Coronavirus News

CMS Announces Medicare Coverage Specifics for COVID-19 Monoclonal Antibody Therapy

The U.S. Food and Drug Administration (FDA), on February 9, 2021, issued an Emergency Use Authorization (EUA) for combination bamlanivimab and etesevimab monoclonal antibody infusion therapy (“Bamlan/Etesev Antibody Therapy”) for the treatment of mild-to-moderate COVID-19 in adults age 65 and older and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who are at high risk for progressing to severe COVID-19On Thursday, February 18, 2021, CMS announced that it has taken further steps to ensure Medicare beneficiaries have wide access to the Bamlan/Etesev Antibody Therapy.  CMS said Medicare would cover the use of this COVID-19 therapy when:

  • used according to the Fact Sheet for Health Care Providers EUA of Bamlanivimab and Etesevimab regarding the limitations of authorized use when administered together; and
  • 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.

CMS stated that, during the COVID-19 Public Health Emergency (PHE), Medicare would cover and pay for Bamlan/Etesev Antibody Therapy the same way it covers and pays for COVID-19 vaccines (when furnished consistent with the EUA).  CMS identified the following specific code(s) for the monoclonal antibody product and specific administration code(s) for Medicare payment: Eli Lilly and Company’s Antibody Bamlanivimab and Etesevimab, (ZIP) EUA effective February 9, 2021:

Q0245:

  • Long descriptor: Injection, bamlanivimab and etesevimab, 2100 mg
  • Short descriptor: bamlanivimab and etesevimab

M0245:

  • Long Descriptor: intravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring
  • Short Descriptor: bamlan and etesev infusions

CMS provided the following additional resources for Medicare’s COVID-19 PHE monoclonal antibody infusion program:

The CMS decision on Medicare coverage for the Bamlan/Etesev Antibody Therapy aligns with recent statements by Dr. David Kessler, former FDA commissioner and co-chair of President Joe Biden’s Coronavirus Task Force, that available COVID-19 antibody treatments are going unused and need to be more widely deployed to prevent hospitalization and death from COVID-19.  Dr. Kessler attributed the issue of underuse to patients and health care providers not being aware of monoclonal antibodies being available as a treatment option.  Dr. Kessler urged Americans who test positive for COVID-19 and who are at high risk for progressing to severe COVID-19 and/or hospitalization (i.e., over 65, have cancer chemo, obesity, diabetes, immunosuppressed) to ask their doctor about starting monoclonal antibody therapy.  To be most effective, Dr. Kessler said “timing is everything, you need to be treated early, within 10 days of symptoms, before hospitalization.”  (See Dr. Kessler Interview, The Rachel Maddow Show, February 17, 2021.)

Kathie McDonald-McClure
Kathie McDonald-McClure leads the Firm’s Data Privacy & Security Service Team and is a member of the Health Care Service Team. She regularly advises on compliance with laws prohibiting kickbacks and regulating provider referrals. She counsels clients on chronic care and population health management initiatives aimed at reducing health care costs. She often advices on HIPAA, GDPR and state data breach laws and on electronic data collection and tracking practices. Other areas of advice include... Read More