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DESCRIPTIONElectrocardiographic body surface mapping (BSM) is a technique that uses multiple (generally 80 or more) electrocardiography (ECG) leads to detect cardiac electrical activity. It is suggested that the use of multiple leads may result in improved diagnostic accuracy compared to the standard 12-lead ECG. One potential use is in the evaluation of suspected acute myocardial infarction. Other potential uses include the diagnosis of pulmonary embolism and location of the accessory pathway in patients with Wolff-Parkinson-White (WPW) syndrome.
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.
The PRIME ECG® System (Heartscape Technologies) was cleared by the U.S. Food and Drug Administration (FDA) in March 2002, through the 510(k) process as being substantially equivalent to existing devices. The PRIME ECG® System with Diagnostic Algorithm was cleared through the same process in June 2003. The indication is recording of electrocardiographic signals on the body surface. This system consists of an 80-lead disposable electrode array in the form of a vest that includes a conducting gel that is applied to the patient’s chest and back. According to the FDA material, the vest can be applied 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 ST segment abnormalities.
POLICYElectrocardiographic body surface mapping is considered investigational for the diagnosis or management of cardiac disorders, including 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 service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
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.
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.