§ 1395bb. Effect of accreditation
(a) Accreditation by American Osteopathic Asso-
ciation or other national accreditation body
(1) If the Secretary finds that accreditation of
a provider entity (as defined in paragraph (4)) by
the American Osteopathic Association or any
other national accreditation body demonstrates
that all of the applicable conditions or require-
ments of this subchapter (other than the re-
quirements of section 1395m(j) of this title) are
met or exceeded—
(A) in the case of a provider entity not de-
scribed in paragraph (3)(B), the Secretary shall
treat such entity as meeting those conditions
or requirements with respect to which the
Secretary made such finding; or
(B) in the case of a provider entity described
in paragraph (3)(B), the Secretary may treat
such entity as meeting those conditions or re-
quirements with respect to which the Sec-
retary made such finding.
(2) In making such a finding, the Secretary
shall consider, among other factors with respect
to a national accreditation body, its require-
ments for accreditation, its survey procedures,
its ability to provide adequate resources for con-
ducting required surveys and supplying informa-
tion for use in enforcement activities, its moni-
toring procedures for provider entities found out
of compliance with the conditions or require-
ments, and its ability to provide the Secretary
with necessary data for validation.
(3)(A) Except as provided in subparagraph (B),
not later than 60 days after the date of receipt
of a written request for a finding under para-
graph (1) (with any documentation necessary to
make a determination on the request), the Sec-
retary shall publish a notice identifying the na-
tional accreditation body making the request,
describing the nature of
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Page 3623
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 1395bb
tion 4204(a) of Pub. L. 100–203, as amended, set out as an
Effective Date note under section 1395i–3 of this title.
Amendment by section 4203(a)(1) of Pub. L. 100–203 ap-
plicable Jan. 1, 1988, except as otherwise specifically
provided in section 1395i–3 of this title, without regard
to whether regulations to implement such amendment
are promulgated by such date, and in applying amend-
ment by section 4203(a)(1) of Pub. L. 100–203 for services
furnished by a skilled nursing facility before Oct. 1,
1990, any reference to a requirement of section
1395i–3(b), (c), or (d) of this title is deemed a reference
to section 1395x(j) of this title, see section 4204(b) of
Pub. L. 100–203, as added by Pub. L. 100–485, set out as
an Effective Date note under section 1395i–3 of this
title.
EFFECTIVE DATE OF 1986 AMENDMENT
Amendment by Pub. L. 99–509 applicable to services
furnished on or after Jan. 1, 1989, with exceptions for
hospitals located in rural areas which meet certain re-
quirements related to certified registered nurse anes-
thetists, see section 9320(i), (k) of Pub. L. 99–509, as
amended, set out as notes under section 1395k of this
title.
EFFECTIVE DATE OF 1984 AMENDMENT
Amendment by Pub. L. 98–369 effective July 18, 1984,
but not to be construed as changing or affecting any
right, liability, status, or interpretation which existed
(under the provisions of law involved) before that date,
see section 2354(e)(1) of Pub. L. 98–369, set out as a note
under section 1320a–1 of this title.
EFFECTIVE DATE OF 1982 AMENDMENT
Amendment by Pub. L. 97–248 applicable to hospice
care provided on or after Nov. 1, 1983, see section
122(h)(1) of Pub. L. 97–248, as amended, set out as a note
under section 1395c of this title.
EFFECTIVE DATE OF 1980 AMENDMENTS
Amendment by Pub. L. 96–611 effective July 1, 1981,
and applicable to services furnished on or after that
date, see section 2 of Pub. L. 96–611, set out as a note
under section 1395l of this title.
For effective date of amendment by section 933(g) of
Pub. L. 96–499, see section 933(h) of Pub. L. 96–499, set
out as a note under section 1395k of this title.
EFFECTIVE DATE OF 1977 AMENDMENT
Amendment by Pub. L. 95–210 applicable to services
rendered on or after first day of third calendar month
which begins after Dec. 31, 1977, see section 1(j) of Pub.
L. 95–210, set out as a note under section 1395k of this
title.
EFFECTIVE DATE OF 1972 AMENDMENT
Pub. L. 92–603, title II, § 299D(c), Oct. 30, 1972, 86 Stat.
1462, provided that: ‘‘The provisions of this section
[amending this section and section 1396a of this title]
shall be effective beginning January 1, 1973, or within
6 months following the enactment of this Act [Oct. 30,
1972], whichever is later.’’
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by section 133(f) of Pub. L. 90–248 applica-
ble with respect to services furnished after June 30,
1968, see section 133(g) of Pub. L. 90–248, set out as a
note under section 1395k of this title.
Pub. L. 90–248, title II, § 228(b), Jan. 2, 1968, 81 Stat.
904, provided that the amendment made by such section
228(b) is effective July 1, 1969.
USE OF STATE OR LOCAL AGENCIES IN EVALUATING
LABORATORIES
Pub. L. 103–432, title I, § 160(a)(2), Oct. 31, 1994, 108
Stat. 4443, provided that: ‘‘An agreement made by the
Secretary of Health and Human Services with a State
under section 1864(a) of the Social Security Act [42
U.S.C. 1395aa(a)] may include an agreement that the
services of the State health agency or other appro-
priate State agency (or the appropriate local agencies)
will be utilized by the Secretary for the purpose of de-
termining whether a laboratory meets the require-
ments of section 353 of the Public Health Service Act
[42 U.S.C. 263a].’’
NURSE AID TRAINING AND COMPETENCY EVALUATION,
FAILURE BY STATE TO MEET GUIDELINES
Pub. L. 101–508, title IV, § 4008(h)(1)(A), Nov. 5, 1990,
104 Stat. 1388–46, provided that: ‘‘The Secretary of
Health and Human Services may not refuse to enter
into an agreement or cancel an existing agreement
with a State under section 1864 of the Social Security
Act [42 U.S.C. 1395aa] on the basis that the State failed
to meet the requirement of section 1819(e)(1)(A) of such
Act [42 U.S.C. 1395i–3(e)(1)(A)] before the effective date
of guidelines, issued by the Secretary, establishing re-
quirements under section 1819(f)(2)(A) of such Act, if
the State demonstrates to the satisfaction of the Sec-
retary that it has made a good faith effort to meet such
requirement before such effective date.’’
§ 1395bb. Effect of accreditation
(a) Accreditation by American Osteopathic Asso-
ciation or other national accreditation body
(1) If the Secretary finds that accreditation of
a provider entity (as defined in paragraph (4)) by
the American Osteopathic Association or any
other national accreditation body demonstrates
that all of the applicable conditions or require-
ments of this subchapter (other than the re-
quirements of section 1395m(j) of this title) are
met or exceeded—
(A) in the case of a provider entity not de-
scribed in paragraph (3)(B), the Secretary shall
treat such entity as meeting those conditions
or requirements with respect to which the
Secretary made such finding; or
(B) in the case of a provider entity described
in paragraph (3)(B), the Secretary may treat
such entity as meeting those conditions or re-
quirements with respect to which the Sec-
retary made such finding.
(2) In making such a finding, the Secretary
shall consider, among other factors with respect
to a national accreditation body, its require-
ments for accreditation, its survey procedures,
its ability to provide adequate resources for con-
ducting required surveys and supplying informa-
tion for use in enforcement activities, its moni-
toring procedures for provider entities found out
of compliance with the conditions or require-
ments, and its ability to provide the Secretary
with necessary data for validation.
(3)(A) Except as provided in subparagraph (B),
not later than 60 days after the date of receipt
of a written request for a finding under para-
graph (1) (with any documentation necessary to
make a determination on the request), the Sec-
retary shall publish a notice identifying the na-
tional accreditation body making the request,
describing the nature of the request, and pro-
viding a period of at least 30 days for the public
to comment on the request. The Secretary shall
approve or deny a request for such a finding, and
shall publish notice of such approval or denial,
not later than 210 days after the date of receipt
of the request (with such documentation). Such
an approval shall be effective with respect to ac-
creditation determinations made on or after
Page 3624
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 1395bb
such effective date (which may not be later than
the date of publication of the approval) as the
Secretary specifies in the publication notice.
(B) The 210-day and 60-day deadlines specified
in subparagraph (A) shall not apply in the case
of any request for a finding with respect to ac-
creditation of a provider entity to which the
conditions and requirements of sections 1395i–3
and 1395x(j) of this title apply.
(4) For purposes of this section, the term ‘‘pro-
vider entity’’ means a provider of services, sup-
plier, facility (including a renal dialysis facil-
ity), clinic, agency, or laboratory.
(b) Disclosure of accreditation survey
The Secretary may not disclose any accredita-
tion survey (other than a survey with respect to
a home health agency or, beginning on Decem-
ber 27, 2020, a hospice program) made and re-
leased to the Secretary by the American Osteo-
pathic Association or any other national accred-
itation body, of an entity accredited by such
body, except that the Secretary may disclose
such a survey and information related to such a
survey to the extent such survey and informa-
tion relate to an enforcement action taken by
the Secretary.
(c) Deficiencies
Notwithstanding any other provision of this
subchapter, if the Secretary finds that a pro-
vider entity has significant deficiencies (as de-
fined in regulations pertaining to health and
safety), the entity shall, after the date of notice
of such finding to the entity and for such period
as may be prescribed in regulations, be deemed
not to meet the conditions or requirements the
entity has been treated as meeting pursuant to
subsection (a)(1).
(d) State or local accreditation
For provisions relating to validation surveys
of entities that are treated as meeting applica-
ble conditions or requirements of this sub-
chapter pursuant to subsection (a)(1), see sec-
tion 1395aa(c) of this title.
(e) Accreditation for dialysis facilities
With respect to an accreditation body that has
received approval from the Secretary under sub-
section (a)(3)(A) for accreditation of provider en-
tities that are required to meet the conditions
and requirements under section 1395rr(b) of this
title, in addition to review and oversight au-
thorities otherwise applicable under this sub-
chapter, the Secretary shall (as the Secretary
determines appropriate) conduct, with respect
to such accreditation body and provider entities,
any or all of the following as frequently as is
otherwise required to be conducted under this
subchapter with respect to other accreditation
bodies or other provider entities:
(1) Validation surveys referred to in sub-
section (d).
(2) Accreditation program reviews (as de-
fined in section 488.8(c) of title 42 of the Code
of Federal Regulations, or a successor regula-
tion).
(3) Performance reviews (as defined in sec-
tion 488.8(a) of title 42 of the Code of Federal
Regulations, or a successor regulation).
(Aug. 14, 1935, ch. 531, title XVIII, § 1865, as added
Pub. L. 89–97, title I, § 102(a), July 30, 1965, 79
Stat. 326; amended Pub. L. 92–603, title II,
§§ 234(h), 244(b), Oct. 30, 1972, 86 Stat. 1413, 1423;
Pub. L. 97–248, title I, §§ 122(g)(4), 128(d)(3), Sept.
3, 1982, 96 Stat. 362, 367; Pub. L. 98–369, div. B,
title III, §§ 2345(a), 2346(a), July 18, 1984, 98 Stat.
1096; Pub. L. 99–509, title IX, §§ 9305(c)(3),
9320(h)(3), Oct. 21, 1986, 100 Stat. 1990, 2016; Pub.
L. 100–203, title IV, §§ 4025(b), 4072(d), Dec. 22,
1987, 101 Stat. 1330–117, as amended Pub. L.
100–360, title IV, § 411(d)(4)(B)(ii), July 1, 1988, 102
Stat. 774; Pub. L. 100–360, title II, §§ 204(c)(3),
(d)(3), July 1, 1988, 102 Stat. 728, 729; Pub. L.
100–485, title VI, § 608(d)(20)(D), Oct. 13, 1988, 102
Stat. 2420; Pub. L. 101–234, title II, § 201(a), Dec.
13, 1989, 103 Stat. 1981; Pub. L. 101–239, title VI,
§§ 6003(g)(3)(C)(iv), 6019(a)–(c), 6115(c), Dec. 19,
1989, 103 Stat. 2153, 2165, 2166, 2219; Pub. L.
101–508, title IV, § 4163(c)(3), Nov. 5, 1990, 104 Stat.
1388–100; Pub. L. 103–432, title I, § 145(c)(4), Oct.
31, 1994, 108 Stat. 4427; Pub. L. 104–134, title I,
§ 101(d) [title V, § 516(b), (c)(2)], Apr. 26, 1996, 110
Stat. 1321–211, 1321–246, 1321–247; renumbered
title I, Pub. L. 104–140, § 1(a), May 2, 1996, 110
Stat. 1327; Pub. L. 108–173, title VII, § 736(a)(12),
Dec. 8, 2003, 117 Stat. 2355; Pub. L. 110–275, title
I, § 125(a), (b)(1), July 15, 2008, 122 Stat. 2519; Pub.
L. 115–123, div. E, title IV, § 50403(a)(1), Feb. 9,
2018, 132 Stat. 217; Pub. L. 116–260, div. CC, title
IV, § 407(a)(2), Dec. 27, 2020, 134 Stat. 3007.)
Editorial Notes
AMENDMENTS
2020—Subsec. (b). Pub. L. 116–260 inserted ‘‘or, begin-
ning on December 27, 2020, a hospice program’’ after
‘‘home health agency’’.
2018—Subsec. (a)(1). Pub. L. 115–123, § 50403(a)(1)(A)(i),
struck out ‘‘or the conditions and requirements under
section 1395rr(b) of this title’’ after ‘‘section 1395m(j) of
this title’’ in introductory provisions.
Subsec. (a)(4). Pub. L. 115–123, § 50403(a)(1)(A)(ii), in-
serted ‘‘(including a renal dialysis facility)’’ after ‘‘fa-
cility’’.
Subsec. (e). Pub. L. 115–123, § 50403(a)(1)(B), added sub-
sec. (e).
2008—Subsec. (a). Pub. L. 110–275, § 125(a), redesig-
nated subsec. (b) as (a) and struck out former subsec.
(a) which provided criteria necessary for an institution
to meet certain requirements enumerated in section
1395x(e) of this title.
Subsec. (a)(1). Pub. L. 110–275, § 125(b)(1)(A), sub-
stituted ‘‘If’’ for ‘‘In addition, if’’.
Subsec. (b). Pub. L. 110–275, § 125(a), (b)(1)(B), redesig-
nated subsec. (c) as (b), substituted ‘‘released to the
Secretary by’’ for ‘‘released to him by the Joint Com-
mission on Accreditation of Hospitals,’’, and struck out
the comma after ‘‘Osteopathic Association’’. Former
subsec. (b) redesignated (a).
Subsecs. (c), (d). Pub. L. 110–275, § 125(a), (b)(1)(C), (D),
redesignated subsecs. (d) and (e) as (c) and (d), respec-
tively, and substituted ‘‘pursuant to subsection (a)(1)’’
for ‘‘pursuant to subsection (a) or (b)(1)’’. Former sub-
sec. (c) redesignated (b).
Subsec. (e). Pub. L. 110–275, § 125(a), redesignated sub-
sec. (e) as (d).
2003—Subsec. (b)(3)(B). Pub. L. 108–173 substituted
‘‘sections’’ for ‘‘section’’.
1996—Subsec. (a). Pub. L. 104–134, § 101(d) [title V,
§ 516(b)(2), (3)], struck out after second sentence: ‘‘In ad-
dition, if the Secretary finds that accreditation of an
entity by the American Osteopathic Association or any
other national accreditation body provides reasonable
assurance that any or all of the conditions of section
1395k(a)(2)(F)(i), 1395x(e), 1395x(f), 1395x(j), 1395x(o),
1395x(p)(4)(A) or (B), paragraphs (15) and (16) of section
1395x(s), section 1395x(aa)(2), 1395x(cc)(2), 1395x(dd)(2), or
Page 3625
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 1395bb
1395x(mm)(1) of this title, as the case may be, are met,
he may, to the extent he deems it appropriate, treat
such entity as meeting the condition or conditions with
respect to which he made such finding.’’ and redesig-
nated fourth sentence as subsec. (c).
Subsec.
(b).
Pub.
L.
104–134,
§ 101(d)
[title
V,
§ 516(b)(3)], added subsec. (b). Former subsec. (b) redes-
ignated (d).
Subsec.
(c).
Pub.
L.
104–134,
§ 101(d)
[title
V,
§ 516(b)(2)], redesignated fourth sentence of subsec. (a)
as subsec. (c).
Subsec. (d). Pub. L. 104–134, § 101(d) [title V, § 516(b)(1),
(c)(2)(A)], redesignated subsec. (b) as (d) and sub-
stituted ‘‘a provider entity’’ for ‘‘a hospital’’, ‘‘the enti-
ty’’ for ‘‘the hospital’’ in two places, and ‘‘the condi-
tions or requirements the entity has been treated as
meeting pursuant to subsection (a) or (b)(1) of this sec-
tion’’ for ‘‘the requirements of the numbered para-
graphs of section 1395x(e) of this title’’.
Subsec.
(e).
Pub.
L.
104–134,
§ 101(d)
[title
V,
§ 516(c)(2)(B)], added subsec. (e).
1994—Subsec.
(a).
Pub.
L.
103–432
struck
out
‘‘1395m(c)(3),’’
after
‘‘conditions
of
section
1395k(a)(2)(F)(i),’’ in closing provisions.
1990—Subsec.
(a).
Pub.
L.
101–508
inserted
‘‘1395m(c)(3),’’ after ‘‘1395k(a)(2)(F)(i),’’ in second sen-
tence.
1989—Subsec. (a). Pub. L. 101–239, § 6115(c), substituted
‘‘paragraphs (15) and (16)’’ for ‘‘paragraphs (14) and
(15)’’.
Pub. L. 101–239, § 6019(b), inserted before period at end
‘‘, except that the Secretary may disclose such a sur-
vey and information related to such a survey to the ex-
tent such survey and information relate to an enforce-
ment action taken by the Secretary’’.
Pub.
L.
101–239,
§ 6003(g)(3)(C)(iv),
substituted
‘‘1395x(dd)(2), or 1395x(mm)(1) of this title’’ for ‘‘or
1395x(dd)(2) of this title’’ in third sentence.
Pub. L. 101–234 repealed Pub. L. 100–360, § 204(c)(3),
(d)(3), and provided that the provisions of law amended
or repealed by such section are restored or revived as
if such section had not been enacted, see 1988 and 1989
Amendment notes.
Subsec. (a)(2). Pub. L. 101–239, § 6019(a), designated ex-
isting provisions as subpar. (A), struck out ‘‘(if it is in-
cluded within a survey described in section 1395aa(c) of
this
title)’’
after
‘‘such
institution’’,
inserted
‘‘, together with any other information directly related
to the survey as the Secretary may require (including
corrective action plans)’’ after ‘‘by such Commission’’,
and added subpar. (B).
Subsec. (b). Pub. L. 101–239, § 6019(c), struck out ‘‘fol-
lowing a survey made pursuant to section 1395aa(c) of
this title’’ after ‘‘if the Secretary finds’’.
1988—Subsec. (a). Pub. L. 100–360, § 411(d)(4)(B)(ii), as
amended by Pub. L. 100–485, § 608(d)(20)(D), added Pub.
L. 100–203, § 4025(b), see 1987 Amendment note below.
Pub. L. 100–360, § 204(d)(3), substituted ‘‘paragraphs
(14) and (15)’’ for ‘‘paragraphs (13) and (14)’’ in third sen-
tence.
Pub. L. 100–360, § 204(c)(3), inserted ‘‘1395m(e)(3),’’
after ‘‘1395k(a)(2)(F)(i),’’ in third sentence.
1987—Subsec. (a). Pub. L. 100–203, § 4072(d), substituted
‘‘paragraphs (13) and (14)’’ for ‘‘paragraphs (12) and (13)’’
in penultimate sentence.
Pub. L. 100–203, § 4025(b), as added by Pub. L. 100–360,
§ 411(d)(4)(B)(ii),
as
amended
by
Pub.
L.
100–485,
§ 608(d)(20)(D), inserted ‘‘(other than a survey with re-
spect to a home health agency)’’ after ‘‘survey’’ in last
sentence.
1986—Subsec. (a). Pub. L. 99–509, § 9305(c)(3), inserted
‘‘, requires a discharge planning process (or imposes
another requirement which serves substantially the
same purpose)’’ after ‘‘the same purpose)’’, and ‘‘clause
(A) or (B) of’’ after ‘‘comply also with’’ in second sen-
tence.
Pub. L. 99–509, § 9320(h)(3), substituted ‘‘paragraphs
(12) and (13)’’ for ‘‘paragraphs (11) and (12)’’ in third sen-
tence.
1984—Subsec. (a). Pub. L. 98–369, § 2346(a), in provi-
sions
following
par.
(4),
substituted
‘‘section
1395k(a)(2)(F)(i), 1395x(e), 1395x(f), 1395x(j), 1395x(o),
1395x(p)(4)(A) or (B), paragraphs (11) and (12) of section
1395x(s), section 1395x(aa)(2), 1395x(cc)(2), or 1395x(dd)(2)
of this title’’ for ‘‘section 1395x(e), (j), (o), or (dd) of this
title’’, and substituted ‘‘entity’’ for ‘‘institution or
agency’’ in two places.
Pub. L. 98–369, § 2345(a), struck out ‘‘(on a confidential
basis)’’ after ‘‘release to the Secretary’’ in par. (2), and
inserted provision that the Secretary may not disclose
any accreditation survey made and released to him by
the Joint Commission on Accreditation of Hospitals,
the American Osteopathic Association, or any other
national accreditation body, of an entity accredited by
such body, in provisions following par. (4).
1982—Subsec. (a). Pub. L. 97–248, § 122(g)(4), sub-
stituted ‘‘(o), or (dd)’’ for ‘‘or (o)’’.
Subsec. (b). Pub. L. 97–248, § 128(d)(3), substituted ‘‘a
hospital’’ for ‘‘an institution’’ and ‘‘the hospital’’ for
‘‘such institution’’.
1972—Pub. L. 92–603 designated existing provisions as
subsec. (a), inserted reference to subsec. (b) of this sec-
tion in opening provisions, redesignated existing provi-
sions as pars. (1) and (3) and added pars. (2) and (4) and
in provisions following par. (4) inserted provisions for
the imposition of a standard which the Secretary deter-
mines is at least equivalent to the standard promul-
gated by the Secretary as described in par. (4), and
added subsec. (b).
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE OF 2008 AMENDMENT; TRANSITION
RULE
Pub. L. 110–275, title I, § 125(d), July 15, 2008, 122 Stat.
2520, provided that:
‘‘(1) Subject to paragraph (2), the amendments made
by this section [amending this section and sections
1395m, 1395w–22, 1395x, 1395aa, and 1395ll of this title]
shall apply with respect to accreditations of hospitals
granted on or after the date that is 24 months after the
date of the enactment of this Act [July 15, 2008].
‘‘(2) For purposes of title XVIII of the Social Security
Act (42 U.S.C. 1395 et seq.), the amendments made by
this section shall not effect [sic] the accreditation of a
hospital by the Joint Commission, or under accredita-
tion or comparable approval standards found to be es-
sentially equivalent to accreditation or approval stand-
ards of the Joint Commission, for the period of time ap-
plicable under such accreditation.’’
EFFECTIVE DATE OF 1994 AMENDMENT
Amendment by Pub. L. 103–432 applicable to mam-
mography furnished by a facility on and after the first
date that the certificate requirements of section 263b(b)
of this title apply to such mammography conducted by
such facility, see section 145(d) of Pub. L. 103–432, set
out as a note under section 1395m of this title.
EFFECTIVE DATE OF 1990 AMENDMENT
Amendment by Pub. L. 101–508 applicable to screening
mammography performed on or after Jan. 1, 1991, see
section 4163(e) of Pub. L. 101–508, set out as a note under
section 1395l of this title.
EFFECTIVE DATE OF 1989 AMENDMENT
Pub. L. 101–239, title VI, § 6019(d), Dec. 19, 1989, 103
Stat. 2166, provided that:
‘‘(1) Except as provided in paragraph (2), the amend-
ments made by this section [amending this section]
shall take effect on the date of the enactment of this
Act [Dec. 19, 1989].
‘‘(2) The amendments made by subsection (a) [amend-
ing this section] shall take effect 6 months after the
date of the enactment of this Act.’’
Amendment by section 6115(c) of Pub. L. 101–239 appli-
cable to screening pap smears performed on or after
July 1, 1990, see section 6115(d) of Pub. L. 101–239, set
out as a note under section 1395x of this title.
Amendment by Pub. L. 101–234 effective Jan. 1, 1990,
see section 201(c) of Pub. L. 101–234, set out as a note
under section 1320a–7a of this title.
Page 3626
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 1395cc
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–485 effective as if included
in the enactment of the Medicare Catastrophic Cov-
erage Act of 1988, Pub. L. 100–360, see section 608(g)(1) of
Pub. L. 100–485, set out as a note under section 704 of
this title.
Amendment by section 204(c)(3), (d)(3) of Pub. L.
100–360 applicable to screening mammography per-
formed on or after Jan. 1, 1990, see section 204(e) of Pub.
L. 100–360, set out as a note under section 1395m of this
title.
Except as specifically provided in section 411 of Pub.
L. 100–360, amendment by section 411(d)(4)(B)(ii) of Pub.
L. 100–360, as it relates to a provision in the Omnibus
Budget Reconciliation Act of 1987, Pub. L. 100–203, ef-
fective as if included in the enactment of that provi-
sion in Pub. L. 100–203, see section 411(a) of Pub. L.
100–360, set out as a Reference to OBRA; Effective Date
note under section 106 of Title 1, General Provisions.
EFFECTIVE DATE OF 1987 AMENDMENT
Amendment by section 4025(b) of Pub. L. 100–203 ap-
plicable with respect to agreements entered into or re-
newed on or after Dec. 22, 1987, see section 4025(c) of
Pub. L. 100–203, as amended, set out as a note under sec-
tion 1395aa of this title.
For effective date of amendment by section 4072(d) of
Pub. L. 100–203, see section 4072(e) of Pub. L. 100–203, set
out as a note under section 1395x of this title.
EFFECTIVE DATE OF 1986 AMENDMENT
Amendment by section 9305(c)(3) of Pub. L. 99–509 ap-
plicable to hospitals as of one year after Oct. 21, 1986,
see section 9305(c)(4) of Pub. L. 99–509, set out as a note
under section 1395x of this title.
Amendment by section 9320(h)(3) of Pub. L. 99–509 ap-
plicable to services furnished on or after Jan. 1, 1989,
with exceptions for hospitals located in rural areas
which meet certain requirements related to certified
registered nurse anesthetists, see section 9320(i), (k) of
Pub. L. 99–509, as amended, set out as notes under sec-
tion 1395k of this title.
EFFECTIVE DATE OF 1984 AMENDMENT
Pub. L. 98–369, div. B, title III, § 2345(b), July 18, 1984,
98 Stat. 1096, provided that: ‘‘The amendments made by
this section [amending this section] shall become effec-
tive on the date of the enactment of this Act [July 18,
1984], and shall apply with respect to surveys released
to the Secretary on, before, or after such date.’’
Pub. L. 98–369, div. B, title III, § 2346(b), July 18, 1984,
98 Stat. 1096, provided that: ‘‘The amendments made by
this section [amending this section] shall become effec-
tive on the date of the enactment of this Act [July 18,
1984].’’
EFFECTIVE DATE OF 1982 AMENDMENT
Amendment by section 122(g)(4) of Pub. L. 97–248 ap-
plicable to hospice care provided on or after Nov. 1,
1983, see section 122(h)(1) of Pub. L. 97–248, as amended,
set out as a note under section 1395c of this title.
Amendment by section 128(d)(3) of Pub. L. 97–248 ef-
fective Sept. 3, 1982, see section 128(e)(3) of Pub. L.
97–248, set out as a note under section 1395x of this title.
EFFECTIVE DATE OF 1972 AMENDMENT
Amendment by section 234(h) of Pub. L. 92–603 appli-
cable with respect to providers of services for fiscal
years beginning after the fifth month following October
1972, see section 234(i) of Pub. L. 92–603, set out as a
note under section 1395x of this title.
TIMING FOR ACCEPTANCE OF REQUESTS FROM
ACCREDITATION ORGANIZATIONS
Pub. L. 115–123, div. E, title IV, § 50403(a)(2), Feb. 9,
2018, 132 Stat. 218, provided that: ‘‘Not later than 90
days after the date of enactment of this Act [Feb. 9,
2018], the Secretary of Health and Human Services shall
begin accepting requests from national accreditation
bodies for a finding described in section 1865(a)(3)(A) of
the Social Security Act (42 U.S.C. 1395bb(a)(3)(A)) for
purposes of accrediting provider entities that are re-
quired to meet the conditions and requirements under
section 1881(b) of such Act (42 U.S.C. 1395rr(b)).’’
AUTHORITY TO RECOGNIZE THE JOINT COMMISSION AS A
NATIONAL ACCREDITATION BODY
Pub. L. 110–275, title I, § 125(c), July 15, 2008, 122 Stat.
2519, provided that: ‘‘The Secretary of Health and
Human Services may recognize the Joint Commission
as a national accreditation body under section 1865 of
the Social Security Act (42 U.S.C. 1395bb), as amended
by this section, upon such terms and conditions, and
upon submission of such information, as the Secretary
may require.’’
§ 1395cc. Agreements with providers of services;
enrollment processes
(a) Filing of agreements; eligibility for payment;
charges with respect to items and services
(1) Any provider of services (except a fund des-
ignated for purposes of section 1395f(g) and sec-
tion 1395n(e) of this title) shall be qualified to
participate under this subchapter and shall be
eligible for payments under this subchapter if it
files with the Secretary an agreement—
(A)(i) not to charge, except as provided in
paragraph (2), any individual or any other per-
son for items or services for which such indi-
vidual is entitled to have payment made under
this subchapter (or for which he would be so
entitled if such provider of services had com-
plied with the procedural and other require-
ments under or pursuant to this subchapter or
for which such provider is paid pursuant to the
provisions of section 1395f(e) of this title), and
(ii) not to impose any charge that is prohib-
ited under section 1396a(n)(3) of this title,
(B) not to charge any individual or any other
person for items or services for which such in-
dividual is not entitled to have payment made
under this subchapter because payment for ex-
penses incurred for such items or services may
not be made by reason of the provisions of
paragraph (1) or (9) of section 1395y(a) of this
title, but only if (i) such individual was with-
out fault in incurring such expenses and (ii)
the Secretary’s determination that such pay-
ment may not be made for such items and
services was made after the third year fol-
lowing the year in which notice of such pay-
ment was sent to such individual; except that
the Secretary may reduce such three-year pe-
riod to not less than one year if he finds such
reduction is consistent with the objectives of
this subchapter,
(C) to make adequate provision for return
(or other disposition, in accordance with regu-
lations) of any moneys incorrectly collected
from such individual or other person,
(D) to promptly notify the Secretary of its
employment of an individual who, at any time
during the year preceding such employment,
was employed in a managerial, accounting, au-
diting, or similar capacity (as determined by
the Secretary by regulation) by an agency or
organization which serves as a fiscal inter-
mediary or carrier (for purposes of part A or
part B, or both, of this subchapter) with re-
spect to the provider,
Cross-references
Connections may be documented source relationships, shared citations or nearby passages. Each explains its basis; a connection alone does not establish applicability to your situation.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Conditions of participation; protection of individual rights; notification of State entities; use of home health aides; medical equipment; individual’s plan of care; compliance with Federal, State, and local laws and regulations** The conditions of participation that a home health agency is required to meet under this subsection are as follows:
(1) The agency protects and promotes the rights of each individual under its care, including each of the following rights:
(A) The right to be fully informed in advance about the care and treatment to be provided by the agency, to be fully informed in advance of any changes in the care or treatment to be provided by the agency that may affect the individual’s well-being, and (except with respect to an individual adjudged incompetent) to participate in planning care and treatment or changes in care or treatment.
(B) The right to voice grievances with respect to treatment or care that is (or fails to be) furnished without discrimination or reprisal for voicing grievances.
(C) The right to confidentiality of the clinical records described in section 1395x(o)(3) of this title.
(D) The right to have one’s property treated with respect.
(E) The right to be fully informed orally and in writing (in advance of coming under the care of the agency) of—
(i) all items and services furnished by (or under arrangements with) the agency for which payment may be made under this subchapter,
(ii) the coverage available for such items and services under this subchapter, subchapter XIX, and any other Federal program of which the agency is reasonably aware,
(iii) any charges for items and services not covered under this subchapter and any charges the individual may have to pay with respect to items and services furn
Stored review status: release_metadata_unconfirmed. The source passage cites 42 U.S.C. § 1395. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
§ 1395. Prohibition against any Federal inter-
ference
Nothing in this subchapter shall be construed
to authorize any Federal officer or employee to
exercise any supervision or control over the
practice of medicine or the manner in which
medical services are provided, or over the selec-
tion, tenure, or compensation of any officer or
employee of any institution, agency, or person
providing health services; or to exercise any su-
pervision or control over the administration or
operation of any such institution, agency, or
person.
(Aug. 14, 1935, ch. 531, title XVIII, § 1801, as added
Pub. L. 89–97, title I, § 102(a), July 30, 1965, 79
Stat. 291.)
Statutory Notes and Related Subsidiaries
SHORT TITLE
For short title of title I of Pub. L. 89–97, which en-
acted this subchapter as the ‘‘Health Insurance for the
Aged Act’’, see section 100 of Pub. L. 89–97, set out as
a Short Title of 1965 Amendment note under section
1305 of this title.
PROTECTING AND IMPROVING GUARANTEED MEDICARE
BENEFITS
Pub. L. 111–148, title III, § 3601, Mar. 23, 2010, 124 Stat.
538, provided that:
‘‘(a) PROTECTING GUARANTEED MEDICARE BENEFITS.—
Nothing in the provisions of, or amendments made by,
this Act [see Short Title note set out under section
18001 of this title] shall result in a reduction of guaran-
teed benefits under title XVIII of the Social Security
Act [42 U.S.C. 1395 et seq.].
‘‘(b) ENSURING THAT MEDICARE SAVINGS BENEFIT THE
MEDICARE
PROGRAM
AND
MEDICARE
BENEFICIARIES.—
Savings generated for the Medicare program under title
XVIII of the Social Security Act under the provisions
of, and amendments made by, this Act shall extend the
solvency of the Medicare trust funds, reduce Medicare
premiums and other cost-sharing for beneficiaries, and
improve or expand gu
Stored review status: historical_2024_not_currentness_verified. The source passage cites 42 U.S.C. § 1395. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Establishment and operation of Account**
(1) **Establishment** — There is created within the Federal Supplementary Medical Insurance Trust Fund established by [section 1395t of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395t&num=0&edition=prelim) an account to be known as the “Medicare Prescription Drug Account” (in this section referred to as the “Account”).
(2) **Funding** — The Account shall consist of such gifts and bequests as may be made as provided in [section 401(i)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section401/i/1&num=0&edition=prelim), accrued interest on balances in the Account, and such amounts as may be deposited in, or appropriated to, such Account as provided in this part.
(3) **Separate from rest of Trust Fund** — Funds provided under this part to the Account shall be kept separate from all other funds within the Federal Supplementary Medical Insurance Trust Fund, but shall be invested, and such investments redeemed, in the same manner as all other funds and investments within such Trust Fund.
**(b) Payments from Account**
(1) **In general** — The Managing Trustee shall pay from time to time from the Account such amounts as the Secretary certifies are necessary to make payments to operate the program under this part, including—
(A) payments under [section 1395w–114 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w-114&num=0&edition=prelim) (relating to low-income subsidy payments);
(B) payments under [section 1395w–115 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w-115&num=0&edition=prelim) (relating to subsidy payments and payments for fallback
Stored review status: release_metadata_unconfirmed. The source passage cites 42 U.S.C. § 1395aa. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
§ 1395aa. Agreements with States
(a) Use of State agencies to determine compli-
ance by providers of services with conditions
of participation
The Secretary shall make an agreement with
any State which is able and willing to do so
under which the services of the State health
agency or other appropriate State agency (or
the appropriate local agencies) will be utilized
by him for the purpose of determining whether
an institution therein is a hospital or skilled
nursing facility, or whether an agency therein is
a home health agency, or whether an agency is
a hospice program or whether a facility therein
is a rural health clinic as defined in section
1395x(aa)(2) of this title, a critical access hos-
pital, as defined in section 1395x(mm)(1) of this
title, or a comprehensive outpatient rehabilita-
tion facility as defined in section 1395x(cc)(2) of
this title, or whether a laboratory meets the re-
quirements of paragraphs (16) and (17) of section
1395x(s) of this title, or whether a clinic, reha-
bilitation agency or public health agency meets
the requirements of subparagraph (A) or (B), as
the case may be, of section 1395x(p)(4) of this
title, or whether an ambulatory surgical center
meets the standards specified under section
1395k(a)(2)(F)(i) of this title, or whether a facil-
ity is a rural emergency hospital as defined in
section 1395x(kkk)(2) of this title. To the extent
that the Secretary finds it appropriate, an insti-
tution or agency which such a State (or local)
agency certifies is a hospital, skilled nursing fa-
cility, rural health clinic, comprehensive out-
patient rehabilitation facility, home health
agency, or hospice program (as those terms are
defined in section 1395x of this title) may be
treated as such by the Secretary. Any
Stored review status: historical_2024_not_currentness_verified. The source passage cites 42 U.S.C. § 1395aa. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Special rules relating to offering of qualified prescription drug coverage**
(1) **In general** — An MA organization on and after January 1, 2006—
(A) may not offer an MA plan described in [section 1395w–21(a)(2)(A) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–21/a/2/A&num=0&edition=prelim) in an area unless either that plan (or another MA plan offered by the organization in that same service area) includes required prescription drug coverage (as defined in paragraph (2)); and
(B) may not offer prescription drug coverage (other than that required under parts A and B) to an enrollee—
(i) under an MSA plan; or
(ii) under another MA plan unless such drug coverage under such other plan provides qualified prescription drug coverage and unless the requirements of this section with respect to such coverage are met.
(2) **Qualifying coverage** — For purposes of paragraph (1)(A), the term “required coverage” means with respect to an MA–PD plan—
(A) basic prescription drug coverage; or
(B) qualified prescription drug coverage that provides supplemental prescription drug coverage, so long as there is no MA monthly supplemental beneficiary premium applied under the plan (due to the application of a credit against such premium of a rebate under [section 1395w–24(b)(1)(C) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–24/b/1/C&num=0&edition=prelim)).
**(b) Application of default enrollment rules**
(1) **Seamless continuation** — In applying [section 1395w–21(c)(3)(A)(ii) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–21/c/3/A/ii&num=0&edition=prelim), an individual who is enrolled in a health benefits p
**(a) Grants** The Secretary of Health and Human Services (in this section referred to as the “Secretary”) shall make grants to States, with approved State regulatory programs under [section 1395ss of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395ss&num=0&edition=prelim), that submit applications to the Secretary that meet the requirements of this section for the purpose of providing information, counseling, and assistance relating to the procurement of adequate and appropriate health insurance coverage to individuals who are eligible to receive benefits under this subchapter (in this section referred to as “eligible individuals”). The Secretary shall prescribe regulations to establish a minimum level of funding for a grant issued under this section.
**(b) Grant applications**
(1) In submitting an application under this section, a State may consolidate and coordinate an application that consists of parts prepared by more than one agency or department of such State.
(2) As part of an application for a grant under this section, a State shall submit a plan for a State-wide health insurance information, counseling, and assistance program. Such program shall—
(A) establish or improve upon a health insurance information, counseling, and assistance program that provides counseling and assistance to eligible individuals in need of health insurance information, including—
(i) information that may assist individuals in obtaining benefits and filing claims under this subchapter and subchapter XIX of this chapter;
(ii) policy comparison information for medicare supplemental policies (as described in [section 1395ss(g)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395ss/g/1
Stored review status: release_metadata_unconfirmed. The source passage cites 42 U.S.C. § 1395i. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
§ 1395i. Federal Hospital Insurance Trust Fund
(a) Creation; deposits; transfers from Treasury
There is hereby created on the books of the
Treasury of the United States a trust fund to be
known as the ‘‘Federal Hospital Insurance Trust
Fund’’ (hereinafter in this section referred to as
the ‘‘Trust Fund’’). The Trust Fund shall consist
of such gifts and bequests as may be made as
provided in section 401(i)(1) of this title, and
such amounts as may be deposited in, or appro-
priated to, such fund as provided in this part.
There are hereby appropriated to the Trust
Fund for the fiscal year ending June 30, 1966, and
for each fiscal year thereafter, out of any mon-
eys in the Treasury not otherwise appropriated,
amounts equivalent to 100 per centum of—
(1) the taxes imposed by sections 3101(b) and
3111(b) of the Internal Revenue Code of 1986
with respect to wages reported to the Sec-
retary of the Treasury or his delegate pursu-
ant to subtitle F of such Code after December
31, 1965, as determined by the Secretary of the
Treasury by applying the applicable rates of
tax under such sections to such wages, which
wages shall be certified by the Commissioner
of Social Security on the basis of records of
wages established and maintained by the Com-
missioner of Social Security in accordance
with such reports; and
(2) the taxes imposed by section 1401(b) of
the Internal Revenue Code of 1986 with respect
to self-employment income reported to the
Secretary of the Treasury or his delegate on
tax returns under subtitle F of such Code, as
determined by the Secretary of the Treasury
by applying the applicable rate of tax under
such section to such self-employment income,
which self-employment income shall be cer-
tified by the Commissioner of Social Securi
Stored review status: historical_2024_not_currentness_verified. The source passage cites 42 U.S.C. § 1395i. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Payments to providers of services or other person regarded as payment to individuals** Any payment under this subchapter to any provider of services or other person with respect to any items or services furnished any individual shall be regarded as a payment to such individual.
**(b) Incorrect payments on behalf of individuals; payment adjustment** Where—
(1) more than the correct amount is paid under this subchapter to a provider of services or other person for items or services furnished an individual and the Secretary determines (A) that, within such period as he may specify, the excess over the correct amount cannot be recouped from such provider of services or other person, or (B) that such provider of services or other person was without fault with respect to the payment of such excess over the correct amount, or
(2) any payment has been made under [section 1395f(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395f/e&num=0&edition=prelim) to a provider of services or other person for items or services furnished an individual,
proper adjustments shall be made, under regulations prescribed (after consultation with the Railroad Retirement Board) by the Secretary, by decreasing subsequent payments—
(3) to which such individual is entitled under subchapter II of this chapter or under the Railroad Retirement Act of 1974 [[45 U.S.C. 231](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title45-section231&num=0&edition=prelim) et seq.], as the case may be, or
(4) if such individual dies before such adjustment has been completed, to which any other individual is entitled under subchapter II of this chapter or under the Railroad Retirement Act of 1974 [[45 U.S.C. 231](https://uscode.house.gov/view.xhtml?r
Stored review status: release_metadata_unconfirmed. The source passage cites 42 U.S.C. § 1395rr. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
§ 1395rr. End stage renal disease program
(a) Type, duration, and scope of benefits
The benefits provided by parts A and B of this
subchapter shall include benefits for individuals
who have been determined to have end stage
renal disease as provided in section 426–1 of this
title, and benefits for kidney donors as provided
in subsection (d) of this section. Notwith-
standing any other provision of this subchapter,
the type, duration, and scope of the benefit pro-
vided by parts A and B with respect to individ-
uals who have been determined to have end
stage renal disease and who are entitled to such
benefits without regard to section 426–1 of this
title shall in no case be less than the type, dura-
tion, and scope of the benefits so provided for in-
dividuals entitled to such benefits solely by rea-
son of that section.
Page 3754
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 1395rr
1 See References in Text note below.
(b) Payments with respect to services; dialysis;
regulations; physicians’ services; target reim-
bursement rates; home dialysis supplies and
equipment; self-care home dialysis support
services; self-care dialysis units; hepatitis B
vaccine
(1) Payments under this subchapter with re-
spect to services, in addition to services for
which payment would otherwise be made under
this subchapter, furnished to individuals who
have been determined to have end stage renal
disease shall include (A) payments on behalf of
such individuals to providers of services and
renal dialysis facilities which meet such re-
quirements as the Secretary shall by regulation
prescribe for institutional dialysis services and
supplies (including self-dialysis services in a
self-care dialysis unit maintained by the pro-
vider or facility), transplantation services
Stored review status: historical_2024_not_currentness_verified. The source passage cites 42 U.S.C. § 1395rr. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
**(a) “Laboratory” or “clinical laboratory” defined** As used in this section, the term “laboratory” or “clinical laboratory” means a facility for the biological, microbiological, serological, chemical, immuno-hematological, 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.
**(b) Certificate requirement** No person may solicit or accept materials derived from the human body for laboratory examination or other procedure unless there is in effect for the laboratory a certificate issued by the Secretary under this section applicable to the category of examinations or procedures which includes such examination or procedure.
**(c) Issuance and renewal of certificates**
(1) **In general** — The Secretary may issue or renew a certificate for a laboratory only if the laboratory meets the requirements of subsection (d).
(2) **Term** — A certificate issued under this section shall be valid for a period of 2 years or such shorter period as the Secretary may establish.
**(d) Requirements for certificates**
(1) **In general** — A laboratory may be issued a certificate or have its certificate renewed if—
(A) the laboratory submits (or if the laboratory is accredited under subsection (e), the accreditation body which accredited the laboratory submits), an application—
(i) in such form and manner as the Secretary shall prescribe,
(ii) that describes the characteristics of the laboratory examinations and other procedures performed by the laboratory including—
(I) the number and types of laboratory examinations and other procedures
Stored review status: release_metadata_unconfirmed. The source passage cites 42 U.S.C. § 263a. This identifies an authority to review, not proof of applicability.