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DESCRIPTIONEvaluation of a patient with chest pain for possible acute coronary syndrome (ACS) in the emergency department includes obtaining a history, a physical examination, ECG monitoring, and laboratory values which include cardiac biomarker levels of troponins and imaging studies. Additional cardiac biomarkers that provide prognostic data may include B-type natriuretic peptide (BNP) and C-reactive protein.
Diagnosis of ACS relies heavily on biomarkers that become elevated following heart muscle necrosis. For this reason, intense research continues into the development and clinical investigation of sensitive biomarkers that do not depend on the presence of irreversible myocardial damage.
Myeloperoxidase (MPO) is an enzyme found in white blood cells. There is some evidence that suggests there are mechanistic links between myeloperoxidase and both inflammation and cardiovascular disease. It has been proposed that MPO could predict early risk for myocardial infarction and could also predict the risk for other major adverse cardiac events in patients with chest pain in the following 30-day and six-month periods.
The U.S. Food and Drug Administration (FDA) has approved several myeloperoxidase immunoassay systems. The PrognostiX CardioMPO™ Enzyme Immunoassay received FDA 510(k) clearance in 2005. The Dimension MPO Flex® reagent cartridge received FDA 510(k) clearance in 2008.
POLICYMyeloperoxidase (MPO) immunoassay to assess cardiac disease risk is considered investigational.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative 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.
05/01/2013: New policy added. Approved by Medical Policy Advisory Committee.
08/04/2015: Code Reference section updated for ICD-10.
06/08/2016: Policy number added. Investigative definition updated in Policy Guidelines section.
SOURCE(S)Blue Cross Blue Shield of Michigan medical policy, Myeloperoxidase (MPO) Immunoassay for Cardiac Disease Risk medical policy
Excellus Blue Cross Blue Shield medical policy, Inflammatory Markers for Coronary Artery Disease Risk
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.