Effective date: rules apply for plan years beginning on or after the date that is 30 months after enactment. Contracts (including extensions or renewals) entered into on or after that effective date between a group health plan or health insurance issuer and an applicable entity must include requirements in this section.

Contract clause: Applicable entities must not limit or delay disclosure of information to the group health plan in a way that prevents the PBM from making the required reports, and must provide PBMs with the relevant information needed for those reports.

Reporting frequency and format: PBMs must submit reports to the group health plan at least every 6 months. At a plan’s request, reports must be provided quarterly instead, under the same conditions, terms, and cost as the semiannual report. Reports must be in plain language, machine-readable format, and in other formats as the Secretary may require.

Required report contents (claims- and drug-level for specified large employers/plans): For specified large-employer plans or where the plan elects (opt-in), reports must include a drug-by-drug list of claims with, for each drug: contracted compensation paid by plan/issuer to the PBM (identified by NDC); contracted compensation paid to the pharmacy; the difference between those amounts; drug names and NDC; dispensing channel (retail, mail, specialty); net price per course or fill after rebates/fees/discounts; total out-of-pocket spending by participants; total net spending; amounts received or expected by plan/issuer from applicable entities (rebates, fees, discounts); amounts received or expected by the PBM from applicable entities; and, to the extent feasible, copay assistance and similar payments from manufacturers.

Additional report contents (plan-level and other required data): Reports must also include total net spending by the plan for drugs, total amount received or expected by the plan from applicable entities (rebates, fees, discounts), amounts paid in rebates/fees/compensation to brokers or advisors (including identity of recipients), explanations of benefit-design parameters that encourage use of affiliated pharmacies, percentage of prescriptions dispensed by affiliated pharmacies, lists of drugs dispensed by affiliated pharmacies, and total gross spending on all drugs under the plan during the reporting period.