CMS could release its long-awaiting "Transitional Coverage for Emerging Technology" rule any time. It's been assigned numbers and a webpage at Reginfo.gov. TCET will replace the abandoned Trump era idea of 4 years auto-coverage for breakthrough devices (MCIT).
As flagged by CMS since a year ago, the rule will probably focus on adaptions of the NCD process, and/or the CED NCD process. (Recall they held a big workshop on CED in February).
They write:
Title: Transitional Coverage for Emerging Technologies (CMS-3421)
Abstract:
This notice provides information to the public on the process we will use to provide transitional coverage for emerging technologies (TCET) through the national coverage determination (NCD) process under the Social Security Act (the Act). This notice does not alter or amend our regulations that establish rules related to the administrative review of NCDs. This notice also announces a 30-day period for the public to submit comments on the TCET pathway.
Find that, here:
https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202304&RIN=0938-AU86
This webpage also lists formal meetings between OMB and stakeholders. One is listed, which occurred June 12, and involved AdvaMed.
At the link above, a 4 page PDF memo used by AdvaMed is posted. (It's one page of policy talking points and 3 of bio's, but I've also Googledoc'd an AI summary).
I believe that the actual CMS rulemaking will be posted on this page (as well as its own unique link):
https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services
