Download Genetic Expression Testing-Oncotype

MEDICAL PRE-AUTHORIZATION CRITERIA
MEDICARE
PROCEDURE/
EQUIPMENT
Genetic Expression Testing, Oncotype DX
CPT/HCPCS
CODES
81519
CRITERIA
MUST MEET ALL OF THE FOLLOWING:
1. The results of the genetic testing will directly impact surveillance or treatment.
2. The individual has breast cancer that is non-metastatic (node negative) or has a lymph
node with a micrometatstatic focus of ≤2mm.
3. The breast tumor is estrogen receptor positive.
4. The breast tumor is HER2 receptor negative.
5. The individual is a candidate for adjuvant chemotherapy (i.e., there are no clinical factors
that would prevent chemotherapy such as advanced age or a significant comorbidity).
6. The individual has been counseled regarding the use of the test and the results will be
used to guide decision making regarding the use of chemotherapy.
NOTE: Requests for Oncotype DX occurring more that 6 months after diagnosis have not been
demonstrated to be medically effective. Additionally, there is no literature supporting repeat
Oncotype DX testing or the use of Oncotype DX for testing multiple tumor sites from the same
individual.
REFERENCES
There is no LCD or NCD on this topic. Therefore, the following resources were used to
develop the guidelines:
1. Hormone therapy with or without combination chemotherapy in treating women who have
undergone surgery for node-negative breast cancer (The TAILORx trial). Sponsored by the
National Cancer Institute. ClinicalTrials.gov NCT00310180. March 29, 2006; updated
November 13, 2015, Accessed at http://clinicaltrials.gov/ct/show/NCT00310180?order=1.
2. Gradishar WJ, Anderson BO, Balassanian R, et al. Breast Cancer. National
Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. 2015. Version
3.2015. Accessed at www.nccn.org/professionals/physician_gls/PDF/breast.pdf.
3. Oncotype DX for the Prediction of Recurrence of Invasive Breast Cancer. Hayes GTE
Report. Winifred S. Hayes, Inc. Dec 11, 2012; updated Dec 8, 2014.
4. Recommendations from the EGAPP Working Group: Can tumor gene expression profiling
improve outcomes in patients with breast cancer? Genet in Med. 2009 Jan; 11(1):66-73.
5. Impact of gene expression profiling tests on breast cancer outcomes. Evidence
Report/Technology Assessment. Agency for Healthcare Research and Quality. 2008 Jan.
Number 160. Accessed at
www.ahrq.gov/downloads/pub/evidence/pdf/brcancergene/brcangene.pdf
6. Ademuyiwa FO, Miller A, O’Connor T, et al. The effects of Oncotype DX recurrence scores
on chemotherapy utilization in a multi-institutional breast cancer cohort. Breast Cancer Res
Treat. 2011 Apr; 126(3):797-802.
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MEDICAL PRE-AUTHORIZATION CRITERIA
MEDICARE
PROCEDURE/
EQUIPMENT
Genetic Expression Testing, Oncotype DX
7. Cobleigh MA, Tabesh B, Bitterman P, et al. Tumor gene expression and prognosis in
breast cancer patients with 10 or more positive lymph nodes. Clin Cancer Res. 2005;11(24
Pt 1):8623-8631.
8. Esteva FJ, Sahin AA, Cristofanilli M, et al. Prognostic role of a multigene reverse
transcriptase-PCR assay in patients with node-negative breast cancer not receiving
adjuvant systemic therapy. Clin Cancer Res. 2005; 11(9):3315-3319.
9. Fan C, Oh DS, Wessels L, et al. Concordance among gene-expression-based predictors
for breast cancer. N Engl J Med. 2006; 355(6):560-569.
10. Geradts J, Bean SM, Bentley RC, Barry WT. The Oncotype DX recurrence score is
correlated with a composite index including routinely reported pathobiologic features.
Cancer Invest. 2010 Sep; 28(9):969-977.
11. Gianni L, Zambetti M, Clark K, et al. Gene expression profiles in paraffin-embedded core
biopsy tissue predict response to chemotherapy in women with locally advanced breast
cancer. J Clin Oncol. 2005; 23(29):7265-7277.
12. Habel LA, Shak S, Jacobs MK, et al. A population-based study of tumor gene expression
and risk of breast cancer death among lymph node-negative patients. Breast Cancer Res.
2006; 8(3):R25.
13. Ishibe N, Schully S, Freedman A, Ramsey DS. Use of Oncotype DX in women with nodepositive breast cancer. PLoS Curr. 2011 July 21; 3:RRN1249. Accessed at
www.ncbi.nlm.nih.gov/pmc/articles/PMC3145540/?report=printable
14. Kelly CM, Krishnamurthy S, Bianchini G, et al. Utility of Oncotype DX risk estimates in
clinically intermediate risk hormone receptor-positive, HER2-normal, grade II, lymph nodenegative breast cancers. Cancer. 2010 Nov; 116(22):5161-5167.
15. Paik S, Shak S, Tang G, et al. A multigene assay to predict recurrence of tamoxifentreated, node-negative breast cancer. N Engl J Med. 2004; 351(27):2817-2826.
16. Paik S, Tang G, Shak S, et al. Gene expression and benefit of chemotherapy in women
with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol. 2006;24
(23):3726-3734.
REVIEW
HISTORY
10/29/08, 10/14/09, 11/10/10, 11/09/11, 12/05/12, 12/03/14 12/09/15
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