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Date Printed: December 17, 2017: 04:38 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.

05-86000-27

Original Effective Date: 07/15/08

Reviewed: 10/31/17

Revised: 11/15/17

Subject: Topographic Genotyping

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:

Topographic genotyping (TG), also called molecular anatomic pathology, integrates microscopic analysis (anatomic pathology) with molecular tissue analysis. Under microscopic examination of tissue and other specimens, areas of interest may be identified and microdissected to increase tumor cell yield for subsequent molecular analysis. Topographic genotyping may permit pathologic diagnosis when first-line analyses are inconclusive.

Interpace Diagnostics (previously known as RedPath Integrated Pathology) has patented a proprietary platform called PathFinderTG. It provides mutational analyses of patient specimens and the patented technology permits analysis of tissue specimens of any size and any age. Interpace offers two tests that use the PathFinderTG platform: PancraGEN and BarreGEN. These molecular tests are intended to be used adjunctively when a definitive pathologic diagnosis cannot be made, because of the inadequate specimen or equivocal histologic or cytologic findings, to inform appropriate surveillance or surgical strategies.

POSITION STATEMENT:

Topographic genotyping (eg, PathFinderTG® -BarreGEN, PancraGEN) is considered experimental or investigational for all indications including the evaluation of pancreatic cyst fluid and Barrett esophagus. 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 topographic genotyping.

REIMBURSEMENT INFORMATION:

None applicable.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products:

The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Loss of Heterozygosity Based Topographic Genotyping with PathfinderTG® (L34864) located at novitas-solutions.com.

DEFINITIONS:

None applicable.

RELATED GUIDELINES:

None applicable.

OTHER:

None applicable.

REFERENCES:

  1. Agency for Healthcare Research and Quality. Technology Assessment – A systematic Review of Topographic Genotyping with PathFinderTG®, 03/01/10.
  2. Blue Cross Blue Shield Association Medical Policy Reference Manual 2.04.52 Molecular Testing for the Management of Pancreatic Cysts or Barrett Esophagus, 07/17.
  3. ClinicalTrials.gov, The Clinical, Radiologic, Pathologic and Molecular Marker Characteristics of Premalignant and Malignant Pancreatic Cysts Study, sponsored by Johns Hopkins University; accessed 10/02/17.
  4. ClinicalTrials.gov, Biomarker Analysis of Central Nervous System Tumors, sponsored by National Cancer Institute (NCI); accessed 10/02/17.
  5. ECRI Institute, Molecular Based Diagnostic Testing Using PathFinderTG, 11/2013.
  6. Finkelstein SD, et al, Natural History of Pancreatic Mucinous Cystic Neoplasms, Journal of Clinical Oncology, 2010 ASCO Annual Meeting, Vol 28, No 15 Supplement, 2010: e21115.
  7. Hayes Inc., PathFinderTG® Test (RedPath Integrated Pathology) for the Diagnosis of Pancreatic Cancer, 12/12/07.
  8. Khalid A, Brugge W, American College of Gastroenterology (ACG), ACG Practice Guidelines for the Diagnosis and Management of Neoplastic Pancreatic Cysts, 10/07.
  9. Locker G, Hamilton S, Harris J, et al., American Society of Clinical Oncology 2006 Update of Recommendations for the Use of Tumor Markers in Gastrointestinal Cancer, accessed at asc.org on 02/12/10.
  10. National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology: central nervous system cancers, Version 1.2017; accessed at nccn.org 10/03/17.
  11. National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology: esophageal and esophagogastric junction cancers, Version 1.2017; accessed at nccn.org 10/03/17.
  12. National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology: hepatobiliary cancers, Version 2.2017; accessed at nccn.org 10/03/17.
  13. National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology: pancreatic adenocarcinoma, Version 2.2017; accessed at nccn.org 10/03/17.
  14. Novitas Solutions, Inc. Local Coverage Determination (LCD): LossofHeterozygosity Based Topographic Genotyping with PathfinderTG® (L34864), accessed at novitas-solutions.com.
  15. Sawhney MS, Devarajan S, O’ Farrel P, et al, Comparison of Carcinoembryonic Antigen and Molecular Analysis in Pancreatic Cyst Fluid, Gastrointest Endosc. 2009; 69(6): 1106-10.
  16. Shaheen NJ, Falk GW,et al. ACG Clinical Guideline: diagnosis and management of Barrett's esophagus. Am J Gastroenterol. Jan 2016;111(1):30-50; quiz 51.
  17. Shen J, Brugge WR, Dimaio CJ, Pitman MB, Molecualr Analysis of Pancreatic Cyst Fluid: A Comparative Analysis with Current Practice of Diagnosis, Cancer Cytopathol. 2009 Jun 25;117(3): 217-27.
  18. Smith DM, et al, Comparison of Microscopic Versus Molecular Approaches in Classifying the Relatedness of Synchonous and Metachronous Cancers, Journal of Clinical Oncology, 2010 ASCO Annual Meeting, Vol 28, No 15 Supplement, 2010: e21091.
  19. Sreenarasimhaiah J, et al, A Comparative Analysis of Pancreas Cyst fluid CEA and Histology with DNA Mutational Analysis in the Detection of Mucin Producing or Malignant Cysts, Journal of the Pancreas, 2009 Mar 9; 10(2): 163-168.
  20. Vege SS, Ziring B, et al. American Gastroenterological Association institute guideline on the diagnosis and management of asymptomatic neoplastic pancreatic cysts. Gastroenterology. Apr 2015;148(4):819-822;quize812-813.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 10/31/17.

GUIDELINE UPDATE INFORMATION:

07/15/08

New Medical Coverage Guideline.

06/15/09

Annual review: position statement maintained, and references updated.

04/15/10

Annual review: position statement maintained, and the description and references updated.

03/15/11

Annual review: position statement maintained and references updated.

03/15/12

Annual review; position statement maintained and references updated.

03/15/13

Annual review; position statement maintained, program exception section and references updated.

03/15/14

Annual review; position statement maintained; Medicare program exception and references updated.

11/01/15

Revision: ICD-9 Codes deleted.

11/15/17

Review; investigational position maintained; title, description section, position statement, and references updated.

Date Printed: December 17, 2017: 04:38 PM