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42 U.S.C. § 1395w–153 (THE PUBLIC HEALTH AND WELFARE)
§ 1395w–153. Condition for coverage of drugs under this part
(a) In general
In order for coverage to be available under this part for covered part D drugs (as defined in section 1395w–102(e) of this title) of a manufacturer, the manufacturer must—
(1) participate in the Medicare coverage gap discount program under section 1395w–114a of this title;
(2) have entered into and have in effect an agreement described in subsection (b) of such section with the Secretary; and
(3) have entered into and have in effect, under terms and conditions specified by the Secretary, a contract with a third party that the Secretary has entered into a contract with under subsection (d)(3) of such section.
(b) Effective date
Subsection (a) shall apply to covered part D drugs dispensed under this part on or after January 1, 2011.
(c) Authorizing coverage for drugs not covered under agreements
Subsection (a) shall not apply to the dispensing of a covered part D drug if—
(1) the Secretary has made a determination that the availability of the drug is essential to the health of beneficiaries under this part; or
(2) the Secretary determines that in the period beginning on January 1, 2011, and 1 December 31, 2011, there were extenuating circumstances.
(d) Definition of manufacturer
In this section, the term “manufacturer” has the meaning given such term in section 1395w–114a(g)(5) of this title.
(Aug. 14, 1935, ch. 531, title XVIII, § 1860D–43, as added Pub. L. 111–148, title III, § 3301(a), Mar. 23, 2010, 124 Stat. 461; amended Pub. L. 111–152, title I, § 1101(b)(1), Mar. 30, 2010, 124 Stat. 1037.)
heading: Editorial Notes
heading: Amendments
text: 2010—Subsec. (b). Pub. L. 111–152, § 1101(b)(1)(A), substituted “January 1, 2011” for “July 1, 2010”.
Subsec. (c)(2). Pub. L. 111–152, § 1101(b)(1)(B), substituted “January 1, 2011, and December 31, 2011,” for “July 1, 2010, and ending on December 31, 2010,”.
42 U.S.C. § 1395w–154 (THE PUBLIC HEALTH AND WELFARE)
§ 1395w–154. Improved Medicare prescription drug plan and MA–PD plan complaint system
(a) In general
The Secretary shall develop and maintain a complaint system, that is widely known and easy to use, to collect and maintain information on MA–PD plan and prescription drug plan complaints that are received (including by telephone, letter, e-mail, or any other means) by the Secretary (including by a regional office of the Department of Health and Human Services, the Medicare Beneficiary Ombudsman, a subcontractor, a carrier, a fiscal intermediary, and a Medicare administrative contractor under section 1395kk–1 of this title) through the date on which the complaint is resolved. The system shall be able to report and initiate appropriate interventions and monitoring based on substantial complaints and to guide quality improvement.
(b) Model electronic complaint form
The Secretary shall develop a model electronic complaint form to be used for reporting plan complaints under the system. Such form shall be prominently displayed on the front page of the Medicare.gov Internet website and on the Internet website of the Medicare Beneficiary Ombudsman.
(c) Annual reports by the Secretary
The Secretary shall submit to Congress annual reports on the system. Such reports shall include an analysis of the number and types of complaints reported in the system, geographic variations in such complaints, the timeliness of agency or plan responses to such complaints, and the resolution of such complaints.
(d) Definitions
In this section:
(1) MA–PD plan
The term “MA–PD plan” has the meaning given such term in section 1395w–151(a)(9) of this title.
(2) Prescription drug plan
The term “prescription drug plan” has the meaning given such term in section 1395w–151(a)(14) of this title.
(3) Secretary
The term “Secretary” means the Secretary of Health and Human Services.
(4) System
The term “system” means the plan complaint system developed and maintained under subsection (a).
(Pub. L. 111–148, title III, § 3311, Mar. 23, 2010, 124 Stat. 475.)
heading: Editorial Notes
heading: Codification
text: Section was enacted as part of the Patient Protection and Affordable Care Act, and not as part of the Social Security Act which comprises this chapter.
42 U.S.C. § 1395ii (THE PUBLIC HEALTH AND WELFARE)
§ 1395ii. Application of certain provisions of sub­chapter II
The provisions of sections 406 and 416(j) of this title, and of subsections (a), (d), (e), (h), (i), (j), (k), and (l) of section 405 of this title, shall also apply with respect to this subchapter to the same extent as they are applicable with respect to subchapter II, except that, in applying such provisions with respect to this subchapter, any reference therein to the Commissioner of Social Security or the Social Security Administration shall be considered a reference to the Secretary or the Department of Health and Human Services, respectively.
(Aug. 14, 1935, ch. 531, title XVIII, § 1872, as added Pub. L. 89–97, title I, § 102(a), July 30, 1965, 79 Stat. 332; amended Pub. L. 92–603, title II, § 242(a), Oct. 30, 1972, 86 Stat. 1419; Pub. L. 98–369, div. B, title III, § 2354(b)(36), July 18, 1984, 98 Stat. 1102; Pub. L. 103–296, title I, § 108(c)(4), Aug. 15, 1994, 108 Stat. 1485.)
heading: Editorial Notes
heading: Amendments
text: 1994—Pub. L. 103–296 inserted before period at end “, except that, in applying such provisions with respect to this subchapter, any reference therein to the Commissioner of Social Security or the Social Security Administration shall be considered a reference to the Secretary or the Department of Health and Human Services, respectively”.
1984—Pub. L. 98–369 struck out the comma after “406” and struck out reference to subsec. (f) of section 405 of this title.
1972—Pub. L. 92–603 struck out reference to provisions of section 408 of this title.
heading: Statutory Notes and Related Subsidiaries
heading: Effective Date of 1994 Amendment
text: Amendment by Pub. L. 103–296 effective Mar. 31, 1995, see section 110(a) of Pub. L. 103–296, set out as a note under section 401 of this title.
heading: Effective Date of 1984 Amendment
text: 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.
heading: Effective Date of 1972 Amendment
text: Amendment by Pub. L. 92–603 not applicable to any acts, statements, or representations made or committed prior to Oct. 30, 1972, see section 242(d) of Pub. L. 92–603, set out as an Effective Date note under section 1320a–7b of this title.
42 U.S.C. § 1395ss–1 (THE PUBLIC HEALTH AND WELFARE)
§ 1395ss–1. Clarification
Any health insurance policy that provides reimbursement for expenses incurred for items and services for which payment may be made under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] but which are not reimbursable by reason of the applicability of deductibles, coinsurance, copayments or other limitations imposed by a Medicare Advantage plan (including a Medicare Advantage private fee-for-service plan) under part C of such title [42 U.S.C. 1395w–21 et seq.] shall comply with the requirements of section 1882(o) of the such 1 Act (42 U.S.C. 1395ss(o)).
(Pub. L. 110–275, title I, § 104(c), July 15, 2008, 122 Stat. 2502.)
heading: Editorial Notes
heading: References in Text
text: The Social Security Act, referred to in text, is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Title XVIII of the Act is classified generally to this subchapter. Part C of title XVIII of the Act is classified to section 1395w–21 et seq. of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables.
heading: Codification
text: Section was enacted as part of the Medicare Improvements for Patients and Providers Act of 2008, and not as part of the Social Security Act which comprises this chapter.
42 U.S.C. § 1395ggg (THE PUBLIC HEALTH AND WELFARE)
§ 1395ggg. Omitted
heading: Editorial Notes
heading: Codification
text: Section, act Aug. 14, 1935, ch. 531, title XVIII, § 1896, as added Pub. L. 105–33, title IV, § 4015(a), Aug. 5, 1997, 111 Stat. 337; amended Pub. L. 106–398, § 1 [[div. A], title VII, § 712(a)(2), (b)–(e)], Oct. 30, 2000, 114 Stat. 1654, 1654A–177, 1654A–178; Pub. L. 107–314, div. A, title VII, § 713, Dec. 2, 2002, 116 Stat. 2589; Pub. L. 108–173, title VII, § 736(c)(8), Dec. 8, 2003, 117 Stat. 2356, authorized the Secretary of Health and Human Services and the Secretary of Defense, acting jointly, to establish a demonstration project for providing medicare health care services to certain medicare-eligible military retirees or dependents in a military treatment facility or by a designated provider, to be conducted during the 4-year period beginning on January 1, 1998.
42 U.S.C. § 1395kkk (THE PUBLIC HEALTH AND WELFARE)
§ 1395kkk. Repealed. Pub. L. 115–123, div. E, title XI, § 52001(a), Feb. 9, 2018, 132 Stat. 298
text: Section, Aug. 14, 1935, ch. 531, title XVIII, § 1899A, as added and amended Pub. L. 111–148, title III, § 3403(a)(1), title X, § 10320(a), Mar. 23, 2010, 124 Stat. 489, 949, established the Independent Payment Advisory Board.
heading: Statutory Notes and Related Subsidiaries
heading: Change of Name
text: Pub. L. 111–148, title X, § 10320(b), Mar. 23, 2010, 124 Stat. 952, which provided that any reference in the provisions of, or amendments made by, section 3403 of Pub. L. 111–148 (enacting this section and section 1395kkk–1 of this title and amending section 1395b–6 of this title and section 207 of Title 18, Crimes and Criminal Procedure) to the “Independent Medicare Advisory Board” be deemed to be a reference to the “Independent Payment Advisory Board”, was repealed by Pub. L. 115–123, div. E, title XI, § 52001(b)(4), Feb. 9, 2018, 132 Stat. 298.
heading: Construction
text: Pub. L. 111–148, title X, § 10320(c), Mar. 23, 2010, 124 Stat. 952, which provided that nothing in the amendments made by section 10320 of Pub. L. 111–148 precluded the Independent Medicare Advisory Board (renamed the Independent Payment Advisory Board) from solely using data from public or private sources to carry out former subsection (f)(3)(B) of this section, was repealed by Pub. L. 115–123, div. E, title XI, § 52001(b)(5), Feb. 9, 2018, 132 Stat. 298.
42 U.S.C. § 1396–1 (THE PUBLIC HEALTH AND WELFARE)
§ 1396–1. Appropriations
For the purpose of enabling each State, as far as practicable under the conditions in such State, to furnish (1) medical assistance on behalf of families with dependent children and of aged, blind, or disabled individuals, whose income and resources are insufficient to meet the costs of necessary medical services, and (2) rehabilitation and other services to help such families and individuals attain or retain capability for independence or self-care, there is hereby authorized to be appropriated for each fiscal year a sum sufficient to carry out the purposes of this subchapter. The sums made available under this section shall be used for making payments to States which have submitted, and had approved by the Secretary, State plans for medical assistance.
(Aug. 14, 1935, ch. 531, title XIX, § 1901, as added Pub. L. 89–97, title I, § 121(a), July 30, 1965, 79 Stat. 343; amended Pub. L. 93–233, § 13(a)(1), Dec. 31, 1973, 87 Stat. 960; Pub. L. 98–369, div. B, title VI, § 2663(j)(3)(C), July 18, 1984, 98 Stat. 1171.)
heading: Editorial Notes
heading: Codification
text: Section was formerly classified to section 1396 of this title.
heading: Amendments
text: 1984—Pub. L. 98–369 struck out “of Health, Education, and Welfare” after “Secretary”.
1973—Pub. L. 93–233 substituted “disabled individuals” for “permanently and totally disabled individuals”.
heading: Statutory Notes and Related Subsidiaries
heading: Effective Date of 1984 Amendment
text: 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 2664(b) of Pub. L. 98–369, set out as a note under section 401 of this title.
heading: Effective Date of 1973 Amendment
text: Amendment by Pub. L. 93–233 effective with respect to payments under section 1396b of this title for calendar quarters commencing after Dec. 31, 1973, see section 13(d) of Pub. L. 93–233, set out as a note under section 1396a of this title.
42 U.S.C. § 1396b–1 (THE PUBLIC HEALTH AND WELFARE)
§ 1396b–1. Payment adjustment for health care-acquired conditions
(a) In general
The Secretary of Health and Human Services (in this subsection referred to as the “Secretary”) shall identify current State practices that prohibit payment for health care-acquired conditions and shall incorporate the practices identified, or elements of such practices, which the Secretary determines appropriate for application to the Medicaid program in regulations. Such regulations shall be effective as of July 1, 2011, and shall prohibit payments to States under section 1903 of the Social Security Act [42 U.S.C. 1396b] for any amounts expended for providing medical assistance for health care-acquired conditions specified in the regulations. The regulations shall ensure that the prohibition on payment for health care-acquired conditions shall not result in a loss of access to care or services for Medicaid beneficiaries.
(b) Health care-acquired condition
In this section.1 the term “health care-acquired condition” means a medical condition for which an individual was diagnosed that could be identified by a secondary diagnostic code described in section 1886(d)(4)(D)(iv) of the Social Security Act (42 U.S.C. 1395ww(d)(4)(D)(iv)).
(c) Medicare provisions
In carrying out this section, the Secretary shall apply to State plans (or waivers) under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] the regulations promulgated pursuant to section 1886(d)(4)(D) of such Act (42 U.S.C. 1395ww(d)(4)(D)) relating to the prohibition of payments based on the presence of a secondary diagnosis code specified by the Secretary in such regulations, as appropriate for the Medicaid program. The Secretary may exclude certain conditions identified under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] for non-payment under title XIX of such Act when the Secretary finds the inclusion of such conditions to be inapplicable to beneficiaries under title XIX.
(Pub. L. 111–148, title II, § 2702, Mar. 23, 2010, 124 Stat. 318.)
heading: Editorial Notes
heading: References in Text
text: The Social Security Act, referred to in subsec. (c), is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Title XIX of the Act is classified generally to this subchapter. Title XVIII of the Act is classified generally to subchapter XVIII (§ 1395 et seq.) of this chapter. For complete classification of this Act to the Code, see section 1305 of this title and Tables.
heading: Codification
text: Section was enacted as part of the Patient Protection and Affordable Care Act, and not as part of the Social Security Act which comprises this chapter.
42 U.S.C. § 1396c (THE PUBLIC HEALTH AND WELFARE)
§ 1396c. Operation of State plans
If the Secretary, after reasonable notice and opportunity for hearing to the State agency administering or supervising the administration of the State plan approved under this subchapter, finds—
(1) that the plan has been so changed that it no longer complies with the provisions of section 1396a of this title; or
(2) that in the administration of the plan there is a failure to comply substantially with any such provision;
the Secretary shall notify such State agency that further payments will not be made to the State (or, in his discretion, that payments will be limited to categories under or parts of the State plan not affected by such failure), until the Secretary is satisfied that there will no longer be any such failure to comply. Until he is so satisfied he shall make no further payments to such State (or shall limit payments to categories under or parts of the State plan not affected by such failure).
(Aug. 14, 1935, ch. 531, title XIX, § 1904, as added Pub. L. 89–97, title I, § 121(a), July 30, 1965, 79 Stat. 351.)
heading: Editorial Notes
heading: Constitutionality
text: For constitutionality of section 121(a) of Pub. L. 89–97, amending this section, see Congressional Research Service, The Constitution of the United States of America: Analysis and Interpretation, Table of Laws Held Unconstitutional in Whole or in Part by the Supreme Court.
42 U.S.C. § 1396q (THE PUBLIC HEALTH AND WELFARE)
§ 1396q. Application of provisions of subchapter II relating to subpoenas
The provisions of subsections (d) and (e) of section 405 of this title shall apply with respect to this subchapter to the same extent as they are applicable with respect to subchapter II, except that, in so applying such subsections, and in applying section 405(l) of this title thereto, with respect to this subchapter, any reference therein to the Commissioner of Social Security or the Social Security Administration shall be considered a reference to the Secretary or the Department of Health and Human Services, respectively.
(Aug. 14, 1935, ch. 531, title XIX, § 1918, as added Pub. L. 98–369, div. B, title III, § 2370(a), July 18, 1984, 98 Stat. 1110; amended Pub. L. 103–296, title I, § 108(d)(5), Aug. 15, 1994, 108 Stat. 1486.)
heading: Editorial Notes
heading: Amendments
text: 1994—Pub. L. 103–296 inserted before period at end “, except that, in so applying such subsections, and in applying section 405(l) of this title thereto, with respect to this subchapter, any reference therein to the Commissioner of Social Security or the Social Security Administration shall be considered a reference to the Secretary or the Department of Health and Human Services, respectively”.
heading: Statutory Notes and Related Subsidiaries
heading: Effective Date of 1994 Amendment
text: Amendment by Pub. L. 103–296 effective Mar. 31, 1995, see section 110(a) of Pub. L. 103–296, set out as a note under section 401 of this title.
heading: Effective Date
text: Pub. L. 98–369, div. B, title III, § 2370(b), July 18, 1984, 98 Stat. 1110, provided that: “The amendment made by this section [enacting this section] shall become effective on the date of the enactment of this Act [July 18, 1984].”
42 U.S.C. § 1396r–7 (THE PUBLIC HEALTH AND WELFARE)
§ 1396r–7. Repealed. Pub. L. 105–33, title IV, § 4713(a), Aug. 5, 1997, 111 Stat. 509
text: Section, act Aug. 14, 1935, ch. 531, title XIX, § 1926, as added Dec. 19, 1989, Pub. L. 101–239, title VI, § 6402(b), 103 Stat. 2260, related to adequate payment levels for obstetrical and pediatric services.
heading: Statutory Notes and Related Subsidiaries
heading: Effective Date of Repeal
text: Pub. L. 105–33, title IV, § 4713(b), Aug. 5, 1997, 111 Stat. 509, provided that: “The repeal made by subsection (a) [repealing this section] shall apply to services furnished on or after October 1, 1997.”
42 U.S.C. § 1397c (THE PUBLIC HEALTH AND WELFARE)
§ 1397c. State reporting requirements
Prior to expenditure by a State of payments made to it under section 1397a of this title for any fiscal year, the State shall report on the intended use of the payments the State is to receive under this division, including information on the types of activities to be supported and the categories or characteristics of individuals to be served. The report shall be transmitted to the Secretary and made public within the State in such manner as to facilitate comment by any person (including any Federal or other public agency) during development of the report and after its completion. The report shall be revised throughout the year as may be necessary to reflect substantial changes in the activities assisted under this division, and any revision shall be subject to the requirements of the previous sentence.
(Aug. 14, 1935, ch. 531, title XX, § 2004, as added Pub. L. 97–35, title XXIII, § 2352(a), Aug. 13, 1981, 95 Stat. 869; amended Pub. L. 111–148, title VI, § 6703(d)(1)(B), Mar. 23, 2010, 124 Stat. 803.)
heading: Editorial Notes
heading: Prior Provisions
text: A prior section 1397c, act Aug. 14, 1935, ch. 531, title XX, § 2004, as added Jan. 4, 1975, Pub. L. 93–647, § 2, 88 Stat. 2346; amended June 17, 1980, Pub. L. 96–272, title II, § 206(a), (b), 94 Stat. 525, related to services program planning, prior to the general revision of this subchapter by section 2352(a) of Pub. L. 97–35.
heading: Amendments
text: 2010—Pub. L. 111–148, which directed substitution of “this division” for “this subchapter” wherever appearing in subtitle 1 of title XX of act Aug. 14, 1935, was executed by making the substitution in two places in this section, which is in subtitle A of title XX act Aug. 14, 1935, to reflect the probable intent of Congress.
42 U.S.C. § 1397j–1 (THE PUBLIC HEALTH AND WELFARE)
§ 1397j–1. General provisions
(a) Protection of privacy
In pursuing activities under this division, the Secretary shall ensure the protection of individual health privacy consistent with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 and applicable State and local privacy regulations.
(b) Rule of construction
Nothing in this division shall be construed to interfere with or abridge an elder’s right to practice his or her religion through reliance on prayer alone for healing when this choice—
(1) is contemporaneously expressed, either orally or in writing, with respect to a specific illness or injury which the elder has at the time of the decision by an elder who is competent at the time of the decision;
(2) is previously set forth in a living will, health care proxy, or other advance directive document that is validly executed and applied under State law; or
(3) may be unambiguously deduced from the elder’s life history.
(Aug. 14, 1935, ch. 531, title XX, § 2012, as added Pub. L. 111–148, title VI, § 6703(a)(1)(C), Mar. 23, 2010, 124 Stat. 785.)
heading: Editorial Notes
heading: References in Text
text: Section 264(c) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (a), is section 264(c) of Pub. L. 104–191, which is set out as a note under section 1320d–2 of this title.
42 U.S.C. § 1397m–4 (THE PUBLIC HEALTH AND WELFARE)
§ 1397m–4. Report
Not later than October 1, 2014, the Secretary shall submit to the Elder Justice Coordinating Council established under section 1397k of this title, the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives, and the Committee on Finance of the Senate a report—
(1) compiling, summarizing, and analyzing the information contained in the State reports submitted under subsections (b)(4) and (c)(4) 1 of section 1397m–1 of this title; and
(2) containing such recommendations for legislative or administrative action as the Secretary determines to be appropriate.
(Aug. 14, 1935, ch. 531, title XX, § 2045, as added Pub. L. 111–148, title VI, § 6703(a)(1)(C), Mar. 23, 2010, 124 Stat. 797.)
heading: Editorial Notes
heading: References in Text
text: Subsection (c)(4) of section 1397m–1 of this title, referred to in par. (1), was redesignated subsec. (c)(5) by Pub. L. 115–70, title V, § 501(3), Oct. 18, 2017, 131 Stat. 1215.