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Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2014, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2014 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

05-86000-29

Original Effective Date: 05/15/10

Reviewed: 02/27/14

Revised: 05/15/14

Subject: Multigene Expression Assay for Predicting Recurrence in Colon Cancer

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References  

DESCRIPTION:

Of patients with stage II colon cancer, 75–80% are cured by surgery alone, and the absolute benefit of chemotherapy for the patient population is small. Those patients who are most likely to benefit from chemotherapy are difficult to identify by standard clinical and pathologic risk factors.

Since 2004 more than a dozen different gene expression profile (GEP) tests have been developed for use as prognostic markers in stage II colon cancer. Information on basic elements of performance including specimen type, sample handling, and technique used for GEP has been reported for many of the tests. The GEP tests are purported to help identify patients with stage II colon cancer who are at high risk for recurrent disease and would be good candidates for adjuvant chemotherapy.

POSITION STATEMENT:

Gene expression assays, including but not limited to the determination of the prognosis of stage ll colon cancer following surgery, are considered experimental or investigational for all indications. The evidence is insufficient to permit conclusions on health outcomes.

BILLING/CODING INFORMATION:

There are no specific CPT or HCPCS codes to report gene expression assays.

ICD-9 Diagnoses Codes That Support Medical Necessity:

Gene expression assays are experimental or investigational for all diagnoses.

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

Gene expression assays are experimental or investigational for all diagnoses.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products: The following were reviewed on the last guideline revised date located at palmettogba.com:

Local Coverage Article for MolDx: Oncotype DX® Colon Cancer Assay Update (A51725)

Local Coverage Determination (LCD): Molecular Diagnostic Tests (MDT) (L33599).

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

Other names used to report the gene expression assays:

ColonPRS®
ColDx®
ColoPrint®
Genefx Colon®
Microchip array, tumor gene expression, colon cancer
OncoDefender®
Oncotype DX®
Tumor gene expression, colon cancer

REFERENCES:

  1. Alberts SR, Yu T, et al, Real-world comparative economics of a 12-gene assay for prognosis in stage II colon cancer. 2013 Gastrointestinal Cancers Symposium January 24-26, 2013.
  2. Blue Cross and Blue Shield Association, Multi-gene Expression Assay for Predicting Recurrence in Colon Cancer (2.04.61), 08/13.
  3. Cartwright T, Chao C, Lee M, et al, Effect of the 12-gene colon cancer assay results on adjuvant treatment recommendations in patients with stage II colon cancer. Curr Med Res Opin. 2014 Feb;30(2):321-8. Epub 2013 Nov 7.
  4. Clark-Langone KM, et al, Translating Tumor Biology Into Personalized Treatment Planning: Analytical Performance Characteristics of the Oncotype DX® Colon Cancer Assay, BMC Cancer 2010, 10:691.
  5. ClinicalTrials.gov, A Prospective Study for the Assessment of Recurrence Risk in Stage II Colon Cancer Patients Using ColoPrint, sponsored by Agendia, accessed 01/16/13.
  6. ClinicalTrials.gov, Leucovorin and Fluorouracil compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed, sponsored by Institute of Cancer Research, United Kingdom, accessed 01/20/11.
  7. ECRI Institute Product Brief, Oncotype DX Multigene Expression Assay (Genomic Health, Inc.) for Predicting Recurrence of Colon Cancer, 07/13.
  8. Figueredo A, Coombes ME, Mukherjee S, Adjuvant Therapy for Completely Resected Stage II Colon Cancer, Cochrane Database System Reviews 2008, Issue 3.
  9. Gray RG, Quirke P, Handley K, et al. Correlation of Number of Nodes Examined and the 12-Gene Colon Cancer Recurrence Score with Recurrence in Stage II Colon Cancer Patients From QUASAR, American Society of Clinical Oncology (ASCO) 2010 Gastrointestinal Cancers Symposium, Abstract 331.
  10. Gray RG, Quirke P, Handley K, et al, Validation study of a quantitative multigene reverse transcriptase-polymerase chain reaction assay for assessment of recurrence risk in patients with stage II colon cancer. J Clin Oncol. 2011 Dec 10;29(35):4611-9.
  11. Kerr D, Gray R, Quirke D, et al, A Quantitative Multigene RT-PCR Assay for Prediction of Recurrence in Stage II Colon Cancer: Selection of the Genes in Four Large Studies and Results of the Independent, Prospectively Designed QUASAR Validation Study, 2009 American Society of Clinical Oncology Annual Meeting, Abstract 400.
  12. Meropol NJ, et al, Use of a Multigene Prognostic Assay for Selection of Adjuvant Chemotherapy in Patients with Stage II Colon Cancer: Impact on Quality-Adjusted Life Expectancy and Costs, American Society of Clinical Oncology 2011 Gastrointestinal Cancers Symposium, Abstract 491.
  13. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Colon Cancer V. 2.2014.
  14. O’Connell MJ, Lavery IC, Gray RG, et al, Comparison of Molecular and Pathologic Features of Stage II and Stage III Colon Cancer in Four Large Studies Conducted for Development of the 12-Gene Colon Cancer Recurrence Score, American Society of Clinical Oncology 2010 Gastrointestinal Cancers Symposium, Abstract 280.
  15. Palmetto GBA, Local Coverage Article for MolDx: Oncotype DX® Colon Cancer Assay Update (A51725), 03/20/12, accessed at palmettogba.com.
  16. Palmetto GBA, Local Coverage Determination (LCD): Molecular Diagnostic Tests (MDT) (L33599), 10/18/13, accessed at palmettogba.com.
  17. Srivastava G, Renfro LA, et al, Prospective Multicenter Study of the Impact of Oncotype DX Colon Cancer Assay Results on Treatment Recommendations in Stage II Colon Cancer Patients, Oncologist. 2014 Apr 7. [Epub ahead of print].
  18. Venook AP, Niedzwiecki D, Lopatin M, et al, Biologic determinants of tumor recurrence in stage II colon cancer: validation study of the 12-gene recurrence score in cancer and leukemia group B (CALGB) 9581. J Clin Oncol. 2013 May 10;31(14):1775-81. Epub 2013 Mar 25.
  19. Webber EM, et al, Oncotype DX Tumor Gene Expression Profiling in Stage II Colon Cancer, PLoS Curr. 2010 September 2: 2: RRN1177.
  20. Yothers G, O’Connell MJ, et al, Validation of the 12-Gene Colon Cancer Recurrence Score in NSABP C-07 As a Predictor of Recurrence in Patients With Stage II and III Colon Cancer Treated With Fluorouracil and Leucovorin (FU/LV) and FU/LV Plus Oxaliplatin, J Clin Oncol. 2013 Dec 20;31(36):4512-9.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 05/22/14.

GUIDELINE UPDATE INFORMATION:

05/15/10

New Medical Coverage Guideline.

03/15/11

Annual review; position statement maintained and references updated.

03/15/12

Annual review; position statement maintained, Program Exceptions section and references updated.

03/15/13

Annual review; investigational status maintained, position statement, description section, and references updated.

03/15/14

Annual review; position statement maintained, Medicare program exception and references updated.

05/15/14

Revision; references updated.

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is copyright 2013, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2013 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association.The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

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Date Printed: September 3, 2014: 12:35 AM