SPECIAL BULLETIN COVID-19 #161: Billing for Administration of Monoclonal Antibodies
HCPCS Code Q0245 - Bamlanivimab and Etesevimab, for intravenous infusion
HCPCS Code M0245 - Bamlanivimab & Etesevimab, administration for infusion and post administration monitoring
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved products, bamlanivimab and etesevimab, to be administered together 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. They are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab and etesevimab 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 Feb. 9, 2021, the North Carolina Medicaid and NC Health Choice programs cover bamlanivimab and etesevimab, for intravenous infusion (N/A) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code Q0245 - Injection, bamlanivimab and etesevimab, 2100 mg.
Bamlanivimab is a sterile, preservative-free, clear to opalescent and colorless to slightly yellow to slightly brown solution available as an injection: 700 mg/20 mL (35 mg/mL) as in a single-dose vial.
Etesevimab is a sterile, preservative-free, clear to opalescent and colorless to slightly yellow to slightly brown solution available as an injection: 700 mg/20 mL (35 mg/mL) in a single-dose vial.
The MABs are to be administered together 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.
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, (e.g., cerebral palsy), OR
- a medical-related technological dependence, (e.g., 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
- Bamlanivimab and etesevimab 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.
- Treatment with bamlanivimab and etesevimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, 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 and etesevimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) is:
- bamlanivimab 700 mg
- etesevimab 1,400 mg
Administer bamlanivimab and etesevimab together 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.
For Medicaid and NC Health Choice Billing
- The ICD-10-CM diagnosis code(s) required for billing is/are:
- U07.1 - COVID-19
- 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: Q0245 - Injection, bamlanivimab and etesevimab, 2100 mg
- One Medicaid and NC Health Choice unit of coverage is: 1 dose (700 mg of bamlanivimab and 1,400 mg of etesevimab)
- The maximum reimbursement rate per unit is: N/A (drugs are federally supplied)
- Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs is/are:
- Bamlanivimab: 00002-7910-01
- Etesevimab: 00002-7950-01
- 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.
- These MABs will only be administered in settings (including freestanding and hospital-based infusion centers, home health agencies, 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:
- M0245 - bamlanivimab and etesevimab, 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
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