DOL’s Proposed PBM Fee Disclosure Rule: Key Themes from the Public Comments

As previously reported, the Department of Labor (DOL) released a proposed rule (Proposed Rule) on January 30, 2026, targeting ERISA disclosure obligations applicable to PBMs. The public comment period closed on April 15, following a 15-day extension, with 564 comments submitted. Below is a summary of some of the key themes we noticed in the comments.

Interaction with the Consolidated Appropriations Act of 2026

Just days after the release of the Proposed Rule, the Consolidated Appropriations Act of 2026 (CAA 2026) was signed into law on February 3, 2026. As discussed previously, the CAA 2026 sets forth a comprehensive statutory framework governing PBM reporting obligations and plan oversight of pharmacy benefit arrangements. Unsurprisingly, the interaction between the Proposed Rule and the CAA 2026 was a prevalent theme in the comments.

Notably, these comments did not reflect a single consensus view on the relationship between the Proposed Rule and the CAA 2026. Instead, comments addressing the CAA 2026 generally took one of four positions: 

Implement the Proposed Rule alongside the CAA 2026 without modification. Several commenters viewed the similarities and potential overlap of the Proposed Rule with the CAA 2026 as a natural extension of the CAA 2026’s transparency and oversight requirements. From this perspective, the Proposed Rule was seen as complementary to, and reinforcing, the Congressional intent of the CAA 2026. These commenters generally argued that the Proposed Rule should proceed as written, notwithstanding any parallel obligations, in order to advance PBM transparency and accountability.

Make targeted amendments to address technical overlap and compliance concerns. Other commenters raised concerns regarding how the Proposed Rule interacts with, or diverges from, the CAA 2026 framework. Many of these stakeholders urged the DOL to make targeted, technical refinements to align the Proposed Rule more closely with the statutory requirements. Their concerns centered on the potential compliance burden created by parallel but slightly different regulatory obligations, particularly with respect to definitions, implementation timelines, reporting frequencies, and audit and recordkeeping standards.

Amend the Proposed Rule to further strengthen oversight. A separate group of commenters advocated not only for technical alignment, but also for more substantive amendments, contending that neither the Proposed Rule nor the CAA 2026 goes far enough. These commenters called for more robust reforms focused on patients and access to care. Examples include proposals calling for the DOL to amend the rule to fully delink PBM compensation from drug rebates, expand disclosure requirements to include direct-to-consumer sales information, address patient access and standards of care, and impose clearer fiduciary duties and accountability standards. These contributors emphasized that transparency alone is insufficient absent stronger substantive protections for patients.

Withdraw the Proposed Rule in light of recent congressional action. Finally, several commenters urged the DOL to withdraw the Proposed Rule entirely in light of the CAA 2026. In addition to highlighting potential compliance conflicts and regulatory confusion, these commenters raised broader administrative concerns. Specifically, they argued that moving forward with the rule fails to adequately account for Congress’s recent action and that the DOL did not sufficiently evaluate existing regulatory frameworks or potential gaps before imposing new obligations.

Legal Objections

In addition to addressing potential conflicts with the CAA 2026, commenters made other legal arguments challenging the DOL’s authority to proceed with the Proposed Rule, including the following:

The Proposed Rule exceeds the DOL’s statutory authority under ERISA §408(b)(2). Commenters argued that §408(b)(2) is a narrowly drawn exemption from the prohibited transaction rules, designed to ensure that a plan’s service contracts are reasonable, that the services are necessary, and that compensation does not exceed a reasonable amount. According to commenters, this limited statutory text cannot support the DOL’s effort to impose a comprehensive regulatory regime on a single category of service provider.

The DOL has violated the Administrative Procedure Act. Commenters argued that the DOL failed to adequately notify the public of the legal authority supporting the Proposed Rule. Commenters observed that the agency’s decision to extend the comment period and solicit input on whether the Proposed Rule should be adjusted in light of the CAA 2026 is procedurally deficient. They argued that the DOL is required to articulate its legal authority and afford commenters a meaningful opportunity to respond.

Other Comments on Proposed Rule

Beyond these threshold questions, many commenters — including those challenging the legality or feasibility of the Proposed Rule in light of the CAA 2026 — also addressed its substantive elements. Many comments addressed the feasibility of the effective date, the scope of the Proposed Rule, and the scope of the proposed audit rights.

Feasibility of Effective Date

The proposed effective date of the rule (plan years beginning on or after July 1, 2026) drew comments from a wide range of stakeholders. Many commenters who generally supported the rule believed that meaningful compliance could not be achieved within such a short timeframe. Commenters pointed to actions covered service providers would need to take before the effective date, including updating internal data and reporting systems (often requiring technical development), evaluating and renegotiating existing contracts (for example, to amend confidentiality clauses that would restrict the required disclosures), and implementing compliance controls and staff training. Smaller PBMs that rely on external partners for data argued that they would be disproportionately impacted due to the need to develop interoperable systems with such partners.

Commenters suggested a range of alternatives, from a minimum of one year from the time a final rule is published to full alignment with the implementation window of the CAA 2026.

Scope of Rule

Commenters disagreed on the appropriate scope of the Proposed Rule, offering competing recommendations to either expand or narrow its application. 

Many health care providers, patient advocacy groups, and plan sponsors, for example, proposed that the scope of the rule should be broader. These comments generally argued in favor of one or more of the following scope expansions:

• Tightening definitions to capture all entities affiliated or under common ownership with PBMs (for example, some commenters were concerned that the definition of “affiliate” refers only to control and not ownership).
• Applying the requirements of the Proposed Rule directly to affiliates, agents, and subcontractors (rather than only directly to the covered service provider who must then gather required information from affiliates, agents, and subcontractors).
• Tightening definitions to ensure that all PBM remuneration streams are adequately captured (for example, some commenters suggested specific types of remuneration to enumerate, such as revenue from copay assistance–related programs, revenue from selling or licensing of patient data, and manufacturer fees paid to offshore GPO subsidiaries). 

By contrast, the strongest support for narrowing the scope of the rule came from the health plan and PBM stakeholders. Although many of these commenters favored withdrawing the rule altogether, several also recommended ways to limit its scope in the event it is finalized. Common requests include the following:

• Narrow the definitions of “pharmacy benefit management services,” “affiliate,” and “agent.” Commenters argued that these definitions, particularly when read together, are far too broad and would sweep in entities far removed from services typically recognized as pharmacy benefits management services and that have no nexus to the PBM services provided.
• Remove requirements to provide drug-level disclosure of manufacturer payments, spread compensation, and formulary placement incentives. Commenters argued that (1) compiling such information would be highly burdensome for covered service providers while providing little value to plan fiduciaries, and (2) the disclosure of price and compensation information would have anti-competitive effects, weaken PBM negotiating leverage with manufacturers, and ultimately raise drug costs for plan sponsors.

Audit Rights

The proposed audit rights drew significant comment, with plan sponsors and advocacy groups generally favoring a broader scope and health plans and PBMs urging that the provision be removed or, alternatively, narrowed through additional restrictions. 

Requests in favor of broader audit rights include:

• Extending audit rights, and the prohibition on restrictive audit conditions, to additional parties such as GPOs, aggregators, brokers, benefit consultants, and TPAs.
• Clarifying that auditors may access claim-level raw data rather than summaries or estimates.
• Expanding the scope of audits beyond verifying the accuracy of disclosures to include review of compliance with underlying contractual obligations, identification of conflicts of interest, and the reasonableness of compensation.

Commenters in the pharmaceutical industry were generally in favor of broad audit rights, and some argued for a federal audit authority rather than relying on audits conducted by fiduciaries.

Requests in favor of more limited audit rights include:

• Capping the volume of records produced or using a statistically valid sample in lieu of full production.
• Imposing reasonable limitations on auditor selection.
• Limiting the scope of audits to verifying disclosure accuracy.
• Providing protection for covered service providers when their affiliates, agents, or subcontractors do not produce requested information.
• Limiting access to competitors’ contracts when a participant in the drug supply chain is auditing in its capacity as a plan sponsor.

Many commenters supported the proposed audit cost split, under which the covered plan would bear all expenses related to selecting and retaining the auditor, and the covered service provider would bear the cost of producing the requested information. Some argued that the covered service provider should bear the full cost of the audit when the audit reveals inaccuracies in the disclosures beyond a specified threshold. Others suggested eliminating any PBM contribution to audit costs in order to ensure full independence.

What’s Next

The Proposed Rule includes an effective date 60 days after publication of the final rule, with the new requirements applying to plan years beginning on or after July 1, 2026. Given the volume and substance of the comments — particularly those addressing the Proposed Rule’s interaction with the CAA 2026, the DOL’s statutory authority, and the feasibility of the proposed timeline — the DOL faces meaningful pressure to revisit key elements of the Proposed Rule before finalizing it. Plan sponsors, PBMs, and other covered service providers should begin assessing how the Proposed Rule, the CAA 2026, or some combination of the two may affect their existing arrangements and compliance infrastructure. We will continue to monitor developments and report on any further DOL action.
 

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