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2013 CCAF Clinical Trial Billing & Operations

2013 CCAF Clinical Trial Billing & Operations. Michael Bertram, PhD, MBA Associate Director For Administration UAB Comprehensive Cancer Center. March 11th, 2013. UAB Background. Matrix University: Research Compliance Independent IT Group UAB Medicine: Inpatient/ Hospital using IDX

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2013 CCAF Clinical Trial Billing & Operations

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

  2. UAB Background • 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

  3. UAB Background (Continued) • 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

  4. Pre-Activation Routine Care Cost Identification • 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

  5. Institutional Process

  6. Active Trial Communications • 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

  7. Improvements • 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

  8. Tools in the Toolbox • 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

  9. Questions

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