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Medicare Plans Draft Rule to Accelerate Medical Device Coverage

Oct. 12, 2022, 7:00 PM

New medical devices could start undergoing review for Medicare coverage before receiving FDA marketing authorization under a proposed rule the Biden administration plans to release in the coming months.

Officials from the Centers for Medicare & Medicaid Services announced Wednesday that the proposal would establish a pathway that medical device manufacturers can enter on a voluntary basis to start getting their products reviewed earlier. The action is part of a series of efforts by the CMS and the Food and Drug Administration to better coordinate their product reviews so that patients can get quicker access to novel treatments and emerging medical technologies.

“The CMS remains committed to establishing an expedited Medicare coverage pathway that achieves timely and predictable coverage of medical devices while at the same time ensuring that coverage is based on scientifically sound clinical evidence,” CMS Chief Medical Officer Lee Fleisher and Chief Operating Officer Jonathan Blum wrote in a piece published in JAMA Internal Medicine.

Fleisher and Blum wrote that the forthcoming CMS proposed rule “would strike a balance between promoting access to emerging medical technologies and maintaining the protections and rigorous evidence standards that are essential to the welfare of Medicare beneficiaries.”

The proposed rule, if finalized, would allow the CMS to conduct an early evidence review so the agency can discuss with the manufacturer the best Medicare coverage pathway based on the strength of the evidence collected on the product, the officials said. They added that the Medicare agency begin the coverage review process prior to a product receiving FDA marketing authorization, “which could require developing an additional evidence development plan and confirming that there are appropriate safeguards and protections for Medicare beneficiaries.”

“If CMS determines that further evidence development is the best coverage pathway, the agency would explore how to reduce the burden on manufacturers, clinicians, and patients while maintaining rigorous evidence requirements,” the authors said.

The proposal follows a decision by the CMS in November 2021 to rescind a Trump-era rule that would have automatically provided four years of Medicare coverage for newly approved medical devices. But many physicians and industry groups that submitted comments on the rule expressed concerns that the policy didn’t have enough specific guardrails in place to ensure the devices receiving coverage, including implants and gene-based tests for cancer and heart disease, would safely and effectively meet the needs of beneficiaries in the long term.

‘Running Side by Side’

CMS Administrator Chiquita Brooks-LaSure and FDA Commissioner Robert M. Califf said in a joint statement in April that “underpinning both of our agencies’ work is the unwavering commitment to use reliable data to ensure that effective treatments are made available to patients.”

The level of coordination between the agencies faced scrutiny especially after CMS announced in April it would only cover Biogen’s Alzheimer’s drug Aduhelm and other treatments like it to patients in CMS-approved clinical trials. This came after the FDA granted accelerated approval to the drug, going against the recommendation of an outside panel of scientific advisers.

The FDA’s mandate allows it to review evidence and clear products it deems safe and effective for their intended use, while the CMS evaluates whether drugs and devices are reasonable and necessary for use in the Medicare population.

In a July webinar with the Alliance for a Stronger FDA, Califf said that ensuring patients get access to new safe and effective medical products should be a joint effort with the CMS to change its current system of regulatory and coverage decisions.

“The US approach up to now has been FDA runs its lap, and then, it drops the baton, and then, the payers and CMS have to pick it up and figure out what’s going on, and then start the next lap,” Califf said at the time. “We ought to be running side by side for 30 or 40 yards before handing off the baton.”

“That means, in the design of late phase studies, for example, making sure there is a connection to what the payers are going to need to understand about you, in comparative effectiveness,” he added.

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editors responsible for this story: Alexis Kramer at akramer@bloomberglaw.com; Brent Bierman at bbierman@bloomberglaw.com