Summary
This white paper outlines best practices for complying with the 340B Drug Pricing Program, which was established to allow safety net providers to purchase drugs at discounted prices. The document explains the importance of the 340B program in supporting vulnerable populations and details the challenges faced by covered entities (CEs) and pharmaceutical manufacturers. It discusses the operational and systems best practices that manufacturers can implement to streamline 340B program management, including managing contract pharmacy relationships and ensuring compliance with pricing agreements. The paper also highlights the implications of recent legal rulings regarding patient eligibility for 340B discounts and the complexities introduced by the growth of the program, including potential risks of regulatory noncompliance and financial liabilities for manufacturers. Additionally, it addresses the need for manufacturers to maintain accurate data on CEs and their relationships with contract pharmacies to prevent issues such as duplicate discounts and overcharging.
