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
Next training March 16, 2012, Crystal Terrace

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!
Any time you submit a study to the IRB, understand that you will need to submit information to FACTr.

6. Getting Started Getting your budget organized…
This is pretty much my desk.

7. Getting Started
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.
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 Freda McClendon to create a radiology requisition.
Are there other areas that you have to set up??

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 (also 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?
Blue Sheet
V60 stands for Patient in a research study – bill to the D&H
V70 stands for Patient in a research study – bill to the insurance provider

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.
Two forms of billing – facility/procedural (VUMC) and professional (VMG)
In outpt clinic – VMG coders enter the data, AutoGen translates the information to MediPac for VUMC billing. If all things match, then billing will either go to D&H account for payment, or to insurance then it goes to Claims (Pt Accounting). When it goes to Pt Acct, the account gets divided by the payer and a claim goes out. In the mean time, the EOB from the insurance company and may or may not get a bill from VU.
In inpt – VMG coders enter the data continuously throughout the time of the hospitalization although it is entered at a few days post to allow for everything to be included. D&H is typically recorded in the WizOrder in the Comments section (rather than using V60/V70).

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
CORES
Notice of invoices ready for approval through
PINK Sheets
If you are listed as the person responsible for the accounting on your study, then you will get all these notifications.
Very important that you look at these and ensure several things!!

12. Study Patient-specific Accounting
Ensure the following is correct
Correct patient
Correct study
Correct procedure
Correct number of times
Correct date of service
Patient
– this may not be your patient
- this patient may no longer be in the study
- one time the “patient” was the “doctor”
Study
- ensure that the patients match the study (sometimes patients get mixed around)
Procedures
- sometimes a previous study patient continues to get billed for procedures after he is no longer in the study (txplnt patient)
- sometimes studies that aren’t supposed to be billed get billed
- sometimes other office visits get billed
- sometimes it may appear to be the right procedure, but the CPT code was wrong and the wrong amount is charged.
Number of Times
- sometimes fingers get fat on a keyboard and what is supposed to be entered as “1” gets entered as “12”
Date of Service
- sometimes there are duplications (you already paid for it once)

15. Patient-specific Accounting
If you find an error, report it.
Notify Sue via fax (6-0945)
Notify Jeannie via
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
Since the Patient Cost Template was initiated, the numbers of errors in billing have reduced dramatically.

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
Monthly you need to check your account to ensure that what is supposed to come out of your account is coming out of your account… and nothing else.
Money will amazingly fall out of your accounts if you are not careful.
10-digit center numbers are very similar and it is very easy for someone to mistakenly enter a debit into the wrong account…
I have paid for:
lab supplies $ 500 or more a pop
computers for other people in the division
travel expenses for other people in the division
patient reimbursements to patients who were not in my study (or any of my studies!)

23. Study Center Accounting
Learn the 5-digit accounting codes
51700, 59003, – 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
These certainly aren’t all the codes.
There are many codes for Salary Dollars. Center numbers pay not only your wages but your benefits. Codes are different for Faculty members, house staff, RNs, other professional staff, non-professional staff, temp employees, etc.
Different departments may code things differently as well.
There are codes that are very specific: postage, and codes that are very vague: office supplies.

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??
Other items that are typically invoiced include:
screen failure patients
unscheduled visits
extra lab draws for safety purposes
IRB fees
Pharmacy set-up, annual, and close out fees
patient reimbursement
equipment
particular procedures – example HRCT will be completed for study purposes if patient has not had one in the past 3 months. That HRCT may not be included in your budget, but may only be paid by an invoice!
FTE support – you may have arranged a deal with your sponsor that they will pay 25% of an FTE – but that you have to invoice that amount quarterly.
With invoices, the contract may require specific line items that you must include to get your money. They may require that you submit invoices within a certain time of the bill being generated.

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
Explain your problem to the sponsor – in writing preferably – and signed by your PI. If you are a good site, they will want to keep your business and keep you enrolling patients.
I have been able to negotiate
all or a portion of an FTE
new refrigerated centrifuge
increased expense rates
payments for specific items
dollars for a new PFT machine
Of course, it is best to anticipate your needs up front and ask for these at the onset… however, the worst they can say is “No” and there is only a 50% chance that they’ll say “No”.

30. Resources Your Department Administrator Dept of Finance (prefer email)
Know this person!
Dept of Finance (prefer )
Dianne McGrath (Contracts, FACTr)
Theresa Shalaby (research rates [through FACTr])
Cara Baughman (Central Registration, StarPanel forms, D&H requests)
Sandy Greeno (Grants, billing issues)
Grants and Contracts
Janet Fry
Carolyn Strickland (Contracts)

31. Thank you for your time and attention
3-7068