Foley Attorneys Author Article Exploring New CMS Proposal for Medicare Coverage of Breakthrough Devices

15 September 2023 American Health Law Association News

Foley & Lardner LLP Health Care Practice Group co-chairs and partners Kyle Faget and Judith Waltz and associate Jessa Boubker authored the article, “CMS Proposes New Medicare Coverage Pathway for Breakthrough Devices,” published in the American Health Law Association’s Health Law Weekly newsletter.

The authors examine the Centers for Medicare & Medicaid Services (CMS) proposed Transitional Coverage for Emerging Technologies (TCET) pathway designed to facilitate Medicare coverage for certain devices designated as “breakthrough devices” by the U.S. Food & Drug Administration. They assess what makes a breakthrough device, how they can secure Medicare coverage, which devices might qualify for coverage under the TCET pathway, and the key features of, exclusions from, and significance of the pathway.

“While this accelerated TCET Pathway would be a step forward in CMS' support of emerging technologies, the TCET Pathway is limited to breakthrough devices and only a legislative change can establish new benefit categories to facilitate the coverage of breakthrough devices and other emerging technologies overall,” the authors conclude.

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