Supreme Court argues procedure over PrEP

No one talked about HIV prevention drugs or breast cancer screenings at the U.S. Supreme Court Monday, April 21, but federal funding for those critical medical efforts and others were at jeopardy in the case before it: Health and Human Services v. Braidwood (aka Kennedy v. Braidwood). While talk on the surface was all about procedure and the meaning of various words within relevant constitutional clauses and statutes, the court's eventual decision could put controversial medications on a trapdoor controlled by political or religious hostilities.

The battleground is the federal Affordable Care Act (ACA). When Congress passed the ACA 15 years ago, the legislation included a requirement that health insurance coverage provided by private employers include certain "preventive health services" at no cost to employees. Congress designated the existing U.S. Preventive Services Task Force (PSTF) to recommend which preventative treatments would be so covered.

Fast-forward to six years ago: The PSTF recommended coverage be extended to pre-exposure prophylaxis (PrEP) to help prevent HIV infection. According to a brief filed by Lambda Legal for Equality California and 34 AIDS organizations, PrEP "reduces the risk of acquiring HIV from sexual contact by approximately 99%." And quoting a U.S. Centers for Disease Control and Prevention paper, the brief added that, "Increased use of PrEP has been linked to a decline in national HIV transmission rates, particularly among young people."

Jose Abrigo, head of Lambda's HIV work, said in a video press release that the case is also about much more than just PrEP.

"This case is about a pillar of the Affordable Care Act —a preventive care pillar of the Affordable Care Act: Cancer screenings, diabetes testing, maternal health services, STI screenings [for sexually transmitted illnesses]." If the court rules for the Braidwood clinic that brought the lawsuit, said Abrigo, "People will have to choose between putting food on the table or getting a mammogram...."

Hashim Mooppan, principal deputy solicitor general for the Trump administration, told the court that the HHS Secretary has ample supervision over the PSTF —he can remove its members "at will" and prevent any recommendation from taking effect.

"In addition, he can require the Task Force to obtain his pre-approval before they issue any recommendation at all," said Mooppan.

Chief Justice John Roberts noted that "What the Task Force does is fairly technical, medically and scientifically. Is the Secretary really supposed to be in the position of going down the line and saying [to the PSTF members], 'I know you think we should use this particular thing with this atomic structure and all that kind of stuff, but I've got a different view on that.' Is that a pertinent consideration in deciding whether they're adequately supervised?"

Mooppan replied that the Secretary "clearly has the authority to do so."

Justice Neil Gorsuch jumped in to note that the authority of the Secretary to appoint the members was not confirmed by the Fifth Circuit decision. (The PSTF website indicates the Secretary appoints them.) Gorsuch wondered whether that issue should be sent back to the appeals court. Mooppan urged the court to make a ruling on the matter.

Jonathan Mitchell, attorney for Braidwood, said the PSTF's "preventive care coverage mandates are neither directed nor supervised by the Secretary of Health and Human Services or by anyone else who has been appointed as a principal officer."

"And it is not even clear that Congress would have approved a regime in which politicians, rather than an independent Task Force, decide the preventive care that insurers must cover," said Mitchell. He said he doesn't agree with the Trump administration's argument that the HHS Secretary can exercise all sorts of power over the PSTF.

"We don't see any way that statutory language can be squared with the regime envisioned by the government, where the Secretary can come in and influence the Task Force decisions on the front end —which Mr. Mooppan once again acknowledged at oral argument he believes the Secretary can do that. And we don't see how that can be squared with the actual statutory language."

Braidwood Management, which oversees a Houston holistic medical practice, couched its legal objection to PrEP in procedural terms: It claims the president should appoint each of the 16 members of the PSTF, and the Senate should confirm them. The Trump administration is relying on the Constitution's Appointments Clause which requires the president appoint and Senate confirm any "officer" of the U.S. government who has "significant authority." But Braidwood argued that the president does not need to appoint the PSTF members if the Secretary of Health and Human Services can review and reject any of the PSTF's recommendations.

In its original lawsuit, Braidwood contended the requirement that employers cover PrEP forces the company to "encourage homosexual behavior, intravenous drug use, and sexual activity outside of marriage between one man and one woman." And the company says that violates their religious beliefs.

The Biden administration, which was in office January 10 when the Braidwood case was accepted for review by the Supreme Court, appealed the Fifth Circuit U.S. Court of Appeals decision. Braidwood, which lost at the district and circuit court levels, also filed an appeal of the Fifth Circuit decision, but the Supreme Court declined Braidwood's petition on January 13.)

The Fifth Circuit upheld the federal district ruling that said PSTF members should be appointed under the Appointments Act. But it said that, while the HHS Secretary has the authority to remove any member, it does not have authority to reject any PSTF recommendation.

Braidwood Management's original lawsuit claimed the company objects to covering the cost of PrEP. According to various briefs in the case, Dr. Steven F. Hotze owns Braidwood, and Braidwood manages the Hotze Health and Wellness Center in Houston. The center identifies as "holistic" and provides numerous treatments, many involving "bioidentical hormones." The Fifth Circuit decision noted that Dr. Hotze considers Braidwood to be a Christian business and that it refuses to hire LGBTQ+ people.

Braidwood claims it has religious objections to homosexuality and that by making the company provide coverage for PrEP, the government is making Braidwood complicit in facilitating homosexual activity. (Court briefs indicate that none of the company's 70 employees ever sought coverage for PrEP.)

The U.S. Preventive Services Task Force sits within the Public Health Service of the Department of Health and Human Services (HHS). Its members are currently appointed by the HHS Secretary to four-year terms.

The legal question the Supreme Court agreed to consider was whether the Fifth Circuit erred when it (1) held that the structure of the PSTF violates the Appointments Clause, and (2) unduly insulates the Task Force from the HHS Secretary's supervision.

"Millions of Americans rely on insurance coverage for preventive services without cost sharing. If allowed to stand," wrote the Biden administration in its petition to the Supreme Court, "the decision below would call into question the legal duty of insurance issuers and group health plans to cover" any preventive service recommended by the Task Force.

A U.S. district court and the Fifth Circuit U.S. Court of Appeals held that the HHS task force members are covered by the Appointments clause and should have been appointed by the President and confirmed by the U.S. Senate. The Fifth Circuit disagreed with the district court solution: to vacate all actions by the task force, including that it could not enforce the preventive-care mandates against Braidwood.

Most groups submitting briefs to the Supreme Court expressed support for funding PrEP, including the American Medical Association, The American Association of Public Health, and the American Cancer Society.

Tomorrow morning, the U.S. Supreme Court will hear arguments in a case that asks whether parents can have storybooks for elementary school children banned from use because they include LGBTQ+ characters. To listen live at 10 a.m., go to. Supreme Court home page and click on "Live Audio."

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