Us Congress 2025-2026 Regular Session

Us Congress House Bill HB2542 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	I
2	2	119THCONGRESS
3	3	1
4	4	STSESSION H. R. 2542
5	5	To amend titles XVIII and XIX of the Social Security Act to provide that
6	6	priority research drugs shall not be treated as line extensions of existing
7	7	drugs for purposes of calculating manufacturer rebates under the Medi-
8	8	care and Medicaid programs, and for other purposes.
9	9	IN THE HOUSE OF REPRESENTATIVES
10	10	APRIL1, 2025
11	11	Mr. D
12	12	AVISof North Carolina (for himself and Mr. PFLUGER) introduced the
13	13	following bill; which was referred to the Committee on Energy and Com-
14	14	merce, and in addition to the Committee on Ways and Means, for a pe-
15	15	riod to be subsequently determined by the Speaker, in each case for con-
16	16	sideration of such provisions as fall within the jurisdiction of the com-
17	17	mittee concerned
18	18	A BILL
19	19	To amend titles XVIII and XIX of the Social Security Act
20	20	to provide that priority research drugs shall not be treat-
21	21	ed as line extensions of existing drugs for purposes of
22	22	calculating manufacturer rebates under the Medicare and
23	23	Medicaid programs, and for other purposes.
24	24	Be it enacted by the Senate and House of Representa-1
25	25	tives of the United States of America in Congress assembled, 2
26	26	SECTION 1. SHORT TITLE. 3
27	27	This Act may be cited as the ‘‘Old Drugs, New Cures 4
28	28	Act’’. 5
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31	31	•HR 2542 IH
32	32	SEC. 2. PRIORITY RESEARCH DRUGS. 1
33	33	(a) I
34	34	NGENERAL.—Section 1927(c)(2)(C) of the So-2
35	35	cial Security Act (42 U.S.C. 1396r–8(c)(2)(C)) is amend-3
36	36	ed by inserting the following new clause before the flush 4
37	37	matter at the end: 5
38	38	‘‘(iv) P
39	39	RIORITY RESEARCH DRUG .— 6
40	40	‘‘(I) R
41	41	EQUEST FOR DESIGNA -7
42	42	TION.—Not later than 90 days fol-8
43	43	lowing the date of enactment of this 9
44	44	clause, the Secretary shall establish 10
45	45	and make effective a process for the 11
46	46	manufacturer of a covered outpatient 12
47	47	drug to request that the Secretary 13
48	48	designate the drug as a priority re-14
49	49	search drug. 15
50	50	‘‘(II) D
51	51	ESIGNATION.—Not later 16
52	52	than 60 calendar days after the re-17
53	53	ceipt of a request under subclause (I), 18
54	54	the Secretary shall designate a cov-19
55	55	ered outpatient drug as a priority re-20
56	56	search drug so long as it meets the 21
57	57	following criteria: 22
58	58	‘‘(aa) As of the date of sub-23
59	59	mission of such request, at least 24
60	60	10 years have elapsed since the 25
61	61	date the drug was approved 26
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64	64	•HR 2542 IH
65	65	under section 505(c) of the Fed-1
66	66	eral Food, Drug, and Cosmetic 2
67	67	Act or section 351(a) of the Pub-3
68	68	lic Health Service Act. 4
69	69	‘‘(bb) The manufacturer of 5
70	70	the drug is investigating such 6
71	71	drug under section 505(i) of the 7
72	72	Federal Food, Drug, and Cos-8
73	73	metic Act or section 351(a)(3) of 9
74	74	the Public Health Service Act for 10
75	75	a new indication that would ad-11
76	76	dress a significant unmet medical 12
77	77	need because there is no alter-13
78	78	native drug approved under sec-14
79	79	tion 505 of the Federal Food, 15
80	80	Drug, and Cosmetic Act or li-16
81	81	censed under section 351 of the 17
82	82	Public Health Service Act for 18
83	83	such indication on the date that 19
84	84	the request under subclause (I) 20
85	85	was submitted to the Secretary. 21
86	86	‘‘(cc) The new indication de-22
87	87	scribed in item (bb) is for a dis-23
88	88	ease or condition that has a high 24
89	89	prevalence among beneficiaries of 25
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92	92	•HR 2542 IH
93	93	Federal health care programs. 1
94	94	For purposes of this clause, a 2
95	95	disease or condition has a high 3
96	96	prevalence among beneficiaries of 4
97	97	Federal health care programs if 5
98	98	at least 33 percent of claims in 6
99	99	the population targeted by the 7
100	100	new indication during the prior 8
101	101	calendar year were paid for 9
102	102	under— 10
103	103	‘‘(AA) a State plan 11
104	104	under this title or a State 12
105	105	child health plan under title 13
106	106	XXI; 14
107	107	‘‘(BB) part D of title 15
108	108	XVIII with respect to an in-16
109	109	dividual who is eligible for 17
110	110	subsidies under section 18
111	111	1860D–14; 19
112	112	‘‘(CC) the drug dis-20
113	113	count program under section 21
114	114	340B of the Public Health 22
115	115	Service Act (42 U.S.C. 23
116	116	256b; or 24
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119	119	•HR 2542 IH
120	120	‘‘(DD) a health care 1
121	121	program administered by the 2
122	122	Department of Veterans Af-3
123	123	fairs.’’. 4
124	124	(b) E
125	125	XCLUSION OF PRIORITYRESEARCHDRUGS 5
126	126	F
127	127	ROMMEDICAIDDEFINITION OFLINEEXTENSION.— 6
128	128	The flush matter at the end of section 1927(c)(2)(C) of 7
129	129	the Social Security Act (42 U.S.C. 1396r–8(c)(2)(C)) is 8
130	130	amended by inserting ‘‘a priority research drug (as des-9
131	131	ignated under clause (iv)) or’’ after ‘‘does not include’’. 10
132	132	(c) E
133	133	XCLUSION OF PRIORITYRESEARCHDRUGS 11
134	134	F
135	135	ROMMEDICAIDBESTPRICESPECIALRULE FORSE-12
136	136	LECTEDDRUGS.—Section 1927(c)(1)(C)(ii)(V) of the So-13
137	137	cial Security Act (42 U.S.C. 1396r–8(c)(1)(C)(ii)(V)) is 14
138	138	amended by inserting ‘‘unless such drug is also designated 15
139	139	as a priority research drug under paragraph (2)(C)(iv) 16
140	140	during such period’’ before the period. 17
141	141	(d) E
142	142	XCLUSION OF PRIORITYRESEARCHDRUGS 18
143	143	F
144	144	ROMMEDICAREDEFINITION OFLINEEXTENSION.— 19
145	145	Section 1860D–14B(b)(5)(B)(ii) of the Social Security 20
146	146	Act (42 U.S.C. 1395w–114b(b)(5)(B)(ii)) is amended by 21
147	147	inserting ‘‘a priority research drug (as designated under 22
148	148	section 1927(c)(2)(C)(iv)) or’’ after ‘‘does not include’’. 23
149	149	Æ
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