CMS Finalizes Expedited TCET Coverage Pathway

The Centers for Medicare & Medicaid Services (CMS) finalized a new Transitional Coverage for Emerging Technologies (TCET) Pathway to expedite Medicare coverage of some FDA-approved breakthrough products.

Under this finalized pathway, eligible US Food and Drug Administration (FDA) designated breakthrough devices that fall within a Medicare benefit category can obtain national coverage for several years (and perhaps upwards of five years) as the manufacturer develops evidence to address gaps identified through contractor-generated evidence preview and pursuant to an evidence development plan (EDP).

TCET is the successor to the Medicare Coverage of Innovative Technology (MCIT) pathway that the Trump Administration finalized in January 2021 and which the Biden Administration repealed in November 2021.

The CMS notices comes after the FDA’s Breakthrough Device review program that has been operational for years. That designation expedites the FDA review process for devices that are novel and could provide more effective treatment for severe conditions. However, medtech industry stakeholders criticized the time lapse between FDA market authorization and CMS coverage determinations. Some cited studies that said it takes CMS an average of over five years to make a coverage determination for a Breakthrough device.

AdvaMed, of which MichBio is a state affiliate of, issued a statement on the new TCET rule, and joined industry stakeholders in decrying the CMS’ decision to limit the expedited TCET coverage pathway to five devices a year and exclude technologies such as diagnostics and digital therapeutics from the pathway despite industry complaints about those provisions in the proposed rule.

The TCET rule’s shortcomings underscores the need for Congress to pass the Ensuring Access to Critical Breakthrough Products Act (H.R. 1691), which would enable a broader set of technologies to receive expedited Medicare coverage.