CurrentCapital BluecrossPolicy AHS - G2174 - Coronavirus Testing in the Outpatient Setting, 1

Coronavirus Testing in the Outpatient Setting

Defines outpatient coverage criteria and limitations for SARS-CoV-2 (COVID-19), SARS, MERS, host antibody, antigen, genotyping, neutralization, and other coronavirus testing for medical decision making; excludes work/school/state/federal mandated testing and addresses reimbursement notes for coding and specimen collection.

Policy Summary

PayerCapital Bluecross

PolicyCoronavirus Testing in the Outpatient Setting

Policy CodePolicy AHS - G2174 - Coronavirus Testing in the Outpatient Setting, 1

Change TypeNo material change

Effective DateSep 18, 2015

Next Review Date

Key ActionLimit use to medical decision making in the outpatient setting; work/school/state/federal mandated testing is excluded.

POLICY UPDATE CHANGES

No material clinical/coverage changes in this update.

6Covered Indications / Scenarios Explicitly Listed

6Not Covered Test Types Explicitly Listed

50Antigen tests with FDA EUA (as of 2022-04-20)

38Kontou meta-analysis sample

178Fox meta-analysis sample

Coverage Summary

Outpatient testing is covered only when used for medical decision making; work-, school-, state-, or federally-mandated SARS-CoV-2 testing is excluded.

Targeted NAATs (e.g., RT-PCR, rapid molecular tests) and certain antigen or serology tests meet coverage when used in specified clinical scenarios (symptomatic individuals, asymptomatic persons with known exposure, MIS-C/MIS-A or PASC evaluation, and other covered indications) as detailed in policy criteria.

Reimbursement is limited to one procedure code per date of service (do not report both HCPCS and CPT for the same procedure on the same DOS), and specimen collection codes are incidental and will not be reimbursed.

Scope summary and key thresholds

Scope summaryOutpatient coverage for SARS-CoV-2 testing for medical decision making; includes NAAT, targeted antigen, and serology in listed clinical scenarios; excludes work/school/state/federal mandated testing

Antigen testing frequency (symptomatic)Once every 48 hours

WHO Ag-RDT minimum performance>=80% sensitivity and >=97% specificity vs NAAT among symptomatic individuals

NAAT positivity caveatNAATs may remain positive up to 90 days; avoid NAAT to detect reinfection within 90 days

MIS fever criterionFever >=38.0°C

MIS systemic inflammation CRPCRP >=3.0 mg/dL (30 mg/L)

Optimal serology timing for prior infection3-5 weeks after symptom onset

Medical-Necessity Criteria

Covered Testing (Meets Coverage Criteria)

Covered when ANY of the following are met: (Preserve nested operator logic). Note: For symptomatic individuals, antigen-detecting rapid diagnostic tests are limited to once every 48 hours.

ANY of the following

ALL of the following
- Targeted nucleic acid testing (e.g., RT-PCR, rapid molecular tests) for SARS-CoV-2 for individuals displaying signs and symptoms of possible COVID-19 infection (See Note 1).
ALL of the following
- Targeted nucleic acid testing (e.g., RT-PCR, rapid molecular tests) for asymptomatic individuals with known exposure to COVID-19.
ALL of the following

Clinical Guidance, Case Definitions, and Testing Algorithms

WHO recommendations for use of SARS-CoV-2 Ag-RDTs; WHO priority uses for Ag-RDTs; WHO self-testing key points

ANY of the following

Symptomatic individuals (suspected COVID-19 cases) in the first 5-7 days since onset of symptoms5-7 days
WHO: Ag-RDTs used within 5-7 days after symptom onset
Asymptomatic individuals limited to contacts of confirmed or probable cases and at-risk health workers (until more evidence available)
WHO: limit asymptomatic use to contacts/at-risk HCWs
Suspected COVID-19 cases in outbreak investigations

ANY of the following

Coding

Coding and reimbursement guidancemixed

No codes listed

Specimen collection codesHCPCSNot Covered

No codes listed

No specific billing codes listed in this sectionmixed

No codes listed

Applicable CPT/HCPCS procedure codes (COVID-19 NAAT, antigen, antibody, genotyping, proprietary tests)mixed

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
87426	Infectious agent antigen detection by immunoassay; SARS-CoV (eg SARS-CoV-2)
87635	Infectious agent detection by nucleic acid (DNA or RNA); 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; SARS-CoV-2
87913	Infectious agent genotype analysis by nucleic acid; SARS-CoV-2, mutation identification in targeted region(s)

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Provider Actions

Documentation Required

Antigen test negative results — confirmatory NAAT recommended

Antigen tests with a negative result in individuals with symptoms or known exposure may be falsely negative; confirmatory NAAT (e.g., RT‑PCR) is recommended when clinical suspicion remains high. Document the indication for confirmatory testing and the timing of specimen collection relative to symptom onset or exposure.

If symptomatic or known exposure and antigen negative → obtain NAAT for confirmation
Record symptom onset date and exposure history on the chart and lab requisition

Documentation Required

MIS-C testing workflow and required documentation

For MIS-C evaluation, obtain both NAAT and serology as part of the diagnostic workup; send serology prior to administration of IVIG when feasible. Document fever duration, evidence of systemic inflammation (e.g., elevated CRP, ferritin), relevant laboratory abnormalities (e.g., platelet count, troponin), and consults with specialists (e.g., infectious disease, cardiology).

Evidence Summary and Test Performance

The evidence section below summarizes key references and performance findings supporting the policy, including systematic reviews and meta-analyses, major public health guidance, and manufacturer EUA performance summaries.

Highlighted evidence items include CDC/WHO guidance and case definitions for MIS and testing strategies, Kontou and Fox meta-analyses on serologic test sensitivity/specificity, neutralizing antibody kinetics (Ko, Wu), and EUA clinical/performance summaries for antigen and molecular assays (e.g., Quidel Sofia2, BD Veritor, LumiraDx) as presented in the policy's evidence list.

Label (coverage)	Value / key metric
Kontou et al. pooled sensitivities (ELISA, CLIA, LFIA)	ELISA combined IgG/IgM sensitivity 0.935; CLIA IgG 0.944, IgM 0.810, combined 0.910; LFIA combined 0.78–0.83; specificities 0.954–0.984
Fox et al. aggregated IgG sensitivity timeline	Average IgG sensitivity: 41.1% at 1 week, 74.9% at 2 weeks, 88.0% at 3 weeks; convalescent (up to 100 days) IgG 89.8%, IgG/IgM 92.9%, total antibodies 94.3%
Quidel Sofia®2 (EUA) — antigen	Reported ~80% PPA and 100% NPA in clinical frozen-sample studies; LoD direct swab 113 mL TCID50, diluted swab 850 mL TCID50; cross‑reactivity only with SARS‑CoV
BD Veritor (EUA) — antigen	Reported 84% PPA, 100% NPA vs RT‑PCR; authorized for symptomatic ≤5 days
LumiraDx (EUA) — antigen	Reported PPA 97.6%, NPA 96.6%; LoD 32 TCID50/mL
Notable multiplex/NAAT LoDs (panel devices)	BioFire RP2.1 LoD: 160 copies/mL (infectious isolate) and 500 copies/mL (heat-inactivated); ePlex RP2 LoD: 0.01 TCID50/mL (~250 copies/mL); QIAstat-Dx LoD: 500 copies/mL
WHO Ag‑RDT performance threshold (for context)	Minimum recommended: ≥80% sensitivity and ≥97% specificity vs NAAT among symptomatic individuals

Definitions

Definitions (short):

MIS-C — Multisystem inflammatory syndrome in children as defined by CDC criteria (fever ≥38°C, hospitalization, systemic inflammation, multisystem involvement) per policy.

MIS-A — Multisystem inflammatory syndrome in adults as defined by CDC criteria (hospitalization, fever, extrapulmonary organ involvement, inflammation, and evidence of SARS-CoV-2).

PPA — Positive percent agreement (used as the EUA/diagnostic sensitivity-equivalent metric).

NPA — Negative percent agreement (used as the EUA/diagnostic specificity-equivalent metric).

LoD — Limit of detection: lowest concentration detectable ≥95% of the time.

PSO — Post symptom onset (days since symptom onset).

NAAT — Nucleic acid amplification test (includes PCR); highly sensitive/specific for current infection.

Ag-RDT — Antigen-detecting rapid diagnostic test: rapid immunoassays detecting viral proteins; high specificity but lower sensitivity than NAATs.

RT-LAMP — Reverse transcription loop-mediated isothermal amplification: faster NAAT method enabling point-of-care use in some formats.

Rapid NAAT — NAAT with short analytic turnaround (commonly ≤30–60 minutes; testing time excludes transport/reporting delays).

Known exposure — Close contact (generally ≥15 minutes cumulative over 24 hours) with a confirmed COVID-19 case.

Thresholds and Technical Limits

Numeric and operational thresholds affecting coverage/testing strategy

Antigen testing frequency (symptomatic)Once every 48 hours

WHO Ag-RDT performance requirement>=80% sensitivity and >=97% specificity (vs NAAT) among symptomatic individuals

NAAT 90-day positivity caveatNAATs may detect RNA up to 90 days post-positive; avoid NAAT for reinfection detection within 90 days

MIS fever and CRP thresholdsFever >=38.0°C; CRP >=3.0 mg/dL (30 mg/L)

MIS cardiac LVEF thresholdsMIS-C cardiac: LVEF <55%; MIS-A severe cardiac: LVEF <50%

BioFire RP2.1 LoD (infectious isolate)160 copies/mL (100% detection in validation)

Revision History

2015-09-18effective

Policy effective

2025-11-01last_reviewLatest

Last review

Policy Summary

PayerCapital Bluecross

PolicyCoronavirus Testing in the Outpatient Setting

Policy CodePolicy AHS - G2174 - Coronavirus Testing in the Outpatient Setting, 1

Change TypeNo material change

Effective DateSep 18, 2015

Next Review Date

Key ActionLimit use to medical decision making in the outpatient setting; work/school/state/federal mandated testing is excluded.

On This Page

Targeted nucleic acid testing (e.g., RT-PCR) for individuals with signs or symptoms of SARS and travel to endemic areas or exposure to persons with SARS.

ALL of the following

Targeted nucleic acid testing (e.g., RT-PCR) for individuals with signs or symptoms of MERS and travel to endemic areas or exposure to persons with MERS.

ALL of the following

Nucleic acid amplification testing and host antibody serology testing 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).

ALL of the following

For symptomatic individuals, antigen-detecting diagnostic tests for SARS-CoV-2 (e.g., antigen rapid tests) once every 48 hours.

Not Covered Testing (Does Not Meet Coverage Criteria)

Not covered when ALL of the following apply:

ALL of the following

Whole genome sequencing of paired specimens from distinct lineages for the diagnosis of SARS-CoV-2 reinfection DOES NOT MEET COVERAGE CRITERIA.
Host antibody serology testing for purposes other than supporting diagnosis of MIS-C, MIS-A, or PASC DOES NOT MEET COVERAGE CRITERIA (including use for assessing immunity or for 'immunity passports').
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.
Testing for other endemic coronaviruses (229E, NL63, OC43, HKU1) DOES NOT MEET COVERAGE CRITERIA.

Community testing of symptomatic individuals meeting suspected COVID-19 case definition

WHO priority use

Detect and respond to suspected outbreaks including remote settings and semi-closed communities where NAAT not immediately available

WHO priority use

Screen asymptomatic individuals at high risk (health workers, contacts of cases, other at-risk persons)

WHO priority use

ALL of the following

Offer self-testing in addition to professionally administered testing services (strong recommendation)
WHO strong recommendation for self-testing
Adapt role and use to national priorities, epidemiology, resources, and local context with community input
Self-testing should be voluntary and not mandatory
Self-testing costs should not be borne by students or workers in certain settings (e.g., schools, workplaces)
Self-test kits should meet WHO minimum performance: ≥80% sensitivity and ≥97% specificity among symptomatic individuals≥80% sensitivity; ≥97% specificity
WHO performance thresholds
Self-testing can be considered for diagnostic and screening purposes; use positive self-test in symptomatic/recent exposure to facilitate linkage to care; for screening, negative self-test could enable participation in activities with consideration for confirmatory testing of positives

CDC and IDSA testing guidance and recommendations

ANY of the following

NAATs (including PCR) recommended as most sensitive and specific to detect current infection; NAATs should not be used within 90 days of a prior positive test to detect reinfectiondo not use within 90 days of prior positive
CDC guidance
Antigen tests are rapid (15-30 minutes), have high specificity but lower sensitivity; a single negative antigen test cannot rule out infection
CDC: treat single negative antigen as not definitive

ANY of the following

If individual has not had COVID-19 or positive test within past 90 days: choose NAAT or antigen; if antigen negative, follow recommended repeat testing
CDC testing algorithm
If positive within past 30 days with symptoms: use antigen test; repeat negatives per guidancewithin 30 days
CDC guidance
If positive within past 30 days without symptoms: testing not recommended to detect new infectionwithin 30 days
CDC guidance
If positive within 31-90 days with or without symptoms: use antigen test; repeat negatives per guidance31-90 days
CDC guidance

ALL of the following

Recommendation 1: Recommend SARS-CoV-2 NAAT in symptomatic individuals suspected of COVID-19 (strong recommendation)
strong recommendation, moderate certainty evidence
Recommendation 2: Suggest collecting swab specimens from NP, AN, OP, MT, saliva, or mouth gargle for symptomatic individuals (conditional)
conditional recommendation
Recommendation 3: Suggest AN and MT swabs may be collected by patients or healthcare providers (conditional)
conditional recommendation
Recommendation 4: Suggest using rapid or standard lab-based NAATs in symptomatic individuals (conditional)
conditional recommendation; rapid NAAT defined variably (<=30-60 min)

ALL of the following

Recommend against using serologic testing to diagnose SARS-CoV-2 infection during the first two weeks following symptom onsetfirst two weeks
strong recommendation, low certainty
Recommend against using IgG antibodies to provide evidence of COVID-19 in symptomatic patients with high clinical suspicion and repeatedly negative NAAT
strong recommendation, very low certainty
Recommend using both IgG antibody testing and NAAT to assist diagnosis of MIS-C
strong recommendation, very low certainty
When evidence of previous infection is desired, suggest testing for IgG, IgG/IgM, or total antibodies 3–5 weeks after symptom onset and suggest against testing for IgM3-5 weeks after onset
conditional recommendation, low certainty

ANY of the following

For symptomatic individuals suspected of having COVID-19, anterior nasal (AN) and mid-turbinate (MT) swab specimens may be collected by either patients (self-collection) or healthcare providers
Conditional recommendation, moderate certainty evidence; provider-collected NP may have higher sensitivity
Use either rapid or standard laboratory-based NAATs in symptomatic individuals suspected of having COVID-19
Conditional recommendation, moderate certainty; rapid NAAT definitions vary
Perform a single NAAT and do not routinely repeat testing after an initial negative NAAT in symptomatic or asymptomatic individuals
Conditional recommendation, very low certainty; repeat testing may be considered 24-48 hours after initial test in some situations

MIS-C and MIS-A case definitions, laboratory criteria, testing priorities and algorithm

ALL of the following

Fever three or more days>=3 days
WHO preliminary case definition for MIS in 0-19 years
At least TWO of
- Rash or bilateral non-purulent conjunctivitis or mucocutaneous inflammation signs (oral, hands or feet)
- Hypotension or shock
- Features of myocardial dysfunction, pericarditis, valvulitis, or coronary abnormalities (including echocardiogram findings or elevated Troponin/NT-proBNP)
- Evidence of coagulopathy (by PT, PTT, elevated d-Dimers)
- Acute gastrointestinal problems (diarrhea, vomiting, or abdominal pain)
Elevated markers of inflammation such as ESR, C-reactive protein, or procalcitonin
No other obvious microbial cause of inflammation, including bacterial sepsis, staphylococcal or streptococcal shock syndromes
Evidence of COVID-19 (RT-PCR, antigen test or serology positive), or likely contact with patients with COVID-19

Meet any of the following classification pathways:

Clinical AND laboratory criteria (Confirmed)
Clinical criteria AND epidemiologic linkage criteria (Probable)
Vital records criteria (Suspect)

Clinical Criteria (illness characterized by all of the following)

Subjective or documented fever (temperature ≥38.0°C)>=38.0°C
Clinical severity requiring hospitalization or resulting in death
Evidence of systemic inflammation indicated by C-reactive protein ≥3.0 mg/dL (30 mg/L)CRP >=3.0 mg/dL
New onset manifestations in at least two of the following categories: cardiac, mucocutaneous, shock, gastrointestinal, hematologic
- Cardiac involvement options
  - Left ventricular ejection fraction <55% OR coronary artery dilatation, aneurysm, or ectasia

CDC Laboratory criteria for MIS-C

Detection of SARS-CoV-2 RNA in a clinical specimen up to 60 days prior to or during hospitalization (molecular amplification test)up to 60 days
CDC laboratory criteria
Detection of SARS-CoV-2 specific antigen in a clinical specimen up to 60 days prior to or during hospitalizationup to 60 days
Detection of SARS-CoV-2 specific antibodies in serum, plasma, or whole blood associated with current illness resulting in or during hospitalization

CDC MIS-A definition (person ≥21 years) — hospitalization and criteria

Hospitalization for ≥24 hours (or hospitalized any length if illness results in death)>=24 hours
CDC MIS-A hospitalization criterion
Subjective or documented fever (≥38.0°C) for ≥24 hours prior to hospitalization or within first 3 days of hospitalization>=38.0°C and >=24 hours
No alternative diagnosis and at least THREE clinical criteria prior to or within first 3 days of hospitalization, with at least ONE primary clinical criterionat least 3 clinical criteria, ≥1 primary
Primary clinical criteria (one required among clinical criteria)

Testing and evaluation priorities for suspected MIS-C

Evaluate children with persistent fever (>=3 days) and moderate-severe illness with organ dysfunction; include vital signs, perfusion, oxygen saturation, early specialist consult>=3 days
Initial evaluation priorities (CBC, UA, ESR, CRP; add ferritin, LDH, CMP, proBNP, troponin, fibrinogen as indicated)
For hospitalized or severely ill patients suspected of MIS-C, perform RT-PCR and serologic testing for SARS-CoV-2; repeat serology later if initially negative; send serology prior to IVIG
CDC/ECDC/AAP/ACR aligned guidance
Consider chest radiograph, EKG, troponin and cardiology consult if abnormal; consider echocardiogram and/or cardiac MRI for myocardial injury
Expanded workup labs (D-dimer, PT/PTT/INR, CRP, ferritin, LDH, fibrinogen, etc.)

MIS-C Testing Algorithm (CDC/ECDC/AAP/ACR aligned guidance)

Long COVID / Post-COVID conditions and CDC definition

Post-COVID conditions (Long COVID) require symptoms present for at least three months after SARS-CoV-2 infection and can be continuous, relapsing/remitting, or progressiveat least three months

CDC definition of Long COVID / Post-COVID conditions

No laboratory test definitively diagnoses Long COVID; diagnosis may be clinical using history and exam, with selective directed testing

Objective lab or imaging findings should not be the only measure; positive viral or serologic test not required to establish diagnosis

Common symptoms (examples)

Bloating/constipation/diarrhea
Difficulty concentrating
Lightheadedness/fast heart rate
Memory change
Persistent fatigue
Post-exertional malaise
Smell/taste problems
Recurring headaches
Shortness of breath/cough
Sleep disturbance

Send SARS‑CoV‑2 serology prior to IVIG when possible
Document subjective or recorded fever ≥38°C and duration
List inflammatory markers (CRP, ESR, ferritin), CBC, troponin, and specialist consult notes on the record

Documentation Required

Adhere to specimen collection and test labeling

Adhere to specimen collection instructions and test labeling exactly as the test IFU/CLIA requirements state. Proper specimen type, adequate volume, correct transport medium, and accurate patient and collection data on the label are required to avoid rejection or non‑reimbursable testing.

Use the specimen type and collection method specified by the assay IFU (e.g., NP, nasal, saliva)
Label specimens with patient identifiers, date/time of collection, specimen source, and collector initials
Ensure timely transport at required temperatures and document chain of custody when applicable

Documentation Required

Antigen test repeat strategy and self-testing considerations

Antigen testing strategies should include repeat testing when initial results are inconsistent with clinical presentation. For symptomatic individuals, antigen testing once every 48 hours is supported; repeat antigen or perform NAAT based on exposure risk and clinical judgment. Self‑testing programs must include documented member education, reporting pathways for positive results, and linkage to clinical care for confirmatory testing when indicated.

Symptomatic antigen testing frequency: once every 48 hours (when indicated)
Repeat antigen testing or confirm with NAAT if high clinical suspicion despite negative antigen
Self-testing programs: provide written instructions, reporting mechanism, and guidance for confirmatory NAAT

Documentation Required

Panel test interpretation and antibody testing timing/limitations

Panel (multiplex) assays and antibody tests have limitations: multiplex panels may detect nucleic acid without distinguishing active infection versus residual RNA, and serology results depend on timing relative to exposure or vaccination. Interpret antibody results based on timing (e.g., IgM/IgG kinetics) and clinical context; antibody testing for most outpatient indications is not covered except to support MIS-C/MIS-A or PASC evaluation as specified.

Panel tests may detect multiple targets; correlate with clinical presentation to avoid over‑interpretation
Host antibody testing: results depend on timing — avoid testing <14 days post‑exposure for reliable IgG interpretation
Neutralization antibody testing is not covered

Billing Rule

Billing rules and specimen documentation

Billing requires appropriate specimen documentation and adherence to single procedure per date-of-service conventions. Include the test performed, specimen source, and date/time collected in the medical record. Labs must bill the specific CPT/HCPCS code(s) that match the performed assay.

Specimen collection is incidental to laboratory testing when performed by the lab; document collection details
One procedure code per date of service unless separate, distinct tests are performed
Report the specific CPT/HCPCS codes corresponding to the test performed

Prior Authorization

Prior authorization and documentation needed for non‑routine testing

Certain tests and testing strategies may require prior authorization or meet coverage conditions; when required, submit clinical justification including symptoms, exposure history, and relevant lab/imaging results. Prior auth may be needed for non‑routine panels or repeat molecular testing outside guideline‑supported intervals.

Prior authorization required for broad multiplex panels not meeting targeted testing criteria
Provide documentation of signs/symptoms or exposure when requesting NAAT beyond routine testing parameters

Time-sensitive surgery — Medically necessary surgeries that should be performed within three months.

Long COVID / PCC — Post-COVID conditions: symptoms persisting or emerging ≥3 months after infection; no definitive laboratory diagnostic test; clinical diagnosis with selective directed testing.

BioFire RP2.1 LoD (heat-inactivated)

LumiraDx reported LoD32 TCID50/mL

Quidel Sofia2 direct swab LoD113 TCID50/mL (direct swab)

Quidel Sofia2 diluted swab LoD850 TCID50/mL (swab diluted into 3 mL reagent)

ePlex RP2 Panel LoD0.01 TCID50/mL (≈250 genomic copies/mL)

Suggest using serologic assays that target nucleocapsid protein rather than spike protein when evidence of prior infection is desired

conditional recommendation, low certainty

Suggest against routine serologic testing in individuals with prior infection or vaccination

conditional recommendation, very low certainty

Troponin elevated above laboratory normal range or indicated as elevated in clinical note

Hematologic involvement options

Platelet count <150,000 cells/uL<150,000 cells/uL
Absolute lymphocyte count (ALC) abnormal

Severe cardiac illness (myocarditis, pericarditis, coronary artery dilatation/aneurysm, new-onset ventricular dysfunction [LVEF<50%], 2nd/3rd degree A-V block, or ventricular tachycardia). Note: cardiac arrest alone does not meet this criterion

LVEF <50% for new ventricular dysfunction

primary clinical criterion

Rash AND non-purulent conjunctivitis

primary clinical criterion

Secondary clinical criteria (examples)

New-onset neurologic signs and symptoms (encephalopathy without prior impairment, seizures, meningeal signs, peripheral neuropathy incl. Guillain-Barré)
Shock or hypotension not attributable to medical therapy
Abdominal pain, vomiting, or diarrhea
Thrombocytopenia (platelet count <150,000/microliter)<150,000

Laboratory criteria (both required)

Evidence of SARS-CoV-2 infection (positive NAAT, serology, or antigen test)
CDC lab requirement
Evidence of systemic inflammation (elevated levels of at least 2 of: CRP, ferritin, IL-6, ESR, procalcitonin)at least 2 markers elevated
CDC lab requirement