On September 15, 2021, the Centers for Medicare & Medicaid Services (CMS) published a proposal (Proposed Rule) in the Federal Register that would repeal the Medicare Coverage of Innovative Technology (MCIT) pathway and “reasonable and necessary” final rule published January 14, 2020 (Final Rule). The Final Rule has an effective date of December 15, 2021. In its Proposed Rule proposing to repeal the Final Rule and seeking comments on that proposal, CMS expresses concerns about the adequacy of evidence needed to demonstrate that a device subject to the MCIT pathway is “reasonable and necessary” for purposes of Medicare coverage as well as operational challenges with the “reasonable and necessary” regulations. Continue reading

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