119-s3019

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3019 Introduced in Senate

    (IS) ]

<DOC>

119th CONGRESS
 1st Session
 S. 3019

 To amend title XI of the Social Security Act to provide for the 
 treatment of orphan drugs under the Medicare Drug Price Negotiation 
 Program.

_______________________________________________________________________

 IN THE SENATE OF THE UNITED STATES

 October 21, 2025

Mr. Welch (for himself, Mr. Wyden, and Ms. Cortez Masto) introduced the 
 following bill; which was read twice and referred to the Committee on 
 Finance

_______________________________________________________________________

 A BILL

 To amend title XI of the Social Security Act to provide for the 
 treatment of orphan drugs under the Medicare Drug Price Negotiation 
 Program.

 Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

 This Act may be cited as the ``No Big Blockbuster Bailouts Act''.

SEC. 2. 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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