Insights

The Departments of Labor (“DOL”), Health and Human Services (“HHS”), and Treasury (the “Tri-Agencies”) have signaled that changes may be coming to the Mental Health Parity and Addiction Equity Act (“MHPAEA”) Final Rule issued on September 8, 2024. On May 9, 2025, the Tri-Agencies filed a Motion for Abeyance in a lawsuit brought by the ERISA Industry Committee (“ERIC”) challenging the 2024 final MHPAEA regulations in the United States District Court for the District of Columbia.[1] The Motion, which was granted by the Court, indicated that the Tri-Agencies intend to “reconsider” the Final Rule, including “whether to issue a notice of proposed rulemaking rescinding or modifying the Final Rule.” Yesterday, on May 15, 2025, the Tri-Agencies issued a notice of non-enforcement stating that they “will not enforce the 2024 Final Rule or otherwise pursue enforcement actions, based on a failure to comply that occurs prior to a final decision in the litigation, plus an additional 18 months.”

Days after President Trump issued an executive order (EO) taking aim at diversity, equity, and inclusion (DEI) programs and prohibiting federal recognition of gender identity apart from biological sex, previously issued draft guidance on diversity in clinical trials was removed from the website of the U.S. Food and Drug Administration (FDA). While the removed guidance was in draft form, it is highly unusual for FDA to revoke or alter draft guidance without issuing a statement or further guidance. This move raises questions about the applicability of statutory obligations to submit clinical trial Diversity Action Plans and the agency’s current thinking on best practices for clinical development.

On January 17, 2025, the Departments of Labor, Health and Human Services, and Treasury (the “Tri-Agencies”) released the 2024 Mental Health Parity and Addiction Equity Act (“MHPAEA”) Report to Congress (the “Report”). The Report is the third report made by the Tri-Agencies to Congress in accordance with the mandate set forth in the 2021 Consolidated Appropriations Act (“CAA”). The CAA requires that, each year starting in 2021, the Tri-Agencies submit a report to Congress summarizing their activity in the prior year to collect comparative analyses from plans and issuers and any findings made with respect to noncompliance with MHPAEA.[1] Under the CAA, the Report is due by October 1 of each year. This year’s version was published on the last working day of the Biden Administration.