Frequently Asked Questions

Allocation, Distribution and Administration of REGEN-COV

Allocation and Distribution

1. How much REGEN-COV is available for allocation to states and territories?
2. What is HHS/ASPR’s strategy for ensuring REGEN-COV reaches healthcare providers quickly?
3. Which healthcare facilities are eligible to receive REGEN-COV allocations?
4. Can a healthcare facility receive additional casirivimab/imdevimab above its allocation if the state/territory’s allocations have not been exhausted?
   
5. What states and U.S. territories have received casirivimab and imdevimab? How much has each received?
6. How long will HHS/ASPR manage the allocation of REGEN-COV?

Data Collection

1. What data elements are needed to help HHS/ASPR allocate REGEN-COV to states and U.S. territories? How is the data collected?
2. Where can a treatment facility find information regarding billing Medicare for monoclonal antibody product?

Allocation and Distribution

1. How much REGEN-COV is available for allocation to states and territories?

The U.S. government is funding large-scale manufacturing of REGEN-COV from Regeneron (the manufacturer of REGEN-COV) which is expected to produce approximately 300,000 patient courses through the end of January 2021.

2. What is HHS/ASPR’s strategy for ensuring REGEN-COV reaches healthcare providers quickly?

The federal government’s priority is to allocate the limited patient courses doses of casirivimab/imdevimab in an efficient, fair, and equitable manner to locations in the country that need it most. The U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response (HHS/ASPR) oversees this process using a similar methodology and ethical considerations used to successfully allocate Veklury (remdesivir) and bamlanivimab:

Step 1: HHS/ASPR determines state and territory allocations for each distribution week using information from the HHS Protect data collection platform.

Step 2: HHS/ASPR notifies state/territorial health departments regarding their allocated amounts of - REGEN-COV for the given distribution week.

Step 3: Health departments, not the federal government, determine how much REGEN-COV eligible healthcare facilities within their respective jurisdictions will receive based on the state/territory’s overall allocation. Health departments communicate information regarding receiving facilities and allowable distribution amounts to AmerisourceBergen (the distributor of the drug). Neither AmerisourceBergen nor Regeneron (the manufacturer of the medicine) are involved in allocation decisions for REGEN-COV.

Step 4: AmerisourceBergen, the distributor, coordinates shipping details with receiving facilities.

Step 5: Receiving facilities administer the therapeutic to COVID-19 patients eligible for treatment using the guidance from the Emergency Use Authorization (EUA)

3. Which healthcare facilities are eligible to receive REGEN-COV allocations?

The EUA allows REGEN-COV to be administered to patients with confirmed mild to moderate COVID-19. REGEN-COV is administered by intravenous (IV) infusion, which presents unique challenges. Eligible patient facilities must have appropriate healthcare staffing, supplies, and equipment to administer IV infusion therapies. The infusion takes approximately one hour and is followed by an observation period of at least one hour. Facilities must have a dedicated patient area or isolation rooms available to administer the medication and provide follow-up patient care in a manner that minimizes infection transmission.

4. Can a healthcare facility receive additional REGEN-COV above its allocation if the state/territory’s allocations have not been exhausted?

A healthcare facility can request additional patient courses through their state/territory health department. If another healthcare facility does not accept or want its allocated amount, those patient courses can be reallocated by the state to other healthcare facilities within their jurisdiction.

5. What states and U.S. territories have received REGEN-COV? How much has each received?

HHS/ASPR maintains a dashboard of allocations to states and territories. This information is posted on the REGEN-COV Allocation Dashboard.

6. How long will HHS/ASPR manage the allocation of REGEN-COV?

The current EUA for REGEN-COV requires the U.S. government to manage allocation of the drug for use consistent with the terms and conditions of the EUA. HHS/ASPR will maintain its current role and responsibilities on behalf of the U.S. government unless and until the terms and conditions of the EUA change. This may occur when the supply of the product meets the demand from the commercial marketplace.

Data Collection

1. What data elements are needed to help HHS/ASPR allocate REGEN-COV to states and U.S. territories? How is the data collected?

The allocation process for REGEN-COV is based on information received from hospitals and states via HHS Protect. Two data points particularly important to allocation are: 1) the number of confirmed COVID-19 cases in the state/territory and 2) the number of confirmed COVID-19 hospitalized patients in the state/territory. These data points will be collected weekly through HHSProtect and compared proportionally by the total number of cases in the country for that week. These two data points, along with other information in HHSProtect, help identify where outbreaks are most active by highlighting changes in COVID-19 patient data over a seven-day period.

2. Where can a treatment facility find information regarding billing Medicare for monoclonal antibody product?

CMS Announces Comprehensive Strategy to Enhance Hospital Capacity Amid COVID-19 Surge.

Provider Toolkit - this toolkit is centered on vaccines; however, there is a wealth of information that is generally applicable for therapeutics. 

COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing - information regarding hospital patient billing of EUA products can be found on page 121 (question #6).