March 19, 2021

HHS Delays Implementation of New Coverage Pathway for Breakthrough Devices

On March 17, HHS announced that it was delaying the implementation of a rule establishing the Medicare Coverage of Innovative Technology (MCIT) pathway  until May 15. The MCIT pathway was designed to accelerate the coverage of new, innovative breakthrough devices by Medicare.  Under the rule, Medicare coverage for breakthrough medical devices would begin immediately upon FDA market authorization or at a date of the manufacturer’s choosing within four years of FDA approval.  Currently, the statutorily defined pathway for a device to obtain a National Coverage Determination generally takes nine to twelve months to complete; the new rule would instead provide immediate, predictable coverage.  Further, because coverage would be national under the MCIT pathway, device manufacturers would not be required to obtain clearance from the regional Medicare administrative contractors (MACs) that make local coverage decisions.