CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Payment Policy COVID-19 Monoclonal Antibody Treatment

Governs coverage and billing/reimbursement for COVID-19 monoclonal antibody drugs and their administration for BCBSRI members, including Medicare Advantage and Commercial products; outlines coding, billing instructions, and cost-sharing waivers.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyPayment Policy COVID-19 Monoclonal Antibody Treatment

Policy CodePolicy N/A

Change TypeNo material change

Effective Date01/01/2022

Next Review DateN/A

Key ActionDo not bill BCBSRI for specified monoclonal antibody Q-codes when the product is supplied to providers at no cost.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

no member cost sharingNo member cost sharing

10-12 daysTreatment window

>12Age requirement

No reimbursementNo reimbursement if free

1/1/2022Billing transition

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Coverage Criteria and Reimbursement Rules

Coverage criteria and billing rules

Covered when ALL of the following are met:

Coverage for monoclonal antibody therapy for mild-to-moderate COVID-19 is provided with no member cost sharing and specific clinical and billing conditions.

ALL of the following

Positive COVID-19 test result required
Patient over 12 years of age
Patient at high risk for progressing to severe COVID-19 and/or hospitalization
Patient not hospitalized (not an inpatient)
Administration given within 10 to 12 days of symptom onset

ALL of the following

BCBSRI will not impose member cost sharing (no deductibles, copayments, or coinsurance) for monoclonal antibody drugs or administration-related services while this policy is in effect

ALL of the following

If the monoclonal antibody product is supplied to the provider at no cost, no reimbursement will be made for the drug HCPCS line when filed to BCBSRI; the claim line will indicate denial as provider liability with no member liability
Providers may append modifier 22 to monoclonal antibody drug codes to indicate the provider purchased the drug

Monoclonal antibody reimbursement criteria

Reimbursement and billing guidance for specified monoclonal antibody Q-codes:

If the provider receives the monoclonal antibody product at no cost, BCBSRI provides no reimbursement and the claim should not be billed to BCBSRI for the drug HCPCS line item (provider liability; no member liability).

For specified drug and administration codes (including Q0245, Q0249 and M0220/M0239/M0240 series), per CMS guidance providers were instructed to submit Medicare Advantage claims to Original Medicare for the period 11/09/20–12/31/21; effective 1/1/22 these codes are covered and should be billed to BCBSRI.

Q0245 (bamlanivimab and etesevimab, 2100 mg) — No reimbursement by BCBSRI when health care providers receive the product at no cost; Effective 11/09/20–12/31/21 submit to Original Medicare per CMS guidelines; Effective 1/1/22 covered and separately reimbursed by BCBSRI.

Q0249 (tocilizumab) — Covered and separately reimbursed effective 1/1/22; no reimbursement by BCBSRI when health care providers receive the product at no cost; during 11/09/20–12/31/21 follow CMS guidance to submit to Original Medicare for Medicare Advantage enrollees.

Billing Codes and Coding Guidance

Monoclonal antibody administration and drug HCPCS/CPT codesHCPCSCovered

M0220	Administration of tixagevimab and cilgavimab injection (per document guidance)
M0239	Intravenous infusion, bamlanivimab (includes infusion and post administration monitoring)
M0240	Intravenous infusion or subcutaneous injection, casirivimab and imdevimab (includes infusion/injection and monitoring)
M0243	Intravenous infusion, casirivimab and imdevimab (includes infusion and monitoring)
M0245	Intravenous infusion; bamlanivimab and etesevimab (includes infusion and monitoring)
M0247	Intravenous infusion; sotrovimab (includes infusion and monitoring)
Q0220	Tixagevimab and cilgavimab, 300 mg (drug HCPCS)
Q0239	Injection, bamlanivimab, 700 mg (drug HCPCS)
Q0240	Injection; casirivimab and imdevimab, 600 mg (drug HCPCS)
Q0243	Injection, casirivimab and imdevimab, 2400 mg (drug HCPCS)

1–10 of 13

1/2

Monoclonal antibody HCPCS Q-codesHCPCSCovered

Q0245	Injection; bamlanivimab and etesevimab, 2100 mg
Q0249	Injection; tocilizumab, 1 mg (COVID-19 hospitalized patients per criteria)

inv-05: CMS original billing period

Historical CMS billing periodEffective 11/09/20–12/31/21: per CMS guidelines, Medicare Advantage claims for specified monoclonal antibody administration and drug Q-codes were to be submitted to Original Medicare (do not bill BCBSRI).

Transition to BCBSRI billingEffective 01/01/22: providers should submit claims for covered monoclonal antibody administration and drug codes to BCBSRI (Covered and Separately Reimbursed).

Affected code examplesExamples of administration and drug codes subject to the billing period guidance include M0220/M0221, M0239, M0240 and Q0220/Q0239/Q0240/Q0245 as noted in CMS/BCBSRI guidance.

inv-06: No reimbursement when product supplied at no cost

No reimbursement when product provided freeIf a provider receives the monoclonal antibody product at no cost, there will be no reimbursement for the monoclonal antibody drug line(s) when filed to BCBSRI; claims will indicate provider liability with no member liability.

Provider option when purchasedIf the provider purchased the monoclonal antibody, the provider should append modifier 22 to the monoclonal antibody drug codes to indicate the product was purchased by the provider.

Claim handling noteDo not bill BCBSRI for the drug HCPCS line if the product was supplied at no cost; follow the guidance that such lines will be denied as provider-liability (member not liable).

inv-07: Provider-supplied-at-no-cost

Definition — provider‑supplied at no costProducts health care providers receive at no cost from manufacturers or government programs (i.e., provider does not purchase the drug).

Reimbursement implicationBCBSRI will not reimburse the monoclonal antibody drug HCPCS line(s) when the product is supplied to the provider at no cost; such claim lines will be denied as provider liability.

Billing actionDo not submit the drug HCPCS line to BCBSRI for reimbursement if the provider received the product at no cost; if purchased, append modifier 22 per instructions.

Provider Actions, Prior Authorization, and Billing Rules

Prior Authorization

Prior authorization: Not applicable. Providers do not need to request prior authorization for monoclonal antibody therapy under this policy.

Note

Coverage conditions

Coverage for monoclonal antibody therapy (including but not limited to bamlanivimab, casirivimab and imdevimab) is available for Medicare Advantage and Commercial members when ALL of the following are met:

Positive COVID-19 test result is required.
Patient is age 12 years or older.
Patient is at high risk for progression to severe COVID-19 and/or hospitalization.
Patient is not currently hospitalized for COVID-19.
Therapy is administered within 10–12 days of symptom onset.

Billing Rule

Billing rule for no-cost monoclonal antibodies

When monoclonal antibody products are supplied to the provider at no cost, do not bill BCBSRI for the specified Q-codes. Follow CMS guidance and submit claims to Original Medicare when applicable. No reimbursement will be made by BCBSRI for products received at no cost by the provider.

Do not bill BCBSRI for Q0245 (bamlanivimab and etesevimab, 2100 mg) when provided at no cost; follow CMS guidance to submit to Original Medicare where applicable.
Do not bill BCBSRI for Q0249 (tocilizumab) or other applicable Q-codes when the product is supplied at no cost to the provider.
Effective date reference: 2022-01-01 — products supplied at no cost have no reimbursement from BCBSRI.

Definitions and EUA Limitations

inv-11: Definition of monoclonal antibodies

DefinitionMonoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight viruses.

Examples (documented)Bamlanivimab; casirivimab and imdevimab; sotrovimab; etesevimab.

PurposeThese products are directed against SARS‑CoV‑2 to block viral attachment/entry and are treated as COVID-19 therapeutics under EUA/coverage guidance.

inv-12: EUA limitations and administration settings

EUA administration setting requirementEUA‑authorized monoclonal antibodies should be administered only in settings with the capability to manage severe infusion reactions and to activate emergency medical services (EMS) as necessary.

Hospitalized patient limitationNot authorized for patients who are hospitalized due to COVID‑19 or who require oxygen therapy for COVID‑19; benefit not shown in hospitalized patients and may be associated with worse outcomes in those requiring high‑flow oxygen or mechanical ventilation.

Provider typesDuring the PHE, a broad range of providers (infusion centers, home health, nursing homes, etc.) may administer treatments consistent with the EUA and CMS guidance.

inv-13: no-cost product

Definition — no‑cost productA monoclonal antibody product that health care providers receive at no charge from the manufacturer or government program (provider did not purchase the drug).

Primary implicationBCBSRI will not reimburse the drug HCPCS line(s) for products received at no cost; claims will be processed as provider liability with no member cost sharing responsibility.

Secondary implication — purchased productIf a provider purchases the product instead of receiving it at no cost, they should append modifier 22 to indicate purchase; reimbursement rules differ when purchased.

Policy Dates and Revision History

2022-01-01reimbursement_stance_changeLatest

Effective 1/1/22 BCBSRI transitioned reimbursement for specified monoclonal antibody Q-codes to be billed to BCBSRI (no longer submitted to Original Medicare) and reiterated that products received at no cost should not be billed to BCBSRI (no reimbursement).

2020-11-09billing_guidance

Per CMS guidance effective 11/09/20 through 12/31/21, providers were instructed to submit certain monoclonal antibody claims to Original Medicare rather than BCBSRI (historical billing period).