AUSTIN, Texas — A group of Christians from Texas is suing to knock down many of the Affordable Care Act’s preventive care mandates, specifically targeting HIV drugs.
The federal government last year began requiring most insurance companies to fully cover HIV prevention medication known as PrEP, sold under the brand names Descovy and Truvada. But in a federal lawsuit filed in North Texas, a group who say they oppose homosexuality on religious grounds are suing to change these rules.
Their lawsuit says the federal system for determining which preventive care insurance companies must cover is unconstitutional and argues the plaintiffs, as people of faith, should be able to opt out of coverage for specific medicines like PrEP and contraception.
Their lawyer is former solicitor general Jonathan Mitchell, best known for helping write the Texas abortion law that empowers everyday citizens to sue people they believe have helped others get an abortion. This is one of at least six suits he is handling that could adversely affect the lives of LGBT Americans, including cases that target gay marriage and employment discrimination.
Physicians and public health experts say HIV rates, especially states like Texas, could increase if they win.
Dr. John Carlo, the former medical director for Dallas County, said although not specifically objected to by the plaintiffs, the lawsuit could put other popular preventive care services like cancer screenings at risk.
He also estimated PrEP usage could be cut in half if Mitchell’s clients win.
This could cause HIV cases to tick up, especially in places like Dallas that the federal government prioritized to lower virus rates. Higher HIV rates not only means more virus in the population, Carlo explained, but also more patients with high medical bills who would eventually pass on this cost to the entire health care system.
“You’d definitely see a resurgence in cases,” said Carlo, now the CEO of the HIV/AIDS nonprofit Prism Health North Texas. “It would be a huge step in the wrong direction for this country’s health.”
Mitchell declined to comment on the lawsuit.
What is PrEP?
During his last year in office, Donald Trump pledged to eliminate HIV in the United States by 2030. Prevention is a key part of the plan.
Most people can live long and healthy lives with HIV while on treatment but there is no cure.
PrEP, which stands for pre-exposure prophylaxis, got CDC approval a decade ago. Manufactured by California-based Gilead Sciences, Truvada and Descovy are once-daily pills. Health care providers can also administer PrEP by shot, under the brand name Apretude, once every two months.
The Centers for Disease Control say PrEP drugs, when taken as prescribed, can reduce the risk of getting HIV from sex by about 99% and by intravenous drug use by about 74%. Some PrEP drugs are also used, along with other drugs, in the treatment of HIV.
But PrEP usage has been slow to catch on.
Cost has been a huge reason. Before generics with list prices as low as $30 a month came on the market last year, the cost for a month’s worth of Truvada topped $1,700. Local HIV and AIDS clinics offered PrEP relief, the federal government issued explainers and even Gilead launched an assistance program.
Despite these hurdles, the CDC boasted that the drugs helped cut HIV infection rates 8% by 2019.
That year, an expert panel tasked with recommending preventive care best practices to the federal government gave PrEP its top rating. Under rules set out by the Affordable Care Act, the decision meant most insurers would be required to cover the drugs as well as associated doctor’s visits and lab tests with absolutely no out-of-pocket cost to the patient.
AIDS and HIV activists applauded the move, anticipating it could further reduce infections, especially among particularly vulnerable populations of Black and Latino men in areas like Texas and the Deep South.
Mitchell filed the lawsuit less than a year later.
Lawsuit targets ‘homosexual behavior’
The Texas suit argues, without providing proof, that PrEP encourages “prostitution, sexual promiscuity and intravenous drug use.”
The plaintiffs also include Fort Worth orthodontist John Kelley, Ashley and Zach Maxwell of Hood County and Joel Miller of Parker County. Miller does not have religious objections to this coverage but says he does not need contraceptive coverage because his wife is past her childbearing years.
Kelley and the Maxwells said they don’t “need or want” PrEP coverage because neither they nor any of their family members “are engaged in behavior that transmits HIV.”
The lawsuit says they also do not want coverage for free STD testing because they are in monogamous relationships. Kelley believes he should be allowed to opt out of this coverage for himself, and the staff he employs at Kelley Orthodontics.
The plaintiffs want the court to rule that insurance companies should have to offer plans that do not cover these preventive services — a carve-out for religious objectors.
“Each of these plaintiffs is a Christian, and they are unwilling to purchase health insurance that subsidizes abortifacient contraception or PrEP drugs that encourage and facilitate homosexual behavior,” the lawsuit stated.
HIV can be transmitted through blood, breast milk, semen, rectal and vaginal fluids, as well as to a child during pregnancy, according to the CDC.
Steve Hotze, physician and political activist, is another plaintiff. Hotze has been a lead supporter of anti-LGBT causes like the so-called bathroom bill and the successful effort to repeal Houston’s equal rights ordinance. He has said he believes LGBT people are “ungodly” and “wicked.”
Hotze and Kelley did not respond to interview requests.
The case is before U.S. District Court Judge Reed O’Connor, a George W. Bush appointee who ruled that Obamacare is unconstitutional. In recent years, O’Connor has become the go-to judge for conservatives seeking favorable rulings on hot-button issues like transgender rights.
A year ago, the judge ruled that a group of religious health care providers need not perform abortions or gender-affirming medical treatments. The Fifth Court of Appeals upheld that decision on Monday.
This month, O’Connor agreed to change the lawsuit’s title to swap Kelley’s name for that of Hotze’s Katy-based health care business. Media coverage of the case had “triggered a wave of threats and cyberbullying” against Kelley and his family, Mitchell wrote in a court filing.
PrEP and the Supreme Court
The government’s lawyers argue Mitchell does not have a case, stating that the mechanism for choosing preventive care coverage mandates is constitutionally sound.
The American Medical Association and dozens of other health care organizations blasted the lawsuit in July, noting access to more than just PrEP could be at stake if the plaintiffs win.
“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, obesity, diabetes, preeclampsia, and hearing, as well as well child visits and access to immunizations critical to maintaining a healthy population,” their statement read.
The American Public Health Association and Association of American Medical Colleges also filed an amicus brief supporting the government.
“Preventive screenings and interventions such as those covered by the ACA are critical to keeping patients healthy and improving long-term health outcomes,” they wrote.
Doron Dorfman, a professor at Seton Hall Law School who researches insurance law and PrEP availability, said this isn’t the first time there has been a religious challenge to the Affordable Care Act’s care mandates.
In 2014, the U.S. Supreme Court narrowly ruled that Hobby Lobby could cite the owners’ Christian faith to decline to cover contraception for its employees. However, that decision applied only to certain for-profit corporations run on religious principles.
What differs now, Dorfman said, is the court after it overturned Roe vs. Wade has signaled it is more open to entertaining challenges to federal government authority and LGBT rights.
“People like this lawyer, who filed a bunch of suits, who is a serial litigator in this area, existed throughout history,” Dorfman said, referencing Mitchell. “I do think the makeup of the Supreme Court and other federal courts make me more concerned.”
In an interview earlier this year, Mitchell said everyone deserves representation.
“White-shoe law firms represent murderers, al-Qaeda terrorists and child molesters like Jeffrey Epstein,” Mitchell told The Dallas Morning News. “Of course, none of those law firms would represent Dr. Hotze, and they would ostracize any lawyer who does. But I don’t enforce a political-correctness test for the clients that I represent.”
Doctors on PrEP
Health care experts said they worry that fewer people will have access to PrEP if Mitchell’s clients win their fight. This could result in higher rates of HIV that would have negative health and financial implications for the entire country.
The federal coverage mandate not only requires the drugs to be made available with no out-of-pocket cost to the patient, but also services like quarterly blood screening and HIV tests. Even with a new generic PrEP drug finally on the market, the combined costs of the drugs and services could price out some patients if full coverage is no longer required.
Plus, some doctors won’t want to switch their patients to the generic version, which is only available for Truvada. Descovy, a newer drug, has been shown to be safer for kidney and bone health.
Carlo warned that allowing for religious carve-outs in coverage could incentivize cost-averse insurance companies to stop covering expensive preventive drugs and services altogether. People living with HIV pay roughly $700,000 in added health care costs over the course of their lifetime.
“It would further disenfranchise people in this country and limit actual health care coverage,” he said. “It’s taking away individual civil liberties through the idea that a company has the authority to tell people what they can and can’t have for health care.”
Christopher Hamilton, CEO of the nonprofit health care provider Texas Health Action, agreed that higher out-of-pocket costs will mean less PrEP usage and more infections.
“You will have to pay more, and that also means that less people will probably have access or utilize this medication and we may see an increase in the number of new HIV diagnoses,” he said. “When people have to pay for prevention, they don’t usually.”
HIV and Dallas
Texas, and Dallas in particular, could be hit particularly hard by new HIV diagnoses.
About one in 10 of the more than 29,000 Americans diagnosed with HIV in 2020 live in Texas, according to the CDC. Dallas had the second-highest number of new HIV cases in the state that year, behind Harris County.
Yet fewer than one in five people at risk for HIV in Dallas County were on PrEP in 2020, CDC data show.
This is worse than the state and national usage averages — and pales in comparison to Travis County, where more than 40% of people who should take PrEP are on it. While HIV rates are highest among Black and Latino men, PrEP usage is far higher in the white community.CDC data shows the disease also impacts people who are not members of the LGBT community. One in five new infections in 2019 were among women — nearly all of whom attributed it to heterosexual contact.
Jeremiah Johnson, the PrEP program director at PrEP4All, a national organization that seeks to make PrEP more accessible, warned there are real-world consequences to legal fights like these.
“We have real problems in getting PrEP equitably out to communities and the communities that most need it. So a lawsuit like this is absolutely going to make that more difficult,” Johnson said. “This is going to punish real people.”
