Which process is used to confirm compliance with the GPO Prohibition?

The process used to confirm compliance with the GPO (Group Purchasing Organization) Prohibition is an audit. An audit is a systematic examination that assesses the effectiveness of a program or process, ensuring that all regulations, guidelines, and requirements are being followed properly.

In the context of the 340B Program, auditing involves a thorough review of the operations, records, and related documents to verify adherence to the GPO Prohibition. This includes ensuring that covered entities do not obtain drugs through a GPO and then sell them to non-qualified entities at discounted prices. Audits serve not only to identify compliance but also to uncover areas for improvement and ensure that practices align with the regulations set forth by the 340B Program.

Other processes such as review, inspection, and evaluation may involve examining data and processes but do not carry the same comprehensive approach and formalized structure that an audit embodies. Auditing provides a more rigorous framework for compliance verification, which is critical in maintaining the integrity of the 340B Program and protecting the benefits intended for eligible entities.