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Defines coverage criteria and limitations for coronavirus (SARS-CoV-2, SARS, MERS, endemic HCoVs) diagnostic testing in the outpatient setting for medical decision-making; excludes testing for work/school/state/federally mandated purposes and addresses reimbursement rules and terminology.
No material clinical or coverage changes identified (has_material_change=false).
Defines outpatient coverage criteria and limitations for diagnostic testing of coronaviruses including SARS‑CoV‑2, SARS, MERS, and endemic HCoVs, specifying medically necessary indications (targeted NAAT/antigen testing for symptomatic patients, testing after exposure, limited multiplex/antigen panels, and serology for MIS‑C/MIS‑A and PASC) and explicit exclusions and billing rules; status: CURRENT.
Medically Necessary / Meets Coverage Criteria
Targeted nucleic acid, antigen, multiplex, and serology testing meet coverage criteria in specified clinical situations:
ANY of the following
See Note 1 for symptom examples
Exclusion: prior infection within 90 days
Send serology prior to IVIG when MIS-C suspected
WHO performance thresholds and timing apply (see policy)
See Note 4 for respiratory infection signs
See Note 4 for respiratory infection signs
Not Covered / Does Not Meet Coverage Criteria
The following tests are not covered for the indicated reasons:
ALL of the following
Defined as distinct lineages per Nextstrain or GISAID
| No codes listed |
| No codes listed |
| 86318 | Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single step method (eg, reagent strip). |
| 86328 | Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single step method (eg, reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]). |
| 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. |
| 0224U | Antibody, SARS-CoV-2, includes titer(s), when performed (Proprietary test: COVID-19 Antibody Test, Mount Sinai Laboratory). |
| 0226U | Surrogate viral neutralization test (sVNT), SARS-CoV-2, ELISA, plasma, serum (Proprietary test: Tru-Immune™). |
| 87426 | Infectious agent antigen detection by immunoassay technique; SARS-CoV (eg, SARS-CoV-2). |
| 87428 | Infectious agent antigen detection by immunoassay; SARS-CoV and influenza A/B. |
| 87811 | Infectious agent antigen detection by immunoassay with direct optical observation; SARS-CoV-2. |
| 87631 | Infectious agent detection by nucleic acid; respiratory virus multiplex, 3-5 targets. |
| 87632 | Infectious agent detection by nucleic acid; respiratory virus multiplex, 6-11 targets. |
| 87633 | Infectious agent detection by nucleic acid; respiratory virus multiplex, 12-25 targets. |
| 87635 | Infectious agent detection by nucleic acid; SARS-CoV-2, amplified probe technique. |
| 87798 | Infectious agent detection by nucleic acid, not otherwise specified; amplified probe technique, each organism. |
| 0115U | Respiratory infectious agent detection by nucleic acid, 18 viral types and subtypes and 2 bacterial targets; ePlex RP Panel (GenMark). |
| 0202U | Pathogen specific nucleic acid, 22 targets including SARS-CoV-2; BioFire RP2.1. |
| 0223U | Pathogen specific nucleic acid, 22 targets including SARS-CoV-2; QIAstat-Dx. |
| 0225U | Pathogen-specific DNA and RNA, 21 targets including SARS-CoV-2; ePlex RP2. |
| U0001 | CDC Novel Coronavirus Real-Time RT-PCR Diagnostic Panel. |
| 87913 | Infectious agent genotype analysis by nucleic acid; SARS-CoV-2 mutation identification in targeted region(s). |
| C9803 | Hospital outpatient clinic visit specimen collection for SARS-CoV-2, any specimen source. |
| 0224U | COVID-19 Antibody Test (Mount Sinai Laboratory) - appears also in antibody group. |
| 0226U | Tru-Immune™ (Ethos Laboratories/GenScript USA Inc.) - surrogate viral neutralization. |
One procedure code reimbursed per date of service
Only one procedure code reimbursed per date of service for the same clinical indication; when multiple COVID-19 test CPT/HCPCS codes are submitted for the same patient, date of service, and indication, reimbursement is limited to a single eligible test per date of service.
Specimen collection incidental
Specimen collection is considered incidental to the laboratory test(s) and is not paid separately unless a separately payable collection code is specifically allowed by the member's benefit or by contract.
Pooling limitations
Pooling of specimens may be permissible only where explicitly supported by the test's EUA/IFU and only when pooling is performed by the laboratory per validated methods; limits on pool size and patient populations apply. Claims for pooled testing may be denied if pooling exceeds allowable pool sizes or is performed contrary to EUA/IFU.
Test-specific platform requirements
Some NAAT or antigen codes may be restricted to specific platforms or test methods per the manufacturer's EUA and payer rules. Verify that the billed code matches the testing method and that the platform is authorized for the specimen type and intended use.
NAAT vs antigen guidance (codes)
NAATs and antigen tests have different codes and clinical uses. Use the appropriate code for the test performed; reimbursement follows coverage for the specific modality. Antigen testing is generally for symptomatic individuals and NAATs for diagnostic confirmation or higher-sensitivity needs.
Limitations based on benefit coverage
Coverage and documentation must reflect the benefit limitations and patient eligibility; confirm that testing meets the policy's clinical indications (symptoms, exposure, MIS-C/MIS-A evaluation, PASC, or other covered reasons) before submitting claims.
Antigen test negative results are presumptive
A negative antigen test result in a symptomatic person is considered presumptive and may require confirmation with a NAAT (molecular) test based on clinical judgment and policy guidance.
Antigen/serology timing considerations
Timing of antigen and serology testing affects interpretation. Antigen tests perform best early in symptomatic infection; serology is most informative ≥14 days after symptom onset and is not useful for diagnosing acute infection.
Panel test limitations and follow-up
Multiplex respiratory panel tests are limited by this policy (covered up to 5 targets for symptomatic respiratory infections). Larger panels or broad panel testing may not be covered and may necessitate targeted testing or follow-up testing when clinically indicated.
Specimen type selection and documentation
Document specimen type and source clearly in the medical record and on the claim as some assays are authorized only for specific specimen types; incorrect specimen type may place the claim at risk for denial.
Use of antibody testing
Antibody (serology) testing is useful for supporting diagnosis of MIS-C/MIS-A or assessing past infection in specific clinical contexts but is not appropriate for acute diagnosis of active infection or for general population screening under this policy.
Use of Ag-RDTs per WHO
Use of Ag-RDTs should follow WHO recommendations for point-of-care antigen-detecting rapid diagnostic tests, including proper patient selection (symptomatic persons within appropriate time window) and adherence to IFU to reduce false results.
Isolation/testing guidance
Isolation and testing guidance should follow public health recommendations; testing may be indicated to inform isolation duration or return-to-work decisions when aligned with clinical and public health criteria.
MIS-C initial evaluation and testing
For suspected MIS-C, document clinical criteria (fever, multisystem involvement, inflammatory markers) and obtain initial screening labs and SARS‑CoV‑2 testing per CDC guidance; include documentation of criteria and tests performed in the medical record.
Specimen selection and timing
Select specimens and timing consistent with the test's performance characteristics and EUA/IFU. For highest sensitivity, collect appropriate upper respiratory specimens early in symptomatic disease for antigen tests and as directed for NAATs; serology timing should reflect expected antibody kinetics.
Specimen and indication constraints — denial risk
Claims for testing may be at risk when tests are used in populations or with specimen types not authorized by the EUA/IFU, or when clinical indications fall outside covered scenarios. Verify EUA authorization and document medical necessity to mitigate denial risk.
Human coronaviruses comprise endemic HCoVs (229E, NL63, OC43, HKU1) that usually cause mild respiratory illness and zoonotic coronaviruses including SARS, MERS, and SARS‑CoV‑2 (the cause of COVID‑19); COVID‑19 caused a global pandemic with substantial morbidity and mortality and a clinical spectrum from asymptomatic to critical illness (including ARDS and multiorgan failure).
Diagnostic modalities include nucleic acid amplification tests (NAATs, e.g., RT‑PCR and rapid molecular assays) for acute infection detection, antigen detection tests (including point‑of‑care Ag‑RDTs) that detect viral proteins and are most useful early in symptomatic illness, and host serologic (antibody) tests (binding and neutralizing) that detect host immune response and are not for diagnosing acute infection.
Viral dynamics peak around symptom onset with upper respiratory viral load declining over ~10 days (but RNA may shed longer); thus NAATs are preferred for diagnosing current infection, antigen tests perform best within ~5–7 days of symptoms and should be used where WHO performance thresholds are met, and serology typically becomes reliable >14 days after symptom onset (IgM/IgA rise earlier but are less reliable; IgG seroconversion averages around 14 days).
Test performance varies by method and timing: NAATs generally have low limits of detection and high sensitivity, multiplex panels and platform‑specific assays (e.g., BioFire, ePlex, QIAstat) have defined LoDs and target lists, Ag‑RDT sensitivities are lower and variable (example studies report sensitivities from ~30% to >80% depending on the assay and timing), and serologic assay sensitivities improve ≥14–21 days PSO with ELISA/CLIA outperforming LFIA in pooled analyses.
Clinical contexts where serology is useful include supporting diagnoses of multisystem inflammatory syndrome in children (MIS‑C) and adults (MIS‑A) and evaluating post‑acute sequelae of SARS‑CoV‑2 infection (PASC)/long COVID; guidelines recommend combining antibody and viral testing for MIS‑C/MIS‑A evaluation and note serology may detect prior infection when NAAT is negative or unavailable.
Guidance from major authorities (CDC, WHO, NIH, IDSA, AAP, ACR) informs specimen selection (upper respiratory samples, saliva, breath in qualified settings, lower respiratory specimens when indicated), testing timing (test exposed contacts ≥5 days post exposure or immediately if symptomatic), isolation strategies, and limitations of serology (should not be used to determine immunity or return‑to‑work) and of antigen tests (negative results are presumptive and may need confirmation by NAAT).
| Term | Definition |
|---|---|
| COVID-19 | |
| Coronavirus disease 2019 | |
| RT-PCR | |
| Reverse transcription polymerase chain reaction | |
| MIS-C | |
| Multisystem inflammatory syndrome in children | |
| MIS-A | |
| Multisystem inflammatory syndrome in adults | |
| PSO | |
| Past Symptom Onset (time since symptom onset) | |
| PPA | |
| Positive Percent Agreement (proportion of reference positives detected) | |
| NPA | |
| Negative Percent Agreement (proportion of reference negatives detected) | |
| LoD | |
| Limit of Detection (lowest concentration detected at least 95% of the time) | |
| TCID50 | |
| Tissue Culture Infectious Dose (measure of infectious virus concentration) | |
| Ag-RDT | |
| Antigen-detecting rapid diagnostic test | |
| NAAT | |
| Nucleic acid amplification test (e.g., RT-PCR) | |
| RT-LAMP | |
| Reverse transcription loop-mediated isothermal amplification | |
| WGS | |
| Whole genome sequencing | |
| EUA | |
| Emergency Use Authorization (FDA) | |
| Long COVID / Post-Acute Sequelae of SARS-CoV-2 | |
| Symptoms lasting 3 or more months not present prior to having COVID-19; common symptoms include dyspnea, fatigue, post-exertional malaise, cognitive impairment, cough, chest pain, etc. | |
| PEM | |
| Post-exertional malaise (worsening of symptoms following even minor physical or mental exertion, typically worsening 12 to 48 hours after activity and lasting for days or weeks) |
Policy last reviewed
Use serology only for listed indications
Includes live-virus and surrogate assays