Parallel Review Expands. But Will It Get More Participants?

The FDA and CMS Dec. 17 announcedthey would expand for two years a pilot program for parallel reviews of medical devices. The program allows CMS to concurrently review a device for Medicare coverage at the same time FDA is reviewing it for approval. It was first launched in 2011 with the intent of reducing the time between FDA market approval and the CMS national coverage determinations (NCDs) of a medical product.

Often, device sponsors focus solely on obtaining FDA approval, only to find that Medicare coverage is not automatically forthcoming. Both agencies rely on clinical data in reaching their decisions, and while the agencies have distinctly different regulatory responsibilities, parallel review can reduce time between FDA approval and Medicare national coverage determinations.

Yet for varying reasons, manufacturers have kept their distance, and there have been just two companies that have entered their devices into the program since it launched. One device industry representative told me the program is a promising step, but the agencies have lots of kinks to work out first. Some feel the process just isn’t beneficial, and there’s always a risk of getting a national non-coverage determination. The program is voluntary, and if companies don’t participate, they can often apply for regional coverage determinations—some places will be successful, some won’t, but the sheer number of regions across the country can be appealing.

Perhaps with the two year extension the kinks can be worked out of the system, and the benefits of increased FDA and CMS collaboration will be clearer for manufacturers.