CMS Finalizes Accelerated Approval Pathway for Devices

The Transitional Coverage for Emerging Technologies (TCET) pathway was finalized by the Centers for Medicare & Medicaid Services (CMS). It aims to provide Medicare beneficiaries with more timely access to new medical technologies. It also seeks to improve the quality of life for people with Medicare and encourage innovation.

Medical devices must meet the following criteria to be eligible for the TCET pathway:

• Designated as a Breakthrough Device by the FDA
• Within a Medicare benefit category
• Not already the subject of an existing Medicare NCD
• Not otherwise excluded from coverage through law or regulation

The TCET pathway will cover up to five FDA-designated Breakthrough Devices per year and would include three stages: pre-market, coverage under the TCET pathway, and transition to post-TCET coverage. The goal would be to finalize a national coverage determination (NCD) within six months after FDA market authorization, which would last for five years.

While the TCET pathway presents the opportunity for swifter Medicare coverage and broader opportunities for CMS engagement and evidentiary review, uncertainties remain. Manufacturers will require a strategy for the TCET nomination and application process, engagement with CMS, data collection, and reporting of data collected for final coverage decision-making.