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Medicare Right to Reject Brain Stimulation Device

Feb. 6, 2007

Medicare Right to Reject Brain Stimulation Device

Agency Agrees With Public Citizen That Vagus Nerve Stimulation Is Ineffective

WASHINGTON, D.C. – The Centers for Medicare & Medicaid Services’ (CMS) proposal to deny reimbursement for the implantation of the Vagus Nerve Stimulation (VNS) device is right, Public Citizen said today.

The agency correctly found that the device “is not reasonable and necessary for treatment of resistant depression,” a decision that is very likely to result in the denial of reimbursement for implantation of this device in Medicare patients. 

On Sept. 6, Public Citizen sought just such a negative “National Coverage Determination” in a letter it sent to CMS. It also petitioned the Food and Drug Administration (FDA) to reverse its July 15, 2005, approval of the device, which Public Citizen opposed when the agency first considered it.

The VNS is surgically implanted at the base of the neck, where it stimulates the vagus nerve, purportedly treating an ill-defined condition the company calls “treatment-resistant depression.” However, the device failed its only properly designed study. Nonetheless, the FDA found a way to overrule the unanimous recommendations of at least 20 staffers and approved the device.

“CMS’s decision likely represents the death knell for VNS in the treatment of depression,” said Peter Lurie, deputy director of Public Citizen’s Health Research Group. “Patients with depression are not well-served by having ineffective treatments available.”

Moreover, the government agency went beyond finding that the device is not “reasonable and necessary,” the standard for Medicare reimbursement, concluding that it “does not believe there is a treatment effect directly attributable to VNS therapy based on the current evidence.”  In effect, the agency is telling the FDA that the device never met the criteria for FDA approval in the first place.

“It is high time for the FDA to admit that it erred and get this high-tech placebo off the market,” said Lurie.