Monday, March 28, 2022

CMS Announcement for March 31 Webinar on Transitional Coverage for Emerging Devices

 CMS held a webinar on the theme, "Transitional Coverage for Emerging Devices," on February 17.   CMS will hold a second webinar on the same theme on Thursday,  March 31, at 3 pm ET (12 noon PT).

A February 17 transcript is here.

Note that CMS is consistently using "Transitional Coverage for Emerging Devices" or TCET as a brand name, or programmatic name, but it doesn't have any specific rules or content yet.   

For the next, March 31 webinar, here's the email invitation as I received it:


CMS is hosting the second in a series of public meetings to obtain feedback to help inform CMS’ development of an alternative coverage pathway to provide transitional coverage for emerging technologies.  

These meetings are part of several steps CMS is taking to help better achieve the goals of timely and predictable Medicare coverage of devices while ensuring that Medicare covers items and services on the basis of scientifically sound clinical evidence and with appropriate safeguards.  

We appreciate all of the helpful stakeholder feedback we received during the first listening session on February 17. The transcript and recording for the February 17 meeting can be found here. The framework for the second listening session on March 31 at 3:00 PM ET  builds upon information gathered in the first session.  

During the March 31 listening session, we would appreciate receiving feedback on the following questions: 

  • Do stakeholders find CMS guidance on acceptable outcomes and durations of follow-up useful within specific therapeutic areas?
  • Engagement with CMS should occur after the results of pivotal clinical trials are available, but early enough to expedite coverage after FDA market authorization.  As we streamline the coverage review process, what is the appropriate timing of stakeholder engagement with CMS?
  • As we work to provide a more collaborative evidence development process, what are stakeholders thoughts on:
  • Should CMS provide early feedback on strengths and weaknesses of the available evidence based upon a preliminary systematic literature review?
  • Should manufacturers propose a fit-for-purpose evidence development plan to resolve any evidence gaps identified during the preliminary systematic literature review as part of the national coverage determination process? 
  • How should CMS approach evidence development requirements for similar devices that are FDA market authorized after a Coverage with Evidence Development decision is finalized? 

You can register for the March 31 listening session by following the link below. If you previously registered for the February 17 session, you do not need to register again to attend the second session on March 31. 

What: CMS Listening Sessions on Transitional Coverage for Emerging Technologies

When: March 31, 2022 3:00 - 4:30 PM ET.

Who should attend: This listening session series is designed for all Medicare and Healthcare Partners.