MCIT Breakthrough Coverage Pathway In Doubt Following CMS Delay

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CMS issued a two-month delay notice for the Medicare Coverage of Innovative Technology program just before its March 15 scheduled start date. The move might ultimately just provide some extra time to operationalize or tweak the automatic medtech coverage pathway, but it also could be a pretext for the Biden administration to stop the program before it begins.

A highly anticipated new program to grant automatic, temporary Medicare coverage to FDA-approved Breakthrough Devices is on ice and its future is not assured.

The Medicare Coverage of Innovative Technology regulation was scheduled to take effect on March 15, but CMS issued a notice on March 12 delaying MCIT for two months and initiating a 30-day comment period. The delay is not a complete surprise, as the rule was finalized in the closing days of the Trump administration, and the new Biden administration had initiated a regulatory freeze allowing time to review unimplemented Trump policies. But the tenor of CMS’ recent notice worries industry advocates.

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