A recent convening of Alabama BCBS’ Medical Policy Group proposed a positive change to their policy on Minimally Invasive SI Joint Surgery to establish MIS SIJ fusion as medically necessary using an FDA-approved device (not specific to any one device type) when all of the following criteria are met: Pain is at least 5 on a 0 to 10 rating scale that impacts quality of life or limits activities of daily living; AND There is an absence of generalized pain behavior (e.g., somatoform disorder) or generalized pain disorders (e.g., fibromyalgia); AND Patients have undergone and failed a minimum six months of intensive non-operative treatment that must include medication optimization, activity modification, bracing, and active therapeutic exercise targeted at the lumbar spine, pelvis, sacroiliac joint, and […]
The International Society for the Advancement of Spine Surgery released two new statements: one focused on bone graft substitutes and the other examining vertebral augmentation. The bone graft substitute statement outlines historical use and U.S. regulatory pathways for bone grafts, including nonstructural allografts, demineralized bone grafts, cellular-based allografts, synthetic bone grafts, autologous cellular grafts and Class III drug-device combination products. “Bone grafting is an essential part of spinal surgery and ever-evolving science,” concluded the recommendation authors. “With each new advance, one needs to understand the characteristics of material, its mechanism of action, the regulatory pathway by which it came to market and the preclinical and human clinical evidence available on which to base a clinical use decision.” The authors found: Nonstructural cancellous allograft […]
Read the Spring 2019 issue of Vertebral Columns. In this issue: Reevaluating indications for cervical TDA, decreasing hospital stays, MIS options for pelvic fixation, maximizing lordosis, and a review of the literature surrounding PROMIS!
Vertebral Augmentation: Coverage Indications, Limitations, and/or Medical Necessity OLIVIER CLERK-LAMALICE,1 DOUGLAS P. BEALL,2 KEVIN ONG,3 MORGAN P. LORIO4 1Western Canada Pain Institute, Edmonton, Alberta, Canada, 2Clinical Radiology of Oklahoma, Edmond, Oklahoma,3Exponent, Inc., Philadelphia, Pennsylvania, 4Hughston Clinic Orthopaedics—Centennial, Nashville, Tennessee ABSTRACT The ISASS Policy Statement on vertebral augmentation has the objectives to provide a background and an update with the latest clinical evidence for the international spine community. A SpineLine Panel Review (2010) appropriately recommended an exploration of ‘‘the seeming disconnect between the conclusions of . . . two [Level I] PRCT’s and previous experience and data’’ regarding vertebral augmentation. ISASS responded by supporting a comprehensive meta-analysis to help frame a cogent historical analysis of vertebral augmentation. This ISASS Policy 2018 […]