Industry Retains Hope as New MCIT Proposal Reaches White House OMB’s Desk

article image
ARTICLE SUMMARY:

CMS has apparently produced a new proposed rule for the Medicare Coverage of Innovative Technology program and sent it for administrative vetting. It could be a positive sign for industry that some version of the automatic coverage pathway will make it over the finish line, but details remain thin and there are no assurances.

CMS has completed work on a new Medicare Coverage of Innovative Technology (MCIT) proposed rule, but the details of how the agency plans to rework the pending program intended to accelerate national Medicare coverage for FDA-designated Breakthrough Devices are not yet public.

The Medicare agency submitted an MCIT proposed rule to the White House Office of Information and Regulatory Affairs (OIRA, part of the Office of Management and Budget) for review on August 27, suggesting that CMS has completed its internal work on the document. OIRA can take anywhere from several weeks to many months to vet agency proposals, but the step gives industry some hope that CMS plans to actually implement some version of the MCIT program, rather than completely cancel it, as some have feared. (See “MCIT Breakthrough Coverage Pathway In Doubt Following CMS Delay,” Market Pathways, March 16, 2021.)

×



This article is restricted to subscribers only.

Sign in to continue reading.

Questions?

We're here to help! Please contact us at: