Currentblue cross blue shield - louisianaPolicy AHS - G2174 - Coronavirus Testing in the Outpatient Setting

Coronavirus Testing in the Outpatient Setting

Defines outpatient coverage criteria and limitations for coronavirus (SARS-CoV-2, SARS, MERS, endemic HCoVs) testing modalities (nucleic acid, antigen, host antibody, panel testing, sequencing/genotyping) for medical decision making; excludes work/school/mandated testing and addresses reimbursement guidance for outpatient claims.

Policy Summary

Payerblue cross blue shield - louisiana

PolicyCoronavirus Testing in the Outpatient Setting

Policy CodePolicy AHS - G2174 - Coronavirus Testing in the Outpatient Setting

Change TypeCoverage & coding updates

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionDocument clinical indication when ordering outpatient coronavirus tests and use NAAT and/or serology as appropriate to support MIS-C, MIS-A, or PASC diagnoses.

SourceLink

POLICY UPDATE CHANGES

Added NAAT as acceptable for MIS-A, MIS-C, and PASC to meet coverage criteria.

Updated CC5 to allow antigen testing for symptomatic individuals once every 48 hours.

Removed CC7 and CC9 due to redundancy with Pathogen Panel Testing policy (G2149).

Removed CPT/HCPCS codes (0224U, 87631, 87632, 87633, 0115U, 0202U, 0223U, 0225U, C9803) in prior revisions.

Reworded CC11 to state host antibody serology testing does NOT meet coverage criteria for situations not otherwise described.

Updated background, guidelines, and extensive evidence-based references (06/01/2025).

7Specific covered/limited indications listed

Coverage Summary

This outpatient coverage policy (AHS - G2174) defines scope for coronavirus testing modalities—nucleic acid amplification tests (NAATs/RT‑PCR), antigen assays, and host antibody/serology tests—for medical decision making in the outpatient setting. Coverage stance is mixed: targeted NAATs and specified antigen testing meet criteria for defined indications, host antibody testing meets coverage only for specific scenarios (eg, supporting MIS‑C/MIS‑A/PASC) and is not covered in many other outpatient situations. Effective date: 06/01/2025; last review: 06/01/2024. The policy’s primary purpose is to provide outpatient testing modality guidance and reimbursement rules (including frequency and coding constraints) for coronavirus-related clinical indications.

Key thresholds & quick facts

Antigen testing frequencyOnce every 48 hours for symptomatic individuals

NAAT positivity persistenceNAATs may remain positive up to 90 days after infection

MIS laboratory detection windowSARS‑CoV‑2 RNA/antigen detection up to 60 days prior to or during hospitalization

Ag‑RDT WHO performance thresholds>=80% sensitivity and >=97% specificity vs NAAT

Fever / CRP thresholds for MISFever >=38.0°C; CRP >=3.0 mg/dL

Effective date / Last reviewEffective: 2025-06-01; Last review: 2024-06-01

Medically Necessary and Not Medically Necessary Criteria

Medically Necessary / Meets Coverage Criteria

ANY of the following

Targeted nucleic acid testing (e.g., RT-PCR, rapid molecular tests) for SARS-CoV-2 meets coverage criteria when the individual is symptomatic (signs or symptoms of possible COVID-19 infection).
See Note 1 for symptom examples.
Targeted nucleic acid testing meets coverage criteria for asymptomatic individuals with known exposure to COVID-19, except when the individual has had a previous COVID-19 infection within the last 90 days.
Targeted nucleic acid testing for detection of SARS coronavirus RNA (SARS) meets coverage criteria for individuals with signs or symptoms of SARS and travel to endemic areas or exposure to persons with SARS.
Targeted nucleic acid testing for detection of MERS coronavirus RNA (MERS) meets coverage criteria for individuals with signs or symptoms of MERS and travel to endemic areas or exposure to persons with MERS.

Supportive Testing for MIS-C, MIS-A, and PASC

Supportive testing for inflammatory/post-acute syndromes

To support a diagnosis of multisystem inflammatory syndrome in children (MIS-C), multisystem inflammatory syndrome in adults (MIS-A), or post-acute sequelae of SARS-CoV-2 infection (PASC), the following testing modalities meet coverage criteria:

Supportive testing for inflammatory/post-acute syndromes: To support a diagnosis of multisystem inflammatory syndrome in children (MIS-C), multisystem inflammatory syndrome in adults (MIS-A), or post-acute sequelae of SARS-CoV-2 infection (PASC)

Nucleic acid amplification testing and host antibody serology testing meet coverage criteria

When ordering tests to support MIS‑C, MIS‑A, or PASC, ensure documentation of timing of prior infection (for example, detection or exposure within the policy’s 60‑day MIS laboratory detection window), relevant clinical criteria (fever, systemic inflammation, organ system involvement per CDC/AAP definitions), and intended test use. Serology for MIS evaluation should be collected and sent prior to IVIG. Surface the provider_actions details (required documentation elements and workflow) when preparing the order and claim.

Test Selection, Specimen Types, and Test Performance

Antigen testing for symptomatic individuals; Antigen panel testing for respiratory tract infection signs/symptoms

Antigen testing coverage and panel limits:

Antigen testing for symptomatic individuals: Symptomatic individualsonce every 48 hours

Antigen-detecting diagnostic tests for SARS-CoV-2 once every 48 hours meet coverage criteria

Antigen panel testing for respiratory tract infection signs/symptoms: Individuals with signs and symptoms of a respiratory tract infection (see Note 4)up to 5 antigens

Meets coverage criteria

Antigen testing performance and limitations:

Serology (Antibody) Testing: Uses and Limitations

Serology (antibody) testing use cases (CDC/AMA/IDSA/AACC)

Guidance on appropriate uses and limitations of serologic testing from CDC, AMA, IDSA, AACC:

Antibody tests detect prior infection or vaccination; do not diagnose current infection.
Not for protection or vaccination guidance: Not recommended to assess protection against infection or to guide vaccination decisions.
Useful for MIS-C/MIS-A diagnosis support: Useful for diagnosis of MIS-C or MIS-A in conjunction with clinical criteria and NAAT.
IDSA recommends IgG/NAAT to assist MIS-C diagnosis
AMA limitations:

Case Definitions: MIS-C, MIS-A, and Long COVID

MIS-C case definition (CDC); MIS-A case definition (CDC); Long COVID (Post-COVID conditions) characterization

CDC clinical and laboratory criteria for MIS-C, MIS-A, and Long COVID are summarized below:

MIS-C case definition (CDC)

Cardiac involvement one of: Left ventricular ejection fraction <55%; coronary artery dilatation/aneurysm/ectasia; troponin elevated above normalLVEF <55%
Mucocutaneous involvement one of: Rash; oral mucosal inflammation; conjunctivitis; extremity findings (erythema/edema)
GI involvement: Abdominal pain, vomiting, or diarrhea

Codes and Coding Notes

COVID-19 Serology & Antibody / Neutralizing Antibody CodesCPT

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; SARS-CoV-2
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

Antigen Detection CodesCPT

87426	Infectious agent antigen detection by immunoassay technique; SARS-CoV (eg SARS-CoV-2)
87428	Infectious agent antigen detection by immunoassay; SARS-CoV-2 and influenza A/B
87811	Infectious agent antigen detection by immunoassay with direct optical observation; SARS-CoV-2

Molecular / NAAT / Genotyping / Sequencing CodesCPT|HCPCS|other

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
87913	Infectious agent genotype analysis by nucleic acid; SARS-CoV-2 mutation identification in targeted region(s)
0226U	Surrogate viral neutralization test (sVNT), SARS-CoV-2, ELISA, plasma, serum (Tru-Immune™) - Proprietary
0408U	Infectious agent antigen detection by bulk acoustic wave biosensor immunoassay, SARS-CoV-2 (Omnia™) - Proprietary
U0001	CDC Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel
U0002	Non-CDC laboratory test for 2019-nCoV (COVID-19), any method

Specimen collection codesHCPCSNot Covered

No codes listed

Removed codes (from revision history)CPT|HCPCS|mixedNot Covered

0224U	Removed (revision note)
87631	Previously removed
87632	Previously removed
87633	Previously removed
0115U	Previously removed
0202U	Previously removed
0223U	Previously removed
0225U	Previously removed
C9803	Deleted (historical)

Added codes (from revision history)CPTCovered

0408U

Added 10/01/2023 (historical)

Billing note: Only one procedure code per date of service will be reimbursed; do not report both the HCPCS and AMA code for the same procedure on the same DOS. Specimen collection codes for coronavirus testing are considered incidental and will not be reimbursed. (See provider_actions billing_rule entries for mapping to billing instructions.)

Provider Actions and Billing Rules

Documentation Required

Clinical indication required

Document clinical indication and timing for each test. Include the specific clinical reason (symptoms, exposure, pre-procedure, MIS suspicion, or PASC evaluation), specimen type used per manufacturer IFU, and any prior positive test within 90 days that changes interpretation. When ordering serology, document the intended clinical use (e.g., support MIS-C/MIS-A diagnosis or PASC evaluation) and the timing relative to symptom onset or exposure.

Clinical indication required: record symptoms/exposure and reason for testing
Document prior SARS-CoV-2 infection within last 90 days (may alter need for NAAT/antigen)

Documentation Required

Interpret antibody test timing and limitations

Interpret antibody (serology) results with attention to timing and limitations: antibodies may not be detectable in the first 2–3 weeks after infection; vaccinated individuals may have vaccine‑induced antibodies that confound anti‑spike assays; neutralizing antibody testing is not supported. State the intended interpretation in the medical record and avoid using serology as the sole evidence of acute infection.

Background and Evidence Summary

Background (brief): Human coronaviruses include endemic HCoVs (229E, NL63, OC43, HKU1), SARS‑CoV, MERS‑CoV, and SARS‑CoV‑2. Diagnostic modalities include molecular NAATs (detect viral RNA), antigen tests (detect viral proteins; rapid but generally less sensitive), and host antibody serology (detect immune response; not for diagnosing acute infection). Viral load for SARS‑CoV‑2 typically peaks around symptom onset and declines over ~10 days; RNA shedding can persist (NAAT positivity) for weeks to months in some individuals. Antibody testing helps identify prior infection or support diagnoses of post‑infectious syndromes but has limitations for inferring immunity.

Evidence / Source	Key finding
CDC reported U.S. COVID-19 deaths (policy background)
Nearly 1.2 million U.S. COVID-19 deaths as of June 1, 2024 — underscores clinical impact and testing importance
RT-PCR LoD examples (multiple studies/assays)
Reported RT-PCR limits of detection vary widely (examples: WHO E gene ~3.9 copies/reaction; some high-throughput assays ~275–689 copies/mL), illustrating high analytic sensitivity of NAATs
Meta-analyses of serology (Lisboa Bastos, Kontou, Fox)
Serologic pooled sensitivities vary by platform: ELISA ~84.3%, LFIA ~66%, CLIA ~97.8%; sensitivity increases with time PSO (eg IgG ~41% week1 → ~88% week3; convalescent ~89.8%) — limits use for acute diagnosis
Quidel Sofia®2 antigen clinical/LoD data
Clinical studies showed ~80% PPA and 100% NPA; direct-swab LoD ~113 TCID50/mL; negative antigen results should be confirmed with NAAT
BD Veritor and LumiraDx antigen performance
BD Veritor: PPA 84%, NPA 100%; LumiraDx: PPA 97.6%, NPA 96.6%, LoD 32 TCID50/mL — antigen performance varies by device
Panel/multiplex NAAT LoD and performance (ePlex, BioFire, QIAstat, CDC Flu SC2)
ePlex detected 59/59 positives (100% PPA), LoD ≈250 copies/mL; BioFire RP2.1 LoD 500 copies/mL (heat-inactivated) and 160 copies/mL (infectious) — multiplex NAATs show high analytic sensitivity but are platform-specific
RT-LAMP/NGS/alternative NAAT methods
RT-LAMP and other rapid NAATs show high specificity and good sensitivity at lower Ct (eg RT-LAMP ~97.5% agreeance for Ct<30); NGS assays (Helix) reported LoD ~125 copies/mL with 100% PPA/NPA in small evaluations
CDC/IDSA/NIH guidance on test choice and antigen repeat strategy
CDC and IDSA recommend NAAT (PCR) as preferred confirmation; CDC recommends repeat antigen testing (2 negatives 48h apart symptomatic; 3 negatives 48h apart asymptomatic); NAATs may remain positive up to 90 days
AAP/ACR guidance for MIS-C/MIS-A testing
Guidelines endorse combined use of NAAT and serology to support MIS-C/MIS-A diagnosis and recommend sending serology prior to IVIG in hospitalized children
Policy revision notes (06/01/2025)
Coverage updated to explicitly allow NAAT and host antibody serology to support MIS-C, MIS-A, and PASC; antigen testing frequency for symptomatic individuals set to once every 48 hours

Regulatory and Guideline Notes

Regulatory and guideline context: FDA issued numerous EUAs for COVID‑19 diagnostics during the PHE and published transition plans for EUA devices; LDTs remain CLIA‑regulated high complexity tests. CDC, IDSA, NIH, AAP, WHO, ECDC and others provide testing recommendations reflected in the policy: NAATs (PCR) are preferred for routine confirmation but may remain positive up to 90 days; antigen tests are rapid (15–30 minutes) and have WHO performance thresholds (≥80% sensitivity, ≥97% specificity) and defined use windows; serology is for prior infection, MIS diagnosis support, surveillance, and not for assessing individual immunity. Guidance also addresses specimen types, rapid NAAT definitions, antigen repeat strategies, and testing frequency/constraints included in coverage.

Revision History

10/01/2023coding_update

CPT code 0408U added to the coding list (historical addition).

01/01/2024coding_update

Multiple CPT/HCPCS codes removed from the policy (e.g., 87631, 87632, 87633, 0115U, 0202U, 0223U, 0225U; deleted C9803).

06/01/2023policy_edit

Reworded host antibody serology criterion (CC11) to state that for all other situations not described above, host antibody serology testing DOES NOT MEET COVERAGE CRITERIA, resulting in removal of CC12.

Policy Summary

Payerblue cross blue shield - louisiana

PolicyCoronavirus Testing in the Outpatient Setting

Policy CodePolicy AHS - G2174 - Coronavirus Testing in the Outpatient Setting

Change TypeCoverage & coding updates

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionDocument clinical indication when ordering outpatient coronavirus tests and use NAAT and/or serology as appropriate to support MIS-C, MIS-A, or PASC diagnoses.

SourceLink

On This Page

Not Medically Necessary / Does NOT Meet Coverage Criteria

ALL of the following

Whole genome sequencing of paired specimens from distinct lineages for diagnosis of SARS-CoV-2 reinfection does NOT meet coverage criteria.
Distinct lineages defined by Nextstrain or GISAID.
Antigen panel testing of 6 or more antigens does NOT meet coverage criteria.
Up to 5 antigens is allowed when criteria met.
Host antibody serology testing DOES NOT meet coverage criteria for situations not specifically described as covered in this policy.
Exceptions include use to support MIS-C/MIS-A/PASC as noted above.
SARS-CoV-2 genotyping in the outpatient setting does NOT meet coverage criteria.
Neutralization antibody testing for SARS-CoV-2 does NOT meet coverage criteria for all situations.
Testing for other endemic human coronaviruses (229E, NL63, OC43, HKU1) does NOT meet coverage criteria.

Testing choice based on prior infection status and symptoms

ALL of the following

Testing choice should consider prior SARS-CoV-2 infection within 90 days: individuals with prior infection within 90 days who are asymptomatic generally do not require repeat NAAT testing after known exposure.<= 90 days
Consistent with policy exclusion for asymptomatic exposed individuals within 90 days of prior infection.
For symptomatic individuals, nucleic acid testing (NAAT) is preferred due to higher sensitivity; antigen testing may be used for symptomatic persons with repeat testing as indicated (see antigen repeat strategy).
For asymptomatic exposed individuals beyond 90 days since prior infection, NAAT testing is covered; antigen testing may be an alternative depending on timing and test availability.> 90 days

Antigen testing repeat strategy

ALL of the following

For symptomatic individuals, antigen-detecting diagnostic tests for SARS-CoV-2 are covered at a frequency of once every 48 hours when used for clinical diagnosis.every 48 hours
Policy III.5.
If an initial antigen test is negative in a symptomatic person with high suspicion for COVID-19, repeat antigen testing every 48 hours for up to two additional tests (total three tests) or confirm with NAAT as clinically indicated.n_of
Repeat strategy increases sensitivity; confirmatory NAAT recommended if clinical concern persists.
Antigen panel testing of up to 5 antigens is covered for individuals with signs or symptoms of a respiratory tract infection when clinically indicated; panels of 6 or more antigens are not covered.<= 5 antigens
Policy III.6 and III.8.

Use of NAAT (IDSA/NIH recommendations)

ANY of the following

Use NAAT (including RT-PCR and rapid molecular tests) as the preferred test in cases where high sensitivity is required — e.g., symptomatic individuals, diagnosis to guide clinical management, pre-procedural testing when required by clinical protocol, or testing of high-risk/exposed persons beyond 90 days from prior infection.
Aligns with IDSA/NIH recommendations favoring NAAT for higher sensitivity.
When rapid turnaround is required and NAAT is unavailable, antigen testing may be used with awareness of lower sensitivity and potential need for confirmatory NAAT in high-suspicion cases.
Operational consideration: follow manufacturer IFU for specimen types and timing relative to symptom onset.

Specimen collection and test performance considerations

ALL of the following

Specimen collection should follow manufacturer instructions; nasopharyngeal, nasal mid-turbinate, anterior nasal, or saliva specimens may be acceptable depending on test IFU and performance characteristics.
Improper specimen type or handling may reduce test sensitivity and lead to false negatives.
Timing of specimen collection relative to symptom onset affects test performance: NAAT has high sensitivity early in infection and for several days; antigen tests perform best within the first 5-7 days of symptom onset when viral load is higher.
Repeat testing strategies and confirmatory NAAT should account for timing.
Laboratory and point-of-care testing must comply with CLIA and FDA/EUA instructions for use, including labeled specimen types and transport conditions.
See FDA / Regulatory Notes group for EUA considerations.

Appropriate Uses of Serologic Testing

ANY of the following

Serologic (antibody) testing may be used to support diagnosis of MIS-C, MIS-A, or PASC when clinical context requires evidence of prior infection in addition to NAAT.
Policy III.4 exception.
Routine host antibody serology testing for diagnosis of acute SARS-CoV-2 infection or for general screening does NOT meet coverage criteria unless specifically indicated in this policy.
Neutralization assays are specifically not covered.
Serologic testing should not be used to determine immune protection or to make decisions about vaccination timing — such uses are not supported by this policy and generally not recommended by public health agencies.

ECDC / WHO Testing Recommendations (selected)

ANY of the following

ECDC/WHO recommend NAAT (PCR) as the reference standard for SARS-CoV-2 diagnosis and support use of antigen-detecting rapid diagnostic tests (Ag-RDTs) for symptomatic individuals and outbreak settings where rapid results are required.
Selected international guidance applied to testing choice and repeat strategies.
Both ECDC and WHO emphasize quality-assured testing, adherence to IFU, and that negative antigen results in symptomatic individuals may require confirmation with NAAT.

Genomic Surveillance

ALL of the following

Genomic surveillance (routine outpatient SARS-CoV-2 genotyping) does NOT meet coverage criteria; sequencing may be appropriate for public health surveillance or research but is outside outpatient coverage per this policy.
Policy III.10.
Whole genome sequencing to document reinfection (paired specimens from distinct lineages) is not covered for outpatient care. Coverage for sequencing may be considered when directly required for public health reporting or by public health agency request, subject to separate arrangements.

AAP Testing Guidance for Children and MIS-C

ANY of the following

AAP guidance: use NAAT as preferred test in children when clinical management depends on accurate diagnosis; antigen tests may be used in pediatric symptomatic patients if rapid results are needed, with confirmatory NAAT for negative antigen-results in high-suspicion cases.
Includes considerations for MIS-C evaluation where serology may assist in demonstrating prior infection.
For evaluation of suspected MIS-C, follow CDC/AAP case definitions and include NAAT and serology as appropriate to support diagnosis; these uses meet coverage criteria under this policy.
See Notes 2 and 3 for MIS-C/MIS-A definitions.

ACR Recommendations

ANY of the following

ACR recommends caution using serologic tests for clinical decision-making in rheumatologic disease; serology may be useful to document prior infection in multisystem inflammatory presentations but is not recommended for determining immunity or changing immunosuppressive therapy without broader clinical context.
Refer to specialty guidance when evaluating immunocompromised patients.

FDA / Regulatory Notes

ALL of the following

FDA/Regulatory notes: Tests should be used in accordance with FDA EUA or cleared/approved labeling; off-label specimen types or indications may reduce test validity and are not supported by this policy unless supported by peer-reviewed evidence and regulatory guidance.
Laboratories must follow CLIA requirements and manufacturer IFU for EUA tests.
Point-of-care and over-the-counter antigen tests authorized under EUA are acceptable when used per manufacturer instructions; negative antigen results in symptomatic individuals may need NAAT confirmation.

Summary of Notable Coverage Criteria Changes (from revision history)

ALL of the following

Summary of notable coverage criteria changes (from revision history): the 2025-06-01 effective revision clarifies antigen repeat frequency (once every 48 hours) for symptomatic diagnosis, reiterates the 90-day exception for asymptomatic exposed individuals with prior infection, and explicitly removes routine outpatient genotyping and neutralization antibody testing from coverage.
See Revision History for full changelog.

Acceptable specimen types for NAAT include nasopharyngeal (NP), anterior nares (AN), oropharyngeal (OP), midturbinate (MT), saliva, and mouth gargle; sensitivity varies by specimen type and self‑collection (AN/MT) may be less sensitive than provider‑collected NP. Adhere to manufacturer IFU and labeled specimen types—deviating from labeled specimen types may produce inaccurate results and risk reimbursement denial unless validated as an LDT or authorized by EUA. Some platforms are constrained to proprietary systems (eg, BioFire RP2.1 on BioFire FilmArray, QIAstat‑Dx on QIAstat Dx Analyzer, Sofia®2 on Sofia®2 system). Rapid NAATs are variably defined in guidance but commonly refer to assays with turnaround times ≤ 30–60 minutes, suitable for point‑of‑care use.

Platform performance & operational thresholds

BioFire RP2.1 LoD500 copies/mL (heat-inactivated) and 160 copies/mL (infectious isolate)

QIAstat‑Dx LoD500 copies/mL (LoD reported; 100% PPA/NPA in trial 30/30)

Sofia®2 LoD113 TCID50/mL (direct swab); 850 TCID50/mL (sample diluted into 3 mL reagent)

Ag‑RDT min performance (WHO)>=80% sensitivity and >=97% specificity compared to NAAT

Pooling positivity cutoffDo not use pooling when individual positivity rate >25%

Ag‑RDT recommended use windowUse within 5–7 days after symptom onset (sensitivity declines after)

MIS-A case definition (CDC): Hospitalization >=24 hours (or any length if death) AND fever >=38.0°C for >=24 hours prior to hospitalization or within first 3 days AND no alternative diagnosis AND >=3 clinical criteria with at least one primary

Primary clinical criteria include severe cardiac illness or rash AND nonpurulent conjunctivitis; secondary criteria include new neurologic signs, shock, GI symptoms, thrombocytopenia; laboratory criteria require evidence of SARS-CoV-2 infection (NAAT, serology, or antigen) AND systemic inflammation with >=2 elevated markers

Long COVID (Post-COVID conditions) characterization: Long COVID is an infection-associated chronic condition present for at least 3 months after SARS-CoV-2 infection; no laboratory test definitively diagnoses Long COVID; diagnosis may be clinical based on history and exam; serologic or viral testing not required to establish diagnosis>=3 months

Common symptoms include fatigue, post-exertional malaise, cognitive issues, GI symptoms, anosmia/ageusia, headache, dyspnea, sleep disturbance

Clinical thresholds (MIS / related)

Fever threshold>= 38.0°C (documented or subjective)

CRP threshold>= 3.0 mg/dL (30 mg/L)

Left ventricular ejection fraction (children)LVEF <55% indicates cardiac involvement in MIS‑C

Left ventricular ejection fraction (adults/MIS‑A)LVEF <50% indicates severe cardiac illness for MIS‑A

Platelet count thresholdPlatelet count <150,000 cells/µL (thrombocytopenia)

MIS detection windowLaboratory detection/epidemiologic linkage up to 60 days prior to hospitalization

MIS‑C age limitApplies to persons <21 years of age

Documentation Required

Combine test results with clinical context

Combine laboratory results with the clinical picture. A negative antigen or NAAT does not exclude infection in the presence of high clinical suspicion; conversely, positive antigen results in low‑prevalence settings may require confirmation. Note any specimen type that is off‑label for the test platform — reimbursement risk may apply.

Combine test results with clinical context for diagnosis and isolation decisions
Reimbursement risk for off‑label specimen types; use platform IFU

Documentation Required

Use of serology for MIS diagnosis

For suspected MIS-C or MIS-A, serology may help support the diagnosis when nucleic acid testing is negative or when the timeframe suggests prior infection. Use serology only as an adjunct to clinical criteria (inflammation markers, multisystem involvement) and document how serology will influence management.

Use of serology for MIS diagnosis: adjunctive, not definitive
Document how serology results will change treatment or disposition

Documentation Required

MIS-C testing workflow and timing

When evaluating MIS-C, MIS-A, or PASC, follow recommended testing timing: obtain NAAT/RT‑PCR early in illness; if negative and MIS is suspected, obtain serology to detect prior infection; consider repeat testing per specialty guidance. Document timing of specimen collection relative to symptom onset and prior test results.

MIS-C testing workflow and timing: early NAAT, serology if NAAT negative or later presentation
Support diagnosis of MIS-C / MIS-A / PASC with combined NAAT and serology as clinically indicated

Documentation Required

Follow regulatory guidance for LDTs and EUAs

Follow manufacturer IFU and regulatory guidance for laboratory‑developed tests (LDTs) and Emergency Use Authorizations (EUAs). Use platform‑specific instructions for specimen type, collection method, transport conditions, and acceptable windows for testing to ensure analytic validity and to reduce denial risk.

Follow regulatory guidance for LDTs and EUAs
Use platform-specific instructions for specimen collection and handling

Documentation Required

Support diagnosis of MIS-C / MIS-A / PASC

Use host antibody testing to support specific clinical questions (e.g., prior infection in MIS, epidemiologic assessment), not for routine acute diagnosis. Explicitly document the clinical question being addressed and how the result will be used in patient management.

Support diagnosis of MIS-C / MIS-A / PASC when documented clinical need exists
Avoid routine serology for acute diagnosis

Billing Rule

Single procedure code per date of service

Only one procedure code may be reported per specimen and date of service when tests are duplicative; follow coding guidance for multiplex panels and combined assays. When a listed CPT/HCPCS code applies, bill that specific code. Avoid unbundling or reporting multiple codes for the same test event.

Single procedure code per date of service
Use of listed CPT/HCPCS codes where applicable

Billing Rule

Specimen collection incidental - not reimbursed

Routine specimen collection (e.g., nasopharyngeal, anterior nasal) by the provider is considered incidental to the laboratory test and is not separately reimbursed if performed at the time of sample acquisition for the molecular/antigen test. Bill only the diagnostic test code.

Specimen collection incidental - not reimbursed

Billing Rule

Pooling limits

Pooled NAAT is allowable only within validated pool sizes per the test's EUA/IFU; do not exceed manufacturer‑specified pooling limits. Document pooling method and pool size on the laboratory requisition to ensure correct processing and coverage determination.

Pooling limits: follow manufacturer EUA for maximum pool size
Document pool size and method on requisition

Billing Rule

Multiplex PCR panel testing routing

Multiplex PCR panels that include SARS‑CoV‑2 should be ordered only when clinically indicated (e.g., symptomatic respiratory illness) and billed according to the specific panel performed. If a multiplex panel is used, do not separately bill for individual pathogen targets included in the panel.

Multiplex PCR panel testing routing: bill the panel code only
Limit panels to clinically indicated respiratory presentations

Billing Rule

Antigen test frequency constraint and confirmation

Antigen test frequency and use should follow public health guidance: for symptomatic individuals, serial Ag‑RDT testing every 48 hours is supported; confirm negative antigen results with NAAT when clinical suspicion is high or results would change management. Prefer NAATs for routine confirmation of negative antigen results.

Antigen test repeat guidance (CDC): symptomatic testing every 48 hours as needed
Confirm negative antigen results with NAAT when necessary
Use NAATs as preferred for routine confirmation

Billing Rule

Ag-RDT use window and exposure timing

WHO and major public health bodies support use of Ag‑RDTs within a limited symptom window (typically within 5–7 days of symptom onset depending on the test). Use antigen testing primarily during that window and follow IFU for the exact days post‑symptom onset.

Ag-RDT use window (WHO): use primarily within the test's supported symptom window (commonly 5–7 days)
Consider timing of testing after exposure: test at appropriate interval post‑exposure per guidance

Denial Risk

Point-of-care serologic tests have limited support

Point‑of‑care serologic tests have limited support for clinical decision making and are generally not recommended for diagnosing acute infection. If used, document the specific clinical rationale and be aware of higher risk of variable performance and reimbursement denial.

Point-of-care serologic tests have limited support
Denial risk for POC serology due to variable performance

Prior Authorization

Prior authorization for testing before time-sensitive procedures

Prior authorization may be required for SARS‑CoV‑2 testing before time‑sensitive procedures (e.g., aerosol‑generating surgery) or when testing is requested outside usual clinical indications. Obtain authorization and document the time‑sensitive nature of the procedure on the request.

Prior authorization for testing before time-sensitive procedures may be required
Document procedure timing and clinical justification for expedited testing

06/01/2025material_revisionLatest

Literature-driven update: added explicit coverage language permitting nucleic acid amplification testing (NAAT) and host antibody serology to support diagnoses of MIS-C, MIS-A, and PASC; added antigen testing frequency constraint allowing antigen tests for symptomatic individuals once every 48 hours; removed multiplex PCR CC7/CC9 (route to Pathogen Panel Testing policy G2149); updated background, guidelines, and evidence references.

Summary of Notable Coverage Criteria Changes (revision history):

- Added explicit language permitting NAAT as acceptable for MIS‑A, MIS‑C, and PASC to meet coverage criteria.

- Updated antigen testing frequency: symptomatic individuals may receive antigen tests once every 48 hours to meet coverage criteria.

- Removed CC7/CC9 and directed multiplex PCR respiratory panel testing to the Pathogen Panel Testing policy (G2149); updated code list (historical removals and addition of CPT 0408U noted).