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Has CMS announced HCPCS code changes related to COVID-19 monoclonal antibody treatments Sotrovimab and REGEN-COV?

Yes. On June 16, 2021, CMS published the MLN Connects article, linked below, that outlines various HCPCS code changes related to Sotrovimab and REGEN-COV COVID-19 monoclonal antibody treatments.

On May 26, 2021, the FDA issued an Emergency Use Authorization (EUA) for GlaskoSmithKline’s Sotrovimab to treat mild-to-moderate COVID-19 in adults and pediatric patients who are at high risk for progression to severe COVID-19. In response to the approval, CMS has established 3 new HCPCS codes to report for Sotrovimab and its administration in either the healthcare or home setting. CMS states these codes will be retroactively effective back to May 26, 2021 – the date the EUA was issued by the FDA. For your convenience we have provided the full long descriptions for the new Sotrovimab HCPCS codes below.

Q0247: Injection, sotrovimab, 500 mg

M0247: Intravenous infusion, sotrovimab, includes infusion and post administration monitoring

M0248: Intravenous infusion, sotrovimab, includes infusion 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

On June 3, 2021, the FDA revised its existing EUA for Regeneron’s monoclonal antibody cocktail of casirivimab and imdevimab, REGEN-COV. The updated EUA allows for a new, lower dosing regimen of 1200 mg (as opposed to the previous dose of 2400 mg) and also allows for the product to be administered subcutaneously. In response, CMS has created new HCPCS code, Q0244, to describe the lower dosage and has revised the HCPCS code descriptions for M0243 and M0244 to also include the newly approved subcutaneous route of administration. Per CMS, new HCPCS code Q0244 will be retroactively effective back to June 3, 2021 – the date of the EUA revision. HCPCS codes M0243 and M0244 have been effective since 11/21/2020.

Q0244: Injection, casirivimab and imdevimab, 1200 mg

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

As always, we would caution that as these changes have just recently been announced by CMS, there may be a delay in MACs and other commercial payers implementing these code changes within their various claims processing systems. We recommend providers track claims for Sotrovimab and REGEN-COV closely over the coming weeks. We will provide any additional updated if and when they are released by CMS.

CMS MLN Connect: “COVID-19: EUAs for Monoclonal Antibody Products”:
https://www.cms.gov/outreach-and-educationoutreachffsprovpartprogprovider-partnership-email-archive/2021-06-17-mlnc#_Toc74742858

CMS COVID-19 Vaccines and Monoclonal Antibodies homepage:
https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/covid-19-vaccines-and-monoclonal-antibodies

FDA Fact Sheet for Health Care Providers – EUA of Sotrovimab:
https://www.fda.gov/media/149534/download

FDA Fact Sheet for Health Care Providers – EUA of Casirivimab and Imdevimab:
https://www.fda.gov/media/143892/download