II
119THCONGRESS
1
STSESSION S. 475
To amend title XVIII of the Social Security Act to ensure appropriate
access to non-opioid pain management drugs under part D of the Medi-
care program.
IN THE SENATE OF THE UNITED STATES
FEBRUARY6 (legislative day, FEBRUARY5), 2025
Mr. T
ILLIS(for himself, Mr. KELLY, Mrs. CAPITO, Mr. KAINE, Mrs. BRITT,
Mrs. S
HAHEEN, Mr. BUDD, Mr. COONS, Mr. CORNYN, Mr. BOOKER, Mr.
M
ORAN, Mr. BENNET, Mr. BANKS, Mr. PADILLA, Mr. DAINES, Mr. WAR-
NER, and Mrs. HYDE-SMITH) introduced the following bill; which was
read twice and referred to the Committee on Finance
A BILL
To amend title XVIII of the Social Security Act to ensure
appropriate access to non-opioid pain management drugs
under part D of the Medicare program.
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 ‘‘Alternatives to Prevent 4
Addiction In the Nation Act’’ or the ‘‘Alternatives to 5
PAIN Act’’. 6
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SEC. 2. APPROPRIATE COST-SHARING FOR QUALIFYING 1
NON-OPIOID PAIN MANAGEMENT DRUGS 2
UNDER MEDICARE PART D. 3
(a) M
EDICAREPARTD.—Section 1860D–2 of the 4
Social Security Act (42 U.S.C. 1395w–102) is amended— 5
(1) in subsection (b)— 6
(A) in paragraph (1)(A), in the matter 7
preceding clause (i), by striking ‘‘paragraphs 8
(8) and (9)’’ and inserting ‘‘paragraphs (8), 9
(9), and (10)’’; 10
(B) in paragraph (2)(A), in the matter 11
preceding clause (i), by striking ‘‘paragraphs 12
(8) and (9)’’ and inserting ‘‘paragraphs (8), 13
(9), and (10)’’; and 14
(C) by adding at the end the following new 15
paragraph: 16
‘‘(10) T
REATMENT OF COST -SHARING FOR 17
QUALIFYING NON -OPIOID PAIN MANAGEMENT 18
DRUGS.— 19
‘‘(A) I
N GENERAL.—For plan years begin-20
ning on or after January 1, 2026, with respect 21
to a covered part D drug that is a qualifying 22
non-opioid pain management drug (as defined 23
in subparagraph (B))— 24
‘‘(i) the deductible under paragraph 25
(1) shall not apply; and 26
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•S 475 IS
‘‘(ii) such drug shall be placed on the 1
lowest cost-sharing tier, if any, for pur-2
poses of determining the maximum co-in-3
surance or other cost-sharing for such 4
drug. 5
‘‘(B) Q
UALIFYING NON-OPIOID PAIN MAN-6
AGEMENT DRUGS.—In this paragraph, the term 7
‘qualifying non-opioid pain management drug’ 8
means a drug or biological product— 9
‘‘(i) that has a label indication ap-10
proved by the Food and Drug Administra-11
tion to reduce postoperative pain or any 12
other form of acute pain; 13
‘‘(ii) that does not act upon the body’s 14
opioid receptors; 15
‘‘(iii) for which there is no other drug 16
or product that is— 17
‘‘(I) rated as therapeutically 18
equivalent (under the Food and Drug 19
Administration’s most recent publica-20
tion of ‘Approved Drug Products with 21
Therapeutic Equivalence Evalua-22
tions’); and 23
‘‘(II) sold or marketed in the 24
United States; and 25
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‘‘(iv) for which the wholesale acquisi-1
tion cost (as defined in section 2
1847A(c)(6)(B)), for a monthly supply 3
does not exceed the monthly specialty-tier 4
cost threshold as determined by the Sec-5
retary from time to time.’’; and 6
(2) in subsection (c), by adding at the end the 7
following new paragraph: 8
‘‘(7) T
REATMENT OF COST -SHARING FOR 9
QUALIFYING NON -OPIOID PAIN MANAGEMENT 10
DRUGS.—The coverage is provided in accordance 11
with subsection (b)(10).’’. 12
(b) C
ONFORMINGAMENDMENTS TO COST-SHARING 13
FORLOW-INCOMEINDIVIDUALS.—Section 1860D–14(a) 14
of the Social Security Act (42 U.S.C. 1395w–114(a)) is 15
amended— 16
(1) in paragraph (1)(D), in each of the clauses 17
(ii) and (iii), by striking ‘‘Subject to paragraph (6)’’ 18
and inserting ‘‘Subject to paragraphs (6) and (7)’’; 19
and 20
(2) by adding at the end the following new 21
paragraph: 22
‘‘(7) T
REATMENT OF COST -SHARING OR DE -23
DUCTIBLE FOR QUALIFYING NON -OPIOID PAIN MAN-24
AGEMENT DRUGS .—For plan years beginning on or 25
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after January 1, 2026, with respect to a covered 1
part D drug that is a qualifying non-opioid pain 2
management drug (as defined in section 1860D– 3
2(b)(10)(B))— 4
‘‘(A) the deductible under section 1860D– 5
2(b)(1) shall not apply; and 6
‘‘(B) such drug shall be placed on the low-7
est cost-sharing tier, if any, for purposes of de-8
termining the maximum co-insurance or other 9
cost-sharing for such drug.’’. 10
SEC. 3. PROHIBITION ON THE USE OF STEP THERAPY AND 11
PRIOR AUTHORIZATION FOR QUALIFYING 12
NON-OPIOID PAIN MANAGEMENT DRUGS 13
UNDER MEDICARE PART D. 14
Section 1860D–4(c) of the Social Security Act (42 15
U.S.C. 1395w–104) is amended— 16
(1) by redesignating paragraph (6), as added by 17
section 50354 of division E of the Bipartisan Budg-18
et Act of 2018 (Public Law 115–123), as paragraph 19
(7); and 20
(2) by adding at the end the following para-21
graph: 22
‘‘(8) P
ROHIBITION ON USE OF STEP THERAPY 23
AND PRIOR AUTHORIZATION FOR QUALIFYING NON - 24
OPIOID PAIN MANAGEMENT DRUGS .— 25
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‘‘(A) IN GENERAL.—For plan years begin-1
ning on or after January 1, 2026, a prescrip-2
tion drug plan or an MA–PD plan may not, 3
with respect to a qualifying non-opioid pain 4
management drug (as defined in section 5
1860D–2(b)(10)(B)) for which coverage is pro-6
vided under such plan, impose any— 7
‘‘(i) step therapy requirement under 8
which an individual enrolled under such 9
plan is required to use an opioid prior to 10
receiving such drug; or 11
‘‘(ii) prior authorization requirement. 12
‘‘(B) S
TEP THERAPY.—In this paragraph, 13
the term ‘step therapy’ means a drug therapy 14
utilization management protocol or program 15
that requires use of an alternative, preferred 16
prescription drug or drugs before the plan ap-17
proves coverage for the non-preferred drug 18
therapy prescribed. 19
‘‘(C) P
RIOR AUTHORIZATION .—In this 20
paragraph, the term ‘prior authorization’ means 21
any requirement to obtain approval from a plan 22
prior to the furnishing of a drug.’’. 23
Æ
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