Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #1:

Diagnosis: chronic diarrhea 

Treatment: Infectious agent detection by nucleic acid (Deoxyribonucleic acid (DNA) or Ribonucleic acid (RNA)); gastrointestinal pathogen (Clostridium difficile, E. (Escherichia) coli, Salmonella, Shigella, norovirus, Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 12-25 targets

The insurer denied coverage for infectious agent detection by nucleic acid (Deoxyribonucleic acid (DNA) or Ribonucleic acid (RNA)); gastrointestinal pathogen (Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 12-25 targets

The denial is upheld

The patient was having abdominal cramps and diarrhea. Previous stool testing was done. The patient remains with episodes of diarrhea, sometimes with bleeding. The physician ordered stool for ova (eggs) and parasites, fecal fat, WBC (white blood cell), Clostridium difficile toxin, calprotectin, and a stool PCR (polymerase chain reaction) for 22 pathogens. The PCR panel was positive for enterotoxigenic E coli (Escherichia coli). The calprotectin was also elevated. 

UpToDate has an article titled "Approach to the adult with chronic diarrhea in resource-rich settings". Stool testing is a recommended part of this workup. Testing for Giardia, clostridium difficile, fecal leukocytes, and fecal calprotectin are advised. The topic of PCR stool testing is addressed under the topic approach to the adult with acute diarrhea in resource-rich settings.The article states that a high degree of clinical correlation is necessary when interpreting results of molecular testing since these assays detect genetic material, which does not always indicate infection with a viable organism. Any specimen that tests positive on a multiplex molecular panel should be submitted for a confirmatory culture. 

This patient has chronic diarrhea and stool testing is advised. However, the PCR testing is not a standard part of the workup for chronic diarrhea. In addition, even for acute diarrhea, it has limitations as compared to doing stool cultures for bacteria and an ova and parasites examination. The scientific evidence does show that PCR testing is a useful test, although confirmatory cultures are still advised according to the UpToDate article. It is a laboratory approved test. However, it has not been shown to be superior to obtaining standard stool cultures. There are no adverse risks to doing the PCR testing but it is advised that if there is a positive test, a stool culture should still be obtained. This patient required testing for bacterial and parasitic infections. However, in view of the need for clinical correlation as well as a confirmatory culture, PCR testing is not the best test for this patient.Therefore, the health care plan acted reasonably and with sound medical judgment. PCR testing is not appropriate. The denial is upheld

In summary, the denial of infectious agent detection by nucleic acid (Deoxyribonucleic acid (DNA) or Ribonucleic acid (RNA)); gastrointestinal pathogen (Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 12-25 targets and coverage for the requested service should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments. 

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for this testing is not substantiated.