Due to the diversity of covered entities and the need for flexibility in program implementation, HRSA recommends that each covered entity establish and document criteria that signifies when a material breach of compliance has occurred. For situations that are a material breach, the covered entity should take steps to inform HRSA while they move to correct the issue, as outlined below. Information should be emailed to HRSA at firstname.lastname@example.org.
Please note that any self disclosure submitted to HRSA between the time the entity receives a HRSA audit engagement letter and the time the audit period is concluded, may be subject to inclusion within the audit review and Final Audit Report.
NOTE: HRSA staff will follow-up with the covered entity authorizing official if any of the requested information is missing from the self-disclosure submitted.
Use Reporting Tool
The 340B Prime Vendor Program has worked with HRSA, covered entities, and manufacturers to develop a suggested tool for the self-disclosure process.
The self-disclosure tool prompts covered entities to consider all issues involved in a self-disclosure. The goal is to help the covered entity re-establish compliance as soon as possible, and provide HRSA with all the necessary information to take appropriate action.
The self-disclosure tool includes:
Provide Detailed Information to all Stakeholders
Covered entities are able to most efficiently and effectively resolve their compliance issue if they provide an immediate remedy to correct the material breach, propose a plan for periodic assessment and continuous monitoring, and outline a clear method to determine when the CAP is completed. Successful covered entities have also routinely identified an implementation date, entity contact person, and clarified an internal 340B communication/education strategy.
Use the Prime Vendor Program site to access 340B tools. Under “Tools for All Entity Types,” select: 340B Self-Disclosure to HRSA.