New Federal Vaccine Recommendations Introduce Ambiguity and Could Lead to Coverage Headaches

Over the past year, Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr. fully replaced members of the Advisory Committee on Immunization Practices (ACIP), with significant consequences for how the body reviews evidence and makes recommendations. ACIP’s recommendations fall into three categories: universal, risk-based, and shared clinical decision-making (SCDM). In a break with past practice, ACIP has begun removing universal recommendations from some vaccines and, without new evidence, effectively downgrading them to an SCDM designation. The remaking of ACIP and the dramatic changes to recommendations drew swift criticism from public health groups, followed by litigation. In March 2026, a federal district court paused the ACIP changes, including the SCDM recommendations. HHS has appealed, but the lawsuit is still in early stages, with final resolution likely years away.

ACIP’s decisions are important not only because they guide public health practice. Its recommendations also directly affect access to care and insurance coverage because they are embedded in the Affordable Care Act’s (ACA) coverage requirements and in an array of state public health statutes. While the ACA requires coverage of all ACIP-recommended vaccines, including those recently given an SCDM recommendation, experience suggests that ACIP’s approach is likely to cause confusion and create barriers to vaccine access.

What Is Shared Clinical Decision-Making?

The American Medical Association defines shared clinical decision-making as a collaborative process that balances clinical evidence and patient values to help the patient make an informed treatment choice. Historically, SCDM has been used to identify a care plan when a course of treatment comes with significant risks alongside benefits, and the approach may be valuable when there isn’t a clear, evidence-based course of action.

ACIP formally adopted an SCDM category for vaccine recommendations in 2019, replacing a “permissive” category. Until last year, ACIP had used SCDM infrequently and narrowly, when the benefits and risks of a vaccine for a specific group were less clear. For example, the meningococcal B vaccine received an SCDM recommendation in 2015 because of short-term vaccine effectiveness and low disease prevalence. Yet even this limited use of SCDM recommendations for vaccines generated confusion and misunderstanding for providers, patients, and payers, including about whether the vaccines were covered by insurance.

Starting in September 2025, ACIP took the unprecedented action of moving six vaccines that were previously universally recommended — and for which the evidence base has not changed — to an SCDM recommendation. Instead of being used as a tool to help patients and providers come to a treatment decision when the evidence is unclear, critics claim the SCDM category is now being deployed to introduce ambiguity when none exists.

ACIP’s Use of SCDM Preserves Coverage, but Increases Confusion

Federal law requires public coverage programs and private health insurance to cover ACIP-recommended vaccines without cost sharing. The Centers for Medicaid and Medicare Services took the position that Medicaid and Medicare Part D must provide zero-dollar coverage of vaccines with an SCDM designation. The law appears clear that private insurers also must cover SCDM-designated vaccines without cost sharing; communications announcing ACIP’s actions said coverage requirements would not be affected.

However, SCDM recommendations still pose risks of confusion and plan compliance challenges. Since the introduction of the SCDM category, and even with an airtight legal argument for coverage, not all private insurance plans have applied the ACA’s coverage and cost-sharing requirements to SCDM recommendations. Even as some insurers commit to maintaining coverage in the face of ACIP changes, others have confusing rules for vaccine coverage that distinguish between SCDM and universal recommendations. Issuer compliance with the ACA’s preventive services requirements has been a longstanding problem. Compliance has been particularly spotty for interventions that have nuanced risk recommendations (as many would argue SCDM recommendations do), like the guidance around HIV preexposure prophylaxis.

What Can Federal and State Regulators Can Do to Mitigate Confusion?

If HHS is committed to maintaining coverage for vaccines with shared clinical decision-making recommendations, it could release subregulatory guidance to clarify this point, as it has done previously for Medicaid and Medicare Part D. Indeed, HHS has issued materials clarifying preventive services coverage requirements and addressing tricky or nuanced recommendations. Federal agencies also could undertake more robust oversight activities, including monitoring active carriers to ensure plans are not using fine print to inappropriately limit access to zero cost-sharing services.

States should also address any confusion caused by SCDM. Illinois finalized a regulation clarifying that any preventive service (i.e., not just vaccines) with an SCDM recommendation must be covered by private insurers without cost sharing. Connecticut’s top insurance regulator explicitly affirmed that ACIP’s decision to reclassify certain vaccines as SCDM does not change the requirement for private insurers to cover them without cost sharing.

ACIP is now using the SCDM category to introduce ambiguity into a settled evidence base. These actions not only cause confusion for providers and patients, they also could lead to confusing policies by payers that erode access to zero cost-share vaccines. Regulators, working with public health partners, can mitigate this confusion by providing clear guidance and ramping up oversight activities to ensure continued access to vaccines without cost sharing.