Billing Coverage Analysis

A prospective coverage analysis (CA) is required for all studies that generate a billable event. If the project is determined not to meet the criteria as a Medicare Qualifying Clinical Trial (MQCT), the Principal Investigator will be notified. For qualifying clinical trials, the HRPP Compliance office will create a Billing Grid for Coverage Analysis (BGCA) and the research team will use the BGCA to complete the Billing Compliance Plan. The steps below describe the process for qualifying clinical trials.

  1. The research team will submit required documents (e.g. protocol, funding agreement, informed consent, FDA letter(s)) to the HRPP Compliance office so that a coverage analysis can be performed.
  2. The HRPP compliance office will conduct a coverage analysis for MQCT and create the BGCA so associated items are assigned to the appropriate charge (e.g. routine care that may be charged to insurance; research related that cannot be charged to insurance).
  3. The HRPP Compliance office returns the BGCA/BCP for MQCT to the PI/Study Coordinator after the CA has been conducted. The BGCA/BCP will be password protected and will require the HRPP Compliance office to unlock if needed.
  4. The department or PI can move forward with sponsor negotiations (as applicable) to finalize study budget.
  5. For MQCT, finalized BGCA/BCP may be uploaded in the e-transmittal.
  6. For MQCT, after IRB approvals are in place, the HRPP Compliance office will meet with the research team to discuss clinical regulatory requirements associated with the project. The goal of this meeting is to make researchers aware of the requirements.
  7. The HRPP Compliance office will work closely with MSU HealthTeam as appropriate, and the department to ensure billing compliance and to register the patient as a subject.
  8. The HRPP Compliance office will be notified when the first subject is enrolled, for MQCT to ensure that the billing process is consistent with the Billing Compliance Plan.
  9. The BGCA/BCP will also be used to run audit reports and to review billing claims to ensure research related items are billed appropriately. This review will be done prior to the subject or their insurance being billed.
  10. Post approval monitoring visits will occur to ensure billing compliance.