119-s475

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 475 Introduced in Senate

    (IS) ]

<DOC>

119th CONGRESS
 1st Session
 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 Medicare 
 program.

_______________________________________________________________________

 IN THE SENATE OF THE UNITED STATES

 February 6 (legislative day, February 5), 2025

Mr. Tillis (for himself, Mr. Kelly, Mrs. Capito, Mr. Kaine, Mrs. Britt, 
 Mrs. Shaheen, Mr. Budd, Mr. Coons, Mr. Cornyn, Mr. Booker, Mr. Moran, 
 Mr. Bennet, Mr. Banks, Mr. Padilla, Mr. Daines, Mr. Warner, 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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

 This Act may be cited as the ``Alternatives to Prevent Addiction In 
the Nation Act'' or the ``Alternatives to PAIN Act''.

SEC. 2. APPROPRIATE COST-SHARING FOR QUALIFYING NON-OPIOID PAIN 
 MANAGEMENT DRUGS UNDER MEDICARE PART D.

    (a) Medicare Part D.--

Section 1860D-2 of the Social Security Act 
(42 U.S.C. 1395w-102) is amended--

    (1) in subsection

    (b) --
        (A) in paragraph

    (1)
        (A) , in the matter preceding 
 clause
            (i) , by striking ``paragraphs

    (8) and

    (9) '' and 
 inserting ``paragraphs

    (8) ,

    (9) , and

    (10) '';
        (B) in paragraph

    (2)
        (A) , in the matter preceding 
 clause
            (i) , by striking ``paragraphs

    (8) and

    (9) '' and 
 inserting ``paragraphs

    (8) ,

    (9) , and

    (10) ''; and
            (C) by adding at the end the following new 
 paragraph:
 ``

    (10) Treatment of cost-sharing for qualifying non-opioid 
 pain management drugs.--
 ``
        (A) In general.--For plan years beginning on or 
 after January 1, 2026, with respect to a covered part D 
 drug that is a qualifying non-opioid pain management 
 drug (as defined in subparagraph
        (B) )--
 ``
            (i) the deductible under paragraph

    (1) shall not apply; and
 ``
            (ii) such drug shall be placed on the 
 lowest cost-sharing tier, if any, for purposes 
 of determining the maximum co-insurance or 
 other cost-sharing for such drug.
 ``
        (B) Qualifying non-opioid pain management 
 drugs.--In this paragraph, the term `qualifying non-
 opioid pain management drug' means a drug or biological 
 product--
 ``
            (i) that has a label indication approved 
 by the Food and Drug Administration to reduce 
 postoperative pain or any other form of acute 
 pain;
 ``
            (ii) that does not act upon the body's 
 opioid receptors;
 ``
            (iii) for which there is no other drug or 
 product that is--
 ``
            (I) rated as therapeutically 
 equivalent (under the Food and Drug 
 Administration's most recent 
 publication of `Approved Drug Products 
 with Therapeutic Equivalence 
 Evaluations'); and
 ``
            (II) sold or marketed in the 
 United States; and
 ``
            (iv) for which the wholesale acquisition 
 cost (as defined in 

section 1847A
            (c) (6)
        (B) ), 
 for a monthly supply does not exceed the 
 monthly specialty-tier cost threshold as 
 determined by the Secretary from time to 
 time.''; and

    (2) in subsection
            (c) , by adding at the end the following 
 new paragraph:
 ``

    (7) Treatment of cost-sharing for qualifying non-opioid 
 pain management drugs.--The coverage is provided in accordance 
 with subsection

    (b)

    (10) .''.

    (b) Conforming Amendments to Cost-Sharing for Low-Income 
Individuals.--

Section 1860D-14

    (a) of the Social Security Act (42 U.S.C. 
1395w-114

    (a) ) is amended--

    (1) in paragraph

    (1)
            (D) , in each of the clauses
            (ii) and
            (iii) , by striking ``Subject to paragraph

    (6) '' and inserting 
 ``Subject to paragraphs

    (6) and

    (7) ''; and

    (2) by adding at the end the following new paragraph:
 ``

    (7) Treatment of cost-sharing or deductible for 
 qualifying non-opioid pain management drugs.--For plan years 
 beginning on or after January 1, 2026, with respect to a 
 covered part D drug that is a qualifying non-opioid pain 
 management drug (as defined in 

section 1860D-2

    (b)

    (10)
        (B) )--
 ``
        (A) the deductible under 

section 1860D-2

    (b)

    (1) shall not apply; and
 ``
        (B) such drug shall be placed on the lowest cost-
 sharing tier, if any, for purposes of determining the 
 maximum co-insurance or other cost-sharing for such 
 drug.''.

SEC. 3. PROHIBITION ON THE USE OF STEP THERAPY AND PRIOR AUTHORIZATION 
 FOR QUALIFYING NON-OPIOID PAIN MANAGEMENT DRUGS UNDER 
 MEDICARE PART D.

 

Section 1860D-4
            (c) of the Social Security Act (42 U.S.C. 1395w-104) 
is amended--

    (1) by redesignating paragraph

    (6) , as added by 

section 50354 of division E of the Bipartisan Budget Act of 2018 
 (Public Law 115-123), as paragraph

    (7) ; and

    (2) by adding at the end the following paragraph:
 ``

    (8) Prohibition on use of step therapy and prior 
 authorization for qualifying non-opioid pain management 
 drugs.--
 ``
        (A) In general.--For plan years beginning on or 
 after January 1, 2026, a prescription drug plan or an 
 MA-PD plan may not, with respect to a qualifying non-
 opioid pain management drug (as defined in 

section 1860D-2

    (b)

    (10)
        (B) ) for which coverage is provided under 
 such plan, impose any--
 ``
            (i) step therapy requirement under which 
 an individual enrolled under such plan is 
 required to use an opioid prior to receiving 
 such drug; or
 ``
            (ii) prior authorization requirement.
 ``
        (B) Step therapy.--In this paragraph, the term 
 `step therapy' means a drug therapy utilization 
 management protocol or program that requires use of an 
 alternative, preferred prescription drug or drugs 
 before the plan approves coverage for the non-preferred 
 drug therapy prescribed.
 ``
            (C) Prior authorization.--In this paragraph, the 
 term `prior authorization' means any requirement to 
 obtain approval from a plan prior to the furnishing of 
 a drug.''.
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