1. 1

2. Correct charge Correct amount Correct payer 2

3. Discuss the purpose of a Billing Grid Discuss the Billing Grid process as a means to obtain/communicate accurate billing Understand and complete the steps to filling out a Billing Grid 3

4. 4 Study Procedures can be paid by: Sponsors 3 rd Party Payers: Private Insurance Medicare Medicaid Study Procedures are not being reimbursed

5. 5 Improper billing can lead to false claims Improper Billing False Claims Penalties

6. Billing a participant/insurance company for research-only procedures Billing a participant/insurance company for services covered by the sponsor Billing for services promised free in the ICF Billing the study for services that should be billed to the sponsor 6

7. Consequences of Incorrect Billing: Fines Committing fraud Loss of time correcting error Failure to recover costs Criminal penalties Financial penalties Loss of Community trust Restriction on research operations 7

8. 8

9. Requires due diligence by all Informing subjects of financial obligations and liability (ICF language very important) Complete billing grid (indicates where specific charges should be billed) Ensure services for study procedures are billed in accordance with the billing grid 9

10. Complexity of the trial Procedures Reimbursement payment Procedures not associated with a CPT/ICD code 10

11. 11 Accurate Billing of procedures associated with clinical trials

12. Start the process during contract/budget negotiation Make sure it is clear what the sponsor is paying for Differentiate between SOC and research procedures where SOC procedures are not being reimbursed by the sponsor Read and evaluate the protocol, ICF (draft is fine) and budget 12

13. 13 Requires communication between the following: PI Coordinator Study Team Clinic/Department manager Clinic/Facility front desk Clinic/Facility billing department Additional departments that may provide services for research procedures Coders Subject Requires oversight by study personnel and Billing department

14. Refer to handouts 14

15. Documents required for a thorough analysis: Protocol Schedule of events Contract (may not see until fully executed) Budget ICF CRF All of these documents have to contain consistent language in regards to the payment of protocol procedures 15

16. Step 1: Complete the header information Step 2: Using the protocol, schedule of events, ICF, and CRF (if available) to complete the procedure and visit information 16

17. Step 3: Detail each subject Visit Step 4: Fill in which procedures will be performed at each visit, indicating this with an X Step 5: Determine which of these procedures are paid for by the sponsor and mark with an R 17

18. Step 6: Determine which of the remaining procedures are SOC and mark as B Step 7: If any procedures are uncompensated mark with a U Step 8: If any remaining procedures cannot be determined to fit into any of these categories, leave as X until assigned by the PI 18

19. Step 9: Discuss the Billing Grid with the research team, especially the PI (PI will have the final determination re: the category of billing for each procedure as indicated with his/her signature on the grid) Step 10: Distribute to “ALL” 19

20. 20 Billing Grid Assure Accuracy CommunicationTrack Billing

21. 21