Healthcare Industry News: Treatment-Resistant Depression
News Release - October 31, 2008
Cyberonics Provides Business Update Based on Final Ambulatory Payment Classification Rate Change Announcement by CMSCompany Reaffirms Fiscal Year 2009 Revenue Guidance
HOUSTON, Oct. 31 (Healthcare Sales & Marketing Network) -- Cyberonics, Inc. (Nasdaq: CYBX ) today announced that the Centers for Medicare and Medicaid Services (CMS) has published the 2009 CMS Outpatient Prospective Payment System (OPPS) Final Rule and Ambulatory Payment Classification (APC) rate for VNS Therapy. The final rule, which goes into effect January 1, 2009, sets reimbursement at $12,545 for insertion of VNS Therapy generators and $7,234 for insertion of associated leads. The final rates are higher than those proposed in July. The current reimbursement rates for VNS Therapy generators and leads are $11,877 and $14,061, respectively.
Although the actual impact of the new reimbursement rates on Cyberonics' business is difficult to quantify at this time, the company continues to expect net sales for fiscal year 2009 of $134 million to $138 million.
"We agree with the Outpatient Advisory Panel's conclusion that emphasized the need for CMS to omit from its analysis certain data that was included incorrectly or that is not applicable to the current CMS-approved procedure," said Dan Moore, Cyberonics' President and Chief Executive Officer. "Therefore, we intend to continue working with CMS to address possible payment inadequacies related to VNS Therapy. This includes providing more accurate claims information to CMS and working with epilepsy support and advocacy groups, as well as key physician thought leaders in the field, to ensure that the safety, efficacy and overall cost-benefit profile of VNS Therapy is well understood. It is important to reiterate that we remain confident in our ability to continue growing our epilepsy business."
About Cyberonics, Inc. and VNS Therapy(TM)
Cyberonics, Inc. (NASDAQ:CYBX ) is a medical technology company with core expertise in neuromodulation. The company developed and markets the Vagus Nerve Stimulation (VNS) Therapy(TM) System, which is FDA-approved for the treatments of refractory epilepsy and Treatment-Resistant Depression. The VNS Therapy System uses a surgically implanted medical device that delivers pulsed electrical signals to the vagus nerve. Cyberonics markets the VNS Therapy System in selected markets worldwide.
Additional information on Cyberonics, Inc. and VNS Therapy(TM) is available at www.cyberonics.com and www.vnstherapy.com.
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," and "forecast," or other similar words. Statements contained in this press release are based upon information presently available to us and assumptions that we believe to be reasonable. We are not assuming any duty to update this information should those facts change or should 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 the impact of the new CMS reimbursement rates, net sales guidance for fiscal 2009 and growing the company's epilepsy business. Our actual results may differ materially. Important factors that may cause actual results to differ include, but are not limited to: continued market acceptance of VNS Therapy and sales of our product; the development and satisfactory completion of clinical trials and/or market test and/or regulatory approval of VNS Therapy for the treatment of other indications; satisfactory completion of post-market studies 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 third-parties; intellectual property protection and potential infringement claims; maintaining compliance with government regulations and obtaining necessary government approvals for new indications; 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 results of the previously disclosed governmental inquiries; the potential identification of material weaknesses in our internal controls over financial reporting; risks and costs associated with such governmental inquiries and any litigation relating thereto or to our stock option grants, procedures, and practices (including the previously disclosed private litigation); uncertainties associated with stockholder litigation; 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, 2008.
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