SPECIAL BULLETIN COVID-19 #154: Monoclonal Antibodies – Billing Guidelines

<p>The U.S. Food and Drug Administration&nbsp;has issued an Emergency Use Authorization to permit the emergency use of the unapproved monoclonal antibodies to be administered for the treatment of mild to moderate COVID-19 in some patients.&nbsp;</p>

     This bulletin was updated on Jan. 6, 2022 in COVID-19 Bulletin #208. 

     Bamlanivimab, for Intravenous Infusion HCPCS code Q0239
     Casirivimab and Imdevimab, for Intravenous Infusion HCPCS code Q0243
     Bamlanivimab-xxxx, Intravenous Infusion and Post Administration Monitoring HCPCS code M0239
     Casirivimab and Imdevimab, Intravenous Infusion and Post Administration Monitoring HCPCS code M0243

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved Monoclonal Antibodies (MABs) to be administered for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization (EUA for Bamlanivumab, and Casirivimab and Imdevimab). They are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Effective with date of service mentioned below, the Medicaid and NC Health Choice programs cover for use in the Physician Administered Drug Program (PADP):

  • Bamlanivimab injection, for intravenous infusion when billed with HCPCS code Q0239 (Injection, bamlanivimab-xxxx, 700 mg) effective Nov. 10, 2020
  • Casirivimab and imdevimab, for intravenous infusion when billed with HCPCS code Q0243 (Injection, casirivimab and imdevimab, 2400 mg) effective Nov. 21, 2020

High risk is defined as patients who meet at least one of the following criteria:

  • Have a body mass index (BMI) ≥35
  • Have chronic kidney disease
  • Have diabetes
  • Have immunosuppressive disease
  • Are currently receiving immunosuppressive treatment
  • Are ≥65 years of age
  • Are ≥55 years of age AND have
    • cardiovascular disease, OR
    • hypertension, OR
    • chronic obstructive pulmonary disease/other chronic respiratory disease
  • Are 12 – 17 years of age AND have
    • BMI ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm, OR
    • sickle cell disease, OR
    • congenital or acquired heart disease, OR
    • neurodevelopmental disorders, for example, cerebral palsy, OR
    • a medical-related technological dependence, for example, tracheostomy, gastrostomy or positive pressure ventilation (not related to COVID-19), OR
    • asthma, reactive airway or other chronic respiratory disease that requires daily medication for control.

LIMITATIONS OF AUTHORIZED USE

  • COVID-19 MABs are not authorized for use in patients:
    • who are hospitalized due to COVID-19, OR
    • who require oxygen therapy due to COVID-19, OR
    • who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity
  • Benefits of treatment with COVID-19 MAB has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation. 

Recommended Dose

  • The dosage of bamlanivimab in adults and pediatric patients 12 years of age and older weighing at least 40 kg is a single intravenous (IV) infusion of 700 mg bamlanivimab administered over at least 60 minutes. Bamlanivimab should be administered as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset. See full prescribing information for further detail.
  • The dosage in adults and in pediatric patients (12 years of age and older weighing at least 40 kg) is 1,200 mg of casirivimab and 1,200 mg of imdevimab administered together as a single intravenous infusion over at least 60 minutes. Casirivimab and imdevimab solutions must be diluted prior to administration. Casirivimab and imdevimab should be given together as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset.

For Medicaid and NC Health Choice Billing

  • The ICD-10-CM diagnosis code required for billing is U07.1 - COVID-19
    • Use additional codes to identify pneumonia or other manifestations:
      • B34.2 - Coronavirus infection, unspecified
      • J12.81 - Pneumonia due to SARS-associated coronavirus 
      • B97.21 - SARS-associated coronavirus as the cause of diseases classified elsewhere
  • Providers must bill with HCPCS code (esp. when drug is not provided free of charge to the provider):  
    • Q0239 - Injection, bamlanivimab-xxxx, 700 mg; OR
    • Q0243: Injection, casirivimab and imdevimab, 2400 mg
  • One Medicaid and NC Health Choice unit of coverage is:
    • 700 mg bamlanivimab; OR
    • 1200 mg casirivimab and 1200 mg imdevimab
  • The maximum reimbursement rate per unit is: N/A (drugs are currently federally supplied)
  • Providers must bill 11-digit NDCs and appropriate NDC units. 
    • NDC for bamlanivimab is 00002-7910-01; OR
    • NDCs for Casirivimab (REGN10933): 61755-0024-01, 61755-0026-01, AND
    • Imdevimab (REGN10987): 61755-0025-01, 61755-0027-01
  • The NDC units should be reported as "UN1"
  • For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update
  • For additional information regarding NDC claim requirements related to the PADP, refer to the PADP Clinical Coverage Policy 1B, Attachment A, H.7 on NC Medicaid's website.

Additional information

  • These MABs will only be administered in settings (including freestanding and hospital-based infusion centers, home health agencies, nursing homes and entities with whom nursing homes contract for this) in accordance with the EUA and in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary. Adverse events associated with medications should be reported on the FDA’s MedWatch reporting program.
  • CMS expects that health care providers will maintain appropriate medical documentation that supports the medical necessity of the service. This includes documentation that supports that the terms of the EUAs are met. The documentation should also include the name of the practitioner who ordered or made the decision to administer the infusion.
  • When MAB doses are provided by the government without charge, providers should only bill for the administration. Health care providers should not include the MAB codes on the claim when the product is provided for free.
  • Administration codes to use:
    • M0239: Long Descriptor: intravenous infusion, bamlanivimab-xxxx, includes infusion and post administration monitoring
    • M0243: Long Descriptor: intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring
  • Rates for administration of the MABs can be found on specific provider fee schedules. 
  • Outpatient hospital claims should be filed with RC 261 and the appropriate HCPCS code.

CONTACT

NCTracks Contact Center: (800) 688-6696

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