August 17, Dear Valued Client:
|
|
- Suzanna Rodgers
- 5 years ago
- Views:
Transcription
1 August 7, 08 Re: CMS Announces 6-Month Period of Enforcement Discretion for Laboratory Date of Service Exception Policy Under the Medicare Clinical Laboratory Fee Schedule (the 4 Day Rule ) Dear Valued Client: As you may be aware, on July 3, 08 the Centers for Medicare & Medicaid Services (CMS) announced that it is exercising enforcement discretion until January, 09, with respect to the laboratory date of service (DOS) exception policy under the Medicare Clinical Laboratory Fee Schedule (CLFS) (See 4 CFR 44.50(b)(5)) (the 4 Day Rule ). This enforcement discretion applies to providers and suppliers with regard to advanced diagnostic laboratory tests (ADLTs) and molecular pathology tests subject to the new laboratory DOS exception policy, as adopted in the CY 08 Medicare Hospital Outpatient Prospective Payment System/Ambulatory Surgical Center final rule published on December 4, 07 (See 8 FR 59393). According to CMS, based on industry feedback that many providers and suppliers would not be able to implement the new laboratory DOS exception by the July, 08 implementation date, CMS granted this extension to enable providers and suppliers additional time to develop the systems changes necessary to enable the performing laboratory to bill for tests subject to the new laboratory DOS exception. During the enforcement discretion period, hospitals may continue to bill for ADLTs and molecular pathology tests that would otherwise be subject to the new laboratory DOS exception, but does not prevent performing laboratories prepared to bill Medicare directly for ADLTs and molecular pathology tests subject to the new laboratory DOS exception from doing so before January, 09. However, per CMS, in no case should both the hospital and the performing laboratory bill for the same test for the same beneficiary. During this enforcement discretion period, will be working with you to facilitate accurate implementation of the new laboratory DOS exception policy by January, 09. To that end, and, to ensure that you have current information on the specific laboratory test codes subject to the laboratory DOS exception, please see the summary table attached as Exhibit A to this letter, which incorporates updated CPT codes published by Palmetto GBA, our Medicare contractor. You may also visit CMS website at: Policy.html. Also, to ensure continued compliance with applicable coverage rules, effective August, 08, will no longer bill third party payers for code G045, Molecular Interpretation. If you have questions regarding this letter and the attachment, please contact your local Territory Business Manager for more information. Thank you for your continued assistance in complying with these updated Medicare changes. Sincerely, Robert J. Shovlin President, Clinical Services Attachment Out-Patient Billing CPT Codes Laboratories Florida Laboratories California 70 Commonwealth Dr., Suite 9 3 Columbia T: Fort Myers, FL 3393 Aliso Viejo, CA 9656 F:
2 Out-Patient Billing CPT Codes Updated Date: August 3, 08 Client Billed Molecular Tests HPV DNA Tissue Testing 8764 No Medicare Billed - Molecular Tests NeoARRAY NeoARRAY SNP/Cytogenetic Profile No 89 NeoLAB NeoLAB AML Profile - No NeoLAB BTK Inhibitor Acquired Resistance Panel - No NeoLAB EGFR T790M - No NeoLAB FLT3 Mutation Analysis - No NeoLAB IDH Mutation Analysis - No 80 7 NeoLAB IDH Mutation Analysis - No 8 8 NeoLAB inv(6), CBFB-MYH Translocation - No NeoLAB KIT (c-kit) Mutation Analysis - No 87 0 NeoLAB KRAS Mutation Analysis - No 875 NeoLAB MDS/CMML Profile - No 8450 NeoLAB Myeloid Disorders Profile - No NeoLAB NPM Mutation Analysis - No NeoLAB NRAS Mutation Analysis - No 83 5 NeoLAB PML-RARA Translocation, t(5;7) - No NeoLAB Prostate - No 00M 7 NeoLAB RUNX-RUNXT (AML-ETO) Translocation, t(8;) - No NeoLAB Solid Tumor Monitor - No 8479 NeoTYPE 9 NeoTYPE AML Prognostic Profile No NeoTYPE AITL/Peripheral T-Cell Lymphoma Profile No 8479 CPT Code G045 is not billed in NeoTYPE, NeoLAB Page
3 Out-Patient Billing CPT Codes Updated Date: August 3, 08 NeoTYPE NeoTYPE AML Favorable-Risk Profile No 8479 NeoTYPE Brain Tumor Profile, No NeoTYPE Breast Tumor Profile No NeoTYPE Cervical Tumor Profile No NeoTYPE CLL Prognostic Profile No NeoTYPE Colorectal Tumor Profile No NeoTYPE Discovery Profile for Solid Tumors No NeoTYPE Endometrial Tumor Profile No NeoTYPE Esophageal Tumor Profile No NeoTYPE Gastric Tumor Profile No NeoTYPE GI Predictive Profile No NeoTYPE GIST Profile No NeoTYPE Head & Neck Tumor Profile No NeoTYPE JMML Profile No NeoTYPE Liposarcoma Fusion Profile No NeoTYPE Liver/Biliary Tumor Profile No NeoTYPE Lung Tumor Profile No NeoTYPE Lymphoma Profile No NeoTYPE MDS/CMML Profile No NeoTYPE Melanoma Profile No NeoTYPE MPN Profile No NeoTYPE Myeloid Disorders Profile No NeoTYPE Other Solid Tumor Profile No NeoTYPE Ovarian Tumor Profile No NeoTYPE Pancreas Tumor Profile No NeoTYPE Precision Profile for Solid Tumors No NeoTYPE Soft Tissue Tumor Profile No NeoTYPE Thyroid Profile No BRCA Mutation & Del/Dup Analysis No BRCA/ Mutation & Del/Dup Analysis No 86 5 Hereditary Cancer Comprehensive Panel No Hereditary Cancer Susceptibility for Pediatrics No Hereditary DNA Repair Panel for Prostate Cancer No 8445 CPT Code G045 is not billed in NeoTYPE, NeoLAB Page
4 Out-Patient Billing CPT Codes Updated Date: August 3, Lynch Syndrome No ABL Kinase Domain Mutation Analysis No ALK Mutation Analysis No Androgen Receptor Mutation Analysis No ASXL Mutation Analysis No ATRX Mutation Analysis No B-Cell Gene Rearrangement No BCL Translocation, t(;4) No BCL Translocation, t(4;8) No BCR-ABL Non-Standard p30 No BCR-ABL Standard p0, p90 No BRAF Mutation Analysis No BRCA Mutation & Del/Dup Analysis No BTK Inhibitor Acquired Resistance Panel No BTK Inhibitor Primary Susceptibility Panel No BTK Mutation Analysis No CALR Mutation Analysis No 89 7 CARD Mutation Analysis No CBL Mutation Analysis No CD79B Mutation Analysis No CEBPA Mutation Analysis No Chimerism/DNA Fingerprinting Analysis No 865 or 866 or 867 or CSF3R Mutation Analysis No CXCR4 Mutation Analysis No DNMT3A Mutation Analysis No EGFR Mutation Analysis No EGFR T790M Germline Mutation Analysis No EGFRvIII Analysis No EPCAM Mutation & Del/Dup Analysis No ETV6 Mutation Analysis No ETV6-RUNX (TEL-AML) Translocation, t(;) No EZH Mutation Analysis No 8479 CPT Code G045 is not billed in NeoTYPE, NeoLAB Page 3
5 Out-Patient Billing CPT Codes Updated Date: August 3, FLT3 Mutation Analysis No GNAS Mutation Analysis No HOXB3 Genotyping No HRAS Mutation Analysis No HSD3B Genotyping No IDH & IDH Mutation Analysis No IgH Clonality/MRD by NGS No IgVH Mutation Analysis No Inherited Bone Marrow Failure Panel No inv(6), CBFB-MYH Translocation No JAK Exon -4 Mutation Analysis No 97 JAK V67F Mutation Analysis No JAK Exon -4 only: 8403x. JAK V67F and Exon -4 run concurrently or by reflex: 870x, 8403x JAK V67F only: 870x. JAK V67F and Exon -4 run concurrently or by reflex: 870x, 8403x 98 KIT (c-kit) Mutation Analysis No KRAS Exon 4 Mutation Analysis No KRAS Mutation Analysis No MET (c-met) Mutation Analysis No MET Exon 4 Deletion Analysis No MGMT Promoter Methylation Analysis No Microsatellite Instability Analysis (MSI) No MLH Mutation & Del/Dup Analysis No MLH Promoter Methylation Analysis No MPL Mutation Analysis No MPN Extended Reflex Panel No MPN Standard Reflex Panel No MSH Mutation & Del/Dup Analysis No 897 MSH6 Mutation & Del/Dup Analysis No 898 CPT Code G045 is not billed in NeoTYPE, NeoLAB Page 4
6 Out-Patient Billing CPT Codes Updated Date: August 3, 08 MYD88 Mutation Analysis No NGS ALK, NTRK, RET, ROS Fusion Profile No NGS ALK, RET, ROS Fusion Profile No NGS Comprehensive Sarcoma Fusion Profile No NGS Ewing Sarcoma Fusion Profile No NGS Non-Ewing Sarcoma Fusion Profile No NGS Pediatric Sarcoma Fusion Profile No NGS Rhabdomyosarcoma Fusion Profile No NGS Thyroid Fusion Profile No 8479 NOTCH Mutation Analysis No 8407 NPM MRD Mutation Analysis No NPM Mutation Analysis No NRAS Exon 4 Mutation Analysis No NRAS Mutation Analysis No 83 6 Oncomine Dx Target Test No 00U 7 PDGFRa Mutation Analysis No PIK3CA Mutation Analysis No PLC-Gamma- Mutation Analysis No PML-RARA Translocation, t(5;7) No PMS Mutation & Del/Dup Analysis No PPMD Mutation Analysis No PTEN Mutation Analysis No PTPN Mutation Analysis No RAS/RAF Panel No RHOA Mutation Analysis No RUNX Mutation Analysis No RUNX-RUNXT (AML-ETO) Translocation, t(8;) No SETBP Mutation Analysis No SF3B Mutation Analysis No SRSF Mutation Analysis No STAT3 Mutation Analysis No T-Cell Receptor Beta Gene Rearrangement No T-Cell Receptor Gamma Gene Rearrangement No 834 CPT Code G045 is not billed in NeoTYPE, NeoLAB Page 5
7 Out-Patient Billing CPT Codes Updated Date: August 3, TERT Promoter Mutation Analysis No TET Mutation Analysis No TP53 Mutation Analysis No TPMT Genotyping No Tumor Mutation Burden No UAF Mutation Analysis No UGTA Genotyping No Universal Fusion/Expression Profile No WT Mutation Analysis No ZRSR Mutation Analysis No 8479 CPT Code G045 is not billed in NeoTYPEs, NeoLAB CPT code(s) updated - See List of tests with updated CPT Code(s) List of Tests with Updated CPT Code(s) Test No. 5 0 Test Name NeoLAB FLT3 Mutation Analysis - NeoLAB KRAS Mutation Analysis - March 08 August 08 No 845, 846 No 8479 No 875, 876 No 875 NeoTYPE Brain Tumor Profile No 8445, G045 No NeoTYPE GI Predictive Profile No 80, 8403x, 875, 876x, 83, 830, G045 No B-Cell Gene Rearrangement No 86, 864 No BCL Translocation, t(4;8) No 840 No BCR-ABL Standard p0, p90 No 806, 807 No BTK Mutation Analysis No 8479 No FLT3 Mutation Analysis No 845 No IDH & IDH Mutation Analysis No 80, 8 No Inherited Bone Marrow Failure Panel No 8455, 8479 No KRAS Mutation Analysis No 875, 876 No 875 Page 6
8 Out-Patient Billing CPT Codes Updated Date: August 3, 08 List of Tests with Updated CPT Code(s) (Continued) Test No. Test Name March 08 August MPN Extended Reflex Panel No 09 MPN Standard Reflex Panel No 89, 870, 840, , 840, 8403 No 8479 No NGS ALK, NTRK, RET, ROS Fusion Profile No 8445 No NGS ALK, RET, ROS Fusion Profile No 8404, 8479x No NGS Comprehensive Sarcoma Fusion Profile NGS Non-Ewing Sarcoma Fusion Profile NGS Pediatric Sarcoma Fusion Profile No 8445 No 8479 No 8445 No 8479 No 8445 No NGS Thyroid Fusion Profile No 8405, 8479x No RAS/RAF Panel No 83x, 8404x, 8405x, 8406x No RUNX Mutation Analysis No 840 No Universal Fusion/Expression Profile No 8455 No Commonwealth Dr., Suite 9 Fort Myers, FL 3393 Phone: / Fax: neogenomics.com 08 Laboratories, Inc. All Rights Reserved. All other trademarks are the property of their respective owners. Rev. 0838
Out-Patient Billing CPT Codes
Out-Patient Billing CPT Codes Updated Date: August 3, 08 Client Billed Molecular Tests HPV DNA Tissue Testing 8764 No Medicare Billed - Molecular Tests NeoARRAY NeoARRAY SNP/Cytogenetic No 89 NeoLAB NeoLAB
More informationMolecular. Oncology & Pathology. Diagnostic, Prognostic, Therapeutic, and Predisposition Tests in Precision Medicine. Liquid Biopsy.
Molecular Oncology & Pathology Hereditary Cancer Somatic Cancer Liquid Biopsy Next-Gen Sequencing qpcr Sanger Sequencing Diagnostic, Prognostic, Therapeutic, and Predisposition Tests in Precision Medicine
More informationNeoTYPE Cancer Profiles
NeoTYPE Cancer Profiles Multimethod Analysis of 25+ Hematologic Diseases and Solid Tumors Anatomic Pathology FISH Molecular The next generation of diagnostic, prognostic, and therapeutic assessment NeoTYPE
More informationNeoTYPE Cancer Profiles
NeoTYPE Cancer Profiles 30+ Multimethod Assays for Hematologic Diseases and Solid Tumors Molecular FISH Anatomic Pathology The next generation of diagnostic, prognostic, and therapeutic assessment What
More informationIllumina Trusight Myeloid Panel validation A R FHAN R A FIQ
Illumina Trusight Myeloid Panel validation A R FHAN R A FIQ G E NETIC T E CHNOLOGIST MEDICAL G E NETICS, CARDIFF To Cover Background to the project Choice of panel Validation process Genes on panel, Protocol
More informationThe Center for PERSONALIZED DIAGNOSTICS
The Center for PERSONALIZED DIAGNOSTICS Precision Diagnostics for Personalized Medicine A joint initiative between The Department of Pathology and Laboratory Medicine & The Abramson Cancer Center The (CPD)
More informationPediatric Oncology & Pathology Services
Pediatric Oncology & Pathology Services Anatomic Pathology Flow Cytometry Cytogenetics Pharma Services Diagnostic, Prognostic, Predictive, and Predisposition Testing Pediatric Oncology & Pathology Services
More informationPatricia Aoun MD, MPH Professor and Vice-Chair for Clinical Affairs Medical Director, Clinical Laboratories Department of Pathology City of Hope
Patricia Aoun MD, MPH Professor and Vice-Chair for Clinical Affairs Medical Director, Clinical Laboratories Department of Pathology City of Hope National Medical Center Disclosures I have no disclosures
More informationTime Matters. Results Count! Company Overview Presentation. August Improving Patient Care through exceptional cancer genetic testing services!
Time Matters. Results Count! Company Overview Presentation August 2014 Improving Patient Care through exceptional cancer genetic testing services! Forward-looking Statements This presentation contains
More informationBlastic Plasmacytoid Dendritic Cell Neoplasm with DNMT3A and TET2 mutations (SH )
Blastic Plasmacytoid Dendritic Cell Neoplasm with DNMT3A and TET2 mutations (SH2017-0314) Habibe Kurt, Joseph D. Khoury, Carlos E. Bueso-Ramos, Jeffrey L. Jorgensen, Guilin Tang, L. Jeffrey Medeiros, and
More informationTEST MENU TEST CPT CODES TAT. Chromosome Analysis Bone Marrow x 2, 88264, x 3, Days
TEST MENU CANCER/LEUKEMIA CHROMOSOME ANALYSIS Chromosome Analysis Bone Marrow 88237 x 2, 88264, 88280 x 3, 88291 4 Days Chromosome Analysis Bone Marrow Core 88237 x 2, 88264, 88280 x 3, 88291 4 Days Chromosome
More informationTargeted Agent and Profiling Utilization Registry (TAPUR ) Study. February 2018
Targeted Agent and Profiling Utilization Registry (TAPUR ) Study February 2018 Precision Medicine Therapies designed to target the molecular alteration that aids cancer development 30 TARGET gene alterations
More informationmolecular oncology services
Molecular Oncology molecular oncology services ATIENTS.ANSWERS.RESULTS. www.aruplab.com/oncology MARCH 2018 Information in this brochure is current as of March 2018. All content is subject to change. lease
More informationPrior Authorization Required: Additional Information:
Genetic Testing for Somatic Tumor Markers MP9486 Covered Service: Prior Authorization Required: Additional Information: Yes when meets criteria below No A first-degree relative is defined as an individual
More informationNext Generation Sequencing in Haematological Malignancy: A European Perspective. Wolfgang Kern, Munich Leukemia Laboratory
Next Generation Sequencing in Haematological Malignancy: A European Perspective Wolfgang Kern, Munich Leukemia Laboratory Diagnostic Methods Cytomorphology Cytogenetics Immunophenotype Histology FISH Molecular
More informationMEDICAL POLICY Genetic Testing for Breast and Ovarian Cancers
POLICY: PG0067 ORIGINAL EFFECTIVE: 07/30/02 LAST REVIEW: 01/25/18 MEDICAL POLICY Genetic Testing for Breast and Ovarian Cancers GUIDELINES This policy does not certify benefits or authorization of benefits,
More informationADRL Advanced Diagnostics Research Laboratory
ADRL Advanced Diagnostics Research Laboratory John DeCoteau, MD FRCP Department of Pathology, Division of Hematopathology University of Saskatchewan Saskatchewan Cancer Agency ADRL Project Objectives New
More informationClick to edit Master /tle style
Click to edit Master /tle style Tel: (314) 747-7337 Toll Free: (866) 450-7697 Fax: (314) 747-7336 Email: gps@wustl.edu Website: gps.wustl.edu GENETIC TESTING IN CANCER Ka/nka Vigh-Conrad, PhD Genomics
More informationSelect analysis on the next pages. Sample request and sending address see last page. Institut für Pathologie und Molekularpathologie
Diagnostic Tumor Genome Analysis Schmelzbergstrasse 12 8091 Zürich Tel.: (+41) 044 255 3929 Fax.: (+41) 044 255 4416 Client (address, telephone number): ngs.pathologie@usz.ch www.pathologie.usz.ch Sample-Nr:
More informationWest Midlands Regional Genetics Laboratory
West Midlands Regional Genetics Laboratory Haemato-oncology service update letter October 2017 Dear colleagues, We are writing to outline the latest developments to our service, aiming to support the management
More informationLaboratory Service Report
Client C7028846-DLP Rochester Rochester, N 55901 Specimen Type Peripheral blood CR PDF Report available at: https://test.mmlaccess.com/reports/c7028846-zwselwql7p.ashx Indication for Test DS CR Pathogenic
More informationNext Generation Sequencing in Clinical Practice: Impact on Therapeutic Decision Making
Next Generation Sequencing in Clinical Practice: Impact on Therapeutic Decision Making November 20, 2014 Capturing Value in Next Generation Sequencing Symposium Douglas Johnson MD, MSCI Vanderbilt-Ingram
More informationPlease Silence Your Cell Phones. Thank You
Please Silence Your Cell Phones Thank You Utility of NGS and Comprehensive Genomic Profiling in Hematopathology Practice Maria E. Arcila M.D. Memorial Sloan Kettering Cancer Center New York, NY Disclosure
More informationOverview. Methods 9/11/2017. Next Generation Sequencing and Precision Medicine in Hematological Malignancies. Genotyping in hematology
Overview Next Generation Sequencing and Precision Medicine in Hematological Malignancies Sharathkumar Bhagavathi, MD University of Iowa Carver College of Medicine NGS as a genotyping platform in hematopathology
More informationExamining Genetics and Genomics of Acute Myeloid Leukemia in 2017
Examining Genetics and Genomics of Acute Myeloid Leukemia in 2017 Elli Papaemmanuil, PhD Memorial Sloan Kettering Cancer Center New York, New York, United States Today s Talk Cancer genome introduction
More informationIntroduction of an NGS gene panel into the Haemato-Oncology MPN service
Introduction of an NGS gene panel into the Haemato-Oncology MPN service Dr. Anna Skowronska, Dr Jane Bryon, Dr Samuel Clokie, Dr Yvonne Wallis and Professor Mike Griffiths West Midlands Regional Genetics
More informationGenetic Testing for Somatic Tumor Markers
Genetic Testing for Somatic Tumor Markers MP9486 Covered Service: Prior Authorization Required: Additional Information: Yes when meets criteria below Yes-as shown below Genetic testing is covered for a
More informationSchedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Haematopathology and Oncology Diagnostic Services (HODS) Addenbrookes Hospital Hills Road Cambridge CB2 0QQ Contact: Brian Warner Tel: +44
More informationCMS will not implement the new tier codes for Medicare/Medicaid claims for calendar year 2012.
January 1, 2012 Re: 2012 AMA CPT Code Changes Dear Valued Client: The American Medical Association (AMA) has made Current Procedural Terminology (CPT) code changes to the 2012 edition of the CPT coding
More informationIntelliGENSM. Integrated Oncology is making next generation sequencing faster and more accessible to the oncology community.
IntelliGENSM Integrated Oncology is making next generation sequencing faster and more accessible to the oncology community. NGS TRANSFORMS GENOMIC TESTING Background Cancers may emerge as a result of somatically
More informationEnhancing Assessment of Myeloid Disorders in the Era of Precision Medicine
Enhancing Assessment of Myeloid Disorders in the Era of Precision Medicine Michelle Afkhami, M.D. Medical Director, Clinical Molecular Diagnostic Laboratory City of Hope National Medical Center Objectives
More informationDate of Birth Gender Ethnicity/Family History Male Female Unknown. (Institutional Billing only. We DO NOT bill patients directly.)
PATIENT INFORMATION Last Name First M.I. CLINICAL LABORATORY Date of Birth Gender Ethnicity/Family History Male Female Unknown Molecular Diagnotics Patient or Sample ID# Institutional Account # (415) 514-8488
More informationMEDICAL POLICY. SUBJECT: MOLECULAR PANEL TESTING OF CANCERS TO IDENTIFY TARGETED THERAPIES (Excluding NSCLC and CRC) EFFECTIVE DATE: 12/21/17
MEDICAL POLICY SUBJECT: MOLECULAR PANEL TESTING OF PAGE: 1 OF: 5 If a product excludes coverage for a service, it is not covered, and medical policy criteria do not apply. If a commercial product, including
More informationFluxion Biosciences and Swift Biosciences Somatic variant detection from liquid biopsy samples using targeted NGS
APPLICATION NOTE Fluxion Biosciences and Swift Biosciences OVERVIEW This application note describes a robust method for detecting somatic mutations from liquid biopsy samples by combining circulating tumor
More informationPredictive biomarker profiling of > 1,900 sarcomas: Identification of potential novel treatment modalities
Predictive biomarker profiling of > 1,900 sarcomas: Identification of potential novel treatment modalities Sujana Movva 1, Wenhsiang Wen 2, Wangjuh Chen 2, Sherri Z. Millis 2, Margaret von Mehren 1, Zoran
More informationPROVIDER POLICIES & PROCEDURES
PROVIDER POLICIES & PROCEDURES GENETIC CANCER SUSCEPTIBILITY PANELS USING NEXT GENERATION SEQUENCING The purpose of this document is to assist providers enrolled in the Connecticut Medical Assistance Program
More informationPersonalised cancer care Information for Medical Specialists. A new way to unlock treatment options for your patients
Personalised cancer care Information for Medical Specialists A new way to unlock treatment options for your patients Contents Optimised for clinical benefit 4 Development history 4 Full FIND IT panel vs
More informationPrecision Medicine and Molecular Testing.
Precision Medicine and Molecular Testing. David A. Sallman, MD Assistant Member Department of Malignant Hematology Moffitt Cancer Center david.sallman@moffitt.org Disclosures Research funding for Celgene
More informationLaboratory Service Report
Specimen Type Peripheral blood CR PDF Report available at: https://test.mmlaccess.com/reports/c7028846-ih2xuglwpq.ashx Indication for Test DS CR Pathogenic utations Detected CR 1. JAK2: c.1849g>t;p.val617phe
More informationClinical Grade Biomarkers in the Genomic Era Observations & Challenges
Clinical Grade Biomarkers in the Genomic Era Observations & Challenges IOM Committee on Policy Issues in the Clinical Development & Use of Biomarkers for Molecularly Targeted Therapies March 31-April 1,
More informationCollaboration between CEQAS and UK NEQAS for Molecular Genetics Solid Tumour EQAs and variant interpretation
Collaboration between CEQAS and UK NEQAS for Molecular Genetics Solid Tumour EQAs and variant interpretation Dr Jenni Fairley Deputy Scheme Director (Molecular Pathology), GenQA, Edinburgh, UK From 1 st
More informationCurrent and future applications of Molecular Pathology. Kathy Walsh Clinical Scientist NHS Lothian
Current and future applications of Molecular Pathology Kathy Walsh Clinical Scientist NHS Lothian Molecular Pathology in Solid tumours Cancer type Genes tested Purpose Associated treatments Non small cell
More informationSureSelect Cancer All-In-One Custom and Catalog NGS Assays
SureSelect Cancer All-In-One Custom and Catalog NGS Assays Detect all cancer-relevant variants in a single SureSelect assay SNV Indel TL SNV Indel TL Single DNA input Single AIO assay Single data analysis
More informationPrecision Oncology: Experience at UW
Precision Oncology: Experience at UW Colin Pritchard MD, PhD University of Washington, Department of Lab Medicine WSMOS Meeting November 1, 2013 Conflict of Interest Disclosures I declare the following,
More informationMolecular Markers in Acute Leukemia. Dr Muhd Zanapiah Zakaria Hospital Ampang
Molecular Markers in Acute Leukemia Dr Muhd Zanapiah Zakaria Hospital Ampang Molecular Markers Useful at diagnosis Classify groups and prognosis Development of more specific therapies Application of risk-adjusted
More informationAccel-Amplicon Panels
Accel-Amplicon Panels Amplicon sequencing has emerged as a reliable, cost-effective method for ultra-deep targeted sequencing. This highly adaptable approach is especially applicable for in-depth interrogation
More informationGenomic Medicine: What every pathologist needs to know
Genomic Medicine: What every pathologist needs to know Stephen P. Ethier, Ph.D. Professor, Department of Pathology and Laboratory Medicine, MUSC Director, MUSC Center for Genomic Medicine Genomics and
More informationMOLECULAR SERVICES. mlabs.umich.edu
MOLECULAR SERVICES mlabs.umich.edu 800.862.7284 PICTURED ON LEFT IS MARWAN TAYEH, PH.D, CLINICAL ASSISTANT PROFESSOR, PEDIATRICS - GENETICS, ON RIGHT IS TODD ACKLEY, LABORATORY MANAGER MLabs is a full-service
More informationEXT ADDRESS CITY LAST NAME ID NUMBER PT. ADDRESS CITY INSURANCE PROVIDER. 0 Other. 0 IGH/B-cell cionaliry (PCR)
THE UNIVERSITY OF TEXAS *Required Fields PHYSICIAN! FACILITY/ CLIENT INFORMATION MDAndersonefief &ter MaltgararEettcy 'REQUESTING PHYSICIAN Division of Pathology! Laboratory Medicine Services Test Requisition
More informationCoverage Determinations Colorectal Carcinoma
July 7, 2016 Dr. Debra Patterson, MD, FACP Novitas Solutions Medical Policy Department Union Trust Building Suite 600 501 Grant Street Pittsburgh, PA 15219-4407 DraftLCDComments@novitas-solutions.com Debra.patterson@novitas-solutions.com
More informationWe are in an era that promises a rational. treatment of cancer patients. Levy et al. Genome Research 22:2201, 2012 Vanderbilt university
Enhancing Assessment of Leukemia with Next Generation Sequencing Michelle Afkhami, M.D. Medical Director, Clinical i l Molecular l Laboratory City of Hope National Medical Center How the Expert Treat Hematologic
More informationEnabling Personalized
Molecular Enabling Personalized Diagnostics Medicine- Targeted Sequencing: NGS-based solutions Silvia Dorn Roel Reinders- Andreas Diplas Friday, 19.06.2015 Company Overview Founded in April 2011 Development
More informationYour single-source laboratory solution. FISH Probe Library
Your single-source laboratory solution. FISH Probe Library Alphabetical List by Probe with Clinical Indication Probe Clinical Indication 1p36 (TP73)/19q13 (GLTSCR) 1q21 (CKS1B) 5q (CSF1R/RPS14) 7q (MDFIC)
More informationObjectives and Financial Disclosure
Enhancing Assessment of Leukemia and Lymphoma with Next Generation Sequencing Michelle Afkhami, M.D. Medical Director, Clinical Molecular Laboratory Assistant Professor, Department of Pathology City of
More informationEnhancing Assessment of Myeloid Leukemia in the Era of Precision Medicine
Enhancing Assessment of Myeloid Leukemia in the Era of Precision Medicine Michelle Afkhami, M.D. Medical Director, Clinical Molecular Diagnostic Laboratory City of Hope National Medical Center How the
More informationNext generation sequencing analysis - A UK perspective. Nicholas Lea
Next generation sequencing analysis - A UK perspective Nicholas Lea King s HMDC LMH is part of an integrated pathology service at King s Haematological Malignancy Diagnostic Centre (HMDC) HMDC serves population
More informationContractor Information. LCD Information
Local Coverage Determination (LCD): MolDX: Genetic Testing for BCR-ABL Negative Myeloproliferative Disease (L36044) Links in PDF documents are not guaranteed to work. To follow a web link, please use the
More informationIllumina s Cancer Research Portfolio and Dedicated Workflows
Illumina s Cancer Research Portfolio and Dedicated Workflows Michael Sohn Clinical Sales Specialist Spain&Italy 2017 2017 Illumina, Inc. All rights reserved. Illumina, 24sure, BaseSpace, BeadArray, BlueFish,
More informationZ Code Listing. Performing Site Test Code Test Description Z Code CPT Codes* IU 75950R 1p 19q FISH ZB1K BCL6 Break apart
Z Code Listing Performing Site Test Code Test Description Z Code CPT Codes* IU 75950R 1p 19q FISH ZB1K4 BCL6 Break apart IU 75989 FISH ZB1K7 c-myc Break apart IU 75948 FISH ZB1KQ IU 75993 Her2 neu FISH
More informationZ Code Listing. Performing Site Test Code Test Description Z Code CPT Codes* IU 75950R 1p 19q FISH ZB1K BCL6 Break apart
Z Code Listing Performing Site Test Code Test Description Z Code CPT Codes* IU 75950R 1p 19q FISH ZB1K4 BCL6 Break apart IU 75989 FISH ZB1K7 c-myc Break apart IU 75948 FISH ZB1KQ IU 75993 Her2 neu FISH
More informationJennifer Hauenstein Oncology Cytogenetics Emory University Hospital Atlanta, GA
Comparison of Genomic Coverage using Affymetrix OncoScan Array and Illumina TruSight Tumor 170 NGS Panel for Detection of Copy Number Abnormalities in Clinical GBM Specimens Jennifer Hauenstein Oncology
More informationEnhancing Assessment of Myeloid Leukemia in the Era of Precision Medicine
Enhancing Assessment of Myeloid Leukemia in the Era of Precision Medicine Michelle Afkhami, M.D. Medical Director, Clinical Molecular Diagnostic Laboratory City of Hope National Medical Center How the
More informationDiagnostica Molecolare!
Diagnostica Molecolare! Aldo Scarpa Unità Diagnostica Molecolare Azienda Ospedaliera Universitaria Integrata di Verona e ARC-NET Centro di Ricerca Applicata sul Cancro PDTA CARCINOMA POLMONARE - IL PAZIENTE
More informationJocelyn Chapman, MD Division of Gynecologic Oncology. Julie S. Mak, MS, MSc Genetic Counselor Hereditary Cancer Clinic
Jocelyn Chapman, MD Division of Gynecologic Oncology Julie S. Mak, MS, MSc Genetic Counselor Hereditary Cancer Clinic Genetics underlies all cancers Somatic or tumor genetics Germline or inherited genetics
More informationThe preclinical efficacy of a novel telomerase inhibitor, imetelstat, in AML: A randomized trial in patient-derived xenografts
The preclinical efficacy of a novel telomerase inhibitor, imetelstat, in AML: A randomized trial in patient-derived xenografts Claudia Bruedigam, Ph.D Gordon and Jessie Gilmour Leukaemia Research Laboratory
More informationIdentification and clinical detection of genetic alterations of pre-neoplastic lesions Time for the PML ome? David Sidransky MD Johns Hopkins
Identification and clinical detection of genetic alterations of pre-neoplastic lesions Time for the PML ome? David Sidransky MD Johns Hopkins February 3-5, 2016 Lansdowne Resort, Leesburg, VA Molecular
More informationThe Next Generation of Hereditary Cancer Testing
The Next Generation of Hereditary Cancer Testing Why Genetic Testing? Cancers can appear to run in families. Often this is due to shared environmental or lifestyle patterns, such as tobacco use. However,
More informationCentoCancer STRIVE FOR THE MOST COMPLETE INFORMATION
CentoCancer STRIVE FOR THE MOST COMPLETE INFORMATION CentoCancer our most comprehensive oncogenetics panel for hereditary mutations Hereditary pathogenic variants confer an increased risk of developing
More informationTransform genomic data into real-life results
CLINICAL SUMMARY Transform genomic data into real-life results Biomarker testing and targeted therapies can drive improved outcomes in clinical practice New FDA-Approved Broad Companion Diagnostic for
More informationMolecular Genetic Testing for the Diagnosis of Haematological Malignancies
Molecular Genetic Testing for the Diagnosis of Haematological Malignancies Dr Anthony Bench Haemto-Oncology Diagnostic Service Cambrıdge Unıversıty Hospitals NHS Foundatıon Trust Cambridge UK Molecular
More informationAPPLICATIONS OF NEXT GENERATION SEQUENCING IN SOLID TUMORS - PATHOLOGIST PROSPECTIVE
AMP COMPANION MEETING SYMPOSIUM AT USCAP 2015 NEXT-GENERATION OF PATHOLOGY: ROLE OF PATHOLOGIST IN NGS-BASED PERSONALIZED MEDICINE APPLICATIONS OF NEXT GENERATION SEQUENCING IN SOLID TUMORS - PATHOLOGIST
More informationThe Next Generation in Cancer Diagnostics.
The Next Generation in Cancer Diagnostics. OncoTarget was created specifically for cancer patients. Every patient s cancer is unique, which is why discovering what makes it unique can be essential for
More informationTargeted NGS in oncology and hemato-oncology using in-house designed gene panels. Joni Van der Meulen Molecular Diagnostics UZ Ghent (MDG) 24/03/2017
Targeted NGS in oncology and hemato-oncology using in-house designed gene panels Joni Van der Meulen Molecular Diagnostics UZ Ghent (MDG) 24/03/2017 MDG = Molecular Diagnostics UZ Ghent Center for Medical
More informationObjectives. Morphology and IHC. Flow and Cyto FISH. Testing for Heme Malignancies 3/20/2013
Molecular Markers in Hematologic Malignancy: Ways to locate the needle in the haystack. Objectives Review the types of testing for hematologic malignancies Understand rationale for molecular testing Marcie
More informationManagement of Myelodysplastic Syndromes
Management of Myelodysplastic Syndromes Peter L. Greenberg, MD Stanford Cancer Institute Myelodysplastic Syndromes: Clinical & Molecular Advances for Disease Classification and Prognostication MDSs: A
More informationClinical Grade Genomic Profiling: The Time Has Come
Clinical Grade Genomic Profiling: The Time Has Come Gary Palmer, MD, JD, MBA, MPH Senior Vice President, Medical Affairs Foundation Medicine, Inc. Oct. 22, 2013 1 Why We Are Here A Shared Vision At Foundation
More informationThe Challenges of Precision Medicine: New Advances in Molecular Diagnostic Testing- Impact for Healthcare
The Challenges of Precision Medicine: New Advances in Molecular Diagnostic Testing- Impact for Healthcare Jessica Wang-Rodriguez, MD Chief, VISN22 Consolidated Pathology and Laboratory Medicine Services
More informationMolecular Testing Updates. Karen Rasmussen, PhD, FACMG Clinical Molecular Genetics Spectrum Medical Group, Pathology Division Portland, Maine
Molecular Testing Updates Karen Rasmussen, PhD, FACMG Clinical Molecular Genetics Spectrum Medical Group, Pathology Division Portland, Maine Keeping Up with Predictive Molecular Testing in Oncology: Technical
More informationPrior Authorization. Additional Information:
Genetic Testing for Cowden Syndrome - PTEN Gene MP9488 Covered Service: Prior Authorization Required: Additional Information: Yes when meets criteria below Yes as shown below Pre and post-test genetic
More informationCDx in oncology Prof. Christophe Le Tourneau, MD, PhD FEAM Geneva September 27, 2018
CDx in oncology Prof. Christophe Le Tourneau, MD, PhD Institut Curie Paris & Saint-Cloud France Head, Department of Drug Development and Innovation (D 3 i) INSERM U900 Research unit Versailles Saint-Quentin-en-Yvelines
More informationLynch Syndrome. Angie Strang, PGY2
Lynch Syndrome Angie Strang, PGY2 Background Previously hereditary nonpolyposis colorectal cancer Autosomal dominant inherited cancer susceptibility syndrome Caused by defects in the mismatch repair system
More informationFamily Assessment. Objectives. Comprehensive Family History Important Inexpensive Underutilized genetic tool
Besides the BRCA genes, what else to consider in hereditary breast and ovarian cancer? Laurie M. Connors DNP, APNG, FNP-BC, AGN-BC Objectives Evaluate personal & family history to assess risk for hereditary
More informationSession 4: Summary and Conclusions
Session 4: Summary and Conclusions Total cases in Session 4 Myeloproliferative neoplasms 16 cases Oral #300 (CEL, NOS) Mastocytosis 2 cases Oral #156 (SM-AHN) Myeloid/lymphoid neoplasms with eosinophilia
More informationSchool of Pathology and Laboratory Medicine: Current and New Research Interests
School of Pathology and Laboratory Medicine: Current and New Research Interests W/Professor Wendy Erber Current Research Interests Viral immunology and immunogenetics Bone pathology and cell signalling
More informationPolicy Specific Section: Medical Necessity and Investigational / Experimental. October 14, 1998 March 28, 2014
Medical Policy Genetic Testing for Colorectal Cancer Type: Medical Necessity and Investigational / Experimental Policy Specific Section: Laboratory/Pathology Original Policy Date: Effective Date: October
More informationCurrent Techniques in Molecular Biology Friedel Nollet, Ph.D.
Current Techniques in Molecular Biology Friedel Nollet, Ph.D. Molecular Biology and Cytometry course May 16-17, 2013 Mol, SCK-CEN, Belgium Sanger DNA sequencing Kary Mullis received a Nobel Prize in chemistry
More informationPrior Authorization. Additional Information:
Genetic Testing for Lynch Syndrome MP9487 Covered Service: Prior Authorization Required: Additional Information: Yes when meets criteria below Yes-as shown below Pre and post test genetic counseling is
More informationShould Mutational Status in Primary Myelofibrosis (PMF) Guide Therapy..YES!!!
Should Mutational Status in Primary Myelofibrosis (PMF) Guide Therapy..YES!!! Lindsay Anne Magura Rein, MD Division of Hematologic Malignancies and Cellular Therapy/BMT A Little Bit of History.. 1665 Advanced
More informationWhat is the status of the technologies of "precision medicine?
Session 2: What is the status of the technologies of "precision medicine? Gideon Blumenthal, MD, Clinical Team Leader, Thoracic and Head/Neck Oncology, Center for Drug Evaluation and Research (CDER), U.S.
More informationMolecular Diagnostics of Myeloid and Lymphoid Neoplasms
Molecular Diagnostics of Myeloid and Lymphoid Neoplasms Molecular Pathology: Principles in Clinical Practice - 2012 John Greg Howe Ph.D. Department of Laboratory Medicine Yale University School of Medicine
More informationSUPPLEMENTARY INFORMATION
Supplementary Information S1 Frequency of DNMT3A mutations in hematologic disorders and their associated clinical phenotypes. Disease Patient population Frequency (%) Associated Clinical Characteristics
More informationChanging the Culture of Cancer Care II. Eric Holland Fred Hutchinson Cancer Research Center University of Washington Seattle
Changing the Culture of Cancer Care II Eric Holland Fred Hutchinson Cancer Research Center University of Washington Seattle Transforming Cancer Therapy Eric Holland Fred Hutchinson Cancer Research Center
More informationDr David Guttery Senior PDRA Dept. of Cancer Studies and CRUK Leicester Centre University of Leicester
Dr David Guttery Senior PDRA Dept. of Cancer Studies and CRUK Leicester Centre University of Leicester dsg6@le.ac.uk CFDNA/CTDNA Circulating-free AS A LIQUID DNA BIOPSY (cfdna) Tumour Biopsy Liquid Biopsy
More informationClinically Useful Next Generation Sequencing and Molecular Testing in Gliomas MacLean P. Nasrallah, MD PhD
Clinically Useful Next Generation Sequencing and Molecular Testing in Gliomas MacLean P. Nasrallah, MD PhD Neuropathology Fellow Division of Neuropathology Center for Personalized Diagnosis (CPD) Glial
More informationContractor Information
Local Coverage Determination (LCD): MolDX: Genetic Testing for BCR-ABL Negative Myeloproliferative Disease (L36186) Links in PDF documents are not guaranteed to work. To follow a web link, please use the
More informationProtein Domain-Centric Approach to Study Cancer Somatic Mutations from High-throughput Sequencing Studies
Protein Domain-Centric Approach to Study Cancer Somatic Mutations from High-throughput Sequencing Studies Dr. Maricel G. Kann Assistant Professor Dept of Biological Sciences UMBC 2 The term protein domain
More informationDisclosure: Objectives/Outline. Leukemia: Genealogy of Pathology Practice: Old Diseases New Expectations. Nothing to disclose.
RC1 Leukemia: Genealogy of Pathology Practice: Old Diseases New Expectations RC2 Disclosure: Nothing to disclose Henry Moon Lecture: UCSF Annual Conference Kathryn Foucar, MD kfoucar@salud.unm.edu May
More informationImpact of Biomarkers in the Management of Patients with Acute Myeloid Leukemia
Impact of Biomarkers in the Management of Patients with Acute Myeloid Leukemia Hartmut Döhner Medical Director, Department of Internal Medicine III Director, Comprehensive Cancer Center Ulm Ulm University,
More information