In January 2021, the Trump administration finalized regulations that would provide 4 years of Medicare coverage to new devices if they were approved by the FDA Breakthrough Pathway - here. The title is, "Medicare Coverage for Innovative Technology," or MCIT.
After several intermediate steps, the Biden administration announced on September 13 it intends to entirely cancel the Breakthrough coverage regulations - here.
(See a listing of all the regulatory steps - here.)
In order to comment the MCIT cancellation, go to this webpage:
- Medicare Program: Medicare Coverage of Innovative Technology and Definition of Reasonable and Necessary (September 14, 2021)
Note, the box in the upper right, "SUPPORT," is for technical support, not a button for making a PayPal donation to CMS or regulations.gov.