BioUtah Urges MCIT Implementation

April 16, 2021

BioUtah has submitted a comment letter to CMS in response to concerns raised by the Biden administration around the Medicare Coverage of Innovative Technology (MCIT) rule finalized under President Trump on January 14. The MCIT program was set to take effect on March 15, but on March 12, in the form of an interim final rule, CMS delayed implementation of the MCIT program until May 15 to seek another round of public comment on operational issues, volume of MCIT devices and risk to Medicare patients.

In its letter, BioUtah has urged CMS to implement MCIT without further dellay.

The MCIT program would provide four years of immediate national coverage under Medicare for FDA-designated breakthrough medical devices and diagnostics upon FDA approval or clearance. This new coverage pathway is very important to a number of BioUtah member companies whose devices or diagnostics have received FDA breakthrough designation, including DiscGenics, IONIG Sciences, PhotoPharmics and RenalytixAI.

The new comment period ends today. After reviewing comments, CMS is not bound to launch the program on May 15. Although the agency could decide to move forward, it also has the authority to issue a  proposed rule and initiative new rule making.