Research Subject Registration & Grant Charges

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

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

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

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

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

8. Abbreviated Registration Box #1

9. Study Contacts Box #2

10. Brief ~or~ Full Registration Box #3

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. 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

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

15. Charge descriptions Box #5

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

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

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/3rd 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. 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. 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. The Bill • Subject receives bill • Assess if Grant Acct or pt/3rd 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. 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. 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