COVID-19 Monoclonal Antibody (mAb) Therapeutics: Information for Providers

COVID-19 Monoclonal Antibody (mAb) Therapeutics: Information for Providers
SHARE

Overview

On Monday, September 13, 2021, the U.S. Department of Health & Human Services (HHS) changed the distribution system for monoclonal antibody (mAb) therapeutics. HHS transitioned from a direct requesting process whereby providers requested directly from the distributor, AmerisourceBergen, to a state/territory-coordinated distribution system. The New York State Department of Health (Department) is now determining where mAb product goes within the State. Each week, New York State will be assigned a weekly allotment of mAb product by HHS. The amount will be based on COVID-19 case burden and mAb therapeutic utilization. The mAbs therapeutics affected are:

 

 

The Department is intaking requests for these mAb therapeutics from NYS providers. The distribution of these therapeutics will remain with AmerisourceBergen. The Department will inform AmerisourceBergen of each provider's request and how much of the request should be filled. As the State will be allotted a finite amount of mAb product each week, providers may not receive the total amount of product they requested. The Department will determine how much product each provider receives based on the supply allotted to the State from HHS. To see the total amount of mAb distributed per week and a breakdown by territory/state, visit the U.S. Department of Health and Human Services website here.

Request COVID-19 Therapeutics

Requests should be submitted online as per the following directions:

 

  • Go to the following link: https://mabrequest.health.ny.gov/nysmab/. You'll need a Health Commerce System (HCS) account to access the form.
    • If you do not have a HCS account, please visit the Health Commerce System, and click on "Don't have an Account? Sign Up Here" to register for an account.
  • Complete all fields of the online form. When you have completed all fields, click the "submit" button. You will receive an email notification confirming your submission.
  • As a reminder, the amount a provider requests may not be the amount the provider receives. The amount received will be based on the supply allotted to the State from HHS.

 

Full details on requesting monoclonal antibody therapeutics can be found in the Guidance on How to Request a Supply of COVID-19 Monoclonal Antibody (mAb) Therapeutics.

 

Timeline of Requesting COVID-19 Therapeutics

 

Below is a visual representation of the important deadlines and timeframes for requesting and receiving mAb Therapeutics.

Sunday Monday Tuesday Wednesday Thursday Friday Saturday  
  5:00 pm Requests for mAb therapeutics due DOH determines site allocations based on Federal allocations and submits orders to AmerisourceBergen by 5:00pm Friday  
Providers receive mAb shipments Drug utilization reporting due in TeleTracking or NHSN DOH HCS form to request mAb therapeutics opens for following week AmerisourceBergen finalizes allotments, notifies providers, and ships mAb therapeutics

Guidance

Provider Requirements

Only providers who have an active account from AmerisourceBergen can submit a request for product at this time. We are working to put in place a process to enroll additional qualified providers. More information will be forthcoming in a separate announcement.

 

In order to receive mAb product, providers must continue to report their weekly utilization data to the Federal government through the appropriate system of HHS Protect, TeleTracking or NHSN, depending on facility type. These reports continue to be due every Wednesday. For more information on the federal reporting requirement, including account information, please visit: Reporting Utilization of COVID-19 Therapeutics.

Updates

Important updates and reminders are sent to subscribers through the COVID-19 Therapeutics listserv. If you are not already amember ofthis listserv, follow the steps below to subscribe.

  1. Send a message to[email protected]
  2. In the body of email enter: subscribe <C19Therapeutics-l> <Firstname> <Lastname>
  3. Remove any signatures in your email
  4. Click Send
  5. You should receive an automated reply confirming your subscription to the listserv and you will receive all messages going forward.

Contact