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Obamacare can't require coverage
for some HIV drugs, federal judge rules
Texas judge rules HIV [PrEP] drug mandate violates religious freedom
  Sept 7
A federal judge in Texas on Wednesday ruled that a provision in the Affordable Care Act that requires businesses to provide health insurance offering HIV-preventative drugs violates the religious freedom of a Christian-run business.
The ruling from U.S. District Judge Reed O'Connor focuses on claims from Braidwood Management, a Christian for-profit corporation owned by Steven Hotze, that its rights were violated by the mandate under the Religious Freedom Restoration Act.
At the center of the decision are pre-exposure prophylaxis drugs, or PrEP drugs, which research has showed these reduce the risk of contracting HIV from sex by about 99%. But Hotze, whose company provides health insurance to about 70 employees, argued that offering coverage for PrEP drugs encouraged "homosexual behavior" and violated "his religious beliefs by making him complicit in encouraging those behaviors."
"Braidwood has shown that the PrEP mandate substantially burdens its religious exercise," O'Connor wrote in the decision.
He added that the defendants, including Department of Health and Human Services Secretary Xavier Becerra, failed to prove that the PrEP mandate can critically reduce the spread of HIV when applied to employers like Braidwood. The agency didn't immediately respond to a request for comment.
It's unclear what impact the ruling could have on other employers that offer ACA-compliant health care to their workers, although it comes after other companies have successfully argued they should be able to decline to provide coverage of preventative health care due to religious objections.
Currently, there are three types of PrEP drugs approved by the FDA, including Truvada and Descovy, which are both manufactured by drugmaker Gilead Sciences.
For instance, the owners of arts and crafts store Hobby Lobby filed a lawsuit in 2012 citing their Christian faith in objecting to providing employee health care coverage for certain types of contraception. In 2014, the Supreme Court ruled in their favor, allowing the company and other private firms to sidestep an Obamacare requirement to cover birth control if it violates their rights under the Religious Freedom Restoration Act.
Texas judge deems Obamacare HIV prevention drug mandate unlawful
Sept 7 2022
Sept 7 (Reuters) - A requirement under the U.S. law known as Obamacare that private insurance plans cover drugs that prevent HIV infection at no cost to patients violates both federal law and the Constitution, a federal judge ruled on Wednesday, siding with conservative lawyers who had challenged the measure on religious grounds.
Ruling in Fort Worth, Texas, U.S. District Judge Reed O'Connor found that the HIV pre-exposure prophylaxis, or PrEP, mandate stemmed from a recommendation by an advisory body formed in violation of constitutional requirements and could infringe upon the rights of employers under a law called the Religious Freedom Restoration Act. The mandate is part of the Affordable Care Act (ACA), as Obamacare is formally called.
The legal challenge was filed in 2020 by eight individuals and two businesses, all from Texas. They argued that the free PrEP requirement, as well as free coverage requirements for contraceptives and the human papillomavirus (HPV) vaccine, requires business owners to pay for services that "encourage homosexual behavior, prostitution, sexual promiscuity and intravenous drug use" despite their religious beliefs.
The conservative America First Legal Foundation is helping to represent the plaintiffs. The group was founded by Stephen Miller, who served as an adviser to Republican former President Donald Trump.
The American Cancer Society Cancer Action Network said in a statement that the ruling could threaten free preventive care more broadly, including routine cancer screenings. O'Connor, an appointee of Republican former President George W. Bush, ruled in 2018 in a previous case that the ACA, a landmark U.S. healthcare law signed by Democratic former President Barack Obama in 2010, was unconstitutional.
The Supreme Court subsequently ruled in 2021 that Texas and other states that had challenged Obamacare with the support of Trump's administration lacked the proper legal standing to pursue that case. The ACA has survived several reviews by the U.S. Supreme Court. read more
O'Connor has not yet specified how his new ruling will be enforced. It is not clear what the judge's decision means for the advisory body, called the Preventive Services Task Force (PSTF), which is convened by an official of the U.S. Department of Health and Human Services (HHS) and recommends a wide range of preventive services to be covered under the ACA.
The judge found that the U.S. Constitution requires that the task force's members be appointed directly by the president.
O'Connor has not yet ruled on the challenge to the contraceptives mandate and rejected the challenge to the HPV vaccine mandate. The HPV vaccine sold by Merck & Co (MRK.N) prevents cancers caused by the virus.
HHS said in a statement that it "continues to work to ensure that people can access healthcare, free from discrimination."
A lawyer for the plaintiffs had no immediate comment.
The PrEP drugs approved in the United States to prevent HIV infection, which can cause AIDS, are made by Gilead Sciences Inc (GILD.O) and by ViiV Healthcare, a joint venture of GSK Plc (GSK.L), Pfizer Inc (PFE.N) and Shionogi & Co Ltd (4507.T).
A GSK spokesperson said PrEP coverage was "critical to ensuring health equity and helping end the HIV epidemic" and that the company would follow the case as it develops.
Key pieces of the Affordable Care Act are in limbo on Wednesday following a ruling from federal district court Judge Reed O'Connor, who sided with a group of Texans challenging the law's requirement that insurers cover certain preventive health services including STD screenings and HIV prevention drugs.
link to court ruling -
Federal judge rules HIV drug mandate violates religious freedom
District judge previously ruled entire 2010 health care law was unconstitutional
A federal judge in Texas on Wednesday ruled that requiring employers to provide the HIV prevention drug PrEP violates their religious freedom.
The judge, Reed O'Connor of Fort Worth, also called into question mandatory coverage of all preventive health care services - a stance that could have a wide-ranging impact on the future of the 2010 health care law.
That law requires employers to provide preventative care, and Reed's ruling is not the first time the Texas judge has issued a decision to chip away at the law. In 2018, O'Connor ruled the entire health law was unconstitutional, a ruling the Supreme Court overturned in 2021.
In the case at hand, Braidwood Management Inc. et al. v. Becerra, six individuals and two businesses challenged the legality of the preventive care mandates under the Constitution and Religious Freedom Restoration Act. The latter prohibits any government agency from substantially burdening an individual's religious practice.
Braidwood provides health insurance to employees but objected to coverage for PrEP because the plaintiff believes the Bible is "the authoritative and inerrant word of God." The company argued that providing coverage of PrEP drugs "facilitates and encourages homosexual behavior, intravenous drug use, and sexual activity outside of marriage between one man and one woman."
Braidwood Management is owned by Steven Hotze, a conservative activist who was recently indicted for actions in connection to the 2020 elections; Hotze faced felony charges of unlawful restraint and aggravated assault with a deadly weapon related to his involvement in a fruitless search for thousands of fraudulent mail ballots.
Hotze's lawyer, Jonathan Mitchell, is the former solicitor general of Texas and has been credited with crafting the Texas abortion law SB 8.
In 2019, the Department of and Human Services recommended preexposure prophylaxis, commonly known as PrEP, to help prevent HIV infection for those at high risk, meaning health insurance plans must cover the drug.
The drug reduces the risk of contracting HIV from sex by roughly 99 percent and from drug injection by about 74 percent. The drug is taken primarily by men who have sex with men but also by heterosexual individuals who may be at high risk for the disease. Survivors of sexual assaults are often prescribed PrEP as well.
O'Connor said that the defendants - the Biden administration - did not show a compelling interest in forcing private, religious corporations to cover PrEP with no cost-sharing or religious exemptions, despite the drug's benefits at curbing the infectious disease.
"Braidwood has shown that the PrEP mandate substantially burdens its religious exercise," he wrote. "The burden thus shifts to Defendants to to show that the PrEP mandate furthers a compelling governmental interest and is the least restrictive means of furthering that interest. Defendants have not carried that burden."
O'Connor also took issue with the 2010 health care law's preventive service mandate, which allows a task force to determine which drugs should be covered as preventive under the law. He argued the task force has too much power and is not confirmed by Congress. He argued that members of the preventative service task force are "unconstitutionally appointed."
Katie Keith, a health law expert with Georgetown University Center on Health Insurance Reforms, cautioned that this case could put coverage of other preventative services at risk, such as cancer screenings or tobacco cessation programs.
Carl Schmid, executive director of the HIV+Hepatitis Policy Institute said he expects the case will soon be appealed.
"Preventive services covered by private insurance plans without cost-sharing, such as HIV testing, hepatitis B and C testing, and PrEP, are all critical and well-established public health preventive services that must continue," he said in a statement. "To single out PrEP, which are FDA approved drugs that effectively prevent HIV, and conclude that its coverage violates the religious freedom of certain individuals, is plain wrong."
It's unclear how broadly the ruling will apply. O'Connor has asked for briefs to be filed by the end of the week, and then he will decide whether this applies to just the parties in question or a broader group.
O'Connor also wrote in his ruling that he will soon issue another briefing addressing whether private businesses must cover contraceptive services -an issue other plaintiffs raised in the case.
Obamacare can't require coverage for some HIV drugs, federal judge rules
The decision - citing an employer's religious freedom - is likely to be appealed September 7, 2022 Wash Post
A federal judge in Texas ruled Wednesday that the Affordable Care Act cannot require a Christian-owned company to cover HIV drugs for its employees because it violated the owners' religious freedom.
In his 42-page ruling, U.S. District Judge Reed O'Connor said the requirement forcing the company to comply with the mandate or pay a penalty, "imposes a substantial burden on religious freedom" He also declared unconstitutional the government's system for deciding which preventive care services should be covered under the health-care law - a decision that could jeopardize a broad range of no-cost services, including screenings for cancer and heart disease, for millions of Americans.
The ruling is the latest in a series of challenges to the health-care law. O'Connor himself ruled the entire law unconstitutional in late 2018 - a decision that did not stand after the Supreme Court upheld the law 7-2 last year, the third time the body had considered such a challenge.
The challenge this time centered on several issues, including whether requiring certain preventive services violated the Religious Freedom Restoration Act, passed by Congress in 1993, and also the authority of the government's Preventive Services Task Force to determine what preventive services employers must cover.
Steve Hotze, one of the plaintiffs and owner of the Christian for-profit corporation Braidwood Management Inc., objected to providing coverage for HIV-prevention drugs, called PrEP, saying they "facilitate and encourage homosexual behavior and sexual activity outside of marriage between one man and one woman."
The ruling followed up on the 2014 Hobby Lobby case, in which the Supreme Court ruled 5-4 that a company could not be required to provide its employees with coverage for contraception, a mandate that the company argued would make it complicit in what it considered sinful behavior.
PrEP, which stands for pre-exposure prophylaxis, was first approved by the U.S. Food and Drug Administration in 2012 and recommended in 2019 by the U.S. Preventive Services Task Force.
O'Connor's ruling met with swift opposition from consumer advocacy groups and many Democrats, who said they expected it to be appealed.
A Biden administration official said the decision was under review. Since the judge did not issue an injunction laying out the scope of his decision, "it's too soon to know really what this means," said the official, who spoke on the condition of anonymity because they were not authorized to discuss the case.
Consumer organization Protect Our Care said the ruling "threatens the Affordable Care Act preventive services requirement that guarantees free access to over 100 preventive health services, including health screenings, routine vaccinations, well baby and child visits, prenatal care, contraception, and more," services used by 150 million Americans, according to the group.
"In a legally sane world, this would be quickly overturned, but that's not the world that we live in" said Ira Lupu, professor emeritus at George Washington University Law School who has specialized in the study of religious freedom.
Lupu said that the new ruling extended the high court's Hobby Lobby decision. "It's not the drug that's sinful," he said. "They're saying many of the people who will want to use this drug will have committed a sin."
Lupu said the ruling relies on the Religious Freedom Restoration Act, enacted in response to an earlier Supreme Court ruling that was viewed as hostile to religion. The 1990 case ruled against a Native American group that wanted to use peyote in its services. The court ruled that the law against use of peyote applied to all, religions groups and nonreligious groups alike.
Texas judge rules that Obamacare's coverage mandate for HIV prevention drug violates religious rights
The GOP's decade-long war against the health law continues with a lawsuit over coverage requirement for testing, vaccines and PrEP.
09/07/2022 11:36 AM EDT
Key pieces of the Affordable Care Act are in limbo on Wednesday following a ruling from federal district court Judge Reed O'Connor, who sided with a group of Texans challenging the law's requirement that insurers cover certain preventive health services including STD screenings and HIV prevention drugs.
It's not clear whether the coverage requirements will be blocked just for the people suing, for everyone in Texas, or nationwide - or whether enforcement of the Obamacare provisions will be blocked immediately or allowed to continue while litigation continues. The Biden administration attorneys defending the law and the conservative groups challenging it have until Friday to present arguments to the court about what the judge should do next and what forms of legal relief the challengers deserve.
Now, the Biden administration attorneys defending the law and the conservative groups challenging it have until Friday to present arguments to the court about what the judge should do next.
O'Connor, a President George W. Bush appointee to the U.S. District Court for the Northern District of Texas and the author of several previous anti-Obamacare rulings, wrote in his decision that conservative employers have been injured by the requirement that they sponsor health insurance that covers sexual health services like the drug Truvada, a preexposure prophylaxis that helps prevent the spread of HIV, in violation of their "sincere religious objections."
Those challenging the law, he said, have a valid belief that if they have to cover these services it will "facilitate and encourage homosexual behavior, intravenous drug use, and sexual activity outside of marriage between one man and one woman."
O'Connor also wrote that the federal advisory board that recommends which preventive health care services have to be covered by insurance doesn't have the legal power to do so - throwing into question whether insurance companies will be allowed to once again deny coverage or charge sky-high copays for common preventive care like vaccines and mental health screenings going forward.
The Department of Health and Human Services did not immediately respond to questions about the ruling, but they are expected to swiftly appeal.
The case is likely to go to the right-leaning 5th U.S. Circuit Court of Appeals and could reach the Supreme Court, which has upheld the Affordable Care Act multiple times but chipped away at significant portions of it including its contraception coverage requirements and Medicaid expansion.

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