News: CMS proposes repealing coverage of breakthrough devices rule

CMS has released a proposal to repeal the final rule Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary.” The rule sought to deliver faster Medicare coverage for medical devices noted as “breakthrough” by the Food and Drug Administration, as well as would have implemented new standards for the definition of “reasonable and necessary.” The initial rule was slated to take effect starting December 15, 2021.

According to CMS, “government processes have slowed beneficiaries’ access to innovative treatments. Despite being deemed safe and effective by the FDA, Medicare beneficiaries have not had predictable, immediate access to innovative breakthrough devices.”

CMS stated that “[they] believe that the finalized MCIT/R&N rule is not in the best interest of the Medicare beneficiaries because the rule may provide coverage without adequate evidence that the Breakthrough Device would be a reasonable and necessary treatment for the Medicare patients that have the particular disease or condition that the device is intended to treat or diagnose.”

The FDA does not currently require clinical trials for medical devices to include Medicare patients, and because Medicare patients have more comorbidities and typically require higher acuity services, as explained by CMS, this could affect patient outcomes.

CMS is seeking a full repeal of the final rule, and inviting additional comments on the reasonable and necessary standards in Medicare. Comments are due within 30 days of September 15, 2021.

Editor’s note: The CMS proposal can be found here.