1. Clinical Trial Billing – Updated Procedures June 2010 Kay M. Perry Pam Sabrsula

2. Today’s Class Will Cover… Reminder about the Billing Rules & Billing Grids Procedural Updates: – Research Activity Billing Trigger – UHS Monthly Report

3. Basic Billing Rules

4. Do Not Double Bill SPONSOR INSURANCE

5. Do not bill for items or services promised for free in the ICF Consent Form

6. Beyond That…. Can usually bill standard of care services/items & research-related complications – Unless sponsor agreed to pay in the CTA Medicare has some additional specific rules, as do commercial payors

7. A “Clinical Trial Billing Rules” course is available in the Knowledge Center! (There is one on Budgeting also!)

8. A Reminder about Pro Fees vs. Tech Fees

9. Radiologist: Professional Component (UT Med) Facility: Technical Component (e.g. University Hospital) Pro Fees vs. Tech Fees In a UT Med clinic: Global (Pro Fee & Tech Fee in one)

10. Be sure to budget for both Be sure to think about the billing for both Be sure to reconcile for both (PS: UHS does not negotiate its rates)

11. Billing Grids Yes, still required! Templates online at: http://research.uthscsa.edu/ocr/clinical.shtml

13. A Few Things Learned Along the Way…. Please list “office visit” if there is one – Some studies pay for it, some don’t – Pro fee may be assessed by UTMed even though the PI is performing Please use CPT terminology, if known, in addition to common parlance – e.g., to you it’s a “6-minute walk test” but to the billing system it may be “Pulmonary Function Test” or “Simple Exercise Test”

14. UT Medicine Forms

15. Hopefully You Will Recall that Two Forms were Introduced in 2009 1.Study Information Form 2.Patient Enrollment Form Forms used to create Research Accounts in EPIC billing system

18. Research Activity Billing Trigger “RABT” Form Required for studies: – With UT Medicine billing – With UHS when you will pay UHS for some services (due to monthly reporting requirement) – Other studies with clinical services where the study pays a provider/facility for a service (for Reconciliation purposes)

19. “RABT” Form Primarily replaces other UT Medicine forms, but also gives details of services (dates, etc.)

20. Additional Details Required Services Information: Billing Grid Week or Visit # (e.g., Visit 1, Visit 2, etc.) Sunrise Visit # (a.k.a. IDX Admit #) Date Description Location/Specialty/Provider Affiliated Billing Entity Bill to: R or T Reconciliation: Invoice Date Invoice # Date Invoice Paid

21. Working with the File One workbook for the entire study One tab for each participant – On the first tab, complete study information only – Then copy the tab to create a new one for each participant

22. Working with the File, continued Monthly UHS report – header fills in automatically, but must copy and paste for each month’s services

23. The RABT and UT Medicine Email the file to UT Medicine: UTMSAResearchBilling@uthscsa.edu UTMSAResearchBilling@uthscsa.edu (will change to a SharePoint site in near future) When a new study has been started or a new participant enrolled – tell them in your email If a participant is taken off the study, notify UT Medicine via email with participant name and study name

24. UHS Monthly Report

25. The RABT and UHS Send the monthly report to Joan Thomas at joan.thomas@uhs-sa.com You can send the entire file, or make a.pdf of the monthly report sheet

26. Other Studies/Locations Primary concern is reconciliation

27. Reconciliation

28. Reconciliation: D uring Study and Prior to Closing Did study team receive all invoices from affiliates, UT Medicine, etc.? – If not, they probably billed the patient/insurance Did study department actually pay the invoices? Balance study patient care expenses to a total of each patient’s costs

29. What research personnel need to do: 1.Continue creating billing grids 2.Copy the billing grid into the RABT spreadsheet if required 3.Send RABT to UT Medicine 4.Reconcile costs, payments, etc. to grids 5.Send monthly report to UHS using RABT Effective July 1 st – you do NOT have to go back in time to create a RABT for your studies (unless you want to)!

30. References http://research.uthscsa.edu/ocr/clinical.shtml HOP 7.7.1 Drugs: – NCD for Routine Costs in Clinical Trials (310.1) – Medicare Claims Processing Manual, Chapter 32, Section 69 Devices: – Medicare Benefit Policy Manual Chapter 14, Section 20 – http://www.trailblazerhealth.com/Policies/Devices /Default.aspx (TrailBlazers is Texas’ Medicare contractor) http://www.trailblazerhealth.com/Policies/Devices /Default.aspx

31. Questions? Kay M. Perry, JD, Regulatory Analyst for Research Operations PerryK3@uthscsa.edu (210) 567-0651 Pam Sabrsula, Project Coordinator sabrsula@uthscsa.edu (210) 567-1338