HHS Secretary PREP Act, 3rd Declaration Impact on the Vaccines for Children (VFC) Program Frequently Asked Questions
Under section 1928(c)(1)(A) of the Social Security Act (42 U.S.C. § 1396s(c)(1)(A)), to qualify as a Vaccines for Children (VFC) program provider, a healthcare professional must be “licensed or otherwise authorized for administration of pediatric vaccines under the law of the State in which the administration occurs[.]” Subject to certain requirements, the recent Public Readiness and Emergency Preparedness (PREP) Act Declaration Third Amendmentpdf iconexternal icon (85 FR 52136, 52140) and HHS guidance authorize licensed pharmacists to order and administer—and licensed or registered pharmacy interns, along with qualified pharmacy technicianspdf iconexternal icon, to administer—ACIP-recommended vaccines to children ages three through eighteen.
Does this amendment allow such pharmacists to enroll as VFC providers for purposes of vaccinating eligible children ages three through eighteen?
State immunization programs are responsible for the VFC program and will enroll interested providers according to the needs of their state’s population and programmatic capacity. The reference in the federal VFC statute to state licensure or other authorization to qualify as a VFC provider incorporates the PREP Act Declaration Third Amendment. The PREP Act allows the Secretary of HHS to authorize non-state-authorized persons to administer or use covered countermeasures and preempts differing or conflicting state requirements. See 42 U.S.C. § 247d-6d(b)(8), (i)(8)(B). Accordingly, the PREP Act, the PREP Act Declaration Third Amendment, and HHS guidance preempt any state legal requirement that prohibits or effectively prohibits qualified pharmacists from ordering and administering, and licensed or registered pharmacy interns, along with qualified pharmacy technicians, acting under the supervision of a state-licensed pharmacist from administering, the designated vaccinations. Therefore, states cannot rely on section 1928(c)(1)(A) of the Social Security Act as a basis for denying a pharmacist enrollment as a VFC provider, if a state law governing licensure or authorization for administration of pediatric vaccines has been preempted by the Declaration and the PREP Act, and the provider meets the conditions specified in the Third Amendment to the Declaration.
How does the PREP Act declaration impact pharmacy enrollment in the VFC program?
The recently announced HHS expansion of pharmacist delivery of childhood vaccine does not change current VFC policy related to pharmacy enrollment aside from preempting state law that would preclude certain pharmacists, and pharmacy interns and technicians, from providing vaccinations to children three years of age and older. The preemption of state law under the PREP Act declaration is expected to remain in effect through the term of the COVID-19 public health emergency.
Do awardees need to get CDC approval prior to enrolling pharmacies in the VFC program?
No. Prior approval from CDC is not required to enroll a pharmacy in the VFC program. Pharmacies may participate in the VFC program depending on their jurisdiction’s VFC policies. Please contact your state, local, or territorial immunization program for further details.
Should pharmacy interns and technicians be documented as providers practicing at this facility in the VFC provider agreement?
No. The provider agreement only requires provider sites to list all licensed healthcare providers (MD, DO, NP, PA, pharmacist) at each facility who have prescribing authority. This would not include RNs, MAs, or pharmacy interns or technicians.
Do pharmacies have to enroll in the VFC program to vaccinate children 18 years and younger with COVID-19 vaccine?
No. The VFC program and the COVID-19 vaccination program are currently separate programs, and each currently has its own enrollment requirements. Pharmacies will have to enroll in the COVID-19 vaccination program to vaccinate individuals age 3 years and older with COVID-19 vaccine.