Never the Twain Shall Meet? Medicare CED Gathering Precedes TCET Rule

article image

CMS convened its MEDCAC advisory committee in February to consider updates to its Coverage With Evidence Development (CED) program. The efforts appear to be feeding into the agency’s work to construct a streamlined (TCET) coverage path new for medtech, but industry groups want to keep the CED and TCET streams separate.

[Editor’s noteThis article was originally published February 8 and updated February 21 to reflect the outcomes of the February 13-14 MEDCAC meeting and provide additional information about possible next steps for CMS.] 

A CMS advisory committee that met this month largely affirmed the agency’s plans to update criteria for data collection under its Coverage With Evidence Development (CED) program, an 18-year-old framework in which national coverage is conditioned on data collection. In parallel, the agency is preparing to issue a proposed rule by spring on a transitional, streamlined coverage pathway for innovative medical devices (Transitional Coverage for Emerging Technologies, TCET). Industry groups are hoping those two efforts stay on distinct tracks.

“The focus here is on a dedicated pathway,” said Mark Leahey, president and CEO of the Medical Device Manufacturers Association, distinguishing the prospective TCET program from the established CED-National Coverage Determination (NCD) process, which companies say can present barriers for pioneering new devices. TCET should be “another tool in the toolbox for innovators to utilize to...enhance patient access,” Leahey stressed in an interview.  

Similarly, AdvaMed views “CED and TCET as entirely separate processes,” an official from that trade association told Market Pathways


This article is restricted to subscribers only.

Sign in to continue reading.


We're here to help! Please contact us at: