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

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

Overview

Beginning in September 2021, the New York State Department of Health (Department) began managing the distribution process for monoclonal antibody (mAb) therapeutics within the State. Each week, New York State will be assigned a weekly allotment of product by the U.S. Department of Health & Human Services (HHS). The amount will be based on COVID-19 case burden and utilization. The products affected are:

 

In addition, there are some products that were previously distributed, but are not currently authorized for use in New York. These products are: 

 

The Department is intaking requests for mAb therapeutics from NYS providers following the process outlined below. The distribution of these therapeutics will remain with AmerisourceBergen. 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. 

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) and Oral Antiviral 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

  •  

    FDA Limits Use of Certain Monoclonal Antibodies

    January 27, 2022 - This document supersedes the January 21, 2022 guidance concerning monoclonal antibody treatment. This guidance outlines recommendations for BAM/ETE and REGEN-COV as they are no longer authorized for use anywhere in the U.S.

     

    Download

Provider Requirements

In order to receive mAb product, providers must continue to comply with Federal reporting requirements for utilization. Courses utilized and courses available for all COVID-19 therapeutics must be reported daily by 11:59 pm in the Health Partner Order Portal (HPOP) on days that you are open for business. 

 

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 – Create HPOP Account

To receive mAb product, you must register in the HHS Health Partner Order Portal (HPOP). The Department will request an account for you, and you will receive a registration link via email from [email protected] with instructions to begin setting up your account. This link will expire within 72 hours, so it is important that registration is completed in a timely manner.

 

Step Four- Additional Information for HPOP Account

After registering, the following actions need to be taken in your HPOP account:

  • Verify address. If your site is listed as a hub, please send your address, hours, and pharmacy contact (if different) to [email protected] All hub addresses need to be verified by the state.
    • There is a checkbox below this field for receiving address which must be selected
  • Verify business hours.
    • There is a checkbox below this field for hours verified which must be selected
  • Enter license number and expiration date (Ex. BoP, medical license, etc.).
  • Select provider type and settings(s) where your facility will administer products.
  • Select the Therapeutics Category ‘Monoclonal Antibody’ and/or ‘Monoclonal Antibody Special’ in your account. ‘Monoclonal Antibody Special’ should be selected if you wish to request Evusheld.
     

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 a member of this 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.

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