A final rule with a later implementation date
DOL released the final regulation October 29, 2026. Its detailed requirements apply to plan years beginning on or after July 1, 2027. The effective date is separately set at 60 days after Federal Register publication. The agency’s released text remains subject to the Federal Register’s technical and formatting review; its calendar publication date was not verified for this article.12
The regulation implements ERISA’s service-arrangement prohibited transaction exemption. Its detailed disclosure framework covers providers expecting at least $1,000 in compensation for pharmacy benefit management services or specified affiliated brokerage and consulting services to covered large self-insured plans. DOL generally describes the size threshold as 100 or more participants or an employer with 100 or more employees, with specific counting rules in the text.23
Fully insured plans and plans whose sponsors are, or are affiliated with, the listed manufacturers, distributors, wholesalers, PBMs, and rebate aggregators are excluded from this regulation’s covered-plan definition. DOL cautions that smaller plans, fully insured plans, and other service providers may still have statutory disclosure obligations under ERISA. The regulation’s narrower scope does not erase those obligations.34
Follow the money through the pharmacy claim
Initial disclosures address direct compensation, manufacturer and aggregator payments, spread by drug and pharmacy channel, and pharmacy recoupments. The last category includes copay clawbacks and other retroactive reimbursement adjustments, with the anticipated number of affected transactions. Providers must also describe arrangements that direct patients to affiliated pharmacies, price protection, formulary incentives, and net drug prices or a verifiable pricing methodology.5
Disclosures must precede new contracts, extensions, and renewals. For extensions and renewals, 90 calendar days in advance is deemed reasonable. Ongoing reports are due within 30 calendar days after each six-month period, or each quarter if requested by the plan. They include compensation received or reasonably expected, and an explanation when a category exceeds its estimate by at least 5 percent or a lower agreed threshold.56
Make the audit right usable
Covered plans may request an audit of disclosure accuracy at least annually and choose their auditor. Necessary information includes claims and transaction-level data and contracts with retail pharmacies, manufacturers, and rebate aggregators, subject to reasonable confidentiality and permitted-use limits. The plan pays its auditor; the provider pays to produce the information. The disclosure period limits the audit’s scope.7
The provider must acknowledge the request within 10 business days and produce the necessary information within a commercially reasonable period, no later than 60 calendar days absent extraordinary circumstances beyond its control. The obligation extends to information held by affiliates, agents, and subcontractors.7
Chad’s analysis: The practical test is reconciliation. Can the plan connect what it paid, what the pharmacy received, what was later recouped, and what each intermediary retained? Definitions, transaction identifiers, and access to underlying records should make that comparison possible. A disclosure that cannot be reconciled offers limited operating value.
Chad’s analysis: These audit rights belong to covered plans. Pharmacy owners should continue to evaluate their own contracts, appeal deadlines, and applicable reimbursement protections separately. The rule offers a stronger route for plan oversight; it does not automatically reverse a pharmacy recoupment or resolve a disputed claim.
Source notes
- U.S. Dep’t of Lab., Pharmacy Benefit Manager Fee Disclosure Final Rule, Overview & Effective and Applicability Dates (released Oct. 29, 2026).
- Improving Transparency into Pharmacy Benefit Manager Fee Disclosure, final rule, RIN 1210-AB37, at 1–2, 350, § 2550.408b-22(p) (Dep’t of Lab. released Oct. 29, 2026) (submitted for Federal Register publication).
- Id. at 331–32, 347–48, § 2550.408b-22(b)–(d), (m)(6)–(7).
- U.S. Dep’t of Lab., Pharmacy Benefit Manager Fee Disclosure Final Rule, Statutory Disclosure Obligations (released Oct. 29, 2026).
- Improving Transparency into Pharmacy Benefit Manager Fee Disclosure, final rule, RIN 1210-AB37, at 333–39, § 2550.408b-22(e) (Dep’t of Lab. released Oct. 29, 2026).
- Id. at 339–43, § 2550.408b-22(g).
- Id. at 343–46, § 2550.408b-22(j)–(k).