A federal judge on Wednesday ruled that mandated coverage of preventive HIV drugs under the Affordable Care Act (ACA) is unconstitutional and violates employers' religious freedom—a decision that could have a significant impact on how other preventive services, including cancer screenings and vaccinations, are covered.

Federal judge rules mandated HIV PrEP coverage is unconstitutional

Under the ACA, most health insurers are required to cover certain recommended preventive services, such as cancer screenings and routine vaccinations, without cost-sharing for patients. In 2019, HHS recommended HIV testing for individuals ages 15 to 65 and preexposure prophylaxis (PrEP) also be covered under ACA's preventive services mandate.

However, in 2020, six individuals and two Texas businesses filed a lawsuit against the mandate, arguing that they should not be required to offer coverage for "PrEP drugs, contraception, the HPV vaccine, and the screenings and behavioral counseling for [sexually transmitted diseases] and drug use."

According to the plaintiffs, the preventive services mandate violates the Religious Freedom Restoration Act because it requires them to cover medication that would "facilitate and encourage homosexual behavior, prostitution, sexual promiscuity, and intravenous drug use."

On Wednesday, U.S. District Judge Reed O'Connor ruled that the ACA's requirement that employers cover HIV PrEP drugs is unconstitutional and violates the plaintiffs' religious rights. In his ruling, O'Connor wrote that the federal government failed to show "a compelling interest in forcing private, religious corporations to cover PrEP drugs with no cost-sharing and no religious exemptions."

In addition, O'Connor ruled that the U.S. Preventive Services Task Force (USPSTF), which recommends what services should be covered under the ACA mandate, violates the Appointments Clause of the Constitution. According to O'Connor, members of the USPSTF are "unconstitutionally appointed" because they are chosen by HHS leaders instead of being appointed by the president and confirmed by the Senate.

Currently, it is unclear whether the ruling will apply only to the plaintiffs in the case or to a broader group. So far, O'Connor has requested that both the defendants and plaintiffs file briefs by Friday before he makes his final decision on the case.

Reaction

According to Katie Keith, a health law expert at Georgetown University, the ruling "is not just about PrEP. It's much broader."

"If we lose the A or B recommendations, then any employer or plan, religious objection or not, could say we're not going to cover that anymore," Keith said.

Separately, Jonathan Adler, a law professor at Case Western Reserve University, agreed with Keith's assessment, saying that the ruling suggests "self-insuring employers could pick and choose what they want to cover based on religious objections to certain types of coverage."

If the ruling is applied broadly, health experts said that it could put coverage of other preventive services, including cancer screenings, at risk for millions of Americans and leave them financially responsible for some of the most expensive preventive services.

"Adding an additional barrier to so many essential medical services is only going to make things worse and it's going to make things disproportionately worse for the most vulnerable," said Mark Fendrick, director of the University of Michigan Center for Value-Based Insurance Design.

Lisa Lacasse, president of the American Cancer Society Cancer Action Network, also spoke out against the ruling. "Before the passage of the Affordable Care Act, high costs and unclear coverage were repeatedly cited among the top reasons people delayed or skipped screenings," she said. "We cannot risk returning to a system wherein every individual has to interpret their complex insurance plans to determine if a recommended mammogram will be covered or to determine how much their colonoscopy may cost."

According to STAT, HHS is expected to appeal the ruling soon. In a statement, a spokesperson for the agency said that it is continuing "to work to ensure that people can access health care, free from discrimination." (Gonzalez, Axios, 9/7; Herman, STAT, 9/7; Stanton, USA Today, 9/7; Firth, MedPage Today, 9/7; Weixel, The Hill, 9/7; Cohen, Roll Call, 9/7; Reed et al., Axios, 9/8)