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