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DESCRIPTIONOrthotic bracing attempts to slow curve progression and reduce the need for fusion surgery in patients with progressive scoliosis. Recently, a fusionless surgical procedure, vertebral body stapling, has been evaluated as an alternative to bracing to slow or correct curve progression in pediatric patients with scoliosis.
Scoliosis is an abnormal lateral and rotational curvature of the vertebral column. Treatment of scoliosis currently depends on 3 factors: the cause of the condition (idiopathic, congenital, or secondary), the severity of the condition (degrees of curve), and the growth of the patient remaining at the time of presentation. Children who have vertebral curves measuring between 25° and 40° with at least 2 years of growth remaining are considered to be at high-risk of curve progression. Genetic markers to evaluate risk of progression are also being evaluated. Since severe deformity may lead to compromised respiratory function and is associated with back pain in adulthood, surgical intervention with spinal fusion is typically recommended for curves that progress to 45° or more.
Bracing is used in an attempt to reduce the need for spinal fusion by slowing or preventing further progression of the curve during rapid growth. Commonly used brace designs include the Milwaukee, Wilmington, Boston, Charleston, and Providence orthoses. The longest clinical experience is with the Milwaukee cervical-thoracic-lumbar-sacral orthosis (CTLSO). Thoracic-lumbar-sacral orthoses (TLSO), such as the Wilmington and Boston braces, are intended to improve tolerability and compliance for extended (over 18 hour) wear, and are composed of lighter-weight plastics with a low-profile (underarm) design. The design of the nighttime Charleston and Providence braces is based on the theory that increased corrective forces will reduce the needed wear time (i.e., daytime), thereby lessening social anxiety and improving compliance. The smart brace consists of a standard rigid brace with a microcomputer system, a force transducer and an air-bladder control system to control the interface pressure. Braces that are more flexible than TLSOs or nighttime braces, such as the SpineCor, are also being evaluated. The SpineCor is composed of a thermoplastic pelvic base with stabilizing and corrective bands across the upper body.
Fusionless surgical procedures such, as vertebral body stapling, are being evaluated as an alternative to bracing. It is hoped that fusionless procedures improve the curve as well as prevent its progression, maintain spine mobility following correction, and provide an effective treatment option for patients who are non-compliant or refuse to wear a brace. In the current stapling procedure, nickel-titanium alloy staples with shape memory are applied to the convex (outer) side of the curve. The shape memory allows the prongs to be straight when cooled and clamp down into the bone when the staple returns to body temperature. The goal of vertebral stapling is to unilaterally reduce the rate of spine growth, thus allowing the other side to “catch up”. The memory shape staple was tested in a goat model of scoliosis for safety and efficacy prior to its use in humans. A concern is that stapling spans the flexible discs, and the immobilized discs may be subject to degeneration. The vertical expandable prosthetic titanium rib (VEPTR), described in more detail in the Vertical Expandable Prosthetic Titanium Rib medical policy, is also being explored for treatment of infantile and juvenile scoliosis that has advanced beyond 45°. Use of the VEPTR requires expansion surgery every 4-6 months as growth occurs and may be replaced as needed. Anterolateral tethering and external fixation devices are also being evaluated.
Some of the braces used for the treatment of scoliosis are considered Class I devices by the U.S. Food and Drug Administration (FDA). Examples include the Boston scoliosis brace and the SpineCor® Scoliosis System.
Staples, using a shape memory nickel-titanium alloy, have 510(k) clearance from the FDA for a variety of indications for bone fixation. For example, Nitinol staples (Sofamor Danek, Memphis TN) are indicated for fixation with spinal systems. Other memory shape staples that have 510(k) clearance for bone fixation include the OSStaple™ and the reVERTO™. Vertebral body stapling in scoliosis is considered off-label use. FDA product code: JDR
A VEPTR has received approval from the FDA under a humanitarian device exemption (HDE). The FDA review noted that the device is indicated for the treatment of thoracic insufficiency syndrome (TIS) in skeletally immature patients. This review also indicated that the device should not be used in patients younger than 6 months. Refer to the Vertical Expandable Prosthetic Titanium Rib medical policy for additional information.
Another related medical policy is Vertebral Stapling and Endoscopic Surgery in the Treatment of Scoliosis.
POLICYA cervical-thoracic-lumbar-sacral or thoracic-lumbar-sacral orthosis may be considered medically necessary for the treatment of scoliosis in juvenile and adolescent patients at high-risk of progression which meets the following criteria:
Use of an orthosis for the treatment of scoliosis that does not meet the criteria above is considered investigational.
Vertebral body stapling for the treatment of scoliosis is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESThis policy does not address conventional surgery for scoliosis in patients with curve angles measuring 45° or more. Brace treatment for idiopathic scoliosis is usually recommended for juveniles and adolescents with curves measuring between 25° and 40° who have not completed spinal growth, with maturity defined as Risser 4, or 2 years post-menarche for girls. Bracing may also be recommended for curves over 20° in a patient who has a rapidly progressing curve with more than 2 years of growth remaining.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY07/22/2010: Approved by Medical Policy Advisory Committee
07/29/2011: Policy reviewed; no changes.
07/12/2012: Removed the following policy statement as it is addressed in the Vertical Expandable Prosthetic Titanium Rib policy: Use of the vertical expandable titanium prosthetic rib (with or without expansion thoracoplasty) for the treatment of scoliosis in patients without thoracic insufficiency is considered investigational. Other policy statements unchanged.
08/09/2013: Policy reviewed; no changes.
07/09/2014: Policy reviewed; description updated. Policy statement unchanged.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.01.83
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.