This workshop will guide you through the essential steps to take when significant clinical research billing (CRB) compliance issues are uncovered during an internal or external audit. Whether your institution needs to establish a CRB program from the ground up or revamp its existing model, this session offers a detailed roadmap from pre-award to revenue cycle and post-award. We will delve into critical topics such as engaging external counsel, determining the need for self-disclosure, identifying and collaborating with key stakeholders, and implementing effective compliance strategies. Participants will gain actionable insights into managing billing charges, securing stakeholder buy-in, and fostering a culture of compliance. This workshop is designed for clinical research professionals, compliance officers, and institutional leaders committed to maintaining the highest standards of research billing integrity.
OBJECTIVES- Engage External Expertise and Assess Disclosure Requirements:
- Determine the appropriate circumstances for involving external counsel with specialized expertise in research billing litigation.
- Establish criteria for assessing the necessity of self-disclosure following audit findings.
- Identify and Collaborate with Key Stakeholders:
- Pinpoint essential internal and external stakeholders critical to CRB compliance.
- Develop effective strategies for securing stakeholder buy-in and facilitating regular collaborative meetings during the change process.
- Implement and Manage a Comprehensive CRB Compliance Program:
- Formulate strategies for managing current billing charges, including the potential implementation of a bill hold.
- Conduct a thorough needs assessment to build a dedicated CRB compliance team (from pre-award to revenue cycle and post-award).
- Establish/restructure robust processes for pre-award activities.
- Cultivate a culture of compliance through targeted training programs tailored to relevant employees.
