MEDICAL POLICY 12.04.74

DNA-Based Testing for Adolescent Idiopathic Scoliosis

BCBSA Ref. Policy: 2.04.74

Effective Date: May 1, 2018

Last Revised: April 3, 2018

Replaces: 2.04.74

RELATED MEDICAL POLICIES:

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POLICY CRITERIA | CODING | RELATED INFORMATION

EVIDENCE REVIEW | REFERENCES | HISTORY

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Introduction

Scoliosis is a condition in which the spine abnormally curves to the side. The abnormal curving

starts for no known reason (it is idiopathic), and usually begins in adolescence. The curve may

be mild or severe, but most of the time it is not painful and does not cause any problems.

However, if the curve becomes severe it can put pressure on the lungs and heart. This can make

it harder to breathe and affect how well the heart can pump blood. Severe curvature may need

to be corrected with surgery.

A genetic test (ScoliScore) has been developed that is supposed to predict whether a childs

mild to moderate scoliosis will become severe. Medical studies have not shown that this test is

effective or helpful in managing patients. For this reason, genetic testing for idiopathic scoliosis

is considered to be unproven (investigational).

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The

rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for

providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can

be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a

service may be covered.

Page | 2 of 10

Policy Coverage Criteria

Testing Investigational Testing for adolescent

idiopathic scoliosis

DNA-based prognostic testing for adolescent idiopathic

scoliosis is considered investigational.

Coding

Note: The ScoliScore AIS (adolescent idiopathic scoliosis) prognostic DNA-based test is a

saliva-based genetic test designed to predict the risk of progression of scoliosis in patients with

AIS. The provider is Axial Biotech, Salt Lake City, UT (aka, Transgenomic, Omaha, NE).

Code Description

CPT 0004M Scoliosis, DNA analysis of 53 single nucleotide polymorphisms (SNPs), using saliva,

prognostic algorithm reported as a risk score

81599 Unlisted multianalyte assay with algorithmic analysis

Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS

codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).

Related Information

Genetic Counseling

Experts recommend formal genetic counseling for patients who are at risk for inherited

disorders and who wish to undergo genetic testing. Interpreting the results of genetic tests and

understanding risk factors can be difficult for some patients. Genetic counseling helps

individuals understand the impact of genetic testing, including the possible effects the test

results could have on the individual or their family members. It should be noted that genetic

counseling may alter the utilization of genetic testing substantially and may reduce

inappropriate testing; further, genetic counseling should be performed by an individual with

experience and expertise in genetic medicine and genetic testing methods.

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Benefit Application

These pathology tests are commercially available only at a single reference laboratory,

Transgenomic.

Evidence Review

Description

Adolescent idiopathic scoliosis (AIS) is a disease of unknown etiology that causes mild-to-severe

spinal deformity in approximately 1% to 3% of adolescents. While there is controversy about the

value of screening and treatment, patients are frequently closely followed once they have been

diagnosed. In cases with significant progression of curvature, both medical (bracing) and

surgical (spinal fusion) interventions are considered. The ScoliScore AIS prognostic DNA-based

test uses an algorithm incorporating results of testing for 53 single-nucleotide variants (SNVs),

along with the patients presenting spinal curve (Cobb angle), to generate a risk score (range, 1-

200). This score can be used qualitatively or quantitatively to predict the likelihood of spinal

curve progression.

Background

Adolescent Idiopathic Scoliosis

Adolescent idiopathic scoliosis (AIS) is the most common pediatric spinal deformity, affecting

1% to 3% of adolescents.1 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 laterally in a C or S shape. 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 a rapid onset and produce considerable

morbidity, school screenings have been recommended. However, screening remains somewhat

controversial, with conflicting guidelines supporting and not supporting this practice..

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Diagnosis

Diagnosis is established by radiologic observation in adolescents (age 10 years until the age of

skeletal maturity) of a lateral spine curvature of 10 or more, as measured using the Cobb

angle.2 The Cobb angle is defined as the angle measured between the maximally tilted proximal

and distal vertebrae of the curve. The curvature is considered mild (40) in a patient who is still growing. Once diagnosed, patients must be monitored over

several years, usually with serial radiographs, for curve progression.

Treatment

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, by Lonstein and Carlson (1984)3 and Peterson and

Nachemson (1995)4, help in triage and treatment decision making about patients with AIS. Tan

et al. (2009) compared a broad array of factors and concluded that Initial Cobb angle

magnitude is the most important predictor of long-term curve progression and behavior past

skeletal maturity. Additionally, they suggest that an initial Cobb angle of 25 (was) an

important threshold magnitude for long-term curve progression.5

Genetic Associations and Scoliosis

The familial nature of this disease was noted as early as 1968.6 About one-quarter of patients

report a positive family history of disease, and twin studies have consistently supported shared

genetic factors.1 Genome-wide linkage studies have reported multiple chromosomal regions of

interest, often not replicated. Ogilvie (2010) has suggested AIS is a complex polygenic trait.7

Ogilvie et al published a study evaluating an algorithm using 53 single-nucleotide variants (SNV)

markers identified from unpublished genome-wide association studies (GWAS) in order to

differentiate patients unlikely to exhibit severe progression in curvature from those at

considerable risk for severe progression. The clinical validity of this assay has recently been

reported in a 2010 retrospective case-control cohort study using this algorithm.2

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ScoliScore AIS

The ScoliScore AIS prognostic DNA-based test (Transgenomic), uses an algorithm incorporating

results of testing for 53 SNVs, along with the patients presenting spinal curve (Cobb angle), to

generate a risk score (range, 1-200) that can be used qualitatively or quantitatively to predict the

likelihood of spinal curve progression. The test is intended for Caucasian patients, aged 9 to 13

years, with a primary diagnosis of AIS with a mild scoliotic curve (defined as

Page | 6 of 10

progression. Studies have identified additional SNVs that may be associated with AIS severity,

but these associations have not been reliably replicated. The clinical validity of DNA-based

testing (either through testing of individual SNVs or an algorithm incorporating SNV results) for

predicting scoliosis progression in patients with AIS has not been established.

There is no direct evidence demonstrating that use of this test results in changes in

management that improve outcomes. The value of early identification and intervention(s) for

people at risk for progression of disease and whether laboratory testing improves disease

identification beyond clinical evaluation are unknown. The evidence is insufficient to determine

the effects of the technology on health outcomes.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this policy are listed in Table 1.

Table 1. Summary of Key Trials

NCT No. Trial Name Planned

Enrollment

Completion

Date

Unpublished

NCT01776125 Genetic Evaluation for the Scoliosis Gene(s) in Patients

With Neurofibromatosis 1 and Scoliosis

100 Aug 2015

(completed)

NCT: national clinical trial.

Clinical Input Received from Physician Specialty Societies and Academic

Medical Centers

While the various physician specialty societies and academic medical centers may provide

appropriate reviewers who collaborate with and make recommendations during this process,

input received does not represent an endorsement or position statement by the physician

specialty societies or academic medical centers, unless otherwise noted.

In response to requests, input was received from 2 specialty societies and 4 academic medical

centers while this policy was under review in 2012. All agreed with this policy and indicated that

DNA-based prognostic testing for AIS (ScoliScore) should be considered investigational.

https://www.clinicaltrials.gov/ct2/show/NCT01776125?term=NCT01776125&rank=1

Page | 7 of 10

Practice Guidelines and Position Statements

In 2011, the International Scientific Society on Scoliosis Orthopaedic and Rehabilitation

Treatment issued guidelines on the conservative treatment of idiopathic scoliosis.22 These

guidelines do not address the role of DNA-based prognostic testing.

U.S. Preventive Services Task Force Recommendations

In 2004, the U.S. Preventive Services Task Force (USPSTF) recommended against the routine

screening of asymptomatic adolescents for idiopathic scoliosis (Grade D Recommendation).23

This recommendation is currently being updated. No USPSTF recommendations for DNA-based

testing for AIS were identified.

Medicare National Coverage

There is no national coverage determination (NCD). In the absence of an NCD, coverage

decisions are left to the discretion of local Medicare carriers.

Regulatory Status

Clinical laboratories may develop and validate tests in-house and market them as a laboratory

service; laboratory-developed tests (LDTs) must meet the general regulatory standards of the

Clinical Laboratory Improvement Amendments (CLIA). Laboratories that offer LDTs must be

licensed by CLIA for high-complexity testing. To date, the U.S. Food and Drug Administration

has chosen not to require any regulatory review of this test.

References

1. Weinstein SL, Dolan LA, Cheng JC, et al. Adolescent idiopathic scoliosis. Lancet. May 3 2008;371(9623):1527-1537. PMID

18456103

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2. Ward K, Ogilvie JW, Singleton MV, et al. Validation of DNA-based prognostic testing to predict spinal curve progression in

adolescent idiopathic scoliosis. Spine (Phila Pa 1976). Dec 1 2010;35(25):E1455-1464. PMID 21102273

3. Lonstein JE, Carlson JM. The prediction of curve progression in untreated idiopathic scoliosis during growth. J Bone Joint Surg

Am. Sep 1984;66(7):1061-1071. PMID 6480635

4. Peterson LE, Nachemson AL. Prediction of progression of the curve in girls who have adolescent idiopathic scoliosis of

moderate severity. Logistic regression analysis based on data from The Brace Study of the Scoliosis Research Society. J Bone

Joint Surg Am. Jun 1995;77(6):823-827. PMID 7782354

5. Tan KJ, Moe MM, Vaithinathan R, et al. Curve progression in idiopathic scoliosis: follow-up study to skeletal maturity. Spine

(Phila Pa 1976). Apr 1 2009;34(7):697-700. PMID 19333102

6. Wynne-Davies R. Familial (idiopathic) scoliosis. A family survey. J Bone Joint Surg Br. Feb 1968;50(1):24-30. PMID 5641594

7. Ogilvie J. Adolescent idiopathic scoliosis and genetic testing. Curr Opin Pediatr. Feb 2010;22(1):67-70. PMID 19949338

8. BLL Partners LLC. Transgenomic Finalizes Divestment of its Genetic Assays & Platforms Business Unit. 2015;

https://www.sec.gov/Archives/edgar/data/1043961/000114420415068699/v425907_ex99-1.htm Accessed April 2018.

9. Bloomberg. Life Sciences Tools and Services: Company Overview of Transgenomic, Inc. 2017;

https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=416660 Accessed April 2018.

10. Roye BD, Wright ML, Matsumoto H, et al. An independent evaluation of the validity of a DNA-based prognostic test for

adolescent idiopathic scoliosis. J Bone Joint Surg Am. Dec 16 2015;97(24):1994-1998. PMID 26677232

11. Roye BD, Wright ML, Williams BA, et al. Does ScoliScore provide more information than traditional clinical estimates of curve

progression? Spine (Phila Pa 1976). Dec 1 2012;37(25):2099-2103. PMID 22614798

12. Bohl DD, Telles CJ, Ruiz FK, et al. A genetic test predicts providence brace success for adolescent idiopathic scoliosis when

failure is defined as progression to >45 degrees. Clin Spine Surg. Apr 2016;29(3):E146-150. PMID 27007790

13. Tang QL, Julien C, Eveleigh R, et al. A replication study for association of 53 single nucleotide polymorphisms in ScoliScore test

with adolescent idiopathic scoliosis in French-Canadian population. Spine (Phila Pa 1976). Apr 15 2015;40(8):537-543. PMID

25646748

14. Xu L, Huang S, Qin X, et al. Investigation of the 53 markers in a DNA-based prognostic test revealing new predisposition genes

for adolescent idiopathic scoliosis. Spine (Phila Pa 1976). Jul 15 2015;40(14):1086-1091. PMID 25811265

15. Xu L, Qin X, Sun W, et al. Replication of association between 53 single-nucleotide polymorphisms in a DNA-based diagnostic

test and AIS progression in Chinese Han population. Spine (Phila Pa 1976). Feb 2016;41(4):306-310. PMID 26579958

16. Ogura Y, Takahashi Y, Kou I, et al. A replication study for association of 53 single nucleotide polymorphisms in a scoliosis

prognostic test with progression of adolescent idiopathic scoliosis in Japanese. Spine (Phila Pa 1976). Jul 15 2013;38(16):1375-

1379. PMID 23591653

17. Noshchenko A, Hoffecker L, Lindley EM, et al. Predictors of spine deformity progression in adolescent idiopathic scoliosis: A

systematic review with meta-analysis. World J Orthop. Aug 18 2015;6(7):537-558. PMID 26301183

18. Sharma S, Gao X, Londono D, et al. Genome-wide association studies of adolescent idiopathic scoliosis suggest candidate

susceptibility genes. Hum Mol Genet. Apr 1 2011;20(7):1456-1466. PMID 21216876

19. Fendri K, Patten SA, Kaufman GN, et al. Microarray expression profiling identifies genes with altered expression in adolescent

idiopathic scoliosis. Eur Spine J. Jun 2013;22(6):1300-1311. PMID 23467837

20. Jiang J, Qian B, Mao S, et al. A promoter polymorphism of tissue inhibitor of metalloproteinase-2 gene is associated with

severity of thoracic adolescent idiopathic scoliosis. Spine (Phila Pa 1976). Jan 1 2012;37(1):41-47. PMID 21228746

21. Qiu Y, Mao SH, Qian BP, et al. A promoter polymorphism of neurotrophin 3 gene is associated with curve severity and bracing

effectiveness in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). Jan 15 2012;37(2):127-133. PMID 22158057

22. Negrini S, Aulisa AG, Aulisa L, et al. 2011 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis

during growth. Scoliosis. Jan 20 2012;7(1):3. PMID 22264320

https://www.sec.gov/Archives/edgar/data/1043961/000114420415068699/v425907_ex99-1.htmhttps://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=416660

Page | 9 of 10

23. U.S. Preventive Services Task Force (USPSTF). Idiopathic Scoliosis in Adolescents: Screening. 2004;

https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/idiopathic-scoliosis-in-

adolescents-screening Accessed April 2018.

History

Date Comments 10/11/11 New Policy Add to Pathology/Laboratory section. Policy created with literature

search through June 2011; considered investigational.

05/24/12 Policy renumbered to 12.04.74 (previously 2.04.74) and reassigned to new Genetic

Testing category.

10/26/12 Replace policy. Rationale section revised based on literature review through June 2012

and results of clinical vetting. Reference 9 added. ICD-10 codes are now effective

10/01/2014. Code 83912 added. Policy statement unchanged.

01/14/13 Coding update. CPT codes 83890 83913 deleted as of 12/31/12; CPT codes 81200

81479 and 81599, effective 1/1/13, are added to the policy.

05/14/13 Update Related Policies. Add 12.04.91.

07/12/13 Coding update. MAAA code 0004M added to the policy.

09/27/13 Replace policy. Policy updated with literature review through 6/18/13; reference 9

added; policy statement unchanged.

07/23/14 Update Related Policies. Remove 12.04.91.

09/08/14 Annual Review. Policy updated with literature review through June 6, 2014; references

11-15 added. No change to policy statement.

09/08/15 Annual Review. Added to the Appendix, Table 1. Categories of Genetic Testing

Addressed in This Policy. Policy updated with literature review through June 1, 2015;

reference 11 added. Policy statement unchanged.

11/01/16 Annual Review, approved October 11, 2016. Policy updated with literature review

through September 15, 2016; reference 18 added. No change to policy statement.

04/01/17 Annual Review, approved March 14, 2017. Policy updated with literature review

through November 7, 2016; references 9, 11, and 13-14 added. Removed Appendix

table. Policy statement unchanged.

09/22/17 Policy moved into new format. No changes to policy statements.

05/01/18 Annual Review, approved April 3, 2018. Policy updated with literature review through

November 2017; references 8-9 added; note 22 updated. Policy statement unchanged.

https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/idiopathic-scoliosis-in-adolescents-screeninghttps://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/idiopathic-scoliosis-in-adolescents-screening

Page | 10 of 10

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Romn (Romanian): Prezenta notificare conine informaii importante. Aceast notificare poate conine informaii importante privind cererea sau acoperirea asigurrii dumneavoastre de sntate prin Premera Blue Cross. Pot exista date cheie n aceast notificare. Este posibil s fie nevoie s acionai pn la anumite termene limit pentru a v menine acoperirea asigurrii de sntate sau asistena privitoare la costuri. Avei dreptul de a obine gratuit aceste informaii i ajutor n limba dumneavoastr. Sunai la 800-722-1471 (TTY: 800-842-5357). P (Russian): . Premera Blue Cross. . , , . . 800-722-1471 (TTY: 800-842-5357). Faasamoa (Samoan): Atonu ua iai i lenei faasilasilaga ni faamatalaga e sili ona taua e tatau ona e malamalama i ai. O lenei faasilasilaga o se fesoasoani e faamatala atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua atu i ai. Faamolemole, ia e iloilo faalelei i aso faapitoa oloo iai i lenei faasilasilaga taua. Masalo o lea iai ni feau e tatau ona e faia ao lei aulia le aso ua taua i lenei faasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo oloo e iai i ai. Oloo iai iate oe le aia tatau e maua atu i lenei faasilasilaga ma lenei famatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY: 800-842-5357). Espaol (Spanish): Este Aviso contiene informacin importante. Es posible que este aviso contenga informacin importante acerca de su solicitud o cobertura a travs de Premera Blue Cross. Es posible que haya fechas clave en este aviso. Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura mdica o ayuda con los costos. Usted tiene derecho a recibir esta informacin y ayuda en su idioma sin costo alguno. Llame al 800-722-1471 (TTY: 800-842-5357). Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471 (TTY: 800-842-5357). (Thai): Premera Blue Cross 800-722-1471 (TTY: 800-842-5357) (Ukrainian): . Premera Blue Cross. , . , , . . 800-722-1471 (TTY: 800-842-5357). Ting Vit (Vietnamese): Thng bo ny cung cp thng tin quan trng. Thng bo ny c thng tin quan trng v n xin tham gia hoc hp ng bo him ca qu v qua chng trnh Premera Blue Cross. Xin xem ngy quan trng trong thng bo ny. Qu v c th phi thc hin theo thng bo ng trong thi hn duy tr bo him sc khe hoc c tr gip thm v chi ph. Qu v c quyn c bit thng tin ny v c tr gip bng ngn ng ca mnh min ph. Xin gi s 800-722-1471 (TTY: 800-842-5357).