H.R. 5343

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 addition, the CMS must make permanent coverage decisions before the end of the transitional period upon a timely request to do so, as specified. The bill provides funds through FY2030 for the CMS to implement the bill.