1. (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. (1) participate in—

      1. (A) for 2011 through 2024, the Medicare coverage gap discount program under section 1395w–114a of this title; and
      2. (B) for 2025 and each subsequent year, the manufacturer discount program under section 1395w–114c of this title;

   2. (2) have entered into and have in effect—

      1. (A) for 2011 through 2024, an agreement described in subsection (b) of section 1395w–114a of this title with the Secretary; and
      2. (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. (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.
2. (b) Effective date 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.

3. (c) Authorizing coverage for drugs not covered under agreements

   1. (1) In general Subject to paragraph (2), subsection (a) shall not apply to the dispensing of a covered part D drug if—

      1. (A) the Secretary has made a determination that the availability of the drug is essential to the health of beneficiaries under this part; or
      2. (B) the Secretary determines that in the period beginning on January 1, 2011, and ¹ December 31, 2011, there were extenuating circumstances.
   2. (2) Exception 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.
4. (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; Pub. L. 117–169, title I, §§ 11001(b)(1)(G)(i), 11201(e)(7), Aug. 16, 2022, 136 Stat. 1853, 1892.)

Editorial Notes

References in Text

Section 5000D(c)(1) of the Internal Revenue Code of 1986, referred to in subsec. (c)(2), is classified to section 5000D(c)(1) of Title 26, Internal Revenue Code.

Amendments

2022—Subsec. (a)(1). Pub. L. 117–169, § 11201(e)(7)(A)(i), added par. (1) and struck out former par. (1) which read as follows: “participate in the Medicare coverage gap discount program under section 1395w–114a of this title;”.

Subsec. (a)(2). Pub. L. 117–169, § 11201(e)(7)(A)(ii), added par. (2) and struck out former par. (2) which read as follows: “have entered into and have in effect an agreement described in subsection (b) of such section with the Secretary; and”.

Subsec. (a)(3). Pub. L. 117–169, § 11201(e)(7)(A)(iii), substituted “section 1395w–114a of this title” for “such section”.

Subsec. (b). Pub. L. 117–169, § 11201(e)(7)(B), added subsec. (b) and struck out former subsec. (b). Prior to amendment, text read as follows: “Subsection (a) shall apply to covered part D drugs dispensed under this part on or after January 1, 2011.”

Subsec. (c). Pub. L. 117–169, § 11001(b)(1)(G)(i), designated existing provisions as par. (1) and inserted heading, substituted “Subject to paragraph (2), subsection” for “Subsection” in introductory provisions, redesignated former pars. (1) and (2) as subpars. (A) and (B), respectively, of par. (1), and added par. (2).

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,”.

¹ So in original. Probably should be followed by “ending on”.