Public Health Emergency - Leading a Nation Prepared
On Sunday, June 28, 2020, the U.S. Department of Health and Human Services (HHS) signed a Memorandum of Agreement with Gilead Sciences, Inc. (the manufacturer of remdesivir) and AmerisourceBergen (the distributor of remdesivir) to secure approximately 500,000 treatment courses of remdesivir for use in American hospitals. This represents 100 percent of Gilead’s projected production for July (94,200 treatment courses), 90 percent of production for August (174,900 treatment courses), and 90 percent of production in September (232,800 treatment courses), in addition to an allocation for clinical trials.At the end of this three-month period, the federal government will assess the COVID-19 environment to determine the best path forward relative to future distributions.
In alignment with the
current terms of the Emergency Use Authorization (EUA) for remdesivir, HHS will oversee the drug’s allocation and distribution process.
To achieve the federal government’s priority of distributing the limited doses of available remdesivir in a fair and equitable manner to locations in the country that need it most, the HHS Office of the Assistant Secretary for Preparedness and Response (HHS/ASPR) will oversee the allocation of the commercially available drug. If states and territories have remaining amounts of donated remdesivir, they should continue allocating the drug to hospitals in their jurisdictions at no cost.
Step 1: HHS/ASPR determines state and territory allocations for each distribution period using information from HHS Protect.
Step 2: HHS/ASPR notifies state/territorial health departments regarding their allocated amounts of remdesivir for the given distribution period.
Step 3: Health departments determine how much remdesivir hospitals within their respective jurisdictions may purchase based on the state/territory’s overall allocation. Health departments communicate information regarding receiving hospitals and allowable purchase amounts to AmerisourceBergen. Neither AmerisourceBergen nor Gilead Sciences, Inc. are involved in allocation decisions for the remdesivir.
Step 4: AmerisourceBergen coordinates shipping details with hospitals identified by their state/territorial health department to receive an allocation of remdesivir. AmerisourceBergen generates invoices for hospitals upon shipping.
Step 5: Hospitals are responsible for payment of remdesivir just as they are for other products used for the treatment of their COVID-19 patients.
Hospitals will pay no more than the wholesale acquisition cost (WAC) set by Gilead, which amounts to approximately $3,200 per treatment course. A treatment course of remdesivir is, on average, 6.25 vials.
The drug will be billed per the standard relationship between AmerisourceBergen and the receiving hospital. Hospitals that do not have an account with AmerisourceBergen should
email firstname.lastname@example.org to complete this process. Generally, patients do not pay directly for hospital administered drugs like remdesivir; rather, for Medicare and most private insurers, the drug’s cost is incorporated into payments made by the insurer.
HHS is using a portion of the $100 billion
CARES Act Provider Relief Fund to reimburse healthcare providers, at Medicare rates, for COVID-related treatment of the uninsured. Hospitals can apply for reimbursement of hospitalization costs through this program. Private insurers (including Humana, Cigna, UnitedHealth Group, and the Blue Cross Blue Shield system) have committed to waive cost-sharing payments for treatment related to COVID-19 for plan members.
The EUA for remdesivir was originally released on May 1, 2020 and allowed remdesivir, manufactured by Gilead, to be distributed and used by licensed health care providers to treat adults and children hospitalized with severe COVID-19. Severe COVID-19 was defined as patients with an oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO), a heart-lung bypass machine.
On August 28, 2020, based on the totality of scientific information available, including data that have become available since the May 1 original issuance of the EUA, the Food and Drug Administration (FDA) revised the EUA for remdesivir to broaden the scope of its authorized uses. Under the revised EUA, remdesivir is authorized for emergency use by healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients, irrespective of their severity of disease.
Remdesivir as a treatment for COVID-19 continues to be evaluated in clinical trials and is available through
expanded access and compassionate use mechanisms for certain patient populations. Preliminary results of a clinical trial supported by the National Institutes of Health suggest that the drug may be associated with faster recovery compared with patients in the study who did not receive the drug.
For more information about remdesivir and the EUA,
visit www.phe.gov. This site will be updated regularly to reflect the current state-by-state dashboard of allocations.
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