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However, upon further review, the administration now believes the rule needs to be withdrawn completely.
