Billing

The Billing Plan

The Billing Plan should be viewed as a regulatory document. Your study may be audited against the billing plan for compliance. Thus, it should be kept readily available for the research nurse or coordinator to follow when subjects are seen. If you deviate from your billing plan, you will need proper documentation.  For example, if bloodwork is ordered by the subject's provider for routine care, and it can be used in place of bloodwork ordered specifically for the study you can bill that procedure as routine care and use the information for both routine and research, rather than do the procedure twice or bill it as pure research. You just need to assure that documentation is available in the physician notes to substantiate that the test/procedures were requested out of medical necessity.

Creating the Billing Plan (See flowchart for detailed directions)

To create your Billing Plan, you will need to take information directly from the protocol’s schedule of events. You must list all billable clinical procedures that are required for the study, and the time points these procedures are done. If a procedure is going to be billed as routine care (i.e. the subject’s third party payer) it should be coded as “RC” in the Billing Plan. If a procedure is going to be billed directly to the study, it is considered to be charged as “pure research” and should be coded “PR.”  In some instances, certain tests would need to be ordered at a higher frequency that would normally occur in clinical practice. In these cases you need to determine or make a “best guess” as to how those procedures should be billed. Keeping your protocol visits in mind, you would need to decide when those tests would most likely be warranted as part of routine care and when they would really only be done for the study. Only those tests done for study, not routine care, would be billed as PR. You will also need to check the CTA and the Informed Consent Form for any specific billing information. If the CTA states that the sponsor will be paying for a specific test or procedure, DO NOT list that procedure in your billing plan as RC. It would be coded as PR. If the Informed Consent Form states that a test or procedure will be free, it should be coded as PR. If a lab test will be sent to a central lab, do not list it in the Billing Plan.  There is a check box at the bottom right of the Billing Plan to check off if a central lab will be involved.