OUTPATIENT GASTROINTESTINAL PATHOGEN PANEL (RECOMMEND PREAUTHORIZATION)

V.49





V.49 OUTPATIENT GASTROINTESTINAL PATHOGEN PANEL (RECOMMEND PREAUTHORIZATION)


Policy

I.  The use of nucleic acid testing using a direct or amplified probe technique with or without quantification of viral load for Gastrointestinal (GI) Pathogen Panel is considered scientifically validated when performed in the inpatient setting. 

II.  GI Pathogen Panel done in all other settings including but not limited to, emergency department, office visits, and all other outpatient settings is considered investigational.



Dates

  • Original Effective
    01-01-2020
  • Last Review
    08-07-2024
  • Next Review
    08-11-2025

Description

For individuals who have signs and/or symptoms of gastroenteritis who receive nucleic acid-based gastrointestinal pathogen panel, the evidence includes prospective and retrospective evaluations of the tests' sensitivity and specificity.  Relevant outcomes include test accuracy and validity, other test performance measures, symptoms, and change in disease status. The evidence suggests that gastrointestinal pathogen 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 a specific pathogen is suspected, 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. 

Tests performed by nucleic acid amplified probe techniques uses a microorganism's DNA or RNA to directly identify specific bacteria, viruses, and/or protozoa rather than standard microorganism detection techniques such as bacterial culture, microscopy with and without stains, direct fluorescent antibody testing, rapid antigen testing, qualitative and quantitative immunoassay for identification of antigens or toxins from stool and single-plex PCR assays.



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Diagnosis

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Codes

      
          Full Description
            Gastrointestinal pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 22 targets (Campylobacter [C. jejuni/C. coli/C. upsaliensis], Clostridium difficile [C. difficile] toxin A/B, Plesiomonas shigelloides, Salmonella, Vibrio [V. parahaemolyticus/V. vulnificus/V. cholerae], including specific identification of Vibrio cholerae, Yersinia enterocolitica, Enteroaggregative Escherichia coli [EAEC], Enteropathogenic Escherichia coli [EPEC], Enterotoxigenic Escherichia coli [ETEC] lt/st, Shiga-like toxin-producing Escherichia coli [STEC] stx1/stx2 [including specific identification of the E. coli O157 serogroup within STEC], Shigella/Enteroinvasive Escherichia coli [EIEC], Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia [also known as G. intestinalis and G. duodenalis], adenovirus F 40/41, astrovirus, norovirus GI/GII, rotavirus A, sapovirus [Genogroups I, II, IV, and V])
      
          Full Description
            Infectious agent detection by nucleic acid (DNA and RNA), gastrointestinal pathogens, 31 bacterial, viral, and parasitic organisms and identification of 21 associated antibiotic-resistance genes, multiplex amplified probe technique
      
          Full Description
            INFECTIOUS AGENT DETECTION BY NUCLEIC ACID (DNA OR RNA); GASTROINTESTINAL PATHOGEN (EG, CLOSTRIDIUM DIFFICILE, E. COLI, SALMONELLA, SHIGELLA, NOROVIRUS, GIARDIA), INCLUDES MULTIPLEX REVERSE TRANSCRIPTION, WHEN PERFORMED, AND MULTIPLEX AMPLIFIED PROBE TECHNIQUE, MULTIPLE TYPES OR SUBTYPES, 3-5 TARGETS
      
          Full Description
            INFECTIOUS AGENT DETECTION BY NUCLEIC ACID (DNA OR RNA); GASTROINTESTINAL PATHOGEN (EG, CLOSTRIDIUM DIFFICILE, E. COLI, SALMONELLA, SHIGELLA, NOROVIRUS, GIARDIA), INCLUDES MULTIPLEX REVERSE TRANSCRIPTION, WHEN PERFORMED, AND MULTIPLEX AMPLIFIED PROBE TECHNIQUE, MULTIPLE TYPES OR SUBTYPES, 6-11 TARGETS
      
          Full Description
            INFECTIOUS AGENT DETECTION BY NUCLEIC ACID (DNA OR RNA); GASTROINTESTINAL PATHOGEN (EG, 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




References

2018

Beal S, Tremblay E, Toffel S, et al. A Gastrointestinal PCR Panel Improves Clinical Managment and Lowers Health Care Costs. Journal of Clinical Microbiology. 2018 January;56(1):1-9.
2013

Caliendo A, Gilbert D, Ginocchio C, et al. Better Tests, Better Care: Improved Diagnostics for Infectious Disease. Improved Infectious Diseases Diagnostics. 2013;57(S3):S139-70.
2017

Freeman K, Tsertsvadze A, Taylor-Phillips S, et al. Agreement between gastrointestinal panel testing and standard microbiology methods for detecting pathogens in suspected infectious gastroenteritis: Test evaluation and meta-analysis in the absence of a reference standard. PLOS ONE. 2017 March 2:1-16.
2015

Palavecino E.One Sample, Multiple Results: The Use of Multiplex PCR for Diagnosis of Infectious Syndromes. AACC. 2015:1-7.
2014

Biswas J, Al-Ali A, Rajput P, et al. A parallel diagnostic accuracy study of three molecular panels for the detection of bacterial gastroenteritis. Eur J Clin Microbiol Infect Dis. 2014;33:2075-2081.
2014

Khare T, Espy M, Cebelinski E, et al. Comparative Evaluation of Two Commercial Muliplex Panels for Detection of Gastrontestinal Pathogens by use of Clinical Stool Specimens. Journal of Clinical Microbiology . 2014 October;52(10):3667-3673.
2014

Jiang Y, Fang L, Shi X, Zhang H, et al. Simultaneous Detection of Five Enteric Viruses Associated with Gastroenteritis by Use of a PCR Assay: a Single Real-Time Muliplex Reaction and Its Clinical Application. Journal of Clinical Microbiology. 2014 April;52(4):1266-1268.

Revisions

03-06-2023

Added new code for 04/01/2023:  0369U