CMS delays effective date of rule intended to hasten Medicare device coverage approval until May

The Biden administration has delayed the start date until May 15 of a rule that aims to hasten Medicare coverage of new medical devices.

The delay of the rule, originally set to go into effect on March 15, is a win for insurers who have said the rule could coverage of unproven devices.

The delay of the rule, which also comes with a new 30-day comment period, is part of a larger regulatory freeze instituted by the Biden White House to review last-minute regulations approved under the Trump administration.

But the regulatory filing on Friday outlining the delay also laid out several concerns that the Biden administration had with the rule.

The rule would create a new pathway that would speed up the Medicare coverage process for devices that are approved via the Food and Drug Administration’s “breakthrough” pathway that are intended to address an unmet medical need.

Devices approved under this pathway would get national Medicare coverage for four years simultaneously with approval by FDA. Normally it can take a year or more to get Medicare coverage for new devices after FDA approval or clearance.

A new concern laid out by the Biden administration is the volume of devices approved under FDA’s breakthrough pathway.

The original rule’s regulatory impact analysis expected the device program would initially apply to a small number of devices, roughly two to five devices falling into the pathway initially and gradually increase after that.

“New data, publicly reported by the FDA on Feb. 16, 2021, … indicated that more than 400 devices have been designated as breakthrough,” the regulatory filing said. “We recognize that not all of those devices will be market-authorized, and we cannot know the precise timing of those market authorizations.”

The agency also wants comments on whether there are procedural issues and if the final rule needs to be rescinded or delayed.

The major insurance group America’s Health Insurance Plans said in comments that the rule could result in a less rigorous evidence-based coverage process and potentially result in premature coverage of unproven devices.”