Fourth Amendment to PREP Act: Expansion of Telehealth and Legal Liability Protections

On December 3rd, the U.S. Department of Health and Human Services (“HHS”) released the Fourth Amendment to the Public Readiness and Emergency Preparedness Act (“PREP Act”). The Fourth Amendment bolsters immunities by establishing legal liability protections to private distribution channels, telehealth providers, and for prioritization decisions.

Private Distribution Channels 

Previously, the PREP Act extended immunity to business, manufacturers, and healthcare providers that produced goods and services covered under the PREP Act pursuant to a contract with the Federal government or other “Authority having Jurisdiction,” defined as “federal, state, local, and tribal authorities and institutions or organizations acting on behalf of those governmental entities.” The Fourth Amendment seeks to extend the protections to private distribution channels. It should be noted that this protection is only effective for conduct on or after December 3, 2020.

Telehealth Providers

The Fourth Amendment authorizes healthcare professionals using telehealth to order and administer Covered Countermeasures. A provider can now order and administer a diagnostic test that received emergency use authorization for patients in a state other than the state where the provider is licensed. Some states have already authorized this practice, but others have not. Therefore, this Amendment preempts state law that prohibits or limits a provider ordering or administering a Covered Countermeasure through telehealth, so long as the provider is licensed.

Training Requirements for Certain Licensed Pharmacists and Pharmacy Interns

The Fourth Amendment modifies the training requirement for certain licensed pharmacists or pharmacy interns to administer specified routine childhood and COVID vaccinations. For ordering and administration of the vaccine, the licensed pharmacy must have completed State licensure immunization training that is required for pharmacy to administer vaccines. In the instance a State does not have specified training requirements, the pharmacist must complete a minimum of twenty (20) hours of vaccination training approved by “Accreditation Counsel for Pharmacy Education (ACPE).” 

Prioritization Decisions

HHS recognizes and addresses many of the realities that have emerged with COVID-19, especially by offering a pathway for immunity based on prioritization decisions. Specifically, liability protections are expanded for “not administering a Covered Countermeasure to one individual in order to administer it to another individual.” 

The Fourth Amendment explains decision making with dose allocation of the vaccine such as administering the COVID-19 vaccination to an individual “who is more vulnerable to COVID-19.” In this situation, “prioritization or purposeful allocation of a Covered Countermeasure, particularly if done in accordance with a public health authority’s directive, can fall within the PREP Act and this Declaration’s liability protections.”

Other Notable Additions

The Fourth Amendment clarifies and defines certain words and actions in the PREP Act. For example, Covered Countermeasures in Section VI of the Declaration is defined as “cover[ing] all qualified pandemic and epidemic products under PREP Act.” 

Next, HHS clarified that the PREP Act Declaration and Fourth Amendment “must be construed in accordance with the Advisory Opinions.” HHS Office of General Counsel issued four advisory opinions that previously stated the guidance was not legally binding. However, the Fourth Amendment clarifies the “Secretary expressly incorporates the Advisory Opinions for that purpose.” 

Furthermore, the Fourth Amendment references the “substantial federal legal and policy issues, and substantial federal legal and policy interests, in having a unified, whole-of-nation response to the COVID-19 pandemic among federal, state, local, and private-sector entities.” For COVID-19 litigation efforts, this increases the likelihood of successful removal of state law claims and assertion of federal jurisdiction. 

Lastly, HHS extended the timeframe for immunity “an additional 12 months” under the Act “through the final day the Declaration of Emergency is in effect or October 1, 2024, whichever occurs first.”

Takeaways

As hard decisions in administering the vaccine become a reality, entities can rest assured that the purposeful allocation and prioritization decisions by not administering a Covered Countermeasure can fall within liability protection. Additionally, these Covered Countermeasures can be administered through telehealth. By preempting the burdensome telehealth licensure requirements, there is more flexibility to use telehealth to screen patients for COVID-19 or for other Covered Countermeasures. Lastly, the previous four Advisory Opinions on the PREP Act now serve as a useful tool of advice that should be construed with the Amendments.