Minimizing Clinical Billing Errors

Most of the human researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.   performed by HSC researchers is conducted in a healthcare setting or uses clinical servicesClinical Servicesinclude clinical care, clinical tests or clinical procedures that are delivered as part of healthcare (i.e. delivered by professional and technical staff in a clinic, hospital, laboratory, research center, etc.).   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 riskBilling RiskThe risk of making clinical billing errors.   , the Clinical Trials Office performs a “Billing Risk Assessment” as part of the initial approval process of all clinical trials and any non- clinical trialClinical Trialone type of Clinical Research that follows a pre-defined plan or protocol. Subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.   that will be using a healthcare organization’s clinical service.

What is needed to complete the billing risk assessment?

• A final protocolProtocolstep-by-step details of how a study will be conducted including objectives, design, procedures, measurements, management and analysis, as well as a discussion of relevant research ethics issues.  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 practiceStandard Practicecare or procedures that are routinely or typically provided absent a research study. (Also called generally accepted practice, routine or conventional care)  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