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DESCRIPTIONOrthotic bracing attempts to slow curve progression and reduce the need for fusion surgery in patients with juvenile or adolescent idiopathic scoliosis who are at high risk of progression. Recently, two fusionless surgical procedures, vertebral body stapling and vertebral body tethering, have been evaluated as an alternative to bracing to slow or correct curve progression in pediatric patients with scoliosis. This policy does not address patients who are not at high risk of progression or conventional fusion surgery for scoliosis in patients with Cobb angles measuring 45° or more.
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. 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 and vertebral body tethering, are being evaluated as alternatives to bracing. Both procedures use orthopedic devices off-label. The goal of these procedures is to unilaterally reduce the rate of spine growth, thus allowing the other side to “catch up.” The mechanism of action is believed to be down-regulation of the growth plate on the convex (outer) side by compression and stimulation of growth on the endplate of the concave side by distraction. In the current stapling procedure, nickel-titanium alloy staples with shape memory are applied to the convex 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. Anterolateral tethering uses polyethylene ligaments that are attached to the convex side of the vertebral bodies by pedicle screws or staples. The ligament can be tightened to provide greater tension than the staple. The optimum degree of tension is not known. The polyethylene ligaments are more flexible than staples and are predicted to allow more mobility of the spine. The goal of a fusionless growth modulating procedure is to improve the curve along with preventing progression, maintain spine mobility following correction, and provide an effective treatment option for patients who are noncompliant or who have a large curve but substantial growth remaining.
Some braces used for the treatment of scoliosis are considered Class I devices by the U.S. Food and Drug Administration (FDA) and are exempt from 510(k) requirements. Examples include the Boston scoliosis brace and the SpineCor® Scoliosis System.
Staples, using a shape memory nickel-titanium alloy, have been cleared for marketing by FDA through the 510(k) process for various bone fixation indications. For example, Nitinol staples (Sofamor Danek, Memphis TN) are indicated for fixation with spinal systems. Other memory shape staples cleared for marketing by FDA through the 510(k) process for bone fixation include the OSStaple™ and the reVERTO™. Vertebral body stapling in scoliosis is considered off-label use. FDA product code: JDR
Related policies -
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 that 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 and vertebral body tethering for the treatment of scoliosis are 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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
This 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.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
08/28/2015: Medical policy revised to add ICD-10 codes. Removed ICD-9 diagnosis code 737.32 from the Covered Codes table in the Code Reference section.
09/17/2015: Policy description updated to include vertebral body tethering as a fusionless surgical procedure. Policy statement revised to add vertebral body tethering as investigational for the treatment of scoliosis. Policy Guidelines section updated to add medically necessary and investigative definitions. Investigational Codes table updated to revise the code description for CPT code 22899 to include vertebral body tethering.
06/01/2016: Policy number A.2.01.83 added.
12/02/2016: Policy description updated regarding fusionless surgical procedures. Policy statements 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.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.