Bill would give breakthrough medical devices four years of automatic Medicare coverage

What does this do?

This bill creates a four-year "transitional coverage period" during which Medicare automatically covers a device once it's designated an FDA "breakthrough device," if used as approved and safe. HHS must decide within 6 months whether a device qualifies, explaining any denial, and Medicare must finish any related national coverage decision before the four years end.

Who does it affect?

The bill affects Medicare patients, especially seniors and people with disabilities, medical device manufacturers, hospitals and doctors using these devices, and CMS, which administers Medicare.

Why does it matter?

The change would speed up patient access to new devices but adds new deadlines, funding needs, and oversight responsibilities for CMS, including monitoring billing for potential misuse.

What does it cost, and who pays?

• $10 million per year
• 2025 through 2030
• funds cms implementation