Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #2:

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 overturned

According to medical records, patient is an adult with past medical history significant for migraines who was evaluated for complaints of diarrheal illness.

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

Advances in PCR (polymerase chain reaction) technology has led to significant changes in diagnosis of viral, bacterial, and/or other infectious agents. The Food and Drug Administration (FDA) has approved several Gastrointestinal (GI) panels that currently are being utilized for more rapid diagnosis. These panels allow for the detection and identification of up to 20 pathogens in as little as one hour. 

According to the 2017 Infectious Diseases Society of America (IDSA) guidelines on management of Infectious Diarrhea, regarding what is the optimal specimen (eg, stool, rectal swab, blood) for maximum yield of bacterial, viral, and protozoal organisms (for culture, immunoassay, and molecular testing). Their recommendation includes that "Molecular techniques generally are more sensitive and less dependent than culture on the quality of specimen."

Based on above findings, including IDSA guidelines, FDA approval, and other studies suggesting gastrointestinal profile stool PCR test, despite some limitations, are an acceptable and perhaps even cost-effective diagnostic option for patients with chronic diarrhea. 

Prior determination of denial of coverage for infectious agent detection by nucleic acid (DNA or RNA) gastrointestinal pathogen, is overturned.

In summary, the denial of infectious agent detection by nucleic acid (DNA or 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 overturned. This treatment is 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 overturned. 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 substantiated.