Vaccine safety and changes happening at the Department of Health and Human Services (HHS) have been an ongoing topic of conversation throughout the past few months. As we have previously discussed here on Say Ahhh!, HHS has announced upcoming studies and potential changes to how vaccines are approved and recommended for different populations. Most notably, the June removal of all 17 then-current members of the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) marked a turning point in U.S. vaccine policy.
As it currently stands, vaccines go through a rigorous process of development, testing, and approval long before they are approved and recommended. After the initial development and clinical trial phases, manufacturers submit a Biological License Application to the Food and Drug Administration (FDA) for approval. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviews safety and efficacy data for new products and provides a recommendation to approve or not approve. This committee is comprised of leading experts in immunology and related fields. Once the vaccine exits the VRBPAC and is approved by the FDA, ACIP meets to review the vaccine’s safety and efficacy data. ACIP votes to recommend (or chooses not to recommend) the product to different population groups, which is then reviewed by the CDC Director and is (usually) adopted. The Secretary of HHS then has the opportunity to veto the recommendation, though that is rare. For pediatric vaccines, the recommendations made by ACIP result in a schedule by age. Even after the full FDA approval and CDC recommendation of a vaccine, ACIP continues to monitor the safety and efficacy, allowing them to modify their recommendations as more data becomes available.
With so many changes underway, there has been renewed interest in how vaccine coverage decisions are made by Medicaid, Medicare and private insurers. In this post, we’ll focus on Medicaid coverage of pediatric vaccines through what is known as the Vaccines for Children (VFC) program.
Since 1994, in response to a measles epidemic in the early 1990s, pediatric vaccines were made available nationwide at no cost (to those eligible) through VFC. VFC serves uninsured children, children with Medicaid coverage, and some children with CHIP coverage (those enrolled in a Medicaid expansion CHIP program, or M-CHIP; children enrolled in separate CHIP programs, or S-CHIP, are not eligible for VFC). VFC is federally funded and is a critical component of improving health care access for children. This program has been shown to increase vaccination rates for those eligible. And studies have conclusively shown that routine childhood immunization using the ACIP pediatric vaccination schedule reduces the incidence of targeted disease – some of which were entirely eliminated.
ACIP, VFC, and Medicaid are inextricably linked in statute and in practice. Section 1902(a)(62) of the Social Security Act (SSA) requires states to “provide for a program for the distribution of pediatric vaccines” in compliance with the rules laid out in section 1928. SSA section 1928 in turn describes this “program for distribution” which is more commonly known as VFC, mentioned above. Under SSA section 1928(c)(2)(B), VFC providers are required to comply with the schedule established by ACIP, and under section 1928(e), the Secretary of HHS must use the ACIP list for purposes of purchasing, delivering and paying for the administration of pediatric vaccines. Separately, under SSA section 1905(r), Medicaid’s pediatric benefit, Early and Periodic Diagnostic, Screening and Treatment (EPSDT) is defined as specifically including vaccines identified in 1928(c)(2)(B).
In other words, the ACIP schedule for pediatric vaccines determines which vaccines must be covered under VFC and available at no cost to children without health insurance, children covered by Medicaid, and children covered by M-CHIP – or nearly half of all children in the U.S..
Regular readers of SayAhhh! are undoubtedly familiar with the tremendous amount of state flexibility afforded in Medicaid. In fact, we often describe Medicaid as a state-federal partnership in which the federal government sets the minimum program rules and states determine the rest – optional coverage and benefits, service delivery systems, provider payment rates, etc. This state flexibility raises an important question – could states decide to cover pediatric vaccines in Medicaid beyond those included in the ACIP schedule?
This question may become even more pressing after the next ACIP meeting, currently scheduled for September 18-19, in which they may consider making changes to the pediatric ACIP schedule. A formal agenda has not yet been posted, and there have been calls to delay or indefinitely postpone the meeting given the shake-up in membership, but in the meantime states are beginning to think through how to respond to potential changes. We’ll explore some state options in a future post.
Editors Note: This topic is rapidly evolving and this blog should be treated as a point in time.
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