Does Not Apply to Commercial Genetic Testing Program effective 6/1/2018
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. Individuals 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. Testing for this allele is commercially available (e.g., CardioIQ® Aspirine Genotype test), but performance characteristics are uncertain, and standardization of testing has not been demonstrated.
Genetic testing for lipoprotein (a) variant(s) (i.e., LPA rs3798220 allele) as a decision aid for aspirin treatment is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
It cannot be determined from available evidence that measurement of the LPA rs3798220 variant improves outcomes.
American College of Cardiology, American Heart Association. (2013). 2013 ACC/AHA guideline on the assessment of cardiovascular risk. Retrieved August 23, 2019 from https://www.acc.org/guidelines.
Anderson, J., Knight, S., May, H., Horne, B., Blair, T., Huntinghouse, J., et al. (2013). Validation and quantification of genetic determinants of lipoprotein-a levels and predictive value for angiographic coronary artery disease. American Journal of Cardiology, 112 (6), 799-804. Abstract retrieved October 11, 2017 from PubMed database.
BlueCross BlueShield Association. Evidence Positioning System. (12:2020). Genetic testing for lipoprotein(a) variant(s) as a decision aid for aspirin treatment (2.04.70). Retrieved June 10, 2021 from https://www.evidencepositioningsystem.com/. (16 articles and/or guidelines reviewed)
CMS.gov: Centers for Medicare & Medicaid Services. Palmetto GBA. (2019, October). Local Coverage Article: MolDX: LPA-aspirin genotpe coding and billing guidelines (A53467). Retrieved June 11, 2021 from https://www.cms.gov.
Kamstrup, P., Tybiærg-Hansen, A., & Nordestgaard, B. (2013). Extreme lipoprotein(a) levels and improved cardiovascular risk prediction. Journal of American College of Cardiology, 61 (11), 1146-1156. Abstract retrieved October 10, 2017 from PubMed database.
National Lipid Association. (2019). Use of lipoprotein(a) in clinical practice: a biomarker whose time has come. A scientific statement from the National Lipid Association. Retrieved August 23, 2019 from https://www.lipid.org/.
Wang, Y., Wang, L., Liu, X., Zhang, Y., Yu, L., Zhang, F., et al. (2014). Genetic variants associated with myocardial infarction and the risk factors in Chinese population. PLoS One, 9 (1), doi:10.1371/journal.pone.0086332. (Level 3 evidence)
ORIGINAL EFFECTIVE DATE: 12/8/2012
MOST RECENT REVIEW DATE: 8/12/2021
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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