Establishes a four-year transitional Medicare coverage period for FDA-designated breakthrough devices and requires the Department of Health and Human Services to decide designation and coverage requests within set deadlines.

• Creates a four-year transitional coverage period for breakthrough devices, starting on the date the Secretary designates the device
• Requires the Secretary to decide designation applications within 6 months and explain in writing why any device is denied
• Requires a final Medicare coverage decision before the transition period ends when a timely request is submitted
• Authorizes review of providers with unusual billing for breakthrough devices and appropriates $10,000,000 per fiscal year from 2025 through 2030

• Energy and Commerce Committee (House)
• Ways and Means Committee (House)

Health