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September 10, 2005
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Hurricane Katrina and It’s Aftermath
Red Cross Sends Counselors to the Gulf Region: The American Red Cross sent several hundred mental health professionals to the Gulf region last week to help survivors of Hurricane Katrina cope with the aftermath of the storm and the subsequent flooding. According to Susan Hamilton, senior associate of the American Red Cross crisis mental health program, mental health workers are especially worried about children, people with existing mental and physical disabilities, and people who were “marginalized” before the storm. (The Wall Street Journal, 9/2/05)
Louisiana Medicaid Beneficiaries in Texas to Receive Benefits: During a trip to the New Orleans area Sunday, Health and Human Services Secretary Mike Leavitt signed an order to allow Medicaid beneficiaries from Louisiana and other states affected by Hurricane Katrina and its aftermath who are in Texas to receive medical services through Texas’ Medicaid program. At the same time, Substance Abuse and Mental Health Services Administrator Charles Currie said that his agency is planning for mental health services for victims of the hurricane and rescue workers. (The Wall Street Journal, 9/5/05; The Associated Press, 9/6/05)
Aftermath to Deepen Psychological Wounds: Mental health experts warn that the violence and chaos that emerged, especially in New Orleans will deepen that psychological distress that Hurricane Katrina survivors will undergo. This is especially true for vulnerable children and children who were separated from their parents. Survivors must also deal with the sights of dead bodies and similar images. Although most people are probably repressing their feelings now, "I think that we will find people adjusting to the experience really for the rest of their lives," said University of South Dakota Disaster Mental Health Institute’s Gerald Jacobs. (Reuters Health, 9/5/05)
Many New Orleans Police Officers Apparently Leave Their Jobs Due to Stress: Feeling overwhelmed with the stress of dealing with Hurricane Katrina and the subsequent flooding of the city, many New Orleans police officers have apparently left their jobs and at least two officers took their own lives. "If I put you out on the street and made you get into gun battles all day with no place to urinate and no place to defecate, I don't think you would be too happy either," said the city’s Superintendent of Police, P. Edwin Compass III. "Our vehicles can't get any gas. The water in the street is contaminated. My officers are walking around in wet shoes." (The New York Times, 9/4/05)
Medicaid Commission Releases First Report
In the first of its two reports, the federal Medicaid Commission made a series of recommendations last week that would save the Medicaid program $11 billion during a five-year period. The commission recommended that drug copayments be increased, especially for drugs not listed on formularies, and that states base their drug reimbursement rates on average drug manufacturer prices, which are generally lower than the prices many state currently use. The commission also recommended placing curbs on asset transfers, which some otherwise unqualified people use to qualify for Medicaid coverage. (Reuters Health, 9/2/05)
American Public Health Association Executive Director Georges Benjamin criticized the proposal, saying that it would “hit minorities and extremely sick people the hardest.” (The Associated Press/WSJ.com, 9/2/05)
Alabama Warns Medicare Beneficiaries to Be on Guard for Scams
Alabama officials warned older adults and other Medicare beneficiaries last week to be on guard for scams related to the new prescription drug benefit, which goes into effect Jan. 1. The warning was prompted by calls from state residents who report that they received calls from people asking for the residents’ Social Security numbers and other personal information. The officials say that Medicare beneficiaries should know the rules of when someone working with Medicare can request personal information and that they should never give out such information unless they are certain that they are talking to a Medicare employee or contractor. (Decatur [Ala.] Daily, 9/5/05)
Federal Agency Releases ADHD Prevalence Estimates: About 8 percent of children between ages 4 and 17 have ever been diagnosed with ADHD, and just over one-half of these children have been treated with drugs, a U.S. Centers for Disease Control and Prevention (CDC) study indicates. Boys in the study were more than twice as likely as girls to be diagnosed with the disorder, the CDC found, with older kids more likely than younger kids to have the diagnosis. Healthcare costs associated with ADHD are estimated to be about $3.3 billion annually, according to the agency. (Reuters Health, 9/2/05)
More Americans Lack Health Insurance, Live in Poverty: Although the number of Americans who lack health insurance coverage increased by 800,000 last year, the percentage of Americans who lack coverage (about 16 percent) stayed about the same, a U.S. Census Bureau report indicates. However, both the number and percentage of Americans living in poverty increased from 2003. About 37 million people live in poverty, or 12.7 percent of the population, an increase of 1 million and about 0.2 percent, respectively. (The Wall Street Journal, 8/31/05)
Depression May Be at the Root of Some Sleepiness: Excessive daytime sleepiness may not only be a reflection of a lack of sleep during the night, researchers report in the Journal of Clinical Endocrinology and Metabolism. In a sampling of more than 16,000 adults, nearly 9 percent reported that they had regular, excessive daytime sleepiness. By far the most significant risk factor associated with excessive sleepiness was depression, followed by diabetes. The researchers recommend that physicians screen patients who complain of sleepiness for these two disorders. (Reuters Health, 9/5/05)
Women Treated for Anorexia May Need Treatment After Hospitalization: Although most women undergoing inpatient treatment for anorexia show signs of improvement after three months of hospitalization, 30 to 70 percent of the women relapse once they leave the hospital and return to their lives, a new study indicates. To address this issue, Rutgers University researcher Robin Sysko wrote that “we need additional strategies to help people once they're leaving an intensive program, because that's the period that's fraught with all kinds of potential difficulties for patients.” (Reuters Health, 9/5/05)
California: Gov. Arnold Schwarzenegger announced an initiative last week to try to end long-term homelessness in the state. As part of the plan, he will commit $50 million to provide mental health services and housing to people in the state who are homeless. He said that the initiative would make the state eligible for federal funds to provide additional mental health and housing. California is one of three states that doesn’t have a council to coordinate services for people who are homeless. (Los Angeles Times, 9/1/05)
New York: Gov. George Pataki signed legislation last month that aims to address the mental health needs of a growing population of older adults in the state. Part of the Geriatric Mental Health Act is to set up a grant program to support finding ways to improve access to mental health care for older adults and improve the quality of those services. (Newsday , 8/24/05) The other.phpect of the new law is to establish a geriatric mental health planning council to “foster the integration of mental health, health and aging services.” (Mental Health Association of New York City press release, 8/24/05)
Washington: The Small Business Health Fairness Act, which has passed the U.S. House of Representatives and is now pending in the Senate, has the potential for undermining the state’s mental health parity law, according to the Washington State Hospital Association. The bill would allow small businesses to form association health plans to provide insurance coverage to their employees. Such plans would be exempt from state laws, including the Washington law that requires insurance companies to offer coverage for mental health services that is comparable to their physical health coverage. (Seattle Weekly, 8/31/05)
AMA CPT Editorial Panel Approves Use of Cyberonics' VNS Therapy(TM) System Programming Codes for Treatment-Resistant Depression.
PR Newswire; 9/8/2005
HOUSTON, Sept. 8 /PRNewswire-FirstCall/ -- Cyberonics, Inc. today announced that it was recently notified by the American Medical Association (AMA) that its CPT Editorial Panel has approved a parenthetical cross reference in the CPT Coding Manual directing physicians to codes 95970, 95974 and 95975 for analysis/programming of neurostimulators, including Cyberonics' VNS Therapy System, for the treatment of treatment-resistant depression (TRD). The parenthetic will appear in the Other Psychiatric Services or Procedures section.
According to the AMA, the clarification of the use of the neurostimulator programming codes to include TRD will be included in the September 2005 issue (Volume 15, Issue 9) of AMA's CPT Assistant and will appear in the 2007 Edition of the CPT Coding Manual. CPT Assistant, a monthly AMA newsletter, is an official tool for accurate information on CPT Codes, Issues and Guidance. CPT Assistant provides timely information on day-to-day coding questions among other resources. In addition to the CPT Editorial Panel notification, the American Psychiatric Association (APA) through the publication Psychiatric News has communicated this coding clarification to all members of APA (http://pn.psychiatryonline.org/cgi/content/full/40/17/23-a ).
"Psychiatrists treating TRD patients with VNS Therapy are now permitted to use the same programming codes for their VNS Therapy System programming services as those used by neurologists for the treatment of patients with pharmaco-resistant epilepsy," commented Robert P. ("Skip") Cummins, Cyberonics' Chairman of the Board and Chief Executive Officer. "The AMA CPT Editorial Panel's favorable coding decision represents a major step forward towards Cyberonics' objective of providing all our TRD customers with the same favorable VNS coverage, coding and reimbursement as exists today in epilepsy. Essentially all the codes related to all VNS Therapy services and procedures in TRD are now in place approximately one month after TRD approval, considerably more quickly relative to approval as was the case in epilepsy. Codes that adequately described surgeons' VNS implant services and neurologists' programming services in epilepsy were not clarified until some 42 months and some 30 months, respectively, following epilepsy approval in July 1997.
"As expected, our remaining challenge in providing TRD patients with universal access to VNS is coverage," continued Mr. Cummins. "We continue to make steady progress in obtaining not only case-by-case prior authorizations, but also favorable regional and national coverage policies across public and private payers. The body of scientific evidence supporting the use and coverage of VNS Therapy in treatment-resistant depression continues to build and now includes not only the product's fully-informative labeling and FDA's Summary of Safety and Effectiveness, but also the recent publication in Biological Psychiatry of the first three manuscripts from the TRD pivotal studies. We expect a number of equally important peer-reviewed journal articles to be published in the months ahead. In summary, Cyberonics remains confident that a greater percentage of patients with TRD will have access to VNS Therapy in the first year following launch on August 1, 2005 than was the case in the first year after epilepsy approval on July 16, 1997."
ABOUT DEPRESSION AND TREATMENT-RESISTANT DEPRESSION
Major Depressive Disorder (MDD) is one of the most prevalent and serious illnesses in the United States, affecting nearly 19 million Americans over the age of 18 in any given year. According to the National Institute of Mental Health, depression is the leading cause of disability in the United States and worldwide. Depression interferes with one's ability to function, feel pleasure or maintain interest in everyday living. MDD is associated with increased mortality due to suicide and comorbid general medical conditions including heart disease and stroke. Depressed patients use twice the healthcare services as non-depressed patients. Total annual costs of depression in the U.S. exceed $80 billion including $30 billion in annual direct treatment costs. A person with depression is 35 times more likely to commit suicide than a person not experiencing depression and 15 percent of previously hospitalized depressed patients commit suicide.
Most psychiatrists define treatment-resistant depression (TRD) as a major depressive episode that has not had an adequate response to two or more adequate antidepressant treatments at appropriate dose and duration. Twenty percent of those with depression or approximately four million people suffer from TRD. For these patients, treatments including psychotherapy, antidepressant medications and electroconvulsive therapy do not work. Studies show that annual healthcare costs for patients with TRD exceed $40,000 per patient per year, approximately six times the cost of those without TRD.
ABOUT VNS THERAPY AND CYBERONICS
Cyberonics, Inc. was founded in 1987 to design, develop and market medical devices for the long-term treatment of epilepsy, depression and other chronic treatment-resistant disorders using a unique therapy, vagus nerve stimulation (VNS). Stimulation is delivered by the VNS Therapy System(TM), an implantable generator similar to a cardiac pacemaker. The VNS Therapy System delivers preprogrammed intermittent mild electrical pulses to the vagus nerve in the patient's neck 24 hours a day. The Company's initial market was epilepsy, a disorder characterized by recurrent seizures. Epilepsy is the second most prevalent neurological disorder. The Cyberonics VNS Therapy System was approved by the FDA on July 16, 1997 for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. The VNS Therapy System is also approved for sale as a treatment for epilepsy in all the European Economic Area, Canada, Australia and other markets. To date, more than 32,000 epilepsy patients in 24 countries have accumulated over 100,000 patient years of experience using VNS Therapy.
The VNS Therapy System was approved by the FDA on July 15, 2005 "as an adjunctive long-term treatment for chronic or recurrent depression for patients 18 years of age and older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments." As part of FDA's approval order, Cyberonics is required to conduct a 450-patient post-market dosing study and a 1,000- patient, five-year patient outcome registry. For more information on VNS Therapy for treatment-resistant depression, including the contraindications, warnings and precautions, see the Physician's and Patient's Manuals and other information at http://www.cyberonics.com/ or http://www.vnstherapy.com/ or call 1-877-NOW 4 VNS.
The VNS Therapy System has been approved for sale in the European Economic Area and in Canada as a treatment for depression in patients with treatment- resistant or treatment-intolerant major depressive episodes, including unipolar depression and bipolar disorder (manic depression) since 2001.
VNS Therapy is at various levels of investigational clinical study as a potential treatment for anxiety disorders, Alzheimer's disease, chronic headache/migraine and bulimia. The Company is headquartered in Houston, Texas and has an office in Brussels, Belgium. For additional information please visit us at http://www.cyberonics.com/ .
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. Such forward-looking statements include statements concerning future publication of important peer-reviewed journal articles related to VNS Therapy for treatment-resistant depression and providing access to VNS Therapy for a greater percentage of patients with TRD in the first year following launch on August 1, 2005 than was the case in the first year after epilepsy approval on July 16, 1997. 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. 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 Alzheimer's disease, anxiety, or other indications; 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 applications; 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; and other risks detailed from time to time in the Company's filings with the SEC.
CONTACT: Pamela B. Westbrook, Vice President of Finance and CFO of Cyberonics, Inc., +1-281-228-7200, or fax, +1-281-218-9332, or firstname.lastname@example.org ; or Helen Shik, Vice President of Schwartz Communications, +1-781-684-0770, or fax, +1-781-684-6500, or email@example.com , for Cyberonics, Inc.
Web site: http://www.cyberonics.com/ http://www.vnstherapy.com/ http://pn.psychiatryonline.org/cgi/content/full/40/17/23-a
COPYRIGHT 2005 PR Newswire Association LLC
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The Warning Signs Of An Impending Bipolar Disorder Manic Episode
Bipolar disorder - as the name implies - involves two distinct set of symptoms. One set throws the individual down into the depths of a massive depression. The other places the individual who suffers with bipolar disorder at the top of a peak manic episode.
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However, for many individuals with bipolar disorder, it's more difficult to recognize the signs of an impending manic episode. After all, a manic episode of bipolar disorder can be mistaken in some cases - especially in the very early formation -- for the lifting of the corresponding mood swing of the depression.
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