Recent developments at the federal legislative and regulatory levels signal a significant shift toward greater transparency requirements in the pharmacy benefit management (PBM) industry.

The Internal Revenue Service (the IRS) recently issued Notice 2026-5 which provides guidance on changes to health saving accounts (HSAs) enacted by the One Big Beautiful Bill Act (OBBBA).

On September 11, 2025, the U.S. Department of Health and Human Services Office of Inspector General (the OIG) issued a favorable advisory opinion (AO 25-10 or the Opinion) regarding an arrangement between a healthcare services company (the Company) and a charitable foundation (the Foundation), whereby the Company makes financial contributions to the Foundation, which then provides grants to families of children receiving a particular type of therapy (the Arrangement). Pursuant to AO 25-10, the OIG will not impose sanctions with respect to the Arrangement, despite the Arrangement potentially generating prohibited remuneration under the federal Anti-Kickback Statute (the AKS) and implicating the civil monetary penalty provision prohibiting inducements to beneficiaries (the Beneficiary Inducements CMP).