CMS Proposes Repeal of Medicare Coverage of Innovative Technology Pathway

September 16, 2021

CMS Proposes MCIT Repeal

On September 13, CMS issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) pathway initally finalized in a January 14, 2021 rule. 

The MCIT pathway would have provided four years of immediate Medicare coverage for FDA-designated breakthrough medical devices and diagnostics that have been market authorized – ensuring that Medicare beneficiaries gain access to innovative medical technologies.

In proposing to jettison MCIT, CMS said that “significant concerns persist about the availability of clinical evidence on Breakthrough Devices when used in the Medicare population…”  MCIT proponents have argued that physicians would determine what’s in the best interest of their patients and that product developers would have to address any evidence concerns in order to obtain permanent coverage. 

Expressing disappointment in the proposed repeal, BioUtah President and CEO, Kelvyn Cullimore, noted that “the MCIT final rule provided coverage certainties that are essential to spur continued investment in medical innovation while ensuring that seniors, including those in our most vulnerable communities, can benefit from cutting-edge medical technologies in a timely manner.”

A number of Utah medical technology companies have received FDA breakthrough designations.

The proposal to repeal MCIT also references the agency’s intent to conduct future rulemaking to explore alternative expedited coverage pathways.

View BioUtah press statement HERE.

VIew AdvaMed press statement HERE.

View MDMA press statement HERE.

VIew Renalytix press statement HERE.

CMS is providing a public comment period through October 15 to allow interested parties to provide feedback about the proposed repeal and potential for future rulemaking.