Amid changes on the Hill that include Democrats taking control of the House, an ongoing lawsuit against Medicare Part B cuts, as well as the Administration’s drug pricing initiative, there are no shortage of factors that may influence the future of the 340B Drug Pricing Program. Hear the view from the Hill on the current political outlook, and the potential implications for the 340B program in the coming months.
- Get an update on the status of the AHA lawsuit and proposed transparency guidelines and stewardship principles around the governance of the program
- Assess the impact of the International Pricing Index (IPI) model on 340B hospitals
- Identify efforts on the Hill to protect the program in light of concerns that 340B savings may be reduced
Professional Staff - Healthcare Committee on Energy and Commerce
U.S. House of Representatives (Invited)
Apexus, the HRSA -designated 340B Prime Vendor, presents a neutral perspective to challenges surrounding the 340B program, and relations between manufacturers and covered entities. Hear about the latest hot topics and best practices from an organization leading the 340B conversation and finding value for all stakeholders.
- Hear an update on the latest 340B program policy, guidance, and trends
- Gain insight into the questions Apexus receives, and how its services are evolving as a result of the call center activity
- Participate in a Q & A forum on top-of-mind challenges across various stakeholders
Both covered entities and manufacturers are often frustrated by the challenges of the 340B program partnership especially in the areas of data sharing and communication. Discuss ways CEs and manufacturers can better collaborate and communicate to mutually optimize the benefit of the program.
- Hear perspectives on what is needed from the other to effectively work together
- Address issues that arise when there are holes in the database, and how to work around them
- Establish effective communication tactics to make sure all parties are speaking the same language and the right individuals are talking to each other
The Civil Monetary Penalties Ruling, effective January 1, 2019, impacts the current dispute resolution process by penalizing manufacturers if they knowingly overcharged a covered entity, and allowing covered entities to take action when there is an overcharge. Discuss the implications of and initial findings resulting from this ruling, including its effect on processes, margins, data sharing, and reporting.
- Review the fundamental changes brought forth by the Civil Monetary Penalties Ruling
- Determine the increased need for data sharing, and process and procedural changes made by all stakeholders
- Evaluate the oversight under this ruling, and the penalties levied to date
Covered Entity Perspective:
System Director, Pharmacy Supply Chain and Contracting
New England Alliance for Health
Manufacturer Perspective TBA
When covered entities utilize both the 340B discount as well as addition discounts, such as Medicaid, this can lead to prohibited duplicative discounts. Manufacturers are faced with the challenge of determining the presence of both discounts and resolving the charge. Hear how data is being use to expedite this process.
- Determine means to leverage data to spot duplicate discounts
- Ascertain procedures to more efficiently utilize the Medicaid exclusion file
- Understand the guidance present to moderate these duplicate discounts
Berkeley Research Group
Berkeley Research Group
Each state has a different process on how they involve themselves in the process of addressing duplicate discounts. As manufacturers often deal with many states at the same time, it is beneficial to understand their varying points of contact. Learn how manufacturers are working most efficiently with different states to resolve discounts.
- Discuss varying states’ level of involvement in dealing with manufacturers and covered entities
- Assess strategies in dealing with uninvolved states versus states that are part of the dispute process
Manager, Government Programs and Reimbursement
A limited distribution network, while restricting the distribution channel, allows for more effective allocation of drugs during a shortage. Manufactures’ need to discuss what obligations they have under the law when constructing these limited distribution networks.
- Construct a limited distribution plan structure to be in compliance
- Examine the new guidelines for controlling and reporting limited distribution networks
- Create methods to allocate drug supply when products fall to penny pricing
Sidley Austin LLP
As manufacturers attempt to work through the data they are permitted to examine and utilize, issues can occur through this ambiguity. Data collection and tracking can allow for manufacturers to provide detailed insights when it comes to handling refunds as well as pricing. This information can benefit all teams across an organization. In order to best utilize available data, analytics surrounding multiple industry variables need to be understood.
- Generate a data collective and track claims from covered entities to paint a full picture of the refund
- Analyze the permitted data to determine inconsistencies within refund requests
- Utilize data variables to provide sales and marketing team with the price fluctuations of 340B drugs
Manager, Channel Operations
Manager, Contract Operations
Manufacturers and covered entities must work alongside each other to enable the 340B program to function appropriately and efficiently. Hear about methods undertaken by manufacturers when addressing negotiations with covered entities.
- Outline strategies to increase effective communication
- Identify productive ways to respond to requests from covered entities
- Develop an effective inquiry process
- Learn tactics to work most effectively with covered entities to assist in self-disclosures
Director, Fraud Investigation Group