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Lower Costs for Non-Opioid Pain Drugs

Full Title:
Alternatives to PAIN Act

Summary#

This bill changes how Medicare Part D treats certain non-opioid pain drugs. It removes the Part D deductible and requires the lowest cost-sharing tier for drugs that meet a new definition of “qualifying non-opioid pain management drugs.” It also bans step therapy that forces patients to try an opioid first, and bans prior authorization, for those drugs. The broad goal is to make some non-opioid pain treatments easier and cheaper to get for people on Medicare.

  • Main change: For qualifying non-opioid drugs, Part D plans (including Medicare Advantage drug plans) must not apply the Part D deductible and must place the drug on the lowest cost-sharing tier starting in plan years on or after January 1, 2026.
  • Prior authorization & step therapy: Plans may not require prior authorization or require patients to try an opioid before covering a qualifying drug.
  • Who qualifies: A qualifying drug must (1) have an FDA label for reducing postoperative or other acute pain, (2) not act on opioid receptors, (3) have no therapeutically equivalent (generic) product sold in the U.S., and (4) have a monthly wholesale acquisition cost at or below the Secretary’s monthly specialty-tier cost threshold.
  • Low-income subsidy rules: The same deductible and tier changes are applied to rules that govern low-income Part D enrollees.
  • Start date: These rules apply to plan years beginning on or after January 1, 2026.

What it means for you#

  • Medicare Part D enrollees: If your drug meets the bill’s definition, you would not owe the Part D deductible for that drug and it should be on the plan’s lowest cost-sharing tier. You also would not face prior authorization or be forced to try an opioid first.
  • Low-income enrollees: The bill applies the same deductible and tier protections to people eligible for low-income subsidy rules.
  • People prescribed acute, non-opioid pain drugs: Patients needing FDA‑approved non-opioid drugs for acute pain (including postoperative pain) could face lower out-of-pocket costs and fewer administrative barriers.
  • Prescribers and pharmacies: Doctors may be able to prescribe qualifying non-opioid drugs without going through prior authorization or step therapy that requires trying an opioid first. Pharmacies would process these prescriptions under the plan’s lowest tier.
  • Part D plan sponsors and MA-PD plans: Plans must change formularies and utilization rules to meet the new requirements for qualifying drugs. They lose the ability to require prior authorization or opioid-first step therapy for those drugs.
  • Drug manufacturers: Single-source non-opioid drugs without therapeutically equivalent products and priced below the specialty-tier threshold could become more attractive because patients pay less and have easier access.

Expenses#

No publicly available information on a fiscal estimate or official cost estimate is provided with the bill text.

  • This could mean higher drug spending under Part D or changes in how costs are shared between plans, beneficiaries, and federal reinsurance, but the bill gives no estimate.
  • Plans may incur administrative costs to change formularies and remove prior authorization or step therapy for qualifying drugs.
  • The bill’s removal of utilization controls for qualifying drugs could shift more costs to plans or to the Medicare program, but the size of any shift is not specified.
  • The use of the Secretary’s “monthly specialty-tier cost threshold” leaves uncertainty about which drugs will qualify and how cost limits will affect spending.

Proponents' View#

The bill appears intended to increase access to certain non-opioid pain treatments and reduce barriers that can delay or block patient access.

  • The bill appears designed to make some non-opioid pain drugs cheaper for Medicare patients by removing the deductible and placing the drug on the lowest cost-sharing tier.
  • It appears intended to prevent plans from requiring patients to try opioids first, thus making non-opioid options easier to obtain.
  • Removing prior authorization could speed patient access and reduce administrative delays.
  • The drug definition limits eligibility to FDA‑approved acute pain drugs that are single-source and not acting on opioid receptors, and it caps eligibility by price (the specialty-tier threshold), which narrows scope to drugs that are not very expensive.

Opponents' View#

The bill’s design raises questions about cost, scope, and implementation that are not resolved in the text.

  • One concern is that removing deductibles and utilization controls could increase Part D drug spending, but the bill provides no cost estimate.
  • The rule that a drug must have no therapeutically equivalent product sold in the U.S. means only single-source drugs qualify; it is unclear how many drugs will meet this test.
  • The Secretary sets the “monthly specialty-tier cost threshold,” but the bill does not specify that threshold or how often it may change, creating uncertainty about which drugs qualify.
  • Removing prior authorization and step therapy for qualifying drugs could reduce plan tools used to guard against inappropriate use or to manage safety, depending on how plans monitor prescribing in other ways.
  • The bill applies only to drugs FDA‑labeled for acute pain (including postoperative pain). It does not address non-opioid treatments for chronic pain, which limits its reach.
  • It is unclear how “monthly supply” and wholesale acquisition cost will be calculated in practice for different dosing schedules or package sizes.

What is unclear: The bill does not say how many drugs will qualify, what the Secretary’s cost threshold will be, or provide a fiscal estimate of federal or plan-level costs.