Does Not Apply to Commercial Genetic Testing Program effective 6/1/2018
A number of highly correlated single nucleotide polymorphisms (SNPs) found in the chromosome 9 region p21 locus (9p21) have been investigated for association with myocardial infarction (MI), particularly early onset MI, and other manifestations of cardiovascular disease. Associations with abdominal aortic aneurysm and intracranial aneurysm have also been reported. Genotyping for 9p21 SNPs has been investigated to identify individuals who may be at increased risk of cardiovascular disorders.
Genotyping for 9p21 single nucleotide polymorphisms for the identification of conditions/diseases, including, but not limited to, the following is considered investigational:
Individuals who may be at increased risk of cardiovascular disease or its manifestations (e.g., MI, ischemic stroke, peripheral arterial disease, coronary artery calcification)
Individuals who may be at increased risk for aneurysmal disease (e.g., abdominal aortic aneurysms, intracranial aneurysms, polypoidal choroidal vasculopathy)
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.
There is insufficient evidence to determine if the use of the 9p21 genetic variant predicts clinical events or improves health outcomes.
American College of Cardiology/American Heart Association. 2013 ACC/AHA guideline on the assessment of cardiovascular risk. Retrieved June 2, 2017 from https://www.acc.org/guidelines.
Chan, K., Patel, R., Newcombe, P., Nelson, C., Qasim, A., Epstein, S., et al. (2013). Association between the chromosome 9p21 locus and angiographic coronary artery disease burden: A collaborative meta-analysis. Journal of the American College of Cardiology, 61 (9), 957-970. (Level 1 evidence)
Dong, L., Wang, H., Wang, D., & Ding, H. (2013). Association of chromosome 9p21 genetic variants with risk of coronary heart disease in the East Asian population: a meta-analysis. Annuls of Human Genetics, 77, 183-190. (Level 1 evidence)
Matoo, S., Fallah, M., Daneshpour, M., Mousavi, R., Sedaghati, K., Hasanzad, M., & Azizi, F. (2017). Increased risk of CHD in the presence of rs7865618 (A allele): Tehran lipid and glucose study. Archives of Iranian Medicine, 20 (3), 153-157. Abstract retrieved June 2, 2017 from PubMed database.
Palmetto Government Benefits Administrators. (2019, October). Local Coverage Article: MolDX: 9p21 genotype test coding and billing guideline (A53657). Retrieved April 16, 2020 from www.cms.gov.
Patel, R., Schmidt, A., Tragante, V., McCubrey, M.S., Holmes, M., Howe, L., et al. (2019). Association of chromosome 9p21 with subsequent coronary heart disease events. Circulation: Genomic & Precision Medicine, 12 (4), e002471. (Level 1 evidence)
Pott, J., Burkhardt, R., Beutner, F., Horn, K., Teren, A., Kirsten, H., et al. (2017). Genome-wide meta-analysis identifies novel loci of plaque burden in carotid artery. Atherosclerosis, 259, 32-40. Abstract retrieved May 29, 2018 from PubMed database.
Sun, J., & Sun, F. (2017). Analysis on the polymorphism of chromosome region 9p21 and the susceptibility of carotid plaque. European Neurology, 77 (1-2), 25-31. (Abstract retrieved May 30, 2019 from PubMed database)
Xu, L.B., Zhang, N.N., Li, B., Weng, J.Y., Li, X.Y., Lu, W.C., et al. (2020). Rs10757274 gene polymorphisms in coronary artery disease: A systematic review and a meta-analysis. Medicine, 99 (3), e18841. Abstract retrieved April 16, 2020 from PubMed database.
ORIGINAL EFFECTIVE DATE: 12/8/2012
MOST RECENT REVIEW DATE: 4/8/2021
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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