Use of State agencies to determine compliance by providers of services with conditions of participation
section 1395x(aa)(2) of this titlesection 1395x(mm)(1) of this titlesection 1395x(cc)(2) of this titlesection 1395x(s) of this titlesection 1395x(p)(4) of this titlesection 1395k(a)(2)(F)(i) of this titlesection 1395x(kkk)(2) of this titlesection 1395x of this titlesection 1395i–3(a) of this titlesection 1395bb of this titlesection 1395bb of this titleThe 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 , a critical access hospital, as defined in , or a comprehensive outpatient rehabilitation facility as defined in , or whether a laboratory meets the requirements of paragraphs (16) and (17) of , or whether a clinic, rehabilitation agency or public health agency meets the requirements of subparagraph (A) or (B), as the case may be, of , or whether an ambulatory surgical center meets the standards specified under , or whether a facility is a rural emergency hospital as defined in . To the extent that the Secretary finds it appropriate, an institution or agency which such a State (or local) agency certifies is a hospital, skilled nursing facility, rural health clinic, comprehensive outpatient rehabilitation facility, home health agency, or hospice program (as those terms are defined in ) may be treated as such by the Secretary. Any State agency which has such an agreement may (subject to approval of the Secretary) furnish to a skilled nursing facility, after proper request by such facility, such specialized consultative services (which such agency is able and willing to furnish in a manner satisfactory to the Secretary) as such facility may need to meet one or more of the conditions specified in . Any such services furnished by a State agency shall be deemed to have been furnished pursuant to such agreement. Within 90 days following the completion of each survey of any health care facility, ambulatory surgical center, rural health clinic, comprehensive outpatient rehabilitation facility, laboratory, clinic, agency, or organization by the appropriate State or local agency described in the first sentence of this subsection, the Secretary 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’ representatives), the pertinent findings of each such survey relating to the compliance of each such health care facility, ambulatory surgical center, rural health clinic, comprehensive outpatient rehabilitation facility, laboratory, clinic, agency, or organization with (1) the statutory 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 individuals who are furnished care or services by any such health care facility, ambulatory surgical center, rural health clinic, comprehensive outpatient rehabilitation facility, laboratory, clinic, agency, or organization. Any agreement under this subsection shall provide for the appropriate 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 participate in the program established under this subchapter (which information shall include any significant deficiencies found with respect to patient care in the most recent certification survey conducted by a State agency or accreditation survey conducted by a private accreditation agency under with respect 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 agency 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 complaints that possesses enforcement authority and has access to survey and certification reports, information gathered by any private accreditation agency utilized by the Secretary under , and consumer medical records (but only with the consent of the consumer or his or her legal representative).
Payment in advance or by way of reimbursement to State for performance of functions of subsection (a)
The Secretary shall pay any such State, in advance 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 services 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.
Use of State or local agencies to survey hospitals
section 1395bb(a)(1) of this titleThe Secretary is authorized to enter into an agreement with any State under which the appropriate State or local agency which performs the certification function described in subsection (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 deficiencies which would, if found to be present, adversely affect health and safety of patients), provider entities that, pursuant to , are treated as meeting the conditions or requirements of this subchapter. The Secretary shall pay for such services in the manner prescribed in subsection (b).
Fulfillment of requirements by States
section 1395i–3(e) of this titlesection 1395i–3(g) of this titleThe 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 and 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 remedies).
Prohibition of user fees for survey and certification
section 1395rr(b)(1) of this titlesection 263a of this titleNotwithstanding any other provision of law, the Secretary may not impose, or require a State to impose, any fee on any facility or entity subject to a determination under subsection (a), or any renal dialysis facility subject to the requirements of , for any such determination or any survey relating to determining the compliance of such facility or entity with any requirement of this subchapter (other than any fee relating to ).
Aug. 14, 1935, ch. 531Pub. L. 89–97, title I, § 102(a)79 Stat. 326Pub. L. 90–248, title I, § 133(f)81 Stat. 852Pub. L. 92–603, title II86 Stat. 1422Pub. L. 95–210, § 1(i)91 Stat. 1488Pub. L. 96–499, title IX94 Stat. 2637Pub. L. 96–611, § 1(a)(2)94 Stat. 3566Pub. L. 97–248, title I, § 122(g)(3)96 Stat. 362Pub. L. 98–369, div. B, title III, § 2354(b)(17)98 Stat. 1101Pub. L. 99–509, title IX, § 9320(h)(3)100 Stat. 2016Pub. L. 100–203, title IV101 Stat. 1330–74Pub. L. 100–360, title IV, § 411l102 Stat. 804Pub. L. 100–485, title VI, § 608(d)(27)(B)102 Stat. 2422Pub. L. 100–360, title II102 Stat. 725Pub. L. 100–485, title VI, § 608(d)(20)(B)102 Stat. 2419Pub. L. 101–234, title II, § 201(a)103 Stat. 1981Pub. L. 101–239, title VI103 Stat. 2152Pub. L. 101–508, title IV104 Stat. 1388–85Pub. L. 103–432, title I108 Stat. 4427Pub. L. 104–134, title I, § 101(d) [title V, § 516(c)(1)]110 Stat. 1321–211Pub. L. 104–140, § 1(a)110 Stat. 1327Pub. L. 105–33, title IV111 Stat. 368Pub. L. 110–275, title I, § 125(b)(3)122 Stat. 2519Pub. L. 116–260, div. CC, title I, § 125(d)(2)134 Stat. 2966(, title XVIII, § 1864, as added , , ; amended , title II, § 228(b), , , 904; , §§ 244(a), 277, 278(a)(16), (b)(15), 299D(a), , , 1452–1454, 1461; , , ; , §§ 933(g), 934(c)(2), , , 2639; , , ; , , ; , , ; , , ; , §§ 4025(a), 4072(d), 4201(a)(2), (d)(4), 4202(a)(1), (c), 4203(a)(1), 4212(b), , , 1330–117, 1330–160, 1330–174, 1330–179, 1330–212, as amended ()(1)(C), (6)(B), , , as amended , , ; , §§ 203(e)(3), 204(c)(2), (d)(3), title IV, § 411(d)(4)(A), , , 728, 729, 774, as amended , (C), , , 2420; , , ; , §§ 6003(g)(3)(C)(iii), 6115(c), , , 2219; , §§ 4154(d)(1), 4163(c)(2), 4207(g), formerly 4027(g), , , 1388–100, 1388–123; , §§ 145(c)(3), 160(a)(1), (d)(4), , , 4443, 4444; , , , 1321–247; renumbered title I, , , ; , §§ 4106(c), 4201(c)(1), , , 373; , , ; , title IV, § 407(a)(3)(A), , , 3007.)
Editorial Notes
Amendments
Pub. L. 116–260, § 407(a)(3)(A)2020—Subsec. (a). , inserted “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 agencies”.
Pub. L. 116–260, § 125(d)(2)section 1395x(kkk)(2) of this title, inserted before period at end of first sentence “, or whether a facility is a rural emergency hospital as defined in ”. Amendment was executed as if closing quotation marks preceded the period in the directory language, to reflect the probable intent of Congress.
Pub. L. 110–2752008—Subsec. (c). substituted “pursuant to section 1395bb(a)(1)” for “pursuant to subsection (a) or (b)(1) of section 1395bb”.
Pub. L. 105–33, § 4201(c)(1)1997—Subsec. (a). , substituted “critical access” for “rural primary care”.
Pub. L. 105–33, § 4106(c), substituted “paragraphs (16) and (17)” for “paragraphs (15) and (16)”.
Pub. L. 104–134section 1395bb of this titlesection 1395cc of this title1996—Subsec. (c). , in first sentence, substituted at end “provider entities that, pursuant to subsection (a) or (b)(1) of , are treated as meeting the conditions or requirements of this subchapter.” for “hospitals which have an agreement with the Secretary under and which are accredited by the Joint Commission on Accreditation of Hospitals.”
Pub. L. 103–432, § 160(a)(1)(B)section 263a of this titlesection 1395x(s) of this title1994—Subsec. (a). , struck out “or (in the case of a laboratory that does not participate or seek to participate in the medicare program) the requirements of ” after “” in first sentence.
Pub. L. 103–432, § 145(c)(3)section 1395m(c)(3) of this titlesection 1395k(a)(2)(F)(i) of this title, struck out “, or whether screening mammography meets the standards established under ” after “” in first sentence.
Pub. L. 103–432, § 160(a)(1)(A)section 263a of this titleSubsec. (e). , inserted before period at end “(other than any fee relating to )”.
Pub. L. 101–508, § 4163(c)(2)section 1395m(c)(3) of this title1990—Subsec. (a). , inserted before period at end of first sentence “, or whether screening mammography meets the standards established under ”.
Pub. L. 101–508, § 4154(d)(1)section 1395x(s) of this titlesection 263a of this titlesection 1395x(s) of this title, substituted “ or (in the case of a laboratory that does not participate or seek to participate in the medicare program) the requirements of ,” for “,” in first sentence.
Pub. L. 101–508, § 4207(g)Pub. L. 103–432, § 160(d)(4)Subsec. (e). , formerly § 4027(g), as renumbered by , added subsec. (e).
Pub. L. 101–239, § 6115(c)1989—Subsec. (a). , substituted “paragraphs (15) and (16)” for “paragraphs (14) and (15)”.
Pub. L. 101–239, § 6003(g)(3)(C)(iii)section 1395x(mm)(1) of this title, inserted “, a rural primary care hospital, as defined in ,” after “1395x(aa)(2) of this title”.
Pub. L. 101–234Pub. L. 100–360 repealed , §§ 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.
Pub. L. 100–360, § 411lPub. L. 100–203, § 4212(b)1988—Subsec. (a). ()(6)(B), amended , see 1987 Amendment note below.
Pub. L. 100–360, § 411lPub. L. 100–485, § 608(d)(27)(B)Pub. L. 100–203, § 4201(d)(4)()(1)(C), as added by , added , see 1987 Amendment note below.
Pub. L. 100–360, § 411(d)(4)(A)(i)Pub. L. 100–485, § 608(d)(20)(B)(i)section 1395bb of this title, as amended by , substituted “most recent certification survey conducted by a State agency or accreditation survey conducted by a private accreditation agency under with respect 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)Pub. L. 100–485, § 608(d)(20)(C), as amended by , 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)Pub. L. 100–485, § 608(d)(20)(B)(ii)section 1395bb of this title, as amended by , substituted “utilized by the Secretary under ” 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)section 1395m(e)(3) of this titlesection 1395k(a)(2)(F)(i) of this title, inserted “, or whether screening mammography meets the standards established under ” after “”.
Pub. L. 100–360, § 203(e)(3), inserted “or a home intravenous drug therapy provider,” after “hospice program” and substituted “hospice program, or home intravenous drug therapy provider” for “or hospice program”.
Pub. L. 100–203, § 4212(b)Pub. L. 100–203, § 4202(c)Pub. L. 100–360, § 411lsection 1396r of this title1987—Subsec. (a). , which directed an amendment of subsec. (a) identical to , was amended generally by ()(6)(B), so that it does not amend this section but rather .
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’ representatives),” after “place” in fifth sentence.
Pub. L. 100–203, § 4201(d)(4)Pub. L. 100–360, § 411lPub. L. 100–485, § 608(d)(27)(B)section 1395i–3(a) of this titlesection 1395x(j) of this title, as added by ()(1)(C), as added by , substituted “conditions specified in ” for “conditions specified in ”.
Pub. L. 100–203, § 4072(d), substituted “paragraphs (13) and (14)” for “paragraphs (12) and (13)” in first sentence.
Pub. L. 100–203, § 4025(a), inserted at end “Any agreement under this subsection shall provide for the appropriate State or local agency to maintain a toll-free hotline (1) to collect, maintain, and continually update information on home health agencies located in the State or locality that are certified to participate in the program established under this subchapter (which information shall include any significant deficiencies found with respect to patient care in the most recent certification survey conducted with respect to the agency, 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 agency) and (2) to receive complaints (and answer questions) with respect to home health agencies in the State or locality. Any such agreement shall provide for such agency to maintain a unit for investigating such complaints that possesses enforcement authority and has access to survey and certification reports, information gathered by any private accreditation agency pursuant to an agreement with the Secretary under this section, and consumer medical records (but only with the consent of the consumer or his or her legal representative).”
Pub. L. 100–203, § 4203(a)(1)Subsec. (d). , 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 remedies)”.
Pub. L. 100–203, § 4202(a)(1)section 1395i–3(g) of this title, inserted “and ” before period at end.
Pub. L. 100–203, § 4201(a)(2), added subsec. (d).
Pub. L. 99–5091986—Subsec. (a). substituted “paragraphs (12) and (13)” for “paragraphs (11) and (12)”.
Pub. L. 98–3691984—Subsec. (c). struck out “the” after “Joint Commission on”.
Pub. L. 97–2481982—Subsec. (a). inserted “or whether an agency is a hospice program” and substituted “home health agency, or hospice program” for “or home health agency”.
Pub. L. 96–611section 1395x(s) of this titlesection 1395x(s) of this title1980—Subsec. (a). substituted “requirements of paragraphs (11) and (12) of ” for “requirements of paragraphs (10) and (11) of ”.
Pub. L. 96–499, § 933(g)section 1395x(cc)(2) of this titlesection 1395x(aa)(2) of this title, inserted “or a comprehensive outpatient rehabilitation facility as defined in ” after “” and “comprehensive outpatient rehabilitation facility,” after “rural health clinic,” in four places.
Pub. L. 96–499, § 934(c)(2)section 1395k(a)(2)(F) of this titlesection 1395x(p)(4) of this title, inserted “, or whether an ambulatory surgical center meets the standards specified under ” after “” and “ambulatory surgical center,” after “health care facility,” in three places.
Pub. L. 95–2101977—Subsec. (a). expanded enumeration of institutions and agencies included under coverage of this subsection by inserting references to rural health clinics in five places.
Pub. L. 92–6031972—Subsec. (a). , §§ 277, 278(a)(16), (b)(15), 299D(a), provided for the furnishing of specialized 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 “extended care facility”.
Pub. L. 92–603, § 244(a)Subsec. (c). , added subsec. (c).
Pub. L. 90–248, § 133(f)1968—Subsec. (a). , 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)section 1396a(a)(24) of this title, struck out last sentence providing for utilization of State facilities to provide consultative services to institutions furnishing medical care, covered in .
Statutory Notes and Related Subsidiaries
Effective Date of 2020 Amendment
section 125(d)(2) of Pub. L. 116–260section 125(g) of Pub. L. 116–260lAmendment by applicable to items and services furnished on or after , see , set out as a note under section 1395 of this title.
Pub. L. 116–260, div. CC, title IV, § 407(a)(3)(B)134 Stat. 3008
Effective Date of 2008 Amendment; Transition Rule
Pub. L. 110–275section 125(d) of Pub. L. 110–275section 1395bb of this titleAmendment by applicable with respect to accreditations of hospitals granted on or after the date that is 24 months after , with transition rule, see , set out as a note under .
Effective Date of 1997 Amendment
section 4106(c) of Pub. L. 105–33section 4106(d) of Pub. L. 105–33section 1395x of this titleAmendment by applicable to bone mass measurements performed on or after , see , set out as a note under .
section 4201(c)(1) of Pub. L. 105–33section 4201(d) of Pub. L. 105–33section 1395f of this titleAmendment by applicable to services furnished on or after , see , set out as a note under .
Effective Date of 1994 Amendment
section 145(c)(3) of Pub. L. 103–432section 263b(b) of this titlesection 145(d) of Pub. L. 103–432section 1395m of this titleAmendment by applicable to mammography furnished by a facility on and after the first date that the certificate requirements of apply to such mammography conducted by such facility, see , set out as a note under .
Effective Date of 1990 Amendment
Pub. L. 101–508, title IV, § 4154(d)(2)104 Stat. 1388–85
section 4163(c)(2) of Pub. L. 101–508section 4163(e) of Pub. L. 101–508lAmendment by applicable to screening mammography performed on or after , see , set out as a note under section 1395 of this title.
Effective Date of 1989 Amendments
section 6115(c) of Pub. L. 101–239section 6115(d) of Pub. L. 101–239section 1395x of this titleAmendment by applicable to screening pap smears performed on or after , see , set out as a note under .
Pub. L. 101–234section 201(c) of Pub. L. 101–234section 1320a–7a of this titleAmendment by effective , see , set out as a note under .
Effective Date of 1988 Amendments
Pub. L. 100–485Pub. L. 100–360section 608(g)(1) of Pub. L. 100–485section 704 of this titleAmendment by effective as if included in the enactment of the Medicare Catastrophic Coverage Act of 1988, , see , set out as a note under .
section 203(e)(3) of Pub. L. 100–360section 203(g) of Pub. L. 100–360section 1320c–3 of this titleAmendment by applicable to items and services furnished on or after , see , set out as a note under .
Pub. L. 100–360section 204(e) of Pub. L. 100–360section 1395m of this titleAmendment by section 204(c)(2), (d)(3) of applicable to screening mammography performed on or after , see , set out as a note under .
section 411 of Pub. L. 100–360lPub. L. 100–360Pub. L. 100–203Pub. L. 100–203section 411(a) of Pub. L. 100–360section 106 of Title 1Except as specifically provided in , amendment by section 411(d)(4)(A), ()(1)(C), (6)(B) of , as it relates to a provision in the Omnibus Budget Reconciliation Act of 1987, , effective as if included in the enactment of that provision in , see , set out as a Reference to OBRA; Effective Date note under , General Provisions.
Effective Date of 1987 Amendment
Pub. L. 100–203, title IV, § 4025(c)101 Stat. 1330–74Pub. L. 100–360, title IV, § 411(d)(4)(B)(i)102 Stat. 774
section 4072(d) of Pub. L. 100–203section 4072(e) of Pub. L. 100–203section 1395x of this titleFor effective date of amendment by , see , set out as a note under .
Pub. L. 100–203section 1395i–3 of this titlesection 4204(a) of Pub. L. 100–203section 1395i–3 of this titleAmendments by sections 4201(a)(2), (d)(4) and 4202(a)(1), (c) of applicable to services furnished on or after , without regard to whether regulations to implement such amendments are promulgated by such date, except as otherwise specifically provided in , see , as amended, set out as an Effective Date note under .
section 4203(a)(1) of Pub. L. 100–203section 1395i–3 of this titlesection 4203(a)(1) of Pub. L. 100–203section 1395x(j) of this titlesection 4204(b) of Pub. L. 100–203Pub. L. 100–485section 1395i–3 of this titleAmendment by applicable , except as otherwise specifically provided in , without regard to whether regulations to implement such amendment are promulgated by such date, and in applying amendment by for services furnished by a skilled nursing facility before , any reference to a requirement of section 1395i–3(b), (c), or (d) of this title is deemed a reference to , see , as added by , set out as an Effective Date note under .
Effective Date of 1986 Amendment
Pub. L. 99–509Pub. L. 99–509section 1395k of this titleAmendment by applicable to services furnished on or after , with exceptions for hospitals located in rural areas which meet certain requirements related to certified registered nurse anesthetists, see section 9320(i), (k) of , as amended, set out as notes under .
Effective Date of 1984 Amendment
Pub. L. 98–369section 2354(e)(1) of Pub. L. 98–369section 1320a–1 of this titleAmendment by effective , 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 , set out as a note under .
Effective Date of 1982 Amendment
Pub. L. 97–248section 122(h)(1) of Pub. L. 97–248section 1395c of this titleAmendment by applicable to hospice care provided on or after , see , as amended, set out as a note under .
Effective Date of 1980 Amendments
Pub. L. 96–611section 2 of Pub. L. 96–611lAmendment by effective , and applicable to services furnished on or after that date, see , set out as a note under section 1395 of this title.
section 933(g) of Pub. L. 96–499section 933(h) of Pub. L. 96–499section 1395k of this titleFor effective date of amendment by , see , set out as a note under .
Effective Date of 1977 Amendment
Pub. L. 95–210section 1(j) of Pub. L. 95–210section 1395k of this titleAmendment by applicable to services rendered on or after first day of third calendar month which begins after , see , set out as a note under .
Effective Date of 1972 Amendment
Pub. L. 92–603, title II, § 299D(c)86 Stat. 1462
Effective Date of 1968 Amendment
section 133(f) of Pub. L. 90–248section 133(g) of Pub. L. 90–248section 1395k of this titleAmendment by applicable with respect to services furnished after , see , set out as a note under .
Pub. L. 90–248, title II, § 228(b)81 Stat. 904, , , provided that the amendment made by such section 228(b) is effective .
Use of State or Local Agencies in Evaluating Laboratories
Pub. L. 103–432, title I, § 160(a)(2)108 Stat. 4443
Nurse Aid Training and Competency Evaluation, Failure by State To Meet Guidelines
Pub. L. 101–508, title IV, § 4008(h)(1)(A)104 Stat. 1388–46