CurrentCapital BluecrossPolicy AHS - G2174
Coronavirus Testing in the Outpatient Setting
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Defines coverage and reimbursement positions for coronavirus (including SARS-CoV-2, SARS, and MERS) testing performed for medical decision-making in the outpatient setting; excludes work/school/state/federally-mandated testing and is dependent on individual benefit coverage.
Policy Summary
PayerCapital Bluecross
PolicyCoronavirus Testing in the Outpatient Setting
Policy CodePolicy AHS - G2174
Change TypeNo material clinical or coverage changes
Effective DateSep 18, 2015
Last ReviewNov 1, 2025
Next Review DateNov 1, 2025
Key ActionDo not report both HCPCS and AMA codes for the same procedure on the same date of service; specimen collection codes are incidental and will not be reimbursed.
SourceLink
POLICY UPDATE CHANGES
No material clinical or coverage changes in this revision.
NAATs coveredTargeted NAATs covered
Every 48 hrsAntigen tests frequency
Not coveredGenotyping/neutralization tests
IncidentalSpecimen collection reimbursement
17 daysMean RNA shedding
0.41%Preop positive rate
Coverage criteria for outpatient coronavirus testing
Outpatient testing coverage criteria
Covered when ALL of the following apply:
Testing is performed for medical decision‑making in the outpatient setting (this policy excludes work/school/state/federally mandated testing).
Targeted NAAT: Targeted nucleic acid testing (e.g., RT‑PCR or rapid molecular NAAT) for SARS‑CoV‑2 MEETS COVERAGE CRITERIA when ordered for: (a) individuals with signs or symptoms of possible COVID‑19; or (b) asymptomatic individuals with known exposure to COVID‑19.
SARS / MERS NAAT: Targeted nucleic acid testing (e.g., RT‑PCR) for SARS or MERS MEETS COVERAGE CRITERIA when ordered for individuals with signs or symptoms consistent with disease and travel to or exposure from endemic areas.
MIS‑C / MIS‑A / PASC support: Nucleic acid amplification testing and host antibody serology to support diagnosis of MIS‑C, MIS‑A, or post‑acute sequelae of SARS‑CoV‑2 infection (PASC) MEET COVERAGE CRITERIA.
Antigen testing frequency: Antigen‑detecting diagnostic tests for SARS‑CoV‑2 MEET COVERAGE CRITERIA for symptomatic individuals, with reimbursement allowed once every 48 hours.
The following tests DO NOT MEET COVERAGE CRITERIA in the outpatient setting: SARS‑CoV‑2 genotyping, neutralization antibody testing, testing for endemic human coronaviruses (229E, NL63, OC43, HKU1), and whole genome sequencing of paired specimens for reinfection evaluation.
Diagnostic testing considerations
Consider the following evidence‑based points when selecting diagnostic or serologic tests:
RT‑PCR/NAAT is the diagnostic standard for acute infection but has limitations: analytic LoD varies across assays, proper specimen collection and timing are critical, and negative results do not exclude infection and must be combined with clinical assessment.
Rapid/POC NAAT: Rapid on‑demand PCR and other point‑of‑care NAAT methods can have high accuracy and may be appropriate when rapid decisions affect care or infection control; consider study evidence and local operational impact.
Antibody (serologic) tests are not for diagnosing acute infection; they are intended to detect prior exposure. Timing affects sensitivity—sensitivity improves substantially ≥14 days and peaks by 3–5 weeks post symptom onset. Use serology primarily for epidemiology, MIS‑C evaluation, or selected clinical scenarios.
Performance of serologic platforms varies: pooled meta‑analyses report ELISA sensitivity ~84.3%, LFIA ~66%, and CLIA ~97.8% with specificities generally high; many point‑of‑care serologic tests have limited supporting evidence and high risk of bias in studies.
IgM and IgA have limited diagnostic windows and should not be used alone to diagnose infection; combined IgG/IgM may increase sensitivity but interpretation is limited by cross‑reactivity and uncertain correlation with immunity.
When choosing assays prefer those with documented analytical performance (LoD, gene targets) and validated clinical sensitivity/specificity in peer‑reviewed evaluations or EUA summaries.
Preprocedural screening consideration: Routine preoperative PCR screening in asymptomatic patients yields low positivity in cited studies and carries cost and scheduling implications; consider local prevalence and clinical impact before universal application.
Coverage considerations and clinical criteria
Clinical-use points, limits, and recommended confirmatory strategies:
Antibody (IgG) testing is useful for detecting prior infection and can help rule out infection when performed >14 days post symptom onset due to higher sensitivity in the convalescent period.
Do not rely on IgM testing alone for diagnosis because of low sensitivity and variable timing; antibody results are adjunctive and best interpreted together with clinical history and NAAT results.
Negative antigen results should be considered presumptive and, when results will affect clinical management or infection control, should be confirmed with an FDA‑authorized molecular NAAT. Positive antigen results are generally reliable but do not exclude co‑infections or necessarily indicate viable virus.
Antigen performance caveat: Some antigen assays demonstrate acceptable sensitivity and specificity in symptomatic patients within the early symptom window, but reported sensitivities vary widely across products and studies; performance declines with lower viral loads.
Multiplex respiratory panels that include SARS‑CoV‑2 can detect multiple pathogens from one specimen and are useful when multiple etiologies are considered; however, they should not be the sole basis for clinical decisions and have higher cost and potential analytic limitations.
Select tests with known EUA or validated performance characteristics; refer to manufacturer IFU for specimen types and limitations to avoid incorrect interpretation or reimbursement issues.
Coverage criteria and limitations
Coverage and clinical‑use criteria and limitations for multiplex respiratory panels and other molecular tests:
Intended use: Multiplex respiratory panels (e.g., BioFire RP2.1, QIAstat‑Dx, ePlex) are intended for patients with signs or symptoms of respiratory infection and are not established for asymptomatic screening or treatment monitoring.
Negative results do not exclude infection; combine results with clinical evaluation and epidemiologic context because false negatives can occur due to sequence variants, inhibitors, sampling error, or organisms not included on the panel.
Retest rule: If the BioFire RP2.1 panel detects four or more organisms, repeat testing on the sample is recommended to confirm results.
Test selection limitation: Do not use BioFire RP2.1 when Bordetella pertussis is specifically suspected because of low sensitivity for pertussis targets; use an FDA‑cleared multi‑copy IS481‑targeting B. pertussis molecular test instead.
Cross‑reactivity and differentiation: Some panels may cross‑react with related animal coronaviruses or be unable to reliably distinguish genetically similar human viruses (e.g., rhinovirus vs enterovirus); follow‑up with culture or sequencing if differentiation is clinically required.
Validation note: Performance characteristics for some panel targets were determined with limited or retrospective specimens; PPA/NPA and LoD vary by platform and target and should inform selection.
Emerging methods: Alternative methods (RT‑LAMP, CRISPR‑based assays, NGS/WGS) show promise but have specific limitations (sensitivity thresholds, infrastructure needs, EUA scope); WGS had no FDA‑approved tests as of May 4, 2022.
Operational/population limits: Test performance in asymptomatic or immunocompromised individuals may be unestablished for some platforms; consult manufacturer IFU and validation data prior to use in these populations.
Pooled testing note: Some EUA panels (e.g., cobas SARS‑CoV‑2 & Influenza A/B) support pooled sample testing; follow validated pooling protocols to avoid loss of sensitivity.
Testing coverage and operational criteria
Operational recommendations from WHO, CDC, and IDSA to guide test selection and use:
NAAT (PCR) is the preferred test for symptomatic individuals suspected of COVID‑19 and should be used as the confirmatory method; NAAT should not be used to retest persons with a positive NAAT within the prior 90 days due to prolonged RNA detection.
Ag‑RDT appropriate uses: Ag‑RDTs that meet WHO minimum performance (≥80% sensitivity, ≥97% specificity) may be used for symptomatic individuals within 5–7 days of symptom onset, for outbreak investigations, for screening high‑risk asymptomatic contacts, and for self‑testing when aligned with national guidance; in low transmission settings NAAT is preferred.
Self‑testing guidance: WHO supports voluntary COVID‑19 self‑testing with Ag‑RDTs as an adjunct to professional testing when kits meet performance standards and local context permits; clear messaging and linkage to care are required.
Acceptable specimen types: Acceptable NAAT specimen types per IDSA include NP, AN, OP, MT swabs, saliva, and mouth gargle; saliva and pooled samples are supported by some evidence and EUAs but require adherence to validated methods and IFU.
Serology has limited clinical uses: population seroprevalence, convalescent plasma donor screening, and specific clinical scenarios (e.g., MIS‑C). Serology should not be used to determine immune status or for immunity passports.
WGS can assist surveillance and outbreak investigations but faces resource and regulatory limitations; as noted, no FDA‑approved WGS tests were identified as of May 4, 2022.
For persons with prior SARS‑CoV‑2 infection, CDC/IDSA advise against NAAT within 90 days of a positive NAAT and recommend antigen testing for certain post‑infection windows if testing is indicated.
Testing recommendations summary
Professional society recommendations restated as actionable criteria:
IDSA — symptomatic NAAT: Perform SARS‑CoV‑2 NAAT in symptomatic individuals suspected of COVID‑19 (strong recommendation).
IDSA — specimen types: Acceptable specimen types for NAAT include NP, AN, OP, MT swabs, saliva, or mouth gargle; AN or OP alone acceptable when other types are not feasible, and AN/MT may be self‑collected per guidance.
Repeat NAAT: Do not routinely repeat NAAT after a single negative test; consider repeat testing 24–48 hours later only in select scenarios (e.g., new/worsening symptoms or high clinical suspicion).
Asymptomatic exposed: IDSA suggests NAAT for asymptomatic individuals with known or suspected exposure, generally recommending testing at least 5 days after exposure unless symptoms occur earlier.
Preprocedure/asymptomatic screening: IDSA suggests against routine NAAT for asymptomatic individuals without known exposure prior to hospitalization or procedures; consider testing in high‑risk settings or when community transmission is high.
Serology timing: IDSA recommends against serology for diagnosis in first 2 weeks; for prior infection testing, suggest serology at 3–5 weeks post symptom onset and recommend assays targeting nucleocapsid for evidence of prior infection.
SHEA/SHA guidance: SHEA suggests against routine universal asymptomatic screening in healthcare facilities and preprocedure asymptomatic screening is unlikely to add benefit when other infection prevention measures are in place.
Coverage and clinical criteria for MIS-C and SARS-CoV-2 testing
MIS‑C and SARS‑CoV‑2 testing criteria for inpatient‑directed evaluations referenced here for outpatient decision support:
Suspected MIS‑C requiring admission: Any child sick enough to warrant admission for fever, abdominal pain, diarrhea, or organ dysfunction in whom MIS‑C is suspected should undergo expanded laboratory and cardiac workup and COVID‑19 testing (RT‑PCR and serology); send serology prior to IVIG when possible.
MIS‑C initial tier: ESR and CRP plus SARS‑CoV‑2 testing (PCR or serology) are considered tier 1 (first‑line) for MIS‑C evaluation.
Severe illness pathway: Severely ill or hemodynamically unstable children should be managed in ED/critical care and transferred to referral centers with early subspecialty consultation; do not delay transfer for testing.
Regulatory context: Laboratory‑developed tests (LDTs) are regulated under CLIA as high complexity tests; FDA issued EUA and transition guidance that laboratories must consider when using LDTs or EUA tests.
Evidence and guidance citations
Key evidence and guidance sources informing the criteria above:
Policy references peer‑reviewed evaluations of antigen, molecular, and serologic tests, WHO/CDC/IDSA/ECDC/AAP guidance documents, FDA EUA summaries and device IFUs, and publications addressing pooling, RT‑LAMP/CRISPR methods, and sequencing approaches.
Coding, test characteristics, and code listings
General coding guidancemixed
| No codes listed |
Laboratory test characteristics (no billing codes provided)mixed
| Document discusses RT-PCR assay performance characteristics (limits of detection) and CDC diagnostic panel gene targets (N gene and RNase P control). |
Panel tests with EUA including SARS-CoV-2mixedCovered
| Multiplex respiratory pathogen panels that include SARS-CoV-2 (e.g., BioFire RP2.1, QIAstatDx Respiratory SARS-CoV-2 Panel, ePlex Respiratory Pathogen Panel 2, cobas SARS-CoV-2 & Influenza A/B, Xpert Xpress SARS-CoV-2/Flu/RSV, Quest Diagnostics RC COVID-19 +Flu RT-PCR, Sofia 2 Flu + SARS Antigen FIA, Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay) |
Panel organism listsmixed
| Organisms commonly listed on multiplex respiratory panels (examples): Adenovirus; HCoV 229E, HKU1, NL63, OC43; SARS-CoV-2; Human metapneumovirus; Rhinovirus/Enterovirus; Influenza A (H1, H3, H1-2009); Influenza B; Parainfluenza viruses 1-4; Respiratory syncytial virus; Bordetella pertussis/parapertussis; Chlamydia pneumoniae; Mycoplasma pneumoniae. |
Pooled-sample NAAT/TMA/RT-PCR EUAsmixed
| References to EUA-authorized pooled-sample assays (examples include UCSD RC SARS-CoV-2 Assay, Poplar SARS-CoV-2 TMA Pooling assay, LabCorp COVID-19 RT-PCR Test) and reported pool sizes (e.g., 5, 7 samples) |
Test types discussedmixed
| Document references NAAT (RT-PCR), antigen, and serology testing modalities and associated specimen-collection considerations (AN, MT, NP, saliva, etc.). |
Listed SARS-CoV-2 test procedure codesCPT | HCPCS | mixedCovered
| 86328 | Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single step method; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) |
| 86408 | Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); screen |
| 86409 | Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); titer |
| 86413 | SARS-CoV-2 antibody, quantitative |
| 86769 | Antibody; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) |
| 87426 | Infectious agent antigen detection by immunoassay technique, qualitative or semiquantitative; severe acute respiratory syndrome coronavirus (eg, SARS-CoV-2) |
| 87635 | Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), amplified probe technique |
| 87798 | Infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified; amplified probe technique, each organism |
| 87811 | Infectious agent antigen detection by immunoassay with direct optical observation; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) |
| 87913 | Infectious agent genotype analysis by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), mutation identification in targeted region(s) |
1–10 of 15
1/2
Diagnostic platforms and multiplex assays referencedmixed
| No codes listed |
RT-PCR limit of detection examples
WHO E gene LoD~3.9 copies per reaction
CDC diagnostic panel LoD1.0–3.2 copies/µL
High-throughput platform example LoD689.3 copies/mL (275.72 copies per reaction) at 95% detection probability
Appropriate timing for serology sensitivity
IgG sensitivity >14 days PSO>14 days post symptom onset — IgG sensitivity increases sharply to ~88.2%–94.1% (study) and pooled IgG sensitivity ≈88–94%
IgM timing and limitationsIgM sensitivity low ≤14 days (as low as ~21.4%) and increases variably >14 days but remains less reliable than IgG
Convalescent-phase sensitivityAverage IgG sensitivity up to 100 days PSO ≈89.8% (meta-analysis)
Limit of detection (examples) — BioFire and ePlex
BioFire RP2.1 LoD (infectious isolate)160 copies/mL (100% detection in 20/20 replicates)
BioFire RP2.1 LoD (heat-inactivated USA‑WA1/2020)500 copies/mL (100% detection in 20/20 replicates)
ePlex RP2 LoD~250 genomic copies/mL (0.01 TCID50/mL by digital droplet PCR) with 100% PPA/NPA in evaluation
Ag-RDT performance threshold
WHO minimum performance for Ag-RDTsSensitivity ≥80% and Specificity ≥97% versus a NAAT reference assay
Optimal Ag-RDT symptom windowConduct within 5–7 days after symptom onset for best performance
Use-context guidanceRecommended in settings with ongoing community transmission (≥5% test positivity) and for symptomatic individuals, outbreak investigations, or screening high-risk contacts
Rapid NAAT turnaround time definitions
FDA rapid NAAT definitionSome authorities (including FDA) define rapid NAAT turnaround time as ≤30 minutes (testing time only)
Alternate rapid NAAT definitionsOther definitions use ≤60 minutes or longer; definitions refer to testing run-time and exclude specimen transport and reporting intervals
Operational noteRapid NAATs typically have few operator steps and may be performed near patient or at point-of-care by non-laboratory staff
MIS-C initial testing tier
MIS-C tier 1 laboratory testsESR and CRP are recommended as part of initial (tier 1) laboratory evaluation for suspected MIS-C
SARS-CoV-2 testing in MIS-C tier 1SARS-CoV-2 testing (RT-PCR or serology) is included as tier 1; send serology prior to IVIG when possible
Initial outpatient workupPerform expanded laboratory and cardiac workup for children sick enough to warrant admission when MIS-C suspected
Pooling and assay EUA references
Pooling strategy referencesCitations include evaluation of RT-qPCR in multisample pools and sample pooling as a community detection strategy (e.g., Yelin et al., Hogan et al.)
FDA EUA pooling summariesFDA EUA summaries of pooled SARS-CoV-2 assays (e.g., Poplar TMA Pooling Assay) are cited as regulatory references
Guidance and evidence catalogReferences list includes FDA EUA documents and peer-reviewed pooling evaluations supporting pooled-sample testing methods
Billing rules, operational guidance, and provider responsibilities
Billing Rule
Billing: single procedure code per date of service; specimen collection incidental
Do not report both HCPCS and AMA (CPT) procedure codes for the same service on the same date of service; only one code per DOS will be reimbursed. Specimen collection codes for coronavirus testing are considered incidental and will not be reimbursed.
Documentation Required
RT‑PCR limitations and need for clinical interpretation
RT‑PCR is the diagnostic standard for acute infection but requires specific instrumentation and is less amenable to point‑of‑care use; negative RT‑PCR results may fluctuate or be unstable over time and should not be used as the sole basis for clinical management—interpret results in the context of specimen timing, collection, and clinical findings.
Billing Rule
Operational impacts: rapid PCR benefits and preoperative testing consequences
Rapid on‑demand PCR and point‑of‑care nucleic acid tests can reduce hospital length‑of‑stay and nosocomial transmission by enabling rapid cohorting and isolation; routine preprocedural PCR in asymptomatic patients has low positivity and may delay or cancel procedures and incur substantial cost.
- Rapid PCR programs helped reduce unnecessary LOS and exposure by quickly separating COVID‑19 positive patients (Yau et al.).
- In one preoperative PCR study, 0.41% of asymptomatic tests were positive; positive results caused procedure delays/cancellations and high per‑positive cost.
Documentation Required
Diagnostic sequencing: use NAAT for management; IgM not diagnostic alone
Do not rely on IgM antibody tests alone for diagnosis; molecular testing (NAAT/RT‑PCR) should guide clinical management and infection control when needed, while IgG serology is useful to detect past infection and to help rule out infection when performed >14 days post‑symptom onset.
- IgM seroconversion may be delayed or absent and IgM should only be supportive alongside molecular tests.
- IgG sensitivity increases substantially >14 days PSO and can be used to detect prior infection or help rule out infection in that window.
Documentation Required
Antigen results: negative results presumptive—confirm per manufacturer/FDA guidance
Treat negative antigen test results as presumptive; confirm a negative antigen when necessary for clinical management or infection control with an FDA‑authorized molecular assay and adhere strictly to manufacturer procedures to avoid invalid results.
- Follow the device's required system and test procedure (e.g., Sofia®2) to avoid performance loss or invalidation.
- Negative antigen results 'should be treated as presumptive and confirmed with an FDA authorized molecular assay, if necessary, for clinical management, including infection control.'
Documentation Required
BioFire RP2.1: retest when ≥4 organisms detected; negative results not definitive
If a BioFire RP2.1 panel detects four or more organisms, retest the sample; recognize that negative panel results do not exclude infection and must be interpreted with clinical context.
- Negative results may occur due to sequence variants, inhibitors, technical error, sample mix‑up, undetected organisms, or specimen type limitations.
Documentation Required
Do not use BioFire RP2.1 for suspected Bordetella pertussis—use FDA‑cleared IS481 tests
Do not use the BioFire RP2.1 panel when Bordetella pertussis is specifically suspected; instead use an FDA‑cleared molecular B. pertussis test that targets the multi‑copy IS481 insertion sequence for higher sensitivity.
- RP2.1 targets a single‑copy ptxP promoter and has lower sensitivity for B. pertussis; use an FDA‑cleared B. pertussis molecular test for suspected cases.
Documentation Required
Follow‑up testing required when viral differentiation is clinically necessary
When differentiation between genetically similar viruses (e.g., rhinovirus vs enterovirus or influenza A variants) is required, obtain follow‑up confirmatory testing (e.g., culture or sequence analysis) rather than relying solely on panel results.
- Some panels cannot reliably distinguish closely related viruses; detected results should be followed up with alternate methods when strain/virus differentiation is clinically necessary.
Documentation Required
Use only labeled specimen types per FDA/EUA or validated LDTs to avoid inaccurate results and denials
Adhere to specimen types listed in the FDA/EUA and individual test labeling; failure to use authorized collection types or to follow validated LDT specimen‑collection methods can produce inaccurate results and may lead to reimbursement denials.
- Follow label/EUA‑authorized specimen types unless an LDT validation or subsequent FDA authorization permits alternatives.
- Non‑adherence to label requirements can result in inaccurate testing and payment denials.
Billing Rule
Avoid NAAT within 90 days after a positive NAAT; use antigen testing per CDC guidance
Do not use NAAT to retest individuals who had a positive NAAT within the prior 90 days; consider antigen testing for specific post‑infection windows per CDC recommendations.
- Viral RNA may persist up to 90 days; CDC advises against NAAT testing within 90 days of a prior positive NAAT and suggests antigen testing in certain 31–90 day windows.
- CDC testing scenarios provide guidance on when NAAT versus antigen testing is appropriate after a recent infection.
Documentation Required
Specimen collection compliance: follow FDA/EUA labels or validated LDTs
Follow FDA/EUA labeling or validated LDT specimen‑type and collection requirements for all assays; adherence is necessary for accurate results and to avoid reimbursement denials.
- IDSA and FDA materials emphasize that collection method and specimen type affect test performance and reimbursement.
Billing Rule
Asymptomatic screening: evaluate local risk/benefit; SHEA advises against routine universal screening
Before implementing universal asymptomatic screening, perform a local facility risk–benefit and infection‑prevention analysis; SHEA recommends against routine universal asymptomatic screening and notes limited incremental benefit when other controls are in place.
- Preprocedure and admission screening may be considered in select high‑risk settings or during high community transmission, but routine universal screening is not recommended.
Documentation Required
MIS‑C evaluation: obtain RT‑PCR and serology (send serology before IVIG) and perform tier‑1 labs
For suspected MIS‑C, perform SARS‑CoV‑2 RT‑PCR and serologic testing as part of the evaluation; send serology prior to IVIG when possible and initiate first‑line labs (e.g., ESR, CRP) and pediatric subspecialty consultation for severely ill children.
- ESR and CRP plus SARS‑CoV‑2 PCR or serology are considered tier‑1 (first‑line) tests in the MIS‑C evaluation.
- Send serology before IVIG because IVIG can affect serologic testing.
Documentation Required
Laboratory regulatory obligations: comply with FDA and CMS/CLIA guidance for LDTs and EUA transition plans
Laboratories and providers must follow FDA and CMS/CLIA guidance for laboratory‑developed tests (LDTs) and the FDA's transition plans for COVID‑19 diagnostics issued during the public health emergency.
- LDTs are regulated by CMS under CLIA as high‑complexity tests; FDA policies during the PHE and the 2023 transition plans affect device/EUA status and use.
Note
Regulatory/EUA references: consult FDA EUA summaries and product instructions for device‑specific use
Refer to FDA EUA summaries and product instructions (e.g., Sofia®2, BD Veritor, LumiraDx, BioFire) cited in the policy for device‑specific authorization, specimen requirements, and procedural details when selecting or interpreting tests.
- The policy cites EUA summaries and manufacturer instructions that define authorized uses, specimen types, and performance limitations for specific devices.
Definitions and abbreviations
SARS-CoV-2 and testing modalities
SARS-CoV-2 definitionSARS-CoV-2: the coronavirus that causes COVID-19; testing modalities include molecular NAAT (RT-PCR), antigen, and antibody assays
Test modality categoriesNAAT (detects viral RNA for acute infection), antigen tests (detect viral proteins for current infection), and antibody/serologic tests (detect host immune response)
NAAT clinical noteNAAT/PCR is the diagnostic standard for acute infection but may remain positive for up to 90 days and requires appropriate specimen collection and timing
MIS-C
MIS-C definition (CDC)Multisystem inflammatory syndrome in children: illness in persons <21 years with fever ≥38°C, clinical severity often requiring hospitalization, systemic inflammation (e.g., elevated CRP), and new multisystem organ involvement
Diagnostic linkage windowMIS-C case criteria allow detection of SARS-CoV-2 nucleic acid/antigen up to 60 days prior to or during hospitalization, or antibody detection, or close contact within 60 days
Initial evaluation guidanceChildren suspected of MIS-C should undergo expanded laboratory and cardiac workup alongside SARS-CoV-2 testing
MIS-A
MIS-A definition (CDC)Multisystem inflammatory syndrome in adults: illness in persons ≥21 years with hospitalization, fever, no alternative diagnosis, multisystem clinical criteria and systemic inflammation
Clinical componentsIncludes primary criteria (e.g., severe cardiac illness, rash, conjunctivitis) and secondary criteria (neurologic signs, shock, GI symptoms, thrombocytopenia) with evidence of SARS-CoV-2 infection and inflammation
Hospitalization requirementMIS-A requires hospitalization for clinical severity in the case definition
VBM
VBM abbreviationVariants Being Monitored (VBM)
ContextCDC classification for lineages with potential impact or previously significant variants now at low circulation
Relation to VOC/VOIVBMs may include lineages downgraded from VOI/VOC when they no longer pose significant public health risk
VOI
VOI abbreviationVariants of Interest (VOI)
AttributesLineages with genetic markers predicted to affect transmission, diagnostics, therapeutics, or immune escape
Epidemiologic signalMay be associated with increased proportion of cases or unique outbreak clusters
VOC
VOC abbreviationVariants of Concern (VOC)
Key featuresMarked by increased transmissibility, more severe disease, reduced neutralization by antibodies, or reduced effectiveness of treatments/vaccines/diagnostics
Public health implicationMay prompt public health action and enhanced surveillance
VOHC
VOHC abbreviationVariants of High Consequence (VOHC)
DefinitionVariants with clear evidence that prevention measures or medical countermeasures have significantly reduced effectiveness compared to prior variants
Current status noteExtremely rare classification reserved for variants with major public health impact
Host antibody testing
Serologic assay definitionHost antibody (serologic) testing detects IgM, IgA, IgG, or total antibodies produced in response to SARS-CoV-2; includes binding and neutralizing antibody assays
UsesUseful for detecting past infection, epidemiologic surveys, and select clinical scenarios (e.g., MIS-C); not recommended for diagnosing acute infection within first 2 weeks
LimitationsTiming affects sensitivity; vaccination and prior infection complicate interpretation; neutralizing assays differ from binding assays and have variable clinical implications
RT-PCR
RT-PCR definitionReverse transcription polymerase chain reaction (RT-PCR) synthesizes cDNA from viral RNA and amplifies specific gene targets to detect acute SARS-CoV-2 infection
Clinical roleDiagnostic standard for acute infection but requires proper specimen collection and timing; negative results should be combined with clinical assessment
LimitationsRequires instrumentation and is less amenable to rapid point-of-care use; results may fluctuate over time
Antigen testing
Antigen testing definitionDirect detection of viral proteins (e.g., spike or nucleocapsid) to indicate presence of virus; typically rapid with results in 15–30 minutes but generally less sensitive than NAAT
Performance characteristicsHigh specificity but variable sensitivity; recommended use when tests meet WHO thresholds and within early symptom window
Operational noteNegative antigen results are presumptive and may require confirmation by NAAT for clinical management
Antibody testing (IgM/IgG)
Antibody test typesIgM and IgG assays detect host immune response; IgG has greater utility for detecting past infection and has higher sensitivity after ~14 days PSO
IgM limitationsIgM may not seroconvert early or may wane after ~35 days PSO; should not be used alone for diagnosis
Utility windowIgG sensitivity improves over weeks with highest accuracy in convalescent phase (up to ~100 days PSO)
Panel testing
Panel testing definitionMultiplex respiratory panels are laboratory assays (often multiplex PCR) that detect and differentiate multiple respiratory pathogens, including SARS-CoV-2, from a single specimen
Use casesUseful when multiple pathogens are in the differential diagnosis; may be costly and not validated for asymptomatic screening
LimitationsNegative results do not exclude infection; panels may have target-specific LoD and risk of amplification competition
PPA / NPA
PPA / NPA definitionPositive Percent Agreement (PPA) and Negative Percent Agreement (NPA) measure concordance with reference methods (PPA = TP/(TP+FN); NPA = TN/(TN+FP))
Use in evaluationsPPA/NPA commonly reported in performance studies for panel and multiplex assays (e.g., ePlex RP2 reported 100% PPA and 100% NPA in evaluation)
Interpretation notePPA/NPA are agreement metrics used when a true gold standard may not be available; they differ from sensitivity/specificity terminology in some regulatory contexts
LoD
LoD definitionLimit of Detection (LoD): the lowest concentration detected at least 95% of the time in assay validation
Platform variabilityLoD varies by platform and target; examples include BioFire RP2.1 (160–500 copies/mL) and ePlex (~250 copies/mL)
Impact on clinical sensitivityLoD influences ability to detect low viral loads and affects assay performance across the course of infection
NAAT
NAAT definitionNucleic acid amplification tests (NAATs), including PCR, detect viral RNA and are highly sensitive and specific for acute SARS-CoV-2 infection
Prolonged positivity noteViral RNA may remain detectable by NAAT for up to 90 days after infection, limiting NAAT use to detect new infections within that window
Clinical implicationNAAT is preferred for diagnosis in symptomatic individuals but may not distinguish infectiousness from residual RNA detection
Ag-RDT
Ag-RDT definitionAntigen-detecting rapid diagnostic test (Ag-RDT): lateral flow or similar immunoassays that detect viral proteins and provide rapid results for current infection
WHO contextWHO recommends Ag-RDTs meeting ≥80% sensitivity and ≥97% specificity be used for symptomatic individuals within 5–7 days of symptom onset and for certain screening contexts
Characteristic tradeoffsAg-RDTs offer speed and accessibility but typically have lower sensitivity than NAAT, especially with low viral load
Antibody testing
Antibody testing roleAntibody testing can detect prior infection or immune response and is useful for seroprevalence and select clinical scenarios but is not diagnostic of acute infection
Policy cautionsSerology should not be used to determine immune status, for immunity passports, or as sole basis for return-to-work decisions
Timing sensitivityTest accuracy increases with time since symptom onset; serology is most informative ≥3 weeks post-infection for prior infection detection
Long COVID / PCC
Long COVID / PCC definitionPost-COVID conditions (PCC/Long COVID): infection-associated chronic condition present at least three months after SARS-CoV-2 infection, affecting one or more organ systems
Diagnostic approachClinical diagnosis informed by history and exam; no laboratory test definitively diagnoses PCC
Role of testingPositive viral or serologic tests are not required to establish a PCC diagnosis though they may help assess prior infection
Rapid NAAT
Rapid NAAT definitionRapid NAAT: nucleic acid amplification tests with varied turnaround definitions (≤30 minutes per FDA or ≤60 minutes in other sources); testing time excludes transport/reporting
MethodologiesIncludes rapid RT-PCR and rapid isothermal NAAT methods; may be suitable for near-patient or point-of-care use
Performance considerationsTest performance may vary by specimen type and evaluated platforms; some rapid NAATs have shown lower sensitivity in certain studies (e.g., Abbott IDNow)
Known exposure
Known exposure definitionClose contact for at least 15 minutes over a 24-hour period with someone who has laboratory-confirmed COVID-19
Suspected exposure examplesWorking or residing in a congregate setting experiencing an outbreak (e.g., long-term care, correctional facility, cruise ship, factory)
Testing timing noteIDSA suggests testing exposed asymptomatic individuals at least 5 days after exposure unless symptoms develop earlier
MIS-C case criteria
MIS-C case criteria elementsFever (>38.0°C), clinical severity requiring hospitalization, CRP >3.0 mg/dL, new onset of manifestations in ≥2 organ categories, and SARS-CoV-2 detection (nucleic acid/antigen up to 60 days prior) or antibodies or close contact within 60 days
Organ system examplesCardiac, mucocutaneous, GI, hematologic, neurologic, and shock manifestations listed in case definition
Evaluation algorithm noteCDC delineates an outpatient/ED testing algorithm for MIS-C including RT-PCR and serology as part of workup
Laboratory-developed test (LDT)
LDT definitionLaboratory-developed tests (LDTs) are tests developed and validated in-house and are regulated by CMS under CLIA as high complexity tests; FDA clearance is not required for clinical use under emergency policies
Regulatory contextFDA issued guidance during the public health emergency and later transition plans for devices/EUAs; labs must follow CLIA requirements for LDTs
Operational implicationLDTs require laboratory validation and adherence to regulatory guidance to support clinical use and reimbursement
whole genome sequencing / NGS
WGS / NGS resourcesWhole genome sequencing (WGS) and next-generation sequencing (NGS) cited for variant surveillance and outbreak response (e.g., Illumina COVIDSeq, Helix COVID-19 NGS Test)
Use casesUseful for surveillance, outbreak investigation, and tracking variants; cited studies demonstrate rapid WGS informing public health decisions
Regulatory noteAs of May 4, 2022 no FDA-approved WGS tests were identified; platforms are referenced via FDA summaries and peer-reviewed literature
EUA
EUA definition and useEmergency Use Authorization (EUA): FDA mechanism authorizing in vitro diagnostics for use during a public health emergency; EUA summaries and device documents are cited to support test performance and authorized uses
EUA resources citedPolicy references FDA EUA summaries for specific devices (e.g., Sofia 2, Veritor, LumiraDx) and maintains links to EUA listings and summaries
Transition planningFDA issued transition plans (e.g., 2023) for devices/EUAs as public health emergency policies evolved
Policy revision history
2015-09-18policy_effective_date
Policy effective date recorded for this reimbursement/payment guidance document.
2025-11-01last_reviewLatest
Last clinical review completed; document metadata lists last review date.
2025-11-01next_review_scheduled
Next review date scheduled (matches last review date in header metadata).
2023-03regulatory_update_citation
FDA transition plan for devices issued EUAs related to COVID-19 referenced in evidence section (FDA transition plan updated March 2023).
Policy Summary
PayerCapital Bluecross
PolicyCoronavirus Testing in the Outpatient Setting
Policy CodePolicy AHS - G2174
Change TypeNo material clinical or coverage changes
Effective DateSep 18, 2015
Last ReviewNov 1, 2025
Next Review DateNov 1, 2025
Key ActionDo not report both HCPCS and AMA codes for the same procedure on the same date of service; specimen collection codes are incidental and will not be reimbursed.
SourceLink
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