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

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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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Page 3619 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395aa Pub. L. 98–369, § 2354(b)(32), substituted ‘‘(j)(15)’’ for ‘‘(j)(11)’’. Pub. L. 98–369, § 2349(b)(1), substituted ‘‘appropriate State agencies’’ for ‘‘the Health Insurance Benefits Ad- visory Council established by section 1395dd of this title, appropriate State agencies,’’. 1982—Pub. L. 97–248 substituted ‘‘(cc)(2)(I), and (dd)(2)’’ for ‘‘and (cc)(2)(I)’’. 1980—Pub. L. 96–499, § 933(f), substituted ‘‘(o)(6), and (cc)(2)(I) of section 1395x’’ for ‘‘and (o)(6) of section 1395x’’. Pub. L. 96–499, § 934(c)(1), inserted ‘‘or by ambulatory surgical centers under section 1395k(a)(2)(F)(i) of this title,’’. 1972—Pub. L. 92–603 substituted ‘‘subsections (e)(9), (f)(4), (g)(4), (j)(11), and (o)(6) of section 1395x of this title’’ for ‘‘subsections (e)(8), (f)(4), (g)(4), (j)(10), and (o)(5) of section 1395x of this title’’. Statutory Notes and Related Subsidiaries 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 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. EFFECTIVE DATE OF 1988 AMENDMENT Amendment by section 203(e)(2) of Pub. L. 100–360 ap- plicable to items and services furnished on or after Jan. 1, 1990, see section 203(g) of Pub. L. 100–360, set out as a note under section 1320c–3 of this title. Amendment by section 204(c)(1) of Pub. L. 100–360 ap- plicable to screening mammography performed 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. EFFECTIVE DATE OF 1984 AMENDMENT Amendment by section 2335(c) of Pub. L. 98–369 effec- tive July 18, 1984, see section 2335(g) of Pub. L. 98–369, set out as a note under section 1395f of this title. Amendment by section 2349(b)(1) of Pub. L. 98–369 ef- fective July 18, 1984, see section 2349(c) of Pub. L. 98–369, set out as a note under section 907a of this title. Amendment by section 2354(b)(32) of Pub. L. 98–369 ef- fective July 18, 1984, but not to be construed as chang- ing or affecting any right, liability, status, or interpre- tation which existed (under the provisions of law in- volved) 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, set out as a note under sec- tion 1395c of this title. EFFECTIVE DATE OF 1980 AMENDMENT Amendment by section 933(f) of Pub. L. 96–499 effec- tive with respect to a comprehensive outpatient reha- bilitation facility’s first accounting period beginning on or after July 1, 1981, see section 933(h) of Pub. L. 96–499, set out as a note under section 1395k of this title. EFFECTIVE DATE OF 1972 AMENDMENT Amendment by Pub. L. 92–603 applicable 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. TERMINATION OF ADVISORY COUNCILS Advisory councils in existence on Jan. 5, 1973, to ter- minate not later than the expiration of the 2-year pe- riod following Jan. 5, 1973, unless, in the case of a coun- cil established by the President or an officer of the Federal Government, such council is renewed by appro- priate action prior to the expiration of such 2-year pe- riod, or in the case of a council established by the Con- gress, its duration is otherwise provided by law. See sections 1001(2) and 1013 of Title 5, Government Organi- zation and Employees. § 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 State agency which has such an agreement may (sub- ject to approval of the Secretary) furnish to a skilled nursing facility, after proper request by such facility, such specialized consultative serv- ices (which such agency is able and willing to furnish in a manner satisfactory to the Sec- retary) as such facility may need to meet one or more of the conditions specified in section 1395i–3(a) of this title. Any such services fur- nished by a State agency shall be deemed to have been furnished pursuant to such agree- ment. Within 90 days following the completion of each survey of any health care facility, ambu- latory surgical center, rural health clinic, com- prehensive outpatient rehabilitation facility, Page 3620 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395aa laboratory, clinic, agency, or organization by the appropriate State or local agency described in the first sentence of this subsection, the Sec- retary shall make public in readily available form and place, and require (in the case of skilled nursing facilities) the posting in a place readily accessible to patients (and patients’ rep- resentatives), the pertinent findings of each such survey relating to the compliance of each such health care facility, ambulatory surgical center, rural health clinic, comprehensive out- patient rehabilitation facility, laboratory, clin- ic, agency, or organization with (1) the statu- tory conditions of participation imposed under this subchapter and (2) the major additional conditions which the Secretary finds necessary in the interest of health and safety of individ- uals who are furnished care or services by any such health care facility, ambulatory surgical center, rural health clinic, comprehensive out- patient rehabilitation facility, laboratory, clin- ic, agency, or organization. Any agreement under this subsection shall provide for the ap- propriate State or local agency to maintain a toll-free hotline (1) to collect, maintain, and continually update information on home health agencies and hospice programs located in the State or locality that are certified to partici- pate in the program established under this sub- chapter (which information shall include any significant deficiencies found with respect to pa- tient care in the most recent certification sur- vey conducted by a State agency or accredita- tion survey conducted by a private accreditation agency under section 1395bb of this title with re- spect to the home health agency or the hospice program, when that survey was completed, whether corrective actions have been taken or are planned, and the sanctions, if any, imposed under this subchapter with respect to the agen- cy or the hospice program) and (2) to receive complaints (and answer questions) with respect to home health agencies and hospice programs in the State or locality. Any such agreement shall provide for such State or local agency to maintain a unit for investigating such com- plaints that possesses enforcement authority and has access to survey and certification re- ports, information gathered by any private ac- creditation agency utilized by the Secretary under section 1395bb of this title, and consumer medical records (but only with the consent of the consumer or his or her legal representative). (b) Payment in advance or by way of reimburse- ment to State for performance of functions of subsection (a) The Secretary shall pay any such State, in ad- vance or by way of reimbursement, as may be provided in the agreement with it (and may make adjustments in such payments on account of overpayments or underpayments previously made), for the reasonable cost of performing the functions specified in subsection (a), and for the Federal Hospital Insurance Trust Fund’s fair share of the costs attributable to the planning and other efforts directed toward coordination of activities in carrying out its agreement and other activities related to the provision of serv- ices similar to those for which payment may be made under part A, or related to the facilities and personnel required for the provision of such services, or related to improving the quality of such services. (c) Use of State or local agencies to survey hos- pitals The Secretary is authorized to enter into an agreement with any State under which the ap- propriate State or local agency which performs the certification function described in sub- section (a) will survey, on a selective sample basis (or where the Secretary finds that a survey is appropriate because of substantial allegations of the existence of a significant deficiency or de- ficiencies which would, if found to be present, adversely affect health and safety of patients), provider entities that, pursuant to section 1395bb(a)(1) of this title, are treated as meeting the conditions or requirements of this sub- chapter. The Secretary shall pay for such serv- ices in the manner prescribed in subsection (b). (d) Fulfillment of requirements by States The Secretary may not enter an agreement under this section with a State with respect to determining whether an institution therein is a skilled nursing facility unless the State meets the requirements specified in section 1395i–3(e) of this title and section 1395i–3(g) of this title and the establishment of remedies under sec- tions 1395i–3(h)(2)(B) and 1395i–3(h)(2)(C) of this title (relating to establishment and application of remedies). (e) Prohibition of user fees for survey and certifi- cation Notwithstanding any other provision of law, the Secretary may not impose, or require a State to impose, any fee on any facility or enti- ty subject to a determination under subsection (a), or any renal dialysis facility subject to the requirements of section 1395rr(b)(1) of this title, for any such determination or any survey relat- ing to determining the compliance of such facil- ity or entity with any requirement of this sub- chapter (other than any fee relating to section 263a of this title). (Aug. 14, 1935, ch. 531, title XVIII, § 1864, as added Pub. L. 89–97, title I, § 102(a), July 30, 1965, 79 Stat. 326; amended Pub. L. 90–248, title I, § 133(f), title II, § 228(b), Jan. 2, 1968, 81 Stat. 852, 904; Pub. L. 92–603, title II, §§ 244(a), 277, 278(a)(16), (b)(15), 299D(a), Oct. 30, 1972, 86 Stat. 1422, 1452–1454, 1461; Pub. L. 95–210, § 1(i), Dec. 13, 1977, 91 Stat. 1488; Pub. L. 96–499, title IX, §§ 933(g), 934(c)(2), Dec. 5, 1980, 94 Stat. 2637, 2639; Pub. L. 96–611, § 1(a)(2), Dec. 28, 1980, 94 Stat. 3566; Pub. L. 97–248, title I, § 122(g)(3), Sept. 3, 1982, 96 Stat. 362; Pub. L. 98–369, div. B, title III, § 2354(b)(17), July 18, 1984, 98 Stat. 1101; Pub. L. 99–509, title IX, § 9320(h)(3), Oct. 21, 1986, 100 Stat. 2016; Pub. L. 100–203, title IV, §§ 4025(a), 4072(d), 4201(a)(2), (d)(4), 4202(a)(1), (c), 4203(a)(1), 4212(b), Dec. 22, 1987, 101 Stat. 1330–74, 1330–117, 1330–160, 1330–174, 1330–179, 1330–212, as amended Pub. L. 100–360, title IV, § 411(l)(1)(C), (6)(B), July 1, 1988, 102 Stat. 804, as amended Pub. L. 100–485, title VI, § 608(d)(27)(B), Oct. 13, 1988, 102 Stat. 2422; Pub. L. 100–360, title II, §§ 203(e)(3), 204(c)(2), (d)(3), title IV, § 411(d)(4)(A), July 1, 1988, 102 Stat. 725, 728, 729, 774, as amended Pub. L. 100–485, title VI, § 608(d)(20)(B), (C), Oct. 13, 1988, 102 Stat. 2419, Page 3621 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395aa 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)(iii), 6115(c), Dec. 19, 1989, 103 Stat. 2152, 2219; Pub. L. 101–508, title IV, §§ 4154(d)(1), 4163(c)(2), 4207(g), formerly 4027(g), Nov. 5, 1990, 104 Stat. 1388–85, 1388–100, 1388–123; Pub. L. 103–432, title I, §§ 145(c)(3), 160(a)(1), (d)(4), Oct. 31, 1994, 108 Stat. 4427, 4443, 4444; Pub. L. 104–134, title I, § 101(d) [title V, § 516(c)(1)], Apr. 26, 1996, 110 Stat. 1321–211, 1321–247; renumbered title I, Pub. L. 104–140, § 1(a), May 2, 1996, 110 Stat. 1327; Pub. L. 105–33, title IV, §§ 4106(c), 4201(c)(1), Aug. 5, 1997, 111 Stat. 368, 373; Pub. L. 110–275, title I, § 125(b)(3), July 15, 2008, 122 Stat. 2519; Pub. L. 116–260, div. CC, title I, § 125(d)(2), title IV, § 407(a)(3)(A), Dec. 27, 2020, 134 Stat. 2966, 3007.) Editorial Notes AMENDMENTS 2020—Subsec. (a). Pub. L. 116–260, § 407(a)(3)(A), in- serted ‘‘and hospice programs’’ after ‘‘information on home health agencies’’, ‘‘or the hospice program’’ after ‘‘the home health agency’’, ‘‘or the hospice program’’ after ‘‘with respect to the agency’’, and ‘‘and hospice programs’’ after ‘‘with respect to home health agen- cies’’. Pub. L. 116–260, § 125(d)(2), inserted before period at end of first sentence ‘‘, or whether a facility is a rural emergency hospital as defined in section 1395x(kkk)(2) of this title’’. Amendment was executed as if closing quotation marks preceded the period in the directory language, to reflect the probable intent of Congress. 2008—Subsec. (c). Pub. L. 110–275 substituted ‘‘pursu- ant to section 1395bb(a)(1)’’ for ‘‘pursuant to subsection (a) or (b)(1) of section 1395bb’’. 1997—Subsec. (a). Pub. L. 105–33, § 4201(c)(1), sub- stituted ‘‘critical access’’ for ‘‘rural primary care’’. Pub. L. 105–33, § 4106(c), substituted ‘‘paragraphs (16) and (17)’’ for ‘‘paragraphs (15) and (16)’’. 1996—Subsec. (c). Pub. L. 104–134, in first sentence, substituted at end ‘‘provider entities that, pursuant to subsection (a) or (b)(1) of section 1395bb of this title, are treated as meeting the conditions or requirements of this subchapter.’’ for ‘‘hospitals which have an agree- ment with the Secretary under section 1395cc of this title and which are accredited by the Joint Commission on Accreditation of Hospitals.’’ 1994—Subsec. (a). Pub. L. 103–432, § 160(a)(1)(B), struck out ‘‘or (in the case of a laboratory that does not par- ticipate or seek to participate in the medicare pro- gram) the requirements of section 263a of this title’’ after ‘‘section 1395x(s) of this title’’ in first sentence. Pub. L. 103–432, § 145(c)(3), struck out ‘‘, or whether screening mammography meets the standards estab- lished under section 1395m(c)(3) of this title’’ after ‘‘section 1395k(a)(2)(F)(i) of this title’’ in first sentence. Subsec. (e). Pub. L. 103–432, § 160(a)(1)(A), inserted be- fore period at end ‘‘(other than any fee relating to sec- tion 263a of this title)’’. 1990—Subsec. (a). Pub. L. 101–508, § 4163(c)(2), inserted before period at end of first sentence ‘‘, or whether screening mammography meets the standards estab- lished under section 1395m(c)(3) of this title’’. Pub. L. 101–508, § 4154(d)(1), substituted ‘‘section 1395x(s) of this title or (in the case of a laboratory that does not participate or seek to participate in the medi- care program) the requirements of section 263a of this title,’’ for ‘‘section 1395x(s) of this title,’’ in first sen- tence. Subsec. (e). Pub. L. 101–508, § 4207(g), formerly § 4027(g), as renumbered by Pub. L. 103–432, § 160(d)(4), added subsec. (e). 1989—Subsec. (a). Pub. L. 101–239, § 6115(c), substituted ‘‘paragraphs (15) and (16)’’ for ‘‘paragraphs (14) and (15)’’. Pub. L. 101–239, § 6003(g)(3)(C)(iii), inserted ‘‘, a rural primary care hospital, as defined in section 1395x(mm)(1) of this title,’’ after ‘‘1395x(aa)(2) of this title’’. Pub. L. 101–234 repealed Pub. L. 100–360, §§ 203(e)(3), 204(c)(2), (d)(3), and provided that the provisions of law amended or repealed by such sections are restored or revived as if such sections had not been enacted, see 1988 and 1989 Amendment notes. 1988—Subsec. (a). Pub. L. 100–360, § 411(l)(6)(B), amend- ed Pub. L. 100–203, § 4212(b), see 1987 Amendment note below. Pub. L. 100–360, § 411(l)(1)(C), as added by Pub. L. 100–485, § 608(d)(27)(B), added Pub. L. 100–203, § 4201(d)(4), see 1987 Amendment note below. Pub. L. 100–360, § 411(d)(4)(A)(i), as amended by Pub. L. 100–485, § 608(d)(20)(B)(i), substituted ‘‘most recent cer- tification survey conducted by a State agency or ac- creditation survey conducted by a private accredita- tion agency under section 1395bb of this title with re- spect to the home health agency,’’ for ‘‘most recent certification survey conducted with respect to the agency,’’. Pub. L. 100–360, § 411(d)(4)(A)(ii)(I), as amended by Pub. L. 100–485, § 608(d)(20)(C), substituted ‘‘such State or local agency to maintain a unit’’ for ‘‘such agency to maintain a unit’’. Pub. L. 100–360, § 411(d)(4)(A)(ii)(II), as amended by Pub. L. 100–485, § 608(d)(20)(B)(ii), substituted ‘‘utilized by the Secretary under section 1395bb of this title’’ for ‘‘pursuant to an agreement with the Secretary under this section’’. Pub. L. 100–360, § 204(d)(3), substituted ‘‘paragraphs (14) and (15)’’ for ‘‘paragraphs (13) and (14)’’. Pub. L. 100–360, § 204(c)(2), inserted ‘‘, or whether screening mammography meets the standards estab- lished under section 1395m(e)(3) of this title’’ after ‘‘section 1395k(a)(2)(F)(i) of this title’’. Pub. L. 100–360, § 203(e)(3), inserted ‘‘or a home intra- venous drug therapy provider,’’ after ‘‘hospice pro- gram’’ and substituted ‘‘hospice program, or home in- travenous drug therapy provider’’ for ‘‘or hospice pro- gram’’. 1987—Subsec. (a). Pub. L. 100–203, § 4212(b), which di- rected an amendment of subsec. (a) identical to Pub. L. 100–203, § 4202(c), was amended generally by Pub. L. 100–360, § 411(l)(6)(B), so that it does not amend this sec- tion but rather section 1396r of this title. Pub. L. 100–203, § 4202(c), inserted ‘‘, and require (in the case of skilled nursing facilities) the posting in a place readily accessible to patients (and patients’ rep- resentatives),’’ after ‘‘place’’ in fifth sentence. Pub. L. 100–203, § 4201(d)(4), as added by Pub. L. 100–360, § 411(l)(1)(C), as added by Pub. L. 100–485, § 608(d)(27)(B), substituted ‘‘conditions specified in sec- tion 1395i–3(a) of this title’’ for ‘‘conditions specified in section 1395x(j) of this title’’. Pub. L. 100–203, § 4072(d), substituted ‘‘paragraphs (13) and (14)’’ for ‘‘paragraphs (12) and (13)’’ in first sen- tence. Pub. L. 100–203, § 4025(a), inserted at end ‘‘Any agree- ment under this subsection shall provide for the appro- priate State or local agency to maintain a toll-free hot- line (1) to collect, maintain, and continually update in- formation on home health agencies located in the State or locality that are certified to participate in the pro- gram established under this subchapter (which infor- mation shall include any significant deficiencies found with respect to patient care in the most recent certifi- cation survey conducted with respect to the agency, when that survey was completed, whether corrective actions have been taken or are planned, and the sanc- tions, if any, imposed under this subchapter with re- spect to the agency) and (2) to receive complaints (and answer questions) with respect to home health agencies in the State or locality. Any such agreement shall pro- vide for such agency to maintain a unit for inves- tigating such complaints that possesses enforcement authority and has access to survey and certification re- ports, information gathered by any private accredita- tion agency pursuant to an agreement with the Sec- retary under this section, and consumer medical Page 3622 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395aa records (but only with the consent of the consumer or his or her legal representative).’’ Subsec. (d). Pub. L. 100–203, § 4203(a)(1), inserted before period at end ‘‘and the establishment of remedies under sections 1395i–3(h)(2)(B) and 1395i–3(h)(2)(C) of this title (relating to establishment and application of rem- edies)’’. Pub. L. 100–203, § 4202(a)(1), inserted ‘‘and section 1395i–3(g) of this title’’ before period at end. Pub. L. 100–203, § 4201(a)(2), added subsec. (d). 1986—Subsec. (a). Pub. L. 99–509 substituted ‘‘para- graphs (12) and (13)’’ for ‘‘paragraphs (11) and (12)’’. 1984—Subsec. (c). Pub. L. 98–369 struck out ‘‘the’’ after ‘‘Joint Commission on’’. 1982—Subsec. (a). Pub. L. 97–248 inserted ‘‘or whether an agency is a hospice program’’ and substituted ‘‘home health agency, or hospice program’’ for ‘‘or home health agency’’. 1980—Subsec. (a). Pub. L. 96–611 substituted ‘‘require- ments of paragraphs (11) and (12) of section 1395x(s) of this title’’ for ‘‘requirements of paragraphs (10) and (11) of section 1395x(s) of this title’’. Pub. L. 96–499, § 933(g), inserted ‘‘or a comprehensive outpatient rehabilitation facility as defined in section 1395x(cc)(2) of this title’’ after ‘‘section 1395x(aa)(2) of this title’’ and ‘‘comprehensive outpatient rehabilita- tion facility,’’ after ‘‘rural health clinic,’’ in four places. Pub. L. 96–499, § 934(c)(2), inserted ‘‘, or whether an ambulatory surgical center meets the standards speci- fied under section 1395k(a)(2)(F) of this title’’ after ‘‘section 1395x(p)(4) of this title’’ and ‘‘ambulatory sur- gical center,’’ after ‘‘health care facility,’’ in three places. 1977—Subsec. (a). Pub. L. 95–210 expanded enumera- tion of institutions and agencies included under cov- erage of this subsection by inserting references to rural health clinics in five places. 1972—Subsec. (a). Pub. L. 92–603, §§ 277, 278(a)(16), (b)(15), 299D(a), provided for the furnishing of special- ized consultative services to skilled nursing facilities, authorized the Secretary to make public the pertinent findings of each survey within 90 days following the completion of each survey of any health care facility, etc., and substituted ‘‘skilled nursing facility’’ for ‘‘ex- tended care facility’’. Subsec. (c). Pub. L. 92–603, § 244(a), added subsec. (c). 1968—Subsec. (a). Pub. L. 90–248, § 133(f), inserted clause at end of first sentence for determining whether a clinic, rehabilitation agency, or public health agency meets the requirements of section 1395x(p)(4)(A) or (B) of this title. Pub. L. 90–248, § 228(b), struck out last sentence pro- viding for utilization of State facilities to provide con- sultative services to institutions furnishing medical care, covered in section 1396a(a)(24) of this title. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2020 AMENDMENT Amendment by section 125(d)(2) of Pub. L. 116–260 ap- plicable to items and services furnished on or after Jan. 1, 2023, see section 125(g) of Pub. L. 116–260, set out as a note under section 1395l of this title. Pub. L. 116–260, div. CC, title IV, § 407(a)(3)(B), Dec. 27, 2020, 134 Stat. 3008, provided that: ‘‘The amendments made by subparagraph (A) [amending this section] shall apply with respect to agreements entered into on or after, or in effect as of, the date that is 1 year after the date of the enactment of this Act [Dec. 27, 2020].’’ EFFECTIVE DATE OF 2008 AMENDMENT; TRANSITION RULE Amendment by Pub. L. 110–275 applicable with re- spect to accreditations of hospitals granted on or after the date that is 24 months after July 15, 2008, with tran- sition rule, see section 125(d) of Pub. L. 110–275, set out as a note under section 1395bb of this title. EFFECTIVE DATE OF 1997 AMENDMENT Amendment by section 4106(c) of Pub. L. 105–33 appli- cable to bone mass measurements performed on or after July 1, 1998, see section 4106(d) of Pub. L. 105–33, set out as a note under section 1395x of this title. Amendment by section 4201(c)(1) of Pub. L. 105–33 ap- plicable to services furnished on or after Oct. 1, 1997, see section 4201(d) of Pub. L. 105–33, set out as a note under section 1395f of this title. EFFECTIVE DATE OF 1994 AMENDMENT Amendment by section 145(c)(3) of Pub. L. 103–432 ap- plicable to mammography furnished by a facility on and after the first date that the certificate require- ments 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 Pub. L. 101–508, title IV, § 4154(d)(2), Nov. 5, 1990, 104 Stat. 1388–85, provided that: ‘‘The amendment made by paragraph (1) [amending this section] shall take effect as if included in the enactment of the Clinical Labora- tory Improvement Amendments of 1988 [Pub. L. 100–578].’’ Amendment by section 4163(c)(2) of Pub. L. 101–508 ap- plicable 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 AMENDMENTS 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. EFFECTIVE DATE OF 1988 AMENDMENTS 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 203(e)(3) of Pub. L. 100–360 ap- plicable to items and services furnished on or after Jan. 1, 1990, see section 203(g) of Pub. L. 100–360, set out as a note under section 1320c–3 of this title. Amendment by section 204(c)(2), (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)(A), (l)(1)(C), (6)(B) of Pub. L. 100–360, as it relates to a provision in the Omnibus Budget Reconciliation Act of 1987, Pub. L. 100–203, effective as if included in the enactment of that provision 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 Pub. L. 100–203, title IV, § 4025(c), formerly § 4025(b), Dec. 22, 1987, 101 Stat. 1330–74, as redesignated and amended by Pub. L. 100–360, title IV, § 411(d)(4)(B)(i), July 1, 1988, 102 Stat. 774, provided that: ‘‘The amend- ment made by this section [amending this section and section 1395bb of this title] shall apply with respect to agreements entered into or renewed on or after the date of enactment of this Act [Dec. 22, 1987].’’ 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. Amendments by sections 4201(a)(2), (d)(4) and 4202(a)(1), (c) of Pub. L. 100–203 applicable to services furnished on or after Oct. 1, 1990, without regard to whether regulations to implement such amendments are promulgated by such date, except as otherwise spe- cifically provided in section 1395i–3 of this title, see sec- 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

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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. § 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

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

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

§ 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, chem- ical, immuno-hematological, hematological, bio- physical, cytological, pathological, or other ex- amination 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 de- rived from the human body for laboratory exam- ination or other procedure unless there is in ef- fect 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 certifi- cate 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 lab- oratory is accredited under subsection (e), the accreditation body which accredited the laboratory submits), an application— (i) in such form and manner as the Sec- retary shall prescribe, (ii) that describes the characteristics of the laboratory examinations and other procedures performed by the laboratory in- cluding— (I) the number and types of laborat

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