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Thursday, March 14, 2013

Will Medtronic's New Device Be A Standard-Bearer?

by Nathaniel Weixel

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Device giant Medtronic is blazing a trail through uncharted waters by allowing both CMS and FDA to concurrently review its new device through a pilot program. That device is called the Simplicity renal denervation system, and is intended for patients with “treatment-resistant hypertension.” By entering into the parallel review program, Medtronic seems to be interested in getting its new device to patients as quickly as possible.

The parallel review program was launched in 2011 as a voluntary way for companies to reduce the time between FDA market approval and CMS national coverage determinations. It’s only intended for the most innovative devices, but Medtronic is one of the first, if not the only, company to publicly announce that is putting a product through that process.

I spoke with an attorney who specializes in FDA, who explained that the program has probably been underutilized because companies are afraid of getting denied Medicare coverage, even if they get FDA approval. Normally, companies get FDA approval for their devices, and then go through a series of local Medicare coverage decisions. Get enough local coverage decisions, eventually you've got de facto national coverage. It takes time, but it’s safer. With the parallel review program though, everything happens at a national level. You get denied national coverage, you’re in trouble. If Medtronic succeeds, it could open the door for others to apply. If not, it would only justify their reasons for staying away.
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