CMS Finalizes Expedited Coverage Pathway for “Breakthrough” Devices

September 10, 2024 – CMS recently released its final notice on the Transitional Coverage for Emerging Technologies (TCET), introducing a new pathway for FDA-designated breakthrough devices to obtain Medicare coverage while evidence is collected via the national coverage determination (NCD) process, specifically through coverage with evidence development (CED).

As highlighted in a CMS fact sheet, the TCET pathway “offers an evidence development framework that enables manufacturers to engage more with CMS before market approval, reducing their burden by providing more flexibility in addressing evidence gaps, ultimately supporting Medicare coverage… [and]… allows for addressing any evidence gaps through studies that are tailored to patients representing the Medicare population.”

CMS expects the TCET pathway will also help streamline the coordination of Medicare benefit category determinations, as well as coding and payment reviews.