Modifiedpartners_health_managementPolicy CG.CP.MP.01

CONCERT INFECTIOUS DISEASE: RESPIRATORY TESTING - Outpatient respiratory pathogen testing coverage criteria

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Defines medical necessity criteria for outpatient diagnostic testing for respiratory infections (viral and bacterial panels, influenza, RSV, SARS-CoV-2, Group A streptococcus) and when those tests are considered clinically indicated for plan members.

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Modifiedpartners_health_managementPolicy CG.CP.MP.01

CONCERT INFECTIOUS DISEASE: RESPIRATORY TESTING - Outpatient respiratory pathogen testing coverage criteria

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Policy Summary

Payerpartners_health_management

PolicyOutpatient respiratory pathogen testing (Respiratory panels, influenza, RSV, SARS-CoV-2, GAS)

Policy CodePolicy CG.CP.MP.01

Change TypeCoding and clinical criteria updates

Effective Date

Last ReviewNov 1, 2024

Next Review DateJan 1, 2025

Key ActionDocument signs/symptoms of acute respiratory infection and the rationale that test results will influence clinical management when ordering respiratory diagnostic tests.

SourceLink

POLICY UPDATE CHANGES

Added 0528U as an in-scope CPT code.

Removed deleted codes U0003, U0004, and U0005.

Expanded coverage criteria for Group A Streptococcus pharyngitis cultures to include patients up to 18 years old (was previously up to 14 years old).

Updated CPT code table descriptions and removed code 0373U.

6+Syndromic panel threshold

5 or fewerMultiplex ≤

3-18Pediatric culture age range

0528UNew CPT added

U0003-U0005Deleted HCPCS codes

dozensCPT/PLA codes referenced

Coverage Criteria for Outpatient Respiratory Pathogen Testing

Syndromic/Multiplex Respiratory Panels with 6 or More Targets

Considered medically necessary when ALL of the following are met:

Overall requirements

Risk criteria: Member is immunocompromised OR has severe pneumonia OR has exacerbations of airway disease
At least one required

SARS-CoV-2, RSV, Influenza A/B, OR Multiplex Respiratory Viral Panels with 5 or Fewer Targets

Considered medically necessary when ALL of the following are met:

Requirements: Member presents in the outpatient setting with signs or symptoms of an acute respiratory infection AND results will influence clinical management

No additional risk criteria required

Bacterial Respiratory Infection/Pneumonia Panels

Considered medically necessary when ALL of the following are met:

Overall requirements

Clinical criteria: New or worsening lung infiltrates OR moderate to severe upper respiratory illness OR has received empiric antibiotics before obtaining cultures OR has possible multidrug-resistant bacteria or polymicrobial infection
One required

Group A Streptococcus Pharyngitis Tests and Cultures

Group A streptococcus testing is considered medically necessary when ALL of the following are met:

RADT or antigen testing: Member presents in the outpatient setting with at least one compatible clinical finding (acute pharyngitis, fever, tonsillopharyngeal inflammation, patchy exudates, palatal petechiae, anterior cervical lymphadenitis, or scarlatiniform rash), does not have features strongly suggesting a viral etiology (eg, cough, rhinorrhea, hoarseness, oral ulcers), and results will influence clinical management

Antibody tests are not supported for diagnosing acute infection

Culture after negative RADT: For culture specifically: member is 3–18 years old AND had a negative group A streptococcus rapid antigen detection test (RADT) AND meets the clinical presentation criteria

Culture only in this pediatric age range after negative RADT

Clinical appropriateness criteria

Clinical testing recommendations and appropriate-use contexts from cited guidelines

Respiratory viral testing - symptomatic: Test symptomatic patients consistent with the infection (eg, CDC: test immediately if symptomatic for COVID-19; consider RSV testing during RSV season); testing when symptoms are present is supported

Reference: CDC guidance

Use of multiplex molecular panels: Molecular multiplex testing for multiple respiratory viruses may be cost-effective compared with antigen or culture methods at certain disease prevalence thresholds and is supported by IDSA guidance

Reference: IDSA 2020

Bacterial NAAT indications: Bacterial NAAT may be most useful when patients have new or worsening lung infiltrates, are moderately to severely ill, have received empiric antibiotics before obtaining cultures, or there is concern for multidrug-resistant bacteria or polymicrobial infection

Reference: IDSA 2020

Coding and Administrative Revisions

Administrative and coding updates referenced in review history — no patient-level coverage criteria are present in these chunks.

Administrative updates: Policy language was updated (eg, wording changed from 'may be considered medically necessary' to 'are considered medically necessary'); CPT code table revised with codes added (eg, 0528U) and deleted codes removed (eg, U0003–U0005).

Operational and coding changes only; see other sections for clinical criteria.

This policy defines coverage for outpatient molecular testing of respiratory pathogens using syndromic/multiplex and targeted panels. Syndromic or multiplex respiratory panels with 6 or more targets are considered medically necessary only when the member presents with signs or symptoms of an acute respiratory infection in the outpatient setting, results will influence clinical management, and the member meets at least one specified risk criterion (for example: immunocompromised, severe pneumonia, or exacerbation of airway disease). Current evidence does not support use of these 6+ target panels for indications outside these criteria. (See policy criteria for specifics.)

Multiplex viral panels with 5 or fewer targets (for example, assays limited to SARS‑CoV‑2, RSV, and/or Influenza A/B) are considered medically necessary when the member presents in the outpatient setting with signs or symptoms of an acute respiratory infection and the results will influence clinical management; evidence does not support use for other indications.

For bacterial respiratory infection/pneumonia panels, testing is considered medically necessary when the member presents with outpatient signs or symptoms of acute respiratory infection, the results will influence clinical management, and the member meets at least one specified clinical criterion such as new or worsening lung infiltrates, moderate to severe upper respiratory illness, prior empiric antibiotics before cultures, or concern for multidrug‑resistant or polymicrobial infection. Current evidence does not support their use for other indications.

These clinical coverage determinations align with guideline-based appropriateness statements: molecular multiplex testing can be useful in symptomatic patients and may be most appropriate when results will change management; bacterial NAAT is most valuable for new/worsening infiltrates, more severe illness, prior antibiotics, or concern for resistant or polymicrobial infection. Providers should document clinical signs/symptoms and the rationale that testing will influence management when ordering these tests.

The CPT and PLA codes listed in this clinical policy are provided for informational purposes only. Inclusion or exclusion of any code does not guarantee coverage; providers must verify appropriate code assignment and any payer-specific requirements prior to claim submission.

The policy's coding table has been updated to remove deleted HCPCS codes. Specifically, U0003, U0004, and U0005 have been removed and are no longer in‑scope; these deleted codes should not be used for claim submission.

Serologic antibody testing for acute respiratory infection is not supported by current evidence for diagnosis of active infection. Specifically, influenza A and B antibody tests and group A streptococcus antibody tests are not supported for diagnosing acute infection and should not be used for that purpose.

Clinical guideline evidence does not support the use of serologic testing to diagnose acute influenza or acute streptococcal pharyngitis. The IDSA states that serologic testing for acute influenza should not be used because results from a single serum specimen cannot be reliably interpreted. Likewise, anti‑streptococcal antibody titers are not recommended for routine diagnosis of acute pharyngitis since they reflect past infection and typically rise weeks after infection.

This section of the clinical policy provides guidance on appropriate testing and coding but is not an exhaustive list of conditions deemed "not medically necessary." The document is intended to guide medical necessity determinations; coverage decisions remain subject to the health plan's coverage documents, applicable state/federal requirements, and payer administrative policies.

Coding and Billing — CPT/HCPCS/PLA/Serology Codes

Example tests (not exhaustive)mixed

Respiratory Viral Panel, PCR (example: Quest Diagnostics)	Example listed in policy reference table
ePlex Respiratory Pathogen Panel (GenMark Diagnostics, Inc)	Example listed in policy reference table
Biofire FilmArray Respiratory Panel 2.1 (Biofire Diagnostics)	Example listed in policy reference table
Xpert Xpress SARS-CoV-2/Flu/RSV (Cepheid)	Example listed in policy reference table
Mycoplasma pneumoniae, DNA PCR (Labcorp)	Example listed in policy reference table
Streptococcus Group A Antigen Detection by Immunoassay	Example listed in policy reference table

Selected PLA/Proprietary Laboratory Assay (PLA) and molecular panel codesCPT

0202U	Infectious disease (bacterial or viral respiratory tract infection), pathogen-specific nucleic acid (DNA or RNA), 22 targets including SARS-CoV-2, qualitative RT-PCR, nasopharyngeal swab, each pathogen reported as detected or not detected
0223U	PLA with identical clinical descriptor to 0202U (see AMA CPT listing)
0225U	Infectious disease pathogen-specific DNA and RNA, 21 targets, amplified probe technique, multiplex RT
0240U	Infectious disease (viral respiratory tract infection), pathogen-specific RNA, 3 targets (SARS-CoV-2, influenza A, influenza B), each pathogen reported as detected or not detected
0241U	Infectious disease (viral respiratory tract infection), pathogen-specific RNA, 4 targets (SARS-CoV-2, influenza A, influenza B, RSV), each pathogen reported as detected or not detected
0528U	Lower respiratory tract infectious agent detection, 18 bacteria, 8 viruses, and 7 antimicrobial-resistance genes, amplified probe technique, each analyte reported as detected or not detected with semiquantitative results for 15 bacteria

Antibody/serology codesCPT

86060	Antistreptolysin O; titer
86328	Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single-step method; SARS-CoV-2
86408	Neutralizing antibody, SARS-CoV-2
86409	Neutralizing antibody, SARS-CoV-2; titer
86413	SARS-CoV-2 antibody, quantitative
86710	Antibody; influenza virus
86769	Antibody; SARS-CoV-2, quantitative

Culture, antigen, and multiple NAAT CPT codesCPT

87040	Culture, bacterial; blood, aerobic, with isolation and presumptive identification of isolates
87070	Culture, bacterial; any other source except urine, blood or stool, aerobic, with isolation and presumptive identification of isolates
87071	Culture, bacterial; quantitative, aerobic with isolation and presumptive identification of isolates, any source except urine, blood or stool
87101	Culture, fungi (mold or yeast) isolation, with presumptive identification of isolates; skin, hair, or nail
87275	Infectious agent antigen detection by immunofluorescent technique; influenza A virus
87276	Infectious agent antigen detection by immunoassay technique; Influenza A or B
87480	Infectious agent detection by nucleic acid (DNA or RNA); Candida species, direct probe technique
87501	Infectious agent detection by nucleic acid; influenza virus, includes reverse transcription, amplified probe technique, each type or subtype
87502	Infectious agent detection by nucleic acid; influenza virus, for multiple types or sub-types, includes multiplex RT, first 2 types or sub-types
87631	Infectious agent detection by nucleic acid; respiratory virus (eg, adenovirus, influenza, coronavirus, metapneumovirus, parainfluenza)

CPT/HCPCS Codes (Coding Implications)mixed

87540	Infectious agent detection by nucleic acid (DNA or RNA); Legionella pneumophila, direct probe technique.
87541	Infectious agent detection by nucleic acid (DNA or RNA); Legionella pneumophila, amplified probe technique.
87542	Infectious agent detection by nucleic acid (DNA or RNA); Legionella pneumophila, quantification.
87550	Infectious agent detection by nucleic acid (DNA or RNA); Mycobacteria species, direct probe technique.
87551	Infectious agent detection by nucleic acid (DNA or RNA); Mycobacteria species, amplified probe technique.
87552	Infectious agent detection by nucleic acid (DNA or RNA); Mycobacteria species, quantification.
87555	Infectious agent detection by nucleic acid (DNA or RNA); Mycobacteria tuberculosis, direct probe technique.
87556	Infectious agent detection by nucleic acid (DNA or RNA); Mycobacteria tuberculosis, amplified probe technique.
87560	Infectious agent detection by nucleic acid (DNA or RNA); Mycobacteria avium-intracellulare, direct probe technique.
87561	Infectious agent detection by nucleic acid (DNA or RNA); Mycobacteria avium-intracellulare, amplified probe technique.

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inv-18: Multiplex panel target count

Policy thresholdSyndromic/multiplex respiratory panels with 6 or more targets are managed under a separate coverage standard (6+ targets).

Alternative thresholdMultiplex respiratory viral panels with 5 or fewer targets are evaluated under criteria specific to 5-or-fewer target panels.

Coverage triggerPanels with 6+ targets are considered medically necessary only when outpatient signs/symptoms of acute respiratory infection are present, results will influence management, and the patient meets at least one risk criterion (immunocompromised, severe pneumonia, or exacerbation of airway disease).

Evidence noteCurrent evidence does not support routine use of syndromic multiplex panels (6+ targets) outside listed indications.

Provider Actions, Documentation, and Billing Guidance

Prior Authorization

Prior authorization: not specified

Prior authorization requirements are not specified in this portion of the clinical policy.

Note

Molecular panel code awareness

The policy references specific PLA/CPT molecular respiratory panel codes for informational coding purposes; providers should verify appropriate code assignment with the payer.

Examples cited include 0202U, 0223U, 0225U, 0240U, 0241U, and 0528U.

Prior Authorization

Prior authorization — general note

No explicit prior authorization rules are provided in these document sections; billing should use the listed CPT/HCPCS codes per payer processes and guidance.

Background and Clinical Context

Respiratory infections such as influenza, RSV, and SARS‑CoV‑2 cause substantial morbidity and may present with overlapping symptoms. Accurate pathogen identification using molecular tests can inform antiviral or antimicrobial decisions and infection control measures, and treatment is often most effective when started within 48–72 hours of symptom onset. Testing approaches include targeted NAATs for specific pathogens (eg, SARS‑CoV‑2, influenza, RSV), multiplex molecular panels that detect multiple viruses or bacteria simultaneously, and bacterial NAATs which can be useful in selected clinical scenarios (for example, new or worsening infiltrates or prior empiric antibiotics). Guideline recommendations support testing symptomatic patients when results will influence management and reserve broad syndromic multiplex panels for higher‑risk or complex cases as defined in the criteria.

Definitions and Key Terms

inv-36: Severe pneumonia definition per IDSA/ATS — major criteria examples

Definition (IDSA/ATS)Severe pneumonia is defined as presence of one major criterion or at least three minor criteria per IDSA/ATS.

Major criteria examplesSeptic shock requiring vasopressors; respiratory failure requiring mechanical ventilation.

Minor criteria examplesRespiratory rate >30 breaths/min; PaO2/FiO2 <250; multilobar infiltrates; confusion/disorientation; uremia (BUN >20 mg/dl); leukopenia (WBC <4,000/µL); thrombocytopenia (platelets <100,000/µL); hypothermia (<36°C); hypotension requiring aggressive fluid resuscitation.

inv-37: Airway disease — definition includes COPD, emphysema, cystic fibrosis, asthma, bronchiectasis

Term definitionAirway disease is a nonspecific term encompassing a heterogeneous group of conditions including chronic obstructive pulmonary disease (COPD), emphysema, cystic fibrosis, asthma, and bronchiectasis.

Policy Revision History and Changes

2024-11-01Annual review / wording and criteria updateLatest

Annual review: changed policy verbiage from 'may be considered medically necessary' to 'are considered medically necessary', expanded Group A Streptococcus pharyngitis culture criteria to include patients up to 18 years old, and updated background/rationale with AAFP 2024 evidence review.

2024-03-01CPT table maintenance

Updated CPT code table descriptions and removed code 0373U during CPT table corrections.

2024-02-01

Policy Summary

Payerpartners_health_management

PolicyOutpatient respiratory pathogen testing (Respiratory panels, influenza, RSV, SARS-CoV-2, GAS)

Policy CodePolicy CG.CP.MP.01

Change TypeCoding and clinical criteria updates

Effective Date

Last ReviewNov 1, 2024

Next Review DateJan 1, 2025

Key ActionDocument signs/symptoms of acute respiratory infection and the rationale that test results will influence clinical management when ordering respiratory diagnostic tests.

SourceLink

On This Page

Group A Strep testing in pharyngitis: Swab the throat and perform RADT and/or culture because clinical features alone do not reliably discriminate GAS from viral pharyngitis; in children/adolescents a negative RADT should be backed up by throat culture; RADT may be omitted in low clinical risk (eg children <3 years)

References: IDSA 2012 and AAFP 2024

Serologic antibody testing for acute influenza or GAS: Serologic testing for acute influenza is not recommended (single serum specimens are not interpretable); anti-streptococcal antibody titers are not useful for routine diagnosis of acute pharyngitis as they reflect past infection and rise weeks after infection

References: IDSA influenza guidance and GAS antibody discussion

inv-19: Multiplex target counts

3-5 targetsCPT 87631: respiratory virus multiplex amplified probe technique, 3-5 targets.

6-11 targetsCPT 87632: respiratory virus multiplex reverse transcription/amplified probe technique, 6-11 targets.

12-25 targetsCPT 87633: respiratory virus multiplex reverse transcription/amplified probe technique, 12-25 targets.

Coding rationaleTarget-count ranges map to distinct CPT descriptors and inform appropriate code selection based on number of analytes included in the panel.

CDC/non-CDC viral identification codes U0001 and U0002 are referenced as examples of HCPCS codes used for viral testing.

Step Therapy

When to escalate to bacterial NAAT

Consider bacterial NAAT (nucleic acid amplification testing) when patients have new or worsening lung infiltrates, are moderately to severely ill, received empiric antibiotics before cultures, or there is concern for multidrug-resistant or polymicrobial infection.

IDSA guidance describes these scenarios as when bacterial NAAT may be most useful.

Documentation Required

Required clinical documentation

Document that the member presented with signs or symptoms of an acute respiratory infection, specify which clinical criteria are met (for example immunocompromised status, severe pneumonia criteria, or airway disease exacerbation), and state that test results will influence clinical management to support medical necessity.

Documentation Required

GAS testing documentation and confirmation

For suspected Group A Streptococcus (GAS) pharyngitis, swab the throat and perform a rapid antigen detection test (RADT) and/or culture when clinical features do not clearly indicate a viral etiology; in children and adolescents a negative RADT should be backed up by a throat culture.

Clinical features supportive of GAS include acute sore throat, fever, tonsillopharyngeal erythema or exudates, tender anterior cervical lymphadenitis, palatal petechiae, or scarlatiniform rash.
Antibody/serologic testing is not recommended for diagnosis of acute GAS pharyngitis.

Billing Rule

Provider billing and administrative compliance

When submitting claims, follow the Health Plan's coverage documents and applicable state and federal requirements; the clinical policy is guidance and does not guarantee payment.

Reference the most up-to-date coding and payer guidance prior to claim submission.

Denial Risk

Syndromic/multiplex 6+ targets — limited indications

Syndromic multiplex respiratory panels with 6 or more targets are limited to outpatient members with signs or symptoms of an acute respiratory infection, when the member meets at least one listed risk criterion (eg, immunocompromised, severe pneumonia, airway disease exacerbation) and results will influence clinical management; other indications are not supported.

Denial Risk

SARS-CoV-2/RSV/Flu or multiplex ≤5 targets — limited indications

SARS‑CoV‑2, RSV, influenza A/B, or multiplex viral panels with five or fewer targets are limited to outpatient members who present with signs or symptoms of an acute respiratory infection and when results will influence clinical management; other indications are not supported.

Denial Risk

Bacterial panels — limited indications

Bacterial respiratory infection/pneumonia panels are limited to outpatient acute respiratory infection when the member meets at least one clinical criterion (eg, new or worsening lung infiltrates, moderate-to-severe illness, prior empiric antibiotics, or concern for MDR/polymicrobial infection) and results will influence management.

Denial Risk

Group A streptococcus testing — conditional

Group A streptococcus testing requires a compatible clinical presentation without strong viral features; for cultures, members aged 3–18 years with a negative RADT should have a throat culture when clinical criteria are met.

Antibody tests are not supported for diagnosing acute GAS infection.

Note

Coding inclusion not guarantee of coverage

Inclusion or exclusion of CPT codes in this clinical policy is informational only and does not guarantee coverage; providers should verify coding and coverage with the payer before claim submission.

Billing Rule

Use of deleted/outdated codes may cause claim processing issues

Failure to use current, in‑scope codes (for example removed/deleted codes such as U0003–U0005) or outdated code descriptions may lead to claim processing issues or denials.

The policy notes removal of deleted codes U0003, U0004, and U0005 and addition of code 0528U in the CPT table.

Note

Provider informational note

Providers should follow the policy's informational guidance when ordering tests and ensure tests are appropriate to the clinical presentation; the clinical policy and coding sections describe examples and context for provider decision-making.

See the policy's coding table for example PLA/CPT molecular panel codes and descriptions.

Note

Provider action — verify payer requirements

Reserved for provider-impact content and administrative reminders from the policy; confirm payer-specific requirements before ordering or billing.

Clinical relevanceIncluded as a risk criterion for higher-complexity testing (eg, syndromic 6+ target panels) when exacerbation is present.

Examples listedCOPD; emphysema; cystic fibrosis; asthma; bronchiectasis.

inv-38: Signs and symptoms of acute respiratory infection — URTI/LRTI symptoms list

Symptoms listUpper or lower respiratory tract symptoms: cough, runny nose, sore throat, bronchitis, pneumonia, bronchiolitis; may occur with or without fever.

Influenza-like illness (ILI)Fever plus either cough or sore throat qualifies as ILI.

Respiratory distressDifficulty breathing characterized by increased respiratory rate and use of accessory muscles; presence supports testing under policy criteria.

inv-39: Molecular multiplex testing — definition and testing modality notes

DefinitionMolecular multiplex testing: simultaneous molecular (NAAT/RT‑PCR) testing for multiple respiratory viruses in a single panel.

Clinical utilityMay be more cost‑effective than antigen or culture methods at certain disease prevalence thresholds and is supported by IDSA guidance for selected indications.

Modality noteTypically performed as NAAT/RT‑PCR or amplified probe techniques with multiple analytes reported as detected/not detected.

inv-40: Bacterial NAAT — definition and clinical utility notes

DefinitionBacterial NAAT: nucleic acid amplification testing for bacterial pathogens (eg, amplified probe NAAT).

IndicationsMost useful for new or worsening lung infiltrates, moderate-to-severe illness, prior empiric antibiotics before cultures, or concern for multidrug‑resistant or polymicrobial infection.

Clinical impactConsidered when results will influence clinical management and guide targeted antimicrobial therapy.

inv-41: Multiplex amplified probe technique — term definition

TermMultiplex amplified probe technique refers to an NAAT method that detects multiple respiratory targets simultaneously using amplified probes.

Association with CPT codesUsed in CPT descriptors for multiplex respiratory virus panels (eg, 87631–87633 describe multiplex amplified probe techniques across target ranges).

Clinical contextTechnique supports rapid simultaneous detection of multiple pathogens for symptomatic patients when indicated.

inv-42: U0001 / U0002 — CDC and Non-CDC viral identification test codes description

Codes describedU0001 = CDC Test; U0002 = Non‑CDC viral identification test, amplified probe.

Usage noteThese HCPCS codes are listed as descriptors for SARS‑CoV‑2 and other viral testing; billing should follow payer guidance and current coding tables.

Coding maintenanceDeleted HCPCS codes U0003–U0005 were removed from scope; providers must use current codes only.

Structural and coding section updates

Added 'Lab' to policy title, removed CPT and ICD-10 codes from the policy reference table, and added a CPT code table while moving the 'coding implications' section.

2024-02-24Approval / administrative entry

Policy developed and reviewed by external specialist; administrative entries recorded in revision history.

2024-11-24Coding addition

Added 0528U as an in-scope CPT code and reordered CPT codes numerically in the code table.

2024-11-24Code removals

Removed deleted HCPCS codes U0003, U0004, and U0005 from the policy scope.