How to protect PrEP coverage, no matter what happens in Braidwood v. Becerra

Since a Texas judge’s decision dropped earlier this spring, Braidwood v. Becerra has sent shudders down public health’s spine. Similar to earlier contraceptive mandate cases, Braidwood involves plaintiff-employers who object to paying for health insurance that includes coverage of disease screenings and PrEP for HIV on moral grounds. Their legal claims challenge the U.S. Preventive Services Task Force’s authority under the Affordable Care Act to determine mandatory coverage of clinical preventive measures. They argue that the specific requirement to cover PrEP, or pre-exposure prophylaxis, for HIV impermissibly burdens their religious exercise under the Religious Freedom Restoration Act.

Now on appeal before the U.S. Court of Appeals for the 5th Circuit, the judge’s decision in March overturned the task force’s role in determining which preventive services must be covered by private health insurance under the ACA and enjoined the requirement that payers cover any of its recommended services, including PrEP for HIV. The decision was stayed by the 5th Circuit on May 15 pending its decision on appeal.

But whether or not the task force survives the impending appeal in Braidwood v. Becerra, there is an opportunity to ensure payer coverage of PrEP is maintained and even improved.

Like foxes guarding the henhouse, payers quickly downplayed concerns and reassured us that preventive services would remain covered despite the decision. The same judge whose decision in Braidwood is now on appeal before the 5^th Circuit Court of Appeals has deferred a potential stay of his decision, citing these reassurances.

However, access to PrEP should not be taken for granted, even if the Braidwood decision had not suspended coverage requirements nationwide. PrEP coverage today is already suboptimal and stands to significantly worsen in the absence of the ACA requirement that payers cover it without cost sharing for patients, in what is known as the first dollar coverage requirement.

The Preventive Services Task Force’s first recommendation for PrEP in 2019 (a full seven years after its approval) was so utterly lacking in clarity that it was initially unclear that payers have to cover all available PrEP products without cost sharing, as well as services necessary for patients taking PrEP (e.g. ongoing bloodwork). Under the ACA’s preventive services implementing rules, if the task force fails, as it did here, to specify the item or service, or the frequency with which it is to be covered without cost sharing, payers are allowed to independently make these determinations.

In 2021, CMS released guidance to clarify that all ancillary services must be covered. But, crucially, it deferred entirely to payers in determining which PrEP product they would cover without cost sharing. Naturally, this means that payers are likely to prefer the least expensive version, even if it’s less effective. This has been shown to interfere with clinically appropriate care, which can in turn result in higher risk of HIV transmission. Patients who can’t afford to pay out of pocket or for cost sharing for the product that is right for them have to work with their providers to seek a waiver from their plans to receive coverage of the appropriate form of PrEP.

This is particularly poor policy for facilitating access to long-acting injectable PrEP, first approved by the Food and Drug Administration in late 2021. Long-acting injectable PrEP has been shown to “substantially reduce HIV incidence” among men who have sex with men, and can improve adherence over oral forms of PrEP, which in turns improves effectiveness. But today, payers are not required to provide coverage of long-acting injectable PrEP and can freely impose patient out-of-pocket costs that can deter usage.

In a well-meaning attempt to ensure that long-acting injectable PrEP would be covered, in 2022 the task force initiated a new evidence review process to update its PrEP recommendations. Its multiyear process can take four or five years. After that, under the ACA’s preventive services implementing rules, payers have until the plan year following the one-year anniversary of a recommendation to implement first dollar coverage. The net result is that patients may wait more than five years from FDA approval before they can access a product intended to improve their adherence and more effectively prevent them from acquiring HIV.

Braidwood’s total suspension of this requirement practically assures that payers will have wide latitude to restrict PrEP coverage and that long-acting injectable PrEP will never be optimally accessible. The collective result is increased risk of HIV transmission and discouraged innovation.

As I recently suggested, a path through Congress to resolve the Braidwood challenges is politically unlikely, but the Biden administration has its own options for addressing the situation. In particular, it could determine that it is no longer practicable to politically insulate the task force and decide to provide it with oversight, possibly involving the Centers for Disease Control and Prevention.

There are in fact a host of options to improve recommendations and coverage for PrEP. In 1996, the task force transferred responsibilities for recommending vaccines to the CDC’s Advisory Committee on Immunization Practices (ACIP). It made eminent sense — since 1964 the ACIP had made vaccine recommendation and possessed the particular expertise to do so.

The task force should now transfer its responsibilities for recommending PrEP to the ACIP. Payers are already required to cover ACIP-recommended immunizations under the ACA, and its role was left intact by Braidwood court. This could avert disruption to PrEP access for millions of Americans.

As health law scholar and former ACIP member Sara Rosenbaum recently observed, a broader mandate is consistent with ACIP’s founding mission to advise the surgeon general “regarding the most effective application in public health practice of specific preventive agents which may be applied in communicable disease control.”

The task force was created in an era when most of the clinical preventive interventions it would consider consisted almost exclusively of disease screenings. Biopharmaceutical prophylactic interventions such as PrEP did not exist. We can hope that many more, increasingly innovative forms of PrEP and other prophylactic products will enter the market in the future.

The CDC already publishes comprehensive, up-to-date PrEP guidelines that reflect the full-range of available options, including long-acting injectable PrEP. Similarly, when the ACIP issues vaccine recommendations, it does so with a particularity that requires first dollar coverage of all vaccine products without payer formulary management.

While it does not act with light speed, the ACIP typically recommends vaccines on a timelier basis than the task force, meaning that its recommendations would be effectuated more rapidly in payor coverage requirements.

The ACIP has shown a willingness to recommended additional non-vaccine or “vaccine-like” products. For many years, it has recommended immunoglobulins. Moreover, its charter was updated in recent years to reflect a responsibility for recommending “use of specific antibody products for prevention of infectious diseases.” PrEP products, like vaccines and other immunizations, cause the body to produce antibodies and as such fall properly within ACIP’s purview.

Such a transfer of authority may raise eyebrows to those who believe the task force is the favorable recommending body or take a “vaccine-centric” view of the ACIP’s role. But it provides an established coverage pathway and recommending PrEP is entirely consistent with its mission and purpose. Bureaucracy should not stand in the way of preventing the spread of HIV and ending the epidemic once and for all.

Richard Hughes IV is a partner with Epstein Becker Green and a professorial lecturer in law at the George Washington University Law School. He served as vice president of public policy at Moderna during the COVID-19 pandemic.