Michael Bertram, PhD, MBAAssociate Director For AdministrationUAB Comprehensive Cancer Center

March 11th, 2013

2013 CCAFClinical Trial Billing &

Operations

Matrix– University:

Research Compliance Independent IT Group

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

UAB Background

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

3rd Party Payer– BCBS of AL 90% of non-CMS Market– Reluctance to cover RCC for CT Participants

UAB Background (Continued)

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

Institutional Process

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

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

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

Questions