Cyberonics Provides Update On Departmental Appeals Board Decision Regarding Coverage Of VNS Therapy® System In Treatment-Resistant Depression
HOUSTON, Jan. 5, 2015 /PRNewswire/ — Cyberonics, Inc. (NASDAQ: CYBX) today announced the receipt of a decision from the Departmental Appeals Board (DAB) of the Department of Health and Human Services.
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,” said Dan Moore, Cyberonics’ President and Chief Executive Officer. “The company is evaluating options for challenging the DAB decision.”
About Cyberonics, Inc. and the VNS Therapy System
Cyberonics, Inc. is a medical technology company with core expertise in neuromodulation. The company develops and markets the VNS Therapy System, which is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression. The VNS Therapy System uses an implanted medical device that delivers pulsed electrical signals to the vagus nerve. Cyberonics markets the VNS Therapy System in selected markets worldwide.
Safe harbor statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. These statements can be identified by the use of forward-looking terminology, including “may,” “believe,” “will,” “expect,” “anticipate,” “estimate,” “plan,” “intend,” “forecast,” or other similar words. Statements contained in this press release are based on information presently available to us and assumptions that we believe to be reasonable. We are not assuming any duty to update this information if those facts change or if we no longer believe the assumptions to be reasonable. Investors are cautioned that all such statements involve risks and uncertainties, including without limitation, statements concerning a challenge to the DAB decision and CMS reimbursement for the treatment-resistant depression indication. Important factors that may cause actual results to differ include, but are not limited to: continued market acceptance of the VNS Therapy System and sales of our products; the development and satisfactory completion of clinical studies; the achievement of regulatory approval for new products, including use of the VNS Therapy System for the treatment of other indications; satisfactory completion of the post-market registry required by the U.S. Food and Drug Administration as a condition of approval for the treatment-resistant depression indication; adverse changes in coverage or reimbursement amounts by the Centers for Medicare & Medicaid Services, state Medicaid agencies and private insurers; the presence or absence of intellectual property protection and potential patent infringement claims; maintaining compliance with government regulations; product liability claims and potential litigation; reliance on single suppliers and manufacturers for certain components; the accuracy of management’s estimates of future expenses and sales; the potential identification of material weaknesses in our internal controls over financial reporting; and other risks detailed from time to time in our filings with the Securities and Exchange Commission (SEC). For a detailed discussion of these and other cautionary statements, please refer to our most recent filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended April 25, 2014, and our Quarterly Report on Form 10-Q for the fiscal quarters ended July 25, 2014 and October 24, 2014.
Additional information about Cyberonics and the VNS Therapy System is available at www.cyberonics.com.
Greg Browne, CFO
100 Cyberonics Blvd.
Houston, TX 77058
Main: (281) 228-7262
Fax: (281) 218-9332
SOURCE Cyberonics, Inc.
Departmental Appeals Board (DAB)
The title Departmental Appeals Board (“DAB”) refers both to the Board Members (collectively the “Board”) that the Secretary appoints and to the larger staff organization. The DAB provides impartial, independent review of disputed decisions in a wide range of Department programs under more than 60 statutory provisions.
The DAB includes the Board itself (supported by the Appellate Division), Administrative Law Judges (“ALJs”) (supported by the Civil Remedies Division), and the Medicare Appeals Council (supported by the Medicare Operations Division). Thus, the DAB has three adjudicatory divisions, each with its own set of judges and staff, as well as its own areas of jurisdiction. The DAB also has a leadership role in implementing Alternative Dispute Resolution (“ADR”) across the Department, since the DAB Chair is the designated Dispute Resolution Specialist under the Administrative Dispute Resolution Act of 1996.
Alternative Dispute Resolution Division
The Alternative Dispute Resolution Division provides alternative dispute resolution (“ADR”) services in appeals filed with the Board’s other three Divisions. ADR in Board cases typically involves either mediation or ombudsman services.
The Appellate Division provides staff support for the Board Members, who are career civil servants appointed by the Secretary to provide an impartial, independent review of disputes arising in a wide range of HHS programs. The Board also provides appellate review of certain types of Administrative Law Judge decisions. In most cases, the Board decision is the final administrative decision of HHS.
Civil Remedies Division
The Civil Remedies Division (“CRD”) provides staff support for the Administrative Law Judges (“ALJs”) assigned to the DAB. The ALJs are qualified under the Federal Administrative Procedure Act to conduct hearings on the record. Generally, the ALJ decision is an initial decision that may be appealed to the Board. If the ALJ decision is not appealed, it represents the final administrative decision.
Medicare Operations Division
The Medicare Operations Division provides staff support to the Administrative Appeals Judges and Appeals Officers on the Medicare Appeals Council. The Council provides the final administrative review of claims for entitlement to Medicare and individual claims for Medicare coverage and payment filed by beneficiaries or health care providers/suppliers.