Us Congress 2025-2026 Regular Session

Us Congress House Bill HB1476 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. 1476
5	5	To amend title XVIII of the Social Security Act to provide a phase-in
6	6	for plasma-derived products under the manufacturer discount program.
7	7	IN THE HOUSE OF REPRESENTATIVES
8	8	FEBRUARY21, 2025
9	9	Mr. H
10	10	UDSON(for himself, Mr. DAVISof North Carolina, Mr. MURPHY, and
11	11	Mr. P
12	12	ETERS) introduced the following bill; which was referred to the
13	13	Committee on Energy and Commerce, and in addition to the Committee
14	14	on Ways and Means, for a period to be subsequently determined by the
15	15	Speaker, in each case for consideration of such provisions as fall within
16	16	the jurisdiction of the committee concerned
17	17	A BILL
18	18	To amend title XVIII of the Social Security Act to provide
19	19	a phase-in for plasma-derived products under the manu-
20	20	facturer discount program.
21	21	Be it enacted by the Senate and House of Representa-1
22	22	tives of the United States of America in Congress assembled, 2
23	23	SECTION 1. SHORT TITLE. 3
24	24	This Act may be cited as the ‘‘Preserving Life-saving 4
25	25	Access to Specialty Medicines in America Act’’ or the 5
26	26	‘‘PLASMA Act’’. 6
27	27	VerDate Sep 11 2014 21:34 Mar 12, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1476.IH H1476
28	28	ssavage on LAPJG3WLY3PROD with BILLS 2
29	29	•HR 1476 IH
30	30	SEC. 2. PHASE-IN FOR PLASMA-DERIVED PRODUCTS UNDER 1
31	31	MANUFACTURER DISCOUNT PROGRAM. 2
32	32	Section 1860D–14C(g)(4) of the Social Security Act 3
33	33	(42 U.S.C. 1395w–114c(g)(4)) is amended— 4
34	34	(1) in subparagraph (A), in the matter pre-5
35	35	ceding clause (i), by striking ‘‘and (C)’’ and insert-6
36	36	ing ‘‘, (C), and (D)’’; 7
37	37	(2) by redesignating subparagraphs (D) and 8
38	38	(E) as subparagraphs (E) and (F), respectively; and 9
39	39	(3) by inserting after subparagraph (C) the fol-10
40	40	lowing: 11
41	41	‘‘(D) P
42	42	HASE-IN FOR PLASMA -DERIVED 12
43	43	PRODUCTS.— 13
44	44	‘‘(i) I
45	45	N GENERAL.—For 2026 and 14
46	46	subsequent years, subject to clause (iv), in 15
47	47	the case of an applicable drug of a manu-16
48	48	facturer that is a plasma-derived product 17
49	49	(as defined in clause (ii)), and that is mar-18
50	50	keted as of August 16, 2022, and dis-19
51	51	pensed for an applicable beneficiary, the 20
52	52	term ‘discounted price’ means the specified 21
53	53	plasma-derived product percent (as defined 22
54	54	in clause (iii)) of the negotiated price of 23
55	55	the applicable drug of the manufacturer. 24
56	56	‘‘(ii) P
57	57	LASMA-DERIVED PRODUCT.—In 25
58	58	this subparagraph, the term ‘plasma-de-26
59	59	VerDate Sep 11 2014 21:34 Mar 12, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1476.IH H1476
60	60	ssavage on LAPJG3WLY3PROD with BILLS 3
61	61	•HR 1476 IH
62	62	rived product’ means an applicable drug 1
63	63	that is a biological product that is derived 2
64	64	from human whole blood or plasma. 3
65	65	‘‘(iii) S
66	66	PECIFIED PLASMA -DERIVED 4
67	67	PRODUCT PERCENT .—In this subpara-5
68	68	graph, the term ‘specified plasma-derived 6
69	69	product percent’ means, with respect to a 7
70	70	year— 8
71	71	‘‘(I) for an applicable drug that 9
72	72	is a plasma-derived product dispensed 10
73	73	for an applicable beneficiary who has 11
74	74	not incurred costs, as determined in 12
75	75	accordance with section 1860D– 13
76	76	2(b)(4)(C), for covered part D drugs 14
77	77	in the year that are equal to or exceed 15
78	78	the annual out-of-pocket threshold 16
79	79	specified in section 1860D– 17
80	80	2(b)(4)(B)(i) for the year— 18
81	81	‘‘(aa) for 2026, 99 percent; 19
82	82	‘‘(bb) for 2027, 98 percent; 20
83	83	‘‘(cc) for 2028, 95 percent; 21
84	84	‘‘(dd) for 2029, 92 percent; 22
85	85	and 23
86	86	‘‘(ee) for 2030 and each 24
87	87	subsequent year, 90 percent; and 25
88	88	VerDate Sep 11 2014 21:34 Mar 12, 2025 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1476.IH H1476
89	89	ssavage on LAPJG3WLY3PROD with BILLS 4
90	90	•HR 1476 IH
91	91	‘‘(II) for an applicable drug that 1
92	92	is a plasma-derived product dispensed 2
93	93	for an applicable beneficiary who has 3
94	94	incurred costs, as determined in ac-4
95	95	cordance with section 1860D– 5
96	96	2(b)(4)(C), for covered part D drugs 6
97	97	in the year that are equal to or exceed 7
98	98	the annual out-of-pocket threshold 8
99	99	specified in section 1860D– 9
100	100	2(b)(4)(B)(i) for the year— 10
101	101	‘‘(aa) for 2026, 99 percent; 11
102	102	‘‘(bb) for 2027, 98 percent; 12
103	103	‘‘(cc) for 2028, 95 percent; 13
104	104	‘‘(dd) for 2029, 92 percent; 14
105	105	‘‘(ee) for 2030, 90 percent; 15
106	106	‘‘(ff) for 2031, 85 percent; 16
107	107	and 17
108	108	‘‘(gg) for 2032 and each 18
109	109	subsequent year, 80 percent. 19
110	110	‘‘(iv) L
111	111	IMITATIONS.—This subpara-20
112	112	graph shall not apply with respect to the 21
113	113	following: 22
114	114	‘‘(I) C
115	115	ERTAIN DRUGS DISPENSED 23
116	116	TO LIS BENEFICIARIES.—An applica-24
117	117	VerDate Sep 11 2014 21:34 Mar 12, 2025 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1476.IH H1476
118	118	ssavage on LAPJG3WLY3PROD with BILLS 5
119	119	•HR 1476 IH
120	120	ble drug described in subparagraph 1
121	121	(B)(i). 2
122	122	‘‘(II) S
123	123	PECIFIED SMALL MANU -3
124	124	FACTURERS.—An applicable drug de-4
125	125	scribed in subparagraph (C)(i).’’. 5
126	126	Æ
127	127	VerDate Sep 11 2014 21:34 Mar 12, 2025 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H1476.IH H1476
128	128	ssavage on LAPJG3WLY3PROD with BILLS