Q&A: Reporting charges for substituted clinical trial drugs

Q: If a patient participating in a clinical trial is allergic to one of the drugs used in the trial, how do we report the drug that is used as a substitute? Are we allowed to charge for this? Is the prescribing and substitution considered part of the clinical trial or routine patient care?

A: At times, it can be difficult to tell whether a given patient care situation is trial-related. These situations are referred to as point-of-care decisions, and they represent circumstances that cannot be predicted when creating the billing intention and study calendar. An example may be a decision to substitute a drug for a patient who is allergic to the trial’s listed antiemetic. The original drug would be reported as a research-related routine cost. The substitute drug is also considered a research-related routine cost, but because it was not described as part of the trial, it won’t be included in the study calendar. When making such point-ofcare decisions, the clinician must decide whether the item or service will be related to the trial, unrelated to the trial, or an item or service for which the trial sponsor will pay.

There’s much confusion about how to report these deviations from the trial documentation. The best practice in these scenarios is for the revenue cycle team to ask questions of the PI, reach out to the trial’s study team, and be as consistent as possible when handling these scenarios. Communication is key through the life of a trial and is especially important in these types of disputes.

For more information, see The Practical Guide to Clinical Trials Billing.