Forbes October 4, 2021
In January 2021, in the waning days of the Trump Administration, the Centers for Medicare and Medicaid Services (CMS) finalized a rule on coverage of breakthrough medical devices. Specifically, the rule would create a new pathway, “Medicare Coverage of Innovative Technology (MCIT),” for medical devices designated as breakthrough by the Food and Drug Administration (FDA), allowing national coverage for on-label uses of devices for four years, after which CMS would determine further coverage status.
Last month, CMS reversed course, by proposing to rescind the rule due primarily to clinical evidence concerns.
The MCIT rule was proposed in response to legitimate stakeholder worries about time lags and coverage uncertainty for devices subject to claim-by-claim coverage determinations. So, CMS’s new proposed regulation...
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