posted by AHIP
on November 2, 2020
The Proposed Rule would establish a new Medicare coverage pathway for FDA-approved breakthrough devices under which national Medicare coverage (both traditional fee-for-service Medicare and Medicare Advantage) would begin on the same day a breakthrough device receives FDA approval and last up to four years.
In our comments, AHIP cited significant concerns that this approach could put seniors, people with disabilities, and the solvency of the Medicare Trust Fund at risk. Our comments noted that currently, when a medical device is approved by the FDA, it must be further evaluated by a plan’s medical policy committee to assess clinical efficacy and safety for this population. The proposed pathway entails a less rigorous evidence-based process that could result in premature coverage of unproven devices for the Medicare population, with no requirement for device manufacturers to conduct additional clinical studies focused on the Medicare population during the coverage period. We recommended that CMS adapt and streamline existing processes to allow for rapid reviews of breakthrough devices, while still fully considering the evidence needed to ensure their safety and effectiveness.
The rule also proposes to codify a modification of Medicare’s definition of “reasonable and necessary” to allow for commercial coverage of an item or service to serve as evidence of appropriateness in CMS’ “reasonable and necessary” assessment. Our comments raised a number of potential unintended consequences of this proposal and recommend that CMS give additional consideration to these issues before moving forward with the proposal.