I 
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 Medi-
care 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 Com-
merce, and in addition to the Committee on Ways and Means, for a pe-
riod to be subsequently determined by the Speaker, in each case for con-
sideration of such provisions as fall within the jurisdiction of the com-
mittee concerned 
A BILL 
To amend titles XVIII and XIX of the Social Security Act 
to provide that priority research drugs shall not be treat-
ed 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 Representa-
tives 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’’. 
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SEC. 2. PRIORITY RESEARCH DRUGS. 
(a) IN GENERAL.—Section 1927(c)(2)(C) of the So-
cial Security Act (42 U.S.C. 1396r–8(c)(2)(C)) is amend-
ed by inserting the following new clause before the flush 
matter at the end: 
‘‘(iv) PRIORITY RESEARCH DRUG.— 
‘‘(I) REQUEST
FOR
DESIGNA-
TION.—Not later than 90 days fol-
lowing 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 re-
search drug. 
‘‘(II) DESIGNATION.—Not later 
than 60 calendar days after the re-
ceipt of a request under subclause (I), 
the Secretary shall designate a cov-
ered outpatient drug as a priority re-
search drug so long as it meets the 
following criteria: 
‘‘(aa) As of the date of sub-
mission of such request, at least 
10 years have elapsed since the 
date the drug was approved 
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under section 505(c) of the Fed-
eral Food, Drug, and Cosmetic 
Act or section 351(a) of the Pub-
lic Health Service Act. 
‘‘(bb) The manufacturer of 
the drug is investigating such 
drug under section 505(i) of the 
Federal Food, Drug, and Cos-
metic Act or section 351(a)(3) of 
the Public Health Service Act for 
a new indication that would ad-
dress a significant unmet medical 
need because there is no alter-
native drug approved under sec-
tion 505 of the Federal Food, 
Drug, and Cosmetic Act or li-
censed 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 de-
scribed in item (bb) is for a dis-
ease or condition that has a high 
prevalence among beneficiaries of 
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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 in-
dividual who is eligible for 
subsidies 
under 
section 
1860D–14; 
‘‘(CC) the drug dis-
count program under section 
340B of the Public Health 
Service 
Act 
(42 
U.S.C. 
256b; or 
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‘‘(DD) a health care 
program administered by the 
Department of Veterans Af-
fairs.’’. 
(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 des-
ignated under clause (iv)) or’’ after ‘‘does not include’’. 
(c) EXCLUSION
OF PRIORITY RESEARCH DRUGS 
FROM MEDICAID BEST PRICE SPECIAL RULE FOR SE-
LECTED DRUGS.—Section 1927(c)(1)(C)(ii)(V) of the So-
cial 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’’. 
Æ 
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