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Labor Department Finalizes Rule Making PBMs Disclose Pay to Self-Insured Employer Plans

The Labor Department's final rule requires pharmacy benefit managers to disclose how they are paid to large self-insured employer health plans.

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The U.S. Department of Labor finalized a rule on Oct. 29, 2026 that requires pharmacy benefit managers (PBMs) to disclose their compensation to employers that sponsor self-insured health plans. Mayer Brown reports that the rule was published in the Federal Register on Nov. 2. Healthcare Dive and Becker's Payer Issues both reported the finalization on Oct. 29.

The Federal Register publication on Nov. 2 is the newest step in the rulemaking. The rule applies to large self-insured plans, and fully insured plans are excluded. Its main obligations fall on PBMs, which must disclose payments before contracts are signed and report them on a set schedule.

Which Employer Plans the Rule Covers

The rule covers self-insured group health plans of employers with at least 100 employees in the prior calendar year, according to Mayer Brown. It also covers self-insured multiemployer plans that average at least 100 participants.

Fully insured plans are excluded. So are plans sponsored by or affiliated with drug manufacturers, distributors, wholesalers, PBMs or rebate aggregators. Mayer Brown says a service provider is covered if it reasonably expects $1,000 or more in direct or indirect compensation, and compensation of $250 or less in aggregate is excluded.

What PBMs Must Disclose and How Often

Before a contract is signed, a PBM must give written disclosure of its services and expected compensation. For renewals or extensions, Mayer Brown says 90 days is treated as reasonable unless the parties agree otherwise. The items include manufacturer payments drug by drug, spread compensation, pharmacy recoupments, termination compensation and net prices.

After a contract starts, PBMs must report actual compensation every six months, or quarterly if the plan requests it, according to Becker's Payer Issues. Mayer Brown says reports are due within 30 days after each period ends, and any category with an overage of 5% or more must be identified and explained.

Becker's says disclosures must use plain language and be available in a machine-readable file on request. Plans may audit the disclosures once a year using an auditor they select. Mayer Brown says the PBM must confirm an audit request within 10 business days and produce records within 60 days, and that the PBM bears the cost of producing that information.

Fiduciary Protections and Reactions to the Rule

The rule includes a class exemption for a plan fiduciary whose PBM fails to comply. Mayer Brown says the fiduciary must not have known of the failure, must request a written correction after discovering it, and must notify the Labor Department within 30 days after the earlier of the PBM's refusal or 90 days after the request. The exemption gives the PBM no relief from civil penalties under ERISA Section 502(i).

Becker's Payer Issues quotes Vince Haley, director of the White House Domestic Policy Council, saying: "No more negotiating in the dark." Healthcare Dive reports that Labor Secretary Keith Sonderling said the rule is a win for American workers who have overpaid at the pharmacy counter.

Healthcare Dive quotes David Marin, president and CEO of the Pharmaceutical Care Management Association, who called the rule "a solution in search of a problem." Marin argued that it duplicates transparency requirements in the Consolidated Appropriations Act of 2026 and burdens smaller PBMs.

Effective Dates and Conflicting Reports

Becker's Payer Issues says the rule takes effect 60 days after Federal Register publication. Mayer Brown gives Jan. 4, 2027 as the effective date. Healthcare Dive says the rule takes effect in July 2027. Mayer Brown and Becker's both say the requirements apply to plan years beginning on or after July 1, 2027.

Mayer Brown says the Labor Department's temporary enforcement policy reaches back to Feb. 3, 2026, for providers and fiduciaries under Section 408(b)(2)(B). Separate pass-through and reporting requirements from the 2026 appropriations law apply to plan years beginning on or after Aug. 3, 2028.

Healthcare Dive reports that the Labor Department expects the rule to lower drug costs for employers and workers by $22 billion over a decade. As of Nov. 5, 2026, the rule has been published in the Federal Register, and its compliance dates have not yet arrived.

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