42 U.S.C. § 1395w–153 — Condition for coverage of drugs under this part

(a) General rule. For coverage under this part of a manufacturer’s covered Part D drugs, the manufacturer must: (1) participate (A) from 2011 through 2024, in the Medicare coverage-gap discount program under section 1395w–114a, and (B) in 2025 and every later year, in the manufacturer discount program under section 1395w–114c; (2) have entered into and continue to have in effect (A) for 2011 through 2024, an agreement with the Secretary^* described in section 1395w–114a(b), and (B) for 2025 and later, an agreement with the Secretary described in section 1395w–114c(b); and (3) have entered into and continue to have in effect, under the Secretary’s terms and conditions, a contract with a third party that has a contract with the Secretary under section 1395w–114a(d)(3).
(b) Effective date. Subsection (a)(1)(A), (2)(A), and (3) applies to covered Part D drugs dispensed on or after January 1, 2011, and before January 1, 2025. Subsection (a)(1)(B) and (2)(B) applies to covered Part D drugs dispensed on or after January 1, 2025.
(c) Coverage when agreements are absent. (1) Subject to paragraph (2), subsection (a) does not apply to dispensing a covered Part D drug^* if (A) the Secretary decides the drug^* is essential to beneficiaries’ health, or (B) the Secretary decides there were extenuating circumstances during January 1, 2011, through December 31, 2011. (2) The essential-drug exception in paragraph (1)(A) does not apply to a manufacturer’s drug during a period described in Internal Revenue Code section 5000D(c)(1) for that manufacturer.
(d) Manufacturer. “Manufacturer” has the meaning given in section 1395w–114a(g)(5); this section does not define that term.