On June 22, the Centers for Medicare & Medicaid Services (CMS) announced the Transitional Coverage for Emerging Technologies (TCET) pathway through a proposed procedural notice in the Federal Register. At that time, it also released three proposed guidance documents, which CMS says “propose a substantial transformation to our approach to coverage reviews and evidence development.”
To help inform the TCET pathway and provide an opportunity for stakeholders to provide comments, CMS will hold a national stakeholder call on August 1, 3-4:30 p.m. ET.
During the listening session, CMS is seeking feedback on the following questions:
- The proposed procedural notice states that the appropriate timeframe for manufacturers to self-nominate for the TCET pathway is approximately 12 months prior to an anticipated Food and Drug Administration decision on a submission as determined by the manufacturer. Is this an appropriate timeframe?
- In terms of the timing for postmarked review, should CMS finalize its proposal to tie the duration of coverage under the TCET pathway to a date specified in the Evidence Development Plan (EDP), including conducting an updated evidence review within six months of the date noted in the EDP?
- How should CMS approach evidence development requirements for second and third to market devices following a coverage with evidence development decision for a breakthrough device in the TCET pathway?
To register for attendance, which must be completed by July 28 at 5 p.m. ET, visit the CMS registration page.
To read a description of the TCET pathway, visit the CMS blog.
To read a TCET fact sheet, visit the CMS webpage.
To read the proposed TCET procedural notice, visit the Federal Register.
To read news coverage, visit “CMS Proposes Pathway for Breakthrough Devices.”
