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Adolescent idiopathic scoliosis (AIS) is the most common pediatric spinal deformity, affecting 1 to 3% of adolescents. This disease, of unknown etiology, occurs in otherwise healthy children with the onset of, and highly correlated with, the adolescent growth spurt. The vertebrae become misaligned such that the spine deviates from the midline laterally and becomes rotated axially. Deviation can occur anteriorly (a lordotic deviation), posteriorly (a kyphotic deviation), or laterally. Although AIS affects females and males in a nearly 1:1 ratio, progression to severe deformity occurs more often in females. Because the disease can have rapid onset and produce considerable morbidity, school screenings have been recommended. However, screening remains somewhat controversial, with conflicting guidelines supporting this practice or alternatively suggesting insufficient evidence for this.
Diagnosis is established by radiologic observation in adolescents (age 10 years until the age of skeletal maturity) of a lateral spine curvature of 10 degrees or more, as measured using the Cobb angle. The Cobb angle is defined as the angulation measured between the maximally tilted proximal and distal vertebrae of the curve. Curvature is considered mild (less than 25º), moderate (25º to 40º), or severe (more than 40º) in a patient still growing. Once diagnosed, patients must be monitored over several years, usually with serial radiographs for curve progression. If the curve progresses, spinal bracing is the generally accepted first-line treatment. If the curve progresses in spite of bracing, spinal fusion may be recommended.
Curve progression has been linked to a number of factors, including sex, curve magnitude, patient age and skeletal maturity. Risk tables have been published by Lonstein and Carlson and Peterson and Nachemson to help in triage and treatment decision making about patients with AIS. Tan and colleagues recently compared a broad array of factors and concluded that using 30º as an endpoint, initial Cobb angle magnitude produces the best prediction of progression outcome.
The familial nature of this disease was noted as early as 1968. About one-quarter of patients report a positive family history of disease, and twin studies have consistently supported shared genetic factors. Genome-wide linkage studies have reported multiple chromosomal regions of interest, often not replicated. Ogilvie has recently suggested AIS is a complex polygenic trait. He and colleagues at Axial Diagnostics have published a study evaluating an algorithm using 53 SNP markers identified from unpublished genome-wide association studies to identify patients unlikely to exhibit severe progression in curvature versus those at considerable risk for severe progression. The clinical validity of this assay has recently been reported in a retrospective case control cohort study using this algorithm.
The ScoliScore™ AIS prognostic DNA-based test (Transgenomic, Omaha, NE), which uses an algorithm incorporating results of testing for 53 SNPs, along with the patient’s presenting spinal curve (Cobb angle), to generate a risk score (range, 1-200), can be used qualitatively or quantitatively to predict the likelihood of spinal curve progression. The test is intended for white (Caucasian) patients, aged 9 to 13 years, with a primary diagnosis of AIS with a mild scoliotic curve (defined as <25°).
The ScoliScore™ AIS prognostic DNA-based test (originally developed by Axial Biotech, Salt Lake City, UT; test rights acquired by Transgenomic in 2013) has not been approved or cleared by the U.S Food and Drug Administration (FDA), but is being offered as a laboratory-developed test. The laboratory performing this test is accredited by the Centers for Medicare and Medicaid under the Clinical Laboratory Improvement Amendments of 1988.
Related medical policies are –
POLICYDNA-based prognostic testing for adolescent idiopathic scoliosis is considered investigational.
POLICY GUIDELINESInvestigative 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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/17/2011: Approved by Medical Policy Advisory Committee.
09/27/2012: Policy reviewed; no changes.
01/14/2013: Added the following new 2013 CPT codes to the Code Reference section: 81479.
11/06/2013: Policy reviewed; no changes.
09/03/2014: Policy reviewed; description updated. Policy statement unchanged. Removed deleted CPT codes 83891, 83898, 83903, and 83912 from the Code Reference section.
07/13/2015: Code Reference section updated for ICD-10.
11/03/2015: Policy description updated regarding tests. Policy statement unchanged. Investigative definition updated in policy guidelines section.
06/06/2016: Policy number added.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.04.74
This may not be a comprehensive list of procedure codes applicable to this policy.
Unlisted molecular pathology procedure