For more information about this blog post, please contact Khaled J. Klele, Ryan M. Magee, Labinot Alexander Berlajolli, or Connor Breza.

As expected, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule, 86 FR 51326, rescinding coverage of medical technologies that the Food and Drug Administration (“FDA”) designates as “breakthrough,” as set forth in the Medicare Coverage of Innovative Technology (the “MCIT”) final rule on January 12, 2021.  The rescission is hardly surprising, given CMS’s delay of the final rule, first in March 2021, and then in May 2021.  The proposed rule cites safety concerns and availability of clinical evidence on the benefits or risks of breakthrough devices as reasons for withdrawal of the MCIT final rule.  Comments on CMS’s proposal to withdraw the MCIT final rule are due on October 15, 2021.