National Medical Policy Subject:

Signal-Averaged Electrocardiography

Policy Number:

NMP401

Effective Date*: December 2007 Updated:

December 2015

This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State's Medicaid manual(s), publication(s), citations(s) and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use

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Source National Coverage Determination (NCD) National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* Other

Reference/Website Link

Centers for Medicare & Medicaid Services (CMS). MEDCAC Meeting 11/9/2011 - The Use of ECG Based Signal Analysis Technologies to Detect Myocardial Ischemia or Coronary Artery Disease. Issue. September 12, 2011b. Available at: https://www.cms.gov/medicare-coveragedatabase/details/medcac-meetingdetails.aspx?MEDCACId=61&fromdb=true. Centers for Medicare & Medicaid. Systematic Review of ECG-based Signal Analysis Technologies for Evaluating Patients With Acute Coronary Syndrome: http://www.cms.gov/medicare-coveragedatabase/details/technology-assessmentsdetails.aspx?TAId=83&MEDCACId=61&fromdb= true&bc=AAAAAAAABAAAAA%3d%3d&

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None

Use Health Net Policy

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Current Policy Statement Health Net, Inc. considers signal-averaged electrocardiography, investigational due to insufficient evidence in the peer review literature demonstrating its clinical utility in improving clinical outcomes. Although studies are still being done, the clinical validity in scientifically controlled studies has not been proven at this time. Health Net, Inc. considers the Premier heart multifunction cardiogram (MCG) not medically necessary. The comparison to angiography, while useful from a research perspective has a limited role in determining clinical utility given that multifunction cardiogram would not be used as a replacement for angiography.

Definitions SAECG CS PPV NPV ARVC VT/VTA cMRI RV LP SCD HRV MCG 3DMPTM/mfEMTTM

Signal-averaged electrocardiography Cardiac sarcoidosis Positive predictive value Negative predictive value Arrhythmogenic right ventricular cardiomyopathy/dysplasia Ventricular tachycardia Cardiac magnetic resonance imaging Right ventricular Late potential Cardiac magnetic resonance imaging Heart rate variability Multifunction Cardiogram Digital Database-Driven Multiphase Functional Electromyocardial Tomography

Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets.

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ICD-9 Codes (May not be all inclusive) 410.10-410.92 411.0-411.89 414.9 427.1 427.41 427.42 427.69 780.2

Acute myocardial infarction Other acute and subacute forms of ischemic heart disease Chronic ischemic heart disease, unspecified Paroxysmal ventricular tachycardia Ventricular fibrillation Ventricular flutter Premature beats, other (ventricular, contractions, systoles) Syncope and collapse

ICD-10 Codes I21.01-I21.4 I22.0-I22.9 I24.0-I24.9 I25.9 I47.2 I49.01 I49.02 I49.3 I49.40-I49.49 R55

ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Subsequent ST elevation (STEMI) myocardial infarction of anterior wall Other acute ischemic heart disease Chronic ischemic heart disease, unspecified Ventricular tachycardia Ventricular fibrillation Ventricular flutter Ventricular premature depolarization Other and unspecified premature depolarization Syncope and collapse

CPT Codes 93278

HCPCS Codes

Signal-averaged electrocardiography (SAECG), with or without ECG

N/A

Scientific Rationale – Update December 2015 Liao et al (2014) reported signal averaged electrocardiogram (SAECG) is a specific and non-invasive tool useful for arrhythmogenic right ventricular cardiomyopathy (ARVC) diagnosis. However, its role in risk stratification of patients with ARVC remains largely undefined. Sixty-four patients fulfilling Task Force ARVC criteria (mean age: 47 ± 14 years-old, 56% male, 50% definite ARVC) were enrolled in this study. The baseline demographic, electrocardiographic, structural, and electrophysiological characteristics were collected. Patients with SAECG fulfilling all 3 Task Force criteria (3+ SAECG) were categorized into group 1, and those fulfilled 2 or less criterion were categorized into group 2. The study endpoints were unstable ventricular arrhythmia (VA), device detectable sustained fast VA (cycle lengths < 240 ms) and cardiovascular death. During a mean follow-up of 21 ± 20 months, 15 primary endpoints including 12 unstable VAs and 3 device-detected fast VAs were met. One patient died of electrical storm, and one patient underwent heart transplantation. The presence of 3+ SAECG predicted malignant events in all patients with definite and non-definite ARVC (p < 0.01, OR = 30.5, 95% CI = 2.5-373.7) and in patients with definite ARVC alone (p = 0.03, OR = 11.1, 95% CI = 1.3-93.9). Patients diagnosed with non-definite ARVC without 3+ SAECG were free from malignant events. The authors concluded SAECG fulfilling all 3 Task Force criteria was an independent risk predictor of malignant events in ARVC patients. SAECG may play a valuable role in ARVC risk stratification.

Scientific Rationale - Update December 2014 Leisy et al. (2013) Timely identification of cardiac ischemia is critical in patients with acute coronary syndrome (ACS). The first test is often the standard, resting 12-lead Signal Averaged Electrocardiography Dec 15

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ECG. Given its limitations, signal analysis enhancements have been proposed. The authors summarize the published evidence for commercially available ECG-based signal analysis technologies. This is a systematic review of the English-language published literature. Published evidence meeting inclusion criteria was available for two devices: PRIME ECG and LP 3000. Meta-analysis of eight studies estimated a 68.4% sensitivity (95% CI, 35.1%-89.7%) and 91.4% specificity (CI, 83.6%-95.7%) for the PRIME ECG, compared with 40.5% sensitivity (CI, 19.6%-65.5%) and 95.0% specificity (CI, 87.9%-98.0%) for the standard 12-lead ECG. Existing evidence is insufficient to confidently inform the appropriate use of ECG-based signal analysis technologies for detecting ischemia or infarct in ACS. Further research is needed to determine in what circumstances, if any, these devices might precede, replace, or add to the standard ECG in test strategies for detecting ischemia or infarct in ACS. Per the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, in addition to determination of LVEF, several other noninvasive strategies have been proposed to identify patients at high risk for arrhythmic events after STEMI, such as signal-averaged or high-resolution ECG, heart rate variability, baroreflex sensitivity, and T-wave alternans (591). These strategies have not been adopted widely because of their limited performance characteristics and are not recommended for routine use. The Premier Heart's Multifunction Cardiogram (MCG) is a non-invasive online diagnostic testing tool designed to assist physicians in detecting heart diseases, including CAD ischemia. There are currently no ongoing Clinical Trials, and there is a paucity of peer-reviewed comparative or controlled studies to support this. The most updated Technology Assessment on ‘Premier Heart's Multifunction Cardiogram’ was from the Agency for Healthcare Research and Quality (AHRQ, 2010), and it notes that the MCG uses ECG data from 2 of the 12 standard leads to perform frequency and time domain analysis. Recordings for over 82 seconds are amplified and sent securely over the Internet to Premier Heart Datacenter, where signal analysis and mathematical transformations are done to derive information that, in particular patterns may signify the presence of disease. The data are compared to a large empirical database to determine a ‘Final Diagnosis’ and ‘Severity Score.’ These are then securely reported back over the internet within several minutes to the requesting provider. ARHQ was unable to determine the details of the proprietary severity scoring.

Scientific Rationale Update – December 2012 The 2012 ACCF/AHA Focused Updated Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial infarction, which is a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, has no mention of signal averaged electrocardiography or Premier multifunction cardiogram (MCG). Hayes (2011) reported that SAECG has a potential benefit to risk stratify patients with impaired left ventricular function who are at high risk of ventricular tachycardia (VTA) or sudden death because of previous myocardial infarction (MI) or otherwise known coronary artery disease (CAD). No benefit is noted when no ischemic disease is present such as dilated nonischemic cardiomyopathy. Per the American College of Cardiology (2008), ‘Abundant data show that an abnormal SAECG may identify patients with prior MI at risk for SCD. Given the high negative predictive value of this test, it may be useful for the identification of patients at low risk. Routine use of the SAECG to identify patients at high risk for SCD is not adequately supported at this time. Further studies are required to assess the utility of this test’. Signal Averaged Electrocardiography Dec 15

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There is a paucity of studies that attempt to determine the clinical utility of the multifunction cardiogram. Even if this test does have good accuracy for diagnosing CAD, its role in clinical practice would still need to be determined. Use of the multifunction cardiogram to screen for CAD would be a departure from usual practice, as screening for CAD has not been shown to improve outcomes. In the nonacute setting, the traditional resting ECG has a limited role in diagnosing CAD. The most common method for diagnosing CAD for this purpose is stress testing. There are no studies comparing the accuracy of multifunction cardiogram to stress testing. The comparison to angiography, while useful from a research perspective has a limited role in determining clinical utility given that multifunction cardiogram would not be used as a replacement for angiography. Because of these limitations, the evidence is not sufficient to determine the impact of the computerized 2-lead resting electrocardiogram analysis (e.g., multifunction cardiogram) on health outcomes, and therefore the use of this device is considered not medically necessary.

Scientific Rationale – Update March 2011 Schuller et al (2011) evaluated the diagnostic utility of signal-averaged ECG (SAECG) for detection of cardiac involvement of cardiac sarcoidosis (CS). Individuals with biopsy proven sarcoidosis and symptoms suggestive of possible cardiac involvement were included in the cohort. Standard criteria for SAECG were used. Subjects were considered to have CS if they met criteria established by the Japanese Ministry of Health and Welfare modified to include cardiac MRI. Of the 88 patients in the cohort, 27 had evidence of CS independent of the SAECG results. The SAECG was abnormal in 14 of these 27 patients and 11 of the 61 of the subjects without cardiac involvement. The sensitivity of SAECG detection of CS was 52% with a specificity of 82%. For the entire cohort, SAECG had a positive predictive value (PPV) of 0.56 and a negative predictive value (NPV) of 0.79. Within a subgroup of 67 patients with an unfiltered QRS duration of