Cyberonics has announced the receipt of a decision from the Departmental Appeals Board (DAB) of the Department of Health and Human Services in the USA.
The decision concludes that the record regarding the VNS Therapy System for treatment-resistant depression is complete and adequate to support the 2007 National Coverage Determination (NCD). The Centers for Medicare & Medicaid Services (CMS) concluded in the 2007 NCD that coverage for the treatment-resistant depression indication is not reasonable and necessary. The decision also clarifies that CMS and its contractors will allow coverage of maintenance services – including replacement of the implanted VNS Therapy device upon battery expiration – for beneficiaries who began receiving VNS Therapy prior to May 4, 2007.
“While we acknowledge the importance of clarity for beneficiaries already benefiting from VNS Therapy, we are disappointed with this decision and disagree with the position taken by CMS. We believe that the total body of evidence presents a compelling rationale for access to the VNS Therapy System in a very ill subpopulation of Medicare beneficiaries,” says Dan Moore, Cyberonics president and chief executive officer. “The company is evaluating options for challenging the DAB decision.”
