Latest Review Date: January 2024

Category: Medical                                                                 

POLICY:

Computerized 2-lead resting electrocardiogram analysis (e.g., multifunction cardiogram) for diagnosing coronary artery disease is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Computerized 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).

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, 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 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% to 90% range. Cardiac angiography is the criterion standard for diagnosing CAD and is used in situations in which 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 analog ECG 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. Six 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.

KEY POINTS:

The most recent literature review was updated through January 4, 2024.

Summary of Evidence

For individuals who are being screened for coronary artery disease (CAD) with computerized 2-lead electrocardiography, the evidence consists of several diagnostic accuracy studies and a systematic review. Relevant outcomes include overall survival, disease-specific, test accuracy, test validity, and morbid events. The systematic review found a calculated sensitivity and specificity of 91.2% and 84.6%, respectively.  However, studies included in the systematic review had several methodologic limitations that reduced their internal validity.  For example, they used convenience samples and had high rates participants exclusion from the analysis. These methodologic limitations create a substantial degree of uncertainty regarding the reported results for diagnostic accuracy. The clinical utility of the technology is also uncertain.  Even if this test has good accuracy for diagnosing CAD, its application in clinical practice would still need to be determined. Use of the computerized 2-lead electrocardiogram analysis to screen for CAD would depart from usual practice, because screening for CAD has not been shown to improve outcomes. In the nonacute setting, the most common method for diagnosing CAD is stress testing, and there is no evidence comparing the accuracy of computerized 2-lead electrocardiography with stress testing. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

No guidelines or statements were identified.

U.S. Preventive Services Task Force Recommendations

No U.S. Preventive Services Task Force (USPSTF) recommendations for computerized 2-lead resting electrocardiogram analysis in patients being screened for coronary artery disease have been identified.

KEY WORDS:

Multifunction cardiogram, 3DMP, coronary artery disease, CAD, atherosclerotic heart disease

APPROVED BY GOVERNING BODIES:

There is at least one commercially available multifunction cardiogram.   In April 2003, the Premier Heart MCG™ system (Premier Heart, Port Washington, NY) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. FDA determined that this device was substantially equivalent to existing devices for use in ECG analysis

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

CPT codes:   

REFERENCES:

1. Amano T, Shinoda N, Kunimura A, et al. Non-invasive assessment of functionally significant coronary stenoses through mathematical analysis of spectral ECG components. Open Heart. 2014; 1(1):e000144.
2. de Jong MC, Genders TS, van Geuns RJ et al. Diagnostic performance of stress myocardial perfusion imaging for coronary artery disease: a systematic review and meta-analysis. Eur Radiol 2012; 22(9):1881-95.
3. Grube E, Bootsveld A, Buellesfeld L et al. Computerized two-lead resting ECG analysis for the detection of coronary artery stenosis after coronary revascularization. Int J Med Sci 2008; 5(2):50-61.
4. Grube E, Bootsveld A, Yuecel S et al. Computerized two-lead resting ECG analysis for the detection of coronary artery stenosis. Int J Med Sci 2007; 4(5):249-63.
5. Hosokawa J, Shen JT, Imhoff M. Computerized 2-lead resting ECG analysis for the detection of relevant coronary artery stenosis in comparison with angiographic findings. Congest Heart Fail 2008; 14(5):251-60.
6. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
7. Kawaji T, Shiomi H, Morimoto T, et al. Noninvasive detection of functional myocardial ischemia: Multifunction Cardiogram Evaluation in Diagnosis of Functional Coronary Ischemia Study (MED-FIT). Ann Noninvasive Electrocardiol. Sep 2015; 20(5):446-453.
8. Strobeck JE, Mangieri A, Rainford N. A paired-comparision of the Multifunction Cardiogram (MCG) and sestamibi SPECT myocardial perfusion imaging (MPI) to quantitative coronary angiography for the detection of relevant coronary artery obstruction (>/=70%) - a single-center study of 116 consecutive patients referred for coronary angiography. Int J Med Sci 2011; 8(8):717-24.
9. Strobeck JE, Shen JT, Singh B et al. Comparison of two-lead, computerized, resting ECG signal analysis device, the MultiFunction-CardioGram, or MCG (a.k.a. 3DMP), to quantitative coronary angiography for the detection of relevant coronary artery stenosis (>70%) – a meta-analysis of all published trials performed and analyzed in the US. Int J Med Sci 2009; 6(4):143-55.
10. Weiss MB, Narasimhadevara SM, Feng GQ et al. Computer-enhanced frequency-domain and 12-lead electrocardiography accurately detect abnormalities consistent with obstructive and nonobstructive coronary artery disease. Heart Dis 2002; 4(1):2-12.

POLICY HISTORY:

Medical Policy Group, December 2010 (2)

Medical Policy Administration Committee, December 2010

Available for comment December 10, 2010 through January 24, 2011

Medical Policy Group, April 2012 (4)

Medical Policy Group, June 2012 (3); Updated verbiage on code 0206T-effective 7/1/12

Medical Policy Panel, November 2012

Medical Policy Group, January 2013 (3): 2013 Update to Key Points and References

Medical Policy Panel, November 2013

Medical Policy Group November 2013 (4): Updated Key points.  No change in policy statement at this time.

Medical Policy Panel, November 2014 (3): Update to Key Points.  No change in policy statement.

Medical Policy Panel, May 2016

Medical Policy Group, May 2016 (4): Updates to Description, Key Points, Key Words and References, No change in policy statement. 

Medical Policy Panel, July 2017

Medical Policy Group, July 2017 (4): Updates to Description, Key Points, Approved by Governing Bodies. No change in policy statement. Policy retired.

Medical Policy Group, December 2019: 2020 Coding update.  Added CPT code 93799.  Moved 0206T from Current Coding to Previous Coding.

Medical Policy Group, August 2021 (4): Reviewed by consensus. Policy statement updated to remove “not medically necessary,” no change to policy intent. Update to References.

Medical Policy Group, January 2023 (4): Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy.  No change to policy statement.

Medical Policy Group, January 2024 (4): Reviewed by consensus. No new published peer-reviewed  literature available  that would alter the coverage statement in this policy. No change to policy statements. Removed the previous coding section and the deleted code 0206T (deleted 12/31/2019). Updates to Key points and Benefit Application.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.