Non-binding Guidance: Rolling Back the Medicare Coverage of Innovative Technology (MCIT) Rule

This installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on the Biden administration's recent proposal to repeal the Medicare Coverage of Innovative Technology ("MCIT") final rule, which was published in January 2021 and initially scheduled to become effective on December 15, 2021. This proposed rule, although published by the Centers for Medicare and Medicaid Services ("CMS"), relates directly to FDA regulation of medical devices because it would provide automatic Medicare coverage to products that FDA approves or authorizes under its Breakthrough Device Program. In this episode, Ropes & Gray life sciences regulatory & compliance head, Greg Levine, and health care partner, Tom Bulleit, will discuss the significance of this development—a reversal of what would've been a significant innovation for Medicare coverage and payment of new device technology—and share some pathways manufacturers of breakthrough devices can use to obtain Medicare coverage after approval while FDA and CMS collect comments on a new program to replace the MCIT program.