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42 U.S.C. § 1395bb — Effect of accreditation

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42 U.S.C. § 1395bb — Effect of accreditation

§ 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,

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1395 — Conditions of participation for home health agencies; home health quality

**(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

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1395 — Prohibition against any Federal inter-

§ 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

Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 1395

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1395aa — Medicare Prescription Drug Account in the Federal Supplementary Medical Insurance Trust Fund

**(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

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1395aa — Agreements with States

§ 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

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1395bb — Application to Medicare Advantage program and related managed care programs

**(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

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1395i — Health insurance information, counseling, and assistance grants

**(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

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1395i — Federal Hospital Insurance Trust Fund

§ 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

Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 1395i

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1395rr — Overpayment on behalf of individuals and settlement of claims for benefits on behalf of deceased individuals

**(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

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1395rr — End stage renal disease program

§ 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

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 263a — Certification of laboratories

**(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

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