Given the intensifying politicization of COVID vaccines, the Secretary of Health’s overt statements about physician liability protection, as well as concerns that some malpractice carriers he indicated that they will exclude COVID related claims, there are additional liability concerns with COVID vaccines specifically.
Do malpractice protections in the PREP Act apply to off-label use of the COVID vaccine?There is a reasonable argument that the immunity provisions of the PREP Act would not apply because administration of the COVID vaccine to healthy children is not authorized by the FDA. The courts will he to rule on this key issue.
Is the malpractice risk the same for the pediatrician who writes a prescription for COVID vaccine for administration elsewhere versus a pediatrician who is administering COVID vaccine in their office? Should medical record documentation be the same in both situations?Yes, the malpractice risk is the same, except for claims that relate specifically to the administration of the vaccine product. Clinical documentation by the ordering physician should be the same whether a prescription is provided or the vaccine is administered.
If my state has a directive recommending administration and insurance coverage for COVID vaccines that goes beyond the FDA label, does this change my liability risk?Generally speaking, state laws or policies that affirm the decision to vaccinate strengthen the provider’s defense that they followed applicable standards of care. However, this does not preclude attempts by litigious parties to initiate potential civil litigation or disciplinary proceedings. It is also possible that a carrier may not cover these claims or provide a defense against them, unless state law explicitly states otherwise.
My liability carrier has a specific clause stating it only covers FDA approved treatments. Is there a difference in liability risk if a product is approved for use in children but for a different indication vs. not being approved in children at all? Would you interpret a clause that “only covers FDA approved treatments” to apply to the current COVID vaccine recommendations in children who are not at higher risk for severe illness?This is a very subjective analysis. While it is reasonable to argue that approval for one group could mean off-label use in this instance should be covered; however, an insurance carrier could maintain that this amounts to an exclusion.
Should pediatricians be obtaining informed consent prior to administration of COVID vaccine for patients who do not he high risk conditions? What about for patients who he high risk conditions?Informed consent is necessary for all clinical interactions with patients including vaccines. Every procedure or medication prescription should include a discussion of the risks, benefits and alternatives to the proposed course of action. Signed informed consent should be considered particularly for patients who receive the vaccine for “off label” indications; this includes patients who do not he high risk conditions. For patients who he high risk conditions, there is alignment with FDA labels, so a signed informed consent is not needed. The clinician's discussion with the patient/family should be documented in the medical record whether or not a consent form is used.
Given the CDC signed off on the ACIP recommendations for shared clinical decision making for COVID vaccines in patients between 6 months – 64 years of age, does this lessen potential liability risk for pediatricians? Is a signed informed consent still necessary?This does lessen the risk of liability greatly; however, the FDA label does not include an indication for healthy children. It is important for a provider to consider risk tolerance when deciding whether to ask patients/caregivers to sign an informed consent.
Is it important to call this an “informed consent” or can this be called something else such as a “waiver”?Yes. The goal is to document informed consent to minimize the prospect of provider liability rather than to legally waive it. While a waiver would theoretically limit responsibility, it does not account for documenting patient/caregiver understanding of medical risks. It is also important to consider the appearance of impropriety in asking a patient to sign a liability waiver specifically for the COVID vaccine.
Is there any requirement about the type of provider that is allowed to he the conversation with the parent/caregiver to meet the definition for Shared Clinical Decision Making?This is entirely dependent on state scope of practice laws, specifically those laws dictating the parameters of patient counseling under standing orders or other arrangements.
Will adolescents be allowed to consent to COVID vaccine administration?In some states a minor can themselves consent while in others a parent or legal guardian must consent. Some states also require that a minor child of a certain age consent along with a parent or legal guardian. This is highly state-specific and forms should be designed accordingly.
Given the CDC recommendation for Shared Clinical Decision Making, do you recommend that specific language be included in medical record documentation? If so, is there any template language that can be provided.Yes. Documentation is recommended that discussion about the vaccine occurred and a decision to vaccinate followed shared clinical decision making. The patient’s desire to receive the protection of vaccination should be adequate, however, notating any additional benefit to the patient is also helpful. The following dot phrase (template language) can be used as a guide:
The patient/caregiver and I engaged in shared clinical decision-making about the benefits and risks of the 2025-2026 COVID-19 vaccine. This discussion included an opportunity for them to ask questions. No contraindication to vaccination was identified, and the patient/caregiver and I collaboratively determined the patient would benefit from vaccination. A COVID-19 vaccine was ordered in the context of shared clinical decision making and educational materials were provided.
Where applicable for patients with underlying conditions add: The patient has ________(indicate underlying condition).
States he changed vaccine exemption laws and he released language regarding civil rights and vaccine requirements. Are there any concerns with practice policies that dismiss patients for not following the recommended vaccine schedule (not COVID-specific)?This is dependent on state requirements. A practice must carefully consider risks of dismissing patients based on their state guidance against the risks of retaining a patient who may put others in their practice at risk.
Currently under the ACA, payers and VFC must cover vaccines on the CDC schedule. Are they legally bound to cover these vaccines, even if they are not administered at the specific age that the CDC schedule recommends? For example, if the CDC schedule no longer recommends a Hepatitis B vaccine birth dose, but recommends it at a later age, would payers be legally bound to pay for this immunization if given shortly after birth?ACA-regulated markets and VFC are different. Under VFC, participating providers are legally bound to follow the ACIP schedule when administering VFC doses. Payers bound by ACA requirements are permitted to manage utilization within the parameters of ACIP recommendations, so their payment policies typically align with the timing on the CDC schedule.