ACIP, CDC, and Insurance Coverage of Vaccines in the United States
As the Trump administration moves to institute changes to the process by which vaccines are recommended for the U.S. public, as well as the actual recommendations themselves1, consumers could lose access to no-cost health insurance coverage of vaccines. This is due to the fact that several laws and regulations tie such coverage to recommendations made by the Advisory Committee on Immunization Practices (ACIP) and/or those made by the Director of the Centers for Disease Control and Prevention (CDC). ACIP is a federal advisory committee established in 1964 to provide advice and guidance to the CDC Director on the use of vaccines for the public. The CDC Director reviews recommendations made by ACIP, and if adopted, they are published as official CDC/HHS recommendations in the Morbidity and Mortality Weekly Report (MMWR). ACIP also is charged with establishing and revising the list of vaccines used for the Vaccines for Children Program. The CDC Director, or Secretary of HHS, can choose not to adopt an ACIP recommendation, to modify it, or to make their own recommendations and, in most, but not all cases, the HHS decision ultimately determines whether coverage is required.
In light of changes made by the administration, this policy brief provides an overview of vaccine coverage requirements by payer or program, as specified in law, regulations, and other policy guidance.2 As it shows, coverage requirements for all payers, except for vaccines covered under Medicare Part B, are currently linked to either ACIP and/or CDC vaccine recommendations. Therefore, a narrowing or removal of a vaccine recommendation, as was recently done for COVID-19, would mean that most insurers would no longer be required to provide no-cost coverage. (see Summary and Detailed Tables below).
Findings
Almost all payers are required to cover recommended vaccines at no-cost. This is currently the case for private insurance and employer-sponsored health plans, Medicaid, and Medicare. There is also a mandatory program for Medicaid-eligible and uninsured children – the Vaccines for Children Program – that provides recommended vaccines for free to eligible children (there is no such program for uninsured adults). The first requirement of coverage was in 1981, as part of Medicare Supplementary Insurance (Part B). The most recent was enacted in 2022, when the Inflation Reduction Act (IRA) required coverage of recommended vaccines under Medicare Part D and expanded Medicaid coverage for some adults not already covered.
Vaccine coverage requirements are linked to ACIP/CDC recommendations in almost every case. All payers, except under Medicare Part B, are required to provide no-cost coverage for vaccines recommended by ACIP/CDC. For example, most private insurers are required to cover vaccines that have, in effect, an ACIP recommendation. Vaccines covered under Medicare Part B are the exception, with four vaccines specifically authorized for coverage at no cost in statute.
The point at which a vaccine is considered “recommended” for purposes of requiring no-cost coverage varies somewhat by payer, and in some cases has been determined through subsequent rule-making or federal policy. For private insurers, Medicare Part D, and Medicaid expansion, the requirement is tied to an ACIP recommendation that has been adopted by the CDC Director, as specified in final regulations or guidance. For traditional Medicaid and CHIP, an ACIP recommendation is sufficient. For purposes of the Vaccines for Children Program, the list specified by ACIP determines what is included.
If ACIP or CDC vaccine recommendations were to be narrowed or removed, as was recently done in the case of COVID-19, most payers would no longer be required to provide no-cost coverage. On May 27, Secretary Kennedy announced that the COVID-19 vaccine was no longer recommended for healthy children, ages six months to 17 years, or for healthy pregnant women (COVID-19 vaccines were previously recommended for all children ages six months or older and pregnancy had previously been considered a condition that put people at increased risk for moderate or severe COVID-19 disease). This means that insurers will no longer be required to provide free vaccines for these populations unless they have an underlying health condition that places them at higher risk (in the case of children, the CDC subsequently revised the pediatric vaccine schedule to base the recommendation on “shared clinical decision-making”, which means free insurance coverage will only be required if a doctor recommends a child be vaccinated based on that child’s individual circumstance).
Table 1: Summary of Vaccine Coverage Requirements by Payer/Program |
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| Payer/Program | Coverage Requirement Linked to CDC/ACIP? | Date When Requirement First Enacted3 |
| Private/Employer-Sponsored Plans | Yes | 2010 |
| Medicare Part B | No | Variable by vaccine, starting in 1981 |
| Medicare Part D | Yes | 2022 |
| Medicaid/CHIP | Yes | 2010 (expansion), 2022 (traditional/CHIP) |
| Vaccines for Children | Yes | 1993 |
| Uninsured Adults | N/A | N/A |
Table 2: Detailed Overview of Vaccine Coverage Requirements by Payer/Program |
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| Payer/Program | Coverage Requirement |
| Private/Employer-sponsored plans4,5 | The Affordable Care Act requires that issuers shall, at a minimum, provide coverage for and shall not impose any cost-sharing requirements for immunizations that have in effect an ACIP recommendation.
Per final ACA regulations, immunizations for routine use in children, adolescents, and adults are considered “in effect” once adopted by the CDC Director. A recommendation is considered to be for “routine use” if it appears on the immunization schedules of the CDC. |
| Medicare Part B6 | Medicare Part B is required to cover pneumococcal (1981), hepatitis B (1984), influenza (1993) and COVID-19 (2020) vaccines without cost sharing, as specified in Title XVIII of the Social Security Act. This requirement is not linked to ACIP or CDC. |
| Medicare Part D7 | Medicare Part D is required to cover at no cost all adult vaccines recommended by ACIP (other than those required by law to be covered under Medicare Part B), as specified in the Inflation Reduction Act of 2022.
Per CMS guidance, this no-cost coverage requirement occurs once an ACIP recommendation is adopted by the CDC Director and posted on the CDC website (all categories of ACIP recommendations are included, not just routine use) |
| Medicaid/CHIP8 | Traditional Medicaid/CHIP: The Inflation Reduction Act requires state Medicaid and CHIP programs to cover adult vaccines recommended by ACIP, and their administration, without cost sharing. Per CMS guidance, the IRA coverage requirement is not limited to vaccines that ACIP includes on immunization schedules or recommends for routine use.
Medicaid expansion: Alternative Benefit Plans must cover vaccines recommended by ACIP for routine use in children, adolescents, and adults that have in effect a recommendation from ACIP with respect to the individual involved. A recommendation is considered in effect after it has been adopted by the CDC Director, and a recommendation is considered to be for routine use if it is listed on the CDC immunization schedule. Medicaid/CHIP children: Medicaid’s EPSDT benefit requires states to cover all vaccines on the CDC/ACIP pediatric immunization schedule without cost sharing for children in Medicaid and Medicaid-expansion CHIP (M-CHIP). Any other vaccines not recommended by ACIP would have to be covered under EPSDT if deemed medically necessary. Medicaid and M-CHIP children generally receive their vaccines through the VFC. Separate state CHIP programs must cover all vaccines recommended by ACIP with no cost sharing. |
| Vaccines for Children9 | Section 1928 of the Social Security Act, as amended by the Omnibus Budget Reconciliation Act of 1993, created the Vaccines for Children Program which requires that the Secretary of HHS shall use, for the purpose of the purchase, delivery, and administration of pediatric vaccines, the recommended pediatric vaccine list established by ACIP for eligible children (Medicaid-eligible, uninsured, underinsured, and American Indian/Alaska Native children age 18 and younger). ACIP also establishes the pediatric vaccine schedule. |
| Uninsured10 | There is no guaranteed program that provides no-cost vaccines to uninsured adults. Rather, there is a discretionary federal program – the 317 program – that, based on funding, can provide grants to states to support immunization infrastructure and provision of recommended vaccines to uninsured adults. |
Endnotes
For example, the FDA recently announced planned changes to the criteria used to approve COVID-19 vaccines, Secretary of Health and Human Services, Robert F. Kennedy Jr. narrowed existing COVID-19 vaccine recommendations and also reconstituted the membership of ACIP.
Also see: https://www.kff.org/coronavirus-covid-19/issue-brief/vaccine-coverage-pricing-and-reimbursement-in-the-u-s/; https://advisory.avalerehealth.com/wp-content/uploads/2023/10/Guide-to-Vaccine-Coverage-Policies.pdf; https://www.healthaffairs.org/content/forefront/vaccine-policy-crisis-secretary-kennedy-dismisses-entire-advisory-committee.
The date in which the requirement takes effect may differ from date first enacted by law.
Private insurance requirements pertain only to non-grandfathered plans and in-network providers.
Sources: Patient Protection and Affordable Care Act; Final Rule: Coverage of Certain Preventive Services Under the Affordable Care Act; CMS, Affordable Care Act Implementation FAQs - Set 12
Sources: Title XVIII of the Social Security Act, §410.57; MedPAC, Medicare vaccine coverage and payment.
Sources: Inflation Reduction Act; CMS, Contract Year 2023 Program Guidance Related to Inflation Reduction Act Changes to Part D Coverage of Vaccines and Insulin; CMS, REVISION - Contract Year 2023 Program Guidance Related to Inflation Reduction Act Changes to Part D Coverage of Vaccines.
Sources: Inflation Reduction Act; CMS, SHO# 23-003, RE: Mandatory Medicaid and Children’s Health Insurance Program Coverage of Adult Vaccinations under the Inflation Reduction Act; Social Security Act §1937; 42 CFR §440.347 - Essential health benefits; CMS, Coverage and Payment of Vaccines and
Omnibus Budget Reconciliation Act of 1993; Social Security Act §1928.
Source: 42 U.S.C. § 247b.