Today AHIP submitted comments on the Centers for Medicare & Medicaid Services’ (CMS) Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” interim final rule that delays the effective date by 60 days to May 15, 2021, and requests additional comments to inform CMS’ determination on whether further actions are appropriate, including revising or rescinding the rule.
The rule establishes 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. The rule also codifies regulatory standards Medicare uses to make “reasonable and necessary” determinations for items and services furnished under Parts A and B.
In our comments, AHIP shares our members’ commitment to providing Medicare-eligible Americans access to new and innovative medical devices that are safe and effective. However, we cite significant concerns that the new coverage pathway could put seniors, people with disabilities, and the solvency of the Medicare Trust Fund at risk. Our comments emphasize the lack of the MCIT pathway to fully and appropriately evaluate safety, efficacy, and value for the Medicare population prior to or post-coverage and point to existing, evidence-based coverage pathways that could and should be leveraged and streamlined to achieve the same goals. Our comments also highlight numerous operational challenges, including those related to decisions on benefit category, coding, and payment levels, and express serious concern over the regulatory impact analysis’ significant underestimation of the volume of devices that could be eligible for the MCIT pathway. Lastly, our comments raise several concerns with codifying Medicare’s “reasonable and necessary” standard and including commercial coverage as an indicator of appropriateness for purposes of Medicare coverage.