Understanding the Changing Vaccine Landscape

ACIP is an expert advisory body that supplies the CDC with recommendations on appropriate vaccine use. Once adopted by the CDC, these recommendations have broad ripple effects for health coverage and other policy areas, including many areas of state policy.

Some healthcare stakeholders have expressed concern about defaulting to CDC recommendations in light of recent events such as:

• Department of Health and Human Services Secretary Robert F. Kennedy Jr. firing and replacing the entire slate of ACIP membership, including new members who have expressed skepticism about CDC’s prior recommendations.
• Recently ousted CDC Director Susan Monarez testifying to Congress that Secretary Kennedy plans to revisit the list of recommended vaccines for kids and teens.
• Remarks from both Secretary Kennedy and President Trump suggesting that pediatric vaccines cause autism—a claim that has been repeatedly debunked.

At its Sept. 18-19 session, ACIP voted on two modest changes to its existing recommendations:

• Continuing to recommend COVID-19 vaccination for everyone over 6 months of age, but downgrading the recommendation from routine use to “shared clinical decision-making,” meaning each individual should make a choice after consulting their provider.
• Strengthening its recommendation that children under age 4 receive two separate vaccinations for varicella (chickenpox) and for measles, mumps and rubella. Previously, ACIP allowed the option of a combination MMRV vaccine, while noting it was not preferred.

ACIP also considered a more significant proposal to delay the initial dose of hepatitis B vaccine for newborns but opted to delay a vote until a future meeting.

To guide healthcare providers, some professional associations like the American Academy of Pediatrics have released their own vaccine recommendations based on their independent assessment of the medical evidence.

Some states have decided to follow suit, including coalitions of Pacific and Northeastern states that will develop vaccine recommendations. Some states have also announced ad hoc policies seeking to preserve access to COVID-19 and other vaccines in response to ACIP’s updated recommendation and the Food and Drug Administration’s narrowed approval of this year’s COVID-19 booster.

As states revisit their vaccine policies, each of the following policy areas presents opportunities for states to apply their own vaccine recommendations alongside the CDC’s.

Health coverage for vaccines: Under federal law, CDC-recommended vaccines must be covered without cost sharing across all major payers, including Medicaid, Medicare and commercial plans. This coverage requirement includes recommendations for shared clinical decision-making. Thus, if the CDC adopts ACIP’s latest recommendations, all payers would remain obligated to cover COVID-19 vaccines, but payers could choose to limit coverage for combination MMRV vaccines for children under 4.

Notably, CDC recommendations establish a floor, but not a ceiling. Ahead of ACIP’s September meeting, the health plan association AHIP announced that its member plans would continue to cover all vaccines under CDC’s pre-September recommendations, through at least the end of 2026.

In Medicaid and the Children’s Health Insurance Program (CHIP), states can choose to cover additional vaccines beyond the federal baseline. Depending on the language in their current state plan, states may or may not need to seek federal approval for an amendment. Some states may already have reserved authority to supplement coverage by, for example, providing for coverage of vaccines “including” those recommended by CDC, or by reserving authority to modify the scope of coverage for preventive services by adding or removing services from the fee schedule.

Meanwhile, under the federal standard for Early and Periodic Screening, Diagnosis and Treatment for Medicaid-covered children and youth under age 21, states must cover any service—vaccine or otherwise—deemed medically necessary for a particular individual. That could include vaccines beyond those on the CDC’s immunization schedule.

States can similarly enhance minimum vaccine coverage in state-regulated private health plans and state employee health plans, and can encourage large-group employer plans to follow suit.

VFC and other vaccine procurement programs. Restrictive ACIP/CDC recommendations could limit vaccine distribution under two key federal programs:

• VFC, through which the CDC supplies vaccines free of charge for providers to administer to children who are covered by Medicaid (but not CHIP), uninsured, underinsured, or American Indian/Alaska Native. To implement ACIP’s recent vote, VFC will continue supplying COVID-19 vaccine, but would limit MMRV vaccine to patients age 4 and up. (As noted above, state Medicaid programs can choose to cover vaccines not available through VFC.)
• CDC provides grants under Section 317 of the Public Health Services Act, through which states can purchase CDC-recommended vaccines for uninsured and underinsured adults. COVID-19 and MMRV vaccines will continue to be available under Section 317.

Some states operate their own “universal purchase” programs funded by state revenues (often generated in part by an excise tax on health plans). The programs may complement VFC by furnishing vaccines for privately insured children, and perhaps also for adults. States can use these programs to provide all CDC-recommended vaccines as well as additional vaccines beyond the CDC’s recommendations (and therefore not available through VFC or 317 grants).

Pharmacist vaccination authority: Pharmacies have become a crucial site for vaccine access, particularly for seasonal vaccines like COVID-19 and influenza. Through an existing federal declaration under the Public Readiness and Emergency Preparedness (PREP) Act, the Department of Health and Human Services has authorized pharmacists nationwide to order and administer COVID-19 vaccine and adult flu vaccine — subject to compliance with CDC’s recommendations and the vaccine uses approved by the FDA. There has been confusion in some states as to how this PREP Act declaration is affected by CDC’s evolving recommendations and FDA’s narrowed approval for the latest COVID-19 booster.

In general, each state decides which vaccines a pharmacist is authorized to administer, whether a prescription or standing order is required, and whether pharmacy technicians and interns are permitted to administer vaccines under pharmacist supervision.

Many of these state laws automatically incorporate CDC’s recommendations, although states vary in how they interpret recommendations with shared clinical decision-making, as well as newly adopted recommendations that have not yet been codified in CDC’s official immunization schedules.

In addition, some states expressly reserve authority to authorize vaccinations beyond those recommended by CDC, including through swift subregulatory processes like statewide standing orders. States could also look to vaccine recommendations issued by the newly established multistate consortia.

Several states have announced policies to ensure that pharmacists remain able to administer COVID-19 vaccines without a prescription, notwithstanding recent updates from CDC and FDA.

Vaccination requirements for day care facilities, schools and healthcare workers: Like pharmacist scope of practice, these types of vaccination requirements are generally established at the state level and sometimes incorporate CDC’s recommendations. Here, too, states can ensure a role for state health officials to supplement CDC’s recommendations.

Separately, states may wish to review their policies on religious exemptions for day care and school vaccination requirements. HHS recently threatened the loss of federal VFC and Medicaid funding for states that fail to follow their own state laws on religious exemptions.

Liability protections for vaccine-related injuries: Under the PREP Act, the Vaccine Injury Compensation Program and the COVID-19 Countermeasures Injury Compensation Program, the federal government provides compensation for certain vaccine-related injuries and creates a liability shield for providers and vaccine manufacturers. However, CDC’s recommendations shape the protections available under all three programs.

Because medical malpractice and product liability are largely regulated at the state level, states can establish their own liability standards and protections for vaccine-related injuries beyond CDC’s recommendations.

CDC’s vaccine recommendations are baked into many federal and state policies. However, states have many opportunities to supplement CDC’s recommendations to ensure that vaccines are covered and available in accordance with the state’s own public health priorities and judgment.