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COLLECTION FOR CYTOLOGIC REVISED DATE: 10/16/02, 09/18/03, 08/19/04, 07/21/05,

ANALYSIS 08/17/06, 08/16/07, 08/21/08


EDITED DATE: 07/15/10, 7/21/11, 07/19/12, 07/18/13,

POLICY NUMBER: 7.01.50 05/22/14, 05/28/15, 03/17/16 CATEGORY: Technology Assessment PAGE: 1 OF: 4

• If a product excludes coverage for a service, it is not covered, and medical policy criteria do not apply.

• If a commercial product, including an Essential Plan product, covers a specific service, medical policy criteria apply to the benefit.

• If a Medicare product covers a specific service, and there is no national or local Medicare coverage decision for the service, medical policy criteria apply to the benefit.


Based upon our criteria and the lack of published peer-reviewed literature, breast duct lavage and collection of epithelial cells via suction have not been medically proven to be effective and are considered investigational in the risk stratification of patients at high risk for breast cancer and in the diagnosis of breast cancer as the influence on patient management and effect on treatment outcomes has not yet been determined.

Refer to Corporate Medical Policy# 11.01.03 regarding Experimental and Investigational Services.


The Federal Employee Health Benefit Program (FEHBP/FEP) requires that procedures, devices or laboratory tests approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational and thus these procedures, devices or laboratory tests may be assessed only on the basis of their medical necessity.


Evaluation of breast duct epithelial cells is proposed as a technique to assess breast cancer risk and as a diagnostic tool for detecting breast cancer. Various techniques for collecting epithelial cells for cytologic analysis have been investigated.

Breast duct lavage, or ductal lavage, is a technique described for use in diagnosing and assessing risk in patients at high risk for developing breast cancer. Breast duct lavage involves identification of the nipple aspirate fluid (NAF) obtained from mammary ducts via nipple aspiration. Using a microcatheter, inserted into the natural nipple opening of the individual mammary ducts, saline is infused and the ductal fluid is withdrawn. The fluid is then analyzed microscopically for cytologic abnormalities. Breast duct lavage is performed using the FirstCyte Breast Test.

The HALO™ Breast Pap Test, by Neomatrix, is a suction system that collects ductal epithelial cells by placing a cup on the breast, warming the breast, and applying suction to bring NAF to the surface. The NAF can then be analyzed for cytologic abnormalities.

Both breast duct lavage and NAF collection may be referred to as a “breast pap smear”.


Ductal lavage: The components of the system used for breast duct lavage, the FirstCyte AspiratorTM, FirstCyte E.Z® MicroCatheter, and MicroDilator have received FDA approval for marketing. There are no prospective data evaluating risk when sampling for cytologic hyperplasia is performed by ductal lavage. The effect of greater prevalence of atypia from ductal lavage on risk estimates is unknown. No studies have used ductal lavage to influence patient management for those whose management was determined by the results of routine surveillance versus surveillance plus epithelial cell cytology analysis. Whether cytologic atypia, or the lack thereof, influences patient management and improves patient outcomes has not been demonstrated in the investigational setting and is unknown.

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Proprietary Information of Excellus Health Plan, Inc.

SUBJECT: BREAST EPITHELIAL CELL EFFECTIVE DATE: 09/19/01 COLLECTION FOR CYTOLOGIC REVISED DATE: 10/16/02, 09/18/03, 08/19/04, 07/21/05, ANALYSIS 08/17/06, 08/16/07, 08/21/08 ARCHIVED DATE: 07/16/09 EDITED DATE: 07/15/10, 7/21/11, 07/19/12, 07/18/13, POLICY NUMBER: 7.01.50 05/22/14, 05/28/15, 03/17/16 CATEGORY: Technology Assessment PAGE: 4 OF: 4 Filassi JR, et al. Can breast nipple fluid collected with automated aspiration and preserved in based-liquid solution improve the cytological samples? Acta Cytol 2013;57(3):276-80.

Francescatti DS, et al. Ductal lavage in the high-risk patient. Am J Surg 2005 Mar;189(3):340-1.

Hartman AR, et al. Breast magnetic resonance image screening and ductal lavage in women at high genetic risk for breast carcinoma. Cancer 2004 Feb 1;100(3):479-89.

Jacobs L, et al. Intraductal therapy for the prevention of breast cancer. Curr Opin Investig Drugs 2010 Jun;11(6):646-52.

Johnson-Maddux A, et al. Reproducibility of cytologic atypia in repeat nipple duct lavage. Cancer 2005 Mar 15;103(6):1129-36.

Johnson-Maddux A, et al. Patient and duct selection for nipple duct lavage. Am J Surg 2004 Oct;188(4):390-4.

Khan SA, et al. Ductal lavage findings in women with known breast cancer undergoing mastectomy. J Natl Cancer Inst 2004 Oct 20;96(20):1510-7.

Kurian AW, et al. Ductal lavage of fluid-yielding and non-fluid-yielding ducts in BRCA1 and BRCA2 mutation carriers and other women at high inherited breast cancer risk. Cancer Epidemiol Biomarkers Prev 2005 May;14(5):1082-9.

National Cancer Institute. Breast cancer screening (PDQ®). Updated 2016 Jan 8 [http://www.cancer.gov/types/breast/hp/breast-screening-pdq] accessed 2/1/16.

National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology™: Breast cancer screening and diagnosis guidelines. v.1. 2014. Last updated 2015 Jul 15 [http://www.nccn.org/professionals/physician_gls/PDF/breastscreening.pdf] accessed 2/1/16.

Patil DB, et al. Reproducibility of ductal lavage cytology and cellularity over a six month interval in high risk women.

Breast Cancer Res Treat 2008 Nov;112(2):327-33.

Proctor KA, et al. Cytologic features of nipple aspirate fluid using an automated non-invasive collection device: a prospective observational study. BMC Women’s Health 2005 Aug 3;5 [http://www.biomedcentral.com/1472-6874/5/10] accessed 11/16/05.


Breast duct lavage, Breast Pap smear, Ductal lavage, Halo™ Breast Pap Test.


Based on our review, breast duct lavage and collection of epithelial cells by suction is not addressed in National or Local Medicare coverage determinations or policies.

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