H.R. 1227 — Alternatives to PAIN Act

This section provides the short title of the Act as the “Alternatives to Prevent Addiction In the Nation Act” or the “Alternatives to PAIN Act.”

This section revises Medicare Part D cost-sharing rules for qualifying non-opioid pain management drugs beginning on or after January 1, 2026. It adds a new category of “qualifying non-opioid pain management drug” to the Part D benefit and requires plans to waive the deductible and place such drugs on the lowest cost-sharing tier, if any, for purposes of determining coinsurance or other cost-sharing. As background, Medicare Part D is the outpatient prescription drug benefit for Medicare beneficiaries. To qualify, a drug or biological product must have an FDA-approved label indication to reduce postoperative pain or another form of acute pain, must not act on opioid receptors, must have no therapeutically equivalent product sold or marketed in the United States, and must have a monthly wholesale acquisition cost that does not exceed the monthly specialty-tier cost threshold set by the Secretary. The section also makes conforming changes to the low-income subsidy rules under Medicare Part D so that these same deductible and cost-sharing protections apply to low-income enrollees.

This section revises Medicare Part D coverage rules by redesignating an existing paragraph in the prescription drug plan requirements from paragraph (6) to paragraph (7) and adding a new paragraph (8) that, for plan years beginning on or after January 1, 2026, prohibits prescription drug plans and Medicare Advantage prescription drug plans (MA-PD plans) from imposing step therapy or prior authorization for qualifying non-opioid pain management drugs covered under the plan. As background, Medicare Part D provides outpatient prescription drug coverage to Medicare beneficiaries through private plans. The new paragraph defines “step therapy” as a utilization management protocol that requires use of one or more alternative, preferred drugs before coverage of the prescribed non-preferred drug, and defines “prior authorization” as any requirement to obtain plan approval before the drug is furnished. (Thus, plans may not require a beneficiary to try an opioid before receiving a covered qualifying non-opioid pain management drug, and may not require advance plan approval for such drugs.)