Access to Innovative Treatments Act of 2026
Sponsored By: Representative Barragán, Nanette Diaz [D-CA-44]
Introduced
Summary
Aligns Medicare coverage decisions with FDA approval for drugs and biologics. It would create a formal review process for adverse national coverage determinations, set timelines for review, require public comment and evidence disclosure, and prevent older coverage rules from blocking newly approved therapies.
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- Patients and families: People prescribed newly approved drugs would be less likely to face Medicare coverage denials that contradict FDA approval.
- Drug makers and providers: Sponsors or clinicians could request a review. The Secretary would have to start reviews within 90 days and open a 30-day public comment period.
- Medicare operations and Part D plans: CMS would need to issue a final decision within 120 days after the comment period and publish clinical evidence when it departs from advisory recommendations. Part D plans could not base payment denials on specified national coverage determinations when applying Part D rules.
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Bill Overview
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Faster Medicare reviews for new drugs
The Secretary would have to start a review of certain Medicare drug and biologic coverage decisions within 90 days after a request. A 30-day public comment period would open when the review starts. The Secretary would have to issue a final decision within 120 days after that comment period ends and say whether coverage is affirmed, reversed, or modified. The final decision would have to include summaries of public comments and publish clinical evidence if it departs from advisory recommendations. If coverage is changed, CMS would assign and implement a temporary or permanent billing code. The Secretary would not be required to start a new review if the same determination had a final decision in the prior two years.
Part D plans can't use old NCDs
If enacted, the bill would bar Part D prescription drug plans and Medicare Advantage drug plans from relying on a prior NCD that denied or limited coverage in a way that conflicts with FDA approval or PHS licensure when deciding that payment would not be made. Plans could not use such a specified NCD to declare a covered Part D drug ineligible for payment. This would remove one basis for denials and some prior-authorization hurdles for newly approved drugs.
Stop old Medicare rules blocking new drugs
If enacted, the bill would prohibit the Secretary from applying an older national coverage determination (NCD) to a drug or biologic approved under FDA law or licensed under the Public Health Service Act when applying that older NCD would deny or limit Medicare coverage in a way that conflicts with the approval or licensure. The rule would only block the part of an earlier NCD that is inconsistent with approval or licensure. This would make it more likely that newly approved therapies get Medicare coverage consistent with their FDA approval or PHS licensure.
Sponsors & CoSponsors
Sponsor
Barragán, Nanette Diaz [D-CA-44]
CA • D
Cosponsors
Joyce (PA)
PA • R
Sponsored 6/24/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov