Bill > S1717

This bill aims to improve Medicare coverage for breakthrough medical devices by creating a new process for faster evaluation and coverage. Specifically, the bill establishes a four-year "transitional coverage period" for devices designated as "breakthrough devices" by the Secretary of Health and Human Services. To qualify, a device must receive priority review from the Food and Drug Administration (FDA). Manufacturers can apply for breakthrough device status, and the Secretary must make a determination within 6 months of the application. During the transitional coverage period, Medicare will provide coverage for these devices, with some exceptions for devices that present undue health risks. The bill requires the Secretary to submit annual reports to Congress detailing the number of breakthrough device applications, designations, and rejections. Additionally, the bill allocates $10 million per year from fiscal years 2026 to 2031 to help implement these changes. The goal is to help patients access innovative medical technologies more quickly by streamlining the Medicare coverage process for cutting-edge medical devices.

Budget and Finance

https://www.congress.gov/bill/119th-congress/senate-bill/1717/all-info