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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

01-93000-32

Original Effective Date: 01/01/10

Reviewed: 08/28/14

Revised: 11/01/15

Subject: Multifunction Cardiogram (MCG)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Other  

DESCRIPTION:

The 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 standard 12-lead resting electrocardiogram (ECG) has limited diagnostic accuracy in the detection of coronary artery disease (CAD). 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 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 100 Hz, 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.

POSITION STATEMENT:

Multifunction cardiogram is considered experimental or investigational for all indications due to the lack of sufficient clinical studies published in the peer-reviewed literature documenting improvement to health outcomes. This technology is promising, but is lacking in its ability to be predictable enough to avoid further diagnostic studies.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

CPT Coding

0206T

Computerized database analysis of multiple cycles of digitized cardiac electrical data from two or more ECG leads, including transmission to a remote center, application of multiple nonlinear mathematical transformations, with coronary artery obstruction severity assessment (investigational)

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) was found at the time of the last guideline reviewed date.

The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Noncovered Services (L29288) located at fcso.com.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

Other indexing terms:

NOTE: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Algorithmic analysis of electrocardiographic-derived data with computer probability assessment

Computerized 2-lead resting electrocardiogram analysis

Digital Database-Driven Multiphase Functional Electromyocardial Tomography

Remote algorithmic analysis of electrocardiographic-derived data

3DMP™/mfEMT™

REFERENCES:

  1. Agency for Healthcare Research and Quality. ECG-based signal analysis technologies. Technology Assessment Report. 2010 May. Project ID CRDD1008. Accessed 06/18/14.
  2. Blue Cross Blue Shield Association Medical Policy Reference Manual; 2.02.25 Computerized 2-lead Resting Electrocardiogram Analysis for the Diagnosis of Coronary Artery Disease (11/14/13).
  3. First Coast Service Options. Medicare Local Coverage Determination (LCD) Noncovered Services (L29288) (05/07/14).
  4. Grube et al. Computerized two-lead resting ECG analysis for the detection of coronary artery stenosis after coronary revascularization. International Journal of Medical Sciences 2008 5(2): pp 50-61
  5. Grube et al. Computerized two-lead resting ECG analysis for the detection of coronary artery stenosis. International Journal of Medical Sciences 2007 4(5): pp 249-26
  6. Hosokawa et al. Computerized 2-Lead resting ECG analysis for the detection of relevant coronary artery stenosis in comparison with angiographic findings. Congestive Heart Failure 2008 14: pp. 251-260
  7. Weiss et al. Computer-enhanced frequency – domain and 12-lead electrocardiography accurately detect abnormalities consistent with obstructive and Non-obstructive coronary artery disease. Heart Disease 2002; 4: pp 2-12.
  8. Strokbeck et al. Comparison of a 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. International Journal of Medical Sciences 2009; 6(4) pp 143-144.
  9. 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. Epub 2011 Oct 28.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 08/28/14.

GUIDELINE UPDATE INFORMATION:

01/01/10

New Medical Coverage Guideline.

04/01/12

2nd quarter HCPCS update; revised descriptor for 0206T.

10/15/12

Annual review; position statement unchanged; references updated.

10/15/13

Annual review; position statement unchanged; Program Exceptions section updated; references updated.

09/15/14

Annual review; position statement unchanged. References updated.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: October 20, 2017: 11:57 AM