U.S. District Judge Reed O'Connor also agreed that aspects of the federal government's system for deciding what preventive care is covered by the ACA violates the Constitution.
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The video above is about the HIV-prevention pill PrEP being covered under most insurance plans.
O'Connor's ruling could threaten access to sexual and reproductive health care for more than 150 million working Americans who are on employer-sponsored health care plans. It is likely to be appealed by the federal government.
This lawsuit is the latest in a decade of legal challenges to the Affordable Care Act, many of which have run through O'Connor's courtroom. In 2018, O'Connor ruled that the entirety of the ACA was unconstitutional, a decision that was struck down by the U.S. Supreme Court.
At issue in the class-action lawsuit is a 2020 mandate requiring health care plans to cover HIV prevention medication, known as PrEP, free of charge as preventive care.
In the suit, a group of self-described Christian business owners and employees in Texas argue that the preventive care mandates violate their constitutional right to religious freedom by requiring companies and policyholders to pay for coverage that conflicts with their faith and personal values.
The lawsuit was filed in 2020 by Austin attorney Jonathan Mitchell, the legal mind behind Texas' civilly enforced six-week abortion ban. In the suit, Mitchell also challenges the entire framework through which the federal government decides what preventive services get covered.
O'Connor threw out several of Mitchell's arguments but agreed that the U.S. Preventive Services Task Force's system for deciding what health care services are required to be fully covered under the ACA violates the Appointments Clause of the U.S. Constitution.
"At a high level, this lawsuit is part of a larger pushback against the government's ability to regulate," said Allison Hoffman, a law professor at Penn Carey Law at the University of Pennsylvania. "And then also asking what happens when regulations and religion clash."
One of the plaintiffs, Dr. Steven Hotze of Katy, often sues the government and elected officials over politically charged issues, including fights with GOP state leaders over emergency COVID-19 orders and an attempt to stop Harris County from expanding voter access.
In the complaint, Hotze said he is unwilling to pay for a health insurance plan for his employees that covers HIV prevention drugs such as Truvada and Descovy, known generally as PrEP, "because these drugs facilitate or encourage homosexual behavior, which is contrary to Dr. Hotze's sincere religious beliefs."
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PrEP reduces the risk of getting HIV by 99% when taken as recommended, according to the U.S. Centers for Disease Control and Prevention. In spite of the assertions by the Christian group in Texas, the CDC also says that 1 in 5 new cases are in women, not men who have sex with men.
"The virus doesn't choose who to infect, it can infect anyone," said Dr. Satish Mocherla, an infectious disease specialist at Legacy Community Health Services in Dallas. "So why a particular demographic is being targeted is a mystery to us."
And contrary to what the lawsuit asserts, PrEP does not "facilitate or encourage homosexual behavior," said John Carlo, CEO of Prism Health North Texas and former public health director of Dallas County. "PrEP prevention research shows that its use does not increase risky behaviors or cause people to have more sex or use more intravenous drugs when using it," Carlo said. "This is well studied."
The other plaintiffs, including John Kelley, a Tarrant County orthodontist, claim they "do not need or want contraceptive coverage in their health insurance. They do not want or need free sexually-transmitted disease testing covered by their health insurance because they are in monogamous relationships with their respective spouses. And they do not want or need health insurance that covers Truvada or PrEP drugs because neither they nor any of their family members are engaged in behavior that transmits HIV."
Kelley was previously the named plaintiff in the case, but the name was changed last month "because the media coverage of this case has triggered a wave of threats and cyberbullying" against Kelley, according to a motion.
Wide-reaching consequences
The lawsuit specifically addresses PrEP, but O'Connor's ruling, which addresses how the federal government can decide what preventive care is covered in employer health care plans, may end up having much more wide-reaching consequences, Hoffman said.
"We're talking about vaccines, we're talking about mammograms, we're talking about basic preventative health care that was being fully covered," she said. "This is opening the doors to things that the ACA tried to eliminate, in terms of health plans that got to pick and choose what of these services they fully covered."
The American Medical Association, along with 60 leading medical organizations, issued a statement condemning the lawsuit.
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"With an adverse ruling, patients would lose access to vital preventive health care services, such as screening for breast cancer, colorectal cancer, cervical cancer, heart disease, diabetes, preeclampsia, and hearing, as well as access to immunizations critical to maintaining a healthy population," the organizations wrote.
While implementation has not been as universal as hoped, fully funded preventive care through the ACA has been shown to be largely effective at improving health outcomes, reducing health care spending and increasing uptake of these services.
"The idea that an employer can shop a la carte for policy coverage goes against what we have learned over the last decade in the effort to end the HIV epidemic," said Carlo, the former Dallas County health director. "This takes us into the wrong direction, and we have only just begun to head into the right one."
At Legacy Community Health Services in Houston, where patients include a large population of those receiving PrEP, the lawsuit has begun to worry those who rely on their insurance to cover their treatment - and those patients are not restricted to members of the LGBTQ community, Mocherla said.
They include hemophiliacs and others who are vulnerable to HIV infection, Mocherla said. The rate of infection since the introduction of pre-exposure prophylaxis has declined in almost every demographic, he said.
Allowing companies to drop free coverage would prevent many of Legacy's patients from being able to afford the treatment, Mocherla said, and would reverse that historic trend of declining HIV rates.
Shutting down access right now, while "we are on the verge of a breakthrough," would set back the effort to eradicate the deadly virus by decades, he said.
"Without prevention, how can you cure the disease?" Mocherla said. "It's just shocking. ... And if ending the HIV epidemic is dear to anyone's heart, we cannot leave prevention aside. And that's why we are mystified. We are all very dismayed."
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