CLINICAL RESEARCH

BILLING GRID:

AN OVERVIEW OF THE 3 CS

DERITA BRAN, RN, CCRCMANAGER, CLINICAL TRIALS OPERATIONSTENNESSEE CLINICAL TRIALS NETWORK 1

THE 3 C’S

• Correct charge

• Correct amount

• Correct payer

2

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 3

PAYMENTS

4

• Study Procedures can be paid by:

• Sponsors

• 3rd Party Payers:• Private Insurance• Medicare• Medicaid

• Study Procedures are not being reimbursed

SO WHAT’S THE BIG DEAL?

5

Improper billing can lead to false claims

Improper Billing

False ClaimsPenalties

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

6

CONSEQUENCESConsequences 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

operations7

WHAT CAN WE DO?

8

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

9

PROBLEMS YOU MAY FACE • Complexity of the trial

• Procedures

• Reimbursement payment

• Procedures not associated with a CPT/ICD code

10

GOAL

11

Accurate Billing of procedures associated with clinical trials

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 12

AVOIDING BILLING ERRORS

CONT’D

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

BILLING GRID EXAMPLE

Refer to handouts

14

INSTRUCTIONSDocuments 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

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

16

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

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

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

BILLING GRID CYCLE

20

Billing Grid

Assure Accuracy

Communication

Track Billing

QUESTIONS

21