On July 19, 2021, the Internal Revenue Service, U.S. Department of Labor, and the U.S. Department of Health and Human Services (the “Tri-Agencies”) issued new frequently asked questions (FAQs) regarding the implementation of the Affordable Care Act (ACA) that provide plans and issuers with enforcement relief until September 17, 2021. After the 60-day period expires, the Tri-Agencies will enforce the ACA’s mandate that all Pre-Exposure Prophylaxis (PrEP) preventive health services described below be covered without imposing cost sharing.

The required coverage of PrEP as a preventive care under the ACA became effective for plan years beginning on or after June 30, 2020. For calendar year group health plans, this means the preventive care coverage mandate for PrEP is effective for the current 2021 calendar plan year.

Action Items

Employer-sponsored group health plans-which are not grandfathered under the ACA-need to check with their group health plan’s insurer or third-party administrator on how all elements of PrEP are being handled. Employers should also verify that the contents of their group health plan’s summary plan description, plan document, and other employee communication materials accurately reflect the coverage of PrEP and are compliant with the requirements by September 17, 2021.

The Tri-Agencies’ prior FAQ XII reminds group health plans that if the plan’s in-network coverage does not cover a preventive care service with no cost sharing, the preventive coverage must be provided via an out-of-network provider with no cost sharing for the preventive service such as PrEP.

Clarification of the Scope of Mandated Coverage

The FAQs clarify that the “no cost sharing” requirements apply to more than the drugs prescribed as part of PrEP. The preventive services covered as PrEP based on the United States Preventive Services Task Force’s (USPSTF) recommendation include far more than the required medication because PrEP care to prevent HIV transmission requires more than a prescription.

All of the following are part of PrEP and must be covered without cost sharing as preventive care under the ACA based on the USPSTF Final Recommendation Statement, which covers FDA-approved PrEP antiretroviral medications and all of the following baseline and monitoring services in order to prevent the spread of HIV infection:

1. HIV testing: Persons must be tested and confirmed to be HIV uninfected before starting PrEP and tested again for HIV every three months while taking PrEP so that, if they have become infected, the medication can be stopped promptly before it could cause a harmful drug resistance to develop.
2. Hepatitis B and C testing: Persons should be screened for hepatitis B virus (HBV) at baseline for the initiation of PrEP consistent with CDC guidelines, so that when the PrEP medications, which suppress HBV replication in the liver, are stopped, persons can be monitored to ensure safety and to rapidly identify any potential injury. Additionally, persons should be screened for hepatitis C virus (HCV) infection at baseline and periodically consistent with CDC guidelines. Screening for HCV infection is indicated for all people with ongoing risk of contracting HCV.
3. Creatinine testing and calculated estimated creatine clearance (eCrCl) or glomerular filtration rate (eGFR): For persons taking PrEP, their estimated eCrCl or eGFR must be measured and calculated at the beginning of treatment to assess if kidney function is in the range for safe prescribing of PrEP medication. Creatinine and eCrCL or eGFR should be checked periodically consistent with CDC guidelines while on PrEP medication to assess for potential kidney injury and to ensure that it is safe to continue PrEP medication.
4. Pregnancy testing: Persons with childbearing potential taking PrEP must be tested for pregnancy at baseline and should be tested again periodically thereafter consistent with CDC guidelines until PrEP is stopped so that pregnant patients, together with their health care providers, can make a fully informed and individualized decision about taking PrEP.
5. Sexually transmitted infection (STI) screening and counseling: Persons taking PrEP must be screened for STIs at baseline and should be screened periodically thereafter consistent with CDC guidelines, which may require multiple anatomic site testing (i.e., genital, oropharyngeal, and rectal) for gonorrhea and chlamydia, and testing for syphilis, together with behavioral counseling, which are recommended to reduce the risk of STIs, the presence of which may increase the likelihood of acquiring HIV sexually.
6. Adherence counseling: Persons taking PrEP must be offered regular counseling for assessment of behavior and adherence consistent with CDC guidelines to ensure that PrEP is used as prescribed and to maximize PrEP’s effectiveness.

Office visits associated with each recommended preventive service applicable to a participant or beneficiary, when such visit is not billed separately, must be provided without cost sharing when the primary purpose of the office visit is for a PrEP-covered preventive service.

While the USPSTF’s preventive care recommendation specifies the frequency of some required services, the group health plan may use reasonable medical management on a required service that does not have a specified frequency. For example, a group health plan could offer the generic version of a PrEP medication with no cost sharing and impose cost sharing on an equivalent branded version of the PrEP medication.

Required Rapid Response on Request to Use Brand Instead of Generic

If the generic version of a PrEP medication is medically inappropriate for an individual, there must be a mechanism by which the individual can get cost sharing on the branded version waived. The mechanism must have an easily accessible, transparent, and sufficiently expedient process for waiving such restriction. The example provided in the FAQs suggests the plan must allow prescribing and accessing PrEP medications on the same day that a participant or beneficiary receives a negative HIV test or decides to start taking PrEP, and the process must not be unduly burdensome on the individual, the health care provider, or a person acting as an authorized representative of the individual. Group health plans will need to work with their third-party administrators to ensure that this mechanism for promptly handling requests for branded PrEP medications meets the requirements of this guidance.

Originally published 22 July 2021.