This bill amends Medicare rules to guarantee coverage of innovative medical devices designated as "breakthrough devices" for a four-year period after their FDA approval. The legislation directs the Secretary of Health and Human Services to designate devices that receive priority FDA review as breakthrough devices, and requires Medicare to cover these devices during their transitional period unless they're used outside FDA-approved guidelines or pose undue safety risks. The Secretary must make designation decisions within six months of a manufacturer's application and must issue final Medicare coverage determinations for breakthrough devices before their transitional period expires. The bill allocates $10 million annually from fiscal years 2026 through 2031 to the Centers for Medicare & Medicaid Services to implement these new requirements, and mandates annual congressional reports on the number of applications and designations processed.
Take Action
Your position
Add a comment
to comment on this bill.
Annotate the text
Highlight any passage on the Summary or Full Text tab to attach a note. Annotations appear on the Annotations tab.