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Date Printed: December 16, 2017: 09:29 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-10000-19

Original Effective Date: 12/15/03

Reviewed: 08/24/17

Revised: 09/15/17

Subject: Breast Ductoscopy

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Breast ductoscopy (also known as fiberoptic ductoscopy, breast endoscopy, or mammary ductoscopy) is a technique that provides for direct visual examination of the breast ducts. The procedure is performed under sedation and involves inserting a fiberoptic, flexible scope through the nipple and threading the scope through the network of ducts deep in the breast. Fluid may be collected through the scope for examination or a thin wire probe may be passed into the breast to visualize the ductal system to detect abnormalities. The use of ductoscopy has been proposed to aid in the detection and management of early stage breast cancer and other forms of intraductal breast disease.

POSITION STATEMENT:

Breast ductoscopy is considered experimental or investigational for all indications. The evidence is insufficient to determine the effects of the technology on health outcomes.

BILLING/CODING INFORMATION:

There is no specific CPT code for breast ductoscopy.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Ductal Lavage and Suction Collection Systems, 02-10000-14

OTHER:

None applicable.

REFERENCES:

  1. Blue Cross Blue Shield Association Medical Policy. “Breast Duct Endoscopy” 2.01.55, (07/08); archived 2009.
  2. ClinicalTrials.gov, Evaluation of the Role of Duct Endoscopy in the Assessment of Cellular Atypia Within Breast Duct Fluid in High-Risk Women Carrying BRCA1/2 or p53 Gene Mutations, sponsored by Royal Marsden NHS Foundation Trust, accessed 07/25/17.
  3. ClinicalTrials.gov, Evaluation Of The Role Of Nipple Aspiration, Ductal Lavage And Duct Endoscopy At The Time Of Surgery In Patients With Breast Cancer, sponsored by Royal Marsden NHS Foundation Trust, accessed 07/25/17.
  4. ClinicalTrials.gov, Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge, sponsored by Sheldon Feldman, accessed 07/25/17.
  5. Denewer A, El-Etribi K, Nada N, El-Metwally M, The Role and Limitations of Mammary ductoscope in Management of Pathologic Nipple Discharge, Breast J. 2008 Sep-Oct; 14(5): 442-9.
  6. Escobar, P. F., Crowe, J. P., Matsunaga, T. & Mokbel, K. (2006). The Clinical Applications of Mammary Ductoscopy. American Journal of Surgery, 191, 211-215.
  7. HAYES Medical Technology Directory. “Breast Ductal Lavage and Fiberoptic Ductoscopy for Breast Cancer Diagnosis and Screening” (BREA0203.12 – 08/23/04), 11/07 update.
  8. Hunerbein M, Dubowy A, Raubach M, Gebauer B, Topalidis T, Schlag P, Gradient Index Ductoscopy and Intraductal Biopsy of Intraductal Breast Lesions, Am J Surg. 2007 Oct; 194(4): 511-4.
  9. Hunerbein M, Schwarz L, Schneider U, Schlag P. Evaluation of pathologic nipple discharge with ductoscopy (let). Journal of the American College of Surgeons. Oct 2003; 197(4).
  10. Kapenhas-Valdes E, Feldman SM, Boolbol SK, The Role of Mammary Ductoscopy in Brest Cancer: A Review of the Literature, Annals of Surgical Oncology, 15(12):3350-3360, 10/08.
  11. Khan SA, Baird C, Staradub VL, Morrow M. Ductal lavage and ductoscopy: the opportunities and the limitations. Clinical Breast Cancer. 01 Aug 2002; 3(3): 192-3. Abstract.
  12. 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 Mar; 108(2): 271-7.
  13. Masood, S. & Khalbuss, W. E. (2005). Nipple Fluid Cytology. Clinics in Laboratory Medicine, 787-794.
  14. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology-Breast Cancer, Version April 2017.
  15. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology-Breast Cancer Screening and Diagnosis, Version June 2017.
  16. Sarakbi, W. A., Salhab, M. & Mokbel, K. (2006). Does Mammary Ductoscopy Have a Role in Clinical Practice? International Seminars in Surgical Oncology, 3, 16.
  17. Sauter ER, Klein-Szanto A, Macgibbon B, Ehya H, Nipple Aspirate Fluid and Ductoscopy to Detect Breast Cancer, Diagn Cytopathol. 2009 Sep 30.
  18. Smith, R., Saslow, D., Sawyer, K. A., Burke, W., Costanza, M. E., Evans, W. P., Foster, R. S., Hendrick, E., Eyre, H. J. & Sener, S. (2003). American Cancer Society Guidelines for Breast Cancer Screening: Update 2003. CA Cancer J. Clin 2003, 53, 141-169.
  19. Uchida K, Fukushima H, Toriumi Y, et al, Mammary Ductoscopy: Current Issues and Perspectives, Breast Cancer, 2009; 16(2): 93-6.
  20. Vaughan A, Crowe JP, Brainard J, Dawson A, et al, Mammary Ductoscopy and Ductal Washings for the Evaluation of Patients with Pathologic Nipple Discharge, Vol 15, Issue 3, pages 254-260, 05/09.
  21. Wu W, Li XR, Yang KY, Dong BN, Chen DJ, Breast Intraductal Lesion Resection Under Breast Fiberoptic Ductoscopy, Zhong Nan Da Xue Xue Bao Yi Xue Ban, 2008 Jan; 33(1): 81-4.
  22. Ye Han, Jianyi Li, et al, Diagnostic value of endoscopic appearance during ductoscopy in patients with pathological nipple discharge. BMC Cancer. 2017 May 2;17(1):300. doi: 10.1186/s12885-017-3288-3.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 08/24/17.

GUIDELINE UPDATE INFORMATION:

12/15/03

New Medical Coverage Guideline – investigational.

12/15/04

Scheduled review and revision of guideline; consisting of updated references and maintaining investigational status.

01/01/06

Annual review – maintain investigational.

11/15/06

Annual review – maintain investigational.

07/15/07

Annual review, investigational status maintained, guideline reformatted, references updated.

10/15/08

Annual review: position statement maintained, references updated.

07/15/09

Annual review: position statement maintained, title revision, and references updated.

04/15/10

Annual review: position statement maintained and references updated.

05/11/14

Revision: Program Exceptions section updated.

11/01/15

Revision: ICD-9 Codes deleted.

09/15/17

Review; Investigational position maintained; title, description and references updated.

Date Printed: December 16, 2017: 09:29 PM