House Ways & Means Committee Considers Legislation to Enhance Medicare Coverage of Breakthrough Devices

July 11, 2024 – On June 27, 2024, the House Committee on Ways & Means favorably reported legislation designed to create a more efficient pathway to Medicare coverage and payment for devices that receive a “breakthrough device” designation from the Food and Drug Administration.

The bipartisan legislation, the Ensuring Patient Access to Critical Breakthrough Products Act (H.R.1691), would essentially roll back limitations made by the Biden Administration to pre-existing coverage and payment. The Biden Administration policy limited the pathway to coverage to five breakthrough devices per year.

The bill, which currently has 86 bipartisan House co-sponsors, was favorably reported with bipartisan support in a 36-5 vote. The five Democrats voting in opposition to the legislation expressed concerns about limiting CMS’ ability to impose guardrails on coverage should device safety issues arise. H.R.1691 was previously approved by the House Committee on Energy and Commerce, which shares jurisdiction over the bill with the Committee on Ways and Means. The next step for the legislation will be consideration by the full House of Representatives.

Available Resources

• House Committee on Ways & Means: Markup of H.R. 1691
• Ensuring Patient Access to Critical Breakthrough Products Act (H.R.1691)