mp-309 - Medical Policies - Florida
Electrocardiographic Body Surface Mapping
Policy Number: MP-309
Latest Review Date: August 2019
Policy Grade: Effective July 28, 2017: Active policy but no longer scheduled for regular literature reviews and updates.
Description of Procedure or Service:
Electrocardiographic body surface mapping (BSM) is an electrocardiographic (ECG) technique that uses multiple (generally 80 or more) electrocardiography leads to detect cardiac electrical activity. It is suggested that the use of multiple leads may result in improved diagnostic accuracy of acute myocardial infarction (AMI) or acute coronary syndrome (ACS), compared with that of the standard 12-lead ECG. No BSM ECG devices with 80 or more leads are currently commercially available in the United States.
Electrocardiographic body surface mapping (BSM) consists of an 80-lead disposable electrode array in the form of a vest and includes a conducting gel that is applied to the patient’s chest and back. The vest can be affixed to the patient in less than five minutes. This system displays clinical data in three forms; a colorimetric 3-D torso image, an 80-lead single beat view, and the 12-lead electrocardiograph (ECG). The colorimetric torso images are said to allow the practitioner to rapidly scan the heart for significant abnormalities.
Currently, in patients presenting to the emergency department with symptoms suggestive of acute coronary syndrome (ACS), a standard 12-lead ECG is obtained. In the presence of ST-segment elevation on the ECG, personnel are activated to respond in a timely manner to open a presumed coronary artery occlusion, either by mechanical means through balloon angioplasty, or medically, through intravenous thrombolytic drugs. The 12-lead ECG has a specificity of 94%, leading to relatively few erroneous interventions. However, the sensitivity is approximately 50%. These patients may be further stratified by scoring systems and time-sensitive cardiac enzymes, which may require up to 24 hours of monitored observation.
BSM is being considered as a method to assist in the rapid identification of patients who would benefit from earlier coronary artery intervention than is achieved utilizing current standard of care.
Electrocardiographic body surface mapping is considered not medically necessary and investigational for all indications including, but not limited to, acute coronary syndrome.
The most recent literature search was performed through March 23, 2017.
Assessment of a diagnostic technology focuses on the following three parameters: 1) technical performance; 2) diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) in relevant clinical populations; and 3) clinical utility, i.e., demonstration that the diagnostic information can be used to improve patient outcomes.
Clinical Context and Proposed Clinical Utility
The proposed clinical utility of BSM evaluated in this review is to improve the accuracy of diagnosing ACS I order to identify those patients who would benefit from medical or surgical coronary artery intervention. The current standard intervention is a 12 lead electrocardiograph which has a relatively high specificity but a relatively low sensitivity. The sensitivity of the 12 lead ECG, however, can be improved by incorporating information from clinical evaluation and cardiac enzyme analysis. Still, a test with a higher sensitivity could be clinically beneficial.
Patterns of electric potentials in normal subjects have been established, and the significance of abnormal signals has been explored over past decades.
Many of the individual studies have shown higher sensitivity for BSM and some have shown lower specificity. For example, in a retrospective study conducted at four centers, Ornato and colleagues reviewed the cardiac enzyme-confirmed cases of acute myocardial infarction (MI) against results of 12-lead ECG and BSM. Due to a change in standard practice during the study, AMI was defined by either elevated troponin or heart-specific creatinine kinase (CK-MB). Of 647 patients, 58 (8.9%) were not analyzed due to lack of enzyme data. Sensitivity comparison between BSM and 12-lead ECG in the CK-MB group favored BSM (100% vs. 72.7%, respectively, p=0.031; n=364), and also in the troponin group (92.9% vs. 60.7%, respectively, p=0.022; n=225). Specificity for BSM was not significantly different from 12-lead ECG in either group (96.5% vs. 97.1 and 94.9 vs. 96.4, both respectively).
Fermann and colleagues found very different performance characteristics of BSM in comparison to 12-lead ECG from other studies. A convenience sample of 150 patients with chest pain presenting to the emergency department had BSM measured within 30 minutes of the standard ECG. Emergency physicians, who had been trained in BSM, interpreted both the BSM and the ECGs at the time of presentation. Both were stored electronically for review by a BSM expert over read; after the study had ended, a convenience sample of 135 BSMs were over read. Of 43 patients, ten (23.3%) judged to have normal BSM by the emergency physicians were found to have abnormal findings or frank infarction by the expert interpreter. Overall correlation between the emergency physicians and expert reviewer was only fair (correlation coefficient κ=0.627; 95% CI: 0.530-0.724). Sensitivity of both standard ECG and BSM were low at 10.5 (95% CI: 1.8-34.5) and 15.8 (95% CI: 4.2-40.5), respectively. This low sensitivity likely reflects the spectrum of patients in the study. Specificities were also comparable between the two groups at 90.1 (95% CI: 83.3-94.4) and 86.3 (95% CI: 78.9-91.4), respectively.
In this publication, 12-lead ECG was compared to 80-lead ECG mapping for detecting high-risk ECG abnormalities. Patients diagnosed with STEMI by 12-lead ECG (n=91), and patients with missing data (n=255) were excluded from the analysis on specificity and sensitivity. When detecting myocardial infarction (MI) and acute coronary syndrome (ACS), the 80-lead ECG mapping sensitivity was significantly higher than the 12-lead ECG for MI (19.4% vs. 10.7%, p=0.0014) and for ACS (12.3% vs. 7.1%, p=0.0025). The authors attributed these low sensitivity rates to the exclusion of STEMI patients in this analysis. Specificity for the 80-lead ECG mapping was significantly lower than the 12-lead ECG for MI (93.9% vs. 96.4%, p=0.0005) and for ACS (93.7% vs. 96.4%, p=0.0005). Positive and negative predictive values and negative and positive likelihood ratios were not statistically different between the 12-lead and 80-lead groups. The 80-lead ECG mapping resulted in the identification of 18 additional MI patients and 21 additional ACS patients who could potentially have benefited from more aggressive treatment. However, the 80-lead ECG mapping results were not incorporated into treatment decision making, and thus, no conclusions can be made from this study on the impact of this technology on patient outcomes. Also, the authors did not explore the impact of decreased specificity, and increased false-positive rates, on patient outcomes. Other limitations of this study include lack of enrollment of low-risk emergency department patients and the lack of power to detect differences in ACS diagnosis.
A small 2014 study from the U.K. evaluated the 80-lead ECG mapping system (PRME-ECG) along with internally-developed software to create a BSM Delta map. The study included 49 patients who presented to the ED with cardiac-sounding chest pain. Using the final diagnosis of ACS as the reference standard, the sensitivity and specificity of the BSM Delta map for diagnosing ACS were 71% (22/31) and 78%,(14/18) respectively. This compares with a sensitivity of 67% (21/31) and specificity of 55% (10/18) when 12-lead ECG was used. The authors did not analyze whether differences in diagnostic accuracy were statistically significant. Moreover, the BSM Delta mapping software, an important part of the diagnostic process in this study, may not be available outside of the European research setting.
Section Summary: Diagnostic Accuracy
Numerous published studies compare the accuracy of BSM with standard 12-lead electrocardiography for the diagnosis of ACS. These studies are mostly retrospective and did not enroll the ideal clinical populations, i.e., consecutive patients presenting with clinical signs/symptoms of ischemia. They also tended to compare the accuracy of BSM alone with 12-lead EKG alone. This is less clinically relevant because 12-lead EKG is not used alone to diagnose ACS, but rather is combined with the clinical presentation and results of cardiac enzymes.
An editorial accompanying the publication of the OCCULT-MI trial acknowledged the limitation of 12-lead ECG in identifying patients with acute MI. However, a distinction was made between those patients for whom it is well established that early intervention is beneficial (i.e., STEMI on standard 12-lead ECG) and those for whom BSM is positive but 12-lead is not. It is not known whether these patients benefit from early intervention. The editorial suggested that the patients identified thusly are more similar to the non-ST elevation myocardial infarction (NSTEMI) patients based on peak troponin levels found in the OCCULT-MI trial and that identification of these patients should not lead to a change in treatment.
Section Summary: Clinical Utility
There are no studies that demonstrate how BSM can be used to change clinical management in ways that improve health outcomes. Indirect evidence suggests that BSM might be used in a subset of patients presenting with suspected ACS to reduce the time to diagnosis and thereby provide revascularization more expediently. Whether this strategy improves outcomes has yet to be demonstrated. In order to demonstrate clinical utility, the ideal study design is a randomized controlled trial in which patients are randomized to BSM or standard 12-lead EKG, and patients are followed for changes in management and clinical outcomes.
For individuals who have suspected or confirmed acute cardiac syndrome who receive ECG BSM, the evidence includes a number of studies on the association between ECG BSM and AMI. Relevant outcomes are overall survival, disease-specific survival, test accuracy, test validity, and morbid events. No prospective trials using BSM to guide treatment were identified. Results of published studies have been variable and an Agency for Healthcare Research and Quality review did not find statistically significant differences in the diagnostic accuracy of BSM and 12-lead ECG. Under ideal conditions, it is possible that BSM has a higher sensitivity than a 12-lead ECG for acute coronary events. However, studies have reported lower specificity with ECG BSM compared with 12-lead ECG, which may lead to false-positive results. There is no evidence demonstrating that electrocardiographic BSM leads to changes in management that improve health outcomes. The evidence is insufficient to determine the effect of the technology on health outcomes.
Practice Guidelines and Position Statements
The American College of Cardiology Foundation guidelines for electrocardiography standardization and interpretation recognize that while the studies of body surface maps from large electrode arrays have provided useful information about localization of ECG information on the thorax, at this time their complexity precludes their use as a substitute for the standard 12-lead ECG for routine recording purposes.
U.S. Preventive Services Task Force Recommendations
The use of 80-lead body surface mapping ECG is not a preventive service.
Electrocardiography, Heartscape, PRIME ECG, 80-lead electrocardiogram, multi-lead electrocardiogram, electrocardiographic body surface mapping, electrocardiographic body surface potential mapping
Approved by Governing Bodies:
In March 2002, the device “PRIME ECG®” (Verathon, Bothell, WA) was cleared for marketing by FDA through the 510(k) process. FDA determined that the device was substantially equivalent to existing devices for use in recording of ECG signals on the body surface. As of April 2016, neither the PRIME ECG device nor its successor, the Heartscape™ 3D ECG System are being marketed in the United States. Product code: DPS.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
As of 01/01/2018, there is no specific code for this procedure. Use unlisted code 93799 to report.
|0178T||Electrocardiogram, 64 leads or greater, with graphic presentation and analysis; with interpretation and report (Deleted 12/31/2017)|
|0179T||tracing and graphics only, without interpretation and report (Deleted 12/31/2017)|
|0180T||nterpretation and report only (Deleted 12/31/2017)|
- Coeytaux RR WJ, Chung E, Gharacholou M. Technology Assessment. ECG-based signal analysis technologies. Prepared for the Agency for Healthcare Research and Quality (AHRQ) by the Duke Evidence-based Practice Center. 2010. Available online at: www.cms.gov/determinationprocess/downloads/id73TA.pdf.
- Coeytaux RM, Leisy PJ, Wagner GS et al. Systematic review of ECG-based signal analysis technologies for evaluating patients with acute coronary syndrome. Agency for Healthcare Research and Quality Technology Assessment Report. Project ID: CRDD0311. June 201 Available online at: www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id83TA-1.pdf. Last accessed December, 2013.
- Daly MJ, Adgey JA, Harbinson MT. Improved detection of acute myocardial infarction in patients with chest pain and significant left main stem coronary stenosis. QJM. Feb 2012; 105(2): 127-135.
- Daly MJ, Finlay DD, Scott PJ et al. Pre-hospital body surface potential mapping improves early diagnosis of acute coronary artery occlusion in patients with ventricular fibrillation and cardiac arrest. Resuscitation 2013; 84(1):37-41.
- Fermann GJ, Lindsell CJ, O'Neil BJ et al. Performance of a body surface mapping system using emergency physician real-time interpretation. Am J Emerg Med 2009; 27(7):816-22.
- Gulrajani RM. The forward and inverse problems of electrocardiography. IEEE Eng Med Biol Mag 1998; 17(5):84-101, 122.
- Hoekstra JW, O'Neill BJ, Pride YB et al. Acute detection of ST-elevation myocardial infarction missed on standard 12-Lead ECG with a novel 80-lead real-time digital body surface map: primary results from the multicenter OCCULT MI trial. Ann Emerg Med 2009; 54(6):779-88 e1.
- Hollander JE. The 80-lead ECG: more expensive NSTEMI or Occult STEMI. Ann Emerg Med 2009; 54(6):789-90.
- Kligfield P, Gettes LS, Bailey JJ et al. Recommendations for the standardization and interpretation of the electrocardiogram: part I: the electrocardiogram and its technology a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society endorsed by the International Society for Computerized Electrocardiology. J Am Coll Cardiol 2007; 49(10):1109-27.
- Lau J, Ioannidis JP, Balk EM et al. Diagnosing acute cardiac ischemia in the emergency department: a systematic review of the accuracy and clinical effect of current technologies. Ann Emerg Med 2001; 37(5):453-60.
- Lefebvre C and Hoekstra J. Early detection and diagnosis of acute myocardial infarction: The potential for improved care with next-generation, user-friendly electrocardiographic body surface mapping. Am J Emerg Med, November 2007; 25(9): 1063-1072.
- Leisy PJ, Coeytaux RR, Wagner GS et al. ECG-based signal analysis technologies for evaluating patients with acute coronary syndrome: a systematic review. J Electrocardiol 2013; 46(2):92-7.
- Menown IB, Allen J, Anderson JM, et al. Early diagnosis of right ventricular or posterior infarction associated with inferior wall left ventricular acute myocardial infarction. American Journal of Cardiology 2000; 85(8): 934-938.
- O'Neil BJ, Hoekstra J, Pride YB et al. Incremental benefit of 80-lead electrocardiogram body surface mapping over the 12-lead electrocardiogram in the detection of acute coronary syndromes in patients without ST-elevation myocardial infarction: Results from the Optimal Cardiovascular Diagnostic Evaluation Enabling Faster Treatment of Myocardial Infarction (OCCULT MI) trial. Acad Emerg Med 2010; 17(9):932-9.
- Ornato JP, Menown IB, Peberdy MA et al. Body surface mapping vs 12-lead electrocardiography to detect ST-elevation myocardial infarction. Am J Emerg Med 2009; 27(7):779-84.
- Owens CG, McClelland AJ, Walsh SJ, et al. Prehospital 80-LAD mapping: Does it add significantly to the diagnosis of acute coronary artery syndromes? J Electrocardiol 2004; 37(Suppl): 223-232.
- Owens C, McClelland A, Walsh S et al. Comparison of value of leads from body surface maps to 12-lead electrocardiogram for diagnosis of acute myocardial infarction. Am J Cardiol 2008; 102(3):257-65.
- Self WH, Mattu A, Martin M, et al. Body surface mapping in the ED evaluation of the patient with chest pain: Use of the 80-lead electrocardiogram system. Am J Emerg Medicine 2006; 24(1): 87-112.
- Thivierge M, Gulrajani RM, Savard P. Effects of rotational myocardial anisotropy in forward potential computations with equivalent heart dipoles. Ann Biomed Eng 1997; 25(3):477-98.
- Zeb M, Mahmoudi M, Garty F, et al. Detection of regional myocardial ischemia by a novel 80-electrode body surface Delta map in patients presenting to the emergency department with cardiac-sounding chest pain. Eur J Emerg Med. Apr 2014; 21(2): 89-97.
Medical Policy Group, June 2007 (1)
Medical Policy Administration Committee, July 2007
Available for comment July 16-September 3, 2007
Medical Policy Group, June 2009 (1)
Medical Policy Group, February 2011 (2): Description, Key Points, Key Words and References updated
Medical Policy Group, August 2011 (1): Update to Key Points and References, no change in Policy statement
Medical Policy Group, August 2012 (1): Update to Key Points and References per MPP update; no change in Policy statement.
Medical Policy Panel, August 2013
Medical Policy Group, December 2013 (2): No change in policy statement. Key Points and References updated with literature search through June 2013.
Medical Policy Panel, August 2014
Medical Policy Group, August 2014 (3): 2014 Updates to Key Points, Governing Bodies & References; no change in policy statement
Medical Policy Panel, August 2015
Medical Policy Group, August 2015 (4): Updates to Key Points. Clarified policy statement to state ECG BSM is investigational ‘for all indications’ including ‘but not limited to’ ACS. Intent remains unchanged, still investigational.
Medical Policy Panel, July 2017
Medical Policy Group, July 2017 (4): Updates to Description, Key Points, and Approved by Governing Bodies. No change to policy statement. Policy retired.
Medical Policy Group, December 2017: Annual Coding Update 2018. Created previous coding section and moved deleted CPT codes 0178T – 0180T to this section. Added existing unlisted CPT code to current coding.
Medical Policy Panel, August 2019
Medical Policy Group, August 2019 (4): Updates to Key Points. No change to Policy Statement. Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy.
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.