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Ductal Lavage and Fiberoptic Ductoscopy of the Mammary Ducts Sur716.019 ______Coverage

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Ductal Lavage and Fiberoptic Ductoscopy of the Mammary Ducts Sur716.019 ______Coverage DUCTAL LAVAGE AND FIBEROPTIC DUCTOSCOPY OF THE MAMMARY DUCTS SUR716.019 ______________________________________________________________________ COVERAGE: Ductal Lavage and Fiberoptic Ductoscopy of the mammary ducts are considered investigational. ______________________________________________________________________ DESCRIPTION: 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 investigated as a diagnostic and risk assessment tool in patients at higher than normal risk of breast cancer but without mammographic abnormalities. For example, the finding of atypical hyperplasia may be associated with an increased risk of breast cancer. Malignant cells may also be identified. Physicians and patients use the results from Ductal Lavage to weigh the risks and benefits of a variety of management options. These options range from or include closer surveillance, chemoprevention therapy (Tamoxifen), and in very high risk women, even consideration of prophylactic mastectomy. Ductal lavage involves several steps: 1. Fluid-yielding mammary ducts are identified using nipple aspiration; 2. A micro-catheter is inserted into the natural nipple opening of the identified individual mammary duct; 3. Saline is infused and ductal fluid withdrawn; and 4. The fluid is analyzed microscopically for cytologic abnormalities. Currently, the FDA has cleared Pro-Duct Health Micro-Stylet ® in May 2000 for marketing. Additional names are InDuct ä Breast Aspirator, Pro-Duct Catheter and Breast Duct Stylet. The Mammary Aspiration Specimen Cytology Test (MASCT) or Breast Aspirator was approved by the FDA in December 2001. Fiberoptic Ductoscopy of the mammary ducts describes an emerging technique that allows direct visual access of the ductal system of the breast through nipple orifice cannulation and exploration. Saline can also be injected and extracted for examination by cytology. Currently, the FDA has cleared ViaDuct ä MicroEndoscope ® in July 2001 for marketing. ______________________________________________________________________ RATIONALE: This position on Ductal Lavage is based on a 2002 TEC Assessment that offered the following observations and conclusions. Validation of a diagnostic technology requires: · the data regarding its technical performance, · its diagnostic performance (such as sensitivity, specificity, and positive and negative predictive value) compared to a gold standard, and · data regarding how the diagnostic information will be used in the management of the patient and whether beneficial health outcomes result. It is difficult to identify a gold standard test to validate the diagnostic performance of ductal lavage. For example, since ductal lavage is performed in patients without mammographic abnormalities there is no obvious target for diagnostic confirmation with a tissue sample. Results of the ductal lavage can be broadly subdivided into: · Those with malignant cells, · Those with atypical hyperplasia, or · Those with benign cells. In cases where cells suspicious for malignancy have been reported, some patients may have undergone either surgical resection of the involved duct or a broader surgical resection. However, there have been no studies published regarding the diagnostic significance in this setting and no studies reported on the results of ductal lavage in patients with mammographic abnormalities who are scheduled to undergo biopsy. In addition, there are no prospective clinical studies in published peer-reviewed literature regarding patient outcomes of breast ductal lavage as a screening method for patients at high risk for breast cancer. Clinical studies have suggested that even in the absence of mammographic abnormalities, atypical hyperplasia may be associated with an increased risk of breast cancer, both in patients at average and high risk. The following treatment options could be considered: · Increased surveillance (ie, an increased frequency of breast self exam or clinical exam or increased frequency of mammography), · A prophylactic mastectomy if other risk factors are present (ie, BRCA 1 or BRCA 2 mutation), or · Chemoprevention with Tamoxifen. Chemoprevention with Tamoxifen is suggested as a promising management strategy for atypical hyperplasia based upon ductal lavage. For example, the National Surgical Adjuvant Breast and Bowel Project P-1 trial randomized 13,388 high risk patients to receive either chemoprevention with Tamoxifen or placebo. The principal outcomes were the subsequent incidence of in situ or invasive cancer over the next five (5) years. This trial reported that overall tamoxifen, was associated with a 49% reduction in incidence of invasive breast cancer. When atypical hyperplasia was present, tamoxifen was associated with an 86% reduction in the incidence of subsequent breast cancer. However, in this trial, atypical hyperplasia was presumably diagnosed in patients with mammographic abnormalities. While the results of the P-1 trial are statistically significant, there is a need to further refine the patient selection criteria for tamoxifen; for example, overall only 4 % of the placebo group compared to 2% of the tamoxifen group developed breast cancer in the five (5) year time interval of the trial. In fact, results of periareolar fine-needle aspiration cytology (specifically atypical hyperplasia) have been proposed as a potential technique for identifying those candidates most likely to benefit from tamoxifen. However, this strategy of patient selection has not been formally investigated. To date, the Fiberoptic Ductoscopy (ductal endoscopy technique or microendoscopic intraductal mammary visualization) has been used in pilot studies of women with spontaneous nipple discharge. There are no studies of ductoscopy where the focus has been on random examinations of high-risk women or that have compared ductoscopy with other breast cancer detection techniques. Fiberoptic ductoscopy is currently being used in research and clinical trial collaborations to demonstrate the value of this technology in the detection and management of early stage breast cancer and other forms of intraductal breast disease. Therefore, the safety and effectiveness of fiberoptic ductoscopy has not been established and is considered investigative. ______________________________________________________________________ DISCLAIMER: State and federal law, as well as contract language, including definitions and specific inclusions/exclusions, takes precedence over Medical Policy and must be considered first in determining coverage. The member’s contract benefits in effect on the date that services are rendered must be used. Any benefits are subject to the payment of premiums for the date on which services are rendered. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically. HMO Blue Texas physicians who are contracted/affiliated with a capitated IPA/medical group must contact the IPA/medical group for information regarding HMO claims/reimbursement information and other general polices and procedures. ______________________________________________________________________ Blue Cross and Blue Shield of Texas, a Division of Health Care Service Corporation, a Mutual Legal Reserve Company* Southwest Texas HMO, Inc.* d/b/a HMO BlueÒ Texas * Independent Licensees of the Blue Cross and Blue Shield Association ______________________________________________________________________ Posted Jan. 7, 2003 .
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