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Legislative analysts are sifting through two big new batches of requirements for the pharmacy benefit managers that help employers provide prescription drug benefits.
One topic getting attention is the rules that could apply when affected employers or other employer health plan fiduciaries want to audit the PBMs, or find out exactly what PBMs are doing.
A team at Foley & Lardner has put the audit rules details in a PBM reform cheat sheet chart.
The Foley & Lardner analysis has revealed a conflict between the new PBM audit laws and the draft DOL regulations: Different parties could end up paying for the PBM audits.
DOL officials wanted the PBMs to help pay the auditors, but Congress prohibited PBMs from paying the auditors.
The team predicts that DOL regulation writers will revise their draft regulations to align with the statutory requirements.
The backdrop: The Foley & Lardner cheat sheet chart summarizes the employer PBM audit rule details included in the new Consolidated Appropriations Act of 2026 spending package, which became law earlier this month.
The chart also summarizes the employer PBM audit rules included in the draft PBM regulations that the U.S. Department of Labor proposed for self-insured employer health plans in January.
The CAA 2026 rules are set to take effect Jan. 29, 2029. They will apply to group health plans and fully insured group health plans, and they will provide annual rebate audit rights for the sponsors and other fiduciaries of health plans governed by the Employee Retirement Income Security Act.
The draft DOL rules would take effect Jan. 1, 2027, for calendar-year plans and provide general PBM audit rights for fiduciaries of the self-insured health plans governed by ERISA.
The audits: Under the CAA 2026 rules, a plan fiduciary would choose the auditor, and the PBM could not pay the auditor, according to the cheat sheet chart.
Under the draft DOL rules, the plan fiduciary would choose the auditor.
The PBM could not limit the audit choice, but the health plan and the PBM would share the cost of paying for the audit.
The Faegre Drinker perspective: Legislative analysts at another firm, Faegre Drinker, have also looked at the audit provisions in the draft DOL regulations.
"The plan would be responsible for expenses related to selecting and retaining the auditor while the PBM would be responsible for costs associated with providing requested information," according to the Faegre Drinker analysis.
apply only to the self-insured employer health plans governed by the federal Employee Retirement Income Security Act.
Plan fiduciaries would have to look at the disclosures PBMs provided and decide whether they should exercise their audit rights, the team says.
"If a PBM fails to make the required disclosures or comply with the plan's audit right after the plan fiduciary notifies the PBM of the failure, the plan fiduciary would be responsible for considering whether to report the PBM's failure to the DOL and whether to terminate its service agreement with the PBM consistent with its duty of prudence under ERISA," the firm adds.
Comments: Members of the public can shape how DOL revises the draft regulations and how the department implements the new CAA 2026 requirements, whether through the existing draft regulations or through a separate regulation drafting process.
Comments on the existing draft DOL regulations are due March 31.
Managers of the federal government's Regulations.gov website have received eight comments so far but have not yet posted any of the comments.
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