What is an Off-Label ADR Procedure? | Dr. Todd Lanman

The term “off-label procedure” relates to how the FDA approves devices. Every implant must go through a clinical trial, and FDA approval follows a long-term study of each patient who receives the implant. For example, if the study is for one-level disc replacement, the disc will become approved for single-level ADR. 

If a patient requires a three-level disc replacement, for example, it technically becomes considered “off-label” because that’s not the use that was explicitly studied in the trial. Off-label procedures are still allowed, and Dr. Lanman performs successful off-label procedures all the time. 

It also tends to be a technicality that insurance companies lean on to avoid paying for surgeries that their policyholders need.