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Lipoprotein-associated phospholipase A2 (Lp-PLA2), also known as platelet-activating factor acetylhydrolase, is an enzyme that hydrolyses phospholipids and is primarily associated with low density lipoproteins (LDLs). Accumulating evidence has suggested that Lp-PLA2 is a biomarker of coronary artery disease (CAD) and may have a proinflammatory role in the progression of atherosclerosis.
LDLs have been identified as the major atherogenic lipoproteins and have long been identified by the National Cholesterol Education Project (NCEP) as the primary target of cholesterol-lowering therapy. LDL particles consist of a surface coat composed of phospholipids, free cholesterol, and apolipoproteins, surrounding an inner lipid core composed of cholesterol ester and triglycerides. Traditional lipid risk factors such as low-density lipoprotein-cholesterol (LDL-C), while predictive on a population basis, are weaker markers of risk on an individual basis. Only a minority of subjects with elevated LDL and cholesterol levels will develop clinical disease, and up to 50% of cases of coronary artery disease (CAD) occur in subjects with ‘normal’ levels of total and LDL-C. Thus, there is considerable potential to improve the accuracy of current cardiovascular risk prediction models.
Lp-PLA2, also known as platelet-activating factor acetylhydrolase, is an enzyme that hydrolyzes phospholipids and is primarily associated with LDLs. Accumulating evidence has suggested that Lp-PLA2 is a biomarker of CAD and may have a proinflammatory role in the progression of atherosclerosis. The recognition that atherosclerosis represents, in part, an inflammatory process has created considerable interest in measurement of proinflammatory factors as part of cardiovascular disease risk assessment.
The U.S. Food and Drug Administration (FDA) cleared for marketing an enzyme-linked immunosorbent assay test, the PLAC test (diaDexus, San Francisco, CA), to measure levels of Lp-PLA2. FDA product code: NOE.
Note: Measurement of lipoprotein A enzyme is a distinct laboratory test. Lipoprotein A enzyme is addressed in the Lipoprotein(a) Enzyme Immunoassay in the Management of Cardiovascular Disease policy.
Related policies -
POLICYMeasurement of lipoprotein-associated phospholipase A2 (Lp-PLA2) 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 HISTORY2/2001: Approved by Medical Policy Advisory Committee (MPAC)
7/11/2001: Code Reference section updated
2/13/2002: Investigational definition added
5/8/2002: Type of Service and Place of Service deleted
8/8/2002: CPT code 82172 description revised, hyperlink added
3/31/2005: Reviewed by MPAC, Lipoprotein-associated phospholipase A2 (Lp-PLA2) is considered investigational, CPT code 82172 Note in Code Reference section “Apolipoprotein B (apo B) and Apolipoprotein E (apo E) testing is considered investigational. Apolipoprotein A (apo A) is covered. See Measurement of Small Low Density Lipoprotein (LDL) Particles medical policy.” deleted
5/12/2005: Code Reference section reviewed, ICD-9 diagnosis code 272.0-272.9, 410-414, 440.0-440.9, V12.50-V12.59, V17.3-V17.4, V77.91, V81.0-V81.2 deleted non-covered codes
5/9/2006: Policy reviewed, no changes
1/3/2007: Code reference section updated per the 2007 CPT/HCPCS revisions
4/4/2007: Policy reviewed, and updated. Homocysteine, apolipoprotein B (apo B), apolipoprotein E, and lipoprotein-associated phospholipase A2 (Lp-PLA2) separated into individual policies. Previously addressed in combination in the Tests used for Screening, Diagnosis, and Management of Dyslipidemia and Cardiovascular Disease policy.
10/7/2008: Policy reviewed, no changes
07/09/2010: Policy description and statement unchanged. FEP verbiage added to the Policy Exceptions section.
08/02/2011: Policy reviewed; no changes.
07/17/2012: Policy reviewed; no changes.
10/15/2013: Policy reviewed; no changes.
08/04/2014: Policy reviewed; description updated regarding low density lipoproteins (LDLs). Policy statement unchanged.
SOURCE(S)Blue Cross Blue Shield Association Policy # 2.04.32
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.