CMS Repeals MCIT/R&N Payment Rule for Breakthrough Devices

The Centers for Medicare and Medicare Services (CMS) is rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule because of concerns that the provisions in the final rule may not have been sufficient to protect Medicare patients. By rescinding this rule, CMS can take action that will better address those safety concerns in the future. 
 
“Although we continue to be in favor of enhancing access to new technologies, we are mindful that they may have unknown or unexpected risks and must first ensure such technologies improve health outcomes for Medicare beneficiaries,” said CMS Administrator Chiquita Brooks-LaSure. “The Medicare program needs to implement policies that balance access and appropriate safeguards.”
 
The MCIT/R&N final rule would have granted expedited Medicare coverage for up to four years for certain Food and Drug Administration (FDA)-designated “breakthrough” devices once it receives or clears 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 intends to explore coverage process improvements that will enhance access to innovative and beneficial medical devices in a way that will better suit the health care needs of people with Medicare. This will also help to establish a process in which the Medicare program covers new technologies on the basis of scientifically sound clinical evidence, with appropriate health and safety protections in place for the Medicare population. 
 
“CMS is committed to coverage that provides an appropriate balance of support for innovation with necessary protections for Medicare patients,” said Dr. Lee Fleisher, 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.”
 
While CMS is officially rescinding the MCIT/R&N final rule, there remain existing and proven pathways that allow for coverage of a specific medical device or service. Devices may still be covered through claim-by-claim determinations, under one or more local coverage determinations, or a national coverage determination. CMS plans to work with the FDA, Agency for Healthcare Research and Quality (AHRQ), medical device manufacturers, and other stakeholders to develop an expeditious process to cover innovative devices that benefit Medicare patients, and intends to hold at least two stakeholder public meetings in CY 2022 to inform our future policy-making in this space.
 
To view the rule, visit: https://public-inspection.federalregister.gov/2021-24916.pdf