Departments Clarify that HIV PrEP Services Must Be Free by September 17

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Back in June of 2019, the United States Preventive Services Task Force (“USPSTF”) released an A-rated recommendation for HIV Preexposure Prophylaxis (“PrEP”). As a result, the Affordable Care Act’s preventive care rules require group health plans to cover recommended PrEP without cost-sharing, effective for plan years beginning on or after June 30, 2020 (i.e., effective January 1, 2021 for plans with calendar year plan years). On July 19, 2021, the Departments of Labor, Health and Human Services, and the Treasury (collectively, the “Departments”) issued jointly-prepared FAQs About Affordable Care Act Implementation Part 47 (the “FAQs”) to clarify these PrEP coverage requirements.

In the FAQs, the Departments highlight that group health plans may not have understood that their coverage requirements apply to support services of the USPSTF’s PrEP recommendation. The FAQs clarify that the USPSTF recommendation includes a combination of certain baseline and monitoring services that are essential to the efficacy of PrEP. The FAQs describe these services, which include HIV testing, Hepatitis B and C testing, creatinine testing, pregnancy testing, sexually transmitted infection (“STI”) screening, and adherence counseling. In addition to covering the recommended services, plans must also cover associated office visits without cost sharing if the service is not billed separately from the office visit and the primary purpose of the visit is the delivery of the recommended service.

The FAQs also provide guidance on when group health plans can use medical management techniques with respect to PrEP coverage. The FAQs make clear that plans may only use such techniques to determine the frequency, method, treatment, or setting for the provision of the recommended PrEP services to the extent that these factors are not specified in the USPSTF recommendation. For example, because the USPSTF recommendation does not specify a particular brand of PrEP, the FAQs provide that a group health plan may impose cost-sharing on a brand-name version of PrEP as long as the plan covers a generic version of PrEP without cost-sharing. However, accommodations must be made if an individual’s health care provider determines that a particular brand of PrEP is medically inappropriate.

Finally, the FAQs include some good news for any noncompliant group health plans, as the Departments will not take enforcement action against plans for failing to provide coverage of the PrEP support services through the period ending 60 days after publication of the FAQs (i.e., September 17, 2021). Before this relief period runs out, group health plans should consider whether they have fully complied with the coverage requirements consistent with the USPSTF recommendation, as clarified by the FAQs.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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