PREP Act Declaration Authorizes COVID-19 Vaccine Administration by Most Health Care Practitioners

On March 11, the U.S. Department of Health & Human Services (HHS) released its latest declaration under the Public Readiness and Emergency Preparedness (PREP) Act. Building on prior declarations, this latest amendment authorizes a broad set of health care practitioners and trainees to prescribe and administer COVID-19 vaccines nationwide, whether or not these activities fall within their normal scope of practice under state law.

The chart below lists the various classes of health care practitioners, trainees and other individuals who have been designated thus far as “qualified persons” under the PREP Act for the specific purpose of prescribing or administering COVID-19 vaccines. The sections that follow provide additional background on the PREP Act’s provisions and HHS’s use of the PREP Act to increase the pool of potential vaccinators for COVID-19 immunization efforts, including HHS’s conclusion that the PREP Act can be used to preempt state laws on scope of practice.

HHS’s COVID-19 PREP Act declarations are scheduled to remain in effect through October 2024 unless terminated sooner. HHS’s PREP Act declarations and related guidance are all available here.

Practitioners Authorized to Prescribe and/or Administer COVID-19 Vaccines Nationwide Pursuant to HHS’s PREP Act Declarations

_{^* For certain individuals, PREP Act preemption and immunity are contingent on compliance with requirements regarding training, supervision and other elements. In addition, the PREP Act generally requires that COVID-19 vaccines be administered in accordance with recommendations from the Advisory Committee on Immunization Practices (ACIP).}

_{^{^} Eligible practitioner classes include: dentist, EMT (advanced or intermediate), midwife, nurse (advanced practice registered nurse, practical nurse or registered nurse), optometrist, paramedic, pharmacist, pharmacy intern, physician, physician assistant, podiatrist, respiratory therapist or veterinarian.}

HHS’s Use of the PREP Act to Preempt State Laws on Scope of Practice

During a public health emergency, the PREP Act allows HHS to designate “qualified persons” who are shielded from liability with respect to losses arising out of the manufacture, distribution, administration or use of certain “medical countermeasures,” such as drugs, medical devices and vaccines. (See 42 U.S.C. §§ 247d–6d and 247d–6e.) In addition to shielding certain COVID-related activities from liability, HHS has issued PREP Act declarations authorizing certain individuals to perform COVID-related clinical activities that are normally restricted to certain classes of licensed health care professionals under state law.

Over the last several months, HHS has issued a number of declarations aimed at expanding the range of practitioners who may prescribe or administer COVID-19 vaccines. HHS defined classes of practitioners who may act as COVID-19 vaccinators, and also authorized vaccination activities by certain practitioners who work across state lines, whose licenses recently lapsed or who are still in training. Acting HHS Secretary Norris Cochran explained the rationale for these measures in a January 2021 press release: “As vaccine supply is made more widely available over the coming months, having additional vaccinators at the ready will help providers and state health departments meet the demand for the vaccine and protect their communities more quickly.” (The full set of current authorizations is contained in HHS’s most recent PREP Act declaration and summarized in the table above.)

HHS does not appear to have used the PREP Act in this manner before the COVID-19 pandemic. To justify these federal authorizations for activities related to COVID-19 vaccines and other “covered countermeasures,” HHS issued advisory opinions concluding that the PREP Act allows HHS to preempt state laws on scope of practice. To take pharmacists as an example, the following implications flow from HHS’s decision to designate pharmacists as “qualified persons” who may prescribe and administer COVID-19 vaccines:

• Licensed pharmacists nationwide are able to prescribe and administer COVID-19 vaccines, notwithstanding any state laws that would normally prevent them from doing so (including, for example, state laws that restrict pharmacists to administering only those vaccines that have been ordered by a physician or authorized under a statewide immunization protocol).  
• Pharmacists are shielded from liability under federal and state law for losses arising out of prescribing or administering COVID-19 vaccines.
• The Centers for Medicare & Medicaid Services (CMS) updated its Medicaid COVID-19 Vaccine Toolkit, which now directs all states to ensure that pharmacists are able to bill Medicaid for COVID-19 vaccine administration services in accordance with the PREP Act, even if the state does not normally provide Medicaid reimbursement for vaccines administered by a pharmacist. (As of the time of writing, CMS had not updated the Toolkit to address the recent PREP Act authorization for several additional practitioner types to order and administer COVID-19 vaccines.)

Practitioners Must Comply With All PREP Act Conditions

Critically, the federal protections outlined above apply only if a qualified person complies with all conditions specified in the PREP Act declaration. For example, certain individuals may be required to complete a CPR certification, an immunization training course, and/or an observation period under the supervision of a licensed practitioner. In addition, HHS generally requires that qualified persons administer COVID-19 vaccines in accordance with recommendations from the Centers for Disease Control & Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) (available here).

States Vary in Their Response to HHS’s PREP Act Declarations

Some states have fully embraced the PREP Act declarations. The Arizona State Board of Pharmacy, for example, issued a statement permitting pharmacy personnel to “follow expanded scope guidance outlined in the HHS Prep Act” declarations.

Some states, by contrast, have not issued any formal statement acknowledging the PREP Act declarations, while others have pushed back against HHS’s assertion of preemptive authority. For example, the New Hampshire Pharmacy Board concluded that HHS’s PREP Act declarations “do not preempt any provision of state law” regarding pharmacist scope of practice, thereby raising the possibility of professional disciplinary action for a pharmacist who does not abide by state laws on vaccine administration.

Meanwhile, most states have taken action under state law to enhance the ability of certain types of practitioners to order and administer COVID-19 vaccines, whether on a temporary basis (such as an Executive Order from the Governor) or on a permanent basis (through a legislative or regulatory change).

Thus, although HHS has declared that PREP Act declarations apply on equal terms nationwide, practitioners seeking to take advantage of PREP Act flexibilities may wish to consult an attorney or check for guidance from their local licensing body.