US regulation of pharmacy benefit managers

The US administration began preparations for a Labor Department regulation intended to increase transparency within pharmacy benefit managers (PBMs). The proposed rule aimed to address rising drug costs and the emergence of pharmacy deserts by requiring PBMs to disclose detailed information regarding drug prices, manufacturer payments, and revenue sources to self-insured employers. It specifically targeted “spread pricing,” a practice where PBMs retain the difference between employer payments and pharmacy reimbursements.

By November, the Department of Labor finalized the regulation under the Employee Retirement Income Security Act (ERISA). The rule mandates that PBMs, brokers, and consultants reveal payments received from drugmakers and pharmacies. It also grants employers the right to audit PBM operations and requires granular data on pharmaceutical prices before contracts are signed or renewed. Regulators estimate these measures could reduce drug costs for employers and workers by $22 billion over the next decade. The rule is scheduled to become effective on January 4, 2027, for plan years beginning on or after July 1, 2027.