Currentpriority healthPolicy 151

Helicobacter pylori (H. pylori) Testing

Defines medical necessity criteria, documentation and coding/billing guidance for noninvasive and biopsy-based testing for active H. pylori infection for commercial, Medicare and Medicaid lines; includes covered and non-covered CPT codes and modifier/place-of-service guidance.

Policy Summary

Payerpriority health

PolicyHelicobacter pylori (H. pylori) Testing

Policy CodePolicy 151

Change TypeNew policy

Effective DateNov 17, 2025

Next Review DateN/A

Key ActionClinical notes must support medical necessity (relevant symptoms, history, risk factors); test results must be retained; for repeat testing include reason and confirmation of adequate washout period after therapy.

SourceLink

POLICY UPDATE CHANGES

New policy created (Date of origin: August 2025) with effective date Nov. 17, 2025.

12Adult covered indications listed

2Pediatric noninvasive indications

2Pediatric biopsy-based indications

6Covered procedure codes

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Coverage Summary

This policy (Policy Number 151) defines medical necessity, documentation, and coding/billing guidance for testing for active Helicobacter pylori (H. pylori). Coverage stance: covered with criteria. Effective date: 2025-11-17 (policy origin Aug. 2025; new policy). At a high level, the policy covers noninvasive testing for active infection using urea breath testing (UBT) and stool antigen testing (SAT), as well as biopsy-based endoscopic histology with rapid urease or culture and susceptibility testing when performed during a covered endoscopy. Specific clinical indications, timing thresholds (e.g., >= 4 weeks after completion of therapy for confirmation of eradication), covered and non-covered CPT codes, and billing/modifier guidance are provided in the policy.

Policy quick facts

Adult covered indications listed12

Pediatric noninvasive indications listed2

Pediatric biopsy-based indications listed2

Covered procedure codes listed6

Non-covered procedure codes listed3

Post-treatment eradication test timing>= 4 weeks after completion of therapy

Medical-Necessity Criteria — Adults (>=18 years)

Medical-Necessity Criteria — Pediatrics (<18 years)

Coding

Covered CPT / Procedure CodesmixedCovered

83013	Urea breath test, analysis
83014	Urea breath test, drug administration
87338	H. pylori, stool antigen
88342/88305	Biopsy-based pathology (only when performed during covered endoscopy)
78267	Urea Breath Test, C-14 (ISOTOPIC); Acquisition for analysis
78268	Urea Breath Test, C-14 (ISOTOPIC); Analysis

Non-Covered CPT / Procedure CodesCPTNot Covered

86677	Antibody; H. pylori
83009	Helicobacter pylori, blood test analysis for urease activity, non-radioactive isotope (e.g., C-13)
86677	Antibody; Helicobacter pylori [laboratory-based]

Modifiers / Billing GuidanceModifier

90	Use Modifier 90 when laboratory services are performed by a reference lab

Provider Actions & Billing Guidance

Documentation Required

Clinical documentation required

Clinical notes must support medical necessity, including relevant symptoms, history, or risk factors. Test results must be retained in the patient's record. For repeat testing, documentation must include reason for repeat and confirmation of adequate washout period after therapy.

Relevant symptoms, history, and risk factors documented
Test results retained in medical record
For repeat testing: state reason and confirm adequate washout period after therapy

Prior Authorization

Pre-Service Organization Determination (Medicare where applicable)

For Medicare indications that do not meet criteria of NCD, local LCD or specific medical policy, a Pre‑Service Organization Determination (PSOD) must be completed.

Background & Definitions

H. pylori is a gram-negative bacterium associated with chronic gastritis, peptic ulcer disease, gastric mucosa-associated lymphoid tissue (MALT) lymphoma, and an increased risk of gastric cancer. Clinical testing modalities described in the policy include noninvasive tests — urea breath test (UBT) and stool antigen test (SAT) — and biopsy-based testing (endoscopic histology plus rapid urease test or culture with susceptibility testing) when performed during a covered endoscopy.

The policy explicitly states that serology (blood antibody) testing is not reliable for determining active infection or eradication status and lists antibody testing (CPT 86677) among non-covered procedure codes. Documentation requirements emphasize clinical justification for testing, retention of results, and confirmation of adequate washout periods for repeat testing.

Term	Definition
Urea Breath Test (UBT)
Non-invasive diagnostic test for active infection.
Stool Antigen Test (SAT)
Immunoassay detecting active infection.
Serology Test
Blood test for antibodies to H. pylori; not reliable for active infection or eradication status.
H. pylori
A gram-negative bacterium associated with chronic gastritis, peptic ulcer disease, gastric mucosa-associated lymphoid tissue (MALT) lymphoma, and increased risk of gastric cancer.

Evidence & Medicare Determinations

Type	Name/Number	Effective Date	Notes
NCD
Refer to CMS

For indications that do not meet criteria of NCD, local LCD or specific medical policy a Pre-Service Organization Determination (PSOD) will need to be completed.

Revision History

Aug. 2025material_changeLatest

New policy created (Date of origin: August 2025) with effective date Nov. 17, 2025. Policy noted as 'New policy' in change history dated Aug. 2025; establishes coverage criteria and coding specifics.