119-hr2542

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2542 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 2542

 To amend titles XVIII and XIX of the Social Security Act to provide 
that priority research drugs shall not be treated as line extensions of 
 existing drugs for purposes of calculating manufacturer rebates under 
 the Medicare and Medicaid programs, and for other purposes.

_______________________________________________________________________

 IN THE HOUSE OF REPRESENTATIVES

 April 1, 2025

 Mr. Davis of North Carolina (for himself and Mr. Pfluger) introduced 
 the following bill; which was referred to the Committee on Energy and 
 Commerce, and in addition to the Committee on Ways and Means, for a 
 period to be subsequently determined by the Speaker, in each case for 
consideration of such provisions as fall within the jurisdiction of the 
 committee concerned

_______________________________________________________________________

 A BILL

 To amend titles XVIII and XIX of the Social Security Act to provide 
that priority research drugs shall not be treated as line extensions of 
 existing drugs for purposes of calculating manufacturer rebates under 
 the Medicare and Medicaid programs, and for other purposes.

 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 ``Old Drugs, New Cures Act''.

SEC. 2. PRIORITY RESEARCH DRUGS.

    (a) In General.--

Section 1927
            (c) (2)
            (C) of the Social Security Act 
(42 U.S.C. 1396r-8
            (c) (2)
            (C) ) is amended by inserting the following new 
clause before the flush matter at the end:
 ``
            (iv) Priority research drug.--
 ``
            (I) Request for designation.--Not 
 later than 90 days following the date 
 of enactment of this clause, the 
 Secretary shall establish and make 
 effective a process for the 
 manufacturer of a covered outpatient 
 drug to request that the Secretary 
 designate the drug as a priority 
 research drug.
 ``
            (II) Designation.--Not later than 
 60 calendar days after the receipt of a 
 request under subclause
            (I) , the 
 Secretary shall designate a covered 
 outpatient drug as a priority research 
 drug so long as it meets the following 
 criteria:
 ``

    (aa) As of the date of 
 submission of such request, at 
 least 10 years have elapsed 
 since the date the drug was 
 approved under 

section 505
            (c) of the Federal Food, Drug, and 
 Cosmetic Act or 

section 351

    (a) of the Public Health Service 
 Act.
 ``

    (bb) The manufacturer of 
 the drug is investigating such 
 drug under 

section 505
            (i) of 
 the Federal Food, Drug, and 
 Cosmetic Act or 

section 351

    (a)

    (3) of the Public Health 
 Service Act for a new 
 indication that would address a 
 significant unmet medical need 
 because there is no alternative 
 drug approved under 

section 505 
 of the Federal Food, Drug, and 
 Cosmetic Act or licensed under 
 

section 351 of the Public 
 Health Service Act for such 
 indication on the date that the 
 request under subclause
            (I) was 
 submitted to the Secretary.
 ``
            (cc) The new indication 
 described in item

    (bb) is for a 
 disease or condition that has a 
 high prevalence among 
 beneficiaries of Federal health 
 care programs. For purposes of 
 this clause, a disease or 
 condition has a high prevalence 
 among beneficiaries of Federal 
 health care programs if at 
 least 33 percent of claims in 
 the population targeted by the 
 new indication during the prior 
 calendar year were paid for 
 under--

 ``

    (AA) a State plan 
 under this title or a 
 State child health plan 
 under title XXI;

 ``

    (BB) part D of 
 title XVIII with 
 respect to an 
 individual who is 
 eligible for subsidies 
 under 

section 1860D-14;

 ``
            (CC) the drug 
 discount program under 
 

section 340B of the 
 Public Health Service 
 Act (42 U.S.C. 256b; or

 ``
            (DD) a health 
 care program 
 administered by the 
 Department of Veterans 
 Affairs.''.

    (b) Exclusion of Priority Research Drugs From Medicaid Definition 
of Line Extension.--The flush matter at the end of 

section 1927
            (c) (2)
            (C) of the Social Security Act (42 U.S.C. 1396r-8
            (c) (2)
            (C) ) 
is amended by inserting ``a priority research drug (as designated under 
clause
            (iv) ) or'' after ``does not include''.
            (c) Exclusion of Priority Research Drugs From Medicaid Best Price 
Special Rule for Selected Drugs.--

Section 1927
            (c) (1)
            (C) 
            (ii) 
            (V) of the 
Social Security Act (42 U.S.C. 1396r-8
            (c) (1)
            (C) 
            (ii) 
            (V) ) is amended by 
inserting ``unless such drug is also designated as a priority research 
drug under paragraph

    (2)
            (C) 
            (iv) during such period'' before the period.
            (d) Exclusion of Priority Research Drugs From Medicare Definition 
of Line Extension.--

Section 1860D-14B

    (b)

    (5)
        (B)
            (ii) of the Social 
Security Act (42 U.S.C. 1395w-114b

    (b)

    (5)
        (B)
            (ii) ) is amended by 
inserting ``a priority research drug (as designated under 

section 1927
            (c) (2)
            (C) 
            (iv) ) or'' after ``does not include''.
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