Medicare Proposes Earlier Coverage Of Breakthrough Devices Through New Pathway

On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) proposed a pathway for earlier Medicare coverage of new medical devices designated by the U.S. Food and Drug Administration (FDA) as Breakthrough Devices. The proposed Transitional Coverage for Emerging Technologies (TCET) pathway represents a substantial change to the current CMS approach to coverage reviews and evidence development.

The proposed TCET pathway would be voluntary. It would provide manufacturers with opportunities for increased pre-market engagement with CMS and a new and unprecedented level of flexibility to address any evidence gaps for Medicare coverage. The goal is to . . .