Centene GI pathogen panels Coverage Update

Coverage and Medical Necessity Criteria

Syndromic Multiplex GI Panel (<=11 targets)

Medically necessary when ALL of the following are met:

setting and intent: Member presents in the outpatient setting with suspected infectious gastroenteritis AND results will influence clinical management

clinical indications (>=1): At least one of: immunocompromised status (e.g., HIV/AIDS, immunosuppression therapy, primary immunodeficiency); recent travel to or contact with travelers from an infectious diarrheal disease–endemic area; dysentery (blood or mucus in stool); fever; dehydration; abdominal pain/tenderness; bacteremia; diarrhea persisting longer than 7 days; symptoms of enteric fever (Typhoid/paratyphoid)

frequency: Testing limited to once per incident of diarrheal disease, or no more than once per 14-day period

Syndromic Multiplex GI Panel (>=12 targets)

Medically necessary when ALL of the following are met:

setting and intent: Member presents in the outpatient setting with suspected infectious gastroenteritis AND results will influence clinical management

clinical indications (>=1): At least one of: immunocompromised status (e.g., HIV/AIDS, immunosuppression therapy, primary immunodeficiency); recent travel to or contact with travelers from an infectious diarrheal disease–endemic area; bacteremia; symptoms of enteric fever (Typhoid/paratyphoid)

frequency: Testing limited to once per incident of diarrheal disease, or no more than once per 14-day period

H. pylori Urea Breath or Stool Antigen Testing

Medically necessary when ANY of the following groups are met:

Group A - direct indications: Active peptic ulcer disease (PUD); low-grade gastric MALT lymphoma; history of endoscopic resection of early gastric cancer (EGC)

Group B - past PUD: Past history of PUD AND previous cure of H. pylori infection has NOT been documented

Group C - dyspepsia: Dyspepsia AND member is younger than 60 years AND does NOT have dyspepsia alarm features AND has NOT undergone previous investigation for dyspepsia (uninvestigated)

Group D-F - other indications: Initiating prophylactic low-dose aspirin; initiating chronic NSAID therapy; unexplained iron deficiency anemia despite appropriate evaluation; adult with idiopathic thrombocytopenic purpura (ITP)

H. pylori Antibody Testing

Antibody tests: H. pylori antibody tests are considered investigational for all indications

Syndromic/Multiplex GI Pathogen Panels — policy update

Policy stance updated for certain multiplex panels

Syndromic/Multiplex GI Pathogen Panels (<=11 targets): Changed policy statement to state panels with 11 or fewer targets are considered medically necessary<=11 targets

Detail and full clinical criteria are documented in the policy coverage criteria sections

Syndromic/multiplex gastrointestinal pathogen panels and Helicobacter pylori diagnostic assays are covered only when the specific medical necessity criteria in this policy are met. Syndromic/multiplex GI panels with 11 or fewer targets are considered medically necessary for outpatient suspected infectious gastroenteritis when the member presents in the outpatient setting, results will influence clinical management, and at least one listed clinical indication is present (for example, immunocompromise, recent travel to an endemic area, dysentery, fever, dehydration, abdominal pain/tenderness, bacteremia, diarrhea >7 days, or symptoms of enteric fever). H. pylori testing by urea breath or stool antigen is considered medically necessary only for the specific indications listed (for example, active PUD, low-grade gastric MALT lymphoma, history of endoscopic resection of early gastric cancer, unconfirmed past PUD, uninvestigated dyspepsia in patients <60 without alarm features, initiation of prophylactic low-dose aspirin or chronic NSAID therapy, unexplained iron deficiency anemia after evaluation, or adult ITP).

During recent coding updates the policy's CPT code table was revised and HCPCS/CPT code 0369U was removed from the CPT coding table; providers should reference the updated CPT code table for current coding descriptors and be aware that removed codes may affect claims if older code lists are used.

Use of syndromic/multiplex GI panels and H. pylori antibody tests for indications not specified as medically necessary in this policy is considered investigational and therefore not medically necessary. H. pylori antibody tests are explicitly listed as investigational for all indications, and syndromic/multiplex GI panels are investigational when ordered for clinical scenarios that do not meet the policy's listed outpatient indications or when test results will not influence clinical management.

Historically, language and review approach for multiplex GI panels have changed across revisions. Notably, the policy was updated to explicitly state that panels with 11 or fewer targets are considered medically necessary, replacing prior wording that they 'may be considered medically necessary' or required different review. Other prior-version statements addressing panels with >11 targets and specific not-medically-necessary wording are retained in revision history and internal coding notes.

Coding and Billing - CPT/HCPCS Guidance

H. pylori and selected GI pathogen CPT codes (part 1)CPT

83013	Helicobacter pylori, blood test analysis for urease activity, non-radioactive isotope (eg, C-13).
83014	Helicobacter pylori; drug administration.
86677	Antibody; Helicobacter pylori.
87338	Infectious agent antigen detection by immunoassay technique (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]), qualitative or semiquantitative; Helicobacter pylori, stool.
87339	Infectious agent antigen detection by immunoassay technique (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]), qualitative or semiquantitative; Helicobacter pylori.
87493	Infectious agent detection by nucleic acid (DNA or RNA); Clostridium difficile, toxin gene(s), amplified probe technique.
87498	Infectious agent detection by nucleic acid (DNA or RNA); enterovirus, amplified probe technique, includes reverse transcription when performed.
87500	Infectious agent detection by nucleic acid (DNA or RNA); vancomycin resistance (eg, enterococcus species van A, van B), amplified probe technique.
87505	Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (eg, Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, Giardia), includes multiplex reverse

GI pathogen and other infectious agent CPT codes (part 2)CPT

87506	transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 3-5 targets.
87507	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.
87551	Infectious agent detection by nucleic acid (DNA or RNA); Mycobacteria species, amplified probe technique.
87556	Infectious agent detection by nucleic acid (DNA or RNA); Mycobacteria tuberculosis, amplified probe technique.
87561	Infectious agent detection by nucleic acid (DNA or RNA); Mycobacteria avium-intracellulare, amplified probe technique.
87650	Infectious agent detection by nucleic acid (DNA or RNA); Streptococcus, group A, direct probe technique.

Additional nucleic acid and multiplex assay codesCPT|HCPCS

87651	Infectious agent detection by nucleic acid (DNA or RNA); Streptococcus, group A, amplified probe technique.
87652	Infectious agent detection by nucleic acid (DNA or RNA); Streptococcus, group A, quantification.
87653	Infectious agent detection by nucleic acid (DNA or RNA); Streptococcus, group B, amplified probe technique.
87797	Infectious agent detection by nucleic acid (DNA or RNA); not otherwise specified; direct probe technique, each organism.
87798	Infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified; amplified probe technique, each organism.
87799	Infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified; quantification, each organism.
87800	Infectious agent detection by nucleic acid (DNA or RNA), multiple organisms; direct probe(s) technique.
87801	Infectious agent detection by nucleic acid (DNA or RNA), multiple organisms; amplified probe(s) technique.
0369U	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.

CPT codes (group A)CPT

87506	transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 3-5 targets.
87507	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.
87551	Infectious agent detection by nucleic acid (DNA or RNA); Mycobacteria species, amplified probe technique.
87556	Infectious agent detection by nucleic acid (DNA or RNA); Mycobacteria tuberculosis, amplified probe technique.
87561	Infectious agent detection by nucleic acid (DNA or RNA); Mycobacteria avium-intracellulare, amplified probe technique.
87650	Infectious agent detection by nucleic acid (DNA or RNA); Streptococcus, group A, direct probe technique.
87651	Infectious agent detection by nucleic acid (DNA or RNA); Streptococcus, group A, amplified probe technique.
87652	Infectious agent detection by nucleic acid (DNA or RNA); Streptococcus, group A, quantification.
87653	Infectious agent detection by nucleic acid (DNA or RNA); Streptococcus, group B, amplified probe technique.
87797	Infectious agent detection by nucleic acid (DNA or RNA); not otherwise specified; direct probe technique, each organism.

CPT codes (group B)CPT

87798	Infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified; amplified probe technique, each organism.
87799	Infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified; quantification, each organism.
87800	Infectious agent detection by nucleic acid (DNA or RNA), multiple organisms; direct probe(s) technique.
87801	Infectious agent detection by nucleic acid (DNA or RNA), multiple organisms; amplified probe(s) technique.
0369U	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.

Repeat testing frequency — once per diarrheal incident / no more than once per 14-day period

Repeat testing frequencyOnce per incident of diarrheal disease OR no more than once per 14-day period

ApplicabilityApplies to syndromic/multiplex gastrointestinal pathogen panels with either 11 or fewer targets or 12 or more targets as specified in policy sections

RationaleLimits duplicate testing during a single diarrheal episode to reduce unnecessary repeat assays and align testing with clinical management needs

Panel target count threshold — 11 or fewer targets

Panel target count threshold11 or fewer targets

Provider Responsibilities, Prior Authorization & Documentation

Denial Risk

Denial risk for 11-or-fewer panels

Denial risk: Syndromic/multiplex gastrointestinal pathogen panels with 11 or fewer targets may be denied when ordered outside the listed outpatient indications. Ensure documentation demonstrates the member presented in an outpatient setting with suspected infectious gastroenteritis and meets at least one specified clinical indication (e.g., immunocompromised status, recent travel to an endemic area, dysentery, fever, dehydration, abdominal pain/tenderness, bacteremia, diarrhea >7 days, or symptoms of enteric fever). Results must be expected to influence clinical management.

Affected codes: CPT 87505 (GI pathogen panel, 1 target?), CPT 87506 (3–5 targets), CPT 87507 (12–25 targets) — verify correct code mapping in coding table prior to claim submission.
Frequency limit: Medically necessary once per incident or no more than once per 14-day period — repeat testing outside this interval may be denied.

Denial Risk

Denial risk for 12-or-more panels

Denial risk: Syndromic/multiplex gastrointestinal pathogen panels with 12 or more targets may be denied when ordered outside the listed outpatient indications. Ensure documentation demonstrates the member presented in an outpatient setting with suspected infectious gastroenteritis and meets at least one specified clinical indication (e.g., immunocompromised status, recent travel to an endemic area, bacteremia, or symptoms of enteric fever). Results must be expected to influence clinical management.

Background and Rationale

Background: Gastrointestinal infections are commonly caused by bacteria, viruses, fungi, and parasites and frequently present as acute diarrheal illness. Multiplex molecular panels can detect multiple enteric pathogens simultaneously and are increasingly used in outpatient evaluation of suspected infectious gastroenteritis. H. pylori infection is evaluated using noninvasive tests such as the urea breath test or stool antigen test for the indications listed in this policy; antibody testing is not recommended and is considered investigational here. Recent coding and policy revisions updated panel target thresholds and CPT coding references; providers should follow the clinical criteria in this document and reference the current CPT code table when ordering and billing these tests.

Definitions and Clinical Terms

Uninvestigated dyspepsia — definition

DefinitionDyspepsia that has not already been evaluated via investigations such as upper GI endoscopy and/or is not already classified as functional or organic dyspepsia.

ContextUsed to determine eligibility for H. pylori testing under the 'dyspepsia' indication when member is younger than 60 and lacks alarm features

Exclusion noteIf dyspepsia has been previously investigated (eg, endoscopy) it is not 'uninvestigated' for purposes of this policy

Dyspepsia alarm features — vomiting, bleeding/anemia, mass, weight loss, dysphagia

Alarm features listVomiting; bleeding or anemia; abdominal mass or unintended weight loss; dysphagia.

Use in criteriaPresence of any alarm feature excludes the 'uninvestigated dyspepsia <60' indication for H. pylori testing

OpenPayer

CONCERT Infectious Disease: Gastroenterologic Testing — GI pathogen panels and H. pylori assays

Coverage and Medical Necessity Criteria

Coding and Billing - CPT/HCPCS Guidance

Provider Responsibilities, Prior Authorization & Documentation

Background and Rationale

Definitions and Clinical Terms