Track Study-Funded Services

Tracking is a legacy study process by which all study-funded services performed are identified and monitored to ensure that these services are not billed to the subject or their insurance.

Each study should have a designated tracking team which must include the study coordinator and the person paying the bills. Excellent communication between study coordinators and fiscal personnel is essential for this process to be effective, and monthly reconciliation of tracking logs is required (see reconciliation section below).

Why Do Study Teams Need to Track?

A study tracking log must be maintained in order to:

  • Monitor all study-funded services associated with the study.
  • Confirm that all services performed have been charged to the appropriate payer (e.g. grant, sponsor, third-party payer).
  • Confirm that all costs associated with the study have only been paid once.
  • Financially protect study participants, investigators and the institution.
  • Ensure compliance with all State and Federal Regulations.
  • Ensure that the study team is following the billing plan.
  • Ensure compliance with UF Health Science Center Policy and Standards.

If a tracking log is not maintained, revenue and/or billing compliance issues may occur. Some examples include:

  • Charges for study-funded services may be billed to patients and/or third-party payers.
  • Invoices may be paid multiple times.
  • Multiple payments may be made for the same service.
  • Payments may be made for services not performed for the study
  • Payments may be made for services for a person who is not a study participant.
  • Professional fees paid by research salary support may be billed to patients or third-party payers in error.
  • Professional fees for non-research services may be incorrectly written off as study services.

What Services Need To Be Tracked?

The tracking team MUST track:

  • All study-funded services that will generate a participant bill. This includes services billed by the UF Health Research Billing Office or outside vendors (e.g. Quest labs).
  • “Reading exception” (e.g., study–only chest X-ray that will be sent to the sponsor for interpretation). In this case, what needs to be verified is that a professional fee was NOT generated.
  • A study physical exam/office visit that an investigator will perform via salary support in a clinic. Again, what needs to be verified is that a professional fee was NOT generated.

If your study has these types of services, it is essential that they are tracked and that the tracking log is sent to the UF Health Research Billing Office on a monthly basis to ensure that fees are not billed to patients or third-party payers in error (see reconciliation below).

Study teams should also be aware of situations where it is possible that an unintended bill will be generated by a study service. Some examples are:

  •  A test/assessment provided by the study coordinator or other study team member in a clinic where that type of test/assessment is billable. (e.g., an ECG, walk test).
  • A billable service that the study team performs and does not plan to enter into the billing system.
  • Study-funded laboratory testing that is mistakenly placed on a participant’s billable account, then later moved to a study-funded account. (For example, when a lab charge is originally placed on a billable account, both a technical fee AND a professional fee may be generated. If the correction is only made to the technical fee, the professional fee may still stay on the patient’s billable account, which is then billed out in error.)

These potentially billable items can pose a high risk for billing errors. Study teams, charge entry and billing personnel must understand the billing plan and carefully follow correct clinic/ancillary procedures to ensure that these situations do not create unintended bills.

What Data Should Be Tracked?

The tracking log should include the following information:

  • Study identification (i.e. study title, PI, R99 number, study project number).Expected service time points (i.e. “screening”, “visit 1”, “end of study”).
  • Names of items/services.*
  • Service/CPT codes.
  • Anticipated pricing.
  • Responsible payer(s).
  • Participant names and medical record numbers.
  • Date that each study-funded service was actually provided (i.e. scheduled visits, admissions.)
  • Service providers/locations.
  • Invoice numbers and dates.
  • Payment information (i.e. voucher numbers, payment amounts, payment dates).
  • Explanations for special circumstances.

* If the study includes bundled services/items (e.g., technical services billed based on an inpatient DRG) which generate professional fee bills, these items/services should be listed separately on the tracking log (e.g., “CT scan of abdomen/pelvis”, “lab testing”).

When Should Study Data Be Entered?

  • Study identification data should be pre-filled into the study-specific tracking log. Note: This should be done prior to study start-up during a face-to-face meeting with all tracking team members. The study billing grid and tracking log should be reviewed and discussed so that all tracking team members understand the study billing and tracking plan.
  • Participant identification data should be entered by the study coordinator as each participant is enrolled.
  • Service data should be entered by the study coordinator immediately after a participant’s study visit.
  • Invoice data should be entered as soon as each invoice is received.
  • Payment data should be entered as each payment is made.

What Format Should I Use for a Tracking Log?

As long as your tracking system creates a log that has the data elements mentioned above, you may use it for tracking. Most study teams choose to track using an Excel file on a shared drive. The Office of Clinical Research (OCR) has a customizable Tracking Log Template which includes the required data elements.

What is Reconciliation?

At least once a month, the study tracking team should perform an internal reconciliation of the tracking log. The team should compare the study-funded services performed to the study invoices received to ensure that:

  • All study-funded services have been recorded in the tracking log.
  • All invoices have been received for those services.
  • The invoices received are for services that actually belong to the study.

If there are any missing or incorrect items, send the most updated tracking log to the UF Health Research Billing Office as soon as these problems are identified:

Reminder: If the study includes potentially billable services (see What Services Need To Be Tracked above), the study team should send the tracking log to the UF Health Research Billing Office any month that a potentially billable service was rendered, so that these offices can confirm that no unintended bill was generated.