What factor does not affect the established cost in 340B program operations?

In the context of 340B program operations, the established cost is influenced by multiple factors that directly impact pricing and purchasing decisions. External auditing processes do not influence the established cost because they are primarily concerned with compliance and accountability rather than pricing structures. Audits are designed to review and verify program compliance with regulatory requirements, ensuring that entities are adhering to the guidelines set by the 340B program.

Conversely, the volume of purchases is crucial as higher volumes can lead to lower per-unit costs due to economies of scale. Service fees vary based on the services provided and can significantly impact overall program costs. Additionally, the health system framework determines the operational structure and delivery of services, which can also influence costs. Therefore, external auditing processes stand apart as they do not directly alter the established costs associated with the 340B program.