(a) In general.—Section 1192(e) of the Social Security Act (42 U.S.C. 1320f–1(e)) is amended—
(1) in paragraph (1), in the matter preceding subparagraph (A), by striking “and (3)” and inserting “through (4)”;
(2) in paragraph (3)(A)—
(A) by striking “only one rare disease or condition” and inserting “one or more rare diseases or conditions”; and
(B) by striking “such disease or condition” and inserting “one or more such rare diseases or conditions (as such term is defined in section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act)”; and
(3) by adding at the end the following new paragraph:
“(4) TREATMENT OF FORMER ORPHAN DRUGS.—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.”.
(b) Application.—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.