On July 19, the US Departments of Labor, Health and Human Services, and Treasury (the Departments) issued Part 47 of their frequently asked questions (FAQs) about Affordable Care Act (ACA) implementation. There are three new FAQs, all of which pertain to coverage of pre-exposure prophylaxis (PrEP) under Section 2713 of the Public Health Service Act (PHS Act). PrEP is an antiretroviral medication for individuals at high risk of contracting human immunodeficiency virus (HIV).
For background, PHS Act Section 2713 requires non-grandfathered group health plans to cover certain preventive services without cost-sharing, including evidence-based items or services with an A or B rating recommended by the United States Preventive Services Task Force (USPSTF). When new USPSTF recommendations and guidelines go into effect, plans have until the first day of the plan year that begins on or after the date that is one year after the new recommendation or guideline goes into effect to comply.
The USPSTF recommended that clinicians offer PrEP “with effective antiretroviral therapy to persons who are at high risk of HIV acquisition,” and gave that recommendation an “A” rating effective June 2019. The Departments now clarify that this recommendation not only requires coverage of PrEP, but also items or services that USPSTF recommends before an individual is prescribed PrEP as part of the determination of whether the medication is appropriate, as well as ongoing follow-up and monitoring. Accordingly, non-grandfathered plans are required to cover associated testing for HIV, Hepatitis B and C, creatinine, pregnancy, and sexually transmitted infection (STI), as well as STI and adherence counseling and all associated office visits in accordance with the PHS Act 2713 regulations.
Further, while the regulations under PHS Act 2713 generally allow non-grandfathered plans to use “reasonable medical management techniques to determine the frequency, method, treatment, or setting” of a particular recommended preventive service, these FAQs provide that reasonable medical management techniques may not be used to restrict the number of times an individual may start PrEP. However, since only the generic version of PrEP is specified in the USPSTF recommendation, non-grandfathered plans may use reasonable medical management techniques to justify the imposition of cost sharing on the branded version, so long as the plan accommodates any individual for whom the generic version would be medically inappropriate in accordance with the PHS Act Section 2713 regulations.
Calendar year plans have until January 1, 2022 to comply, but non-calendar year plans that begin on or before September 17, 2021 (60 days after publication) should confirm they (or their third-party administrators) are prepared to cover PrEP by that date in accordance with this latest guidance.