HHS Amends PREP Act Declaration, Expands Access to COVID-19 Countermeasures Via Telehealth
On December 3, the U.S. Department of Health and Human Services (HHS) issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to critical countermeasures against COVID-19.
The fourth amendment to the PREP Act will help expand access to important services via telehealth, increase availability of authorized personal protective equipment (PPE), and make it easier to administer eventual COVID-19 vaccines.
Key Expansions Made by the Fourth Amendment
Among other things, the fourth amendment to the PREP Act will:
Authorize 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. (While many states have decided to permit healthcare personnel in other states to provide telehealth services to patients within their borders, not all states have done so.)
Provide an additional pathway to satisfy the Declaration’s Limitations on Distribution section. Now covered persons have immunity under the PREP Act if they use on-label covered countermeasures licensed, approved, cleared, or authorized by the FDA (or that are permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption) to combat the COVID-19 public health emergency, without satisfying the Declaration’s other Limitations on Distribution, such as having an agreement with the federal government.
Provide a new pathway for immunity under the PREP Act for covered persons who use respiratory protective devices approved by NIOSH that the Secretary determines to be a priority for use to combat the COVID-19 public health emergency, without satisfying the Declaration’s other restrictions, such as having an agreement with the federal government.
Expand the scope of PREP Act immunity to cover potentially more healthcare providers who could administer COVID-19 and other vaccines by modifying and clarifying what CPR and other training is required for certain pharmacists, pharmacy interns, and pharmacy technicians to order or administer childhood or COVID-19 vaccines pursuant to the PREP Act declaration.
Clarify 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. The amendment also incorporates the HHS Office of the General Counsel’s advisory opinions concerning the PREP Act and Declaration.
HHS Press Release on the Fourth Amendment to the PREP Act outlines the authorizations of the fourth amendment and provides an informative question and answer section.
PREP Act Homepage contains background information on the PREP Act, the initial declaration for COVID-19, and the previous three amendments that have been made since the use of the PREP Act was declared on March 17, 2020.
Federal Register Notice for the Fourth Amendment to the PREP ACT contains the republished declaration and notice of amendment.