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Date Printed: August 18, 2017: 10:33 AM

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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.

02-10000-14

Original Effective Date: 05/15/02

Reviewed: 06/22/17

Revised: 07/15/17

Subject: Ductal Lavage and Suction Collection Systems

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:

Since most breast cancer begins in the epithelial cells that line the ducts, analysis of epithelial cells found in breast ductal fluid has been studied as an early indicator of breast cancer. If atypical, these cells may indicate the possibility of future breast cancer. Breast ductal fluid can be obtained by fine needle aspiration, nipple aspiration via suction, or ductal lavage.

Ductal lavage is a technique for collecting epithelial cells from the breast ducts for cytological analysis for identification of atypical cells. Ductal lavage enables the retrieval of these cells using a microcatheter inserted into the milk ducts through the nipple orifices. A saline solution is flushed through the catheter into the ducts to wash out cells for cytological examination. The technique is directed at patients identified as being at high risk for breast cancer. The procedure has been dubbed "breast pap smear" because like the test for cervical cancer, it is a nonsurgical approach to identifying abnormal cells prior to their development into cancer.

Several devices have been approved by the U.S. Food & Drug Administration (FDA) including suction collection systems. In these systems, small breast cups are adjusted on the patient’s breast. 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 for cytological abnormalities.

POSITION STATEMENT:

Breast ductal aspiration and cytology is considered experimental or investigational for all indications including breast cancer screening and breast cancer risk assessment. The evidence is insufficient to determine the effects of the technology on health outcomes.

BILLING/CODING INFORMATION:

There is no specific CPT or HCPCS code for breast ductal lavage or suction.

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:

None

RELATED GUIDELINES:

Breast Duct Endoscopy (Ductoscopy), 02-10000-19

OTHER:

None applicable.

REFERENCES:

  1. American Cancer Society (ACS), Prevention and Early Detection- Mammograms and Other Breast Imaging Procedures, revised 09/26/08, accessed at cancer.org on 04/06/09.
  2. American Society of Breast Surgeons Consensus Statement on Screening Mammography, 10/29/15; accessed at breastsurgeons.org.
  3. American Society of Breast Surgeons Official statement: Ductal Lavage and Cell-Based Risk Assessment, 05/06/07.
  4. Blue Cross Blue Shield Association Medical Policy Reference Manual 2.01.45 Epithelial Cell Cytology in Breast Cancer Risk Assessment and High-Risk Patient Management (Ductal Lavage), archived 2009.
  5. Blue Cross Blue Shield Association Technology Evaluation Center. “Use of Epithelial Cell Cytology in Breast Cancer Risk Assessment and High-Risk Patient Management”, 06/02.
  6. ClincialTrials.gov. Study of Ductal Lavage in Women at High Risk for Breast Cancer, sponsored by the University of California, San Francisco & National Cancer Institute (NCI), accessed on 05/10/07.
  7. 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, London, accessed 05/12/08.
  8. ClinicalTrials.gov. Feasibility Study of Evaluating Breast Cancer Patients with Ductal Lavage, sponsored by the University of Michigan, accessed on 05/10/07.
  9. ClinicalTrials.gov. The Intraduct Environment: A Novel Approach to Risk Assessment of Women with a Family History of Breast Cancer, sponsored by Royal Marsden, London, accessed 05/12/08.
  10. Danforth DN, Warner AC, et al, An Improved Breast Epithelial Sampling Method for Molecular Profiling and Biomarker Analysis in Women at Risk for Breast Cancer. Breast Cancer (Auckl). 2015 Jun 8;9:31-40.
  11. ECRI Institute, Ductal Lavage and Nipple Aspiration for Identifying Women at High Risk of Breast Cancer, 02/07.
  12. Hayes Medical Technology Directory-Breast Ductal Lavage and Fiberoptic Ductoscopy For Breast Cancer Diagnosis and Screening (BREA0203.12), 08/23/04 – 11/07 Update.
  13. National Cancer Institute (NCI), Breast Cancer Screening (PDQ®)–Health Professional Version, accessed at cancer.org.
  14. National Comprehensive Cancer Network (NCCN), Breast Cancer Screening and Diagnosis Practice Guidelines in Oncology, Version 2.2016-May 3, 2017.
  15. Ob/Gyn News (01/16/02), New Guidelines Issued For Ductal Lavage Use, Cancer 2002; 94: 292-298.
  16. Patil DB, Lankes HA, Nayar R, et al, Reproducibility of Ductal Lavage Cytology and Cellularity Over a Six Month Interval in High Risk Women, Breast Cancer Res Treat. 2007 Dec 21.
  17. Pro-Duct Health: Ductal Lavage Access The Source of Breast Cancer. Retrieved 03/19/02 from the Internet Web Site.
  18. Smith RA, Saslow D, Sawyer K A, Burke W, et al, American Cancer Society Guidelines for Breast Cancer Screening: Update 2003. CA Cancer J Clin 2003, 53:141-169.
  19. U.S. Food & Drug Administration (FDA), Breast Cancer Screening - Nipple Aspirate Test Is Not An Alternative To Mammography: FDA Safety Communication. Accessed at fda.gov.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 06/22/17.

GUIDELINE UPDATE INFORMATION:

05/15/02

New Medical Coverage Guideline.

07/01/03

Annual review. 07/01/03 HCPCS Update, added code 0046T and 0047T.

06/15/04

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

05/15/05

Scheduled review and revision to guideline; consisting of updated references.

06/15/06

Annual review; maintain investigational.

06/15/07

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

07/15/08

Annual review: position statement maintained, references updated.

01/01/09

Annual HCPCS coding update: deleted codes 0046T and 0047T.

05/15/09

Annual review: position statement maintained and references updated.

05/11/14

Revision: Program Exceptions section updated.

07/15/17

Revision; Position statement, description section, and references updated.

Date Printed: August 18, 2017: 10:33 AM