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L.2.04.454
Lipoprotein(a) (LPA) is a lipid-rich particle similar to low-density lipoprotein and has been determined to be an independent risk factor for coronary artery disease. Patients with a positive test for the LPA genetic variant rs3798220 have a higher risk for thrombosis and therefore may derive greater 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.
Lipoprotein(a)
Extensive epidemiologic evidence has determined that lipoprotein(a) (LPA) blood level is an independent risk factor for cardiovascular disease. The overall risk associated with LPA levels appears to be modest, and the degree of risk may be mediated by other factors such as low-density lipoprotein (LDL) levels and/or hormonal status.
Over time, a person's LPA levels remain relatively stable; however, levels have been known to vary up to 1000-fold between different people, and this is most likely due to genetics. A single-nucleotide variant in the LPA gene, LPA rs3798220, has been associated with both elevated LPA levels and an increased risk of cardiovascular disease.This variant 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 coronary artery disease. It is also prescribed as primary prevention for some patients who are at increased risk of coronary artery disease. Current recommendations for primary prevention consider the future risk of cardiovascular events weighed against the bleeding risk of aspirin. The U.S. Preventive Services Task Force 2013 guidelines recommended aspirin for men between the "age of 45 to 79 years when the potential benefit due to reduction in myocardial infarctions outweighs the potential harm due to an increase in gastrointestinal hemorrhage;" the Task Force made the same recommendation for women between the ages of 55 and 79 years. Given such guidelines that recommend individualizing the risk-benefit ratio of aspirin therapy, additional tools that could aid in better defining the benefits of aspirin, and/or the risk of bleeding, have potential utility for clinicians who are making decisions about aspirin therapy.
The Cardio IQ® LPA Aspirin Genotype test 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 test may aid physicians in better estimating the benefit and risk ofaspirintherapy and therefore may aid in deciding whether to prescribeaspirin for individual patients.
Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratory-developed tests must meet the general regulatory standards of the Clinical Laboratory Improvement Amendments. Berkeley HeartLab/Quest Diagnostics is certified under the auspices of the Clinical Laboratory Improvement Amendments. Laboratories that offer laboratory-developed tests must be licensed by the Clinical Laboratory Improvement Amendments for high-complexity testing. To date, the U.S. Food and Drug Administration has chosen not to require any regulatory review of this test.
A related medical policy is Measurement of Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) in the Assessment of Cardiovascular Risk .
The use of genetic testing for the LPA rs3798220 allele (LPA-AspirinGenotype) is considered investigational in patients who are being considered for treatment with aspirin to reduce the risk of cardiovascular events.
None
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Genetic Counseling
Experts recommend formal genetic counseling for patients who are at risk for inherited disorders and who wish to undergo genetic testing. Interpreting the results of genetic tests and understanding risk factors can be difficult for some patients; genetic counseling helps individuals understand the impact of genetic testing, including the possible effects the test results could have on the individual or their family members. It should be noted that genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing; further, genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.
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.
07/21/2011: 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.
10/27/2017: Policy description updated regarding laboratory-developed tests. Policy statement unchanged. Policy Guidelines updated to add genetic counseling information.
10/29/2018: Policy description updated regarding the U.S. Preventive Services Task Force guidelines. Policy statement unchanged.
11/18/2019: Policy reviewed; no changes.
11/24/2020: Policy reviewed; no changes.
03/28/2023: Policy reviewed. Policy statement unchanged. Medical policy number changed from "A.2.04.70" to "L.2.04.454."
04/30/2024: Policy reviewed; no changes.
07/31/2025: Policy reviewed; no changes.
Blue Cross Blue Shield Association policy # 2.04.70
This may not be a comprehensive list of procedure codes applicable to this policy.
Code Number | Description |
CPT-4 | |
84999 | Unlisted chemistry procedure |
HCPCS | |
ICD-10 Procedure | |
ICD-10 Diagnosis |
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