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www.fdanews.com/articles/89500-citing-insufficient-evidence-cms-says-it-may-not-reimburse-vns-for-treatment-resistant-depression

CITING INSUFFICIENT EVIDENCE, CMS SAYS IT MAY NOT REIMBURSE VNS FOR TREATMENT-RESISTANT DEPRESSION

February 12, 2007

The kinds of information the Centers for Medicare & Medicaid Services (CMS) relies on when making coverage decisions may not be what firms expect, as one company recently found out.

The CMS said last week it may not provide reimbursement for Cyberonics' vagus nerve stimulation (VNS) therapy for treatment-resistant depression (TRD), despite support for the device from patients and physicians.

Cyberonics submitted a formal request to the CMS in July 2006 requesting the agency cover VNS for TRD as part of the agency's national policy. Coverage for the treatment is currently left to local Medicare officials.

In suggesting that it may not cover the Cyberonics device, the agency cited insufficient evidence that VNS is a "reasonable and effective" treatment for TRD.

One of the primary stumbling blocks to reimbursement for VNS apparently lies in the definition of TRD itself, which is "variable," the CMS said. "Until a scientifically valid definition exists, [the current definition] is of little help in treatment selection for individual patients."

(http://www.fdanews.com/ddl/34_7/)