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Is a New Long-Acting Monoclonal Antibodies for Pre-Exposure Prevention of COVID-19 an Option for You?

Published on 

Wednesday, January 12, 2022

In December 2021, the FDA announced (link) an Emergency Use Authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kg [about ">link) pounds]).

According to the announcement, Evusheld is for people not currently infected with or who have not had recent exposure to an individual who has COVID-19. Additionally, the EUA requires that the individual either have:

  • “moderate to severely compromised immune systems due to a medical condition or due to taking immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination (examples of such medical conditions or treatments can be found in the fact sheet for health care providers) or;
  • a history of severe adverse reactions to a COVID-19 vaccine and/or component(s) of those vaccines, therefore vaccination with an available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended.”

The FDA reinforces the fact that this medication is not a substitute for a COVID-19 vaccine and “urges the public to get vaccinated if eligible.” They also advise patients to talk with their health care provider to determine if this is an appropriate prevention option.

CMS has updated their COVID-19 Vaccines and Monoclonal Antibodies webpage (link) to include the code and the national payment allowance for Evusheld.

Also, CMS reminded providers in the December 16 edition of MLN Connects (link) that “if you vaccinate or administer monoclonal antibody treatment to patients enrolled in Medicare Advantage (MA) plans on or after January 1, 2022, submit claims to the MA Plan. Original Medicare won’t pay these claims.”

Article Author: Beth Cobb, RN, BSN, ACM, CCDS
Beth Cobb, RN, BSN, ACM, CCDS, is the Manager of Clinical Analytics at Medical Management Plus, Inc. Beth has over twenty-five years of experience in healthcare including eleven years in Case Management at a large multi-facility health system. In her current position, Beth is a principle writer for MMP’s Wednesday@One weekly e-newsletter, an active member of our HIPAA Compliance Committee, MMP’s Education Department Program Director and co-developer of MMP’s proprietary Compliance Protection Assessment Tool.

This material was compiled to share information.  MMP, Inc. is not offering legal advice. Every reasonable effort has been taken to ensure the information is accurate and useful.