communication has the
capacity to deceive members of the public;
(ii) The frequency and scope of the violation, and whether a specific
segment of the population was targeted;
(iii) The degree to which any misrepresentation or deception may have
been mitigated by a clear, prominent and conspicuously-placed disclaimer
of association with the Government;
(iv) The prior history of the organization in its willingness or
refusal to comply with informal requests to correct violations;
(v) The history of prior offenses of the individual or entity in
their misuse of Departmental and program words, letters, symbols and
emblems; and
(vi) Such other matters as justice may require.
(b) Determining the amount of the penalty or assessment. In taking
into account the factors listed in paragraph (a)(1) of this section, the
following circumstances are to be considered --
(1) Nature and circumstances of the incident. It should be
considered a mitigating circumstance if all the items or services or
incidents subject to a determination under 1003.102 included in the
action brought under this part were of the same type and occurred within
a short period of time, there were few such items or services or
incidents, and the total amount claimed or requested for such items or
services was less than $1,000. It should be considered an aggravating
circumstance if --
(i) Such items or services or incidents were of several types,
occurred over a lengthy period of time;
(ii) There were many such items or services or incidents (or the
nature and circumstances indicate a pattern of claims or requests for
payment for such items or services or a pattern of incidents);
(iii) The amount claimed or requested for such items or services was
substantial; or
(iv) The false or misleading information given resulted in harm to
the patient, a premature discharge or a need for additional services or
subsequent hospital admission.
(2) Degree of culpability. It should be considered a mitigating
circumstance if the claim or request for payment for the item or service
was the result of an unintentional and unrecognized error in the process
respondent followed in presenting claims or requesting payment, and
corrective steps were taken promptly after the error was discovered. It
should be considered an aggravating circumstance if --
(i) The respondent knew the item or service was not provided as
claimed or if the respondent knew that the claim was false or
fraudulent;
(ii) The respondent knew that the items or services were furnished
during a period that he or she had been excluded from participation and
that no payment could be made as specified in 1003.102(a)(3) or because
payment would violate the terms of an assignment or an agreement with a
State agency or other agreement or limitation on payment under
1003.102(b); or
(iii) The respondent knew that the information could reasonably be
expected to influence the decision of when to discharge a patient from a
hospital.
(3) Prior offenses. It should be considered an aggravating
circumstance if at any time prior to the incident or presentation of any
claim or request for payment which included an item or service subject
to a determination under 1003.102, the respondent was held liable for
criminal, civil or administrative sanctions in connection with a program
covered by this part or any other public or private program of
reimbursement for medical services.
(4) Other wrongful conduct. It should be considered an aggravating
circumstance if there is proof that a respondent engaged in wrongful
conduct, other than the specific conduct upon which liability is based,
relating to government programs or in connection with the delivery of a
health care item or service. The statute of limitations governing civil
money penalty proceedings will not apply to proof of other wrongful
conduct as an aggravating circumstance.
(5) Financial condition. It should be considered a mitigating
circumstance if imposition of the penalty or assessment without
reduction will jeopardize the ability of the respondent to continue as a
health care provider. In all cases, the resources available to the
respondent will be considered when determining the amount of the penalty
and assessment.
(6) Other matters as justice may require. Other circumstances of an
aggravating or mitigating nature should be taken into account if, in the
interests of justice, they require either a reduction of the penalty or
assessment or an increase in order to assure the achievement of the
purposes of this part.
(c) In determining the amount of the penalty and assessment to be
imposed for every item or service or incident subject to a determination
under 1003.102(a) and (b)(1) through (b)(4) --
(1) If there are substantial or several mitigating circumstances, the
aggregate amount of the penalty and assessment should be set at an
amount sufficiently below the maximium permitted by 1003.103(a) and
1003.104, to reflect that fact.
(2) If there are substantial or several aggravating circumstances,
the aggregate amount of the penalty and assessment should be set at an
amount sufficiently close or at the maximum permitted by 1003.103(a)
and 1003.104, to reflect that fact.
(3) Unless there are extraordinary mitigating circumstances, the
aggregate amount of the penalty and assessment should never be less than
double the approximate amount of damages and costs (as defined in
paragraph (d) of this section) sustained by the United States, or any
State, as a result of claims or incidents subject to a determination
under 1003.102(a) and (b)(1) through (b)(4).
(d) (1) The standards set forth in this section are binding, except
to the extent that their application would result in imposition of an
amount that would exceed limits imposed by the United States
Constitution.
(2) The amount imposed will not be less than the approximate amount
required to fully compensate the United States, or any State, for its
damages and costs, tangible and intangible, including but not limited to
the costs attributable to the investigation, prosecution and
administrative review of the case.
(3) Nothing in this section will limit the authority of the
Department to settle any issue or case as provided by 1003.126, or to
compromise any penalty and assessment as provided by 1003.128.
(57 FR 3347, Jan. 29, 1992)
42 CFR 1003.107 Determinations regarding exclusion.
(a) In determining whether to exclude a person and the duration of an
exclusion, the Department will take into account the factors set forth
in 1003.106. Where there are aggravating circumstances as described in
1003.106(b), the person should be excluded. In the case of an exclusion
based on a determination under 1003.102(b) (2) or (3), the length of
the exclusion may not exceed 5 years.
(b) Nothing in this section will limit the authority of the
Department to settle any issue or case as provided by 1003.126 or to
compromise any exclusion as provided by 1003.128.
(57 FR 3348, Jan. 29, 1992)
42 CFR 1003.108 Penalty not exclusive.
A penalty imposed under this part is in addition to any other
penalties prescribed by law.
42 CFR 1003.109 Notice of proposed determination.
(a) If the Inspector General proposes to impose a penalty and
assessment, or to exclude a respondent from participation in Medicare or
a State health care program in accordance with this part, he or she must
serve notice of the action by any manner authorized by Rule 4 of the
Federal Rules of Civil Procedure. The notice will include --
(1) Reference to the statutory basis for the penalty, assessment and
exclusion;
(2) A description of the claims, requests for payment, or incidents
with respect to which the penalty, assessment and exclusion are proposed
(except in cases where the Inspector General is relying upon statistical
sampling in accordance with 1003.133 in which case the notice shall
describe those claims and requests for payment comprising the sample
upon which the Inspector General is relying and will also briefly
describe the statistical sampling technique utilized by the Inspector
General);
(3) The reason why such claims, requests for payment or incidents
subject the respondent to a penalty, assessment and exclusion; the
amount of the proposed penalty, assessment and the period of proposed
exclusion (where applicable);
(4) Any circumstances described in 1003.106 which were considered
when determining the amount of the proposed penalty and assessment and
the period of exclusion;
(5) Instructions for responding to the notice, including --
(i) a specific statement of respondent's right to a hearing, and
(ii) a statement that failure to request a hearing within 60 days
permits the imposition of the proposed penalty, assessment and exclusion
without right of appeal; and
(6) In the case of a notice sent to a respondent who has an agreement
under section 1866 of the Act, the notice will also indicate that the
imposition of an exclusion may result in the termination of the
provider's agreement in accordance with section 1866(b)(2)(C) of the
Act.
(b) Any person upon whom the Inspector General has proposed the
imposition of a penalty, assessment or exclusion may appeal such
proposed penalty, assessment or exclusion in accordance with 1005.2 of
this chapter. The provisions of part 1005 of this chapter govern such
appeals.
(57 FR 3348, Jan. 29, 1992)
42 CFR 1003.110 Failure to request a hearing.
If the respondent does not request a hearing within the time
prescribed by 1003.109(a), the Inspector General may impose the
proposed penalty, assessment, and exclusion, or any less severe penalty,
assessment, and suspension. The Inspector General shall notify the
respondent by certified mail, return receipt requested, of any penalty,
assessment, and exclusion that has been imposed and of the means by
which the respondent may satisfy the judgment. The respondent has no
right to appeal a penalty, assessment, and exclusion, with respect to
which he or she has not requested a hearing.
(51 FR 34777, Sept. 30, 1986, as amended at 57 FR 3348, Jan. 29,
1992)
42 CFR 1003.114 Collateral estoppel.
(a) Where a final determination that the respondent presented or
caused to be presented a claim or request for payment falling within the
scope of 1003.102 has been rendered in any proceeding in which the
respondent was a party and had an opportunity to be heard, the
respondent shall be bound by such determination in any proceeding under
this part.
(b) In a proceeding under this part that --
(1) Is against a person who has been convicted (whether upon a
verdict after trial or upon a plea of guilty or nolo contendere) of a
Federal crime charging fraud or false statements, and
(2) Involves the same transactions as in the criminal action, the
person is estopped from denying the essential elements of the criminal
offense.
(57 FR 3348, Jan. 29, 1992)
42 CFR 1003.126 Settlement.
The Inspector General has exclusive authority to settle any issues or
case, without the consent of the ALJ or the Secretary, at any time prior
to a final decision by the Secretary. Thereafter, the General Counsel
has such exclusive authority.
42 CFR 1003.127 Judicial review.
Section 1128A(e) of the Act authorizes judicial review of a penalty,
assessment or exclusion that has become final. Judicial review may be
sought by a respondent only with respect to a penalty, assessment or
exclusion with respect to which the respondent filed an exception under
1005.21(c) of this chapter unless the failure or neglect to urge such
exception will be excused by the court in accordance with section
1128A(e) of the Act because of extraordinary circumstances.
(57 FR 3348, Jan. 29, 1992)
42 CFR 1003.128 Collection of penalty and assessment.
(a) Once a determination by the Secretary has become final,
collection of any penalty and assessment will be the responsibility of
HCFA, except in the case of the Maternal and Child Health Services Block
Grant program, where the collection will be the responsibility of the
PHS, and in the case of the Social Services Block Grant program, where
the collection will be the responsibility of the Office of Human
Development Services.
(b) A penalty and assessment imposed under this part may be
compromised by the General Counsel, after consultation with the
Inspector General, and may be recovered in a civil action brought in the
United States district court for the district where the claim was
presented, or where the respondent resides.
(c) The amount of a penalty and assessment when finally determined,
or the amount agreed upon in compromise, may be deducted from any sum
then or later owing by the United States, or by a State agency, to the
respondent.
(d) Matters that were raised or that could have been raised in a
hearing before an ALJ or in an appeal under section 1128A(e) of the Act
may not be raised as a defense in a civil action by the United States to
collect a penalty under this part.
(51 FR 34777, Sept. 30, 1986, as amended at 57 FR 3349, Jan. 29,
1992)
42 CFR 1003.129 Notice to other agencies.
Whenever a penalty, assessment or exclusion become final, the
following organizations and entities will be notified about such action
and the reasons for it -- the appropriate State or local medical or
professional association; the appropriate Peer Review Organization; as
appropriate, the State agency responsible or the administration of each
State health care program; the appropriate Medicare carrier or
intermediary; the appropriate State or local licensing agency or
organization (including the Medicare and Medicaid State survey
agencies); and the long-term care ombudsman. In cases involving
exclusions, notice will also be given to the public of the exclusion and
its effective date.
(57 FR 3349, Jan. 29, 1992)
42 CFR 1003.132 Limitations.
No action under this part will be entertained unless commenced, in
accordance with 1003.109(a) of this part, within 6 years from the date
on which the claim was presented, the request for payment was made, or
the incident occurred.
(57 FR 3349, Jan. 29, 1992)
42 CFR 1003.133 Statistical sampling.
(a) In meeting the burden of proof set forth in 1005.15, the
Inspector General may introduce the results of a statistical sampling
study as evidence of the number and amount of claims and/or requests for
payment as described in 1003.102 that were presented or caused to be
presented by respondent. Such a statistical sampling study, if based
upon an appropriate sampling and computed by valid statistical methods,
shall constitute prima facie evidence of the number and amount of claims
or requests for payment as described in 1003.102.
(b) Once the Inspector General has made a prima facie case as
described in paragraph (a) of this section, the burden of production
shall shift to respondent to produce evidence reasonably calculated to
rebut the findings of the statistical sampling study. The Inspector
General will then be given the opportunity to rebut this evidence.
(51 FR 34777, Sept. 30, 1986, as amended at 57 FR 3349, Jan. 29,
1992)
42 CFR 1003.134 Effect of exclusion.
The effect of an exclusion will be as set forth in 1001.1901 of this
chapter.
(57 FR 3349, Jan. 29, 1992)
42 CFR 1003.135 Reinstatement.
A person who has been excluded in accordance with this part may apply
for reinstatement at the end of the period of exclusion. The OIG will
consider any request for reinstatement in accordance with the provisions
of 1001.3001 through 1001.3004 of this chapter.
(57 FR 3349, Jan. 29, 1992)
42 CFR 1003.135 PART 1004 -- IMPOSITION OF SANCTIONS ON HEALTH CARE PRACTITIONERS AND PROVIDERS OF HEALTH CARE SERVICES BY A PEER REVIEW ORGANIZATION
42 CFR 1003.135 Subpart A -- General Provisions
Sec.
1004.1 Scope and definitions.
42 CFR 1003.135 Subpart B -- Sanctions Under the PRO Program; General
Provisions
1004.10 Statutory obligations of practitioners and other persons.
1004.20 Sanctions.
42 CFR 1003.135 Subpart C -- PRO Responsibilities
1004.30 Basic responsibilities.
1004.40 Action on identification of a violation.
1004.50 Action on determination of a violation.
1004.60 Final PRO determination of a violation.
1004.70 PRO report to OIG.
1004.80 Basis for recommended sanction.
42 CFR 1003.135 Subpart D -- OIG Responsibilities
1004.90 Acknowledgment and review of report.
1004.100 Notice of sanction.
42 CFR 1003.135 Subpart E -- Effect and Duration of Exclusion
1004.110 Effect of an exclusion on Medicare payments and services.
1004.120 Reinstatement after exclusion.
42 CFR 1003.135 Subpart F -- Appeals
1004.130 Appeal rights.
Authority: 42 U.S.C. 1302 and 1320c-5.
Source: 51 FR 34783, Sept. 30, 1986, unless otherwise noted.
42 CFR 1003.135 Subpart A -- General Provisions
42 CFR 1004.1 Scope and definitions.
(a) Scope. This part implements section 1156 of the Act (PROs) by --
(1) Setting forth certain obligations imposed on practitioners and
providers of services under Medicare;
(2) Establishing criteria and procedures for the reports required
from PSROs and PROs when there is failure to meet those obligations;
(3) Specifying the policies and procedures for making determinations
on violations and imposing sanctions; and
(4) Defining the procedures for appeals by the affected party and the
procedures for reinstatements.
(b) Definitions. As used in this part, unless the context indicates
otherwise:
Economically means that services are provided at the least expensive,
medically appropriate type of setting or level of care available.
Exclusion means that items or services furnished or ordered by a
specified health care practitioner, provider, or other person during a
specified period are not reimbursed under Medicare.
Gross and flagrant violation means a violation of an obligation has
occurred in one or more instances which presents an imminent danger to
the health, safety or well-being of a Medicare beneficiary or places the
beneficiary unnecessarily in high-risk situations.
Health care services or Services means services or items for which
payment may be made (in whole or in part) under the Medicare program.
Obligation means any of the obligations specified at section 1156(a)
of the Act.
OIG stands for the Office of the Inspector General, Department of
Health and Human Services.
Other person means a hospital or other health care facility, an
organization, or an agency that furnishes health care services for which
payment may be made under the Medicare program.
Physician means a doctor of medicine or osteopathy or another
individual who is authorized under State or Federal law to practice
medicine and surgery or osteopathy.
Practitioner means a physician or other health care professional
licensed under State law to practice his or her profession.
PRO area means the geographic area subject to review by a particular
PRO.
Provider means a hospital or other health care facility, agency, or
organization.
Sanction means an exclusion or monetary penalty that the Secretary
may impose on a practitioner or other person as a result of a
recommendation from a PRO.
Substantial violation in a substantial number of cases means a
pattern of care has been provided that is inappropriate, unnecessary, or
does not meet recognized professional standards of care, or is not
supported by the necessary documentation of care as required by the PRO.
42 CFR 1004.1 Subpart B -- Sanctions Under the PRO Program; General Provisions
42 CFR 1004.10 Statutory obligations of practitioners and other
persons.
It is the obligation of any health care practitioner or other person
who furnishes or orders health care services that may be reimbursed
under Medicare, to ensure, to the extent of his or her authority, that
those services are --
(a) Furnished economically and only when and to the extent medically
necessary;
(b) Of a quality that meets professionally recognized standards of
health care; and
(c) Supported by evidence of the medical necessity and quality of the
services in the form and fashion that the reviewing PRO may reasonably
require (including copies of the necessary documentation and evidence of
compliance with pre-admission or pre-procedure review requirements to
ensure that the practitioner or other person is meeting the obligations
imposed by section 1156(a) of the Act.
42 CFR 1004.20 Sanctions.
In addition to any other sanction provided under law, a practitioner
or other person may be --
(a) Excluded from Medicare; or
(b) In lieu of exclusion and as a condition for continued
participation in Medicare, if the violation involved the provision or
ordering of health care services that were medically improper or
unnecessary, required to pay an amount not in excess of the cost of the
improper or unnecessary services that were furnished or ordered. The
practitioner or other person will be required either to pay the monetary
assessment within 6 months of the date of notice or have it deducted
from any sums the Federal Government owes the practitioner or other
person.
42 CFR 1004.20 Subpart C -- PRO Responsibilities
42 CFR 1004.30 Basic responsibilities.
(a) The PRO must use its authority or influence to enlist the support
of other professional or government agencies to ensure that each
practitioner or other person complies with the obligations specified in
1004.10.
(b) When the PRO identifies situations where the obligations
specified in 1004.10 are violated, it will afford the practitioner or
other person reasonable notice and opportunity for discussion and, if
appropriate, a suggested method for correcting the situation and a time
period for a corrective action in accordance with 1004.40 and 1004.50.
(c) The PRO must submit a report to the OIG after the notice and
opportunity provided under paragraph (b) of this section (and corrective
action, if appropriate), if the PRO determines that the practitioner or
other person has --
(1) Failed substantially to comply with any obligation in a
substantial number of cases; or
(2) Grossly and flagrantly violated any obligation in one or more
instances.
(d) The PRO report to the OIG must comply with the provisions of
1004.70.
(e) The PRO must deny services or items ordered by an excluded
practitioner or other person when the PRO identifies the services or
items and reports the findings to HCFA.
(51 FR 34783, Sept. 30, 1986, as amended at 57 FR 3349, Jan. 29,
1992)
42 CFR 1004.40 Action on identification of a violation.
(a) When a PRO identifies a violation, it must determine the source
and the nature of the violation.
(b) If the PRO determines that the violation is gross and flagrant,
it must proceed in accordance with 1004.50.
(c) If the PRO determines that the violation is a substantial
violation in a substantial number of cases, it must send the
practitioner or other person a written initial notice of the
identification of a violation containing all of the following
information:
(1) The obligation involved.
(2) The situation, circumstances or activity that resulted in a
violation.
(3) The authority and responsibility of the PRO to report violations
of obligations.
(4) A suggested method for correcting the situation and a time period
for corrective action, if appropriate.
(5) The sanction that the PRO could recommend to the OIG.
(6) An invitation to submit additional information to or discuss the
problem with representatives of the PRO within 20 days of receipt of the
notice. The date of receipt is presumed to be 5 days after the date on
the notice, unless there is a reasonable showing to the contrary.
(7) A summary of the information used by the PRO in arriving at its
determination of a violation of an obligation and a synopsis of its
conclusions.
(57 FR 3349, Jan. 29, 1992)
42 CFR 1004.50 Action on determination of a violation.
(a) Written notice. The PRO must give written notice to the
practitioner or other person if it determines that --
(1) A substantial violation has occurred in a substantial number of
cases; or
(2) A violation is gross and flagrant in one or more cases.
(b) Contents. The notice must contain the following information:
(1) The determination of a violation.
(2) The obligation violated.
(3) The basis for the determination.
(4) A suggested method for correcting the situation and a time period
for corrective action, if appropriate.
(5) The sanction the PRO will recommend to the OIG.
(6) The right of the practitioner or other person to submit to the
PRO within 30 days of receipt of the notice, additional information or a
written request for a meeting with the PRO to review and discuss the
determination, or both. The date of receipt is presumed to be 5 days
after the date on the notice, unless there is a reasonable showing to
the contrary.
(7) A copy of the material used by the PRO in arriving at its
determination.
(c) Review of PRO determination.
(1) On the basis of additional information received, the PRO shall
affirm or modify its determination. If the PRO affirms its
determination, it may suggest a method for correcting the situation and
a time period for corrective action. If the issue is resolved to the
PRO's satisfaction, the PRO shall close the case.
(2) The PRO must give written notice to the practitioner or other
person, of any action it takes as a result of the additional information
received, as specified in 1004.60
(Approved by the Office of Management and Budget under control number
0938-0444)
(51 FR 34783, Sept. 30, 1986, as amended at 57 FR 3349, Jan. 29,
1992)
42 CFR 1004.60 Final PRO determination of a violation.
If the issue is not resolved to the PRO's satisfaction as specified
in 1004.50(c), the PRO must --
(a) Submit its report and recommendation to the OIG; and
(b) Send the affected practitioner or other person a concurrent final
notice, with a copy of the PRO report that is being forwarded to the
OIG, advising that --
(1) The PRO recommendation has been submitted to the OIG;
(2) The practitioner or other person has 30 days from receipt of this
final notice to submit any additional written material or documentary
evidence to the OIG at its central office location. The date of receipt
is presumed to be five days after the date on the notice, unless there
is a reasonable showing to the contrary; and
(3) Due to the 120-day statutory requirement specified at
1004.90(e), the period for submitting additional information will not be
extended and any material received by the OIG after the 30-day period
will not be considered.
(c) Provide notice to the State medical board when it submits a
report and recommendation to the OIG with respect to a physician or
other authorized individual whom the board is responsible for licensing.
(Approved by the Office of Management and Budget under control number
0938-0444)
(51 FR 34783, Sept. 30, 1992, as amended at 57 FR 3349, Jan. 29,
1992)
42 CFR 1004.70 PRO report to OIG.
(a) Manner of reporting. If the PRO determines that a substantial
violation has occurred in a substantial number of cases or that a gross
and flagrant violation has occurred, it must submit a report and
recommendation to the OIG at the regional office with jurisdiction.
(b) Content of report, The PRO report must include the following
information --
(1) Identification of the practitioner or other persons and when
applicable, the name of the director, administrator, or owner of the
entity involved;
(2) The type of health care services involved;
(3) A description of each failure to comply with an obligation,
including specific dates, places, circumstances, and any other relevant
facts;
(4) Pertinent documentary evidence;
(5) Copies of written correspondence and written summaries of oral
exchanges with the practitioner or other person regarding the violation;
(6) The PRO's determination that an obligation under section 1156(a)
of the Act has been violated and that the violation is substantial and
has occurred in a substantial number of cases or is gross and flagrant;
(7) The professional qualifications of the PRO's reviewers' and
(8) The PRO's sanction recommendation.
(c) PRO Recommendation. The PRO must specify in its report --
(1) The sanction recommended;
(2) The amount of the monetary penalty recommended, if applicable;
(3) The period of exclusion recommended, if applicable; and
(4) A recommendation as to whether the practitioner or other person
is unable or unwilling substantially to comply with the obligation that
was violated.
(Approved by the Office of Management and Budget under control number
0938-0444)
42 CFR 1004.80 Basis for recommended sanction.
The PRO's specific recommendation must be based on a consideration of
--
(a) The type of offense involved:
(b) The severity of the offense;
(c) The deterrent value;
(d) The practitioner's or other person's previous sanction record;
(e) The availability of alternative sources of services in the
community; and
(f) Any other factors that the PRO considers relevant (for example,
the duration of the problem).
42 CFR 1004.80 Subpart D -- OIG Responsibilities
42 CFR 1004.90 Acknowledgement and review of report.
(a) Acknowledgement. The OIG will inform the PRO of the date it
received the PRO's report and recommendation.
(b) Review. The OIG will review the PRO report and recommendation to
determine whether --
(1) The PRO is following its procedures;
(2) A violation has occurred; and
(3) The practitioner or other person has demonstrated an
unwillingness or lack of ability substantially to comply with an
obligation.
(c) Rejection of the PRO recommendation. If the OIG decides that a
sanction is not warranted, it will notify the PRO that recommended the
sanction and the affected practitioner or other person that the
recommendation is rejected.
(d) Decision of sanction. If the OIG decides that a violation of
obligations has occurred, it will determine the appropriate sanction by
considering --
(1) The recommendation of the PRO;
(2) The type of offense;
(3) The severity of the offense;
(4) The previous sanction record of the practitioner or other person;
(5) The availability of alternative sources of services in the
community;
(6) Any prior problems the Medicare carrier or intermediary has had
with the practitioner or other person;
(7) Whether the practitioner or other person is unable or unwilling
to comply substantially with the obligations, including whether, prior
to the PRO's recommendation, he or she entered into a corrective action
plan and, if so, whether he or she successfully completed such
corrective action plan.
(8) Any other matters relevant to the particular case.
(e) Exclusion sanction. If the PRO submits a recommendation for
exclusion to the OIG, and a determination is not made by the 120th day
after actual receipt by the OIG, the exclusion sanction recommended will
become effective and the OIG will provide notice in accordance with
1004.100(f).
(f) Monetary penalty. If the PRO recommendation is to assess a
monetary penalty, the 120-day provision does not apply and the OIG will
provide notice in accordance with 1004.100 (a) through (e).
(51 FR 34783, Sept. 30, 1986, as amended at 57 FR 3350, Jan. 29,
1992)
42 CFR 1004.100 Notice of sanction.
(a) The OIG notifies the practitioner or other person of the adverse
determination and of the sanction to be imposed.
(b) The sanction is effective 15 days from the date of receipt of the
notice. The date of receipt is presumed to be 5 days after the date on
the notice, unless there is a reasonable showing to the contrary.
(c) The notice specifies --
(1) The legal and factual basis for the determination;
(2) The sanction to be imposed;
(3) The effective date and, if appropriate, the duration of the
exclusion;
(4) The appeal rights of the practitioner or other person; and
(5) In the case of exclusion, the earliest date on which the OIG will
accept a request for reinstatement.
(d) The OIG notifies the public by publishing in a newspaper of
general circulation in the PRO area a notice that identifies the
sanctioned practitioner or other person, the obligation that has been
violated, the sanction imposed and, if the sanction is exclusion, the
effective date and duration.
(e) Notice of the sanction is also provided to the following entities
as appropriate:
(1) The PRO that originated the sanction report.
(2) PROs in adjacent areas.
(3) State Medicaid fraud control units and State licensing bodies.
(4) Appropriate Medicare contractors and State agencies.
(5) Hospitals, including the hospital where the sanctioned
individual's case originated and where the individual currently has
privileges, if known; skilled nursing facilities, home health agencies,
and health maintenance organizations (HMOs).
(6) Medical societies and other professional organizations.
(7) Medical carriers and intermediaries, health care prepayment
plans, and other affected agencies and organizations.
(f) If an exclusion sanction is effected because a decision was not
made within 120 days after receipt of the PRO recommendation,
notification is as follows:
(1) The OIG notifies the practitioner or other person that the
exclusion from the Medicare program is effective 15 days from the date
the notice is received by the practitioner or other person. The date of
receipt is presumed to be five days after the date on the notice, unless
there is a reasonable showing to the contrary.
(2) Notice of the sanction is also provided as specified in paragraph
(e) of this section.
(3) As soon as possible after the 120th day, the OIG will issue a
notice to the practitioner or other person affirming the PRO
recommendation or modifying the recommendation based on the OIG's review
of the case.
(51 FR 34783, Sept. 30, 1986, as amended at 52 FR 22454, June 12,
1987; 57 FR 3350, Jan. 29, 1992)
42 CFR 1004.100 Subpart E -- Effect and Duration of Exclusion
42 CFR 1004.110 Effect of an exclusion on Medicare payments and
services.
The effect of an exclusion will be as set forth in 1001.1901 of this
chapter.
(57 FR 3350, Jan. 29, 1992)
42 CFR 1004.120 Reinstatement after exclusion.
A person who has been excluded in accordance with this part may apply
for reinstatement at the end of the period of exclusion. The OIG will
consider any request for reinstatement in accordance with the provisions
of 1001.3001 through 1001.3005 of this chapter.
(57 FR 3350, Jan. 29, 1992)
42 CFR 1004.120 Subpart F -- Appeals
42 CFR 1004.130 Appeal rights.
(a) Right to administrative review. (1) A practitioner or other
person dissatisfied with an OIG determination, or an exclusion that
results from a determination not being made within 120 days, is entitled
to appeal such sanction in accordance with part 1005 of this chapter.
(2) Due to the 120-day statutory requirement specified in
1004.90(e), the following limitations apply --
(i) The period of time for submitting additional information will not
be extended.
(ii) Any material received by the HHS after the 30-day period
allowed, will not be considered by the ALJ or the Departmental Appeals
Board (DAB).
(3) The OIG's determination continues in effect unless reversed by a
hearing.
(b) Right to judicial review. Any practitioner or other person
dissatisfied with a final decision of the Secretary may file a civil
action in accordance with the provisions of section 205(g) of the Act.
(57 FR 3350, Jan. 29, 1992)
42 CFR 1004.130 PART 1005 -- APPEALS OF EXCLUSIONS, CIVIL MONEY
PENALTIES AND ASSESSMENTS
Sec.
1005.1 Definitions.
1005.2 Hearing before an administrative law judge.
1005.3 Rights of parties.
1005.4 Authority of the ALJ.
1005.5 Ex parte contacts.
1005.6 Prehearing conferences.
1005.7 Discovery.
1005.8 Exchange of witness lists, witness statements and exhibits.
1005.9 Subpoenas for attendance at hearing.
1005.10 Fees.
1005.11 Form, filing and service of papers.
1005.12 Computation of time.
1005.13 Motions.
1005.14 Sanctions.
1005.15 The hearing and burden of proof.
1005.16 Witnesses.
1005.17 Evidence.
1005.18 The record.
1005.19 Post-hearing briefs.
1005.20 Initial decision.
1005.21 Appeal to DAB.
1005.22 Stay of initial decision.
1005.23 Harmless error.
Authority: 42 U.S.C. 405(a), 405(b), 1302, 1320a-7, 1320a-7a and
1320c-5.
Source: 57 FR 3350, Jan. 29, 1992, unless otherwise noted.
42 CFR 1005.1 Definitions.
Civil money penalty cases refer to all proceedings arising under any
of the statutory bases for which the OIG has been delegated authority to
impose civil money penalties under Medicare or the State health care
programs.
DAB refers to the Departmental Appeals Board or its delegatee.
Exclusion cases refer to all proceedings arising under any of the
statutory bases for which the OIG has been delegated authority to impose
exclusions under Medicare or the State health care programs.
42 CFR 1005.2 Hearing before an administrative law judge.
(a) A party sanctioned under any criteria specified in parts 1001,
1003 and 1004 of this chapter may request a hearing before an ALJ.
(b) In exclusion cases, the parties to the proceeding will consist of
the petitioner and the IG. In civil money penalty cases, the parties to
the proceeding will consist of the respondent and the IG.
(c) The request for a hearing will be made in writing, signed by the
petitioner or respondent or by his or her attorney. The request must be
filed within 60 days after the notice, provided in accordance with
1001.2002, 1001.2003 or 1003.109, is received by the petitioner or
respondent. For purposes of this section, the date of receipt of the
notice letter will be presumed to be 5 days after the date of such
notice unless there is a reasonable showing to the contrary.
(d) The request for a hearing will contain a statement as to the
specific issues or findings of fact and conclusions of law in the notice
letter with which the petitioner or respondent disagrees, and the basis
for his or her contention that the specific issues or findings and
conclusions were incorrect.
(e) The ALJ will dismiss a hearing request where --
(1) The petitioner's or the respondent's hearing request is not filed
in a timely manner;
(2) The petitioner or respondent withdraws his or her request for a
hearing;
(3) The petitioner or respondent abandons his or her request for a
hearing; or
(4) The petitioner's or respondent's hearing request fails to raise
any issue which may properly be addressed in a hearing.
42 CFR 1005.3 Rights of parties.
(a) Except as otherwise limited by this part, all parties may --
(1) Be accompanied, represented and advised by an attorney;
(2) Participate in any conference held by the ALJ;
(3) Conduct discovery of documents as permitted by this part;
(4) Agree to stipulations of fact or law which will be made part of
the record;
(5) Present evidence relevant to the issues at the hearing;
(6) Present and cross-examine witnesses;
(7) Present oral arguments at the hearing as permitted by the ALJ;
and
(8) Submit written briefs and proposed findings of fact and
conclusions of law after the hearing.
(b) Fees for any services performed on behalf of a party by an
attorney are not subject to the provisions of section 206 of title II of
the Act, which authorizes the Secretary to specify or limit these fees.
42 CFR 1005.4 Authority of the ALJ.
(a) The ALJ will conduct a fair and impartial hearing, avoid delay,
maintain order and assure that a record of the proceeding is made.
(b) The ALJ has the authority to --
(1) Set and change the date, time and place of the hearing upon
reasonable notice to the parties;
(2) Continue or recess the hearing in whole or in part for a
reasonable period of time;
(3) Hold conferences to identify or simplify the issues, or to
consider other matters that may aid in the expeditious disposition of
the proceeding;
(4) Administer oaths and affirmations;
(5) Issue subpoenas requiring the attendance of witnesses at hearings
and the production of documents at or in relation to hearings;
(6) Rule on motions and other procedural matters;
(7) Regulate the scope and timing of documentary discovery as
permitted by this part;
(8) Regulate the course of the hearing and the conduct of
representatives, parties, and witnesses;
(9) Examine witnesses;
(10) Receive, rule on, exclude or limit evidence;
(11) Upon motion of a party, take official notice of facts;
(12) Upon motion of a party, decide cases, in whole or in part, by
summary judgment where there is no disputed issue of material fact; and
(13) Conduct any conference, argument or hearing in person or, upon
agreement of the parties, by telephone.
(c) The ALJ does not have the authority to --
(1) Find invalid Federal statutes or regulations or Secretarial
delegations of authority;
(2) Enter an order in the nature of a directed verdict;
(3) Compel settlement negotiations;
(4) Enjoin any act of the Secretary;
(5) Review the exercise of discretion by the OIG to exclude an
individual or entity under section 1128(b) of the Act, or determine the
scope or effect of the exclusion,
(6) Set a period of exclusion at zero, or reduce a period of
exclusion to zero, in any case where the ALJ finds that an individual or
entity committed an act described in section 1128(b) of the Act, or
(7) Review the exercise of discretion by the OIG to impose a CMP,
assessment or exclusion under part 1003 of this chapter.
42 CFR 1005.5 Ex parte contacts.
No party or person (except employees of the ALJ's office) will
communicate in any way with the ALJ on any matter at issue in a case,
unless on notice and opportunity for all parties to participate. This
provision does not prohibit a person or party from inquiring about the
status of a case or asking routine questions concerning administrative
functions or procedures.
42 CFR 1005.6 Prehearing conferences.
(a) The ALJ will schedule at least one prehearing conference, and may
schedule additional prehearing conferences as appropriate, upon
reasonable notice to the parties.
(b) The ALJ may use prehearing conferences to discuss the following
--
(1) Simplification of the issues;
(2) The necessity or desirability of amendments to the pleadings,
including the need for a more definite statement;
(3) Stipulations and admissions of fact or as to the contents and
authenticity of documents;
(4) Whether the parties can agree to submission of the case on a
stipulated record;
(5) Whether a party chooses to waive appearance at an oral hearing
and to submit only documentary evidence (subject to the objection of
other parties) and written argument;
(6) Limitation of the number of witnesses;
(7) Scheduling dates for the exchange of witness lists and of
proposed exhibits;
(8) Discovery of documents as permitted by this part;
(9) The time and place for the hearing;
(10) Such other matters as may tend to encourage the fair, just and
expeditious disposition of the proceedings; and
(11) Potential settlement of the case.
(c) The ALJ will issue an order containing the matters agreed upon by
the parties or ordered by the ALJ at a prehearing conference.
42 CFR 1005.7 Discovery.
(a) A party may make a request to another party for production of
documents for inspection and copying which are relevant and material to
the issues before the ALJ.
(b) For the purpose of this section, the term documents includes
information, reports, answers, records, accounts, papers and other data
and documentary evidence. Nothing contained in this section will be
interpreted to require the creation of a document, except that requested
data stored in an electronic data storage system will be produced in a
form accessible to the requesting party.
(c) Requests for documents, requests for admissions, written
interrogatories, depositions and any forms of discovery, other than
those permitted under paragraph (a) of this section, are not authorized.
(d) This section will not be construed to require the disclosure of
interview reports or statements obtained by any party, or on behalf of
any party, of persons who will not be called as witnesses by that party,
or analyses and summaries prepared in conjunction with the investigation
or litigation of the case, or any otherwise privileged documents.
(e) (1) Within 10 days of service of a request for production of
documents, a party may file a motion for a protective order.
(2) The ALJ may grant a motion for a protective order if he or she
finds that the discovery sought --
(i) Is unduly costly or burdensome,
(ii) Will unduly delay the proceeding, or
(iii) Seeks privileged information.
(3) The burden of showing that discovery should be allowed is on the
party seeking discovery.
42 CFR 1005.8 Exchange of witness lists, witness statements and
exhibits.
(a) At least 15 days before the hearing, the ALJ will order the
parties to exchange witness lists, copies of prior written statements of
proposed witnesses and copies of proposed hearing exhibits, including
copies of any written statements that the party intends to offer in lieu
of live testimony in accordance with 1005.16.
(b) (1) If at any time a party objects to the proposed admission of
evidence not exchanged in accordance with paragraph (a) of this section,
the ALJ will determine whether the failure to comply with paragraph (a)
of this section should result in the exclusion of such evidence.
(2) Unless the ALJ finds that extraordinary circumstances justified
the failure to timely exchange the information listed under paragraph
(a) of this section, the ALJ must exclude from the party's
case-in-chief:
(i) The testimony of any witness whose name does not appear on the
witness list, and
(ii) Any exhibit not provided to the opposing party as specified in
paragraph (a) of this section.
(3) If the ALJ finds that extraordinary circumstances existed, the
ALJ must then determine whether the admission of such evidence would
cause substantial prejudice to the objecting party. If the ALJ finds
that there is no substantial prejudice, the evidence may be admitted.
If the ALJ finds that there is substantial prejudice, the ALJ may
exclude the evidence, or at his or her discretion, may postpone the
hearing for such time as is necessary for the objecting party to prepare
and respond to the evidence.
(c) Unless another party objects within a reasonable period of time
prior to the hearing, documents exchanged in accordance with paragraph
(a) of this section will be deemed to be authentic for the purpose of
admissibility at the hearing.
42 CFR 1005.9 Subpoenas for attendance at hearing.
(a) A party wishing to procure the appearance and testimony of any
individual at the hearing may make a motion requesting the ALJ to issue
a subpoena if the appearance and testimony are reasonably necessary for
the presentation of a party's case.
(b) A subpoena requiring the attendance of an individual may also
require the individual to produce evidence at the hearing in accordance
with 1005.7.
(c) When a subpoena is served by a respondent or petitioner on a
particular individual or particular office of the OIG, the OIG may
comply by designating any of its representatives to appear and testify.
(d) A party seeking a subpoena will file a written motion not less
than 30 days before the date fixed for the hearing, unless otherwise
allowed by the ALJ for good cause shown. Such request will:
(1) Specify any evidence to be produced,
(2) Designate the witnesses, and
(3) Describe the address and location with sufficient particularity
to permit such witnesses to be found.
(e) The subpoena will specify the time and place at which the witness
is to appear and any evidence the witness is to produce.
(f) Within 15 days after the written motion requesting issuance of a
subpoena is served, any party may file an opposition or other response.
(g) If the motion requesting issuance of a subpoena is granted, the
party seeking the subpoena will serve it by delivery to the individual
named, or by certified mail addressed to such individual at his or her
last dwelling place or principal place of business.
(h) The individual to whom the subpoena is directed may file with the
ALJ a motion to quash the subpoena within 10 days after service.
(i) The exclusive remedy for contumacy by, or refusal to obey a
subpoena duly served upon, any person is specified in section 205(e) of
the Social Security Act (42 U.S.C. 405(e)).
42 CFR 1005.10 Fees.
The party requesting a subpoena will pay the cost of the fees and
mileage of any witness subpoenaed in the amounts that would be payable
to a witness in a proceeding in United States District Court. A check
for witness fees and mileage will accompany the subpoena when served,
except that when a subpoena is issued on behalf of the IG, a check for
witness fees and mileage need not accompany the subpoena.
42 CFR 1005.11 Form, filing and service of papers.
(a) Forms. (1) Unless the ALJ directs the parties to do otherwise,
documents filed with the ALJ will include an original and two copies.
(2) Every pleading and paper filed in the proceeding will contain a
caption setting forth the title of the action, the case number, and a
designation of the paper, such as motion to quash subpoena.
(3) Every pleading and paper will be signed by, and will contain the
address and telephone number of the party or the person on whose behalf
the paper was filed, or his or her representative.
(4) Papers are considered filed when they are mailed.
(b) Service. A party filing a document with the ALJ or the Secretary
will, at the time of filing, serve a copy of such document on every
other party. Service upon any party of any document will be made by
delivering a copy, or placing a copy of the document in the United
States mail, postage prepaid and addressed, or with a private delivery
service, to the party's last known address. When a party is represented
by an attorney, service will be made upon such attorney in lieu of the
party.
(c) Proof of service. A certificate of the individual serving the
document by personal delivery or by mail, setting forth the manner of
service, will be proof of service.
42 CFR 1005.12 Computation of time.
(a) In computing any period of time under this part or in an order
issued thereunder, the time begins with the day following the act, event
or default, and includes the last day of the period unless it is a
Saturday, Sunday or legal holiday observed by the Federal Government, in
which event it includes the next business day.
(b) When the period of time allowed is less than 7 days, intermediate
Saturdays, Sundays and legal holidays observed by the Federal Government
will be excluded from the computation.
(c) Where a document has been served or issued by placing it in the
mail, an additional 5 days will be added to the time permitted for any
response. This paragraph does not apply to requests for hearing under
1005.2.
42 CFR 1005.13 Motions.
(a) An application to the ALJ for an order or ruling will be by
motion. Motions will state the relief sought, the authority relied upon
and the facts alleged, and will be filed with the ALJ and served on all
other parties.
(b) Except for motions made during a prehearing conference or at the
hearing, all motions will be in writing. The ALJ may require that oral
motions be reduced to writing.
(c) Within 10 days after a written motion is served, or such other
time as may be fixed by the ALJ, any party may file a response to such
motion.
(d) The ALJ may not grant a written motion before the time for filing
responses has expired, except upon consent of the parties or following a
hearing on the motion, but may overrule or deny such motion without
awaiting a response.
(e) The ALJ will make a reasonable effort to dispose of all
outstanding motions prior to the beginning of the hearing.
42 CFR 1005.14 Sanctions.
(a) The ALJ may sanction a person, including any party or attorney,
for failing to comply with an order or procedure, for failing to defend
an action or for other misconduct that interferes with the speedy,
orderly or fair conduct of the hearing. Such sanctions will reasonably
relate to the severity and nature of the failure or misconduct. Such
sanction may include --
(1) In the case of refusal to provide or permit discovery under the
terms of this part, drawing negative factual inferences or treating such
refusal as an admission by deeming the matter, or certain facts, to be
established;
(2) Prohibiting a party from introducing certain evidence or
otherwise supporting a particular claim or defense;
(3) Striking pleadings, in whole or in part;
(4) Staying the proceedings;
(5) Dismissal of the action;
(6) Entering a decision by default; and
(7) Refusing to consider any motion or other action that is not filed
in a timely manner.
(b) In civil money penalty cases commenced under section 1128A of the
Act or under any provision which incorporates section 1128A(c)(4) of the
Act, the ALJ may also order the party or attorney who has engaged in any
of the acts described in paragraph (a) of this section to pay attorney's
fees and other costs caused by the failure or misconduct.
42 CFR 1005.15 The hearing and burden of proof.
(a) The ALJ will conduct a hearing on the record in order to
determine whether the petitioner or respondent should be found liable
under this part.
(b) Burden of proof in civil money penalty cases under part 1003, in
Peer Review Organization exclusion cases under part 1004, and in
exclusion cases under 1001.701, 1001.901 and 1001.951. In civil money
penalty cases under part 1003, in Peer Review Organization exclusion
cases under part 1004, and in exclusion cases under 1001.701, 1001.901
and 1001.951 of this chapter --
(1) The respondent bears the burden of going forward and the burden
of persuasion with respect to affirmative defenses and any mitigating
circumstances; and
(2) The IG bears the burden of going forward and the burden of
persuasion with respect to all other issues.
(c) Burden of proof in all other exclusion cases. In all exclusion
cases except those governed by paragraph (b) of this section, the ALJ
will allocate the burden of proof as the ALJ deems appropriate.
(d) The burden of persuasion will be judged by a preponderance of the
evidence.
(e) The hearing will be open to the public unless otherwise ordered
by the ALJ for good cause shown.
(f) (1) A hearing under this part is not limited to specific items
and information set forth in the notice letter to the petitioner or
respondent. Subject to the 15-day requirement under 1005.8, additional
items or information may be introduced by either party during its
case-in-chief unless such information or items are --
(i) Privileged;
(ii) Disqualified from consideration due to untimeliness in
accordance with 1004.130(a)(2)(ii); or
(iii) Deemed otherwise inadmissible under 1005.17.
(2) After both parties have presented their cases, evidence may be
admitted on rebuttal even if not previously exchanged in accordance with
1005.8.
42 CFR 1005.16 Witnesses.
(a) Except as provided in paragraph (b) of this section, testimony at
the hearing will be given orally by witnesses under oath or affirmation.
(b) At the discretion of the ALJ, testimony (other than expert
testimony) may be admitted in the form of a written statement. Any such
written statement must be provided to all other parties along with the
last known address of such witness, in a manner that allows sufficient
time for other parties to subpoena such witness for cross-examination at
the hearing. Prior written statements of witnesses proposed to testify
at the hearing will be exchanged as provided in 1005.8.
(c) The ALJ will exercise reasonable control over the mode and order
of interrogating witnesses and presenting evidence so as to:
(1) Make the interrogation and presentation effective for the
ascertainment of the truth,
(2) Avoid repetition or needless consumption of time, and
(3) Protect witnesses from harassment or undue embarrassment.
(d) The ALJ will permit the parties to conduct such cross-examination
of witnesses as may be required for a full and true disclosure of the
facts.
(e) The ALJ may order witnesses excluded so that they cannot hear the
testimony of other witnesses. This does not authorize exclusion of --
(1) A party who is an individual;
(2) In the case of a party that is not an individual, an officer or
employee of the party appearing for the entity pro se or designated as
the party's representative; or
(3) An individual whose presence is shown by a party to be essential
to the presentation of its case, including an individual engaged in
assisting the attorney for the IG.
42 CFR 1005.17 Evidence.
(a) The ALJ will determine the admissibility of evidence.
(b) Except as provided in this part, the ALJ will not be bound by the
Federal Rules of Evidence. However, the ALJ may apply the Federal Rules
of Evidence where appropriate, for example, to exclude unreliable
evidence.
(c) The ALJ must exclude irrelevant or immaterial evidence.
(d) Although relevant, evidence may be excluded if its probative
value is substantially outweighed by the danger of unfair prejudice,
confusion of the issues, or by considerations of undue delay or needless
presentation of cumulative evidence.
(e) Although relevant, evidence must be excluded if it is privileged
under Federal law.
(f) Evidence concerning offers of compromise or settlement made in
this action will be inadmissible to the extent provided in Rule 408 of
the Federal Rules of Evidence.
(g) Evidence of crimes, wrongs or acts other than those at issue in
the instant case is admissible in order to show motive, opportunity,
intent, knowledge, preparation, identity, lack of mistake, or existence
of a scheme. Such evidence is admissible regardless of whether the
crimes, wrongs or acts occurred during the statute of limitations period
applicable to the acts which constitute the basis for liability in the
case, and regardless of whether they were referenced in the IG's notice
sent in accordance with 1001.2002, 1001.2003 or 1003.109.
(h) The ALJ will permit the parties to introduce rebuttal witnesses
and evidence.
(i) All documents and other evidence offered or taken for the record
will be open to examination by all parties, unless otherwise ordered by
the ALJ for good cause shown.
(j) The ALJ may not consider evidence regarding the issue of
willingness and ability to enter into and successfully complete a
corrective action plan when such evidence pertains to matters occurring
after the submittal of the case to the Secretary. The determination
regarding the appropriateness of any corrective action plan is not
reviewable.
42 CFR 1005.18 The record.
(a) The hearing will be recorded and transcribed. Transcripts may be
obtained following the hearing from the ALJ.
(b) The transcript of testimony, exhibits and other evidence admitted
at the hearing, and all papers and requests filed in the proceeding
constitute the record for the decision by the ALJ and the Secretary.
(c) The record may be inspected and copied (upon payment of a
reasonable fee) by any person, unless otherwise ordered by the ALJ for
good cause shown.
(d) For good cause, the ALJ may order appropriate redactions made to
the record.
42 CFR 1005.19 Post-hearing briefs.
The ALJ may require the parties to file post-hearing briefs. In any
event, any party may file a post-hearing brief. The ALJ will fix the
time for filing such briefs which are not to exceed 60 days from the
date the parties receive the transcript of the hearing or, if
applicable, the stipulated record. Such briefs may be accompanied by
proposed findings of fact and conclusions of law. The ALJ may permit
the parties to file reply briefs.
42 CFR 1005.20 Initial decision.
(a) The ALJ will issue an initial decision, based only on the record,
which will contain findings of fact and conclusions of law.
(b) The ALJ may affirm, increase or reduce the penalties, assessment
or exclusion proposed or imposed by the IG, or reverse the imposition of
the exclusion. In exclusion cases where the period of exclusion
commenced prior to the hearing, any period of exclusion imposed by the
ALJ will be deemed to commence on the date such exclusion originally
went into effect.
(c) The ALJ will issue the initial decision to all parties within 60
days after the time for submission of post-hearing briefs and reply
briefs, if permitted, has expired. The decision will be accompanied by
a statement describing the right of any party to file a notice of appeal
with the DAB and instructions for how to file such appeal. If the ALJ
fails to meet the deadline contained in this paragraph, he or she will
notify the parties of the reason for the delay and will set a new
deadline.
(d) Except as provided in paragraph (e) of this section, unless the
initial decision is appealed to the DAB, it will be final and binding on
the parties 30 days after the ALJ serves the parties with a copy of the
decision. If service is by mail, the date of service will be deemed to
be 5 days from the date of mailing.
(e) If an extension of time within which to appeal the initial
decision is granted under 1005.21(a), except as provided in
1005.22(a), the initial decision will become final and binding on the
day following the end of the extension period.
42 CFR 1005.21 Appeal to DAB.
(a) Any party may appeal the initial decision of the ALJ to the DAB
by filing a notice of appeal with the DAB within 30 days of the date of
service of the initial decision. The DAB may extend the initial 30 day
period for a period of time not to exceed 30 days if a party files with
the DAB a request for an extension within the initial 30 day period and
shows good cause.
(b) If a party files a timely notice of appeal with the DAB, the ALJ
will forward the record of the proceeding to the DAB.
(c) A notice of appeal will be accompanied by a written brief
specifying exceptions to the initial decision and reasons supporting the
exceptions. Any party may file a brief in opposition to exceptions,
which may raise any relevant issue not addressed in the exceptions,
within 30 days of receiving the notice of appeal and accompanying brief.
The DAB may permit the parties to file reply briefs.
(d) There is no right to appear personally before the DAB, or to
appeal to the DAB any interlocutory ruling by the ALJ.
(e) The DAB will not consider any issue not raised in the parties'
briefs, nor any issue in the briefs that could have been raised before
the ALJ but was not.
(f) If any party demonstrates to the satisfaction of the DAB that
additional evidence not presented at such hearing is relevant and
material and that there were reasonable grounds for the failure to
adduce such evidence at such hearing, the DAB may remand the matter to
the ALJ for consideration of such additional evidence.
(g) The DAB may decline to review the case, or may affirm, increase,
reduce, reverse or remand any penalty, assessment or exclusion
determined by the ALJ.
(h) The standard of review on a disputed issue of fact is whether the
initial decision is supported by substantial evidence on the whole
record. The standard of review on a disputed issue of law is whether
the initial decision is erroneous.
(i) Within 60 days after the time for submission of briefs and reply
briefs, if permitted, has expired, the DAB will issue to each party to
the appeal a copy of the DAB's decision and a statement describing the
right of any petitioner or respondent who is found liable to seek
judicial review.
(j) Except with respect to any penalty, assessment or exclusion
remanded by the ALJ, the DAB's decision, including a decision to decline
review of the initial decision, becomes final and binding 60 days after
the date on which the DAB serves the parties with a copy of the
decision. If service is by mail, the date of service will be deemed to
be 5 days from the date of mailing.
(k) (1) Any petition for judicial review must be filed within 60 days
after the DAB serves the parties with a copy of the decision. If
service is by mail, the date of service will be deemed to be 5 days from
the date of mailing.
(2) In compliance with 28 U.S.C. 2112(a), a copy of any petition for
judicial review filed in any U.S. Court of Appeals challenging a final
action of the DAB will be sent by certified mail, return receipt
requested, to the Associate General Counsel, Inspector General Division,
HHS. The petition copy will be time-stamped by the clerk of the court
when the original is filed with the court.
(3) If the Associate General Counsel receives two or more petitions
within 10 days after the DAB issues its decision, the Associate General
Counsel will notify the U.S. Judicial Panel on Multidistrict Litigation
of any petitions that were received within the 10-day period.
42 CFR 1005.22 Stay of initial decision.
(a) In a CMP case under section 1128A of the Act, the filing of a
respondent's request for review by the DAB will automatically stay the
effective date of the ALJ's decision.
(b) (1) After the DAB renders a decision in a CMP case, pending
judicial review, the respondent may file a request for stay of the
effective date of any penalty or assessment with the ALJ. The request
must be accompanied by a copy of the notice of appeal filed with the
Federal court. The filing of such a request will automatically act to
stay the effective date of the penalty or assessment until such time as
the ALJ rules upon the request.
(2) The ALJ may not grant a respondent's request for stay of any
penalty or assessment unless the respondent posts a bond or provides
other adequate security.
(3) The ALJ will rule upon a respondent's request for stay within 10
days of receipt.
42 CFR 1005.23 Harmless error.
No error in either the admission or the exclusion of evidence, and no
error or defect in any ruling or order or in any act done or omitted by
the ALJ or by any of the parties, including Federal representatives such
as Medicare carriers and intermediaries and Peer Review Organizations,
is ground for vacating, modifying or otherwise disturbing an otherwise
appropriate ruling or order or act, unless refusal to take such action
appears to the ALJ or the DAB inconsistent with substantial justice.
The ALJ and the DAB at every stage of the proceeding will disregard any
error or defect in the proceeding that does not affect the substantial
rights of the parties.
42 CFR 1005.23 PART 1006 -- INVESTIGATIONAL INQUIRIES
Sec.
1006.1 Scope.
1006.2 Contents of subpoena.
1006.3 Service and fees.
1006.4 Procedures for investigational inquiries.
1006.5 Enforcement of a subpoena.
Authority: 42 U.S.C. 405(d), 405(e), 1302 and 1320a-7a.
Source: 57 FR 3354, Jan. 29, 1992, unless otherwise noted.
42 CFR 1006.1 Scope.
(a) The provisions in this part govern subpoenas issued by the
Inspector General, or his or her delegates, in accordance with sections
205(d) and 1128A(j) of the Act, and require the attendance and testimony
of witnesses and the production of any other evidence at an
investigational inquiry.
(b) Such subpoenas may be issued in investigations under section
1128A of the Act or under any other section of the Act that incorporates
the provisions of section 1128A(j).
(c) Nothing in this part is intended to apply to or limit the
authority of the Inspector General, or his or her delegates, to issue
subpoenas for the production of documents in accordance with 5 U.S.C.
6(a)(4), App. 3.
42 CFR 1006.2 Contents of subpoena.
A subpoena issued under this part will --
(a) State the name of the individual or entity to whom the subpoena
is addressed;
(b) State the statutory authority for the subpoena;
(c) Indicate the date, time and place that the investigational
inquiry at which the witness is to testify will take place;
(d) Include a reasonably specific description of any documents or
items required to be produced; and
(e) If the subpoena is addressed to an entity, describe with
reasonable particularity the subject matter on which testimony is
required. In such event, the named entity will designate one or more
individuals who will testify on its behalf, and will state as to each
individual so designated that individual's name and address and the
matters on which he or she will testify. The individual so designated
will testify as to matters known or reasonably available to the entity.
42 CFR 1006.3 Service and fees.
(a) A subpoena under this part will be served by --
(1) Delivering a copy to the individual named in the subpoena;
(2) Delivering a copy to the entity named in the subpoena at its last
principal place of business; or
(3) Registered or certified mail addressed to such individual or
entity at its last known dwelling place or principal place of business.
(b) A verified return by the individual serving the subpoena setting
forth the manner of service or, in the case of service by registered or
certified mail, the signed return post office receipt, will be proof of
service.
(c) Witnesses will be entitled to the same fees and mileage as
witnesses in the district courts of the United States (28 U.S.C. 1821
and 1825). Such fees need not be paid at the time the subpoena is
served.
42 CFR 1006.4 Procedures for investigational inquiries.
(a) Testimony at investigational inquiries will be taken under oath
or affirmation.
(b) Investigational inquiries are non-public investigatory
proceedings. Attendance of non-witnesses is within the discretion of
the OIG, except that --
(1) A witness is entitled to be accompanied, represented and advised
by an attorney; and
(2) Representatives of the OIG and the Office of the General Counsel
are entitled to attend and ask questions.
(c) A witness will have an opportunity to clarify his or her answers
on the record following the questions by the OIG.
(d) Any claim of privilege must be asserted by the witness on the
record.
(e) Objections must be asserted on the record. Errors of any kind
that might be corrected if promptly presented will be deemed to be
waived unless reasonable objection is made at the investigational
inquiry. Except where the objection is on the grounds of privilege, the
question will be answered on the record, subject to the objection.
(f) If a witness refuses to answer any question not privileged or to
produce requested documents or items, or engages in conduct likely to
delay or obstruct the investigational inquiry, the OIG may seek
enforcement of the subpoena under 1006.5.
(g) (1) The proceedings will be recorded and transcribed.
(2) The witness is entitled to a copy of the transcript, upon payment
of prescribed costs, except that, for good cause, the witness may be
limited to inspection of the official transcript of his or her
testimony.
(3) (i) The transcript will be submitted to the witness for
signature.
(ii) Where the witness will be provided a copy of the transcript, the
transcript will be submitted to the witness for signature. The witness
may submit to the OIG written proposed corrections to the transcript,
with such corrections attached to the transcript. If the witness does
not return a signed copy of the transcript or proposed corrections
within 30 days of its being submitted to him or her for signature, the
witness will be deemed to have agreed that the transcript is true and
accurate.
(iii) Where, as provided in paragraph (g)(2) of this section, the
witness is limited to inspecting the transcript, the witness will have
the opportunity at the time of inspection to propose corrections to the
transcript, with corrections attached to the transcript. The witness
will also have the opportunity to sign the transcript. If the witness
does not sign the transcript or offer corrections within 30 days of
receipt of notice of the opportunity to inspect the transcript, the
witness will be deemed to have agreed that the transcript is true and
accurate.
(iv) The OIG's proposed corrections the record of transcript will be
attached to the transcript.
(h) Testimony and other evidence obtained in an investigational
inquiry may be used by the OIG or DHHS in any of its activities, and may
be used or offered into evidence in any administrative or judicial
proceeding.
42 CFR 1006.5 Enforcement of a subpoena.
A subpoena to appear at an investigational inquiry is enforceable
through the District Court of the United States and the district where
the subpoenaed person is found, resides or transacts business.
42 CFR 1006.5 PART 1007 -- STATE MEDICAID FRAUD CONTROL UNITS
Sec.
1007.1 Definitions.
1007.3 Scope and purpose.
1007.5 Basic requirement.
1007.7 Organization and location requirements.
1007.9 Relationship to, and agreement with, the Medicaid agency.
1007.11 Duties and responsibilities of the unit.
1007.13 Staffing requirements.
1007.15 Applications, certification and recertification.
1007.17 Annual report.
1007.19 Federal financial participation (FFP).
1007.21 Other applicable HHS regulations.
Authority: 42 U.S.C. 1396b(a)(6), 1396b(b)(3) and 1396b(q).
Source: 57 FR 3355, Jan. 29, 1992, unless otherwise noted.
42 CFR 1007.1 Definitions.
As used in this part, unless otherwise indicated by the context:
Employ or employee, as the context requires, means full-time duty
intended to last at least a year. It includes an arrangement whereby an
individual is on full-time detail or assignment to the unit from another
government agency, if the detail or assignment is for a period of at
least 1 year and involves supervision by the unit.
Provider means an individual or entity that furnishes items or
services for which payment is claimed under Medicaid.
Unit means the State Medicaid fraud control unit.
42 CFR 1007.3 Scope and purpose.
This part implements sections 1903(a)(6), 1903(b)(3), and 1903(q) of
the Social Security Act, as amended by the Medicare-Medicaid Anti-Fraud
and Abuse Amendments (Pub. L. 95-142). The statute authorizes the
Secretary to pay a State 90 percent of the costs of establishing and
operating a State Medicaid fraud control unit, as defined by the
statute, for the purpose of eliminating fraud in the State Medicaid
program.
42 CFR 1007.5 Basic requirement.
A State Medicaid fraud control unit must be a single identifiable
entity of the State government certified by the Secretary as meeting the
requirements of 1007.7 through 1007.13 of this part.
42 CFR 1007.7 Organization and location requirements.
Any of the following three alternatives is acceptable:
(a) The unit is located in the office of the State Attorney General
or another department of State government which has Statewide authority
to prosecute individuals for violations of criminal laws with respect to
fraud in the provision or administration of medical assistance under a
State plan implementing title XIX of the Act;
(b) If there is no State agency with Statewide authority and
capability for criminal fraud prosecutions, the unit has established
formal procedures that assure that the unit refers suspected cases of
criminal fraud in the State Medicaid program to the appropriate State
prosecuting authority or authorities, and provides assistance and
coordination to such authority or authorities in the prosecution of such
cases; or
(c) The unit has a formal working relationship with the office of the
State Attorney General and has formal procedures for referring to the
Attorney General suspected criminal violations occurring in the State
Medicaid program and for effective coordination of the activities of
both entities relating to the detection, investigation and prosecution
of those violations. Under this requirement, the office of the State
Attorney General must agree to assume responsibility for prosecuting
alleged criminal violations referred to it by the unit. However, if the
Attorney General finds that another prosecuting authority has the
demonstrated capacity, experience and willingness to prosecute an
alleged violation, he or she may refer a case to that prosecuting
authority, as long as the Attorney General's Office maintains oversight
responsibility for the prosecution and for coordination between the unit
and the prosecuting authority.
42 CFR 1007.9 Relationship to, and agreement with, the Medicaid agency.
(a) The unit must be separate and distinct from the Medicaid agency.
(b) No official of the Medicaid agency will have authority to review
the activities of the unit or to review or overrule the referral of a
suspected criminal violation to an appropriate prosecuting authority.
(c) The unit will not receive funds paid under this part either from
or through the Medicaid agency.
(d) The unit will enter into an agreement with the Medicaid agency
under which the Medicaid agency will agree to comply with all
requirements of 455.21(a)(2) of this title.
42 CFR 1007.11 Duties and responsibilities of the unit.
(a) The unit will conduct a Statewide program for investigating and
prosecuting (or referring for prosecution) violations of all applicable
State laws pertaining to fraud in the administration of the Medicaid
program, the provision of medical assistance, or the activities of
providers of medical assistance under the State Medicaid plan.
(b) (1) The unit will also review complaints alleging abuse or
neglect of patients in health care facilities receiving payments under
the State Medicaid plan and may review complaints of the
misappropriation of patient's private funds in such facilities.
(2) If the initial review indicates substantial potential for
criminal prosecution, the unit will investigate the complaint or refer
it to an appropriate criminal investigative or prosecutive authority.
(3) If the initial review does not indicate a substantial potential
for criminal prosecution, the unit will refer the complaint to an
appropriate State agency.
(c) If the unit, in carrying out its duties and responsibilities
under paragraphs (a) and (b) of this section, discovers that
overpayments have been made to a health care facility or other provider
of medical assistance under the State Medicaid plan, the unit will
either attempt to collect such overpayment or refer the matter to an
appropriate State agency for collection.
(d) Where a prosecuting authority other than the unit is to assume
responsibility for the prosecution of a case investigated by the unit,
the unit will insure that those responsible for the prosecutive decision
and the preparation of the case for trial have the fullest possible
opportunity to participate in the investigation from its inception and
will provide all necessary assistance to the prosecuting authority
throughout all resulting prosecutions.
(e) The unit will make available to Federal investigators or
prosecutors all information in its possession concerning fraud in the
provision or administration of medical assistance under the State plan
and will cooperate with such officials in coordinating any Federal and
State investigations or prosecutions involving the same suspects or
allegations.
(f) The unit will safeguard the privacy rights of all individuals and
will provide safeguards to prevent the misuse of information under the
unit's control.
42 CFR 1007.13 Staffing requirements.
(a) The unit will employ sufficient professional, administrative, and
support staff to carry out its duties and responsibilities in an
effective and efficient manner. The staff must include:
(1) One or more attorneys experienced in the investigation or
prosecution of civil fraud or criminal cases, who are capable of giving
informed advice on applicable law and procedures and providing effective
prosecution or liaison with other prosecutors;
(2) One or more experienced auditors capable of supervising the
review of financial records and advising or assisting in the
investigation of alleged fraud; and
(3) A senior investigator with substantial experience in commercial
or financial investigations who is capable of supervising and directing
the investigative activities of the unit.
(b) The unit will employ, or have available to it, professional staff
who are knowledgeable about the provision of medical assistance under
title XIX and about the operation of health care providers.
42 CFR 1007.15 Applications, certification and recertification.
(a) Initial application. In order to receive FFP under this part,
the unit must submit to the Secretary, an application approved by the
Governor, containing the following information and documentation --
(1) A description of the applicant's organization, structure, and
location within State government, and an indication of whether it seeks
certification under 1007.7 (a), (b), or (c);
(2) A statement from the State Attorney General that the applicant
has authority to carry out the functions and responsibilities set forth
in this part. If the applicant seeks certification under 1007.7(b),
the statement must also specify either that --
(i) There is no State agency with the authority to exercise Statewide
prosecuting authority for the violations with which the unit is
concerned, or
(ii) Although the State Attorney General may have common law
authority for Statewide criminal prosecutions, he or she has not
exercised that authority;
(3) A copy of whatever memorandum of agreement, regulation, or other
document sets forth the formal procedures required under 1007.7(b), or
the formal working relationship and procedures required under
1007.7(c);
(4) A copy of the agreement with the Medicaid agency required under
1007.9;
(5) A statement of the procedures to be followed in carrying out the
functions and responsibilities of this part;
(6) A projection of the caseload and a proposed budget for the
12-month period for which certification is sought; and
(7) Current and projected staffing, including the names, education,
and experience of all senior professional staff already employed and job
descriptions, with minimum qualifications, for all professional
positions.
(b) Conditions for, and notification of certification. (1) The
Secretary will approve an application only if he or she has specifically
approved the applicant's formal procedures under 1007.7 (b) or (c), if
either of those provisions is applicable, and has specifically certified
that the applicant meets the requirements of 1007.7;
(2) The Secretary will promptly notify the applicant whether the
application meets the requirements of this part and is approved. If the
application is not approved, the applicant may submit an amended
application at any time. Approval and certification will be for a
period of 1 year.
(c) Conditions for recertification. In order to continue receiving
payments under this part, a unit must submit a reapplication to the
Secretary at least 60 days prior to the expiration of the 12-month
certification period. A reapplication must --
(1) Advise the Secretary of any changes in the information or
documentation required under paragraphs (a) (1) through (5) of this
section;
(2) Provide projected caseload and proposed budget for the
recertification period; and
(3) Include or reference the annual report required under 1007.17.
(d) Basis for recertification. (1) The Secretary will consider the
unit's reapplication, the reports required under 1007.17, and any other
reviews or information he or she deems necessary or warranted, and will
promptly notify the unit whether he or she has approved the
reapplication and recertified the unit.
(2) In reviewing the reapplication, the Secretary will give special
attention to whether the unit has used its resources effectively in
investigating cases of possible fraud, in preparing cases for
prosecution, and in prosecuting cases or cooperating with the
prosecuting authorities.
(Approved by the Office of Management and Budget under control number
0990-0162)
42 CFR 1007.17 Annual report.
At least 60 days prior to the expiration of the certification period,
the unit will submit to the Secretary a report covering the last 12
months (the first 9 months of the certification period for the first
annual report), and containing the following information --
(a) The number of investigations initiated and the number completed
or closed, categorized by type of provider;
(b) The number of cases prosecuted or referred for prosecution; the
number of cases finally resolved and their outcomes; and the number of
cases investigated but not prosecuted or referred for prosecution
because of insufficient evidence;
(c) The number of complaints received regarding abuse and neglect of
patients in health care facilities; the number of such complaints
investigated by the unit; and the number referred to other identified
State agencies;
(d) The number of recovery actions initiated by the unit; the number
of recovery actions referred to another agency; the total amount of
overpayments identified by the unit; and the total amount of
overpayments actually collected by the unit;
(e) The number of recovery actions initiated by the Medicaid agency
under its agreement with the unit, and the total amount of overpayments
actually collected by the Medicaid agency under this agreement;
(f) Projections for the succeeding 12 months for items listed in
paragraphs (a) through (e) of this section;
(g) The costs incurred by the unit; and
(h) A narrative that evaluates the unit's performance; describes any
specific problems it has had in connection with the procedures and
agreements required under this part; and discusses any other matters
that have impaired its effectiveness.
(Approved by the Office of Management and Budget under control number
0990-0162)
42 CFR 1007.19 Federal financial participation (FFP).
(a) Rate of FFP. Subject to the limitation of this section, the
Secretary will reimburse each State by an amount equal to 90 percent of
the costs incurred by a certified unit which are attributable to
carrying out its functions and responsibilities under this part.
(b) Retroactive certification. The Secretary may grant certification
retroactive to the date on which the unit first met all the requirements
of the statute and of this part. For any quarter with respect to which
the unit is certified, the Secretary will provide reimbursement for the
entire quarter.
(c) Amount of FFP. FFP for any quarter will not exceed the higher of
$125,000 or one-quarter of 1 percent of the sums expended by the
Federal, State, and local governments during the previous quarter in
carrying out the State Medicaid program.
(d) Costs subject to FFP. (1) FFP is available under this part for
the expenditures attributable to the establishment and operation of the
unit, including the cost of training personnel employed by the unit.
Reimbursement will be limited to costs attributable to the specific
responsibilities and functions set forth in this part in connection with
the investigation and prosecution of suspected fraudulent activities and
the review of complaints of alleged abuse or neglect of patients in
health care facilities.
(2) (i) Establishment costs are limited to clearly identifiable costs
of personnel that --
(A) Devote full time to the establishment of the unit which does
achieve certification; and
(B) Continue as full-time employees after the unit is certified.
(ii) All establishment costs will be deemed made in the first quarter
of certification.
(e) Costs not subject to FFP. FFP is not available under this part
for expenditures attributable to --
(1) The investigation of cases involving program abuse or other
failures to comply with applicable laws and regulations, if these cases
do not involve substantial allegations or other indications of fraud;
(2) Efforts to identify situations in which a question of fraud may
exist, including the screening of claims, analysis of patterns of
practice, or routine verification with recipients of whether services
billed by providers were actually received;
(3) The routine notification of providers that fraudulent claims may
be punished under Federal or State law;
(4) The performance by a person other than a full-time employee of
the unit of any management function for the unit, any audit or
investigation, any professional legal function, or any criminal, civil
or administrative prosecution of suspected providers;
(5) The investigation or prosecution of cases of suspected recipient
fraud not involving suspected conspiracy with a provider; or
(6) Any payment, direct or indirect, from the unit to the Medicaid
agency, other than payments for the salaries of employees on detail to
the unit.
42 CFR 1007.21 Other applicable HHS regulations.
Except as otherwise provided in this part, the following regulations
from 45 CFR subtitle A apply to grants under this part:
Part 16, subpart C -- Department Grant Appeals Process -- Special
Provisions Applicable To Reconsideration of Disallowances (Note that
this applies only to disallowance determinations and not to any other
determinations, e.g., over certification or recertification);
Part 74 -- Administration of Grants;
Part 75 -- Informal Grant Appeals Procedures;
Part 80 -- Nondiscrimination Under Programs Receiving Federal
Assistance Through the Department of Health and Human Services,
Effectuation of Title VI of the Civil Rights Act of 1964;
Part 81 -- Practice and Procedure for Hearings Under 45 CFR Part 80;
Part 84 -- Nondiscrimination on the Basis of Handicap in Programs and
Activities Receiving or Benefiting From Federal Financial Assistance;
Part 91 -- Nondiscrimination on the Basis of Age in HHS Programs or
Activities Receiving Federal Financial Assistance.
42 CFR 1007.21 FINDING AIDS
A list of CFR titles, subtitles, chapters, subchapters and parts and
an alphabetical list of agencies publishing in the CFR are included in
the CFR Index and Finding Aids volume to the Code of Federal Regulations
which is published separately and revised annually.
Material Approved for Incorporation by Reference
Table of CFR Titles and Chapters
Alphabetical List of Agencies Appearing in the CFR
Table of OMB Control Numbers
Redesignation Tables
List of CFR Sections Affected
Title 42-Public Health
Material Approved for Incorporation by Reference
Material Approved for Incorporation by Reference
The Director of the Federal Register has approved under 5 U.S.C.
552(a) and 1 CFR Part 51 the incorporation by reference of the following
publications. This list contains only those incorporations by reference
effective as of the revision date of this volume. Incorporations by
reference found within a regulation are effective upon the effective
date of that regulation. For more information on incorporation by
reference, see the preliminary pages of this volume.
42 CFR 1007.21 42 CFR CHAPTER IV (PARTS 430-End)
HEALTH CARE FINANCING ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
42 CFR
American National Standards Institute
Available from Engineering Societies' Library, 345 E. 47th St., New
York, NY 10017
ANSI A117.1-1971 Specifications for Making Buildings and Facilities
Accessible to and Usable by Physically Handicapped People 442.330(a)(2)
and (b)
National Academy of Sciences
Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418
Recommended Dietary Allowances Current Edition, 1980 (9th Ed.)
442.332(a)(1)
National Fire Protection Association
Batterymarch Park, Quincy, MA 02269
NFPA Standard No. 101, Life Safety Code 1985 483.470(i)
NFPA Standard No. 220, Standard on Type of Building Construction
(1979 Ed.) 442.323
Chap.
42 CFR 1007.21 Table of CFR Titles and Chapters
42 CFR 1007.21 Title 1 -- General Provisions
I Administrative Committee of the Federal Register (Parts 1 -- 49)
II Office of the Federal Register (Parts 50 -- 299)
III Administrative Conference of the United States (Parts 300 -- 399)
IV Miscellaneous Agencies (Parts 400 -- 500)
42 CFR 1007.21 Title 2 -- (Reserved)
42 CFR 1007.21 Title 3 -- The President
I Executive Office of the President (Parts 100 -- 199)
42 CFR 1007.21 Title 4 -- Accounts
I General Accounting Office (Parts 1 -- 99)
II Federal Claims Collection Standards (General Accounting Office --
Department of Justice) (Parts 100 -- 299)
42 CFR 1007.21 Title 5 -- Administrative Personnel
I Office of Personnel Management (Parts 1 -- 1199)
II Merit Systems Protection Board (Parts 1200 -- 1299)
III Office of Management and Budget (Parts 1300 -- 1399)
IV Advisory Committee on Federal Pay (Parts 1400 -- 1499)
V The International Organizations Employees Loyalty Board (Parts 1500
-- 1599)
VI Federal Retirement Thrift Investment Board (Parts 1600 -- 1699)
VII Advisory Commission on Intergovernmental Relations (Parts 1700 --
1799)
VIII Office of Special Counsel (Parts 1800 -- 1899)
IX Appalachian Regional Commission (Parts 1900 -- 1999)
XI United States Soldiers' and Airmen's Home (Parts 2100 -- 2199)
XIV Federal Labor Relations Authority, General Counsel of the Federal
Labor Relations Authority and Federal Service Impasses Panel (Parts 2400
-- 2499)
XV Office of Administration, Executive Office of the President (Parts
2500 -- 2599)
XVI Office of Government Ethics (Parts 2600 -- 2699)
42 CFR 1007.21 Title 6 -- Economic Stabilization (Reserved)
42 CFR 1007.21 Title 7 -- Agriculture
Subtitle A -- Office of the Secretary of Agriculture (Parts 0 -- 26)
Subtitle B -- Regulations of the Department of Agriculture
I Agricultural Marketing Service (Standards, Inspections, Marketing
Practices), Department of Agriculture (Parts 27 -- 209)
II Food and Nutrition Service, Department of Agriculture (Parts 210
-- 299)
III Animal and Plant Health Inspection Service, Department of
Agriculture (Parts 300 -- 399)
IV Federal Crop Insurance Corporation, Department of Agriculture
(Parts 400 -- 499)
V Agricultural Research Service, Department of Agriculture (Parts 500
-- 599)
VI Soil Conservation Service, Department of Agriculture (Parts 600 --
699)
VII Agricultural Stabilization and Conservation Service (Agricultural
Adjustment), Department of Agriculture (Parts 700 -- 799)
VIII Federal Grain Inspection Service, Department of Agriculture
(Parts 800 -- 899)
IX Agricultural Marketing Service (Marketing Agreements and Orders;
Fruits, Vegetables, Nuts), Department of Agriculture (Parts 900 -- 999)
X Agricultural Marketing Service (Marketing Agreements and Orders;
Milk), Department of Agriculture (Parts 1000 -- 1199)
XI Agricultural Marketing Service (Marketing Agreements and Orders;
Miscellaneous Commodities), Department of Agriculture (Parts 1200 --
1299)
XIV Commodity Credit Corporation, Department of Agriculture (Parts
1400 -- 1499)
XV Foreign Agricultural Service, Department of Agriculture (Parts
1500 -- 1599)
XVI Rural Telephone Bank, Department of Agriculture (Parts 1600 --
1699)
XVII Rural Electrification Administration, Department of Agriculture
(Parts 1700 -- 1799)
XVIII Farmers Home Administration, Department of Agriculture (Parts
1800 -- 2099)
XXI Foreign Economic Development Service, Department of Agriculture
(Parts 2100 -- 2199)
XXII Office of International Cooperation and Development, Department
of Agriculture (Parts 2200 -- 2299)
XXV Office of the General Sales Manager, Department of Agriculture
(Parts 2500 -- 2599)
XXVI Office of Inspector General, Department of Agriculture (Parts
2600 -- 2699)
XXVII Office of Information Resources Management, Department of
Agriculture (Parts 2700 -- 2799)
XXVIII Office of Operations, Department of Agriculture (Parts 2800 --
2899)
XXIX Office of Energy, Department of Agriculture (Parts 2900 -- 2999)
XXX Office of Finance and Management, Department of Agriculture
(Parts 3000 -- 3099)
XXXI Office of Environmental Quality, Department of Agriculture
(Parts 3100 -- 3199)
XXXII Office of Grants and Program Systems, Department of Agriculture
(Parts 3200 -- 3299)
XXXIII Office of Transportation, Department of Agriculture (Parts
3300 -- 3399)
XXXIV Cooperative State Research Service, Department of Agriculture
(Parts 3400 -- 3499)
XXXVI National Agricultural Statistics Service, Department of
Agriculture (Parts 3600 -- 3699)
XXXVII Economic Research Service, Department of Agriculture (Parts
3700 -- 3799)
XXXVIII World Agricultural Outlook Board, Department of Agriculture
(Parts 3800 -- 3899)
XXXIX Economic Analysis Staff, Department of Agriculture (Parts 3900
-- 3999)
XL Economics Management Staff, Department of Agriculture (Parts 4000
-- 4099)
XLI National Agricultural Library, Department of Agriculture (Part
4100)
42 CFR 1007.21 Title 8 -- Aliens and Nationality
I Immigration and Naturalization Service, Department of Justice
(Parts 1 -- 499)
42 CFR 1007.21 Title 9 -- Animals and Animal Products
I Animal and Plant Health Inspection Service, Department of
Agriculture (Parts 1 -- 199)
II Packers and Stockyards Administration, Department of Agriculture
(Parts 200 -- 299)
III Food Safety and Inspection Service, Meat and Poultry Inspection,
Department of Agriculture (Parts 300 -- 399)
42 CFR 1007.21 Title 10 -- Energy
I Nuclear Regulatory Commission (Parts 0 -- 199)
II Department of Energy (Parts 200 -- 699)
III Department of Energy (Parts 700 -- 999)
X Department of Energy (General Provisions) (Parts 1000 -- 1099)
XV Office of the Federal Inspector for the Alaska Natural Gas
Transportation System (Parts 1500 -- 1599)
XVII Defense Nuclear Facilities Safety Board (Parts 1700 -- 1799)
42 CFR 1007.21 Title 11 -- Federal Elections
I Federal Election Commission (Parts 1 -- 9099)
42 CFR 1007.21 Title 12 -- Banks and Banking
I Comptroller of the Currency, Department of the Treasury (Parts 1 --
199)
II Federal Reserve System (Parts 200 -- 299)
III Federal Deposit Insurance Corporation (Parts 300 -- 399)
IV Export-Import Bank of the United States (Parts 400 -- 499)
V Office of Thrift Supervision, Department of The Treasury (Parts 500
-- 599)
VI Farm Credit Administration (Parts 600 -- 699)
VII National Credit Union Administration (Parts 700 -- 799)
VIII Federal Financing Bank (Parts 800 -- 899)
IX Federal Housing Finance Board (Parts 900 -- 999)
XI Federal Financial Institutions Examination Council (Parts 1100 --
1199)
XIII Farm Credit System Assistance Board (Parts 1300 -- 1399)
XIV Farm Credit System Insurance Corporation (Parts 1400 -- 1499)
XV Thrift Depositor Protection Oversight Board (Parts 1500 -- 1599)
XVI Resolution Trust Corporation (Parts 1600 -- 1699)
42 CFR 1007.21 Title 13 -- Business Credit and Assistance
I Small Business Administration (Parts 1 -- 199)
III Economic Development Administration, Department of Commerce
(Parts 300 -- 399)
42 CFR 1007.21 Title 14 -- Aeronautics and Space
I Federal Aviation Administration, Department of Transportation
(Parts 1 -- 199)
II Office of the Secretary, Department of Transportation (Aviation
Proceedings) (Parts 200 -- 399)
III Office of Commercial Space Transportation, Department of
Transportation (Parts 400 -- 499)
V National Aeronautics and Space Administration (Parts 1200 -- 1299)
42 CFR 1007.21 Title 15 -- Commerce and Foreign Trade
Subtitle A -- Office of the Secretary of Commerce (Parts 0 -- 29)
Subtitle B -- Regulations Relating to Commerce and Foreign Trade
I Bureau of the Census, Department of Commerce (Parts 30 -- 199)
II National Institute of Standards and Technology, Department of
Commerce (Parts 200 -- 299)
III International Trade Administration, Department of Commerce (Parts
300 -- 399)
IV Foreign-Trade Zones Board (Parts 400 -- 499)
VII Bureau of Export Administration, Department of Commerce (Parts
700 -- 799)
VIII Bureau of Economic Analysis, Department of Commerce (Parts 800
-- 899)
IX National Oceanic and Atmospheric Administration, Department of
Commerce (Parts 900 -- 999)
XI Technology Administration, Department of Commerce (Parts 1100 --
1199)
XII United States Travel and Tourism Administration, Department of
Commerce (Parts 1200 -- 1299)
XIII East-West Foreign Trade Board (Parts 1300 -- 1399)
XIV Minority Business Development Agency (Parts 1400 -- 1499)
Subtitle C -- Regulations Relating to Foreign Trade Agreements
XX Office of the United States Trade Representative (Parts 2000 --
2099)
Subtitle D -- Regulations Relating to Telecommunications and
Information
XXIII National Telecommunications and Information Administration,
Department of Commerce (Parts 2300 -- 2399)
42 CFR 1007.21 Title 16 -- Commercial Practices
I Federal Trade Commission (Parts 0 -- 999)
II Consumer Product Safety Commission (Parts 1000 -- 1799)
42 CFR 1007.21 Title 17 -- Commodity and Securities Exchanges
I Commodity Futures Trading Commission (Parts 1 -- 199)
II Securities and Exchange Commission (Parts 200 -- 399)
IV Department of the Treasury (Parts 400 -- 499)
42 CFR 1007.21 Title 18 -- Conservation of Power and Water Resources
I Federal Energy Regulatory Commission, Department of Energy (Parts 1
-- 399)
III Delaware River Basin Commission (Parts 400 -- 499)
VI Water Resources Council (Parts 700 -- 799)
VIII Susquehanna River Basin Commission (Parts 800 -- 899)
XIII Tennessee Valley Authority (Parts 1300 -- 1399)
42 CFR 1007.21 Title 19 -- Customs Duties
I United States Customs Service, Department of the Treasury (Parts 1
-- 199)
II United States International Trade Commission (Parts 200 -- 299)
III International Trade Administration, Department of Commerce (Parts
300 -- 399)
42 CFR 1007.21 Title 20 -- Employees' Benefits
I Office of Workers' Compensation Programs, Department of Labor
(Parts 1 -- 199)
II Railroad Retirement Board (Parts 200 -- 399)
III Social Security Administration, Department of Health and Human
Services (Parts 400 -- 499)
IV Employees' Compensation Appeals Board, Department of Labor (Parts
500 -- 599)
V Employment and Training Administration, Department of Labor (Parts
600 -- 699)
VI Employment Standards Administration, Department of Labor (Parts
700 -- 799)
VII Benefits Review Board, Department of Labor (Parts 800 -- 899)
VIII Joint Board for the Enrollment of Actuaries (Parts 900 -- 999)
IX Office of the Assistant Secretary for Veterans' Employment and
Training, Department of Labor (Parts 1000 -- 1099)
42 CFR 1007.21 Title 21 -- Food and Drugs
I Food and Drug Administration, Department of Health and Human
Services (Parts 1 -- 1299)
II Drug Enforcement Administration, Department of Justice (Parts 1300
-- 1399)
42 CFR 1007.21 Title 22 -- Foreign Relations
I Department of State (Parts 1 -- 199)
II Agency for International Development, International Development
Cooperation Agency (Parts 200 -- 299)
III Peace Corps (Parts 300 -- 399)
IV International Joint Commission, United States and Canada (Parts
400 -- 499)
V United States Information Agency (Parts 500 -- 599)
VI United States Arms Control and Disarmament Agency (Parts 600 --
699)
VII Overseas Private Investment Corporation, International
Development Cooperation Agency (Parts 700 -- 799)
IX Foreign Service Grievance Board Regulations (Parts 900 -- 999)
X Inter-American Foundation (Parts 1000 -- 1099)
XI International Boundary and Water Commission, United States and
Mexico, United States Section (Parts 1100 -- 1199)
XII United States International Development Cooperation Agency (Parts
1200 -- 1299)
XIII Board for International Broadcasting (Parts 1300 -- 1399)
XIV Foreign Service Labor Relations Board; Federal Labor Relations
Authority; General Counsel of the Federal Labor Relations Authority;
and the Foreign Service Impasse Disputes Panel (Parts 1400 -- 1499)
XV African Development Foundation (Parts 1500 -- 1599)
XVI Japan-United States Friendship Commission (Parts 1600 -- 1699)
42 CFR 1007.21 Title 23 -- Highways
I Federal Highway Administration, Department of Transportation (Parts
1 -- 999)
II National Highway Traffic Safety Administration and Federal Highway
Administration, Department of Transportation (Parts 1200 -- 1299)
III National Highway Traffic Safety Administration, Department of
Transportation (Parts 1300 -- 1399)
42 CFR 1007.21 Title 24 -- Housing and Urban Development
Subtitle A -- Office of the Secretary, Department of Housing and
Urban Development (Parts 0 -- 99)
Subtitle B -- Regulations Relating to Housing and Urban Development
I Office of Assistant Secretary for Equal Opportunity, Department of
Housing and Urban Development (Parts 100 -- 199)
II Office of Assistant Secretary for Housing-Federal Housing
Commissioner, Department of Housing and Urban Development (Parts 200 --
299)
III Government National Mortgage Association, Department of Housing
and Urban Development (Parts 300 -- 399)
V Office of Assistant Secretary for Community Planning and
Development, Department of Housing and Urban Development (Parts 500 --
599)
VI Office of Assistant Secretary for Community Planning and
Development, Department of Housing and Urban Development (Parts 600 --
699)
VII Office of the Secretary, Department of Housing and Urban
Development (Section 8 Housing Assistance Programs and Public and Indian
Housing Programs) (Parts 700 -- 799)
VIII Office of the Assistant Secretary for Housing -- Federal Housing
Commissioner, Department of Housing and Urban Development (Section 8
Housing Assistance Programs and Section 202 Direct Loan Program) (Parts
800 -- 899)
IX Office of Assistant Secretary for Public and Indian Housing,
Department of Housing and Urban Development (Parts 900 -- 999)
X Office of Assistant Secretary for Housing -- Federal Housing
Commissioner, Department of Housing and Urban Development (Interstate
Land Sales Registration Program) (Parts 1700 -- 1799)
XI Solar Energy and Energy Conservation Bank, Department of Housing
and Urban Development (Parts 1800 -- 1899)
XII Office of Inspector General, Department of Housing and Urban
Development (Parts 2000 -- 2099)
XV Mortgage Insurance and Loan Programs under the Emergency
Homeowners' Relief Act, Department of Housing and Urban Development
(Parts 2700 -- 2799)
XX Office of Assistant Secretary for Housing -- Federal Housing
Commissioner, Department of Housing and Urban Development (Parts 3200 --
3699)
XXV Neighborhood Reinvestment Corporation (Parts 4100 -- 4199)
42 CFR 1007.21 Title 25 -- Indians
I Bureau of Indian Affairs, Department of the Interior (Parts 1 --
299)
II Indian Arts and Crafts Board, Department of the Interior (Parts
300 -- 399)
III National Indian Gaming Commission (Parts 500 -- 599)
IV Office of Navajo and Hopi Indian Relocation (Parts 700 -- 799)
42 CFR 1007.21 Title 26 -- Internal Revenue
I Internal Revenue Service, Department of the Treasury (Parts 1 --
799)
42 CFR 1007.21 Title 27 -- Alcohol, Tobacco Products and Firearms
I Bureau of Alcohol, Tobacco and Firearms, Department of the Treasury
(Parts 1 -- 299)
42 CFR 1007.21 Title 28 -- Judicial Administration
I Department of Justice (Parts 0 -- 199)
III Federal Prison Industries, Inc., Department of Justice (Parts 300
-- 399)
V Bureau of Prisons, Department of Justice (Parts 500 -- 599)
VI Offices of Independent Counsel, Department of Justice (Parts 600
-- 699)
VII Office of Independent Counsel (Parts 700 -- 799)
42 CFR 1007.21 Title 29 -- Labor
Subtitle A -- Office of the Secretary of Labor (Parts 0 -- 99)
Subtitle B -- Regulations Relating to Labor
I National Labor Relations Board (Parts 100 -- 199)
II Bureau of Labor-Management Relations and Cooperative Programs,
Department of Labor (Parts 200 -- 299)
III National Railroad Adjustment Board (Parts 300 -- 399)
IV Office of Labor-Management Standards, Department of Labor (Parts
400 -- 499)
V Wage and Hour Division, Department of Labor (Parts 500 -- 899)
IX Construction Industry Collective Bargaining Commission (Parts 900
-- 999)
X National Mediation Board (Parts 1200 -- 1299)
XII Federal Mediation and Conciliation Service (Parts 1400 -- 1499)
XIV Equal Employment Opportunity Commission (Parts 1600 -- 1699)
XVII Occupational Safety and Health Administration, Department of
Labor (Parts 1900 -- 1999)
XX Occupational Safety and Health Review Commission (Parts 2200 --
2499)
XXV Pension and Welfare Benefits Administration, Department of Labor
(Parts 2500 -- 2599)
XXVI Pension Benefit Guaranty Corporation (Parts 2600 -- 2699)
XXVII Federal Mine Safety and Health Review Commission (Parts 2700 --
2799)
42 CFR 1007.21 Title 30 -- Mineral Resources
I Mine Safety and Health Administration, Department of Labor (Parts 1
-- 199)
II Minerals Management Service, Department of the Interior (Parts 200
-- 299)
III Board of Surface Mining and Reclamation Appeals, Department of
the Interior (Parts 300 -- 399)
IV Geological Survey, Department of the Interior (Parts 400 -- 499)
VI Bureau of Mines, Department of the Interior (Parts 600 -- 699)
VII Office of Surface Mining Reclamation and Enforcement, Department
of the Interior (Parts 700 -- 999)
42 CFR 1007.21 Title 31 -- Money and Finance: Treasury
Subtitle A -- Office of the Secretary of the Treasury (Parts 0 -- 50)
Subtitle B -- Regulations Relating to Money and Finance
I Monetary Offices, Department of the Treasury (Parts 51 -- 199)
II Fiscal Service, Department of the Treasury (Parts 200 -- 399)
IV Secret Service, Department of the Treasury (Parts 400 -- 499)
V Office of Foreign Assets Control, Department of the Treasury (Parts
500 -- 599)
VI Bureau of Engraving and Printing, Department of the Treasury
(Parts 600 -- 699)
VII Federal Law Enforcement Training Center, Department of the
Treasury (Parts 700 -- 799)
VIII Office of International Investment, Department of the Treasury
(Parts 800 -- 899)
42 CFR 1007.21 Title 32 -- National Defense
Subtitle A -- Department of Defense
I Office of the Secretary of Defense (Parts 1 -- 399)
V Department of the Army (Parts 400 -- 699)
VI Department of the Navy (Parts 700 -- 799)
VII Department of the Air Force (Parts 800 -- 1099)
Subtitle B -- Other Regulations Relating to National Defense
XII Defense Logistics Agency (Parts 1200 -- 1299)
XVI Selective Service System (Parts 1600 -- 1699)
XIX Central Intelligence Agency (Parts 1900 -- 1999)
XX Information Security Oversight Office (Parts 2000 -- 2099)
XXI National Security Council (Parts 2100 -- 2199)
XXIV Office of Science and Technology Policy (Parts 2400 -- 2499)
XXVII Office for Micronesian Status Negotiations (Parts 2700 -- 2799)
XXVIII Office of the Vice President of the United States (Parts 2800
-- 2899)
42 CFR 1007.21 Title 33 -- Navigation and Navigable Waters
I Coast Guard, Department of Transportation (Parts 1 -- 199)
II Corps of Engineers, Department of the Army (Parts 200 -- 399)
IV Saint Lawrence Seaway Development Corporation, Department of
Transportation (Parts 400 -- 499)
42 CFR 1007.21 Title 34 -- Education
Subtitle A -- Office of the Secretary, Department of Education (Parts
1 -- 99)
Subtitle B -- Regulations of the Offices of the Department of
Education
I Office for Civil Rights, Department of Education (Parts 100 -- 199)
II Office of Elementary and Secondary Education, Department of
Education (Parts 200 -- 299)
III Office of Special Education and Rehabilitative Services,
Department of Education (Parts 300 -- 399)
IV Office of Vocational and Adult Education, Department of Education
(Parts 400 -- 499)
V Office of Bilingual Education and Minority Languages Affairs,
Department of Education (Parts 500 -- 599)
VI Office of Postsecondary Education, Department of Education (Parts
600 -- 699)
VII Office of Educational Research and Improvement, Department of
Education (Parts 700 -- 799)
42 CFR 1007.21 Title 35 -- Panama Canal
I Panama Canal Regulations (Parts 1 -- 299)
42 CFR 1007.21 Title 36 -- Parks, Forests, and Public Property
I National Park Service, Department of the Interior (Parts 1 -- 199)
II Forest Service, Department of Agriculture (Parts 200 -- 299)
III Corps of Engineers, Department of the Army (Parts 300 -- 399)
IV American Battle Monuments Commission (Parts 400 -- 499)
V Smithsonian Institution (Parts 500 -- 599)
VII Library of Congress (Parts 700 -- 799)
VIII Advisory Council on Historic Preservation (Parts 800 -- 899)
IX Pennsylvania Avenue Development Corporation (Parts 900 -- 999)
XI Architectural and Transportation Barriers Compliance Board (Parts
1100 -- 1199)
XII National Archives and Records Administration (Parts 1200 -- 1299)
42 CFR 1007.21 Title 37 -- Patents, Trademarks, and Copyrights
I Patent and Trademark Office, Department of Commerce (Parts 1 --
199)
II Copyright Office, Library of Congress (Parts 200 -- 299)
III Copyright Royalty Tribunal (Parts 300 -- 399)
IV Assistant Secretary for Technology Policy, Department of Commerce
(Parts 400 -- 499)
V Under Secretary for Technology, Department of Commerce (Parts 500
-- 599)
42 CFR 1007.21 Title 38 -- Pensions, Bonuses, and Veterans' Relief
I Department of Veterans Affairs (Parts 0 -- 99)
42 CFR 1007.21 Title 39 -- Postal Service
I United States Postal Service (Parts 1 -- 999)
III Postal Rate Commission (Parts 3000 -- 3099)
42 CFR 1007.21 Title 40 -- Protection of Environment
I Environmental Protection Agency (Parts 1 -- 799)
V Council on Environmental Quality (Parts 1500 -- 1599)
42 CFR 1007.21 Title 41 -- Public Contracts and Property Management
Subtitle B -- Other Provisions Relating to Public Contracts
50 Public Contracts, Department of Labor (Parts 50-1 -- 50-999)
51 Committee for Purchase from the Blind and Other Severely
Handicapped (Parts 51-1 -- 51-99)
60 Office of Federal Contract Compliance Programs, Equal Employment
Opportunity, Department of Labor (Parts 60-1 -- 60-999)
61 Office of the Assistant Secretary for Veterans Employment and
Training, Department of Labor (Parts 61-1 -- 61-999)
Subtitle C -- Federal Property Management Regulations System
101 Federal Property Management Regulations (Parts 101-1 -- 101-99)
105 General Services Administration (Parts 105-1 -- 105-999)
109 Department of Energy Property Management Regulations (Parts 109-1
-- 109-99)
114 Department of the Interior (Parts 114-1 -- 114-99)
115 Environmental Protection Agency (Parts 115-1 -- 115-99)
128 Department of Justice (Parts 128-1 -- 128-99)
132 Department of the Air Force (Parts 132-1 -- 132-99)
Subtitle D -- Other Provisions Relating to Property Management
(Reserved)
Subtitle E -- Federal Information Resources Management Regulations
System
201 Federal Information Resources Management Regulation (Parts 201-1
-- 201-99)
Subtitle F -- Federal Travel Regulation System
301 Travel Allowances (Parts 301-1 -- 301-99)
302 Relocation Allowances (Parts 302-1 -- 302-99)
303 Payment of Expenses Connected with the Death of Certain Employees
(Parts 303-1 -- 303-2)
304 Payment from a non-Federal source for travel expenses (Parts
304-1 -- 304-99)
42 CFR 1007.21 Title 42 -- Public Health
I Public Health Service, Department of Health and Human Services
(Parts 1 -- 199)
IV Health Care Financing Administration, Department of Health and
Human Services (Parts 400 -- 499)
V Office of Inspector General-Health Care, Department of Health and
Human Services (Parts 1000 -- 1999)
42 CFR 1007.21 Title 43 -- Public Lands: Interior
Subtitle A -- Office of the Secretary of the Interior (Parts 1 --
199)
Subtitle B -- Regulations Relating to Public Lands
I Bureau of Reclamation, Department of the Interior (Parts 200 --
499)
II Bureau of Land Management, Department of the Interior (Parts 1000
-- 9999)
42 CFR 1007.21 Title 44 -- Emergency Management and Assistance
I Federal Emergency Management Agency (Parts 0 -- 399)
IV Department of Commerce and Department of Transportation (Parts 400
-- 499)
42 CFR 1007.21 Title 45 -- Public Welfare
Subtitle A -- Department of Health and Human Services, General
Administration (Parts 1 -- 199)
Subtitle B -- Regulations Relating to Public Welfare
II Office of Family Assistance (Assistance Programs), Administration
for Children and Families, Department of Health and Human Services
(Parts 200 -- 299)
III Office of Child Support Enforcement (Child Support Enforcement
Program), Administration for Children and Families, Department of Health
and Human Services (Parts 300 -- 399)
IV Office of Refugee Resettlement, Administration for Children and
Families Department of Health and Human Services (Parts 400 -- 499)
V Foreign Claims Settlement Commission of the United States,
Department of Justice (Parts 500 -- 599)
VI National Science Foundation (Parts 600 -- 699)
VII Commission on Civil Rights (Parts 700 -- 799)
VIII Office of Personnel Management (Parts 800 -- 899)
X Office of Community Services, Administration for Children and
Families, Department of Health and Human Services (Parts 1000 -- 1099)
XI National Foundation on the Arts and the Humanities (Parts 1100 --
1199)
XII ACTION (Parts 1200 -- 1299)
XIII Office of Human Development Services, Department of Health and
Human Services (Parts 1300 -- 1399)
XVI Legal Services Corporation (Parts 1600 -- 1699)
XVII National Commission on Libraries and Information Science (Parts
1700 -- 1799)
XVIII Harry S. Truman Scholarship Foundation (Parts 1800 -- 1899)
XXI Commission on Fine Arts (Parts 2100 -- 2199)
XXII Christopher Columbus Quincentenary Jubilee Commission (Parts
2200 -- 2299)
XXIV James Madison Memorial Fellowship Foundation (Parts 2400 --
2499)
42 CFR 1007.21 Title 46 -- Shipping
I Coast Guard, Department of Transportation (Parts 1 -- 199)
II Maritime Administration, Department of Transportation (Parts 200
-- 399)
III Coast Guard (Great Lakes Pilotage), Department of Transportation
(Parts 400 -- 499)
IV Federal Maritime Commission (Parts 500 -- 599)
42 CFR 1007.21 Title 47 -- Telecommunication
I Federal Communications Commission (Parts 0 -- 199)
II Office of Science and Technology Policy and National Security
Council (Parts 200 -- 299)
III National Telecommunications and Information Administration,
Department of Commerce (Parts 300 -- 399)
42 CFR 1007.21 Title 48 -- Federal Acquisition Regulations System
1 Federal Acquisition Regulation (Parts 1 -- 99)
2 Department of Defense (Parts 200 -- 299)
3 Department of Health and Human Services (Parts 300 -- 399)
4 Department of Agriculture (Parts 400 -- 499)
5 General Services Administration (Parts 500 -- 599)
6 Department of State (Parts 600 -- 699)
7 Agency for International Development (Parts 700 -- 799)
8 Department of Veterans Affairs (Parts 800 -- 899)
9 Department of Energy (Parts 900 -- 999)
10 Department of the Treasury (Parts 1000 -- 1099)
12 Department of Transportation (Parts 1200 -- 1299)
13 Department of Commerce (Parts 1300 -- 1399)
14 Department of the Interior (Parts 1400 -- 1499)
15 Environmental Protection Agency (Parts 1500 -- 1599)
16 Office of Personnel Management Federal Employees Health Benefits
Acquisition Regulation (Parts 1600 -- 1699)
17 Office of Personnel Management (Parts 1700 -- 1799)
18 National Aeronautics and Space Administration (Parts 1800 -- 1899)
19 United States Information Agency (Parts 1900 -- 1999)
22 Small Business Administration (Parts 2200 -- 2299)
24 Department of Housing and Urban Development (Parts 2400 -- 2499)
25 National Science Foundation (Parts 2500 -- 2599)
28 Department of Justice (Parts 2800 -- 2899)
29 Department of Labor (Parts 2900 -- 2999)
34 Department of Education Acquisition Regulation (Parts 3400 --
3499)
35 Panama Canal Commission (Parts 3500 -- 3599)
44 Federal Emergency Management Agency (Parts 4400 -- 4499)
51 Department of the Army Acquisition Regulations (Parts 5100 --
5199)
52 Department of the Navy Acquisition Regulations (Parts 5200 --
5299)
53 Department of the Air Force Federal Acquisition Regulation
Supplement (Parts 5300 -- 5399)
57 African Development Foundation (Parts 5700 -- 5799)
61 General Services Administration Board of Contract Appeals (Parts
6100 -- 6199)
63 Department of Transportation Board of Contract Appeals (Parts 6300
-- 6399)
99 Cost Accounting Standards Board, Office of Federal Procurement
Policy, Office of Management and Budget (Parts 9900 -- 9999)
42 CFR 1007.21 Title 49 -- Transportation
Subtitle A -- Office of the Secretary of Transportation (Parts 1 --
99)
Subtitle B -- Other Regulations Relating to Transportation
I Research and Special Programs Administration, Department of
Transportation (Parts 100 -- 199)
II Federal Railroad Administration, Department of Transportation
(Parts 200 -- 299)
III Federal Highway Administration, Department of Transportation
(Parts 300 -- 399)
IV Coast Guard, Department of Transportation (Parts 400 -- 499)
V National Highway Traffic Safety Administration, Department of
Transportation (Parts 500 -- 599)
VI Federal Transit Administration, Department of Transportation
(Parts 600 -- 699)
VII National Railroad Passenger Corporation (AMTRAK) (Parts 700 --
799)
VIII National Transportation Safety Board (Parts 800 -- 899)
X Interstate Commerce Commission (Parts 1000 -- 1399)
42 CFR 1007.21 Title 50 -- Wildlife and Fisheries
I United States Fish and Wildlife Service, Department of the Interior
(Parts 1 -- 199)
II National Marine Fisheries Service, National Oceanic and
Atmospheric Administration, Department of Commerce (Parts 200 -- 299)
III International Regulatory Agencies (Fishing and Whaling) (Parts
300 -- 399)
IV Joint Regulations (United States Fish and Wildlife Service,
Department of the Interior and National Marine Fisheries Service,
National Oceanic and Atmospheric Administration, Department of
Commerce); Endangered Species Committee Regulations (Parts 400 -- 499)
V Marine Mammal Commission (Parts 500 -- 599)
VI Fishery Conservation and Management, National Oceanic and
Atmospheric Administration, Department of Commerce (Parts 600 -- 699)
42 CFR 1007.21 CFR Index and Finding Aids Subject/Agency Index
List of Agency Prepared Indexes Parallel Tables of Statutory Authorities
and Rules Acts Requiring Publication in the Federal Register List of CFR
Titles, Chapters, Subchapters, and Parts
42 CFR 1007.21 Alphabetical List of Agencies Appearing in the CFR
CFR Title, Subtitle or
Agency
Chapter
ACTION 45, XII
Administrative Committee of the Federal Register 1, I
Administrative Conference of the United States 1, III
Advisory Commission on Intergovernmental Relations 5, VII
Advisory Committee on Federal Pay 5, IV
Advisory Council on Historic Preservation 36, VIII
African Development Foundation 22, XV; 48, 57
Agency for International Development 22, II; 48, 7
Agricultural Marketing Service 7, I, IX, X, XI
Agricultural Research Service 7, V
Agricultural Stabilization and Conservation Service 7, VII
Agriculture Department
Agricultural Marketing Service 7, I, IX, X, XI
Agricultural Research Service 7, V
Agricultural Stabilization and Conservation Service 7, VII
Animal and Plant Health Inspection Service 7, III; 9, I
Commodity Credit Corporation 7, XIV
Cooperative State Research Service 7, XXXIV
Economic Analysis Staff 7, XXXIX
Economic Research Service 7, XXXVII
Economics Management Staff 7, XL
Energy, Office of 7, XXIX
Environmental Quality, Office of 7, XXXI
Farmers Home Administration 7, XVIII
Federal Acquisition Regulation 48, 4
Federal Crop Insurance Corporation 7, IV
Federal Grain Inspection Service 7, VIII
Finance and Management, Office of 7, XXX
Food and Nutrition Service 7, II
Food Safety and Inspection Service 9, III
Foreign Agricultural Service 7, XV
Foreign Economic Development Service 7, XXI
Forest Service 36, II
General Sales Manager, Office of 7, XXV
Grants and Program Systems, Office of 7, XXXII
Information Resources Management, Office of 7, XXVII
Inspector General, Office of 7, XXVI
International Cooperation and Development Office 7, XXII
National Agricultural Library 7, XLI
National Agricultural Statistics Service 7, XXXVI
Operations Office 7, XXVIII
Packers and Stockyards Administration 9, II
Rural Electrification Administration 7, XVII
Rural Telephone Bank 7, XVI
Secretary of Agriculture, Office of 7, Subtitle A
Soil Conservation Service 7, VI
Transportation, Office of 7, XXXIII
World Agriculture Outlook Board 7, XXXVIII
Air Force Department 32, VII; 41, Subtitle C, Ch. 132
Federal Acquisition Regulation Supplement 48, 53
Alaska Natural Gas Transportation System, Office of the Federal
Inspector 10, XV
Alcohol, Tobacco and Firearms, Bureau of 27, I
AMTRAK 49, VII
American Battle Monuments Commission 36, IV
Animal and Plant Health Inspection Service 7, III; 9, I
Appalachian Regional Commission 5, IX
Architectural and Transportation Barriers Compliance Board 36, XI
Arms Control and Disarmament Agency, U.S. 22, VI
Army Department 32, V
Engineers, Corps of 33, II; 36, III
Federal Acquisition Regulation 48, 51
Assistant Secretary for Technology Policy, Department of Commerce 37,
IV
Benefits Review Board 20, VII
Bicentennial of the United States Constitution, Commission on the 45,
XX
Bilingual Education and Minority Languages Affairs, Office of 34, V
Blind and Other Severely Handicapped, Committee for Purchase from 41,
51
Board for International Broadcasting 22, XIII
Budget, Office of Management and 5, III
Census Bureau 15, I
Central Intelligence Agency 32, XIX
Child Support Enforcement, Office of 45, III
Christopher Columbus Quincentenary Jubilee Commission 45, XXII
Civil Rights Commission 45, VII
Civil Rights, Office for (Education Department) 34, I
Claims Collection Standards, Federal 4, II
Coast Guard 33, I; 46, I, III; 49, IV
Commerce Department 44, IV
Census Bureau 15, I
Assistant Secretary for Technology Policy 37, IV
Economic Affairs, Under Secretary 37, V
Economic Analysis, Bureau of 15, VIII
Economic Development Administration 13, III
Endangered Species Committee 50, IV
Export Administration Bureau 15, VII
Federal Acquisition Regulation 48, 13
Fishery Conservation and Management 50, VI
International Trade Administration 15, III; 19, III
National Institute of Standards and Technology 15, II
National Marine Fisheries Service 50, II, IV
National Oceanic and Atmospheric Administration 15, IX; 50, II, III,
IV, VI
National Telecommunications and Information Administration 15, XXIII;
47, III
Patent and Trademark Office 37, I
Productivity, Technology and Innovation, Assistant Secretary for 37,
IV
Secretary of Commerce, Office of 15, Subtitle A
Technology Administration 15, XI
Under Secretary for Technology 37, V
United States Travel and Tourism Administration 15, XII
Commercial Space Transportation, Office of, Department of
Transportation 14, III
Commission on the Bicentennial of the United States Constitution 45,
XX
Committee for Purchase from the Blind and Other Severely Handicapped
41, 51
Commodity Credit Corporation 7, XIV
Commodity Futures Trading Commission 17, I
Community Planning and Development, Office of Assistant Secretary for
24, V, VI
Community Services, Office of 45, X
Comptroller of the Currency 12, I
Construction Industry Collective Bargaining Commission 29, IX
Consumer Product Safety Commission 16, II
Cooperative State Research Service 7, XXXIV
Copyright Office 37, II
Copyright Royalty Tribunal 37, III
Cost Accounting Standards Board, Office of Federal Procurement Policy
48, 99
Council on Environmental Quality 40, V
Customs Service, United States 19, I
Defense Department 32, Subtitle A
Air Force Department 32, VII; 41, Subtitle C, Ch. 132
Army Department 32, V; 33, II; 36, III, 48, 51
Engineers, Corps of 33, II; 36, III
Federal Acquisition Regulation 48, 2
Navy Department 32, VI; 48, 52
Secretary of Defense, Office of 32, I
Defense Logistics Agency 32, XII
Defense Nuclear Facilities Safety Board 10, XVII
Delaware River Basin Commission 18, III
Drug Enforcement Administration 21, II
East-West Foreign Trade Board 15, XIII
Economic Affairs, Under Secretary (Commerce) 37, V
Economic Analysis, Bureau of 15, VIII
Economic Analysis Staff, Department of Agriculture 7, XXXIX
Economic Development Administration 13, III
Economics Management Staff 7, XL
Economic Research Service 7, XXXVII
Education, Department of
Bilingual Education and Minority Languages Affairs, Office of 34, V
Civil Rights, Office for 34, I
Educational Research and Improvement, Office of 34, VII
Elementary and Secondary Education, Office of 34, II
Federal Acquisition Regulation 48, 34
Postsecondary Education, Office of 34, VI
Secretary of Education, Office of 34, Subtitle A
Special Education and Rehabilitative Services, Office of 34, III
Vocational and Adult Education, Office of 34, IV
Educational Research and Improvement, Office of 34, VII
Elementary and Secondary Education, Office of 34, II
Employees' Compensation Appeals Board 20, IV
Employees Loyalty Board, International Organizations 5, V
Employment and Training Administration 20, V
Employment Standards Administration 20, VI
Endangered Species Committee 50, IV
Energy, Department of 10, II, III, X; 41, 109
Federal Acquisition Regulation 48, 9
Federal Energy Regulatory Commission 18, I
Energy, Office of, Department of Agriculture 7, XXIX
Engineers, Corps of 33, II; 36, III
Engraving and Printing, Bureau of 31, VI
Environmental Protection Agency 40, I; 41, 115; 48, 15
Environmental Quality, Office of (Agriculture Department) 7, XXXI
Equal Employment Opportunity Commission 29, XIV
Equal Opportunity, Office of Assistant Secretary for 24, I
Executive Office of the President 3, I
Administration, Office of 5, XV
Export Administration Bureau 15, VII
Export-Import Bank of the United States 12, IV
Family Assistance, Office of 45, II
Family Support Administration 45, II, III, IV, X
Farm Credit Administration 12, VI
Farm Credit System Assistance Board 12, XIII
Farm Credit System Insurance Corporation 12, XIV
Farmers Home Administration 7, XVIII
Federal Acquisition Regulation 48, 1
Federal Aviation Administration 14, I
Federal Claims Collection Standards 4, II
Federal Communications Commission 47, I
Federal Contract Compliance Programs, Office of 41, 60
Federal Crop Insurance Corporation 7, IV
Federal Deposit Insurance Corporation 12, III
Federal Election Commission 11, I
Federal Emergency Management Agency 44, I; 48, 44
Federal Energy Regulatory Commission 18, I
Federal Financial Institutions Examination Council 12, XI
Federal Financing Bank 12, VIII
Federal Grain Inspection Service 7, VIII
Federal Highway Administration 23, I, II; 49, III
Federal Home Loan Mortgage Corporation 1, IV
Federal Housing Finance Board 12, IX
Federal Information Resources Management Regulations 41, Subtitle E,
Ch. 201
Federal Inspector for the Alaska Natural Gas Transportation System,
Office of 10, XV
Federal Labor Relations Authority, and General Counsel of the Federal
Labor Relations Authority 5, XIV; 22, XIV
Federal Law Enforcement Training Center 31, VII
Federal Maritime Commission 46, IV
Federal Mediation and Conciliation Service 29, XII
Federal Mine Safety and Health Review Commission 29, XXVII
Federal Pay, Advisory Committee on 5, IV
Federal Prison Industries, Inc. 28, III
Federal Procurement Policy Office 48, 99
Federal Property Management Regulations 41, 101
Federal Property Management Regulations System 41, Subtitle C
Federal Railroad Administration 49, II
Federal Register, Administrative Committee of 1, I
Federal Register, Office of 1, II
Federal Reserve System 12, II
Federal Retirement Thrift Investment Board 5, VI
Federal Service Impasses Panel 5, XIV
Federal Trade Commission 16, I
Federal Travel Regulation System 41, Subtitle F
Finance and Management, Department of Agriculture 7, XXX
Fine Arts Commission 45, XXI
Fiscal Service 31, II
Fish and Wildlife Service, United States 50, I, IV
Fishery Conservation and Management 50, VI
Fishing and Whaling, International Regulatory Agencies 50, III
Food and Drug Administration 21, I
Food and Nutrition Service 7, II
Food Safety and Inspection Service 9, III
Foreign Agricultural Service 7, XV
Foreign Assets Control, Office of 31, V
Foreign Claims Settlement Commission of United States 45, V
Foreign Economic Development Service 7, XXI
Foreign Service Grievance Board 22, IX
Foreign Service Impasse Disputes Panel 22, XIV
Foreign Service Labor Relations Board 22, XIV
Foreign-Trade Zones Board 15, IV
Forest Service 36, II
General Accounting Office 4, I, II, III
General Sales Manager, Office of 7, XXV
General Services Administration
Contract Appeals Board 48, 61
Federal Acquisition Regulation 48, 5
Federal Information Resources Management Regulations 41, Subtitle E,
Ch. 201
Federal Property Management Regulations System 41, 101, 105
Federal Travel Regulation System 41, Subtitle F
Payment of Expenses Connected With the Death of Certain Employees 41,
303
Relocation Allowances 41, 302
Travel Allowances 41, 301
Geological Survey 30, IV
Government Ethics, Office of 5, XVI
Government National Mortgage Association 24, III
Grants and Program Systems, Office of 7, XXXII
Great Lakes Pilotage 46, III
Harry S. Truman Scholarship Foundation 45, XVIII
Health and Human Services, Department of 45, Subtitle A
Child Support Enforcement, Office of 45, III
Community Services, Office of 45, X
Family Assistance, Office of 45, II
Family Support Administration 45, II, III, IV, X
Federal Acquisition Regulation 48, 3
Food and Drug Administration 21, I
Health Care Financing Administration 42, IV
Human Development Services Office 45, XIII
Inspector General, Office of 42, V
Public Health Service 42, I
Refugee Resettlement, Office of 45, IV
Social Security Administration 20, III; 45, IV
Health Care Financing Administration 42, IV
Housing and Urban Development, Department of
Community Planning and Development, Office of Assistant Secretary for
24, V, VI
Equal Opportunity, Office of Assistant Secretary for 24, I
Federal Acquisition Regulation 48, 24
Government National Mortgage Association 24, III
Housing -- Federal Housing Commissioner, Office of Assistant
Secretary for 24, II, VIII, X, XX
Inspector General, Office of 24, XII
Mortgage Insurance and Loan Programs Under Emergency Homeowners'
Relief Act 24, XV
Public and Indian Housing, Office of Assistant Secretary for 24, IX
Secretary, Office of 24, Subtitle B, VII
Solar Energy and Energy Conservation Bank 24, XI
Housing -- Federal Housing Commissioner, Office of Assistant
Secretary for 24, II, VIII, X, XX
Human Development Services Office 45, XIII
Immigration and Naturalization Service 8, I
Indian Affairs, Bureau of 25, I
Indian Arts and Crafts Board 25, II
Information Agency, United States 22, V; 48, 19
Information Resources Management, Office of, Agriculture Department
7, XXVII
Information Security Oversight Office 32, XX
Inspector General, Office of, Agriculture Department 7, XXVI
Inspector General, Office of, Health and Human Services Department
42, V
Inspector General, Office of, Housing and Urban Development
Department 24, XII
Inter-American Foundation 22, X
Intergovernmental Relations, Advisory Commission on 5, VII
Interior Department
Endangered Species Committee 50, IV
Federal Acquisition Regulation 48, 14
Federal Property Management Regulations System 41, 114
Fish and Wildlife Service, United States 50, I, IV
Geological Survey 30, IV
Indian Affairs, Bureau of 25, I
Indian Arts and Crafts Board 25, II
Land Management Bureau 43, II
Minerals Management Service 30, II
Mines, Bureau of 30, VI
National Park Service 36, I
Reclamation Bureau 43, I
Secretary of the Interior, Office of 43, Subtitle A
Surface Mining and Reclamation Appeals, Board of 30, III
Surface Mining Reclamation and Enforcement, Office of 30, VII
United States Fish and Wildlife Service 50, I, IV
Internal Revenue Service 26, I
International Boundary and Water Commission, United States and Mexico
22, XI
International Cooperation and Development Office, Department of
Agriculture 7, XXII
International Development, Agency for 22, II
International Development Cooperation Agency 22, XII
International Development, Agency for 22, II
Overseas Private Investment Corporation 22, VII
International Joint Commission, United States and Canada 22, IV
International Organizations Employees Loyalty Board 5, V
International Regulatory Agencies (Fishing and Whaling) 50, III
International Trade Administration 15, III; 19, III
International Trade Commission, United States 19, II
Interstate Commerce Commission 49, X
Japan-United States Friendship Commission 22, XVI
Joint Board for the Enrollment of Actuaries 20, VIII
Justice Department 28, I; 41, 128
Drug Enforcement Administration 21, II
Federal Acquisition Regulation 48, 28
Federal Claims Collection Standards 4, II
Federal Prison Industries, Inc. 28, III
Foreign Claims Settlement Commission of the United States 45, V
Immigration and Naturalization Service 8, I
Offices of Independent Counsel 28, VI
Prisons, Bureau of 28, V
Labor Department
Benefits Review Board 20, VII
Employees' Compensation Appeals Board 20, IV
Employment and Training Administration 20, V
Employment Standards Administration 20, VI
Federal Acquisition Regulation 48, 29
Federal Contract Compliance Programs, Office of 41, 60
Federal Procurement Regulations System 41, 50
Labor-Management Relations and Cooperative Programs, Bureau of 29, II
Labor-Management Standards, Office of 29, IV
Mine Safety and Health Administration 30, I
Occupational Safety and Health Administration 29, XVII
Pension and Welfare Benefits Administration 29, XXV
Public Contracts 41, 50
Secretary of Labor, Office of 29, Subtitle A
Veterans' Employment and Training, Office of the Assistant Secretary
for 41, 61; 20, IX
Wage and Hour Division 29, V
Workers' Compensation Programs, Office of 20, I
Labor-Management Relations and Cooperative Programs, Bureau of 29, II
Labor-Management Standards, Office of 29, IV
Land Management, Bureau of 43, II
Legal Services Corporation 45, XVI
Library of Congress 36, VII
Copyright Office 37, II
Management and Budget, Office of 5, III; 48, 99
Marine Mammal Commission 50, V
Maritime Administration 46, II
Merit Systems Protection Board 5, II
Micronesian Status Negotiations, Office for 32, XXVII
Mine Safety and Health Administration 30, I
Minerals Management Service 30, II
Mines, Bureau of 30, VI
Minority Business Development Agency 15, XIV
Miscellaneous Agencies 1, IV
Monetary Offices 31, I
Mortgage Insurance and Loan Programs Under the Emergency Homeowners'
Relief Act, Department of Housing and Urban Development 24, XV
National Aeronautics and Space Administration 14, V; 48, 18
National Agricultural Library 7, XLI
National Agricultural Statistics Service 7, XXXVI
National Archives and Records Administration 36, XII
National Bureau of Standards 15, II
National Capital Planning Commission 1, IV
National Commission for Employment Policy 1, IV
National Commission on Libraries and Information Science 45, XVII
National Credit Union Administration 12, VII
National Foundation on the Arts and the Humanities 45, XI
National Highway Traffic Safety Administration 23, II, III; 49, V
National Indian Gaming Commission 25, III
National Institute of Standards and Technology 15, II
National Labor Relations Board 29, I
National Marine Fisheries Service 50, II, IV
National Mediation Board 29, X
National Oceanic and Atmospheric Administration 15, IX; 50, II, III,
IV, VI
National Park Service 36, I
National Railroad Adjustment Board 29, III
National Railroad Passenger Corporation (AMTRAK) 49, VII
National Science Foundation 45, VI; 48, 25
National Security Council 32, XXI
National Security Council and Office of Science and Technology Policy
47, II
National Telecommunications and Information Administration 15, XXIII;
47, III
National Transportation Safety Board 49, VIII
Navy Department 32, VI; 48, 52
Neighborhood Reinvestment Corporation 24, XXV
Nuclear Regulatory Commission 10, I
Occupational Safety and Health Administration 29, XVII
Occupational Safety and Health Review Commission 29, XX
Office of Independent Counsel 28, VII
Office of Navajo and Hopi Indian Relocation 25, IV
Offices of Independent Counsel, Department of Justice 28, VI
Operations Office, Department of Agriculture 7, XXVIII
Overseas Private Investment Corporation 22, VII
Oversight Board 12, XV
Packers and Stockyards Administration 9, II
Panama Canal Commission 48, 35
Panama Canal Regulations 35, I
Patent and Trademark Office 37, I
Payment of Expenses Connected With the Death of Certain Employees 41,
303
Peace Corps 22, III
Pennsylvania Avenue Development Corporation 36, IX
Pension and Welfare Benefits Administration, Department of Labor 29,
XXV
Pension Benefit Guaranty Corporation 29, XXVI
Personnel Management, Office of 5, I; 45, VIII; 48, 17
Federal Employees Health Benefits Acquisition Regulation 48, 16
Postal Rate Commission 39, III
Postal Service, United States 39, I
Postsecondary Education, Office of 34, VI
President's Commission on White House Fellowships 1, IV
Presidential Documents 3
Prisons, Bureau of 28, V
Productivity, Technology and Innovation, Assistant Secretary
(Commerce) 37, IV
Property Management Regulations System, Federal 41, Subtitle C
Public Contracts, Department of Labor 41, 50
Public Health Service 42, I
Railroad Retirement Board 20, II
Reclamation Bureau 43, I
Reduction in Meeting and Training Allowance Payments 41, 304
Refugee Resettlement, Office of 45, IV
Regional Action Planning Commissions 13, V
Relocation Allowances 41, 302
Research and Special Programs Administration 49, I
Resolution Trust Corporation 12, XVI
Rural Electrification Administration 7, XVII
Rural Telephone Bank 7, XVI
Saint Lawrence Seaway Development Corporation 33, IV
Science and Technology Policy, Office of 32, XXIV
Science and Technology Policy, Office of, and National Security
Council 47, II
Secret Service 31, IV
Securities and Exchange Commission 17, II
Selective Service System 32, XVI
Small Business Administration 13, I; 48, 22
Smithsonian Institution 36, V
Social Security Administration 20, III; 45, IV
Soil Conservation Service 7, VI
Solar Energy and Energy Conservation Bank, Department of Housing and
Urban Development 24, XI
Soldiers' and Airmen's Home, United States 5, XI
Special Counsel, Office of 5, VIII
Special Education and Rehabilitative Services, Office of 34, III
State Department 22, I
Federal Acquisition Regulation 48, 6
Surface Mining and Reclamation Appeals, Board of 30, III
Susquehanna River Basin Commission 18, VIII
Technology Administration 15, XI
Tennessee Valley Authority 18, XIII
Thrift Supervision Office, Department of the Treasury 12, V
Trade Representative, United States, Office of 15, XX
Transportation, Department of 44, IV
Coast Guard 33, I; 46, I, III; 49, IV
Commercial Space Transportation, Office of 14, III
Contract Appeals Board 48, 63
Federal Acquisition Regulation 48, 12
Federal Aviation Administration 14, I
Federal Highway Administration 23, I, II; 49, III
Federal Railroad Administration 49, II
Maritime Administration 46, II
National Highway Traffic Safety Administration 23, II, III; 49, V
Research and Special Programs Administration 49, I
Saint Lawrence Seaway Development Corporation 33, IV
Secretary of Transportation, Office of 14, II; 49, Subtitle A
Urban Mass Transportation Administration 49, VI
Transportation, Office of, Department of Agriculture 7, XXXIII
Travel Allowance 41, 301
Travel and Tourism Administration, United States 15, XII
Treasury Department 17, IV
Alcohol, Tobacco and Firearms, Bureau of 27, I
Comptroller of the Currency 12, I
Customs Service, United States 19, I
Engraving and Printing, Bureau of 31, VI
Federal Acquisition Regulation 48, 10
Federal Law Enforcement Training Center 31, VII
Fiscal Service 31, II
Foreign Assets Control, Office of 31, V
Internal Revenue Service 26, I
Monetary Offices 31, I
Secret Service 31, IV
Secretary of the Treasury, Office of 31, Subtitle A
Thrift Supervision Office 12, V
United States Customs Service 19, I
Truman, Harry S. Scholarship Foundation 45, XVIII
Under Secretary for Technology, Department of Commerce 37, V
United States and Canada, International Joint Commission 22, IV
United States Arms Control and Disarmament Agency 22, VI
United States Customs Service 19, I
United States Fish and Wildlife Service 50, I, IV
United States Information Agency 22, V; 48, 19
United States International Development Cooperation Agency 22, XII
United States International Trade Commission 19, II
United States Postal Service 39, I
United States Soldiers' and Airmen's Home 5, XI
United States Trade Representative, Office of 15, XX
United States Travel and Tourism Adminstration 15, XII
Urban Mass Transportation Administration 49, VI
Veterans Affairs Department 38, I; 48, 8
Veterans' Employment and Training, Office of the Assistant Secretary
for 41, 61; 20, IX
Vice President of the United States, Office of 32, XXVIII
Vocational and Adult Education, Office of 34, IV
Wage and Hour Division 29, V
Water Resources Council 18, VI
Workers' Compensation Programs, Office of 20, I
World Agriculture Outlook Board 7, XXXVIII
42 CFR 1007.21 42 CFR (10-1-92 Edition)
42 CFR 1007.21 OMB Control Numbers
42 CFR 1007.21
42 CFR 1007.21
42 CFR 1007.21 Table of OMB Control Numbers
The OMB control numbers for chapter IV of title 42 appear in
400.310. Sections 400.300 and 400.310 are reprinted below for the
convenience of the user.
42 CFR 1007.21 Subpart C -- OMB Control Numbers for Approved
Collections of Information
Source: 49 FR 4477, Feb. 7, 1984, unless otherwise noted.
42 CFR 400.300 Scope.
This subpart collects and displays control numbers assigned by the
Office of Management and Budget (OMB) to collections of information
contained in HCFA regulations, in accordance with OMB's regulations for
controlling paperwork burdens on the public, 5 CFR Part 1320. HCFA
intends that the subpart comply with the requirements of section 3507(f)
of the Paperwork Reduction Act of 1980, 44 U.S.C. Chapter 35 which
requires that agencies shall not engage in a ''collection of
information'' without obtaining a control number from OMB.
42 CFR 400.310 Display of currently valid OMB control numbers.
(53 FR 16268, May 6, 1988; 53 FR 21762, June 9, 1988, as amended at
53 FR 36571, Sept. 21, 1988; 54 FR 21066, May 16, 1989)
42 CFR 400.310 42 CFR (10-1-92 Edition)
42 CFR 400.310 Redesignation Table I
42 CFR 400.310
42 CFR 400.310
42 CFR 400.310 Redesignation Table I
At 51 FR 22042, June 17, 1986, certain sections of regulations
formerly appearing in title 42, part 405, subpart J were redesignated as
part 482.
For the convenience of the user, the following table shows the
relationship of the redesignated sections.
42 CFR 400.310 42 CFR (10-1-92 Edition)
42 CFR 400.310 Redesignation Table II
42 CFR 400.310
42 CFR 400.310
42 CFR 400.310 Redesignation Table II
At 51 FR 34764, Sept. 30, 1986, a document was published by the
Department of Health and Human Services which established in title 42 a
new chapter V, Office of Inspector General -- Health Care, consisting of
parts 1000 through 1004. This document also removed part 101 from title
45. A second document at 51 FR 34786, Sept. 30, 1986 amended title 42,
parts 412, 420, 455, 466, 474, and 489.
This table identifies the sections of 42 CFR chapter IV and 45 CFR
subtitle A from which the new 42 CFR chapter V derives its content. In
the case of title 45, all of the source sections were redesignated. In
the case of 42 CFR chapter IV, some of the source sections were
redesignated, but others were retained in chapter IV and duplicated in
chapter V.
42 CFR 400.310 42 CFR (10-1-92 Edition)
42 CFR 400.310 Redesignation Table III
42 CFR 400.310
42 CFR 400.310
42 CFR 400.310 Redesignation Table III
At 52 FR 22446, June 12, 1987, certain sections of regulations
appearing in title 42, part 405, subparts F and O were redesignated as
part 498 of title 42.
For the convenience of the user, the following table shows the
relationship of the redesignated sections.
42 CFR 400.310 42 CFR (10-1-92 Edition)
42 CFR 400.310 Redesignation Table IV
42 CFR 400.310
42 CFR 400.310
42 CFR 400.310 Redesignation Table IV
At 53 FR 23100, June 17, 1988, 405.1901 -- 405.1913 (subpart S),
formerly appearing in title 42, part 405, were redesignated as part 488
of title 42.
For the convenience of the user, the following table shows the
relationship of the redesignated sections.
42 CFR 400.310 42 CFR (10-1-92 Edition)
42 CFR 400.310 Redesignation Table V
42 CFR 400.310
42 CFR 400.310
42 CFR 400.310 Redesignation Table V
At 53 FR 36571, Sept. 21, 1988, the Department of Health and Human
Services revised part 430. The following derivation table identifies
the sections of 45 CFR chapter IV from which 42 CFR chapter IV derives
its content.
42 CFR 400.310 42 CFR (10-1-92 Edition)
42 CFR 400.310 Redesignation Table VI
42 CFR 400.310
42 CFR 400.310
42 CFR 400.310 Redesignation Table VI
At 54 FR 33355, August 14, 1989, 405.1201 -- 405.1230 (subpart L),
formerly appearing in title 42, part 405, were redesignated as part 484
of title 42.
For the convenience of the user, the following table shows the
relationship of the redesignated sections.
42 CFR 400.310 42 CFR (10-1-92 Edition)
42 CFR 400.310 Redesignation Table VII
42 CFR 400.310
42 CFR 400.310
42 CFR 400.310 Redesignation Table VII
In title 42, part 431, 431.800 -- 431.865 (subpart P), were
redesignated at 55 FR 22165, May 31, 1990. The following tables show
the relationship of the former sections to the current ones.
42 CFR 400.310 42 CFR (10-1-92 Edition)
42 CFR 400.310 List of CFR Sections Affected
42 CFR 400.310 List of CFR Sections Affected
All changes in this volume of the Code of Federal Regulations which
were made by documents published in the Federal Register since January
1, 1986, are enumerated in the following list. Entries indicate the
nature of the changes effected. Page numbers refer to Federal Register
pages. The user should consult the entries for chapters and parts as
well as sections for revisions.
For the period before January 1, 1986, see the ''List of CFR Sections
Affected, 1949-1963, 1964-1972, and 1973-1985'' published in seven
separate volumes.
42 CFR 400.310 1986
42 CFR
51 FR
Page
Chapter IV
430.0 (b)(3) revised 36227
431.17 (b) introductory text, (1) introductory text and (iv) revised;
(b)(1)(vi) added 7210
431.56 Added 41350
431.300 Revised 7210
431.305 (b)(6) added 7210
431.306 (d) revised; (g) added 7210
431.800 (h) revised 7210
431.804 (c)(6) revised 7210
433 Authority citation revised 41350
433.10 (b) amended 41350
433.32 -- 433.45 (Subpart B) Authority citation revised 36227
433.40 Added 36227
433.111 Revised 45330
433.112 Heading and (a) revised 45330
433.139 (d) revised 16319
435 Heading revised 41350
435.2 Introductory text revised 41350
435.3 Amended 41350
435.4 Amended 7211
435.135 Revised 12330
Technical correction 12855
435.136 Added 12330
Technical correction 12855
435.732 Added; CFR correction 3959
435.910 (a), (b)(3), and (e) introductory text and (3) revised;
(b)(1), (c), and (d) removed; (g) added 7211
435.912 Heading revised 7211
435.919 Heading revised 7211
435.920 (b) revised 7211
435.940 -- 435.965 Undesignated center heading 7211
435.940 Added 7211
435.945 Added 7211
435.948 Added 7212
435.952 Added 7212
435.955 Added 7213
435.960 Added 7213
Section number and (a) correctly designated 13501
435.965 Added 7213
435.1009 Amended 19181
440.1 Amended 22041
440.10 Heading and (a)(3) amended 22041
440.40 Heading and (a) amended 22041
440.140 Revised 22041
440.150 Heading and (a) amended 22041
440.250 (d) amended 22041
441.11 (b)(3) revised; (c) (2), (4), and (6) amended 22041
441.13 (a)(2) amended 22041
441.40 Amended 22041
442 Authority citation revised 21558
442.1 (a) amended 24490
442.2 Amended 24491
442.30 (a) introductory text and (4) revised 21558
442.117 -- 442.119 Added 24491
442.321 (a) interim revision and (c) interim addition (47 FR 47393)
confirmed 23545
442.322 Interim revision (47 FR 47393) confirmed 23545
442.323 Interim revision (47 FR 47393) confirmed 23545
442.401 Amended 13227
442.507 Removed 13227
442.508 Revised 13227
(b)(1)(iii) corrected 16688, 17341
Interim revision (47 FR 47393) confirmed 23545
442.509 Removed 13228
447.40 (a) revised 24491
447.252 (c) amended 34833
447.371 (a) amended 34833
455 Heading and authority citation revised 34787
455.1 Revised 34787
455.2 Introductory text amended 34788
455.3 Added 34788
455.15 (a)(1) amended 34788
455.100 -- 455.106 (Subpart B) Authority citation removed 34788
455.101 Amended 34788
455.200 -- 455.234 (Subpart C) Removed 34788
455.208 (c)(1) corrected 9793
455.213 (b)(1) corrected 9793
455.300 (Subpart D) Removed 34788
456.2 (b)(1) amended; (b)(2) removed; (b)(3) redesignated as (b)(2)
43198
456.51 (a)(1) amended; (a)(2) removed 22041
456.144 (c)(1) amended 43198
456.244 (c)(1) amended 43198
456.344 (c)(1) amended 43198
456.501 (c) amended 22042
456.650 (c)(1) amended; (c)(2) removed; (c)(3) redesignated as
(c)(2) 43198
456.654 (a)(4) amended 43198
460 Removed 43196
461 Removed 43196
462 Authority citation revised 43197
462.1 Amended 43197
462.2 -- 462.16 (Subpart B) Removed 43197
463 Removed 43197
466 Authority citation revised; section authority citations removed
34788
Authority citation revised 43197
466.1 Amended 43197
466.2 -- 466.63 (Subpart B) Removed 43197
466.70 (f) added 34788
473 Authority citation revised 43197
473.1 -- 473.6 (Subpart A) Removed 43197
474 Removed 34788
476 Authority citation revised 43197
476.1 -- 476.4 (Subpart A) Removed 43197
478 Removed 43197
482 Added (regulations transferred from 405.1011 -- 405.1042 (Subpart
J)) 22042
Authority citation corrected 27847
482.12 (a)(1) corrected 27847
482.25 (b)(9) corrected 27848
482.26 (b)(1) corrected 27848
482.27 (a)(3)(iii)(A) corrected 27848
482.57 (b)(2) corrected 27848
482.60 (a) corrected 27848
482.61 (a)(4) corrected 27848
482.62 (b)(2) and (g)(1) corrected 27848
482.66 Introductory text corrected 27848
(a) introductory text amended and (a)(1) amended 34833
485.70 Introductory text amended 41352
489 Authority citation revised 16789, 24492, 34788
489.1 Introductory text revised 24492
489.2 (a) amended 24492
489.3 Heading revised; text amended 24492
489.12 (b)(2) amended 34833
489.21 (b)(3) amended 22052
489.23 (d) added; interim 16789
(d)(2) amended 41352
489.30 Heading and (b) heading, (1), and (2) revised; (a)(3)
amended; (a)(4) and (b)(5) added 41350
489.32 (b) amended 34833
489.52 -- 489.57 (Subpart E) Heading revised 24492
489.50 Redesignated as 489.66 24492
489.53 Revised 24492
489.54 Added 24492
(d) amended 34788
489.57 Revised 24493
489.60 -- 489.66 (Subpart F) Heading added 24493
489.60 Added 24493
489.62 Added 24493
489.64 Added 24493
489.66 Redesignated from 489.50 24492
Chapter V
Chapter V Chapter established 34766
1000 (Subchapter A and part) Added 34766
1000 -- 1004 (Subchapter B) Added 34767
1001 Added 34767
1001.221 (b) corrected 37577
1002 Added 34772
1003 Added 34777
1003.100 (a) corrected 39528
1003.106 (c)(1) and (2) corrected 39528
1003.115 (b)(5) corrected 39528
1003.116 (b)(2)(i) correctly designated 37577
(b)(2)(ii) corrected 39528
1004 Added 34783
42 CFR 400.310 1987
42 CFR
52 FR
Page
Chapter IV
430.0 (b)(2)(ii) amended; eff. 10-29-87 28657
431.56 (b)(2) corrected 4499
431.153 (d)(1) amended 22454
431.305 (b) introductory text republished; (b)(7) added 5975
431.306 (h) added 5975
433 Authority citation revised 5975
433.138 Revised 5975
434.2 Amended 22322
435.945 (b) revised 5977
435.960 Revised 5977
440.30 (c) revised 47934
441.11 Revised 32550
442.16 Introductory text revised 32551
442.40 Added 32551
442.42 Added 32551
442.336 (a) revised 22645
Technical correction 23628
447.253 (a) and (b) introductory text, (1)(ii)(B), and (2) revised;
(b)(1)(ii) introductory text republished; eff. in part 10-26-87 28147
447.256 (a)(1) amended; eff. 10-26-87 28147
447.257 Undesignated center heading and section added; eff.
10-26-87 28147
447.272 Added; eff. 10-26-87 28147
447.280 Revised; eff. 10-26-87 28148
447.301 Added; eff. 10-29-87 28657
447.321 Revised; eff. 10-26-87 28148
447.331 Revised; eff. 10-29-87 28657
447.332 Revised; eff. 10-29-87 28658
447.333 Revised; eff. 10-29-87 28658
466.70 (e)(2) redesignated as (e)(3); new (e)(2) added 33059
485.74 Amended 22454
489 Authority citation revised 27765
489.16 (c)(2) amended 22454
489.21 (g) added 27765
489.53 (d) amended 22454
498 Added; regulations transferred from 405.640 and 405.1501 --
405.1595 (Subpart O) 22446
498.3 (b) introductory text republished; (b)(10) added 27765
Chapter V
1001 Authority citation revised 11651
1001.3 Amended 22454
1001.100 Revised 11651
1001.104 Added 11651
1001.128 (b) and (c) amended 22454
1001.134 (d) revised 11651
(b)(2)(ii) amended 22454
1001.201 (c) amended 22454
1003 Authority citation revised 11651
1003.100 (a) revised 11652
1003.102 (b) introductory text revised; (b)(3) added 11652
1004.100 (g) amended 22454
1004.130 (a)(1) amended 22454
42 CFR 400.310 1988
42 CFR
53 FR
Page
Chapter IV
430 Revised; eff. 10-21-88 36571
431.610 (f)(1) amended; eff. 10-3-88 20494
431.625 (a)(1) corrected 657
434.27 (a) introductory text republished; (a)(3) revised 12016
434.36 Revised 12016
434.55 Removed 12016
435 Final notification 16550
435.722 (c) revised 3595
Technical correction 12681
435.725 (a), (b) introductory text, (c) introductory text and (4),
and (d) revised; (e) and (f) added 3595
Technical correction 12681
435.733 (a), (b) introductory text, (c) introductory text and (4),
and (d) revised; (e) and (f) added 3596
Technical correction 12681
435.832 (a), (b) introductory text, (c) introductory text and (4),
and (d) revised; (e) and (f) added 3596
Correctly designated 5344
Technical correction 12681
435.952 (g) amended 6648
435.1009 Corrected 657
Amended; eff. 10-3-88 20495
436.832 (a), (b) introductory text, (c) introductory text and (4),
and (d) revised; (e) and (f) added 3597
Technical correction 12681
440.150 (c)(3) amended; eff. 10-3-88 20495
441.10 Introductory text republished; (i) added 6549
441.13 Heading revised; (c) added 6549
441.16 Added 48647
442 Authority citation revised 20495
442.1 (a) amended 1993
(a) amended; eff. 10-3-88 20495
442.2 Amended 1993
442.13 (b)(1) amended; (c) revised; eff. 10-3-88 20495
442.14 (b)(3) amended; eff. 10-3-88 20495
442.16 (b) amended; eff. 10-3-88 20495
442.30 (a) introductory text republished; (a) (1) and (4) revised;
eff. 10-3-88 20495
(a) introductory text and (4) revised; (a)(5) redesignated as (a)(8)
and revised; new (a) (5), (6), and (7) added 23101
442.100 -- 442.119 (Subpart C) Heading revised 1993
442.100 Revised; eff. 10-3-88 20495
442.101 (d) and (e) revised; eff. 10-3-88 20495
442.105 (e) amended 1993
Heading and introductory text revised; eff. 10-3-88 20496
442.109 Redesignated from 442.110 1993
442.110 Redesignated as 442.109; new 442.110 redesignated from
442.111 and (a) amended 1993
Heading revised; eff. 10-3-88 20496
442.111 Redesignated as 442.110 and (a) amended; new 442.111
redesignated from 442.112 and heading revised 1993
442.112 Redesignated as 442.111 and heading revised; new 442.112
redesignated from 442.113 and heading revised 1993
(c)(5) amended 1994
442.113 Redesignated as 442.112 and heading revised; new 442.113
redesignated from 442.115 and heading revised 1993
(a) introductory text amended 1994
442.114 Added 1994
442.115 Redesignated as 442.113 and heading revised 1993
Added 1994
442.116 Added 1994
442.117 (a) introductory text republished; (a)(1) revised; eff.
10-3-88 20496
442.118 (b)(1) and (3)(i) amended; eff. 10-3-88 20496
442.119 (a)(1) and (b)(1) amended; eff. 10-3-88 20496
442.252 Removed; eff. 10-3-88 20496
442.254 (b) revised; eff. 10-3-88 20496
442.321 (a), (c) and footnote 1 revised 11509
442.322 Removed 11509
442.323 Revised 11509
442.400 -- 442.516 (Subpart G) Removed; eff. 10-3-88 20496
466.86 (a)(1)(i) amended 6648
482 Authority citation revised 6549
482.2 (a)(2) amended 6648
482.12 (c) introductory text republished; (c)(5) added 6549
(c)(5)(i)(B) corrected 18987
482.41 (b)(1) and footnote 1 revised 11509
483 Added; eff. 10-3-88 20496
485 Heading and authority citation revised 6549
Authority citation corrected 18987
485.301 -- 485.308 (Subpart D) Added 6549
485.304 (a) corrected 9172
(g)(1) and (m) corrected 18987
485.305 Heading corrected 18987
485.306 (a) introductory text corrected 9172
Heading correctly revised 18987
488 Added 22859
488.18 Redesignated from 405.1903 and (a) and (b) amended 23100
488.20 Redesignated from 405.1904 and (a) amended 23100
488.24 Redesignated from 405.1905 23100
488.26 Redesignated from 405.1906 and revised 23100
488.28 Redesignated from 405.1907 and (a) amended 23100
488.50 Redesignated from 405.1908 and (a) introductory text and (1),
(b) and (c) amended 23100
488.52 Redesignated from 405.1909 and (a), (b), (c) and (d) amended
23100
488.54 Redesignated from 405.1910 23100
488.56 Redesignated from 405.1911 and heading revised and (a) and (b)
amended 23100
488.60 Redesignated from 405.1912 and heading revised, (a) and (b)
and (f) amended, and nomenclature change 23100
488.64 Redesignated from 405.1913 and nomenclature change 23100
489 Authority citation revised 38535
Addendum corrected 38835
489.23 Removed 38535
489.30 (a)(4) amended 6649
Amendment at 53 FR 6649 removed 12945
498.2 Amended 6551
498.3 (b) introductory text republished; (b)(4) revised 6551
(b)(4) amended 6649
498.56 (a)(1) and (b) introductory text republished; (b)(5) added
31335
Chapter V
1003.132 Revised 49413
42 CFR 400.310 1989
42 CFR
54 FR
Page
Chapter IV
433 Authority citation revised 5459
433.10 (b) revised 21066
433.32 -- 433.45 (Subpart B) Authority citation removed 5459
433.110 (a)(2)(ii) revised 41973
433.111 (b) revised 41973
433.112 Authority citation removed 5459
(a) and (b) introductory text republished, (b)(6) revised; (c) added
41973
433.113 (a) introductory text republished; (a)(2) revised 41973
433.114 (b)(2) amended 41973
433.116 Authority citation removed 5459
433.119 Revised 41973
433.120 Heading and (a) revised 41974
433.121 Heading, (a), and (b) revised 41974
433.122 Revised 41974
433.130 Nomenclature change 41974
433.131 Nomenclature change 41974
433.138 (g)(1)(i) amended; interim 8741
433.300 -- 433.322 (Subpart F) Added 5459
433.304 Corrected 8435
433.316 (c)(2) and (3) corrected 8435
433.318 (c) introductory text corrected 8435
435.541 Revised 50761
435.911 (a) introductory text republished; (a)(1) revised 50762
435.945 (a) revised; (h) added; interim 8741
435.952 (a), (c), (d), and (e) revised; interim 8741
435.953 Added; interim 8742
436.541 Revised 50762
441.11 Nomenclature change; (c) introductory text republished;
(c)(8) added 4027
442.2 Amended 5358
Eff. 1-1-90 29717
Regulation at 54 FR 5358 and 54 FR 29717 effective date delayed to
10-1-90 53611
442.13 (b)(1) amended 5358
Eff. 1-1-90 29717
(b) and (c)(2) correctly revised; eff. 1-1-90 37466
Regulation at 54 FR 5358 and 54 FR 29717 effective date delayed to
10-1-90 53611
442.30 (a)(1) revised 5358
Eff. 1-1-90 29717
(a)(1) correctly revised; eff. 1-1-90 37467
Regulation at 54 FR 5358 and 54 FR 29717 effective date delayed to
10-1-90 53611
442.101 (d)(1) revised 5358
Eff. 1-1-90 29717
(d)(1) correctly revised; eff. 1-1-90 34767
Regulation at 54 FR 5358 and 54 FR 29717 effective date delayed to
10-1-90 53611
442.105 Heading and introductory text revised; (c)(1) and (d)(1)
amended 5358
Eff. 1-1-90 29717
Introductory text correctly revised; eff. 1-1-90 34767
Regulation at 54 FR 5358 and 54 FR 29717 effective date delayed to
10-1-90 53611
442.117 (a) amended 5358
Eff. 1-1-90 29717
(a)(1) correctly revised; eff. 1-1-90 37467
Regulation at 54 FR 5358 and 54 FR 29717 effective date delayed to
10-1-90 53611
442.118 (a) and (b)(1) and (3)(i) amended 5358
Eff. 1-1-90 29717
(a), (b)(1) and (3)(i) correctly revised; eff. 1-1-90 37467
Regulation at 54 FR 5358 and 54 FR 29717 effective date delayed to
10-1-90 53611
442.119 (a)(1) and (b)(1) amended 5359
Eff. 1-1-90 29717
Regulation at 54 FR 5359 and 54 FR 29717 effective date delayed to
10-1-90 53611
442.200 -- 442.202 (Subpart D) Removed 5359
Eff. 1-1-90 29717
Regulation at 54 FR 5359 and 54 FR 29717 effective date delayed to
10-1-90 53611
442.250 -- 442.254 (Subpart E) Removed 5359
Eff. 1-1-90 29717
Regulation at 54 FR 5359 and 54 FR 29717 effective date delayed to
10-1-90 53611
442.300 -- 442.346 (Subpart F) Removed 5359
Eff. 1-1-90 29717
Regulation at 54 FR 5359 and 54 FR 29717 effective date delayed to
10-1-90 53611
447.251 Amended 5359
Eff. 1-1-90 29717
Regulation at 54 FR 5359 and 54 FR 29717 effective date delayed to
10-1-90 53611
447.253 (b)(1)(iii) added; (b) introductory text republished 5359
Eff. 1-1-90 29717
Regulation at 54 FR 5359 and 54 FR 29717 effective date delayed to
10-1-90 53611
447.255 (a) revised; introductory text republished 5359
Eff. 1-1-90 29717
Regulation at 54 FR 5359 and 54 FR 29717 effective date delayed to
10-1-90 53611
447.272 (a) and (b) revised 5359
Eff. 1-1-90 29717
Regulation at 54 FR 5359 and 54 FR 29717 effective date delayed to
10-1-90 53611
482.66 Heading, introductory text, (a) introductory text, (1), (4)
and (b) revised; (a) (2) and (3) amended; (a) (6) and (7) added;
interim; (eff. 10-10-89) 37275
483 Heading and authority citation revised 5359
Eff. 1-1-90 29717
Regulation at 54 FR 5359 and 54 FR 29717 effective date delayed to
10-1-90 53611
483.1 -- 483.75 (Subpart B) Added 5359
Eff. 1-1-90 29717
Regulation at 54 FR 5359 and 54 FR 29717 effective date delayed to
10-1-90 53611
483.10 (c)(4) corrected 8261
483.20 (b)(4)(i) corrected 8261
483.25 (l)(2)(1) corrected 8261
483.28 (c) corrected 8261
483.80 Added; interim (eff. 10-10-89) 37276
484 Redesignated from 405.1201 -- 405.1230 (Subpart L) and revised
33367
488.1 Amended 5373
Eff. 1-1-90 29717
Regulation at 54 FR 5373 and 54 FR 29717 effective date delayed to
10-1-90 53611
488.3 Heading and (a)(2) amended 5373
Eff. 1-1-90 29717
Regulation at 54 FR 5373 and 54 FR 29717 effective date delayed to
10-1-90 53611
484.12 (c) corrected 35131
488.18 (a) and (b) amended 5373
Eff. 1-1-90 29717
Regulation at 54 FR 5373 and 54 FR 29717 effective date delayed to
10-1-90 53611
488.20 (a) and (c) amended 5373
Eff. 1-1-90 29717
Regulation at 54 FR 5373 and 54 FR 29717 effective date delayed to
10-1-90 53611
488.24 (a) and (b) amended 5373
Eff. 1-1-90 29717
Regulation at 54 FR 5373 and 54 FR 29717 effective date delayed to
10-1-90 53611
488.26 (a) amended 5373
Eff. 1-1-90 29717
Regulation at 54 FR 5373 and 54 FR 29717 effective date delayed to
10-1-90 53611
488.28 (a) and (b) amended 5373
Eff. 1-1-90 29717
Regulation at 54 FR 5373 and 54 FR 29717 effective date delayed to
10-1-90 53611
488.50 (a) introductory text, (b), (d) introductory text, and (e)
amended 5373
Eff. 1-1-90 29717
Regulation at 54 FR 5373 and 54 FR 29717 effective date delayed to
10-1-90 53611
489 Eff. 1-1-90 29717
489.3 Amended 5373
Eff. 1-1-90 29717
Regulation at 54 FR 5373 and 54 FR 29717 effective date delayed to
10-1-90 53611
489.10 (a)(1) and (b) amended 5373
Eff. 1-1-90 29717
Regulation at 54 FR 5373 and 54 FR 29717 effective date delayed to
10-1-90 53611
489.12 (a)(3) revised; (b) removed 4027
489.13 (a) amended 5373
Eff. 1-1-90 29717
Regulation at 54 FR 5373 and 54 FR 29717 effective date delayed to
10-1-90 53611
489.15 (b) and (d)(2)(ii) amended 5373
Eff. 1-1-90 29717
Regulation at 54 FR 5373 and 54 FR 29717 effective date delayed to
10-1-90 53611
489.20 Introductory text revised; (a) through (d) amended; (f)
through (j) added 41747
489.34 Added 41747
489.53 (a)(3) and (b)(1) amended 5373
Eff. 1-1-90 29717
Regulation at 54 FR 5373 and 54 FR 29717 effective date delayed to
10-1-90 53611
489.60 (a) introductory text amended 5373
Eff. 1-1-90 29717
Regulation at 54 FR 5373 and 54 FR 29717 effective date delayed to
10-1-90 53611
489.62 (a) and (c) amended 5373
Eff. 1-1-90 29717
Regulation at 54 FR 5373 and 54 FR 29717 effective date delayed to
10-1-90 53611
489.64 (a)(1) and (b)(1) amended 5373
Eff. 1-1-90 29717
Regulation at 54 FR 5373 and 54 FR 29717 effective date delayed to
10-1-90 53611
498.3 (d) (1), (2), and (10) amended 5373
Eff. 1-1-90 29717
Regulation at 54 FR 5373 and 54 FR 29717 effective date delayed to
10-1-90 53611
Chapter V
1001.107 (c) revised 9995
1001.128 (b) and (c) revised 9995
42 CFR 400.310 1990
42 CFR
55 FR
Page
Chapter IV
431 Technical correction 25773
431.800 Revised 22166
431.800 -- 431.808 Undesignated center heading added 22166
431.801 Redesignated as 431.861 and (a)(1), (2), and (b) amended
22166, 22170
431.802 Redesignated as 431.862 and (a)(1), (2), and (b) amended;
new 431.802 added 22166, 22170
431.803 Redesignated as 431.863 and heading revised; (a)(1), (2),
(d)(3), (e)(1) and (2)(v)(B) amended 22166, 22170
431.804 Redesigated as 431.864 and heading, (a), (d)(4), (e)(1)
introductory text, (2)(v)(B) revised; (e)(4) redesignated as (f);
(d)(9) and (e) introductory text amended; (e)(2) and (v) republished;
new 431.804 added 22166, 22170
431.806 Added 22166
431.808 Added 22166
431.810 -- 431.822 Undesignated center heading and sections added
22167
431.830 -- 431.836 Undesignated center heading and sections added
22170
431.861 Redesignated from 431.801 and (a)(1), (2), and (b) amended
22160, 22170
431.862 Redesignated from 431.802 and (a)(1), (2), and (b) amended
22166, 22170
431.863 Redesignated from 431.803 and heading revised; (a)(1), (2),
(d)(3), (e)(1) and (2)(v)(B) amended 22166, 22170
431.864 Redesignated from 431.804 and heading, (a), (d)(4), (e)(1)
introductory text, (2)(v)(B) revised; (e)(4) redesignated as (f);
(d)(9) and (e) introductory text amended; (e)(2) and (v) republished
22166, 22170
431.865 Added 22171
433.112 (b)(6) corrected 1820
(a) revised 4375
433.116 (a) revised 4375
433.119 (c)(3) corrected 1820
433.121 (a) corrected 1820
433.137 (b) revised; (c) added 48606
(b)(1) corrected 52130
433.138 (a) and (e) revised; (k) added 1432
(k) introductory text and (4) corrected 5118
433.139 (b) introductory text republished; (b)(2) and (e) revised;
(b)(3) added 1432
(b)(3)(i) corrected 5118
433.145 Revised 48606
433.147 Heading, (a), (b)(5), (c), and (d) revised; (b) introductory
text republished 48606
434.2 Amended 51295
434.10 -- 434.14 (Subpart B) Heading revised 51295
434.14 Removed 51295
434.20 (a) revised; (b) and (c) amended 23744
(a) and (e) revised 51295
434.21 (b) introductory text amended 51295
434.26 (b)(3) redesignated as (b)(4); new (b)(3) and (5) added 23744
Technical correction 25774
434.27 (b) revised; (c) through (g) added 23744
(b)(2) corrected 33407
434.40 -- 434.44 (Subpart D) Added 51295
434.50 -- 434.65 (Subpart D) Redesignated as Subpart E 51295
434.70 -- 434.78 (Subpart E) Redesignated as Subpart F 51295
435 Technical correction 52130
435.1 (a) revised; (f) and (g) added; eff. 10-9-90 36818
435.3 (a) amended; eff. 10-9-90 36819
(a) amended 48607
435.115 (e) added 48607
435.116 Undesignated center heading and (c) revised 48607
435.118 Redesignated as 435.119 48607
435.119 Redesignated from 435.118 48607
435.120 Revised; eff. 11-15-90 33705
435.121 Revised; eff. 11-15-90 33705
435.137 Added 48607
435.138 Added 48608
435.139 Undesignated center heading and section added; eff. 10-9-90
36819
435.170 Undesignated heading and section added 48608
435.212 Revised 23745
435.225 Added 48608
435.227 Added 48608
435.301 (b) and (b)(1) introductory texts republished; (b)(1)(iv)
added 48609
435.326 Revised 23745
435.350 Added; eff. 10-9-90 36819
435.402 Removed; eff. 10-9-90 36819
435.403 (g) revised 48609
435.406 Added; eff. 10-9-90 36819
435.408 Added; eff. 10-9-90 36819
435.604 Revised 48609
435.724 (a) revised; (d) added 48609
435.725 (c) introductory text republished; (c)(5) added; eff.
11-15-90 33705
435.733 (c) introductory text republished; (c)(5) added; eff.
11-15-90 33705
435.1011 Heading and (b) revised 48609
436.2 Amended; eff. 10-9-90 36820
(a) amended 48609
436.114 (e) added 48610
436.120 (c) revised 48610
436.122 Added 48610
436.128 Added; eff. 10-9-90 36820
436.224 Added 48610
436.301 (b) and (b)(1) introductory texts republished; (b)(1)(iv)
added 48610
436.330 Added; eff. 10-9-90 36820
436.402 Removed; eff. 10-9-90 36820
436.403 (f) revised 48610
436.406 Added; eff. 10-9-90 36820
436.408 Added; eff. 10-9-90 36821
436.604 Revised 48610
(c) corrected 52130
440 Technical correction 52130
440.30 (a) revised 9575
440.165 (c) revised 48611
440.200 Revised; eff. 10-9-90 36822
440.210 Revised 48611
440.220 Revised; eff. 10-9-90 36822
Introductory text republished; (e) added 48611
440.250 (h) revised; (m) and (n) added; eff. 10-9-90 36822
(p) added 48611
440.255 Added; eff. 10-9-90 36823
447.20 Added 1433
447.21 Added 1433
447.35 Removed 2653
447.45 (f)(1) and (2) revised 1434
447.53 (b) introductory text and (2) revised 48611
(b)(2) corrected 52130
482.27 Revised 9575
483.75 (l) revised; eff. 10-1-90 9575
(l)(1)(ii) corrected 33907
483.460 (n) revised 9576
Heading corrected 33907
488.52 Revised 9576
(a) corrected 33908
489 Technical correction 1820
493 Added 9576
493.2 Corrected 33908
493.801 -- 493.807 (Subpart H) Eff. 1-1-91 9576
493.825 (a) corrected 33908
493.847 (a) corrected 33908
493.861 (d) corrected 33908
493.911 (b)(2) corrected 33908
493.915 (c)(2) corrected 33908
493.917 (c)(4) corrected 33908
493.927 (c)(2) corrected 33908
493.931 (b) corrected 33908
493.933 (c)(2) corrected 33908
493.937 (c)(2) corrected 33908
493.945 (b)(2)(ii) and (B) corrected 33908
493.958 (d)(3)(ii)(A)(1) corrected; (d)(3)(ii)(B)(3) and (iii)
correctly designated 33908
493.959 (a)(3) and (d) corrected 33908
493.1215 Corrected 33908
493.1217 (a)(1)(i), (4), and (g) corrected 33908
493.1219 (c)(1) corrected 33908
493.1223 Corrected 33908
493.1229 (a) corrected 33908
493.1257 (b)(1), (c)(3), (4)(i), (d)(1)(i), (ii), (2), (3), (4), (h),
and (i) corrected 33908
493.1269 (b) corrected 33908
493.1279 Corrected 33908
493.1415 (b)(3) corrected 33908
493.1417 (b)(3) corrected 33909
493.1421 (g)(3)(iii) and (m) corrected 33909
493.1433 (b)(1) and (4)(i)(B) corrected 33909
493.1501 Introductory text and (g) corrected 33909
494 Added; interim 53522
42 CFR 400.310 1991
42 CFR
56 FR
Page
Chapter IV
430.2 (b) amended 8845
430.3 (b) amended 8845
430.20 (b)(1) amended; (b)(2) redesignated as (3); new (b)(2) added
8845
430.25 Added 8846
430.33 (c)(2) amended 8846
430.42 (b)(1) and (2) introductory text amended 8846
431 Response to comments 65853
431.40 -- 431.56 (Subpart B) Revised 8847
Heading corrected 23022
431.50 (b) introductory text corrected 23022
431.120 Added; eff. 4-1-92 48918
433 Authority citation revised 46386, 48918, 56139
433.15 (b)(8) added; eff. 4-1-92 48918
433.45 Revised; eff. 1-1-92 46386
Revised 56139
Regulation at 56 FR 56139 withdrawn 64195
434.20 (a) correctly revised; (e) corrected 10515
435.212 Revised 8849
435.406 (a)(2) amended 10807
435.408 (b)(13) revised 10807
435.725 (a), (c)(1) introductory text, (i), (ii), (4), (5) and (d)
revised 8850
(c)(2) and (3) amended 8854
435.733 (a), (c)(1) introductory text, (i), (ii), (4), (5) and (d)
revised 8850
(c)(2) and (3) amended 8854
435.832 (a), (c)(1) introductory text, (i), (ii), (4) and (d) revised
8850
(c)(2) and (3) amended 8854
435.1009 Amended 8854
Corrected 23022
436.408 (b)(13) revised 10807
436.832 (a), (c)(1), (4) and (d) revised 8851
(c)(2) and (3) amended 8854
440.50 Revised 8851
440.90 Revised 8851
440.110 (a)(2)(i) and (b)(2)(ii) amended 8854
440.140 (a)(2) amended 8854
440.210 Correctly revised 10807, 24010
440.220 (b) and (c) amended 10807
Correctly revised 10808, 24011
440.250 (p) correctly revised 24011
440.255 (a), (b)(1), and (c)(1) revised 10807
441.10 (f) revised 8851
(f) corrected 23022
441.35 Added 8851
441.400 -- 441.404 (Subpart I) Added; interim; eff. 10-24-91 48114
442 Technical correction 49147
442.1 (a) revised; eff. 4-1-92 48865
442.2 Amended; eff. 4-1-92 48865
442.12 (a) revised; eff. 4-1-92 48865
442.13 (b) and (c)(2) revised; eff. 4-1-92 48865
442.20 Removed; eff. 4-1-92 48865
442.30 (a) introductory text and (1) revised; eff. 4-1-92 48865
442.40 (b) and (c) revised; eff. 4-1-92 48865
442.42 (a) amended; eff. 4-1-92 48866
442.100 -- 442.119 (Subpart C) Heading revised; eff. 4-1-92 48866
442.101 Revised; eff. 4-1-92 48866
442.105 (e) removed 30698
Revised; eff. 4-1-92 48866
442.110 (a) amended 30698
Heading and (a) revised; eff. 4-1-92 48866
442.111 Removed; eff. 4-1-92 48866
442.112 Removed 30698
442.113 Removed 30698
442.114 Removed 30698
442.115 Removed 30698
442.116 Revised 30698
442.117 Heading and (a)(1) revised; eff. 4-1-92 48866
442.118 (a), (b)(1) and (3)(i) revised; eff. 4-1-92 48866
447.251 Amended; eff. 4-1-92 48867
447.255 (a) revised; eff. 4-1-92 48867
447.272 (a) and (b) revised; eff. 4-1-92 48867
455.20 (b) amended 8854
482.12 (c) introductory text republished; (c)(1) introductory text,
(2) and (4) revised 8852
(c)(1)(iv) and (4) correctly revised 23022
482.66 Regulation at 54 FR 37275 confirmed; introductory text, (a)
introductory text, (6) introductory text and (7) introductory text
republished; (a)(4), (6)(i), (7)(i) and (b) revised 56546
483 Authority citation revised 48867, 54546
Heading and authority citation revised 48918
483.1 Revised; eff. 4-1-92 48867
483.5 Revised; eff. 4-1-92 48867
483.10 Revised; eff. 4-1-92 48867
483.12 Revised; eff. 4-1-92 48869
483.13 Revised; eff. 4-1-92 48870
483.15 Revised; eff. 4-1-92 48871
483.20 Revised; eff. 4-1-92 48871
483.25 Revised; eff. 4-1-92 48873
483.28 Removed; eff. 4-1-92 48873
483.29 Removed; eff. 4-1-92 48873
483.30 Revised; eff. 4-1-92 48873
483.35 Revised; eff. 4-1-92 48874
483.40 Revised; eff. 4-1-92 48875
483.45 Revised; eff. 4-1-92 48875
483.55 Revised; eff. 4-1-92 48875
483.60 Revised; eff. 4-1-92 48875
483.65 Revised; eff. 4-1-92 48876
483.70 Revised; eff. 4-1-92 48876
483.75 Revised; eff. 4-1-92 48877
Heading and (e) revised; introductory text republished; eff.
4-1-92 48918
483.80 Removed 54546
483.150 -- 483.158 (Subpart D) Added; eff. 4-1-92 48919
483.150 (a) corrected 59331
483.156 Correctly designated 59331
483.400 -- 483.480 (Subpart D) Redesignated as Subpart I; eff.
4-1-92 48918
484 Nomenclature changes 32973
484.4 Amended 32973
484.10 (e)(1) introductory text and (2) revised 32973
484.14 Heading, (c), (d), (f) through (h), (i) introductory text,
(2)(i) and (ii) introductory text revised 32973
(g) and (i)(2)(i) corrected 51334
484.16 Amended 32974
484.18 Heading and (c) revised 32974
484.30 (a) revised 32974
484.32 Introductory text revised 32974
484.36 (a)(2), (b)(2)(iii), (3)(i), (ii), (6) and (d) revised; (e)
added 32974
484.36 (a)(2)(i)(F) and (G)(1) corrected 51334
(a)(2)(i)(F) and (G)(1) corrected 51334
485.58 (e) revised 8852
488 Authority citation revised 48879
488.1 Amended; eff. 4-1-92 48879
488.3 Heading; (a)(1) and (2) revised; eff. 4-1-92 48879
488.10 (a)(1) amended; eff. 4-1-92 48879
488.11 Revised; eff. 4-1-92 48879
488.18 (a) and (b) revised; eff. 4-1-92 48879
488.20 (a) and (c) amended; eff. 4-1-92 48879
488.24 (a) and (b) amended; eff. 4-1-92 48879
488.26 (a) amended; eff. 4-1-92 48879
488.28 (a) and (b) amended; eff. 4-1-92 48879
488.50 (a) introductory text revised; eff. 4-1-92 48879
488.56 (a), (b) introductory text and (2) amended; eff. 4-1-92 48879
489 Authority citation revised 48879
489.31 Revised 23022
489.53 (a)(3) and (b)(1) amended; eff. 4-1-92 48879
489.60 (a) introductory text amended; eff. 4-1-92 48879
489.66 (a) amended 8854
491.2 (d)(3) amended 8854
498.3 (b)(10) amended; (d)(2) and (3) revised 8854
(b)(8), (d)(1), (2) and (10) amended; eff. 4-1-92 48879
Chapter V
1001 Heading and authority citation revised 35984
1001.1 Revised 35984
1001.951 -- 1001.953 (Subpart E) Added 35984
1003 Authority citation revised 28492, 42537
1003.100 Revised 28492, 42537
1003.101 Amended 28492
1003.102 (c)(1) and (2) redesignated as (d)(1) and (2) and
republished; new (c) and (d)(3) added 28492
(b)(1)(iii), (2) and (3)(ii) revised; (b)(4) added 42537
1003.103 Revised 28493
(a) revised; (c) added 42537
1003.105 (a) revised 28493, 42538
1003.106 (a), (b) introductory text, (1), (2), (3) and (c) revised
28493
(a)(1), (3), (b) introductory text and (c) introductory text revised
42538
1003.109 (a) revised 28494
(a) introductory text revised 42538
1003.114 (a), (b) and (c) revised 28494
(a) revised 42538
1003.125 (c) revised 28494
42 CFR 400.310 1992
42 CFR
57 FR
Page
Chapter IV
431.20 Added; interim 8202
431.107 (a) revised; (b) introductory text republished; (b)(2) and
(3) revised; (b)(4) added; interim 8202
431.610 (g) introductory text republished; (g)(1) revised 43923
431.635 Added 28103
433.123 Revised; eff. 10-26-92 38782
434.28 Added; interim 8202
435.3 Amended; interim 29155
435.217 Revised; interim 29155
435.726 (b) revised; interim 29155
435.735 (b) revised; interim 29155
436.2 Amended; interim 29155
436.217 Revised; interim 29155
440.1 Revised; interim 29155
440.30 Introductory text republished; (a) and (c) revised 7135
440.181 Added; interim 29156
440.250 (k) revised; interim 29156
441.350 -- 441.365 (Subpart H) Added; interim 29156
441.351 OMB number pending 29156
441.352 OMB number pending 29156
441.353 OMB number pending 29156
441.356 OMB number pending 29156
441.365 OMB number pending 29156
442.1 (a) amended 43924
442.13 (c)(2) revised 43924
442.40 (b)(1) amended 43924
442.101 (c) amended 43924
442.105 (e) removed 43924
442.110 (a) amended 43924
447.250 (c) and (d) redesignated as (d) and (e); new (c) added;
eff. 10-23-92 43921
447.253 (a) amended; (c) through (g) redesignated as (e) through
(i); new (c) and (d) added; eff. 10-23-92 43921
447.255 (a) amended 43924
447.272 (a) amended 43924
482 Authority citation revised 7136, 33899
482.27 Revised 7136
482.53 (b)(3) revised 7136
482.52 (a) introductory text, (a)(4) and (5) revised 33900
482.57 (b)(2) revised 7136
483 Authority citation revised 7136
Authority citation revised 8202, 43924
483.1 (a)(1) amended 43924
483.5 Amended 43924
483.10 Introductory text republished; (b)(4) revised; (b)(8), (9)
and (10) redesignated as (b)(9), (10) and (11) and revised; new (b)(8)
added; interim 8202
(b)(2)(i), (c)(4)(ii), (g)(1), (2), (j)(1)(iv), (2), (m), (o)(1),
(ii) and (2) amended 43924
483.12 (a)(5)(D), (6), and (d)(1)(ii) amended 43924
483.13 (c)(1)(ii)(A) and (iii) amended 43924
483.15 (a), (f)(2)(i) introductory text, (A) and (B) amended 43924
483.20 (e), (f)(1)(i)(B) and (ii)(B) amended; (d)(1) revised 43924
483.25 (g)(2) and (l) amended 43925
483.30 (d)(1)(iv) amended 43925
483.45 (a) introductory text and (2) amended 43925
483.60 (d) amended 43925
483.65 (c) amended 43925
483.70 (a)(1)(ii), (2) and (d)(1)(v) amended 43925
483.75 Heading and (j) revised 7136
(j)(2)(i) and (iii) amended; (o)(4) added 43925
483.410 (e) added 43925
483.460 (n) revised 7136
484 Authority citation revised 7136
Authority citation revised 8203
484.10 Introductory text republished; (c)(2) revised; interim 8203
484.14 (j) added 7136
485 Authority citation revised 7137
485.58 (g) added 7137
485.304 Introductory text republished; (q) added 7137
488 Authority citation revised 7137, 24982, 34012, 43925
488.1 Amended 24982
488.52 Removed 7137
488.56 (a) introductory text, (b) introductory text and (2) amended
43925
488.201 -- 488.211 (Subpart D) Added 34012
489 Heading revised 8203
489.10 (b) redesignated as (c) and revised; new (b) added; interim
8204
489.20 Introductory text republished; (d) revised 33900
Introductory text republished; (k) added 36018
489.31 (a)(1) amended 36018
489.100 -- 489.104 (Subpart I) Added; interim 8203
491 Authority citation revised 7137
491.1 -- 491.11 (Subpart A) Heading revised 24982
491.1 Revised 24982
491.2 Amended 24982
491.4 Revised 24982
491.5 (a) revised 24982
491.6 Revised 24983
491.7 Revised 24983
491.8 Revised 24983
491.9 (c)(2) and (d)(1)(iii) revised; (d)(1) introductory text
republished 7137
Revised 24983
491.10 (a) and (b) revised 24984
491.11 Revised 24984
493 Authority citation revised 7137
493.1 -- 493.25 (Subpart A) Revised 7139
493.2 Amended 7236, 34013
Corrected 35761
493.35 -- 493.39 (Subpart B) Added 7142
493.43 -- 493.51 (Subpart C) Added 7143
493.55 -- 493.63 (Subpart D Added 7144
493.501 -- 493.521 (Subpart E) Added 34014
493.602 -- 493.649 (Subpart F) Added 7213
493.602 -- 493.634 Text removed 7139
493.633 (b) corrected 31664
493.639 (b) corrected 31664
493.701 (Subpart G) Removed 7139
493.801 -- 493.865 (Subpart H) Revised 7146
493.901 -- 493.959 (Subpart I) Revised 7151
493.1101 -- 493.1111 (Subpart J) Revised 7162
493.1201 -- 493.1285 (Subpart K) Revised 7163
493.1401 -- 493.1495 (Subpart L) Redesignated as subpart M and
revised 7172
493.1501 (Subpart M) Redesignated as 493.1701 (Subpart P) 7172
493.1601 (Subpart N) Redesignated as 493.1775 (Subpart Q) 7172
493.1701 -- 493.1721 (Subpart P) Revised 7183
493.1701 -- 493.1710 (Subpart O) Removed 7172
493.1775 -- 493.1780 (Subpart Q) Revised 7184
493.1800 -- 493.1850 (Subpart R) Added 7237
493.1804 (c)(1) corrected 35761
493.1809 Corrected 35761
493.1826 (a)(1)(ii) corrected 35761
493.1834 (b) corrected 35761
493.1844 (c)(1) corrected 35761
493.2001 (Subpart T) Added 7185
494 Authority citation revised 7185
494.51 Revised 7185
498 Authority citation revised 8204, 24984
Heading revised 43925
498.2 Amended 24984
498.3 (b) introductory text republished; (b)(11) added; interim
8204
(b)(7) revised 24984
(d)(11) and (12) added 34021
(b)(8) amended 43925
498.5 (j) amended 43925
Chapter V
1000 Authority citation revised 3329
1000.10 Amended 3329
1000.20 Amended 3330
1001 Revised 3330
1001.301 (a) and (b)(1)(i) correctly revised 9669
1001.1601 (a)(1) correctly revised 9669
1002 Revised 3343
1003 Authority citation revised 3345
1003.100 Revised 3345
1003.101 Amended 3345
1003.102 Revised 3345
(b)(2) correctly revised 9670
1003.103 Revised 3346
1003.105 Revised 3346
1003.106 Revised 3347
1003.107 Revised 3348
1003.109 Revised 3348
1003.110 Amended 3348
1003.111 Removed 3348
1003.112 Removed 3348
1003.113 Removed 3348
1003.114 Revised 3348
1003.115 -- 1003.125 Removed 3348
1003.127 Revised 3348
1003.128 (a) and (d) revised 3349
1003.129 Revised 3349
1003.130 Removed 3349
1003.131 Removed 3349
1003.132 Revised 3349
1003.133 (a) amended 3349
1003.134 Added 3349
1003.135 Added 3349
1004 Authority citation revised 3349
1004.30 (b) and (c) introductory text revised 3349
1004.40 Revised 3349
1004.50 (b) and (c)(1) revised 3349
1004.60 (c) added 3349
1004.90 (d)(7) revised 3350
1004.100 (g) removed 3350
1004.110 Revised 3350
1004.120 Revised 3350
1004.130 Revised 3350
1005 Added 3351
1006 Added 3354
1007 Added 3355
42
Public Health
PART 430 TO END
Revised as of October 1, 1992
CONTAINING
A CODIFICATION OF DOCUMENTS
OF GENERAL APPLICABILITY
AND FUTURE EFFECT
AS OF OCTOBER 1, 1992
With Ancillaries
Published by
the Office of the Federal Register
National Archives and Records
Administration
as a Special Edition of
the Federal Register
Washington, DC 20402-9328
42 CFR 400.310 Table of Contents
Page
Explanation v
Title 42:
Chapter IV -- Health Care Financing Administration, Department of
Health and Human Services (continued)
Chapter V -- Office of Inspector General-Health Care (HHS)
Finding Aids:
Material Approved for Incorporation by Reference
Table of CFR Titles and Chapters
Alphabetical List of Agencies Appearing in the CFR
Table of OMB Control Numbers
Redesignation Tables
List of CFR Sections Affected
42 CFR 400.310 Explanation
The Code of Federal Regulations is a codification of the general and
permanent rules published in the Federal Register by the Executive
departments and agencies of the Federal Government. The Code is divided
into 50 titles which represent broad areas subject to Federal
regulation. Each title is divided into chapters which usually bear the
name of the issuing agency. Each chapter is further subdivided into
parts covering specific regulatory areas.
ISSUE DATES
Each volume of the Code is revised at least once each calendar year
and issued on a quarterly basis approximately as follows:
Title 1 through Title 16 as of January 1
Title 17 through Title 27 as of April 1
Title 28 through Title 41 as of July 1
Title 42 through Title 50 as of October 1
The appropriate revision date is printed on the cover of each volume.
LEGAL STATUS
The contents of the Federal Register are required to be judicially
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie
evidence of the text of the original documents (44 U.S.C. 1510).
HOW TO USE THE CODE OF FEDERAL REGULATIONS
The Code of Federal Regulations is kept up to date by the individual
issues of the Federal Register. These two publications must be used
together to determine the latest version of any given rule.
To determine whether a Code volume has been amended since its
revision date (in this case, October 1, 1992), consult the ''List of CFR
Sections Affected (LSA),'' which is issued monthly, and the ''Cumulative
List of Parts Affected,'' which appears in the Reader Aids section of
the daily Federal Register. These two lists will identify the Federal
Register page number of the latest amendment of any given rule.
EFFECTIVE AND EXPIRATION DATES
Each volume of the Code contains amendments published in the Federal
Register since the last revision of that volume of the Code. Source
citations for the regulations are referred to by volume number and page
number of the Federal Register and date of publication. Publication
dates and effective dates are usually not the same and care must be
exercised by the user in determining the actual effective date. In
instances where the effective date is beyond the cut-off date for the
Code a note has been inserted to reflect the future effective date. In
those instances where a regulation published in the Federal Register
states a date certain for expiration, an appropriate note will be
inserted following the text.
OMB CONTROL NUMBERS
The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires Federal
agencies to display an OMB control number with their information
collection request. Many agencies have begun publishing numerous OMB
control numbers as amendments to existing regulations in the CFR. These
OMB numbers are placed as close as possible to the applicable
recordkeeping or reporting requirements.
OBSOLETE PROVISIONS
Provisions that become obsolete before the revision date stated on
the cover of each volume are not carried. Code users may find the text
of provisions in effect on a given date in the past by using the
appropriate numerical list of sections affected. For the period before
January 1, 1986, consult either the List of CFR Sections Affected,
1949-1963, 1964-1972, or 1973-1985, published in seven separate volumes.
For the period beginning January 1, 1986, a ''List of CFR Sections
Affected'' is published at the end of each CFR volume.
INCORPORATION BY REFERENCE
What is incorporation by reference? Incorporation by reference was
established by statute and allows Federal agencies to meet the
requirement to publish regulations in the Federal Register by referring
to materials already published elsewhere. For an incorporation to be
valid, the Director of the Federal Register must approve it. The legal
effect of incorporation by reference is that the material is treated as
if it were published in full in the Federal Register (5 U.S.C. 552(a)).
This material, like any other properly issued regulation, has the force
of law.
What is a proper incorporation by reference? The Director of the
Federal Register will approve an incorporation by reference only when
the requirements of 1 CFR part 51 are met. Some of the elements on
which approval is based are:
(a) The incorporation will substantially reduce the volume of
material published in the Federal Register.
(b) The matter incorporated is in fact available to the extent
necessary to afford fairness and uniformity in the administrative
process.
(c) The incorporating document is drafted and submitted for
publication in accordance with 1 CFR part 51.
Properly approved incorporations by reference in this volume are
listed in the Finding Aids at the end of this volume.
What if the material incorporated by reference cannot be found? If
you have any problem locating or obtaining a copy of material listed in
the Finding Aids of this volume as an approved incorporation by
reference, please contact the agency that issued the regulation
containing that incorporation. If, after contacting the agency, you
find the material is not available, please notify the Director of the
Federal Register, National Archives and Records Administration,
Washington DC 20408, or call (202) 523-4534.
CFR INDEXES AND TABULAR GUIDES
A subject index to the Code of Federal Regulations is contained in a
separate volume, revised annually as of January 1, entitled CFR Index
and Finding Aids. This volume contains the Parallel Table of Statutory
Authorities and Agency Rules (Table I), and Acts Requiring Publication
in the Federal Register (Table II). A list of CFR titles, chapters, and
parts and an alphabetical list of agencies publishing in the CFR are
also included in this volume.
An index to the text of ''Title 3 -- The President'' is carried
within that volume.
The Federal Register Index is issued monthly in cumulative form.
This index is based on a consolidation of the ''Contents'' entries in
the daily Federal Register.
A List of CFR Sections Affected (LSA) is published monthly, keyed to
the revision dates of the 50 CFR titles.
REPUBLICATION OF MATERIAL
There are no restrictions on the republication of material appearing
in the Code of Federal Regulations.
INQUIRIES AND SALES
For a summary, legal interpretation, or other explanation of any
regulation in this volume, contact the issuing agency. Inquiries
concerning editing procedures and reference assistance with respect to
the Code of Federal Regulations may be addressed to the Director, Office
of the Federal Register, National Archives and Records Administration,
Washington, DC 20408 (telephone 202-512-1557). Sales are handled
exclusively by the Superintendent of Documents, Government Printing
Office, Washington, DC 20402 (telephone 202-783-3238).
Martha L. Girard,
Director,
Office of the Federal Register.
October 1, 1992.
42 CFR 400.310 THIS TITLE
Title 42 -- Public Health is composed of three volumes. The parts in
these volumes are arranged in the following order: Parts 1-399, parts
400-429 and part 430 to end. The first volume (parts 1-399) contains
current regulations issued under chapter I -- Public Health Service
(HHS). The second volume (parts 400-429) includes regulations issued
under chapter IV -- Health Care Financing Administration (HHS) and the
third volume (part 430 to end) contains the remaining regulations in
chapter IV and the regulations issued under chapter V by the Office of
Inspector General-Health Care (HHS). The contents of these volumes
represent all current regulations codified under this title of the CFR
as of October 1, 1992.
The OMB control numbers for the Health Care Financing Administration
appear in 400.310 of chapter IV. For the convenience of the user
subpart C consisting of 400.300-400.310 is reprinted in the Finding
Aids section of the third volume.
Redesignation tables appear in the Finding Aids section of all
volumes.
For this volume Ann Worley was Chief Editor. The Code of Federal
Regulations publication program is under the direction of Richard L.
Claypoole, assisted by Alomha S. Morris.
43 CFR 0.0 43 CFR Subtitle A (10-1-92 Edition)
43 CFR 0.0 Bureau of Land Management, Interior
43 CFR 0.0 Title 43 -- Public Lands: Interior
43 CFR 0.0 (This book contains parts 1 to 999)
Part
SUBTITLE A -- Office of the Secretary of the Interior 1
SUBTITLE B -- Regulations Relating to Public Lands:
chapter i -- Bureau of Reclamation, Department of the Interior 230
43 CFR 0.0 43 CFR Subtitle A (10-1-92 Edition)
43 CFR 0.0 Office of the Secretary of the Interior
43 CFR 0.0 Subtitle A -- Office of the Secretary of the Interior
Editorial Note: For the Table of Public Land orders formerly
appearing in this volume, see the appendix to chapter II, title 43, Code
of Federal Regulations, parts 4000 to End.
Part
Page
1 Practices before the Department of the Interior
2 Records and testimony; Freedom of Information Act
3 Preservation of American antiquities
4 Department hearings and appeals procedures
5 Making pictures, television productions or sound tracks on certain
areas under the jurisdiction of the Department of the Interior
6 Patent regulations
7 Protection of archaeological resources
8 Joint policies of the Departments of the Interior and of the Army
relative to reservoir project lands
9 Intergovernmental review of Department of the Interior programs and
activities
11 Natural resource damage assessments
12 Administrative requirements and audit requirements and cost
principles for assistance programs
13 Vending facilities operated by blind persons
14 Petitions for rulemaking
15 Key Largo Coral Reef Preserve
16 Conservation of helium
17 Nondiscrimination in federally-assisted programs of the Department
of the Interior
18 New restrictions on lobbying
19 Wilderness preservation
20 Employee responsibilities and conduct
21 Occupancy of cabin sites on public conservation and recreation
areas
22 Administrative claims under the Federal Tort Claims Act and
indemnification of Department of the Interior employees
23 Surface exploration, mining and reclamation of lands
24 Department of the Interior fish and wildlife policy:
State-Federal relationships
26 Grants to States for establishing Youth Conservation Corps
programs
27 Nondiscrimination in activities conducted under permits,
rights-of-way, public land orders, and other Federal authorizations
granted or issued under Title II of Public Law 93-153
28 Fire protection emergency assistance
29 Trans-Alaska Pipeline Liability Fund
32 Grants to States for establishing Young Adult Conservation Corps
(YACC) program
33 Allocation of duty-free watches from the Virgin Islands, Guam, and
American Samoa (Note)
34 Requirements for equal opportunity during construction and
operation of the Alaska Natural Gas Transportation System
35 Administrative remedies for fraudulent claims and statements
36 Transportation and utility systems in and across, and access into,
conservation system units in Alaska
38 Pay of U.S. Park Police -- interim geographic adjustments
43 CFR 0.0
43 CFR 0.0 43 CFR Subtitle A (10-1-92 Edition)
43 CFR 0.0 Office of the Secretary of the Interior
43 CFR 0.0 PART 1 -- PRACTICES BEFORE THE DEPARTMENT OF THE INTERIOR
Sec.
1.1 Purpose.
1.2 Definitions.
1.3 Who may practice.
1.4 Disqualifications.
1.5 Signature to constitute certificate.
1.6 Disciplinary proceedings.
Authority: Sec. 5, 23 Stat. 101; 43 U.S.C. 1464.
Source: 29 FR 143, Jan. 7, 1964, unless otherwise noted.
43 CFR 1.1 Purpose.
This part governs the participation of individuals in proceedings,
both formal and informal, in which rights are asserted before, or
privileges sought from, the Department of the Interior.
43 CFR 1.2 Definitions.
As used in this part the term:
(a) Department includes any bureau, office, or other unit of the
Department of the Interior, whether in Washington, DC, or in the field,
and any officer or employee thereof;
(b) Solicitor means the Solicitor of the Department of the Interior
or his authorized representative;
(c) Practice includes any action taken to support or oppose the
assertion of a right before the Department or to support or oppose a
request that the Department grant a privilege; and the term
''practice'' includes any such action whether it relates to the
substance of, or to the procedural aspects of handling, a particular
matter. The term ''practice'' does not include the preparation or
filing of an application, the filing without comment of documents
prepared by one other than the individual making the filing, obtaining
from the Department information that is available to the public
generally, or the making of inquiries respecting the status of a matter
pending before the Department. Also, the term ''practice'' does not
include the representation of an employee who is the subject of
disciplinary, loyalty, or other personnel administrative proceedings.
43 CFR 1.3 Who may practice.
(a) Only those individuals who are eligible under the provisions of
this section may practice before the Department, but this provision
shall not be deemed to restrict the dealings of Indian tribes or members
of Indian tribes with the Department.
(b) Unless disqualified under the provisions of 1.4 or by
disciplinary action taken pursuant to 1.6:
(1) Any individual who has been formally admitted to practice before
the Department under any prior regulations and who is in good standing
on December 31, 1963, shall be permitted to practice before the
Department.
(2) Attorneys at law who are admitted to practice before the courts
of any State, the District of Columbia, the Commonwealth of Puerto Rico,
American Samoa, the Trust Territory of the Pacific Islands, or the
District Court of the Virgin Islands will be permitted to practice
without filing an application for such privilege.
(3) An individual who is not otherwise entitled to practice before
the Department may practice in connection with a particular matter on
his own behalf or on behalf of
(i) A member of his family;
(ii) A partnership of which he is a member;
(iii) A corporation, business trust, or an association, if such
individual is an officer or full-time employee;
(iv) A receivership, decedent's estate, or a trust or estate of which
he is the receiver, administrator, or other similar fiduciary;
(v) The lessee of a mineral lease that is subject to an operating
agreement or sublease which has been approved by the Department and
which grants to such individual a power of attorney;
(vi) A Federal, State, county, district, territorial, or local
government or agency thereof, or a government corporation, or a district
or advisory board established pursuant to statute; or
(vii) An association or class of individuals who have no specific
interest that will be directly affected by the disposition of the
particular matter.
43 CFR 1.4 Disqualifications.
No individual may practice before the Department if such practice
would violate the provisions of 18 U.S.C. 203, 205, or 207.
43 CFR 1.5 Signature to constitute certificate.
When an individual who appears in a representative capacity signs a
paper in practice before the Department, his signature shall constitute
his certificate:
(a) That under the provisions of this part and the law, he is
authorized and qualified to represent the particular party in the
matter;
(b) That, if he is the partner of a present or former officer or
employee, including a special Government employee, the matter in respect
of which he intends to practice is not a matter in which such officer or
employee of the Government or special Government employee participates
or has participated personally and substantially as a Government
employee through decision, approval, disapproval, recommendation, the
rendering of advice, investigation or otherwise and that the matter is
not the subject of such partner's official Government responsibility;
(c) That, if he is a former officer or employee, including a special
Government employee, the matter in respect of which he intends to
practice is not a matter in which he participated personally and
substantially as a Government employee through decision, approval,
disapproval, recommendation, the rendering of advice, investigation, or
otherwise, while so employed and, if a period of one year has not passed
since the termination of his employment with the Government, that the
matter was not under his official responsibility as an officer or
employee of the Government; and
(d) That he has read the paper; that to the best of his knowledge,
information, and belief there is good ground to support its contents;
that it contains no scandalous or indecent matter; and that it is not
interposed for delay.
43 CFR 1.6 Disciplinary proceedings.
(a) Disciplinary proceedings may be instituted against anyone who is
practicing or has practiced before the Department on grounds that he is
incompetent, unethical, or unprofessional, or that he is practicing
without authority under the provisions of this part, or that he has
violated any provisions of the laws and regulations governing practice
before the Department, or that he has been disbarred or suspended by any
court or administrative agency. Individuals practicing before the
Department should observe the Canons of Professional Ethics of the
American Bar Association and those of the Federal Bar Association, by
which the Department will be guided in disciplinary matters.
(b) Whenever in the discretion of the Solicitor the circumstances
warrant consideration of the question whether disciplinary action should
be taken against an individual who is practicing or has practiced before
the Department, the Solicitor shall appoint a hearing officer to
consider and dispose of the case. The hearing officer shall give the
individual adequate notice of, and an opportunity for a hearing on, the
specific charges against him. The hearing shall afford the individual
an opportunity to present evidence and cross-examine witnesses. The
hearing officer shall render a decision either (1) dismissing the
charges, or (2) reprimanding the individual or suspending or excluding
him from practice before the Department.
(c) Within 30 days after receipt of the decision of the hearing
officer reprimanding, suspending, or excluding an individual from
practice before the Department, an appeal may be filed with the
Solicitor, whose decision shall be final.
43 CFR 1.6 PART 2 -- RECORDS AND TESTIMONY; FREEDOM OF INFORMATION ACT
43 CFR 1.6 Subpart A -- Opinions in Adjudication of Cases,
Administrative Manuals
Sec.
2.1 Purpose and scope.
2.2 Opinions in adjudication of cases.
2.3 Administrative manuals.
43 CFR 1.6 Subpart B -- Requests for Records
2.11 Purpose and scope.
2.12 Definitions.
2.13 Records available.
2.14 Requests for records.
2.15 Preliminary processing of requests.
2.16 Action on initial requests.
2.17 Time limits for processing initial requests.
2.18 Appeals.
2.19 Action on appeals.
2.20 Fees.
2.21 Waiver of fees.
2.22 Special rules governing certain information concerning coal
obtained under the Mineral Leasing Act.
43 CFR 1.6 Subpart C -- Declassification of Classified Documents
2.41 Declassification of classified documents.
43 CFR 1.6 Subpart D -- Privacy Act
2.45 Purpose and scope.
2.46 Definitions.
2.47 Records subject to Privacy Act.
2.48 Standards for maintenance of records subject to the Act.
2.49 (Reserved)
2.50 Federal Register notices describing systems of records.
2.51 Assuring integrity of records.
2.52 Conduct of employees.
2.53 Government contracts.
2.54 -- 2.55 (Reserved)
2.56 Disclosure of records.
2.57 Accounting for disclosures.
2.58 -- 2.59 (Reserved)
2.60 Request for notification of existence of records: Submission.
2.61 Requests for notification of existence of records: Action on.
2.62 Requests for access to records.
2.63 Requests for access to records: Submission.
2.64 Requests for access to records: Initial decision.
2.65 Requests for notification of existence of records and for access
to records: Appeals.
2.66 Requests for access to records: Special situations.
2.67 -- 2.69 (Reserved)
2.70 Amendment of records.
2.71 Petitions for amendment: Submission and form.
2.72 Petitions for amendment: Processing and initial decision.
2.73 Petitions for amendments: Time limits for processing.
2.74 Petitions for amendment: Appeals.
2.75 Petitions for amendment: Action on appeals.
2.76 (Reserved)
2.77 Statements of disagreement.
2.78 (Reserved)
2.79 Exemptions.
43 CFR 1.6 Subpart E -- Compulsory Process and Testimony of Employees
2.80 Compulsory process.
2.82 Testimony of employees.
Appendix A to Part 2 -- Fees
Appendix B to Part 2 -- Bureaus and Offices of the Department of the
Interior
Authority: 5 U.S.C. 301, 552 and 552a; 31 U.S.C. 9701; and 43
U.S.C. 1460.
Source: 40 FR 7305, Feb. 19, 1975, unless otherwise noted.
43 CFR 1.6 Subpart A -- Opinions in Adjudication of Cases, Administrative Manuals
43 CFR 2.1 Purpose and scope.
This subpart contains the regulations of the Department of the
Interior concerning the availability to the public of opinions issued in
the adjudication of cases and of administrative manuals. Persons
interested in obtaining access to other records are directed to the
procedures for submission of Freedom of Information requests set out in
Subpart B of this part.
43 CFR 2.2 Opinions in adjudication of cases.
(a)(1) Copies of final decisions and orders issued on and after July
1, 1970, in the following categories of cases are available for
inspection and copying in the Office of Hearings and Appeals, Ballston
Building No. 3, 4015 Wilson Boulevard, Arlington, Va. 22203:
(i) Contract appeals;
(ii) Appeals from decisions rendered by departmental officials
relating to the use and disposition of public lands and their resources
and the use and disposition of mineral resources in certain acquired
lands of the United States and in the submerged lands of the Outer
Continental Shelf;
(iii) Appeals from orders and decisions issued by departmental
officials and administrative law judges in proceedings relating to mine
health and safety; and
(iv) Appeals from orders and decisions of administrative law judges
in Indian probate matters other than those involving estates of Indians
of the Five Civilized Tribes and Osage Indians.
(2) Copies of final opinions and orders issued in the following
categories of cases are available for inspection and copying in the
Docket and Records Section, Office of the Solicitor, Interior Building,
Washington, DC 20240:
(i) Tort claims decided in the headquarters office of the Office of
the Solicitor, and appeals from decisions of Regional Solicitors or
Field Solicitors on tort claims;
(ii) Irrigation claims under Public Works Appropriation Acts (e.g.,
79 Stat., 1103) or 25 U.S.C. 388 decided in the headquarters office of
the Office of the Solicitor, and appeals from decisions of Regional
Solicitors on irrigation claims;
(iii) Appeals under 2.18 respecting availability of records;
(iv) Appeals from decisions of officials of the Bureau of Indian
Affairs, and Indian enrollment appeals; and
(v) Appeals from decisions of officers of the Bureau of Land
Management and of the Geological Survey in proceedings relating to lands
or interests in land, contract appeals, and appeals in Indian probate
proceedings, issued prior to July 1, 1970.
(3) An Index-Digest is issued by the Department. All decisions,
opinions and orders issued in the categories of cases described in
paragraphs (a)(1), (i), (ii), and (iii) of this section (that is,
contract appeals, land appeals, and mine health and safety appeals), are
covered in the Index-Digest; in addition, the Index-Digest covers the
more important decisions, opinions and orders in the remaining
categories of cases described in paragraphs (a)(1)(iv) and (a)(2) (i)
through (iv) of this section, and the more important opinions of law
issued by the Office of the Solicitor. The Index-Digest is available
for use by the public in the Office of Hearings and Appeals, Ballston
Building No. 3, 4015 Wilson Boulevard, Arlington, Va. 22203, in the
Docket and Records Section, Office of the Solicitor, Interior Building,
Washington, DC 20240, and in the offices of the Regional Solicitors and
Field Solicitors. Selected decisions, opinions, and orders are
published in a series entitled ''Decisions of the United States
Department of the Interior'' (cited as I.D.), and copies may be obtained
by subscription from the Superintendent of Documents, U.S. Government
Printing Office, Washington, DC 20402.
(4) Copies of final opinions and orders issued by Regional Solicitors
on tort claims and irrigation claims, and copies of final opinions and
orders on appeals in Indian probate proceedings issued by Regional
Solicitors prior to July 1, 1970, are available for inspection and
copying in their respective offices. Copies of final opinions and
orders issued by Field Solicitors on tort claims are available for
inspection and copying in their respective offices.
(b)(1) Copies of final decisions and orders issued prior to July 1,
1970, on appeals to the Director, Bureau of Land Management, and by
hearing examiners of the Bureau of Land Management, in proceedings
relating to lands and interests in land are available for inspection and
copying in the Office of Hearings and Appeals, Ballston Building No. 3,
4015 Wilson Boulevard, Arlington, Va. 22203, and in the offices of the
Departmental administrative law judges.
(2) Copies of final decisions, opinions and orders issued on and
after July 1, 1970, by departmental administrative law judges in all
proceedings before them are available for inspection and copying in
their respective offices and in the Office of Hearings and Appeals,
Ballston Building No. 3, 4015 Wilson Boulevard, Arlington, VA 22203.
(3) Copies of final decisions, opinions and orders issued by
administrative law judges in Indian probate proceedings are available
for inspection and copying in their respective offices.
43 CFR 2.3 Administrative manuals.
The Departmental Manual is available for inspection in the
Departmental Library, Interior Building, Washington, DC, and at each of
the regional offices of bureaus of the Department. The administrative
manuals of those bureaus which have issued such documents are available
for inspection at the headquarters officers and at the regional offices
of the bureaus.
43 CFR 2.3 Subpart B -- Requests for Records
Source: 52 FR 45586, Nov. 30, 1987, unless otherwise noted.
43 CFR 2.11 Purpose and scope.
(a) This subpart contains the procedures for submission to and
consideration by the Department of the Interior of requests for records
under the Freedom of Information Act.
(b) Before invoking the formal procedures set out below, persons
seeking records from the Department may find it useful to consult with
the appropriate bureau FOIA officer. Bureau offices are listed in
Appendix B to this part.
(c) The procedures in this subpart do not apply to:
(1) Records published in the Federal Register, opinions in the
adjudication of cases, statements of policy and interpretations, and
administrative staff manuals that have been published or made available
under subpart A of this part.
(2) Records or information compiled for law enforcement purposes and
covered by the disclosure exemption described in 2.13(c)(7) if --
(i) The investigation or proceeding involves a possible violation of
criminal law; and
(ii) There is reason to believe that --
(A) The subject of the investigation or proceeding is not aware of
its pendency, and
(B) Disclosure of the existence of the records could reasonably be
expected to interfere with enforcement proceedings.
(3) Informant records maintained by a criminal law enforcement
component of the Department under an informant's name or personal
identifier, if requested by a third party according to the informant's
name or personal identifier, unless the informant's status as an
informant has been officially confirmed.
43 CFR 2.12 Definitions.
(a) Act and FOIA mean the Freedom of Information Act, 5 U.S.C. 552.
(b) Bureau refers to all constituent bureaus of the Department of the
Interior, the Office of the Secretary, and the other Departmental
offices. A list of bureaus is contained in Appendix B to this part.
(c) Working day means a regular Federal workday. It does not include
Saturdays, Sundays or public legal holidays.
43 CFR 2.13 Records available.
(a) Department policy. It is the policy of the Department of the
Interior to make the records of the Department available to the public
to the greatest extent possible, in keeping with the spirit of the
Freedom of Information Act.
(b) Statutory disclosure requirement. The Act requires that the
Department, on a request from a member of the public submitted in
accordance with the procedures in this subpart, make requested records
available for inspection and copying.
(c) Statutory exemptions. Exempted from the Act's statutory
disclosure requirement are matters that are:
(1)(i) Specifically authorized under criteria established by an
Executive order to be kept secret in the interest of national defense or
foreign policy and
(ii) Are in fact properly classified pursuant to such Executive
order;
(2) Related solely to the internal personnel rules and practices of
an agency;
(3) Specifically exempted from disclosure by statute (other than the
Privacy Act), provided that such statute --
(i) Requires that the matters be withheld from the public in such a
manner as to leave no discretion on the issue, or
(ii) Establishes particular criteria for withholding or refers to
particular types of matters to be withheld;
(4) Trade secrets and commercial or financial information obtained
from a person and privileged or confidential;
(5) Inter-agency or intra-agency memorandums or letters which would
not be available by law to a party other than an agency in litigation
with the agency;
(6) Personnel and medical files and similar files the disclosure of
which would constitute a clearly unwarranted invasion of personal
privacy;
(7) Records or information compiled for law enforcement purposes, but
only to the extent that the production of such law enforcement records
or information --
(i) Could reasonably be expected to interfere with enforcement
proceedings,
(ii) Would deprive a person of a right to a fair or an impartial
adjudication,
(iii) Could reasonably be expected to constitute an unwarranted
invasion of personal privacy,
(iv) Could reasonably be expected to disclose the identity of a
confidential source, including a State, local, or foreign agency or
authority or any private institution which furnished information on a
confidential basis, and, in the case of a record or information compiled
by a criminal law enforcement authority in the course of a criminal
investigation, or by an agency conducting a lawful national security
intelligence investigtion, information furnished by a confidential
source,
(v) Would disclose techniques and procedures for law enforcement
investigations or prosecutions or would disclose guidelines for law
enforcement investigations or prosecutions if such disclosure could
reasonably be expected to risk circumvention of the law, or
(vi) Could reasonably be expected to endanger the life or physical
safety of any individual;
(8) Contained in or related to examination, operating, or condition
reports prepared by, on behalf of, or for the use of an agency
responsible for the regulation or supervision of financial institutions;
or
(9) Geological and geophysical information and data, including maps,
concerning wells.
(d) Decisions on requests. It is the policy of the Department to
withhold information falling within an exemption only if --
(1) Disclosure is prohibited by statute or Executive order or
(2) Sound grounds exist for invocation of the exemption.
(e) Disclosure of reasonably segregable nonexempt material. If a
requested record contains material covered by an exemption and material
that is not exempt, and it is determined under the procedures in this
subpart to withhold the exempt material, any reasonably segregable
nonexempt material shall be separated from the exempt material and
released.
43 CFR 2.14 Requests for records.
(a) Submission of requests. (1) A request to inspect or copy records
shall be made to the installation where the records are located. If the
records are located at more than one installation or if the specific
location of the records is not known to the requester, he or she may
direct a request to the head of the appropriate bureau or to the
bureau's FOIA officer. Addresses for bureau heads and FOIA officers are
contained in Appendix B to this part.
(2) Exceptions. (i) A request for records located in all components
of the Office of the Secretary (other than the Office of Hearings and
Appeals) shall be submitted to: Director, Office of Administrative
Services, U.S. Department of the Interior, Washington, DC 20240. A
request for records located in the Office of Hearings and Appeals shall
be submitted to: Director, Office of Hearings and Appeals, 4015 Wilson
Boulevard, Arlington, Virginia 22203.
(ii) A request for records of the Office of Inspector General shall
be submitted to: Inspector General, Office of the Inspector General,
U.S. Department of the Interior, Washington, DC 20240.
(iii) A request for records of the Office of the Solicitor shall be
submitted to: Solicitor, Office of the Solicitor, U.S. Department of
the Interior, Washington, DC 20240.
(b) Form of requests. (1) Requests under this subpart shall be in
writing and must specifically invoke the Act.
(2) A request must reasonably describe the records requested. A
request reasonably describes the records requested if it will enable an
employee of the Department familiar with the subject area of the request
to locate the record with a reasonable amount of effort. If such
information is available, the request should identify the subject matter
of the record, the date when it was made, the place where it was made,
the person or office that made it, the present custodian of the record,
and any other information that will assist in locating the requested
record. If the request involves a matter known by the requester to be
in litigation, the request should also state the case name and court
hearing the case.
(3)(i) A request shall --
(A) Specify the fee category (commercial use, news media, educational
institution, noncommercial scientific institution, or other) in which
the requester claims the request to fall and the basis of this claim
(see 2.20(b) through (e) for definitions) and
(B) State the maximum amount of fees that the requester is willing to
pay or include a request for a fee waiver.
(ii) Requesters are advised that, under 2.20 (f) and (g), the time
for responding to requests may be delayed --
(A) If a requester has not sufficiently identified the fee category
applicable to the request,
(B) If a requester has not stated a willingness to pay fees as high
as anticipated by the Department or
(C) If a fee waiver request is denied and the requester has not
included an alternative statement of willingness to pay fees as high as
anticipated by the Department.
(4) A request seeking a fee waiver shall, to the extent possible,
address why the requester believes that the criteria for fee waivers set
out in 2.21 are met.
(5) To ensure expeditious handling, requests should be prominently
marked, both the envelope and on the face of the request, with the
legend ''FREEDOM OF INFORMATION REQUEST.''
(c) Creation of records. A request may seek only records that are in
existence at the time the request is received. A request may not seek
records that come into existence after the date on which it is received
and may not require that new records be created in response to the
request by, for example, combining or compiling selected items from
manual files, preparing a new computer program, or calculating
proportions, percentages, frequency distributions, trends or
comparisons. In those instances where the Department determines that
creating a new record will be less burdensome than disclosing large
volumes of unassembled material, the Department may, in its discretion,
agree to creation of a new record as an alternative to disclosing
existing records.
43 CFR 2.15 Preliminary processing of requests.
(a) Scope of requests. (1) Unless a request clearly specifies
otherwise, requests to field installations of a bureau may be presumed
to seek only records at that installation and requests to a bureau head
or bureau FOIA officer may be presumed to seek only records of that
bureau.
(2) If a request to a field installation of a bureau specifies that
it seeks records located at other installations of the same bureau, the
installation shall refer the request to the other installation(s) or the
bureau FOIA officer for appropriate processing. The time limit provided
in 2.17(a) does not start until the request is received at the
installation having the records or by the bureau FOIA officer.
(3) If a request to a bureau specifies that it seeks records of
another bureau, the bureau may return the request (or the relevant
portion thereof) to the requester with instructions as to how the
request may be resubmitted to the other bureau.
(b) Intradepartmental consultation and referral. (1) If a bureau
(other than the Office of Inspector General) receives a request for
records in its possession that originated with or are of substantial
concern to another bureau, it shall consult with that bureau before
deciding whether to release or withhold the records.
(2) As an alternative to consultation, a bureau may refer the request
(or the relevant protion thereof) to the bureau that originated or is
substantially concerned with the records. Such referrals shall be made
expeditiously and the requester shall be notified in writing that a
referral has been made. A referral under this paragraph does not
restart the time limit provided in 2.17.
(c) Records of other departments and agencies. (1) If a requested
record in the possession of the Department of the Interior originated
with another Federal department or agency, the request shall be referred
to that agency unless --
(i) The record is of primary interest to the Department,
(ii) The Department is in a better position than the originating
agency to assess whether the record is exempt from disclosure, or
(iii) The originating agency is not subject to the Act.
The Department has primary interest in a record if it was developed
or prepared pursuant to Department regulations, directives or request.
(2) In accordance with Execuctive Order 12356, a request for
documents that were classified by another agency shall be referred to
that agency.
(d) Consultation with submitters of commercial and financial
information. (1) If a request seeks a record containing trade secrets
or commercial or financial information submitted by a person outside of
the Federal government, the bureau processing the request shall provide
the submitter with notice of the request whenever --
(i) The submitter has made a good faith designation of the
information as commercially or financially sensitive, or
(ii) The bureau has reason to believe that disclosure of the
information may result in commercial or financial injury to the
submitter.
Where notification of a voluminous number of submitters is required,
such notification may be accomplished by posting or publishing the
notice in a place reasonably calculated to accomplish notification.
(2) The notice to the submitter shall afford the submitter a
reasonable period within which to provide a detailed statement of any
objection to disclosure. The submitter's statement shall explain the
basis on which the information is claimed to be exempt under the FOIA,
including a specification of any claim of competitive or other business
harm that would result from disclosure. The statement shall also
include a certification that the information is confidential, has not
been disclosed to the public by the submitter, and is not routinely
available to the public from other sources.
(3) If a submitter's statement cannot be obtained within the time
limit for processing the request under 2.17, the requester shall be
notified of the delay as provided in 2.17(f).
(4) Notification to a submitter is not required if:
(i) The bureau determines, prior to giving notice, that the request
for the record should be denied;
(ii) The information has previously been lawfully published or
officially made available to the public;
(iii) Disclosure is required by a statute (other than the FOIA) or
regulation (other than this subpart);
(iv) Disclosure is clearly prohibited by a statute, as described in
2.13(c)(3);
(v) The information was not designated by the submitter as
confidential when it was submitted, or a reasonable time thereafter, if
the submitter was specifically afforded an opportunity to make such a
designation; however, a submitter will be notified of a request for
information that was not designated as confidential at the time of
submission, or a reasonable time thereafter, if there is substantial
reason to believe that disclosure of the information would result in
competitive harm.
(vi) The designation of confidentiality made by the submitter is
obviously frivolous; or
(vii) The information was submitted to the Department more than 10
years prior to the date of the request, unless the bureau has reason to
believe that it continues to be confidential.
(5) If a requester brings suit to compel disclosure of information,
the submitter of the information will be promptly notified.
43 CFR 2.16 Action on initial requests.
(a) Authority. (1) Requests to field installations shall be decided
by the head of the installation or by such higher authority as the head
of the bureau may designate in writing.
(2) Requests to the headquarters of a bureau shall be decided only by
the head of the bureau or an official whom the head of the bureau has in
writing designated.
(3) Requests to the Office of the Secretary may be decided by the
Director of Administrative Services, an Assistant Secretary or Assistant
Secretary's designee, and any official whom the Secretary has in writing
designated.
(4) A decision to withhold a requested record, to release a record
that is exempt from disclosure, or to deny a fee waiver shall be made
only after consultation with the office of the appropriate associate,
regional, or field solicitor.
(b) Form of grant. (1) When a requested record has been determined
to be available, the official processing the request shall notify the
requester as to when and where the record is available for inspection
or, as the case may be, when and how copies will be provided. If fees
are due, the official shall state the amount of fees due and the
procedures for payment, as described in 2.20.
(2) If a requested record (or portion thereof) is being made
available over the objections of a submitter made in accordance with
2.15(d), both the requester and the submitter shall be notified of the
decision. The notice to the submitter (a copy of which shall be made
available to the requester) shall be forwarded a reasonable number of
days prior to the date on which disclosure is to be made and shall
include:
(i) A statement of the reasons why the submitter's objections were
not sustained;
(ii) A specification of the portions of the record to be disclosed,
if the submitter's objections were sustained in part; and
(iii) A specified disclosure date.
(3) If a claim of confidentiality has been found frivolous in
accordance with 2.15(d)(4)(vi) and a determination is made to release
the information without consultation with the submitter, the submitter
of the information shall be notified of the decision and the reasons
therefor a reasonable number of days prior to the date on which
disclosure is to be made.
(c) Form of denial. (1) A decision withholding a requested record
shall be in writing and shall include:
(i) A reference to the specific exemption or exemptions authorizing
the withholding;
(ii) If neither a statute or an Executive order requires withholding,
the sound ground for withholding;
(iii) A listing of the names and titles or positions of each person
responsible for the denial; and
(iv) A statement that the denial may be appealed to the Assistant
Secretary -- Policy, Budget and Administration and a description of the
procedures in 2.18 for appeal.
(2) A decision denying a request for failure to reasonably describe
requested records or for other procedural deficiency or because
requested records cannot be located shall be in writing and shall
include:
(i) A description of the basis of the decision;
(ii) A list of the names and titles or positions of each person
responsible; and
(iii) A statement that the matter may be appealed to the Assistant
Secretary -- Policy, Budget and Administration and a description of the
procedures in 2.18 for appeal.
43 CFR 2.17 Time limits for processing initial requests.
(a) Basic limit. Requests for records shall be processed promptly.
A determination whether to grant or deny a request shall be made within
no more than 10 working days after receipt of a request. This
determination shall be communicated immediately to the requester.
(b) Running of basic time limit. (1) The 10 working day time limit
begins to run when a request meeting the requirements of 2.14(b) is
received at a field installation or bureau headquarters designated in
2.14(a) to receive the request.
(2) The running of the basic time limit may be delayed or tolled as
explained in 2.20 (f), (g) and (h) if a requester --
(i) Has not stated a willingnes to pay fees as high as are
anticipated and has not sought and been granted a full fee waiver, or
(ii) Has not made a required advance payment.
(c) Extensions of time. In the following unusual circumstances, the
time limit for acting on an initial request may be extended to the
extent reasonably necessary to the proper processing of the request, but
in no case may the time limit be extended for more than 10 working days:
(1) The need to search for and collect the requested records from
field facilities or other establishments that are separate from the
installation processing the request;
(2) The need to search for, collect, and appropriately examine a
voluminous amount of separate and distinct records demanded in a single
request; or
(3) The need for consultation, which shall be conducted with all
practicable speed, with another agency having a substantial interest in
the determination of the request or among two or more components of the
Department having substantial subject-matter interest therein.
(d) Notice of extension. A requester shall be notified in writing of
an extension under paragraph (c) of this section. The notice shall
state the reason for the extension and the date on which a determination
on the request is expected to be made.
(e) Treatment of delay as denial. If no determination has been
reached at the end of the 10 working day period for deciding an initial
request, or an extension thereof under paragraph (c) of this section,
the requester may deem the request denied and may exercise a right of
appeal in accordance with 2.18.
(f) Notice of delay. When a determination cannot be reached within
the time limit, or extension thereof, the requester shall be notified of
the reason for the delay, of the date on which a determination may be
expected, and of the right to treat the delay as a denial for purposes
of appeal to the Assistant Secretary -- Policy, Budget and
Administration, including a description of the procedures for filing an
appeal in 2.18.
43 CFR 2.18 Appeals.
(a) Right of appeal. A requester may appeal to the Assistant
Secretary -- Policy, Budget and Administration when --
(1) Records have been withheld,
(2) A request has been denied for failure to describe requested
records or for other procedural deficiency or because requested records
cannot be located,
(3) A fee waiver has been denied, or
(4) A request has not been decided within the time limits provided in
2.17.
(b) Time for appeal. An appeal must be received no later than 20
working days after the date of the initial denial, in the case of a
denial of an entire request, or 20 working days after records have been
made available, in the case of a partial denial.
(c) Form of appeal. (1) An appeal shall be initiated by filing a
written notice of appeal. The notice shall be accompanied by copies of
the original request and the initial denial and should, in order to
expedite the appellate process and give the requester an opportunity to
present his or her arguments, contain a brief statement of the reasons
why the requester believes the initial denial to have been in error.
(2) The appeal shall be addressed to the Freedom of Information Act
Appeals Officer, Office of the Assistant Secretary -- Policy, Budget and
Administration, U.S. Department of the Interior, Washington, DC 20240.
(3) To expedite processing, both the envelope containing a notice of
appeal and the face of the notice should bear the legend ''FREEDOM OF
INFORMATION APPEAL.''
43 CFR 2.19 Action on appeals.
(a) Authority. Appeals shall be decided by the Assistant Secretary
-- Policy, Budget and Administration, or the Assistant Secretary's
designee, after consultation with the Solicitor, the Director of Public
Affairs and the appropriate program Assistant Secretary.
(b) Time limit. A final determination shall be made within 20
working days after receipt of an appeal meeting the requirements of
2.18(c).
(c) Extensions of time. (1) If the time limit for responding to the
initial request for a record was not extended under the provisions of
2.17(c) or was extended for fewer than 10 working days, the time for
processing of the appeal may be extended to the extent reasonably
necessary to the proper processing of the appeal, but in no event may
the extension, when taken together with any extension made during
processing of the initial request, result in an aggregate extension with
respect to any one request of more than 10 working days. The time for
processing of an appeal may be extended only if one or more of the
unusual circumstances listed in 2.17(c) requires an extension.
(2) The appellant shall be advised in writing of the reasons for the
extension and the date on which a final determination on the appeal is
expected to be dispatched.
(3) If no determination on the appeal has been reached at the end of
the 20 working day period, or the extension thereof, the requester is
deemed to have exhausted his administrative remedies, giving rise to a
right of review in a district court of the United States, as specified
in 5 U.S.C. 552(a)(4). When no determination can be reached within the
applicable time limit, the appeal will nevertheless continue to be
processed. On expiration of the time limit, the requester shall be
informed of the reason for the delay, of the date on which a
determination may be reached to be dispatched and of the right to seek
judicial review.
(d) Form of decision. (1) The final determination on an appeal shall
be in writing and shall state the basis for the determination. If the
determination is to release the requested records or portions thereof,
the Assistant Secretary -- Policy, Budget and Administration shall
immediately make the records available or instruct the appropriate
bureau to make them immediately available. If the determination upholds
in whole or part the initial denial of a request for records, the
determination shall advise the requester of the right to obtain judicial
review in the U.S. District Court for the district in which the withheld
records are located, or in which the requester resides or has his or her
principal place of business or in the U.S. District Court for the
District of Columbia, and shall set forth the names and titles or
positions of each person responsible for the denial.
(2) If a requested record (or portion thereof) is being made
available over the objections of a submitter made in accordance with
2.15(d), the submitter shall be provided notice as described in
2.16(b)(2).
43 CFR 2.20 Fees.
(a) Policy. (1) Unless waived pursuant to the provisions of 2.21,
fees for responding to FOIA requests shall be charged in accordance with
the provisions of this section and the schedule of charges contained in
Appendix A to this part.
(2) Fees shall not be charged if the total amount chargeable does not
exceed $15.00.
(3) Where there is a reasonable basis to conclude that a requester or
group of requesters acting in concert has divided a request into a
series of requests on a single subject or related subjects to avoid
assessment of fees, the requests may be aggregated and fees charged
accordingly.
(b) Commercial use requests. (1) A requester seeking records for
commercial use shall be charged fees for costs incurred in document
search, duplication and review.
(2) A commercial use requester may not be charged fees for time spent
resolving legal and policy issues affecting access to requested records.
(3) A commercial use request is a request from or on behalf of a
person who seeks information for a use or purpose that further the
commercial, trade or profit interests of the requester or the person on
whose behalf the request is made. The intended use of records may be
determined on the basis of information submitted by a requester and from
reasonable inferences based on the identity of the requester and any
other available information.
(c) Educational and noncommercial scientific institution requests.
(1) A requester seeking records under the auspices of an educational
institution in furtherance of scholarly research or a noncommercial
scientific institution in furtherance of scientific research shall be
charged for document duplication, except that the first 100 pages of
paper copies (or the equivalent cost thereof if the records are in some
other form) shall be provided without charge.
(2) Such requesters may not be charged fees for costs incurred in --
(i) Searching for requested records,
(ii) Examining requested records to determine whether they are exempt
from mandatory disclosure,
(iii) Deleting reasonably segregable exempt matter,
(iv) Monitoring the requesters' inspection of agency records, or
(v) Resolving legal and policy issues affecting access to requested
records.
(3) An ''educational institution'' is a preschool, a public or
private elementary or secondary school, an institution of graduate
higher education, an institution of undergraduate higher education, an
institution of professional education, or an institution of vocational
education, which operates a program or programs of scholarly research.
(4) A ''noncommercial scientific institution'' is an institution that
is not operated for commerce, trade or profit and that is operated
solely for the purpose of conducting scientific research the results of
which are not intended to promote any particular product or industry.
(d) News media requests. (1) A representative of the new media shall
be charged for document duplication, except that the first 100 pages of
paper copies (or the equivalent cost thereof if the records are in some
other form) shall be provided without charge.
(2) Representatives of the news media may not be charged fees for
costs incurred in --
(i) Searching for requested records,
(ii) Examining requested records to determine whether they are exempt
from mandatory disclosure,
(iii) Deleting reasonably segregable exempt matter,
(iv) Monitoring the requester's inspection of agency records, or
(v) Resolving legal and policy issues affecting access to requested
records.
(3)(i) A ''representative of the news media'' is any person actively
gathering news for an entity that is organized and operated to publish
or broadcast news to the public. The term ''news'' means information
that is about current events or that is (or would be) of current
interest to the public. Examples of news media entities include, but
are not limited to, television or radio stations broadcasting to the
public at large, and publishers of periodicals (but only in those
instances when they can qualify as disseminators of ''news'') who make
their products available for purchase or subscription by the general
public. As traditional methods of news delivery evolve (e.g.,
electronic dissemination of newspapers through telecommunications
services), such alternative media would be included in this category.
(ii) Free-lance journalists may be considered ''representatives of
the news media'' if they demonstrate a solid basis for expecting
publication through a news organization, even though not actually
employed by it. A publication contract or past record of publication,
or evidence of a specific free-lance assignment from a news organization
may indicate a solid basis for expecting publication.
(e) Other requests. (1) A requester not covered by paragraphs (b),
(c) or (d) of this section shall be charged fees for document search and
duplication, except that the first two hours of search time and the
first 100 pages of paper copies (or the equivalent cost thereof if the
records are in some other form) shall be provided without charge.
(2) Such requesters may not be charged for costs incurred in --
(i) Examining requested records to determine whether they are exempt
from disclosure,
(ii) Deleting reasonably segregable exempt matter,
(iii) Monitoring the requester's inspection of agency records, or
(iv) Resolving legal and policy issues affecting access to requested
records.
(f) Requests for clarification. Where a request does not provide
sufficient information to determine whether it is covered by paragraph
(b), (c), (d) or (e) of this section, the requester should be asked to
provide additional clarification. If it is necessary to seek such
clarification, the request may be deemed to have not been received for
purposes of the time limits established in 2.17 until the clarification
is received. Requests to requesters for clarification shall be made
promptly.
(g) Notice of anticipated fees. Where a request does not state a
willingness to pay fees as high as anticipated by the Department, and
the requester has not sought and been granted a full waiver of fees
under 2.21, the request may be deemed to have not been received for
purposes of the time limits established in 2.17 until the requester has
been notified of and agrees to pay the anticipated fee. Advice to
requesters with respect to anticipated fees shall be provided promptly.
(h) Advance payment. (1) Where it is anticipated that allowable fees
are likely to exceed $250.00 and the requester does not have a history
of prompt payment of FOIA fees, the requester may be required to make an
advance payment of the entire fee before processing of his or her
request.
(2) Where a requester has previously failed to pay a fee within 30
calendar days of the date of billing, processing of any new request from
that requester shall ordinarily be suspended until the requester pays
any amount still owed, including applicable interest, and makes advance
payment of allowable fees anticipated in connection with the new
request.
(3) Advance payment of fees may not be required except as described
in paragraphs (h) (1) and (2) of this section.
(4) Issuance of a notice requiring payment of overdue fees or advance
payment shall toll the time limit in 2.17 until receipt of payment.
(i) Form of payment. Payment of fees should be made by check or
money order payable to the Department of the Interior or the bureau
furnishing the information. The term United States or the initials
''U.S.'' should not be included on the check or money order. Where
appropriate, the official responsible for handling a request may require
that payment by check be made in the form of a certified check.
(j) Billing procedures. A bill for collection, Form DI-1040, shall
be prepared for each request that requires collection of fees. The
requester shall be provided the first sheet of the DI-1040. This
Accounting Copy of the Form shall be transmitted to the agency's finance
office for entry into accounts receivable records. Upon receipt of
payment from the requester, the recipient shall forward the payment
along with a copy of the DI-1040 to the finance office.
(k) Collection of fees. The bill for collection or an accompanying
letter to the requester shall include a statement that interest will be
charged in accordance with the Debt Collection Act of 1982, 31 U.S.C.
3717, and implementing regulations, 4 CFR 102.13, if the fees are not
paid within 30 calendar days of the date of the bill for collection is
mailed or hand-delivered to the requester. This requirement does not
apply if the requester is a unit of state or local government. Other
authorities of the Debt Collection Act of 1982 shall be used, as
appropriate, to collect the fees (see 4 CFR Parts 101-105).