Humana Comprehensive Molecular Profiling for Hematologic Malignancies and Solid Tumors Form

. Description Comprehensive molecular profiling (also referred to as comprehensive genomic profiling) is a type of test that involves a combination of laboratory methodologies to detect genetic alterations and biomarkers in bone marrow or tumor tissue to aid in the management of hematologic malignancies and solid tumors. Techniques can vary from test to test and may include: • Chromogenic in situ hybridization (CISH) • Fluorescence in situ hybridization (FISH) • Fragment analysis • Immunohistochemistry (IHC) • Next-generation sequencing (NGS) Comprehensive Molecular Profiling for Hematologic Malignancies and Solid Tumors Effective Date: 01/01/2024 Revision Date: 01/01/2024 Review Date: 06/22/2023 Policy Number: HUM-0595-007 Page: 2 of 23 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. • Polymerase chain reaction (PCR) • Pyro sequencing (PyroSeq) • Sanger sequencing • Whole exome sequencing (WES) • Whole genome sequencing (WGS) • Whole transcriptome sequencing Testing results may aid in diagnosis, prognosis, monitoring, surveillance, guide treatment decisions and determine eligibility for participation in clinical trials. Some assays are purportedly used to provide information regarding microsatellite instability (MSI), measurable (minimal) residual disease (MRD) and tumor mutational burden (TMB). For information regarding TMB, please refer to Pharmacogenomics and Companion Diagnostics Medical Coverage Policy. Comprehensive molecular profiling may be utilized for the detection of MRD which is a term used for hematologic malignancies and is defined as the small number of cancer cells that remain in the body following treatment. Examples include ClonoSEQ MRD Detection and MyMRD Gene Panel Assay. LungOI is an artificial-intelligence (AI)-based molecular profiling that uses a digitized biopsy image and is proposed for the diagnosis of lung cancer. (Refer to Coverage Limitations section) Molecular profiling in conjunction with in vitro chemoresistance and chemosensitivity assays has been proposed to guide treatment decisions. (Refer to Coverage Limitations section) For information regarding in vitro chemoresistance and chemosensitivity assays, please refer to In Vitro Chemoresistance and Chemosensitivity Assays Medical Coverage Policy. For information regarding FoundationOne CDx, please refer to Pharmacogenomics and Companion Diagnostics Medical Coverage Policy. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Comprehensive Molecular Profiling for Hematologic Malignancies and Solid Tumors Effective Date: 01/01/2024 Revision Date: 01/01/2024 Review Date: 06/22/2023 Policy Number: HUM-0595-007 Page: 3 of 23 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. For information regarding FoundationOne Liquid, please refer to Liquid Biopsy Medical Coverage Policy. For information regarding Oncomine Dx Target Test for cholangiocarcinoma, please refer to Genetic Testing for Diagnosis and Monitoring of Cancer Medical Coverage Policy. For information regarding genetic testing for the following, please refer to Genetic Testing Medical Coverage Policy: • DNA banking or preservation • General population screening • Individual 17 years of age or younger for adult-onset conditions • Interpretation and reporting for molecular pathology procedure • Polygenic risk score (PRS) and single nucleotide polymorphisms (SNPs) • Repeat germline or somatic genetic testing • Retrieved archival tissue Humana recognizes that the field of genetic testing is rapidly changing and that other tests may become available. Coverage Determination Any state mandates for comprehensive molecular profiling for hematologic malignancies and solid tumors take precedence over this medical coverage policy. Genetic testing may be excluded by certificate. Please consult the member’s individual certificate regarding Plan coverage. Apply General Criteria for Genetic and Pharmacogenomics Tests when disease- or gene-specific criteria are not available on a medical coverage policy. For information regarding general criteria for genetic tests, please refer to Genetic Testing Medical Coverage Policy. Comprehensive Molecular Profiling for Hematologic Malignancies Humana members may be eligible under the Plan for comprehensive molecular profiling consisting of 50 or fewer genes (81450, 81451) for acute myeloid leukemia when the following criteria are met: See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Comprehensive Molecular Profiling for Hematologic Malignancies and Solid Tumors Effective Date: 01/01/2024 Revision Date: 01/01/2024 Review Date: 06/22/2023 Policy Number: HUM-0595-007 Page: 4 of 23 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. • For diagnostic workup; OR • Relapsed or refractory disease (NOTE: testing may be repeated at each relapse or progression); OR • To determine clinical trial eligibility Comprehensive Molecular Profiling for Solid Tumors Humana members may be eligible under the Plan for comprehensive molecular profiling (consisting of 50 or fewer genes) for solid tumors (81445, 81449) when the following criteria are met: • Diagnosed with recurrent, relapsed, refractory, metastatic or advanced stage III or IV cancer; AND • Has not previously received comprehensive molecular profiling for the same tumor type; AND • Treatment with anticancer therapy is being considered Measurable (Minimal) Residual Disease Humana members may be eligible under the Plan for ClonoSEQ MRD Detection (0364U) for the assessment of MRD for the following indications when criteria are met: • Acute lymphoblastic leukemia; AND o Prior to treatment for baseline assessment; OR o Assessment of molecular relapse or persistent low-level disease burden; OR o Following induction or consolidation; OR o Surveillance; OR • Chronic lymphoblastic leukemia; AND o Prior to treatment for baseline assessment; OR o Following treatment; OR See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Comprehensive Molecular Profiling for Hematologic Malignancies and Solid Tumors Effective Date: 01/01/2024 Revision Date: 01/01/2024 Review Date: 06/22/2023 Policy Number: HUM-0595-007 Page: 5 of 23 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. • Multiple myeloma; AND o Prior to treatment for baseline assessment; OR o Suspected complete response following induction, high-dose therapy/autologous stem cell transplant, consolidation or maintenance Humana members may be eligible under the Plan for MyMRD Gene Panel Assay (0171U) for the assessment of MRD for acute myeloid leukemia when the following criteria are met: • Prior to treatment for baseline assessment; OR • Following initial induction; OR • Before allogenic hematopoietic cell transplantation Note: The criteria for comprehensive molecular profiling for hematologic malignancies and solid tumors are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information. Coverage Limitations Humana members may NOT be eligible under the Plan for comprehensive molecular profiling for any indications or tests other than those listed above including, but may not be limited to: • ACTOnco IVD Assay • Adjunct to in vitro chemoresistance and chemosensitivity assays • Altera Tumor Genomic Profiling (offered in conjunction with Signatera; refer to Liquid Biopsy Medical Coverage Policy) • Caris Molecular Intelligence (MI) including, but may not be limited to: o Caris MI Profile Comprehensive Testing o Caris MI Tumor Seek See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Comprehensive Molecular Profiling for Hematologic Malignancies and Solid Tumors Effective Date: 01/01/2024 Revision Date: 01/01/2024 Review Date: 06/22/2023 Policy Number: HUM-0595-007 Page: 6 of 23 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. • CureMatch (0794T) • FoundationOne Heme • Guardant360 TissueNext (0334U) • Integrated Mutation Profiling of Actionable Cancer Targets (MSK-IMPACT) (0048U) • LungOI (0414U) • Moffitt STAR (Solid Tumor Actionable Result) • Myriad Precise Tumor • NeoTYPE Cancer Profiles including, but may not be limited to: o NeoTYPE Breast Tumor Profile o NeoTYPE Broad Reach Tumor Profiles including Hematologic Disease Profile and Solid Tumor Profile o NeoTYPE Cancer Profile (offered as a reflex test for CancerTYPE ID; for information regarding CancerTYPE ID, please refer to Gene Expression Profiling for Cancer Indications Medical Coverage Policy) o NeoTYPE CLL Prognostic Profiling o NeoTYPE Next-Gen Cancer Specific Profiles including Hematologic Disease Profile and Solid Tumor Profile • OmniSeq panels including, but may not be limited to: o OmniSeq Advance o OmniSeq Comprehensive o OmniSeq INSIGHT o OmniSeq Target See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Comprehensive Molecular Profiling for Hematologic Malignancies and Solid Tumors Effective Date: 01/01/2024 Revision Date: 01/01/2024 Review Date: 06/22/2023 Policy Number: HUM-0595-007 Page: 7 of 23 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. • OncoExTra (formerly known as Oncomap ExTra and GEM ExTra) (0329U) • ONcoGxOne • Oncomap (formerly known as Oncotype MAP Pan-Cancer Tissue Test and Paradigm Cancer Diagnostic [PCDx]) (0244U) • OncoPlus Universal Cancer Mutation Analysis Panel • PCDx • PGDx elio tissue complete (0250U) • Prima panels including, but may not be limited to: o Prima Comprehensive Tumor Panel o Prima Somatic Cancer Mutation Panel • Quest Diagnostics Solid Tumor Expanded Panel (0379U) • StrataNGS • Strata Select (0391U) • SureSeq CLL + CNV Panel • Targeted DNA and RNA genomic sequence analysis panel of 51 or more genes associated with solid organ or hematolymphoid neoplasm (CPT code 81455, 81456) • Tempus panels including, but may not be limited to, Tempus xT • TheraMap panels including, but may not be limited to: o TheraMap: Myeloid Malignancies o TheraMap: Solid Tumor o TheraMap: Solid Tumor with Reflex See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Comprehensive Molecular Profiling for Hematologic Malignancies and Solid Tumors Effective Date: 01/01/2024 Revision Date: 01/01/2024 Review Date: 06/22/2023 Policy Number: HUM-0595-007 Page: 8 of 23 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language. Background Additional information about cancer may be found from the following websites: • American Cancer Society • National Library of Medicine Medical Alternatives Physician consultation is advised to make an informed decision based on an individual’s health needs. Humana may offer a disease management program for this condition. The member may call the number on his/her identification card to ask about our programs to help manage his/her care. Provider Claims Codes Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure. CPT® Code(s) 81445 81449 Description Comments Targeted genomic sequence analysis panel, solid organ neoplasm, DNA analysis, and RNA analysis when performed, 5- 50 genes (eg, ALK, BRAF, CDKN2A, EGFR, ERBB2, KIT, KRAS, NRAS, MET, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed Targeted genomic sequence analysis panel, solid organ neoplasm, 5-50 genes (eg, ALK, BRAF, CDKN2A, EGFR, ERBB2, KIT, KRAS, MET, NRAS, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed; RNA analysis See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Comprehensive Molecular Profiling for Hematologic Malignancies and Solid Tumors Effective Date: 01/01/2024 Revision Date: 01/01/2024 Review Date: 06/22/2023 Policy Number: HUM-0595-007 Page: 9 of 23 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Targeted genomic sequence analysis panel, hematolymphoid neoplasm or disorder, DNA analysis, and RNA analysis when performed, 5-50 genes (eg, BRAF, CEBPA, DNMT3A, EZH2, FLT3, IDH1, IDH2, JAK2, KRAS, KIT, MLL, NRAS, NPM1, NOTCH1), interrogation for sequence variants, and copy number variants or rearrangements, or isoform expression or mRNA expression levels, if performed Targeted genomic sequence analysis panel, hematolymphoid neoplasm or disorder, 5-50 genes (eg, BRAF, CEBPA, DNMT3A, EZH2, FLT3, IDH1, IDH2, JAK2, KIT, KRAS, MLL, NOTCH1, NPM1, NRAS), interrogation for sequence variants, and copy number variants or rearrangements, or isoform expression or mRNA expression levels, if performed; RNA analysis Targeted genomic sequence analysis panel, solid organ or hematolymphoid neoplasm, DNA analysis, and RNA analysis when performed, 51 or greater genes (eg, ALK, BRAF, CDKN2A, CEBPA, DNMT3A, EGFR, ERBB2, EZH2, FLT3, IDH1, IDH2, JAK2, KIT, KRAS, MLL, NPM1, NRAS, MET, NOTCH1, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed Targeted genomic sequence analysis panel, solid organ or hematolymphoid neoplasm or disorder, 51 or greater genes (eg, ALK, BRAF, CDKN2A, CEBPA, DNMT3A, EGFR, ERBB2, EZH2, FLT3, IDH1, IDH2, JAK2, KIT, KRAS, MET, MLL, NOTCH1, NPM1, NRAS, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, or isoform expression or mRNA expression levels, if performed; RNA analysis Solid organ neoplasm, genomic sequence analysis panel, interrogation for sequence variants; DNA analysis, microsatellite instability Solid organ neoplasm, genomic sequence analysis panel, interrogation for sequence variants; DNA analysis, copy number variants and microsatellite instability 81450 81451 81455 81456 81457 81458 Not Covered if used to report any test outlined in Coverage Limitations section Not Covered New Code Effective 01/01/2024 New Code Effective 01/01/2024 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Comprehensive Molecular Profiling for Hematologic Malignancies and Solid Tumors Effective Date: 01/01/2024 Revision Date: 01/01/2024 Review Date: 06/22/2023 Policy Number: HUM-0595-007 Page: 10 of 23 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 81459 Solid organ neoplasm, genomic sequence analysis panel, interrogation for sequence variants; DNA analysis or combined DNA and RNA analysis, copy number variants, microsatellite instability, tumor mutation burden, and rearrangements 81479 Unlisted molecular pathology procedure 81540 0022U 0048U 0171U 0211U Oncology (tumor of unknown origin), mRNA, gene expression profiling by real-time RT-PCR of 92 genes (87 content and 5 housekeeping) to classify tumor into main cancer type and subtype, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a probability of a predicted main cancer type and subtype Targeted genomic sequence analysis panel, non-small cell lung neoplasia, DNA and RNA analysis, 23 genes, interrogation for sequence variants and rearrangements, reported as presence/absence of variants and associated therapy(ies) to consider Oncology (solid organ neoplasia), DNA, targeted sequencing of protein-coding exons of 468 cancer-associated genes, including interrogation for somatic mutations and microsatellite instability, matched with normal specimens, utilizing formalin- fixed paraffin-embedded tumor tissue, report of clinically significant mutation(s) Targeted genomic sequence analysis panel, acute myeloid leukemia, myelodysplastic syndrome, and myeloproliferative neoplasms, DNA analysis, 23 genes, interrogation for sequence variants, rearrangements and minimal residual disease, reported as presence/absence Oncology (pan-tumor), DNA and RNA by next-generation sequencing, utilizing formalin-fixed paraffin-embedded tissue, interpretative report for single nucleotide variants, copy number alterations, tumor mutational burden, and microsatellite instability, with therapy association New Code Effective 01/01/2024 Not Covered if used to report any test outlined in Coverage Limitations section Not Covered Not Covered Not Covered Test Obsolete/No Longer Available See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Comprehensive Molecular Profiling for Hematologic Malignancies and Solid Tumors Effective Date: 01/01/2024 Revision Date: 01/01/2024 Review Date: 06/22/2023 Policy Number: HUM-0595-007 Page: 11 of 23 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 0244U 0250U 0329U 0334U 0364U 0379U Oncology (solid organ), DNA, comprehensive genomic profiling, 257 genes, interrogation for single-nucleotide variants, insertions/deletions, copy number alterations, gene rearrangements, tumor-mutational burden and microsatellite instability, utilizing formalin-fixed paraffin-embedded tumor tissue Oncology (solid organ neoplasm), targeted genomic sequence DNA analysis of 505 genes, interrogation for somatic alterations (SNVs [single nucleotide variant], small insertions and deletions, one amplification, and four translocations), microsatellite instability and tumor-mutation burden Oncology (neoplasia), exome and transcriptome sequence analysis for sequence variants, gene copy number amplifications and deletions, gene rearrangements, microsatellite instability and tumor mutational burden utilizing DNA and RNA from tumor with DNA from normal blood or saliva for subtraction, report of clinically significant mutation(s) with therapy associations Oncology (solid organ), targeted genomic sequence analysis, formalin-fixed paraffin-embedded (FFPE) tumor tissue, DNA analysis, 84 or more genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability and tumor mutational burden Oncology (hematolymphoid neoplasm), genomic sequence analysis using multiplex (PCR) and next-generation sequencing with algorithm, quantification of dominant clonal sequence(s), reported as presence or absence of minimal residual disease (MRD) with quantitation of disease burden, when appropriate Targeted genomic sequence analysis panel, solid organ neoplasm, DNA (523 genes) and RNA (55 genes) by next- generation sequencing, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutational burden Not Covered Not Covered Not Covered Not Covered New Code Effective 04/01/2023 Not Covered New Code Effective 04/01/2023 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Comprehensive Molecular Profiling for Hematologic Malignancies and Solid Tumors Effective Date: 01/01/2024 Revision Date: 01/01/2024 Review Date: 06/22/2023 Policy Number: HUM-0595-007 Page: 12 of 23 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Oncology (solid tumor), DNA and RNA by next-generation sequencing, utilizing formalin-fixed paraffin-embedded (FFPE) tissue, 437 genes, interpretive report for single nucleotide variants, splice- site variants, insertions/deletions, copy number alterations, gene fusions, tumor mutational burden, and microsatellite instability, with algorithm quantifying immunotherapy response score Oncology (lung), augmentative algorithmic analysis of digitized whole slide imaging for 8 genes (ALK, BRAF, EGFR, ERBB2, MET, NTRK1-3, RET, ROS1), and KRAS G12C and PD-L1, if performed, formalin-fixed paraffin-embedded (FFPE) tissue, reported as positive or negative for each biomarker Not Covered New Code Effective 07/01/2023 Not Covered New Code Effective 10/01/2023 Description Comments Patient-specific, assistive, rules-based algorithm for ranking pharmaco-oncologic treatment options based on the patient's tumor-specific cancer marker informationobtained from prior molecular pathology, immunohistochemical, or other pathology results which have been previously interpreted and reported separately Not Covered New Code Effective 07/01/2023 Description Comments 0391U 0414U CPT® Category III Code(s) 0794T HCPCS Code(s) No code(s) identified References 1. 2. American Academy of Dermatology (AAD). Guidelines of care for the management of primary cutaneous melanoma. https://www.aad.org. Published January 2019. Accessed May 30, 2023. American Society of Clinical Oncology (ASCO). Metastatic pancreatic cancer: ASCO guideline update. https://www.asco.org. Published 2020. Accessed May 30, 2023. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Comprehensive Molecular Profiling for Hematologic Malignancies and Solid Tumors Effective Date: 01/01/2024 Revision Date: 01/01/2024 Review Date: 06/22/2023 Policy Number: HUM-0595-007 Page: 13 of 23 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 3. 4. 5. 6. 7. 8. 9. American Society of Clinical Oncology (ASCO). Somatic genomic testing in patients with metastatic or advanced cancer: ASCO provisional clinical opinion. https://www.asco.org. Published February 17, 2022. Accessed May 30, 2023. American Thyroid Association (ATA). 2021 American Thyroid Association guidelines for management of patients with anaplastic thyroid cancer: American Thyroid Association Anaplastic Thyroid Cancer Guidelines Task Force. https://www.thyroid.org. Published 2021. Accessed May 30, 2023. Association for Molecular Pathology (AMP). Guidelines for validation of next- generation sequencing-based oncology panels: a joint consensus recommendation of the Association for Molecular Pathology and College of American Pathologists. https://www.amp.org. Published May 2017. Accessed May 30, 2023. Association for Molecular Pathology (AMP). Clinical significance of DNA variants in chronic myeloid neoplasms: a report of the Association for Molecular Pathology. https://www.amp.org. Published November 2018. Accessed May 30, 2023. Association for Molecular Pathology (AMP). Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors: guideline from the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. https://www.amp.org. Published March 2018. Accessed May 30, 2023. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Next generation sequencing (NGS) (90.2). https://www.cms.gov. Published November 13, 2020. Accessed May 30, 2023. College of American Pathologists (CAP). Molecular biomarker testing for the diagnosis of diffuse gliomas: guideline from the College of American Pathologists in collaboration with the American Association of Neuropathologists, Association for Molecular Pathology, and Society for Neuro-Oncology. https://www.cap.org. Published May 2022. Accessed May 30, 2023. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Comprehensive Molecular Profiling for Hematologic Malignancies and Solid Tumors Effective Date: 01/01/2024 Revision Date: 01/01/2024 Review Date: 06/22/2023 Policy Number: HUM-0595-007 Page: 14 of 23 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 10. ECRI Institute. ECRI Genetic Test Assessment. Altera Tumor Profiling Test (Natera, Inc.) for guiding targeted therapy selection for solid tumor cancers. https://www.ecri.com. Published July 2022. Accessed May 8, 2023. 11. ECRI Institute. ECRI Genetic Test Assessment. clonoSEQ Assay (Adaptive Biotechnologies) for assessing prognosis of blood cancers and monitoring minimal residual disease. https://www.ecri.com. Published August 2022. Accessed May 8, 2023. 12. ECRI Institute. ECRI Genetic Test Assessment. GEM ExTra Cancer Panel (Ashion Analytics) for guiding targeted therapy for solid tumors and hematological malignancies. https://www.ecri.com. Published August 2021. Accessed May 8, 2023. 13. ECRI Institute. ECRI Genetic Test Assessment. Hematology Profile (Genomic Testing Cooperative) for evaluating hematologic diseases. https://www.ecri.com. Published September 2022. Accessed May 8, 2023. 14. ECRI Institute. ECRI Genetic Test Assessment. NeoLAB Myeloid Disorders Profile (NeoGenomics Laboratories, Inc.) to assess prognosis, guide therapy, and monitor treatment response for myeloid disorders. https://www.ecri.com. Published February 2021. Accessed May 8, 2023. 15. ECRI Institute. ECRI Genetic Test Assessment. OmniSeq Insight (OmniSeq, LLC) for guiding therapy selection for solid tumor cancers. https://www.ecri.com. Published July 2022. Accessed May 8, 2023. 16. ECRI Institute. ECRI Genetic Test Assessment. OncoGxOne (Admera Health) for guiding targeted therapy selection for solid tumor cancers. https://www.ecri.com. Published July 2022. Accessed May 8, 2023. 17. ECRI Institute. ECRI Genetic Test Assessment. Paradigm Cancer Diagnostic PCDx Test (Paradigm Diagnostics, Inc.) for guiding targeted therapy for solid tumors. https://www.ecri.com. Published March 2021. Accessed May 8, 2023. 18. ECRI Institute. ECRI Genetic Test Assessment. PGDx elio tissue complete (Personal Genome Diagnostics, Inc.) for guiding targeted therapy for solid See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Comprehensive Molecular Profiling for Hematologic Malignancies and Solid Tumors Effective Date: 01/01/2024 Revision Date: 01/01/2024 Review Date: 06/22/2023 Policy Number: HUM-0595-007 Page: 15 of 23 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. tumor cancers. https://www.ecri.com. Published August 2021. Accessed May 8, 2023. 19. ECRI Institute. ECRI Genetic Test Assessment. Prima Comprehensive Tumor Panel (MedGenome Labs Pvt Ltd) for guiding targeted cancer therapy. https://www.ecri.com. Published August 2020. Accessed May 8, 2023. 20. ECRI Institute. ECRI Genetic Test Assessment. Prima Somatic Cancer Mutation Panel (MedGenome Labs Pvt Ltd) for guiding targeted cancer therapy. https://www.ecri.com. Published July 2020. Accessed May 8, 2023. 21. ECRI Institute. ECRI Genetic Test Assessment. StrataNGS (Strata Oncology, Inc.) for guiding targeted therapy for solid tumor cancers. https://www.ecri.com. Published August 2021. Accessed May 8, 2023. 22. ECRI Institute. ECRI Genetic Test Assessment. Tempus xT (Tempus) to guide targeted therapy for solid tumor cancers. https://www.ecri.com. Published November 2022. Accessed May 8, 2023. 23. ECRI Institute. ECRIgene (ARCHIVED). Caris Molecular Intelligence Profiling Test (Caris Life Sciences) for informing management of solid tumors. https://www.ecri.com. Published April 2018. Accessed May 8, 2023. 24. ECRI Institute. ECRIgene (ARCHIVED). MSK-IMPACT (MSKCC) genomic profiling test for guiding targeted therapy for solid tumors. https://www.ecri.com. Published February 2019. Accessed May 8, 2023. 25. ECRI Institute. ECRIgene (ARCHIVED). Oncomine Dx Target Test (Thermo Fisher Scientific, Inc.) companion diagnostic for guiding targeted therapy for NSCLC. https://www.ecri.com. Published June 2018. Accessed May 9, 2023. 26. ECRI Institute. ECRIgene Genetic Test Product Brief. FoundationOne Heme (Foundation Medicine, Inc.) genomic profiling test for guiding therapy for blood cancers and sarcomas. https://www.ecri.com. Published January 2020. Accessed May 8, 2023. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Comprehensive Molecular Profiling for Hematologic Malignancies and Solid Tumors Effective Date: 01/01/2024 Revision Date: 01/01/2024 Review Date: 06/22/2023 Policy Number: HUM-0595-007 Page: 16 of 23 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 27. Hayes, Inc. Genetic Test Evaluation (GTE) Synopsis (ARCHIVED). OmniSeq Comprehensive (OmniSeq). https://evidence.hayesinc.com. Published February 2, 2017. Accessed May 9, 2023. 28. Hayes, Inc. Genetic Test Evaluation (GTE) Synopsis (ARCHIVED). OmniSeq Target. https://evidence.hayesinc.com. Published October 29, 2015. Accessed May 9, 2023. 29. Hayes, Inc. Genetic Test Evaluation (GTE) Synopsis (ARCHIVED). Paradigm Cancer Diagnostic (PCDx) Test. https://evidence.hayesinc.com. Published August 27, 2015. Accessed May 9, 2023. 30. Hayes, Inc. Molecular Test Assessment. clonoSEQ (Adaptive Biotechnologies). https://evidence.hayesinc.com. Published June 22, 2022. Accessed May 9, 2023. 31. Hayes, Inc. Molecular Test Assessment. FoundationOneHeme (Foundation Medicine Inc.). https://evidence.hayesinc.com. Published January 18, 2018. Updated February 4, 2022. Accessed May 9, 2023. 32. Hayes, Inc. Molecular Test Assessment. MI Profile (Caris Life Sciences) for the intended use as a broad molecular profiling tool. https://evidence.hayesinc.com. Published May 3, 2022. Accessed May 9, 2023. 33. Hayes, Inc. Molecular Test Assessment. MI TumorSeek (Caris Life Sciences). https://evidence.hayesinc.com. Published September 17, 2019. Updated August 25, 2020. Accessed May 9, 2023. 34. Hayes, Inc. Precision Medicine Insights. Comprehensive molecular profiling test(s) for solid tumors intended to be used as broad molecular profiling tool to assigned matched therapy. https://evidence.hayesinc.com. Published January 11, 2022. Accessed May 9, 2023. 35. Hayes, Inc. Precision Medicine Research Brief. Guardant360 TissueNext (Guardant Health Inc.). https://evidence.hayesinc.com. Published May 3, 2023. Accessed May 9, 2023. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Comprehensive Molecular Profiling for Hematologic Malignancies and Solid Tumors Effective Date: 01/01/2024 Revision Date: 01/01/2024 Review Date: 06/22/2023 Policy Number: HUM-0595-007 Page: 17 of 23 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 36. Hayes, Inc. Precision Medicine Research Brief. 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