Gastrointestinal Pathogen Nucleic Acid Detection Panel Testing
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Medical necessity and coding criteria for multiplex gastrointestinal pathogen nucleic acid amplification (NAAT) panel testing for non‑Medicare health plans affiliated with Centene (Arizona Complete Health). Applies to providers ordering stool GI pathogen panels and billing for related CPT codes.
No material clinical or coverage changes in this revision.
Medical Necessity Criteria
inv-01: Standard panel (3–5 targets) medical necessity
Covered when ALL of the following are met for panels of five or fewer targets:
All conditions A–G required
inv-02: Expanded panel (>5 targets) medical necessity
Expanded panels (>5 targets) considered medically necessary when ALL criteria in section I are met AND one of the following applies:
One of these expanded criteria in addition to section I required
inv-03: Covered when meeting policy Sections I or II
Policy includes detailed medical necessity criteria in sections I and II (replaced in 03/23 and annual reviews thereafter).
Full logical tree is contained in Sections I and II of the policy; see policy text for complete requirements.
Panel testing is not always required when a focused, pathogen-specific approach will provide the information needed for patient management. The policy specifies that targeted testing is not appropriate must be met for panel testing to be considered medically necessary, meaning panels should not be used when targeted assays would suffice for clinical decision-making. Documentation should demonstrate why targeted testing would be inadequate before choosing a multiplex panel.
During the 03/23 revision the policy text was reorganized and Section III was removed. The current excerpt no longer includes the specific exclusions or language that had been located in the prior Section III; reviewers should rely on the updated Sections I and II and the policy's exclusions and not assume the prior Section III content remains applicable.
Expanded-panel CPT/PLA codes (87506, 87507, 0369U) are listed as supporting medical necessity only when billed with qualifying place-of-service codes or appropriate diagnosis codes as specified in the policy (Table 3 and Tables 4–5). Use of these expanded panel codes without meeting those place-of-service and diagnosis code conditions may not satisfy the policy's medical necessity requirements.
The excerpt does not present explicit standalone "not medically necessary" statements; rather, coverage determinations are based on whether the case meets the policy criteria in Sections I and II. The policy was revised and reorganized (03/23 and subsequent annual reviews), and the applicability of medical necessity depends on meeting the current criteria and documentation requirements.
Indications Considered Medically Necessary
inv-27: Acute or persistent diarrhea with clinical suspicion of infectious etiology; immunocompromised patients; severe GI pathology; critically ill patients — coverage criteria (top-level nodes)
Covered indications (top-level):
These are the principal covered indications described in Section I and II of the policy.
inv-28: Acute gastroenteritis / acute diarrheal illness where multiplex molecular testing is clinically indicated per guidelines (references: ACG, IDSA, Hayes, CMS LCDs)
Acute gastroenteritis / acute diarrheal illness where multiplex molecular testing is clinically indicated per guideline-referenced criteria:
References: Hayes, ACG, IDSA, CMS LCDs (see policy references).
CPT, HCPCS, ICD-10 and Place-of-Service Coding
| 87505 | Infectious agent detection by nucleic acid; 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, three to five targets |
| 87506 | Infectious agent detection by nucleic acid; gastrointestinal pathogen (eg, Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, 6 to 11 targets. |
| 87507 | Infectious agent detection by nucleic acid; gastrointestinal pathogen (eg, Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, 12 to 25 targets. |
| 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 |
| A00.0 | Cholera due to Vibrio cholerae 01, biovar cholerae |
| 19 | Off Campus - Outpatient Hospital |
| 21 | Inpatient Hospital |
| 22 | On Campus - Outpatient Hospital (Observation) |
| 23 | Emergency Room - Hospital |
| D89.89 | Other specified disorders involving the immune mechanism, not elsewhere classified. |
| E08.43 | Diabetes mellitus due to underlying condition with diabetic autonomic (poly)neuropathy. |
| E10.43 | Type 1 diabetes mellitus with diabetic autonomic (poly)neuropathy. |
| E11.43 | Type 2 diabetes mellitus with diabetic autonomic (poly)neuropathy. |
| E13.43 | Other specified diabetes mellitus with diabetic autonomic (poly)neuropathy. |
| K50.011 | Crohn's disease of small intestine with rectal bleeding. |
| K50.012 | Crohn's disease of small intestine with intestinal obstruction. |
| K50.013 | Crohn's disease of small intestine with fistula. |
| K50.018 | Crohn's disease of small intestine with other complication. |
| K50.111 | Crohn's disease of large intestine with rectal bleeding. |
| 87506 | Molecular assay (example moved from Table 1 to Table 2 in policy). |
| 0369U | Specific CPT/HCPCS panel code added to Table 2. |
| 0097U | Deleted CPT code (removed from policy). |
Ordering, Documentation and Billing Actions
Prior authorization / billing restrictions for expanded panels
Expanded gastrointestinal pathogen panel CPT codes 87506, 87507, and PLA 0369U are considered to support medical necessity only when billed with the specific places of service listed in Table 3 (Off Campus-Outpatient Hospital (19), Inpatient Hospital (21), On Campus - Outpatient Hospital (22), Emergency Room - Hospital (23)) or when billed with an appropriate diagnosis code from the ICD-10 lists added in Tables 4–6. Providers should ensure place of service and diagnosis coding align with those tables when submitting claims for these expanded panel codes.
Prior authorization and affected codes
The policy identifies CPT/PLA codes used for coverage decisions and documents recent code updates; code 0369U was added to Table 2, deleted code 0097U was removed, and CPT 87506 was moved from Table 1 to Table 2. Prior authorization may be required per plan rules when billing these CPT/PLA codes for expanded panels.
- Codes referenced in policy updates: 0369U (added), 0097U (removed), 87506 (moved between tables).
- Tables 1–3 are used to identify CPT codes relevant to coverage determination; follow plan prior authorization rules for these codes.
Documentation and ordering expectations
Orders must be accompanied by documentation in the medical record that clearly states the specific clinical indications for testing, the specific reasons for performing panel testing, and the ordering provider's type/specialty and place of service; the order should come from a provider who documents these items.
- Document specific clinical indication(s) for the test (e.g., suspicion of active infection, immunocompromised status).
- Document the specific reason the panel (rather than targeted testing) is being performed.
- Include ordering provider type/specialty and the place of service in the record.
Coding and billing updates required
Update billing and coding practices to reflect the policy changes: use the CPT/PLA codes listed in Tables 1–3 as revised (including addition of 0369U and relocation of 87506) and ensure place of service and diagnosis code pairings follow the updated tables to support medical necessity.
- Use CPT/PLA codes consistent with Tables 1–3 after the March 2023–2025 updates.
- Ensure claims for expanded panel codes include the required place of service or supporting ICD-10 diagnosis codes from the updated tables.
Required documentation in the medical record
The medical record must clearly state: (1) the specific clinical indications for testing, (2) the specific reasons for performing panel testing (why panel testing rather than targeted testing), and (3) the provider type/specialty and place of service.
- Required elements to document in the medical record: clinical indication, reason for panel use, ordering provider type/specialty, and place of service.
- Documentation must be clear and contemporaneous to support medical necessity determinations.
Documentation required to support medical necessity
To support medical necessity for expanded panel billing, documentation and claims must reference the ICD-10 diagnosis codes and place-of-service codes listed in the policy Tables (Tables 3–6) and use the CPT/PLA codes shown in the updated code tables.
- Include appropriate ICD-10 codes from Tables 4–6 when billing expanded panel codes.
- Ensure the place of service on the claim matches one of the Table 3 POS codes required for codes in Table 2.
Documentation-based denials
Failure to document the required clinical indications, reasons for performing panel testing, provider type/specialty, and place of service in the medical record may trigger denial of the claim.
- Denials may result if the record lacks the policy-specified documentation elements (clinical indication, reason for panel testing, provider specialty, place of service).
Denial risk for not meeting medical necessity criteria
Claims that do not meet the policy's medical necessity criteria (Sections I and II), including the updated Criteria II threshold (>5 targets), are at risk for denial of coverage.
- Ensure all required criteria in Section I are met for standard panels (≤5 targets) and that expanded panel conditions in Section II are satisfied for panels >5 targets.
- Be aware Criteria II was revised from >6 to >5 targets; billing for expanded panels without meeting the updated criteria may be denied.
Who May Order and What Must Be Documented
Ordering provider must document clinical indication and POS
Orders must be placed by a provider who documents the clinical indication, reasons for panel testing, provider specialty, and place of service in the medical record.
- The ordering provider is responsible for recording the specific clinical justification and place of service at time of order.
Applicability to non‑Medicare plans; check Medicare policies for Medicare members
This policy applies to non‑Medicare plans affiliated with Centene; for Medicare members providers should refer to Medicare‑specific policies (NCDs/LCDs) as ordering and reimbursement may differ.
- Review applicable Medicare NCDs/LCDs before ordering for Medicare members; the policy explicitly specifies applicability to non‑Medicare plans.
Test Frequency and Special Situations
Situations Not Supported
Tests should not be billed or performed when a targeted diagnostic approach would provide equivalent clinical information or when required documentation, intended-use population, or validated test performance is not met. The policy identifies as not covered testing scenarios where targeted testing would suffice or where the provider fails to document the specific clinical indications, reasons for panel testing, provider specialty/type, and place of service in the medical record.
The policy history documents removal of deleted CPT code 0097U. After code deletions or reassignments, certain previously billed tests or coding configurations may no longer be supported; providers should use the current CPT/PLA codes listed in the policy and verify that removed codes such as 0097U are not used.
Key Terms and Definitions
Clinical and Technical Background
Multiplex nucleic acid amplification tests (multiplex NAAT or GI pathogen panels) detect DNA or RNA from multiple bacterial, viral, and parasitic gastrointestinal pathogens and generally provide higher diagnostic yield and faster results than many conventional methods. These panels can identify pathogens not readily detected by culture or antigen tests and may shorten time to targeted therapy, but they can also detect low-level carriage or multiple organisms whose clinical significance may be unclear.
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