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 Self-Disclose to HRSA while they move to correct the issue. Self-Disclosures should be submitted 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 has concluded, may be subject to inclusion within the audit review and Final Audit Report.
Comprehensive self-disclosures include the following elements:
- Letter to HRSA that includes the 340B ID
- Description of the violation that occurred
- Corrective Action Plan (CAP) to fix the problem moving forward
- Strategy to work with manufacturers that includes plans for financial remedy if repayment is necessary.
The CAPs, including any settlement with manufacturers, are expected to be completed within six months of the initial Self-Disclosure submission to OPA. Covered entities that are unable to meet this expectation may be subject to a HRSA audit. Covered entities are expected to submit progress reports as specified by HRSA and a final report at the end of the six month period.
The 340B Prime Vendor Program has worked with HRSA, covered entities, and manufacturers to develop a suggested tool for Self-Disclosures that provides a comprehensive template that may be used by entities to submit a Self-Disclosure to HRSA. Transparency is critical, and the best practice for covered entities is to disclose the full extent and duration of the material breach. 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. Covered entities should customize the tool to fit the circumstances surrounding the non-compliance issue.
HRSA will review the Self-Disclosure to ensure the violation has been fully addressed and development of a CAP, including working out any necessary financial remedy in good faith with all affected manufacturers.
HRSA will follow-up with the covered entity Authorizing Official if any information is missing or additional information is required.
When all criteria are met, the covered entity will receive a written communication that the matter is closed.
Use the Prime Vendor Program site to access 340B tools. Under “Tools for All Entity Types,” select: 340B Self-Disclosure to HRSA. For additional information or assistance with creating a Self-Disclosure, you may contact the Prime Vendor Program at: