Lexology September 16, 2021
Dinsmore & Shohl LLP

On Sept. 15, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” final rule, which was published on Jan. 14, 2021, and would be effective on Dec. 15, 2021.

In June 2021, we reported on CMS’ decision to delay the MCIT Program Final Rule (The Rule). At that time, the agency said it could revise, further postpone, or even repeal The Rule. According to the Sept. 15 Federal Register Notice, CMS decision to repeal The Rule was based on a finding that it is not in the best interest of Medicare beneficiaries, because the change could result in coverage for FDA-designated...

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Topics: CMS, FDA, Govt Agencies, Insurance, Medical Devices, Medicare
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