Clinical Research Billing Grid: An Overview of the 3 C s Derita Bran, RN, CCRC Manager, Clinical Trials Operations Tenn

1. Clinical Research Billing Grid: An Overview of the 3 CsDerita Bran, RN, CCRCManager, Clinical Trials OperationsTennessee Clinical Trials Network

2. The 3 C’s • Correct charge • Correct amount • Correct payer

3. Objectives • 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

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

5. So what’s the big deal? Improper billing can lead to false claims

6. Improper Billing • 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

7. Consequences • 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

8. What can we do?

9. Responsibilities • 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

10. Problems You may Face • Complexity of the trial • Procedures • Reimbursement payment • Procedures not associated with a CPT/ICD code

11. GOal Accurate Billing of procedures associated with clinical trials

12. Avoiding billing errors • 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

13. Avoiding billing errors cont’d • 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. Billing Grid Example Refer to handouts

15. Instructions • 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

16. Creating a Billing Grid 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

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

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

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”

20. Billing grid cycle

21. Questions