ModifiedBlue Cross Blue Shield - Rhode IslandPolicy N/A

Monoclonal antibody and antiviral treatments for COVID-19 — Coverage and Billing

Coverage and billing rules for FDA-approved or authorized monoclonal antibody and antiviral COVID-19 treatments and their administration for BCBSRI Commercial and Medicare Advantage members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMonoclonal antibody and antiviral treatments for COVID-19 — Coverage and Billing

Policy CodePolicy N/A

Change TypeMODIFIED — Material clarifications to coverage, reimbursement, and cost-share treatment

Effective DateJan 1, 2022

Next Review DateJan 5, 2024

Key ActionDo not bill BCBSRI for specified monoclonal antibody HCPCS codes for dates of service on or after 1/25/22; submit to Original Medicare where CMS guidance applies.

SourceLink

POLICY UPDATE CHANGES

Cost-share waivers for covered monoclonal antibody and administration services ended for Commercial products after the COVID PHE and for Medicare Advantage per specified dates; cost sharing will follow subscriber agreements/Evidence of Coverage thereafter.

Several monoclonal antibody HCPCS codes (Q0243, Q0244, Q0245, Q0247, Q0249) are marked Not Covered for dates of service on or after 1/25/22 with instructions to submit to Original Medicare and not bill BCBSRI.

J0248 (remdesivir) is listed as Covered and Separately Reimbursed effective 12/23/21 when purchased by the healthcare provider.

99211 E/M service reimbursement guidance for Commercial products effective 8/31/2022 until the PHE ends.

10–12 daystiming requirement

>12 yrsminimum age

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Noneprior authorization

1/25/22codes Not Covered on/after

J0248 coveredremdesivir status

Coverage Criteria for Monoclonal Antibody and Antiviral COVID-19 Treatments

Initial therapy coverage

Monoclonal antibody therapy is covered when ALL of the following are met:

Monoclonal antibody treatment coverage criteria: Positive COVID-19 test result

Monoclonal antibody treatment coverage criteria: Age over 12 yearsAge > 12 years

Monoclonal antibody treatment coverage criteria: At high risk for progression to severe COVID-19 and/or hospitalization (per FDA EUA/CDC guidance)

Coverage limited to FDA EUA limitations and CDC guidance; providers must follow those criteria.

Monoclonal antibody treatment coverage criteria: Not hospitalized at time of treatment

Monoclonal antibody treatment coverage criteria: Therapy administered within 10 to 12 days of symptom onsetGiven within 10 to 12 days of symptoms

Monoclonal antibody codes — coverage by DOS

Coverage determinations by HCPCS code and date of service:

Q0243/Q0244/Q0245/Q0247 status: For dates of service on or after 1/25/22 these HCPCS codes (Q0243, Q0244, Q0245, Q0247) are Not Covered by BCBSRI and should be submitted to Original Medicare per CMS guidance; do not bill BCBSRI.DOS >= 2022-01-25

Effective 1/1/22-1/24/22 these codes were Covered and Separately Reimbursed per the document for specified earlier periods.

Q0249 status: Q0249 (tocilizumab for certain hospitalized COVID-19 patients) is Not Covered for dates of service on or after 1/25/22; follow CMS guidance and submit to Original Medicare where applicable; do not bill BCBSRI.DOS >= 2022-01-25

Effective 11/09/20-12/31/21 and certain earlier periods it was subject to CMS guidance and separate reimbursement as noted.

Covered drugs and services

Exceptions and covered items:

J0248 remdesivir: J0248 (remdesivir, 1 mg) is Covered and Separately Reimbursed when purchased by the healthcare provider.effective 2021-12-23

No reimbursement when products are received at no cost by the healthcare provider; documentation should reflect acquisition/payment status.

99211 E/M for Commercial products: 99211 Evaluation & Management service is reimbursed for Commercial products effective 8/31/2022 until the PHE ends; reimbursement is via paper claim (CVS S60).effective 2022-08-31

Applies to Commercial products only.

USG‑supplied product billing: No reimbursement for product charges when products were provided to the health care provider at no cost by the US government; do not bill BCBSRI for USG‑supplied products on hand.

Certain monoclonal antibody product codes are explicitly excluded from coverage for dates of service on or after the end dates listed in the coding table. Examples from the policy include M0239 / Q0239 (bamlanivimab) which is Not Covered for DOS on or after 4/17/21, and several casirivimab/imdevimab and related product codes that are Covered and Separately Reimbursed for limited earlier periods but Not Covered for DOS on or after 1/25/22. The coding tables list the specific HCPCS/administration codes and their applicable effective and end dates; providers must follow those date-based coverage rules when billing.

BCBSRI will not reimburse claims submitted to BCBSRI for monoclonal antibody products that the health care provider received at no cost. The coding entries for multiple HCPCS product codes explicitly state "No reimbursement for claims submitted to BCBSRI for products health care providers receive at no cost"; providers should document acquisition and payment status and follow CMS/Original Medicare billing guidance where applicable.

Use of bamlanivimab alone is no longer authorized and is not covered for dates of service on or after the FDA revocation/effective end date. The policy coding shows M0239 / Q0239 (bamlanivimab) as Not Covered for DOS on or after 4/17/21, consistent with the EUA revocation and the accompanying billing instruction to submit to Original Medicare per CMS guidance rather than billing BCBSRI.

For dates of service on or after 1/25/22, BCBSRI designates several monoclonal antibody HCPCS product codes as Not Covered. The policy lists Q0243, Q0244, Q0245, Q0247 (and notes Q0249 in related entries) with the coverage status Not Covered for DOS on or after 1/25/22, and instructs providers to submit to Original Medicare per CMS guidelines where those rules apply and not to bill BCBSRI for those codes dated on or after that cutoff.

Coding and Billing Codes

Monoclonal antibody and related drug codesHCPCS

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 (home)
M0224	Intravenous infusion or subcutaneous injection, casirivimab and imdevimab, includes infusion/injection and post administration monitoring (home)
M0239	intravenous infusion; bamlanivimab; includes infusion and post administration monitoring
M0240	intravenous infusion or subcutaneous injection, casirivimab and imdevimab, subsequent repeat doses
M0241	intravenous infusion or subcutaneous injection, casirivimab and imdevimab, includes home administration
M0243	intravenous infusion, casirivimab and imdevimab, includes infusion and post administration monitoring
M0244	intravenous infusion or subcutaneous injection, casirivimab and imdevimab, includes home administration

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Additional COVID-19 drug HCPCS codesHCPCS

Q0249	Injection; tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with COVID-19 who are receiving systemic corticosteroids and supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO only, 1 mg
J0248	Injection, remdesivir, 1 mg

E/M code for Commercial productsCPTCovered

99211

Evaluation & Management Service

inv-12: Timing — given within 10 to 12 days of symptom onset

Timing for mAb therapyTherapy must be given within 10 to 12 days of symptom onset

SettingFor Medicare Advantage, BCBSRI will adhere to CMS claims guidelines for monoclonal antibody filing

Associated criteriaOnly for non-hospitalized patients at high risk of progressing to severe COVID-19 or hospitalization

inv-13: Age — minimum age for coverage (>12 years)

Minimum age> 12 years (over 12 years of age)

Test requirement

Provider Actions, Billing Rules, and Documentation Requirements

Prior Authorization

Not applicable

Documentation Required

Provider actions

Coverage limited to indications and patient risk factors consistent with the FDA Emergency Use Authorization (EUA) and CDC guidance. BCBSRI may request medical records retrospectively to ensure that EUA guideline criteria were met for monoclonal antibody therapies.

Providers must follow EUA and CDC guidance when administering monoclonal antibody therapies.
BCBSRI reserves the right to request medical records to verify criteria were met.

Background

Monoclonal antibodies are laboratory-made proteins designed to mimic elements of the immune system to neutralize pathogens; in the context of COVID-19 they have been used to treat mild-to-moderate disease in patients with positive SARS-CoV-2 tests who are at increased risk of progression to severe illness or hospitalization. Emergency Use Authorizations for these agents have changed over time (for example, authorizations and distribution policies affecting bamlanivimab and other agents), and those regulatory changes directly affect coverage and billing instructions in this policy.

Definitions and Regulatory Notes

inv-24: Monoclonal antibody (mAb) — definition and CMS system note

DefinitionMonoclonal antibody (mAb): laboratory-made proteins that mimic the immune system to fight viruses

Policy noteMonoclonal antibody products are considered COVID-19 vaccines per CMS system note

Clinical scopeUsed to treat mild-to-moderate COVID-19 in high-risk patients with positive tests

inv-25: EUA/CMS guidance — Emergency Use Authorization revocation or CMS guidance affecting reimbursement

EUA revocation exampleFDA revoked the EUA for bamlanivimab when administered alone (effective April 16, 2021), affecting coverage for that product

CMS/system guidance impactBCBSRI will follow CMS claims guidelines for monoclonal antibodies; CMS system notes may classify mAb products as COVID-19 vaccines

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMonoclonal antibody and antiviral treatments for COVID-19 — Coverage and Billing

Policy CodePolicy N/A

Change TypeMODIFIED — Material clarifications to coverage, reimbursement, and cost-share treatment

Effective DateJan 1, 2022

Next Review DateJan 5, 2024

Key ActionDo not bill BCBSRI for specified monoclonal antibody HCPCS codes for dates of service on or after 1/25/22; submit to Original Medicare where CMS guidance applies.

SourceLink

On This Page

Providers may only bill for products they purchase commercially; BCBSRI may deny drug line items supplied at no cost and reserve right to request records.

Positive COVID-19 test results required

Clinical statusPatient must be non-hospitalized and at high risk for progression to severe disease

Billing Rule

Product cost documentation

When monoclonal antibody products are supplied to providers at no cost (for example, purchased/distributed by the U.S. Government), BCBSRI will not reimburse the drug product if submitted. If a provider elects to submit a claim for a drug that was provided at no cost, the drug line item will be denied as provider liability and no member liability will apply. Providers should document acquisition source and payment status for each product.

No reimbursement for drug product lines when product received at no cost.
Claims for drugs supplied at no cost will show a denial for the drug line item — provider liability, not member liability.
Document acquisition/payment source for each product.

Billing Rule

Claims when product purchased by provider

If monoclonal antibody drugs were purchased by the provider, append modifier 22 to the monoclonal antibody HCPCS code to indicate the product was purchased commercially and not supplied by the U.S. Government. Providers may bill only for products purchased commercially and should not bill BCBSRI for USG‑purchased/supplied products on hand.

When purchased by provider, append modifier 22 to the monoclonal antibody HCPCS code.
Do not bill BCBSRI for U.S. Government purchased/supplied products.

Denial Risk

Not covered if DOS on/after 1/25/22

For listed monoclonal antibody HCPCS codes with dates of service on or after 2022-01-25, BCBSRI will not cover these claims; submit to Original Medicare where applicable per CMS guidance. Providers should not bill BCBSRI for DOS on/after 2022-01-25 for these codes.

Q0243, Q0244, Q0245, Q0247, Q0249, Q0249 (tocilizumab), Q0244 (casirivimab/imdevimab 1200 mg), etc. — Not Covered for DOS on/after 2022-01-25; submit to Original Medicare per CMS guidance.
Effective 1/1/22–1/24/22 these codes were covered and separately reimbursed; effective 1/25/22 onward: Not Covered by BCBSRI.

Billing Rule

Remdesivir reimbursement

Remdesivir (J0248) — Covered and separately reimbursed when purchased by the healthcare provider effective 2021-12-23. No reimbursement for remdesivir when the product is received at no cost.

J0248 Injection, remdesivir, 1 mg — Covered and separately reimbursed when purchased by provider effective 2021-12-23.
No reimbursement for J0248 when product received at no cost.

Billing Rule

99211 reimbursement for Commercial products

99211 Evaluation & Management service for Commercial products is reimbursed effective 2022-08-31 through the end of the Public Health Emergency (PHE). Reimbursement is handled via paper claim (CVS S60 referenced).

99211 reimbursed for Commercial products effective 8/31/2022 until PHE ends.
Reimbursed via paper claim per CVS S60 guidance.

Operational effectChanges to EUA status or CMS guidance may remove authorization and reimbursement for specific products