Establishment of program

The Secretary shall establish a Drug Price Negotiation Program (in this part referred to as the “program”). Under the program, with respect to each price applicability period, the Secretary shall— For purposes of this part: The term “initial price applicability year” means a year (beginning with 2026). The term “price applicability period” means, with respect to a qualifying single source drug, the period beginning with the first initial price applicability year with respect to which such drug is a selected drug and ending with the last year during which the drug is a selected drug. The term “selected drug publication date” means, with respect to each initial price applicability year, February 1 of the year that begins 2 years prior to such year. The term “negotiation period” means, with respect to an initial price applicability year with respect to a selected drug, the period— beginning on the sooner of— For purposes of this part: The term “manufacturer” has the meaning given that term in section 1395w–3a(c)(6)(A) of this title. The term “maximum fair price eligible individual” means, with respect to a selected drug— The term “maximum fair price” means, with respect to a year during a price applicability period and with respect to a selected drug (as defined in section 1320f–1(c) of this title) with respect to such period, the price negotiated pursuant to section 1320f–3 of this title, and updated pursuant to section 1320f–4(b) of this title, as applicable, for such drug and year. The term “reference product” has the meaning given such term in section 262(i) of this title. The term “total expenditures” includes, in the case of expenditures with respect to part D of subchapter XVIII, the total gross covered prescription drug costs (as defined in section 1395w–115(b)(3) of this title). The term “total expenditures” excludes, in the case of expenditures with respect to part B of such subchapter, expenditures for a drug or biological product that are bundled or packaged into the payment for another service. The term “unit” means, with respect to a drug or biological product, the lowest identifiable amount (such as a capsule or tablet, milligram of molecules, or grams) of the drug or biological product that is dispensed or furnished. Notwithstanding the provisions of this part, in the case of initial price applicability year 2026, the following rules shall apply for purposes of implementing the program: Subsection (b)(4) shall be applied— Section 1320f–1 of this title shall be applied— Section 1320f–3(b)(2) of this title shall be applied—