Medicare To Cover Test To Determine Need for Cardiac Device
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 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).
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.
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. However, he said that the decision in the short term could increase the number of ICDs implanted as physicians overcome resistance to the procedure (Wall Street Journal, 3/22).