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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: 02/27/14

Revised: 11/01/15

Subject: PathFinderTG® Molecular Testing

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:

The patented PathFinderTG® test is a molecular test to be used adjunctively in cases in which a definitive pathologic diagnosis cannot be rendered on a tissue or cytology specimen, either due to inadequate specimen or equivocal histologic or cytologic findings. This approach may be referred to as “molecular anatomic pathology.” RedPath, the test provider, suggests that the PathFinderTG® results provide useful and definitive diagnostic and prognostic information and reliably predict treatment response for multiple organ systems.

The testing involves the following steps:

For some specimens such as fluid aspirates, DNA is extracted from the fluid, since there may be little or no cellular content. The molecular testing consists of applying panels of molecular markers previously defined for each organ system or clinical question.

This patented diagnostic test is available only through RedPath Integrated Pathology (Pittsburgh, PA). The PathFinderTG® Molecular Testing is not subject to review by the U.S. Food and Drug Administration (FDA) because it is a laboratory-developed test (LDT) conducted only at RedPath Integrated Pathology’s licensed laboratory. Laboratories performing LDTs must be licensed for high-complexity testing under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). RedPath is licensed under CLIA.

POSITION STATEMENT:

Molecular testing using the PathFinderTG® is considered experimental or investigational, as there is insufficient clinical evidence to support the use of this test for all indications. There is a lack of scientific evidence regarding the impact of this technology on health outcomes and outcomes with this technology compared with existing alternatives (i.e. incremental value) are not known.

BILLING/CODING INFORMATION:

There is no specific CPT or HCPCS code for PathFinderTG® Molecular Testing.

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® (L31144) located at novitas-solutions.com.

DEFINITIONS:

Microdissection: dissection of tissues under a microscope or magnifying glass, usually done be teasing the tissues apart by means of needles.

Oncogenic: origin and growth of a neoplasm.

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, PathFinderTG® Molecular Testing, 2.04.52, 05/13.
  3. ECRI Institute, Molecular Based Diagnostic Testing Using PathFinderTG, 11/2013.
  4. 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.
  5. Hayes Inc., PathFinderTG® Test (RedPath Integrated Pathology) for the Diagnosis of Pancreatic Cancer, 12/12/07.
  6. Highmark Medicare Services, Provider Bulletin, RedPath – PathFinder TG, 06/26/07, accessed 01/12.
  7. Khalid A, Brugge W, American College of Gastroenterology (ACG), ACG Practice Guidelines for the Diagnosis and Management of Neoplastic Pancreatic Cysts, 10/07.
  8. 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.
  9. Novitas Solutions, LCD L31144: Loss of Heterozygosity Based Topographic Genotyping with PathfinderTG®, 04/12.
  10. 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.
  11. 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.
  12. 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.
  13. 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.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 02/27/14.

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.

Date Printed: October 20, 2017: 02:02 PM