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Medical Policy: 02.04.30
Original Effective Date: December 2010
Reviewed: November 2011
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Idiopathic scoliosis is a structurally fixed lateral curvature of the spine with rotation of the vertebral bodies with at least a 10 degree curvature as demonstrated on radiographic films and confirmed by measurement of the Cobb angle. The Cobb angle measurement involves 3 steps: locating the superior end vertebra; locating the inferior end vertebra; and, drawing intersecting perpendicular lines from the superior surface of the superior end vertebra and from the inferior surface of the inferior end vertebra. The angle of deviation of the perpendicular lines from a straight line is the angle of the curve. Idiopathic scoliotic curves of more than 10 degrees are estimated to occur in 2% to 3% of children under the age of 16. Once scoliosis is diagnosed the curve must be evaluated for probability of progression. Most authors define progression as an increase of 5 degrees or more determined by the Cobb measurement over 2 or more office visits. Currently there is no proven approach to determining if the progression will continue and what the final curve will be. Some factors have been found to be related to curve progression. Progression is more likely in girls than in boys, double curves are more likely to progress than single curves, and single thoracic curves tend to be more progressive than single lumbar curves. The incidence of curve progression is known to increase with the curve magnitude.
Recently, there has been interest in associating genetic markers with curve progression to identify those at highest risk who may be appropriate candidates for less aggressive monitoring and/or earlier and potentially less invasive intervention strategies. It has been theorized that a prognostic test with an adequately high negative predictive value could change the usual monitoring practice by identifying the majority of patients who will not experience significant curve progression. The ScoliScore™ AIS Prognostic Test (Axial Biotech™, Inc. Salt Lake City, Utah), is a saliva-based genetic test designed to predict the risk of progression of scoliosis. The test is designed for patients diagnosed with mild (10-25 degree Cobb angle) adolescent idiopathic scoliosis (AIS) between the ages of 9 and 13 years of age, and self-reported Caucasian (defined as North American, South American, European, Eastern European, Middle Eastern, Southwest Asian descent). The ScoliScore™ algorithm integrates genotypes for 53 DNA markers and the patient’s presenting Cobb angle. On a scale of 1-200, the resulting score can be interpreted as “low risk” (1-50), “intermediate risk” (51-180), or “high risk” (181-200). According to recent validation studies, low risk scores predict a ≥ 99% probability that the patient’s AIS will not progress to a severe curve. No studies have been published demonstrating an improvement in health outcomes, or that the use of DNA-based predictive testing is at least as or more beneficial than established management of AIS.
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Prior Approval:
Not applicable
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Policy:
The use of DNA-based prognostic tests including, but not limited to, the ScoliScore™ AIS Prognostic Test, to predict spinal curve progression in adolescent idiopathic scoliosis is considered investigational.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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Selected References:
- S. Terry Canale and James H. Beatty, Campbell’s Operative Orthopaedics, 11th ed., Mosby Elsevier, Philadelphia, PA, 2008, Chap 38.
- Cheng JC, Tang NL, Yeung HY et al. Genetic associations of complex traits: using idiopathic scoliosis as an example. Clin Orthop Relat Res 2007; 462:6-10.
- Ward K, Ogilvie J, Argyle V et al. Polygenic inheritance of adolescent idiopathic scoliosis: a study of extended families in Utah. Am J Med Genet A 2010; 152:1178-88.
- Ogilvie J, Braun J, Argyle V et al. The search for idiopathic scoliosis genes. Spine. 2006 Mar 15. 31(6):679-81.
- Ward K, Ogilvie J, Singleton M et al. Validation of DNA-based prognostic testing to predict spinal curve progression in adolescent idiopathic scoliosis. Spine 2010; 35(25):E1455-E1464.
- Sharma S, Gao X, Londono D et al. Genome-wide association studies of adolescent idiopathic scoliosis suggest candidate susceptibility genes. Hum Mol Genet. 2011 Apr 1;20(7):1456-66. Epub 2011 Jan 7.
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Policy History:
Date Reason Action
December 2010 New topic New policy
November 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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