This article was written by Phil Waters and Maryanne Tomazic and published in The Regulatory Review on October 25, 2021.
Ending the HIV epidemic is within reach. Community advocacy and medical advances have provided the tools to prevent the transmission and contraction of HIV, but health care barriers prevent many individuals from accessing this care. Recent guidance aims to clarify practices around the coverage of HIV preventive care but faces a potential threat from the courts.
Pre-exposure prophylaxis (PrEP), a medication that prevents the transmission of HIV when used as prescribed, has been an important tool in the effort to curb new transmissions. Approved by the U.S. Food and Drug Administration (FDA) in 2018, PrEP is a remarkably effective biomedical prevention, reducing the risk of getting HIV from sex by 99 percent and from injection drug use by 74 percent.
The medication stands as a “core pillar” in the U.S. Department of Health and Human Service’s initiative known as Ending the HIV Epidemic in the United States. PrEP use, however, remains low.
Fewer than 25 percent of individuals who could benefit from PrEP are taking it, in part due to the costs associated with the regimen. An effective PrEP regimen is more than just a pill; it includes periodic HIV testing, hepatitis B and C testing, creatinine testing, kidney function tests, pregnancy testing, STI screening, and adherence counseling.
Even when PrEP medication is covered by insurance, these additional costs make accessing the regimen prohibitive.
Fortunately, the Affordable Care Act (ACA) includes a provision that facilitates access to preventive services with proven clinical efficacy at no additional cost to the consumer. Section 2713 of the ACA requires all non-grandfathered private health plans to cover preventive services at no cost when those services are rated “A” or “B” by the U.S. Preventive Services Task Force (USPSTF).
The USPSTF awards its ratings after reviewing clinical data and concluding that the services likely provide a substantial or moderate net benefit. In June of 2019, PrEP received an “A” recommendation from the USPSTF, paving the way for no-cost access beginning in 2021.
The USPSTF recommendation was helpful, yet left many unanswered questions as advocates noted that the recommendation alone might not ensure full coverage.
For example, the USPSTF recommendation to “offer preexposure prophylaxis (PrEP) with effective antiretroviral therapy” seemed only to consider PrEP as a pill, leaving the question unanswered as to whether additional services needed for an effective PrEP regimen must also be covered without cost sharing.
In addition, the USPSTF’s recommendation was released when FDA had only approved one drug for PrEP. Currently, FDA has approved two regimens and a generic competitor available to consumers, and soon FDA may approve a long-acting, injectable version of PrEP.
Despite calls from advocates to clarify guidance prior to the start of the 2021 plan year, insurers began rolling out their interpretations of the new USPSTF recommendation without any further details from regulators.
As one could expect, implementation came with varying levels of comprehensiveness. Because PrEP medications are also used as part of HIV treatment regimens, many insurers continued to simply list the medication on their drug lists on high cost-sharing tiers, and few explicitly included coverage of the ancillary services for PrEP clearly in plan marketing documents.
The U.S. Department of Labor, the U.S. Department of Health and Human Services, and the U.S. Department of the Treasury alleviated much of this confusion by issuing guidance to insurers earlier this summer.
This tri-agency interpretation from the departments clarified that PrEP services are included within the USPSTF recommendation and must be covered at no cost. The departments further explained that this coverage requirement extends to services needed before PrEP initiation—for example, initial lab testing and associated visits—and for ongoing monitoring.
Recognizing the apparent confusion over the coverage of ancillary services, the departments stated that they would not take enforcement action against any plan or issuer until 60 days post-publication of the FAQ—a period which has now passed— and they urged state regulators to take a similar enforcement strategy.
Plans and insurers are now on notice that coverage policies must be restructured accordingly. Ideally, insurers will update public-facing plan materials—formularies and summaries of benefits—to inform individuals shopping for coverage what PrEP medications and services are covered at no cost.
Public information about the coverage of PrEP medications and services would not only provide greater transparency to consumers, but it would also be an essential tool for regulators to hold insurers accountable to their Section 2713 obligations.
With respect to the frequency of coverage, the departments have clarified that plans and insurers may not use medical management techniques that limit how often someone can access PrEP services. In particular, the departments have noted that because individuals start, stop, and re-start PrEP regimens as appropriate, restricting how often individuals may start PrEP when determined appropriate by their health care provider is not reasonable.
The departments have only provided one example of what would constitute reasonable medical management—insurers may cover the generic version of PrEP without cost-sharing and impose cost-sharing on the equivalent branded PrEP. Even this example has limits as the departments noted that plans must accommodate individuals for whom a particular PrEP medication is clinically appropriate via an exceptions process or mechanism to facilitate no-cost access.
Even though this guidance is a win for people with and at risk of contracting HIV, advocates may not want to celebrate just yet as another legal challenge to the ACA makes its way through the courts. In the federal district court case, Kelley v. Becerra, the plaintiffs argue that the authority vested in the USPSTF by Section 2713 is unconstitutional, taking aim squarely at the preventive coverage provision that the departments’ guidance is built on.
Citing the appointments clause of the Constitution, the plaintiffs argue that the Constitution prohibits bodies such as the USPSTF from wielding authority because its members are not appointed by the President or a head of an agency. The plaintiffs also cite the non-delegation doctrine and argue that the USPSTF’s authority is too broad and unbridled to influence national coverage mandates.
Although the Kelley case has a long way to go before it could have a significant impact, if the plaintiffs prove successful, the case could wind up reversing the ACA’s work in expanding no-cost preventive services and limiting the federal government’s authority to regulate health insurance.
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