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  • What’s Next After Judge Strikes Down Preventive Care Mandate?

    What’s Next After Judge Strikes Down Preventive Care Mandate?

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    March 31, 2023 – Health experts around the country are scrambling to determine which preventive services may no longer be free to patients after after Thursday’s ruling by a federal court judge that struck down part of Affordable Care Act. 

    U.S. District Court Judge Reed O’Connor ruled that the ACA’s prevention mandate, which provides screenings for multiple conditions from lung cancer to sexually transmitted infections with no out-of-pocket costs, violates the plaintiffs’ religious rights and is unconstitutional.

    Meanwhile, health experts were researching exactly how many preventive services might be affected and said no changes would likely occur immediately. The Department of Justice on Friday filed a notice that it plans to appeal. 

    Reactions

    Numerous health and other organizations reacted strongly against the ruling while acknowledging that no changes are expected immediately. 

    In a statement, the American Academy of Family Physicians said it is “alarmed and disappointed” by the ruling and said it will “create insurmountable barriers to screenings, counseling, and preventive medications that improve patient and population health, including pre-exposure prophylaxis (PrEP) medications for the prevention of HIV.”

    Margaret A. Murray, president of the Association for Community Affiliated Plans, which represents 79 health plans that provide coverage to more than 25 million people, said in a statement that the decision, if implemented, would erode access to an entire range of preventive health services. “Families deserve better than having bedrock protections of the health reform law invalidated with a two-page ruling.” 

    The the O’Neill Institute for National and Global Health Law at Georgetown University made clear the ruling could cause important preventive services to skyrocket in cost. 

    “Unless it is stayed, the decision will make preventive health services unaffordable for millions of Americans and limit their ability to get early treatment for diseases such as colorectal and lung cancer, diabetes, and depression, to name a few,” the group said in a statement.

    What’s Next?

    Legal experts said that a stay in the case, known as Braidwood v. Becerra, could be granted until the appeal is decided so that services remain in place.

    “It could even go to the Supreme Court,” said Cynthia Cox, vice president and director of the Program on the Affordable Care Act for the Kaiser Family Foundation, a nonprofit focused on national health issues.

    What Care Is Affected?

    Under the ACA, preventive services that have an A or B grade from the U.S. Preventive Services Task Force, a volunteer, independent panel of experts, are covered with no out-of-pocket costs. Over the years, the USPSTF has given 53 A or B grades covering 46 recommendations.

    The ruling contends that the preventive services mandate is unconstitutional because it violates the U.S. Constitution’s Appointments Clause. That clause requires that such decisions be made by a federal official appointed by the president or a department head. The task force is an independent panel of volunteer experts who comb through evidence before making its recommendations.

    According to the court ruling, only those recommendations issued in 2010 or later, when the ACA went into effect, would be struck down. While the USPSTF website does not have a list of how many A or B grades have been issued (or upgraded to A or B) since 2010, Cox estimates that about a dozen would potentially be scrapped. 

    At a Kaiser Family Foundation seminar on the ruling Thursday, Cox and other experts speculated that some of the newer recommendations, such as lung cancer and skin cancer screenings, as well as a recommendation to provide cholesterol-lowering statins at no cost for at-risk people, might no longer be entirely free. 

    However, “I think it’s very likely insurers will still cover” those programs, said Larry Levitt, Kaiser’s executive vice president for health policy, but cost-sharing with a copay could be added to certain services.

    “This ruling does not affect vaccines,” Cox said. Recommendations for vaccines come from the CDC’s Advisory Committee on Immunization Practices. Pregnancy care is also not likely to be affected, Cox and other experts said. One exception, she said, could be screening for perinatal depression. 

    “There’s a lot of concern about what this could mean for access to care,” Cox said. “Even small cost sharing [amounts] can deter people from getting preventive care.” 

    In the next few days, more clarity is expected about which preventive services remain and which do not, she said.

    Until more is known, Cox urged people to remember that “The list of services that remains free is much longer than the list that might become subject to cost sharing.” Her advice: “Don’t panic, and still get the preventive care that’s recommended to you.”

    Timelines

    Levitt and other experts said it’s unlikely any coverage changes would happen immediately, as insurer’s contracts generally are in place for the year.

    Changes would probably come, if the ruling holds, next calendar year, Levitt said. Beyond the ACA, states are free to require coverage for these services, he said, and some do. “But states can’t reach self-insured plans, which cover most people.”

    Action Plan

    Until the legal arguments are sorted out, people can take a number of steps, said Meredithe McNamara, MD, assistant professor of pediatrics and an adolescent medicine specialist at Yale University School of Medicine, who has researched the effect of eliminating coverage for the HIV preventive medication known as PrEP.

    Among them:

    • Reach out to your health care provider to discuss how it might affect care.
    • Call insurance providers and demand continued access to preventive care without cost sharing.
    • Contact elected officials and request a federal workaround.

    Preventive services “get people in the door,” she said, and provide valuable health counseling. 

    The U.S. Preventive Services Task Force makes its recommendations based on medical evidence that certain services help prevent disease spread or improve treatment through early detection.

    “If cost becomes a barrier to preventive care, that could lead to worse health outcomes, whether it’s later-stage lung cancer diagnoses or more HIV transmission,” Cox said. 

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  • HIV Infections Could Spike After Ruling on Affordable Care Act: Experts

    HIV Infections Could Spike After Ruling on Affordable Care Act: Experts

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    March 30, 2023 — A federal judge in Texas on Thursday struck down the preventive services mandate of the Affordable Care Act, ruling that the need to provide these services violated the religious rights of the plaintiffs. 

    One of the  plaintiffs who filed the lawsuit is  Steven Hotze, MD, a Texas doctor and conservative talk radio host. He said providing health insurance coverage for medication taken daily to prevent HIV to his employees would make him complicit in behaviors that he said violate his religious beliefs.

    The ruling applies nationwide, and public health experts were quick to criticize the decision. 

    “The human cost of this decision is very real,” said Meredithe McNamara, MD, an assistant professor of pediatrics and adolescent medicine specialist at Yale University. Yale researchers, anticipating the ruling, estimated in a recent study that eliminating coverage of the medication, known as PrEP (preexposure prophylaxis), which was mandated for health insurers under the Affordable Care Act, will result in at least 2,000 new HIV infections within a year.

    The two brand-name medications approved for PrEP, Truvada and Descovy, cost about $1,800 a month or more without insurance. Generic versions are available for less but are not always available, experts said. Other financial programs, including some by drugmakers, offer assistance to those who qualify. The mandate to provide PrEP coverage began in June 2020, after the U.S. Preventive Services Task Force (USPSTF), an independent panel of experts, gave it an “A” recommendation. Federal law requires any preventive services with an A or B to be covered.

    The ruling could also affect much more than just insurance coverage of PrEP. American Medical Association President Jack Resneck Jr., MD, in a statement, said the ACA required insurers and health plans to cover dozens of preventive health services with no cost to patients for things like early detection of cancer, hypertension, diabetes, and sexually transmitted infections. 

    “Millions of patients could lose first-dollar coverage for cholesterol treatment, tobacco and alcohol cessation, immunizations, and childhood screenings for lead poisoning, hearing loss, and autism,” he said. “Care that is critical to reducing maternal mortality would also be jeopardized. These preventive-care requirements that for 10 years have enabled millions of Americans to improve their health could just go away as a result of this flawed ruling.”

    “The government will surely appeal, and has every right to do so,” said Nicholas Bagley, a professor of law at the University of Michigan. “The big question is whether the courts will enter a stay, pending the appeal. I’d expect them to do so, but we will see.”

    Even without a stay, Bagley said, most insurance plans are annual, so coverage may not change right away, but that’s not certain. The ruling applies to preventive care guidelines issued after 2010, when the Affordable Care Act was enacted. The contraceptive mandate has been challenged in this case, Bagley said, but was rejected in September. He expects that decision to be appealed.   

    HIV Prevention: Key Strategy

    Prevention, including the use of PrEP, is a key strategy of the federal initiative Ending the HIV Epidemic in the U.S.  It aims to decrease new diagnoses to 3,000 by 2030. New diagnoses had decreased 8% from 2016 to 2019, according to the CDC, but there is work to be done to reach the 2030 goal. In 2020, there were 30,635 new HIV diagnoses. When taken correctly, PrEP reduces the risk of becoming infected by 99%, according to the CDC.

    In 2020, about 25% of the 1.2 million people in the U.S. for whom PrEP was recommended were actually prescribed it, up from about 3% in 2015, according to the CDC.

    One of those is Dan, a gay marketing professional in the Midwest who asked that his real name not be used. He has taken PrEP for about a decade. His employer’s health insurance plan covers it, and it’s important to him. 

    “I am sexually active, but not that much,” he said. Even so, he counts on the medication for protection when he is sexually active. If the coverage is taken away? “I would probably stop taking it,” he said.

    Yale Study and the Effect of Ending the Coverage

    Researchers from Yale University estimate that eliminating the PrEP coverage would result in at least 2,000 entirely preventable HIV infections in the following year, as PrEP usage declines without the mandated coverage. That estimate only takes into account the effect on men who have sex with men, not other people also at risk for HIV infection who could benefit from PrEP, such as those who inject drugs or women who have sex with an infected person.

    As a result, the estimate is very conservative, says study leader A. David Paltiel, PhD, a professor of health policy at the Yale School of Public Health. His team used U.S.-based data on HIV infection, current rates of PrEP coverage and effectiveness, and the estimated reduction in coverage if access to private health insurance benefits were curtailed.

    “We underestimated the number knocked out of PrEP coverage” if the repeal goes national, he said. Right now, about 28% of all men who have sex with men are getting coverage for PrEP, Paltiel estimates. “For every 1% drop from the 28%, there would be 114 new infections,” he said. The researchers also calculated that the percentage of people taking the drug would drop to about 10%. “If that happened, it will result in about 2,000 new infections in the following year. OK? There are people who are going to be left high and dry.”

    More on Braidwood Management v. Becerra

    In the lawsuit, Braidwood Management v. Becerra, several Christian-owned businesses and several people in Texas sued the federal government, saying the preventive services mandate violates their religious beliefs under the Religious Freedom Restoration Act, a 1993 federal law that guarantees interests in religious freedom are protected.

    The plaintiffs also argue that the Affordable Care Act requirement to provide recommended preventive services violates the Constitution’s Appointments Clause, which requires people the president appoints to positions be confirmed by the Senate. The Preventive Services Task Force members are instead appointed by the heads of agencies within the Health and Human Services Department.

    Since it was created in 1984, the task force has weighed in on numerous preventive measures, such as when to screen people for diseases and other questions, making evidence-based recommendations to help health care providers care for patients. 

    More Reactions

    In a statement, Bruce J. Packett, executive director of the American Academy of HIV Medicine, said the Yale report “highlights the critical necessity of taking into account public health repercussions of judicial decisions.”

    The effects of eliminating coverage could be catastrophic for HIV reduction efforts, he said. And, he pointed out, “the report only accounts for the effects of not requiring insurers to cover PrEP through one year; the authors did not calculate primary HIV transmissions that would happen well after a year and the secondary infections from those primary infections.”

    Also at risk, Packett said, is the authority of the Preventive Services Task Force. 

    “Striking down the USPSTF’s ability to recommend important evidence-based health care preventive services would be detrimental across the entirety of the public health goals of the United States,” he said. 

    The Braidwood Management case is “misreading science,” according to McNamara and other Yale researchers. In mid-February, they posted a report, explaining how the PrEP mandate promotes public health not for a segment of the population but the population as a whole. PrEP benefits public health, much like any vaccine or other preventive measure for avoiding infection.

    The researchers call PrEP “one of the most celebrated biomedical successes in the global fight to end the HIV epidemic.” 

    The harms of granting a nationwide injunction against requiring health insurance plans to cover PrEP would affect some ethnic groups disproportionately, McNamara said. Most affected, she said, would be Black and Latino gay and bisexual men, as well as transgender women.

    Younger at-risk people would also be at a disadvantage, said McNamara, who cares for adolescents in her clinic. “I can tell you that not having cost sharing for HIV prevention essentially means they aren’t going to use it at all,” she said.

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