FDA, CMS extend little-used pilot program that grants parallel review for some devices

The FDA and Centers for Medicare & Medicaid Services are expanding an as-yet little-used pilot program for two more years that lets eligible companies pursue regulatory and reimbursement approval for a given product at the same time.

As Bloomberg BNA reported, only two companies have used the program since the initiative launched in 2011. In theory, they stand to gain plenty. If companies agree to FDA-CMS parallel review, it could slash the time needed to bring a product to market and gain vital revenue in the form of Medicare coverage. Right now, the FDA PMA approval process is time consuming and expensive on its own. With that in hand, however, med tech companies that have a new device or diagnostic typically must then pursue Medicare coverage before they can really hit the ground running, something that can also be a lengthy process. Private insurers often sign on after CMS/Medicare does, so without CMS on board, a product launch can be dead in the water.

Taking care of both tasks at the same time looks great on paper. The idea is that parallel review would be not just quicker, but also spur more innovation in the marketplace.

Who can participate? According to the FDA's website, a company can apply if its devices fall under the PMA or de novo approval process, can be counted under Medicare Part A or B and aren't subject to a national coverage decision. Up to 5 companies annually can pursue this process, the FDA noted.

At least one industry insider told Bloomberg BNA that the program, while promising, has been clunky so far, and that potential participants are wary of taking part for a variety of reasons. Pursuing regional CMS coverage decisions after gaining regulatory approval is often seen as safer, the story noted.

Assuming the FDA and CMS can improve on the initial pilot, the program could be a boon to companies as pitched. But there are other outside factors that could minimize its benefit. Parallel review process or not, device and diagnostics operations are having a harder time these days obtaining Medicare coverage. Healthcare reform has left companies having to prove their new med tech devices and diagnostics improve the standard of care and also help manage or reduce healthcare costs. That's become a challenge to overcome on its own that isn't likely to change anytime soon.

- read the Bloomberg BNA blog