August 20, 2021
In mid-July of 2021, the U.S. Departments of Labor, Health and Human Services (HHS), and the Treasury (agencies) issued guidance clarifying what group health plans must cover, without cost-sharing, to satisfy an “A” recommendation made in 2019 by the U.S. Preventive Services Task Force (USPSTF) for Pre-Exposure Prophylaxis (PrEP), medication and essential support services for persons at high risk for human immunodeficiency virus (HIV) acquisition. The services must be covered by September 19, 2021
The guidance clarifies that in addition to covering PrEP medication, group health plans must cover all essential support services, including testing for HIV, Hepatitis B and C, kidney function [creatinine testing and calculated estimated creatine clearance (eCrCl) or glomerular filtration rate (eGFR)], pregnancy, and sexually transmitted infection (STI), as well as screening and counseling, adherence counseling and associated office visits. Furthermore, group health plans may not use reasonable medical management techniques to restrict how often eligible participants receive these tests if it is specified in the recommendation. For example, HIV screening requires participants to be tested prior to treatment and once every 3 months, while other testing guidelines are less clear. Finally, the guidance clarifies that group health plans may not restrict the number of times plan participants may start PrEP if it is determined to be medically appropriate by their provider.
Group health plans may, however, use reasonable medical management techniques to impose cost-sharing on the branded version of PrEP while not doing so for the generic, since the USPSTF recommendation did not specify coverage of the brand. However, plans must make reasonable accommodations for individuals whose providers have determined that a brand or generic version of the medication would be medically inappropriate.
If you have questions, comments, or concerns about these or other regulatory and compliance issues, please contact us.
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