340B Center of Excellence Operational Framework

This document is a guide that outlines the operational framework for establishing a 340B Center of Excellence (COE) within pharmaceutical organizations. It describes the significance of the 340B Drug Pricing Program, which is projected to exceed $150 billion in gross sales in 2024, and highlights the challenges faced by pharmaceutical manufacturers in managing 340B operations. The guide emphasizes the need for a centralized governance model that can effectively manage the complexities of the 340B program. It details the components of a 340B COE, including strategy development, business process management, performance management, and knowledge management. Each component is designed to enhance operational efficiency and drive financial performance. The guide also discusses the potential benefits of a COE, such as improved coordination of 340B initiatives, rapid innovation, and robust financial reporting. By adopting a COE approach, organizations can better navigate the evolving landscape of the 340B program and optimize their operational strategies.