The Health Resources and Services Administration (HRSA), Healthcare Systems Bureau (HSB), Office of Pharmacy Affairs (OPA) regularly conducts audits of covered entities to ensure compliance with 340B Drug Pricing Program (340B Program) requirements. When a covered entity undergoes an audit by HRSA and has findings or evidence of non-compliance with a 340B Program requirement, the covered entity must provide a corrective action plan (CAP) to HRSA describing the planned and implemented actions to ensure program compliance. The CAP may also include the covered entity’s plans and actions addressing any potential repayment to manufacturers as a result of the non-compliance. HRSA continuously reviews and updates processes to improve program integrity, and has identified a number of areas to strengthen in the audit process. Based on our review, HRSA is updating our audit expectations regarding the implementation of a covered entity’s CAP, including any settlements with manufacturers, as outlined below. Many covered entities have already been able to meet these expectations through the course of their audits. In addition, HRSA is implementing these changes in order to ensure the CAP and repayment process are completed in a timely manner. Corrective Action Plan Implementation and Repayment
To learn more about 340B Program integrity and the HRSA 340B Audit Process, see https://www.hrsa.gov/opa/program-integrity/index.html If you have any questions, or need further information, the 340B contracted Prime Vendor Program is available at ApexusAnswers@340bpvp.com or by phone at 888-340-2787. |
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