ModifiedAmbetter NevadaPolicy CG.CP.MP.04

Concert Infectious Disease: Gastroenterologic Testing — Multiplex GI Panels and H. pylori Testing (Coverage Criteria)

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Outpatient policy governing appropriate use, medical necessity criteria, and coding implications for multiplex GI pathogen panels and Helicobacter pylori diagnostic tests for members of Ambetter Nevada/Centene-affiliated health plans.

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ModifiedAmbetter NevadaPolicy CG.CP.MP.04

Concert Infectious Disease: Gastroenterologic Testing — Multiplex GI Panels and H. pylori Testing (Coverage Criteria)

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Policy Summary

PayerAmbetter Nevada

PolicyMultiplex GI pathogen panels and H. pylori testing — coverage criteria

Policy CodePolicy CG.CP.MP.04

Change TypeMaterial coding and coverage clarification

Effective Date

Last ReviewMar 24, 2023

Next Review Date

Key ActionOrder multiplex GI panels and H. pylori tests only when medical necessity criteria are met and verify coding against the updated CPT table before billing.

SourceLink

POLICY UPDATE CHANGES

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

Removed 0369U from the CPT table.

For Syndromic/Multiplex Gastrointestinal Pathogen Panels with 11 or fewer targets: policy statement changed from 'may be considered medically necessary' to 'are considered medically necessary.'

Added CPT codes 87650 and 0369U to Coding Table (note: later removed 0369U).

11 or fewerThreshold for one panel category

12 or moreThreshold for broader panel category

≤14 daysFrequency limit

Medically necessaryH. pylori antigen stance

InvestigationalH. pylori antibody stance

NotedCoding revisions

Medical Necessity and Investigational Criteria

11-or-fewer target panels — Medically Necessary

Considered medically necessary when ALL of the following are met (outpatient setting):

Primary

Clinical risk factors (at least one required): One or more of: immunocompromised status (e.g., HIV/AIDS, immunosuppression therapy, primary immunodeficiency); recent travel to/contact with travelers from an infectious diarrheal disease–endemic area; dysentery (presence of blood or mucus in stool); fever; dehydration; abdominal pain/tenderness; bacteremia; diarrhea persisting longer than 7 days; symptoms of enteric fever (Typhoid/paratyphoid)
Examples listed in policy
Clinical utility: Results of the testing will influence the member's clinical management

12-or-more target panels — Medically Necessary

Considered medically necessary when ALL of the following are met (outpatient setting):

Primary

Clinical risk factors (at least one required): One or more of: immunocompromised status (e.g., HIV/AIDS, immunosuppression therapy, primary immunodeficiency); recent travel to/contact with travelers from an infectious diarrheal disease–endemic area; bacteremia; symptoms of enteric fever (Typhoid/paratyphoid)
Note: dysentery, fever, dehydration, abdominal pain, prolonged diarrhea and some other criteria listed for smaller panels are not repeated here
Clinical utility: Results of the testing will influence the member's clinical management

H. pylori urea breath or stool antigen — Medically Necessary

Considered medically necessary when ANY of the following indications are present:

H. pylori indications: Any of: active peptic ulcer disease (PUD); low-grade gastric mucosa-associated lymphoid tissue (MALT) lymphoma; history of endoscopic resection of early gastric cancer (EGC); past history of PUD when previous cure of H. pylori infection has NOT been documented; dyspepsia in patients younger than 60 years without alarm features and who have uninvestigated dyspepsia; initiating prophylactic low-dose aspirin; initiating chronic NSAID therapy; unexplained iron deficiency anemia despite appropriate evaluation; adult idiopathic thrombocytopenic purpura (ITP)

Based on ACG guideline recommendations

H. pylori antibody tests — Investigational

Stance for antibody testing

Antibody tests: H. pylori antibody (serologic) tests are considered investigational for all indications; serology is generally inferior to tests that identify active infection and is only rarely appropriate (e.g., in select cases of documented PUD where other testing is not suitable)

Medical necessity for small multiplex GI panels (policy change/clarification)

Policy statement change for small multiplex panels

Syndromic/Multiplex GI Pathogen Panels ≤11 targets: Syndromic/multiplex gastrointestinal pathogen panels with 11 or fewer targets are considered medically necessary.<=11 targets

Change from previous 'may be considered medically necessary' to definitive 'are considered medically necessary.'

Panels and tests not meeting the specific criteria listed under the medically necessary sections are considered investigational. This includes syndromic/multiplex gastrointestinal pathogen panels and Helicobacter pylori tests when ordered for indications that are not enumerated in the applicable medically necessary criteria sets. Providers should ensure the clinical presentation and listed indications are met before ordering or billing these assays.

For clarity, syndromic/multiplex GI pathogen panels are covered only when the documented outpatient clinical criteria for the applicable panel size (≤11 targets or ≥12 targets) are met and when results will influence clinical management; otherwise they are investigational. Likewise, H. pylori antibody tests are investigational for all indications (see H. pylori urea breath or stool antigen criteria for acceptable testing alternatives).

A coding correction was made in the most recent revisions: CPT code 0369U was removed from the CPT table. Providers must use the updated CPT table in the policy when selecting procedure codes for claims submission.

Syndromic/multiplex gastrointestinal pathogen panels ordered for indications outside the specific medically necessary criteria described for the ≤11-target and ≥12-target panels are considered not medically necessary / investigational. Additionally, H. pylori antibody (serology) tests are considered investigational for all indications and should not be used in place of urea breath or stool antigen testing when evaluation of active infection is required.

The policy documents several coding updates and corrections, including moving coding into a dedicated CPT table and correcting CPT descriptions. Aside from the explicit removal of 0369U, there are no additional new not-medically-necessary conditions specified in the coding-change notes beyond the panel-size medical necessity distinctions already described in the policy.

CPT / HCPCS Coding and Panel Size Keys

Referenced CPT/HCPCS codesmixed

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 transcription, when performed.
87506	transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 3-5 targets.

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CPT codes describedCPT

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.

Additional CPT codes describedCPT

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 (noted as removed later).

Panel target count distinction (11-or-fewer vs 12-or-more)

Defined panel categoriesTwo panel-size categories used for coverage decisions: '11-or-fewer targets' and '12-or-more targets'.

Coverage difference by target countPanels with 11 or fewer targets are considered medically necessary when criteria are met; panels with 12 or more targets have a separate, more restrictive clinical criteria set.

Frequency limit applies to both categoriesBoth 11-or-fewer and 12-or-more target panels are considered medically necessary once per incident of diarrheal disease or no more than once per 14-day period when criteria are met.

Panel target count threshold emphasized (11 or fewer targets)

Threshold specified11 or fewer targets is the threshold at which panels are explicitly designated 'considered medically necessary' when criteria are met.

Ordering, Billing, and Documentation Guidance

Prior Authorization

Verify medical necessity and coding before ordering

Order multiplex GI pathogen panels and H. pylori tests only when the policy’s medical necessity criteria are met and when you can document that test results will influence clinical management (e.g., immunocompromised status, recent travel to endemic area, dysentery, fever, prolonged diarrhea, or other listed indications). Verify the appropriate CPT code that matches the panel target count before submitting the claim.

Ensure the clinical indication(s) required by the policy are present in the chart at the time of ordering.
Document how the test result will change treatment or management.
Match the test ordered (11-or-fewer vs 12-or-more targets) to the CPT code selected.

Billing Rule

Clinical Background

Gastrointestinal infections can be caused by bacteria, viruses, parasites and, less commonly, fungi; they commonly present as acute gastroenteritis with vomiting and/or diarrhea. Multiplex molecular platforms allow simultaneous detection of multiple enteric pathogens and can improve pathogen identification in appropriate clinical contexts. These assays should be targeted to situations where results will influence management — for example, severe or prolonged illness, immunocompromised patients, recent travel to endemic regions, dysentery, bacteremia, or other features listed in the policy — rather than used indiscriminately for all cases of diarrheal disease.

Key Definitions and Terms

Definition — Uninvestigated dyspepsia

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

Context for H. pylori testingUninvestigated dyspepsia is an indication considered for H. pylori urea breath or stool antigen testing when other listed criteria are met (per policy guidance).

Exclusion from alarm featuresIf dyspepsia has been investigated or is classified as functional/organic, it does not meet the 'uninvestigated dyspepsia' definition used here.

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

Alarm features listDyspepsia alarm features include vomiting; bleeding or anemia; abdominal mass or unintended weight loss; and dysphagia.

Clinical implication

Policy Summary

PayerAmbetter Nevada

PolicyMultiplex GI pathogen panels and H. pylori testing — coverage criteria

Policy CodePolicy CG.CP.MP.04

Change TypeMaterial coding and coverage clarification

Effective Date

Last ReviewMar 24, 2023

Next Review Date

Key ActionOrder multiplex GI panels and H. pylori tests only when medical necessity criteria are met and verify coding against the updated CPT table before billing.

SourceLink

On This Page

Policy change notedLanguage changed from 'may be considered medically necessary' to 'are considered medically necessary' for panels with 11 or fewer targets (documented as a material revision).

Apply outpatient criteriaThe 11-or-fewer target panels are evaluated under outpatient clinical criteria including specified risk factors and demonstrated clinical utility.

Use the policy’s updated CPT table for billing

When billing, use the updated CPT code table referenced in the policy and the current CPT guidance; do not rely on removed or outdated code descriptions. Providers must select CPT codes that reflect the test performed as listed in the policy’s coding section.

Reference the policy’s CPT table and current AMA CPT manuals prior to claim submission.
Do not bill with codes that no longer match the corrected CPT descriptions in the policy’s table.

Step Therapy

No formal step therapy — follow listed indications

This policy does not establish a formal step-therapy sequence; coverage is determined by whether the listed clinical indications are met and whether results will influence clinical management.

Order tests based on the specific medical indications in the policy rather than on a prerequisite testing sequence.

Note

Follow lab submission guidance and correct claims if needed

If additional provider actions are needed (e.g., lab-specific submission instructions or coordination with the performing laboratory), follow the laboratory’s billing and submission guidance and ensure documentation aligns with policy requirements.

Confirm lab-specific requirements and attach clinical documentation showing management impact.
Correct any claim submissions that use outdated policy numbers or coding.

Documentation Required

Reference current CPT guidance and document clinical utility

Reference current CPT guidance when coding and include documentation in the medical record that testing is being performed because results will influence clinical management. The policy specifically notes that providers should reference the most up-to-date professional coding guidance prior to claim submission.

Include the clinical indication and a brief rationale in the chart linking the test to management decisions.
Cite the CPT code description that matches the assay performed.

Billing Rule

Ensure submitted CPT codes match corrected CPT table

Use the corrected CPT code table when submitting claims; ensure the coding description you bill matches the corrected CPT table in the policy (do not use removed or superseded descriptions).

Verify the CPT description in the policy’s CPT table equals the code you submit.
Update internal charge sheets and lab billing templates to reflect the corrected table.

Denial Risk

Adhere to frequency limits for repeat testing

Do not perform repeat multiplex GI panel testing more than once per incident of diarrheal disease and not more often than once per 14-day period unless clinically justified and documented, as such repeats may not meet medical necessity.

Document the clinical justification for repeat testing if performed within 14 days or during the same diarrheal episode.

Denial Risk

Avoid using removed CPT codes or incorrect policy numbers

Claims submitted using CPT codes removed from the CPT table (for example, 0369U) or with incorrect/uncorrected policy numbers may be denied or require correction; update claims and billing systems to remove retired codes and use current policy identifiers.

Do not bill with code 0369U — it was removed from the CPT table per the policy.
Correct the policy number on claims if previously submitted with an incorrect policy identifier.

Presence of any alarm feature alters evaluation and management and is specifically noted in policy definitions for dyspepsia assessment.

Relevance to testingPatients with alarm features are not considered to have 'uninvestigated dyspepsia' for the narrow indication referenced for H. pylori testing.

Definition — Gastroenteritis (vomiting and/or diarrhea)

DefinitionGastroenteritis is characterized by vomiting and/or diarrhea.

Typical presentationGI infections presenting as acute gastroenteritis may be bacterial, viral, parasitic, or other etiologies and are the clinical context for multiplex GI panel testing.

Scope for panelsPolicy applies to suspected infectious gastroenteritis in the outpatient setting when other specified clinical criteria are met.

Definition — Multiplex amplified probe technique (nucleic acid-based testing detecting multiple targets)

Technique descriptionMultiplex amplified probe technique refers to nucleic acid-based testing methods that detect multiple organism targets in a single assay using amplified probe technologies.

CPT linkageThis technique is described across multiple CPT codes (e.g., 87506, 87507, 87801, 87798) in the policy's coding implications section.

Use caseUsed for syndromic/multiplex gastrointestinal pathogen panels that identify multiple bacterial, viral, and parasitic organisms in one test.