ModifiedBlue Cross Blue Shield - Rhode IslandPolicy N/A

COVID-19 monoclonal antibody and antiviral treatments

This policy governs coverage, coding, and reimbursement for FDA-approved or authorized monoclonal antibody and antiviral treatments for COVID-19 for BCBSRI members (Commercial and Medicare Advantage) and describes cost-share and billing instructions.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyCOVID-19 monoclonal antibody and antiviral treatments

Policy CodePolicy N/A

Change TypeClarified coverage timingbilling and cost-share updates

Effective DateJan 1, 2022

Next Review DateSep 18, 2025

Key ActionDocument product administered (Q- or J-code), date of service, and whether the product was purchased or received at no cost when submitting claims.

SourceLink

POLICY UPDATE CHANGES

For dates of service on or after May 12, 2023, BCBSRI will cover FDA approved and authorized monoclonal antibody and antiviral treatments for COVID-19 in accordance with the applicable Subscriber Agreement and/or Evidence of Coverage.

Beginning with dates of service on or after 1/1/2022 providers should bill BCBSRI for Medicare Advantage plan services rather than submitting to Original Medicare.

Beginning with dates of service on or after July 1, 2023 (Medicare Advantage) and on or after May ?, 2023 (Commercial), the cost share waiver will no longer apply and cost sharing will follow applicable Evidence of Coverage/Subscriber Agreement.

Not requiredPrior authorization

>12Age threshold

10–12 days

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Administration window

Q & J codesCode types referenced

Coverage Criteria for COVID-19 Monoclonal Antibodies and Antivirals

Initial therapy coverage criteria

Monoclonal antibody therapy for mild-to-moderate COVID-19 is covered when ALL of the following are met:

Eligibility requirements: Patient has positive COVID-19 test result

Age: Patient is over 12 years of age> 12 years

Risk status: Patient is at high risk for progressing to severe COVID-19 and/or hospitalization

High risk per FDA EUA/CDC guidance

Hospitalization status: Patient is not hospitalized

Timing: Therapy is given within 10 to 12 days of symptom onsetwithin 10-12 days

Coverage for hospitalized COVID-19 patients

Covered when ALL of the following are met:

Hospitalized patients on corticosteroids requiring advanced respiratory support: Patient is a hospitalized adult or pediatric patient receiving systemic corticosteroids and requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.as stated

Applies to tocilizumab and selected monoclonal antibodies per listed Q-codes.

Product-specific reimbursement stance

Coverage and billing instructions vary by product and effective date:

Code- and date-specific payer instructions: Some products should be submitted to Original Medicare per CMS guidelines and not billed to BCBSRI; other codes are covered and separately reimbursed for specified effective date ranges; several codes are marked 'Not Covered for DOS on or after' specified cutoff dates.see code effective dates

Provider must follow the effective date and acquisition status (purchased vs supplied at no cost) shown for each code.

E/M reimbursement (Commercial)

Commercial-only E/M reimbursement during PHE:

99211 reimbursement: 99211 evaluation & management service reimbursed for commercial products effective 8/31/2022 until the public health emergency (PHE) ends.PHE status

Commercial-products only.

The policy lists multiple administration and infusion CPT/HCPCS codes that are explicitly labeled as Not Covered for dates of service on or after specified cutoff dates. Examples include codes for bamlanivimab, casirivimab/imdevimab, sotrovimab, and related administration codes (for example, M0239, M0240–M0248), which show coverage windows followed by the statement Not Covered for DOS on or after the listed dates.

Several drug HCPCS and Q-code entries are called out with Not Covered for DOS on or after specific dates and with separate notes when products were received at no cost. Examples from the policy include Q0220–Q0222 (tixagevimab/cilgavimab, bebtelovimab) and multiple additional Q/J codes (Q0239, Q0240–Q0247, Q0249, Q5156, J0248) that show effective coverage ranges or CMS-directed submission followed by a Not Covered for DOS on or after cutoff. The policy also indicates No reimbursement to BCBSRI where the product was supplied to the provider at no cost.

Coverage for monoclonal antibody therapies is constrained by the FDA Emergency Use Authorization (EUA) limitations and by clinical indications and risk-factor criteria as issued and updated by the CDC. The policy requires that use follow the EUA and CDC guidance (for example, eligibility for mild‑to‑moderate COVID‑19 in patients at high risk for progression) and states that BCBSRI may request medical records retrospectively to confirm that treatments met those EUA/CDC criteria.

Coding and Billing Codes

Drug HCPCS codes (selected)HCPCSCovered

Q0220	Tixagevimab and cilgavimab, 300 mg
Q0221	Tixagevimab co-packaged with cilgavimab, administered as 2 separate consecutive intramuscular injections
Q0222	Injection, bebtelovimab, 175 mg
Q0224	Injection, pemivibart 4500 mg

Administration and infusion CPT/HCPCS codesmixedCovered

M0220	Administration of Tixagevimab and cilgavimab injection
M0221	Administration of Tixagevimab and cilgavimab injection (alternate)
M0222	Intravenous injection, bebtelovimab, includes injection and post administration monitoring
M0223	Intravenous injection, bebtelovimab, includes injection and post administration monitoring in the home
M0235	Intravenous infusion, monoclonal antibody products for hospitalized patients receiving systemic corticosteroids and requiring supplemental oxygen/ventilation/ECMO
M0237	Intravenous infusion, tocilizumab-anoh, for hospitalized adult patients with COVID-19 receiving systemic corticosteroids and supplemental oxygen/ventilation/ECMO
M0238	Intravenous infusion; tocilizumab-anoh second dose
M0239	Intravenous infusion, bamlanivimab; includes infusion and post administration monitoring
M0240	Intravenous infusion or subcutaneous injection, casirivimab and imdevimab, includes infusion/injection and post administration monitoring, subsequent repeat doses
M0241	Intravenous infusion or subcutaneous injection, casirivimab and imdevimab, in the home/residence

1–10 of 18

1/2

Monoclonal antibody Q-codesHCPCS

Q0220	Tixagevimab and cilgavimab, 300 mg
Q0221	Tixagevimab co-packaged with cilgavimab, administered as 2 separate consecutive intramuscular injections
Q0222	Injection, bebtelovimab, 175 mg
Q0224	Injection, pemivibart 4500 mg
Q0235	Injection, monoclonal antibody products with an indication for post-exposure prophylaxis or treatment of COVID-19 for hospitalized patients on corticosteroids requiring oxygen/ventilation/ECMO

Additional monoclonal and antiviral Q/J codesHCPCS | CPT | mixed

Q0237	Injection, tocilizumab-anoh, for hospitalized adult patients with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen/ventilation/ECMO
Q0239	Injection; bamlanivimab-XXxx; 700 mg
Q0240	Injection, casirivimab and imdevimab, 600 mg
Q0243	Injection, casirivimab and imdevimab, 2400 mg
Q0244	Injection, casirivimab and imdevimab, 1200 mg
Q0245	Injection, bamlanivimab and etesevimab, 2100 mg
Q0247	Injection, sotrovimab, 500 mg
Q0249	Injection, tocilizumab, for hospitalized adults and pediatric patients (2 years and older) with COVID-19 receiving systemic corticosteroids and requiring oxygen/ventilation/ECMO
Q5156	Injection, tocilizumab-anoh (avtozma), biosimilar; 1 mg
J0248	Injection, remdesivir, 1 mg

E/M code (Commercial products)CPTCovered

99211

Evaluation & Management Service

Age

Age thresholdPatient must be over 12 years of age (>12 years)

Applies toMedicare Advantage and Commercial products when other criteria met

Evidence basisPer coverage criteria requiring age >12 for monoclonal antibody therapy for mild-to-moderate COVID-19

Administration window

Administration windowTherapy must be given within 10 to 12 days of symptom onset

Timing requirement context

Provider Actions, Documentation, and Billing Instructions

Prior Authorization

Prior authorization is not required for monoclonal antibody therapies covered under this policy.

Documentation Required

Clinical Coverage Prerequisites

Coverage for monoclonal antibody therapy (Medicare Advantage and Commercial) is subject to the following clinical prerequisites: a positive COVID-19 test, age over 12 years, patient at high risk for progression to severe COVID-19 and/or hospitalization, patient is not currently hospitalized, and administration is within the authorized symptom-onset window (typically within 10–12 days of symptom onset). For Medicare Advantage, BCBSRI will follow CMS claims guidelines and EUA/CDC guidance regarding indications and documentation.

Background

Monoclonal antibodies are laboratory‑made proteins designed to mimic the immune system’s ability to fight viruses. In the context of COVID‑19 these agents have been used to treat patients with mild‑to‑moderate disease who are at high risk for progression to severe illness and/or hospitalization. The policy references the EUA history (for example, bamlanivimab’s EUA and later revocation) and notes operational considerations such as the need to administer these products where staff and medications to manage severe infusion reactions (including anaphylaxis) are immediately available.

Definitions

Monoclonal antibody

DefinitionLaboratory-made proteins designed to mimic the immune system's ability to fight viruses (monoclonal antibodies)

Regulatory noteMonoclonal antibody products are considered COVID-19 vaccines per CMS for certain administrative purposes

Clinical useUsed to treat mild-to-moderate COVID-19 in patients at high risk for progression to severe disease or hospitalization under EUA/approved indications

Hospitalized adults and pediatric patients indication

DefinitionHospitalized adult or pediatric patients receiving systemic corticosteroids and requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO

Associated productsApplies to tocilizumab (Q0237/Q0249) and selected monoclonal antibodies specified by Q-codes for hospitalized patients

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyCOVID-19 monoclonal antibody and antiviral treatments

Policy CodePolicy N/A

Change TypeClarified coverage timingbilling and cost-share updates

Effective DateJan 1, 2022

Next Review DateSep 18, 2025

Key ActionDocument product administered (Q- or J-code), date of service, and whether the product was purchased or received at no cost when submitting claims.

SourceLink

On This Page

One of the coverage criteria for monoclonal antibody therapy for mild-to-moderate COVID-19

Applies toMedicare Advantage and Commercial products when other criteria met

Hospitalized patient oxygen/ECMO requirement

Hospitalized-patient requirementPatient is receiving systemic corticosteroids and requires supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)

Applies to which productsTocilizumab and selected monoclonal antibodies (per listed Q-codes) for hospitalized adults and pediatric patients

Reimbursement stanceCovered and separately reimbursed when the above clinical and code-specific conditions are met (effective dates vary by code)

Billing Rule

Submit Code-Specific Claims per Payer Guidance

Providers must submit code-specific claims per payer and CMS guidance. Some Q- and J-codes (and other specified codes) have payer-specific submission instructions or effective-date windows; follow the coding section and CMS guidance when determining whether to submit to BCBSRI or to Original Medicare.

Submit claims using the listed Q- and J-codes according to the effective dates and payer guidance in the Coding section.
Per CMS guidance, certain codes (e.g., some Q022x / Q023x / Q024x / Q0239 / Q0240 / Q0243 / J-codes) should be submitted to Original Medicare and not billed to BCBSRI for the specified date ranges.

Denial Risk

No Reimbursement for USG-Supplied Drug Products

Do not bill BCBSRI for monoclonal antibody drug products that were supplied to the provider at no cost by the U.S. Government (USG). Claims for such drug line items will be denied as provider liability and no reimbursement will be issued.

If the product was supplied by the USG at no cost, the drug line item will be denied as provider liability.
Members are not liable for costs related to USG-supplied monoclonal antibody products.

Documentation Required

Documentation of Product, Date of Service, and Acquisition

If a monoclonal antibody product was commercially purchased by the provider, providers should document purchase and indicate this on the claim (see modifier guidance). Providers may bill BCBSRI only for products that were purchased commercially.

When the provider purchased the monoclonal antibody, append the appropriate modifier (per coding section) to indicate the product was purchased and not supplied by the USG.
Providers may bill BCBSRI only for commercially purchased products; do not bill BCBSRI for USG-purchased/supplied stock on hand.

Billing Rule

Billing to Wrong Payer or After Cutoff Dates

Claims billed to the wrong payer or submitted after the stated coverage cutoff dates risk denial. Adhere to the 'Not Covered for DOS on or after' dates and CMS guidance about submitting specific codes to Original Medicare when applicable.

Do not bill BCBSRI for codes/dates that CMS guidance requires be submitted to Original Medicare.
Claims with Dates of Service (DOS) on or after specified cutoff dates listed in the Coding section may be denied.

Denial Risk

DOS Beyond Coverage Cutoff

Several monoclonal antibody products are listed with specific "Not Covered for DOS on or after" dates. Claims submitted for DOS on or after those dates are subject to denial. Verify the effective and cutoff dates in the Coding section before submitting a claim.

Examples include Q0220/Q0221/Q0222/Q0239/Q0240/Q0243 and others that carry "Not Covered for DOS on or after" dates — confirm applicable dates in the Coding section.
Providers should confirm current coverage windows and deletion dates prior to billing.

Documentation Required

Retrospective Medical Record Requests

BCBSRI reserves the right to request medical records retrospectively to confirm that administered treatments met EUA, FDA, and CDC guideline criteria and policy prerequisites. Providers should retain documentation to support medical necessity and compliance with EUA conditions.

Maintain clinical records demonstrating positive COVID-19 test results, symptom onset date, risk factors for progression, and that the patient was not hospitalized at time of administration.
Be prepared to provide EUA Fact Sheet documentation and any ordering/consent records if requested.

Coverage conditionThese patients may be covered and separately reimbursed for specified products when code- and date-specific requirements are met