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Medicare Approves New Test to Prevent Sudden Cardiac
Arrest
 Microvolt T-Wave Alternans
finds need for
implantable defibrillator
March 22, 2006 Medicare has issued a final
decision that it will cover a new noninvasive test that will help
determine if patients need an implantable cardioverter defibrillator to
prevent sudden cardiac arrest. The Microvolt T-Wave Alternans test
detects fluctuations linked with increased risk for life-threatening
problems with heart rhythm. It measures electrical activity in the heart
patients as they exercise and detects electrical signals not found by
electrocardiograms. Following is a report from KaiserNet.org and a news
release from the developer, Cambridge Heart.
 Medicare To Cover Heart Disease Test That
Determines Candidates for Implantable Cardioverter Defibrillator
CMS on
Tuesday decided to allow Medicare coverage for a noninvasive test
developed by
Cambridge Heart
that determines the need for implantable cardioverter defibrillators,
the Wall Street Journal reports (Pagan Westphal, Wall Street Journal,
3/22).
The test, called the Microvolt T-Wave Alternans,
"is covered for the evaluation of patients at risk of sudden cardiac
death, only when the spectral analytic method is used," according to
CMS. CMS also said that the test should not serve as the only technique
for "stratifying high-risk patients" (Kamp, Dow Jones, 3/21). CMS did
not make the test a prerequisite for Medicare coverage of ICDs, and the
decision does not apply to Medicaid.
The test detects fluctuations linked with increased
risk for life-threatening problems with heart rhythm (Wall Street
Journal, 3/22). The test, which costs $322 on average, measures
electrical activity in the heart patients as they exercise and detects
electrical signals not found by electrocardiograms (Moore,
Minneapolis Star
Tribune, 3/21).
Patients who receive a positive test result are
considered at risk for sudden cardiac arrest. However, patients who
receive a negative test result have only a 3% risk for death from
life-threatening problems with heart rhythm within two years (Wall
Street Journal, 3/22). The machine used to administer the test costs
$30,000, and sensors cost about $75 per patient. ICDs cost between
$30,000 and $35,000 (Dow Jones, 3/21).
Implications
The CMS decision likely will "expand the pool of patients who might use
the test and to trigger more coverage on the part of private insurers,"
according to the Wall Street Journal. In addition, the decision could
save Medicare about $700 million annually, provided that physicians
implant ICDs only in beneficiaries who receive positive results,
according to Paul Chan, a cardiology fellow at the
University of
Michigan. Chan said, "Not only is it a more cost-effective
approach, it's a more sustainable approach." Bruce Nudell, an analyst
with
Bernstein
Research, said that the decision in the long term could
reduce the number of patients eligible for ICDs, which is "somewhat
concerning" for medical device companies.
Reaction
The CMS decision affirms "what we've worked on for over a decade,"
Cambridge Heart CEO David Chazanovitz said (Wall Street Journal, 3/22).
Medtronic
and
St. Jude Medical,
which manufacturer ICDs, have begun separate clinical trials to study
the effectiveness of the test. Representatives for both companies said
that the test has potential but requires additional clinical data. In a
letter send to CMS in January,
Guidant,
which manufactures ICDs, said that the test "appears to be promising"
but added that Medicare beneficiaries should "receive full consideration
for ICD therapy and not be turned away based just on the results of one
simple test" (Dow Jones, 3/21).
"Reprinted with
permission from kaisernetwork.org You can view the entire
Kaiser Daily Health Policy Report, search the archives, and sign up
for email delivery at
www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser
Daily Health Policy Report is published for
kaisernetwork.org, a free service of The Henry J. Kaiser Family
Foundation. © 2006 Advisory Board Company and Kaiser Family Foundation.
All rights reserved.
News Release by Cambridge Heart
Medicare Issues Final National Coverage for
Microvolt T-Wave Alternans Testing; Patented Analytic Spectral Method
Required
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About Sudden Cardiac Death |
| |
by Cambridge Heart
Sudden Cardiac Death, sometimes referred to as
Sudden Cardiac Arrest, is a failure in the heart's electrical system in
which the heart stops suddenly and without warning. In the US, over
400,000 adults die each year from sudden cardiac arrest.
Sudden cardiac arrest differs from a heart attack,
also called a myocardial infarction, in that a myocardial infarction
results when a part of the heart is starved of oxygen - called ischemia.
This happens when a clot or blockage obstructs one of the arteries that
supply blood to the heart. Sudden cardiac arrest is caused by
life-threatening ventricular arrhythmias. One of the most common
arrhythmias is called ventricular fibrillation. This is when the lower
chambers of the heart quiver and are incapable of pumping blood out to
the rest of the body. A victim of sudden cardiac arrest immediately
stops breathing, has little or no detectable pulse and, with no
intervention, will die within minutes.
Most people who suffer from a ventricular
arrhythmia have an underlying electrical disorder of the heart that can
usually be detected by the
Microvolt T-Wave Alternans (MTWA) Test.
Any one can be a victim of sudden cardiac arrest
but some people are at greater risk.
These are people with:
● a previous history of cardiac arrest or life threatening ventricular
arrhythmias
● documented heart disease and symptoms of possible arrhythmias such as
fainting
● elevated risk including patients with
> congestive heart failure
> prior heart attack
> family history of sudden death and coronary artery disease.
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March 22, 2006 - Cambridge Heart, Inc. (OTCBB:CAMH)
yesterday announced the publication of a final National Coverage
Determination by The Centers for Medicare and Medicaid Services which
states, "Microvolt T-Wave Alternans (MTWA) diagnostic testing is covered
for the evaluation of patients at risk of sudden cardiac death, only
when the analytic spectral method is used." The final NCD covers the
same patient populations as announced in the proposed decision released
on December 21, 2005.
The final decision memorandum was the culmination
of a nine month process which involved two separate public comment
periods. In the final decision memorandum CMS conducted a comprehensive
clinical evidence review citing numerous studies of MTWA. CMS determined
that there is adequate evidence to conclude that MTWA testing, using a
spectral analysis, can improve net health outcomes and is reasonable and
necessary for Medicare beneficiaries who are candidates for ICD
placement.
Within the decision CMS stated, "Extensive clinical
evidence has revealed that patients with symptoms of life threatening
arrhythmias who test positive for T-Wave Alternans are at significant
risk for subsequent development of sudden cardiac events including
death, while those who test negative are at minimal risk."
Commenting on CMS' decision memo, David A.
Chazanovitz, President and CEO of Cambridge Heart, Inc. said, "It is
clear that Medicare understands the value MTWA testing can bring to
cardiologists caring for patients at risk for Sudden Cardiac Death, and
with this decision allows caregivers to incorporate MTWA testing into
their diagnosis algorithm. This decision represents the clinical
validation of MTWA testing and it will serve as a catalyst for clinical
cardiologists to refer to implanting physicians those patients most
likely to benefit from ICD therapy. The decision to require the use of
our patented analytic spectral method only reaffirms what the data has
demonstrated. We will continue to work with providers and physicians to
improve the quality of care for all patients, Medicare and private
insured, and establish MTWA as a standard of care in cardiology."
To read the full decision memorandum
Click
Here.
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 Web
click here.
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.
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