H.R. 5343 · In committee · Health

Ensuring Patient Access to Critical Breakthrough Products Act

What it does

Provides Medicare coverage for medical devices approved under the FDA Breakthrough Devices Program.
Allows designated devices temporary Medicare coverage during a four-year transitional period, with manufacturers applying to CMS for the designation.
Requires qualifying devices to have received FDA priority review, premarket approval based on data including Medicare beneficiaries, general Medicare coverage eligibility, and no undue risk outweighing benefits.
Requires CMS to approve or deny applications within six months, explain denials, and make permanent coverage decisions before the transitional period ends on timely request, with funding through fiscal year 2030.

Official summary

Ensuring Patient Access to Critical Breakthrough Products Act This bill provides for Medicare coverage of medical devices that are approved under the Food and Drug Administration (FDA) Breakthrough Devices Program. (Under the program, manufacturers work with the FDA to expedite the review and approval of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions.) The bill allows designated medical breakthrough devices to be temporarily covered under Medicare during a four-year transitional period. Manufacturers must apply to the Centers for Medicare & Medicaid Services (CMS) to receive this designation. Qualifying devices must (1) have received priority review from the FDA, (2) received premarket approval (if applicable) based on clinical data that includes data from Medicare beneficiaries, (3) already generally qualify for Medicare coverage, and (4) not present an undue risk of harm that outweighs potential clinical benefits for Medicare beneficiaries. The CMS must approve or deny applications within six months of receipt and must provide an explanation in the case of a denial. In…

Latest action

Sep 17, 2025: Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 37 - 3.

Committee: House Ways and Means