WWW.BOOK.XLIBX.INFO
FREE ELECTRONIC LIBRARY - Books, abstracts, thesis
 
<< HOME
CONTACTS

«MEDICAL POLICY SUBJECT: BREAST EPITHELIAL CELL EFFECTIVE DATE: 09/19/01 COLLECTION FOR CYTOLOGIC REVISED DATE: 10/16/02, 09/18/03, 08/19/04, ...»

MEDICAL POLICY

SUBJECT: BREAST EPITHELIAL CELL EFFECTIVE DATE: 09/19/01

COLLECTION FOR CYTOLOGIC REVISED DATE: 10/16/02, 09/18/03, 08/19/04, 07/21/05,

ANALYSIS 08/17/06, 08/16/07, 08/21/08

ARCHIVED DATE: 07/16/09

EDITED DATE: 07/15/10, 7/21/11, 07/19/12, 07/18/13,

POLICY NUMBER: 7.01.50 05/22/14, 05/28/15, 03/17/16 CATEGORY: Technology Assessment PAGE: 1 OF: 4

• If a product excludes coverage for a service, it is not covered, and medical policy criteria do not apply.

• If a commercial product, including an Essential Plan product, covers a specific service, medical policy criteria apply to the benefit.

• If a Medicare product covers a specific service, and there is no national or local Medicare coverage decision for the service, medical policy criteria apply to the benefit.

POLICY STATEMENT:

Based upon our criteria and the lack of published peer-reviewed literature, breast duct lavage and collection of epithelial cells via suction have not been medically proven to be effective and are considered investigational in the risk stratification of patients at high risk for breast cancer and in the diagnosis of breast cancer as the influence on patient management and effect on treatment outcomes has not yet been determined.

Refer to Corporate Medical Policy# 11.01.03 regarding Experimental and Investigational Services.

POLICY GUIDELINES:

The Federal Employee Health Benefit Program (FEHBP/FEP) requires that procedures, devices or laboratory tests approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational and thus these procedures, devices or laboratory tests may be assessed only on the basis of their medical necessity.

DESCRIPTION:

Evaluation of breast duct epithelial cells is proposed as a technique to assess breast cancer risk and as a diagnostic tool for detecting breast cancer. Various techniques for collecting epithelial cells for cytologic analysis have been investigated.

Breast duct lavage, or ductal lavage, is a technique described for use in diagnosing and assessing risk in patients at high risk for developing breast cancer. Breast duct lavage involves identification of the nipple aspirate fluid (NAF) obtained from mammary ducts via nipple aspiration. Using a microcatheter, inserted into the natural nipple opening of the individual mammary ducts, saline is infused and the ductal fluid is withdrawn. The fluid is then analyzed microscopically for cytologic abnormalities. Breast duct lavage is performed using the FirstCyte Breast Test.

The HALO™ Breast Pap Test, by Neomatrix, is a suction system that collects ductal epithelial cells by placing a cup on the breast, warming the breast, and applying suction to bring NAF to the surface. The NAF can then be analyzed for cytologic abnormalities.

Both breast duct lavage and NAF collection may be referred to as a “breast pap smear”.

RATIONALE:

Ductal lavage: The components of the system used for breast duct lavage, the FirstCyte AspiratorTM, FirstCyte E.Z® MicroCatheter, and MicroDilator have received FDA approval for marketing. There are no prospective data evaluating risk when sampling for cytologic hyperplasia is performed by ductal lavage. The effect of greater prevalence of atypia from ductal lavage on risk estimates is unknown. No studies have used ductal lavage to influence patient management for those whose management was determined by the results of routine surveillance versus surveillance plus epithelial cell cytology analysis. Whether cytologic atypia, or the lack thereof, influences patient management and improves patient outcomes has not been demonstrated in the investigational setting and is unknown.

–  –  –

Proprietary Information of Excellus Health Plan, Inc.

SUBJECT: BREAST EPITHELIAL CELL EFFECTIVE DATE: 09/19/01 COLLECTION FOR CYTOLOGIC REVISED DATE: 10/16/02, 09/18/03, 08/19/04, 07/21/05, ANALYSIS 08/17/06, 08/16/07, 08/21/08 ARCHIVED DATE: 07/16/09 EDITED DATE: 07/15/10, 7/21/11, 07/19/12, 07/18/13, POLICY NUMBER: 7.01.50 05/22/14, 05/28/15, 03/17/16 CATEGORY: Technology Assessment PAGE: 4 OF: 4 Filassi JR, et al. Can breast nipple fluid collected with automated aspiration and preserved in based-liquid solution improve the cytological samples? Acta Cytol 2013;57(3):276-80.

Francescatti DS, et al. Ductal lavage in the high-risk patient. Am J Surg 2005 Mar;189(3):340-1.

Hartman AR, et al. Breast magnetic resonance image screening and ductal lavage in women at high genetic risk for breast carcinoma. Cancer 2004 Feb 1;100(3):479-89.

Jacobs L, et al. Intraductal therapy for the prevention of breast cancer. Curr Opin Investig Drugs 2010 Jun;11(6):646-52.

Johnson-Maddux A, et al. Reproducibility of cytologic atypia in repeat nipple duct lavage. Cancer 2005 Mar 15;103(6):1129-36.

Johnson-Maddux A, et al. Patient and duct selection for nipple duct lavage. Am J Surg 2004 Oct;188(4):390-4.

Khan SA, et al. Ductal lavage findings in women with known breast cancer undergoing mastectomy. J Natl Cancer Inst 2004 Oct 20;96(20):1510-7.

Kurian AW, 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.

National Cancer Institute. Breast cancer screening (PDQ®). Updated 2016 Jan 8 [http://www.cancer.gov/types/breast/hp/breast-screening-pdq] accessed 2/1/16.

National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology™: Breast cancer screening and diagnosis guidelines. v.1. 2014. Last updated 2015 Jul 15 [http://www.nccn.org/professionals/physician_gls/PDF/breastscreening.pdf] accessed 2/1/16.

Patil DB, et al. Reproducibility of ductal lavage cytology and cellularity over a six month interval in high risk women.

Breast Cancer Res Treat 2008 Nov;112(2):327-33.

Proctor KA, et al. Cytologic features of nipple aspirate fluid using an automated non-invasive collection device: a prospective observational study. BMC Women’s Health 2005 Aug 3;5 [http://www.biomedcentral.com/1472-6874/5/10] accessed 11/16/05.

KEY WORDS:

Breast duct lavage, Breast Pap smear, Ductal lavage, Halo™ Breast Pap Test.

CMS COVERAGE FOR MEDICARE PRODUCT MEMBERS

Based on our review, breast duct lavage and collection of epithelial cells by suction is not addressed in National or Local Medicare coverage determinations or policies.

–  –  –





Similar works:

«JPET Fast Forward. Published on January 24, 2006 as DOI: 10.1124/jpet.105.097121 JPET Fast article has notPublished on January 24, final versionDOI:10.1124/jpet.105.097121 This Forward. been copyedited and formatted. The 2006 as may differ from this version. JPET #97121 Protease-activated receptor-2 peptides activate neurokinin-1 receptors in the mouse isolated Downloaded from jpet.aspetjournals.org at ASPET Journals on May 26, 2016 trachea HUGH T. ABEY, DAVID P. FAIRLIE, JAMES D. MOFFATT,...»

«ASU in the News 9/26/07-10/2/07 ASU in the News Table of Contents: 09/20/2007 ASU prof hopes to wire brains for leadership............. 4 SOURCE: The Wall Street Journal, New York, NY Article Images for ASU prof hopes to wire brains for leader. 5 09/25/2007 ASU study: Germs get stronger in space................ 11 SOURCE: Chicago Sun-Times, Chicago, IL Article Image for ASU study: Germs get stronger in space... 12 09/28/2007 ASU scientists recaluculate date of...»

«Prognosis after Aortic Valve Replacement with Mechanical Valves and Bioprostheses Use of Meta-analysis and Microsimulation John P. A. Puvimanasinghe ISBN: 90-77595-21-X © 2004, J.P.A. Puvimanasinghe All rights reserved. No part of this thesis may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording or by any other information storage or retrieval system, without written permission from the author. Cover: Prosthetic aortic valve...»

«Homelessness, Housing, and Health Geography: The Impact of Housing on the Health of Chronically Ill Homeless Adults A DISSERTATION SUBMITTED TO THE FACULTY OF THE GRADUATE SCHOOL OF THE UNIVERSITY OF MINNESOTA BY Dawn Petroskas IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF DOCTOR OF PHILOSOPHY Dr. Joan Liaschenko August, 2011 © Dawn Petroskas, 2011 i Acknowledgements A thousand thanks to: The Minnesota Nurses Association Foundation, for funding my research. Dr. Gavin Andrews,...»

«Centre For Computing Services (CCS) Computer Training Courses Introduction Welcome to the training course brochure produced by the Centre for Computing Services. What is available? A range of different courses will be offered. Some of these are designed to introduce you to basic IT skills, others to develop the skills which you already have, and others are designed to assist you in using different technologies to find and use information – please see the descriptions for more information...»

«Klinik für Herzund Kreislauferkrankungen Technische Universität München Deutsches Herzzentrum München (Direktor: Univ. -Prof. Dr. A. Schömig) Interaktion coxsackieviraler Proteasen mit dem kardioprotektiven Interleukin-6-Typ-Signaltransduktionsweg Christian Bradaric Vollständiger Abdruck der von der Fakultät für Medizin der Technischen Universität München zur Erlangung des akademischen Grades eines Doktors der Medizin (Dr. med.) genehmigten Dissertation. Vorsitzender: Univ. -Prof. Dr....»

«University of Pennsylvania School of Social Policy & Practice (SP2) Extramural Study Student Manual November 1, 2007 Table of Contents Page Important Phone Numbers and Web Sites.. 2 Penn Policies for Study Abroad.. 2 Health Information Form and Physician’s Statement.. 3 Students Under Disciplinary Sanctions.. 4 Statement on Security Issues Related to Travel and Study.. 4 Accommodations.. 5 Local Transportation.. 5 Rail Passes... 6 Documents... 6 Passports... 6 Visa/Entry Documents...»

«ELIA D. TAIT WOJNO, PH.D. James A. Baker Institute for Animal Health Department of Microbiology and Immunology College of Veterinary Medicine Cornell University 235 Hungerford Hill Road, Room 135 Ithaca, NY 14853 Telephone: 607 256 5635 Email: elia.taitwojno@cornell.edu CURRENT POSITION • Assistant Professor, Cornell University, College of Veterinary Medicine, Baker Institute for Animal Health, Department of Microbiology and Immunology, Ithaca, NY. Dissecting the contribution of innate immune...»

«0 PLACE MATTERS for Education in Orleans Parish: A Community Health Equity Report on Educational Policies The contents of this 2014 Orleans Parish Place Matters report reflect the views of the authors and do not necessarily reflect the views of the National Urban League, the Urban League of Greater New Orleans, or the National Collaborative for Health for Health Equity, the Center on Human Needs at the Virginia Commonwealth University, and the Virginia Network for Geospatial Health Research....»

«Transformative Professional Development Tool in Infant Mental Health: Reflective Practice Shelley Neilsen Gatti, Ph.D, University of St. Thomas & Christopher Watson, Ph. D, IMH-E® (IV), University of Minnesota DEC Conference, 2011 A day in the life of an early interventionist When early interventionist, Kelly, drives up to the apartment she tells herself, “It’s okay, I can do this.” Then she gets out of her car, grabs her bag and walks to the door. Dominic, an engaging 18-month old with...»

«Viruses 2013, 5, 902-927; doi:10.3390/v5030902 OPEN ACCESS viruses ISSN 1999-4915 www.mdpi.com/journal/viruses Article Lost in Transcription: Molecular Mechanisms that Control HIV Latency Ran Taube 1,* and Boris Matija Peterlin 2,3 The Shraga Segal Department of Microbiology Immunology and Genetics, Faculty of Health Sciences, Ben-Gurion University of the Negev, P.O. Box 653, Beer-Sheva, 84105, Israel Department of Medicine, Microbiology and Immunology, Rosalind Russell Medical Research Center,...»

«JPET Fast Forward. Published on November 28, 2006 as DOI: 10.1124/jpet.106.114165 JPET Fast Forward. Published on and formatted. The final version may differ from this version. This article has not been copyedited November 28, 2006 as DOI:10.1124/jpet.106.114165 JPET #114165 Title Page SECOISOLARICIRESINOL DIGLUCOSIDE (SDG): RELEVANCE TO ANGIOGENESIS AND CARDIOPROTECTION AGAINST ISCHEMIA-REPERFUSION INJURY Downloaded from jpet.aspetjournals.org at ASPET Journals on May 25, 2016 Suresh Varma...»





 
<<  HOME   |    CONTACTS
2016 www.book.xlibx.info - Free e-library - Books, abstracts, thesis

Materials of this site are available for review, all rights belong to their respective owners.
If you do not agree with the fact that your material is placed on this site, please, email us, we will within 1-2 business days delete him.