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TAKE TWO: CMS’s Second Attempt to Streamline Breakthrough Device Coverage Limited to 5 Devices Per Year

Health Law Advisor

On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) announced its proposed “Transitional Coverage for Technologies” (TCET) pathway—the Biden administration’s highly anticipated take on a mechanism to expedite coverage for certain devices designated by the U.S. Food and Drug Administration (FDA) as breakthrough devices. [1]

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