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FDA-CMS Parallel Review Program Gets Expected Extension to Cover Medtronic, Other Devices

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By Alexander Gaffney, RF News Editor

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In an expected announcement, the US Food and Drug Administration (FDA) and US Centers of Medicare and Medicaid Services (CMS) have announced they plan to extend and continue a pilot program first launched in 2011 to investigate how devices could close the gap between regulatory approval and reimbursement by payors.

Background

The pilot program, known as Parallel Review, was conceived in October 2011 as a way to allow 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) process—the process by which it comes to a decision regarding whether it will pay for a product, generally through Medicare—are usually 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 looks to change this by allowing concurrent review, hypothetically allowing companies to reduce the gap between obtaining FDA approval and a reimbursement decision. Because Medicare is one of the largest purchasers, if not the largest, of medical device products in the US, a positive NCD can sometimes be a de facto approval for a product, 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.

An Expected Extension

The program has already seen several devices participate, including Medtronic's Symplicity Renal Denervation Device, a catheter-based procedure intended to reduce hypertension by moderating nerve output.

That device is due to see joint FDA/CMS review in 2014 or 2015, Medtronic announced in March 2013.

And based on those future plans, it is of little surprise that both agencies have announced the pilot program will continue for at least another two years.

In a Federal Register announcement posted on 17 December 2013, the agencies said the program's new tentative end date is 18 December 2015. Further extensions of the program may be permitted, the agencies wrote.


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