Bill to Grant 4-Year Insurance Coverage for Breakthrough Medical Devices Passes Ways and Means, with Significant Discount

By Emma Beavins July 2, 2024 –

The House Ways and Means Committee on Thursday passed bipartisan legislation that would grant Medicare four years of coverage for new health technologies while the Centers for Medicare & Medicaid Services (CMS) makes a nationwide decision.

The new version of the bill, voted on by the House Resources and Appropriations Committee, reduces the cost of the bill by 75% compared to the version that the House Energy and Commerce Committee approved in November. It allocates $10 million per year for five years for the project for CMS.

The Ensuring Patient Access to Critical Breakthrough Products Act of 2024, if passed, would provide any device designated as “breakthrough” by the Food and Drug Administration (FDA) with four years of Medicare coverage. The bill’s co-sponsor, Rep. Susan DelBene, R-Washington, said during the hearing that it takes CMS more than five years, on average, to make a national coverage determination for FDA breakthrough devices.

DelBene said the only factor that relates to how quickly CMS looks at medical devices is the size of the company making the device, not the amount of clinical data the device contains.

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