Public Health Emergency - Leading a Nation Prepared
The administration of several monoclonal antibodies, active against SARS-CoV-2 (COVID-19), requires intravenous infusion. In order to bolster capacity at the state, tribal, local, and territorial (STLT) levels to deliver infusions in an outpatient setting, we have developed the following operational and logistical guidance for this example model. Facilities and providers should follow state and local regulations/guidelines for each set up and consult the relevant FDA Fact Sheets for Healthcare Providers for additional requirements.
This Monoclonal Antibody Infusion Center model is designed as a point-to-point unidirectional flow model. This model includes a patient intake, infusion, and post-infusion observation areas. There are instances where you may see one or more of these areas combined.
The minimum infusion times for the monoclonal antibodies may vary from 16 minutes to 70 minutes (in alignment with product EUA), followed by a post-infusion observation period of at least 60 minutes. Refer to FDA Fact Sheet for Healthcare Providers: casirivimab/imdevimab and bamlanivimab/etesevimab for more information.
This Monoclonal Antibody Infusion Center Model is designed to be scalable to facility size, community needs, and level of staffing. The example highlighted is dedicated to operating on a 12-hour workday, with a 15 infusion patient, 15 observation patient capacity.
In this model, all patients have received positive SARS-CoV-2 test results, which speaks to the need for comprehensive
infection-control and prevention practices, including
Standard Precautions and
Considerations for Alternate Care Sites. Healthcare providers should follow recommended infection prevention and control measures for care of COVID-19 patients. In addition, staff should be trained in recommended IPC measures, including proper donning and doffing of PPE and safe disposal of PPE.
This document intends to provide a detailed logistical and operational model for a Therapeutic Infusion Center capable of furnishing monoclonal antibodies to treat COVID-19. This document does not establish new facility conditions of participation that are required to bill for services (in certain settings) under federal programs, and does not represent new Medicare/Medicaid payment, coverage or enrollment rules.
Entrance or Check-in
Post Infusion Observation
Total Staff Required
1 RN / Medical Tech (Basic/ Paramedic) with Triage skills 1 Runner 1 Scribe/Registrar (optional)
1 Physician / Advanced Practioner (onsite or accessible via telemedicine) 2 RN 2 Healthcare workers 1 Environmental Staff (optional)
1 RN 1 Healthcare worker 1 Runner 1 Environmental Staff (optional)
(plus 1 optional)
(plus 1 optional)
(plus 1 optional)
Total: 0 (plus 1 optional)
Total:10 (plus 4 optional)
Note: Donning and Doffing areas along with Hot and Cold zones are dependent on facility layout.
Figure 1: Example of a15 Patient Infusion Center Layout
Many health insurers, including Medicare and Medicaid, will make payments to health care providers that furnish monoclonal antibodies (mAbs) used to treat COVID-19.
Medicare has publicly defined payment policies for COVID-19 mAb products and their intravenous infusion during the Public Health Emergency. Freestanding infusion centers, Alternate Care Sites, and other hospital-based temporary expansion sites may administer mAbs used to treat COVID-19 in accordance with their FDA EUAs. Ensure that hospital conditions of participation and provider-based rules comply with 1135 waivers issued under
For mAb products that providers purchase, Medicare’s payment rate for is 95% of average wholesale price (AWP). Please refer to future notice-and-comment rulemaking for coding and payment rates for administration of mAb products. For more information on Medicare coverage and payment policies for mAbs used to treat COVID-19, please refer to CMS guidance:
Medicare’s policies may not be adopted by other health insurers. Organizations establishing new programs to infuse mAbs used to treat COVID-19 are encouraged to contact state Medicaid programs and insurers that they have contracts with to determine coverage and payment policies established by that state/insurer.
For information on obtaining monoclonal antibodies for non-hospital sites, refer to the
FAQs for non-hospital sites.
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