On October 21, 2024, the Tri-Agencies (HHS, DOL, and Treasury) jointly issued FAQs About Affordable Care Act and Women’s Health and Cancer Rights Act Implementation Part 68. The document provides clarification of preventive service coverage of pre-exposure prophylaxis (PrEP) drug treatment to reduce the risk of HIV infection as well as guidance on breast reconstruction surgery under the Women’s Health and Cancer Rights Act (WHCRA).
The Affordable Care Act (ACA) requires non-grandfathered group health plans to cover certain preventive services without cost-sharing, including certain evidence-based items and services recommended by the United States Preventive Services Task Force (USPSTF). WHCRA sets forth coverage requirements for reconstructive surgery following a mastectomy. The FAQ can be found at CMS.gov.
PrEP Coverage. When the USPSTF first added PrEP treatment as an “A” recommendation, the FDA had only approved one drug formulation – so at that time only tenofovir disoproxil fumarate and emtricitabine (brand name Truvada®) was covered under health plans at 100%. Since that time, two more drug treatments have been approved:
- Emtricitabine/tenofovir alafenamide (brand name Descovy®) approved by the FDA for PrEP in October 2019; and
- Cabotegravir (brand name Apretude®) the first long-acting injectable PrEP medication approved by the FDA in December 2021.
The FAQ clarifies that all these approved formulations of PrEP must be covered by health plans at 100% and that specified baseline and monitoring services for administration of these formulations must be provided in accordance with these expanded recommendations as of the first plan or policy year beginning on or after August 31, 2024.
The FAQ advises that health plans must cover the approved formulations without cost-sharing and are not permitted to apply medical management techniques to direct the use of one formulation over another. If your plan currently limits coverage to a single formulation of PrEP, an amendment to your plan document may be needed.
Coverage of Breast Reconstruction. The FAQ also reiterates that health plans that provide medical and surgical services for mastectomy and are subject to WHCRA are required to provide coverage for all stages of breast reconstruction (if the patient elects reconstruction). This includes coverage for chest wall reconstruction with aesthetic flat closure if chosen by the patient in consultation with the patient’s physician. The agencies note that cost-sharing may be imposed if deemed appropriate and if consistent with cost-sharing for other plan benefits.
If you have any questions regarding the FAQ, or any ACA or WHCRA issue, please contact Erin Kelly, Director of Compliance and Human Resources at 740-522-7368.