Prior authorization request form Form

Gene Expression Profiling

Last Review Date: April 10, 2026 
Number: MG.MM.LA.13z

Medical Guideline Disclaimer The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the member meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request preauthorization or post-payment review. The clinical review criteria expressed below reflects how EmblemHealth determines whether certain services or supplies are medically necessary. This clinical policy is not intended to pre-empt the judgment of the reviewing medical director or dictate to health care providers how to practice medicine. Health care providers are expected to exercise their medical judgment in rendering appropriate care. Health care providers are expected to exercise their medical judgment in rendering appropriate care.
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 guideline and a member's benefits program, the benefits program will govern. Identification of selected brand names of devices, tests and procedures in a medical coverage policy is for reference only and is not an endorsement of any one device, test or procedure over another. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication.
EmblemHealth may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us in administering health benefits. The MCG™ Care Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. EmblemHealth Services Company, LLC, has adopted this policy in providing management, administrative and other services to EmblemHealth Plan, Inc., EmblemHealth Insurance Company, EmblemHealth Services Company, LLC, and Health Insurance Plan of Greater New York (HIP) related to health benefit plans offered by these entities. All of the aforementioned entities are affiliated companies under common control of EmblemHealth Inc. 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. Note: This guideline includes gene expression analysis, gene sequencing, and other techniques. (Skip cross referencing and go directly to Guideline Section) Related Medical Guidelines
Analysis of KRAS Status Carrier Screening for Parents or Prospective Parents Gene Expression Profiling and Biomarker Testing for Breast Cancer Medical Necessity Guidelines: Experimental, Investigational or Unproven Services Related MCG Criteria (list not all-inclusive) Alzheimer’s disease — MCG #s: A-0590 (early onset), A-0809 (late onset) Amyotrophic Lateral Sclerosis (ALS) — A-0591 Ataxia-Telangiectasia - ATM Gene — A-0593 Autism Spectrum Disorders/Developmental Delay/Intellectual Disability (See MCG #s below for chromosomal microarray analysis and whole genome/exome sequencing) BCR-ABL1 Genetic Mutation Testing in Chronic Myelogenous Leukemia and Acute Lymphoblastic Leukemia — A-0759, A-0771 Breast Cancer — PALB2 Gene — A-0989 Breast Cancer (Hereditary) — Gene Panel — A-0767

Breast or Ovarian Cancer (Hereditary) — BRCA1 and BRCA2 Genes — A-0499 Cancer of Unknown Primary — A-0673 Cancer Multiomic Molecular Profiling — A-0789 Canavan Disease - ASPA Gene — A-0595 Cardiac Ion Channel Genetic Testing — MCG #s: A-0594 (Brugada Syndrome), A-0607 (Long QT Syndrome), A-0636 (Catecholaminergic Polymorphic Ventricular Tachycardia), A-0831 (Romano-Ward Syndrome), A-0833 (Andersen-Tawil Syndrome), A-0834 (Timothy Syndrome), A- 0918 Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) Syndrome — A-0668 Coronary Artery Disease — A-0656 (KIF6 Gene) —, A-0658 (Genetic Panel) Cowden Syndrome — A-0585 Cystic Fibrosis —A-0597 Deafness and Hearing Loss — MCG #s: A-0596 (Nonsyndromic - GJB2, MT-RNR1, MT-TS1, POU3F4, PRPS1, and SMPX Genes), A-0823 (Nonsyndromic - Microarray and Multigene Panels), A-0802 (Usher Syndrome) Diabetes Mellitus — MCG #s: A-0598 (Maturity-Onset Diabetes of the Young), A-0826 (Type 2), A-0824 (Permanent Neonatal), A-0825 (Transient Neonatal) Epidermal Growth Factor Receptor Mutation Analysis for Patients with Non-Small-Cell Lung Cancer — A-0795 Factor V Leiden Mutation Analysis — A-0600 Familial Hypercholesterolemia — A-0958 Familial Hyperinsulinism — A-0777 Fanconi Anemia —A-0 683 Frontotemporal Dementia (FTD) — A-0906 Glycogen Storage Disease, Type I — A-0684 Heart-Transplant Rejection (AlloMap®) — A-0623 Hereditary Cardiomyopathy — MCG #s: A-0627 (Arrhythmogenic Right Ventricular), A-0633 (Nonsyndromic), A-0648 (Dilated) Hereditary Pancreatitis — MCG #s: A-0646 (CFTR, CPA1, CTRC, PRSS1, and SPINK1 genes), A-0797 (next generation sequencing panel) Huntington Disease — A-0605 Li-Fraumeni Syndrome - TP53 Gene — A-0584 Melanomas, cutaneous — MCG #s: A-0601 (BAP1, CDK4, and CDKN2A Genes), A-0837 (Gene Expression Profiling) Multiple Endocrine Neoplasia (MEN) Syndrome — A-0582 (Type 1), A-0842 (Type 2) Muscular Dystrophies (Duchenne, Becker)— A-0608 Neuroblastoma - MYCN Gene and Gene Expression Profiling — A-0610 Neurofibromatosis - NF1 Gene — A-0581 Niemann-Pick Disease (Acid Sphingomyelinase Deficiency) — A-0611 Ovarian Cancer (Hereditary) — Gene and Gene Panel Testing —A-0782 Pancreatic Cancer (Hereditary) — Gene Panel — A-0797 Pancreatitis (Hereditary) — A-0646 Parkinson Disease — A-0671 Peripheral Neuropathies — A-0691 Polycystic Kidney Disease — MCG #s: A-0725 (Autosomal Dominant), A-0852 (Autosomal Recessive) Prostate Cancer - BRCA1 and BRCA2 Genes — A-0612 Prostate Cancer (Hereditary) — Gene Panel — A-0854 RET Proto-Oncogene Germline Mutations — A-0842 Retinal Disorders (Hereditary) – Gene Panels — A-0912 Retinoblastoma – NF1 gene — A-0686 Rett Syndrome — A-0687 Statin-Induced Myopathy — A-0981

Chromosomal Microarray Analysis (CMA) — MCG #s: A-0588 (Autism Spectrum Disorders), A-0810 (Developmental Delay), A-0812 (Prenatal Testing), A-0917 (Congenital Anomalies), A-0924 (Intellectual Disability) Noninvasive Prenatal Testing (NIPT) — MCG#s A-0848 (Microdeletion Syndromes), A-0849 (Monogenic Disorders), A-0850 (Sex Chromosome Disorders) Whole genome/exome sequencing — MCG #s: A-0710 (Cancer), A-0865 (Cardiovascular Disorders), A-0866 (Primary Immunodeficiency Disorders), A-0870 (Autism Spectrum Disorders), A-0871 (Metabolic, Mitochondrial, and Neurologic Disorders), A-0872 (Congenital Anomalies), A-0926 (Developmental Delay and Intellectual Disability)

Guideline Members are eligible for GEP testing per the related policies above and as applicable below: I. Advanced cancer, next generation sequencing (NGS), when performed with a diagnostic lab test that has received FDA approval or clearance* when the following criteria are met:

1. Member has
   i. either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and ii. not been previously tested using the same NGS test for the same cancer genetic content; and iii. decided to seek further cancer treatment (e.g., therapeutic chemotherapy)
2. The diagnostic laboratory test using NGS must have: i. FDA approval or clearance as a companion in vitro diagnostic; and ii. an FDA approved or cleared indication for use in that patient’s cancer; and iii. results provided to the treating physician for management of the patient using a report template to specify treatment options
   • See List of Cleared or Approved Companion Diagnostic Devices to match the test with the drug under consideration. The member’s Pharmacy benefit should be checked for formulary inclusion. (Note: The FDA’s list of tests approved for use in conjunction with specific drugs may be searched in its entirety by selecting “All” in the “Show entries” drop down menu) The following tests are not covered for Medicaid members, as proprietary lab analysis (PLA) codes (those ending in “u”) are not reimbursed by NYS Medicaid (list may not be all-inclusive):
      FoundationOne CDx (0037U)  FoundationOne Liquid CDx (0239U)  Guardant360 CDx (0242U)  LeukoStrat CDx FLT3 (0023U)  myChoice® CDx (0172U)  Oncomine Dx Target Test (0022U)
      Praxis Extended RAS Panel (0111U)  therascreen FGFR RGQ RT-PCR Kit (0154U)  therascreen PIK3CA RGQ PCR Kit (0155U [tumor tissue], 0177U [plasma]) II. Breast cancer, clinical management
     (See EmblemHealth Gene Expression Profiling and Biomarker Testing for Breast Cancer Medical Guideline) III. Non-small cell lung cancer (NSCLC) Guardant360 lab-developed test (LDT) (see Section I for the FDA-approved Guardant360 CDx companion diagnostic test)
3. Medically necessary for Medicare members when LCD criteria, Plasma-Based Genomic Profiling in Solid Tumors, are met
4. Medically necessary for Commercial members for indications outside the scope of a companion diagnostic when: i. The member has a diagnosis of metastatic or recurrent NSCLC, AND ii. NSCLC diagnosis has been confirmed based on a histopathologic assessment of tumor tissue, AND iii. No previous multi-gene panel testing has been performed for NSCLC, AND

iv. Insufficient tumor tissue is available for broad molecular profiling and member is unable to undergo an additional standard tissue biopsy due to documented medical reasons (i.e., invasive tissue sampling is contraindicated due to the member’s clinical condition) IV. NSCLC/Metastatic colorectal cancer, tumor tissue evaluation — Medicare members only per Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms LCD (e.g., OncoVantage®) V. Hematolymphoid diseases, evaluation of blood or bone marrow samples (i.e., acute myelogenous leukemia [AML], myelodysplastic syndromes [MDS], myeloproliferative neoplasms [MPN]) — covered for all lines of business using criteria from LCD: Genomic Sequence Analysis Panels in the Treatment of Hematolymphoid Diseases

• Note regarding the following proprietary lab tests:
• The clonoSEQ® assay is considered medically necessary for the initial assessment of dominant clonal sequences and for response assessment after primary treatment for members diagnosed with acute lymphoblastic leukemia, (ALL), chronic lymphocytic leukemia (CLL), or multiple myeloma (MM).
• The MyMRD® NGS Panel is considered medically necessary to identify Identify tumor-specific markers for post-treatment monitoring of any of these cancers: Acute myeloid leukemia (AML), Myelodysplastic syndrome (MDS), Myeloproliferative neoplasms (MPN). MyMRD is also considered medically necessary to monitor and evaluate refractory and relapsed disease.
  VI. Prostate cancer
  1. 4Kscore, ConfirmMDx™, and ExoDx®Prostate IntelliScore (EPI) (aka ExosomeDx®) — covered for Commercial and Medicare using criteria from Billing and Coding: Biomarker Testing for Prostate Cancer Diagnosis
  2. Genomic Prostate Score (formerly Oncotype DX®) — covered for Medicare using criteria from LCD: Prostate Cancer Genomic Classifier Assay for Men with Localized DiseaseCommercial coverage discontinued eff. Feb. 1, 2023.
  3. IsoPSA — covered for Commercial and Medicare members ≥ 50 years of age with confirmed presence of moderately elevated PSA (> 4 ng/ml and ≤ 25 ng/ml), no other relative contraindication for prostate biopsy present, and life expectancy ≥ 10 years.
  4. Prolaris® Prostate Cancer and Decipher® Prostate — covered for Commercial and Medicare members with very-low risk, low-risk, favorable/unfavorable intermediate- risk, or high-risk localized or biochemically recurrent prostate cancer as a guide to management (i.e., active surveillance or definitive therapy) when life expectancy is ≥ 10 years.
     Commercial coverage discontinued eff. Feb. 1, 2023, reinstated eff. Jan. 1, 2025
  5. PCA3 (e.g., Progensa) — covered for Commercial (eff. 5/3/2021) and Medicare when all biopsies in previous encounter(s) are negative for prostatic cancer, the subsequent prostate specific antigen (PSA) is rising, and when the member or physician wants to avoid repeat biopsy (“watchful waiting”)
  6. ProMark® Protemomic Prognostic Test — covered for all lines of business using criteria from LCD: ProMark Risk Score

The following tests are not covered for Medicaid members, as proprietary lab analysis (PLA) codes (those ending in “u”) are not reimbursed by NYS Medicaid:  ExoDx Prostate IntelliScore (EPI) (0005U)  Genomic Prostate Score® (GPS) Test (previously Oncotype DX,0047U) The following tests are not covered for Medicaid members, as they are not on the Medicaid Lab Fee Schedule:  4KScore (81539)  ConfirmMDx (81551)  Decipher (81542)  Prolaris (81541) VII. Thyroid lesions with indeterminate cytology, one-time testing

1. Afirma Thyroid FNA Analysis®
2. ThyGeNEXT® (formerly ThyGenX and miRInform®)
3. ThyraMIR Thyroid miRNA classifier
4. ThyroSeq next generation sequencing The following tests are not covered for Medicaid members, as proprietary lab analysis (PLA) codes (those ending in “u”) are not reimbursed by NYS Medicaid:
    ThyGeNEXT (0245U)  ThyraMIR (0018U)  ThyroSeq (0026U) VIII. Transplant rejection testing, all members, as applicable:
5. AlloMap® Heart
6. AlloSure®:
   i. Heart (covered as a standalone or in combination with the AlloMap)
   ii. Kidney
   iii. Lung
   IX. Uveal melanoma (UM), primary and localized (DecisionDx) is covered for Commercial and Medicare members when the following criteria are met:
7. Member has primary, localized uveal melanoma
8. No evidence of metastatic disease
9. No previous DecisionDx-UM testing performed after current diagnosis when a result was successfully obtained
   X. Whole exome/genome sequencing — MCG medically-necessary criteria sets (see Limitations/Exclusions for investigational indications):
10. A-0866 — Whole Genome/Exome Sequencing - Primary Immunodeficiency Disorders
11. A-0871 — Whole Genome/Exome Sequencing - Metabolic, Mitochondrial, and Neurologic Disorders
12. A-0872 — Whole Genome/Exome Sequencing - Congenital Anomalies
13. A-0926 — Whole Genome/Exome Sequencing - Developmental Delay and Intellectual Disability
14. A-0870 Whole Genome/Exome Sequencing - Autism Spectrum Disorders Limitations/Exclusions II. Gene expression profiling is not considered medically necessary in the absence of the following:
15. Analytical/clinical validity

2. Clinical utility (i.e., result does not impact medical management, e.g., surgery, change in surveillance, chemotherapy, hormonal manipulation, etc.) III. Confirmation of consumer-based testing (including, but not limited to Health + Ancestry [23andMe] has not been shown to be of clinical value and remains experimental/investigational. Testing will be approved only for members who otherwise meet the clinical criteria in these policies IV. The sequencing of more than 50 genes for hereditary cancer in the absence of a personal or family history of cancer is not considered medically necessary due to insufficient evidence of therapeutic value Testing is considereed medically necessary per National Comprehensive Cancer Network (NCCN) genetic/familial testing criterias for individual syndromes (See also MCG’s gene testing criteria for breast, ovarian, pancreatic, prostate, colorectal, endometrial and gastric cancers) Requests for will be reviewed on a case-by-case basis when the member’s personal/family history suggests multiple inherited cancer syndromes or when prior limited testing was negative but suspicion remains V. Whole exome/genome sequencing are not considered medically necessary due to insufficient evidence of therapeutic value the following indications (see section IX for medically necessary indications):
3. Population-based screening
4. Cancer testing to identify targeted therapies
5. Preimplantation genetic diagnosis and screening
6. Invasive prenatal (fetal) testing
7. Products of conception and pregnancy loss
8. Testing for chromosomal rearrangements See also the following MCG criteria:
9. A-0710 — Whole Genome/Exome Sequencing - Cancer
10. A-0865 — Whole Genome/Exome Sequencing - Cardiovascular Disorders VI. The following GEP tests are not considered medically necessary due to insufficient evidence of therapeutic value (list not all-inclusive; note exceptions):
11. 23-Gene NGS Pyruvate Metabolism and Related Disorders Panel
12. 23andMe Health + Ancestry Service
13. Abbott Alinity™ m STI Assay (covered Commercial and Medicare)
14. Accelerate PhenoTest® BC kit
15. ADmark® Alzheimer’s Evaluation
16. Albinism Panel
17. AmHPR Helicobacter Pylori Antibiotic Resistance NGS Panel
18. ARISk Autism Risk Assessment Test
19. Autosomal Dominant and Recessive Polycystic Kidney Disease Nextgen Sequencing (NGS) Panel
20. AvertD™
21. Avise tests i. CTD ii. MTX (aka Avise PG) (covered for Medicare) iii. Lupus
22. BluePrint®
23. BreastNext® (covered for Medicare per Medicare Fee Schedule)

14. BreastOncPx™
15. BreastPRS
16. BREVAGen/BREVAGenplus
17. Bridge Urinary Tract Infection Detection and Resistance Test
18. CancerIntercept
19. CancerNext® (covered for Medicare per Fee Schedule), CancerNext-ExpandedTM
20. CancerTYPE ID® (covered for Medicare)
21. Carbohydrate Metabolism Deficiency NextGen DNA Screening Panel
22. Cardiac DNA Insight
23. Cardiovascular Health Panel
24. CellSearch System®
25. CGD Universal Test Panel
26. Ciliopathies: Sequencing Panel
27. Ciliopathy NextGen Sequencing (NGS) Panel
28. Clarava
29. ClonoSEQ® (covered for Medicare and Commercial; see Section V)
30. ColoNext® (covered for Medicare per Medicare Fee Schedule)
31. ColoVantage
32. Complete Hereditary Spastic Paraplegia Evaluation Panel
33. Complete Lung
34. Comprehensive Brain Malformations Next Generation Sequencing Panel
35. Comprehensive Dystonia NextGen DNA Screening Panel
36. Comprehensive Inherited Retinal Dystrophies Sequencing Panel
37. Comprehensive Molecular Genetic Panel Comprehensive Muscular Dystrophy/Myopathy Next Generation DNA Sequencing Panel
38. Comprehensive Molecular Genetic Panel
39. Congenital Myopathy NextGen Sequencing (NGS) Panel
40. Congenital Stationary Night Blindness panel
41. Connective Tissue NGS Panel
42. Corus® CAD (Coverage rescinded for Medicare members eff. Dec. 12, 2018 based on noncoverage Local Coverage Determination: MolDX: Corus® CAD Assay)
43. Craniosynostosis next generation sequencing (NGS) panel
44. DecisionDx tests i. DiffDx - Melanoma ii. Glioblastoma iii. SCC
45. Decipher (covered for Commercial and Medicare; see Section VI)
46. DecodEX Microbial Genetic Identification
47. Distal Hereditary Motor Neuropathy NextGen Sequencing (NGS) Panel
48. Ehlers-Danlos Syndrome NGS Panel Dominant and Recessive
49. ENGAUGE™-cancer-DLBCL (covered for Medicare)
50. Envisia Genomic Classifier (covered for Medicare)
51. Epi proColon
52. EpiSign Complete
53. ExoDx®Prostate IntelliScore (EPI) (aka ExosomeDx®) (covered for Medicare)
54. ExomeNext
55. ExomeNext-Rapid
56. Expanded Pan-Ethnic Panel

57. Familial Hemiplegic Migraine NextGen Sequencing (NGS) Panel Fetal Akinesia Deformation Sequence/Lethal Multiple Pterygium Syndrome NextGen Sequencing (NGS) Panel
58. FoundationOne CDx (covered for Commercial and Medicare; see Section I)
59. FoundationOne RNA (covered for Medicare)
60. FoundationOne® Heme
61. FoundationOne Liquid CDx (covered for Commercial and Medicare; see Section I)
62. GeneAware
63. GeneFx® Colon
64. GeneFx® Lung
65. GeneKey
66. GeneStrat™
67. GeneSight (covered for Medicare)
68. Genome PACT
69. GeneTrails® Solid Tumor Panel
70. Genomic Unity® AR Analysis
71. Genomic Unity® CACNA1A Analysis (covered for Commercial and Medicare)
72. Genomic Unity® CSTB Analysis (covered for Commercial and Medicare)
73. Genomic Unity® FXN Analysis (covered for Commercial and Medicare)
74. Genomic Unity® SMN1/2 Analysis (covered for Commercial and Medicare)
75. Genomind® Pharmacogenetics Report (covered Medicare)
76. Genomind Professional PGx Express CORE Anxiety & Depression
77. GPS Cancer
78. Guardant360® LDT (covered for Commercial and Medicare; see Section III)
79. Guardant360 CDx (covered for Commercial and Medicare; see Section I)
80. Guardant Reveal™ (covered for Medicare)
81. Haystack MRD™
82. Healthy Weight DNA Insight
83. Healthy Woman DNA Insight
84. HCMNext
85. H/I Gene Expression Ratio
86. Hemophagocytic Lymphohistiocytosis Panel by next generation sequencing (NGS)
87. Hereditary Spherocytosis/Elliptocytosis NextGen Sequencing Panel
88. HERmark (Covered for Medicare, see Gene Expression Profiling and Biomarker Testing for Breast Cancer)
89. HLA-DQB1*06:02 typing for the diagnosis or management of narcolepsy
90. HOX13:IL17BR
91. Hypokalemic and Hyperkalemic Periodic Paralysis Disorders NGS Sequencing Panel
92. Immunoscore®
93. Insight® DX Breast Cancer Profile
94. Intellectual Disability (IDNEXT) Panel
95. Insight TNBCtype
96. Invitae
    i. Autoinflammatory Syndromes Panel ii. Dystonia Comprehensive Panel iii. Epilepsy iv. Hereditary Spastic Paraplegia Panel v. Hypoglycemia panel vi. Overgrowth Syndromes Panel vii. PCM MRD Monitoring

viii. PCM Tissue Profiling and MRD Baseline Assay ix. Primary Ciliary Dyskinesia Panel x. Primary Immunodeficiency Panel

97. IsoPSA® (covered Commercial and Medicare, see Section VI)
98. Leukoencephalopathy NGS Panel
99. Lipodystrophy NGS Panel
100. LungLB
101. LUNGSEQ® Panel
102. Lymph3Cx Lymphoma Molecular
103. Subtyping Assay
104. Macula Risk PGx
105. Macular Degeneration Mutation Analysis
106. Mammastatin
107. Medication Management Neuropsychiatric Panel (covered Medicare)
108. miReview®
109. Mammostrat
110. Melaris®
111. Molecular Intelligence
112. My5-FU™ (previously OnDose™)
113. myChoice® CDx (Covered for Commercial and Medicare; see Section I)
114. myPath® Melanoma (covered Medicare)
115. MyPRS® Myeloma Prognostic Risk Signature
116. Myriad Foresight® Carrier Screen (previously Counsyl Foresight Carrier Screen)
117. myRisk™
118. MSK-IMPACT (covered for Medicare; see Section I)
119. NavDx (covered Medicare)
120. Neurotransmitter Metabolism Deficiency NextGen DNA Screening Panel
121. Next Gen RASopathy Panel
122. Next Generation Sequencing Panel for ASXL1, RECQL4, RNU4ATAC, SOX2
123. NextStepDx PLUS®
124. NGS Epilepsy/Seizure Panel
125. NGS RASopathy Panel
126. OmniSeq Comprehensive
127. Oncomine Dx Target (Covered for Commercial and Medicare members; see Section I)
128. Oncotype DX® tests i. AR-V7 Nucleus (covered for Medicare) ii. Breast DCIS (covered for Medicare) iii. Colon cancer (covered for Medicare) iv. Prostate (aka Genomic Prostate Score, covered for Medicare, see Section VI)
129. Oncotype MAP™ PanCancer Tissue Test (covered for Medicare)
130. Oncofocus®
131. OncoMap™ ExTra (formerly GEM ExTra™) (covered for Medicare)
132. OncoVantage®(covered for Medicare)
133. OnkoMatch™
134. OnkoSight™ next generation sequencing for hematologic malignancies
135. Oncovue
136. OnoCEE
137. OPA 1 gene sequencing for autosomal dominant optic atrophy and/or optic neuropathy
138. Osteogenesis Imperfecta NGS Panel-Recessive
139. OvaNext™ (covered for Medicare)

140. Overa (aka OVA1 Next Generation or second-generation Multivariate Index Assay [MIA2G] test)
141. PAM50 Breast Cancer Intrinsic Classifier™
142. PancNext™
143. PancraGEN® (previously Pathfinder TG®) (Medicare coverage rescinded eff. 02/07/2025)
144. PancreaSeq Genomic Classifier
145. Panexia®
146. PanGIA Prostate
147. Paradigm Cancer Diagnostics [PCDx] Test
148. Pediatric Neurology Region of Interest Trio
149. Percepta Bronchial Genomic Classifier (covered for Medicare)
150. Pervenio™ Lung NGS (covered for Medicare)
151. PIGMENTED LESION Assay (covered for Medicare)
152. Pontocerebellar Hypoplasia Panel
153. Post-Op Px™ (formerly the Prostate Px Plus)
154. Praxis Extended RAS Panel (covered for Commercial and Medicare members; see Section I)
155. Praxis Somatic Transcriptome (covered for Medicare)
156. Praxis Transcriptome (covered for Medicare)
157. PredictSure IBD
158. PreludeDx™ DCISionRT®
159. Preparent Global Panel
160. Previstage™
161. Progenity CFnxt
162. Progenity® Pan-Ethnic Carrier Screening Panel
163. Prolaris (covered for Commercial and Medicare, see Section VI)
164. PROGENSA® PCA3 (Covered for Commercial and Medicare members; see Section VI)
165. ProOnc TumorSource DX
166. Proove profile panels (e.g., Opioid Risk Panel)
167. Prometheus® IBD sgi Diagnostic™
168. Prospera™ (Covered Medicare)
169. ProstateNext
170. ProstateNow
171. RadTox cfDNA
172. RenalNext™
173. ResponseDX Tissue Origin Test Rotterdam/Veridex (covered for Medicare)
174. RetnaGene AMD
175. Rotterdam Signature
176. Saethre-Chotzen Syndrome (TWIST) Sequencing and MLPA (Greenwood Genetic Center)
177. ScolioScore™ AIS Prognostic Test
178. SelectMDx for prostate cancer
179. Sema4 Signal Hereditary Cancer High Prevalence Panel
180. Signatera™ (Covered Medicare)
181. Spastic Paraplegia Next Generation Sequencing Panel
182. Stickler Syndrome NGS Panel
183. SymGene68™ Next Generation Sequencing Cancer Panel
184. SYMPHONY™ Genomic Breast Cancer Profile (combines BluePrint, MammaPrint and TargetPrint tests)
185. Skeletal Dysplasia Ciliopathy NGS Panel
186. SYMPHONY™ Personalized Breast Cancer Genomic Profile

187. TAADNext
188. Target Now™ molecular profiling test (aka MI Profile, MI Profile X)
189. TargetPrint®
190. Tempus nP (covered Medicare)
191. therascreen FGFR RGQ RT-PCR Kit (Covered for Commercial and Medicare members; see Section I)
192. therascreen PIK3CA RGQ PCR Kit (Covered for Commercial and Medicare members; see Section I)
193. TheraPrint®
194. theraSEEK Sequence Analysis for Functional Disorders
195. Thrombocytopenia NextGen Sequencing (NGS) Panel
196. TruGenome Undiagnosed Disease Test
197. TruGenome Technical Sequence Data (whole exome sequencing test for labs and physicians who will make their own clinical interpretations make their own clinical interpretations)
198. TruGraf® Kidney (covered for Medicare)
199. Tuteva
200. Universal Carrier Panel
201. Vectra DA (covered for Medicare)
202. Vita Risk™
203. Vitreoretinopathy NGS Panel
204. BDX-XL2 (formerly Xpresys Lung) (covered for Medicare) Revision History Apr 10, 2026 Added cross-reference to MCG criteria for Whole Genome/Exome Sequencing in Autism Spectrum Disorders in Guideline section Added Oncomap™ ExTra, Praxis Transcriptome, and Praxis Somatic Transcriptome as investigational (covered Medicare) Removed Guardant Shield™ as investigational Nov 14, 2025 Added clarification that sequencing more than 50 genes for hereditary cancer without a personal or family cancer history is unproven and not medically necessary Sept 12, 2025 Added transplant rejection language to positive-coverage section Added AvertD™ as investigational
     Added Genomind® Pharmacogenetics Report, Medication Management Neuropsychiatric Panel, and Tempus nP as investigational (covered Medicare) July 11, 2025 Added positive AlloSure® kidney and AlloSure lung coverage for Commercial and Medicaid members Added Haystack MRD™ to investigational list June 13, 2025 Added positive coverage criteria for the MyMRD® NGS Panel
     Removed Myeloid Molecular Profile from Limitations/Exclusions May 9, 2025 Added Commerial and Medicare coverage of the Abbott Alinity™ m STI Assay, Guardant Shield, and IsoPSA® tests Added NavDx Medicare Coverage Added Immunoscore® as investigational for all members Apr. 11, 2025 Added Guardant Reveal Medicare coverage Feb. 14, 2025 Consolidated 4Kscore, ConfirmMDx™, and ExoDx®Prostate IntelliScore (EPI) sections Reinstated Prolaris Commercial coverage eff. 1/1/2025

Consolidated Decipher and Prolaris sections and updated criteria
Added FoundationOne RNA and Prospera as investigational (covered Medicare) Updated Signatera investigational listing to communicate positive Medicare coverage Added notation to PancraGen investigational listing to communicate Medicare non-coverage eff. 2/7/2025 Aug. 15, 2024 Added DecisionDx Uveal Melanoma Commercial coverage (previously Medicare only) Feb. 9, 2024 Added Invitae Epilepsy and Hypoglycemia panels to investigational list Nov. 10, 2023 Added the following tests to investigational list: Genome PACT Primary Ciliary Dyskinesia Panel ProstateNow TruGraf as investigational (covered Medicare) Jul. 14, 2023 Added ClonoSEQ coverage Added the following tests to investigational list: Invitae Dystonia Comprehensive Panel and Hereditary Spastic Paraplegia Panel, PredictSure IBD, RadTox cfDNA Updated Medical Policy cross-referencing Oct. 14, 2022 Communicated discontinuance of Commercial coverage for Oncotype DX Prostate® and Prolaris® eff. Feb. 1, 2023 Added AlloSure® Heart (as a standalone or combination test with AlloMap [aka HeartCare Comprehensive Solution]) to investigational list (The AlloMap remains a covered standalone test for all members) Aug. 12, 2022 Added whole genome/exome sequencing section citing medically-necessary MCG criteria sets Updated Limitations/Exclusions section citing investigational MCG criteria sets Updated MCG cross-referencing
Jul. 27, 2022 Added explanatory for searching the FDA’s List of Cleared or Approved Companion Diagnostic Devices web page Apr. 13, 2022 Added the following tests to investigational list: Accelerate PhenoTest® BC kit, Bridge Urinary Tract Infection Detection and Resistance Test, Clarava, DecisionDx DiffDx – Melanoma, DecisionDx SCC, EpiSign Complete, Invitae PCM MRD Monitoring, Invitae PCM Tissue Profiling and MRD Baseline Assay, LungLB, PancreaSeq Genomic Classifier, PreludeDx™ DCISionRT® and Tuteva Feb. 18, 2022 Added Invitae Overgrowth Syndromes Panel as investigational Positive coverage notations added commensurate with Medical Technologies Database listings and Medicare Fee Schedule: ENGAUGE™-cancer-DLBCL (Medicare) Genomic Unity® AR Analysis (Medicare) Genomic Unity® CACNA1A Analysis (covered Commercial and Medicare) Genomic Unity® CSTB Analysis (covered Commercial and Medicare) Genomic Unity® FXN Analysis (covered Commercial and Medicare) Genomic Unity® SMN1/2 Analysis (covered Commercial and Medicare) myPath®Melanoma (Medicare) Oncotype MAP™ PanCancer Tissue Test (Medicare) OvaNext™ (Medicare) Oct. 19, 2021 Added Guardant Reveal™ as investigational Added note in Limitations/Exclusions designating BreastNext, CancerNext, and ColoNext as Medicare-covered per Medicare Fee Schedule
July 14, 2021 Added Commercial coverage for 4Kscore and ConfirmMDx (eff. 1/20/2021)

Added Commercial coverage for FoundationOne Liquid CDx and Guardant360 LDT Added Medicare coverage for ExoDx®Prostate IntelliScore (EPI) Added noncoverage note communicating that Proprietary lab analysis (PLA) codes are not covered for Medicaid members, as they are not reimbursed by NYS Medicaid Added noncoverage note communicating that CPT codes which are not on the Medicaid Lab Fee Schedule are not covered Updated list of lab tests regarded as investigational Jul. 8, 2020 Added MSK-IMPACT for Medicare members Removed FoundationOne CDx from Limitations/Exclusions Feb. 14, 2020 Added Plasma-Based Genomic Profiling in Solid Tumors LCD specific to Guardant360® for Medicare members Apr. 12, 2019 Added genomic sequence analysis panels (e.g., OncoVantage®) for Medicare members Mar. 8, 2019 Added Oncotype DCIS, Oncotype DX AR-V7 Nucleus and Xpresys Lung tests for Medicare members Feb. 8, 2018 Added Clonoseq® for Medicare members Added link to MYvantage® Hereditary Comprehensive Cancer Panel Medical Guideline and removed MYvantage from Limitations/Exclusions
Oct. 12, 2018 Removed Corus® CAD Medicare coverage effective Dec. 12. 2018 Aug. 8, 2018 Added Medicare coverage of Guardant360® Pervenio™ Lung NGS
May 5, 2018 Added Commercial and Medicaid coverage of the Decipher, Oncotype, Prolaris and ProMark gene/biomarker expression profiling tests for prostate cancer to pre-existing Medicare coverage Apr. 13, 2018 Added FoundationOne CDx test coverage for Medicare members Removed the following test, Thyroid, FNA Cytomorphology with Molecular tests (Quest), from the list of covered tests for thyroid lesions with indeterminate cytology (no longer available from Quest) Added language communicating noncoverage of testing to confirm results of consumer-based testing Added language clarifying that whole exome and whole genome sequencing is considered investigational Updated list of lab tests regarded as investigational
Apr. 14, 2017 Added ThyraMIR Thyroid miRNA classifier to list of eligible tests for thyroid lesions with indeterminate cytology Added Melaris to investigational list Feb. 2, 2017 Added the following tests to investigational list: Oncofocus®, Previstage™ Sept. 9, 2016 Added the following tests to investigational list: DecodEX, Oncovue, OvaNext™, Panexia® Aug. 12, 2016 Added Medicare coverage for CancerTYPE ID®. Added the following tests to investigational list: BrevaGEN/BrevaGENplus, My5-FU™ (previously OnDose™), OncoVantage™, OPA 1 gene sequencing for autosomal dominant optic atrophy and/or optic neuropathy, Proove Opioid Risk Test Jul. 8, 2016 Added the following tests to investigational list: Combined Cardiac Panel, Counsyl preconception carrier genetic screening, miReview®, Myeloid Molecular Profile, Paradigm Cancer Diagnostics [PCDx] Test, Pediatric Neurology Region of Interest Trio, Progenity® Pan-Ethnic Carrier Screening Panel, Rotterdam Signature, Saethre-Chotzen Syndrome (TWIST) Sequencing and MLPA, SelectMDx for prostate cancer 5/13/2016 Added Medicare coverage for Prosigna™ Breast Cancer Prognostic Gene Signature Assay.
Added GeneStrat and Molecular Intelligence to list of investigational tests.

Reinstated coverage of the following tests for Medicare members: Corus® CAD, ConfirmMDx™, Decipher® Prostate Classifier, Oncotype DX® Colon, Oncotype DX® prostate, Prolaris® and ResponseDX Tissue Origin Test
4/8/2016 Tests no longer covered for Medicare members (NGS Medicare Molecular Pathology LCD effective 4/1/2016) — Corus® CAD, ConfirmMDx™, Decipher® Prostate Classifier, Oncotype DX® colon, Oncotype DX® prostate, Prolaris® and ResponseDX Tissue Origin Test.
Non-covered tests added to investigational list — GeneFx® Colon, myPath® (NGS Medicare Molecular Pathology LCD effective 4/1/2016) 12/21/2015 Amended Limitations/Exclusions Section to reflect positive Medicare coverage for Oncotype Prostate. 10/9/2015 Amended Limitations/Exclusions Section to reflect positive Medicare coverage for Decipher Prostate Classifier and Prolaris 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 April 21, 2026. Centers for Medicare & Medicaid Services. National Coverage Determination for Next Generation Sequencing (NGS). Version 2. January 2020. https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?ncdid=372&ncdver=2&KeyWord=next%20generation%20sequencing&KeyWordLookUp=Title&KeyWordSearchType=Exact&bc=CA AAAAAAAAAA. Accessed April 21, 2026. National Cancer Care Network (NCCN). Clinical Practice Guidelines in Oncology. Colon Cancer. Version 2.2026. https://www.nccn.org/guidelines/category_1. Accessed April 21, 2026. National Cancer Care Network (NCCN). Clinical Practice Guidelines in Oncology. Cutaneous Melanoma. Version 2.2026. https://www.nccn.org/guidelines/category_1. Accessed April 21, 2026. National Cancer Care Network (NCCN). Clinical Practice Guidelines in Oncology. Acute Myeloid Leukemia. V3.2026. https://www.nccn.org/guidelines/category_1. Accessed April 21, 2026. National Cancer Care Network (NCCN). Clinical Practice Guidelines in Oncology. Multiple Myeloma. Version 3.2026. https://www.nccn.org/guidelines/category_1. Accessed April 21, 2026. National Cancer Care Network (NCCN). Clinical Practice Guidelines in Oncology. Myelodysplastic Syndromes. V3.2026. https://www.nccn.org/guidelines/category_1. Accessed April 21, 2026. National Cancer Care Network (NCCN). Clinical Practice Guidelines in Oncology. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Version 2.2026. https://www.nccn.org/guidelines/category_1. April 21, 2026.National Cancer Care Network (NCCN). Clinical Practice Guidelines in Oncology. Non-Small Cell Lung Cancer Version 5.2026. https://www.nccn.org/guidelines/category_1. Accessed April 21, 2026. National Cancer Care Network (NCCN). Clinical Practice Guidelines in Oncology. Occult Primary . Version 1.2026. https://www.nccn.org/guidelines/category_1. Accessed April 21, 2026. National Cancer Care Network (NCCN). Clinical Practice Guidelines in Oncology. Prostate Cancer Version 5.2026. https://www.nccn.org/guidelines/category_1. Accessed April 21, 2026. National Cancer Care Network (NCCN). Clinical Practice Guidelines in Oncology. Prostate Cancer Early Detection Version 2.2026. https://www.nccn.org/guidelines/category_2. Accessed April 21, 2026. New York State Department of Health. New York State Medicaid Program Fee-For-Service Laboratory Procedure Codes and Coverage Guidelines Manual. April 2026. https://www.emedny.org/providermanuals/laboratory/. Accessed April 21, 2026. Specialty-matched clinical peer review.