The Centers for Medicare and Medicaid Services (CMS) said it is rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule. The agency said it is concerned that the provisions in the final rule may not have been sufficient to protect Medicare patients.
The MCIT/R&N final rule would have granted expedited Medicare coverage for up to four years for certain U.S. Food and Drug Administration (FDA)-designated “breakthrough” devices once they receive or clear market authorization. However, the kinds of clinical studies needed for FDA market authorization might not consider the differences in clinical profiles, complexities of medical conditions, or associated treatments of the diverse population of Medicare patients, CMS said.
“CMS is committed to coverage that provides an appropriate balance of support for innovation with necessary protections for Medicare patients,” said Lee Fleisher, MD, CMS Chief Medical Officer and Director for the Center for Clinical Standards and Quality (CCSQ). “Under the rule we are repealing, CMS may have covered devices without adequate evidence to demonstrate that the device would be reasonable and necessary to diagnose or treat the Medicare population for particular medical conditions.”
CMS said it is exploring other regulatory options. In the meantime, “devices may still be covered through claim-by-claim determinations, under one or more local coverage determinations, or a national coverage determination.”