The Centers for Medicare and Medicare Services (CMS) is repealing the “Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” final rule. In rescinding the rule, CMS acknowledges concerns that requirements in the final rule may be inadequate to safeguard Medicare patients. The retraction gives CMS the opportunity to take additional action that will better serve Medicare patients — addressing safety concerns that could potentially endanger the Medicare population.
While CMS’s commitment to enhancing and expanding access to new technologies remains strong, the agency also recognizes its responsibility to its beneficiaries — implementing policies that balance access with appropriate safeguards. CMS found that clinical evidenced-based studies needed for FDA approval may not have considered the differences in clinical profiles, complexities of medical conditions, or associated treatments across a diverse Medicare patient population — leading to possible unintended consequences or unexpected risks for Medicare patients. CMS also recognizes that it could have potentially covered innovative technology that lacks sufficient evidence to demonstrate clinical efficacy of these devices — indicating whether technologies are “reasonable and necessary” to diagnose and/or or treat Medicare patients for specific medical problems.
CMS plans to work with the FDA, medical device manufacturers, and other stakeholders to develop an efficient process to balance coverage of innovative devices that benefit Medicare patients with adequate safeguards — intending to hold at least two stakeholder public meetings in CY 2022 to inform on future policymaking in this space.
AASM staff will continue to monitor updates on future guidance or rulemaking. Questions can be sent to firstname.lastname@example.org.