12.04.74 dna-based testing for adolescent idiopathic scoliosis · · 2018-03-21dna-based testing...
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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:
None
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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.
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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
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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
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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
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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
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037338 (07-2016)
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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).