New Guidance for Required PrEP Coverage

As discussed in our prior blog post, employer-sponsored health plans must soon provide pre-exposure prophylaxis (“PrEP”) drugs as a preventive service under the Affordable Care Act (“ACA”).  This means the HIV drugs must be offered at no cost to participants for all participants at risk for HIV exposure beginning in the 2021 plan year by all non-grandfathered health plans. PrEP is a daily antiretroviral medication that helps prevent high-risk individuals from acquiring HIV and is seen as a preventive drug to help end the spread of HIV.

Last month, the Departments of Health and Human Services, Labor, and the Treasury issued new guidance which clarified PrEP drug requirements. The new guidance ancillary and support services related to PrEP are also covered by the cost sharing protections.  This means that all non-grandfathered private health plans must cover those services, along with the PrEP medication, without cost sharing.

The guidance refers to the guidelines from the Centers for Disease Control and Prevention (“CDC”), which state that PrEP itself is a “comprehensive intervention” that includes the medication and essential support services.  Specifically, plans may not require cost sharing on items and services to start on the PrEP drugs or for monitoring while using the drugs.  These items and services include HIV testing; hepatitis B and C testing; kidney function tests; pregnancy testing; STI screening and counseling; and adherence counseling.

In addition, plans may not use reasonable medical management techniques to restrict the frequency of PrEP services if the frequency is specified by underlying guidance.   For example, the preventive care recommendation for PrEP states that an individual should receive HIV testing every three months while using PrEP.  Because the frequency is specified, plans may not limit access or require cost sharing on these visits.

The guidance also clarified that any office visits related to PrEP services must be covered without cost sharing when the preventive service (i.e., PrEP or an essential support service) is not billed separately from the office visit. Said another way, if a visit’s primary purpose is for the preventive service and it is not billed separately, then the visit should be covered without cost sharing.

While medical management cannot be used in many circumstances, the guidance does allow it in a limited capacity.  The guidance does permit plans to only cover the generic version of PrEP without cost sharing and to charge for the name brand version.     However, plans must accommodate, without cost sharing, any participant who must use the name brand drug for medical reasons.  Plans will need to have an easy and quick appeals process to permit participants, or their medical provider, to request the name brand drugs. As stated in the guidance this process will need to be nearly instantaneous.  The process should allow a participant to receive the required medication on the same day the participant is tested for HIV or begins to take PrEP.

While guidance clarified what must be covered, it recognized that many plans do not provide this type of comprehensive PrEP coverage.   To accommodate these plans, the guidance provides for a 60-day enforcement grace period.  This time period will allow plan sponsors to review and amend their plans, if necessary. During this time, the Departments will not take enforcement action against a plan that fails to provide these services without cost to participants.

Plans sponsors should contact their insurers or TPAs now to inquire if this new guidance is being addressed.  In addition, plan sponsors should review their current health plan documents to see if any plan amendments are necessary to comply with these requirements.  If you have any questions about your plan’s PrEP coverage or any other benefits related issue, please contact any of Graydon’s employee benefits team.

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