1. UAB Clinical Trials Office Lunch & Learn Sponsored by: UAB Clinical Trials Office Clinical Billing Review http://www.uab.edu/osp/clinical-billing-review January 15, 2014 Kaul Human Genetics Building Finley Conference Center

2. Agenda Provider based billing of TKC services- Nicole Halbrooks Clinical Trials Office (CTO) initiatives & updates- Carolyn Whitmire & Penny Jester Clinical Trial Billing Compliance Reminders- René Jooste & Ashley Specht OIRB – Nancy Stansfield Upcoming meeting date- February 19, Finley Conf Center, 12-1pm

3. What Is “Provider Basing” and What Does It Mean to UAB Medicine? Nicole Halbrooks, CPC Sr. Manager-Compliance & Reimbursement Review UAHSF-MSO

4. Clinical Trials Office (CTO) Updates Carolyn Whitmire & Penny Jester Admin Co-Directors, Clinical Trials Office

5. Responses to CTO Questionnaire Provide support/personnel/training for clinical trials Guidance document for clinical trials Website for a list of clinical trials with names of coordinators and financial contacts Improved process for research monitors to access to EHR Help with building SiteMinder Eliminate green order sheets for research labs Training for budget development and best practices for financial management of clinical trials Improve process for Hospital’s review of category B device trial; document and advertise process

6. Clinical Trial Billing Compliance Reminders René Jooste & Ashley Specht UAB Clinical Trials Office

7. Change of Location of Clinical Billable Service after Initial FAP Review Example: initial location- Lung Health Center/ CSU/Derm research area- service not billed by UABH/ MSO- Clinical Trial Billing Notice (CTBN) not required new location- Highlands hospital- service billed by UABH/MSO- CTBN required Location change must be submitted to CBR for review- using study amendment submission

8. Manual Clinical Trial Billing Notices (CTBN’S) manual CTBN’s not acceptable for any newly activated studies best practice- type the required information handwriting must be legible (after faxing) NCT#’s (ClinicalTrials.gov registry numbers) - add this # to the CTBN if applicable

9. CTBN Performance Reports 10/11/2013 – 01/10/2014

10. CTBN Overall Performance 10/11/2013 – 01/10/2014 UAB Clinical Trials Office (CTO) Clinical Billing Review Unit Siteminder Performance Report Summary Appointments and CTBNs 10/11/2013 – 01/10/2014 Overall Summary Total CTBNs Filed1776 Original1729 Revised47 % On Time84% % Late16% Total Appointments1758 % On-Time81% % Late19%

11. SiteMinder 100% Club PI and Study Coordinators 100% Scheduling and Keeping Appointments 10/11/2013 – 01/20/2014 002 - Gyn/Onc 012 - Microbicide 015 - Card:Nuc 030 - Neuro - Muscular 060 - OB/GYN-MFM 097 - Psychiatry

12. 003-Radiation Oncology100 006-Pulmonary100 007-Nephrology100 008-Nephrology100 010-1917 Clinic100 012-Microbicide100 014-Clinical Nutrition100 017-Cardiology-EP100 021-Rheumatology/Immunology100 023-PM&R100 030-Neuro - Muscular100 066-OTOL100 069-Surg - Neuro100 093-Peds:Hem/Onc100 026-GI/HEP95 083-OB/GYN:WPMRS92 005-Pulmonary80 CTBN YTD Performance Units 80% and Above Through January 2014

13. Nancy Stansfield Asst. Dir Institutional Review Bd nstansfield@uab.edu (205) 975-3922 13 OIRB

14. Wednesday February 19, 2013: 12-1pm Kaul Human Genetics Building Finley Conference Center 14 February CTO Lunch & Learn