Clinical & Quality Management MEDICAL POLICY DUCTAL LAVAGE AND FIBEROPTIC DUCTOSCOPY FOR CANCER SCREENING Policy Number: 2015M0096A Effective Date: December 1, 2015 Table of Contents: Page: Cross Reference Policy: POLICY DESCRIPTION 2 Breast Reconstructive Surgery, COVERAGE RATIONALE/CLINICAL CONSIDERATIONS 2 2013M0043A BACKGROUND 2 REGULATORY STATUS 3 Genetic Testing, 2015M0038B CLINICAL EVIDENCE 4 APPLICABLE CODES 5 Genetic Expression Assays for Breast Tumor Tissue Oncotype DX®/ REFERENCES 6 MammaPrint®, 2014M0008B POLICY HISTORY/REVISION INFORMATION 7 INSTRUCTIONS: “Medical Policy assists in administering UCare benefits when making coverage determinations for members under our health benefit plans. When deciding coverage, all reviewers must first identify enrollee eligibility, federal and state legislation or regulatory guidance regarding benefit mandates, and the member specific Evidence of Coverage (EOC) document must be referenced prior to using the medical policies. In the event of a conflict, the enrollee's specific benefit document and federal and state legislation and regulatory guidance supersede this Medical Policy. In the absence of benefit mandates or regulatory guidance that govern the service, procedure or treatment, or when the member’s EOC document is silent or not specific, medical policies help to clarify which healthcare services may or may not be covered. This Medical Policy is provided for informational purposes and does not constitute medical advice. In addition to medical policies, UCare also uses tools developed by third parties, such as the InterQual Guidelines®, to assist us in administering health benefits. The InterQual Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. Other Policies and Coverage Determination Guidelines may also apply. UCare reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary and to provide benefits otherwise excluded by medical policies when necessitated by operational considerations.” Copyright 2015, Proprietary Information of UCare Page. 1 of 7 Clinical & Quality Management MEDICAL POLICY POLICY DESCRIPTION: This policy discusses ductal lavage and fiberoptic ductoscopy, two methods of collecting breast fluid. The obtained fluids undergo cytological examination of the ductal epithelial cells to assist in assessing the patient’s risk for breast cancer. These procedures are intended to be used in conjunction with clinical breast examination and mammography for the early detection and pathological diagnosis of nonpalpable breast cancers and precancerous lesions in high-risk women with normal or indeterminate findings by radiological and physical examination. Examination of nipple aspirate fluid is sometimes called the “breast pap smear.” COVERAGE RATIONALE / CLINICAL CONSIDERATIONS: Breast ductal lavage is considered UNPROVEN AND NOT MEDICALLY NECESSARY for the use of breast cancer screening of either low-risk or high-risk women due to insufficient published clinical evidence in peer-reviewed medical literature demonstrating the safety and/or impact on health outcomes or patient management. Fiberoptic ductoscopy, with or without ductal lavage, is considered UNPROVEN AND NOT MEDICALLY NECESSARY due to insufficient published clinical evidence in peer-reviewed medical literature demonstrating the safety and/or impact on health outcomes or patient management. The HALO® Breast Pap Test is considered UNPROVEN AND NOT MEDICALLY NECESSARY for use in breast cancer screening of either low-risk or high-risk women due to insufficient published clinical evidence in peer-reviewed medical literature demonstrating the safety and/or impact on health outcomes or patient management. Clinical Considerations: The FDA states a nipple aspirate fluid test is not a replacement for mammography, other breast imaging tests, or breast biopsy, and should not be used alone to screen for or diagnose breast cancer. BACKGROUND: Some breast cancers are believed to arise from a series of progressive cytogenetic and histopathological changes that are reflected by transformation of normal tissue to mild hyperplasia, moderate hyperplasia, and atypical hyperplasia followed by carcinoma in situ (CIS) and invasive cancer. Breast cancer risk increases by 1.5 to 2 times in the presence of proliferative breast disease without atypia or usual hyperplasia, and by 4 to 5 times with a biopsy history of atypical hyperplasia. However, it remains unclear whether a cytological diagnosis of atypia correlates directly with a subsequent histopathological diagnosis of atypical hyperplasia or breast cancer. Breast biopsies, open surgical excision, or excision of the duct are performed when a palpable lump, mammographic abnormality, or bloody nipple discharge is found. It has been hypothesized that identification of breast cancer at an early, preclinical phase might allow for earlier treatment and an improved prognosis. Noninvasive methods for collecting and analyzing epithelial cells and other biomarkers of early breast cancer in fluid specimens obtained from the ducts of the breast Copyright 2015, Proprietary Information of UCare Page. 2 of 7 Clinical & Quality Management MEDICAL POLICY have been evaluated. Studies have shown that breast cancer risk is increased when atypical hyperplasia is found in nipple aspirate fluid (NAF) specimens, and following a diagnosis of atypical hyperplasia by periareolar fine-needle aspiration (FNA) cytology. However, nipple aspiration has limited utility for diagnosis since inadequate NAF specimens are collected in up to 50% of women. Breast ductal lavage (DL) and fiberoptic ductoscopy (FDS) are used to evaluate patients at risk for breast cancer. These procedures are intended to be used in conjunction with clinical breast examination and mammography for the early detection and pathological diagnosis of nonpalpable breast cancers and precancerous lesions in high-risk women with normal or indeterminate findings by radiological and physical examination. Breast DL is an invasive technique for the collection of breast ductal epithelial cells for cytological analysis. A microcatheter is inserted into each NAF-producing duct, local anesthetic is infused, and saline is introduced to wash out the ductal contents, which are analyzed cytopathologically. DL is intended to be used in high-risk women with normal findings on clinical breast examination (CBE) and mammography for the early detection of nonpalpable breast cancers and precancerous lesions. The purpose is to provide information for risk stratification. Fiberoptic ductoscopy (FDS), the direct visualization of the breast duct lining using a very thin fiberoptic scope, has been employed to identify the source of atypical cells found on DL, as well as for evaluation of abnormal nipple discharge in conjunction with aspiration cytology, biopsy, or surgical excision. FDS systems have microendoscopes with an outer air channel on the fiberscope, which permits instillation and re- collection of saline to retrieve cells from the breast ductal system. Nipple aspiration can also be done noninvasively, using the HALO Breast Pap Test system. HALO is an automated system that collects nipple aspirate fluid (NAF) using a combination of heat, massage and suction. REGULATORY STATUS: 1. U.S. FOOD AND DRUG ADMINISTRATION (FDA): Devices for collecting ductal fluid can be found at the following website using product code KNW. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed Oct 1, 2015. The HALO® Breast Pap Test (HALO Healthcare) was approved for marketing by the FDA on September 23, 2002. The device is intended to non-invasively extract samples of breast duct fluid for breast cancer screening, providing a sample for a "Pap smear" for the breast. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/K020848.pdf. Accessed Oct 1, 2015. On December 12, 2013, the FDA issued a Safety Alert regarding nipple aspirate testing. The alert states that a nipple aspirate test is not a replacement for mammography, other breast imaging tests, or breast biopsy, and should not be used by itself to screen for or diagnose breast cancer. The FDA is not aware of any valid scientific data to show that a nipple aspirate test by itself is an effective screening tool for any medical condition including the early detection of breast cancer or other breast disease. Certain manufactures are promoting the use of nipple aspirate tests as a stand-alone evaluation tool for screening and diagnosing breast cancer, claiming they are an alternative to biopsy or mammography. They also claim that a nipple aspirate test can detect pre-cancerous abnormalities and Copyright 2015, Proprietary Information of UCare Page. 3 of 7 Clinical & Quality Management MEDICAL POLICY diagnose breast cancer before mammography with just a sample of a few cells. The FDA is concerned that women will believe these misleading claims about a nipple aspirate test and not get mammograms and/or other needed breast imaging tests or biopsies. This may lead to serious adverse health consequences. Possible health consequences include false negative test results, indicating the absence of breast cancer when cancer exists, and false positive test results, indicating the presence of breast cancer when none exists. False negative results may lead to delayed diagnosis and/or delayed treatment of breast cancer, with increased