The departments of Labor, Health and Human Services, and the Treasury have issued ACA FAQs Part 68 providing new guidance on the Affordable Care Act’s (ACA’s) mandate that employer-sponsored group health plans cover preventive care services with no cost sharing. In addition, the FAQs offer guidance on compliance with the Women’s Health and Cancer Rights Act (WHCRA), which provides protections for individuals who elect breast reconstruction in connection with a mastectomy.
The ACA requires certain preventive care services to be provided by non-grandfathered employer-sponsored group health plans and health insurance issuers without cost sharing (i.e., no copay, coinsurance or deductible). These include evidence-based items or services with an “A” or “B” rating in the current recommendations of the United States Preventive Services Task Force (USPSTF).
On June 11, 2019, the USPSTF released a recommendation with an “A” rating that clinicians offer pre-exposure prophylaxis (PrEP) with “effective antiretroviral therapy to persons who are at high risk of HIV acquisition.” The departments subsequently issued an FAQ clarifying that the 2019 USPSTF recommendation for PrEP encompasses U.S. Food and Drug Administration (FDA)-approved PrEP antiretroviral medications as well as specified baseline and monitoring services that are essential to the efficacy of PrEP. On August 22, 2023, the USPSTF updated its recommendation with respect to PrEP and identified two additional FDA-approved formulations of PrEP.
The new FAQs clarify that plans and issuers must cover, without cost sharing, specified oral and injectable formulations of PrEP, as well as certain baseline and monitoring services, consistent with the 2023 USPSTF recommendation, for plan years beginning on or after one year from the issue date of the recommendation (i.e., plan years beginning on or after August 31, 2024, or January 1, 2025, for calendar-year plans). The 2023 USPSTF recommendation for PrEP specifies three formulations of medications approved by the FDA for use as PrEP. Therefore, plans and issuers must cover, without any out-of-pocket costs for individuals, the three FDA-approved PrEP formulations (two oral and one injectable); also they may not use medical management techniques to direct individuals prescribed PrEP to use one formulation over another.
The new guidance is intended to ensure that individuals receive coverage consistent with the ACA’s preventive services mandate. The FAQs include several examples of how plans and issuers, working with their network providers, can ensure that they cover recommended preventive items and services without cost sharing. Some key points in the guidance are as follows:
WHCRA provides protections for individuals who elect breast reconstruction in connection with a mastectomy. The FAQs clarify that if a plan subject to WHCRA provides medical and surgical benefits for a mastectomy, it must provide coverage for all stages of breast reconstruction, including surgery and reconstruction of the other breast, if only one was treated, to produce a symmetrical appearance, in a manner determined in consultation with the attending physician and the patient. This includes coverage for chest wall reconstruction with aesthetic flat closure if the patient so chooses after consulting with the attending physician.