Minimizing Clinical Billing Errors

Most of the human research performed by HSC researchers is conducted in a healthcare setting or uses clinical services at healthcare organizations to perform certain procedures (e.g., radiology/imaging, laboratory testing, clinical support staff). 

Depending on the nature of the study, the clinical services can be billed to either the participant’s healthcare insurance or must be paid by the research.  It is important to determine the appropriate payor for each study procedure before the study begins to avoid making clinical billing errors (“billing risk”).

To minimize billing risk, the Clinical Trials Office performs a “Billing Risk Assessment” as part of the initial approval process of all clinical trials and any non-clinical trial that will be using a healthcare organization’s clinical service.

What is needed to complete the billing risk assessment?

  • A final protocol detailing the study procedures
  • The budget section of the grant or contract, if external funded.

The CTO will create a Research Coverage Analysis that contains a complete list of study procedures, which are considered standard practice or research driven, how often each is performed, who and where they will be performed, and which will be paid for by the research and which can be billed to insurance.

The Research Coverage Analysis is critical to the approval process.  The information contained in the RCA is also used:

  • as part of the IRB & Institutional approval application
  • to negotiate agreements with service providers (e.g., affiliate hospitals, radiology)
  • to develop and negotiate a study budget
  • when processing patient charges in EPIC