I
119THCONGRESS
1
STSESSION 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
APRIL1, 2025
Mr. D
AVISof 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-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Old Drugs, New Cures 4
Act’’. 5
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•HR 2542 IH
SEC. 2. PRIORITY RESEARCH DRUGS. 1
(a) I
NGENERAL.—Section 1927(c)(2)(C) of the So-2
cial Security Act (42 U.S.C. 1396r–8(c)(2)(C)) is amend-3
ed by inserting the following new clause before the flush 4
matter at the end: 5
‘‘(iv) P
RIORITY RESEARCH DRUG .— 6
‘‘(I) R
EQUEST FOR DESIGNA -7
TION.—Not later than 90 days fol-8
lowing the date of enactment of this 9
clause, the Secretary shall establish 10
and make effective a process for the 11
manufacturer of a covered outpatient 12
drug to request that the Secretary 13
designate the drug as a priority re-14
search drug. 15
‘‘(II) D
ESIGNATION.—Not later 16
than 60 calendar days after the re-17
ceipt of a request under subclause (I), 18
the Secretary shall designate a cov-19
ered outpatient drug as a priority re-20
search drug so long as it meets the 21
following criteria: 22
‘‘(aa) As of the date of sub-23
mission of such request, at least 24
10 years have elapsed since the 25
date the drug was approved 26
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•HR 2542 IH
under section 505(c) of the Fed-1
eral Food, Drug, and Cosmetic 2
Act or section 351(a) of the Pub-3
lic Health Service Act. 4
‘‘(bb) The manufacturer of 5
the drug is investigating such 6
drug under section 505(i) of the 7
Federal Food, Drug, and Cos-8
metic Act or section 351(a)(3) of 9
the Public Health Service Act for 10
a new indication that would ad-11
dress a significant unmet medical 12
need because there is no alter-13
native drug approved under sec-14
tion 505 of the Federal Food, 15
Drug, and Cosmetic Act or li-16
censed under section 351 of the 17
Public Health Service Act for 18
such indication on the date that 19
the request under subclause (I) 20
was submitted to the Secretary. 21
‘‘(cc) The new indication de-22
scribed in item (bb) is for a dis-23
ease or condition that has a high 24
prevalence among beneficiaries of 25
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•HR 2542 IH
Federal health care programs. 1
For purposes of this clause, a 2
disease or condition has a high 3
prevalence among beneficiaries of 4
Federal health care programs if 5
at least 33 percent of claims in 6
the population targeted by the 7
new indication during the prior 8
calendar year were paid for 9
under— 10
‘‘(AA) a State plan 11
under this title or a State 12
child health plan under title 13
XXI; 14
‘‘(BB) part D of title 15
XVIII with respect to an in-16
dividual who is eligible for 17
subsidies under section 18
1860D–14; 19
‘‘(CC) the drug dis-20
count program under section 21
340B of the Public Health 22
Service Act (42 U.S.C. 23
256b; or 24
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‘‘(DD) a health care 1
program administered by the 2
Department of Veterans Af-3
fairs.’’. 4
(b) E
XCLUSION OF PRIORITYRESEARCHDRUGS 5
F
ROMMEDICAIDDEFINITION OFLINEEXTENSION.— 6
The flush matter at the end of section 1927(c)(2)(C) of 7
the Social Security Act (42 U.S.C. 1396r–8(c)(2)(C)) is 8
amended by inserting ‘‘a priority research drug (as des-9
ignated under clause (iv)) or’’ after ‘‘does not include’’. 10
(c) E
XCLUSION OF PRIORITYRESEARCHDRUGS 11
F
ROMMEDICAIDBESTPRICESPECIALRULE FORSE-12
LECTEDDRUGS.—Section 1927(c)(1)(C)(ii)(V) of the So-13
cial Security Act (42 U.S.C. 1396r–8(c)(1)(C)(ii)(V)) is 14
amended by inserting ‘‘unless such drug is also designated 15
as a priority research drug under paragraph (2)(C)(iv) 16
during such period’’ before the period. 17
(d) E
XCLUSION OF PRIORITYRESEARCHDRUGS 18
F
ROMMEDICAREDEFINITION OFLINEEXTENSION.— 19
Section 1860D–14B(b)(5)(B)(ii) of the Social Security 20
Act (42 U.S.C. 1395w–114b(b)(5)(B)(ii)) is amended by 21
inserting ‘‘a priority research drug (as designated under 22
section 1927(c)(2)(C)(iv)) or’’ after ‘‘does not include’’. 23
Æ
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