May 2015 Added ResponseDX:Colon as investigational since there is a paucity of peer-reviewed literature to support this.
August 2015 Added TreatmentMAP, Paradigm Cancer Diagnostic (PCDx) Test and COLMOL:NGS Colon Cancer Panel as
investigational.
September 2015 Update – Added Oncotype DX Prostate Cancer Assay and Decipher Prostate Cancer Classifier to investigational section of the policy.
October 2015 Added Tissue of Origin (ResponseDX) to the investigational section of the policy, since there is a paucity of peer- reviewed literature to support it.
November 2015 Added ThyGenX Thyroid Oncogene Panel/ThyraMIR
([predecessor -miRInform Thyroid) and ThyroSeq v.2 Next Generation Sequencing Panel as investigational. Added JAK2 as medically necessary for specific diagnoses
January 2016 Added FoundationOne Heme as investigational since there is a paucity of peer reviewed literature to support this testing.
This policy is based on the following evidence-based guidelines:
1. American College of Medical Genetics. ACMG Statement on Direct-to-Consumer Genetic Testing. April 2008.
2. Basch E, Oliver TK, Vickers A, et al. Screening for prostate cancer with prostate- specific antigen testing: American Society of Clinical Oncology Provisional Clinical Opinion. J Clin Oncol. 2012 Aug 20;30(24):3020-5. Available at:
http://www.asco.org/institute-quality/screening-prostate-cancer-prostate- specific-antigen-psa-testing-american-society
3. Gilligan TD, Hayes DF, Seidenfeld J, Temin S. ASCO Clinical Practice Guideline on Uses of Serum Tumor Markers in Adult Males With Germ Cell Tumors. J Oncol Pract. 2010 Jul;6(4):199-202. Available at:
http://www.asco.org/institute-quality/asco-clinical-practice-guideline-uses- serum-tumor-markers-adult-males-germ-cell
4. Harris L, Fritsche H, Mennel R, et al. American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. J Clin Oncol. 2007 Nov 20;25(33):5287-312. Available at:
http://www.asco.org/institute-quality/american-society-clinical-oncology-2007- update-recommendations-use-tumor-markers
5. Hayes Genetic Test Overview. GTE Report. Afirma Thyroid FNA Analysis. Aug. 2012. Update Feb. 2014
6. Hayes Genetic Test Overview. GTE Synopsis. Target Now Molecular Profiling Test (Caris Life Sciences). Sept 2012
7. Hayes Genetic Test Overview. GTE Synopsis. ColoNext. June 2012. 8. Hayes Genetic Test Overview. GTE Synopsis. DecisionDx-GBM. Oct 2012 9. Hayes Genetic Test Overview. GTE Report. DecisionDx-UM Gene Expression
Assay for Risk Stratification of Patients with Uveal Melanoma. Dec 2011. Update Apr. 2013
10. Hayes Medical Technology Directory. Ancillary ImmunoCyt/uCyt+ Testing for Bladder Cancer Screening and Detection. Sept 2008. Update Sept. 2012 11. Hayes Medical Technology Directory. Ancillary UroVysion Fluorescence In Situ
Hybridization (FISH) Testing for Bladder Cancer Screening and Detection. Jul 2008. Update Jul. 2012
12. Locker GY, Hamilton S, Harris J, et al. ASCO 2006 update of recommendations for the use of tumor markers in gastrointestinal cancer. J Clin Oncol. 2006 Nov 20;24(33):5313-27. Available at: http://www.asco.org/institute-quality/asco- 2006-update-recommendations-use-tumor-markers-gastrointestinal-cancer 13. National Cancer Institute. Cancer Genetics Risk Assessment and Counseling.
(PDQ)last modified June 2013. Available at:
http://www.cancer.gov/cancertopics/pdq/genetics/risk-assessment-and- counseling/HealthProfessional
14. National Comprehensive Care Network. NCCN Clinical Practice Guidelines in Oncology. Bladder Cancer. Version 1.2013
15. National Comprehensive Care Network. NCCN Clinical Practice Guidelines in Oncology. Breast Cancer. Version 3.2013. Updated Version 1. 2014. Updated Version 3.2014.
16. National Comprehensive Care Network. NCCN Clinical Practice Guidelines in Oncology. Central Nervous System cancers. Version 2.2013 update Version 1.2014
17. National Comprehensive Care Network. NCCN Clinical Practice Guidelines in Oncology. Genetic/Familial High-Risk Assessment: Breast and Ovarian. Version 3.2013. Updated version 2. 2014.
18. National Comprehensive Care Network. NCCN Clinical Practice Guidelines in Oncology. Non-Hodgkin’s Lymphomas. Version1.2013
19. National Comprehensive Care Network. NCCN Clinical Practice Guidelines in Oncology. Neuroendocrine Tumors. Version 2.2013
20. National Comprehensive Care Network. NCCN Clinical Practice Guidelines in Oncology. Occult Primary. Version I.2013. Updated Version 1, 2014. 21. National Comprehensive Care Network. NCCN Clinical Practice Guidelines in
22. National Comprehensive Care Network. NCCN Clinical Practice Guidelines in Oncology. Pancreatic Adenocarcinoma. Version 1.2013. Updated Version 1, 2014. Updated Version1.2015.
23. National Comprehensive Care Network. NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer. Version 2. 2012. Updated Version 2.2013. Updated Version 1.2014. Update Version 1.2015
24. National Comprehensive Care Network. NCCN Clinical Practice Guidelines in Oncology. Testicular Cancer. Version I.2013
25. National Comprehensive Care Network. NCCN Clinical Practice Guidelines in Oncology. Thyroid Carcinoma. Version 2.2013. Update 2.2015
26. National Comprehensive Care Network. NCCN Clinical Practice Guidelines in Oncology. Uterine Neoplasms. Version I.2013
27. Society of Gynecologic Oncology. Use of CA125 for Monitoring Ovarian Cancer. June 2009. Available at: https://www.sgo.org/newsroom/position-statements- 2/use-of-ca125-for-monitoring-ovarian-cancer/
28. Hayes. Genetic Test Evaluation (GTE). Molecular Intelligence for Colorectal Cancer (CRC) (Caris Life Sciences). January 15, 2014.
29. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Colon Cancer. Version 2, 2014.
30. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Soft Tissue Sarcoma. Version 1. 2013.
31. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Melanoma. Version 2.2013. Updated Version 2. 2014. Updated Version 4. 2014. Version 1.2015.
32. Gharib H, Papini E, Paschke R, Duick DS, Valcavi R, Hegedus L, Vitti P,
AACE/AME/ETA Task Force on Thyroid Nodules. American Association of Clinical Endocrinologists, Associazione Medici Endocrinologi, and European Thyroid Association medical guidelines for clinical practice for the diagnosis and
management of thyroid nodules. Endocr Pract. 2010 May-Jun;16(Suppl 1):1-43. Available at: https://www.aace.com/files/thyroid-guidelines.pdf
33. American Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules, Cooper DS, Doherty GM, Haugen BR, Kloos RT, Lee SL, Mandel SJ, Mazzaferri EL, McIver B, Pacini F, Schlumberger M, Sherman SI, Steward DL, Tuttle RM. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid. 2009
Nov;19(11):1167-214. Available at:
http://thyca.org/download/document/409/DTCguidelines.pdf
34. Febbo, PG, Ladanyi, M, Aldape, KD, et al. NCCN Task Force Report: Evaluating the Clinical Utility of Tumor Markers in Oncology. J Natl Compre Canc Netw. 2011;9:S1-S31.
35. Hayes. GTE Overview. Myriad myRisk Hereditary Cancer, May 5, 2014.
36. Hayes. GTE Overview. Myeloma Prognostic Risk Signature (MyPRS Plus) Test for Myeloma. July 17, 2014.
37. Hayes. GTE Overview. DecisionDx-Melanoma. September 4, 2014.
38. Hayes. GTE Overview. BreastTrue High Risk Panel for Hereditary Breast Cancer (Pathway Genomics Corp.) January 8, 2015.
39. Hayes. GTE Overview. Breast Cancer Index. Breast Cancer Index for Prognosis of Breast Cancer Recurrence (bioTheranostics Inc.) December 11, 2014.
40. Hayes. GTE Overview. Oncotype DX Prostate Cancer Assay for Prostate Cancer Prognosis (Genomic Health Inc.) December 9, 2014.
41. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer. Version 1.2015.
42. Hayes. GTE Overview. iGene Cancer Panel. June 15, 2015.
43. Hayes. GTE Overview. High/Moderate Risk Panel for Hereditary Cancer Risk (GeneDx Inc.). January 29, 2015.
44. Hayes. GTE Overview. Pancreatic Cancer Panel for Hereditary Pancreatic Cancer (GeneDx Inc.). January 29, 2015.
45. Hayes. GTE Synopsis. SYMGENE68 NGS Cancer Panel. March 12, 2015. 46. Hayes. GTE Overview. TreatmentMAP. July 30, 2015.
47. Hayes. GTE Overview. COLMOL: NGS Colon Cancer Panel. August 6, 2015. 48. Hayes. GTE Overview. Paradigm Cancer Diagnostic (PCDX) Test. August 27,
2015
49. Hayes. GTE Report. Tissue of Origin Test (ResponseDX). October 1, 2015. 50. Hayes GTE Report. miRInform Thyroid. Apr.2014. Update Mar. 2015
51. Hagen BR, Alexander EK, Bible KC, et al. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and
Differentiated Thyroid Cancer. Thyroid. 2015 Oct 14. Available at: http://www.thyca.org/download/document/409/DTCguidelines.pdf 52. Hayes GTE Synopsis. ThyroSeq. Apr. 2015.
53. Hayes. GTE Overview. FoundationOne Heme. December 2015.