Joe Grogan, one of the leaders in health policy for the Trump White House, is now a policy expert associated with USC and recently published an excellent blog on the need for Medicare coverage of breakthrough devices.
Below I provide a link to his September 2021 blog, as well as some background.
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October 27, 2021, the USC Schaeffer Center for health policy hosted a webinar with Scott Gottlieb, former head of FDA, and Joe Grogan, who headed health policy for the Trump White House. The webinar mentioned a recent blog by Grogan on the Schaeffer Center website. It's worth reading. One headline therein: "CMS's Concerns Used as Justification for Rescinding the Rule are Unfounded."
> > > Find the Grogan blog, dated September 23, 2021, here.
The MCIT Rule
The MCIT rule is "Medicare Coverage for Innovative Technologies," and was finalized by the Trump administration in early January. It promised 4 years of coverage for any device approved by FDA as a "breakthrough device."
MCIT was put on hold by the Biden administration in March 2021, and proposed to be permanently canceled in September 2021. (See the cancellation rule here. See my blog on the cancellation announcement here. My short video on the cancellation here. My later blog, in October, on some of the submitted Public Comments, here.)
Broader Problems with Medical Device Coverage
In the USC webinar on October 27, Grogan also spent substantial time to describing the pain and duration of problems caused by our awkward and slow device coding, coverage, and pricing. Scott Gottlieb noted that the impetus for MCIT came from FDA leadership, which worked directly with Seema Verma as head of CMS. Verma, in turn, had to overcome opposition from staff under her in order to get the rule proposed and finalized during Year 4 of the Trump administration.
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There's been legislation introduced in Congress that would reproduce what had been proposed as MCIT - here. Something like MCIT is also included in possible future legislation called 21st Century Cures 2.0.
See an auto-transcript of the MCIT remarks today, here.
