Biden Administration Delays Effective Date and Opens Another Comment Period for New Medicare Coverage Pathway for Breakthrough Medical Devices and Definition of “Reasonable and Necessary”
CMS delayed the effective date of a groundbreaking Medicare coverage regulation issued in the final days of the Trump Administration. The Final Rule entitled, “Medicare Program: Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’” published in the Federal Register on January 14, 2021 (the “MCIT Final Rule”), would establish a novel coverage pathway for breakthrough devices as well as codify in regulation a definition for the Medicare coverage standard of “reasonable and necessary” that includes reference to commercial insurer coverage decisions as a basis for Medicare coverage. The MCIT Final Rule is now subject to a 30-day public comment period so that CMS can determine whether to revise or rescind the MCIT Final Rule by May 15, 2021, its new, delayed effective date. Comments are due to CMS by April 16, 2021.