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Friday, April 5, 2013

Cyberonics Provides Update On Submission To CMS


Published: April 4, 2013 

Cyberonics, Inc. By Cyberonics, Inc.

HOUSTON, April 4, 2013 — /PRNewswire/ -- Cyberonics, Inc. (NASDAQ:CYBX) today provided an update on its recent submission to the Centers for Medicare & Medicaid Services ("CMS") seeking reimbursement coverage for the treatment-resistant depression ("TRD") indication for the VNS Therapy® System.

As previously announced, the company submitted a request to CMS for reconsideration of coverage for VNS Therapy for TRD and expected to receive a formal acknowledgment from CMS accepting or rejecting its request by the end of March 2013. To date, the company has not received a formal response from CMS, but is engaged in an ongoing dialogue regarding the reconsideration request. At this time, the timing and ultimate outcome of the dialogue is uncertain.

"We believe the total body of evidence that began appearing in the scientific literature in 2000 presents compelling rationale for access to VNS Therapy in a very ill subpopulation of Medicare beneficiaries," said Dan Moore, Cyberonics' President and Chief Executive Officer. "We look forward to continuing our discussion with CMS with the objective of securing this access, although there can be no assurance that the coverage objectives will be met." 

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