ModifiedWellCarePolicy CG.CP MP.04

Gastrointestinal pathogen testing (syndromic multiplex panels and H. pylori assays)

Defines medical necessity and coding guidance for outpatient gastrointestinal pathogen testing, including syndromic multiplex GI panels and H. pylori assays, for members of WellCare-affiliated health plans.

Policy Summary

PayerWellCare

PolicyGastrointestinal pathogen testing (syndromic multiplex panels and H. pylori assays)

Policy CodePolicy CG.CP MP.04

Change TypeCoding corrections and clarified medical necessity for ≤11-target panels

Effective Date

Next Review Date

Key ActionObtain prior authorization when ordering syndromic multiplex GI panels and document outpatient setting and clinical indications; use the updated coding table and do not bill with removed code 0369U.

SourceLink

POLICY UPDATE CHANGES

Added CPT code table and moved the 'coding implications' section.

Corrected coding descriptions in CPT table and removed CPT code 0369U.

For Syndromic/Multiplex Gastrointestinal Pathogen Panels with 11 or fewer targets: changed policy statement to state panels are medically necessary under specified criteria.

Added CPT codes 87650 and 0369U to the coding table (0369U later removed per correction).

Added CPT code table and moved the "coding implications" section.

Corrected coding descriptions in CPT table; removed 0369U.

Added 87650 and 0369U to Coding Table (later removed as noted).

Corrected policy number from CG.CP MP.104 to CG.CP MP.04.

For Syndromic/Multiplex Gastrointestinal Pathogen Panels with 11 or Fewer Targets: changed policy statement to be considered medically necessary.

11target cutoff for '11 or fewer' panels

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Coverage and Medical Necessity Criteria

11-or-fewer Target Multiplex Panel — Medically Necessary

Covered when ALL of the following are met:

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

Clinical indications (at least one): Immunocompromised status (eg, HIV/AIDS, immunosuppression therapy, primary immunodeficiency) OR recent travel to/contact with travelers from an infectious diarrheal disease-endemic area OR dysentery (blood or mucus in stool) OR fever OR dehydration OR abdominal pain/tenderness OR bacteremia OR diarrhea persisting longer than 7 days OR symptoms of enteric fever (eg, typhoid/paratyphoid).

Frequency: Testing limited to once per incident of diarrheal disease (no more than once per 14-day period).

12-or-more Target Multiplex Panel — Medically Necessary

Covered when ALL of the following are met:

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

Frequency: Testing limited to once per incident of diarrheal disease (no more than once per 14-day period).

H. pylori Urea Breath or Stool Antigen Testing — Medically Necessary

Covered when ANY of the following indications are present:

Indications list: Active peptic ulcer disease (PUD) OR low-grade gastric mucosa-associated lymphoid tissue (MALT) lymphoma OR history of endoscopic resection of early gastric cancer OR past history of PUD without documented prior cure of H. pylori OR uninvestigated dyspepsia in patients <60 years without alarm features OR initiating chronic NSAID therapy OR unexplained iron deficiency anemia despite appropriate evaluation OR adult idiopathic thrombocytopenic purpura (ITP).

H. pylori Antibody Testing — Investigational

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

Panels and tests described in this policy are limited to the specific indications listed. Panels and tests that are ordered for indications not explicitly addressed in the criteria (for example, routine or general population screening with multiplex gastrointestinal panels, or uses of H. pylori antibody tests) are considered investigational and not covered.

The policy's coding table was corrected to remove HCPCS code 0369U. This code should not be used for claims submission; use the updated CPT/HCPCS codes and descriptions from the policy's coding table when billing to avoid coding errors or denials.

Syndromic/multiplex gastrointestinal pathogen panels that are performed for indications other than those specifically listed in this policy are considered investigational and not medically necessary. Panels with either <=11 targets or >=12 targets are covered only when the outpatient clinical criteria and frequency limits in the policy are met; use outside those criteria may result in denial.

Coding and Billing Guidance

Referenced CPT/HCPCS CodesCPT

83013	Helicobacter pylori, blood test analysis for urease activity, non-radioactive isotope (eg, C-13).
83014	Helicobacter pylori; administration drug.
86677	Antibody; Helicobacter pylori.
87338	Infectious agent antigen detection by immunoassay technique; Helicobacter stool (eg, pylori).
87339	Infectious agent antigen detection by immunoassay technique; Helicobacter pylori.
87493	Infectious agent detection by nucleic acid (DNA or RNA); Clostridium difficile, toxin gene(s).
87498	Infectious agent detection by nucleic acid (DNA or RNA); enterovirus, amplified technique.
87500	Infectious agent detection by nucleic acid (DNA or RNA); vancomycin resistance (eg, enterococcus species van A van B) probe technique amplified.
87505	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.
87506	Infectious agent detection by nucleic acid (DNA or RNA); multiplex amplified technique, multiple types or subtypes, 3-5 targets.

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Temporarily listed HCPCS (removed later)HCPCS

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/HCPCS codes referencedmixed

87796	Infectious agent detection by nucleic acid (DNA or RNA); not otherwise specified; direct technique_each organism probe.
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

Panel target count cutoff

Cutoff definitionPanels are classified by number of targets: 11 or fewer targets (<=11) versus 12 or more targets (>=12)

Coverage rule for <=11 targetsSyndromic/multiplex GI pathogen panels with 11 or fewer targets are medically necessary when outpatient setting with suspected infectious gastroenteritis, a qualifying clinical indication is present, and results will influence management; limited to once per diarrheal incident (no more than once per 14 days)

Coverage rule for >=12 targetsSyndromic/multiplex GI pathogen panels with 12 or more targets are medically necessary when outpatient setting with suspected infectious gastroenteritis, a qualifying clinical indication is present (narrower list), and results will influence management; limited to once per diarrheal incident (no more than once per 14 days)

Frequency limit (both categories)Testing limited to once per incident of diarrheal disease (no more than once per 14-day period)

Required Provider Actions and Operational Notes

Prior Authorization

Prior Authorization May Be Required

Prior authorization may be required before ordering syndromic multiplex gastrointestinal pathogen panels. Verify member-specific prior authorization requirements with WellCare before testing to avoid delays or denials.

Check prior authorization rules and submit required documentation when requesting syndromic multiplex GI pathogen panels.
Confirm whether the specific panel (by target count and CPT code) requires prior authorization.

Documentation Required

Required Clinical Documentation

Document the outpatient clinical presentation and that testing will influence clinical management. Include signs/symptoms (e.g., diarrhea duration, fever, dysentery), immunocompromised status, recent travel or exposure history, and other listed indications in the medical record.

Record setting: outpatient visit.
Document specific clinical indications that meet policy criteria (e.g., immunocompromised status, recent travel to endemic area, bacteremia, dysentery, fever, dehydration, abdominal pain/tenderness, diarrhea >7 days, symptoms of enteric fever).

Background and Scope

Gastrointestinal infections are caused by a range of organisms including bacteria, viruses, parasites, and fungi and are diagnosed using methods such as culture, microscopy, immunoassays, and molecular testing. Syndromic/multiplex molecular panels can detect multiple enteric pathogens simultaneously and are intended for situations where identifying the causative agent will influence management. Clinical guidance supports targeted testing for patients with moderate-to-severe disease, immunocompromised status, recent travel to endemic areas, dysentery, bacteremia, persistent diarrhea, or other listed indications. Conversely, indiscriminate use of multiplex panels or antibody-based H. pylori tests for screening is discouraged because many diarrheal illnesses are self-limited and such testing may be unwarranted.

Definitions and Test Descriptions

Uninvestigated dyspepsia — definition

DefinitionUninvestigated dyspepsia: dyspepsia not previously evaluated with investigations such as upper GI endoscopy and not already classified as functional or organic dyspepsia.

Context for H. pylori testingUsed as an indication in policy for H. pylori urea breath or stool antigen testing when uninvestigated dyspepsia occurs in patients <60 years without alarm features.

Relation to managementPresence of uninvestigated dyspepsia helps determine appropriateness of noninvasive H. pylori testing per covered indications.

Dyspepsia alarm features

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

Use in eligibility

Policy Summary

PayerWellCare

PolicyGastrointestinal pathogen testing (syndromic multiplex panels and H. pylori assays)

Policy CodePolicy CG.CP MP.04

Change TypeCoding corrections and clarified medical necessity for ≤11-target panels

Effective Date

Next Review Date

SourceLink

On This Page

Billing Rule

Investigational or Excess Frequency

Panels performed outside the policy criteria or more frequently than allowed (no more than once per incident / no more than once per 14-day period) are considered investigational or not covered. Order testing only when criteria and frequency limits are met.

Syndromic/multiplex GI panels with 11 or fewer targets: medically necessary once per incident or no more than once per 14-day period.
Syndromic/multiplex GI panels with 12 or more targets: medically necessary once per incident or no more than once per 14-day period.
Panels for indications not listed in the policy are investigational and not covered.

Billing Rule

Use Updated Coding Descriptions

Use the updated CPT coding table when submitting claims. Do not use removed or retired codes (for example, 0369U was removed and must not be used). Verify the correct CPT code that corresponds to the panel ordered (by target count) and include any required modifiers or supporting documentation.

Do not submit claims with removed code 0369U — use the current CPT codes that reflect panel content and target count (e.g., 87505, 87506, 87507 as applicable).
Ensure CPT descriptions and code selection match the ordered test's methodology and target count.
Check prior authorization and coding table updates before claim submission.