HHS, DOL, and IRS jointly issued FAQs on mandatory coverage of preventive health services for HIV pre-exposure prophylaxis (HIV PrEP). For context, the Affordable Care Act requires group health plans and insurers to provide certain preventive services without cost sharing, including certain evidence-based elements and services in the current Services Task Force recommendations. United States Preventive Services (USPSTF). The USPSTF issued a recommendation regarding 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 recommended by the USPSTF before an individual is prescribed an antiretroviral drug, as part of determining the drug’s suitability and for follow-up and continuous monitoring. This includes coverage of related tests for HIV, hepatitis B and C, creatinine, pregnancy and sexually transmitted infections, as well as adherence counseling and associated office visits. Additionally, plans and insurers may use reasonable medical management techniques as the USPSTF recommendation does not specify the frequency, method, treatment, or setting of delivery of HIV PrEP services. In this regard, the FAQs indicate that it would not be reasonable to limit the number of times a person can begin HIV PrEP since the USPSTF recommendation specifies the frequency of services. On the other hand, medical management techniques can be used to encourage people prescribed HIV PrEP to use specific items and services, as the USPSTF does not specify frequency, method , the treatment or setting of an item or service. For example, because the brand 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 still imposing a cost sharing on an equivalent brand version. Because plans and insurers may not have understood that the requirements apply to all support services in the USPSTF recommendation, the agencies indicate that they will not take enforcement action for failure to provide such coverage for 60 days after posting the FAQs.
EBIA comment: For some plans, the costs associated with this USPSTF recommendation may be significant. Although some reasonable medical management techniques may be permitted, the FAQs remind plans and insurers that they must have an easily accessible, transparent, and timely exceptions process that is not unduly burdensome. For more information, see the EBIA Group health plan mandates manual in Section XIV.C (“Required Coverage of Preventive Health Services”) and the EBIA Manual. Health care reform manual in section XII.C.3 (“Recommendations of the United States Preventive Services Task Force (USPSTF)”). See also EBIA Self-Insured Health Plans manual in section XIII.C (“Mandatory Benefits by the Federal Government”).
Contributing editors: EBIA staff.
