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

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.

New Providers

Follow the steps below to register to begin requesting mAb therapeutics

Step One – Complete the COVID-19 Therapeutics Provider Enrollment Form

Complete the form located within the Health Commerce System (HCS) here: https://mabrequest.health.ny.gov/nysmab/newprovider. Fill out all applicable fields and upload a copy of (1) your valid NYS license and (2) an AmerisourceBergen Letter of Affiliation (LOA) if you are a physician and the address on your physician’s license does not match the shipping address provided on the enrollment form. A link to the LOA can be found in the enrollment form.    

  • If you do not have a HCS account, please visit the Health Commerce System website, and click on “Don’t have an Account? Sign Up Here” to register for an account. 

Step Two – NYS Review

The mAb therapeutics team at the Department will review your enrollment form to make sure the necessary documentation has been submitted and that you are licensed and in current good standing in NYS. If your submission is rejected, you will receive an email from the Department via [email protected] with an explanation and any next steps (if needed). If your submission is accepted, the Department will move to Step Three.  

Step Three – Department Sends Information to AmerisourceBergen

In order to receive mAb product from AmerisourceBergen, your site must be included in their system. You will also need an AmerisourceBergen account.  

  • If you already have an AmerisourceBergen account, your site information, along with the copy of your license and completed LOA (if applicable), will be sent to AmerisourceBergen. They require this information to be able to send you mAb product. 
  • If you do not have an AmerisourceBergen account, the Department will submit your site location information, copy of your license, and completed LOA (if applicable) to AmerisourceBergen, and they will create an account for you. 

Step Four- Site Locations and HHS TeleTracking Account

Once your AmerisourceBergen account has been set up:

  • The Department will email you a link to an additional form to complete, which asks you to identify all site locations mAb product will be dispensed or administered. This information will be used by the Department to understand the number and location of the sites you are sending mAb product to. 
  • You will need to sign up for a HHS Protect, TeleTracking or NHSN account by following the directions here: Reporting Utilization of COVID-19 Therapeutics. For more information on Federal reporting requirements, please see the next section, “Provider Requirements.”

Step Five – Request Therapeutics

Once you have submitted a complete list of all your site(s), the Department will notify you via email that you can request mAb product for your site. Follow the process outlined in the “Request COVID-19 Therapeutics” section to submit requests to receive mAb product.

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