Clinical Research in Community Health Systems – Compliance Risks and Solutions
Why Should You Attend:
Community Health Systems are by nature complex organizations. This complexity increases daily with current trends as these systems merge, consolidate and expand. Arguably more “open” systems than academic centers, they often host clinical research and research procedures in multiple settings, sometimes without their knowledge.
Complex and risk-laden financial relationships also develop as multiple parties execute contracts that may or may not address or protect the concerns of the CHS. This dramatically increases risk related to the Anti-Kickback Statute, the False Claims Act, HIPAA, Medicare Secondary Payer Rule and the Stark Rule. Referral relationships, clinical trial contract terms and clinical trial billing flow all must be examined and managed to minimize their related risks.
This session will examine how compliance professionals and clinical research professionals can work together to get their arms around these risks and manage them effectively.
Learning Objectives:
At the end of this session, attendees will be able to:
- Distinguish risks peculiar to Community Health Systems engaged in clinical research
- Create a work-list of risk items related to clinical research to investigate and manage effectively
- Develop an approach to clinical research that allows physician/investigators to engage and continue in clinical trials while effectively managing related risks
Areas Covered in the Webinar:
- Risk laden relationships created by clinical research in community health systems
- Hot button contract terms and how to manage them
- Managing the on-boarding process for the physician conducting clinical research in the clinic setting
- Identifying and managing HIPAA risks relate to clinical research in the CHS setting
- Managing conflict of interest and payments to physicians in the CHS setting
