BlueCross BlueShield of Tennessee Medical Policy Manual

Cytologic Evaluation in Breast Cancer Risk Assessment

DESCRIPTION

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.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

There remains insufficient evidence to evaluate the impact of this technology on net health outcomes.

SOURCES 

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         

ID_BT

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.

This document has been classified as public information.