Article Detail - JE Part B

• CMS Takes Further Steps to Ensure Medicare Beneficiaries Have Wide Access to COVID-19 Antibody Treatment
• COVID-19 Vaccines and Monoclonal Antibody Infusion: Enforcement Discretion Relating to SNF Consolidated Billing

CMS Takes Further Steps to Ensure Medicare Beneficiaries Have Wide Access to COVID-19 Antibody Treatment

The U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for the investigational monoclonal antibody therapy, casirivimab and imdevimab, administered together, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive COVID-19 test results who are at high risk for progressing to severe COVID-19 and/or hospitalization. Casirivimab and imdevimab, administered together, 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. Review the Fact Sheet for Health Care Providers EUA of Casirivimab and Imdevimab regarding the limitations of authorized use when administered together.

During the COVID-19 Public Health Emergency (PHE), Medicare will cover and pay for these infusions the same way it covers and pays for COVID-19 vaccines (when furnished consistent with the EUA).

CMS identified specific code(s) for the monoclonal antibody product and specific administration code(s) for Medicare payment: Regeneron’s Antibody Casirivimab and Imdevimab (REGN-COV2) , EUA effective November 21, 2020.

Q0243:

Long descriptor: Injection, casirivimab and imdevimab, 2400 mg

Short descriptor: casirivimab and imdevimab

M0243:

Long Descriptor: intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring

Short Descriptor: casirivi and imdevi infusion

Additional Resources: 

• List COVID-19 monoclonal antibody infusion billing codes, payment allowances and effective dates
• Monoclonal Antibody COVID-19 Infusion Program Instruction
• CMS COVID-19 Vaccine Provider Toolkit

COVID-19 Vaccines and Monoclonal Antibody Infusion: Enforcement Discretion Relating to SNF Consolidated Billing

To facilitate the efficient administration of COVID-19 vaccines to Skilled Nursing Facility (SNF) residents, CMS is exercising enforcement discretion with respect to statutory provisions requiring consolidated billing by SNFs as well as any associated statutory references and implementing regulations, including as interpreted in pertinent guidance. Through the exercise of this discretion, we will allow Medicare-enrolled immunizers working within their scope of practice and subject to applicable state law, including, but not limited to, pharmacies working with the United States, as well as infusion centers, and home health agencies, to bill directly and receive direct reimbursement from the Medicare program for vaccinating Medicare Part A SNF residents. This enforcement discretion, and accordingly the ability for entities other than the SNF to submit claims for these monoclonal antibody products and their administration furnished to Medicare Part A SNF residents, is limited to the period described in the above-cited enforcement discretion notice.