Treatment is Unreasonable and Unnecessary, Public Citizen Says

WASHINGTON, D.C. – Public Citizen today urged the Centers for Medicare & Medicaid Services (CMS) not to reimburse for the surgically implanted Vagus Nerve Stimulation (VNS) electronic device in the treatment of severe depression because it is ineffective.

Public Citizen is apparently the first advocacy group to seek a National Coverage Determination denying reimbursement under Medicare. The consumer group also is filing a petition today with the Food and Drug Administration (FDA) urging the reversal of its July 2005 approval of VNS for depression.

The VNS device is implanted beneath a patient’s left collar bone in an outpatient procedure that costs about $25,000, including the device itself. The device was first approved for the treatment of severe epilepsy in 1997, but Houston-based Cyberonics, Inc., pushed for it to be approved for severe depression as well, claiming that the potential severe depression market encompassed 4.4 million people in the United States alone. The device was approved for the latter indication on July 15, 2005. Cyberonics filed a request for national Medicare reimbursement for use of the device to treat severe depression on July 24, 2006.

Cyberonics, which manufactures VNS, has already sought and been denied approval for reimbursement from 10 local CMS contractors in 14 states. To date, no contractors have agreed to reimburse for the device. Although the FDA has approved VNS for severe depression, the Social Security Act allows Medicare-sponsored reimbursement only if the device is proved “reasonable and necessary,” which Public Citizen contends it is not. This is a more rigorous standard than that followed by the FDA.

The FDA requires that a medical device be proven safe and effective, which Cyberonics has yet to do, Public Citizen says. Cyberonics conducted a three-month study of VNS’ effectiveness in which half the participants’ VNS devices were not turned on. VNS patients fared no better than patients whose device was not turned on. Instead the company has relied upon a series of non-randomized, unblinded studies with questionable control groups to make its claim for the effectiveness of the device.

“Without proof that VNS is a viable therapy for severe depression, it is unreasonable for the Medicare program to reimburse for this device,” said Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group. “With substantial constraints on the Medicare budget and so many clear needs going unmet, it seems absurd to flush away millions of dollars on this unproven device.”

Cyberonics’ request to CMS is an eleventh-hour attempt to save a failing product, Lurie said. Because of the unfavorable reimbursement decisions, the company estimates that only 1,600 devices had been implanted as of July 2006. The company may be delisted from Nasdaq because of a federal investigation into allegedly improper options provided to company executives.

Recently, the company was also embarrassed because it arranged for a ghostwriter to pen an article touting VNS in the journal Neuropsychopharmacology. The journal neglected to disclose that all eight academic authors, including the journal editor who was the lead author, had received financial support from Cyberonics. The editor resigned as a result.

The Senate Committee on Finance has conducted an investigation into VNS’ approval for severe depression. The investigation, released in February 2006, revealed that at least 20 senior FDA staff had recommended against approving VNS for severe depression, with none favoring approval – but the director of the FDA’s Center for Devices and Radiological Health overruled them all.

“FDA’s approval of VNS for severe depression was an embarrassment, both scientifically and procedurally,” said Lurie. “Now is the time to set the record straight by revoking approval for this device.”

To view a copy of the letter to CMS, visit: http://www.citizen.org/publications/release.cfm?ID=7456.

To view a copy of the petition to the FDA, visit: http://www.citizen.org/publications/release.cfm?ID=7457.