The "Access to Innovative Treatments Act of 2026" amends the Social Security Act to provide a review process for adverse national coverage determinations for drugs under Medicare. It stipulates that the Secretary must initiate a review within 90 days of a request, allowing for a 30-day public comment period. The Secretary must make a final decision within 120 days, including summaries of public comments and responses, as well as making clinical evidence available when the decision differs from Medicare Coverage Advisory Committee recommendations. Additionally, the Act prohibits the application of existing national coverage determinations to newly approved drugs and biologicals if it would result in a denial inconsistent with their approval or licensure.
Access to Innovative Treatments Act of 2026
This 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.
