Oncology & Hematology Coding Alert

Question: The Food and Drug Administration (FDA) recently approved REGEN-COV for emergency use as a postexposure prophylaxis for immunocompromised patients exposed to COVID-19. What should we know about the treatment, and how should we go about coding it?

North Carolina Subscriber

Answer: On July 30, 2021, the FDA expanded the emergency use of REGEN-COV (casirivimab and imdevimab, administered together) from treating “mild to moderate 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, including hospitalization or death” to use as a “post-exposure prophylaxis in certain adults and pediatric individuals.”

This use is intended for individuals “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 who have either “been exposed to an individual infected with SARS-CoV-2” or who are “at high risk of exposure to an individual infected with SARSCoV-2” (Source: www.fda.gov/media/145610/download).

If your provider decides to go ahead and administer the drug to one of your patients, the REGEN-COV website tells you to use the following codes for the infusion or injection, drug, and diagnosis:

• M0243 (Intravenous infusion or subcutaneous injection, casirivimab and imdevimab includes infusion or injection, and post administration monitoring) for the infusion or subcutaneous injection in an outpatient setting, excluding use in the patient’s home.
• M0244 (… 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) for the infusion or subcutaneous injection in the patient’s home or place of residence.
• Q0244 (Injection, casirivimab and imdevimab, 1,200 mg) for the drug product.
• U07.1 (COVID-19) for the diagnosis (Source: www.regencov.com/content/pdf/treatment-covid19-coding-reference-sheet.pdf).

But remember: Per the FDA press release, “REGEN-COV is authorized for intravenous infusion. Subcutaneous injection is authorized as an alternative route of administration when intravenous infusion is not feasible and would lead to delay in treatment.” Additionally, “REGEN-COV may only be administered in settings 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.”

Also, the FDA has only approved the use of REGEN-COV on an emergency basis during the COVID-19 pandemic. The drug is still awaiting the FDA’s full approval.