Medicare can currently deny or limit coverage of certain FDA-approved drugs through a decision called a national coverage determination, and patients have had no formal way to challenge that decision. This bill creates a review process: patients, doctors, or drug makers could request a review, the government would take public comments for 30 days, and a final decision would be due within about five months of that comment period ending. It also stops Medicare and Medicare drug plans from applying an older coverage decision to block or limit coverage of a newly approved drug when doing so conflicts with the drug's FDA approval. Seniors and other Medicare beneficiaries seeking access to newer treatments, along with the doctors who prescribe them, are the main people affected by the change.
Average Household Impact
- Medicare coverage appeals process — Lets patients challenge denials of FDA-approved drug coverage
Corporate Benefits
- Medicare reimbursement for new drugs — Older coverage decisions can't block newly FDA-approved drugs
Congressional Summary
Access to Innovative Treatments Act of 2026This bill requires the Centers for Medicare & Medicaid Services (CMS) to review adverse national coverage determinations of drugs under Medicare within 30 days of receiving a request to do so.Specifically, the CMS must review within 30 days any denials or limitations of coverage that are inconsistent with the drug's approval by the Food and Drug Administration (FDA). The bill's requirements do not apply if the CMS already conducted such a review within a two-year period.The bill also prohibits the CMS from applying prior coverage determinations that were made for drugs before they were approved by the FDA if such determinations are inconsistent with the drug's approval.
Details
- Congress
- 119th
- Chamber
- House
- Status
- summarized
- Action
- Introduced in House
- Action Date
- 2026-06-24
- Date Added
- 2026-07-15
- Source
- Congress.gov →
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