{"subscriber":false,"subscribedOffers":{}} Braidwood v Becerra’s Vaccine Access Threat | Health Affairs

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Doi: 10.1377/forefront.20231128.866643
A gavel with a vial of vaccine sits on a desk.

Free coverage of immunizations recommended by experts is on the line in Braidwood Management v Becerra, now pending in the United States Court of Appeals for the Fifth Circuit. The lower court decision struck down coverage recommendations by the United States Preventive Services Task Force (USPSTF) adopted after the date of ACA enactment. On appeal, however, plaintiffs have revived their initial claims and once again challenge all of the coverage recommendations made by multiple expert bodies, spanning women’s health, child health, and immunizations.

Were the Fifth Circuit to roll back preventive coverage to pre-enactment levels, such a ruling would eliminate hundreds of benefits adopted post-enactment. Here, we focus on what a ruling overturning the free immunization guarantee would mean. Given the complexities of insurance markets and the particular nuances of immunization coverage, Braidwood’s impact across public and private insurance will vary. In the non-grandfathered private insurance and employer plan markets, a decision in plaintiffs’ favor would have an immediate, direct impact on coverage. In the case of the Medicare and the traditional Medicaid markets, a favorable decision likely will create a strong legal precedent for equally damaging claims. All told, the direct and indirect effects of Braidwood would impact coverage for over 150 million Americans with private health coverage as well Medicaid expansion plans covering 20 million lives.

Braidwood Challenges The ACA’s Preventive Services Coverage Requirement

The ACA amended federal law to require non-grandfathered private insurers, employer health plans, and plans enrolling the Medicaid expansion population to cover preventive services without cost sharing. The amendment primarily focused on four separate service categories: child health recommendations by the Health Resources and Services Administration (HRSA), HRSA-recommended women’s health services, services with an A or B rating recommended by the USPSTF, and immunizations recommended by the Advisory Committee on Immunization Practices (ACIP). At the time of enactment, dozens of services were recommended by these bodies and translated to no-cost coverage under the law.

Since March 2010, these expert bodies have expanded their recommendations to include over 100 additional benefits, including 89 services related to maternal and infant health, 24 services for children and adolescents, and, as discussed below, numerous immunization benefits. As the Health and Human Services (HHS) Secretary has adopted these recommendations and incorporated them into federal coverage requirements, insurance has been strengthened accordingly.

In his March 2023 decision, trial court judge Reed O’Connor concluded that the recommendations made after the date of enactment by the USPSTF were unenforceable because of constitutional deficiencies in the process for appointing USPSTF members. At the same time, Judge O’Connor rejected the plaintiffs’ position that the HRSA and ACIP recommendations were similarly fatally constitutionally flawed, finding that both of these bodies satisfied the constitutional considerations that the USPSTF failed.

Thus, at least for the moment, requirements to cover women’s and children’s services and vaccines remain legally binding. However, on appeal, the plaintiffs are asking for reconsideration of their arguments regarding HRSA and ACIP. The Fifth Circuit could side with the plaintiffs and strike down the entire body of post-enactment recommendations, including, of course, immunizations.

A Closer Look At The Scope Of The ACA’s Immunization Coverage Requirement

Limiting The Scope Of The Preventive Benefit Guarantee

The ACA preventive benefit provision specifies that private and some public health insurance policies cover “immunizations that have in effect a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.” It is this provision that establishes the guarantee of free ACIP-recommended immunizations. 

Under the ACA and its rules, the immunization guarantee, like other preventive benefit guarantees, is subject to certain limits. First, in consideration of the time it can take to implement changes in the terms of coverage, coverage is only mandated starting the plan year following the one-year anniversary of a recommendation. The effect of this grace period is that newly recommended services adopted by the HHS Secretary (both immunizations and other services) might not be covered until nearly two years later. Second, the rules allow insurers and plans to limit coverage to in-network providers.

Rapid Coverage Of COVID-19 Preventive Services

The CARES Act, signed into law on March 27, 2020, built on the core preventive service coverage requirement established under the ACA. The CARES Act requires coverage of “any qualifying coronavirus preventive service” recommended by the USPSTF or ACIP, “pursuant to Section 2713 of the Public Health Service Act.” Such coverage would have been automatic under the ACA. However, for COVID preventive services, the CARES Act also made two key modifications to the preventive coverage guarantee. First, the Act greatly expedited coverage requirements by requiring cost-free coverage of COVID preventive services within 15 days of an ACIP recommendation. Second, CARES Act implementing regulations required insurers to pay for COVID immunizations and other COVID preventive services even when furnished by out-of-network providers. Although the out-of-network coverage requirement expired with the end of the Public Health Emergency this year, the overall rapid coverage requirement remains in place.

A question could arise as to whether the CARES Act would mandate coverage of COVID vaccines even if the Fifth Circuit invalidates all ACIP-covered mandates under the ACA. However, despite its special treatment of COVID services, mandatory coverage under the CARES Act relies on the underlying preventive services provision of the ACA. And because no COVID vaccines were in fact yet available in March 2020, the Act’s coverage function relies in the same way on USPSTF or ACIP recommendation, rendering it vulnerable to the plaintiffs’ arguments regarding the constitutional deficiency of those expert bodies. As a result, should Section 2713 be restricted to pre-ACA-enactment coverage standards, COVID immunization coverage requirements also would be swept away.

Braidwood’s Risks For Other Vaccines

Beyond COVID, the ACIP has made a number of important vaccine recommendations since the ACA’S passage. Notable recommendations in the past 3 years alone include the recent respiratory syncytial virus (RSV), COVID, and a universal Hepatitis B recommendation for persons of all ages. These vaccines will no longer be subject to coverage requirements if Section 2713 is overturned.

The potential fate of flu vaccines under Braidwood is unclear. ACIP first recommended routine flu vaccines for all people aged 6 and older in February 2010, just before the ACA was passed. However, the recommendations did not go into effect until the beginning of the 2010–11 influenza season in August 2010. Arguably, this recommendation would withstand a decision invalidating all post-ACA enacted coverage because the vote occurred prior to the ACA’s enactment. However, the timing of its effectiveness could jeopardize vaccine coverage for the 18 to 49 population. Centers for Medicare & Medicaid Services (CMS) and Centers for Disease Control and Prevention (CDC) only recently began to recognize recommendations as effective immediately upon publication on the CDC website rather than publication in the Morbidity and Mortality Weekly Reports as was previously the case.

Moreover, for vaccines already recommended in 2010, such as influenza and pneumococcal conjugate, updates to the vaccines and corresponding recommendations over time arguably render them obsolete. This is because influenza vaccine strains are typically changed to match those circulating during a season and the ACIP recommends those new vaccines annually. Likewise, pneumococcal conjugate vaccines have seen the addition of new serotypes. The older recommended formulations are no longer indicated, recommended, or manufactured; they have become clinically obsolete. As a result, the reach of Braidwood could extend to multiple critical immunizations.

The plaintiffs’ Religious Freedom Restoration Act (RFRA) arguments, while applied in Braidwood to PrEP for HIV prevention, could also threaten access to vaccines under future claims. For example, employers could claim a religious objection to covering Mpox vaccine, because Mpox is frequently sexually transmitted. And, should an HIV vaccine become available in the future, RFRA objections could weaken coverage requirements as well.

What Would Happen To Medicare And Medicaid Coverage?

A decision affirming the plaintiffs’ ACIP claims would impact vaccine access for some Medicaid enrollees and could set precedent for future claims impacting broader sets of both Medicaid and Medicare enrollees.

Medicaid

Braidwood could directly impact coverage for the roughly 20 million low-income adults who became eligible for Medicaid under the ACA’s expansion. Under the ACA, coverage for the expansion population must meet the law’s essential health benefits requirements, including the preventive services requirement. Therefore, expansion enrollees currently have coverage of ACIP-recommended vaccines without cost sharing. An expansive ruling for the plaintiffs in Braidwood could eliminate this guarantee, threatening access for a population who are particularly unlikely to be able to afford cost sharing for vaccines.

For adults who are covered under Medicaid through traditional eligibility categories (low-income children, exceptionally poor parents, pregnant women, adults eligible on the basis of disability), the ACA did not mandate no-cost coverage of preventive services for adults (children receive comprehensive preventive benefits through Medicaid’s longstanding early and periodic screening, diagnostic, and treatment benefit). As a result, until recently, states could exclude adult vaccines from their Medicaid plans or, if covered, impose cost sharing requirements. However, the Inflation Reduction Act (IRA) of 2022 established no-cost coverage of ACIP-recommended vaccines for all adults in Medicaid beginning in 2023. Braidwood likely would not have a direct impact on this new coverage mandate but could open the door for two types of follow-on challenges—one aimed at adult coverage, and the other aimed at pediatric vaccines, which also link to ACIP recommendations (42 U.S.C. section 1396d(r)).

Medicare Part B Vaccines Will Likely Escape The Braidwood Challenge

Pneumococcal pneumonia, influenza, and COVID vaccines are covered under Medicare Part B. When Congress first enacted the requirements to cover pneumococcal and influenza vaccines in the 1980s. it did not tie this coverage to the ACIP’s recommendations, instead specifying these vaccines in the Medicare statute. Congress also amended Part B through the CARES Act, requiring coverage of approved COVID vaccines. CMS later interpreted this requirement to include those vaccines authorized for emergency use, recognizing that vaccine access would otherwise be delayed for older adults.

Because coverage for Part B vaccines has been explicitly established in statute rather than being conditional on ACIP recommendations, COVID, influenza, and pneumococcal vaccines for older adults likely escape the Braidwood threat.

Medicare Part D Vaccine Coverage Is At Risk

However, this approach was not used in subsequent laws broadening vaccine coverage for Medicare beneficiaries. In passing the IRA, Congress sought to extend the promise of first-dollar vaccine coverage to those covered under Medicare Part D. Unlike the earlier Medicare vaccine provisions, the IRA reflected the ACA approach by amending Medicare Part D to tie first-dollar coverage requirements for non-Part B-covered vaccines to ACIP recommendations. As a result, should the plaintiffs succeed in overturning the ACIP recommendations, the IRA’s vaccine provisions could face similar claims.

Therefore, vaccines covered under Part D—such as RSV, Tetanus/diphtheria/acellular pertussis (Tdap), and shingles vaccines—may face future legal risks should the appeals court side with the Braidwood plaintiffs.

Sizing Up The Impact

While most attention surrounding Braidwood revolved around PrEP for HIV and disease screenings, the threat to vaccines remains alive.

Prior to the ACA, payer coverage and cost sharing was inconsistent and shown to impact vaccine uptake. Even if a payer does cover a vaccine, subjecting a patient to any amount of out-of-pocket costs may discourage vaccination. Assurances that vaccines would be adequately covered by payers in spite of a potential unfavorable ruling should be viewed with skepticism. This has become most evident with recently approved RSV vaccines.

The ACA’s preventive services coverage requirement was a substantial step toward ensuring that all Americans have access to vaccines. By tying insurance law to the ACIP’s recommendations, it promises vaccine coverage that is continuously up to date in accord with ever-evolving vaccine innovation and science. Braidwood threatens to sever that tie.

Science and medicine are not static, but continuously evolving. Should the courts bring an end to the guarantee of free vaccines, our nation may lose ground against many disease threats, both new and old.

Authors’ Note

Richard Hughes regularly advises vaccine manufacturers and represented amici who entered a brief in Braidwood v. Becerra. The views reflected here are his own.

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