CMS Rescinds Rule Expediting Medicare Coverage of Breakthrough Devices

CMS has officially rescinded a final rule published by the Trump Administration that would have expedited the Medicare coverage process for breakthrough devices. The agency said it will take a different action to increase beneficiary access to innovative medical devices.

“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,” CMS Administrator Chiquita Brooks-LaSure said in an announcement earlier today. “The Medicare program needs to implement policies that balance access and appropriate safeguards.”

Released in 2014, the final rule titled “Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’” would have granted expedited Medicare coverage for up to four years for certain devices classified as “breakthrough” by the Food and Drug Administration (FDA). The process would have started once a device received or cleared market authorization.

The rule was slated to take effect on December 15, 2021, after several implementation delays.

However, CMS said in the announcement today 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.”

“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,” said Lee Fleisher, MD, CMS Chief Medical Officer and Director for the Center for Clinical Standards and Quality.

The move also withdraws a new definition of “reasonable and necessary” in Parts A and B of the Medicare program. The final rule would have been updated to consider private payer coverage of services when determining if services are reasonable and necessary.

Public comments revealed significant concern with the new approach, with many stakeholders citing potential issues with flexibility of decisions and possibly equitable access to care. CMS also previously said the new definition would have created “implementation and appeals process challenges.”

With the rule repealed, CMS said it will consider Medicare coverage process improvements to increase beneficiary access to innovative medical devices “in a way that will better suit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,” the agency added.