Sec. 44301. Expanding and clarifying the exclusion for orphan drugs under the Drug Price Negotiation Program
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Section 1192(e) of the Social Security Act ( 42 U.S.C. 1320f–1(e) ) is amended— in paragraph (1), in the matter preceding subparagraph (A), by striking and
(3)and inserting through
(4); in paragraph (3)(A)— by striking only one rare disease or condition and inserting one or more rare diseases or conditions ; and by striking such disease or condition and inserting one or more rare diseases or conditions (as such term is defined in section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act) ; and by adding at the end the following new paragraph: In the case of a drug or biological product that, as of the date of the approval or licensure of such drug or biological product, is a drug or biological product described in paragraph (3)(A), paragraph (1)(A)(ii) or (1)(B)(ii) (as applicable) shall apply as if the reference to the date of such approval or the date of such licensure , respectively, were instead a reference to the first day after the date of such approval for which such drug is not a drug described in paragraph (3)(A) or the first day after the date of such licensure for which such biological product is not a biological product described in paragraph (3)(A) , respectively. . The amendments made by subsection
(a)shall apply with respect to initial price applicability years (as defined in section 1191(b) of the Social Security Act ( 42 U.S.C. 1320f(b) )) beginning on or after January 1, 2028.
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- 42 USC 1320f–1(e)
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Sec. 44301
Expanding and clarifying the exclusion for orphan drugs under the Drug Price Negotiation Program
Cite42 USC 1320f–1(e)
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