CMS adds HCPCS codes for monoclonal antibody product PEMGARDA

Wednesday, May 1, 2024

The FDA recently issued an emergency use authorization for PEMGARDA (pemivibart), a monoclonal antibody product for the pre-exposure prophylaxis of COVID-19 in certain adults and adolescents.

The product is authorized for those who are not currently infected with COVID-19, are at least 12 years old, weigh at least 88 pounds, and are moderately or severely immunocompromised.

CMS added the following Healthcare Common Procedure Coding System (HCPCS) level II codes to bill for this product:

  • Q0224 (Injection, pemivibart, for the pre-exposure prophylaxis only, for certain adults and adolescents [12 years of age and older weighing at least 40 kg] with no known SARS-CoV-2 exposure, and who either have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments, and are unlikely to mount an adequate immune response to COVID-19 vaccination, 4500 mg)
  • M0224 (Intravenous infusion, pemivibart, for the pre-exposure prophylaxis only, for certain adults and adolescents [12 years of age and older weighing at least 40 kg] with no known SARS-CoV-2 exposure, who either have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments, includes infusion and post administration monitoring

Both codes became effective on March 22. The payment allowances for Q0224 and M0224 are $6,583.50 and $450.00, respectively.

Revenue integrity professionals can find more information on these HCPCS codes on the CMS vaccine pricing webpage. Keep an eye out for updates to Medicare payment for COVID-19 monoclonal antibodies here. Additional information can be found in CMS’ COVID-19 Provider Toolkit.

Editor's note: Find more NAHRI resources on COVID-19 vaccines and treatments here.