CMS Opens National Coverage Determination for Microvolt T-Wave Alternans Test.BEDFORD, Mass. -- Cambridge Heart (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :CAMH CAMH Centre for Addiction and Mental Health CAMH Contemporary Arts Museum Houston (Houston, TX) CAMH Comprehensive Accreditation Manual for Hospitals ) today announced that the Centers for Medicare and Medicaid Services The Centers for Medicare and Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (DHHS) that administers the Medicare program and (CMS (1) See content management system and color management system. (2) (Conversational Monitor System) Software that provides interactive communications for IBM's VM operating system. ) have opened a National Coverage Determination (NCD) for Microvolt microvolt one-millionth (10-6) of a volt; abbreviated µV. T-Wave Alternans (MTWA MTWA Microvolt T-Wave Alternans MTWA Maximum Total Weight Authorised MTWA Metro Toronto Wrestling Association MTWA Maximum Takeoff Weight Authorized ). The Medicare NCD process is intended to provide uniform coverage of innovative medical technologies across the entire country. Most Medicare coverage decisions are made on a local level by the numerous local carriers. The NCD process is a 6-9 month process whereby CMS seeks public comment and evaluates the evidence to determine if a medical item, service, procedure or technology is reasonable and necessary for the diagnosis or treatment of Medicare patients. "We are very pleased that CMS decided to open the NCD based on data demonstrating MTWA's clinical value in the specific patient populations newly eligible for ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device. ICD abbr. implantation." stated David A. Chazanovitz, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Cambridge Heart, Inc. "Following Medicare's NCD for implantable cardioverter defibrillators (ICDs) for MADIT MADIT Cardiology A clinical trial–Multicenter Automatic Defibrillator Implantation Trial that evaluated the effects of implanted defibrillators–IDs in Pts with CAD at high risk of ventricular arrhythmia II and SCD-HeFT patients, it became clear to us that an NCD would be necessary so that MTWA data could be more broadly available to physicians treating Medicare beneficiaries. With its clinical value as a negative predictor of the risk of sudden cardiac death Sudden Cardiac Death Definition Sudden cardiac death (SCD) is an unexpected death due to heart problems, which occurs within one hour from the start of any cardiac-related symptoms. SCD is sometimes called cardiac arrest. , MTWA can help physicians direct ICD therapy and assure the most appropriate care for our senior citizens." Mr. Chazanovitz added, "Currently, MTWA is covered by most local Medicare carriers under CPT CPT See: Carriage Paid To code 93025. The basis of our request is to expand current CMS coverage policy to include those individuals who are now eligible for ICDs as primary prevention for sudden cardiac death. The MTWA NCD is currently the subject of a 30- day public comment period." The tracking page for the NCD can be found at: http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=165 About the Cambridge Heart Microvolt T-Wave Alternans Test The Cambridge Heart Microvolt T-Wave Alternans Test measures extremely subtle beat-to-beat fluctuations in a person's heartbeat called T-wave alternans. These tiny heartbeat variations - measured at one millionth of a volt - are detected in any clinical setting where titration of the heart rate is possible. The preparation for the test consists of placing proprietary sensors on a patient's chest. Extensive clinical research has shown that patients with symptoms of or at risk of life threatening arrhythmias who test positive for T-wave alternans are at significant risk for subsequent sudden cardiac events including sudden death, while those who test negative are at minimal risk. About Cambridge Heart Cambridge Heart is engaged in the research, development and commercialization of products for the non-invasive diagnosis of cardiac disease. Using innovative technologies, the Company is addressing such key problems in cardiac diagnosis as the identification of those at risk of sudden cardiac arrest. The Company's products incorporate its proprietary technology, Microvolt T-Wave Alternans, and are the only diagnostic tools cleared by the U.S. Food and Drug Administration to non-invasively measure microvolt levels of T-wave alternans. The Company, founded in 1990, is based in Bedford, Massachusetts and is traded on the OTCBB under the symbol CAMH. Cambridge Heart can be found on the World Wide Web at www.cambridgeheart.com Statements contained in this press release that are not purely historical, are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. In some cases, we use words such as "believes", "expects", "anticipates", "plans", "estimates", "could" and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements. Factors that may cause or contribute to such differences include customer delays in making final buying decisions, decreased demand for our products, failure to obtain funding necessary to develop or enhance our technology, adverse results in future clinical studies of our technology, failure to obtain or maintain patent protection for our technology, failure to obtain or maintain adequate levels of third-party reimbursement for use of our products and other factors identified in our most recent Annual Report on Form 10-K under "Factors Which May Affect Future Results", which is on file with the SEC. In addition, any forward-looking statements represent our estimates only as of today and should not be relied upon as representing our estimates as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our estimates change. |
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