Agencies Issue FAQs (Part 47) About Mandatory Preventive Coverage of HIV PrEP

HHS, DOL, and the IRS have jointly issued FAQs about mandated preventive health services coverage for HIV Preexposure Prophylaxis (HIV PrEP). As background, the Affordable Care Act requires group health plans and insurers to provide certain preventive services without cost-sharing, including certain evidence-based items and services in the current recommendations of the United States Preventive Services Task Force (USPSTF). The USPSTF released a recommendation about HIV PrEP in June 2019, triggering a coverage requirement for plans and insurers for plan years beginning on or after June 30, 2020.

The FAQs clarify that plans and insurers must also cover items or services that the USPSTF recommends before an individual is prescribed anti-retroviral medication, as part of the determination of whether the medication is appropriate and for ongoing follow-up and monitoring. This includes coverage of associated testing for HIV, Hepatitis B and C, creatinine, pregnancy, and sexually transmitted infection, as well as adherence counseling, and associated office visits. Furthermore, plans and insurers may use reasonable medical management techniques to the extent the USPSTF recommendation does not specify the frequency, method, treatment, or setting for the provision of HIV PrEP services. In this regard, the FAQs advise that it would not be reasonable to restrict the number of times the individual may start HIV PrEP since the USPSTF recommendation specifies the frequency of services. On the other hand, medical management techniques may be used to encourage individuals who are prescribed HIV PrEP to use specific items and services, to the extent the USPSTF does not specify an item’s or service’s frequency, method, treatment, or setting. For example, since the branded version of HIV PrEP is not specified in the USPSTF recommendation, plans or insurers may cover the generic version of PrEP without cost-sharing while imposing cost-sharing on an equivalent branded version. Because plans and insurers may not have understood that the requirements apply to all support services of the USPSTF’s recommendation, the agencies indicate that they will not take enforcement action for failing to provide such coverage for 60 days after publication of the FAQs.

EBIA Comment: For some plans, the costs associated with this USPSTF recommendation may be significant. While certain reasonable medical management techniques may be permitted, the FAQs remind plans and insurers that they must have an easily accessible, transparent, and expedient exceptions process that is not unduly burdensome. For more information, see EBIA’s Group Health Plan Mandates manual at Section XIV.C (“Required Preventive Health Services Coverage”) and EBIA’s Health Care Reform manual at Section XII.C.3 (“United States Preventive Services Task Force (USPSTF) Recommendations”). See also EBIA’s Self-Insured Health Plans manual at Section XIII.C (“Federally Mandated Benefits”).

Contributing Editors: EBIA Staff.