Medical Policy

 

Subject: Computer Analysis and Probability Assessment of Electrocardiographic-Derived Data
Document #: MED.00074 Publish Date:    02/28/2018
Status: Reviewed Last Review Date:    01/25/2018

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 (MCG) technology 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 for the evaluation of suspected CAD, including coronary angiography, stress tests or echocardiography. Since most testing for CAD focuses on confirming the diagnosis in symptomatic individuals, there has been interest in developing better prognostic tests for evaluation of asymptomatic at-risk individuals.  To date, the published studies of MCG have focused on subjects with known CAD, for example, individuals scheduled for angiography (Grube, 2007; Grube, 2008; Hosokawa, 2008; Weiss, 2002).  No large, well designed studies have been identified that focused on the diagnostic and predictive utility of MCG, compared to other conventional diagnostic tests.  To date, the published evidence on safety, efficacy and utility of the MCG device is insufficient to determine the appropriate use of this technology in the management of cardiac conditions.  Further study is needed to demonstrate clinical utility and how use of this device will impact treatment management.

An assessment report was issued by the Agency for Healthcare Research and Quality (AHRQ) for use of ECG-based signal analysis technologies in the evaluation of individuals with suspected CAD (Coeytaux, 2010). After reviewing the available clinical and scientific evidence, the report 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, the AHRQ conducted a systematic review of the published literature on ECG-based signal analysis technologies for evaluating individuals with acute coronary syndrome (ACS) (Coeytaux, 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

The MultiFunction Cardiogram MCG (Premier Heart, Port Washington, NY), is a computerized ECG device that uses algorithmic analysis for the evaluation of known or suspected CAD.  This device uses a diagnostic computer program that is designed to enhance the specificity of resting ECGs to detect CAD. 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 the MCG device, all diagnoses of CAD were validated based on expert diagnosticians, laboratory values, (for example, 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]

 

 

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. 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. 2015; 20(5):446-453.
  5. Strobeck JE, Shen JT, Singh B, 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. Int J Med Sci. 2009; 6(4):143-155.
  6. 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. Coeytaux RR, Leisy PJ, Wagner GS, et al. 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 December 12, 2017.
  2. Coeytaux RR, Williams JW Jr, Chung E, et al. 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.pdfAccessed on December 12, 2017.
  3. U.S. Food and Drug Administration (FDA). 510(k) Premarket notification database. Cardiotron EKG Multi-phase Information Analysis System (Premier Heart LLC). No. K992703. Rockville, MD: FDA. March 20, 2000. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf/K992703.pdf. Accessed on December 12, 2017.
Websites for Additional Information
  1. American College of Cardiology. Available at: http://www.cardiosource.org/. Accessed on December 12, 2017.
  2. American Heart Association. Available at: http://www.americanheart.org. Accessed on December 12, 2017.
Index

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

Document History

Status

Date

Action

Reviewed

01/25/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording was updated from “Current Effective Date” to “Publish Date.”  The Rationale, Background and References sections were updated.

Reviewed

02/02/2017

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 title: 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