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Has CMS announced new HCPCS codes to report for the COVID-19 monoclonal antibody treatment Tocilizumab?

Yes. On July 22, 2021, CMS published the MLN Connects article linked below entitled, “COVID-19: EUA for Tocilizumab Monoclonal Antibody Product”. In the article, CMS announced that 3 new HCPCS codes have been established to report tocilizumab and its associated administration. For your convenience, we have included the long descriptions for each of the new codes below. Per the article, the HCPCS codes Q0249, M0249 and M0250 are retroactively effective back to June 24, 2021, the same date the FDA issued its Emergency Use Authorization (EUA) for tocilizumab.

Q0249: Injection, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) only, 1 mg

M0249: Intravenous infusion, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) only, includes infusion and post administration monitoring, first dose

M0250: Intravenous infusion, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) only, includes infusion and post administration monitoring, second dose

As noted in the HCPCS code long descriptions, tocilizumab is currently only approved by the FDA for administration to COVID-19 patients who are hospitalized, are receiving corticosteroids and require supplemental oxygen, ventilation or ECMO. Additional clinical details regarding tocilizumab and its administration can be reviewed on the “FDA Fact Sheet for Healthcare Providers” linked below.

You may be wondering why CMS established HCPCS codes for tocilizumab given that the drug is only approved to be administered in the inpatient setting – and HCPCS codes are not generally reported on inpatient claims. It is important to remember that for the duration of the COVID-19 Public Health Emergency (PHE), CMS is covering COVID-19 monoclonal antibody treatments under the same benefit category as COVID-19 vaccines; meaning, these products can be reimbursed separately in addition to inpatient DRG payments, so long as the treatment is provided in accordance with the FDA’s EUA. In order to receive the additional reimbursement, providers should submit separate 12X claims for tocilizumab and its administration when provided to inpatients. Additional billing guidance can be found on the CMS “Medicare Billing for COVID-19 Vaccine Shot Administration” webpage linked below.

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 Tocilizumab closely over the coming weeks. We will provide additional information as needed.

CMS MLN Connects, “COVID-19: EUA for Tocilizumab Monoclonal Antibody Product”:
https://www.cms.gov/outreach-and-educationoutreachffsprovpartprogprovider-partnership-email-archive/2021-07-22-mlnc#_Toc77687195

FDA Fact Sheet for Healthcare Providers: Emergency Use Authorization for Actemra (Tocilizumab):
https://www.fda.gov/media/150321/download

CMS “Medicare Billing for COVID-19 Vaccine Shot Administration” webpage:
https://www.cms.gov/medicare/covid-19/medicare-billing-covid-19-vaccine-shot-administration