340B University OnDemandTM Curriculum
Introduction to the 340B Drug Pricing Program
Provides a foundational overview of the 340B Program and serves as a primer for the rest of the modules in this curriculum.
340B Stakeholder Perspectives
Describes the major stakeholders and their roles in the 340B Program.
Outlines the types of 340B-eligible organizations and eligibility and compliance requirements for covered entities.
Describes how the 340B prices are calculated and the roles and requirements of manufacturers, wholesalers, and HRSA for the 340B prices.
Provides an overview of the compliance cornerstones of the 340B Program, including diversion/patient definition, duplicate discounts, GPO Prohibition, and orphan drug exclusion.
340B & Medicaid
Defines duplicate discounts and how they occur, as well as stakeholder roles in identifying and/or preventing them.
HRSA’s Medicaid Exclusion File
Discusses the role of the Medicaid Exclusion File (MEF) in preventing duplicate discounts and the uses of the MEF by 340B stakeholders.
I: 340B Drug Delivery Models
Provides an overview of the various drug delivery models in 340B implementation and identifies decision points and requirements for each model.
II: GPO Prohibition
Defines the GPO Prohibition, which entities are subject to its requirements, and when an entity may use a GPO in a compliant manner.
III: Orphan Drug Exclusion
Defines the Orphan Drug Exclusion, which entities are subject to its requirements, and approaches for compliance.
IV: Contract Pharmacy
Discusses the decision points of entering into contract pharmacy arrangements, as well as the process and compliance elements of these arrangements.
V: Entity-Owned Pharmacy
Discusses compliance and operational considerations of using an entity-owned pharmacy model.
VI: Mixed-Use Areas
Discusses 340B inventory models in mixed-use areas of a hospital and the role in compliance of split-billing software and multiple purchasing account types.
Audit Process & Preparedness
Discusses the process of HRSA and manufacturer audits of covered entities, as well as the types of self-audits to maintain a compliant 340B Program.
PVP Contracting: Maximizing Value
Describes the role and benefits of the Prime Vendor Program (PVP), including contracting solutions to maximize value for PVP participants.
340B Hot Topics
Reviews frequently asked 340B compliance questions related to Medicaid, diversion, inventory control, and self-disclosure, and discusses current events in 340B.
340B for the C-Suite
Tailored to executive leadership; discusses the value and risks to an organization associated with the 340B Program.
340B & the Manufacturer
Outlines compliance and operational requirements for manufacturers, including the requirements of the pharmaceutical pricing agreement.
340B & the Distributor
Outlines compliance and operational requirements for distributors, including the role in processing chargebacks.