HHS expands access to COVID-19 countermeasures in PREP Act declaration
The new amendment to the Public Readiness and Emergency Preparedness Act declaration aims to open more pathways for telehealth use and distribution of the COVID-19 vaccine
By Laura French
WASHINGTON — The Department of Health and Human Services (HHS) has issued an amendment to the 2020 Public Readiness and Emergency Preparedness Act (PREP Act) declaration to increase access to COVID-19 countermeasures.
The amendment, issued Thursday, is the fourth amendment to the declaration, which provides immunity from liability for providers administering certain countermeasures during the COVID-19 pandemic.
“During the pandemic, the Trump Administration has made broader use of the PREP Act to expand access to potentially life-saving countermeasures than we’ve ever done before in a public health emergency,” said HHS Secretary Alex Azar in a statement. “This new use of the PREP Act will help expand access to important services via telehealth, increase availability of authorized PPE, and make it easier to administer eventual COVID-19 vaccines.”
The new PREP Act declaration amendment:
- Authorizes healthcare personnel using telehealth to order or administer covered countermeasures, such as a diagnostic test that has received an Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA), for patients in a state other than the state where the healthcare personnel are already permitted to practice.
- Provides an additional pathway to satisfy the declaration’s Limitations on Distribution section, giving covered persons immunity if they use on-label covered countermeasures licensed, approved, cleared or authorized by the Food and Drug Administration (FDA), or permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption, to combat the COVID-19 public health emergency.
- Provides a new pathway for immunity for covered persons who use respiratory protective devices approved by NIOSH that the secretary of HHS determines to be a priority for use to combat the COVID-19 public health emergency.
- Clarifies the scope of PREP Act immunity in various ways. For instance, the amendment makes explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and the declaration’s liability protections. This could apply to a COVID-19 vaccine being administered to one person instead of another based on each person's relative vulnerability to COVID-19.
Read the full amendment on the HHS Public Health Emergency website.