Despite support from a wide range of stakeholders and bipartisan congressional support, the U.S. CMS has suspended implementation of the Medicare Coverage of Innovative Technology (MCIT) rule through Dec. 15, 2021. CMS argued that most of the approved or cleared breakthrough devices are already covered through existing payment mechanisms, but the delay opens the door to any one of multiple possible legislative solution, such as follow-on legislation to the 21st Century Cures Act.