July 28, 2021
Agencies Issue Guidance on Coverage Requirements for HIV-Related Medications
On July 19, the U.S. departments of Treasury, Health and Human Services and Labor issued guidance, in the form of frequently asked questions (FAQs), clarifying the scope of the preventive services coverage requirements for group health plans as applied to preexposure prophylaxis (PrEP) for the prevention of Human Immunodeficiency Virus (HIV).
Under the Affordable Care Act (ACA), group health plans and insurers must provide benefits for, and may not impose cost-sharing on, certain items and services deemed to be “preventive services.” Under the ACA and the relevant regulations, preventive services include evidence-based items or services that have an “A” or “B” rating from the United States Preventive Services Task Force (USPSTF) with respect to the individual involved.
In June 2019, the USPSTF released a recommendation with an “A” rating that doctors offer PrEP with effective antiretroviral therapy to individuals at high risk of HIV. As such, plans and insurers were required to cover PrEP consistent with this recommendation for plan years beginning on or after June 30, 2020.
The recently-issued FAQs provide that plans and insurers are required to provide coverage without cost-sharing not just for PrEP, but also for the items and services that the USPSTF recommends should be received by participants (1) prior to being prescribed anti-retroviral medication to determine whether the medication is appropriate and (2) for ongoing follow-up and monitoring (PrEP support services). PrEP support services include HIV testing, hepatitis testing, pregnancy testing, and adherence counseling, among other items and services, as described in detail in the FAQs.
The FAQs also:
- Confirm that plans and insurers must cover without cost-sharing office visits associated with PrEP support services when the services are not billed separately from the office visit and the PrEP support services are the primary purpose of the office visit. This is consistent with the general rule for all preventive services.
- Confirm that plans and insurers may not use medical management techniques to restrict the frequency of PrEP support services, to the extent the frequency is specified in the USPSTF recommendation. This is also consistent with the general rule for all preventive services.
- Confirm that plans and insurers may use reasonable medical management techniques to encourage individuals prescribed PrEP to use specific items and services (to the extent not otherwise specified in the USPSTF recommendation), including covering a generic version of PrEP without cost-sharing and imposing cost-sharing on an equivalent branded version, so long as the plan has in place the required exceptions process.
The agencies also provide that, because plans and insurers may not have understood the full scope of this requirement, they will not take enforcement action related to PrEP support services through the period ending 60 days after publication of the FAQs (i.e., September 17, 2021).
For more information, please contact Katy Johnson, senior counsel, health policy.