Braidwood Management Inc. threatens to upend recently enacted programs to curb new HIV cases

On June 5, 1981, the Centers for Disease Control (CDC) announced the presence of a rare form of pneumonia in five previously healthy gay men in its Morbidity and Mortality Weekly Report — it wouldn’t be until 1986 that the Reagan administration mentioned “AIDS” in public. Around this time, about 16,500 people had perished from AIDS. With the brave advocacy of groups such as ACT UP and medical advances, the landscape of HIV/AIDS prevention and treatment has changed dramatically; available daily or long-term (injectable) treatments not only dramatically improve the quality of life for those with HIV but will even suppress the amount of virus to undetectable levels and thus become untransmittable.

In addition to innovative HIV treatment, we now have better tools for prevention. PrEP, or pre-exposure prophylaxis, is a medicine that dramatically reduces a person’s chances of HIV infection by about 99%. Through a daily antiviral tablet or quarterly injection, the medicine helps stop the virus from spreading throughout the body when taken correctly. While the use of PrEP has increased since its first approval, only an estimated 36% of those eligible for the prevention tool have received a prescription. Additionally, the equity in PrEP usage by race and ethnicity has decreased. In 2019, the Trump administration enacted the Ending the HIV Epidemic (EHE), a multi-pillar initiative to dramatically reduce new HIV diagnoses and improve the quality of care for those living with HIV. However, the impact of EHE and other initiatives is under threat by the evolving case of Braidwood Management Inc. v. Becerra.  

One of the critical features of the Affordable Care Act, Section 2713, mandated the complete coverage of preventative services graded “A” or “B’ by the U.S. Preventative Services Task Force in private employer health plans. In 2019, the USPSTF issued an “A” grade for PrEP (expanding it to injectable PrEP in 2023), meaning that private plans were now required to cover PrEP without cost-sharing. While litigation surrounding the contraceptive coverage requirements of the ACA is nothing new (see Burwell v. Hobby Lobby), Braidwood targets the preventative care provisions mentioned above.

The plaintiffs in Braidwood brought forth significant challenges to the ACA preventative care mandate: they claimed that, among other things, the mandate violated RFRA because it substantially burdened the religious exercise of plaintiffs who objected to supplying PrEP on religious grounds and that recommendations violated Article II’s Appointments Clause. The District Court held that the USPSTF members were not adequately appointed under the Appointments Clause and rejected Braidwood’s nondelegation arguments. Thus, this challenge preliminarily struck down the preventative services mandate. While the Fifth Circuit stayed the District Court’s decision in May 2023, appellate oral arguments continued on March 4, 2024.

If the Fifth Circuit upholds the District Court’s decisions, not only would private employer plans have the discretion to choose whether to cover preventative services, but it would erase the progress the nation has made in HIV prevention and treatment. One report estimates that if PrEP coverage amongst men who have sex with men decreases from 28% to 10%, it will result in 2,083 new HIV diagnoses within the next year. However, all may not be lost entirely if the Fifth Circuit doesn’t decide in favor of HHS: one proposition suggests transferring authority to recommend PrEP from the USPSTF to the CDC’s Advisory Committee on Immunization Practice (ACIP). Although only time will tell, the Fifth Circuit may uphold the District Court’s ruling and such threatens the progress we have made in HIV-treatment and prevention.

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