Departments Issue Guidance on PrEP Preventive Care Coverage

On July 19, 2021, the Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments), published FAQs About Affordable Care Act Implementation Part 47 (“FAQs Part 47”) to provide clarifying guidance relating to coverage of HIV Preexposure Prophylaxis (PrEP) as a preventive service without cost sharing.

Action Required Now

By September 17, 2021, non-grandfathered plans should ensure their plans cover PrEP for participants, beneficiaries, and enrollees without cost sharing and that their medical management for PrEP is in accordance with the DOL guidance.


On June 11, 2019, the United States Preventive Services Task Force (USPSTF) released a recommendation with an “A” rating that clinicians offer PrEP with “effective antiretroviral therapy to persons who are at high risk of human immunodeficiency virus (HIV) acquisition.” Consistent with the USPSTF recommendation, for plan years beginning on or after June 30, 2020, non-grandfathered plans must cover PrEP for participants, beneficiaries, and enrollees without cost sharing.


The three Q&As set forth in FAQs Part 47 provide the clarifications and requirements below regarding the PrEP preventive service. Because plans may not have understood that these requirements apply to all support services of the USPSTF’s recommendation for PrEP, the Departments will delay enforcement until 60 days after publication of FAQs Part 47 (i.e., September 17, 2021).

  • Plans are required to provide coverage without cost sharing for items or services that the USPSTF recommends should be received by an individual prior to being prescribed anti-retroviral medication. The USPSTF’s recommendation for PrEP includes a combination of baseline and monitoring services including certain clinical assessments necessary to ensure the medication prescribed for PrEP is given to at-risk persons who are not infected with HIV and who have no medical contraindications. Monitoring services include:
    • HIV testing
    • Hepatitis B and C testing
    • Creatinine testing and calculated estimated creatine clearance (eCrCl) or glomerular filtration rate (eGFR)
    • Pregnancy testing
    • Sexually transmitted infection (STI) screening and counseling
    • Offering Adherence Counseling

Plans also are required to cover without cost sharing office visits associated with each recommended preventive service applicable to the individual when the service is not billed separately (or is not tracked as individual encounter data separately) from an office visit, and the primary purpose of the office visit is the delivery of the recommended preventive service.

  • The USPSTF PrEP recommendation specifies the frequency of certain services for individuals specified in the recommendation. A plan may not restrict the frequency of benefits for services specified in the USPSTF recommendation for PrEP, such as HIV and STI screening. However, plans may use reasonable medical management techniques to determine the frequency, method, treatment, or setting for the provision of a recommended preventive service to the extent not specified in the applicable recommendation or guideline.
  • Plans may use reasonable medical management techniques to encourage individuals prescribed PrEP to use specific items and services, to the extent the frequency, method, treatment, or setting is not specified in the USPSTF recommendation. For example, since the branded version of PrEP is not specified in the USPSTF recommendation, plans may cover a generic version of PrEP without cost sharing and impose cost sharing on an equivalent branded version. However, plans 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 care provider, by having a mechanism for waiving the otherwise applicable cost sharing for the brand or non-preferred brand version. Plans utilizing reasonable medical management techniques must have an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual, provider or authorized representative.

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