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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 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. Although treatment for elevated coronary disease risk with statins targets cholesterol levels, selection for treatment involves estimation of future CAD risk using well validated prediction models that use additional variables.
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.
Interest in Lp-PLA2 as a possibly causal risk factor for CAD has generated development and testing of Lp-PLA2 inhibitors as a new class of drugs to reduce risk of CAD. However, clinical trials of Lp-PLA2 inhibitors have not shown significant reductions in CAD end points. Furthermore, assessment of Lp-PLA2 levels was not involved in the selection or management of subjects in the clinical trials.
In December 2014, FDA cleared for marketing through the 510(k) process a quantitative enzyme assay for Lp-PLA2 activity PLAC® Test (diaDexus, San Francisco, CA). It was considered substantially equivalent to a previous version of the PLAC test (diaDexus) which was cleared for marketing in July 2003. 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 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 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.
07/31/2015: Code Reference section updated for ICD-10.
11/03/2015: Policy description updated regarding tests. Policy statement unchanged. Investigative definition updated in policy guidelines section.
01/18/2016: Policy description updated regarding testing of Lp-PLA2 inhibitors to reduce risk of coronary artery disease. Policy statement unchanged.
06/06/2016: Policy number added.
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.