Cytologic Evaluation in Breast Cancer Risk Assessment
The analysis of epithelial cells from breast duct fluid is intended to assess an individual's risk for breast cancer. A variety of techniques exist to obtain epithelial cells for cytologic evaluation, including random periareolar fine needle aspiration, nipple aspirate fluid, ductal lavage and suction.
Most breast cancers develop from the epithelial cells that line the breast ducts. Because abnormalities in these tissues may indicate an elevated risk of developing breast cancer, histologic examination of these tissues has been proposed as an aid to identify individuals at risk. The clinical utility of these tests (e.g. FirstCyte™ Breast Test, HALO Nipple Aspirate Fluid collection system) is still being evaluated.
Cytologic evaluation of epithelial cells to determine breast cancer risk 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 remains insufficient evidence to evaluate the impact of this technology on net health outcomes.
American College of Obstetricians and Gynecologists. (2017, September). ACOG Practice bulletin #182: hereditary breast and ovarian cancer syndrome. Retrieved July 24, 2018 from https://www.acog.org/.
Danforth, D., Warner, A., Wangsa, D., Ried, T., Duelli, D., Filie, A., & Prindiville, S. (2015). An improved breast epithelial sampling method for molecular profiling and biomarker analysis in women at risk for breast cancer. Breast Cancer: Basic and Clinical Research, 9, 31-40. (Level 4 evidence)
De Groot, J.S., Moelans, C.B., Elias, S.G., Hennink, A., Verolme, B., Suijkerbuijk, M., et al. (2015). Repeated nipple fluid aspiration: compliance and feasibility results from a prospective multicenter study. PLoS One, 10 (5), e0127895.
Hornberger, J., Chen, S.C., Li, Q., Kakad, P., & Quay, S.C. (2015). Proliferative epithelial disease identified in nipple aspirate fluid and risk of developing breast cancer: a systematic review. Current Medical Research and Opinion, 31 (2), 253-262. (Level 1 evidence)
National Comprehensive Cancer Network. (2019, May). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Breast cancer screening and diagnosis. v 1.2019. Retrieved July 8, 2019 from the National Comprehensive Cancer Network.
U.S. Food and Drug Administration. (2013). Nipple aspirate test: safety communication – breast cancer screening test is not an alternative to mammography. Retrieved July 8, 2019 from https://wayback.archive-it.org/7993/20170112164659/http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm378489.htm.
U.S. Preventive Services Task Force (USPSTF). (2016). Screening for breast cancer: U.S. Preventive Services Task Force recommendation statement. Retrieved July 8, 2019 from https://www.uspreventiveservicestaskforce.org/.
ORIGINAL EFFECTIVE DATE: 11/12/2005
MOST RECENT REVIEW DATE: 8/8/2019
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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