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Date Printed: June 25, 2017: 01:27 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.

02-10000-14

Original Effective Date: 05/15/02

Reviewed: 04/30/09

Revised: 05/11/14

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:

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 those 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 is a non-invasive technique for collecting epithelial cells from the mammary ducts for cytologic analysis for identification of abnormal cells (cancerous and pre-cancerous cells). Most breast cancer begins in the epithelial cells that line the ducts and lobes of the breast. Ductal lavage is able to collect approximately 40,000 cells per duct, including cells from deep within the breast and has been promoted as an adjunct to standard breast cancer detection methods, such as mammography and physical examination.

Ductal lavage can be performed by a physician or other trained personnel in a physician’s office or outpatient clinic and takes about 30 minutes to perform. First, an anesthetic cream is applied to the nipple area, followed by gentle suction to the nipple to elicit fluid droplets on the surface of the nipple. A flexible microcatheter (intended for single use) is inserted into a milk duct opening located by the fluid droplets on the nipple. A small amount of anesthetic is infused intraductally, through the catheter. Saline is flushed through the microcatheter to wash (lavage) cells from the breast ducts. The cells are sent to a laboratory for analysis by cytology to detect abnormalities of the epithelial lining of the breast ducts. This may be repeated so that cellular changes can be followed in high-risk women. One of several devices cleared for marketing by the FDA is the FirstCyte Breast Test (Cytyc).

A suction collection system, the HALO NAF 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.

POSITION STATEMENT:

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 is considered experimental or investigational, as there is insufficient clinical evidence to support the use of cytologic analysis of epithelial cells for high-risk patients. Techniques of collecting nipple aspiration fluid include, but are not limited to, ductal lavage and suction. There is insufficient evidence in medical literature regarding the clinical utility and effectiveness of these procedures to permit conclusions on net health outcomes.

BILLING/CODING INFORMATION:

There is no specific CPT or HCPCS code for cytologic analysis of epithelial cells from nipple aspirations to assess breast cancer risk (i.e., ductal lavage and 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:

Atypical hyperplasia: a benign (non-cancerous) condition in which cells have abnormal features and are increased in number.

Gail Index (Risk): uses risk factors such as age, family history, age at first menstrual period, and number of breast biopsies to calculate a woman’s chance of developing breast cancer. Developed by the National Cancer Institute (NCI).

RELATED GUIDELINES:

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

OTHER:

Other names used to report ductal lavage:

Breast Ductal Lavage
Breast Pap Smear

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 (ASBS). Official statement: Ductal Lavage and Cell-Based Risk Assessment, 05/06/07.
  3. 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), 06/08.
  4. 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.
  5. 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.
  6. 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.
  7. ClinicalTrials.gov. Feasibility Study of Evaluating Breast Cancer Patients with Ductal Lavage, sponsored by the University of Michigan, accessed on 05/10/07.
  8. 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.
  9. ECRI Institute, Ductal Lavage and Nipple Aspiration for Identifying Women at High Risk of Breast Cancer, 02/07.
  10. Food and Drug Administration (FDA) 510(k) Summary, Pro-Duct Catheter #K000135, 04/10/00.
  11. Hayes Medical Technology Directory-Breast Ductal Lavage and Fiberoptic Ductoscopy For Breast Cancer Diagnosis and Screening (BREA0203.12), 08/23/04 – 11/07 Update.
  12. National Comprehensive Cancer Network, Inc., Breast Cancer Screening and Diagnosis Practice Guidelines in Oncology, v.1.2009.
  13. Ob/Gyn News (01/16/02), New Guidelines Issued For Ductal Lavage Use, Cancer 2002; 94: 292-298.
  14. 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.
  15. Pro-Duct Health: Ductal Lavage Access The Source of Breast Cancer. Retrieved 03/19/02 from the Internet Web Site.
  16. 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.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 04/30/09.

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.

Date Printed: June 25, 2017: 01:27 PM