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Key Takeaways:
Within a one-week period, there were two actions at the federal level to increase pharmacy benefits manager (PBM) transparency. The Consolidated Appropriations Act of 2026 (CAA 2026) and Department of Labor (DOL) proposed regulations on PBM compensation disclosures (DOL Proposed Rules) are complementary but differ in significant respects. CAA 2026 is broader in scope (applying to all group health plans, including fully insured arrangements), but has a later effective date and creates distinctions based on employer/plan size. In contrast, the DOL Proposed Rules only cover compensation disclosures and apply only to self-funded ERISA plans but would take effect much sooner and apply uniformly regardless of employer size.
From a compliance perspective, CAA 2026's express civil penalties ($10,000 per day for non-disclosure; $100,000 per item for false information) provide a more direct enforcement mechanism, whereas the DOL Proposed Rules leverage the ERISA prohibited transaction framework, which can result in excise taxes and equitable remedies but lacks the same bright-line penalty structure.
Notably, CAA 2026 mandates 100% rebate pass-through for plans subject to ERISA, while the DOL Proposed Rules require only disclosure of rebates retained versus passed through — a key distinction for plan sponsors and industry actors.
Potential for DOL Regulatory Revisions:
Given the near-simultaneous issuance of CAA 2026 and the DOL Proposed Rules, there is significant potential for the DOL to revise its final rule to align with the statutory requirements enacted in CAA 2026. The DOL Proposed Rules were developed pursuant to Executive Order 14273 and build upon the existing ERISA Section 408(b)(2) framework, but the proposal was finalized before the DOL could fully account for the comprehensive PBM transparency and rebate pass-through requirements that Congress subsequently enacted in CAA 2026. As a result, the DOL will likely need to harmonize its disclosure requirements, timing provisions, and employer-size distinctions with those mandated by statute to avoid duplicative or conflicting obligations for plan sponsors, PBMs, and other covered entities.
Plan sponsors and PBMs should anticipate that the DOL's final rule (expected after the comment deadline) may be significantly revised to coordinate with CAA 2026's requirements. In particular, the DOL may need to reconsider its proposed July 1, 2026 applicability date, given that CAA 2026 does not take effect until January 1, 2029 for calendar-year plans, creating a potential gap period during which the DOL's more limited disclosure requirements would apply to self-insured ERISA plans before the broader CAA 2026 mandates take effect — including 100% rebate pass-through for ERISA plans. Stakeholders should monitor the DOL's response to public comments and any coordination efforts between the DOL and other federal agencies (including the U.S. Department of Health and Human Services) to ensure a unified regulatory approach to PBM oversight.
Comparison Table
The table below compares key elements of CAA 2026 and the DOL Proposed Rules.
| Category | CAA 2026 | DOL Proposed Rules |
| Effective Date |
January 1, 2029, for calendar year plans. [Plan years beginning 30 months after enactment]. |
January 1, 2027, for calendar year plans. [Effective 60 calendar days after publication of the final rule; applicable to plan years beginning on or after July 1, 2026]. |
| Applicability |
Disclosure requirements apply directly to: (1) group health plans, (2) health insurance issuers offering group health insurance coverage, and (3) entities providing pharmacy benefit management services on behalf of such plans or issuers. Indirect application to "applicable entities" including drug manufacturers, distributors, wholesalers, rebate aggregators, applicable group purchasing organizations, and their subsidiaries, affiliates, or subcontractors. Rebate pass-through requirements apply to entities providing pharmacy benefit management services for ERISA plans (ropes in carriers, Third-Party Administrators (TPAs), rebate aggregators, and others). |
Direct application to self-funded ERISA group health plans. Indirect application to "covered service providers" that contract with self-insured group health plans to provide pharmacy benefit management services.
|
| Employer Size Distinction |
Large employers (100+ employees) and large plans (100+ participants) receive detailed drug-level PBM reports with contracted compensation, rebates, spread, and pricing data. Smaller employers/plans receive a more limited summary document with aggregate information. |
Apply to all self-insured ERISA plans regardless of employer
size. |
| Plans Covered | Group health plans (both fully insured and self-funded) and health insurance issuers under ERISA, the Internal Revenue Code, and the Public Health Service Act. |
Self-insured ERISA group health plans only. Fully insured group health plans are explicitly excluded (reserved for future action). |
| Civil Penalties |
Express civil monetary penalties:
|
Enforcement is through ERISA's prohibited transaction framework under §408(b)(2).
|
| Reporting Frequency | Semiannual reports (or quarterly at plan's request). | Initial disclosures before entering/renewing contracts, semiannual disclosures (within 30 days after each six-month period), and disclosures of information for employer reporting upon request. |
| Information to be Disclosed |
Detailed drug-level data for large employers/plans including:
|
Similar disclosure categories including:
|
| Rebate Pass-Through Requirement |
100% rebate pass-through required for ERISA plans only.
|
No rebate pass-through mandate; disclosure only.
|
| Audit Rights |
Annual rebate audit rights required for ERISA plans only.
|
Annual audit rights required.
|
| Fiduciary Relief/Safe Harbor | Innocent plan fiduciary exemption for failures attributable to PBMs, provided fiduciary did not know and reasonably believed compliance occurred. |
Administrative class exemption for responsible plan fiduciaries if PBM fails to comply, provided fiduciary:
|
| Legal Authority | Enacted through statutory amendment to the Public Health Service Act, ERISA, and Internal Revenue Code. | Administrative regulation under ERISA §408(b)(2)(A), §408(b)(2)(B), and §505. |
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
