Medical Policy



Subject: Computer Analysis and Probability Assessment of Electrocardiographic-Derived Data
Document #: MED.00074 Current Effective Date:    03/29/2017
Status: Reviewed Last Review Date:    02/02/2017

Description/Scope

This document addresses remote algorithmic analysis of electrocardiographic-derived data with computer probability assessment which involves analysis of a 2-lead resting ECG from leads II and V5 that is amplified and digitized for computer analysis at a centralized data facility. An example of this technology is the Multifunction CardioGramTM (MCG), which was formerly known as Digital Database-Driven Multiphase Functional Electromyocardial Tomography (3DMPTM /mfEMT™) (Premier Heart, LLC, Port Washington, NY).

Note: This document does not address signal averaged electrocardiography (SAECG).

Note: Please see the following related documents for additional information:

Position Statement

Investigational and Not Medically Necessary:

Remote algorithmic analysis of electrocardiographic-derived data with computer probability assessment is considered investigational and not medically necessary for all indications.

Rationale

The Multifunction CardioGram has been proposed as a technique to improve the sensitivity of a resting electrocardiogram (ECG) to detect coronary artery disease (CAD) and ischemia. As such, the technique could potentially provide a non-invasive and convenient office-based alternative to other anatomic or functional techniques to evaluate CAD, including coronary angiography, stress tests or echocardiography. Additionally, most testing for CAD focuses on its diagnosis in symptomatic individuals. Therefore, there has been interest in developing better prognostic tests for CAD in the much larger group of asymptomatic but at-risk individuals. Published studies of MCG have focused on individuals with known CAD. For example, all studies enrolled individuals scheduled for angiography (Grube, 2007; Grube, 2008; Hosokawa, 2008; Weiss, 2002). No study was identified that focused on the diagnostic and predictive ability of MCG compared to other imaging techniques or prognostic factors. Additionally, there were no studies that focused on how MCG could be used in the management of individuals with different symptoms and risk factors. The clinical utility of computerized 2-lead ECG analysis in the management of individuals with suspected or known coronary artery disease has not been established.

An Agency for Healthcare Research and Quality (AHRQ) technology assessment assessed the use of ECG-based signal analysis technologies for the evaluation of individuals with suspected CAD (AHRQ, 2010). After reviewing clinical and scientific evidence available the assessment concluded:

There is currently little available evidence that pertains to the utility of ECG-based signal analysis technologies as a diagnostic test among patients at low to intermediate risk of CAD who present in the outpatient setting with the chief complaint of chest pain. The limited evidence that is available demonstrates proof of concept, particularly for the 3DMP and PRIME ECG devices. Further research is needed to better characterize the performance characteristics of these devices to determine in what circumstances, if any, these devices might precede, replace, or add to the standard ECG in test strategies for the diagnosis of CAD in the patient population of interest.

In 2012 AHRQ conducted a systematic review of the published literature on ECG-based signal analysis technologies for evaluating patients with acute coronary syndrome (ACS) (AHRQ, 2012). The researchers concluded:

Existing research is largely insufficient to confidently inform the appropriate use of ECG-based signal analysis technologies in diagnosing CAD and/or ACS. Further research is needed to better describe the performance characteristics of these devices to determine in what circumstances, if any, these devices might precede, replace, or add to the standard ECG in test strategies to identify clinically significant CAD in the patient population of interest. To fully assess the impact of these devices on diagnostic strategies for patients with chest pain, test performance needs to be linked to clinically important outcomes through modeling or longitudinal studies.

Background/Overview

Multifunction CardioGram represents a diagnostic computer program that is designed to enhance the specificity of resting ECGs to detect coronary artery disease. An ECG device records a 2-lead resting ECG that is amplified and digitized for computer analysis at a centralized data facility. The digital data is then subjected to a variety of mathematical transformations which are used to generate a severity score between 0 and 20, with a higher score indicating a higher likelihood of myocardial ischemia and coronary artery stenosis. The resulting data is then compared to a reference database to generate a final diagnostic output. The reference database is comprised of data from trials conducted between 1978 and 2000 from 30 different institutions. In the preliminary investigation of MCG all diagnoses of coronary artery disease were validated based on expert diagnosticians, laboratory values (i.e. changes in cardiac enzymes) or angiography.

Definitions

Coronary artery disease: A disease characterized by narrowing or blockage of the blood vessels supplying blood to the heart.

Myocardial ischemia: Inadequate blood supply (circulation) to a part of the heart due to blockage of the vessels supplying blood to the area.

Stenosis: A narrowing in a blood vessel such as an artery. This narrowing is usually caused by fatty deposits (atherosclerosis) in the vessel wall.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:

CPT  
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 [MCG, 3DMP/mfEMT]
   
ICD-10 Diagnosis  
  All diagnoses
   
References

Peer Reviewed Publications:

  1. 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.
  2. 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):249-263.
  3. Hosokawa J, Shen JT, Imhoff M. Computerized 2-lead resting ECG analysis for the detection of relevant coronary stenosis in comparison with angiographic findings. Congest Heart Fail. 2008; 14(5):251-260.
  4. Weiss MB, Narasimhadevara SM, Feng GQ, Shen JT. 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.

Government Agency, Medical Society, and other Authoritative Publications:

  1. Agency for Healthcare Research and Quality. ECG-based signal analysis technologies. Technology Assessment Report. 2010 May. Project ID CRDD1008. Available at: https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id73TA.pdf . Accessed on November 30, 2016.
  2. Agency for Healthcare Research and Quality. Systematic review of ECG-based signal analysis technologies for evaluating patients with acute coronary syndrome. Technology Assessment Report. 2012 June. Project ID CRDD0311. Available at: http://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id83TA-1.pdf. Accessed November 30, 2016.
Websites for Additional Information
  1. American College of Cardiology. Available at: http://www.cardiosource.org/. Accessed on November 30, 2016.
  2. American Heart Association. Available at: http://www.americanheart.org. Accessed on November 30, 2016.
Index

Computerized 2-Lead Resting Electrocardiogram Analysis
Digital Database-Driven Multiphase Electromyocardial Tomography
Multifunction CardioGram MCG
3DMP/mfEMT

Document History
Status Date Action
Reviewed 02/02/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Updated the Rationale and References sections.
Reviewed 02/04/2016  MPTAC review. Updated References. Removed ICD-9 codes from Coding section.
Reviewed 02/05/2015 MPTAC review. Updated Description, Rationale, References and Websites.
Reviewed 02/13/2014 MPTAC review. Updated References and Websites sections.
Reviewed 02/14/2013 MPTAC review. Websites updated.
  07/01/2012 Updated Coding section with 07/01/2012 CPT descriptor change.
Revised 02/16/2012 MPTAC review. Changed titled: Computer Analysis and Probability Assessment of Electrocardiographic-Derived Data. Re-scoped policy: removing Signal-Averaged Electrocardiography investigational and not medically necessary statement. Re-scoped Description, Background, and Index. Updated References and Websites. Updated Coding section; removed code 93278, no longer addressed.
Reviewed 02/17/2011 MPTAC review. Removed the phrase "and/or" from position statement. Rationale updated. References and Websites updated.
Revised 02/25/2010 MPTAC review. Investigational and not medically necessary statement was clarified. References updated.
  01/01/2010 Updated Coding section with 01/01/2010 CPT changes.
  05/21/2009 Updated Rationale and References.
Revised 02/26/2009 MPTAC review. Changed title to Computer Analysis of Electrocardiography (ECG). Investigational and not medically necessary statement added for Digital Database-Driven Multiphase Functional Electromyocardial Tomography (3DMP/mfEMT). Rationale, Coding and References updated.
Reviewed 02/21/2008 MPTAC review. The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary."  This change was approved at the November 29, 2007 MPTAC meeting. References were updated.
Reviewed 03/08/2007 MPTAC review. References were updated.
Revised

03/23/2006

 

MPTAC review. Information within the investigational/not medically necessary document statement and the rationale section was expanded to include specific reference to indications for ARVD, based on comments from the ACC. References were also updated. 
Revised 09/22/2005 MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization. 
Pre-Merger Organizations Last Review Date Document Number Title
Anthem, Inc.     No policy
WellPoint Health Networks, Inc. 03/01/2004 2.04.04 Signal-Averaged Electrocardiography