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Health Resources and Services Administration
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Office of Pharmacy Affairs UpdateJanuary 2016

340B Audits - "News to Use in 2016"

Covered entities that participate in the 340B Drug Pricing Program must ensure program integrity and maintain accurate records documenting compliance with all 340B Program requirements.
With the start of Fiscal Year 2016, the HRSA Office of Pharmacy Affairs (OPA) is providing some news and reminders to help facilitate covered entities through the auditing process and minimize operational burden.

Public Notice of Audit Findings

The covered entity is ultimately responsible for identifying all affected manufacturers and for contacting each to notify them of program violations and to begin a dialogue on a method for possible repayment.  Covered entities audited in Fiscal Year 2016 will no longer be required to post on HRSA’s website a public letter informing manufacturers of audit violations that involve possible repayment.  However, HRSA will post a public notice on the 340B Program website to inform manufacturers regarding violations that have occurred.  This notice will include findings of the 340B Program audit requiring possible repayment, and covered entity contact information for manufacturers to utilize for questions.

Electronic Submissions

In an effort to reduce paper documents, OPA now accepts all audit-related submissions in a new email inbox.  Electronic versions of documents can be sent via email to 340baudit@hrsa.gov. Hard copies are no longer required to accompany the electronic submission and OPA strongly encourages use of electronic submissions to streamline the audit review. With the increase of electronic correspondence, HRSA reminds covered entities of the importance in keeping contact information accurate and up-to-date on their 340B database record. Covered entities are encouraged to include their contact information with any electronic submissions, and to provide clear and concise information, which helps facilitate the review process.

Duplicate Discounts: Pending cases

Oftentimes covered entities have Corrective Action Plans (CAPs) related to duplicate discounts that are still “pending” with OPA. These entities have provided all necessary information to the respective state Medicaid agencies; however, in some cases, those state agencies may not have responded or have ceased responding. It is current HRSA policy that audits remain open until settlements have been finalized with all affected manufacturers, including completion of any necessary repayment.  Therefore, the lack of response from the state Medicaid agency does not constitute confirmation that affected manufacturers are not owed possible repayment.

Before an audit may be closed, covered entities are required to submit an attestation letter to OPA stating the CAP has been fully implemented and settlements have been finalized with all affected manufacturers, including completion of any necessary repayment.  In the letter, covered entities are required to specify the date of completion for CAP implementation and the date of completion for the last of any necessary repayment. Covered entities seeking action or clarification from the state Medicaid agency should not submit the attestation letter until they have received confirmation from the state Medicaid agency confirming that any necessary repayment has been completed.

These tidbits on the 340B Program audit process are intended to help audited covered entities and improve the efficiency of the process for covered entities and OPA. If you have any questions, or need further information, the team at ApexusAnswers - a service of the 340B contracted Prime Vendor Program - stands ready to assist by email (ApexusAnswers@340bpvp.com) or by phone (888-340-2787).