The Centers for Medicare & Medicaid Services today repealed a final rule codifying how it defines “reasonable and necessary” coverage for items and services furnished under Medicare Parts A and B, as proposed in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 said 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.

 

Related News Articles

Headline
The Department of Health and Human Services and the Centers for Medicare & Medicaid Services Aug. 21 announced the creation of a Healthcare Advisory…
Headline
A JAMA study published Aug. 18 found that plan design changes by Medicare Part D insurers, particularly for Medicare Advantage plans, following passage of the…
Headline
The AHA Aug. 11 urged the Centers for Medicare & Medicaid Services to prioritize payments to hospitals from the Rural Health Transformation Program. The…
Chairperson's File
Public
The recently enacted One Big Beautiful Bill Act will bring big changes to health care. AHA President and CEO Rick Pollack joined me for a Leadership Dialogue…
Headline
The Senate Health, Education, Labor and Pensions Committee yesterday voted 12-11 along party lines to recommend the confirmation of Brian Christine, M.D., to…
Headline
The House Ways and Means Subcommittees on Health and Oversight held a joint hearing today to discuss lessons learned, challenges and opportunities to improve…