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Can you afford to risk your 340B program status and pay potential fines due to partial compliance?
Your Audit Trail is not compliant with 340B guidelines if you can only provide the following:
  • Tracking only by physician name on retail contract pharmacy transactions
  • Relying on a card for proof of patient definition
  • Ignoring or not tracking mixed-use (inpatient- outpatient) inventory


  • Meeting the patient definition partially


Can you link your retail outlet 340B dispensations to the following points?
  • Patient date of visit at your hospital
  • Location of visit as properly accounted for on the Medicare Cost Report of the hospital.
  • The actual healthcare service received
  • Recognized physician (employed, contracted or
    documented affiliate)
  • Dispensing information from the retail site
  • Equivalent usage and replenishment of the drug



During an audit you must be able to provide the necessary documentation within the required timeframes.
If you are not prepared, your covered entity may be in a position to pay fines, lose 340B status and deal with a lengthy appeal process.
Can you verify that 340B drugs are not being diverted to your inpatients?
Do you have dynamic 340B Policies and Procedures that fully cover the scope of your program, reflect the execution of your program and describe your implemented compliance safeguards?