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CMS has officially rescinded a final rule published by the Trump Administration that would have expedited the Medicare coverage process for breakthrough devices.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.

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

“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.

 

Source: https://revcycleintelligence.com/news/cms-rescinds-rule-expediting-medicare-coverage-of-breakthrough-devices