FDA, CMS to Launch Speedy Coverage Pathway for Breakthrough Medical Devices

Certain breakthrough-designated medical devices that receive market authorization will become eligible for Medicare coverage at the same time under a new coverage pathway announced Thursday by the FDA and the Centers for Medicare & Medicaid Services (CMS).

The new program “represents an unprecedented alignment and coordination” between the two agencies, said John Brooks, chief policy and regulatory officer at CMS.

As device manufacturers “come to the FDA and seek approval of regulatory devices, CMS will coordinate with FDA to provide guidance to manufacturers and help them understand what targets they need to hit in order to achieve coverage immediately upon approval in the CMS program,” Brooks said on a phone call with reporters.

Manufacturers whose medical devices have been FDA designated as Class III breakthrough devices — those addressing an unmet need for Medicare beneficiaries — will be eligible for the Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway. Certain moderate-risk Class II devices will also be considered for the program.

On the call, Grace Graham, the FDA’s deputy commissioner for policy, legislation, and international affairs, noted that “increasingly, we have heard from innovators in the medical device space that FDA may no longer be their biggest concern.”

Companies have said they would like CMS to participate earlier on, so that when trials are designed they meet the standards not only for FDA clearance or approval but also to support Medicare coverage decisions, she said.

Under RAPID, CMS will issue a proposed national coverage determination the same day that an eligible device receives FDA market authorization, triggering the statutorily required 30-day public comment period, CMS and FDA said in a press release. “This streamlined approach could enable predictable Medicare national coverage and payment as soon as 2 months after market authorization, compared to approximately a year or more under the current pathway.”

“FDA and CMS each play a critical role in getting new medical devices to patients, and they work most effectively when aligned sooner in that process,” CMS Administrator Mehmet Oz, MD, MBA, said in the press release. “The RAPID coverage pathway brings our two agencies together earlier, cutting red tape for innovators, and helping beneficiaries access new, life-changing health technology faster.”

On the call, a senior CMS official noted that there are currently 40 devices that would qualify for the RAPID pathway, and about 20 additional devices could participate as well through the Transitional Coverage for Emerging Technologies program, which was also designed to speed access to new technologies. That program “will be paused for new candidates as CMS focuses on the successful implementation of the RAPID coverage pathway,” the agencies said in the press release.

A proposed procedural notice outlining the RAPID coverage pathway will soon be published in the Federal Register and will include a 60-day comment period. The effective date of the new pathway is expected to be the date of publication of the final notice in the Federal Register.