RT Journal Article
SR Electronic
T1 Utilization of Bone-Anchored Annular Defect Closure to Prevent Reherniation Following Lumbar Discectomy: Overcoming Barriers to Clinical Adoption and Market Access
JF International Journal of Spine Surgery
JO Int J Spine Surg
FD International Society for the Advancement of Spine Surgery
SP 8592
DO 10.14444/8592
A1 Morgan P. Lorio
A1 William C. Watters
A1 Betsy H. Grunch
A1 Andrew K. Metzger
A1 Kai-Uwe Lewandrowski
A1 Jon E. Block
A1 Gunnar B.J. Andersson
YR 2024
UL https://www.ijssurgery.com/content/early/2024/04/03/8592.abstract
AB While achieving premarket approval from the US Food and Drug Administration represents a significant milestone in the development and commercialization of a Class III medical device, the aftermath endeavor of gaining market access can be daunting. This article provides a case study of the Barricaid annular closure device (Barricaid), a reherniation reduction device, which has been demonstrated to decrease the risk of suffering a recurrent lumbar intervertebral disc herniation. Following Food and Drug Administration approval, clinical adoption has been slow due to barriers to market access, including the perception of low-quality clinical evidence, questionable significance of the medical necessity of the procedure, and imaging evidence of increased likelihood of vertebral endplate changes. The aim of this article is to provide appropriate examination, rationale, and rebuttal of these concerns. Weighing the compendium of evidence, we offer a definition of a separate and unique current procedural terminology code to delineate this procedure. Adoption of this code will help to streamline the processing of claims and support the conduct of research, the evaluation of health care utilization, and the development of appropriate medical guidelines.