SPECIAL BULLETIN COVID-19 #180: 9th Amendment to the Public Readiness & Emergency Preparedness Act NC Medicaid licensed pharmacists authorized to order and administer REGEN-COV monoclonal antibodies
Effective Sept. 13, 2021 the NC DHHS issued a NC State Health Director’s Statewide Standing Order for Subcutaneous Administration of casirivimab/imdevimab (REGEN-COV) Monoclonal Antibodies to meet the goal of the 9th Amendment to the Public Readiness & Emergency Preparedness (PREP) Act. This standing order authorizes any NC Medicaid licensed pharmacist to order and administer REGEN-COV and for pharmacy technicians/interns to administer it, in accordance with the conditions of their licensure and/or scope of practice to include subcutaneous injections, or pursuant to orders issued under North Carolina Executive Order 232, or as a covered person under the federal PREP Act functioning as monoclonal antibody providers to administer casirivimab/imdevimab (REGEN-COV) authorized by the FDA through an Emergency Use Authorization (EUA) and per conditions of this order.
Medicaid and NC Health Choice beneficiaries are eligible for this treatment if age 12 years and older, weigh at least 40 kg (88.2 lb.), who present requesting and consent to treatment with monoclonal antibodies (casirivimab/imdevimab or REGEN-COV) for treatment of mild to moderate COVID-19 or for post-exposure prophylaxis to COVID-19, who self-attest to being at high risk for severe COVID-19 disease. Patients should have legal and decisional capacity to consent to treatment with monoclonal antibodies (casirivimab/imdevimab or REGEN-COV), in accordance with NC GS § 90-21.5.
Casirivimab/imdevimab (REGEN-COV) can only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion/injection or hypersensitivity reaction (such as anaphylaxis), and the ability to activate EMS, as necessary and according to local protocol.
See previously published Billing guidelines for REGEN-COV for medical (non-pharmacist) providers who order MABs.
Medicaid/NC Health Choice Billing Information:
- Medicaid and/or NC Health Choice beneficiary must be age 12 years or older
- Claims must be submitted as Professional (CMS-1500/837P transaction) or Institutional (UB-04/837I transaction) claims
- Administration must be via subcutaneous route only
- The ICD-10-CM diagnosis code(s) required for billing are:
- U07.1 - COVID-19
- B34.2 - Coronavirus infection, unspecified
- B97.21 - SARS-associated coronavirus as the cause of diseases classified elsewhere
- Z20.822 - Contact with and (suspected) exposure to COVID-19
Drug HCPCS and Administration HCPCS codes to use when a pharmacist orders and/or administers REGEN-COV:
Q0240 - 600 mg (300 mg of casirivimab and 300 mg of imdevimab)
M0240 - Intravenous infusion or subcutaneous injection, casirivimab and imdevimab includes infusion or injection, and post administration monitoring, subsequent repeat doses
M0241 - Intravenous infusion or subcutaneous injection, casirivimab and imdevimab includes infusion or injection, 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, subsequent repeat doses
Q0244 - 1,200 mg (600 mg of casirivimab and 600 mg of imdevimab)
M0243 - Intravenous infusion or subcutaneous injection, casirivimab and imdevimab includes infusion or injection, and post administration monitoring
M0244 - Intravenous infusion or subcutaneous injection, casirivimab and imdevimab includes infusion or injection, 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
- The maximum reimbursement rate for drug product per unit is $0.00
- The maximum reimbursement rate per administration of the MAB is:
- $450 per SQ injection for M0240 and M0243
- $750 per SQ injection for M0241 and M0244 for injection and monitoring in the home or residence
- Modifier “SK” MUST be appended to the drug HCPCS code AND the administration code to allow claims to process when a pharmacist is the ordering provider.
- Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are:
- 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 (co-formulated)
- Casirivimab (REGN10933): 61755-0024-01, 61755-0026-01
- Imdevimab (REGN10987): 61755-0025-01, 61755-0027-01
NCTRACKS Contact Center: 800-688-6696