Source
(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. 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)(20)(B), (C), (27)(B),Oct. 13, 1988, 102 Stat. 2419, 2420, 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; 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.)
Amendments
2008—Subsec. (c).
Pub. L. 110–275substituted “pursuant to section
1395bb
(a)(1)” for “pursuant to subsection (a) or (b)(1) ofsection
1395bb”.
1997—Subsec. (a).
Pub. L. 105–33, § 4201(c)(1), substituted “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) ofsection
1395bb of this title, are treated as meeting the conditions or requirements of this subchapter.” for “hospitals which have an agreement 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 participate or seek to participate in the medicare program) 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 established 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 before period at end “(other than any fee relating to section
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 established 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 medicare program) the requirements of section
263a of this title,” for “section
1395x
(s) of this title,” in first sentence.
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. 101–234repealed
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), amended
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 certification survey conducted by a State agency or accreditation survey conducted by a private accreditation agency under section
1395bb of this title 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), 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 established 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 intravenous drug therapy provider,” after “hospice program” and substituted “hospice program, or home intravenous drug therapy provider” for “or hospice program”.
1987—Subsec. (a).
Pub. L. 100–203, § 4212(b), which directed 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 section 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’ representatives),” 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 section
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 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).”
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 remedies)”.
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. 99–509substituted “paragraphs (12) and (13)” for “paragraphs (11) and (12)”.
1984—Subsec. (c).
Pub. L. 98–369struck out “the” after “Joint Commission on”.
1982—Subsec. (a).
Pub. L. 97–248inserted “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. 96–611substituted “requirements 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 rehabilitation 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 specified under section
1395k
(a)(2)(F) of this title” after “section
1395x
(p)(4) of this title” and “ambulatory surgical center,” after “health care facility,” in three places.
1977—Subsec. (a).
Pub. L. 95–210expanded enumeration of institutions and agencies included under coverage 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 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”.
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 providing for utilization of State facilities to provide consultative services to institutions furnishing medical care, covered in section
1396a
(a)(24) of this title.
Effective Date of 2008 Amendment; Transition Rule
Amendment by
Pub. L. 110–275applicable with respect to accreditations of hospitals granted on or after the date that is 24 months after July 15, 2008, with transition 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. 105–33applicable 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. 105–33applicable 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. 103–432applicable to mammography 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
Section 4154(d)(2) of
Pub. L. 101–508provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as if included in the enactment of the Clinical Laboratory Improvement Amendments of 1988 [
Pub. L. 100–578].”
Amendment by section 4163(c)(2) of
Pub. L. 101–508applicable 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. 101–239applicable 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. 101–234effective 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. 100–485effective as if included in the enactment of the Medicare Catastrophic Coverage 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. 100–360applicable 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. 100–360applicable 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.
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
Section
4025
(c), formerly § 4025(b), of
Pub. L. 100–203, 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 amendment 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. 100–203applicable 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 specifically provided in section
1395i–3 of this title, see section 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. 100–203applicable 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 amendment by section 4203(a)(1) of
Pub. L. 100–203for 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. 99–509applicable 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 section
1395k of this title.
Effective Date of 1984 Amendment
Amendment by
Pub. L. 98–369effective 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. 97–248applicable 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. 96–611effective 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. 95–210applicable 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
Section 299D(c) of
Pub. L. 92–603provided 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. 90–248applicable 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.
Section 228(b) of
Pub. L. 90–248provided that the amendment made by such section
228
(b) is effective July 1, 1969.
Use of State or Local Agencies in Evaluating Laboratories
Section 160(a)(2) of
Pub. L. 103–432provided that: “An agreement made by the Secretary of Health and Human Services with a State under section 1864(a) of the Social Security Act [subsec. (a) of this section] may include an agreement that the services of the State health agency or other appropriate State agency (or the appropriate local agencies) will be utilized by the Secretary for the purpose of determining whether a laboratory meets the requirements of section 353 of the Public Health Service Act [section
263a of this title].”
Nurse Aid Training and Competency Evaluation, Failure by State To Meet Guidelines
Section 4008(h)(1)(A) of
Pub. L. 101–508provided 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 [this section] on the basis that the State failed to meet the requirement of section 1819(e)(1)(A) of such Act [section
1395i–3
(e)(1)(A) of this title] before the effective date of guidelines, issued by the Secretary, establishing requirements under section 1819(f)(2)(A) of such Act, if the State demonstrates to the satisfaction of the Secretary that it has made a good faith effort to meet such requirement before such effective date.”