Access to Innovative Treatments Act of 2026

This bill would require the Centers for Medicare & Medicaid Services (CMS) to review requests regarding Medicare coverage denials or limitations for drugs within 30 days if those restrictions are inconsistent with Food and Drug Administration (FDA) approval. The proposal would also prohibit CMS from applying coverage determinations made before a drug's FDA approval if those prior decisions conflict with the final approved use. These expedited review requirements would not apply if CMS has already conducted a similar review for the drug within the preceding two years.

This bill primarily affects the Centers for Medicare & Medicaid Services (CMS), which would be required to adhere to new 30-day timelines for reviewing certain drug coverage determinations. The legislation also impacts Medicare beneficiaries and healthcare providers by addressing denials or limitations of drug coverage that are inconsistent with Food and Drug Administration (FDA) approvals. Additionally, the bill affects pharmaceutical manufacturers whose FDA-approved drugs are subject to national coverage determinations under the Medicare program.

• Mandatory review of adverse Medicare coverage determinations. Requires the Centers for Medicare & Medicaid Services (CMS) to review requests regarding drug coverage denials or limitations within 30 days if those determinations are inconsistent with FDA approval.
• Limitations on frequency of coverage reviews. Specifies that the mandatory 30-day review requirement does not apply if the CMS has already conducted a review of the drug's coverage determination within the preceding two-year period.
• Restriction on applying pre-approval coverage determinations. Prohibits the CMS from applying coverage determinations made before a drug received FDA approval if those prior determinations conflict with the terms of the drug's eventual approval.

The bill modifies the administrative processes of the Centers for Medicare & Medicaid Services (CMS) regarding national coverage determinations for drugs under the Medicare program. It specifically limits the application of prior coverage determinations made before Food and Drug Administration (FDA) approval and establishes new timelines for reviewing coverage denials that conflict with FDA approval standards.

The bill aims to expedite the review of Medicare coverage for drugs by requiring the Centers for Medicare & Medicaid Services to reconsider coverage denials or limitations that conflict with FDA approval within 30 days of a request. It also prevents the application of pre-approval coverage restrictions that are inconsistent with a drug's eventual FDA-approved indications.