New FDA Approved Therapy for Depression: Timeline from Prescription to Procedure


On July 18, 2005, the U.S. Food and Drug Administration(FDA) approved vagus nerve stimulation as a treatment for chronic depression. On August 18th, I was a part of a conference call hosted by the manufacturer of the vagus nerve stimulator.

According to Company officials, it is going to take a long time for reimbursement to reach universal coverage by third party payers at the overall policy level. The procedure was just approved by the FDA. Insurance companies are giant bureaucracies with many layers of people whose only job is to say "NO". It is just a fact of life that reimbursement will take time to "grind" through the system.

That is why I devoted an entire eighteen page chapter of my book to insurance codes and the reimbursement process. The Patient Advocate Foundation gave me permission to reprint its guide to the insurance reimbursement and appeal process. The Patient Advocate Foundation is a national non-profit organization that serves as an active liaison between the patient and their insurer.

The manufacturer of the stimulator reiterated on its conference call on August 18th, that insurance coverage will be on a case-by-case basis. In the first two weeks of the official launch, there has been a wide variance by third party reimbursers for VNS Therapy and depression. On a case by case basis, some patients have able to obtain to get pre- approval by Medicare, the VA and private insurance companies. At the other extreme, some reimburers have said absolutely not, maybe, we need to think about it, etc. The Company indicated that the more that patient's fight for reimbursement, the better chance they have to obtain approval.

Charles Donovan was a patient in the FDA investigational trial of vagus nerve stimulation as a treatment for chronic or recurrent treatment-resistant depression. He was implanted with the vagus nerve stimulator in April of 2001. The treatment completely changed his life. He chronicles his journey from the grips of depression thanks to vagus nerve stimulation therapy in his book:

Out of the Black Hole: The Patient's Guide to Vagus Nerve Stimulation and Depression

The book was exhibited at the American Psychiatric Association's Annual Meeting in late May. It is available on his web site, 24 hours a day/7 days a week through the toll free number 1-888-VAGUS-88, Amazon.com and Barnes & Noble. He is founder of the www.VagusNerveStimulator.com">http://www.VagusNerveStimulator.com Web Site.


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