On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) announced the TCET pathway through a proposed procedural notice in the Federal Register and released three proposed guidance documents. Collectively, these documents propose a substantial transformation to our approach to coverage reviews and evidence development.
As a part of CMS continued commitment to engage stakeholders on an ongoing basis, CMS will hold a national stakeholder call on August 1, 2023 to help inform the TCET pathway and provide an opportunity for stakeholders to provide comments.
During the listening session, we would appreciate receiving 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 FDA decision on a submission as determined by the manufacturer. Is this an appropriate timeframe?
- In terms of the timing for postmarket 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?
When: Tuesday, August 1 from 3:00 4:30 PM
Who should attend: This stakeholder call is intended for all Medicare and healthcare partners.
RSVP: by registering in advance for this webinar: Click here
Please RSVP by July 28, 2023 at 5:00 PM ET. Please indicate on the registration form if you wish to speak at the meeting.
After registering, you will receive a confirmation email containing information about joining the webinar. This meeting is closed to press.
Additional Resources:
- A blog describing the TCET pathway can be found here: https://www.cms.gov/blog/transforming-medicare-coverage-new-medicare-coverage-pathway-emerging-technologies-and-revamped
- For a fact sheet on TCET: https://www.cms.gov/newsroom/fact-sheets/notice-comment-transitional-coverage-emerging-technologies-cms-3421-nc
To read the proposed TCET procedural notice, visit: https://www.federalregister.gov/documents/2023/06/27/2023-13544/medicare-program-transitional-coverage-for-emerging-technologies
