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WellPoint To Cover Microvolt T-Wave Alternans Testing |
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The Largest Private
Insurer in the Coverage to 34 million
Individuals BEDFORD,
Mass.--(BUSINESS WIRE)--Nov. 13, 2006--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 About 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 About the 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. CONTACT: At Cambridge
Heart, Inc. |