Medicare drug denials get a fast-track appeal—but at what cost?
H.R. 9418 — Access to Innovative Treatments Act of 2026 · Filed by Nanette Barragán (D-CA) · 1 cosponsor · Introduced Jun 24, 2026 · Referred to committee
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What it does
This bill creates a formal review process allowing drugmakers and others to challenge Medicare's decisions to deny or limit coverage of FDA-approved drugs. When a drug is approved by the FDA but Medicare refuses to cover it nationally, the bill requires Medicare to review the decision within 90 days, hold a 30-day public comment period, and issue a final decision within 120 days—with Medicare required to explain its reasoning and release clinical evidence if it reverses course. The bill also prevents Medicare from applying old coverage denials to newly approved drugs and blocks Medicare Part D plans from using outdated national coverage denials when deciding whether to cover a drug.
Why we flagged it
The bill's core function is to establish a formal, time-bound review and appeal process for Medicare national coverage determinations (NCDs) that deny or limit coverage of FDA-approved drugs. It is not a direct subsidy or carve-out, but a procedural mechanism that shifts decision-making pressure toward coverage approval.
What the text implies
- The 90-120 day review timeline may be too compressed for rigorous clinical evidence review, potentially forcing Medicare to approve drugs on limited data to meet the deadline.
- By prohibiting Medicare from applying prior NCDs to newly approved drugs, the bill may create a loophole where a drug approved for a narrow indication can be used off-label without Medicare coverage review.
The full analysis lists 5 implications of this text.
Who stands to gain
pharmaceutical manufacturers; biopharmaceutical companies; medical device manufacturers