The Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have announced that they are making permanent their “Program for Parallel Review of Medical Devices,” which is now operating as a pilot program. The parallel review initiative allows concurrent FDA and CMS review of a medical device with the goal of reducing the time between FDA marketing approval or granting of a de novo request and Medicare coverage decisions, thereby “facilitating earlier access to innovative medical technologies for Medicare beneficiaries.” Acceptance of a device into the parallel review program does not modify FDA’s premarket review criteria (thus leaving preemption unaffected) or CMS’s coverage criteria.
In the notice announcing the extension of the parallel review program, the agencies observe that the pilot program benefitted manufacturers by providing feedback to help design pivotal trials that can answer both agencies’ evidentiary questions. The notice also cites the program’s success in facilitating issuance of a Medicare national coverage determination less than two months after a medical technology (the CologuardTM colorectal cancer screening test) received FDA premarket approval.
The agencies are soliciting nominations from manufacturers of additional innovative medical devices to participate in the parallel review program. However, due to FDA and CMS resource issues, the permanent program, like the pilot program, will still only accept five candidates per year. More information is available on the FDA website.