Compliance News | July 21, 2021

New ACA FAQs Clarify Coverage Required for HIV Prevention

All group health plans that are non-grandfathered under the ACA must cover a long list of preventive services without cost sharing. This includes pre-exposure prophylaxis (or PrEP) for prevention of HIV. On July 19, 2021, the Departments of Labor, Health and Human Services, and Treasury (the Departments) issued detailed guidance addressing the scope of HIV preventive services that must be covered.

Male Nurse Taking A Blood Sample

Background on PrEP and HIV prevention

The ACA requires non-grandfathered group health plans to provide certain preventive services without cost sharing. This includes services with an “A” or “B” recommendation from the U.S. Preventive Services Task Force (USPSTF).

In June 2019, the USPSTF released an “A” recommendation that clinicians offer PrEP with antiretroviral therapy to persons at high risk of HIV. The ACA requirement to cover this medication without cost sharing took effect with plan years beginning one year later. For a July 1 plan year, it took effect for the plan year beginning July 1, 2020. For a calendar-year plan, it took effect January 1, 2021.

Currently, there are two brand-name medications available for this purpose (Truvada® and Descovy®), one of which (Truvada®) has a generic equivalent.

Overview of the new guidance

The new guidance clarifies certain requirements related to coverage of the drugs themselves, as well as the range of monitoring and support services that also must be covered without cost sharing.

Coverage for the HIV preventive medications

The guidance permits plan sponsors to cover the generic version of PrEP without cost sharing and charge cost sharing for the brand version. However, plans must accommodate any person for whom a particular medication (either generic or brand) would be medically inappropriate, as determined by the person’s own health care provider. This means having a mechanism for waiving the otherwise applicable cost sharing for the brand (or the non-preferred brand). This mechanism must be easily accessible, transparent and sufficiently expedient.

Coverage of related monitoring and support services

In general, the Departments interpret the USPSTF guidelines and the ACA preventive services regulations to require coverage of the services necessary to determine if PrEP should be prescribed, as well as the services necessary for ongoing follow-up and monitoring while taking PrEP. This includes the following:

  • HIV testing — This is needed before starting PrEP to confirm the person is not infected with HIV, and is also required every three months while taking PrEP.
  • Hepatitis B and C testing — Screening for Hepatitis B is required at baseline for initiation of PrEP, and screening for Hepatitis C is required at baseline and periodically thereafter.
  • Kidney function tests — Tests to determine kidney function are needed at the beginning of treatment, and they also need to be performed periodically while on PrEP.
  • Pregnancy testing — People with childbearing potential who are taking PrEP must be tested for pregnancy at baseline and periodically thereafter.
  • Screening and counseling for sexually transmitted infections (STIs) — This is required at baseline and periodically thereafter, along with behavioral counseling to reduce the risk of STIs.
  • Adherence counseling — Regular counseling needs to be offered to ensure that PrEP is used as prescribed and its effectiveness is maximized.

Coverage of office visits may be required

Under general rules applicable to ACA preventive services, in-network office visits must also be covered without cost sharing if the specific preventive service (e.g., HIV testing) is not billed separately and the primary purpose of the office visit is the delivery of the recommended preventive service.

Implications for plan sponsors

Plan sponsors and plan administrators may wish to confirm with their pharmacy benefit managers and the entities responsible for paying medical claims that these services are or will be covered without cost sharing. Plan sponsors should ensure that plan documents and summary plan descriptions correctly identify how payment for PrEP and related services should be made.

Because plan sponsors and plan administrators may not have understood that these monitoring and support services must also be covered, the Departments announced that they will not take enforcement action against a plan for failing to cover these services for the period ending 60 days after publication of this guidance.

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This page is for informational purposes only and does not constitute legal, tax or investment advice. You are encouraged to discuss the issues raised here with your legal, tax and other advisors before determining how the issues apply to your specific situations.

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