Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Pancreatic cyst.
Treatment: Topographic Genotyping (cpt 81479).
The insurer denied the Topographic Genotyping (cpt 81479).
The denial is upheld. 

The patient is a female patient. She had a pancreatic cyst identified on imaging studies.  The patient underwent a drainage procedure. As part of the evaluation, the fluid drained was sent for topographical analysis. The plan declined coverage, as it deems this service to be experimental/investigational in nature.

No, the health plan should not cover the Topographic Genotyping.
Pathfinder TG (topographic genotyping) is a promising technology, but credible medical evidence is lacking. It should be considered experimental.  This test has not been proven effective in peer-reviewed medical journals or other credible sources.

The PancraGen [formerly PathFinderTG (RedPath Integrated Pathology, Pittsburgh, PA)], also known as topographic genotyping, is described by the manufacturer as a quantitative genetic mutational analysis platform for resolving "indeterminate, atypical, suspicious, equivocal and non-diagnostic specimen" diagnoses from pathology specimens (9). The manufacturer states that PancraGen  [PathFinder TG] "focuses on acquired mutational damage rather than inherited genetic predisposition for certain diseases, although there are certain NIH [National Institutes of Health] recommended inherited conditions for which we do test."  The manufacturer states that the temporal sequence of acquired mutational damage revealed by the PancraGen [PathFinderTG] test is an earlier demonstration of tumor biological aggressiveness than current staging systems that rely on the depth of invasion already achieved by the tumor.  Available published evidence for topographic genotyping focuses on retrospective analyses of pathology specimens examining correlations of test results with tumor. There are no prospective clinical outcome studies on the use of topographic genotyping in guiding patient management.

The patient in this case underwent diagnostic studies, which identified a pancreatic cyst. The patient underwent an EUS (endoscopic ultrasound) with drainage. The standard approach to the management of the cyst aspirate would be "Assessment of cyst mucin and CEA [carcinoembryonic antigen] [which] are complementary, with the best profile obtained when both markers are determined along with cytology. This combination provides a good sensitivity, PPV [positive predictive value], and NDLR  [negative diagnostic likelihood ratio], as well as reasonable PPV [positive predictive value], and [positive diagnostic likelihood ratio]." (6)

As there are no prospective clinical studies on the use of topographic genotyping in guiding patient management. Current evidence-based guidelines from leading medical professional organizations do not include recommendations for topographic genotyping. At this time, the topographic genotyping (PathFinderTG), also known as RedPath Integrated Pathology is investigational and therefore not medically appropriate, as it is experimental/investigational for this patient's condition.

No, the Topographic Genotyping is not likely to be more beneficial.
Current evidence-based guidelines from leading medical professional organizations do not include recommendations for topographic genotyping.