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Independent Third Party 340B Compliance Audits

Don't lose your 340B status!


HRSA is now performing 340B compliance audits and covered entities may lose their 340B status if not compliant with the overall stewardship of the program for which it was intended.

PBIRx® can perform an independent third party 340B compliance audit. The PBIRx® audit would be performed on-site by a PBIRx® audit team including pharmacists, analysts, and specialists in pharmacy benefits. The evaluation report would prepare a covered entity for an actual HRSA audit and indicate areas to be addressed which may compromise the covered entities participation in the 340B program.

PBIRx® 340B Program Integrity

HRSA remains committed to the integrity of the 340B program, including preventing the diversion of covered drugs to non-qualified patients and preventing drugs from being subject to duplicate discounts under both the 340B program and Medicaid rebate program. The final notice now requires, rather than suggests as in the proposed version, that the following provisions be addressed.

PBIRx® assists its clients by reporting on the validity of the following:

  • Ship to, Bill to Procedure
  • Patient Eligibility Verification
  • Prescriber Eligibility Verification
  • Comprehensive Pharmacy Services
  • Tracking System
  • Arrangement to Prevent Duplicate Discounts
  • Audits
  • Certification of Contract Pharmacy Compliance
  • Response in the Event of Diversion or Duplicate Discounts
  • Recertification Process for Covered Entities
  • Services
    • To determine:
      1. Whether the program was implemented in accordance with the requirements of the 340B program, and
      2. The effectiveness of procedures in place over procurement, inventory, distribution, dispensing and billing of 340B drugs.
  • The Compliance Process
    • Review of facility's policies, procedures and processes pertaining to 340B medications
    • Verification of internal controls in place to prevent diversion and duplicate discounts
    • Testing, on targeted basis, of transactions that pertain to 340B medications

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