US Code

Public Law 119-102 (07/12/2026)

42 U.S.C. § 1395w–153

Condition for coverage of drugs under this part

Section text and notes

(a)

In general

section 1395w–102(e) of this titleIn order for coverage to be available under this part for covered part D drugs (as defined in ) of a manufacturer, the manufacturer must—
(1)
participate in—
(A)
section 1395w–114a of this title for 2011 through 2024, the Medicare coverage gap discount program under ; and
(B)
section 1395w–114c of this title for 2025 and each subsequent year, the manufacturer discount program under ;
(2)
have entered into and have in effect—
(A)
section 1395w–114a of this title for 2011 through 2024, an agreement described in subsection (b) of with the Secretary; and
(B)
section 1395w–114c of this title for 2025 and each subsequent year, an agreement described in subsection (b) of with the Secretary; and
(3)
section 1395w–114a of this title 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 .
(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 , and before , and paragraphs (1)(B) and (2)(B) of such subsection shall apply to covered part D drugs dispensed under this part on or after .

(c)

Authorizing coverage for drugs not covered under agreements

(1)

In general

Subject 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)
1
1 So in original. Probably should be followed by “ending on”.
the Secretary determines that in the period beginning on , and  , there were extenuating circumstances.
(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.

(d)

Definition of manufacturer

section 1395w–114a(g)(5) of this titleIn this section, the term “manufacturer” has the meaning given such term in .

Aug. 14, 1935, ch. 531 Pub. L. 111–148, title III, § 3301(a)124 Stat. 461 Pub. L. 111–152, title I, § 1101(b)(1)124 Stat. 1037 Pub. L. 117–169, title I136 Stat. 1853 (, title XVIII, § 1860D–43, as added , , ; amended , , ; , §§ 11001(b)(1)(G)(i), 11201(e)(7), , , 1892.)

Editorial Notes

References in Text

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

Amendments

Pub. L. 117–169, § 11201(e)(7)(A)(i)section 1395w–114a of this title2022—Subsec. (a)(1). , added par. (1) and struck out former par. (1) which read as follows: “participate in the Medicare coverage gap discount program under ;”.

Pub. L. 117–169, § 11201(e)(7)(A)(ii)Subsec. (a)(2). , 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”.

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

Pub. L. 117–169, § 11201(e)(7)(B)Subsec. (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 .”

Pub. L. 117–169, § 11001(b)(1)(G)(i)Subsec. (c). , 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).

Pub. L. 111–152, § 1101(b)(1)(A)2010—Subsec. (b). , substituted “” for “”.

Pub. L. 111–152, § 1101(b)(1)(B)Subsec. (c)(2). , substituted “, and ,” for “, and ending on ,”.