Report Challenges Court Decision on PrEP and Public Health

blue PrEP pills and a prescription bottle

A new report from a team of medical, public health, and legal experts challenges a federal court decision ruling it unconstitutional to mandate employer-sponsored insurance coverage of Pre-Exposure Prophylaxis (PrEP), a highly effective biomedical measure for preventing HIV. The decision, the authors show, fails to address the scientific evidence, slights the compelling public interest in HIV prevention, engages in invidious stereotyping of LGBTQ people, and creates a loophole by which employers could deny insurance coverage for nearly any medical condition for any group whose conduct is disfavored by a religious belief.

The report, “Braidwood Misreads the Science: the PrEP Mandate Promotes Public Health for the Entire Community” was issued on Feb. 13, 2023 by co-authors Meredithe McNamara, M.D., M.Sc. (Yale School of Medicine); Dini Harsono, M.Sc. (Yale School of Public Health); E. Jennifer Edelman, M.D., M.H.S. (Yale School of Medicine); Aliza Norwood, M.D. (University of Texas at Austin Dell Medical School), Samantha V. Hill, M.D., M.P.H. (University of Alabama at Birmingham); A. David Paltiel, Ph.D., (Yale School of Public Health, Yale School of Management), Gregg Gonsalves, Ph.D. (Yale School of Public Health); and Anne Alstott, J.D. (Yale Law School).

“Our goal with this report is to inform litigation and policy with scientific evidence that demonstrates the compelling public interest in unfettered access to PrEP,” said McNamara. “PrEP is an extremely valuable preventative currently benefiting many individuals who are at risk for HIV.”

In September 2022, a federal district judge in Texas ruled in favor of plaintiffs challenging the federal mandates that require private insurance policies to cover PrEP, a class of medications that is highly effective in preventing HIV infection. PrEP has been celebrated as a major success in the global fight to end HIV, and the United States Preventive Services Task Force (USPSTF) recommends PrEP as evidence-based care to promote HIV prevention. Federal law requires most private insurers to cover preventive care that are strongly recommended by the USPSTF.

The Texas lawsuit, Braidwood Management v. Becerra, granted two separate legal challenges to the PrEP mandate. First, the court held that the process for appointing the USPSTF violated the Appointments Clause of the U.S. Constitution. Plaintiffs have requested a nationwide injunction, which could invalidate all preventive care mandates issued by the USPSTF, including cancer screenings, immunizations, and medications that treat diabetes and help control cholesterol.

Second, the judge ruled that the PrEP mandate violates the plaintiff’s rights under the Religious Freedom Restoration Act (RFRA). The owner of Braidwood had alleged that “providing coverage of PrEP drugs ‘facilitates and encourages homosexual behavior, intravenous drug use, and sexual activity outside of marriage between one man and one woman,’ and [that] providing coverage of PrEP drugs in Braidwood’s self-insured plan would make him complicit in those behaviors.”

Several medical societies, including the American Medical Association and the American Cancer Society, have emphasized the importance of USPSTF mandates for public health. The new report adds a focus on PrEP and argues that the Braidwood decision disregards the compelling state interest in HIV prevention via private insurance and fails to consider the state’s compelling interest in LGBTQ equality. 

The co-authors produce new empirical evidence to show that the public health consequences of a nationwide injunction against the PrEP mandate would be serious and adverse. They found that if PrEP coverage among men who have sex with men is reduced from its current base value of 28% to 10%, the result would be an expected additional 2,083 new HIV infections (up from a base of 28,200 infections) in the coming year. This is a conservative estimate, the authors explain, and does not take into account the detrimental effect to other communities.

Additionally, the report shows that the decision constructs a religious exemption that rests on unfounded empirical assertions. As framed, the exemption could open a legal loophole for nearly any business to deny insurance coverage on religious grounds, since courts cannot reliably distinguish between sincere and insincere religious beliefs.

“The Braidwood exemption is dangerously permissive and discriminatory. As framed, it could permit nearly any business to claim a religious exemption and opt out of virtually any type of preventative measure or health care,” said Alstott.

According to the report, scientific evidence shows that the state has a compelling public interest in enforcing the PrEP mandate, which benefits everyone as a public health measure, much like a vaccine. But the decision frames PrEP as a niche treatment that only benefits some individuals.

“Behaviorally vulnerable populations including youth and LGBTQIA+ people, as well as heterosexual people living in the Southern U.S., will be particularly harmed by the Braidwood ruling, which has the potential to further worsen disparities in HIV in this region of the country,” said Hill.

The impact of the decision in the Texas case is not limited to individuals who take PrEP, the authors warn. “If the Braidwood court decides to adopt an injunction against the PrEP Mandate and to grant a religious exemption to PrEP insurance coverage, the Braidwood decision will undermine public health for all,” they write.