Q&A: Conducting a retrospective charge segregation review

Wednesday, July 17, 2019

Q: What are the pros and cons of conducting a 100% retrospective charge segregation review for clinical trial claims?

A: The configuration of the research module in the organization’s EHR and the level of risk tolerated by the organization will drive the charge segregation process. The institution’s risk tolerance may vary depending on factors such as the number and type of trials in the health systems’ trial portfolio and past experiences with the research team and their compliance with charging policy. Past bad actors generally earn their higher spot on the risk continuum. Another factor could be the number of trained staff available to review the charges and segregate them. A 100% retrospective charge segregation review allows for the most risk avoidance. It requires all charges to route to a designated location for 100% retrospective review, which is also known as 100% charge segregation. For our current purposes, we will call the designated location “research work queues” (WQ). These WQs are designed to allow the responsible party to categorize or bucket the charges into the three billing categories:

  • Related to the trial, billable to study participant and/or insurance
  • Related to the trial, billable to the trial sponsor
  • Unrelated to the trial, billable to study participant and/or insurance; services rendered to medically treat the patient


This approach is the most labor intensive but, from an internal control perspective, also constitutes the strongest billing error prevention control. This approach relies on an actual person to route the charges to the appropriate bucket, and that provides an advantage because humans can detect nuance when sorting charges into research-related or patient care buckets. There are some disadvantages, however, such as delays in claims processing and cash flow. With a 100% retrospective review, the sheer volume of charges that needs to be reviewed can be overwhelming for even a small research enterprise. However, this approach provides the organization with significant risk mitigation by requiring all charges related to study participants to be held in a WQ until the centralized team can review them. Lastly, human error is a risk with this approach. To reduce this risk, many organizations couple the 100% retrospective review with a monitoring plan.

Editor’s note: For more information see The Practical Guide to Clinical Trials Billing.