I 

118TH CONGRESS 

2D SESSION H. R. 8267 

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 

MAY 7, 2024 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Old Drugs, New Cures 

5 Act’’. 


ssavage on LAPJG3WLY3PROD with BILLS
2 

•HR 8267 IH

1 SEC. 2. PRIORITY RESEARCH DRUGS. 

2 (a) IN GENERAL.—Section 1927(c)(2)(C) of the So3 cial Security Act (42 U.S.C. 1396r–8(c)(2)(C)) is amend4 ed by inserting the following new clause before the flush 

5 matter at the end: 

6 ‘‘(iv) PRIORITY RESEARCH DRUG.— 

7 ‘‘(I) REQUEST FOR DESIGNA8 TION.—Not later than 90 days fol9 lowing the date of enactment of this 

10 clause, the Secretary shall establish 

11 and make effective a process for the 

12 manufacturer of a covered outpatient 

13 drug to request that the Secretary 

14 designate the drug as a priority re15 search drug. 

16 ‘‘(II) DESIGNATION.—Not later 

17 than 60 calendar days after the re18 ceipt of a request under subclause (I), 

19 the Secretary shall designate a cov20 ered outpatient drug as a priority re21 search drug so long as it meets the 

22 following criteria: 

23 ‘‘(aa) As of the date of sub24 mission of such request, at least 

25 10 years have elapsed since the 

26 date the drug was approved 


ssavage on LAPJG3WLY3PROD with BILLS
3 

•HR 8267 IH

1 under section 505(c) of the Fed2 eral Food, Drug, and Cosmetic 

3 Act or section 351(a) of the Pub4 lic Health Service Act. 

5 ‘‘(bb) The manufacturer of 

6 the drug is investigating such 

7 drug under section 505(i) of the 

8 Federal Food, Drug, and Cos9 metic Act or section 351(a)(3) of 

10 the Public Health Service Act for 

11 a new indication that would ad12 dress a significant unmet medical 

13 need because there is no alter14 native drug approved under sec15 tion 505 of the Federal Food, 

16 Drug, and Cosmetic Act or li17 censed under section 351 of the 

18 Public Health Service Act for 

19 such indication on the date that 

20 the request under subclause (I) 

21 was submitted to the Secretary. 

22 ‘‘(cc) The new indication de23 scribed in item (bb) is for a dis24 ease or condition that has a high 

25 prevalence among beneficiaries of 


ssavage on LAPJG3WLY3PROD with BILLS
4 

•HR 8267 IH

1 Federal health care programs. 

2 For purposes of this clause, a 

3 disease or condition has a high 

4 prevalence among beneficiaries of 

5 Federal health care programs if 

6 at least 33 percent of claims in 

7 the population targeted by the 

8 new indication during the prior 

9 calendar year were paid for 

10 under— 

11 ‘‘(AA) a State plan 

12 under this title or a State 

13 child health plan under title 

14 XXI; 

15 ‘‘(BB) part D of title 

16 XVIII with respect to an in17 dividual who is eligible for 

18 subsidies under section 

19 1860D–14; 

20 ‘‘(CC) the drug dis21 count program under section 

22 340B of the Public Health 

23 Service Act (42 U.S.C. 

24 256b; or 


ssavage on LAPJG3WLY3PROD with BILLS
5 

•HR 8267 IH

1 ‘‘(DD) a health care 

2 program administered by the 

3 Department of Veterans Af4 fairs.’’. 

5 (b) EXCLUSION OF PRIORITY RESEARCH DRUGS

6 FROM MEDICAID DEFINITION OF LINE EXTENSION.— 

7 The flush matter at the end of section 1927(c)(2)(C) of 

8 the Social Security Act (42 U.S.C. 1396r–8(c)(2)(C)) is 

9 amended by inserting ‘‘a priority research drug (as des10 ignated under clause (iv)) or’’ after ‘‘does not include’’. 

11 (c) EXCLUSION OF PRIORITY RESEARCH DRUGS

12 FROM MEDICAID BEST PRICE SPECIAL RULE FOR SE13 LECTED DRUGS.—Section 1927(c)(1)(C)(ii)(V) of the So14 cial Security Act (42 U.S.C. 1396r–8(c)(1)(C)(ii)(V)) is 

15 amended by inserting ‘‘unless such drug is also designated 

16 as a priority research drug under paragraph (2)(C)(iv) 

17 during such period’’ before the period. 

18 (d) EXCLUSION OF PRIORITY RESEARCH DRUGS

19 FROM MEDICARE DEFINITION OF LINE EXTENSION.— 

20 Section 1860D–14B(b)(5)(B)(ii) of the Social Security 

21 Act (42 U.S.C. 1395w–114b(b)(5)(B)(ii)) is amended by 

22 inserting ‘‘a priority research drug (as designated under 

23 section 1927(c)(2)(C)(iv)) or’’ after ‘‘does not include’’. 

Æ 


ssavage on LAPJG3WLY3PROD with BILLS