Access to Innovative Treatments Act of 2023

The Access to Innovative Treatments Act of 2023 creates a new process for Medicare to review coverage denials or limitations for FDA-approved drugs and biologicals. It requires Medicare to conduct a 30-day review of such decisions, including a 30-day public comment period, and issue a final decision within 30 days of the comment period, with transparency about evidence and public input. The bill also prohibits Medicare from applying outdated coverage decisions to newly approved drugs that would deny coverage inconsistent with FDA approval. This directly affects Medicare beneficiaries seeking coverage for innovative treatments and Medicare Part D plans managing drug coverage.