The Centers for Medicare and Medicaid Services has determined that it will not cover vagus nerve stimulation for treatment-resistant depression.
The therapy, marketed by Cyberonics Inc. of Houston, has been used successfully in epilepsy but has been more controversial as a depression treatment. The Food and Drug Administration approved vagus nerve stimulation (VNS) in 2005 for adjunctive long-term treatment of chronic or recurrent depression in patients aged 18 years or older who do not have an adequate response to four or more antidepressant therapies.
But the approval came over the objections of a large number of FDA scientists, according to a year-long investigation by the Senate Finance Committee. The committee's report, issued in March 2006, questioned whether VNS therapy met FDA's safety and effectiveness standards.
In May, CMS issued its final decision. The agency stated that, “there is sufficient evidence to conclude that vagus nerve stimulation is not reasonable and necessary for treatment of resistant depression.”
Cyberonics has been struggling to gain wider coverage of its device by private health insurers. But, in a statement, the company said that so far, 300 payers have covered VNS for “more than 3,000 patients.”