August 17, Dear Valued Client:

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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 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

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