
Department of Labor Proposed Rule Could Further Bolster PBM Transparency
Key Takeaways
- The proposal would require PBMs and affiliated vendors to disclose direct and indirect remuneration so ERISA fiduciaries can assess compensation, select “reasonable” arrangements, and identify conflicted incentives.
- ERISA’s prohibited-transaction framework is leveraged by tightening the 408(b)(2) service-provider exception, effectively making transparency a prerequisite for lawful contracting with self-insured employer plans.
Just before monumental PBM reform was signed into law, as well as a landmark settlement between the FTC and Express Scripts, the Department of Labor proposed its own set of PBM regulations.
Introduced by the Department of Labor’s (DOL) Employee Benefits Security Administration, a newly proposed regulation could increase transparency among the fees and compensation that pharmacy benefit managers (PBMs) receive, according to a DOL news release.1
“Under President Trump’s bold leadership, the DOL is shining a bright light into PBMs’ business practices—delivering unprecedented transparency to an otherwise opaque industry,” DOL Secretary Lori Chavez-DeRemer said in the release. “When middlemen are forced to operate in the sunlight, American workers and their families win.”
Despite coming before the historical
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According to the DOL press release, this new rule would force transparency among PBMs from the perspective of health care plan fiduciaries.1 In turn, PBMs and their affiliated service providers would have to disclose detailed financial information, allowing said fiduciaries to take action based on the reasonableness of PBM compensation and any conflicts of interest among PBMs.
Although not considered a Congressional action with the weight of a bill signed into law, this rule is an amendment to the Employee Retirement Income Security Act (ERISA).
“ERISA generally prohibits transactions between employer-sponsored self-insured group health plans and so-called parties in interest, including entities that provide services to the plan,” according to Ropes & Gray LLP.4 “Under an exception to this rule, ERISA Section 408(b)(2) allows plans to enter into service contracts where the services are necessary, and the related service arrangement is reasonable and provides for only reasonable compensation.”
On top of the rule’s implementation of ERISA, it is also an extension of President Donald Trump’s Executive Order 14273, titled “Lowering Drug Prices by Once Again Putting Americans First.” Signed last year in April, this new PBM transparency rule is the DOL playing its part as outlined in the president’s declaration.5
In the executive order, the administration called on the secretary of labor specifically to work on improving employer health plan fiduciary transparency regarding the direct and indirect fees and compensation gathered by PBMs.
“The Department of Labor is delivering on President Trump’s promise to fix a broken health care system by introducing radical transparency into drug costs,” said DOL Deputy Secretary Keith Sonderling.1 “This action will allow employers to see the full extent of the fees charged by PBMs, enabling them to negotiate a better deal for themselves and American workers.”
How the DOL Rule Falls in Line with Additional PBM Reform
Just days after the DOL proposed its rule, on February 3, President Trump signed an omnibus funding bill consisting of the Consolidated Appropriations Act of 2026.3,4 Among many provisions outlined in the new law, the Centers for Medicare and Medicaid Services (CMS) will now have greater authority to oversee PBM-pharmacy contracts, giving pharmacies more power to challenge PBM control and ensure much fairer business relationships than in the past.
On top of several provisions designed to eliminate predatory PBM contracting, the law is also targeting the delinking of PBM compensation.
“The notion of delinking PBM reimbursement from list prices is essentially trying to remove that perverse financial incentive that aligned a PBM’s profits and revenue with the list price of the drug,” Jesse Dresser, Esq, partner in the Life Sciences Department and head of the Pharmacy Practice Group at Frier Levitt Attorneys at Law,
Under the delinking provision, PBMs would be forced not to derive any revenue based on the list price of a prescription drug, which they have historically tied to high-priced drugs to further increase their profits. With PBM incentives delinked from drug prices, experts agree this could create a landscape where PBMs and pharmacists alike aim to give patients the highest-quality medication rather than the highest price.
Finally, with the settlement made between the FTC and Cigna’s major PBM Express Scripts, the company will be forced to dedicate $7 billion in the next 10 years toward improving patients’ out-of-pocket drug costs. Along with the massive financial penalty aimed at Express Scripts, it is also expected to revamp its business practices to avoid any wrongdoing toward patients and pharmacies alike.2
With the DOL rule under a comment period until March 31—as well as many provisions under the new law and FTC settlement still needing to be rolled out—there is still much that needs to be done in the near future to ensure these actions are followed through. However, these events serve as a beacon of hope for many community pharmacies and their patients, who have been at the will of major PBMs for much of the past few decades.4
“I commend the DOL and Secretary Chavez-DeRemer for taking bold action to empower patients and hold PBMs accountable,” concluded US Department of Health and Human Services Secretary Robert F. Kennedy Jr.1 “The Trump administration is delivering radical transparency to the prescription drug market and lowering costs for the American people.”
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