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Electrocardiographic (ECG) body surface mapping (BSM) is an electrocardiographic technique that uses multiple (generally 80 or more) electrocardiography leads to detect cardiac electrical activity. The use of multiple leads may result in improved diagnostic accuracy of acute myocardial infarction (AMI) or acute coronary syndrome (ACS), compared to the standard 12-lead ECG. No BSM ECG devices with 80 or more leads are currently commercially available in the United States.
Electrocardiographic 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 5 minutes. This system displays clinical data in 3 forms; a colorimetric 3-D torso image, an 80-lead single beat view, and the 12-lead 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 myocardial ischemia, 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 though 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 about 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 currently achieved utilizing current standard of care. The negative predictive value of the test, which has the potential to identify patients who do not require further evaluation with serial cardiac enzymes and clinical observation, is not currently receiving attention as a research topic.
In March 2002, the device PRIME ECG® (Verathon, Bothell, WA) was cleared for marketing by the U.S. Food and Drug Administration (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 July 2014, neither the PRIME ECG device nor its successor, the Heartscape™ 3D ECG System are being marketed in the United States.
POLICYElectrocardiographic body surface mapping is considered investigational for all indications including but not limited to acute coronary syndrome.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY6/13/2007: Policy added
7/25/2007: Reviewed and approved by the Medical Policy Advisory Committee (MPAC)
7/10/2009: Policy reviewed, no changes
09/09/2010: Policy description updated regarding uses for this technology. FEP verbiage added to the Policy Exceptions section.
09/23/2011: Policy reviewed; no changes.
09/27/2012: Policy reviewed; no changes.
11/15/2013: Policy reviewed; no changes.
10/08/2014: Policy reviewed; description updated regarding devices. Policy statement unchanged.
07/20/2015: Code Reference section updated for ICD-10.
10/20/2015: Policy description updated regarding devices. Policy statement revised to state that electrocardiographic body surface mapping is investigational for all indications. It previously stated: Electrocardiographic body surface mapping is considered investigational for the diagnosis or management of cardiac disorders, including acute coronary syndrome. Investigative definition updated in the policy guidelines section.
SOURCE(S)Blue Cross Blue Shield Association Policy # 2.02.23
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.