What is often required to maintain compliance within the 340B Program?

Maintaining compliance within the 340B Program is crucial for ensuring that covered entities continue to benefit from the discounts and support intended by the program. Annual facility audits are a critical component of this process. These audits help to verify that the facility is accurately utilizing the resources available through the 340B Program and adhering to all relevant rules and regulations.

Conducting these audits allows for the identification of any discrepancies in the program's usage, ensuring that the entity is not only compliant but also effectively managing the program to serve eligible patients. This process fosters accountability and helps maintain the integrity of the program, making it essential for compliance.

Regular staff training may also play a role in compliance but is generally not as formalized as annual audits. Data sharing with competitors and outsourcing patient records do not align with compliance practices associated with the 340B Program, as they could undermine patient confidentiality and the integrity of the program's intent.