Friday, June 30, 2023

TCET: Follow up from STAT PLUS (June 30, 2023), Genomeweb (July 13, 2023)

Short Take:  STAT PLUS publishes a bigger, more detailed article on TCET, with interviews.


On June 22, 2023, CMS released its long-awaited "Transitional Coverage" or TCET rules.  My lengthy original blog here.  

I posted an update on June 28, covering an additional TCET document, which is about new rules for "coverage with evidence development."  Here.

On June 30, Lizzy Lawrence at STAT published a deep-dive subscription article including interviews with multiple stakeholders.  Find it here.

Find July follow up at Genomeweb, here.



  • STAT: See prior articles from 2022 where STAT looks at BT Devices as a whole, here, in a lengthy and detailed piece of journalism.  It notes that early BT approvals ran 70% and when the program became more popular they fell to 40%.
  • STAT: See a very useful a STAT "BT Tracker" here.   
  • FDA: doesn't list devices "inside" the BT program (consistent with never discussing products under review), but FDA does publish those devices which have exited the BT program with approvals - here.  (Currently about 60 of these).  FDA also publishes bar charts of BT status granted per year and a chart parsing them by medical device area (e.g. "cardiology.")   


The Feeble Status of Parallel Review - 2 for 96

The STAT article cites an FDA Q&A about the feeble status of Parallel Review.  It states, "there have been 96 formal requests to participate - two devices have completed Parallel Review.   Cologuard 2014, FMI 2017."  Here.   Let me add, I've known companies that outreached to FDA re Parallel Review and got a curt "Nope!" email response quickly.  I'm not sure if FDA logs those as "formal requests."  So the attempts at P.R. might be much higher than what FDA logged as 96 formal requests.