CMS will not implement the new tier codes for Medicare/Medicaid claims for calendar year 2012.

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1 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 manual. Along with other annual updates, there are a significant number of newly assigned codes for molecular diagnostics. On November 1, 2011, Center for Medicare & Medicaid Services (CMS) announced the following: CMS will not implement the new tier codes for Medicare/Medicaid claims for calendar year CMS will continue to use the 2011 molecular codes for the reporting and payment for these services, and will not publish valuations for these new codes at this time. For many third party payers, including Medicare and Medicaid, we will continue billing with the 2011 molecular codes; however, we will be prepared to bill the 2012 molecular tier codes as third party payers implement. The enclosed chart lists the individual molecular tests affected and the appropriate CPT code changes. These tests may also be included in panels or profiles. If you need additional information, please refer to the 2012 AMA CPT Code book or our website QuestDiagnostics.com. We appreciate your support and look forward to continuing to serve all of your laboratory needs. Sincerely, Quest Diagnostics Nichols Institute, Valencia

2 Test Name S BK BK 5342SR SR 5352 CPT Code(s) Tier CPT Code(s) ACCUTYPE METFORMIN, BLOOD 83891, 83892, 83898, 83909, 83912, ALPHA-1-ANTITRYPSIN DEFICIENCY FETAL STUDY 83891, 83900, 83909, 83912, with reflex to W/REFLEX TO MCC 83914x ALPHA-1-ANTITRYPSIN GENOTYPR 83891, 83900, 83909, 83912, 83914x ALPHA-1-ANTITRYPSIN GENOTYPR - SALIVA 83891, 83900, 83909, 83912, ALPHA-THALASSEMIA GENOTYPR (21 mutations = 14 point mutations + 7 deletions 83914x , 83894, 83896x21, 83900, 83901, 83909, AMPLICHIP CYP450 2D6 & 2C19 GENOTYPR - FDA test; chip 83891, 83892x2, 83900x2, 83901x2, BAALC (BRAIN AND ACUTE LEUKEMIA, CYTOPLASMIC) ULTRAQUANT 88385_TC 81225, , x2, 83900, 83902, B-CELL & T-CELL GENE REARRANGEMENT DETECTR 83891, 83898x3, 83900, 83901x3, B-CELL & T-CELL GENE REARRANGEMENT DETECTR- PARAFFIN BLOCK B-CELL GENE REARRANGEMENT DETECTR B-CELL GENE REARRANGEMENT DETECTR - PARAFFIN BLOCK 83909x4, , , 83898x3, 83900, 83901x3, 83907, 83909x4, , , 83898x3, 83909x3, , 83898x3, 83907, 83909x3, BCR/ABL ULTRAQUANT MAJOR 210 KD TRANSCRIPT BM, W/SER REP 83891, 83896, 83898, 83902, BCR/ABL ULTRAQUANT MAJOR 210 KD TRANSCRIPT BONE MARROW 83891, 83896, 83898, 83902, BCR/ABL ULTRAQUANT MAJOR 210 KD TRANSCRIPT WB, W/SER REP 83891, 83896, 83898, 83902, BCR/ABL ULTRAQUANT MAJOR 210 KD TRANSCRIPT WHOLE BLOOD 83891, 83896, 83898, 83902,

3 5344SR SR BK FH 5434 BCR/ABL ULTRAQUANT MINOR 190 KD TRANSCRIPT BM, W/SER REP 83891, 83896, 83898, 83902, BCR/ABL ULTRAQUANT MINOR 190 KD TRANSCRIPT BONE MARROW 83891, 83896, 83898, 83902, BCR/ABL ULTRAQUANT MINOR 190 KD TRANSCRIPT WB, W/SER REP 83891, 83896, 83898, 83902, BCR/ABL ULTRAQUANT MINOR 190 KD TRANSCRIPT WHOLE BLOOD 83891, 83896, 83898, 83902, CHROMOSOMES X & Y ANEUPLOIDY DETECTR 83891, 83900, x8, 83909, CHROMOSOMES X & Y ANEUPLOIDY DETECTR- PARAFFIN BLOCK [PCR] No code 83891, 83900, x8, 83907, 83909, No code CYSTIC FIBROSIS 23 MUTATION ANALYSIS 83891, 83892, 83900, 83901x21, CYSTIC FIBROSIS 23 MUTATION ANALYSIS W/FAMILY HISTORY CYSTIC FIBROSIS 23 MUTATION ANALYSIS, FETUS W/REFLEX MCC DPD 5-FU GENOTYPR 83909, 83912, 83914x , 83892, 83900, 83901x21, 83909, 83912, 83914x , 83892, 83900, 83901x21, 83909, 83912, 83914x with reflex to DPD 5-FU GENOTYPR - SALIVA 83891, 83898, 83909, 83912, S S S FACTOR II (PROTHROMBIN) GENOTYPR FACTOR II (PROTHROMBIN) GENOTYPR - SALIVA FACTOR V [LEIDEN] GENOTYPR FACTOR V [LEIDEN] GENOTYPR - SALIVA 83891, 83898, 83909, 83912, , 83898, 83909, 83912, , 83898, 83909, 83912, , 83898, 83909, 83912, , 83898, 83909, 83912, FAMILIAL MEDITERRANEAN FEVER (FMF) GENOTYPR 83891, 83894, x12, 83900, x2, 83909, HEMOCHROMATOSIS GENOTYPR 83891, 83900, 83909, 83912, 83914x

4 5369S BK S S 5034 RGW RKC HEMOCHROMATOSIS GENOTYPR - SALIVA 83891, 83900, 83909, 83912, JAK2 EXONS 12 & 13 MUTATION, QUALITATIVE, PLASMA 83914x , 83898, 83902, 83904x2, JAK2 V617F MUTATION, QL, W/RFX EXONS 12, 13 & MPL W515, S , 83898, 83902, 83904, JAK2 V617F MUTATION, QUAL PCR, PLASMA W/RFX EXONS 12, , 83898, 83902, 83904, JAK2 V617F MUTATION, QUAL, PCR KRAS MUTATION ANALYSIS 83891, 83898, 83902, 83904, , 83892x2, 83898x2, 83904x4, 83909x2, MICROSATELLITE INSTABILITY (MSI) DETECTR 83891x2, 83900, 83901x12, 83909x2, MICROSATELLITE INSTABILITY (MSI) DETECTR - PARAFFIN 83891x2, 83900, 83901x12, 83907, MPL W515 & MPL S505 MUTATION ANALYSIS, QUAL, PLASMA 83909x2, , 83898, 83902, 83904x2, MTHFR C677T/A1298C GENOTYPR 83891, 83900, 83909, 83912, 83914x MTHFR C677T/A1298C GENOTYPR - SALIVA 83891, 83900, 83909, 83912, 83914x NRAS MUTATION ANALYSIS PLASMINOGEN ACTIVATOR INHIBITOR (PAI-1) GENOTYPR 83891, 83892x2, 83898x2, 83904x4, 83909x2, , 83898, 83909, 83912, PLASMINOGEN ACTIVATOR INHIBITOR (PAI-1) GENOTYPR - SALIVA 83891, 83898, 83909, 83912, RAS MUTATION ANALYSIS, CELL-BASED (test is KRAS + HRAS + NRAS) REFLEX FACTOR V [LEIDEN] GENOTYPR with reflex to and/or reflex to with reflex to , 83898x3, 83904x3, 83909x3, , 81404, , 83898, 83909, 83912, REFLEX MATERNAL CELL CONTAMINATION DETECTION 83891, 83900x2, 83901x6, 83909x2,

5 BK S 5353SNY S T-CELL GENE REARRANGEMENT DETECTR 83891, 83900, 83901x3, 83909, T-CELL GENE REARRANGEMENT DETECTR- PARAFFIN BLOCK THROMBOTIC RISK ASSESSR FOR OBSTETRIC COMPLICATIONS TPMT GENOTYPR TPMT GENOTYPR - SALIVA TPMT GENOTYPR - SALIVA [NY] , 83900, 83901x3, 83907, 83909, , 83900, 83901x2, 83909x3, 83912x3, 83914x , 81240, UGT1A1 (CAMPTOSAR/IRINOTECAN) GENOTYPR 83891, 83898, 83909, WARFARIN SENSITIVITY DETECTR (VKORC1 AND CYP 2C9) WARFARIN SENSITIVITY DETECTR (VKORC1 AND CYP 2C9) - SALIVA , , 81227

6 Quest Diagnostics Test Name ABL Kinase Domain Mutation in CML, Plasma-based, Leumeta(R) AccuType(R) CP, Clopidogrel CYP2C19 Genotype Quest Diagnostics- VALENCIA S51337 S52048 Stacking CPT Codes 83891, 83894, 83902, (x6), (x6), 83904, , (x2), 83900, (x2), 83909, (x10), NEW Tier Codes Effective 1/1/2012 Achondroplasia Mutation Alpha-Globin Common Mutation AML1/ETO t(8;21) Quantitative Real-Time PCR Angiotensin II Type 1 Receptor (AGTR1) Gene 1166A>C Polymorphism (NY) Ashkenazi Jewish Panel BCR/ABL Gene Rearrangement, Quantitative PCR, Plasma-based, Leumeta(R) Beta-Globin Complete Bloom Syndrome DNA Mutation BRAF Mutation CAH (21-Hydroxylase Deficiency) Common Mutations Canavan Disease Mutation Chronic Lymphocytic Leukemia, IgVH Mutation Status, Cell-based C-KIT Mutation, Cell-based S51405 S51015 S51379 S52513N S51560 S52518 S51293 S51562 S51867 S51446 S51568 S50975 S , (x3), 83909, 83914, 83900, , 83900, (x5), 83894, , (x2), (x2), (x2), , (x3), 83898, 83909, 83914, (x2), (x2), (x8), 83900, (x27), (x60), (x8) 83891, 83898, (x2), 83900, (x3), , (x2), (x4), (x4), (x4), , 83898, x2, 83909, 83914, , (x3), (x3), (x3), (x3), (x3), , 83900, (x2), 83894, (x3), 83909, (x11), , 83900, x2, 83909, x4, 83901, , 83894, 83902, 83900, (x4), 83904, 83909, , (x5), (x5), (x10), (x5), (CF), (CANAVAN), (GAUCHER), (FANCONI), (BLOOM), (TAY SACHS), (FAMILIAL DYS), (NEIMANN PICK)

7 Quest Diagnostics Test Name Colorectal Cancer Mutation Panel (KRAS, PIK3CA, BRAF, NRAS) Quest Diagnostics- VALENCIA S52415 Stacking CPT Codes 83891, (x7), (x3), (x10), (x14), 83907, (x10), (x4) NEW Tier Codes Effective 1/1/ , 81210, 81404, (x3), (x3), 83907, (x3), ColoVantage (methylated Septin 9) ColoVantage (methylated Septin 9) (NY) , (x3), (x3), , (x3), (x3), Cystic Fibrosis Rare Mutation, One Exon Factor V HR2 Allele DNA Mutation Familial Dysautonomia Mutation Fanconi's Anemia DNA Mutation Follicular Lymphoma, bcl-2/jh t(14;18), Real-time PCR, Cell-based Fragile X DNA, Fetus Gaucher Disease, DNA Mutation S50337 S51402 S51574 S51577 S52422/ S52506 S51604 S , 83909, 83898, 83904, , 83909, 83898, 83914, , (x2), 83909, 83898, (x2), , (x2), 83909, 83898, (x2), , (x3), (x3), , 83900, 83898, 83909, (x2), 83894, 83896, 83897, , 83892, 83909, 83900, (x8), Genomic Alterations, Postnatal, ClariSure(R) Oligo-SNP Array S , 83891, 83892, Glycogen Storage Disease Type Ia Mutation (Ashkenazi Jewish) S , (x3), 83909, 83900, (x2), HLA-B27, DNA Typing S , (x30), HLA-A,B Class I DNA Typing S , (x60), (x2), (x2) (x2) HLA Class I A,B,C DNA Typing S , (x3), (x90), (x3) 81372

8 Quest Diagnostics Test Name Quest Diagnostics- VALENCIA Stacking CPT Codes NEW Tier Codes Effective 1/1/2012 HLA Class II DR, DQ DNA Typing S , 83900, 83898, (x30), HLA Typing for Celiac Disease S , 83900, 83901, (x20), (x2) HLA Typing for Narcolepsy S , (x35), 83898, 83900, 83901, (x2), HLA-A High Resolution SBT Typing S , 83900, (x6), HLA-A,B,C CLASS I DNA TYPING HLA-A29 DNA Typing HLA-B High Resolution SBT Typing HLA-B*1502 Typing HLA-B*5701 Typing HLA-B51 DNA Typing HLA-C Class I DNA Typing HLA-DRB1 Class II DNA Typing HLA-DQB1 Class II DNA Typing HLA-DQB1 High Resolution SBT Typing HLA-DRB1 High Resolution SBT Typing Human Platelet Antigen 1 Genotype S51545 S52431 S51548 S52122 S51551 S52371 S51549 S51550 S51407 S51409 S52488 S , (x90), (x3), (3) , 83900, (x6), , (x15), 83898, , 83900, (x15), (1), (2), (4), (1) (1), (1), (3), (1) , (x2), (x2), Huntington Disease Mutation S , 83900, 83909, JAK2 Mutation (V617F), Quantitative, Plasma-based, Leumeta(R) Lung Cancer Mutation Panel (EGFR, KRAS, ALK) Mantle Cell Lymphoma, bcl-1/jh t(11;14), Real-time PCR, Cell-based S51995 S52293 S , 83896, 83898, (x2), , 83892(x3), EGFR 83891, 83892, (x4), (x6), (x8), (x4), (x4), 83912; (x6), (x2), KRAS 81275; ALK (x2), 88275, (x2);88275; , (x2), (x2),

9 Quest Diagnostics Test Name Maple Syrup Disease (MSUD) Mutation (Ashkenazi Jewish) Quest Diagnostics- VALENCIA S51386 MEN2 and FMTC Mutations, Exons 10, 11, (NY) S51812 Mucolipidosis Type IV Mutation S51588 Niemann-Pick Disease Mutation S51592 Pain Management, CYP450 2D6/2C19 GENO, QL NEW Tier Codes Effective Stacking CPT Codes 1/1/ , (x3), 83909, 83900, 83901, (x3), (x2), (x6), (x2), (x6), (x6), , , 83898, x2, 83909, x2, , 83900, x2, 83909, x4, , (x2), (x2), (x2), TC 81226, , 83902, 83898, (x2), , 83898, (x3), 83909, 83914, , (X3), (x3), (x3), PDGFRA Mutation S52487 Plasminogen Activator Inhibitor-1 (PAI-1) 4G/5G S51324 PML/RARA t(15;17), Quantitative Real-Time PCR, Cell-based S50330 Prader-Willi/Angelman Syndrome, DNA Methylation S , 83900, 83909, , (x2), (x6), 83894, (x6), Rett Syndrome Mutation S (x6), Sickle Cell Anemia, DNA Probe, Fetus Tay-Sachs Disease Mutation XSense(R), Fragile X with Reflex Y Chromosome Microdeletion, DNA S51453 S51598 S51603 S , (x2), (x4), (x2), (x2), (x2) 88235, , 83892, 83909, 83900, (x7), (x2), , 83900, 83898, (x2), with reflex to southern blot 83891, (x2), 83894, 83896, 83897, with reflex to , 83900, (x18), 83894, CellSearch(R) Circulating Tumor Cells, Breast S (x2), 88361, T, 0280T CellSearch(R) Circulating Tumor Cells, Colon S (x2), 88361, T, 0280T CellSearch(R) Circulating Tumor Cells, Prostate S (x2), 88361, T, 0280T

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