CurrentBlue Cross Blue Shield - MississippiPolicy N/A

Medicare coverage and billing for COVID-19 monoclonal antibody infusions

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Governs Medicare coverage, coding, payment, and billing instructions for monoclonal antibody therapies for mild-to-moderate COVID-19 administered under FDA EUAs; affects Medicare-enrolled providers and suppliers including infusion centers, hospitals, nursing homes, home health agencies, pharmacies, and providers administering vaccines/infusions to SNF residents.

Policy Summary

PayerBlue Cross Blue Shield - Mississippi

PolicyMedicare coverage and billing for COVID-19 monoclonal antibody infusions

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNov 9, 2020

Next Review DateN/A

Key ActionMaintain documentation supporting EUA terms and medical necessity and include the ordering practitioner's name on administration claims; when product is government-provided, bill only for administration and omit product codes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

95% AWPproduct payment rate if purchased

$310approx admin payment

No cost sharingbeneficiary cost sharing

Q0239,Q0243,Q0245,M0239,M0243,M0245identified codes

Medicare Coverage and Billing Criteria

Medicare coverage and billing criteria

Covered when ALL of the following are met:

Infusions are furnished consistent with the FDA Emergency Use Authorization (EUA) for each monoclonal antibody product (treatment of mild-to-moderate COVID-19 in patients with a positive COVID-19 test who are at high risk for progression to severe disease and/or hospitalization).

Infusions are administered in settings with immediate access to medications to treat severe infusion reactions (e.g., anaphylaxis) and the ability to activate emergency medical services (EMS) as necessary, per EUA requirements.

Medicare payment conditions during the COVID-19 public health emergency (PHE) are met: Medicare will cover and pay for EUA-consistent monoclonal antibody infusions under Section 3713 of the CARES Act; CMS may set product payment at 95% of AWP if providers purchase products; Medicare will not pay for products provided free by the government.

Beneficiary cost sharing: Medicare beneficiaries pay no cost sharing for these infusion therapy products (no copayment/coinsurance and no deductible).

Billing and documentation requirements are met: when product is provided free by the government, providers bill only for administration and do not include product codes; providers must retain documentation supporting EUA terms and medical necessity, including the ordering practitioner’s name (applicable to single-claim and roster billing).

Provider/supplier scope and enrollment: services are furnished and billed by Medicare-enrolled providers and suppliers (including freestanding and hospital-based infusion centers, home health agencies, nursing homes, pharmacies, and others) in accordance with EUA conditions and Medicare enrollment and billing rules; CMS will exercise enforcement discretion for SNF consolidated billing to allow direct billing by immunizers when specified.

Product and Administration Coding

Monoclonal antibody product and administration codesHCPCSCovered

Q0239	Injection, bamlanivimab, 700 mg
M0239	Intravenous infusion, bamlanivimab, includes infusion and post administration monitoring
Q0243	Injection, casirivimab and imdevimab, 2400 mg
M0243	Intravenous infusion, casirivimab and imdevimab, includes infusion and post administration monitoring
Q0245	Injection, bamlanivimab and etesevimab, 2100 mg
M0245	Intravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring

Administration payment basis

Payment basisPayment based on one hour infusion and post-administration monitoring (Medicare national average ≈ $310).

Setting used for rateRate derived from hospital outpatient setting one-hour infusion + monitoring.

Future rate methodologyCMS may use similar methodology for additional products based on expected infusion time consistent with EUA or FDA approval.

Documentation, Billing Instructions, and Enrollment

Documentation Required

Documentation and billing instructions — preserve EUA evidence; omit product codes when product free

Maintain medical record documentation that demonstrates the EUA terms were met and supports the medical necessity of the infusion; documentation must include the name of the practitioner who ordered or authorized the infusion even when claims are submitted on a roster bill. When COVID-19 monoclonal antibody doses are provided by the government at no charge, bill only for the administration and do not include monoclonal antibody product codes on the claim.

Keep records showing EUA requirements were satisfied and medical necessity.
Include ordering practitioner's name on documentation for each administration, including roster-billed services.
If product provided free by government, submit claims only for administration and omit product HCPCS codes.

Billing Rule

Enrollment and SNF billing discretion — Medicare-enrolled immunizers may bill directly

Medicare-enrolled immunizers (for example, pharmacies, infusion centers, and home health agencies) may bill Medicare directly for vaccinating or infusing SNF residents under CMS enforcement discretion; these providers follow the same enrollment process as other COVID-19 vaccine/infusion administrators.

CMS will exercise enforcement discretion of SNF consolidated billing to allow direct billing and reimbursement by Medicare.
Providers must follow the standard Medicare enrollment process for COVID-19 vaccine/infusion administrators.

Key Terms and Billing Concepts

Emergency Use Authorization (EUA)

DefinitionEmergency Use Authorization (EUA): FDA authorization allowing investigational monoclonal antibody therapies for treatment of mild-to-moderate COVID-19 in specified high-risk adults and pediatric patients; authorizations include requirements for safe administration and review of the EUA Fact Sheet for Health Care Providers.

Administration requirementsMay only be administered in settings with immediate access to medications to treat severe infusion reactions (e.g., anaphylaxis) and the ability to activate EMS as necessary.

Scope of useEUAs issued for bamlanivimab; casirivimab + imdevimab; and bamlanivimab + etesevimab for specified populations during the COVID-19 PHE.

Roster billing

Allowed practiceProviders may submit administration claims on a roster bill for groups of beneficiaries in accordance with each product's EUA.

Documentation requirementEven when using roster billing, providers must maintain medical documentation that supports EUA terms and medical necessity and must include the name of the ordering practitioner.

Product billing when government-providedIf doses are provided by the government without charge, providers should bill only for administration and must not include product codes on the claim.

Policy Summary

PayerBlue Cross Blue Shield - Mississippi

PolicyMedicare coverage and billing for COVID-19 monoclonal antibody infusions

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNov 9, 2020

Next Review DateN/A

SourceLink

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Medicare coverage and billing for COVID-19 monoclonal antibody infusions

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Sign up for all Blue Cross Blue Shield - Mississippi policy alerts

Know when Blue Cross Blue Shield - Mississippi releases new policies or updates existing guidance.

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Medicare Coverage and Billing Criteria

Medicare coverage and billing criteria

Covered when ALL of the following are met:

Beneficiary cost sharing: Medicare beneficiaries pay no cost sharing for these infusion therapy products (no copayment/coinsurance and no deductible).

Product and Administration Coding

Monoclonal antibody product and administration codesHCPCSCovered

Q0239	Injection, bamlanivimab, 700 mg
M0239	Intravenous infusion, bamlanivimab, includes infusion and post administration monitoring
Q0243	Injection, casirivimab and imdevimab, 2400 mg
M0243	Intravenous infusion, casirivimab and imdevimab, includes infusion and post administration monitoring
Q0245	Injection, bamlanivimab and etesevimab, 2100 mg
M0245	Intravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring

Administration payment basis

Payment basisPayment based on one hour infusion and post-administration monitoring (Medicare national average ≈ $310).

Setting used for rateRate derived from hospital outpatient setting one-hour infusion + monitoring.

Future rate methodologyCMS may use similar methodology for additional products based on expected infusion time consistent with EUA or FDA approval.

Documentation, Billing Instructions, and Enrollment

Documentation Required

Documentation and billing instructions — preserve EUA evidence; omit product codes when product free

Keep records showing EUA requirements were satisfied and medical necessity.
Include ordering practitioner's name on documentation for each administration, including roster-billed services.
If product provided free by government, submit claims only for administration and omit product HCPCS codes.

Billing Rule

Enrollment and SNF billing discretion — Medicare-enrolled immunizers may bill directly

CMS will exercise enforcement discretion of SNF consolidated billing to allow direct billing and reimbursement by Medicare.
Providers must follow the standard Medicare enrollment process for COVID-19 vaccine/infusion administrators.

Key Terms and Billing Concepts

Emergency Use Authorization (EUA)

Scope of useEUAs issued for bamlanivimab; casirivimab + imdevimab; and bamlanivimab + etesevimab for specified populations during the COVID-19 PHE.

Roster billing

Allowed practiceProviders may submit administration claims on a roster bill for groups of beneficiaries in accordance with each product's EUA.

Product billing when government-providedIf doses are provided by the government without charge, providers should bill only for administration and must not include product codes on the claim.