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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.
Investigative 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 HISTORY05/01/2013: New policy added. Approved by Medical Policy Advisory Committee.
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.