SPECIAL BULLETIN COVID-19 #177: Casirivimab and Imdevimab Approved for Emergency Use REGEN-COV™: Billing Guidelines
Casirivimab and Imdevimab, for Intravenous Infusion or Subcutaneous Injection (REGEN-COV™ [2400 mg, 1200 mg, or 600 mg]): Billing Guidelines
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved products casirivimab and imdevimab 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. Casirivimab and imdevimab are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of casirivimab and imdevimab 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 Nov. 21, 2020, the NC Medicaid and NC Health Choice programs cover casirivimab and imdevimab, for intravenous infusion or subcutaneous injection (REGEN-COV™ (2400 mg, 1200 mg, and 600 mg)) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code:
- HCPCS code Q0240 - Injection, casirivimab and imdevimab, 600 mg
- HCPCS code Q0243 - Injection, casirivimab and imdevimab, 2400 mg
- HCPCS code Q0244 - Injection, casirivimab and imdevimab, 1200 mg
LIMITATIONS OF AUTHORIZED USE
- Casirivimab and imdevimab 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
- Benefit of treatment with casirivimab and imdevimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19.
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, in adult and pediatric individuals (12 years of age and older weighing at least 40 kg) for post-exposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:
- not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications) AND
- have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC) OR
- who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons).
LIMITATIONS OF AUTHORIZED USE
- Post-exposure prophylaxis with REGEN-COV (casirivimab and imdevimab) is not a substitute for vaccination against COVID-19.
- REGEN-COV (casirivimab and imdevimab) is not authorized for pre-exposure prophylaxis for prevention of COVID-19.
See package insert for recommended dose. INTRAVENOUS INFUSION IS STRONGLY RECOMMENDED. SUBCUTANEOUS INJECTION IS AN ALTERNATIVE ROUTE OF ADMINISTRATION WHEN INTRAVENOUS INFUSION IS NOT FEASIBLE AND WOULD LEAD TO DELAY IN TREATMENT.
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:
- Q0244 - Injection, casirivimab and imdevimab, 1200 mg
- Q0240 - Injection, casirivimab and imdevimab, 600 mg
- Q0243 - Injection, casirivimab and imdevimab, 2400 mg
- The maximum reimbursement rate per unit is: none, this drug is provided free of charge
- Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs is/are:
- Casirivimab (REGN10933): 61755-0024-01, 61755-0026-01
- Imdevimab (REGN10987): 61755-0025-01, 61755-0027-01
- REGEN-COV 2-VL DOSE PK (EUA): 61755-0035-02
- REGEN-COV 8-VL DOSE PK (EUA): 61755-0036-08
- REGEN-COV 5VL(1 CAS,4IMD)(EUA): 61755-0037-05
- REGEN-COV 5VL(4CAS,1 IMD)(EUA): 61755-0038-05
- REGEN-COV 600-600 MG/10ML(EUA): 61755-0039-01
- 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 Medicaid's website.
- 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:
- M0243: Long Descriptor: Intravenous infusion or subcuteaneous injection, casirivimab and imdevimab includes infusion or injection, 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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