US Department of Labor proposes historic pharmacy benefit manager fee disclosure rule

WASHINGTON - The U.S. Department of Labor's Employee Benefits Security Administrationtoday issued a landmark proposed regulation designed to bring overdue transparency to the fees and compensation pharmacy benefit managers receive.

The proposed regulation is the most significant federal reform of prescription drug middlemen proposed in decades and builds on the accomplishments of the administration's first term. It also advances President Trump's Executive Order, "Lowering Drug Prices by Once Again Putting Americans First,"that directed federal agencies take additional steps to create a fairer prescription drug market that lowers costs and ensures accountability across the health care system. By lowering drug costs, the Trump administration is putting money back in the pockets of American workers and retirees, their families, and businesses.

"Under President Trump's bold leadership, the Department of Labor is shining a bright light into pharmacy benefit managers' business practices - delivering unprecedented transparency to an otherwise opaque industry," said Secretary Lori Chavez-DeRemer. "When middlemen are forced to operate in the sunlight, American workers and their families win. Hidden fees and distorted incentives have no place in American healthcare."

"The Department of Labor is delivering on President Trump's promise to fix a broken healthcare system by introducing radical transparency into drug costs" said Deputy Secretary Keith Sonderling. "This action will allow employers to see the full extent of the fees charged by pharmacy benefit managers, enabling them to negotiate a better deal for themselves and American workers."

PBMs act as an intermediary in the prescription drug supply chain for employer-sponsored self-insured group health plans that provide coverage to approximately 90 million Americans. Health plan fiduciaries, however, often cannot obtain full transparency into the payments that PBM service providers and their affiliates receive from drug manufacturers, pharmacies, and others.

The proposed rule would require pharmacy benefit managers to make disclosures to plan fiduciaries that would allow them to assess the reasonableness of compensation for the services and to fulfill their duties under the Employee Retirement Income Security Act.

"I commend the Department of Labor and Secretary Chavez-DeRemer for taking bold action to empower patients and hold pharmacy benefit managers accountable. The Trump Administration is delivering radical transparency to the prescription drug market and lowering costs for the American people. This needed reform will help fix a broken system, protect families, and Make America Healthy Again," said Department of Health and Human Services Secretary Robert F. Kennedy Jr.

Issued under ERISA's statutory service provider prohibited transaction exemption, the proposed rule requires PBMs to disclose the following information for the first time:

• Rebates and other payments from drug manufacturers.
• Compensation received when the price paid by the plan for a prescription drug exceeds the amount reimbursed to the pharmacy.
• Payments recouped from pharmacies in connection with prescription drugs dispensed to the plan.

The proposed regulation would also allow plan fiduciaries to audit the accuracy of PBM disclosures and provides additional relief for plan fiduciaries if their PBM fails to meet its obligation.

Now available for public inspection, comments on the proposal are due 60 days from its Jan. 30 publication in the Federal Register.

Read the notice of proposed rulemaking on pharmacy benefit manager disclosures .