Fifth PREP Act Declaration Amendment Expands Eligible COVID-19 Vaccination Providers

The Department of Health and Human Services ("HHS") issued a Fifth Amendment to the Declaration under the Public Readiness and Emergency Preparedness (PREP) Act on January 28, 2021. The new Amendment greatly simplifies options for companies and healthcare providers trying to manage vaccination administration programs staffed by healthcare providers from other states.

Under the new Amendment, the definition of "eligible persons" is expanded to include:

• Healthcare providers who may not be licensed in the state where they are administering the vaccines. Specifically, any healthcare provider who is licensed or certified in a state to prescribe, dispense, or administer COVID-19 vaccines may provide those services in any other state without obtaining a new professional license in the other state.

• Physicians, registered nurses, and practical nurses whose licenses expired within the past five years. These individuals have the professional expertise and training to prescribe, dispense, or administer COVID-19 vaccines. The Fifth Amendment authorizes them to do so in any state as long as the person's license or certification was active and in good standing prior to the date it went inactive.

In order to qualify, people under either category must complete the CDC COVID-19 vaccine training. In addition, on-site observation is required for a transition period for anyone who is not currently practicing or whose license or certification expired.

Simplifies Staffing Plans & Closes Existing Gaps

From the initial PREP Act Declaration March 17, 2020 through today, finding a path for simplifying and expanding access to COVID-19 testing and vaccines has required multiple iterations. In particular, the Third Amendment to the Declaration expanded prescribing and testing authority to pharmacists, and the Fourth Amendment declared preemption of state licensure laws and other state laws that impede telehealth providers. The license preemption did not apply to personnel administering vaccines outside of the states where they are licensed, creating a gap that has contributed to the slowness of vaccination rollout. HHS's Fifth Amendment now has addressed that gap, extending licensure preemption to any healthcare provider administering the COVID-19 vaccine for whom vaccine administration is authorized by their licensure. For companies with personnel in multiple states, such as pharmacy chains, health clinics, and regional providers of all kinds, this will make it much easier to comply with the law while also being able to flexibly staff vaccination efforts across broader geographic areas.

HHS has gathered the initial Declaration, all five Amendments, plus the HHS General Counsel advisory opinions and related HHS guidance on one webpage. The arc of the evolution of the Declaration and related policies has included:

• March 17, 2020 - Declaration initiates liability immunity for authorized countermeasures against COVID-19 if they are undertaken by covered persons. Countermeasures are broad and include drugs or devices, tests to diagnose the illness, treatments for the illness, and vaccinations. The covered persons described include, among others, manufacturers, distributors, and persons qualified to prescriber, administer, deliver, distribute, or dispense countermeasures.

• April 15, 2020 - First Amendment to the Declaration made several changes to the original Declaration to expand definitions of covered countermeasures and make other changes to improve consistency with countermeasures authorized under the CARES Act.

• June 8, 2020 - Second Amendment to the Declaration to further expand what qualifies as a "covered countermeasure," specifically to add items that "limit the harm COVID-19 might otherwise cause." This reflects language that appears in the statute and was inadvertently omitted from the original Declaration and First Amendment.

• August 24, 2020 - Third Amendment to the Declaration is where things became more interesting in regards to the "qualified persons" covered by the PREP Act. As noted above, qualified persons are a category of covered person under the Act who are generally immune from suit under federal and state law with respect to certain claims arising from administration or use of the countermeasures. Up to this point, Amendments had been used primarily to refine what qualified as a countermeasure. Countermeasures include specific items, such as tests for diagnosing COVID-19, and the language added by the Second Amendment regarding "limiting harm." Now, the pivot was to expand who are the qualified persons and to add countermeasures that are not directly tied to COVID-19 itself but that are still within the scope of HHS's authority to limit harm caused by the pandemic. Specifically, the Third Amendment (i) preempted any state requirements that did not allow licensed pharmacists and qualified pharmacy interns to prescribe and administer vaccines (including the COVID-19 vaccine) and (ii) acknowledging a significant decrease in well-child visits and routine childhood vaccinations due to people avoiding coronavirus exposure, as well as the need for current childhood vaccinations to support reopening efforts, added the ACIP-recommended vaccinations to covered countermeasures. There are training and other related requirements detailed in the Amendment.

• December 3, 2020 - Fourth Amendment to the Declaration continued to seek practical approaches to address challenges faced by healthcare providers and the public as the public health emergency continued. Among other things, this Amendment (i) expanded "qualified persons" again, to include healthcare personnel using telehealth to order or administer covered countermeasures for patients in states other than the state where the telehealth provider is licensed to practice, and (ii) modified training and recordkeeping requirements for the pharmacists authorized under the Third Amendment to administer vaccines (including the COVID-19 vaccine). The licensure waiver did not extend to other types of healthcare providers. As a result, it became apparent during the COVID-19 vaccine rollout over the past several weeks that a gap existed - professional state licensure requirements in states that did not provide waivers for vaccine administration continued to stymie efforts to adequately staff vaccination programs and expand capacity quickly. The PREP Act preemption for telehealth services was helpful, but not expansive enough to reach vaccine administration.

• January 28, 2021 - As discussed above, the Fifth Amendment to the Declaration has significantly addressed the gap in access to qualified and trained personnel by further expanding the definition of "qualified person" to include in general healthcare providers who have the expertise and training but perhaps not the state license in the state that needs them the most at a given moment. The Fifth Amendment also smartly includes confirmation that, even though the state licensure flexibility now exists, the requirements applicable to pharmacists administering vaccines under the sections of the Declaration created by the Third and Fourth Amendments continue to apply, such as the training and recordkeeping requirements that were previously established.

Given the drawn out public health emergency and Biden administration's stated focus on improving the national response, it is possible this new Amendment will be followed by others as barriers or new needs emerge that could be appropriately ameliorated through use of the PREP Act.

For more information on the PREP Act or any of the Amendments, please contact your Quarles & Brady attorney or:

• Katea M. Ravega: (317) 399-2849 / katea.ravega@quarles.com
• Roger N. Morris: (602) 229-5269 / roger.morris@quarles.com
• Nicholas H. Meza: (602) 229-5439 / nicholas.meza@quarles.com