Federal Judge’s Ruling Throws Preventive Care Access Into Question

On March 30, District Judge Reed O’Connor ruled in the Braidwood Management v Becerra case that not only was Braidwood Management not required to cover pre-exposure prophylaxis (PrEP), a medicine that prevents HIV infection, due to its religious beliefs, but also that the US Preventive Services Task Force (USPSTF) had no federal jurisdiction in mandating coverage of various preventive services. This ruling confirmed his prior ruling in September 2022 and threw the future of coverage for preventive services into question.

O’Connor has a history of rulings on the Affordable Care Act (ACA). His ruling in 2018 deemed the ACA unconstitutional due to the elimination of a penalty for people who did not have health insurance. The ruling did not stand when the case was presented to the Supreme Court in 2021.¹ O’Connor had also previously thrown out the antidiscrimination provisions in the ACA in late 2019, according to Bloomberg Law.²

This new ruling from O’Connor stays in line with his previous rulings and could affect millions in the United States. The Wall Street Journal¹ estimates that 150 million individuals could lose access to preventive care services after this injunction, as the ACA required all health care providers to provide no-cost preventive care as part of their plans. With PrEP and general preventive services suddenly in danger of becoming inaccessible to those who need them most, the ramifications of these decisions are more important to highlight than ever.

PrEP: A Valuable Ally in the Fight Against the HIV Epidemic

The first aspect of the Braidwood Management v Becerra case dealt with the requirement that all preventive care be covered under the ACA.

“The religious beliefs were kind of another aspect of this ruling,” said Meredithe McNamara, MD, MS, FAAP, assistant professor of pediatrics at Yale School of Medicine. “Employers who had a problem with PrEP, who somehow believed that PrEP facilitated behavior that they didn’t agree with, that was kind of the original impetus for filing suit.”

According to The Wall Street Journal, the lawsuit objected to covering contraception, screenings for sexually transmitted diseases and drug use, and vaccination against human papillomavirus along with the objection to covering PrEP. The reasoning was that it “facilitate[d] and encourage[d] homosexual behavior, prostitution, sexual promiscuity, and intravenous drug use.”

“One of the miracles of the [ACA] is the fact that it does require employers to provide coverage for any preventive services that obtain a grade A [or B] rating from the [USPSTF],” said David Paltiel, PhD, MBA, professor of public health at the Yale School of Public Health. “It had opened up the possibility of [PrEP] for a large swath of the eligible population…and the fact that the judge has made this decision really curtails our ability to enact the plan to end the epidemic.”

This decision could leave multiple populations at risk of worse health outcomes due to increasing HIV spread. A recent study, coauthored by Paltiel and McNamara, found that approximately 114 people could contract HIV per 1% of the population no longer covered, for a figure as high as 2000 more HIV infections within a year.³

“The truth of the matter is, when you label PrEP as a medication that only benefits a small group of people based on their sexual orientation, it really obfuscates the ways in which HIV has ravaged communities of color throughout the United States,” said McNamara. “And not only is that unscientific, but it’s also discriminatory.”

Paltiel noted that those most at risk given this decision are Black and Latino Americans, transgender women, and injection drug users.

“There is now what seems like a judicial precedent for denying health care to anybody based on their identity.…If somebody doesn’t agree with someone’s sexual behaviors, then it opens up a whole caveat of different types of health care that can be chipped away at and deprived,” said McNamara.

McNamara also noted that religious objections could now be viewed as an effective way to try to dismantle the ACA. The pending appeal, she said, could establish precedents for how much the federal government needs to safeguard public health.

Preventive Care Threatened Across All Avenues

Although PrEP is a large focus of the ruling, preventive services in general could also be affected. All recommendations from the USPSTF established after March 2010 could be called into question should this ruling stand in higher court.

“While a lot of attention has been devoted to [PrEP] for HIV, it’s important to point out that the [USPSTF] has assigned an A or B rating to over 50 services, including screening for depression, obesity, substance abuse, tobacco cessation, hepatitis, hyperlipidemia, diabetes, and 4 cancers,” said Mark Fendrick, MD, co–editor in chief of The American Journal of Managed Care^® and director of the Center for Value-Based Insurance Design at the University of Michigan.

In a blog post about the topic,⁴ Fendrick and coauthor Nicholas Bagley, JD, wrote that value-based insurance design, wherein high-value care like preventive care would necessitate little to no out-of-pocket payments for the majority of patients, was embedded into the ACA for all services that garner an A or B rating from the USPSTF. However, the Braidwood Management v Becerra case argued that this was unconstitutional due to the Appointments Clause, which necessitates that government decisions come from federal officers that are appointed by the president or department head, which the USPSTF’s volunteer board does not qualify as.

“This section of the ACA…is one of the most popular provisions of the ACA. It has had bipartisan political support from the beginning,” said Fendrick. “It has increased screenings, improved health outcomes, and reduced racial disparities in health care access.”

Fendrick noted that Black Americans, Latin Americans, Asian Americans, and Pacific Islanders have benefited more from the preventive care mandate than White populations. He said that if this ruling were to stand in higher court, it could hamper efforts to reduce health care disparities for Americans with low income, communities of color, and those who live in rural states.

“As a physician and not a lawyer, I’m concerned about the implications if this ruling were to be upheld….In my opinion, we reverse a growing movement among public and private health plans and employers to expand coverage of high-value services by lowering cost sharing through deductibles, co-payments, or coinsurance,” said Fendrick.

Another major part of this ruling was what it meant for preventive care guidelines set forth by the USPSTF. All guidelines made after March 2010 would no longer be valid. This could lead to outdated guidelines being used in preventive care.

“A good example of this is the colorectal cancer screening [USPSTF] recommendation, which has been revised more than once.…The more recent recommendations include more novel technologies, such as Cologuard, which is a stool DNA test, which wasn’t even available at the time of the first recommendation,” said Fendrick. “So going back to the future to these older recommendations [has] significant concerns, from my perspective, in the fact that as innovation moves forward so quickly, it might actually be a disservice to patients to recommend older, potentially less proven or less effective therapies.”

Next Steps: What Happens Now?

Although this ruling has major implications for accessible preventive care, there are still several next steps before the ruling can affect patients.

Insurers are not likely to drop no-cost preventive care immediately, as most contracts last through the end of the year, according to The Wall Street Journal. Legal experts are also sure that the Biden administration will appeal the ruling to the US Court of Appeals for the Fifth Circuit, which, depending on how the case proceeds, could land the case in the Supreme Court.

Fendrick noted that in recent research he conducted, 80% of large employers that he surveyed said that they would not impose cost sharing on preventive services, regardless of the status of the mandate. However, his concern was that, even among employers who kept the existing services at no cost sharing, future recommendations may not get the same grace extended.

With this knowledge, even if the impact of this ruling will likely not be felt imminently, the ruling itself should raise concerns for the long-term availability of preventive care and other health care services.

“Everyone should be aware of how vulnerable this type of health care is right now. We need federal protections to ensure no interruptions in care,” said McNamara. “I think we’re living in an age where, if the idea of religious objection is used as a weapon to chip away at health care, everything is fair game.”

Both McNamara and Fendrick said that lawmakers had the ability to ensure that these preventive services were still available for the majority of Americans.

“It’s my hope that we could bring together a broad, multistakeholder coalition to bring about the idea that access to preventive care should not be a partisan issue. Both Democrats and Republicans alike should consider the strong benefits that have already been evaluated and confirmed by this policy,” said Fendrick. “They could easily put in place a legislative fix that would codify the preventive care mandate and allow it to remain in place so that over 200 million Americans can benefit from enhanced access to these high value services.”

The ruling from O’Connor has put preventive care access into question, but ways to mitigate or prevent the elimination of these services are still possible. As the ruling is appealed and judged at higher courts, all eyes will be on future rulings and efforts to shape preventive care coverage in the United States.

References

1. Armour S. Judge strikes down some Affordable Care Act rules on preventive health services. The Wall Street Journal. March 30, 2023. Accessed April 4, 2023. https://www.wsj.com/articles/judge-strikes-down-some-affordable-care-act-rules-on-preventive-health-services-8da6f2b0
2. Pazanowski MA, Rozen C. Obamacare preventive care mandate limited by federal judge. Bloomberg Law. March 30, 2023. Accessed April 3, 2023. https://news.bloomberglaw.com/health-law-and-business/obamacare-preventive-services-mandate-blocked-by-federal-judge
3. Klein HE. PrEP court ruling could lead to thousands of preventable HIV cases. AJMC. March 29, 2023. Accessed April 3, 2023. https://www.ajmc.com/view/prep-court-ruling-could-lead-to-thousands-of-preventable-hiv-cases
4. Bagley N, Fendrick AM. A Texas judge just invalidated the preventive services mandate. what happens next? Health Affairs. March 30, 2023. Accessed April 4, 2023. https://www.healthaffairs.org/content/forefront/texas-judge-just-invalidated-preventive-services-mandate-happens-next