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. It also requested additional comments to inform CMS’ determination on whether further actions are appropriate, including revising or rescinding the rule.
- MCIT functions for manufacturer benefit: The rule, known as the Medicare Coverage of Innovative Technology (MCIT), would provide Medicare coverage of the devices for four years. During the four-year period, CMS advises that manufacturers develop additional evidence showing the applicability of their products to Medicare beneficiaries so can apply for further coverage.
- A new Medicare passage for all: The rule establishes a new Medicare coverage pathway for FDA-approved breakthrough devices under which national Medicare coverage 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.
- Breakthrough innovations and life-saving technologies: “This new proposal would give Medicare beneficiaries faster access to the latest lifesaving technologies and provide more support for breakthrough innovations by finally delivering Medicare reimbursement at the same time as FDA approval,” said Alex Azar, the Department of Health and Human Services Secretary.
- AHIP Comments on CMS: AHIP shares its members’ commitment to providing Medicare-eligible Americans access to new and innovative medical devices that are safe and effective. Their comments emphasize the lack of the MCIT pathway to fully and appropriately evaluate safety, efficacy, and value for the Medicare population before or post-coverage and point to existing, evidence-based coverage pathways that could and should be leveraged and streamlined to achieve the same goals.
- Concern for the regulatory impact of MCIT :The comments also highlight numerous operational challenges, including those related to decisions on benefit category, coding, and payment levels. They 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.