Community Health Plan Washington GI NAAT Coverage

Coverage Criteria for GI Multiplex NAAT Panels

Initial coverage for 3-5 target panels

Covered when ALL of the following are met for 3-5 target panels

3-5 target panel medical necessity

Clinical indication: Member has one of the following clinical indications: (1) immunocompetent with presumption of active infection or infection-associated complications (including exacerbation of underlying disease) that require identification of a causative organism for appropriate management; OR (2) immunocompromised (including HIV/AIDS, patients on immunosuppressive medications such as chemotherapy, biologics, transplant immunosuppressants, or high-dose systemic corticosteroids, and inherited immune deficiencies). Note: atypical clinical presentations are considered appropriate indications; in immunocompromised patients testing may be performed once as part of pre-transplant evaluation regardless of symptoms.
Additional requirements: All of the following additional requirements are met: (a) test results will impact clinical management in a manner demonstrated in peer-reviewed literature to improve outcomes; (b) testing is performed according to the intended use and validated population for the registered test; (c) targeted testing is not appropriate for the clinical scenario; (d) the panel includes at least the minimum pathogens required for clinical decision making for its intended use; (e) the registered test demonstrates equivalent or superior analytical and clinical validity to established standard-of-care methods for the majority of targets on the panel; (f) the medical record documents specific clinical indications for testing, specific reasons for performing the panel, provider type/specialty, and place of service.

Testing expanded panels that exceed 5 targets is not covered for patients who do not meet the policy’s expanded‑panel criteria because, in many outpatient immunocompetent cases, identifying the specific organism is unlikely to change clinical management and may delay treatment. Panels of 3–5 targets are recognized as clinically appropriate in outpatient settings for common viral pathogens, but ordering larger multiplex panels for patients without the stated indications (for example, not immunocompromised, not critically ill, and without severe or persistent diarrheal features) does not meet medical necessity under this policy.

Per the revision log, the policy text removed the prior note referencing "atypical clinical presentations" from Section I.A.1. This change was documented as a non‑clinical wording update during the annual review (revision dates noted 03/24 and 03/25) and does not alter the clinical coverage criteria otherwise described in Section I. A copy of the revision summary is retained in the policy history.

The policy limits routine use of large multiplex panels because, outside of specified high‑risk situations, identification of additional organisms beyond a focused group of common targets does not generally alter treatment decisions. In outpatient immunocompetent patients without indications listed for expanded testing, results from broad panels can identify organisms of uncertain clinical significance or nonviable nucleic acid and therefore are unlikely to change immediate management; this risk of low yield and potential delay in therapy supports restricting panels to 6 targets or fewer unless the expanded‑panel criteria are met.

This policy provides medical necessity guidance and applies the full coverage criteria described elsewhere in the document. For operational use, providers should follow the detailed criteria for 3–5 target panels and for expanded panels (>5 targets), including documentation requirements and place‑of‑service billing prerequisites, which are set out in the policy tables and referenced CMS LCD/LCA guidance. Orders must include clinical indication and justification consistent with the policy to support coverage determinations.

Indications Where Testing is Covered

Detection of nucleic acid from multiple GI pathogens

Covered indications for multiplex gastrointestinal pathogen NAAT panels

Covered indications: Detection of nucleic acid from multiple gastrointestinal pathogens is covered for patients with clinical suspicion of infectious gastroenteritis or colitis when identification will affect management, including: immunocompromised patients; patients with severe or persistent diarrheal illness; and immunocompromised patients undergoing pre-transplant evaluation (testing may be performed once regardless of symptoms).

Evaluation of acute gastroenteritis and infectious diarrhea

Evaluation of acute gastroenteritis and infectious diarrhea where multiplex NAAT panels are appropriate per referenced guidelines and CMS LCDs

Guideline- and LCD-referenced use: Multiplex NAAT panels may be used for evaluation of acute gastroenteritis and infectious diarrhea when the clinical scenario and patient risk factors align with evidence-based guidance and applicable CMS local coverage determinations; providers should refer to cited ACG and IDSA guidelines and relevant CMS LCDs for indication specifics.

Codes and Billing Guidance

Covered CPT Codes (3-5 targets)CPTCovered

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, and multiplex amplified probe technique, multiple types or subtypes, three to five targets

Covered CPT/PLA Codes (expanded panels)mixedCovered

87506	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, 6 to 11 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 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

Place of Service codes required for some expanded-panel billingRevenue

19	Off Campus- Outpatient Hospital
21	Inpatient Hospital
22	On Campus - Outpatient Hospital (Observation)
23	Emergency Room - Hospital

ICD-10 Diagnosis Codes supporting medical necessity for expanded panelsICD-10Covered

A00.0	Cholera due to Vibrio cholerae 01, biovar cholerae
A09	Infectious gastroenteritis and colitis, unspecified
R19.7	Diarrhea, unspecified
B20	Human immunodeficiency virus [HIV] disease
D61.810	Antineoplastic chemotherapy induced pancytopenia
D70.9	Neutropenia, unspecified

Updated CPT codes referenced in revision log (CPT additions)CPT

0369U

CPT code added to Table 2 per revision log

ICD-10 codes referenced in policy textICD-10

D80.5	Immunodeficiency with increased immunoglobulin M [IgM]
D80.6	Antibody deficiency with near-normal immunoglobulins or with hyperimmunoglobulinemia
D80.8	Other immunodeficiencies with predominantly antibody defects
D80.9	Immunodeficiency with predominantly antibody defects, unspecified
D81.0	Severe combined immunodeficiency [SCID] with reticular dysgenesis
D81.1	Severe combined immunodeficiency [SCID] with low T- and B- cell numbers
D81.2	Severe combined immunodeficiency [SCID] with low or normal B-cell numbers
D81.30	Adenosine deaminase deficiency, unspecified
D81.31	Severe combined immunodeficiency due to adenosine deaminase deficiency
D81.32	Adenosine deaminase 2 deficiency

1–10 of 126

1/13

Panel target count (CPT / PLA mapping)

3-5 targetsCPT 87505 — gastrointestinal pathogen NAAT, multiplex, 3 to 5 targets

6-11 targetsCPT 87506 — gastrointestinal pathogen NAAT, multiplex, 6 to 11 targets

12-25 targetsCPT 87507 — gastrointestinal pathogen NAAT, multiplex, 12 to 25 targets

31-organism panel (with resistance genes)PLA 0369U — gastrointestinal pathogens, 31 organisms plus identification of 21 associated antibiotic‑resistance genes

Provider Requirements and Billing Actions

Billing Rule

Expanded-panel coding and place-of-service requirement

Expanded-panel CPT codes listed in Table 2 (e.g., 87506, 87507, 0369U) support medical necessity only when billed with an approved place of service from Table 3 and with diagnosis codes from both Table 4 and Table 5. Panels that exceed the standard target count (expanded panels) must meet the policy clinical criteria for expanded testing (see policy Section II) and the member's documentation must justify the broader panel selection. Expanded panels billed without meeting these place-of-service and clinical criteria are at risk for denial.

Affected CPT codes: 87506, 87507, 0369U
Required Place of Service: codes listed in Table 3 (e.g., 19, 21, 22, 23)
Must also be billed with diagnosis codes from Table 4 and Table 5

Documentation Required

Clinical documentation to support coding

Ordering and Operational Requirements

Prior Authorization

Ordering must document indication, reason for panel, provider type and place of service; expanded panels need extra justification

The order must include documentation of the clinical indication, the specific reason for panel testing, and the ordering provider's type/specialty and place of service; orders for expanded panels should include additional justification per the expanded-panel criteria.

Include why targeted testing is not appropriate and how results will affect management when ordering expanded panels.
For expanded panels, document which qualifying expanded-panel criterion (II.A.1 or II.A.2) is met.

Note

Follow state, Medicare LCD/LCA, and Health Plan requirements when ordering

When ordering testing, follow applicable state rules, Medicare LCDs/LCAs and Health Plan requirements cited in the policy; refer to the policy tables and CMS resources referenced for coding and coverage guidance.

Refer to CMS LCD L38229, molDX local coverage determinations/articles, and the policy's tables for correct billing and coverage prerequisites.

Frequency Limits and Re-testing

Frequency limits — general

Explicit frequency limitsNo explicit frequency limits provided in this policy segment

Clinical judgementRepeat testing frequency should follow clinical indications and referenced CMS LCD/local rules when applicable

DocumentationMedical record must document clinical indication and reason for repeat or panel testing

Multiplex gastrointestinal pathogen panels — frequency guidance

Frequency governed by CMS guidanceMultiplex gastrointestinal pathogen panel testing frequency is per applicable CMS LCDs and local coverage articles

Reference LCDs/articlesSee referenced LCDs and local coverage articles (e.g., L38229, L39226, and related MolDX articles) for billing/frequency specifics

Not Covered Indications

Not covered: routine use of expanded multiplex gastrointestinal pathogen testing when identification of the organism would not change clinical management — for example, many outpatient immunocompetent patients without the policy’s expanded‑panel indications. In these settings, the policy states that the benefit of broader pathogen identification does not outweigh the potential harms of delayed treatment or discovery of findings unlikely to affect care. Coverage for expanded panels is limited to the circumstances explicitly listed in the expanded‑panel criteria.

Specific tests, indications, and billing requirements that are not covered or that require additional justification are provided in the policy’s coding and exclusion tables and in the cited CMS local coverage determinations. Providers should consult those tables and the referenced LCD/LCA documents for exact not‑covered test listings, required place of service codes, and diagnosis code pairings to ensure documentation and billing align with coverage rules.

Definitions and Key Terms

Multiplex NAAT / CIDT — definition

DefinitionMultiplex NAAT / CIDT = nucleic acid amplification tests that simultaneously detect multiple viral, bacterial, and parasitic GI pathogen DNA/RNA targets; included in culture-independent diagnostic tests (CIDT)

PurposeUsed for qualitative detection of multiple pathogens causing infectious gastroenteritis and colitis with faster turnaround and higher sensitivity than many conventional methods

LimitationsMay detect nonviable organisms, low-level colonization, or mixed infections of uncertain clinical significance; interpretation requires clinical correlation

Immunocompromised — definition and scope

DefinitionImmunocompromised = patients with weakened immune systems, including those with HIV/AIDS, patients receiving immunosuppressive medications (chemotherapy, biologics, transplant immunosuppressants, high‑dose systemic corticosteroids), and inherited immunodeficiencies

Background and Evidence Context

Multiplex nucleic acid amplification tests (NAATs), also called culture‑independent diagnostic tests, detect nucleic acid from multiple viral, bacterial, and parasitic gastrointestinal pathogens simultaneously. These assays typically provide results more rapidly and with greater analytical sensitivity than many conventional methods, but can detect nonviable organisms or mixed infections of uncertain significance; therefore their use is focused where pathogen identification will meaningfully affect management, such as in immunocompromised or critically ill patients, persistent or severe diarrheal illness, or pre‑transplant evaluation.

OpenPayer

Gastrointestinal Pathogen Nucleic Acid Detection Panel Testing