Today CMS issued a rule permanently canceling the MCIT program for breakthrough devices. I wrote an adjacent blog about this - here.
There's a really odd treatment of "diagnostic test" and I felt it was worth calling out as its own short article with its own headline.
CMS View of "Diagnostic Test" vs "Device"
There's an odd flip flop in today's final rule. In discussing how many BT devices either were already covered or were irrelevant for Medicare coverage, CMS states, "The majority of BT that would have been eligible for the MCIT were already paid by an existing mechanism, (or) were directed to a pediatric population, (or) were a diagnostic lab test, or were subject to an NCD or had no benefit category."