Official Summaries

Alternatives to Prevent Addiction In the Nation Act or the Alternatives to PAIN Act

This bill reduces cost-sharing and prohibits the imposition of certain utilization requirements under the Medicare prescription drug benefit for certain non-opioid pain management drugs.

Specifically, the bill requires such drugs to be covered without a deductible and to be placed on the lowest cost-sharing tier (if any). The bill also prohibits the imposition of prior authorization requirements (i.e., requiring prior approval from a plan) or step therapy requirements (i.e., requiring the use of alternative drugs before a drug is covered under a plan) with respect to such drugs.

Current Full Text

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

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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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