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Labor's final PBM rule requires fee disclosure and audit access for covered large self-insured health plans

2 min read

Fictional editorial illustration reused from the Hugin archive; healthcare setting; not a PBM, plan fiduciary or reported consultation. Not documentary evidence.

This record was prepared on the date shown and recovered after a publishing interruption.

A Labor Department final rule scheduled for Federal Register publication November 2 requires covered pharmacy-benefit service providers to disclose compensation to fiduciaries of large self-insured ERISA health plans. It also provides audit access and machine-readable compensation information on request. The requirements apply to plan years beginning on or after July 1, 2027; the rule does not promise lower individual prescription prices.

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Providers of pharmacy-benefit management services will have to disclose specified compensation and allow accuracy audits for covered large self-insured health plans under a Labor Department final rule. The public-inspection copy is scheduled to be published in the Federal Register on November 2, 2026.

Which arrangements the rule covers

The regulation implements the service-contract disclosure requirements of the Employee Retirement Income Security Act, or ERISA. The information goes to the plan fiduciary responsible for entering, extending or renewing the arrangement.

Covered providers enter a contract or arrangement with a covered plan and reasonably expect at least $1,000 in direct or indirect compensation for pharmacy-benefit services or specified advice or referral arrangements involving those providers or their affiliates. The rule excludes plans whose benefits are exclusively insured and plans sponsored by specified drug-industry businesses or their affiliates.

The disclosures address direct fees, manufacturer payments, pharmacy recoupments and spread compensation: the difference between what the plan pays for a drug and what the pharmacy is paid. They also address incentives affecting the list of covered drugs. Initial disclosures precede contracting, extension or renewal; recurring disclosures are semiannual, or quarterly at the plan's request.

A right to check the figures

At a covered plan's written request, the provider must allow an audit of disclosure accuracy not less than once per year. The plan fiduciary chooses the auditor; the provider cannot limit that selection. The plan pays for selecting and retaining the auditor, while the provider pays to supply the requested information.

The provider must make reasonably necessary records available, including relevant contracts and claims or transaction-level data, subject to the rule's confidentiality provisions. This audit right checks disclosures; it is not an unrestricted right to investigate every aspect of a service contract.

On request, compensation descriptions must also be supplied in a standard machine-readable file within a reasonable time. These are rights for covered plans and their fiduciaries, not a requirement to publish each contract for everyone to see.

Effective date and applicability differ

The inspection copy retains a bracketed effective-date instruction for 60 days after publication. The Register's official metadata substitutes January 4, 2027. By this desk's count, sixty days after scheduled November 2 publication is January 1, a federal holiday. The Register's drafting handbook moves a calculated date falling on a holiday or weekend to the next federal business day, here January 4. This is an effective date, not a comment deadline.

The rule separately prints applicability to plan years beginning on or after July 1, 2027. Publication remains scheduled; the record reviewed does not establish realized savings or a particular patient's price.

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