CMS rescinds final rule for ‘breakthrough’ medical devices

The Centers for Medicare and Medicare Services is rescinding a final rule that would have granted expedited Medicare coverage for certain “breakthrough” devices.

The decision to rescind the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule is due to concerns that its provisions are insufficient to protect Medicare patients. 

The MCIT/R&N final rule gave expedited Medicare coverage for up to four years for certain Food and Drug Administration-designated “breakthrough” devices once they received or cleared market authorization.

CMS said that 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.

WHY THIS MATTERS

By rescinding this rule, CMS can take action to better address safety concerns in the future, the agency said. 

CMS said it intends to explore coverage process improvements that will enhance access to innovative and beneficial medical devices in a way that will better suit the healthcare needs of people with Medicare. This will also help 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. 

THE LARGER TREND

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 said it plans to work with the FDA, Agency for Healthcare Research and Quality, medical device manufacturers and other stakeholders to develop an efficient process to cover innovative devices that benefit Medicare patients.

Two stakeholder public meetings will be held in 2022 to inform future policy-making.

ON THE RECORD

“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.”

“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. “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.”

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