Friday, November 12, 2021

MCIT Final Rule Includes Odd Treatment of "Diagnostic Tests"

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"

In the original September 2020 proposal, CMS said it would cover breakthrough devices for four years.  Then, CMS also asked the public, if it should "also" cover breakthrough diagnostic tests or drugs.   This made no sense, because FDA views IVDs as devices, so diagnostic tests are already included in the regulation for breakthrough devices.   In the January 2021 final rule, CMS clarified that "diagnostic tests" were naturally part of the covered range of breakthrough devices.

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."   

Why on earth diagnostic tests under BT review are put together with "pediatric devices" and "devices with no benefit category" is cryptic.  Many BT devices are diagnostic tests and would have greatly benefited from accelerated MCIT coverage.