PrEP is used to prevent HIV infection.
The Supreme Court heard oral arguments last month in a case that could affect what kinds of preventive care services, technologies and medicines are covered at no charge to the patient as a result of provisions contained in the Affordable Care Act. This includes cancer screenings such as mammograms and colonoscopies, statins for heart disease, immunizations, counseling on health behaviors related to weight management, alcohol and drug use, prenatal testing and HIV prevention (preexposure prophylaxis) medications.
The case was brought by Braidwood Management, a Christian for-profit corporation owned by Steven Hotze, a Texas doctor and Republican activist who has previously filed multiple lawsuits against the ACA. While the Trump administration is defending the ACA law in the case in question, should the federal government win, the precise shape preventive care coverage requirements will take depends on the discretion of Secretary of Health and Human Services, Robert F. Kennedy. This is particularly relevant with respect to PrEP, as the administration has been cutting funds earmarked for HIV prevention, including treatment and research.
PrEP is nearly 100% effective at preventing infection. This facilitated it being covered at no cost for millions of people. Moreover, several large trials have demonstrated that a treatment called lenacapavir can also prevent HIV transmission with just two injections annually. The product is expected to be approved by the Food and Drug Administration for prevention later this year. However, it’s uncertain whether free access will be guaranteed.
The plaintiffs in the Braidwood case challenged the ACA’s requirement to cover preventive services, as explained in an issue brief published by KFF. In particular, the plaintiffs object to providing their 70 employees fully reimbursed access to PrEP. They argue that religious beliefs prevent them from doing so. Correspondingly, they allege that the requirement violates the Religious Freedom Restoration Act.
They further maintain that the U.S. Preventive Services Task Force is unconstitutional because its members are not appointed by the president or confirmed by the Senate. The Supreme Court is specifically considering whether USPSTF’s structure violates the U.S. Constitution’s Appointments Clause. USPSTF is an independent entity that makes recommendations regarding whether public health insurance programs should include certain preventive services. And the ACA requires all insurers, including those in the commercial sector as well as self-insured employers, to cover preventive services and technologies that are recommended by the USPSTF with no patient cost-sharing.
Besides public programs such as Medicare and Medicaid, a number of ACA requirements extend to the commercial sector. This means that over 150 million Americans with commercial health insurance can gain access to free preventive care through the ACA.
Under successive administrations, the federal government has argued that the USPSTF’s oversight by the Secretary of Health and Human Services is constitutionally appropriate because HHS may remove members at will and can determine when health insurance issuers must start providing coverage for new recommendations.
Should the administration prevail in the current case, it’s unclear what Kennedy will do to affect the precise coverage criteria for preventive care, including PrEP. The Secretary of HHS has considerable influence regarding the composition of the USPSTF task force and can support or override its recommendations. This has the potential to determine whether PrEP is available at no cost to patients and how generous the coverage is. For example, does an older, cheaper PrEP product get recommended over a newer, more expensive drug?
What may give pause are the large cuts that Kennedy has instituted across HHS agencies, which include substantial reductions in funding for HIV prevention, as reported by Politico. The secretary has also called for an eight-year pause in infectious disease research. And perhaps most notably, past remarks of Kennedy seem to question a causal relationship between HIV and AIDS. Moreover, the President’s Emergency Plan for AIDS Relief or PEPFAR, a global health program initiated 20 years ago by President George W. Bush, is presently barred under an order from the Trump administration from providing PrEP to LGBTQ+ people. The program may only provide pregnant and breast-feeding women with PrEP.
It’s not just the executive branch that is raising questions about the future of PrEP coverage. Republican lawmakers have signaled intentions to cut or alter a variety of healthcare programs that deliver PrEP. Last year, for example, the House of Representatives proposed $770 million in cuts to HIV-specific programs. GOP legislators are also talking about measures such as putting hard caps on Medicaid funding to states or diminishing the federal matching rate. Medicaid is a key payer in the HIV space.
Experts suggest that raising access or cost barriers for PrEP would disproportionately harm younger patients, people of color and those with lower incomes. Compounding this problem, the challenge in public health—particularly around diseases such as HIV—is often getting the message across to people in the most vulnerable communities, where disease and treatment awareness may already be subpar. Substantial reductions in funding for HIV prevention efforts could further hamper this public health messaging.
Insurance contracts are typically written and defined by calendar year, so whatever happens regarding the court case, people won’t see changes until 2026. Also, these services will still likely have to be reimbursed to some degree by health insurers as essential health benefits through a separate provision of the ACA. But they may not be free anymore and the comprehensiveness of coverage could be curtailed as under the essential health benefits clause, usually only one item in each therapeutic class has to be included.
