493 Form

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Medical Policy Breast Duct Endoscopy Table of Contents
• Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 493 BCBSA Reference Number: 2.01.55A (For Plan internal use only) NCD/LCD: NA Related Policies
None Policy
Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity Medicare Members: Managed Care HMO BlueSM and Medicare PPO BlueSM

Breast duct endoscopy is considered INVESTIGATIONAL.

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) This is not a covered service. Commercial PPO and Indemnity This is not a covered service. Medicare HMO BlueSM This is not a covered service. Medicare PPO BlueSM This is not a covered service.

CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

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CPT Codes There is no specific CPT code for this service.

Description Breast duct endoscopy is a technique that provides for direct visual examination of the breast ducts through nipple orifice cannulation and exploration. The technique has been investigated in the following clinical situations: • Diagnostic technique in women with spontaneous nipple discharge, where endoscopy might function as an alternative to surgical excision, • Technique to obtain cellular material to stratify women for risk of breast cancer, • As a follow-up test for women with atypical cytology as detected by ductal lavage, • Delineation of intraductal disease to define margins of surgical resection, and

The direct delivery of therapeutic agents, including photodynamic therapy, laser ablation, topical biological agents, etc.

Summary The majority of published studies consisted of uncontrolled case series or retrospective studies. The procedure is considered investigational because its impact on health outcomes is uncertain.

Policy History Date Action 9/2022 Annual policy review. Policy updated with literature review through September 2022.
References added. Policy statements unchanged. 2/2020 Policy updated with literature review through February 1, 2020, no references added. Policy statements unchanged. 11/2011- 4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates. No changes to policy statements.
9/2011 Reviewed - Medical Policy Group - Urology and Obstetrics/Gynecology. No changes to policy statements. 7/2011 Reviewed - Medical Policy Group - Hematology and Oncology. No changes to policy statements. 10/2010 Reviewed - Medical Policy Group - Urology and Obstetrics/Gynecology. No changes to policy statements. 9/2010 Reviewed - Medical Policy Group - Hematology and Oncology. No changes to policy statements. 9/2009 Reviewed - Medical Policy Group - Hematology and Oncology. No changes to policy statements. 10/2008 Reviewed - Medical Policy Group - Urology and Obstetrics/Gynecology. No changes to policy statements. 10/2008 Reviewed - Medical Policy Group - Hematology and Oncology. No changes to policy statements. 9/2008 Annual policy review. No changes to policy statements. 8/2008 Annual policy review. No changes to policy statements. 10/2007 Reviewed - Medical Policy Group - Urology and Obstetrics/Gynecology. No changes to policy statements. 9/2007 Reviewed - Medical Policy Group - Hematology and Oncology. No changes to policy statements. 5/2007 Annual policy review. No changes to policy statements. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines

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Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines References

1. Love SM, Barsky SH. Breast-duct endoscopy to study stages of cancerous breast disease. Lancet 1996; 348(9033):997-9.
2. Shen KW, Wu J, Lu JS et al. Fiberoptic ductoscopy for patients with nipple discharge. Cancer 2000; 89(7):1512-9.
3. Shen KW, Wu J, Lu JS et al. Fiberoptic ductoscopy for breast cancer patients with nipple discharge. Surg Endosc 2001; 15(11):1340-5.
4. Dooley WC. Routine operative breast endoscopy during lumpectomy. Ann Surg Oncol 2003; 10(1):38-42.
5. Dooley WC, Francescatti D, Clark L et al. Office-based breast ductoscopy for diagnosis. Am J Surg 2004; 188(4):415-8.
6. Matsunaga T, Kawakami Y, Namba K et al. Intraductal biopsy for diagnosis and treatment of intraductal lesions of the breast. Cancer 2004; 101(10):2164-9.
7. Sauter ER, Ehya H, Schlatter L et al. Ductoscopic cytology to detect breast cancer. Cancer J 2004; 10(1):33-41.
8. Moncrief RM, Nayar R, Diaz LK et al. A comparison of ductoscopy-guided and conventional surgical excision in women with spontaneous nipple discharge. Ann Surg 2005; 241(4):575-81.
9. Sauter ER, Ehya H, Klein-Szanto AJ et al. Fiberoptic ductoscopy findings in women with and without spontaneous nipple discharge. Cancer 2005; 103(5):914-21.
10. Grunwald S, Bojahr B, Schwesinger G et al. Mammary ductoscopy for the evaluation of nipple discharge and comparison with standard diagnostic techniques. J Minim Invasive Gynecol 2006; 13(5):418-23.
11. Al Sarakbi W, Salhab M, Mokbel K. Does mammary ductoscopy have a role in clinical practice? Int Semin Surg Oncol 2006; 3:16.
12. Sharma R, Dietz J, Wright H et al. Comparative analysis of minimally invasive microductectomy versus major duct excision in patients with pathologic nipple discharge. Surgery 2005; 138(4):591-7.
13. NCCN Clinical Practice Guidelines in Oncology. Breast cancer screening and diagnosis guidelines. V.I.2006; http://www.nccn.org/professionals/physician_gls/PDF/breast-screening.pdf
14. Louie LD, Crowe JP, Dawson AE et al. Identification of breast cancer in patients with pathologic nipple discharge: does ductoscopy predict malignancy? Am J Surg 2006; 192(4):530-3.
15. Hunerbein M, Dubowy A, Raubach M et al. Gradient index ductoscopy and intraductal biopsy of intraductal breast lesions. Am J Surg 2007; 194(4):511-4.
16. Grunwald S, Heyer H, Paepke S et al. Diagnostic value of ductoscopy in the diagnosis of nipple discharge and intraductal proliferations in comparison to standard methods. Onkologie 2007; 30(5):243-8.
17. Liu GY, Lu JS, Shen KW et al. Fiberoptic ductoscopy combined with cytology testing in the patients of spontaneous nipple discharge. Breast Cancer Res Treat 2008; 108(2):271-7.
18. NCCN Clinical Practice Guidelines in Oncology. Breast cancer screening and diagnosis guidelines. V.1.2008; http://www.nccn.org/professionals/physician_gls/PDF/breast-screening.pdf. (Accessed June 13, 2008)
19. Jacobs VR, Paepke S, Ohlinger R et al. Breast ductoscopy: technical development from a diagnostic to an interventional procedure and its future perspective. Onkologie 2007; 30(11):545-9
20. G Gui et al. INTEND II Randomized Clinical Trial of Intraoperative Duct Endoscopy in Pathological Nipple Discharge. Br. J Surg, 105 (12), 1583-1590 Nov 2018 PMID: 30238438
21. Gui G et al. The INTEND 1 randomized controlled trial of duct endoscopy as an indicator of margin excision in breast conservation surgery. Breast Cancer Res Treat. 2021 Apr;186(3):723-730.