Be PrEPared: The Complex & Ongoing Battle for PrEP in the Courts

In September, 2023, hundreds of key stakeholders and advocates convened in Washington, DC, to attend the annual United States Conference on HIV/AIDS (USCHA). The yearly conference featured over 120+ sessions on critical topics like biomedical HIV prevention, aging, service delivery, health equity, and telehealth, all while centering on the needs of those with HIV and the mission to end the epidemic. One of the primary conversations at the conference was access to and implementation of PrEP, an incredibly effective but underused tool in the fight against HIV. A ground-breaking piece of legislation, the PrEP Access and Coverage Act, was introduced in June 2021. And in 2022, the National Minority AIDS Council (NMAC) released a letter calling for a national PrEP program. Yet still, PrEP is relatively unknown and certainly not utilized in its maximum capacity, especially for Black queer men.

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What is PrEP?

Pre-exposure prophylaxis (PrEP) is a medication that drastically lowers the risk of acquiring HIV from sex or injection drug use.  Proven safe and effective, the U.S. FDA approved its use in 2012. Now available as pills or shots, an estimated 1.2 million Americans could benefit from PrEP. While the CDC identifies 1.2 million people needing PrEP, only 9% of Black individuals accessed it by 2020, compared to 66% of White individuals. The power of PrEP as a revolutionary tool to decrease HIV in the Black queer community is unmatched. For example, PrEP lowers the HIV risk from sex by 99% and injection drug use by at least 74%.

Why is it controversial? See Braidwood v Becerra.

Despite its effectiveness, PrEP has been marred by political controversy and setbacks. Sex-based stigma and lack of awareness still continue to be massive barriers in large-scale rollout. Culturally, PrEP has instigated discussions about responsibility, sexuality, and moral judgments. The drug has often been mistakenly labeled as a "party drug" or an enabler of promiscuous behavior, overshadowing its profound preventative capabilities. Some critics argue that its availability might lead to riskier sexual behaviors and a decline in condom usage, potentially increasing the spread of other STIs.

Cultural beliefs often become enshrined in and protected by court rulings. PrEP has been subjected to legal scrutiny multiple times, with most debates centering on the Affordable Care Act and its “preventive services provision.” In 2021, the Departments of Health and Human Services, Labor, and Treasury clarified how PrEP should be covered under the ACA. In short, the joint guidance mandated that nearly all health insurers must cover the cost of  PrEP, without any cost sharing. This covers both the drug and associated clinic visits and lab tests. Consequently, prescriptions for PrEP should be free for insured individuals.

However, other cases have emerged since then and have gutted this ruling. Take the case of Braidwood vs. Becerra. In their lawsuit, the Christian plaintiffs argued that “the PrEP mandate forces religious employers to provide coverage for drugs that facilitate and encourage homosexual behavior, prostitution, sexual promiscuity, and intravenous drug use.”   In Braidwood vs. Becerra,  Christian-owned businesses and six Texas individuals argued that being forced to cover PrEP infringed on their religious rights. On September 7, 2022, Judge Reed O’Connor of the US District Court in Texas, a Trump-appointed judge, agreed, concluding that covering PrEP violated the religious rights of the objecting plaintiffs. Research estimates this ruling would cause over 2000 preventable HIV acquisitions annually if implemented. The authors explain, “With the ACA's current 28% PrEP coverage among high-risk men who have sex with men (MSM), the CDC estimates 21,867 new yearly HIV infections among MSM. A decrease in PrEP coverage to 10% would result in an additional 2057 HIV infections annually.”

The federal government appealed this ruling, and on May 15, 2023, the 5th Circuit Court of Appeals temporarily halted Judge O’Connor’s decision. While the appeal is pending, the government can enforce the preventive services requirement, meaning PrEP should still be covered under insurance. What is true in policy does not often translate to practice, as individuals are still frequently left with unexpected medical bills and lab fees.

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Recent Advocacy and PrEP Advancements to celebrate.

Even with setbacks, advocacy for PrEP has gained traction. The previously mentioned PrEP Coverage and Access Act would mandate that both private and public insurers cover the HIV prevention pill and associated services, eliminating out-of-pocket expenses. The bill also introduces a grant program to help states, territories, and tribal communities expand PrEP access and diminish disparities. This program also targets physicians, educating them about PrEP and its clinical practices. Furthermore, the act finances public campaigns to educate high-need communities about PrEP's safety and efficacy, aiming to combat-related stigmas. Unfortunately, this bill has yet to be reintroduced in the current legislative session.

Other massive gains are noteworthy. In August 2023, The United States Preventive Services Task Force, an independent advisory board of medical experts, strongly endorsed a more comprehensive range of H.I.V. prevention methods. Published in JAMA, the U.S. Preventive Services Task Force granted its top “grade A” recommendation to three PrEP medications, updating its prior nod to just Truvada. Descovy and the bi-monthly injectable, Apretude (cabotegravir), have joined the list. This means insurers would be legally required to cover Apretude and Descovy by January 2025. However, the previously mentioned lawsuit in the 5th U.S. Circuit Court of Appeals could overturn this ruling.

What comes next? The Intersection of Public Health and Courts 

In the ongoing healthcare rights and public policy saga, few drugs have garnered as much attention as PrEP. As an essential tool in the fight against HIV, PrEP has undeniably proven its effectiveness. However, the complex intersection of courts, public policy, and health has made its accessibility a hotly contested issue. 

The journey of PrEP bears a striking resemblance to the struggles faced by contraception in the U.S. Both represent significant advances in public health and have the potential to transform lives, particularly for marginalized communities. Employers and religious groups have contested both coverage, citing religious beliefs. Similar to the circuit case of Braidwood v Becerra, in Burwell v. Hobby Lobby Stores, Inc.,  in a 5-to-4 decision, the Supreme Court ruled that "closely held corporations" like Hobby Lobby could deny birth control coverage to their employees, setting a new precedent. Both rulings underscore a recurring tension- the intersection of individual and collective health benefits versus deeply held personal morals, corporate interests, and religious beliefs. 

The paths of PrEP, abortion, & contraception through the U.S. legal system are emblematic cases of how health advancements can become entangled in broader socio-political debates. The lengths of this battle have yet to be seen, considering Trump appointed 28% of all active federal judges, including 54 appellate and 174 district court judges.

The battle for PrEP seems far from the Supreme Court, but if the overturn of abortion, affirmative action, and LGBTQIA+ rights are any indication, it is closer than we may want to believe.