OPA Describes Best Practices for Resolving Contract Pharmacy Non-Compliance

28 Jun 2018

OPA recently posted a program update entitled “Best Practices for Covered Entities: Resolving Contract Pharmacy Related Non-Compliance.”  In the update, OPA states that it has concerns about contract pharmacies and/or third party administrators (TPAs) providing repayment to manufacturers for 340B transactions that have been dispensed but later deemed 340B ineligible, especially when the covered entity has no prior knowledge of the non-compliance.  OPA asserts that manufacturer repayments in this manner “would not comply with 340B Program requirements that the covered entity retain responsibility for ensuring full compliance and integrity of its use of the 340B Program.”  OPA describes several best practices for resolving non-compliance in the contract pharmacy setting, including that a covered entity that wishes to reclassify purchases at a contract pharmacy may issue a credit-and-rebill according to standard business practices but should first notify manufacturers of the non-compliance.  Covered entities should also provide manufacturers with a clear audit trail that reflects the actual timing and facts underlying a transaction upon reclassifying the purchase, according to OPA’s program update.  OPA states that covered entities should review their agreements with contract pharmacies and TPAs with respect to their processes for resolving diversion and duplicate discounts to ensure those processes comply with 340B requirements.

Category: HRSA

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