Clinicians who continue administering vaccines that have been removed from the Centers for Disease Control and Prevention's recommended schedule face minimal legal liability and should experience no immediate disruption to insurance reimbursement, according to legal and policy analysis published in JAMA.

The guidance arrives as the newly reconstituted Advisory Committee on Immunization Practices (ACIP) and the CDC have issued a series of decisions that depart sharply from established scientific consensus. The analysis, authored by Michelle M. Mello, JD, of Stanford University School of Medicine and Stanford Law School; Rochelle P. Walensky, MD, of Massachusetts General Hospital and Harvard Medical School; Michael T. Osterholm, PhD, of the Center for Infectious Disease Research and Policy at the University of Minnesota; and Troyen A. Brennan, MD, of Harvard T.H. Chan School of Public Health, addressed the practical questions confronting physicians and pharmacists in this fractured guidance environment.

Federal Vaccine Policy: A Timeline of Disruption

In June 2025, the Department of Health and Human Services secretary replaced all 17 ACIP members with new appointees. The reconstituted committee subsequently reversed several longstanding recommendations: removal of thimerosal-containing multidose influenza vaccines (June/July 2025), elimination of the measles-mumps-rubella vaccine combination option for the first dose in children younger than 3 years (September 2025), and replacement of routine hepatitis B vaccination for newborns with "shared clinical decision-making" if the pregnant mother's test results for hepatitis B surface antigen are negative (December 2025).

The December hepatitis B decision placed ACIP in direct conflict with greater than 45 medical societies—led by the American Academy of Pediatrics (AAP) and including the American Academy of Family Physicians (AAFP), the Infectious Diseases Society of America (IDSA), and the American College of Obstetricians and Gynecologists (ACOG)—all of which reaffirmed support for universal hepatitis B vaccination at birth.

The January 2026 action bypassed standard processes entirely. "In early January 2026, the administration took another destabilizing action without any ACIP meeting, public discussion, or consultation with career experts at the CDC," the researchers wrote. Two HHS officials urged the CDC to remove multiple vaccines from routine pediatric recommendations: hepatitis A and B, meningococcus, rotavirus, respiratory syncytial virus, influenza, and COVID-19. The evidence "assessment" offered as justification "focused heavily on issues of public trust and what other countries require—not the 'scientific, evidence-based, data-driven' analysis it promised," according to the researchers.

Malpractice Risk Assessment

The core legal analysis concluded that clinicians who continue following established specialty society recommendations face no meaningful increase in liability exposure. "The lodestar for negligence determinations is reasonableness, which is heavily informed by customary practice," the researchers explained. When authoritative guidelines diverge, "adherence to any can be considered reasonable." The legal standard is further clarified: "where 2 clinical approaches are each followed by a sizeable number of respectable clinicians, both meet the legal standard of care."

Clinicians defending against potential claims can point to guidelines from multiple authoritative professional societies and the underlying medical evidence. "Continuing to follow an established standard of practice is not negligent merely because a new standard is endorsed by some bodies," the researchers stated. While litigation costs remain a consideration, "the rarity of injury and difficulty of proving causation make successful claims unlikely."

A separate concern involves the National Vaccine Injury Compensation Program (VICP), which covers vaccines recommended by the CDC for routine use in children or during pregnancy. A shorter recommended list could theoretically increase civil litigation exposure. However, the VICP's liability shield extends to vaccine administrators, covering both vaccine-related injuries and those caused by the vaccination process itself, such as shoulder injury related to vaccine administration. Plaintiffs in civil suits would need to prove negligence—a requirement not present in VICP proceedings—which the researchers characterized as difficult to establish.

Insurance and Payment Landscape

Private insurance coverage appears stable through at least the end of 2026. America's Health Insurance Plans and the Blue Cross Blue Shield Association pledged that member plans will continue covering vaccinations on ACIP's list as of September 2025 without cost-sharing. The researchers anticipated continued coverage from commercial insurers beyond 2026 "because costs are relatively small, vaccines are among the most cost-effective interventions in health care, and their coverage decisions have long relied heavily on specialty society expertise."

State actions may further insulate vaccine access. As of September 2025, 13 states had enacted requirements for insurers to cover COVID-19 vaccinations following federal requirements being called into question. The formation of the Northeast Public Health Collaborative and the West Coast Health Alliance—regional bodies intended to supplant ACIP recommendations with guidance harmonized with medical societies—suggests additional state-level responses may emerge.

Federal payment programs present more complex considerations. Medicare Part B covers pneumococcal, hepatitis B, influenza, and COVID-19 vaccinations with no cost-sharing, and these requirements are not linked to ACIP. However, Medicare Part D bases its no-cost coverage requirement on ACIP's list. The Vaccines for Children (VFC) program, which has provided cost-free vaccines to under- and uninsured children and those with Medicaid coverage since 1994, operates from a list ACIP established specifically for the program. When ACIP changes recommendations, it must vote on a resolution to make a corresponding change in VFC coverage—a step not taken in the January 2026 decision.

"The CDC's decision in January 2026 to shrink its list of recommended vaccines did not involve ACIP, and, thus far, the administration has stated that VFC and Medicaid coverage will not change," the researchers noted, adding that this "position—mentioned only in a fact sheet, not in the CDC's decision memorandum—could change at any time."

Pharmacy Administration Considerations

State scope-of-practice laws introduce additional complexity for pharmacist-administered vaccines. Some state statutes specify that pharmacists may only administer vaccines recommended by ACIP or the CDC. The researchers cited West Virginia's statute as an example that "invites interpretation by authorizing vaccinations 'in accordance with definitive treatment guidelines for immunizations promulgated by the latest notice from the CDC.'" Changes to the CDC schedule could therefore effectuate greater restrictions on pharmacist vaccinations in certain jurisdictions.

Several states responded by creating their own lists of approved vaccinations, drawing on recommendations from the AAP and AAFP or prior ACIP lists.

Patient Counseling Implications

The "shared clinical decision-making" designation for certain vaccines—notably hepatitis B—signals a lower level of ACIP confidence about the risk-benefit balance but does not impose new informed consent requirements beyond those already mandated under federal law, which requires clinicians to provide a CDC-created information sheet on vaccine risks and benefits prior to administration.

The researchers acknowledged that clinicians may encounter "greater surprise or resistance from parents who have heard that the vaccines in question are no longer CDC-recommended or required by their state for school entry." They recommended that clinicians "provide opportunities for dialogue and be prepared with a comprehensible explanation of why they continue to recommend vaccines, emphasizing the stability of the underlying scientific evidence and continued support from medical societies."

Recommendations for Practice

The researchers' concluding guidance was direct: "Changes to the vaccines recommended by ACIP and the CDC need not, and should not, substantially affect clinical practice." They advised clinicians to monitor payment changes but otherwise maintain current practices: "Going forward, clinicians should stay abreast of payment changes but feel confident in continuing to recommend and administer vaccines in accordance with unswerving professional consensus."

The most significant outstanding concern involves federal programs. "More concerning is the prospect of restrictions on payment by Medicare, Medicaid, and the VFC program, although that appears stable for now," the researchers wrote.

State Medicaid programs considering contingency plans should note that if VFC coverage is removed for specific vaccines, states would have the option to continue coverage as an optional benefit, though doing so would require federal oversight and potentially a waiver provision for cost-free vaccination—with the state bearing the entire cost.

Disclosures can be found in the published perspective.

Source: JAMA