This bulletin was updated on Jan. 6, 2022 in COVID-19 Bulletin #208.
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product sotrovimab monoclonal antibody (MAB) 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 progression to severe COVID-19, including hospitalization or death. They are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of sotrovimab 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 June 28, 2021, the Medicaid and NC Health Choice programs cover sotrovimab for intravenous infusion for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code Q0247 - Injection, sotrovimab, 500 mg.
Strength/Package Size(s): Sotrovimab is a sterile, preservative-free, clear, colorless or yellow to brown solution available as:
- Injection: 500 mg/8 mL (62.5 mg/mL) solution in a single-dose vial for intravenous infusion after dilution.
The following medical conditions or other factors may place adults and pediatric patients (12 to 17 years of age weighing at least 40 kg) at higher risk for progression to severe COVID-19:
- Older age (for example ≥65 years of age)
- Obesity or being overweight (for example, adults with BMI >25 kg/m2, or if 12 to 17 years of age, have BMI ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm)
- Pregnancy
- Chronic kidney disease
- Diabetes
- Immunosuppressive disease or immunosuppressive treatment
- Cardiovascular disease (including congenital heart disease) or hypertension
- Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
- Sickle cell disease
- Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
- Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation [not related to COVID-19])
LIMITATIONS OF AUTHORIZED USE
- Sotrovimab is 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).
- Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID-19. SARS-CoV-2 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 sotrovimab 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 500 mg of sotrovimab. Sotrovimab should be given as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset. Sotrovimab must be diluted and administered as a single intravenous infusion over 30 minutes. 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: Q0247 - Injection, sotrovimab, 500 mg
- One Medicaid and NC Health Choice unit of coverage is: 500 mg
- The maximum reimbursement rate per unit is: N/A (federally funded)
- Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs is: 00173-0901-86
- The NDC units should be reported as "UN1"
- For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update and PADP Clinical Coverage Policy 1B, Attachment A, H.7 on Medicaid's website.
Additional information
- These MABs will[FC1] [HD2] [PR3] 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:
- M0247 - Intravenous infusion, sotrovimab, 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 Call Center: 800-688-6696