1. Managing your Study Budget Wendi R. Mason, NP Interstitial Lung Disease Program Coordinator

2. Objectives By the end of this discussion, participants will understand general aspects of FACTr have a brief understanding of Patient Billing understand the various areas that remove money from your budget and why recognize that money could be erroneously removed from your budget understand the process of invoicing a sponsor know who to contact with particular questions be introduced to some organizational tools for managing budgets

3. The future of budget building is here! Financial Accountability and Compliance Tracking for Research also known as FACTr - initiated on March 1, 2010 - contact Sandy Greeno to schedule training

4. FACTr – General Points  A web-based process that replaces the Excel version of the Patient Cost Template and Word version of the exemption request  Provides a shared source of your study billing information to CTBC, Central Reg, VMG / Pt Acct, G&C, and others  Dept of Finance is actively uploading all current studies (so you don’t have to!)  D&H Account request  Pricing requests (“researchratesrus” is no more)

5. FACTr Website Get your Training scheduled! Bookmark the site! https://webapp.mis.vanderbilt.edu/factr/logout.jsp Any time you submit a study to the IRB, understand that you will need to submit information to FACTr.

6. Getting Started

7. Your budget was agreed upon, the contract has been executed, the IRB has approved your study, and you are ready to enroll your first patient! What do you need?

8. Getting Started Center number from your Division – 10 digit number D&H number – request through FACTr (or contact Cara Baughman) Register your Center and D&H into CORES.  http://www.mc.vanderbilt.edu/root/vumc.php?site=CFUIS&doc=1 3512 http://www.mc.vanderbilt.edu/root/vumc.php?site=CFUIS&doc=1 3512 With FACTr, you do not need to set up Central Registration, but you still need to complete the Research Registration Form in StarPanel as you enroll patients. Other research forms that include these numbers?  Radiology research – ensures radiology procedures are billed to the right place. Contact Josh Williams to create a radiology requisition.

9. Patient Billing Your patient presented for his visit. You’ve ensured that your billing sheet shows the appropriate billing numbers across the top: either Routine Care (previously called Standard of Care) or your D&H numbers. You’ve correctly marked the back of the form with V60 or V70 codes in addition to other ICD-9s. What happens in the patient’s billing cycle next?

10. Patient Billing PSRs enter encounter form data VMG coders enter data AutoGen translates the data into MediPac for VUMC billing Pt Accounting / Claims Patient receives an EOB from insurer and/or VMG (professional) and/or VUMC (facility) bill.

11. Study Patient-specific Accounting Within a month, you (or your Division) will begin to see bills that have generated from this patient.  Facility/Procedural billing – Sue Swann Through Campus Mail – pink sheet attached to a billing sheet  Professional billing – Jeanie Waddell Through email  CORES Notice of invoices ready for approval through email

12. Study Patient-specific Accounting Ensure the following is correct  Correct patient  Correct study  Correct procedure  Correct number of times  Correct date of service

15. Patient-specific Accounting If you find an error, report it.  Notify Sue via fax (6-0945)  Notify Jeannie via email  Reject a CORES invoice Sue and Jeannie will consult Sandy Greeno regarding the issue and corrections will be made. Rejecting a CORES invoice will get you a phone call from the department that you rejected.

16. Clearly identify the error and fax to Sue

17. Study Patient-specific Accounting Errors shouldn’t happen repetitively. If they do, find the source of the problem and correct it there.  Example: professional billing for PFTs

18. Study Patient-specific Accounting Monitor the specific patient’s charges that hit your center.  Create a worksheet or flowchart of what charges should hit your D&H  Consider including: routine care, reimbursements, CRC charges, pharmacy charges, additional expenses that you need to invoice for that are particular to that patient

19. Study Patient-specific Accounting - Billing Flowsheet

20. What happens when you don’t monitor your Patient Specific Account:

21. Study Center Accounting Closely monitor the study center number  FinData – created monthly (DoM)  E-Dog – real time* Your Division should provide you access Learn what is supposed to be taken from this center number.  Your salary?  A percentage of PI salary?  Phone/pager expenses?  Study-related expenses?  Are there division-related taxes?

22. Study Center Accounting - FinData Sheets

23. Study Center Accounting Learn the 5-digit accounting codes  51700, 59003, 59203 – RN salary  63410 – patient facility fees (amounts should match your sheets from Sue and/or Jeanie)  63400 – patient reimbursements/subject participation  61400 – IRB fees (should match your invoices, CORES report),  34170 – Deposits from sponsors! Create a spreadsheet to help you monitor the debits and credits to your study center

24. Study Center Accounting

25. What happens when you don’t monitor your center number…

26. Invoice your Sponsor The fine print of your contract may state:  “IRB fees are pass through costs and are to be invoiced to…”  “reimbursement of unscheduled visit in the amount of $956 will be made upon receipt of invoice”  “A $1500 one time payment will be made upon IRB approval for pharmacy set up fee upon receipt of invoice.” Who do you think is creating these invoices??

27. Invoice your Sponsor Include your center number on this invoice in preferably more than one place!

28. What happens when you don’t invoice the Sponsor as directed by the contract?

29. Renegotiating the Contract Don’t be afraid to contact the sponsor and tell them that you need more money to :  Continue the trial There may be expenses you did not anticipate Annual increases in expenses  Enroll more subjects We need another study coordinator to help with the increased load.  Buy a needed or better machine / equipment EKG machine  Upgrade computer equipment to meet the demands of the study Web-based CRF entry

30. Resources Your Department Administrator  Know this person! Dept of Finance (prefer email)  Dianne McGrath (Contracts, FACTr) 2-4549  Cara Baughman (Central Registration, StarPanel forms, D&H requests) 6-2641  Sandy Greeno (Grants, billing issues) 3-3653 Grants and Contracts  Janet Fry 6-5886

31. Thank you for your time and attention wendi.mason@vanderbilt.edu 3-7068