CMS Issues Proposed Rule to Establish National Medicare Coverage Pathway for Medical Devices with Breakthrough Designation and Modifies Definition of “Reasonable and Necessary”

Today, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to establish a Medicare coverage pathway for medical devices designated as breakthrough by the Food and Drug Administration (FDA). The new proposed Medicare Coverage of Innovative Technology (MCIT) pathway would significantly accelerate Medicare coverage of new breakthrough devices by beginning national coverage [...] Read More