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DESCRIPTIONComputerized 2-lead resting electrocardiogram analysis (e.g.,multifunction cardiogram) is a computerized analysis of a 2-lead resting electrocardiogram that has been proposed for use as a diagnostic test for coronary artery disease (CAD). This policy will review the evidence on accuracy and clinical utility of the multifunction cardiogram.
The standard 12-lead resting electrocardiogram (ECG) has limited diagnostic accuracy in the detection of coronary artery disease. Because of its limited accuracy, the resting ECG has only a limited role in the diagnosis of chronic CAD. Stress testing, either at rest or with exercise, combined with single-photon emission computed tomography (SPECT) or echocardiographic imaging, is the most common initial test in the diagnostic work-up of chronic CAD. Sensitivities and specificities for stress testing vary, but generally fall in the 75%-90% range. Cardiac angiography is the gold standard for diagnosing CAD, and is used in situations where CAD needs to be confirmed following stress testing.
The multifunction cardiogram is intended to improve on the performance of the standard ECG for diagnosing CAD. The study device records a 2-lead EKG tracing for 82 seconds using leads II and V5 together with proprietary hardware and software. The analog EKG tracing is then amplified, digitized, down-sampled to a rate of 100Hz, and encrypted for digital transmission. The digitized information is transmitted to a central server for further analysis. At the central server, the tracings undergo a series of mathematical transformations and signal averaging. There are 6 mathematical transformations included: power spectrum, coherence, phase angle shift, impulse response, cross-correlation, and transfer function. Following these transformations, the patterns found in the tracing are compared to a large reference database collected by the manufacturer. A severity score is generated, indicating the likelihood that CAD is present. The severity score ranges from 0-20, with a score of 4.0 suggested as the cutoff for the presence of clinically significant CAD.
Also, see the related medical policy, Signal-Averaged Electrocardiography.
POLICYComputerized 2-lead resting electrocardiogram analysis (e.g.,multifunction cardiogram) is considered investigational for diagnosing coronary artery disease.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY03/31/2011: Approved by Medical Policy Advisory Committee.
01/17/2012: Policy reviewed; no changes.
03/13/2013: Policy reviewed; no changes.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.02.25
This may not be a comprehensive list of procedure codes applicable to this policy.