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Lipoprotein(a) (LPA) is a lipid-rich particle similar to low-density lipoprotein (LDL) and has been determined to be an independent risk factor for coronary artery disease (CAD). Patients with a positive test for the LPA genetic variant rs3798220 have a higher risk for thrombosis and therefore may derive more benefit from the anti-thrombotic properties of aspirin. As a result, testing for the rs3798220 variant has been proposed as a method of stratifying benefit from aspirin treatment.
A large amount of epidemiologic evidence has determined that LPA blood level is an independent risk factor for cardiovascular disease. The overall degree of risk associated with LPA levels appears to be modest, and the degree of risk may be mediated by other factors such as LDL levels and/or hormonal status.
Levels of LPA are relatively stable in individuals over time, but vary up to 1000-fold between individuals, presumably on a genetic basis. A single nucleotide polymorphism (LPA rs3798220) in the LPA gene, has been associated with both elevated levels of Lipoprotein (a) and an increased risk of cardiovascular disease. This polymorphism substitutes methionine for isoleucine at amino acid position 4399 and is also called I4399M. Mendelian randomization studies have supported the hypothesis that this genetic variant, and the subsequent increase in LPA levels, are causative of cardiovascular disease.
Aspirin is a well-established treatment for patients with known CAD. It is also prescribed as primary prevention for some patients who are at increased risk of CAD. Current recommendations for primary prevention consider the future risk of cardiovascular events weighed against the bleeding risk of aspirin. U.S. Preventive Services Task Force guidelines from 2009 recommend aspirin for men between the ages of 45-79 when the benefit in reducing myocardial infarction (MI) exceeds the risk of bleeding, particularly gastrointestinal hemorrhage; and for women between the ages of 55-79 years when the benefit in reducing stroke exceeds the risk of gastrointestinal bleeding. Given guidelines such as these that recommend individualizing the risk/benefit ratio of aspirin therapy, additional tools that would aid in better defining the benefits of aspirin, and/or the risk of bleeding, have potential utility for clinicians who are making decisions on aspirin therapy.
LPA-Aspirin Genotype is a commercially available genetic test (Berkeley HeartLab, a Quest Diagnostics service) that detects the presence of the rs3798220 allele. Patients with a positive test for rs3798220 have a higher risk for thrombosis, and therefore may derive more benefit from the anti-thrombotic properties of aspirin. It has been proposed that the additional information obtained from the LPA-Aspirin Check® test may aid physicians in better estimating the benefit/risk of aspirin therapy and therefore may aid in deciding whether to prescribe aspirin for individual patients.
The LPA-Aspirin Genotype test has not been cleared or approved by the U.S. Food and Drug Administration. Thus, genotyping is offered as a laboratory-developed test. Clinical laboratories may develop and validate tests in-house (“home-brew”) and market them as a laboratory service; such tests must meet general regulatory standards of the Clinical Laboratory Improvement Act (CLIA).The laboratory offering the service must be licensed by CLIA for high-complexity testing. Berkeley HeartLab/Quest Diagnostics is a CLIA-certified laboratory.
A related medical policy is Measurement of Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) in the Assessment of Cardiovascular Risk.
POLICYThe use of genetic testing for the LPA rs3798220 allele (LPA-Aspirin Genotype) is considered investigational in patients who are being considered for treatment with aspirin to reduce risk of cardiovascular events.
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.
POLICY HISTORY07/21/2011: Approved by Medical Policy Advisory Committee.
07/13/2012: Policy reviewed; no changes.
08/14/2013: Policy reviewed; no changes.
06/19/2014: Policy reviewed; description updated. Policy statement unchanged.
07/30/2015: Code Reference section updated for ICD-10.
09/22/2015: Policy description updated regarding the LPA-Aspirin Genotype test. Policy statement updated to change "LPA-Aspirin Check®" to "LPA-Aspirin Genotype." Investigative definition updated in the Policy Guidelines section.
06/06/2016: Policy number A.2.04.70 added.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.04.70
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
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