Cytologic Evaluation in Breast Cancer Risk Assessment

BlueCross BlueShield of Tennessee Medical Policy Manual

DESCRIPTION

The National Cancer Institute reports that an estimated one in seven women in the United States will develop breast cancer over her lifetime. Breast cancer is thought to start in the lining of the milk duct or lobule. The analysis of epithelial cells from breast duct fluid is intended as a tool 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 (RPFNA) and nipple aspirate fluid (NAF).

Note: This policy does not address cytologic evaluation for diagnostic purposes.

POLICY

Cytologic evaluation of epithelial cells to determine breast cancer risk is considered investigational.

See also: Breast Duct Endoscopy

IMPORTANT REMINDERS

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.

ADDITIONAL INFORMATION

The procedure may assist in detecting atypical cytology. However, there is no evidence that this knowledge alters the health outcomes expected from conventional treatments readily available now.

SOURCES

American Cancer Society. (2010, September). Nipple discharge exam (nipple smear). Retrieved December 8, 2010 from http://www.cancer.org/Healthy/FindCancerEarly/WomensHealth/Non-CancerousBreastConditions/non-cancerous-breast-conditions-nipple-discharge-exam?docSelected=non-cancerous-breast-conditions-fibroadenomas.

American Society of Breast Surgeons. Official statement. (2007, May). Ductal cell-based risk assessment. Retrieved December 8, 2010 from http://www.breastsurgeons.org/statements/PDF_Statements/Ductal_Cell.pdf.

Bhandare, D., Navar, R., Bryk, M., Hou, N., Cohn, R., Golewale, N., et al. (2005). Endocrine biomarkers in ductal lavage samples from women at high risk for breast cancer. Cancer Epidemiology, Biomarkers & Prevention, 14 (11), 2620-2627. (Level Evidence 3 - Independent study)

BlueCross BlueShield Association. Medical Policy Reference Manual. (6:2008). Epithelial cell cytology in breast cancer risk assessment and high-risk patient management (ductal lavage and suction collection systems) (2.01.45). Retrieved July 31, 2012 from BlueWeb. (26 articles and/or guidelines reviewed)

Johnson-Maddux, A., Ashfaq, R., Cler, L., Naftalis, E., Leitch, A. M., Hoover, S., et al. (2005). Reproducibility of cytologic atypia in repeat nipple duct lavage. Cancer, 103 (6), 1129-1136. (Level Evidence 3 - Independent study)

Meisner, A. W., Fekrazad, M. H., & Royce, M. E. (2008). Breast disease: Benign and malignant. The Medical Clinics of North America, 92 (5), 1115-1141.

Sneige, N., Liu, B., Yin, G., Gong, Y., & Arun, B. K. (2006). Correlation of cytologic findings and chromosomal instability detected by fluorescence in situ hybridization in breast fine-needle aspiration specimens from women at high risk for breast cancer. Modern Pathology, 19 (5), 622-629. (Level Evidence 3 - Independent study)

Tice, J. A., Milke, R., Adduci, K., Petrakis, N. L., King, E., & Wrensch, M. R. (2005). Nipple aspirate fluid cytology and the gail model for breast cancer risk assessment in a screening population. Cancer Epidemiology, Biomarkers and Prevention, 14 (2), 324-328. (Level Evidence 1 - Independent study)

U. S. Food and Drug Administration. (2000, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K000135. Retrieved May 15, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf/K000135.pdf.

Visvanathan, K., Santor, D., Ali, S. Z., Breewster, A., Arnold, A., Armstrong, D. K., et al. (2007). The reliability of nipple aspirate and ductal lavage in women at increased risk for breast cancer--A potential tool for breast cancer risk assessment and biomarker evaluation. Cancer Epidemiology, Biomarkers & Prevention, 16 (5), 950-955. (Level Evidence 3 - Independent study)

ORIGINAL EFFECTIVE DATE: 11/12/2005

MOST RECENT REVIEW DATE: 9/13/2012

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.