What is and what isn’t covered with legislation.
The Public Readiness and Emergency Preparedness Act (PREP Act) was enacted in 2005 to provide limited liability protections to those “Covered Persons” who use “Covered Countermeasures” in response to a pandemic or epidemic. The liability protections afforded by the PREP Act are not always in effect. Instead, implementation of the PREP Act only occurs when certain public officials declare an actual public health emergency or the credible risk of a public health emergency. On March 10, Secretary of Health and Human Services Alex Azar issued just such a declaration: https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx.
Here’s a summary of what the PREP Act involves.
Who is Covered Under the PREP Act?
“Covered Persons” who are immunized include anyone authorized to “prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers.” The preamble to Sec. Azar’s Declaration specifically states that such definition includes “a licensed health professional or other individual authorized to prescribe, administer, or dispense Covered Countermeasures under the law of the state in which the Covered Countermeasure was prescribed, administered, or dispensed.”
What is Covered Under the PREP Act?
Immunity under the PREP Act only applies to “Covered Countermeasures,” but the definition of a “Covered Countermeasure” includes any drug, biologic (including vaccines), diagnostic test or other device used to treat, diagnose, cure, prevent, or mitigate COVID-19, or used to decrease the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product.
What Activities are Covered Under the PREP Act?
The PREP Act only applies to “Recommended Activities,” which are defined as “the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures.” The term “administration” is defined in the Declaration as “physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for purpose of distributing and dispensing countermeasures.
The preamble to Sec. Azar’s Declaration gives several examples of immunized activities including vaccine manufacture, inadvertent negligence in prescribing of medications by a physician, slip and fall injuries at countermeasure sites, allegations of lax security at such sites, or motor vehicle collisions relating to delivery of countermeasures. Determinations will be made on a case-by-case basis. However, if you are providing care or taking measures to diagnose or prevent COVID in your care of a patient, make sure that fact is mentioned somewhere in your patient’s chart.
What Activities are not Covered?
If an action doesn’t directly relate to COVID countermeasures, it is not immune from liability under the PREP Act. “Medical negligence” is immunized. Even “recklessness” is immunized. Any actions taken with willful misconduct are not immunized. Willful misconduct means that a person did something that should not be done and knew that the action would probably result in an unjustified injury to another person. For example, giving overdoses of medication to euthanize sick patients and “cull the herd” won’t qualify for immunity under the PREP Act … and will probably get you thrown in prison for a long time.
What Immunity is Provided Under the PREP Act?
Section 247d-6d(a)(1) of the PREP Act states that a “Covered Person” is immune from any liability under Federal or State law for any claim of loss relating to administration or use of a “covered countermeasure.” The term “loss” has a wide definition and specifically includes death; actual or feared physical, mental, or emotional injuries; and loss/damage to property. Immunity only applies if the actions occurred during the Emergency Declaration and if the countermeasure was used or administered in response to the threat specified in the Declaration (in this case, COVID).
Since powers and actions of State Medical Boards are controlled by Federal and State law and since the PREP Act immunizes any “liability” under Federal or State law, I would argue that the PREP Act also immunizes potential State Medical Board actions. Make sure that a patient’s medical record contains a reference to COVID if actions are being taken to diagnose, prevent or treat the disease.
How Long Does Immunity Under the PREP Act Last?
Immunity from liability for Covered Countermeasures begins when the Declaration was created (March 10, 2020) and lasts through the earlier of either Oct. 1, 2024 or the last day of the “emergency Declaration” that gave rise to the applicability of the PREP Act. In other words, at some point, the president will make an announcement that the COVID Emergency Declaration is no longer in effect. At that point, immunity under the PREP Act will cease. Watch the news for such an announcement.
Note that in addition to the PREP Act, governors in several states have issued executive orders providing additional immunity from liability for medical care. Contact your state’s medical society to see if those added protections may apply to you.
Do you advise any special notation in the EMR that would help to trigger this protection in the event that should become necessary? Thank you in advance.