CMS wants to pull Trump-era pathway that speeds up Medicare coverage of breakthrough medical devices

by Robert King | Sep 13, 2021 

The Biden administration wants to pull a controversial Trump-era regulation that would hasten Medicare coverage of breakthrough devices, handing the insurance industry a win.

The Centers for Medicare & Medicaid Services (CMS) issued Monday a proposed rule that would withdraw the rule that creates a new pathway that mandates Medicare coverage as soon as a breakthrough medical device is authorized by the Food and Drug Administration. CMS said the pathway could lead Medicare to cover unnecessary products.

The agency had “significant concerns” about the availability of clinical evidence of breakthrough medical devices when used on the Medicare patient population “as well as the benefit or risks of these devices with respect to use in the Medicare population upon receipt of coverage,” the new proposed rule said.

The Trump administration finalized the pathway Jan. 14, less than a week before President Joe Biden was sworn in. The Biden administration delayed the implementation date, which was set to March, until December of this year.

However, upon further review, the administration now believes the rule needs to be withdrawn completely.


Chris J. Stewart

Chris currently serves as President and CEO of Surgio Health. Chris has close to 20 years of healthcare management experience, with an infinity to improve healthcare delivery through the development and implementation of innovative solutions that result in improved efficiencies, reduction of unnecessary financial & clinical variation, and help achieve better patient outcomes. Previously, Chris was assistant vice president and business unit leader for HPG/HCA. He has presented at numerous healthcare forums on topics that include disruptive innovation, physician engagement, shifting reimbursement models, cost per clinical episode and the future of supply chain delivery.

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