Pharmacy benefit managers face regulatory scrutiny and new US rules

Pharmacy benefit managers (PBMs) are facing increased regulatory scrutiny and legal settlements in the United States. The Federal Trade Commission (FTC) recently reached agreements with Express Scripts and CVS Caremark following investigations into practices that may have contributed to higher drug costs, particularly regarding insulin rebates. While these settlements impose new requirements on drug formularies and pharmacy payments, legal experts suggest they may allow for workarounds that limit their impact on patient costs.

Simultaneously, the Department of Labor (DOL) has proposed new PBM regulations. Industry representatives, including mid-market PBMs, have criticized the rule as duplicative of the Consolidated Appropriations Act (CAA). Critics argue the proposed mandates impose excessive compliance costs that could disproportionately affect smaller competitors, potentially stifling market competition and favoring larger incumbents.