Friday, May 14, 2021

CMS Again Delays "Breakthrough Rule" - MCIT - This Time Until December 15, 2021

On Friday afternoon, May 14, 2021, CMS released a decision to delay the MCIT rule until December 15.   

The agency provided several pages of discussion of pro's and con's regarding MCIT, based on public comment solicited March 15-April 15.   

The rule, finalized in January, promised to provide four years of Medicare coverage for FDA-cleared or -approved "breakthrough" devices.

All CMS is legally doing is delaying the rule in the form it was written this past January.  Since CMS also seems to foresee multiple problems with the existing rule, it's very unlikely (or I'd say impossible) that CMS will simply implement the existing, suspended rule, but on December 15.  Rather, sometime on or before December 15 CMS may revisit with "new rules."

Read the CMS announcement here:

See my 4 minute video on the story, here:

See my Friday morning update, written before the delay was published that afternoon, but including some recent news article links: