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The Affordable Care Act (“ACA”) requires that non-grandfathered health plans cover certain preventive benefits without cost sharing. The U.S. Preventive Services Task Force expanded the list of covered benefits to include pre-exposure prophylaxis (“PrEP”), a medicine that effectively prevents HIV, for persons at high risk of HIV. Health plans must cover the drug at no cost beginning with plan years on or after July 1, 2020.
Recently, the Departments of Labor, Health and Human Services, and Treasury released further guidance in an FAQ clarifying the coverage of PrEP itself along with the scope of services that must be covered in tandem with PrEP. Generally, plans will be in compliance with the ACA as long as they cover a single version of PrEP, including the generic version, at no cost share. However, if a participant’s medical provider determines that the covered medication is not medically appropriate for that participant, the plan must make an exception by waiving the otherwise applicable cost sharing for a brand or non-preferred brand version.
The guidance further clarifies that health plans are also required to cover with no cost share items and services that are necessary to determine if a PrEP prescription is appropriate, along with and items and services for the ongoing monitoring of a participant who is prescribed PrEP. Related services include HIV testing, Hepatitis B and C testing, tests to assess potential kidney injury, pregnancy testing, STI screening and counseling, and regular counseling to ensure that PrEP is used as prescribed.
While health plans should have already been covering PrEP as a preventive benefit, these additional services may not have been on the radar. Plans should work to cover these additional items and services as quickly as possible, but the Departments stated that they will not take enforcement action on the clarifications contained in this new FAQ until 60 days after the publication of the guidance, or September 17, 2021.