S 5349
Ensuring Patient Access to Critical Breakthrough Products Act of 2024
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- Passed Senate
- Passed House
- To President
- Became Law
Bill overview
This bill, the Ensuring Patient Access to Critical Breakthrough Products Act of 2024, aims to improve Medicare coverage for new medical devices considered ‘breakthrough’ by the Food and Drug Administration. It establishes a ‘transitional coverage period’ of four years for these devices, allowing Medicare to cover them more quickly while the government assesses their clinical benefits and potential risks. The bill also creates a process for the Secretary of Health and Human Services to designate devices as breakthrough and requires regular reporting on the designation process.
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