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U.S. Department of Health and Human Services
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Self-Disclosure Process

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 340bselfdisclosure@hrsa.gov.

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.

  1. Covered Entity Reports Issue to HRSA – including the following information:
  • 340B ID;
  • the violation that occurred;
  • scope of the problem;
  • a corrective action plan (CAP) to fix the problem moving forward;
  • a strategy to inform affected manufactures (if applicable); and
  • a plan for financial remedy if repayment is owed.
  1. Covered Entity Works with Manufacturer
  • Covered entity and the manufacturer work out any necessary financial remedy in good faith.
  1. HRSA Reviews Self-Disclosure, including:
  • violation information;
  • CAP, ensuring that it fully addresses issues causing the violation;
  • repayment plan and/or completion of plan; and
  • completion of contact to all affected manufacturers.

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.

  1. HRSA Closes Self-Disclosure
  • When all criteria under Step #3 are met, the covered entity receives written communication that the matter is closed.

Self-Disclosure Best Practices

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:

  • a sample letter to HRSA,
  • a list of tips when contacting manufacturers,
  • a format for summarizing non-compliance,
  • a template for a CAP, and
  • tips directly from manufacturers on the best ways to resolve issues quickly and completely.

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.

More Information

Use the Prime Vendor Program site to access 340B tools. Under “Tools for All Entity Types,” select: 340B Self-Disclosure to HRSA.