ACA Preventive Care Challenge Covering PrEP Ruled to Violate Religious Freedom

In litigation involving the Affordable Care Act's (ACA's) preventive health services requirements, a Texas district court held that the coverage mandate for preexposure prophylaxis (PrEP) to prevent HIV infections violated an employer's rights under the  Religious Freedom Restoration Act of 1993.

On September 7, 2022, U.S. District Judge Reed O'Connor ruled that the ACA's requirement for employers and insurance companies to provide free coverage of HIV prevention drugs was unconstitutional. The judge's rationale for his decision rested on the fact that he deemed it a violation of a Christian business owner's freedom of religion.

For context, according to the U.S. Centers for Disease Control and Prevention, medications can reduce a person's risk of getting HIV from sexual activity or intravenous drug use and is a highly effective preventive treatment for HIV. PrEP drugs reduce the risk of getting HIV from sex by 99% and from injectable drug use by 74%. The cost of a PrEP prescription can run as high as $22,000 annually.

The district court also found that the appointment process for the entities that determine which preventive services must be covered under the ACA is unconstitutional.

Background of Preventive Health Services Under the ACA

• Evidence-Based Services: Evidence-based items or services with a rating of "A" or "B" under current recommendations from the U.S. Preventive Services Task Force (USPSTF), including PrEP drugs to prevent HIV infections.
• Immunizations: Routine immunizations are recommended by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC), including the human papillomavirus (HPV) and the COVID-19 vaccine.
• Preventive Care and Screenings through Age 21: Preventive care and screenings for infants and children through age 21 under guidelines supported by the Health Resources and Services Administration (HRSA), including screenings and counseling related to tobacco use, obesity, alcohol abuse, and sexually transmitted infections.
• Preventive Care and Screenings for Women: Preventive care and screenings for women under HRSA guidelines, including contraceptives.

Details of the Case

Braidwood Management v. Becerra involved a small business owner who was joined by six individuals as well as one other business. The plaintiff objected on religious grounds to obtaining or providing health insurance coverage that included HPV vaccines, STI and drug-related screenings and counseling, PrEP, and contraceptives.

The plaintiff claimed that he did not want to “facilitate and encourage homosexual behavior, intravenous drug use, and sexual activity outside of marriage between one man and one woman” and that he felt he would be complicit in behaviors he believed to be immoral if he provided insurance coverage for PrEP medications to his employees under his self-insured plan. The business owner further claimed that this was due to his Christian beliefs and how he interpreted the Bible.

Government lawyers argued that it was wrong to assume that PrEP drugs “facilitated or encouraged” these behaviors. However, the Court found the argument to be irrelevant as the “correctness” of beliefs does not matter. Only the “sincerity” of those held beliefs matters. Ultimately, the Court ruled that this mandate imposed a substantial burden on the religious freedom of the small business owner that was not permitted under the Religious Freedom Restoration Act (RFRA). The RFRA requires that the government use the least restrictive means of promoting a compelling governmental interest when it burdens religious freedom. In this case, the Court determined that requiring coverage for PrEP was not the least restrictive means to promoting a compelling governmental interest.

Importantly, the Court also ruled that the appointment process for the USPSTF, ACIP, and HRSA (entities that determine which items and services must be covered under the ACA's preventive health services rules) is unconstitutional. In short, according to the rules, the appointees needed to be nominated by the President and confirmed by the Senate, and, without such formal appointment process, they would not be permitted to make these authoritative binding decisions. The court found that ACIP and HRSA appointments were valid, however, the USPSTF appointment process was not, leaving the question of the legality of the decisions made by that entity.

The Potential Impact

This ruling is significant in that it shows the increasing tension between the public health of employees and society-at-large on the one hand and the religious rights of private employers on the other.

It is likely that this ruling will be challenged in a higher court. Notably, Judge O’Connor had previously faced off against the ACA when he ruled that the ACA was unconstitutional in 2018 based on the zeroed-out individual mandate penalty. That ruling was later overturned by the U.S. Supreme Court. Those disagreeing with the ruling would point out that Judge O’Connor’s reading of what is constitutional vs. not is likely seen through a biased filter.

Public health officials have expressed concerns that if this ruling stands, it could weaken the ACA mandate to provide no-cost preventive care such as vaccines or cancer screenings like colonoscopies or mammograms. Some have postulated that coverage for contraception and Plan B could stand next in line to be challenged under the religious freedom argument.

Opponents would argue that the religious freedom of an employer to deny lifesaving coverage to employees who have different beliefs is discriminatory. In addition, the Court failed to comment on the lack of factual support for the business owner’s statement that access to such medication could encourage behaviors like intravenous drug use and premarital sex.

A Crystal Ball

It is reasonable to wonder what we might see in response. Given the ongoing nature of the case, it is unlikely that insurers and group health plans will rush to drop coverage without cost sharing for 2023. However, should the ruling be finalized, it is likely that insurers and some group health plans would react by imposing copays and deductibles to many of the preventive services that are now required to be covered on a zero-cost basis.

We also might see more liberal states choosing to be proactive and try to recreate preventive mandates for fully insured plans (similar to how we saw states recreate the individual mandate). Recall, however, that states cannot govern self-funded plans, so that would only create a partial solution. That solution might also be problematic, since, if certain preventive care measures are restricted on a federal level but mandated on a state level, plans would face a conflict relative to providing first dollar coverage under an HDHP plan and then running afoul of the restrictions for HSA contributions.

This is a complex issue, especially since the current mix in the high court would likely lean toward favoring the religious freedom argument. It is thus unlikely that challengers will rush to appeal the issue. Unfortunately, the crystal ball in this case is solidly cloudy. We think that it is just too early to say what we might expect in the future as this issue unfolds.