On November 12, 2021, CMS officially and finally announced it was *canceling* the "MCIT" rule, which had been finalized in the closing weeks of the Trump administration in January.
The Medical Coverage for Innovation Technology rule would have automatically covered new FDA-approved "Breakthrough" devices for four years, under Medicare.
The policy had previously been put on hold and then proposed for cancellation. The Biden administration promises two stakeholder workshops in CY2022 on other ways to improve Medicare coverage.
BACKGROUND
A few weeks ago I posted a cloud zip file of some of the most interesting public comments in favor of MCIT (here). I also flagged a blog that was pro-MCIT by Joe Grogan, who was one of the leaders for health policy in the White House in 2019/2020. Scott Gottlieb and Grogan discussed reasons why MCIT was good in a recent webinar here.
CMS PRESS RELEASE
https://www.cms.gov/newsroom/press-releases/cms-repeals-mcitrn-rule-will-consider-other-coverage-pathways-enhance-access-innovative-medical
FINAL DECISION (FEDERAL REGISTER)
November 15, 2021. 86 FR 62944-58. Here.
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Coverage at MedCity
here. Coverage at Genomeweb
here.
Legislation has been introduced to recreate the MCIT coverage by lawmaking, but it's too early to judge whether it's likely to pass (
here). HR
4043. See also HR 5333 in 2019. HR 5009 in 2016.
Update: Said legislation, or similar, is
Section 404, the MCIT section of
21st Century Cures Version 2, released November 17, HealthCareDive
here.
Nerd Note. 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 that 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 FDA BT review are put together in this sentence 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.
Second Nerd Note - Repetitive
I'll go out on a limb and say I usually find most CMS rules to be pretty well written. (Of course, when you hit an ambiguous sentence that affects you directly, that's memorable.)
In the case of the MCIT final rule, produced very quickly, I can't say that. It's unusually meandering and circuitous and repetitive.
Third Nerd Note - Med Advantage
There were comments that Medicare Advantage plans may fail to match Medicare Fee for Service coverage (as they should) or impose reasonable barriers to access. CMS made a short neutral remark in response.
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Scott Gottlieb discussed the role of MCIT in a detailed webinar he gave to Stanford Biodesign earlier this year,
here.
