FDA, CMS Extend Parallel Device Review Program

The U.S. Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) have extended a pilot program first launched in 2011 to investigate ways devices could close the gap between regulatory approval and reimbursement by payors.

Known as Parallel Review, the program was created in October 2011 as a way to allow medtech companies to get their products from an investigational stage to reimbursement more quickly. At present, FDA’s approval process and CMS’ national coverage determination (NCD) technique—the means by which the latter agency decides whether it will pay for a product (generally through Medicare)—usually are treated as separate entities, handled by different staff and at different times of the development lifecycle.

“Often, device sponsors focus solely on obtaining FDA approval, only to find that Medicare coverage is not automatically forthcoming,” FDA explained in a statement at the time of the pilot program’s launch. “Both agencies rely on clinical data in reaching their decisions, and while the two agencies have distinctly different regulatory responsibilities, parallel review can reduce time between FDA approval and Medicare national coverage determinations.”

The Parallel Review pilot program aims to change the autonomous analyses by allowing concurrent review, hypothetically allowing companies to reduce the gap between obtaining FDA approval and a reimbursement decision. Since Medicare is one of the nation’s largest purchasers of medical device products, a positive NCD often can be a de facto approval, as without the NCD a product might not have a market.

“The parallel review program has the potential to increase patient access to innovative devices that improve clinical outcomes. Our goal is to reduce regulatory burden and improve patient outcomes,” added Patrick Conway, CMS’ chief medical officer.

Only two companies have used the program since the initiative launched in 2011; Medtronic Inc. took advantage of the procedure to jumpstart the regulatory processes for its Symplicity Renal Denervation device, a catheter-based product that reduces hypertension by moderating nerve output. That device is slated to undergo joint FDA/CMS review this year or next, Medtronic announced in March 2013.

The program is limited to five companies annually, though any firm is eligible to participate if its devices fall under the PMA or de novo approval processes, or they can be counted under Medicare Part A or B and are not subject to a national coverage decision.

While promising, companies remain wary of taking advantage of the program to expedite the regulatory process. Pursuing regional CMS coverage decisions after gaining regulatory approval often is considered a safer (less risky) authorization route.

There’s still time for a change of heart, though: Both organizations have announced the pilot program will continue for at least another two years, expiring on Dec. 18, 2015. And neither agency is ruling out further extensions.