Participation in the federal 340B Drug Pricing Program (340B Program) allows eligible hospitals and other “covered entities” to achieve significant savings on outpatient drug expense. However, complex regulations, enrollment and participation challenges often result in less than optimal savings and compliance risks. Pharmacy business operations are highly complex and subject to a mix of State and Federal regulations and oversight. Providers are subject to pharmacy-related audits by the OIG, State Boards of Pharmacy, State Medicaid Agencies, and pharmaceutical manufacturers. Participation in the 340B Program requires compliance with specific regulatory requirements, presents added layers of compliance and financial risk, and requires focused efforts to maintain and demonstrate compliance in a heightened audit and enforcement environment.

To minimize the risks of non-compliance and negative audit findings, 340B covered entities should establish policies and procedures, controls, and auditing and monitoring methodologies to ensure compliance with regulatory requirements. This usually requires integration of 340B compliance in the organization’s compliance program and plans for auditing and monitoring as well as collaboration and coordinated efforts between various departments including Compliance, Pharmacy, Physician Services, Information Technology, and Medical Records.  

Join us for this presentation with Matt Vogelien, a Director in Wellspring+Stockamp, Huron Healthcare’s Compliance & Investigations Practice, as he provides an overview of the 340B Program, examines the compliance requirements, and discusses practical, hands-on compliance strategies for 340B covered entities. The presentation will focus on:

• Overview of the 340B Program and compliance requirements included in Federal regulations
• Highlight of healthcare reform changes and other recent developments related to the 340B Program
• Examination of four key 340B Program compliance requirements and discussion of common challenges and breakdowns
• Discussion of new annual, independent audit “expectations” for 340B covered entities using contract pharmacy services
• Operational suggestions for reducing the risk of non-compliance and meeting the government’s expectations for controls, documentation, and audits
• Recommendations for integrating 340B Compliance into your overall compliance and risk management programs

Examples from real world experiences will be used to illustrate the key points and recommendations

Who Should Attend

• Hospitals and other Healthcare Providers who participate in the 340B Program
• CFO, CEO
• Chief Compliance Officer
• Chief Risk Officer
• Chief Pharmacy Officer/Pharmacy Director
• General Counsel

About the Presenter

Matt Vogelien, is a Director in the Healthcare Compliance & Investigations group of Wellspring+Stockamp, Huron Healthcare. His experience spans a variety of healthcare organizations, including large, for-profit health systems, academic medical centers, and non-profit hospitals. He has assisted clients with corporate integrity agreement implementation and compliance review, voluntary disclosure analysis, regulatory compliance program assessment and Joint Commission accreditation preparation, financial exposure analysis, revenue cycle redesign, and class action litigation document discovery. Matt has also led engagements focused on pharmacy risk assessment, integration of pharmacy and compliance, and 340B Program compliance audits.

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