CMS Outlines New Expedited Medicare Coverage Pathway, Revamps Evidence Development Framework

The Centers for Medicare and Medicaid Services (CMS) recently announced a proposed Transitional Coverage for Emerging Technologies (TCET) pathway to improve the Medicare coverage process when making decisions on certain emerging technologies at the national level. The proposal includes a procedural notice and several guidance documents about Medicare coverage reviews and evidence development.

The notice outlines an expedited pathway for emerging technologies to qualify for Medicare coverage. CMS created the TCET pathway to provide a mechanism for coverage for certain new, innovative technologies with limited or developing evidence in the Medicare population. It uses national coverage determination (NCD) and coverage with evidence development (CED) processes to expedite Medicare coverage of certain U.S. Food and Drug Administration (FDA)-designated breakthrough devices. The pathway provides manufacturers with opportunities for increased pre-market engagement with CMS and a new and unprecedented level of flexibility to address any evidence gaps for coverage.

The TCET pathway fact sheet indicates:

• Manufacturer participation is voluntary.
• CMS may conduct an early evidence review (Evidence Preview) before the FDA decides on marketing authorization for the device, and discuss with the manufacturer the best available coverage pathways depending on the strength of the evidence.
• CMS may initiate discussions with manufacturers about any evidence gaps for coverage purposes and the types of study designs that could address the before FDA marketing authorization. The manufacturer may then propose an Evidence Development Plan (EDP). As part of the EDP development process, CMS would work with manufacturers to efficiently meet both CMS evidence development and FDA post-market requirements.

CMS’ goal is to finalize a TCET NCD within six months after FDA market authorization. It intends to have coverage under the TCET NCD continue only as long as is needed to facilitate the timely generation of evidence that can inform patient and clinician decision-making and lead to a predictable, long-term Medicare coverage determination. In addition to the TCET procedural notice, CMS issued proposed criteria in an updated Coverage with Evidence Development guidance documents based on the November 2022 Agency for Healthcare Research and Quality (AHRQ) Report and February 2023 Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting, as well as National Coverage Analysis Evidence Review guidance to more clearly allow fit-for-purpose study designs.

The public will have 60 days to provide comments on the TCET procedural notice and proposed CED and Evidence Review guidance documents. Public comment regarding the proposed TCET pathway must be received by 5 pm, Aug. 28.

Public comment about the proposed CED must be submitted by Aug. 21. CMS will respond to public comments in a subsequent final notice. Lastly, CMS will soon announce the opening of an NCD pilot that will incorporate aspects of the new evidence development framework outlined in the TCET procedural notice and guidance documents.
The American College of Radiology® (ACR®) continues to review the proposed procedural notice and proposed guidance documents and is working on a detailed summary. The ACR will likely submit comments to CMS by the comment period deadline. If you have questions, contact Alicia Blakey, ACR Principal Economic Policy Analyst.