This session will be Close to the Press
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
Apexus the HRSA 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
Vice President, Federal Programs
Pharmaceutical Research and Manufacturers of America (PhRMA)
DATA MANAGEMENT, AUDIT PREPARATION, AND COMPLIANCE)
Having and using the right data is essential to a well-functioning 340B program, in order to effectively manage the day-to-day aspects of the program and maintain compliance. It is also important to work closely with information technology team members to understand how different EHRs handle information. Discuss tactics to make sure you are tracking, analyzing, and sharing the right information, and learn how it can be advantageous to both your savings within and advocacy for the program.
- Hear tips to make the most out of your split-billing software to enhance compliance and maximize savings
- Establish a good working relationship with IT and develop a monitoring system to know if and when files fail
- Ensure files are automated, when possible, and the right data is submitted to the Third Party Administrator
- Learn key elements on reporting savings and compliance to demonstrate stewardship
San Mateo Medical Center
Head of Industry Relations
Sentry Data Systems
A successful program requires dedicated oversight as well as regular assessments to make sure operations are running smoothly, and any problems can be quickly remedied. Understand the processes and infrastructure to have in place to review billing, inventory, safety measures, and any operational details that might get missed.
- Develop a protocol to make sure day-to-day operations as well as monthly and quarterly assessments are addressing key problem areas
- Test staff knowledge and build a team that can address important compliance and safety issues
- Discuss common compliance pitfalls that can be addressed to improve operations and increase savings
Vice President, Regulatory Affairs and Compliance
President and Chief Executive Officer
Charter Oak Health Center, Inc.
Notification that your entity will be audited can be intimidating, but knowing what to expect and being prepared can alleviate much of the pressure. In this extended discussion, hear from entities that have experienced an audit, learn from experts that help prepare and respond to audits, and share your own experiences and concerns about establishing an effective audit plan and recognizing key areas of program integrity to have in place.
Prepare for a Site Visit with Continued Readiness Elements
- Assess the steps you should take to prepare for an audit
- Share the operational process of what a site visit is like and what to expect
- Establish program assessments, including self-audits in areas of operations, software, staffing, tracking, and reporting
- Form a task force, such as a pharmacy oversight committee, that can be mobilized when an audit occurs
- Conduct independent, external audits to prepare for the eventuality of an actual audit
- Develop strategies to get the most out of your external audits
Hear Trends in Recent Audit Findings, Pitfalls, and Next Steps for Corrective Action
- Highlight new focus areas as a result of recent changes in the auditors and audit process
- Assess the data that is being requested, and how to provide it from start to finish
- Navigate pitfalls in mixed use settings or with clinic administered drugs
- Establish a process for capturing the appropriate information in the medical record, and know what is most important to have documented
- Define the role of revenue cycle managers, IT, and others in assisting during an audit
- Create a plan for corrective action in the event there are findings
Meet, network, and share experiences with colleagues of similar backgrounds as attendees break into roundtable discussion groups to address challenges specific to certain types of entities.