Us Congress 2025-2026 Regular Session

Us Congress Senate Bill SB475 Compare Versions

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

Old	New	Differences
1	1	II
2	2	119THCONGRESS
3	3	1
4	4	STSESSION S. 475
5	5	To amend title XVIII of the Social Security Act to ensure appropriate
6	6	access to non-opioid pain management drugs under part D of the Medi-
7	7	care program.
8	8	IN THE SENATE OF THE UNITED STATES
9	9	FEBRUARY6 (legislative day, FEBRUARY5), 2025
10	10	Mr. T
11	11	ILLIS(for himself, Mr. KELLY, Mrs. CAPITO, Mr. KAINE, Mrs. BRITT,
12	12	Mrs. S
13	13	HAHEEN, Mr. BUDD, Mr. COONS, Mr. CORNYN, Mr. BOOKER, Mr.
14	14	M
15	15	ORAN, Mr. BENNET, Mr. BANKS, Mr. PADILLA, Mr. DAINES, Mr. WAR-
16	16	NER, and Mrs. HYDE-SMITH) introduced the following bill; which was
17	17	read twice and referred to the Committee on Finance
18	18	A BILL
19	19	To amend title XVIII of the Social Security Act to ensure
20	20	appropriate access to non-opioid pain management drugs
21	21	under part D of the Medicare program.
22	22	Be it enacted by the Senate and House of Representa-1
23	23	tives of the United States of America in Congress assembled, 2
24	24	SECTION 1. SHORT TITLE. 3
25	25	This Act may be cited as the ‘‘Alternatives to Prevent 4
26	26	Addiction In the Nation Act’’ or the ‘‘Alternatives to 5
27	27	PAIN Act’’. 6
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30	30	•S 475 IS
31	31	SEC. 2. APPROPRIATE COST-SHARING FOR QUALIFYING 1
32	32	NON-OPIOID PAIN MANAGEMENT DRUGS 2
33	33	UNDER MEDICARE PART D. 3
34	34	(a) M
35	35	EDICAREPARTD.—Section 1860D–2 of the 4
36	36	Social Security Act (42 U.S.C. 1395w–102) is amended— 5
37	37	(1) in subsection (b)— 6
38	38	(A) in paragraph (1)(A), in the matter 7
39	39	preceding clause (i), by striking ‘‘paragraphs 8
40	40	(8) and (9)’’ and inserting ‘‘paragraphs (8), 9
41	41	(9), and (10)’’; 10
42	42	(B) in paragraph (2)(A), in the matter 11
43	43	preceding clause (i), by striking ‘‘paragraphs 12
44	44	(8) and (9)’’ and inserting ‘‘paragraphs (8), 13
45	45	(9), and (10)’’; and 14
46	46	(C) by adding at the end the following new 15
47	47	paragraph: 16
48	48	‘‘(10) T
49	49	REATMENT OF COST -SHARING FOR 17
50	50	QUALIFYING NON -OPIOID PAIN MANAGEMENT 18
51	51	DRUGS.— 19
52	52	‘‘(A) I
53	53	N GENERAL.—For plan years begin-20
54	54	ning on or after January 1, 2026, with respect 21
55	55	to a covered part D drug that is a qualifying 22
56	56	non-opioid pain management drug (as defined 23
57	57	in subparagraph (B))— 24
58	58	‘‘(i) the deductible under paragraph 25
59	59	(1) shall not apply; and 26
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62	62	•S 475 IS
63	63	‘‘(ii) such drug shall be placed on the 1
64	64	lowest cost-sharing tier, if any, for pur-2
65	65	poses of determining the maximum co-in-3
66	66	surance or other cost-sharing for such 4
67	67	drug. 5
68	68	‘‘(B) Q
69	69	UALIFYING NON-OPIOID PAIN MAN-6
70	70	AGEMENT DRUGS.—In this paragraph, the term 7
71	71	‘qualifying non-opioid pain management drug’ 8
72	72	means a drug or biological product— 9
73	73	‘‘(i) that has a label indication ap-10
74	74	proved by the Food and Drug Administra-11
75	75	tion to reduce postoperative pain or any 12
76	76	other form of acute pain; 13
77	77	‘‘(ii) that does not act upon the body’s 14
78	78	opioid receptors; 15
79	79	‘‘(iii) for which there is no other drug 16
80	80	or product that is— 17
81	81	‘‘(I) rated as therapeutically 18
82	82	equivalent (under the Food and Drug 19
83	83	Administration’s most recent publica-20
84	84	tion of ‘Approved Drug Products with 21
85	85	Therapeutic Equivalence Evalua-22
86	86	tions’); and 23
87	87	‘‘(II) sold or marketed in the 24
88	88	United States; and 25
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91	91	•S 475 IS
92	92	‘‘(iv) for which the wholesale acquisi-1
93	93	tion cost (as defined in section 2
94	94	1847A(c)(6)(B)), for a monthly supply 3
95	95	does not exceed the monthly specialty-tier 4
96	96	cost threshold as determined by the Sec-5
97	97	retary from time to time.’’; and 6
98	98	(2) in subsection (c), by adding at the end the 7
99	99	following new paragraph: 8
100	100	‘‘(7) T
101	101	REATMENT OF COST -SHARING FOR 9
102	102	QUALIFYING NON -OPIOID PAIN MANAGEMENT 10
103	103	DRUGS.—The coverage is provided in accordance 11
104	104	with subsection (b)(10).’’. 12
105	105	(b) C
106	106	ONFORMINGAMENDMENTS TO COST-SHARING 13
107	107	FORLOW-INCOMEINDIVIDUALS.—Section 1860D–14(a) 14
108	108	of the Social Security Act (42 U.S.C. 1395w–114(a)) is 15
109	109	amended— 16
110	110	(1) in paragraph (1)(D), in each of the clauses 17
111	111	(ii) and (iii), by striking ‘‘Subject to paragraph (6)’’ 18
112	112	and inserting ‘‘Subject to paragraphs (6) and (7)’’; 19
113	113	and 20
114	114	(2) by adding at the end the following new 21
115	115	paragraph: 22
116	116	‘‘(7) T
117	117	REATMENT OF COST -SHARING OR DE -23
118	118	DUCTIBLE FOR QUALIFYING NON -OPIOID PAIN MAN-24
119	119	AGEMENT DRUGS .—For plan years beginning on or 25
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122	122	•S 475 IS
123	123	after January 1, 2026, with respect to a covered 1
124	124	part D drug that is a qualifying non-opioid pain 2
125	125	management drug (as defined in section 1860D– 3
126	126	2(b)(10)(B))— 4
127	127	‘‘(A) the deductible under section 1860D– 5
128	128	2(b)(1) shall not apply; and 6
129	129	‘‘(B) such drug shall be placed on the low-7
130	130	est cost-sharing tier, if any, for purposes of de-8
131	131	termining the maximum co-insurance or other 9
132	132	cost-sharing for such drug.’’. 10
133	133	SEC. 3. PROHIBITION ON THE USE OF STEP THERAPY AND 11
134	134	PRIOR AUTHORIZATION FOR QUALIFYING 12
135	135	NON-OPIOID PAIN MANAGEMENT DRUGS 13
136	136	UNDER MEDICARE PART D. 14
137	137	Section 1860D–4(c) of the Social Security Act (42 15
138	138	U.S.C. 1395w–104) is amended— 16
139	139	(1) by redesignating paragraph (6), as added by 17
140	140	section 50354 of division E of the Bipartisan Budg-18
141	141	et Act of 2018 (Public Law 115–123), as paragraph 19
142	142	(7); and 20
143	143	(2) by adding at the end the following para-21
144	144	graph: 22
145	145	‘‘(8) P
146	146	ROHIBITION ON USE OF STEP THERAPY 23
147	147	AND PRIOR AUTHORIZATION FOR QUALIFYING NON - 24
148	148	OPIOID PAIN MANAGEMENT DRUGS .— 25
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151	151	•S 475 IS
152	152	‘‘(A) IN GENERAL.—For plan years begin-1
153	153	ning on or after January 1, 2026, a prescrip-2
154	154	tion drug plan or an MA–PD plan may not, 3
155	155	with respect to a qualifying non-opioid pain 4
156	156	management drug (as defined in section 5
157	157	1860D–2(b)(10)(B)) for which coverage is pro-6
158	158	vided under such plan, impose any— 7
159	159	‘‘(i) step therapy requirement under 8
160	160	which an individual enrolled under such 9
161	161	plan is required to use an opioid prior to 10
162	162	receiving such drug; or 11
163	163	‘‘(ii) prior authorization requirement. 12
164	164	‘‘(B) S
165	165	TEP THERAPY.—In this paragraph, 13
166	166	the term ‘step therapy’ means a drug therapy 14
167	167	utilization management protocol or program 15
168	168	that requires use of an alternative, preferred 16
169	169	prescription drug or drugs before the plan ap-17
170	170	proves coverage for the non-preferred drug 18
171	171	therapy prescribed. 19
172	172	‘‘(C) P
173	173	RIOR AUTHORIZATION .—In this 20
174	174	paragraph, the term ‘prior authorization’ means 21
175	175	any requirement to obtain approval from a plan 22
176	176	prior to the furnishing of a drug.’’. 23
177	177	Æ
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