The Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA) submitted comments last week to the Centers for Medicare & Medicaid Services (CMS) on the agency’s proposal to repeal the Medicare Coverage of Innovative Technology (MCIT) final rule. Comments from both associations highlighted concerns with the repeal of the final rule and its impact on innovation for the medical device industry. 

Pathway History  

In September, CMS issued a proposed rule that would withdraw the existing regulation that created a pathway mandating an expedited four-year journey to Medicare coverage for medical devices that had been authorized by the United States Food and Drug Administration (FDA) as a breakthrough device. The original rule, which was published by CMS on January 14, 2021 by the Trump Administration, faced sustained pushback from the insurance industry. And before releasing the proposed rule change, CMS had delayed implementation of the Trump era rule on two prior occasions this year, with the agency indicating that the pathway may inadvertently lead Medicare to cover unnecessary products. 

As previously noted, AdvaMed and MDMA submitted comments in opposition to the repeal of the MCIT, and each association took a slightly different approach with their comments. AdvaMed pushed for CMS to keep the existing rule and provided feedback to address specific concerns regarding the outlined pathway. MDMA asked for CMS to develop a new rule which included the pathway along with the incorporation of received feedback on the existing rule, the association was targeting June 2022 for the agency to complete its work on the new rule.   

Possible Alternative Route 

If CMS does go ahead and repeal the MCIT, a congressional option still exists through the CURES 2.0 legislation of which Colorado Rep. Diana DeGette along with Missouri Rep. Fred Upton released a draft version earlier this year. While it does not appear the legislation will be moving forward before the end of this year, it would provide a viable path for the codification of an expedited pathway for designated medical devices. A policy brief published earlier this month by Duke University’s Margolis Center for Health Policy provides background on the draft legislation’s Medicare coverage provisions: Modernizing Access for Breakthrough Devices: Cures 2.0 Act Provisions on Medicare Coverage.   

CBSA’s Work to Communicate Concerns About the Proposed Repeal 

CBSA earlier this week conducted outreach to the offices of Senators Bennet and Hickenlooper on the proposed repeal. In addition to providing background information about the repeal, a Congressional sign-on letter to CMS expressing concerns about the repeal being led by Democratic Senator Maggie Hassan was shared with the offices. Congressional outreach to CMS has included a letter from Republican Senators Mike Crapo, Richard Burr, Cathy Rodgers, and Kevin Brady expressing their concerns with the proposed repeal. 

CBSA collaborates with our partners to improve the drug, device, and diagnostic review and approval process. The association supports policies that lead to greater consistency, predictability, and transparency in the FDA’s review programs and help to bring safe and effective innovative therapies and technologies to patients. The association is also committed to working with Congress, federal agencies, and stakeholders to develop a workable framework for the regulation of diagnostic tests that does not impede patient access to precision diagnostics or restrain innovation.