On December 3, 2020, the U.S. Department of Health and Human Services ("HHS") amended its Public Readiness and Emergency Preparedness Act ("PREP Act") Declaration for Medical Countermeasures Against COVID-19 (the "COVID-19 Declaration") in order to extend the scope of the PREP Act liability protections and to provide additional clarification to the public regarding these protections by issuing a Fourth Amendment.
Of note, the Fourth Amendment: (i) expands access to certain telehealth services during the COVID-19 public health emergency; (ii) creates a "third distribution channel" even if there is no federal agreement to cover those activities and those activities are not part of the authorized activity of an Authority Having Jurisdiction as defined in the PREP Act; (iii) clarifies that there can be situations where not administering a Covered Countermeasure to a particular individual can fall within the PREP Act; and (iv) clarifies that cases implicating the PREP Act must be adjudicated in federal court.
PREP Act Background
Under the PREP Act, the Secretary of HHS ("Secretary") is authorized to issue declarations that provide tort liability immunity to particular individuals and entities against claims of loss caused by, arising out of, relating to, or resulting from the development, manufacture, testing, distribution, administration, or use of medical countermeasures to a disease or health condition that the Secretary has deemed to be a present, or credible risk of a future, public health emergency ("PREP Act Declarations"). Specifically, "Covered Persons" who are providing "Covered Countermeasures," as those terms are defined in the PREP Act, are granted tort liability immunity. The PREP Act's broad tort liability immunity does not extend to acts of "willful misconduct" as defined in the PREP Act. Furthermore, it is important to note that a PREP Act Declaration is distinct from the Secretary's declaration of a public health emergency, as a PREP Act Declaration may provide tort liability immunity for activities both before and after a declared public health emergency.
Fourth Amendment to the COVID-19 PREP Act Declaration
On December 3, 2020, the Secretary issued a Fourth Amendment to the COVID-19 Declaration that was initially issued on March 10, 2020. For more information regarding the COVID-19 Declaration, please see our previous alert on this topic here. Some of the noteworthy changes set forth in the Fourth Amendment are highlighted below.
- Certain Telehealth Providers are Identified as
"Covered Persons." The Fourth Amendment
specifies an additional category of "Covered Persons"
under the COVID-19 Declaration. Specifically, healthcare
personnel may order and administer a "Covered
Countermeasure" through telehealth for a patient in another
state, so long as the healthcare personnel: (i) are permitted to
order and administer a Covered Countermeasure through telehealth in
a state and (ii) comply with the legal requirements of the state in
which they are permitted to order and administer the "Covered
Countermeasure" by means of telehealth.
- Third Method of Distribution of "Covered Countermeasures" is Added. In the Fourth Amendment, the Secretary amends the COVID-19 Declaration to create a "third distribution channel" that extends PREP Act coverage to additional private-distribution channels under certain circumstances. In order to qualify for this third distribution channel, "a Covered Person must manufacture, test, develop, distribute, administer, or use the Covered Countermeasure pursuant to the FDA licensure, approval, clearance, or authorization (or pursuant to an Investigational New Drug Application or Investigational Device Exemption), or the NIOSH approval." The Secretary provides the following example: "a manufacturer, distributor, program planner, or qualified person engages in manufacturing, testing, development, distribution, administration, or use of a COVID-19 test pursuant to an FDA Emergency Use Authorization for that COVID-19 test. If the Covered Person satisfies all other requirements of the PREP Act and Declaration, there will be PREP Act coverage even if there is no federal agreement to cover those activities and those activities are not part of the authorized activity of an Authority Having Jurisdiction."
- Clarifies that Non-Administration of Covered Countermeasures is Covered by the PREP Act. In the Fourth Amendment, the Secretary clarifies that "there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and this Declaration's liability protections."
- Clarifies that Cases Involving the PREP Act Must be Adjudicated in Federal Court. In the Fourth Amendment, the Secretary highlights that there are substantial benefits in having a unified response to the COVID-19 pandemic among federal, state, local, and private-sector entities. The Secretary further emphasizes that "[u]nder the PREP Act, the sole exception to the immunity from suit and liability of covered persons is an exclusive Federal cause of action against a Covered Person for death or serious physical injury proximately caused by willful misconduct by such Covered Person."
- Effective Time Period. In the Fourth Amendment, the Secretary clarifies that the COVID-19 Declaration liability protections remain in place "through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first."
Before relying upon the possibility of immunity under the COVID-19 Declaration, providers and suppliers must be aware of the circumstances under which these protections may be available.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.