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Dr. Richard L. Rudolph, Cyberonics

Although approved by the FDA in 2005, the Centers for Medicare and Medicaid Services has not yet issued a national coverage decision for VNS therapy tied to depression (although coverage for epilepsy is in place).

Dr. Richard Rudolph, chief medical officer for the Houston-based device manufacturer Cyberonics, says, "In the absence of a national coverage decision, then the regional Medicare plans make their own local coverage decisions."

He adds that while approximately 1,500 patients have received implants for treatment-resistant depression in the United States, there have been many more inquiries by physicians and patients alike.

"They have often been stymied because of the insurance issues," he notes. "We believe there are many out there interested in VNS therapy and who could definitely benefit from it, but right now it is not feasible because they can't get insurance coverage."

Cyberonics has recently applied to CMS to request a national coverage decision. The process includes a public comment period and typically takes six to nine months to complete, which means a decision could be reached by early 2007.

Citing medical costs tied to the specific patient population targeted for VNS therapy, which can include hospitalization and expenses linked to electroconvulsive therapy, Cyberonics believes that amortizing out the cost over time represents a medical savings even when factoring in the percentage of patients who ultimately don't respond to the implant.

"We think you can make a compelling argument that VNS therapy is not only a benefit to the patient from a clinical perspective but of economic benefit to the payer," Rudolph states.

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