Appeal type: Experimental/Investigational
Decision: Overturned


Diagnosis: Diarrhea.
Treatment: gastrointestinal pathogen panel stool testing.
The insurer denied coverage for gastrointestinal pathogen panel stool testing.
The denial is overturned.

The patient is a male with a past medical history significant for gastroesophageal reflux disease, thrombocytopenia, anxiety disorder, and mild depression who was evaluated by an internal medicine specialist for complaints of diarrhea, lightheadedness, headache, stomach cramps, bloating, and nausea. Coverage of gastrointestinal pathogen PCR (polymerase chain reaction) stool panel is requested.

Nucleic acid probes are available for the identification of a wide variety of microorganisms, offering more rapid identification than standard cultures. Nucleic acid probes can also be used to quantitate the number of microorganisms present. This technology offers advantages over standard techniques when rapid identification is clinically important. 	

The evidence for the use of a nucleic acid-based gastrointestinal pathogen panel in individuals with signs and/or symptoms of gastroenteritis includes prospective and retrospective evaluations of the tests' sensitivity and specificity. Relevant outcomes include test accuracy and validity, overall survival, and change in disease status. The evidence suggests that these panels are likely to identify both bacterial and viral pathogens with high sensitivity, compared with standard methods. Access to a rapid method for etiologic diagnosis of gastrointestinal infections may lead to more effective early treatment and infection control measures. However, in most instances, when there is suspicion of a specific pathogen, individual tests could be ordered. There may be a subset of patients with an unusual presentation who would warrant testing for a panel of pathogens at once, but that subset has not been well-defined. The evidence is insufficient to determine the effects of the technology on health outcomes. 	
 	 	 		
Classically, the identification of microorganisms relied either on the culture of body fluids or tissues or the identification of antigens, using a variety of techniques including direct fluorescent antibody technique and qualitative or quantitative immunoassays.
These techniques are problematic when the microorganism exists in very small numbers or is technically difficult to culture. Indirect identification of microorganisms by immunoassays for specific antibodies reactive with the microorganism is limited by difficulties in distinguishing between past exposure and current infection.
			
Access to a rapid method for etiologic diagnosis of gastrointestinal infections may lead to more effective early treatment and infection-control measures. However, in some instances, when there is suspicion of a specific pathogen, individual tests could be ordered. There is a subset of patients with a presentation that warrants testing for a panel of pathogens at once, but that subset has not been well defined for all patients.

The scientific literature does support the use of PCR testing before obtaining routine stool culture and examination for ova and parasites. The PCR panel has FDA (food and drug administration) approval. The patient is a good candidate for this test, and it is the best available treatment. The adverse risks are not increased. PCR testing is likely to be more beneficial as compared to routine stool cultures and examination for ova and parasites. 

The carrier's denial of gastrointestinal pathogen panel stool testing should be overturned.