[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7142 Introduced in House (IH)]

<DOC>






118th CONGRESS
  2d Session
                                H. R. 7142

 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 HOUSE OF REPRESENTATIVES

                            January 30, 2024

    Mrs. Miller-Meeks (for herself and Mr. Cardenas) introduced the 
   following bill; which was referred to the Committee on Energy and 
  Commerce, and in addition to the Committee on Ways and Means, for a 
 period to be subsequently determined by the Speaker, in each case for 
consideration of such provisions as fall within the jurisdiction of the 
                          committee concerned

_______________________________________________________________________

                                 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; FINDINGS.

    (a) Short Title.--This Act may be cited as the ``Alternatives to 
Prevent Addiction In the Nation Act'' or the ``Alternatives to PAIN 
Act''.
    (b) Findings.--Congress finds the following:
            (1) In 2019, approximately 10 million people misused 
        prescription opioids.
            (2) 3 million U.S. citizens and 16 million individuals 
        worldwide have had or currently suffer from opioid use disorder 
        (OUD).
            (3) In 2021, the number of overdose deaths involving 
        opioids was 10 times the number in 1999, and overdoses 
        involving opioids killed more than 80,000 people in 2021 alone.
            (4) Most Medicare beneficiaries are prescribed opioids to 
        manage post-surgical pain.
            (5) Data from 2017 indicates that, of those prescribed an 
        abundance of opioids, 90% did not properly dispose of the 
        extra.
            (6) A combination of opioid overreliance, improper storage, 
        and easy access to opioids can worsen the addiction crisis.
            (7) 1 study from 2019 found that among young people 
        misusing opioids, over 55% obtained them from friends or 
        relatives.
            (8) Some individuals require opioids to manage their 
        condition including for chronic pain and palliative care.
            (9) Nothing should interfere with the ability of a health 
        care provider to prescribe or administer a course of treatment 
        that is medically appropriate.

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), by striking ``paragraphs 
                (8) and (9)'' and inserting ``paragraphs (8), (9), and 
                (10)'';
                    (B) in paragraph (2)--
                            (i) in subparagraph (A), by striking 
                        ``paragraphs (8) and (9)'' and inserting 
                        ``paragraphs (8), (9), and (10)'';
                            (ii) in subparagraph (C)(i), in the matter 
                        preceding subclause (I), by striking ``and 
                        (9)'' and inserting ``, (9), and (10)''; and
                            (iii) in subparagraph (D)(i), in the matter 
                        preceding subclause (I), by striking ``and 
                        (9)'' and inserting ``, (9), and (10)'';
                    (C) in paragraph (3)(A), in the matter preceding 
                clause (i), by striking ``and (9)'' and inserting 
                ``(9), and (10)'';
                    (D) in paragraph (4)(A)(i), by striking 
                ``paragraphs (8) and (9),'' and inserting ``paragraphs 
                (8), (9), and (10),''; and
                    (E) 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, 2025, 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) that is not a schedule I, II, or 
                        III controlled substance;
                            ``(iv) 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) which is sold or marketed in 
                                the United States; and
                            ``(v) 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)'';
            (2) in paragraph (2)--
                    (A) in subparagraph (B), by striking ``Subject to 
                paragraphs (8) and (9)'' and inserting ``Subject to 
                paragraphs (8), (9), and (10)'';
                    (B) in subparagraph (D), by striking ``Subject to 
                paragraph (6)'' and inserting ``Subject to paragraphs 
                (6) and (7)''; and
                    (C) in subparagraph (E), by striking ``Subject to 
                paragraph (6)'' and inserting ``Subject to paragraphs 
                (6) and (7)''; and
            (3) by adding at the end the following new paragraph:
            ``(7) No application of cost-sharing or deductible for 
        qualifying non-opioid pain management drugs.--For plan years 
        beginning on or after January 1, 2025, 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 of the Social Security Act (42 U.S.C. 1395w-104) is 
amended in subsection (c) by adding at the end the following paragraph:
            ``(7) Prohibition on use of step therapy and prior 
        authorization for qualifying non-opioid pain management 
        drugs.--
                    ``(A) In general.--A prescription drug plan may 
                not, with respect to a qualifying non-opioid pain 
                management drug 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 prescription drug plan prior to 
                the furnishing of a drug.
                    ``(D) Qualifying non-opioid pain management 
                drugs.--In this paragraph, the term `qualifying non-
                opioid pain management drug' has the meaning given that 
                term in section 1860D-2(b)(10)(B).''.

SEC. 4. RULE OF CONSTRUCTION.

    Nothing in the amendments made by this Act may be construed to 
limit or interfere with the authority of a health care provider to 
prescribe or administer any legally marketed drug to a patient for any 
condition or disease within a legitimate health care practitioner-
patient relationship.
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