HRSA audits of covered entities include contract pharmacy arrangements. The covered entity must have fully auditable records that demonstrate compliance with all 340B Program requirements. Also, the entity remains responsible for ensuring their contract pharmacy arrangements meet statutory obligations to ensure against diversion or duplicate discounts. HRSA recommends that covered entities perform quarterly internal audits and annual independent audits (or more frequent as necessary) of all their utilized contract pharmacies to ensure 340B Program compliance. HRSA also recommends that covered entities maintain written policies and procedures to describe contract pharmacy oversight activities. These should include effective procedures for review of the patient eligibility determination system used at contract pharmacies, and reconciliation of dispensing, purchasing, and billing records to ensure that diversion and duplicate discounts have not occurred.
If the covered entity determines that drug diversion or duplicate discounts occurred or that it is otherwise unable to comply with its responsibility to reasonably ensure compliance, the covered entity should fill out a Self-Disclosure while they move to correct the issue. Self-Disclosures should be submitted to HRSA at 340bselfdisclosure@hrsa.gov.