S.Amdt. 4701

SA 4701. Mr. WELCH (for himself, Mr. Wyden, Ms. Cortez Masto, Mr.
Lujan, and Mr. Van Hollen) submitted an amendment intended to be
proposed by him to the bill S. 1383, to establish the Veterans Advisory
Committee on Equal Access, and for other purposes; which was ordered to
lie on the table; as follows:

At the appropriate place, insert the following:

SEC. __. TREATMENT OF ORPHAN DRUGS UNDER THE MEDICARE DRUG
PRICE NEGOTIATION PROGRAM.

(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 ``through (4)'' and inserting ``and (3)'';
(2) in paragraph (3)--
(A) by striking subparagraph (A);
(B) by redesignating subparagraphs (B) and (C) as
subparagraphs (A) and (B), respectively; and
(C) 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
(3) by striking paragraph (4) and inserting the following
new paragraph:
``(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.''.
(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.
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