CMS Requests Feedback on PBM Regulation Under CAA 2026

On June 16, 2026, the Centers for Medicare & Medicaid Services (CMS) released a request for information (RFI) titled “Pharmacy Benefit Manager Compensation and Data Collection.” This RFI seeks industry feedback on Section 6224 of the Consolidated Appropriations Act of 2026 (CAA 2026), which aims to regulate the compensation of pharmacy benefit managers (PBMs) and their affiliates related to Medicare Part D drugs. New data-reporting requirements are set to commence on January 1, 2028.

The RFI provides insights into CMS's preliminary approach to implementing Section 6224, identifying areas needing additional oversight. By structuring the inquiry into six distinct categories, CMS highlights its enforcement priorities leading up to 2028.

A critical focus for CMS is classifying entities as PBMs. The questions aim to clarify the scope of "related services" and identify entities performing PBM functions without adopting this designation. This reflects CMS's concern that some entities might structure operations to evade Section 6224's requirements.

Questions concerning “affiliates” showcase CMS’s focus on indirect payment arrangements. The agency queries whether data vendors, group purchasing organizations, and pharmacies should be viewed as PBM affiliates subject to the CAA's fee restrictions, probing how these affiliations align with existing regulatory frameworks.

The RFI underscores the need for transparency and fair market value in PBM fees. CMS seeks to understand compensation models for PBMs, especially when fees aren't tied to specific services, or seem contingent on drug pricing, coverage decisions, or business volume. This includes examining "incentive payments" to address transparency gaps.

CMS also scrutinizes fair market value assessment methods, emphasizing the need to prevent pricing influences from PBM market power or integration with other pharmaceutical supply chain participants. The agency strives to ensure that pricing remains fair and uninfluenced by market dominance.

Finally, the RFI highlights CMS's ambition to establish a robust data reporting system for enhanced oversight and regulatory compliance. Focus areas include monitoring drug utilization, pricing, enrollee expenses, and PBM-related financial flows. Feedback on the RFI is due by July 20, 2026, as CMS continues assessing public comments and CAA 2026 implementation developments.