HRS Monitors Legislation Aims to Expand Medicare Coverage for Breakthrough Medical Devices

December 19, 2024 – Legislation introduced in the U.S. Senate (and previously passed by the House Ways and Means Committee) aims to expedite Medicare coverage for FDA-designated breakthrough devices.

The Ensuring Patient Access to Critical Breakthrough Products Act of 2024—sponsored by Senators Todd Young (R-IN) and Alex Padilla (D-CA)—proposes a four-year transitional Medicare coverage period for breakthrough devices upon FDA authorization. This is intended to address the current estimated delay of 5.7 years for Medicare coverage of breakthrough devices.

During the transitional period, developers would collaborate with CMS to establish permanent coverage, with CMS retaining the authority to suspend transitional coverage if new evidence indicates safety or efficacy concerns. If passed in the Senate, the legislation would surpass the scope of CMS’s existing Transitional Coverage for Emerging Technologies (TCET) pathway, which is limited to five devices annually and excludes diagnostic products.

Available Resources

• Ensuring Patient Access to Critical Breakthrough Products Act of 2024 [pdf]
• H.R 1691 – Ensuring Patient Access to Critical Breakthrough Products Act of 2024