1. “How do I Access Hospital Services for a Study? Office of Clinical Investigative Services Human Research University November 2013 OCIS 706-721-6247 www.gru.edu/OCIS1

2. Goal: Participants will be able to schedule a study patient for a hospital service. Objectives Participants will be able to: 1.Define basic clinical trial terms and concepts. “The Foundation” 2.Define the elements needed to set-up a study to access hospital services accurately. “The Preparation” 3.Schedule visits and procedures and process hospital invoices. “The Process” OCIS 706-721-6247 www.gru.edu/OCIS2 Goal and Objectives

3. Georgia Regents University “campus side” Georgia Regents Medical Center “the Hospital”, “MCG Health Inc” Children’s Hospital of Georgia Children’s Medical Center PPG (Physician’s Practice Group) Georgia Regents Medical Associates OCIS 706-721-6247 www.gru.edu/OCIS3 “The Foundation”

4. PeopleSoft GRU Financial System HealthQuest Hospital Financial System IDX Patient Scheduling System Visits and Procedures OCIS 706-721-6247 www.gru.edu/OCIS4 “The Foundation”

5. PowerChart Electronic Medical Record PowerTrials Hospital Clinical Trial Management System MRN Medical Record Number OCIS 706-721-6247 www.gru.edu/OCIS5 “The Foundation”

6. Two Types of Bills Hospital facility fees –Pt. Accounting Physician professional fees -PPG OCIS 706-721-6247 www.gru.edu/OCIS6 “The Foundation”

7. Charge Master List of hospital prices Available thru OCIS Clinical Research Discount 60% on Hospital charges 92% on labs (except send-outs) PPG fees Available from OCIS OCIS 706-721-6247 www.gru.edu/OCIS7 “The Foundation”

8. The Payer “Study/Research Plan” The Guarantor The CPI # assigned to study OCIS 706-721-6247 www.gru.edu/OCIS8 “The Foundation”

9. CPI Corporate Person Index Account number assigned to study by hospital “Dummy Account” Encounter Form Used to bill for outpatient charges UB-04 Electronic inpatient claim form OCIS 706-721-6247 www.gru.edu/OCIS9 “The Foundation”

10. Study Payment Models  Study pays for everything  “Carve Out”- Routine Care billed to insurance. Study pays for study-related expenses  Medicare Qualified studies OCIS 706-721-6247 www.gru.edu/OCIS10 “The Foundation”

11. May bill to Medicare/Insurance If all of the following criteria are met  Qualified study  Medically reasonable and necessary  Sponsor is not paying for it  Medicare covers it for all beneficiaries  Approved study billing grid See Medicare Qualification Form on OCIS website OCIS 706-721-6247 www.gru.edu/OCIS11 “The Foundation”

12. Radiology Services  See Radiology Form & Instructions on OCIS website  Remember physician professional fee OCIS 706-721-6247 www.gru.edu/OCIS12 “The Preparation”

13. Hospital Pathology Department - Clinical Pathology - Body fluids Hospital Pathology Services - Anatomical Pathology - Tissue samples See Pathology Form & Instructions on OCIS website OCIS 706-721-6247 www.gru.edu/OCIS13 “The Preparation”

14. Final elements  Fully executed contract  Study entered in PowerTrials by OCIS  Receive CPI# and labels from OCIS OCIS 706-721-6247 www.gru.edu/OCIS14 “The Preparation”

15. Study stickers from OCIS: Rm BB 8514 OCIS 706-721-6247 www.gru.edu/OCIS15 “The Preparation” Study Label VISIT GUARANTOR: CPI# 002352898 PI: McGraw, Phil M.D. STUDY INFO: HAC# Pro000076 Contact: O. Winfrey BILL TO: STUDY/RESEACH PLAN Ext. 1-Hollywood IDX FSC 54/ IDX PLAN S007

16. To schedule a study clinic visit –all procedures billed to study 1.Patient entered in PT by the site 2.Call Central Scheduling: ext. 1-2273 3. Provide patient info (SS#, MRN, DOB) 4. Reason for Visit/Chief Complaint: “Study” 4. The Payer: Study/Research Plan 5. Visit Guarantor: CPI# OCIS 706-721-6247 www.gru.edu/OCIS16 “ The Process”

17. Patient Arrival  Patient arrives at clinic  Front Desk “arrives patient” in IDX  Encounter Form is generated  Place green study label in upper left corner  EF contains study procedures ONLY OCIS 706-721-6247 www.gru.edu/OCIS17 “The Process”

18.  A second visit must be scheduled in IDX  A second encounter form needs to be generated  Second encounter form - Green study label goes on upper left hand corner  Check the procedure(s) to be billed to study. Physician signs Encounter Form OCIS 706-721-6247 www.gru.edu/OCIS18 “The Process” Routine Clinic Visit with Study Procedure(s)

19. To order  Order is written in PowerChart.  Indicate “bill to study” Provide CPI#.  MD “fires” the order  Send hard copy via order.comorder.com To schedule  Standard procedures call: 1-2273  Specialized procedures: 1-9729  Payer is “Study/Research Plan”  Policy Number is CPI#. Guarantor is Study CPI #  Call Radiology to verify OCIS 706-721-6247 www.gru.edu/OCIS19 “The Process” Radiology Procedure to be Billed to Study

20. If there is a corresponding clinic visit  Order written in PowerChart.  Indicate “bill to study”. Provide study CPI#  Put green study label on tube If no clinic visit  Call Central Scheduling 1-2273  You need a “lab only” visit created in IDX  Provide study CPI#  Put green study label on tube and paperwork If after hours: at lab, ask for “down time” label be put on tube. Provide study CPI#. OCIS 706-721-6247 www.gru.edu/OCIS20 “The Process” Lab to be billed to Study

21. If study pays for everything  Admitting physician submits the Advance Directive  States everything is to be billed to study  Work with Hospital Patient Access Services Extension 1-2561 OCIS 706-721-6247 www.gru.edu/OCIS21 “The Process” Inpatient Study Stay

22. If some items are to be billed to study Cheryl Egan cegan@gru.edu (ext.1-7267)cegan@gru.edu Provide following information  Patient name/medical record number  Study CPI number  Item(s) to be billed to study OCIS 706-721-6247 www.gru.edu/OCIS22 “The Process” Inpatient Study

23.  Indicate study visit # (cycle # and day if applicable)  Indicate if unscheduled visit or adverse event treatment  Submit to HMS  HMS scans to the Clinical Trials section of the chart  Check in chart to see that its in the correct location Research Progress Note OCIS 706-721-6247 www.gru.edu/OCIS23

24. How to handle a correct bill  Study contact receives bill  Bill is verified  Check request generated  Payment due within 30 days of service  Authorization to Budget OCIS 706-721-6247 www.gru.edu/OCIS24 “The Process”

25.  Study contact receives bill  Bill is inaccurate  Email Cheryl Egan (extension 1-7267) Pt. name and date of service Study Name. Visit# (Cycle and Day if applicable) Explanation of the requested changes  If correction needed a revised claim will be sent  Pay from revised claim OCIS 706-721-6247 www.gru.edu/OCIS25 “The Process” How to handle an incorrect biil

26. OCIS 706-721-6247 www.gru.edu/OCIS26 “Homeward Leg” CRITICAL for study close-out  Verify any outstanding bills with Patient Accounting  Change study status in PowerTrials

27. Questions??? OCIS 706-721-6247 www.gru.edu/OCIS27