1. University of Michigan Medical School Calendar Review & Analysis Office (CRAO) Gina Vuocolo-Branch, Director November 1, 2011

2. Brief History of June 2000, President Clinton issued an executive memorandum; Medicare will pay for routine care services provided during clinical trials –UMHS Leadership recognizes the need for a Clinical Research compliance office to ensure consistency and compliance to billing regulations Clinical Research Billing Unit (CRBU) established; now known as CRAO Hard stop in IRB approval process-Ancillary Committee status Billing Calendar mandatory –Study activities cannot begin without CRAO approval

3. Clinical Research Billing (CRB) Compliance  Billing calendar completion and timely submission of subject enrollment to the Revenue Cycle Research Billing (RCRB) staff is essential to routing charges to the correct payor Billing Calendar Subject Enrollment Billing Compliance

4. What Happens When You Don’t Get It Right? Northwestern University$5.5 million settlement John Hopkins$2.6 million settlement Hospital Settlement $5.4 million cardiac device settlement TJU$2.6 million settlement Univ of LouisvilleMandated to review 1,151 open studies Beth Israel Deaconess$920,000 settlement Medical College of Georgia$6.1 million settlement Univ of CA at San Diego$4.7 million settlement Mayo$6.5 million University of Alabama$3.4 million Dr LaHaye$1.1 million settlement Yale University194,000 Rush UniversityMore than $ 1 million *Exclusion from government contracting, subcontracting or involvement in procurement programs can also be imposed

5. CRB Issues Statistics

6. Products and Services Medicare Coverage Analysis (MCA) Billing Calendar Review Review the study protocol, informed consent, billing calendar, budgets, and contract for harmony including removing MSP Conditional Language and follow the UMHS Position Statement for Subject injury payment Clinical Research Billing Issue resolution Audit study exempt status Various education sessions

7. Interfacing Departments  Internal Customers  IRBMED  Study Team Members  Grants Office  UMHS Revenue Cycle  DRDA  CCC CTO  UMHS Compliance  Investigators  Internal Customers  Business Development  MICHR CTO  Office of Research  IT Support (MSIS, ITS, MCIT)  Subjects  University Audit  Revenue Cycle Executive Committee  External Customer  eThority

8. Staffing-Current

9. Staffing Trends  FY 10 - 6 FTE’s  FY 11 - 9 FTE’s  Coders moved from UMHS Rev Cycle to reduce process review turnaround time  FY 12 – 11FTE’s  Implementation of MBECT  Training, help desk, training manual, etc.  MiChart CRB project

10. Study Statistics July 2010 – June 2011

11. Current Tactical Initiatives Final roll out of M Budget Enrollment Calendar Tool (MBECT) –Milestones & Analysis with Invoicing –New platform in 2012 CRB Policy Implementation Development of best practice policy & procedures Identify root causes & trends of CRB issues and implement solutions Re-design of content of website

12. Efficiency Opportunities Integrate MCRU billing calendar and budget in MBECT –Negates duplicative work for study team members Continue collaboration with the IRB and DRDA in order to improve the approval process of studies

13. Thank You

14. Appendix Mission and Goals Organization Chart Key Performance Indicators Clinical Research Improvements

15. Mission and Goal 1515 Mission: The mission of the Calendar Review & Analysis Office (CRAO) is to complete a Medicare Coverage Analysis (MCA) and Billing Calendar Review for all Human Subject Clinical Trials that have billable items and services to assure consistency with all five core documents to support the appropriate adjudication of charges. Vision: The CRAO’s vision is to support and collaborate with researchers and study teams to produce a uniform process for the Research Billing Calendar, Budget and Enrollment. We provide stellar customer service and foster partnerships with various other research support areas internal and external to UMHS. Goal: The CRAO would like to ensure the Clinical Research Billing process is universally utilized throughout the research continuum and is compliant.

16. CRB and CRAO Timeline  June 2000 – President Clinton signs executive memorandum to authorizing “(Medicare) payment for routine patient care costs...and costs due to medical complications associated with participation in clinical trials”  Sept. 2000 – National Coverage Decision (NCD) defined how Medicare will reimburse providers for services to patients on trial  2003 – Rush University Medical Center voluntarily disclosed billing errors related to NCD  2005 – UM Clinical Research Billing Team formed to review and recommend improvements to clinical research billing process  November 2006 – Billing calendars required by investigators (no hard stop)  January 2007 – CRBU organized under MICHR  April 2008 – CRBU re-organized under Office of Research Rebuilding staff and significant operational changes Transitioning from ‘policing’ to ‘service’ model  March 2009 – Implemented automatic workflow tracking system (Jira)  September 2009 – Senior Manager hired and office named changed to CRAO  Fall 2009 – Lean principles process  March 2010 – Ancillary Committee status in eResearch (eRRM)  October 2010 – M Budget Enrollment Calendar Tool (MBECT) roll out

17. Organizational Structure

18. Key Performance Indicators CRAO review turn-around-time Number of new studies approved by each Analyst Number of amendments approved by each Analyst Number of CRB issues –Incorrectly billed as routine care (healthcare plan) –Incorrectly billed to Sponsor/7000 account

19. Clinical Research Improvements Instituted steeper clinical discounts for professional and hospital fees for clinical research Implemented lean initiative to remove bottlenecks and increase efficiency of billing calendar workflow Reduced turnaround time for the CRAO review process for new applications and amendments from 164 days to 15; average is now 13 days for new and 6 days for amendments Launched clinical research pricing tool to assist study teams in preparing study budgets Offered training workshops for faculty and study coordinators on the nuts and bolts of billing calendars Improved access to clinical research support services by moving CRAO, IRBMED, MICHR and CCC Clinical Trials Office to NCRC Partnered with Hospital to fund mechanism for payment for subject injury when not covered by sponsor (includes NIH) Established CRAO as an Ancillary Committee within eResearch Implement of M Budget Enrollment Calendar Tool; a robust clinical trials software application

20. THANK YOU! www.med.umich.edu/u/medschool-crao/mbect.htm