CMS clarifies the preventive services requirements for PrEP 

Scientific advancements over the past four decades have made it possible to dramatically reduce new cases of HIV. The use of PrEP (pre-exposure prophylaxis) can prevent people from acquiring HIV. When taken consistently, PrEP therapy is highly effective in reducing the risk of HIV transmission. Research indicates that it can decrease the risk of acquiring HIV from sexual activity by approximately 99% and from injection drug use by at least 74%.

Investing in HIV preventive care is a lot less expensive than treating the condition. Estimates suggest that lifetime management costs for HIV range from over $300,000 to nearly $1 million. So for employers, promoting HIV prevention and treatment adherence is not only the right thing to do, but also good for business. In fact, most employer-sponsored health plans must cover PrEP – without any cost-sharing for the patient.

Late in 2024, CMS clarified the ACA preventive services requirements around PrEP. For plan years starting on or after Aug. 31, 2024, nongrandfathered group health plans must cover all three approved formulations of PrEP without cost sharing or without medical management techniques that favor one formulation over another. Truvada was the only FDA-approved PrEP medication when no-cost coverage for high-risk individuals was first mandated for the 2021 plan year. The updated PrEP recommendation includes coverage of two additional FDA-approved PrEP formulations – Descovy (taken daily orally) and Apretude (injectable medication administered by a healthcare provider once every other month). There is also a generic version of Truvada available.

Employer group health plan sponsors should talk with their carrier or third-party administrator and pharmacy benefit manager to ensure PrEP is covered at $0 cost share for all three drugs and that any utilization management strategies mandating one formulation over another have been removed. Prior guidance may allow plans to cover the generic version of Truvada without cost-sharing and impose cost sharing on the brand version, subject to certain conditions. If your administrator hasn’t updated their claims processing systems to comply with this guidance, ask when the updates will be completed and how any claims that were processed improperly will be readjudicated.

In addition to covering PrEP, non-grandfathered plans must also cover baseline HIV testing and ongoing monitoring at no cost to members. Baseline HIV testing involves several critical steps, including a review of medical history and discussion of risk factors, associated testing, and screening for sexually transmitted infections. A negative HIV test is required prior to starting PrEP. Additional services, including counseling and education about HIV prevention, must also be provided at no cost.

Employers should also be ready to address coverage questions from plan participants.

Two years ago, Mercer joined a coalition of companies, U.S. Business Action to End HIV, to help achieve what was once thought impossible – the end of the HIV epidemic in the US by 2030. In addition to complying with the ACA preventive services requirements, we hope you will join Mercer and the community of companies committed to taking action to end the HIV epidemic. Together, we’ll learn, innovate and collaborate to achieve the greatest impact. Learn more at healthaction.org/endhiv.