RedPath’s PathFinderTG is considered investigational/experimental and therefore, not covered and not eligible for payment.  There is a lack of independent clinically-validated testing of RedPath’s technology involving correlation of RedPath’s PathFinderTG results to patient outcome data.   A participating, preferred, or network provider can bill the member for the denied service.

Description

RedPath Integrated Pathology, Inc. is a pathology services company that integrates traditional pathology practice with molecular genetic analysis.  RedPath provides advanced molecular topographic genotyping utilizing its PathFinder TG process when microscopic analysis and special staining methods cannot provide the needed definitive diagnosis on specimens sent to RedPath by pathologists or laboratories.

PathFinderTG is a molecular DNA-based cancer diagnostic test which obtains a genetic fingerprint of mutations from routine histology and cytology slides as well as fluid samples.  RedPath uses a proprietary process that begins with the microdissection of cells from targeted areas of interest from chemically fixed histology and cytology slides.  RedPath is also able to test acellular fluids. The process incorporates DNA amplification, as well as molecular profiling against a broad panel of mutations (15 to 20 different markers) that include tumor suppressor genes and oncogenes known to be part of the mutational profile for each tumor type. Combined with the morphologic review, PathFinderTG provides a comprehensive analysis and report.   A written summary of the number and type of mutations found, if any, is provided and the temporal sequence of mutation acquisition is described. A diagnosis with detailed commentary, including a summary of the molecular profile of the patient’s specimen, is provided in the context of available clinical history and pathology information.

The physician referring the case(s) to RedPath prepare and sign a request/requisition for RedPath’s PathFinder TG diagnostic assay and indicate the following on the request:

• Date sample/specimen obtained; Date sample/specimen sent to RedPath;
• Place of service where sample/specimen obtained (inpatient hospital, outpatient hospital, Ambulatory Surgical Center, etc.)
• Clinical history and rationale for referring the case for further analysis

As there isn't a specific procedure code or codes to define the PathFinder TG service, claims for these services should be billed utilizing the not otherwise classified code 84999 with the description “PathFinder TG” noted on the claim descriptor for this NOC code. Modifier 90 - Reference (Outside) Laboratory – should be appended to code 84999.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

02/2008, RedPath’s PathFinderTG considered investigational

Determination of Sequential Mutation Accumulation in Pancreas and Bile duct Brushing Cytology, Modern Pathology, Volume 19, 4/2006

Patterns of Allelic Loss of Synchronous Adenocarcinomas of the Lung, American Journal of Surgical Pathology, Volume 29, No. 7, 7/2005

Microdissection-Based Genotyping Assists Discrimination of Reactive Gliosis from Glioma, American Journal of Clinical Pathology, Volume 121, 2004