Gene Expression Profiling

Gene Expression Profiling
Last Review Date: November 19, 2014
Number: MG.MM.LA.13a
Medical Guideline Disclaimer
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evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information,
EmblemHealth will not be able to properly review the request for prior authorization. The clinical review criteria expressed below reflects how
EmblemHealth determines whether certain services or supplies are medically necessary. EmblemHealth established the clinical review criteria
based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical
literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based
guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other
relevant factors). EmblemHealth expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further
relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically
necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some
programs exclude coverage for services or supplies that EmblemHealth considers medically necessary. If there is a discrepancy between this
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Definitions
Gene expression profiling (GEP) is a technology for identifying the genes that are active in a given
sample of cells or tissue. This technique enables profiling of genes that are differentially expressed in
disease states; thereby providing diagnostic and prognostic information for molecular subclassification.
(Related administrative guideline Genetic Counseling and Testing)
Guideline
Members are eligible for GEP testing as follows:
I.
Breast cancer (invasive); one-time testing using either:
1. HerMark® (Covered for Medicare members only)
2. MammaPrint® (EmblemHealth Medical Guideline)
3. Oncotype DX® (EmblemHealth Medical Guideline)
II.
Post-heart-transplant rejection; allowable frequency every 1–3 months
1. AlloMap® (EmblemHealth Medical Guideline)
III.
Thyroid lesions with indeterminate cytology; one-time testing
1. Afirma Thyroid FNA Analysis®
Limitations/Exclusions
I.
GEP testing is not considered medically necessary in the absence of the following:
1.
Analytical/clinical validity
Gene Expression Profiling
Last review: November 19, 2014
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2.
II.
Clinical utility (i.e., result does not impact medical management; e.g., surgery, change in
surveillance, chemotherapy, hormonal manipulation, etc.
GEP testing is not considered medically necessary when performed with any test other than
those listed above, as there is insufficient evidence of therapeutic value; (list not all-inclusive):
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
BluePrint®
BreastOncPx™
CancerTYPE ID®
ConfirmMDx™ (Covered for Medicare members only)
Corus® CAD (Covered for Medicare members only)
DecisionDx-Melanoma
ENGAUGE™-cancer-DLBCL
GeneFx® Lung
GeneSight (Covered for Medicare members only)
H/I Gene Expression Ratio
HERmark (Covered for Medicare members only)
HOX13:IL17BR
Mammastatin
Mammostrat
miRview® mets²
MyPRS Plus™
Oncotype DX® tests — breast DCIS, colon and prostate cancers
Pervenio™ Lung NGS
Prolaris®
ProOnc TumorSource DX
ProsignaTM
ResponseDX Tissue Origin Test (Covered for Medicare members only)
Rotterdam/ Veridex
SYMPHONY™ Genomic Breast Cancer Profile (combines BluePrint, MammaPrint and
TargetPrint tests)
25. TargetPrint®
References
AHRQ. Technology Assessment on Genetic Testing or Molecular Pathology Testing of Cancers with Unknown Primary Site
to Determine Origin. February 2013.
http://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id90TA.pdf. Accessed July 21, 2014.
EmblemHealth. AlloMap® Molecular Expression Testing for Post-Heart-Transplant Rejection. December 2013.
http://www.emblemhealth.com/~/media/Files/PDF/_med_guidelines/MG_AlloMap_Testing.pdf. Accessed July 22, 2014.
EmblemHealth. Gene Expression Profiling for Breast Cancer — MammaPrint®. June 2014.
http://www.emblemhealth.com/~/media/Files/PDF/_med_guidelines/MG_MammaPrint.pdf. Accessed July 22, 2014.
EmblemHealth. Gene Expression Profiling for Breast Cancer — Oncotype DX® Breast Cancer Assay. June 2014.
http://www.emblemhealth.com/~/media/Files/PDF/_med_guidelines/MG_Oncotype.pdf. Accessed July 22, 2014.
Hayes Inc. GTE Report. DecisionDx-UM (Castle Biosciences Inc.) Gene Expression Assay for Risk Stratification of Patients
with Uveal Melanoma. April 2011, updated review April 2014.
National Cancer Care Network (NCCN). Clinical Practice Guidelines in Oncology. Colon Cancer. Version 3.2014.
http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#site. Accessed July 22, 2014.
Gene Expression Profiling
Last review: November 19, 2014
Page 3 of 3
National Cancer Care Network (NCCN). Clinical Practice Guidelines in Oncology. Melanoma. Version 4.2014.
http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#site. Accessed July 22, 2014.
National Cancer Care Network (NCCN). Clinical Practice Guidelines in Oncology. Multiple Myeloma. Version 2.2014.
http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#site. Accessed July 22, 2014.
National Cancer Care Network (NCCN). Clinical Practice Guidelines in Oncology. Non-Hodgkin’s Lymphomas. Version
3.2014. http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#site. Accessed July 22, 2014.
National Cancer Care Network (NCCN). Clinical Practice Guidelines in Oncology. Non-Small Cell Lung Cancer Version
4.2014. http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#site. Accessed July 22, 2014.
National Cancer Care Network (NCCN). Clinical Practice Guidelines in Oncology. Occult Primary (Cancer of Unknown
Primary [CUP]). Version 3.2014. http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#site. Accessed July
22, 2014.
National Cancer Care Network (NCCN). Clinical Practice Guidelines in Oncology. Prostate Cancer Version 2.2014.
http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#site. Accessed July 22, 2014.
National Cancer Instititue. Intraocular (Uveal) melanoma Treatment (PDQ®). July 2014.
http://www.cancer.gov/cancertopics/pdq/treatment/intraocularmelanoma/HealthProfessional/page1/AllPages.
Accessed July 21, 2014.
Palmetto GBA. MolDX Afirma Assay by Veracyte Coding and Billing Guidelines (M00015). January 2012.
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCat/MolDx%20Website~MolDx~Browse%20By%20Topic~Cover
ed%20Tests~8Q7MRU7038?open&navmenu=Browse^By^Topic||||. Accessed July 22, 2014.
Palmetto GBA. MolDX®Corus CAD Test Coding and Billing Guidelines (M0009). January 2012.
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCat/MolDx%20Website~MolDx~Browse%20By%20Topic~Cover
ed%20Tests~8WXQ5R5416?open&navmenu=Browse^By^Topic||||. Accessed July 22, 2014.
Palmetto GBA. MolDX® HERmark Assay by Monogram Coding and Billing Guidelines (M00028). December 2011.
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCat/MolDx%20Website~MolDx~Browse%20By%20Topic~Cover
ed%20Tests~8TVSBJ3016?open&navmenu=Browse^By^Topic||||. Accessed July 22, 2014.
Palmetto GBA. MolDX® ResponseDX Tissue of Origin® Coding and Billing Guidelines (M00034). June 2014.
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCat/MolDx%20Website~MolDx~Browse%20By%20Topic~Cover
ed%20Tests~9LKMFT7574?open&navmenu=Browse^By^Topic||||. Accessed July 22, 2014.
Specialty-matched clinical peer review.

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