ModifiedPremera BluecrossPolicy N/A

Coronavirus Testing in the Outpatient Setting (Routine Test Management Policy)

Governs outpatient medical decision-making testing for human coronaviruses (including SARS-CoV-2) and specifies reimbursable and non-reimbursable tests in the outpatient setting for Premera Bluecross members.

Policy Summary

PayerPremera Bluecross

PolicyCoronavirus Testing in the Outpatient Setting (Routine Test Management Policy)

Policy CodePolicy N/A

Change TypeMaterial coverage update (non-reimbursable tests added)

Effective Date02/06/2026

Next Review DateN/A

Key ActionDo not submit claims for outpatient SARS-CoV-2 genotyping or for neutralization antibody testing; these services are non-reimbursable.

SourceLink

POLICY UPDATE CHANGES

SARS-CoV-2 genotyping in the outpatient setting and neutralization antibody testing for SARS-CoV in any situation are not reimbursable.

New policy approved October 14, 2025 and effective February 6, 2026.

1non-reimbursable test categories added

4codes listed for NAb/genotype

02/06/2026effective date

Outpatient onlyscope

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.

provider notification period

Coverage Criteria

Non-reimbursable Tests

The following outpatient tests are not reimbursable:

Non-reimbursable tests in outpatient setting: 1) SARS-CoV-2 genotyping in the outpatient setting is not reimbursable; 2) Neutralization antibody testing for SARS-CoV-2 is not reimbursable in any situation.

Excluded due to lack of published evidence of benefit for diagnosis and treatment.

Nucleic Acid (RT-PCR) Testing

Covered when used for diagnosis of acute SARS-CoV-2 infection with appropriate timing and specimen collection:

Use of nucleic acid testing: RT-PCR (NAAT) is used to diagnose acute SARS-CoV-2 infection when appropriate primers and specimen types are used; results must be interpreted in clinical context as viral RNA declines after recovery and RT-PCR cannot be used to determine past infection.

Negative results do not preclude infection; specimen quality and timing affect sensitivity.

IDSA NAAT testing recommendations

Summary of IDSA recommendations for SARS-CoV-2 NAAT testing:

Symptomatic testing: Recommend NAAT in symptomatic individuals suspected of having COVID-19; a positive result may inform therapy, isolation, and contact tracing.

Symptomatic defined as presence of common COVID-19 symptoms; consider variant and patient population limitations.

Acceptable specimen types: Collect swab specimens from nasopharynx (NP), anterior nares (AN), oropharynx (OP), midturbinate (MT), or use saliva or mouth gargle as indicated; follow FDA labeling or validated LDTs for permitted specimen types.

AN or OP alone may yield more false negatives compared to combined or other specimen types.

Repeat testing: Suggest performing a single NAAT and not routinely repeating testing after a negative result; consider repeat testing 24–48 hours later if clinically indicated (new/worsening symptoms, poor specimen, timing).24-48 hours if indicated

Repeat testing reserved for specific clinical circumstances.

SHEA/ASA/APSF recommendations on asymptomatic screening

Society consensus on asymptomatic screening in healthcare settings:

Asymptomatic universal screening: Recommend against routine universal asymptomatic screening for SARS-CoV-2 in healthcare facilities; preprocedure asymptomatic screening is unlikely to provide incremental benefit when other infection prevention strategies are in place.

Admission screening may be considered during increased community transmission in select settings (e.g., behavioral health, congregate care).

Serologic testing guidance (AMA, AACC, IDSA, ECDC)

Guidance on appropriate uses and limitations of serologic (antibody) testing:

Appropriate uses: Serology may be used for population-level seroprevalence studies, convalescent plasma donor evaluation, late-phase diagnosis or complications (e.g., MIS-C), and vaccine response or epidemiologic studies.

IDSA suggests testing 3–5 weeks after symptom onset when evidence of prior infection is desired.

Inappropriate uses: Serologic testing should not be used to determine individual immune status, issue 'immunity certificates', inform return-to-work decisions, or be the sole basis for diagnosing acute infection.

Limitations include false positives, cross-reactivity, and inability to distinguish vaccination from prior infection.

Genotyping and genomic surveillance

Role of genotyping and sequencing in SARS-CoV-2 management:

Genomic surveillance is essential to detect and monitor variants of concern or interest and to inform public health; clinical uses of genotyping are currently limited and evolving as interpretation improves.

Recommend integrated sequencing strategies with representative sampling for reliable surveillance.

This policy applies only to outpatient testing for medical decision-making and specifically excludes testing that is required by work, school, state, or federal mandates. Specimen collection fees related to such testing are considered incidental under the policy and are not separately reimbursed. Providers should verify member benefits for any mandate-driven testing because this policy does not govern those situations.

The BioFire RP2.1 multiplex respiratory panel has documented limitations relevant to coverage decisions: it cannot reliably differentiate certain pathogens (for example, human rhinovirus versus enterovirus) and demonstrates low sensitivity for Bordetella pertussis. When B. pertussis is suspected, an FDA-cleared B. pertussis molecular test should be used instead of the RP2.1. If differentiation between viruses (e.g., rhinovirus vs enterovirus) is clinically required after a positive RP2.1 result, follow-up testing with an alternate method such as culture or sequence analysis is recommended.

Multiplex respiratory panels that cannot reliably distinguish genetically similar viruses (notably rhinovirus versus enterovirus) should not be used as the sole basis for clinical decisions. If clinical management requires definitive differentiation, the panel result should prompt reflex or supplemental testing (for example, cell culture or sequencing) to establish the specific etiology.

The World Health Organization does not recommend viral culture/isolation as a routine diagnostic procedure and advises that saliva should not be used as the sole specimen type for routine clinical diagnostics. When paired serology is being considered after negative NAAT in a strongly suspected case, WHO notes that an acute and a convalescent serum specimen collected 2–4 weeks apart may be used to demonstrate seroconversion.

Major professional organizations concur that serologic (antibody) testing should not be used to determine individual immune status or to support return-to-work, cohorting, personal protective equipment, or "immunity certificate" decisions. Antibody testing is appropriate for population seroprevalence, convalescent plasma donor evaluation, late-phase diagnosis or complications (e.g., MIS-C), and vaccine response studies, but not for certifying individual protective immunity.

Antibody tests have important limitations for individual-level clinical interpretation: a positive antibody result cannot determine current infectiousness, and in the absence of a prior positive diagnostic test, serology cannot reliably time the date of infection. Antibody titres that correlate with protection are not established and serologic assays cannot distinguish vaccination-induced from infection-induced responses in many spike-targeting assays.

The policy explicitly states that outpatient SARS‑CoV‑2 genotyping and neutralization antibody testing for SARS‑CoV‑2 are not reimbursable. This non‑reimbursable designation applies to these services in the outpatient setting and is effective per the policy history.

The rationale for excluding outpatient SARS‑CoV‑2 genotyping and neutralization antibody testing from reimbursement is a lack of published evidence demonstrating clinical benefit for diagnosis or treatment in the outpatient setting. The policy text notes these exclusions were added because available literature does not confirm that these tests are required or beneficial for individual patient care.

Society guidance and consensus statements recommend against routine universal asymptomatic screening in healthcare settings. Preprocedure and admission screening of asymptomatic individuals without known exposure is generally discouraged except in specific high‑risk settings or during periods of increased community transmission where targeted screening may be justified.

Covered Indications

Diagnosis of acute SARS-CoV-2 infection

Use NAAT (RT-PCR) for diagnosis when symptoms and specimen timing support testing:

Diagnosis of acute SARS-CoV-2 infection: RT-PCR (NAAT) should be used to diagnose acute infection when appropriately timed and collected; interpret results in the clinical context because viral RNA declines after recovery and negative results do not exclude infection.

RT-PCR cannot be used to detect past infection.

Diagnosis of acute SARS-CoV-2 infection — interpretation and repeat testing

Interpret NAAT results with clinical context and consider repeat testing only when indicated:

NAAT interpretation and repeat testing: Negative RT-PCR results should not be used as the sole basis for patient management and must be combined with clinical observations, history, and epidemiologic information; repeat testing may be considered for poor specimen collection or early sampling.24-48 hours if repeat testing indicated

Not Covered

Outpatient SARS‑CoV‑2 genotyping and neutralization antibody testing are defined in this policy as not covered for reimbursement in the outpatient setting. Claims for these services are subject to denial when submitted for outpatient medical decision‑making purposes.

Antibody (serologic) tests are not appropriate to diagnose or exclude acute SARS‑CoV‑2 infection; the FDA and professional guidance emphasize that serology should not be used for acute diagnostic decisions. Likewise, RT‑PCR (NAAT) is not a test for determining past infection because viral RNA usually declines to very low or undetectable levels after recovery.

Positive antigen test results have limitations: they cannot distinguish between SARS‑CoV and SARS‑CoV‑2, and they do not differentiate viable (cultivable) from non‑viable virus. Negative antigen results should be treated as presumptive and, when clinically necessary, confirmed with an FDA‑authorized molecular assay.

Whole genome sequencing (WGS) has practical and operational limitations for routine outpatient use, including high cost, reagent shortages, and the need for specialized infrastructure and trained staff. As of the cited literature, there were no FDA‑approved WGS tests specifically for this purpose, limiting WGS as a routine reimbursable outpatient diagnostic option.

Serologic testing should not be used to certify immune status or to issue "immunity certificates." Antibody tests are primarily useful for population‑level research, seroprevalence, donor screening, and certain late‑phase clinical scenarios, but are not reliable to determine protection from infection at the individual level.

Using serologic test results to make decisions about individual protective immunity, return‑to‑work, cohorting, or personal protective equipment allocation is discouraged. Professional bodies list these uses among inappropriate applications of serology due to false positives, cross‑reactivity, and uncertainty about correlates of protection.

Coding

Listed CPT/CPT-reported codesCPT

86408	Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID19]); screen
86409	Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID19]); titer
87913	Infectious agent genotype analysis by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]), mutation identification in targeted region(s)
0226U	Surrogate viral neutralization test (sVNT), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), ELISA, plasma, serum (Proprietary test: Tru-Immune; Lab/Manufacturer: Ethos Laboratories/GenScript USA Inc)

Pooling positivity-rate cutoff

Pooling positivity-rate cutoffDo not use pooled testing strategies when the expected positivity rate for the population to be tested exceeds 25% (per FDA EUA guidance).

EUA-specific pool sizesPooling is permitted only up to the pool size specified in a test's EUA (examples include Quest up to 4, UCSD RT‑PCR up to 5, Poplar TMA up to 7).

Rationale for cutoffPooling becomes inefficient and may miss positives when individual positivity exceeds ~25%, so EUA documents recommend avoiding pooling above this threshold.

Provider Actions and Operational Guidance

Denial Risk

Denial triggers and non‑reimbursable codes

The following testing and billing actions require attention by providers: SARS‑CoV‑2 genotyping (e.g., 87913, 0226U) and neutralizing antibody tests (e.g., 86408, 86409) are not reimbursable in the outpatient setting and are at risk of claim denial. Specimen collection codes for coronavirus testing are considered incidental and will not be reimbursed.

Non‑reimbursable codes: CPT 86408, 86409 (neutralizing antibody testing); CPT 87913 and HCPCS 0226U (genotyping/surrogate neutralization)
Specimen collection codes for coronavirus testing are incidental (no separate reimbursement)

Billing Rule

Pooling sample requirements and efficiency threshold

Pooling of samples is an authorized strategy only when consistent with FDA EUAs and local test labeling; pool size limits vary by authorized assay. Avoid pooling when community positivity is high (FDA guidance: do not pool if expected positivity >25%). When a pooled test is positive, follow the EUA or lab procedure to deconvolute and test individual specimens.

Ordering Requirements

Note

Order RT‑PCR for outpatient acute infection; mind timing/specimen

This policy applies to outpatient medical decision‑making; order RT‑PCR for suspected acute infection with attention to appropriate timing and specimen collection.

Policy scope: outpatient setting only.
RT‑PCR should be ordered when diagnosing acute infection, considering timing relative to symptom onset.

Note

Order RT‑PCR for suspected acute infection; select specimen site per guidance

Order RT‑PCR for patients suspected of acute SARS‑CoV‑2 infection and consider specimen site (NP, AN, OP, MT, saliva) per test labeling and guidance.

Anterior nasal swabs have adequate sensitivity in some studies but specimen type must match test authorization or LDT validation.

Note

Order antigen tests per EUA for provider‑suspected cases and POC use

Frequency Limits and Testing Intervals

NAAT and antibody tests — timing-based guidance for repeat testing

NAAT timing for repeat testingDo not routinely repeat NAAT immediately after a negative result; consider repeat NAAT 24–48 hours later only if clinically indicated (e.g., new/worsening symptoms or suspected poor specimen collection).

Antibody test timing for prior-infection evidenceWhen seeking evidence of prior infection, perform serologic (antibody) testing 3–5 weeks after symptom onset for optimal sensitivity (IDSA recommendation).

CDC guidance on NAAT after prior positiveNAAT may remain positive up to 90 days; CDC advises against NAAT testing within 90 days of a prior positive test to detect a new infection unless reinfection is strongly suspected.

BioFire RP2.1 (and similar multiplex panels) — retest guidance

Multiplex panel retest triggerIf a multiplex respiratory panel (e.g., BioFire RP2.1) detects four or more organisms on a single run, the sample should be retested.

Definitions

Definition — RT-PCR

RT‑PCR definitionReverse transcription polymerase chain reaction (RT‑PCR) is a molecular technique that converts viral RNA to complementary DNA (cDNA) and amplifies target sequences to detect acute SARS‑CoV‑2 infection.

Use for acute diagnosisRT‑PCR, when used with appropriate primers targeting SARS‑CoV‑2 RNA, is the primary diagnostic method for acute infection (CDC RT‑PCR Diagnostic Panel).

LimitationsRT‑PCR cannot reliably indicate past infection and requires specific laboratory instrumentation; results can be affected by timing and specimen quality.

Definition — Neutralizing antibody testing (NAb) and associated CPT codes

Neutralizing antibody (NAb) definitionNeutralizing antibody testing detects functional antibodies that prevent viral infection (neutralization) and are often reported as aggregate titers or performed as surrogate viral neutralization tests (sVNT).

Background and Evidence Summary

Background: SARS‑CoV‑2 is an enveloped RNA virus causing COVID‑19. Diagnostic modalities include NAAT (RT‑PCR) to detect viral RNA, antigen tests for direct viral protein detection, and serologic assays to detect host antibody responses. Viral load typically peaks near symptom onset and declines as infection resolves; because of this kinetic, NAAT is the primary method to diagnose acute infection while antibody tests are more informative in the convalescent phase or for population surveillance.

References

Selected references supporting the policy include product performance and guidance documents (for example, GenMark ePlex RP2 panel), society guidance (IDSA, SHEA/ASA/APSF), WHO and ECDC scientific briefs on antigen and antibody testing, and FDA/CMS policy statements. These citations underpin recommendations on diagnostic test selection, limitations of serology and antigen testing, sequencing considerations, and the rationale for non‑reimbursement of certain outpatient tests.

Revision History

2025-11-01policy_creation

New policy approved October 14, 2025 and published with a history entry dated 11/01/25 documenting approval and effective-date planning.

2026-02-06material_change_effective_dateLatest

Material change: outpatient SARS-CoV-2 genotyping and neutralization antibody testing for SARS-CoV declared non-reimbursable effective for dates of service on or after 2026-02-06 following a 90-day provider notification period.

2020-02-01

Policy Summary

PayerPremera Bluecross

PolicyCoronavirus Testing in the Outpatient Setting (Routine Test Management Policy)

Policy CodePolicy N/A

Change TypeMaterial coverage update (non-reimbursable tests added)

Effective Date02/06/2026

Next Review DateN/A

Key ActionDo not submit claims for outpatient SARS-CoV-2 genotyping or for neutralization antibody testing; these services are non-reimbursable.

SourceLink

On This Page

Asymptomatic exposed individuals: Suggest NAAT testing in asymptomatic individuals with known or suspected exposure; test at least 5 days after exposure or earlier if symptoms develop.>=5 days after exposure (unless symptomatic)

Use rapid or lab-based NAATs per clinical scenario and resources.

Pre-procedure and admission testing: Suggest against routine NAAT in asymptomatic individuals without known exposure for hospital admission or procedures; consider testing for time-sensitive surgery or high-risk settings during high community transmission.

Balance testing with other infection prevention strategies.

Use of NAAT to guide isolation: Suggest against routine repeat NAAT to guide release from isolation or to routinely repeat NAAT in patients with recent infection, because RNA detection may not reflect infectious virus.

Ct values are insufficient to determine infectiousness.

Reports document initial negatives followed by later positives due to timing or collection issues.

Assessment of prior exposure / seroepidemiology

Assessment of prior exposure or seroepidemiology uses antibody testing when appropriately timed:

Timing for serology: When evidence of prior infection is desired, test for IgG or combined IgG/IgM (or total antibodies) three to five weeks after symptom onset; sensitivity increases substantially after 2–3 weeks and into convalescence.3-5 weeks post symptom onset

Antibody tests are not appropriate for diagnosing acute infection.

Detection of prior infection, antigen testing windows, multiplex panel use

Detection of prior infection and use of antigen and multiplex panels in symptomatic individuals:

Serology in convalescence: Antibody tests perform better weeks after symptom onset and can detect prior infection during convalescence or support diagnosis of complications.

Rapid antibody tests may be useful in convalescent phase; sensitivity low early in infection.

Antigen testing windows: Many antigen tests are authorized for use within early symptomatic periods (e.g., first 5–7 days); antigen tests may be used for symptomatic individuals per test authorization.<=5-7 days of symptom onset (per WHO guidance)

Negative antigen tests may need confirmation with molecular assays if clinical management depends on result.

Multiplex panel use: Multiplex respiratory panels (e.g., BioFire RP2.1, QIAstat‑Dx) are intended for use in persons with signs or symptoms of respiratory infection and are not established for asymptomatic screening; if four or more organisms are detected, retest the sample.

Negative panel results do not exclude infection; panels should not be sole basis for decision making.

Patients suspected of COVID-19 — assays indicated

Assays indicated for patients suspected of COVID-19 by their healthcare provider:

Assays for suspected patients: Several proprietary panel assays (e.g., QIAstat‑Dx Respiratory SARS‑CoV‑2 panel, BioFire RP2.1, Illumina COVIDSeq) are indicated for use in patients suspected of COVID-19 and should not be used as the sole basis for diagnosis or treatment decisions.

Test performance in immunocompromised or asymptomatic individuals may be limited.

Diagnosis of acute infection — NAAT or antigen from URT; society recommendations

Society and public health recommendations for diagnostic testing of acute infection:

Preferred tests and specimens: Use NAAT or antigen tests from upper respiratory tract specimens (NP, MT, AN); IDSA recommends NAAT for symptomatic individuals and NIH/CDC guidance supports NAAT or antigen testing depending on context.

Follow test-specific authorization and specimen type guidance.

Repeat testing guidance: Do not routinely repeat NAAT in asymptomatic persons within 90 days of a prior positive test (except healthcare workers); repeat NAAT in symptomatic persons per clinical judgment.90 days

NAAT may remain positive up to 90 days per CDC guidance.

Evaluation of MIS-C / MIS-A

Use of serology to support evaluation of MIS-C / MIS-A:

MIS-C / MIS-A evaluation: Serologic testing (antibody) can support the diagnosis of MIS-C or MIS-A as part of the laboratory evidence criteria in conjunction with NAAT or antigen testing and clinical criteria.

Serology should be obtained prior to IVIG when possible in hospitalized children.

Self-testing / screening

Guidance on self-testing/screening with antigen rapid diagnostic tests (Ag-RDTs):

WHO self-testing recommendation: WHO supports voluntary self-testing with Ag-RDTs that meet minimum performance thresholds (>=80% sensitivity and >=97% specificity among symptomatic individuals) and emphasizes voluntary use, appropriate messaging, and linkage to care.>=80% sensitivity and >=97% specificity

Self-testing should be voluntary and adapted to local context.

Diagnostic testing for symptomatic individuals & asymptomatic exposed

Diagnostic testing recommendations for symptomatic persons and asymptomatic exposed individuals:

Symptomatic individuals: NAAT is the preferred initial diagnostic test in symptomatic individuals; antigen tests may be used per authorization and clinical judgment.

Specimen collection and transport are critical to result quality.

Asymptomatic exposed individuals: Test asymptomatic individuals with known exposure at least 5 days after exposure or immediately if symptoms develop; use rapid or laboratory-based NAATs or antigen tests as indicated.>=5 days post exposure (unless symptomatic)

Consider individual risk factors and testing resources.

Convalescent plasma donor screening & seroprevalence studies

Appropriate uses of serology for donor screening and seroprevalence studies:

Convalescent plasma and seroprevalence: Serologic assays are appropriate for convalescent plasma donor screening and population seroprevalence studies and are not intended to determine individual immunity.

Use within well-defined testing plans and contexts.

Evaluation of suspected MIS-C

MIS-C inpatient evaluation testing sequence and operational notes:

MIS-C evaluation sequence: Initial and inpatient evaluation of suspected MIS-C should include SARS-CoV-2 PCR and serology; serology should be collected before administering IVIG when possible.

Include expanded inflammatory and cardiac testing per pediatric guidance.

Symptomatic pediatric testing

Symptomatic pediatric testing approach:

Pediatric symptomatic testing: For symptomatic children, NAATs (PCR) or antigen tests can be used; if an antigen test is negative in a symptomatic child, consider repeating the antigen test at 48 hours per guidance.48 hours if repeat antigen testing indicated

Consider prior infection and the 90-day NAAT caveats in interpretation.

Antibody tests are not appropriate for diagnosing acute infection or for determining individual protective immunity. Limitations include difficulty distinguishing vaccine‑induced from infection‑induced antibodies (especially with spike‑targeting assays), unknown protective titre thresholds, and inability to time infection in the absence of a prior positive diagnostic test.

Restating the coverage stance: outpatient SARS‑CoV‑2 genotyping and any neutralization antibody testing for SARS‑CoV are identified as non‑reimbursable services under this policy and are at risk for claim denial when submitted for outpatient testing purposes.

EUA‑specific pool sizes (examples): Quest up to 4 samples; UCSD up to 5; Poplar up to 7 — follow the specific EUA labeling
Do not use pooling if positivity >25% (FDA)
Pooling efficiency best in low‑prevalence settings

Prior Authorization

Prior authorization guidance

No prior authorization requirements are specified in this section of the policy. There are no provider‑facing authorization or step‑therapy criteria described for SARS‑CoV‑2 testing within the documented policy text.

Prior authorization: none specified in this policy section
No explicit provider authorization or denial criteria present

Note

Preprocedural testing impact

Preprocedural screening yields are low in asymptomatic populations; routine preoperative PCR testing can cause procedural delays or cancellations and carries cost implications. Use local institutional protocols and weigh benefits versus resource/cost impact when ordering asymptomatic preprocedural tests.

Study example: low positive rate (~0.41%) in asymptomatic preoperative testing with high number needed to test and cost per positive
Preprocedural testing may delay or cancel procedures — coordinate with surgical and administrative teams

Documentation Required

Limitations of panel‑only decision making and panel retest guidance

Do not base clinical management solely on multiplex panel results. Positive panel findings indicate detection of an agent but do not exclude coinfection or establish causation; negative results do not rule out infection. Retest panels that detect an implausibly high number of organisms (e.g., four or more) per manufacturer instructions.

If a panel detects ≥4 organisms, retest the sample per BioFire guidance
Negative panel results may be due to sequence variants, inhibitors, sampling error, or pathogens not on the panel
Panel results must be integrated with clinical observations and patient history

Note

Testing approach, NAAT timing, and preferred initial/repeat testing

NAAT/RT‑PCR is the preferred test for diagnosing acute infection in symptomatic patients. Do not repeat NAAT in asymptomatic persons within 90 days of a prior positive test except for healthcare workers or other exceptional clinical circumstances. For symptomatic children, either NAAT or antigen testing is acceptable; repeat a negative antigen in children after 48 hours per AAP guidance.

Preferred initial test: NAAT (PCR) for symptomatic individuals
Do not repeat NAAT within 90 days of prior positive test for asymptomatic persons (CDC/NIH guidance)
Symptomatic children: NAAT or antigen; if antigen negative consider repeat antigen at 48 hours

Documentation Required

Specimen collection and labeling adherence

Specimen collection and labeling must follow FDA‑authorized test labels or validated LDT procedures. Failure to adhere to specified specimen types, collection methods, or transport conditions can affect test accuracy and may result in reimbursement denial.

Use specimen types and collection methods authorized for the specific NAAT/assay or validated in an LDT
Document collection method, date/time, and specimen type in the medical record to support test interpretation and billing

Documentation Required

Result interpretation, documentation, and MIS‑C/MIS‑A testing timing

Result interpretation should always combine test results with clinical observations, epidemiologic context, and patient history. Negative NAAT or antigen results do not exclude infection; document clinical correlation and rationale for testing in the medical record. For MIS‑C/MIS‑A workup, document clinical criteria and laboratory evidence and obtain serology prior to IVIG when admitted.

Negative results must be interpreted with clinical context and documented in chart notes
MIS‑C/MIS‑A: document clinical criteria, labs, and epidemiologic linkage; obtain serology before IVIG administration in hospitalized children
When NAAT is negative but clinical suspicion remains, consider repeat testing or alternative assays per guidelines

Note

Additional and follow‑up testing for strain differentiation

For situations requiring strain differentiation or when panel assays cannot distinguish closely related viruses (e.g., rhinovirus vs enterovirus or SARS‑CoV vs SARS‑CoV‑2), consult public health authorities and pursue confirmatory methods such as cell culture, sequence analysis, or targeted assays.

Follow state/local public health guidance for additional testing when differentiation is required
Consider reflex testing with culture or sequencing when panels cannot differentiate pathogens

Note

Consult member benefits

Consult member benefit booklets or member services to determine individual coverage and benefit limitations. This policy is a guide; member contracts may differ and coverage is subject to plan terms.

Always confirm coverage specifics with the member's benefit booklet or member services before ordering tests that may be non‑reimbursable

Some antigen tests are authorized for use in individuals suspected of COVID‑19 by their healthcare provider and for point‑of‑care settings; order antigen tests only within their authorized use window (e.g., within first 5–7 days of symptoms for many assays).

Quidel Sofia2 and BD Veritor are EUA‑authorized for provider‑suspected individuals and POC use; follow manufacturer instructions for specimen and timing.

Note

Order tests only for patients suspected of COVID‑19 and with authorized specimen types

Order tests intended for use in patients suspected of COVID‑19 by their healthcare provider and ensure the specimen type is authorized by the test (some tests have specific specimen authorizations).

BioFire RP2.1 and QIAstat‑Dx panels are intended for symptomatic individuals and are validated for specific instrument systems and specimen types.

Note

Order testing based on clinical presentation and IDSA/NIH guidance

Testing decisions should follow clinical presentation and national guidance (IDSA/NIH); perform NAAT for symptomatic individuals per recommendations.

IDSA and WHO recommendations inform when NAAT or antigen testing is appropriate based on symptoms and exposure.

Billing Rule

Adhere to FDA‑authorized specimen collection or validated LDTs

Specimen collection must adhere to FDA‑authorized test labels or validated LDT procedures to avoid inaccurate results and possible reimbursement denials.

Failure to follow label requirements, unless validated by an LDT, can lead to inaccurate results and reimbursement denials.

Note

For MIS‑C, order PCR + serology; send serology prior to IVIG

For inpatient MIS‑C evaluation, perform both SARS‑CoV‑2 PCR and serology and collect serology before IVIG administration.

Serology may be needed later if initial tests are negative, but must be sent prior to IVIG.

Note

Verify coverage with member benefits or customer service

Consult the member benefit booklet or contact customer service to determine whether there are benefit limits or coverage restrictions before ordering these services.

Policy is a guide; actual coverage is subject to member plan terms.

Intended use limitationBioFire RP2.1 is not established for specimens collected from individuals without signs or symptoms of respiratory infection; results should not be the sole basis for management.

Negative result considerationsA negative multiplex panel result does not necessarily exclude infection due to possible sequence variants, inhibitors, sampling errors, or organisms not included on the panel.

Pooled RT‑PCR/TMA assays authorized under EUA

Pooling allowed per EUAPooled RT‑PCR/TMA testing is permitted only for assays and pool sizes specifically authorized under their EUAs (pool sizes vary by test).

Do not pool if positivity >25%Per FDA EUA guidance, do not use pooling strategies when the expected positivity rate for the tested population exceeds 25% due to inefficiency and reduced sensitivity.

Examples of EUA pool sizesIllustrative EUAs include Quest (up to 4), UCSD RC (5), Poplar TMA (7), and LabCorp (5); follow each EUA's specified conditions and limits.

NAAT — avoid repeating NAAT within 90 days of prior positive test

Avoid NAAT within 90 days of prior positiveNAAT (including RT‑PCR) should generally not be repeated within 90 days of a prior positive test in asymptomatic persons because viral RNA can persist and yield positive results for up to 90 days (CDC guidance).

Exception for healthcare workers / clinical suspicionConsider testing within 90 days only when reinfection is strongly suspected or per occupational health guidance for healthcare personnel.

Interpretation noteA positive NAAT within 90 days may represent residual RNA rather than active infectious virus; clinical correlation is required.

NAAT — repeat NAAT not routinely recommended

Routine repeat NAAT not recommendedIDSA suggests performing a single NAAT and not routinely repeating testing after a negative NAAT; repeat testing is reserved for specific clinical scenarios (e.g., new/worsening symptoms, timing issues, or poor specimen quality).

Timing for repeat if indicatedIf repeat NAAT is clinically indicated after a negative result, it should generally be performed 24–48 hours after the initial test.

Clinical context requiredDecisions to repeat NAAT should be guided by clinical and epidemiologic context rather than routine practice.

Associated CPT/CPT-reported codes

Examples of listed codes: 86408 (NAb screen), 86409 (NAb titer), and 0226U (sVNT ELISA proprietary reporting).

Clinical use limitationsNeutralizing antibody assays may provide functional information but are not reimbursable for outpatient SARS‑CoV‑2 testing per this policy due to lack of demonstrated clinical benefit.

Definition — RT-PCR technical description

RT‑PCR technical descriptionRT‑PCR synthesizes complementary DNA from RNA templates and amplifies target sequences using primers to detect SARS‑CoV‑2 RNA in respiratory specimens.

Specimen considerationsRT‑PCR is performed on upper or lower respiratory specimens and requires adherence to validated specimen types and collection methods to ensure accuracy.

Not for past infection detectionBecause viral RNA levels typically decline after recovery, RT‑PCR is not appropriate for reliably identifying past infection.

Definition — Serological (antibody) testing

Serological (antibody) testing definitionLaboratory assays that detect host immunoglobulins (IgM, IgA, IgG) or total antibodies produced in response to SARS‑CoV‑2 infection; may report specific isotypes or total antibody.

Types of serologic assaysCommon assay formats include ELISA, chemiluminescent immunoassays (CLIA), and lateral flow immunoassays (LFIA); neutralization assays specifically assess functional antibody activity.

Intended usesSerologic testing is used for assessing prior exposure, seroprevalence studies, convalescent plasma donor screening, and MIS‑C evaluation, not for diagnosing acute infection.

Definition — Antibody testing characteristics and timing

Antibody timing and sensitivityAntibody sensitivity increases with time since symptom onset: average seroconversion for IgM ~12 days and IgG ~14 days; IgG sensitivity rises substantially after 14 days.

Recommended timing for prior-infection testingWhen evidence of prior infection is desired, test for IgG (or IgG/IgM or total antibodies) three to five weeks after symptom onset for best accuracy (IDSA).

LimitationsEarly after symptom onset (<14 days) antibody tests have low sensitivity and should not be used to rule out acute infection; results cannot reliably determine protective immunity or timing without prior positive diagnostic test.

Definition — Antigen testing

Antigen testing definitionAntigen tests detect viral proteins (e.g., nucleocapsid or spike) to indicate current infection and are often used as rapid point‑of‑care assays.

Performance considerationsAntigen tests are generally less sensitive than NAATs but have high specificity; WHO recommends Ag‑RDTs meeting ≥80% sensitivity and ≥97% specificity for diagnosis in symptomatic patients within 5–7 days of symptom onset.

Use and confirmationA single negative antigen test cannot rule out infection; CDC recommends repeat antigen testing or confirmatory NAAT as appropriate based on symptoms and exposure.

Definition — Multiplex respiratory panel

Multiplex respiratory panel definitionA multiplex respiratory panel is a nucleic acid or antigen‑based assay that simultaneously detects and differentiates multiple respiratory pathogens from a single specimen (e.g., BioFire RP2.1, QIAstat‑Dx, ePlex).

Intended populationThese panels are intended for patients with signs or symptoms of respiratory infection and are not established for use in asymptomatic screening.

Result interpretation cautionPanels are qualitative and may not quantify organism load; detection of multiple organisms or negative results require clinical correlation and, in some cases, retesting.

Definition — PPA / NPA metrics

PPA / NPA definitionPositive Percent Agreement (PPA) and Negative Percent Agreement (NPA) are metrics used to report clinical performance of diagnostic assays compared to a reference standard (e.g., TP/(TP+FN) for PPA).

Use in reportsManufacturers commonly report PPA and NPA in IFUs and validation studies to convey concordance with comparator assays; interpret within study context and sample selection.

Example performanceSome multiplex panels report very high PPA/NPA (e.g., ePlex reported 100% PPA/NPA in a specific validation study), but performance may vary by specimen type and population.

Definition — Limit of Detection (LoD)

Limit of Detection (LoD) definitionLoD is the lowest concentration at which an assay detects the target at least 95% of the time; reported LoDs vary by platform and target (examples: BioFire RP2.1 LoD 500 copies/mL; other panels 160–250 copies/mL).

Impact on sensitivityLower LoD corresponds to higher analytical sensitivity; differences in LoD can affect detection of low‑level infections and pooling performance.

Reported examplesBioFire RP2.1 reported LoD 500 copies/mL (heat‑inactivated) and 160 copies/mL in another assessment; ePlex reported LoD ~250 genomic copies/mL.

Definition — NAAT and note about prolonged positivity

NAAT definition and prolonged positivity noteNucleic acid amplification tests (NAATs), including RT‑PCR and isothermal methods, detect SARS‑CoV‑2 RNA; NAATs may remain positive for up to 90 days after infection, reflecting persistent RNA rather than infectious virus.

Clinical implicationsBecause NAAT can detect residual RNA for weeks to months, NAAT results must be interpreted with clinical context when performed after recent infection.

Testing guidanceCDC recommends against NAAT to test someone who tested positive within the past 90 days unless reinfection is suspected.

Definition — Ag-RDT (antigen-detecting rapid diagnostic test)

Ag‑RDT definitionAntigen‑detecting rapid diagnostic tests (Ag‑RDTs) are quick immunoassays that detect viral proteins to identify current infection and are intended for use early in symptomatic illness (commonly within 5–7 days of symptom onset).

Performance thresholdsWHO recommends Ag‑RDTs meeting ≥80% sensitivity and ≥97% specificity compared to a NAAT reference for use in diagnosing symptomatic COVID‑19 cases.

Operational useAg‑RDTs are useful for rapid detection, outbreak response, and settings lacking immediate NAAT access, but negative results may need confirmation with NAAT depending on context.

Definition — Serology/Antibody test utility and limits

Serology utility and limitsSerologic (antibody) testing is useful for population seroprevalence, convalescent plasma donor screening, and supporting late‑phase or complication diagnoses (e.g., MIS‑C), but is not suitable for diagnosing acute infection or determining individual immunity.

Timing affects utilityAntibody assays have limited sensitivity early after infection and are most informative weeks after symptom onset (e.g., >14 days); IDSA suggests 3–5 weeks for evidence of prior infection.

Inability to determine protectionAntibody test results cannot reliably determine protective immunity or timing of infection, and spike‑targeting assays may not distinguish vaccination from natural infection.

Definition — NAAT variants and methods

NAAT variants and methodsNAAT encompasses RT‑PCR and isothermal amplification methods, including rapid point‑of‑care and standard laboratory‑based assays; method selection affects turnaround and may impact sensitivity.

Rapid NAAT definitionRapid NAATs are assays with short turnaround (definitions vary: ≤30–60 minutes) and may be suitable for near‑patient testing but require validation for intended use.

Pooling and NAATPooling strategies have been authorized for specific NAAT assays under EUA but must follow EUA‑specified methods and pool sizes; avoid pooling when positivity >25%.

Definition — Serologic testing general note

Serologic testing general noteSerologic tests detect prior infection or vaccine response and are primarily used for epidemiology and selected clinical contexts (e.g., MIS‑C), not for making return‑to‑work or immunity decisions.

Assay diversityA wide variety of serologic assays exist (ELISA, CLIA, LFIA, neutralization assays), and lack of standardization makes cross‑test comparisons difficult.

Cross‑reactivity riskSome assays may cross‑react with antibodies to other human coronaviruses, affecting specificity in certain contexts.

Definition — Variants of Concern/Interest (VOCs/VOIs)

Variants of Concern/Interest (VOCs/VOIs)VOCs and VOIs are SARS‑CoV‑2 variants that may increase transmissibility, disease severity, or affect public health measures; genomic surveillance with representative sequencing strategies is essential to detect and monitor them.

Surveillance roleRobust integrated sequencing and sampling strategies are required to ensure representativeness and reliability of findings for public health action.

Clinical use limitationClinical uses of genotyping/sequencing are currently limited in outpatient care and routine outpatient genotyping is not reimbursable per policy.

Definition — Antibody (serologic) test limitations

Antibody test limitationsAntibody tests should not be used to determine individual immune status, issue 'immunity certificates', or make return‑to‑work or PPE decisions because they cannot reliably indicate protection or timing of infection.

Cross‑reactivity and vaccine effectsSpike‑targeting assays cannot distinguish vaccination from natural infection; lack of standard correlates of protection limits interpretation.

Appropriate usesAppropriate uses include seroprevalence studies, donor screening, and adjunctive testing for complications like MIS‑C when timed correctly.

Definition — MIS-C

MIS‑C definitionMultisystem Inflammatory Syndrome in Children (MIS‑C) is a post‑infectious hyperinflammatory condition associated with prior SARS‑CoV‑2 exposure, characterized by persistent fever, systemic inflammation, multisystem organ involvement, and laboratory or epidemiologic evidence of recent SARS‑CoV‑2 infection or exposure.

Age and clinical criteriaMIS‑C is defined in persons <21 years with fever, inflammation, multisystem involvement, and absence of a more likely alternative diagnosis; features include cardiac, gastrointestinal, mucocutaneous, hematologic, or shock presentations.

Testing roleEvaluation includes NAAT and serology (antibody) testing; serology should be collected prior to IVIG administration when possible, as antibodies may support the diagnosis when PCR is negative.

FDA issued immediate policy guidance in February 2020 on high-complexity laboratory diagnostics performed prior to Emergency Use Authorization during the public health emergency.

2020-05-11guidance_update

FDA updated the February 2020 diagnostics guidance on May 11, 2020, clarifying the policy applies for the duration of the COVID-19 public health emergency.

2023-03transition_policy

FDA released transition plans in March 2023 outlining recommendations for devices and diagnostics that had operated under EUA during the COVID-19 public health emergency.