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L.2.02.408
Computerized 2-lead resting electrocardiogram analysis (e.g., multifunction cardiogram) is a computerized assessment of a 2-lead resting electrical activity of the heart. It has been proposed for use as a diagnostic test for coronary artery disease (CAD). The 12-lead resting electrocardiogram (ECG) analysis is a standard tool in the detection of acute cardiac ischemia, but has less accuracy for monitoring for chronic changes associated with coronary artery disease (CAD). Therefore, 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 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 criterion standard for diagnosing CAD and is used when 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 ECG tracing for 82 seconds, using leads II and V5 together with proprietary hardware and software. The analogue ECG tracing is then amplified, digitized, down-sampled to a rate of 100 Hz, and encrypted for digital transmission. The digitized information is transmitted to a central server for analysis. At the central server, the tracings undergo a series of mathematical transformations and signal averaging. Six mathematical transformations are 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 with 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 threshold for the presence of clinically significant CAD.
There is at least one commercially available multifunction cardiogram. In 2003, the Premier Heart MCGÔsystem (Premier Heart, Port Washington, NY) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices for use in electrocardiogram analysis.
Also, see the related medical policy, Signal-Averaged Electrocardiography .
Computerized 2-lead resting electrocardiogram analysis (e.g., multifunction cardiogram) is considered investigational for diagnosing coronary artery disease.
Federal 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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
03/31/2011: Approved by Medical Policy Advisory Committee.
01/17/2012: Policy reviewed; no changes.
03/13/2013: Policy reviewed; no changes.
03/05/2014: Policy reviewed; no changes.
01/08/2015: Policy reviewed; no changes.
07/13/2015: Code Reference section updated for ICD-10.
06/06/2016: Policy number A.2.02.25 added. Investigative definition updated in Policy Guidelines section.
07/05/2016: Policy description updated regarding devices. Policy statement unchanged.
06/06/2017: Policy description updated regarding electrocardiogram analysis. Policy statement unchanged.
05/24/2018: Medical policy link updated in policy description.
12/19/2019: Code Reference section updated to make note of deleted CPT code.
02/12/2020: Code Reference section updated to add CPT code 93799.
12/12/2022: Policy number changed from "A.2.02.25" to "L.2.02.408." Policy reviewed. Policy statement unchanged. Code Reference section updated to remove deleted CPT code 0206T.
08/21/2023: Policy reviewed; no changes.
08/22/2024: Policy reviewed; no changes.
Blue Cross Blue Shield Association policy # 2.02.25
This may not be a comprehensive list of procedure codes applicable to this policy.
Code Number | Description |
CPT-4 | |
93799 | Unlisted cardiovascular service or procedure |
HCPCS | |
ICD-10 Procedure | |
ICD-10 Diagnosis |
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