Subject:
Epithelial Cell Cytology in Breast Cancer Risk Assessment and High-Risk Patient Management (Ductal Lavage and Suction Collection Systems)
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Different collection systems have been investigated as techniques to obtain nipple aspirates; the collected epithelial cells are then examined cytologically. These techniques have been evaluated as a diagnostic and risk assessment tool in patients at high risk of breast cancer but without clinical or mammographic findings. For example, the finding of atypical hyperplasia may be associated with an increased risk of breast cancer. Malignant cells may also be identified in rare cases.
Ductal lavage of the mammary ducts describes a technique for collecting epithelial cells from individual mammary ducts for subsequent cytologic analysis. It has been investigated as a diagnostic and risk assessment tool in patients at high risk of breast cancer with negative physical examinations and mammograms. Ductal lavage involves several steps. First, fluid yielding mammary ducts are identified using a nipple aspirator. Next, a flexible microcatheter is inserted about a centimeter into the existing nipple opening of the individual mammary ducts. Saline (about 10-20 ml.) is then slowly introduced in 2 ml. increments to "rinse" the duct and collect epithelial cells. The fluid is withdrawn through the catheter into a collection syringe. The fluid is then analyzed microscopically for the presence of benign, atypical (premalignant), or malignant cells. The FirstCyte Breast Test (Cytyc) is a device used for ductal lavage that has been cleared for marketing by the U.S. Food and Drug Administration (FDA).
A suction collection system, the HALO NAF (nipple aspirate fluid) Collection System (Neomatrix) has also received FDA clearance as a technique to collect ductal epithelial cells. In this system, small breast cups are placed on the woman’s breast and adjusted to fit. The system is then engaged and automatically warms the breast and applies light suction to bring nipple aspirate fluid to the surface. Similar to ductal lavage, the fluid is then analyzed microscopically for cytologic abnormalities.
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
Cytologic analysis of epithelial cells from nipple aspirations as a technique to assess breast cancer risk and manage patients at high risk of breast cancer or to diagnose breast cancer is considered investigational. Techniques of collecting nipple aspiration fluid include, but are not limited to, ductal lavage and suction.
Medicare Coverage:
There is no National Coverage Determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
[INFORMATIONAL NOTE: The available literature and published data regarding ductal lavage and suction collection systems for breast cancer risk assessment are inadequate to draw conclusions regarding their clinical utility and impact on net health outcomes.
Visvanathan et al. (Cancer Epidemiol Biomarkers Prev 2007) evaluated the reliability of nipple aspirate fluid (NAF) and ductal lavage at two time points 6 months apart in women (n=69) at increased risk for breast cancer. Eligible women had a 5-year Gail risk of 1.66% or higher or lifetime risk of >20%, and/or a family history or personal history of breast cancer. All ducts that produced NAF were cannulated. Participants (mean age, 47 years) were enrolled over 35 months. Forty-seven returned for a second visit. Of the women who returned for a second visit, 18 of 24 who produced NAF had at least one duct successfully cannulated. Twenty-four ducts in 14 women were lavaged twice. Among these ducts, cellular yield for the two time points was inconsistent and only fair cytologic agreement was observed. The authors concluded that the use of ductal lavage is limited by technical challenges in duct cannulation, inconsistent NAF production, a high rate of inadequate cellular material for diagnosis, fair cytologic reproducibility, and low participant return rates.
Khan et al. (Cancer Prev Res 2009) reported on a proof-of-principle phase 2 study to assess the utility of ductal lavage to measure biomarkers of tamoxifen action. The authors' conclusions are as follows: "...we observed the expected changes in tamoxifen-related biomarkers; however, poor reproducibility of biomarkers in the observation group, the 53% attrition rate of subjects from recruitment to biomarker analyses, and the expense of ductal lavage are significant barriers to the use of this procedure for biomarker assessment over time."
In May 2007, The American Society of Breast Surgeons updated their official statement, Ductal Cell-Based Risk Assessment. The statement included the following: "Ductal lavage is a minimally-invasive method of collecting breast epithelial cells for cytological examination. Cytologic interpretation of fluid obtained by ductal lavage is not an approved screening tool for the detection of breast cancer. The American Society of Breast Surgeons cautions that ductal lavage should not replace standard cancer screening methods. Long-term studies are necessary to better define the risk assessment contribution of cytologic atypia detected via these and other methods. The American Society of Breast Surgeons encourages participation in such trials."
The 2015 (Version1.2015) National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology, breast cancer screening and diagnosis guidelines state that current evidence does not support the routine use of ductal lavage as a screening procedure.
According to the American Cancer Society, ductal lavage is an experimental test developed for women who have no symptoms of breast cancer but are at very high risk for the disease.
The National Cancer Institute's Physician Data Query (PDQ) on breast cancer screening includes a section on pathologic diagnosis of breast cancer with the following statement: ..."Fine-needle aspiration, nipple aspiration, and ductal lavage are three methods of obtaining cells from breast tissue or ductal epithelium for cytological examination. None of these technologies has been tested in controlled trials of screening or compared with other breast cancer screening modalities."]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Epithelial Cell Cytology in Breast Cancer Risk Assessment and High-Risk Patient Management (Ductal Lavage and Suction Collection Systems)
Ductal Lavage of the Mammary Ducts
Mammary Ducts, Ductal Lavage of the
HALO NAF Collection System
Nipple Aspirate Fluid
References:
1. Dooley W, Veronesi R, Ganz P, et al. Identification of premalignant and malignant breast cells in mammogram- and physical- exam-negative women by ductal lavage. Proceedings ASCO. 2000;19:76a.
2. Fabian CJ, Kimler BF, Zalles CM, et al. Short-term breast cancer prediction by random periareolar fine-needle aspiration cytology and the Gail Risk Model. J Natl Cancer Inst. 2000;92(15):1217-1227.
3. Wrench MR, Petrakis NL, King EB, et al. Breast cancer incidence in women with abnormal cytology in nipple aspirates of breast fluid. Am J Epidemiology1991;135(2):130-141.
4. Fisher B, Costantion JP, Wickerham DL, et al. Tamoxifen for prevention of breast cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst. 1998;90(18):1371-1388.
5. TEC Clearinghouse, Technologica. April 2001.
6. Chlebowski RT, Collyar DE, Somerfield MR, et al. American Society of Clinical Oncology Technology Assessment on Breast Cancer Risk Reduction Strategies: Tamoxifen and Raloxifene. J Clin Oncol 1999 Jun;17(6):1939-1955.
7. Dupont WD, Parl FF, Hartmann WH, et al. Breast Cancer Risk Associated with Proliferative Breast Disease and Atypical Hyperplasia. Cancer 1993;71:1258-1265.
8. Dupont WD, Page DL. Risk Factors for Breast Cancer in Women with Proliferative Breast Disease. N Engl J Med 1985 Jan;312:146-151.
9. Page DL, Dupont WD, Rogers LW, et al. Atypical Hyperplastic Lesions of the Female Breast. Cancer 1985;55:2698-2708.
10. Dooley WC, Ljung B, Veronesi U, et al. Ductal Lavage for Detection of Cellular Atypia in Women at High Risk for Breast Cancer. J Natl Cancer Inst 2001 Nov;93(21):1624-1632.
11. O’Shaughnessy JA, Ljung B, Dooley WC, et al. Ductal Lavage and the Clinical Management of Women at High Risk for Breast Carcinoma. Cancer 2002 Jan;94(2):292-298.
12. National Comprehensive Cancer Network (NCCN). Clincal Practice Guidelines in Oncology: Breast Cancer Screening and Diagnosis Guidelines. Version 1.2009, 03/03/09.
13. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Breast Cancer Risk Reduction. Version 1.2006, 03/20/06.
14. National Cancer Institute (NCI). News from the NCI. May 30, 2002 (//newscenter.cance.gov/pressreleases/Lavage.html) (accessed 10/30/2002)
15. Morrow M, Vogel V, Ljung BM, et al. Evaluation and Management of the Woman with an Abnormal Ductal Lavage. J AM Coll Surg 2002 May;194(5):648-656.
16. Blue Cross and Blue Shield Association. Technology Evaluation Center (TEC) Assessment Program: Use of Epithelial Cell Cytology in Breast Cancer Risk Assessment and High-Risk Patient Management. Volume 17, No. 1, June 2002.
17. ECRI. Windows on Medical Technology. Ductal Lavage and Nipple Aspiration for Identifying Women at High Risk of Breast Cancer. Issue No. 80, July 2002.
18. Badve S, Wiley E, Rodriguez N. Assessment of utility of ductal lavage and ductoscopy in breast cancer – a retrospective analysis of mastectomy specimens. Mod Pathol. 2003 Mar;16(3):206-9.
19. American Cancer Society. How Is Breast Cancer Diagnosed? Detailed Guide: Breast Cancer. Revised: 09/02/05. www.cancer.org (last accessed 08/02/06).
20. National Cancer Institute (NCI). Screening for Breast Cancer. Health Professional Version; date last modified: 07/21/06. www.cancer.gov (last accessed 08/02/06).
21. Smith RA, Saslow D, Sawyer KA et al. American Cancer Society guidelines for breast cancer screening: update 2003. CA Cancer J Clin. 2003 May-Jun;53(3):141-69.
22. The American Society of Breast Surgeons. Official Statement: Ductal Lavage and Cell-Based Risk Assessment. Approved April 30, 2003. [Available at: http://www.breastsurgeons.org/statements/Ductal_Cell.pdf (last accessed 06/10/2009.]
23. Brogi E, Robson M, Panageas KS et al. Ductal lavage in patients undergoing mastectomy for mammary carcinoma: a correlative study. Cancer. 2003 Nov;98(10):2170-6.
24. Khan SA, Wiley EL, Rodriquez N, et al. Ductal lavage findings in women with known breast cancer undergoing mastectomy. J Natl Cancer Inst 2004 Oct 20;96(20):1510-7.
25. Kurian AW, Mills MA, Jaffee M, 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.
26. Fabian CJ, Kimler BF, Mayo MS, et al. Breast-tissue sampling for risk assessment and prevention. Endocr Relat Cancer 2005 Jun;12(2):185-213.
27. ECRI Institute. Health Technology Assessment Information Service (HTAIS). Custom Hotline Response: Ductal lavage and nipple aspiration for identifying women at high risk of breast cancer. Updated 02/14/2007. Accessed 07/21/08.
28. Hayes Directory: Breast ductal lavage and fiberoptic ductoscopy for breast cancer diagnosis and screening. August 23, 2004. (accessed 08/07/06).
29. Mitchell G, Antill YC et al. Nipple aspiration and ductal lavage in women with a germline BRCA1 or BRCA2 mutation. Breast Cancer Res. 2005;7(6):R1122-31. Epub 2005 Nov 14.
30. Kurian AW, Mills MA 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.
31. American Cancer Society. Cancer Reference Information. Breast Cancer: Early Detection. Revised 09/17/2007. [Available at http://www.cancer.org/docroot/CRI/content/CRI_2_6x_Breast_Cancer_Early_Detection.asp (accessed 07/21/2008).]
32. Visvanathan K, Santor D, Ali SZ, et al. The reliability of nipple aspirate and ductal lavage in women at increased risk for breast cancer - a potential tool for breast cancer risk assessment and biomarker evaluation. Cancer Epidemiol Biomarkers Prev 2007 May;16(5):950-5.
33. Carruthers CD, Chapleskie LA, Flynn MB, et al. The use of ductal lavage as a screening tool in women at high risk for developing breast carcinoma. Am J Surg 2007 Oct;194(4):463-6.
34. Lang JE, Kuerer HM. Breast ductal secretions: clinical features, potential uses, and possible applications. Cancer Control 2007 Oct;14(4):350-9.
35. Tondre J, Nejad M, Casano A, et al. Technical Enhancements to Breast Ductal Lavage. Am Surg Oncol 2008 Jul 18. [Epub ahead of print]
36. Khan SA, Lankes HA, Patil DB et al. Ductal lavage is an inefficient method of biomarker measurement in high-risk women. Cancer Prev Res (Phila Pa) 2009;2(3): 265-73.
37. National Cancer Institute. Breast cancer screening (PDQ). [Available at: http://www.cancer.gov/cancertopics/pdq/screening/breast/HealthProfessional/page4.]
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39. UpToDate. Screening for breast cancer: Strategies and recommendations. Literature review current through April 2016; topic last updated March 09, 2016
40. National Comprehensive Cancer Network (NCCN) Guidelines. Breast Cancer Screening and Diagnosis. Version 1.2015, 0715/2015.
41. American Cancer Society (ACS). Breast Cancer: How is breast cancer diagnosed? Last reviewed: 06/10/2015. Available at http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-diagnosis
42. UpToDate. Screening for breast cancer: Evidence for effectiveness and harms. Literature review current through April 2016; topic last updated July 29, 2015.
43. Elmore JG. Screening for breast cancer: Strategies and recommendations. In: UpToDate, Aronson MD, Vora SR (Eds), UpToDate, Waltham, MA. (Accessed on May 7, 2017.)
44. Elmore JG. Screening for breast cancer: Evidence for effectiveness and harms .In: UpToDate, Aronson MD, Melin JA (Eds), UpToDate, Waltham, MA. (Accessed on May 7, 2017.)
45. Elmore JG. Screening for breast cancer: Evidence for effectiveness and harms .In: UpToDate, Aronson MD, Melin JA (Eds), UpToDate, Waltham, MA. (Accessed on April 2, 2018.)
46. Elmore JG. Screening for breast cancer: Evidence for effectiveness and harms .In: UpToDate, Aronson MD, Melin JA (Eds), UpToDate, Waltham, MA. (Accessed on April 2, 2019.)
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
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