Medical Necessity Determination for Vertebral Body Tethering
Vertebral body tethering (VBT) is NOT medically indicated for this patient because the procedure is considered unproven/investigational by established criteria, and the patient meets clear indications for the gold standard treatment of posterior spinal fusion given his 50-degree curve and skeletal immaturity. 1, 2
Determination: NOT MEDICALLY NECESSARY
The requested procedure (CPT 0657T, 22899) does not meet medical necessity criteria for the following reasons:
Primary Rationale - Unproven Status
VBT is explicitly classified as unproven by MCG criteria because the effectiveness of this approach has not been established through sufficient high-quality evidence. 3, 4
The procedure remains investigational with significantly greater variability in outcomes compared to posterior spinal fusion, which is the established gold standard. 3
While recent case series show promising correction rates up to 70%, these are retrospective studies with limited long-term follow-up, not the level of evidence required to establish a procedure as proven. 3, 4
Clinical Criteria Analysis
This patient clearly meets surgical thresholds for PROVEN intervention:
50-degree thoracolumbar curve exceeds the 45-50 degree threshold where surgical intervention is indicated for skeletally immature patients. 1, 2
At 14 years old with ongoing growth potential, curves >20 degrees have progression likelihood exceeding 70%, and this patient's 50-degree curve has substantial risk of continued progression. 1, 5
Two years of bracing compliance (22 hours daily) demonstrates failure of conservative management to prevent progression to surgical thresholds. 1
Complication Profile Concerns
VBT carries a significantly different and concerning complication profile:
Overall complication rate of 23% in meta-analysis, with tether breakage occurring in 21.9% of cases. 4
Overcorrection occurs in 11% of cases, requiring additional intervention. 6
Spinal fusion conversion rate of 7.2%, meaning patients may ultimately require the standard procedure anyway after experiencing VBT complications. 4
Approach-related pulmonary complications occur in 3% of cases. 6
Standard of Care Alternative
Posterior spinal fusion with instrumentation is the appropriate medically necessary procedure:
This is the established standard surgical approach for curves exceeding 45-50 degrees in skeletally immature patients. 1, 2
Bone grafting (allograft and/or autograft) achieves solid arthrodesis with predictable outcomes. 1, 2
Long-term outcomes and effectiveness are well-established through decades of evidence. 3
Pre-Surgical Requirements
Before ANY surgical intervention, the following evaluation is mandatory:
MRI of the complete spine must be obtained to rule out neural axis abnormalities, particularly given this is a thoracolumbar curve pattern. 7, 1, 2
Neural axis abnormalities occur in 2-4% of adolescent idiopathic scoliosis patients and can include Chiari I malformation, cord syrinx, cord tethering, or intrinsic spinal cord tumor. 7, 5
Detection of these anomalies before surgery may significantly influence surgical management and outcomes. 7, 2
Critical Pitfalls to Avoid
Do not pursue unproven procedures when established effective treatments exist - this patient has a clear indication for posterior spinal fusion, which has predictable outcomes and established long-term safety. 1, 3
Do not assume VBT is "less invasive" without considering the 23% complication rate and 7.2% conversion to fusion rate - patients may end up with multiple surgeries rather than one definitive procedure. 4
Do not proceed with any surgical intervention without pre-operative MRI - neural axis abnormalities must be ruled out before surgical planning. 7, 1, 2
Recommended Course of Action
Approve posterior spinal fusion with instrumentation (standard CPT codes for spinal fusion, not VBT codes) contingent on:
Pre-operative MRI of complete spine without contrast to evaluate for neural axis abnormalities. 7, 1, 2
Confirmation of skeletal immaturity status (Risser stage) to optimize surgical timing. 1
Standard pre-operative medical clearance appropriate for major spinal surgery. 2
Deny vertebral body tethering (CPT 0657T, 22899) as investigational/unproven per MCG criteria and lack of established effectiveness compared to standard surgical treatment. 3, 4