Access to Innovative Treatments Act of 2026

Key Points

• The bill creates a formal review process when Medicare denies or limits coverage for FDA-approved drugs and biologicals. Anyone can request a review, and the government must begin within 90 days of the request.
• The review includes a 30-day public comment period followed by a final decision within 120 days. The final decision must include summaries of public comments and responses, plus clinical evidence when the decision differs from advisory committee recommendations.
• Medicare would be banned from applying old national coverage determinations to newly approved drugs if doing so would deny or limit coverage in ways that conflict with the FDA's approval. This targets the gap between FDA approval and Medicare coverage.
• When a review results in reversing or modifying a coverage denial, the government must assign billing codes so doctors can prescribe and get reimbursed for the treatment without long administrative delays.
• Part D prescription drug plans would also be prevented from using adverse national coverage determinations to deny coverage for drugs. This extends the bill's protections to the outpatient prescription drug benefit, not just traditional Medicare.