ModifiedHealthfirstPolicy N/A

Coronavirus Testing in the Outpatient Setting

Defines coverage, limitations, and reimbursement rules for outpatient testing for human coronaviruses (including SARS-CoV-2) for medical decision-making; applies to Healthfirst providers and members in North Carolina (state-specific regulations referenced).

Policy Summary

PayerHealthfirst

PolicyCoronavirus Testing in the Outpatient Setting

Policy CodePolicy N/A

Change TypeClarifications, code removals, and coverage expansion for MIS diagnoses

Effective DateOct 15, 2025

Next Review DateN/A

Key ActionConfirm negative rapid antigen results with an FDA-authorized molecular assay when necessary for clinical management and document testing indication for outpatient medical decision-making.

SourceLink

POLICY UPDATE CHANGES

Updated the background, guidelines and recommendations, and evidence‑based scientific references; literature review did not necessitate modifications to coverage criteria but made clarifying changes and code removals.

Removed CPT codes 86318, 87428, 87631, 87632, 87633, 0115U, 0202U, 0223U, 0225U, C9803 and others across revision history entries.

Added NAAT as an acceptable test for MIS‑A and MIS‑C alongside antibody serology testing.

Targeted NAAT coveredTargeted NAAT covered

48hAntigen testing frequency

Excluded

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Genotyping/neutralization excluded

IncidentalSpecimen collection incidental

0.41%Pre-op PCR positive rate

15+Codes listed/changed

Coverage Criteria for SARS-CoV-2 Testing

NAAT (RT-PCR) Covered Indications

Targeted nucleic acid testing (e.g., RT‑PCR, rapid molecular tests) for SARS‑CoV‑2 meets coverage when ANY of the following are met:

NAAT covered indications: a) Individuals displaying signs and symptoms of possible COVID-19 infection

See Note 1 for symptom examples

NAAT covered indications: b) Asymptomatic individuals with known exposure to COVID-19 EXCEPT when the individual has had a previous COVID-19 infection within the last 90 days90 days

NAAT covered indications: c) Individuals with signs or symptoms of SARS and who have traveled to endemic areas or been exposed to persons with SARS — targeted RT‑PCR for SARS coronavirus RNA meets coverage

NAAT covered indications: d) Individuals with signs or symptoms of MERS and who have traveled to endemic areas or been exposed to persons with MERS — targeted RT‑PCR for MERS coronavirus RNA meets coverage

Additional Covered Uses

Additional covered indications:

MIS/PASC support: Nucleic acid amplification testing AND host antibody serology testing to support diagnosis of MIS‑C, MIS‑A, or PASC

See Notes 2 and 3 for MIS definitions

Antigen testing: For symptomatic individuals, antigen‑detecting diagnostic tests for SARS‑CoV‑2 are covered once every 48 hours48 hours

Antigen testing — interpretation and operational criteria

Use and interpretation guidance

Antigen test performance and interpretation: Antigen tests must be performed on the specified platform (e.g., Sofia2 where required) and per manufacturer instructions; a positive antigen result cannot distinguish SARS‑CoV from SARS‑CoV‑2 or viable versus non‑viable virus, and negative antigen results should be treated as presumptive and confirmed with an FDA‑authorized molecular assay if necessary for clinical management (including infection control).

Antigen tests have lower sensitivity at low viral loads and may perform differently on frozen versus fresh samples.

Multiplex respiratory panel — interpretation and operational criteria

Multiplex panel use and limitations

Panel testing constraints: Multiplex respiratory panels (e.g., BioFire RP2.1, QIAstat‑Dx, ePlex RP2, cobas, CDC Flu SC2) are qualitative, must be run on their proprietary systems, are not intended as the sole basis for diagnosis or patient management, and negative results do not exclude infection; some panels have limitations including reduced sensitivity for specific targets (e.g., B. pertussis on BioFire RP2.1) and inability to reliably distinguish closely related viruses (e.g., rhinovirus versus enterovirus).

If four or more organisms are detected the sample should be retested; follow-up testing or alternate methods may be required to differentiate certain pathogens.

Test selection and special-case criteria

Use-case guidance and when specific test types are appropriate:

WHO Ag‑RDT use conditions: Ag‑RDTs that meet WHO minimum performance requirements can be used to diagnose symptomatic individuals within ~5–7 days of symptom onset and in settings with ongoing community transmission; for asymptomatic testing limit use to contacts and high‑risk workers; when transmission is low, NAAT is preferred or used to confirm Ag‑RDT results.WHO performance and epidemiologic context

References WHO recommendations for Ag‑RDT use

CDC testing selection guidance: Use NAAT/PCR as first‑line in most situations; antigen tests are acceptable in specified scenarios per CDC (including repeat antigen strategies); avoid NAAT for diagnosing new infection within 90 days of a prior positive due to persistent RNA detection.time since prior positive test

CDC guidance on test selection and retesting windows

MIS‑C laboratory criteria:

MIS-C diagnostic criteria (CDC summary)

Covered when ALL of the following are present as defined by CDC:

MIS‑C core criteria: Subjective or documented fever; clinical severity requiring hospitalization or resulting in death; evidence of systemic inflammation (e.g., CRP ≥30 mg/L); new onset manifestations in ≥2 categories (cardiac, mucocutaneous, gastrointestinal, hematologic); and laboratory evidence of SARS‑CoV‑2 infection or epidemiologic linkage within 60 days.see children nodes

Cardiac examples include LVEF <55% or coronary artery changes; hematologic criterion includes platelet count <150,000/µL.

MIS-A diagnostic criteria (CDC summary)

Covered when ALL of the following are met:

MIS‑A core criteria: Hospitalization >24 hours AND subjective or documented fever for ≥24 hours prior to or within the first 3 days of hospitalization; no alternative diagnosis; at least 3 clinical criteria with ≥1 primary (severe cardiac illness OR rash plus non‑purulent conjunctivitis); evidence of SARS‑CoV‑2 infection (NAAT, antigen, or serology) AND evidence of systemic inflammation (elevated ≥2 markers such as CRP, ferritin, IL‑6, ESR, procalcitonin).see text

Cardiac arrest alone does not meet the primary cardiac criterion; thrombocytopenia is platelet count <150,000/µL.

Long COVID considerations

Clinical diagnosis guidance:

Long COVID features: Symptoms present for at least 3 months after SARS‑CoV‑2 infection; presentation can be relapsing/remitting and involve multiple organ systems; no single laboratory test definitively diagnoses Long COVID — serology or PCR may help document prior infection but are not required for diagnosis.>=3 months

Post‑exertional malaise commonly worsens 12–48 hours after exertion and can last days to weeks.

Covered clinical indications for SARS-CoV-2 testing

Covered uses and clinical scenarios described by cited societies and agencies include:

Primary recommended uses of serology: Serologic testing is supported for identifying past infection or recovery, screening convalescent plasma donors, epidemiology/seroprevalence studies, vaccine response studies, and supporting diagnosis in symptomatic patients with late presentation or after negative molecular testing; it is not recommended as the primary approach for acute diagnosis.

Based on AACC and ECDC guidance

MIS‑C evaluation: Serology (antibody) and RT‑PCR testing should be performed for suspected MIS‑C; serology may be positive more often than PCR and may be needed later if initial tests are negative.

AAP and ACR guidance

Testing in symptomatic or exposed individuals: NAAT (PCR) and antigen tests are appropriate for symptomatic patients; repeat antigen testing at 48 hours may be reasonable after a negative antigen per AAP/FDA guidance; serology is not useful for return‑to‑work or determining individual immunity.

AAP and AACC notes

Revision summary (coverage impacts)

Summary of revisions to coverage criteria

Revisions noted: Literature review did not necessitate modifications to core coverage criteria; clarifications were made, some codes removed, antigen panel testing for respiratory pathogens moved to policy G2149; NAAT was added as acceptable for MIS‑A and MIS‑C; antigen testing frequency for symptomatic individuals updated to once every 48 hours.

Reflects revision history entries referenced in the policy.

Whole genome sequencing of paired specimens to establish SARS‑CoV‑2 reinfection and routine outpatient SARS‑CoV‑2 genotyping do not meet coverage criteria. Neutralization antibody testing and testing for endemic human coronaviruses (229E, NL63, OC43, HKU1) are also listed as not covered. These exclusions reflect the policy determination that the available evidence does not support routine clinical benefit for these applications in the outpatient setting.

Antigen-detecting assays must be used per their EUA/manufacturer labeling and, where specified, on the required platform (for example, the Sofia2 system). A positive antigen result cannot distinguish SARS‑CoV from SARS‑CoV‑2 and antigen tests do not differentiate viable from non‑viable virus. Antigen tests are authorized for use on specified specimen types (typically nasal or nasopharyngeal swabs); use on non‑labeled specimen types without a validated LDT may produce inaccurate results and risk reimbursement denial. Negative antigen results should be treated as presumptive and confirmed with an FDA‑authorized molecular assay when needed for clinical management because antigen sensitivity is lower at low viral loads and varies by test and specimen handling.

The BioFire Respiratory Panel 2.1 (RP2.1) is a qualitative multiplex assay intended for use on the BioFire FilmArray systems and has specific organism performance limitations. Of note, the RP2.1 has comparatively low sensitivity for Bordetella pertussis and should not be used when pertussis is specifically suspected; an FDA‑cleared B. pertussis molecular test is recommended in that setting. The panel may also have difficulty distinguishing closely related viruses (for example, rhinovirus versus enterovirus) and cannot reliably identify every strain or variant; results should be interpreted in clinical context and followed up with alternate methods if specific differentiation is required.

WHO guidance notes that nucleic acid testing (NAAT) is the primary method for routine confirmation and specifically recommends that saliva should not be used as the sole specimen type for routine clinical diagnostics. While saliva has been evaluated as an alternative specimen and may be acceptable in selected settings, WHO discourages relying on saliva alone for routine diagnostic use.

For MIS‑C surveillance and reporting, if the clinical treatment team documents a final diagnosis of Kawasaki disease, that diagnosis should be considered an alternative and the case should not be reported to national MIS‑C surveillance systems; clinical documentation should reflect that determination.

Serologic (antibody) testing has important limitations and is not appropriate for diagnosing or excluding acute SARS‑CoV‑2 infection or for certifying individual protective immunity or return‑to‑work decisions. FDA and professional society guidance emphasize that antibody results should not be used alone to make clinical decisions about acute infection or to determine individual immunity; serology is primarily useful for documenting prior infection, epidemiology/seroprevalence, donor screening, or as an adjunct when used appropriately by clinicians experienced in interpretation.

Prior versions of this policy made specific explicit changes clarifying that SARS‑CoV‑2 genotyping in the outpatient setting does not meet coverage criteria. This exclusion (genotyping non‑coverage for outpatient testing) was added in prior revisions and remains in effect.

Host antibody serology testing for situations not explicitly covered by the listed indications is stated as not meeting coverage criteria. In other words, serologic testing is not covered when used outside the specified, supported clinical scenarios (for example, routine screening to determine immunity or for unspecified diagnostic use).

Antibody tests should not be used to diagnose or exclude acute SARS‑CoV‑2 infection. FDA policy explicitly states that results from antibody testing should not be used for diagnostic decision‑making for active infection, and expert guidance cautions about cross‑reactivity, timing‑dependent sensitivity, and uncertain correlation between measured antibody levels and protective immunity.

Rapid antigen tests have significantly lower sensitivity than NAATs in some settings; therefore, they should not be used alone for definitive diagnosis when clinical management or infection control requires high sensitivity. Published evaluations demonstrate wide sensitivity variability across RADTs, and point estimates as low as ~30% have been reported for some assays, underscoring the need for confirmatory molecular testing when a highly sensitive result is required.

Because of lower sensitivity, the rapid antigen test alone is not recommended for initial COVID‑19 diagnosis in settings where sensitivity is critical. When antigen testing is used for symptomatic individuals, negative antigen results that would change clinical management or infection control should be confirmed with an FDA‑authorized molecular assay.

Routine serologic testing to determine immune status, to issue so‑called 'immunity certificates,' or to guide return‑to‑work or cohorting decisions is not supported. Professional societies (AMA, AACC, IDSA and others) advise that serology should not be used to make these individual placement or workforce decisions because antibody presence does not reliably indicate protective immunity.

Antibody tests are not supported for determining individual immunity or for operational decisions such as placement or grouping of individuals. The policy aligns with AACC and ECDC guidance that serologic results cannot reliably determine protection and therefore should not drive cohorting, PPE assignment, or return‑to‑work decisions.

Multiplex PCR panels detecting six or more respiratory pathogens were removed from this policy and are now managed under the separate G2149 — Pathogen Panel Testing policy. Providers should refer to G2149 for coverage and operational details for larger multiplex panels.

Indications Where Testing Is Covered

inv-85: Acute diagnostic testing with NAAT for symptomatic patients, exposures, suspected SARS/MERS, MIS/PASC support

Acute diagnostic testing and related coverage considerations:

Acute diagnostic NAAT: NAAT (e.g., RT‑PCR, rapid molecular tests) for symptomatic patients, asymptomatic individuals after exposure (unless prior infection within 90 days), and for suspected SARS or MERS with relevant travel/exposure meets coverage.90 days (prior infection exclusion)

Policy applies to outpatient testing for medical decision‑making.

MIS/PASC support: NAAT, antigen, or serology can support diagnosis of MIS‑C, MIS‑A, or PASC when clinical criteria are present.

See MIS‑C and MIS‑A diagnostic criteria for required clinical and laboratory elements.

inv-86: Pre-procedural screening of asymptomatic patients (NAAT/PCR) and antigen EUA limitations

Pre‑procedural and EUA considerations:

Frequency and Retesting Limits

Antigen-detecting diagnostic tests (symptomatic individuals) — once every 48 hours

Policy frequencyAntigen-detecting diagnostic tests for symptomatic individuals are covered once every 48 hours.

ApplicabilityApplies to antigen rapid tests used for symptomatic individuals per manufacturer/EUA labeling.

Revision noteFrequency updated in 12/04/2024 revision and reiterated in 06/04/2025 update.

Pre-procedural PCR — frequency or repeat instructions

Policy statementPre-procedural PCR screening (asymptomatic) is described in published protocols but the policy does not specify a repeat frequency for pre-procedural PCR testing.

Study findingOne pre-operative study (n=7,579) detected 0.41% positives, with impact on scheduling and costs; number needed to test was 244.

Coding, Reimbursement, and Code Lists

Specimen collection codesmixedNot Covered

specimen collection codes

Specimen collection codes for coronavirus testing are considered incidental and will not be reimbursed

Coding duplicationmixed

HCPCS and AMA procedure codes

Do not bill both HCPCS and AMA code for same procedure and date of service; only one code reimbursed

Clinical case definitions referencedmixed

MIS-C clinical/diagnostic criteria

CDC case definitions and laboratory criteria for MIS-C (includes molecular, antigen, and serology detection within specified timeframes)

Applicable SARS-CoV-2 test codes (CPT/HCPCS/Proprietary)mixed

86328	Immunoassay for infectious agent antibody(ies) qualitative or semiquantitative
86408	Neutralizing antibody, SARS-CoV-2; screen
86409	Neutralizing antibody, SARS-CoV-2; titer
86413	SARS-CoV-2 antibody, quantitative
86769	Antibody; SARS-CoV-2
87426	Infectious agent antigen detection by immunoassay technique; SARS-CoV-2 (qualitative or semiquantitative)
87635	Infectious agent detection by nucleic acid (RNA) SARS-CoV-2
87798	Infectious agent detection by nucleic acid, not otherwise specified; amplified probe technique
87811	Infectious agent antigen detection by immunoassay with direct optical observation; SARS-CoV-2
87913	Infectious agent genotype analysis by nucleic acid; SARS-CoV-2 mutation identification in targeted region(s)

1–10 of 14

1/2

Coding changes (added/removed) referenced in revision historyCPT

86318	removed
87428	removed
87631	removed
87632	removed
87633	removed
0115U	removed
0202U	removed
0223U	removed
0225U	removed
C9803	deleted (effective 01/01/2024)

1–10 of 15

1/2

Antigen testing frequency — once every 48 hours for symptomatic individuals (coding frequency note)

Coding frequency noteAntigen testing frequency for symptomatic individuals: once every 48 hours.

ContextThis frequency was added/confirmed in the 12/04/2024 revision and reiterated in later updates.

Provider actionEnsure claims reflect frequency limits and clinical indication to support coverage.

BioFire RP2.1 LoD — 500 copies/mL (heat-inactivated) and 160 copies/mL (infectious)

BioFire RP2.1 LoD (heat-inactivated)500 copies/mL (heat-inactivated isolate).

Provider Actions, Documentation, and Denial Risk

Prior Authorization

Prior authorization — verify for listed SARS‑CoV‑2 codes

Potential prior-authorization may apply for certain SARS-CoV-2 test codes. Verify payer-specific prior-authorization rules before ordering tests that fall outside routine targeted NAAT for symptomatic or exposed individuals.

Check prior-authorization requirements for specialized or high-cost SARS-CoV-2 assays and sequencing codes before performing testing.
Review the member’s benefit and Healthfirst prior-authorization policies for listed CPT/HCPCS codes (see Applicable Codes).

Denial Risk

Denial risk for non-covered tests

Tests that do not meet the coverage criteria described in this policy (for example, routine screening unrelated to medical decision-making, genotyping for outpatient use, neutralization antibody testing, and tests for endemic non-covered coronaviruses) may be denied. Requests must be supported by documentation showing clinical indications.

Ordering Requirements and Test Use

Documentation Required

Order tests only for outpatient medical decision‑making

Testing must be ordered for medical decision‑making in the outpatient setting and consistent with the member's benefit coverage; applicability of coverage depends on the individual's evidence of coverage and plan rules.

Note

Follow EUA labeling and confirm negative antigen results as directed

Follow the manufacturer's EUA labeling and intended use (including intended populations, specimen types, and point‑of‑care settings); negative antigen results that influence management should be handled per the guidance (repeat or confirm with NAAT as indicated).

Use antigen tests within the EUA‑authorized symptom window (e.g., within first five days for some EUA tests).
Confirm negative antigen results with molecular assays when required for clinical decisions.

Tests and Uses That Do Not Meet Coverage

The policy specifically excludes outpatient SARS‑CoV‑2 genotyping, routine whole genome sequencing to adjudicate reinfection, neutralization antibody testing, and testing for endemic human coronaviruses from coverage. These items are listed as not covered and may be denied if submitted for routine outpatient medical decision‑making.

Point‑of‑care serologic tests and some rapid antibody lateral flow assays have demonstrated variable and sometimes poor accuracy in published studies and meta‑analyses. Because of uncertain performance for diagnostic use, point‑of‑care serologic tests with poor or uncertain accuracy are not supported for standalone diagnostic use and do not meet coverage.

Rapid antigen tests used alone are not covered as a definitive diagnostic method in clinical scenarios where confirmatory molecular testing is clinically necessary due to sensitivity limitations. Policy guidance recommends confirming negative antigen results with NAAT when a more sensitive diagnostic result is required for patient management or infection control.

WHO advises against routine viral culture or isolation as a diagnostic procedure and does not recommend viral culture for routine clinical diagnosis. Such procedures are therefore not supported as a standard diagnostic approach in the outpatient setting.

Serologic testing is not supported as the primary diagnostic approach, nor for determining protective immunity, return‑to‑work, cohorting, or PPE decisions. These uses are explicitly discouraged by professional organizations and are considered not medically necessary for routine coverage.

Antibody tests should not be used to make individual immunity determinations, return‑to‑work decisions, or placement/grouping decisions in congregate settings. Reimbursement for such uses is not supported due to lack of clinical utility for individual decision‑making.

Definitions and Abbreviations

NAAT / RT-PCR definition

DefinitionNAAT / RT-PCR: nucleic acid amplification tests (e.g., RT-PCR) that detect viral RNA and are the most sensitive and specific tests for current infection.

Detection windowRT-PCR detects viral RNA during the initial phase of infection when viral RNA concentrations are high; RNA declines after recovery.

Clinical roleUsed to diagnose acute infection; follow specimen type and timing guidance when ordering.

Serology / Antibody testing definition

DefinitionSerology / Antibody testing: assays that detect host immunoglobulins (IgM, IgA, IgG, or total antibodies) produced in response to SARS-CoV-2 infection.

Use casesPrimarily used to detect prior infection, support late-phase diagnosis, convalescent plasma donor screening, epidemiology, and vaccine response studies.

Background and Evidence Summary

Human coronaviruses are a family of enveloped, positive‑sense RNA viruses that include seven species known to infect humans; SARS‑CoV‑2 is the causative agent of COVID‑19 and can produce a spectrum of illness from asymptomatic infection to severe respiratory and systemic disease. Diagnostic approaches discussed in this policy include nucleic acid amplification testing (NAAT/RT‑PCR), antigen‑detecting diagnostic tests, and host antibody serology, each with specific operational characteristics and roles in clinical care and public health.

Policy Summary

PayerHealthfirst

PolicyCoronavirus Testing in the Outpatient Setting

Policy CodePolicy N/A

Change TypeClarifications, code removals, and coverage expansion for MIS diagnoses

Effective DateOct 15, 2025

Next Review DateN/A

Key ActionConfirm negative rapid antigen results with an FDA-authorized molecular assay when necessary for clinical management and document testing indication for outpatient medical decision-making.

SourceLink

On This Page

Case identification may rely on detection of SARS‑CoV‑2 RNA, antigen, or specific antibodies within 60 days prior to or during hospitalization, or epidemiologic linkage; self‑administered positive antigen or molecular tests meet laboratory criteria.

CDC MIS‑C reporting criteria

Pre‑procedural screening: Pre‑procedural NAAT/PCR screening of asymptomatic patients has been used in published protocols; one study reported 0.41% positive rate among 7,579 preoperative tests with impacts on scheduling and cost.

Providers should document indication and impact on procedures when applicable.

Antigen EUA limitations: Antigen tests authorized under EUA are often limited to symptomatic individuals within early days of symptom onset per manufacturer labeling; follow EUA instructions for intended populations and specimen types.

Failure to follow label instructions may invalidate results.

inv-87: Patients suspected of COVID-19 by their healthcare provider — test intended populations

Intended populations for multiplex panels:

Patients suspected by provider: Multiplex respiratory panels and other EUA assays are intended for use in patients suspected of COVID‑19 by their healthcare provider; positive results indicate active infection but do not exclude co‑infection and must be interpreted with clinical correlation.

Panel performance may be unestablished in immunocompromised or asymptomatic individuals for some assays.

inv-88: Diagnostic testing for suspected infection and public health surveillance (incl. variant detection) — includes RT-LAMP, CRISPR, NGS

Diagnostic testing modalities and surveillance use:

Rapid molecular and point‑of‑care NAAT: RT‑LAMP and CRISPR‑enhanced assays may be appropriate where rapid point‑of‑care molecular testing is needed; these methods have demonstrated high agreement with RT‑qPCR at higher viral loads (e.g., Ct <30).CT <30 (performance reference)

OpVCRISPR and validated RT‑LAMP protocols can extend rapid molecular testing options.

NGS for surveillance: NGS/WGS assays (e.g., Illumina COVIDSeq, Helix COVID‑19 NGS) are used for surveillance and variant detection consistent with their EUA indications; reported LODs and performance should guide ordering and interpretation.LOD 125 gce/mL (example)

Order NGS assays per EUA‑specified specimen types.

inv-89: Pooled screening — pooled RT-PCR/TMA testing descriptions and workflows

Pooled testing workflows and limits:

Pooled screening: Pooled RT‑PCR/TMA testing is described for population screening with validated pool sizes and confirmation workflows; detection of a single positive sample has been reported in pools up to 32 samples, with increasing false negatives at larger pool sizes.pools up to 32

Use EUA‑authorized pooling procedures and confirmatory testing as required.

inv-90: Support diagnosis of MIS-C or MIS-A when clinical criteria present — molecular, antigen, or serology within specified windows

Supportive laboratory evidence when clinical criteria present:

MIS diagnostic support: When clinical criteria for MIS‑C or MIS‑A are met, molecular (NAAT/PCR), antigen, or serologic evidence of current or prior SARS‑CoV‑2 infection within specified windows (commonly up to 60 days) supports the diagnosis.60 days

Self‑administered positive antigen or molecular tests meet laboratory criteria per CDC guidance.

inv-91: Serology to support diagnosis in late-phase illness or complications (useful when molecular negative)

Serology use in late‑phase illness and complications:

Serology for late‑phase evaluation: Host antibody serology testing is useful to support diagnosis in late‑phase illness or complications (e.g., when molecular testing is negative) and for epidemiology and convalescent plasma donor screening.

Serology should not be used to determine individual immunity or for return‑to‑work decisions.

inv-92: Additional supported uses — late presentation, donor screening, epidemiology, vaccine response studies

Additional supported uses where clinical context warrants:

Supported late/epidemiologic uses: Support diagnosis in symptomatic patients with late presentation or after negative molecular testing; MIS‑C evaluation; donor screening; epidemiology/seroprevalence studies; vaccine response studies.

Order tests appropriate to the clinical or study objective.

inv-93: Support diagnosis of MIS‑C, MIS‑A, or PASC — NAAT and serology meet coverage as of 12/04/2024 revision

Policy update reflecting coverage expansion for inflammatory syndromes:

MIS/PASC coverage update: As of the 12/04/2024 revision, NAAT and host antibody serology testing meet coverage criteria to support diagnoses of MIS‑C, MIS‑A, or PASC.

See revision history for details on code and note changes.

inv-94: Symptomatic individuals — antigen-detecting diagnostic tests covered once every 48 hours

Frequency limit for symptomatic antigen testing:

Symptomatic antigen frequency: Antigen‑detecting diagnostic tests for SARS‑CoV‑2 meet coverage criteria when used once every 48 hours for symptomatic individuals.48 hours

Updated in revision history per 12/04/2024 and later summaries.

Operational noteFollow local institutional protocols and document indications and any procedure delays or cancellations when positive.

Retest sample if panel detects four or more organisms — operational retesting guidance

Retest triggerIf a multiplex respiratory panel result shows four or more organisms detected, the sample should be retested.

RationalePanels are qualitative and multiple detections may reflect contamination, mixed infection, or technical issues; retesting helps verify results.

Interpretation noteA negative panel result does not exclude infection; results must be integrated with clinical and epidemiologic context.

NAAT/PCR — do not repeat NAAT within 90 days of prior positive for diagnosing current infection

Policy ruleDo not repeat NAAT/PCR within 90 days of a prior positive when diagnosing current infection due to persistent RNA detection.

CDC rationaleViral RNA may persist for up to 90 days; repeat NAATs can produce persistent positives and confound interpretation.

DocumentationIf testing within 90 days is considered, document clinical justification and follow public health guidance.

NAAT — repeat after 24-48 hours if clinically considered following initial negative

Repeat interval after initial negativeIf repeat NAAT is clinically considered following an initial negative, repeat testing should generally occur 24–48 hours after the initial test.

When to consider repeatConsider repeat testing for new or worsening symptoms, suspected poor specimen collection, or strong clinical/epidemiologic suspicion.

Guidance sourceConsistent with IDSA remarks recommending repeat NAAT 24–48 hours after an initial negative when indicated.

Serologic testing — frequency guidance and use cases (supporting text)

Primary usesSerologic (antibody) testing is used to support diagnosis in late-phase illness, MIS-C/MIS-A evaluation, convalescent plasma donor screening, epidemiology/seroprevalence, and vaccine response studies.

Not for acute diagnosisSerology should not be used to diagnose or exclude acute SARS-CoV-2 infection or to determine individual protective immunity or return-to-work decisions.

Specimen types and timingSerologic testing is performed on serum, plasma, or whole blood; antibody detection is delayed relative to symptom onset and may be positive when molecular tests are negative in later presentation.

Antigen-detecting diagnostic tests for symptomatic individuals — once every 48 hours (duplicate reference)

Policy frequency (duplicate)Antigen-detecting diagnostic tests for symptomatic individuals are covered once every 48 hours.

Coverage noteFollow manufacturer/EUA labeling for intended use and specimen types when ordering antigen tests.

ConfirmationNegative antigen results should be considered presumptive and confirmed with molecular testing when clinically necessary.

BioFire RP2.1 LoD (infectious)160 copies/mL (infectious isolate).

Operational notePanel performance varies by target and specimen type; use with specified FilmArray systems per manufacturer instructions.

ePlex RP2 LoD — 0.01 TCID50/mL (~250 genomic copies/mL)

ePlex RP2 LoD0.01 TCID50/mL, approximately 250 genomic copies/mL (determined by digital droplet PCR).

Study basisLoD derived from serial dilution testing with ≥20 replicates per concentration as described in manufacturer evaluation.

InterpretationLoD reported for nasopharyngeal specimens tested in the referenced performance study; follow EUA instructions for use.

RT-qPCR cycle threshold — CT <30 agreement with RT-LAMP ~97.5%

RT-qPCR CT benchmarkRT-qPCR cycle threshold CT <30 shows high agreement with RT-LAMP (~97.5% agreeance for CT <30).

ImplicationRT-LAMP performs best at higher viral loads (lower CT values); agreement declines as CT increases above 30.

Use-caseConsider RT-LAMP as a rapid molecular alternative when CT is expected to be low (early symptomatic period) and in validated settings.

NGS limit of detection — 125 genetic copy equivalents per mL

NGS LODLimit of detection for Illumina COVIDSeq reported as 125 genetic copy equivalents per mL.

EUA contextIllumina COVIDSeq and other NGS assays have EUAs for qualitative detection from specified specimen types; follow EUA instructions when ordering.

Surveillance useNGS/WGS primarily used for surveillance and variant identification rather than routine outpatient diagnosis.

Pooled testing — pools up to 32 with note on increased false negatives at larger pools

Pool size reportedPooled testing reported with detection of single positives in pools up to 32 samples.

Sensitivity caveatDetection performance declines and false negatives increase at larger pool sizes; pooled strategies require confirmatory workflows for positive pools.

Operational examplesEUAs exist for several pooled assays (e.g., UCSD RC five-sample RT-PCR, Poplar seven-sample TMA, LabCorp five-sample RT-PCR); follow EUA pooling instructions.

LVEF threshold (MIS-C/MIS-A references) — <55% (MIS-C) or <50% (MIS-A severe cardiac illness)

MIS-C cardiac thresholdLeft ventricular ejection fraction (LVEF) threshold for cardiac involvement in MIS-C: <55%.

MIS-A severe cardiacSevere cardiac illness criterion in MIS-A references new-onset ventricular dysfunction with LVEF <50% in the policy text.

Clinical contextCardiac involvement examples also include coronary artery dilation, aneurysm, or elevated troponin per CDC criteria.

Platelet count threshold — <150,000 / µL (lab threshold reference)

Platelet thresholdThrombocytopenia defined as platelet count <150,000/µL for hematologic involvement in MIS criteria.

Use in case classificationPlatelet count <150,000/µL qualifies as one of the hematologic criteria for MIS-C/MIS-A per CDC definitions.

DocumentationInclude laboratory evidence when reporting MIS cases and combine with clinical findings and epidemiologic linkage as required.

Antigen test frequency duplicate note — once every 48 hours

Duplicate frequency noteAntigen-detecting tests for symptomatic individuals: once every 48 hours (policy repeated in multiple sections).

Billing implicationEnsure claims adhere to the frequency limit when submitting antigen test charges for symptomatic patients.

Clinical confirmationNegative antigen tests should be confirmed with molecular testing when clinically indicated.

Denial is likely when testing is requested for work/school/mandated screening or for services explicitly stated as not meeting coverage criteria (e.g., SARS-CoV-2 genotyping in outpatient setting, neutralization antibody testing).

Include clinical justification and applicable symptom/exposure documentation with the request to reduce denial risk.

Billing Rule

Coding duplication — submit only one procedure code per DOS

Do not submit both HCPCS and CPT procedure codes for the same service and date of service. AMA guidance and Healthfirst reimbursement practice allow only one test code per date of service; submitting duplicate codes may lead to partial reimbursement or denial.

Use the single most specific and appropriate code for the test performed; avoid billing an HCPCS code and an AMA CPT code for the same assay on the same date of service.

Documentation Required

Confirm negative antigen results when indicated

Negative rapid antigen test results should be treated as presumptive when clinically indicated. Confirm with an FDA-authorized molecular assay (NAAT/PCR) when necessary for clinical management, infection control, or when symptoms/high-risk exposure are present.

Follow CDC guidance: repeat antigen testing (2 negatives for symptomatic; 3 for asymptomatic spaced 48 hours) or confirm with a NAAT as clinically appropriate.
Document rationale for confirmatory testing in the medical record to support medical necessity.

Denial Risk

Failure to perform antigen tests using authorized procedures and specimen types

Antigen tests must be performed according to the authorized system and manufacturer instructions (e.g., Sofia2 where specified). Failure to adhere to the test procedure, specimen type, or labeling specified by the manufacturer (or validated via LDT/CLIA high-complexity validation) can invalidate results and jeopardize reimbursement.

Use only authorized specimen types (e.g., nasal or nasopharyngeal swab for specified antigen assays) unless the lab has valid LDT documentation.
Maintain records that the test was performed on the authorized platform and followed the manufacturer’s instructions to support claim payment.

Note

Ag‑RDT performance limits and confirmation risk

Understand Ag‑RDT limitations: sensitivity is lower than NAATs and performance declines outside the recommended symptom-onset window or in low-prevalence settings. Use NAAT confirmation where positive predictive value is low or clinical consequences demand higher sensitivity or specificity.

Perform Ag‑RDTs within 5–7 days of symptom onset when possible; in low community transmission settings prefer NAAT for first-line testing.
Document testing rationale and any confirmatory NAAT performed.

Documentation Required

NAAT persistence — consider prior positive test within 90 days

NAAT (PCR) may remain positive for up to 90 days after infection; retesting within 90 days can yield persistent positives that do not indicate new infection. Use clinical history and timing to determine appropriateness of repeat NAATs.

Do not routinely use NAAT to diagnose reinfection within 90 days of a prior positive test unless clinically indicated and documented.
Document prior positive test dates and clinical justification for repeat NAAT to support medical necessity.

Documentation Required

Specimen collection and test labeling requirements

Specimen collection and correct labeling must follow FDA-authorized specimen types and instructions. Deviations require documented LDT validation and CLIA high‑complexity compliance; failure to adhere can produce inaccurate results and reimbursement denial.

Adhere to manufacturer-specified collection methods (e.g., NP, AN, MT swabs) and transport media.
If using non‑authorized specimen types, retain LDT validation documentation and CLIA compliance records to support testing and billing.

Billing Rule

Billing & coding compliance — follow national and payer rules

Follow accepted coding and billing practices (NCCI, NCD/LCD, CPT/HCPCS/ICD-10, modifier rules). Failure to follow these guidelines may lead to denials, recoupment, or claim edits by Healthfirst.

Do not use disallowed code combinations; apply correct modifiers and follow global/multiple procedure rules.
Keep clinical documentation that supports the code(s) billed (indication, specimen type, test method, results, and impact on medical decision-making).

Documentation Required

Test indication and follow‑up documentation

Document the indication for testing and expected impact on clinical management. For pre-procedural PCR testing, record why the test is needed and what actions will follow a positive result. Proper documentation reduces denial risk.

Include signs/symptoms, exposure history, prior positive test dates, and how results will influence treatment or infection control.
For pre-op testing record the potential procedural delay or cancellation criteria tied to a positive result.

Note

Multiplex panel — retest and follow‑up for multiple detections

For multiplex respiratory panel results with four or more organisms detected, retest the sample. Negative panel results do not exclude infection; follow-up testing or alternate methods may be required for pathogen differentiation.

Retest when the panel reports four or more detected organisms to confirm results.
If differentiation between similar viruses (e.g., rhinovirus vs enterovirus) is clinically necessary, perform confirmatory testing such as sequencing or culture and document rationale.

Documentation Required

MIS‑C / MIS‑A — laboratory and clinical documentation requirements

For MIS‑C and MIS‑A evaluations, document qualifying laboratory evidence (PCR, antigen, or serology) and the required initial labs and clinical findings. Follow specialty guidance (CDC, AAP, ACR) for complete workup and documentation to support coverage and reporting.

Include laboratory evidence: positive NAAT, antigen, or serology within specified timeframes as described by CDC case definitions.
Document clinical criteria (fever, organ involvement, inflammation markers) and initial labs (CBC, CRP, ESR, troponin, BNP, D‑dimer, coagulation studies).
Send serology prior to immunomodulatory therapy when possible; retain documentation of consults and cardiology evaluations if indicated.

Order tests for patients suspected of COVID‑19 and correlate clinically

Order tests intended for patients suspected of COVID‑19 by their healthcare provider and interpret results in the context of the clinical presentation; positive results indicate active infection but do not exclude co‑infection.

Note

Order NGS assays consistent with EUA specimen types

Order NGS‑based EUA assays only for the specimen types and indications listed in their EUAs (e.g., NP, OP, anterior nasal, mid‑turbinates, BAL, as authorized by the test EUA).

Documentation Required

Adhere to FDA‑labeled specimen collection or document LDT validation

Collect specimens according to FDA‑labeled specimen types and collection instructions; if deviating from labeled specimen types, ensure the lab has validated the method as an LDT and document that validation.

Note

Order MIS‑C testing through clinicians evaluating suspected cases

Order MIS‑C testing and expanded panels only when clinicians evaluating suspected MIS‑C are involved (often pediatric subspecialists); follow guidance on timing of serology and initial screening labs.

Send serologic tests prior to certain interventions as recommended.
Include CBC, ESR, CRP and other initial screening labs in documentation.

Note

No extra ordering provider restrictions specified

No additional ordering provider restrictions are specified in the policy; providers must adhere to coding, documentation, and payer rules when ordering and submitting claims.

Consistent with earlier revisions, SARS‑CoV‑2 genotyping in the outpatient setting does not meet coverage criteria. Additionally, multiplex panels of six or more respiratory pathogens were removed from this policy and are now addressed under the G2149 policy.

LimitationsNot recommended as primary approach for acute diagnosis or to determine individual protective immunity or return-to-work decisions.

Antigen test definition

DefinitionAntigen test: diagnostic assay that detects viral proteins (e.g., nucleocapsid or spike) directly from respiratory specimens; often available as rapid point-of-care tests.

Performance characteristicsAntigen tests generally have high specificity but lower sensitivity than NAATs; negative results may be presumptive and require confirmation when clinically necessary.

Specimen typesCommonly authorized for nasal or nasopharyngeal swabs per EUA/labeling; follow manufacturer instructions for approved specimen types.

Serologic/antibody test definition (duplicate cluster)

DefinitionSerologic/antibody test: assays that detect host immunoglobulins produced in response to SARS-CoV-2 infection; may detect IgM, IgG, IgA, or total antibodies.

Clinical noteSerologic tests can help identify prior infection but have timing-dependent sensitivity and cannot reliably determine protective immunity.

Specimen typesPerformed on serum, plasma, or whole blood; not recommended for saliva or CSF for routine serology.

Limit of Detection (LoD) definition

DefinitionLimit of Detection (LoD): the lowest concentration at which a test detects the target (e.g., copies per mL) at a predefined detection probability (often ≥95%).

ImplicationLoD informs analytic sensitivity and influences the test's ability to detect low viral loads and guide interpretation.

ReportingLoD values are typically reported in manufacturer/EUA performance data and vary by assay and specimen matrix.

PPA / NPA definition

DefinitionPPA / NPA: Positive Percent Agreement (PPA) approximates sensitivity vs a reference method; Negative Percent Agreement (NPA) approximates specificity in comparative studies.

Use in evaluationsPPA/NPA are reported in manufacturer and validation studies to compare new assays to reference tests (e.g., RT-PCR).

Interpretation cautionPPA/NPA depend on study populations and specimen sets; contextualize with LoD and clinical performance.

RT-LAMP definition

DefinitionRT-LAMP: reverse transcription loop-mediated isothermal amplification—an isothermal nucleic acid amplification method using multiple primers and strand-displacing polymerase enabling faster, simpler amplification without a thermal cycler.

PerformanceRT-LAMP can achieve high agreement with RT-qPCR at low CT values (e.g., ~97.5% for CT <30) and may be adapted for point-of-care use.

Operational noteAssays require validation and appropriate workflow controls; some implementations use colorimetric readouts for rapid detection.

CRISPR-based detection definition (OpVCRISPR example)

DefinitionCRISPR-based detection: assays that combine isothermal amplification (RT-LAMP) with CRISPR-Cas nuclease collateral cleavage to generate a visible fluorescent or colorimetric signal (e.g., OpVCRISPR).

Performance exampleOpVCRISPR demonstrated 100% agreement with CDC RT-PCR in a small validation set and enables potential point-of-care molecular detection.

LimitationsMethods may still require RNA extraction and further integration to achieve streamlined sample-to-result workflows.

NGS/WGS definition

DefinitionNGS/WGS: next-generation sequencing / whole genome sequencing—high-throughput sequencing approaches used for SARS-CoV-2 detection and surveillance, including variant identification.

EUA examplesIllumina COVIDSeq and Helix COVID-19 NGS assays have EUAs for qualitative detection from specified specimen types; reported LoD for Illumina COVIDSeq is 125 gce/mL.

Primary roleUsed mainly for surveillance and outbreak investigation rather than routine outpatient diagnosis; WGS informs genomic surveillance strategies.

MIS-C / MIS-A definition

DefinitionMIS-C / MIS-A: multisystem inflammatory syndromes in children and adults characterized by fever, multi-organ involvement, systemic inflammation, and laboratory or epidemiologic evidence of recent SARS-CoV-2 infection (commonly within 60 days).

Laboratory linkageDiagnostic support can include detection of SARS-CoV-2 RNA, antigen, or specific antibodies within the specified time windows per CDC criteria.

Clinical featuresCardiac, mucocutaneous, gastrointestinal, hematologic, and neurologic manifestations are common; cardiac involvement includes reduced LVEF or coronary changes.

Long COVID / Post-COVID conditions definition

DefinitionLong COVID / Post-COVID conditions: an infection-associated chronic condition present for at least three months after SARS-CoV-2 infection, with relapsing, remitting, or progressive multisystem symptoms.

Diagnostic roleNo single laboratory test definitively diagnoses Long COVID; serology or PCR may help document prior infection but are not required for diagnosis.

Common featuresSymptoms include fatigue, cognitive impairment, dyspnea, post-exertional malaise, sleep disturbance, and others across organ systems.

LDT definition

DefinitionLDT: Laboratory-Developed Test—tests developed and validated within a laboratory and performed as CLIA high-complexity tests; LDTs require in-house validation and CLIA compliance.

Regulatory noteLDTs are not FDA-approved/cleared but are regulated under CLIA as high-complexity tests; failure to validate per CLIA can risk denial or regulatory action.

Ordering implicationDeviation from FDA-labeled specimen types requires validated LDT documentation to avoid inaccurate results and reimbursement issues.

Serology (antibody) testing definition (redundant entry)

DefinitionSerology (antibody) testing for SARS-CoV-2: assays detecting anti-nucleocapsid and/or anti-spike antibodies to document prior infection or immune response to vaccination.

Testing limitationsSerologic results may not differentiate natural infection from vaccination (spike-targeting assays) and are not recommended to determine individual immunity.

Specimen typesPerformed on serum, plasma, or whole blood; dried blood spots used less frequently.

NAAT definition (redundant)

DefinitionNAAT: nucleic acid amplification testing (e.g., RT-PCR) that detects viral RNA and is the preferred method for diagnosing acute SARS-CoV-2 infection.

PerformanceHighly sensitive and specific; detects one or more viral RNA genes; viral RNA may persist up to 90 days after infection impacting repeat testing decisions.

Clinical implicationUse NAAT for most diagnostic scenarios; follow timing and specimen guidance for interpretation.

Antigen-detecting diagnostic tests definition (redundant)

DefinitionAntigen-detecting diagnostic tests: immunoassays that detect specific viral proteins, often as rapid point-of-care assays with quick turnaround but lower sensitivity than NAATs.

Operational guidanceFollow EUA/manufacturer labeling for intended populations, specimen types, and platform requirements (e.g., Sofia2 where specified).

InterpretationPositive antigen results are generally reliable; negative results in symptomatic or high-risk settings should be confirmed with molecular testing when clinically indicated.