PBM Reform is Law – DOL Should Withdraw Its Duplicative Proposal

The Department of Labor’s proposed rule on “Improving Transparency into Pharmacy Benefit Manager Fee Disclosure” comes at a time when Congress has just taken significant action in this space. In recently submitted comments, PCMA explains why the Department should withdraw the proposal and reassess its approach in light of the comprehensive transparency and reporting framework established by Congress in the Consolidated Appropriations Act of 2026 (CAA).

PBMs play a central role in helping employers, unions, and public programs manage prescription drug benefits and control costs for patients. By negotiating with drug manufacturers, designing formularies, and administering pharmacy networks, PBMs help lower drug spending and improve access to medications for more than 289 million Americans.

Since the proposal was issued, Congress enacted the CAA, establishing a detailed and coordinated federal framework governing PBM transparency, reporting, and plan oversight. While we have raised concerns with aspects of the law, it nonetheless reflects Congress’s chosen approach and now serves as the governing structure for PBM transparency moving forward.

We have already outlined how the DOL rule will increase costs, reduce competition, and hurt smaller PBMs. Here is greater detail about the numerous reasons the DOL rule should be withdrawn.

Authority Exceeded

Any regulatory action should be evaluated in light of the fact that PBM reform is now law. In addition, the proposal would require disclosure of broad financial arrangements that exist outside the plan-provider relationship. In doing so, it raises serious questions about whether the Department has exceeded the authority Congress granted under ERISA.

Undermines CAA

The proposal also raises concerns under the Administrative Procedure Act. While the Department acknowledged that the CAA may affect the rule, it has not clearly explained how it interprets the new statutory provisions or how they impact its regulatory authority. Without that clarity, stakeholders cannot meaningfully engage with the CAA rulemaking process.

Misaligned with CAA Details

Further, the proposal is misaligned with the CAA in key respects, including scope, definitions, reporting structures, audit provisions, and implementation timelines. These differences would require PBMs and plan sponsors to build and maintain parallel compliance systems to satisfy overlapping and potentially conflicting requirements. The result would be increased cost, operational complexity, and a greater risk of inconsistent or less useful disclosures.

Extraordinary Burden on Smaller PBMs

These challenges are amplified by the operational realities of PBM arrangements, which involve complex, multi-party relationships and distributed data systems. Generating the disclosures contemplated by the proposal would require significant system changes, coordination across entities, and ongoing administrative effort. The burden would fall particularly heavily on small employers and union plans, which often lack the resources and infrastructure to absorb and act on large volumes of technical information.

In conclusion, these considerations should lead to the withdrawal of the proposed rule and a reassessment of whether additional regulatory action is necessary after the CAA has been implemented and evaluated in practice. If the Department determines that further rulemaking is warranted, any future proposal should be carefully aligned with the statutory framework to ensure a coherent, efficient, and workable approach.

At a time when stakeholders are focused on improving affordability and access, regulatory efforts should build on the framework Congress has already established, not create duplicative or conflicting requirements that increase burden without improving outcomes.

Read the full letter HERE.