In FAQ guidance (July 19, 2021), the DOL, HHS, and Treasury (Departments) have clarified how health plans and insurers must cover pre-exposure prophylaxis (PrEP) and related services under the Affordable Care Act's (ACA's) preventive health services rules. The FAQs expand on a US Preventive Services Task Force (USPSTF) "A" rating recommendation (issued June 11, 2019) that providers offer PrEP with "effective antiretroviral therapy" to individuals who are at high risk of acquiring human immunodeficiency virus (HIV) (see Practice Note, Preventive Health Services Under the ACA, Other Than Contraceptives: Preexposure Prophylaxis (PrEP)). As background, ACA implementing rules require non-grandfathered group health plans and health insurers to cover, without cost-sharing, evidence-based items or services that are recommended by the USPSTF with a rating of "A" or "B." Under the ACA's preventive health service rules, the USPSTF's PrEP recommendation applied to plans and insurers for plan years beginning on or after June 30, 2020.

In issuing the FAQs, the Departments acknowledged that plans and insurers may not have understood that the USPSTF's June 2019 recommendation on PrEP also applies to coverage of PrEP-related support services. The FAQs therefore:

Assuming calendar days, the Departments' limited nonenforcement period will end on September 17, 2021. The Departments encouraged the states to take a similar enforcement approach regarding coverage types under their jurisdiction.

The FAQs specify that plans and insurers must provide first-dollar coverage of items and services that the USPSTF has recommended participants and beneficiaries to receive before being prescribed PrEP. According to the Departments, these support items and services are part of the determination of whether PrEP is appropriate for that individual—and for ongoing follow-up and monitoring. The June 2019 USPSTF recommendation cited guidance from the Centers for Disease Control and Prevention (CDC), that listed a combination of baseline and monitoring services that enhance PrEP's efficacy. These support services:

The FAQs include the following six-part list of baseline and monitoring services that the Departments view as part of the PrEP recommendation:

Plans and insurers also must cover, without cost-sharing, office visits associated with each recommended preventive service for a participant or beneficiary when:

Plans or insurers may not use reasonable medical management techniques to limit the frequency of benefits for PrEP-related support services (as specified in the USPSTF recommendation), such as HIV and STI screening (see Practice Note, Preventive Health Services Under the ACA, Other Than Contraceptives: Use of Reasonable Medical Management). This is because the USPSTF's PrEP recommendation specifies the frequency of certain of these services. (Under the ACA's preventive health services rules, reasonable medical management may be used to determine the frequency of a recommended preventive service only to the extent not specified in the applicable recommendation or guideline.)

Also, when PrEP is medically appropriate for an individual, it would not be reasonable to restrict how often the individual may start PrEP.

However, because the branded version of PrEP is not specified in the USPSTF determination, plans and insurers may:

But plans and issuers also must accommodate any individual for whom a particular PrEP medication (generic or brand name) would be medically inappropriate, as determined by the individual's health provider. This requires a method for waiving cost-sharing (which would otherwise be imposed) for the brand or non-preferred brand version.

Finally, the FAQs include an example of an exceptions process for plans or insurers that use permitted reasonable medical management practices. The exceptions process would allow PrEP to be prescribed and accessed on the same day that a participant or beneficiary receives a negative HIV test or decides to start taking PrEP.

Plan sponsors and their advisors may be surprised regarding the scope of PrEP-related support services that, under the Departments' FAQs, fall under the June 2019 USPSTF recommendation. Although at least some of the support services are also covered preventive health services on a stand-alone basis, plans and insurers may wish to review how they are handling the listed items (for example, adherence counseling)—particularly given the relatively short nonenforcement period provided under the FAQs.