Proposed Bill Would Extend Medicare Coverage of Breakthrough Devices

A bipartisan group of members of the U.S. House of Representatives introduced a bill requiring Medicare to cover all devices that have an FDA Breakthrough Designation for four years while the FDA and the Centers for Medicare and Medicaid Services (CMS) make a final coverage determination.

The Ensuring Patient Access to Critical Breakthrough Products Act of 2023 “removes unnecessary barriers that prevent seniors from accessing the most innovative and cutting-edge treatments,” said Rep. Brad Wenstrup (R-Ohio), the bill’s lead sponsor.

CMS published a similar final rule in January 2021 that provided four years of Medicare coverage for innovative medical devices but later rescinded it based on safety concerns for Medicare patients. The agency is now drafting a proposed rule to accelerate the device coverage.

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