Breast Ductal Lavage for Detection of Breast Cancer Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 09|01|2001 POLICY LAST REVIEWED: 01|07|2026 OVERVIEW Ductal lavage is a method of collecting breast ductal epithelial cells for cytological analysis. It can be used as a risk assessment tool in women with a higher risk of breast cancer. Breast Ductal Lavage is sometimes called the “breast pap smear.” MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION Not applicable POLICY STATEMENT Medicare Advantage Plans Breast ductal lavage is considered not covered as the evidence is insufficient to determine the effects of the technology on health outcomes in comparison to more established techniques for acquisition and evaluation of breast cytology.
Fiberoptic ductoscopy is considered not covered for the detection, diagnosis, or treatment of breast cancer as the evidence is insufficient to determine the effects of the technology on health outcomes or to permit scientific conclusion regarding the role of breast duct endoscopy in the evaluation and management of patients with known or suspected breast cancer.
Commercial Products Breast ductal lavage is considered not medically necessary, as the evidence is insufficient to determine the effects of the technology on health outcomes in comparison to more established techniques for acquisition and evaluation of breast cytology.
Fiberoptic ductoscopy is considered not medically necessary for the detection, diagnosis, or treatment of breast cancer as the evidence is insufficient to determine the effects of the technology on health outcomes or to permit scientific conclusion regarding the role of breast duct endoscopy in the evaluation and management of patients with known or suspected breast cancer.
COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable not medically necessary/not covered benefits/coverage. BACKGROUND All ductal and lobular breast cancers originate in a single layer of epithelial cells that line the ductal/lobular system of all milk ducts. Ductal lavage enables the retrieval of these cells using a microcatheter inserted into the milk ducts through the nipple orifices. A saline solution is flushed through the catheter into the ducts to wash out cells for cytological examination. The ductal lavage technique is directed at patients identified as being at high risk for breast cancer utilizing the Gail index, a personal history of breast cancer, or evidence of BRCA mutation and have no mammographic abnormality. The gold standard for examination of these cells has been nipple aspiration with cytopathological examination of the specimen. Ductal lavage is designed to harvest an increased number of cells with the ability to gather Medical Coverage Policy | Breast Ductal Lavage for Detection of Breast Cancer

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

cells from individual milk ducts. Each breast has 6 to 8 milk ducts. The technique is based upon decades of research indicating that breast cancer originates in the epithelial lining of the milk ducts and involves a series of molecular changes from normal to abnormal to malignant. As long as the abnormal cells are contained within the ducts or lobules, they are termed preinvasive disease. Once they have invaded surrounding tissue, they are considered invasive cancer.

The procedure has been dubbed “breast pap smear” because like the test for cervical cancer, it is a nonsurgical approach to identifying abnormal cells prior to their development into cancer. The HALO® Breast Pap Test (Halo Healthcare, Inc, Irvine, CA) is a U.S. Food and Drug Administration (FDA) approved, noninvasive device that is positioned on the nipple and acquires ductal fluid by applying heat, cyclic compression and suction. This device is discussed in one small study funded by the manufacturer and concludes that although the device can collect the duct fluid noninvasively, well-designed randomized controlled studies are required to determine the utility of cytological analysis of breast ductal fluid (Proctor, 2007). Mammography is the standard for early detection for breast cancer. However, by the time an abnormality is detected via mammography, the lesion has grown to a size of 1 to 2 cm and may have been present for 6 to 8 years.

The value of cytopathological examination of specimens from the breast, especially from nipple aspiration is well documented. However, no studies utilizing cells acquired via ductal lavage have been reported. There is as yet no consensus among practicing cytopathologists as to the criteria for interpreting specimens obtained by ductal lavage. While the technique may be theoretically interesting and even promising in early studies, it has yet to be the subject of sufficient controlled studies to allow for a determination of its effectiveness, accuracy and safety in both an absolute sense and in comparison to more established techniques for acquisition and evaluation of breast cytology. It is not presently known how the technique will modify management of the high-risk patient.

Fiberoptic ductoscopy is a technique that provides direct visual examination of the breast ducts through nipple orifice cannulation and exploration. It has been explored in the following clinical situations:
• Diagnostic technique in women with spontaneous nipple discharge (as potential alternative to surgical exploration) • A follow-up to atypical cytology from ductal lavage specimen • Delineation of ductal disease to define margins for surgical resection
• Direct delivery of therapeutic agents

There is minimal published information about how fiberoptic ductoscopy would be used in the management of the patients either in determining the need for other diagnostic tests, such as mammography or ductography, determining the need for biopsy or excision, or determining the extent of surgical excision. Although ductoscopy may be a useful technique for diagnosing ductal carcinoma in situ, (DCIS) prior to surgery, there is no data reporting on how the results of ductoscopy influences either the decision to undergo biopsy or excision or the extent of the excision. The data is insufficient to permit scientific conclusion regarding the role of breast duct endoscopy in the evaluation and management of patients with known or suspected breast cancer.

CODING Medicare Advantage Plans and Commercial Products There is no specific CPT code(s) for Breast Ductal Lavage or Fiberoptic Ductoscopy. Claims should be filed with the following Unlisted CPT code below: 19499 Unlisted procedure, breast

RELATED POLICIES Unlisted Procedures

PUBLISHED Provider Update, March 2026

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

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500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

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    This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS