A core provision of the Affordable Care Act (ACA), responsible for ensuring hundreds of millions of Americans receive free access to preventive services, faces a serious legal challenge March 4.
On Monday, the Fifth Circuit Court of Appeals will listen to oral arguments for Braidwood v. Becerra. In September 2022, a lower court ruled that nonprofit Christian-owned Braidwood Management should not be required to cover PrEP drugs for HIV as it violates their rights under the Religious Freedom Restoration Act.
The lower court decision was appealed by the federal government in March 2023. While the lower court's ruling is not yet in effect, the Fifth Circuit's decision later this year could spell trouble for one of the most critical aspects of the ACA. Regardless of the outcome, the case will almost certainly get appealed up to the Supreme Court, experts told Fierce Healthcare.
The appeal will judge whether the preventive services provisions in the ACA are unconstitutional. Since 2010, private plans and Medicaid expansion programs are mandated to cover preventive products and services without cost sharing.
"The uncertainty this creates for patients can't be undersold," said United States of Care co-founder and CEO Natalie Davis. "It's the most important part of the ACA. It has literally saved lives."
She added: "My sense is that not only do the American people not know that this court case is happening, but that even people in the healthcare industry are unaware of this case and the widespread implications that it would have for people."
Plaintiffs argued in the district court that officials within the U.S. Preventive Services Task Force (PSTF), the Advisory Committee on Immunization Practices and the Health Resources and Services Administration were not properly appointed, meaning they must be appointed by the president, a court or senior department head, therefore violating the appointments clause. The lower court declared that only PSTF violated this clause.
They also argued all three entities violated the nondelegation doctrine, which forbids Congress from delegating responsibilities to administrative agencies under some cases. The district court ruled the ACA did not violate the nondelegation doctrine, though it left open the possibility a higher court could disagree.
Preventive services have positively impacted nearly 152 million people in 2020 and have led to increases in disease screenings and detections, according to the Commonwealth Fund.
What to expect
"I don't think the arguments will be anything unpredictable," said Richard Hughes IV, a healthcare attorney for Epstein Becker Green and lead counsel for the HIV+Hepatitis Policy Institute. The organization submitted an amicus brief with 24 other groups in support of the federal government in June.
He said the plaintiffs will continue to argue members of each of the three governmental entities were unlawfully appointed, effectively putting the authority of these bodies in the spotlight. They will also bring up the religious rights they have, though Hughes anticipates the feds will avoid this topic.
The government may suggest the court sever a statutory provision of the PSTF that says it must be insulated from political influence, allowing the task force to be preserved, he said.
Andrew Twinamatsiko, co-director of the O'Neill Institute's Health Policy and the Law Initiative, expects the litigation will not center around the nondelegation doctrine, as the plaintiffs will be preserving that argument for the Supreme Court.
"The strategy here is that the Supreme Court might be more receptive to changing the approach to nondelegation than what has been in existence," he explained.
Hughes also sees a parallel between this case and the cases involving the Chevron deference that the Supreme Court has already heard oral arguments about, an idea that allows federal agencies to administer laws that are ambiguous and require expert opinion when law is not abundantly clear. It allows civil servants to create technical rules, in agencies like the Centers for Medicare & Medicaid Services, when expertise is required.
But the conservative majority Supreme Court is wary of the power and regulatory authority given to these agencies over the years.
"It's going to offer a preview into how this court really thinks about these issues," said Hughes.
The Fifth Circuit is a traditionally conservative-leaning court that often hears health regulatory challenges. Two Trump-appointed judges and one Biden-appointed judge will be on the panel. Twinamatsiko said it's possible the court will hear the case before a larger panel.
All this points to a world where it may be likely federal agencies have less say in regulatory decision-making and preventive services are not covered by insurers.
"It very well could uphold the district court's decision," said Barbara Zabawa, owner of the Center for Health & Wellness Law, and an associate professor of law and healthcare attorney.
She said if preventive services are no longer required by plans, people will seek out these services through the wellness industry. Although the ruling could help insurers and employer plans in the short term, she argues that patients and the Medicare system will suffer.
"Before the ACA was passed in 2010, very few insurers actually provided preventive services, especially at no cost sharing because it's not in their economic interest," said Zabawa. "If you're going to have people use preventive care, the economic benefit isn't realized until many, many years down the road."