§ 1395w–153. Condition for coverage of drugs under this part
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/usc/title-42/section-1395w-153A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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— participate in— for 2011 through 2024, the Medicare coverage gap discount program under section 1395w–114a of this title ; and for 2025 and each subsequent year, the manufacturer discount program under section 1395w–114c of this title ; have entered into and have in effect— for 2011 through 2024, an agreement described in subsection
(b)of section 1395w–114a of this title with the Secretary; and for 2025 and each subsequent year, an agreement described in subsection
(b)of section 1395w–114c of this title with the Secretary; and 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 section 1395w–114a of this title . Paragraphs (1)(A), (2)(A), and
(3)of subsection
(a)shall apply to covered part D drugs dispensed under this part on or after January 1, 2011 , and before January 1, 2025 , and paragraphs (1)(B) and (2)(B) of such subsection shall apply to covered part D drugs dispensed under this part on or after January 1, 2025 . Subject to paragraph (2), subsection
(a)shall not apply to the dispensing of a covered part D drug if— the Secretary has made a determination that the availability of the drug is essential to the health of beneficiaries under this part; or the Secretary determines that in the period beginning on January 1, 2011 , and 1 December 31, 2011 , there were extenuating circumstances. Paragraph (1)(A) shall not apply to a covered part D drug of a manufacturer for any period described in section 5000D(c)(1) of the Internal Revenue Code of 1986 with respect to the 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 ; Pub. L. 117–169, title I , §§ 11001(b)(1)(G)(i), 11201(e)(7), Aug. 16, 2022 , 136 Stat. 1853 , 1892.)
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- Pub. L. 111-148
- 124 Stat. 461
- Pub. L. 111-152
- 124 Stat. 1037
- 136 Stat. 1853
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§ 1395w–153
Condition for coverage of drugs under this part
Pub. L.Pub. L. 111-148
Stat.124 Stat. 461
Pub. L.Pub. L. 111-152
Stat.124 Stat. 1037
Stat.136 Stat. 1853
Cites 6Cited by 0 across 0 sources