Ductal lavage (0046T, 0047T) is considered experimental/investigational and therefore, not covered and not eligible for payment. There is insufficient evidence in medical literature to support the effectiveness of this procedure. More investigational trials are needed in order to determine whether ductal lavage will have an effect on outcomes. A participating, preferred, or network provider can bill the member for the denied service.

Description

The majority of all breast cancers begin in the cells lining the milk ducts. These cells may show the first signs of cancer months or even years before a tumor can be seen on mammogram or felt in a physical exam. Ductal lavage of the mammary ducts describes a technique for collecting epithelial cells from individual mammary ducts for subsequent cytologic analysis. Ductal lavage has been developed as a diagnostic and risk assessment tool in patients at high risk of breast cancer but without mammographic abnormalities. The finding of atypical cells has been shown to have predictive value in determining risk for breast cancer development. Ductal lavage may also identify malignant cells. Ductal lavage should only be used in addition to mammography and physical examination and after risk assessment shows the patient is at increased risk of developing breast cancer.

Ductal lavage is a minimally invasive procedure that involves several steps and takes approximately 30 minutes. First, after an anesthetic cream is applied to the nipple, using a nipple aspirator, a small amount of nipple aspirate fluid (NAF) is elicited to locate fluid-yielding ducts for lavage. Next, a microcatheter is inserted into each NAF-yielding duct through its natural opening on the nipple surface. Saline is infused through the microcatheter into the duct to collect epithelial cells. The ductal fluid is then withdrawn through the catheter and deposited into a collection vial. The fluid is then analyzed microscopically for cytologic abnormalities.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Under the Federal Employee's Program, all services that utilized FDA approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient's condition. Ductal lavage of the mammary ducts is considered an eligible service when determined medically necessary based on the patient's condition.

PRN References

08/2001, Ductal lavage considered investigational

Identification of Pre-Malignant and Malignant Breast Cells by Ductal Lavage: Results from a Multicenter Trial, Proceedings ASCO 2000; 19: 76a Ductal Lavage for Detection of Cellular Atypia in Women at High Risk for Breast Cancer, The Journal of the National Cancer Institute, Volume 93, No. 21, 11/2001

Ductal Lavage and the Clinical Management of Women at High Risk for Breast Carcinoma, Cancer, Volume, 94, No. 2, 01/2002

Breast Cancer Risk in Women with Abnormal Cytology in Nipple Aspirates of Breast Fluid, Journal of the National Cancer Institute, Volume 93, No. 23, 12/2001

Short-Term Breast Cancer Prediction by Random Periareolar Fine-Needle Aspirate Cytology and the Gail Risk Model, The Journal of the National Cancer Institute, Volume 92, No. 15, 08/2000

The Role of Tamoxifen in Breast Cancer Prevention, Annals of the New York Academy of Sciences, 12/2001

Ductal Lavage, Nipple Aspiration, and Ductoscopy for Breast Cancer Diagnosis, Current Oncology Reports, Volume 5, No. 1, 01/2003

Ductal Lavage in the Screening of High-Risk Women, Current Women's Health Reports, Volume 3, No. 2, 04/2003

Ductal Lavage; Clinical Utility and Future Promise, Surgical Clinics of North America, Volume 83, No. 4, 08/2003

Assessment of Utility of Ductal Lavage and Ductoscopy in Breast Cancer - A Retrospective Analysis of Mastectomy Specimens, Modern Pathology, Volume 16, No. 3, 03/2003

Ductal Lavage in Patients Undergoing Mastectomy for Mammary Carcinoma, A Correlative Study, Cancer, Volume 98, No. 10, 11/2003

Patterns of Reduced Nipple Aspirate Fluid Production and Ductal Lavage Cellularity in Women at High Risk for Breast Cancer, Breast Cancer Research, Volume 7, No. 6, 10/2004

Paired Ductal Lavage and Fine Needle Aspiration Specimens from Patients with Breast Carcinoma, Diagnostic Cytopathology, Volume 33, No. 6, 12/2005

Cytomorphology as a Risk Predictor:  Experience with Fine Needle Aspiration Biopsy, Nipple Fluid Aspiration, and Ductal Lavage, Clinics in Laboratory Medicine, Volume 25, No. 4, 12/2005