S3019-119

2. Treatment of orphan drugs under the Medicare Drug Price Negotiation Program 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 through (4) and inserting and (3); in paragraph (3)— by striking subparagraph (A); by redesignating subparagraphs (B) and (C) as subparagraphs (A) and (B), respectively; and in subparagraph (A)(iii), as redesignated by subparagraph (B) of this paragraph, by striking with respect to and inserting subject to paragraph (4), with respect to; and by striking paragraph (4) and inserting the following new paragraph: In the case of a drug that is designated as a drug for one or more rare diseases or conditions and for which the only approved indication (or indications) is for 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), paragraph (3)(A) shall be applied by substituting $400,000,000 for $200,000,000 in clause (i) of such paragraph. 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. (4) Treatment of orphan drugs In the case of a drug that is designated as a drug for one or more rare diseases or conditions and for which the only approved indication (or indications) is for 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), paragraph (3)(A) shall be applied by substituting $400,000,000 for $200,000,000 in clause (i) of such paragraph. .