Brooke Marchetti, Project Administrator

1. Part 1The Journey of a Clinical Trial Application through the Office of Sponsored Programs and Research Support (OSPARS) Brooke Marchetti, Project Administrator

2. Journey Agenda • Familiarize the research community with OSPARS and our new processes • Explain the steps necessary to obtain approval for conducting research within UPMC facilities • Describe the process involved in the preliminary risk management review

3. About Us – Your Journey Guides • OSPARS is the central point of coordination for sponsored programs and clinical trials and is UPMC’s authorized representative for grants, contracts and other agreements from external sponsors • OSPARS facilitates sponsored programs and clinical trials by assisting in reviewing and endorsing proposals, negotiating agreements, accepting and authorizing awards, interpreting sponsor rules and guidelines, and providing post-award administration services

4. Choosing Destination • Receipt of protocol synopsis from sponsor • Determination of study feasibility by study team • Confidentiality Disclosure Agreement (CDA) received and to be sent to OSPARS for negotiation Travel Warning: Entry into sponsor’s web portals, or viewing of CD may have the same legal/confidentiality implications as signing paper CDA

5. Journey Preparation After CDA is finalized, you will receive study packet from sponsor and need to do the following: • Detailed feasibility determination in dept • Apply for departmental and scientific review • Seek guidance for CPT codes • Obtain pricing for procedures at destination hospitals/facilities for budget • Complete and/or obtain necessary documents for OSPARS review • Obtain unique identifier from your department

6. Journey Path – OSPARS or Pitt?

7. Travel Tips • Request Pricing • Budgeting • IRB Preparation • Fiscal Review Preparation • CTRC Preparation • Device Study Preparation • Drug Study Preparation

8. Documents Needed for OSPARS Journey • Completed Clinical Trials Application • Completed Fiscal Review and Institutional Account Request Form • Departmental Risk Management Approval • Most Current Protocol Version • Investigator Brochure (IB) • Draft Clinical Trial Agreement (CTA) with Proposed Budget • Template Informed Consent Form (ICF) • Signed Cost Summary Sheet (CTRC study)

9. Details of Risk Management Tour • Review of ICF cost, subject injury and HIPPA language • Ensure ICF language in compliance with UPMC policies and Clinical Trial Agreement (CTA) or Master Agreement with Sponsor • Comments sent to study team within 5 business days of submission for concurrence with proposed changes to ICF • Travel Highlight: Thorough review and quick turnaround in response to requests/comments will prevent delay in Central IRB approval

10. IRB Review Tour Details • Submit revised ICF to sponsor for approval • When sponsor approves, submit to Central IRB with protocol, Investigator Brochure (IB), and all study documents that need IRB approval

11. Additional Tour Details • All investigators must complete research training modules (including Good Clinical Practice) in HS Connect and Conflict of Interest in MyHub • OSPARS negotiates contract language while department negotiates budget – process transparent to all parties • For Device Studies, OSPARS determines need for CMS coverage determination and works with study team to prepare packet for submission to CMS intermediary • For Drug Studies, OSPARS will notify IDS for review – study team will decide whether or not to use their services

12. CTRC Review Tour (Committee Review) • Complete online CRTC portal request http://ctrc.upmc.edu • Schedule and complete budget meeting with CTRC • Obtain fully signed cost summary agreement form • After complete submission received in OSPARS, the CTRC is notified to review • Flow charts and additional information available on SharePoint

13. Tips to Making the Journey a Success • Meet with research administrator to prepare budget • Respond to OSPARS requests and comments within 5 business days • Forward IRB approval/Final budget to OSPARS as soon as received

14. Requirements for Journey Completion • IRB approval • Fiscal approval with Finalized Budget • Contract Execution – Site initiation visit can occur • CTRC approval (if applicable) • CMS approval (if applicable for device trial) • OSPARS approval

15. The Journey Continues (Continuing Review) • All changes to the study require review and approval from OSPARS • Continuing Oversight form – no longer required • Notification of changes to occur via e-mail to OSPARS inbox (Please follow appropriate format for subject line) • Body of e-mail must contain the name and phone number for contact person and information specific to the reason for submission, as outlined on our SharePoint site

16. Questions About Booking a Journey Through OSPARS Please visit our Share Point: https://spis.upmc.com/corporate/Finance/ospars/default.aspx Problems accessing Share Point, please e-mail OSPARS@upmc.edu

17. Part 2On the Road Again…Costs and Billing in Clinical Trials Presented by: Office of Sponsored Program and Research Support (OSPARS)

18. Points of Interest on Road Trip • Need for Fiscal review and changes in processes for obtaining Institutional Accounts and Plan Codes • UPMC billing processes for Clinical Research studies/activities provided through hospital(s), clinics, UPMC facilities and Physician Services Division • Shared responsibilities in ensuring billing compliance in accordance to federal regulations and UPMC policy

19. Why is Fiscal Review Required? • To establish a risk management review plan for billing of clinical/research services within UPMC to comply with internal polices and external regulations

20. Does My Study Require Fiscal Review? Will research subjects undergo any of the following that could potentially be billed by or occur within UPMC? • Diagnostic and/or interventional procedures • Administration of drugs • Insertion of medical devices • Collection of biological specimens • Laboratory assays • Any other patient care services * Not fully inclusive list

21. Fiscal Review Process Updates and Reminders • New Combination Fiscal Review and Institutional Account Request form • Budget and proof of funding requirements (OSPARS and Pitt trials) • OSPARS and WPIC plan for requesting IA #’s and Program Codes

22. Research Fiscal Review Completion Tips • Schedule of events reconciles with protocol and ICF in OSIRIS Sections 2.5, 2.6, 2.7 • Payment method reflects ICF, sponsor’s budget, and schedule of events • Indicate if one or both IA accounts (FIA/PIA) needed with procedures

23. Determination of Routine/Research Costs • Study team in conjunction with guidance from PI is providing draft outline of what they determine to be routine and research costs as relates to clinical trial • OSPARS will review to assure items listed and designated as routine/research are within requirements of National Coverage Determination • PI provides sign off on final determination and agreement via email response

24. Medicare Qualifying Trial Determination • Study must meet 7 “desirable” characteristics of a clinical trial and 3 other criteria pertaining to study purpose, design and therapeutic intent (see handout) • Qualifying status determined by OSPARS in conjunction with PI input of therapeutic intent

25. Review of New Form • See Packet

26. How to Submit Fiscal/Institutional Account Request Form • Submit pricing request • Complete sections 1, 2 & 5 using section 3 for reference • For facility charges to PBSInstPriceReq1@upmc.edu • For professional/physician charges to PSDResearchRateBillingRequests@upmc.edu • Submit form to OSPARS with study submission for Fiscal Review • Complete section 4

27. How Do I Obtain Pricing Quotes for Budgeting? • CPT codes are essential to ensure appropriate test is performed and billed (including CDM codes will expedite processing of request) • Request codes from Sponsor when research budget is received to lessen need to hunt for codes

28. Budgeting Tips • Budget for inflation (recommend 5% increase per year). CDM charges typically change January 1st and July 1st, however changes may occur at various times during the year • Facility research rates are based on Medicare cost report (RCC rates) • Remember to obtain rates for each individual facility and budget for professional fees associated with services provided at the hospital (Diagnostic Imaging, EKGs, Pathology)

29. Objective of Research Billing Processes • To ensure adequate processes are in place to bill clinical services to appropriate payor(s): • Third Party • Research Participant • Study (through Institutional Account or Plan Code)

30. What are IA’s, Plan Codes and Program Codes? • Institutional Accounts • An "FIA" is a facility institutional account (7777 xxxxx 9500) that is used to bill a clinical trial for the cost of performing the actual test at any UPMC facility • A "PIA" is a physician institutional account (010-80-00000XXXX or 110-80-00000XXXX), used by UPP to bill a clinical trial for the services of a physician to "read" or "interpret" the results of a test • Insurance Plan Codes • When an entire inpatient stay will be billed to clinical trial • When the inpatient charges will need to be audited BEFORE billing the payor • Program Codes • WPIC assigns # for study to allow treatment program to be entered into eRecord and to route charges to IA #’s

31. How Do I obtain my IA, Plan code? • Once OSPARS receives PI concurrence to fiscal comments and funding is confirmed, the following steps will occur: • Fiscal Reviewer will upload approved FRIAR form into OSIRIS (for Pitt studies) • Fiscal Reviewer will send approved FRIAR form in e-mail to study team, copying Lisa Hennigan • Study team will forward completed Program Code Request and approved FRIAR form to Lisa Hennigan • Lisa Hennigan will forward each form to the respective departments to have IA #’s and Program Codes created

32. Methods of Billing to IA’s • Program code is entered into eRecords • Lab Requisition is submitted for WPIC lab • Research Requisition is submitted for procedures performed outside of WPIC

33. Completing Research Requisition • It should accompany participant to all departments outside of WPIC • Form is used to ensure that outside departments properly bill to FIA/PIA • The contacts listed below should also receive the Research Requisition via e-mail: • Patient Access • Ancillary Department (lab/imaging/cardiology) • PBSResearchReq1@upmc.edu • PSDResearchRequisitions@upmc.edu

34. Final Reminders • Contact Patient Billing Customer Service at (800) 854-1745 and notify Institutional Billing via e-mail at the address below immediately if you are made aware of error in billing • PBSInstPriceReq1@upmc.edu • PSDResearchRateBillingRequests@upmc.edu • Contact PSD/PBS when participant terminated or withdrawn from study • Contact OSPARS of overall study closure

35. Why is it Important to Follow Research Billing Processes? • Helps to meet Billing Compliance Guidelines/Requirements • Avoids for cause investigations/fines/penalties/payor participation restrictions • Prevents double billing (Example: billing insurance when the service already covered by the study/grant) • Prevents inappropriate billing (Example: third party payor billed for procedures that should have been billed to research account) • It’s the right thing to do

36. Wrap up • Questions? • Resources

37. Contact Information • Patient Business Services (PBS) • PBSInstPriceReq1@upmc.edu for Pricing Requests/IA issues • PBSResearchReqs@upmc.edu for Research Requisitions • Patient Business Customer Service 1-800-854-1745 • Physician Services Division (PSD) • PSDResearchRateBillingRequests@upmc.edu for Pricing Requests/IA issues • PSDResearchRequisitions@UPMC.edu for Research Requisitions • Michelle Mathier (412) 442-9631 or Karen Krapp (412) 432-7579 • Office of Sponsored Programs and Research Support (OSPARS) • OSPARS@upmc.edu • (412) 647-4461