S 475 — Alternatives to PAIN Act

Summary

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

Bill Text

• Introduced Introduced in Senate Current html February 06, 2025

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill introduces provisions for appropriate cost-sharing and prohibits step therapy and prior authorization for qualifying non-opioid pain management drugs under Medicare Part D.

• 42 U.S.C. 1395w-102

  paragraphs (8) and (9) → paragraphs (8), (9), and (10)

  This change adds a new category for qualifying non-opioid pain management drugs to the existing structures of Medicare Part D.

• 42 U.S.C. 1395w-102

  paragraphs (8) and (9) → paragraphs (8), (9), and (10)

  This change updates the reference to include the new paragraph for cost-sharing treatment for non-opioid pain management drugs.

• 42 U.S.C. 1395w-102

  (10) Treatment of cost-sharing 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 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.

  This addition establishes specific cost-sharing rules for qualifying non-opioid pain management drugs under Medicare Part D.

• 42 U.S.C. 1395w-102

  (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.

  This defines what qualifies as a non-opioid pain management drug for the purposes of the bill.

• 42 U.S.C. 1395w-114(a)

  Subject to paragraph (6) → Subject to paragraphs (6) and (7)

  This change aligns cost-sharing references by including a new paragraph about non-opioid pain management drugs.

• 42 U.S.C. 1395w-114(a)

  (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.

  This establishes specific rules for cost-sharing for low-income individuals regarding non-opioid pain management drugs.

• 42 U.S.C. 1395w-104

  (8) Prohibition on use of step therapy and prior authorization for qualifying non-opioid pain management drugs.-- 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.

  This prohibits plans from requiring prior opioid use or prior authorization for non-opioid pain management drugs.

Action History

1. February 06, 2025

   Introduced in Senate

2. February 06, 2025

   Read twice and referred to the Committee on Finance.

Sponsors

• Thomas Tillis · Primary
• Mark Kelly · Cosponsor
• Shelley Moore Capito · Cosponsor
• Tim Kaine · Cosponsor
• Katie Boyd Britt · Cosponsor
• Jeanne Shaheen · Cosponsor
• Ted Budd · Cosponsor
• Christopher A. Coons · Cosponsor
• John Cornyn · Cosponsor
• Cory A. Booker · Cosponsor
• Jerry Moran · Cosponsor
• Michael F. Bennet · Cosponsor
• Jim Banks · Cosponsor
• Alex Padilla · Cosponsor
• Steve Daines · Cosponsor
• Mark R. Warner · Cosponsor
• Cindy Hyde-Smith · Cosponsor
• John Boozman · Cosponsor
• Raphael G. Warnock · Cosponsor
• James C. Justice · Cosponsor
• Amy Klobuchar · Cosponsor
• John Kennedy · Cosponsor
• Catherine Cortez Masto · Cosponsor
• Marsha Blackburn · Cosponsor
• Ruben Gallego · Cosponsor
• King, Angus S., Jr. · Cosponsor
• Jon Ossoff · Cosponsor
• Jeff Merkley · Cosponsor
• Tim Sheehy · Cosponsor
• Deb Fischer · Cosponsor
• Adam B. Schiff · Cosponsor
• Richard Blumenthal · Cosponsor
• Jon Husted · Cosponsor
• Tammy Duckworth · Cosponsor
• Roger Marshall · Cosponsor
• David McCormick · Cosponsor
• Mazie K. Hirono · Cosponsor

Subjects