A Coverage Analysis is a systematic review of all procedures detailed in the study protocol to determine:
To conduct a coverage analysis, a thorough review of all study documents, clinic procedures, and national guidelines must be performed. At UTHealth, this starts with the billing risk review by the Clinical Research Finance and Administration (CRFA) team. Each week, the CRFA team reviews all protocols submitted to the Institutional Review Board from the prior week. While reviewing the protocol, CRFA analyzes the schedule of activities to determine if any activity could generate a charge in the clinical billing system. If a study has an activity that could generate a bill, it is designated as a billing risk.
After identifying a billing risk, the CRFA team then builds out the schedule of events in the Coverage Analysis and Budget tool. The CRFA team will identify which visit each activity occurs during this build out. The CRFA team will then email the Coverage Analysis skeleton to the department administrator who will work with the Principal Investigator to determine the location where each procedure will be done and whether that procedure is standard of care or research for that visit. For all items that are determined to be standard of care, the department must provide a justification referencing a national guideline or peer reviewed publication which indicates that the activity is adequate and necessary in the treatment of the patient’s condition.
Once this information has been completed by the department, they will submit the Coverage Analysis along with the signed answers to the Qualifying Questions and Billing Certification Form to the CRFA team for final review and approval. If the CRFA team has any questions or comments, they will work with the department to get to a final Coverage Analysis that is acceptable to both parties. CRFA team will then send the final Coverage Analysis to the Committee for Protection of Human Subjects for upload into iRIS, create the necessary EG billing accounts in GE Centricity, and notify Memorial Hermann of the completed Coverage Analysis (when necessary).
In the terms of the UTHealth Coverage Analysis, standard of care activities are those which the patient would receive regardless of their participation in the study, while research costs are those that being performed outside of this. Another way to think about the difference, is whether or not your normal clinic practice is changing to accommodate the service or procedure. In addition, any activities which are promised as free of charge in the Informed Consent Form automatically become research costs.
Helpful websites for standard of care vs research: