H.R. 9418: Access to Innovative Treatments Act of 2026

This bill would change how Medicare handles certain coverage decisions for drugs and biological products.

What it would do

• It would create a formal process for reviewing certain national coverage determinations (NCDs) that deny or limit Medicare coverage for a drug or biological product, especially when that coverage decision conflicts with the product’s FDA approval or biological license.
• When someone requests a review of one of these coverage decisions, the Secretary of Health and Human Services would have to begin the review within 90 days.
• Once the review starts, there would be a 30-day public comment period for people and organizations to weigh in on whether the decision should stay the same, be reversed, or be changed.
• Within 120 days after the comment period ends, the Secretary would have to issue a final decision.
• That final decision would need to include:
  • summaries of the public comments and responses to them,
  • the clinical evidence and other data used in the decision if the final decision differs from the Medicare Coverage Advisory Committee’s recommendation, and
  • if the decision reverses or changes the coverage denial, a temporary or permanent billing code would have to be assigned and implemented.
• There would be a limit on repeat requests: if the Secretary has already made a final decision on the same coverage determination within the past 2 years, a new request would not automatically trigger another required review. The Secretary could still choose to review it again on their own.
• The bill would also prevent Medicare from using an older NCD, issued before a drug or biological was approved or licensed, to deny or limit coverage in a way that conflicts with that later approval or license.
• For Medicare Part D prescription drug plans and Medicare Advantage Part D plans, the bill would stop them from relying on one of these covered NCDs when deciding that payment cannot be made for a drug.

Plain-English effect

In practical terms, the bill would make it easier to challenge certain Medicare coverage denials for newer drugs and biological products, require faster review and more transparency, and limit the use of older Medicare coverage rules that do not match later FDA approval or licensing decisions.

Relevant Companies

• LLY — Eli Lilly could be affected if Medicare coverage decisions for its drugs are reviewed or changed under this process.
• REGN — Regeneron could be affected if Medicare coverage policy changes for its biologic products are reviewed or reversed.
• AMGN — Amgen could be affected by changes in Medicare coverage determinations for biological products.
• BMY — Bristol Myers Squibb could be affected if Medicare coverage rules for certain approved drugs are altered.
• MRK — Merck could be affected if coverage reviews change access to drugs under Medicare.
• PFE — Pfizer could be affected if Medicare coverage decisions for its drugs or biologics are challenged or modified.
• ABBV — AbbVie could be affected by changes in Medicare coverage treatment for approved pharmaceuticals.
• VRTX — Vertex could be affected if coverage decisions for specialty drugs are reviewed under this process.