Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Hives, Irritable Bowel Syndrome.
Treatment: Gastrointestinal pathogen panel.
The insurer denied the gastrointestinal pathogen panel.
The determination is upheld.

This patient with known irritable bowel syndrome presented with hives. The attending provider ordered the Gastrointestinal (GI) Panel to determine if the patient's hives were due to an infectious pathogen. The patient notes in a letter that in the week or two prior to her appointment, she experienced consistent diarrhea which she brought up with her physician. At issue is whether the proposed health service or treatment gastrointestinal pathogen panel is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The proposed health service or treatment gastrointestinal pathogen panel was not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The GI panel is not used to evaluate the etiology of hives in patients and even if she had diarrhea, the GI panel is not recommended as opposed to traditional stool studies. Based on current evidence the GI Panel may be used as adjunct to traditional methods for testing stool for pathogens. There is insufficient evidence to support the routine use of multiplex testing for enteric pathogens in all patients presenting with diarrhea since these tests frequently detect microbes at non-pathogenic levels. Moreover, some of the pathogens detected in this "catch all" test have no specific treatment options. If Clostridium (C) difficile infection was suspected in this patient, then stool for C Difficile Toxin A & B would have been adequate rather than the GI Panel.
The Gastrointestinal Panel is a 19plex laboratory-developed gastrointestinal pathogen panel (GPP) using analyte-specific reagents (ASRs) to simultaneously screen directly in fecal specimens for diarrhea-causing pathogens, including bacteria (Campylobacter jejuni, Salmonella species (spp.), Shigella spp., enterotoxigenic Escherichia coli [ETEC], Shiga toxin-producing Escherichia (E) coli [STEC], E. coli O157:H7, Vibrio cholerae, Yersinia enterocolitica, and toxigenic Clostridium difficile), parasites (Giardia lamblia, Cryptosporidium spp., and Entamoeba histolytica), and viruses (norovirus GI and GII, adenovirus 40/41, and rotavirus A).
Although the gastrointestinal panel offers acceptable sensitivity and moderate agreement with conventional microbiological methods, cost-benefit studies should be performed before introducing this method into algorithms for microbiological diagnostics. Moreover, while the ability to cover for a broad spectrum of GI pathogens in a single test is an appealing advantage of multiplex technology, the impact of multiplex tests on the management and treatment of patients with GI illness is still unclear, as no standard therapy exists for some of the pathogens represented on these panels. A potential drawback of molecular technologies is the need to predefine the particular microbes being sought. In addition, the significance of an identified organism may not be clear as these molecular technologies, which involve nucleic acid amplification, are limited to existing knowledge of a microbes' genome and do not discriminate between viable and non-viable organisms. As a result, they can detect microbes at non- pathogenic levels. Because of the high rates of asymptomatic carriage of enteropathogens, this can be a considerable problem. To confound matters, further multiplex techniques are more commonly associated with increased detection of mixed infections and the relative importance of each pathogen may be unclear.
Based on the clinical data provided, the GI panel in this patient was not medically necessary, particularly since the patient requested this test since she believed that her hives could be due to her irritable bowel syndrome (IBS) and the medical records provided including the review of symptoms do not list diarrhea, abdominal pain, nausea or vomiting as any of her presenting symptoms.