On Dec. 3, 2021 the U.S. Food and Drug Administration revised the emergency use authorization (EUA) of bamlanivimab and etesevimab (previously authorized for pediatric patients age 12 and older weighing at least 40 kilograms, or about 88 pounds), to additionally authorize bamlanivimab and etesivimab administered together for the treatment of mild to moderate COVID-19 in all younger pediatric patients including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death. This revision also authorizes bamlanivimab and etesevimab to be administered together for post-exposure prophylaxis for prevention of COVID-19 in all pediatric patients including newborns, at high risk of progression to severe COVID-19, including hospitalization or death.
The dosage in adults (age 18 and older) and pediatric patients (<18 years and weighing at least 40 kg) is bamlanivimab 700 mg and etesevimab 1,400 mg. The dosage for pediatric patients weighing less than 40 kg will vary depending on body weight:
- >20 kg to <40 kg: 350 mg bamlanivimab and 700 mg etesevimab
- >12 kg to 20 kg: 175 mg bamlanivimab and 350 mg etesevimab
- 1 kg to 12 kg: 12 mg/kg bamlanivimab and 24 mg/kg etesevimab
Bamlanivimab and etesevimab are not authorized for use in patients age two and older who are hospitalized due to COVID-19. Moreover, Bbmlanivimab and etesevimab are not authorized for use in patients, regardless of age, who:
- require oxygen therapy and/or respiratory support due to COVID-19
- require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory
- support due to underlying non-COVID-19 related comorbidity
Effective with date of service Dec. 3, 2021, the 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, for all ages.
For Medicaid and NC Health Choice Billing
- The ICD-10-CM diagnosis code(s) required for billing 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
- Z20.822 - Contact with and (suspected) exposure to COVID-19
- Providers must bill with HCPCS code: Q0245 - Injection, bamlanivimab and etesevimab, 2100 mg
- One Medicaid and NC Health Choice unit of coverage is:
- prior to Dec. 3, 2021 - 1 dose (700 mg of bamlanivimab and 1,400 mg of etesevimab)
- as of Dec. 3, 2021 – information on unit of coverage is not yet available
- 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 and 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.
Additional information
- 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 - intravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring
- M0246 - Intravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring in the home or residence; this includes a beneficiary’s home that has been made provider-based to the hospital during the COVID-19 public health emergency
Rates for administration of the MABs can be found on specific provider fee schedules.
Contact
NCTracks Contact Center: 800-688-6696