Does Not Apply to Commercial Genetic Testing Program effective 6/1/2018
A number of single nucleotide variants (SNVs), which are single base-pair variations in the DNA sequence of the genome, have been associated with breast cancer and are common in the population, but confer only small increases in risk. Commercially available assays purportedly test for a number of SNVs and predict an individual’s risk of breast cancer relative to the general population. Some of these assays incorporate clinical information into risk prediction algorithms. The intent of this type of test is to identify subjects without a family history of breast cancer who may be at increased risk due to single nucleotide variants and may benefit from more intensive surveillance.
Examples of genetic testing assays for non-familial breast cancer risk assessment include but are not limited to BREVAGen™ and BREVAGenplus™.Note: This policy does not address testing for BRCA1, BRCA2, PALB2, TP53 or PTEN single gene variants associated with inherited breast cancer.
Nonfamilial genetic testing of one or more single nucleotide variants to predict an individual’s risk of developing breast cancer 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.
There is a lack of high-quality evidence to determine if SNV-based risk assessment has any impact on health care outcomes. The U.S. Preventive Services Task Force and American Cancer Society recommend mammography for breast cancer screening in average risk individuals.
American Cancer Society. (2017). American Cancer Society recommendations for the early detection of breast cancer. Retrieved November 29, 2017 from https://www.cancer.org/cancer/breast-cancer/screening-tests-and-early-detection/american-cancer-society-recommendations-for-the-early-detection-of-breast-cancer.html.
BlueCross BlueShield Association. Evidence Positioning System. (10:2018). Use of common genetic variants (single nucleotide variants) to predict risk of nonfamilial breast cancer (2.04.63). Retrieved October 26, 2018 from http://www.evidencepositioningsystem.com. (90 articles and/or guidelines reviewed)
McCarthy, A., Armstrong, K., Handorf, E., Jones, M., Chen, J., Demeter, M. B., et.al. (2013). Incremental impact of breast cancer SNP panel on risk classification in a screening population of white and African American women. Breast Cancer Research and Treatment, 138 (3), 889-898. (Level 2 evidence)
U.S. Preventive Service Task Force (February, 2016) Screening for breast cancer: U.S. Preventive Services Task Force recommendation statement. Retrieved October 26, 2018 from https://www.uspreventiveservicestaskforce.org.
Young, M., Forrest, L., Rasmussen, V., James, P., Mitchell, G., Sawyer, S., et al. (2017). Making sense of SNPs: Women’s understanding and experiences of receiving a personalized profile of their breast cancer risks. Journal of Genetic Counseling, 2017 Nov 22. Doi: 10.1007/s10897-017-0162-z. [Epub ahead of print]. Abstract retrieved November 29, 2017 from PubMed database.
ORIGINAL EFFECTIVE DATE: 4/14/2011
MOST RECENT REVIEW DATE: 1/10/2019
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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