This Just In ... Gag Clause Enforcement and Pharmacy Transparency Audits Intensify in 2026
Federal regulators are ramping up enforcement of the Consolidated Appropriations Act’s (CAA) gag clause prohibition, and employers are beginning to feel the impact. While most plan sponsors completed their first gag clause attestation in 2023 and repeated the process in 2024 and 2025, 2026 is the year agencies are shifting from education to verification.
The Department of Labor (DOL) and Department of Health and Human Services (HHS) have begun issuing targeted audit notices re-questing documentation that employers:
- have removed contractual language restricting access to cost or quality data
- can obtain claims and pricing information from TPAs and PBMs
- have visibility into pharmacy reimbursement arrangements
- can share data with third-party auditors or analytics vendors
Early audit letters show a strong focus on pharmacy benefit contracts, especially spread pricing, rebate arrangements, and data-sharing limitations. Regulators want proof that employers can access the information needed to evaluate PBM performance and comply with other CAA transparency requirements.
Plan sponsors relying on legacy PBM con-tracts or opaque pricing models may face the greatest scrutiny. Brokers are advising clients to review:
- PBM contract amendments
- data-access provisions
- audit rights
- pass-through pricing guarantees
With pharmacy costs continuing to rise, regulators view transparency as essential to protecting plan participants. Employers who proactively confirm compliance — and ensure their vendors can support documentation re-quests — will be better positioned to avoid penalties and withstand audits throughout 2026.
This Just In ... Gag Clause Enforcement and Pharmacy Transparency Audits Intensify in 2026
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