1. Michael Bertram, PhD, MBA Associate Director For Administration UAB Comprehensive Cancer Center March 11th, 2013 2013 CCAF Clinical Trial Billing & Operations

2. Matrix – University:  Research  Compliance  Independent IT Group – UAB Medicine:  Inpatient/ Hospital using IDX  Outpatient Using Cerner Millennium/HealthQUest  Independent IT Group  Separate Billing  March 1 st, 2014All clinical entities under UAB Hospital Umbrella  Transitioned to Provider Based Billing UAB Background

3. Legal Action – Gober/ USA vs UAB-Whistleblower Lawsuit – Clinical Trial Double Billing Settlement – University Reaction Reactive Era – Central “CTMS” Acquired – Centralized Clinical Trial Billing Control – Institutional Clinical Trial Billing Policies & Procedures – 100% Audit of Inpatient Subject Visits 3 rd Party Payer – BCBS of AL 90% of non-CMS Market – Reluctance to cover RCC for CT Participants UAB Background (Continued)

4. Cancer Center Review – Determination of Medicare Coverage  Protocol Review  ICF Review – Separate Allowable Costs (First Pass) – Medicare Supplemental Coverage Review – Clinical Event Review with PI – Review Language for Consistency Institutional Review – Newly formed Institutional CTO – Clinical Billing Review Pre-Activation Routine Care Cost Identification

5. Institutional Process

6. Approved Protocol Routine Care Cost Patient On Trial Patient On Treatment Patient Off Trial Patient Schedule Patient Visited – Scheduled items occurred or not – Unscheduled items occurred Active Trial Communications

7. Streamline Routine Care Cost Review – Coverage Analysis System – Share Electronically – Document In One Place Integrate Systems – Allow free flow of information between entities – Improve Timeliness – Improve Accuracy – Eliminate Redundancy Improvements

8. Culture and Process are Compliant- Systems & Tools are Not OnCore CTMS-Cancer Center – MPI/EMMI Interface – Coverage Analysis Module – Documents Routine Care Cost Analysis – Planned Visit Report – Clinical Trial Billing Notice Cerner Millennium (PowerTrials and PowerPlans) – Billing Path Based on Coverage Analysis – Built in Upfront as Part of Activation Process Tools in the Toolbox

9. Questions