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U.S. Department of Health and Human Services

Healthcare Facilities

Distribution of COVID-19 Monoclonal Antibody Therapeutics

Infusion sites and specialty physician offices can provide monoclonal antibody (mAb) therapy for non-hospitalized patients that have tested positive for COVID-19 and have mild to moderate symptoms. These treatments are indicated for eligible patients 12 years and older with a high risk of progressing to severe forms of COVID-19 or being hospitalized.

Infusion sites (based on classes of trade) are able to order REGEN-COV and bamlanivimab/etesevimab monoclonal antibodies for their facilities. The administration of these COVID-19 therapeutics requires intravenous infusion.



​​
​​
Consider becoming an infusion site

Planning
to Administer mAbs


​Ordering
Product



Tracking
Utilization



​Seeking Reimbursement
and Coverage


Staying
Up-to-date



Step 1: Consider becoming an Infusion Site

If you are considering having your health care facility offer COVID-19 mAb therapy, you can quickly evaluate your readiness in three steps:

  1. Does your facility have the infrastructure to meet the needs for treatment? If not, is your facility prepared to make the required changes to be ready?
  2. Is your current staff able to support outpatient mAbs administration? If not, is your facility prepared to add or reassign staff as necessary?
  3. Are your procedures and processes able to identify and treat mAbs patients within 10-day recommended timeframe? If not, is your facility prepared to add to or to adjust relevant procedures and processes?
To learn more about considerations for offering mAbs therapy, check out our guide Becoming a Site to Administer COVID-19 mAb Therapy and the COVID-19 Monoclonal Antibody Therapeutics Calculator for Infusion Sites.

Step 2: Planning for mAbs Administration

Once your facility has decided to offer COVID-19 mAb therapy, your facility will need  a plan to carry out the following activities:

  1. Allocate dedicated space and develop a plan to manage patient flow.
        • Develop a clear process for patients that are coming to your clinical site including scheduling requirements.
        • Design your admission process to minimize risk of spread per facility requirements/directions/guidelines.
        • Designate a dedicated room available for treatment.
  2. Obtain infusion components (IV kits, infusion chair/bed, IV pole, vital sign monitoring equipment, emergency medications).
  3. Assign sufficient amount of personnel to meet the expected demand, which includes having plans in place for nurses/IV techs, physicians, pharmacists, or other licensed medical professionals. You will likely need a dedicated team to treat patients.
  4. Prepare for the drug administration process. The treatment typically takes 16 minutes to one hour and is followed by a one-hour post-treatment observation period.
        • Develop a clear treatment and monitoring plan for the infusion process.
        • Define emergency protocols for addressing potential infusion reactions or complications.
        • Define a clear process for patient follow-up, using telemedicine when possible.
  5. Ensure a process for reimbursement is in place (non-drug administrative costs)
  6. Prepare for reporting adverse events and record keeping
The HHS/ASPR Monoclonal Antibody Infusion Center Model offers examples of setting up a COVID-19 mAb infusion center at your site, including: facility layout; patient flow, stations, and staffing; supplies; infection control and prevention; and reimbursement.

Step 3: Ordering Product

All sites that meet the requirements for administering monoclonal antibody therapeutics must order bamlanivimab/etesevimab (Lilly), and/or REGEN-COV (Regeneron) directly from AmerisourceBergen Corporation (ABC), the drugs’ sole distributor. The products remain free of charge to requesting sites. To learn more, see the direct ordering process guide and place orders directly with ABC using the C19 Therapies Direct Order Request system.

Step 4: Tracking Utilization

All sites that use monoclonal antibody therapeutics are required to report on utilization of the product every Wednesday. To learn more about your facility’s reporting requirements, see the process for tracking utilization of COVID-19 therapeutics.

Step 5: Reimbursement and Coverage

Reimbursement and coverage for monoclonal antibody therapeutics varies by provider.

 

Step 6: Stay up-to-date

HHS / ASPR Office Hours

Join us for informative biweekly sessions to learn more about the administration of COVID-19 mAbs. This meeting is an open forum for state and territorial health officer, health care providers and sites of care to ask us your questions on administration of therapies.

  • Office Call Sessions: HHS / ASPR Allocation, Distribution, Administration of COVID-19 Therapeutics
    Thursdays (2:00-2:30PM ET)       
  • State, Local, Tribal, and Territorial Public Health Officials:
    Wednesdays (2:00-2:45PM ET)
  • Healthcare Systems and State Hospital Associations
    Wednesdays (3:15-4:00PM ET)

Please email COVID19Therapeutics@hhs.gov to request Zoom links for these calls.

Project ECHO Clinical Grand Rounds

Project ECHO, in collaboration with ASPR, hosted the Outpatient Therapeutics Mini-Series for clinical overview and examples of administration models This mini-series provided a deep dive on new and emerging COVID-19 outpatient therapeutics, including monoclonal antibodies. The goal of this mini-series was to equip clinicians with the appropriate knowledge, resources, and tools needed to initiate and scale administration of these therapies and reduce strain on the U.S. healthcare system.


  • This page last reviewed: September 13, 2021