We now have very effective screening, counseling, and medications to improve the health of all Americans. These evidence-based practices include mammography to prevent breast cancer, behavioral counseling to prevent childhood obesity, and screening to prevent anxiety and depression. The list goes on. Yet, for religious reasons, among others, some people object to providing insurance coverage for certain potentially lifesaving practices. The most recent example is coverage for pre-exposure prophylaxis (PrEP) medications, used to prevent the transmission of HIV. These objections could result in increased out of pocket payments for all Americans for the best proven tests and interventions in preventive medicine, or worse, avoidance of these preventive measures and poorer health outcomes.
The issue of not effectively stopping the spread of HIV was raised by six people and two businesses in Texas in the case of Braidwood Management v. Becerra. The plaintiffs were upset that employer-sponsored health plans were required to cover PrEP medicines, which are highly effective in reducing the spread of HIV. They argued that requiring insurers to cover these drugs violated religious freedom. One plaintiff argued drugs that effectively stop the transmission of HIV encouraged homosexual behavior. U.S. district judge Reed O’Connor agreed that PrEP coverage infringed on the plaintiffs’ religious beliefs against homosexuality under the Religious Freedom Restoration Act.
To understand the decision, we must dig deeper. The manner in which preventive services are funded in the U.S. is unique. Under the Affordable Care Act (ACA), preventive services are reviewed by an expert volunteer panel known as the U.S. Preventive Services Task Force (USPSTF). The task force commissions independent scientific reviews of the evidence for a wide range of preventive medical and behavioral treatments. Using stringent criteria, they identify treatments or tests supported by high quality research. Under the ACA, most medical insurance companies must cover services that receive an A or B recommendation from the task force — these are services with at least moderate certainty of a substantial or moderate net benefit. The policy has led to a significant expansion in access to the most valuable preventive services. In the case of PrEP, the task force found the evidence for net benefit substantial and issued an A recommendation.
Over the years, the task force has faced several controversies, but rarely controversies based on moral principles suggesting that prevention violates religious freedoms. Most often, they are criticized for applying exceptionally high scientific standards. Instead of depending on clinical judgment, the group reviews evidence that the preventive practice improves health and longevity, typically by considering the results of multiple randomized clinical trials. In the Braidwood Management case, there was no challenge to the scientific basis for the task force’s A recommendation. Instead, according to the judge, the reason to void healthcare coverage was that the task force members were not appropriately appointed under the Appointments Clause of the U.S. Constitution. In particular, the plaintiffs argued successfully that the appointments clause might require that task force members be appointed by a Senate confirmed official.
How are task force members appointed? The director of the Agency for Healthcare Research and Quality (AHRQ) — a position that does not require Senate confirmation — appoints the 16 task force members. Prior to the task force appointments, there is an extensive vetting process that includes detailed evaluations for conflicts of interest. By any standard, task force members have achieved the highest level of respect from their peers. The task force independently looks at all evidence prior to making recommendations. Every step of the process (announcing topics and updates, input on research questions, comments on research review, and then comments on draft recommendations) is completely transparent, allowing stakeholders, with pros or cons, to have a voice.
Since the implementation of the ACA, we have made remarkable strides and ensured that evidence based preventive medicine is available to most people without a copayment. The ruling in the Braidwood Management case places the entire USPSTF process in jeopardy. Suggesting that the task force members are not appropriately appointed challenges the legitimacy of all task force recommendations and the continuing reimbursement of prevention services in the U.S.
Higher courts will need time to determine whether Judge O’Connor got it right. According to the task force manual, the AHRQ director is responsible for convening and supporting the task force. It is not an advisory council and not subject to the Federal Advisory Committees Act (FACA) rules. So, it does not require secretary-level approval of the nominees. And, even if the O’Connor decision prevails, there is a simple technical fix. Task force members could be appointed by the Secretary of HHS based on the recommendation of the AHRQ director.
Let’s be clear. The Braidwood Management case was about moral grievance, not about a scrupulously thorough process for assuring evidence-based recommendations. The USPSTF remains one of the few shining examples of the productive confluence of evidence-based medicine and public policy. As a result, U.S. doctors can be assured that their decisions about preventive services are informed by contemporary evidence vetted by the best minds in a fair deliberative public forum.
We understand some people oppose birth control and HIV treatment on moral grounds. That debate will require important conversations in communities. But let’s not let this debate destroy the established system that assures hundreds of millions of patients that the preventive services they receive are based on the best available evidence. There must be a better way to address religious objections without putting the nation’s public health in peril.
Robert M. Kaplan, PhD, MA, is a faculty member at Stanford University’s Clinical Excellence Research Center, a former associate director of the National Institutes of Health, and a former chief science officer for the U.S. Agency for Healthcare Research and Quality (AHRQ). Karina W. Davidson, PhD, MASc, is senior vice president of research, dean of academic affairs, and director of the Institute of Health System Science at the Feinstein Institutes of Northwell Health. She also is the Barbara and Donald Zucker endowed professor at the Zucker School of Medicine at Hofstra/Northwell, and the immediate past chair of USPSTF.
All opinions expressed are the authors’ own and do not necessarily reflect those of any organizations or institutions with which they are currently or were previously affiliated.