1. 1 Research Subject Registration & Grant Charges Clinical Research Education Series August 29 th, 2006 Marta Sears

2. 2 Overview Form Review Discuss SOC (Standard of Care) Tips Professional Fees Summarize Primary Changes How to Set Up the form Informing & Scheduling the Subject The Bill Sample Packet Review

3. 3 What ? Replacement Clarian Form Charges and Registration Related Process

4. 4 Why ? Process Improvement ↓ Billing Errors ↓ Uncollected $ Track # subjects # studies room use

5. 5 How to Implement ? Committee: Team, Team Managers, Project Directors Pilot: 6/1/06 to 8/31/06 Initiation: 9/1/06

6. 6 “The Form” Current Version “GRANT CHARGE FORM” New Version, eff 9/1/06 “RESEARCH REGISTRATION / GRANT CHARGE FORM”

7. 7

8. 8 Abbreviated Registration Box #1

9. 9 Study Contacts Box #2

10. 10 Brief ~or~ Full Registration Box #3

11. 11 “Routine Services” ~ or~ Standard of Care (SOC) A service that would be provided to the patient whether or not they were participating in a clinical trial. The service is medially indicated for the diagnosis ~or~ for a patient receiving the specific drug or treatment. Example: wlkly PT/PTT for coumadin titrations Intercurrent unrelated medical event, ie: UTI

12. 12 NOT a routine SOC research services Not routine SOC: Performed only because of clinical trial participation Tests Procedures Visits Establish at time of budget process. Bill to sponsor Example: Protocol required Daily PT/PTT when wkly is the standard

13. 13

14. 14 Study Identifiers / Account #’s Box #4

15. 15 Charge descriptions Box #5

16. 16 Box # 5 Note List Grant Account charges ONLY Do NOT list NON-Grant Account Charges Pre-Fill box columns….. for a specific study Where do I find service codes & charges??? Is the charge going to match our budget?? “ √ ” all items…… for a specific visit date

17. 17 Where are Service Codes & Charges??? Abbreviated Price List Small sample Missing additional associated charges Requiring contact with Clarian service area Study Manager, down the road, to include pricing Contact List (service area) Verify charges & Associated charges w/ Clarian service area Obtain quote via email (written) ie: the medication charge in addition to a procedure charge Maintained by UH AOC, Riley not listed Prior FIS / EPIC documents May list procedure svc code & charges Abbrev Price List & Contact List: Will be kept on SOM OCR web site

18. 18 Will Charge Match our Budget?? IDEALLY Service codes & Charges are identified at the point in time that the study budget is built Verify Charge w/ Clarian PFS 35% discount Verify service area Charge matches PFS Svc Code Charge How? List quoted charge on “the form” & submit to PFS However, charge will not continue to be seen on the form Clarian Charges do ↑ Sponsor budget should allow for ↑ expenses PFS: Patient Financial Service, 962-8090

19. 19 Professional Fees “The form” is a Clarian form However, the form may be utilized for professional fees, ie: Radiology Associates, etc. if acceptable w/ the specific professional practice area The coordinator or department support person will contact the professional area to determine / negotiate charges & to verify what form will be used Consideration should be made if the professional is already compensated through the grant account, ie: the PI

20. 20 Primary Changes in the Process Clarian now tracks subject visits, even if there are no procedures or Clarian staff utilized Check Box #5 “Exam/Consult Room” …. No Charge Now submit expected grant charges up front to Camille, improving communication & ↓’ing chance for subject billing error Now encouragement to submit form directly to each service area or practice plan (ie: Radiology Associate) to ↓ patient billing errors Pilot program improved communication about research between Clarian and IU, with other potential committee’s to come

21. 21 Related Process Refer to the “Research Grant Process” document

22. 22 Set Up a Pre-Filled Form Contact Camille Gilliam at PFS w/ information for Box #2,4,5 May also include quotes to PFS for verification May send via fax, email or phone call Send Camille the IRB approved DRA Camille will provide “the form” by email (Word Doc) w/ the assigned Clarian Grant Account # Camille will also campus mail the form, along with other information

23. 23 Camille Gilliam Patient Financial Services Email cgilliam@clarian.orgcgilliam@clarian.org Fax# 962-0861 Phone# 962-8090

24. 24 Informing the Subject Inform subject: Under what circumstances Full Registration (obtaining insurance information) may occur Inform subject: What expenses are paid or not paid by the grant account Inform subject: What expenses may be the patient/3 rd party responsibility & if pre-certification is needed Consider standard of care expenses Consider adverse events related to the study Consider medical events not related to the study The Informed Consent should adequately describe The Informed Consent should be signed prior to study related procedures

25. 25 Scheduling the Subject Schedule subject, including use of “the form”, appropriate requisition, per Clarian service area standards, ie: Phlebotomy:Walk In ECG:Walk In Neuro MD visit:Outlook, Full Registration PFT Lab:Call in advance GI:Place on a list if CRC only MDC:List if CRC only

26. 26 Pre-Filled subject specific Form Complete Box #1 & 3 for the specific subject At or Prior to the subject visit: Complete date of visit (top) Check off applicable charges in Box #5 Submit copy directly to the service area or professional area, ie: 1 form to UH Radiology 1 form faxed to Radiology Associates (Rita Bridge) Emailing the form w/ subject identifiers is not secure Service area will submit the form to Camille Camille will call if charge is unclear

27. 27 The Bill Subject receives bill Assess if Grant Acct or pt/3 rd Party responsibility If Grant Acct, then process FIS (Financial Information Services) expense itemization for verification & approval. If not correct put on Hold, notify accounting If non-research staff are utilized = Charge ie: Difficult stick. Request Clarian staff to draw = charge

28. 28 Clinical Trials Charge Forms Clarian “Research Registration / Grant Charge Form”, 35% discount, Camille Gilliam 962-8090 “Custom Lab Test Request”, research rates, contact Kim Weir 745-2775 Wishard Complete “Research Study Initiation Request Form” & send to Alice Roff at Wishard. Contact Tina Noonan 278-5802. Use of over-ride number. New IU SOM flat research rate of 125% of Medicare at Wishard Practice Plan Encounter Forms Contact appropriate practice plan administrator Contact Marcia Gonzales, Compliance Officer (278-4891) for questions, in addition to seeking direction from service area administration (ie: UMDA, Clarian dept)

29. 29 Handouts Research Registration / Grant Charge Form Illustrations / Samples Research Grant Process Flow Sheet Clarian Grant Charge Form Procedure for PFS Contact List Abbreviated Clarian Charge Code