By Pension and Benefits Editorial Staff
The Departments of Labor, Health and Human Services (HHS), and the Treasury (Departments) have issued frequently asked questions (FAQs) on the coverage of HIV Pre-Exposure Prophylaxis (PrEP).
PrEP given “A” rating. 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.” Accordingly, plans and issuers must cover PrEP consistent with the USPSTF recommendation without cost sharing for plan years beginning on or after one year from the issue date of the recommendation (in this case, plan or policy years beginning on or after June 30, 2020).
Coverage prior to prescription. The FAQs indicate that plans and issuers must provide coverage without cost sharing for items or services that the USPSTF recommends should be received by a participant, beneficiary, or enrollee prior to being prescribed anti-retroviral medication as part of the determination of whether such medication is appropriate for the individual and for ongoing follow-up and monitoring.
As described in the USPSTF Final Recommendation Statement, the purpose of the recommendation is to decrease the risk of HIV transmission for persons who are at high risk of HIV infection. The USPSTF also notes that “the CDC provides a complete discussion of implementation considerations for PrEP, including baseline and follow-up testing and monitoring, time to achieving protection, and discontinuing PrEP.”
Plans and issuers are also required to cover, without cost sharing, office visits associated with each recommended preventive service applicable to the participant, beneficiary, or enrollee 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.
Frequency of benefits. A plan or issuer cannot use reasonable medical management techniques to restrict the frequency of benefits for services specified in the USPSTF recommendation for PrEP, such as HIV and STI screening, in a manner specified under other existing USPSTF recommendations, or otherwise.
The USPSTF PrEP recommendation specifies the frequency of certain services for individuals specified in the recommendation. Plans and issuers may use reasonable medical management techniques to determine the frequency, method, treatment, or setting for the provision of a recommended preventive service only to the extent not specified in the applicable recommendation or guideline.
In addition, when PrEP is medically appropriate for an individual specified in the USPSTF recommendation, as determined by the individual’s health care provider, it would not be reasonable to restrict the number of times the individual may start PrEP.
Reasonable medical management techniques. Consistent with PHS Act section 2713 and its implementing regulations, plans and issuers 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 and issuers may cover a generic version of PrEP without cost sharing and impose cost sharing on an equivalent branded version.
However, plans and issuers 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.
Exceptions process. If utilizing reasonable medical management techniques, plans and issuers must have an easily accessible, transparent, and sufficiently expedient exceptions process (for example, one that allows prescribing and accessing PrEP medications on the same day that a participant, beneficiary, or enrollee receives a negative HIV test or decides to start taking PrEP) that is not unduly burdensome on the individual or a provider (or other individual acting as an authorized representative), as set forth in the Departments’ previous guidance.
SOURCE: FAQs About Affordable Care Act Implementation, Part 47, July 19, 2021
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