CMS proposes to repeal rule on Medicare ‘reasonable and necessary’ definition

The Centers for Medicare & Medicaid Services yesterday proposed repealing a final rule codifying how it defines “reasonable and necessary” coverage for items and services furnished under Medicare Parts A and B, which is scheduled to take effect Dec. 15. The final rule also establishes a Medicare coverage pathway for innovative medical devices designated as breakthrough by the Food and Drug Administration. Beginning tomorrow, CMS will accept comments for 30 days on the proposed repeal and the agency’s intent to conduct future rulemaking to explore the definition of “reasonable and necessary” coverage and an expedited coverage pathway for innovative beneficial technologies. 

In comments submitted last November, AHA warned against an earlier proposal that national and local Medicare coverage determinations consider the extent to which certain items or services are covered by a majority of commercial insurers, noting that such an approach could reduce coverage in the Medicare program and transparency in coverage determinations.