View all text of Subpart 5 [§ 1395w-151 - § 1395w-154]
§ 1395w–153. Condition for coverage of drugs under this part
(a) In generalIn 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—
(A) for 2011 through 2024, the Medicare coverage gap discount program under section 1395w–114a of this title; and
(B) for 2025 and each subsequent year, the manufacturer discount program under section 1395w–114c of this title;
(2) have entered into and have in effect—
(A) for 2011 through 2024, an agreement described in subsection (b) of section 1395w–114a of this title with the Secretary; and
(B) for 2025 and each subsequent year, an agreement described in subsection (b) of section 1395w–114c of this title 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 section 1395w–114a of this title.
(b) Effective date
(c) Authorizing coverage for drugs not covered under agreements
(1) In generalSubject to paragraph (2), subsection (a) shall not apply to the dispensing of a covered part D drug if—
(A) the Secretary has made a determination that the availability of the drug is essential to the health of beneficiaries under this part; or
(B) the Secretary determines that in the period beginning on January 1, 2011, and 1
1 So in original. Probably should be followed by “ending on”.
December 31, 2011, there were extenuating circumstances.(2) Exception
(d) Definition of manufacturer
(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.)