Assessing Common Challenges in Clinical Research Billing Audits

Ryan Meade
Managing Director, Aegis Compliance & Ethics Center
August 1st, 2013

Clinical Research Billing (CRB) is extremely complex, requiring significant documentation and detailed processes. Performing routine CRB audits is necessary to ensure accuracy and to uncover opportunities for improvement. However, conducting these audits can be challenging, to say the least. Gathering the necessary documents, selecting the patients and choosing the claims to audit can be difficult for many sites.

Gathering Documents

Audits require a considerable amount of documentation such as the clinical trial agreement, funding documents, study calendar, and medical records, to name a few. Unfortunately, these documents are often in many different places, which makes preparing for an audit and long and tedious task.

Selecting Patients

Another common challenge in auditing is patient selection. Before starting an audit, it is important to determine whether it will include a random selection of patients, regardless of how long they have been active in the study, or if it will only include patients who have reached a certain number of visits. With this criteria decided, you must then know where you can find the patient information. Do you have a central database? Or do you need to ask for information from individual departments or physicians?

Choosing Claims

Identifying the claims relevant to the study can be streamlined by having a full study calendar readily available. Because non-study visits are not relevant to CRB audits, knowing which visits were study-related versus which ones were not is crucial to the process. Depending on how the site records patient visits, obtaining this information may require communication from multiple departments.

With a central location to store documents, a complete patient database, as well as visit and financial management tools, a clinical trial management system (CTMS) can be a valuable asset to sites when performing CRB audits. Whether or not you currently utilize a CTMS though, it is important to know exactly how an audit should be performed. 

Compliance and Regulatory

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