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The Centers for Medicare & Medicaid Services today a final rule codifying how it defines “reasonable and necessary” coverage for items and services furnished under Medicare Parts A and B, as proposed in September. Scheduled to take effect Dec. 15, the rule also provided an expedited Medicare coverage pathway for certain innovative medical devices designated as breakthrough by the Food and Drug Administration, which CMS may not have provided sufficient safety protections.  

CMS instead plans to work with the Food and Drug Administration, Agency for Healthcare Research and Quality, medical device makers and other stakeholders to develop an expeditious process to cover innovative devices for Medicare patients, and to hold at least two public meetings in 2022 to inform such policymaking.

In comments submitted on the proposed rule last November, AHA strongly opposed the elevation of definitional guideposts from a manual provision to enforceable standards in the Code of Federal Regulations, especially without a comprehensive assessment of the impact of that change and a clearer articulation of the process by which the new standard would be imposed.