Healthcare Industry News: Cambridge Heart
News Release - November 13, 2006
WellPoint To Cover Microvolt T-Wave Alternans TestingThe Largest Private Insurer in the U.S. Provides Healthcare Coverage to 34 million Individuals
BEDFORD, Mass.--(HSMN NewsFeed)--Cambridge Heart, Inc. (OTCBB:CAMH ) today announced that WellPoint/Anthem has revised its Coverage Policy Bulletin (MED.00041) on Microvolt T Wave Alternans agreeing to make it a covered benefit for its beneficiaries in California and 13 other states. The revised policy now states:
"Microvolt T-wave alternans (beat-to-beat variability in the amplitude of the T-wave) using the spectral analytic method is considered medically necessary for the evaluation of patients at risk of sudden cardiac death who meet the approved criteria for implantable cardioverter defibrillator (ICD) placement."
WellPoint's approved criteria for ICD placement addresses a comprehensive set of cardiac disease conditions well beyond the SCDHeFT patient set that is in the spotlight at this time. The policy deems MTWA medically necessary for diagnosis within the SCDHeFT population, but like Medicare and the other private carriers, WellPoint also reimburses the use of MTWA for patients with:
1. History of cardiac arrest due to ventricular fibrillation (VF) or ventricular tachycardia (VT) and which is not due to reversible or transient causes; or
2. Spontaneous sustained VT, in patients with structural heart disease; or
3. Spontaneous sustained VT, in patients without structural heart disease, that is not amenable to other treatments; or
4. Syncope of undetermined origin with clinically relevant, hemodynamically significant, sustained VT or VF induced at electrophysiological study when drug therapy is ineffective, not tolerated, or not preferred; or
5. Familial or inherited conditions with a high risk for life-threatening ventricular tachyarrhythmias such as long QT syndrome or hypertrophic cardiomyopathy; or
6. Previous myocardial infarction and coronary artery disease (CAD), at least 40 days post myocardial infarction and three months post coronary artery revascularization surgery with an ejection fraction equal to or less than 35% after maximal medical therapy; or
7. Ischemic dilated cardiomyopathy (IDCM) with NYHA Class II or III heart failure, documented prior myocardial infarction (MI), at least 40 days post MI, and measured left ventricular ejection fraction (LVEF) less than or equal to 35%; or
8. Non-ischemic dilated cardiomyopathy (NIDCM) greater than 9 months duration, NYHA Class II or III heart failure, and measured LVEF less than or equal to 35%.
"We are extremely pleased that WellPoint has decided to provide coverage for our Spectral Analytic Method Microvolt T-Wave Alternans test." said Jeff Langan, President and CEO of Cambridge Heart, Inc. "WellPoint is the largest private insurer in California and 9 other states, and coupled with its Anthem subsidiary, is a leading provider in four other states as well. The vast majority of private insurance patients in the USA are now under covered as are Medicare patients. This represents a key milestone in our objective of gaining private insurance coverage for MTWA testing."
About Cambridge Heart
Cambridge Heart (www.cambridgeheart.com) is engaged in the development and commercialization of products for the non-invasive diagnosis of cardiac disease, particularly the identification of those at risk of sudden cardiac arrest. The Company's products incorporate its proprietary Microvolt T-Wave Alternans measurement technologies, coupled with its patented Spectral Analytic Method and ultra-sensitive disposable electrodes. Only Spectral Analytic Method MTWA tests are reimbursed by Medicare under its National Coverage Policy that covers patients with a wide variety of cardiac symptoms. Other major insurers in the USA also have coverage policies for the test. The T-Wave Alternans test is included in the Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death jointly developed by the American College of Cardiology (ACC), The American Heart Association (AHA) and the European Society of Cardiology (ESC). The Company, founded in 1990, is based in Bedford, Massachusetts and is traded on the OTCBB under the symbol CAMH.
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 who are at risk of, life threatening arrhythmias that 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.
Statements contained in this press release about anticipated revenue growth, and all other statements that are not purely historical, are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act 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.
Source: Cambridge Heart
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