The Supreme Court on Friday granted the HIV-prevention field a historic win — yet with a major caveat — as it upheld a federally appointed health task force’s authority to mandate no-cost insurance coverage of certain preventive interventions, but clarifying that the Health and Human Services secretary holds dominion over the panel.
The 6-3 decision in Kennedy v. Braidwood Management, Inc. essentially leaves in place a popular pillar of the Affordable Care Act, which mandates that most insurers cover various task force-recommended preventive screenings, therapies and interventions, with no out-of-pocket costs imposed on patients. The case reached the high court after a group of Christian businesses in Texas objected to being compelled to cover a certain drug used for HIV prevention, known as PrEP, given their claims that it “promotes homosexuality.”
“Since our efforts to address HIV in the U.S. are under attack on so many levels, preserving insurers’ requirement to cover preventive services, including PrEP, will help ensure access to people who need it,” said Carl Schmid, executive director of the HIV + Hepatitis Policy Institute, a patient advocacy group in Washington, D.C.
But the court clarified the scope of the task force’s independence, thus potentially compromising its impact. Addressing concerns that the 16-member volunteer task force’s power over insurers was unconstitutional, the justices asserted that the health secretary holds the authority to appoint and dismiss the panelists and to block their new recommendations from mandating insurance coverage. The secretary could also possibly direct the panel, including one stocked with his or her own hand-picked members, to revisit previous recommendations that have already gone into effect.
Given the unpredictable nature and unconventional approach to health policy of the current health secretary, Robert F. Kennedy Jr., HIV advocates are concerned that he might undermine the task force’s current or future endorsements of HIV-prevention medications, known as PrEP.
The ruling “is a victory in the sense that it leaves intact the requirement to cover task-force recommendations,” said attorney Richard Hughes, a partner with Epstein Becker Green in Washington, D.C., who represented a group of HIV advocacy organizations in submitting a friend-of-the-court brief in the casel. “It was always going to be a double-edged sword, as the political accountability that salvaged its authority comes with the ability to alter its recommendations.”
The U.S. has secured only a modest decline recently in HIV cases, and HIV advocates stand at a crossroads amid the Trump administration’s dramatic withdrawal of support for their cause.
Promisingly, the Food and Drug Administration last week approved a long-acting injectable form of PrEP, Yeztugo, made by Gilead Sciences. Injected every six months, Yeztugo overwhelmingly bested Truvada, a daily-pill form of PrEP also made by Gilead, at lowering HIV transmissions in clinical trials.
But Yeztugo has debuted as the Trump administration is gutting the Centers for Disease Control and Prevention’s HIV-prevention division and after it canceled scores of HIV-related research grants.
HIV experts have warned that this upheaval could lead HIV to rise again.
Kennedy v. Braidwood Management, Inc.
The plaintiffs’ initial religious-liberty complaint was ultimately dropped from the case. The court more narrowly considered the constitutionality of an ACA provision that lent effective authority to a longstanding volunteer medical task force to mandate no-cost insurance coverage to preventive interventions that the expert group rated highly, including PrEP.
The plaintiffs argued that because the task force was not appointed by the president and confirmed by the Senate, granting it such power over insurance markets violated the Constitution’s appointments clause. The justices grappled with the task force’s balance of independence versus accountability. In particular, they sought to determine whether the task force members were appointed by the Senate-confirmed Health and Human Services secretary.
In addition to PrEP, the task force has issued high scores, for example, to screening for lung cancer, diabetes, and HIV; treatment to help quit smoking; and behavioral counseling to prevent heart disease.
Had the Supreme Court fully sided with the plaintiffs, insurers would have been free to drop such popular benefits or, at the very least, to impose related co-pays and other cost sharing.
Writing for the majority, Justice Brett Kavanaugh found that the health secretary has the power “to appoint Task Force members, and no statute restricts their removal.” He was joined by an ideological mix of colleagues, including Chief Justice John Roberts and Justice Amy Coney Barrett on the right, and Justices Sonia Sotomayor, Elena Kagan and Ketanji Brown Jackson on the left.
Concerns and uncertainty about Kennedy
HIV advocates expressed concern that Kennedy might undo the task force’s recommendation for PrEP, or at the least deprioritize ensuring that Yeztugo receives a clear coverage mandate.
Earlier this month, Kennedy dismissed the entire CDC Advisory Committee on Immunization Practices, or ACIP, and replaced them with his own hand-picked selections, including one notable anti-vaccine activist. At the first meeting of the newly formed committee this week, ACIP dropped recommendations for some flu vaccines over claims, widely debunked by researchers, that one ingredient in them is tied to autism.
Mitchell Warren, executive director of the HIV advocacy nonprofit AVAC, expressed concern about “what happened with the CDC ACIP this week, as it could be a harbinger of what a secretary of HHS can do to twist committees and task forces that should be composed of experts guided by science to ones that are guided by ideology and politics.”
In an email to NBC News, Carmel Shachar, faculty director of the Health Law and Policy Clinic at Harvard Law School, characterized Kennedy’s potential approach to overseeing the health task force as unpredictable.
“RFK has been skeptical of the medical approach to HIV/AIDS in the past, and that may color his attitude to revising PrEP guidance,” Shachar said.
HHS did not immediately respond to a request for comment about the HIV advocates’ concerns.
In 2019, the health task force granted Truvada as PrEP a top rating. The drug was already widely covered by insurers. But under ACA rules, the task force’s recommendation meant that by January 2021, insurance plans needed to cease imposing cost-sharing for the drug.
The Centers for Medicare and Medicaid Services, or CMS, then clarified that insurers were also forbidden to impose cost sharing for the quarterly clinic visits and lab tests required for a PrEP prescription.
A CDC study published in October found that about 200,000 people were using PrEP at any point in 2023.
In 2019, the FDA approved another Gilead daily pill, Descovy, for use as PrEP. In late 2021, ViiV Healthcare’s Apretude — an injection given every two months — was also green lit.
The health task force gave top ratings to both of the newer forms of PrEP in 2023, which triggered a mandate for no-cost coverage to begin in January.
A generic version of Truvada emerged in 2020 and now costs as little as $30 per month. The list prices of the three brand-name PrEP drugs range from about $2,200 to $2,350 a month.
How the court’s ruling could play out for HIV prevention
Were Kennedy to appoint task force members who ultimately voided the PrEP coverage mandate, generic Truvada, at the very least, would still likely remain widely covered by insurance. But insurers would be free to demand cost-sharing for all forms of PrEP, including for required clinic visits and lab tests. And they could restrict access to the more expensive versions, including by imposing prior authorization requirements and higher cost sharing.
Research suggests that even a small increase in monthly out-of-pocket costs for PrEP can depress its use and that those who accordingly forgo a prescription are especially likely to contract HIV.
Johanna Mercier, Gilead’s chief commercial officer, said even before the health task force’s 2023 insurance mandate for Descovy went into effect in January, the drug’s coverage was still pretty solid. Private insurers provided unrestricted coverage of Descovy for PrEP to 74% of commercially insured people, and 40% of prescriptions for the drug had no co-pay. After the mandate went into effect — including after CMS released a clarification on the PrEP-coverage mandate in October — those rates increased to 93% and 85%, respectively.
This experience, Mercier said, has left the company optimistic that an increasing proportion of health plans will cover Yeztugo during the coming months.
Health-policy experts are not certain whether the existing PrEP rating from the task force automatically applies to Yeztugo, or whether the drug will require its own rating to ensure coverage comes with no cost sharing.
If Apretude’s history is any guide, a requirement for Yeztugo to receive a specific rating could delay a no-cost insurance-coverage mandate for the drug from going into effect until January 2027 or 2028.
It’s also possible that CMS could release guidance clarifying that the existing mandate for PrEP coverage applies to Yeztugo, which would likely have a more immediate impact on coverage.
However, Elizabeth Kaplan, director of health care access at Harvard’s Health Law and Policy Clinic, said in an email that “given this administration’s and RFK’s stated priorities,” the publication of a guidance on Yeztugo coverage by an HHS division “appears unlikely.”
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