Additional PREP Act Amendments Accommodate Vaccination Administration Needs

Morgan Lewis - Health Law Scan
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Morgan Lewis - Health Law Scan

Given the significant push to vaccinate the public since the start of 2021, the increasing availability of vaccines, and the need to recruit additional personnel to administer vaccinations, the secretary of the US Department of Health and Human Services (HHS) has again amended its declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to accommodate some workforce barriers that had not been previously contemplated.

Several times since the beginning of 2021, the secretary has cited an “urgent need to expand the pool of COVID-19 vaccinators to respond effectively to the pandemic” as the rationale for issuing multiple amendments to the PREP Act declaration focused exclusively on expanding workforce personnel in the fight against the pandemic.

The PREP Act authorizes the HHS secretary to issue a declaration to provide immunity from liability against claims of losses resulting from a “covered countermeasure.” We have previously reported on the issuance of the original PREP Act declaration and the multiple amendments issued since the original PREP Act declaration by HHS with respect to COVID-19; see The PREP Act: Considerations for Healthcare Providers and HHS Expands PREP Act Liability Immunity. The declaration, as amended, provides broad immunity from liability to covered persons engaged in activities such as the manufacturing, distribution, or administration of a COVID-19 vaccine that has received emergency use authorization (EUA) or approval from the US Food and Drug Administration (FDA).

The latest Fifth, Sixth, and Seventh Amendments added Subsections (g) and (h) to the original Prep Act declaration, with the express goal of reducing personnel or workforce barriers to further rapid vaccine administration across the United States.

Issued on February 2, 2021, the Fifth Amendment ensures that healthcare professionals can cross state lines to administer vaccinations without fear of violation of any state licensing or other prohibition. This amendment authorizes “any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer vaccines under the law of any State” to administer COVID-19 vaccines in any other state in association with an effort by a governmental authority to administer vaccines. So long as the individual’s license or certification is not otherwise otherwise suspended or restricted by a state licensing authority or surrendered in some fashion, the PREP Act protection from liability will apply. Any contrary state law is preempted.

To fit within the protection offered by the Fifth Amendment, individuals must show completion of the Centers for Disease Control and Prevention (CDC) COVID-19 Vaccine Training modules. For those healthcare professionals not actively in practice, documentation of an observation period by a currently practicing healthcare professional adequately experienced in vaccination who confirms the competency of the healthcare professional is required.

The Sixth Amendment to the declaration adds additional qualified personnel to the category of qualified persons covered under the PREP Act. This amendment expands PREP Act protection to any federal government employee, contractor, or volunteer who would distribute or dispense COVID-19 vaccines. This expansion appears to ensure that individuals who otherwise would not be covered receive the liability protection afforded by the PREP Act, “even if those authorized duties or responsibilities ordinarily would not extend to members of the public or otherwise would be more limited in scope than the activities” that such individuals would normally be authorized to carry out. Again, any contrary state law is preempted.

Finally, the Seventh Amendment to the PREP Act declaration, issued on March 16, 2021, seeks to further expand vaccinations by extending PREP Act protection to midwives, paramedics, advanced or intermediate emergency medical technicians (EMTs), physician assistants, respiratory therapists, dentists, podiatrists, optometrists, and veterinarians administering COVID-19 vaccines.

In all circumstances, the additional personnel must be administering a vaccine authorized for use by the FDA and should be administering the vaccination in accordance with the recommended guidelines produced by the Advisory Committee on Immunization Practices (ACIP). Additionally, documentation must be available illustrating that an observation period occurred in which a currently practicing healthcare professional experienced in administering intramuscular injections confirmed the competency of the healthcare provider or student. All personnel must be appropriately certified or licensed in their home state.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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