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A close-up image of a gavel lying on top of a stethoscope.

Braidwood Management v. Becerra, scheduled for oral argument in the Fifth Circuit Court of Appeals today, March 4, has the potential to undermine decades of bipartisanship and groundbreaking innovation aimed at ending the transmission of the HIV virus that causes AIDS. This would have long-lasting consequences for preventive health care and society in general. Even more broadly, the case has received significant attention for its potential to essentially decimate the Affordable Care Act’s (ACA’s) guarantee of coverage without cost sharing for hundreds of categories of free preventive health care.

One of these categories is pre-exposure prophylaxis (PrEP). Since its introduction in 2012, PrEP has been applauded by Republicans and Democrats alike as a highly effective public health tool to prevent HIV’s transmission, reducing the risk of acquiring HIV through sexual transmission by approximately 99 percent. In 2019, the US Preventive Services Task Force (USPSTF) issued a “Grade A” recommendation for PrEP, in turn triggering the requirement to cover it without cost-sharing for those with commercial health insurance under Section 2713 of the Public Health Service Act (Section 2713), the ACA’s preventive services coverage mandate.

Braidwood’s RFRA Claims

The Braidwood plaintiffs argue that HHS lacks the authority to impose binding preventive coverage standards; they allege constitutional deficiencies—specifically violations of the Constitution’s Appointments clause—in the process used to identify the effective preventive services that will be subject to free coverage. But in the case of PrEP, the plaintiffs go further: They argue that requiring employers to cover PrEP or consumers to buy individual policies that include PrEP violates their rights under the Religious Freedom and Restoration Act (RFRA) because PrEP coverage makes them complicit in sexual acts outside of a marriage between one man and one woman. RFRA prohibits the government from “substantially burden[ing] a person’s exercise of religion” unless “the burden…is in furtherance of a compelling governmental interest” and such government activity “is the least restrictive means of furthering that compelling governmental interest.”

Even if the Braidwood plaintiffs fail in their effort to nullify free preventive coverage in its entirety, their religious freedom claim threatens to upend insurance coverage for Americans whenever the employer objects to coverage of a service or technology on religious grounds, potentially denying access to prevention that literally saves lives. The Braidwood plaintiffs’ religious freedom argument would further an erosion that began in Burwell v. Hobby Lobby Stores, Inc. with contraceptive coverage. The Obama Administration had initially limited a religious exemption to the contraceptive coverage requirement to closely held religious employers whose employees shared their religious beliefs. Hobby Lobby broadened the exemption’s availability to other employers, followed by further broadening under the Trump administration, affirmed in Little Sisters of the Poor v. Pennsylvania. The Braidwood case represents the next step, an attempt to establish not only that RFRA requires allowing religious employers to continue rolling back coverage of medically necessary health care products and services beyond contraceptives, but also to force the government’s forfeiture of public health goals.

Although in Hobby Lobby the Supreme Court (wrongly in our view) rejected the government’s arguments that religious claims should give way to public health imperatives, the presence of public health concerns significant enough to overcome religious rights is irrefutable in the case of PrEP, not only because of its clinical efficacy but also because of its ability to prevent disease transmission. As discussed more fully below, the plaintiffs prevailed on their RFRA challenge at trial before Judge Reed O’Connor and the Biden administration did not raise the issue on appeal. The Fifth Circuit could nevertheless take up the issue on its own—although this is admittedly unlikely—and it is our view that the court should reject the plaintiffs’ position and overrule Judge O’Connor’s conclusions regarding RFRA.

The Litigation Landscape

In 2020, Braidwood, a Christian-owned small business, along with six individuals in Texas filed suit to prevent the federal government from enforcing Section 2713. Braidwood, which provides health insurance to approximately 70 employees through a self-insured plan subject to Section 2713, argued that “compulsory coverage” of PrEP violates RFRA by making the company complicit in “facilitating homosexual behavior, drug use, and sexual activity outside of marriage between one man and one woman.”

In his March 30, 2023 final decision, Judge O’Connor of the Northern District of Texas sided with Braidwood on its major claims. (Plaintiffs challenging various aspects of the ACA have intentionally brought their cases before Judge O’Connor and he has upheld the challenges on multiple occasions, including striking down the entire ACA in Texas v. California, which was later overruled by the Supreme Court.) Judge O’Connor agreed with the plaintiffs on their constitutional challenges to the USPSTF and their RFRA arguments. On the RFRA claims, he leaned heavily on Supreme Court precedent from Hobby Lobby.

On appeal to the Fifth Circuit, the Biden administration has challenged Judge O’Connor’s ruling on the constitutionality of the Task Force’s authority. However, while it appealed the full decision, it refrained from challenging the court’s RFRA holding in its briefs. Issues not raised in a party’s brief on appeal are generally considered abandoned, meaning that the government likely cannot make an argument on the RFRA question at any level of appeal.

Under a current stay agreed to by the parties, the plaintiffs are not required to comply with the ACA’s requirement to cover PrEP. Should the Fifth Circuit let the lower court’s RFRA holding stand, this would essentially automatically permit objecting employers nationwide to claim religious exemptions from covering PrEP.

By declining to argue the RFRA claims before the Fifth Circuit, the government may have saved the question for another day and avoided setting a national legal precedent. However, even applying the obligatory strict scrutiny standard, mandatory PrEP coverage should withstand the plaintiffs’ RFRA claims for several reasons.

The Mandatory Cost-Free Coverage Of Preventive Services, Including PrEP, Does Not Substantially Burden Religion.

The plaintiffs have provided no evidence that PrEP “facilitates” the behaviors that they claim violate their religious freedom. Furthermore, while there are persistent disparities in HIV’s impact, the disease affects Americans from all walks of life—regardless of gender, sexual orientation, marital status, or religious beliefs. PrEP prevents an individual from acquiring a lifelong infection and works regardless of sexual orientation or relationship status. For example, someone who is heterosexual and married to an opposite-sex partner living with HIV can use PrEP to avoid contracting the virus.

The Government Has A Compelling Interest In Ensuring Cost-Sharing-Free Coverage Of PrEP.

Covering PrEP without cost sharing is crucial to protecting the health of individuals, curbing the spread of infectious disease, stabilizing health insurance risk pools, and preventing payers and employers from incurring costlier care due to increased incidence of HIV. Moreover, PrEP can be unaffordable to patients out of pocket (even though it can lower total cost of care over long periods of time). Blunting Section 2713 would narrow access only to those able to afford deductibles and cost sharing, exacerbating health inequities.

Additionally, PrEP is one of three core pillars of the government’s initiative to end the HIV epidemic in the United States. The USPSTF coverage mandate has played a key role in supporting that pillar: In 2022, approximately 31.4 percent of individuals for whom PrEP was recommended were prescribed it, up from approximately 3 percent in 2015 before the USPSTF assigned it an “A” grade. This outcome is not surprising, as out-of-pocket costs have repeatedly been shown to deter preventive care. Crucial to PrEP is that it not only protects individuals, as does contraception, but it also prevents transmission of disease, thereby creating a federal interest that eclipses even the government’s strong interest in accessible contraception.

Required Coverage Of PrEP Is The Least Restrictive Means To Achieve Compelling Governmental Interests.

By design, 2713 eliminates the cost to patients associated with recommended drugs and services. The ACA’s coverage requirement directly addresses the millions of Americans at risk of acquiring HIV for whom PrEP would be otherwise unaffordable.

Contrary to Justice Alito’s earlier suggestion in Hobby Lobby, it would be far more administratively burdensome for the government to coordinate with individual employees or employers to ensure that all employees have access to PrEP, as compared to the employer administering the benefit itself as it does for virtually every other medically necessary health care service. The Braidwood plaintiffs' RFRA argument would also shift the cost of PrEP to the United States government from the private insurance companies and employers that bear the cost under 2713.

Were the government to have to step in to provide coverage when companies lodged religious objections to covering particular interventions, as per Alito, this would shift the administrative burden of securing coverage to employees, who might not have the resources to navigate a separate coverage program—they might not be aware of the process to obtain a medicine like PrEP, or even that their employer had declined to cover it. Additionally, this process would increase the already significant stigma surrounding HIV, which could cause employees to forgo PrEP altogether; this is turn could lead to increased HIV transmission and individual and societal harms, undermining the government’s compelling interest in preventing HIV transmission.

Creating a new and separate program would also raise its own political and logistical challenges. For example, in January 2023, the Biden administration proposed creating a new program for individuals to obtain contraceptive services at no cost from a willing provider without any involvement by their employer or other objecting entity. Legislation has already been introduced to block the use of federal funds to implement or enforce this program. This demonstrates that, in contrast to Justice Alito’s reasoning in Hobby Lobby, the creation of entirely new programs to accommodate RFRA is not necessarily a viable option for the government to achieve its objectives.

A Decision To Uphold The RFRA Exception Would Set A Precedent That Could Broaden RFRA To A Degree Which Was Not Intended By Congress.

If the plaintiffs’ RFRA claim were to prevail in Braidwood, the endless array of concocted religious objections that could arise beyond PrEP would risk turning RFRA and many other laws into a farce. Employers could claim a religious objection to covering screening and treatment for sexually transmitted diseases, or vaccines related to sexual health—or, conceivably, diabetes testing or treatment because gluttony is a sin. A religious objection to blood transfusions could lead to a refusal to cover them. Upholding the District Court’s decision would be equivalent to permitting “open season” for religious opposition to any health care product or service that is even remotely interpreted by an employer to infringe on their alleged religious beliefs.

The consequences would not be limited to health care. For example, an employer could potentially be granted a RFRA exemption from paying Federal and Medical Leave Act (FMLA) benefits if the reason for an employee’s leave contravened the employer’s religious beliefs (e.g., to take care of a child born outside the confines of marriage).

In sum, because the government maintains a compelling interest in mandating cost-free coverage of PrEP, plaintiffs did not credibly claim that providing access to cost-free PrEP substantially burdens their Christian faith, and the coverage mandate is the least restrictive means to achieve the government’s compelling interest in preventing transmission of HIV, plaintiffs’ RFRA claim should be deemed invalid by the courts. Arguably, Hobby Lobby opened the door to this kind of overbroad application of RFRA. But the courts should use Braidwood—with its clear public health implications—to articulate limits to that decision before threats to health care access expand further.

No End In Sight

Even if the Biden Administration is successful in arguing that the USPSTF’s powers are a legal exercise of the Appointments Clause, the District Court’s RFRA holding will continue to loom over Section 2713 and undermine its broad guarantee of cost-free access to preventive services. Congress enacted Section 2713 to promote widespread utilization of evidence-backed interventions that prevent adverse health outcomes for individuals and society at large. It accomplishes this by assuring patients and providers that most insured patients can access preventive care without first-dollar coverage requirements. This assurance is deteriorating because of Braidwood and earlier cases, notably Hobby Lobby.

The Biden administration may have made the judgment that preserving its RFRA claim on appeal is a fight not worth having—recognizing that a loss for mandatory cost-free coverage of PrEP alone is better than the further expansion of RFRA rights for religious employers. The result of this silence is that the District Court’s decision to excuse the Braidwood plaintiffs from PrEP coverage will almost certainly be left standing. Given the lack of appeal on the RFRA claim, it is highly unlikely that the Fifth Circuit will exercise its own discretion to address the RFRA claims in Braidwood, as it is highly unusual for an appeals court to overturn an issue that is not pressed by a party. Should the question reach the Supreme Court in Braidwood or a future case, the current ideological makeup of the Court heavily favors acceptance of the plaintiffs’ RFRA claims, even in the case of a drug aimed at protecting the public’s health that would be otherwise unaffordable to many who are at risk of acquiring HIV.

If the issue is decided in favor of the plaintiffs or if the lower court’s ruling is left intact, the administration may be forced to create a pathway to accommodate religious exemptions, as the Obama administration did for contraceptives. Even if it does, the legislative intent of Section 2713 will be substantially hindered, as new administrative hurdles will stand between patients and preventive care.

Moreover, while the District Court’s remedy was specific to PrEP, its reasoning is not. The outcome of this case could have never-ending consequences for a wide spectrum of employee benefits to which employers may ostensibly have religious objections, along with ever-worsening consequences for public health.

Authors’ Note

 Hughes and Minnick were counsel to amici in Braidwood v. Becerra and argued in favor of reversing the lower's court's RFRA holding in their brief.

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