1. Clinical Research Billing and Coverage Analyses CCAF 2014 Meeting San Diego, CA April 14, 2014

2. 2 Background City of Hope (COH) is located in close proximity to the Norris Cancer Center at the University of Southern California and was aware of USC/Tenet’s settlement related to clinical research billing A process was put in place prior to 2010, but changing guidelines and an internal reorganization in 2012 provided the opportunity to identify and implement improvements COH commissioned a gap analysis with recommendations and an updated policy and procedure manual

3. 3 The Clinical Research Billing Process The clinical research billing (CRB) process is complex and requires coordination and harmonization between partnering institutions (the hospital, the physician practice plan, and where applicable, the university). © 2014 Huron Consulting Group. All Rights Reserved.

4. 4 Call to Action COH initiated the following: CRB Steering Committee: Executive leadership, faculty and administrators provide decision-making support to the Working Group while removing hurdles to progress. CRB Working Group: Front-line staff and faculty design, improve and/or validate business processes critical to ensuring efficiency, financial accountability, and compliance within clinical research billing processes. Increased frequency of auditing Increased focus on a CTMS that would improve the communication and the workflow

5. 5 Additional Steps Taken Customer satisfaction survey of faculty and focused discussions on opportunities for improvement Comprehensive review of workflow, communication, and procedures Revamping of processes in clinical research operations and the revenue cycle for the physician practice and the hospital Reorganization of staff and reporting lines within financial and operational clinical research programs, e.g., centralized support of diverse clinical programs with alignment to the disease teams

6. 6 Results Increased engagement among faculty and administrators Increased accountability to the faculty and administrators An improved workflow, communication process, and set of tools Clear policies and defined processes based on up-to-date information Identification and clarification of clinical research billing responsibilities A budget estimator tool for Letters of Intent Signs of improvement in the turnaround times for budgets and contracts

7. 7 Lessons Learned Implementing a clinical research billing process was much more complicated to discuss and revise than anyone anticipated Early involvement of leadership from the faculty, administrators, compliance, and revenue cycle was beneficial Small tweaks to the process had ripple effects in the revenue cycle and had to be addressed more globally Technology options are limited, but are critically necessary

8. 8 Questions? Ashley Baker Lee Senior Vice President, Research Operations City of Hope Email: ashlee@coh.org Phone (626) 256-HOPE(4673), ext. 63463 Mobile (310) 938-9524