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A federal judge on Thursday the Affordable Care Act (ACA) provision requiring all insurers to cover certain preventive services free of charge, angering the law's supporters.

"Individual Plaintiffs need not comply with the preventive care coverage recommendations of the U.S. Preventive Services Task Force (USPSTF) issued on or after March 23, 2010 [the date the ACA was enacted], because the members of the Task Force have not been appointed in a manner consistent with Article II's Appointments Clause," wrote Judge Reed O'Connor of the U.S. District Court for the Northern District of Texas. "Accordingly, the Court enjoins Defendants [HHS] and their officers, agents, servants, and employees from implementing or enforcing the PrEP [pre-exposure prophylaxis] mandate as against these Plaintiffs."

Decision Builds on September Ruling

O'Connor was referring to the coverage mandate for drugs that greatly reduce -- by 99%, according to some studies -- the likelihood that partners of people with HIV will contract the virus. PrEP is one of several preventive services and treatments that the plaintiffs in the lawsuit, known as Braidwood v. Becerra, do not want to cover for their employees because, they say, doing so violates their religious beliefs. But the ruling also applies more broadly to many other preventive services.

O'Connor, who was nominated by President George W. Bush, issued a similar ruling on the case last September, but waited until now to rule on how broad the decision will be. The ACA requires all insurers to cover -- free of charge to patients -- any preventive service that was given an "A" (high certainty that the net benefit is substantial) or "B" (high certainty that the net benefit is moderate, or there is moderate certainty that the net benefit is moderate to substantial) rating by the Task Force, which currently applies to more than 100 preventive services.

However, O'Connor wrote, as of now, "[HHS] and their officers, agents, servants, and employees are enjoined from implementing or enforcing ... compulsory coverage requirements in response to an 'A' or 'B' rating from the Task Force in the future."

Some Preventive Services Unaffected

The ruling won't affect all preventive services, Alina Salganicoff, PhD, senior vice president and director of women's health policy at the Kaiser Family Foundation (KFF), said Thursday during a reporter briefing on the ruling. "Screenings like mammography, colorectal cancer screening, and cervical cancer screening would still be included [for coverage at no charge] because they were included before the ACA [was passed] as part of the Task Force recommendations," she said. "But some of the newer screenings -- for example, lung cancer screening or skin cancer screening, which is usually done in a clinical visit -- would not be included in that list."

She noted that because lung cancer screening involves a CT scan, it "could be quite costly if people have to pay cost-sharing for them." The ruling also doesn't apply to women's preventive health services recommended by the Health Resources and Services Administration (HRSA), or to vaccines recommended by the CDC's Advisory Committee on Immunization Practices (ACIP), she said; the plaintiffs had also asked that services recommended by those agencies not be mandated for first-dollar coverage.

As far as how health insurers are likely to respond to the ruling, "I think it's very likely that insurers will still cover these preventive services, but insurers may very well charge patient cost-sharing for these services, when they are permitted to," said Larry Levitt, executive vice president for health policy at KFF, during the briefing. "This will likely, in most cases, not happen immediately because insurance contracts are in place for the calendar year ... So any effects on coverage are likely to take effect starting next calendar year."

And although there is a long history of states regulating private insurers, "there are real limits to what states can do here, in that states can regulate private insurance, but self-insured employer plans -- which cover most people with private insurance -- cannot be touched by state regulations," he added.

Appeals to Come

Whether the ruling will take effect at all will depend on how things play out in court, said Laurie Sobel, JD, associate director of women's health policy at KFF. "Both sides are appealing; nobody's happy with this decision," she said. While the Biden administration is appealing the part of the ruling declaring that delegation of benefit decisions to the USPSTF was unconstitutional, "the plaintiffs are appealing their claims that the delegation to ACIP and HRSA are also unconstitutional," she said. "So all of the preventive services are kind of up for grabs as we go through the appeal process to the Fifth Circuit and [likely] to the Supreme Court."

Health insurers reacted cautiously to the ruling. "As we review the decision and its potential impact ... we want to be clear: Americans should have peace of mind there will be no immediate disruption in care or coverage," Matt Eyles, president and CEO of AHIP (formerly known as America's Health Insurance Plans), . "We fully expect that this matter will continue on appeal, and we await the federal government's next steps in the litigation, as well as any guidance from relevant federal agencies."

Rep. Frank Pallone Jr. (D-N.J.), ranking member of the House Energy & Commerce Committee, blasted the decision. "The decision ... imperils access to lifesaving care including mammograms, lung cancer and skin cancer screenings, screenings for pregnant women and newborns, and PrEP," he . "It has no basis in the law, will unnecessarily cause confusion, and will put lives at risk if people are forced to forgo routine screenings and treatment."

"The Department of Justice should immediately move to appeal this reckless decision and have it stayed so that Americans do not lose access to care," Pallone said. "I am also calling on all healthcare insurers to commit to continuing to cover all preventive services without cost-sharing while this case is litigated and until final disposition of the lawsuit. There is no excuse to eliminate consumer protections because of a meritless decision that I expect will rightfully be overturned on appeal. I will be following up with insurers for their commitments in writing."

Jack Resneck Jr., MD, president of the American Medical Association (AMA), called the ruling "deeply flawed," noting that "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. Care that is critical to reducing maternal mortality would also be jeopardized. These preventive-care requirements that for ten years have enabled millions of Americans to improve their health could just go away as a result of this flawed ruling."

The ruling will disproportionately affect low-income and historically marginalized communities "that are least able to afford it," he added.

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