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

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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 2012. 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

Test Name 5270 1518 1515 1515S 5220 4565 5310 5040 5040BK 5044 5044BK 5342SR 5342 5352SR 5352 CPT Code(s) Tier CPT Code(s) ACCUTYPE METFORMIN, BLOOD 83891, 83892, 83898, 83909, 83912, 83914 81400 ALPHA-1-ANTITRYPSIN DEFICIENCY FETAL STUDY 83891, 83900, 83909, 83912, 81332 with reflex to W/REFLEX TO MCC 83914x2 81265 ALPHA-1-ANTITRYPSIN GENOTYPR 83891, 83900, 83909, 83912, 83914x2 81332 ALPHA-1-ANTITRYPSIN GENOTYPR - SALIVA 83891, 83900, 83909, 83912, ALPHA-THALASSEMIA GENOTYPR (21 mutations = 14 point mutations + 7 deletions 83914x2 81332 83891, 83894, 83896x21, 83900, 83901, 83909, 83912 81257 AMPLICHIP CYP450 2D6 & 2C19 GENOTYPR - FDA test; chip 83891, 83892x2, 83900x2, 83901x2, BAALC (BRAIN AND ACUTE LEUKEMIA, CYTOPLASMIC) ULTRAQUANT 88385_TC 81225, 81226 83891, 83896 x2, 83900, 83902, 83912 81401 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, 83912 81261, 81342 83891, 83898x3, 83900, 83901x3, 83907, 83909x4, 83912 81261, 81342 83891, 83898x3, 83909x3, 83912 81261 83891, 83898x3, 83907, 83909x3, 83912 81261 BCR/ABL ULTRAQUANT MAJOR 210 KD TRANSCRIPT BM, W/SER REP 83891, 83896, 83898, 83902, 83912 81206 BCR/ABL ULTRAQUANT MAJOR 210 KD TRANSCRIPT BONE MARROW 83891, 83896, 83898, 83902, 83912 81206 BCR/ABL ULTRAQUANT MAJOR 210 KD TRANSCRIPT WB, W/SER REP 83891, 83896, 83898, 83902, 83912 81206 BCR/ABL ULTRAQUANT MAJOR 210 KD TRANSCRIPT WHOLE BLOOD 83891, 83896, 83898, 83902, 83912 81206

5344SR 5344 5354SR 5354 5859 5859BK 5432 5432FH 5434 BCR/ABL ULTRAQUANT MINOR 190 KD TRANSCRIPT BM, W/SER REP 83891, 83896, 83898, 83902, 83912 81207 BCR/ABL ULTRAQUANT MINOR 190 KD TRANSCRIPT BONE MARROW 83891, 83896, 83898, 83902, 83912 81207 BCR/ABL ULTRAQUANT MINOR 190 KD TRANSCRIPT WB, W/SER REP 83891, 83896, 83898, 83902, 83912 81207 BCR/ABL ULTRAQUANT MINOR 190 KD TRANSCRIPT WHOLE BLOOD 83891, 83896, 83898, 83902, 83912 81207 CHROMOSOMES X & Y ANEUPLOIDY DETECTR 83891, 83900, 83901 x8, 83909, CHROMOSOMES X & Y ANEUPLOIDY DETECTR- PARAFFIN BLOCK [PCR] 83912 No code 83891, 83900, 83901 x8, 83907, 83909, 83912 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, 83914x23 81220 83891, 83892, 83900, 83901x21, 83909, 83912, 83914x23 81220 83891, 83892, 83900, 83901x21, 83909, 83912, 83914x23 81220 with reflex to 81265 5383 DPD 5-FU GENOTYPR - SALIVA 83891, 83898, 83909, 83912, 83914 81400 5383S 5371 5371S 1966 1966S 5290 5369 FACTOR II (PROTHROMBIN) GENOTYPR FACTOR II (PROTHROMBIN) GENOTYPR - SALIVA FACTOR V [LEIDEN] GENOTYPR FACTOR V [LEIDEN] GENOTYPR - SALIVA 83891, 83898, 83909, 83912, 83914 81400 83891, 83898, 83909, 83912, 83914 81240 83891, 83898, 83909, 83912, 83914 81240 83891, 83898, 83909, 83912, 83914 81241 83891, 83898, 83909, 83912, 83914 81241 FAMILIAL MEDITERRANEAN FEVER (FMF) GENOTYPR 83891, 83894, 83896 x12, 83900, 83901 x2, 83909, 83912 81402 HEMOCHROMATOSIS GENOTYPR 83891, 83900, 83909, 83912, 83914x3 81256

5369S 5392 5396 5394 5395 5032 5046 5046BK 5398 4562 4562S 5030 5375 5375S 5034 RGW RKC HEMOCHROMATOSIS GENOTYPR - SALIVA 83891, 83900, 83909, 83912, JAK2 EXONS 12 & 13 MUTATION, QUALITATIVE, PLASMA 83914x3 81256 83891, 83898, 83902, 83904x2, 83912 81403 JAK2 V617F MUTATION, QL, W/RFX EXONS 12, 13 & MPL W515, S505 83891, 83898, 83902, 83904, 83912 JAK2 V617F MUTATION, QUAL PCR, PLASMA W/RFX EXONS 12, 13 83891, 83898, 83902, 83904, 83912 JAK2 V617F MUTATION, QUAL, PCR KRAS MUTATION ANALYSIS 83891, 83898, 83902, 83904, 83912 81270 83891, 83892x2, 83898x2, 83904x4, 83909x2, 83912 81275 MICROSATELLITE INSTABILITY (MSI) DETECTR 83891x2, 83900, 83901x12, 83909x2, 83912 81301 MICROSATELLITE INSTABILITY (MSI) DETECTR - PARAFFIN 83891x2, 83900, 83901x12, 83907, MPL W515 & MPL S505 MUTATION ANALYSIS, QUAL, PLASMA 83909x2, 83912 81301 83891, 83898, 83902, 83904x2, 83912 81402 MTHFR C677T/A1298C GENOTYPR 83891, 83900, 83909, 83912, 83914x2 81291 MTHFR C677T/A1298C GENOTYPR - SALIVA 83891, 83900, 83909, 83912, 83914x2 81291 NRAS MUTATION ANALYSIS PLASMINOGEN ACTIVATOR INHIBITOR (PAI-1) GENOTYPR 83891, 83892x2, 83898x2, 83904x4, 83909x2, 83912 81404 83891, 83898, 83909, 83912, 83914 81400 PLASMINOGEN ACTIVATOR INHIBITOR (PAI-1) GENOTYPR - SALIVA 83891, 83898, 83909, 83912, 83914 81400 RAS MUTATION ANALYSIS, CELL-BASED (test is KRAS + HRAS + NRAS) REFLEX FACTOR V [LEIDEN] GENOTYPR 81270 with reflex to 81403 and/or reflex to 81402 81270 with reflex to 81403 83891, 83898x3, 83904x3, 83909x3, 83912 81403, 81404, 81403 83891, 83898, 83909, 83912, 83914 81241 REFLEX MATERNAL CELL CONTAMINATION DETECTION 83891, 83900x2, 83901x6, 83909x2, 83912 81265

5042 5042BK 4555 5353 5353S 5353SNY 5384 5055 5055S 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] 83912 81402 83891, 83900, 83901x3, 83907, 83909, 83912 81402 83891, 83900, 83901x2, 83909x3, 83912x3, 83914x4 81291, 81240, 81241 83914 81401 83914 81401 83914 81401 UGT1A1 (CAMPTOSAR/IRINOTECAN) GENOTYPR 83891, 83898, 83909, 83912 81350 WARFARIN SENSITIVITY DETECTR (VKORC1 AND CYP 2C9) WARFARIN SENSITIVITY DETECTR (VKORC1 AND CYP 2C9) - SALIVA 83914 81355, 81227 83914 81355, 81227

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, 83898 (x6), 83909 (x6), 83904, 83912 81401 83891, 83892 (x2), 83900, 83901 (x2), 83909, 83914 (x10), 83912 81225 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 S51068 83891, 83892 (x3), 83909, 83914, 83900, 83912 81401 83891, 83900, 83901 (x5), 83894, 83912 81257 83891, 83898 (x2), 83896 (x2), 83902 (x2), 83912 81401 83891, 83892 (x3), 83898, 83909, 83914, 83912 81400 83891 (x2), 83892 (x2), 83909 (x8), 83900, 83901 (x27), 83914 (x60), 83912 (x8) 83891, 83898, 83902 (x2), 83900, 83896 (x3), 83912 81206 83891, 83892 (x2), 83909 (x4), 83898 (x4), 83904 (x4), 83912 81404 83891, 83898, 83892 x2, 83909, 83914, 83912 81209 83891, 83898 (x3), 83894 (x3), 83892 (x3), 83909 (x3), 83904 (x3), 83912 81210 83891, 83900, 83901 (x2), 83894, 83892 (x3), 83909, 83914 (x11), 83912 81402 83891, 83900, 83892 x2, 83909, 83914 x4, 83901, 83912 81200 83891, 83894, 83902, 83900, 83901 (x4), 83904, 83909, 83912 81260 83891, 83898 (x5), 83892 (x5), 83904 (x10), 83909 (x5), 83912 81404 81220 (CF), 81200 (CANAVAN), 81251 (GAUCHER), 81242 (FANCONI), 81209 (BLOOM), 81255 (TAY SACHS), 81260 (FAMILIAL DYS), 81330 (NEIMANN PICK)

Quest Diagnostics Test Name Colorectal Cancer Mutation Panel (KRAS, PIK3CA, BRAF, NRAS) Quest Diagnostics- VALENCIA S52415 Stacking CPT Codes 83891, 83892 (x7), 83894 (x3), 83898 (x10), 83904 (x14), 83907, 83909 (x10), 83912 (x4) NEW Tier Codes Effective 1/1/2012 81275, 81210, 81404, 83898 (x3), 83904 (x3), 83907, 83909 (x3), 83912 ColoVantage (methylated Septin 9) 16983 ColoVantage (methylated Septin 9) (NY) 16984 83891, 83896 (x3), 83898 (x3), 83912 81401 83891, 83896 (x3), 83898 (x3), 83912 81401 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 S51581 83891, 83909, 83898, 83904, 83912 81221 83891, 83909, 83898, 83914, 83912 81400 83891, 83892 (x2), 83909, 83898, 83914 (x2), 83912 81260 83891, 83892 (x2), 83909, 83898, 83914 (x2), 83912 81242 83891, 83896 (x3), 83898 (x3), 83912 81402 83891, 83900, 83898, 83909, 83892 (x2), 83894, 83896, 83897, 83912 81243 83891, 83892, 83909, 83900, 83914 (x8), 83912 81251 Genomic Alterations, Postnatal, ClariSure(R) Oligo-SNP Array S52307 88386, 83891, 83892, 83898 81229 Glycogen Storage Disease Type Ia Mutation (Ashkenazi Jewish) S51378 83891, 83892 (x3), 83909, 83900, 83914 (x2), 83912 81250 HLA-B27, DNA Typing S51544 83891, 83896 (x30), 83900 83912 81374 HLA-A,B Class I DNA Typing S52243 83891, 83896 (x60), 83900 (x2), 83912 (x2) 81373 (x2) HLA Class I A,B,C DNA Typing S51545 83891, 83900 (x3), 83896 (x90), 83912 (x3) 81372

Quest Diagnostics Test Name Quest Diagnostics- VALENCIA Stacking CPT Codes NEW Tier Codes Effective 1/1/2012 HLA Class II DR, DQ DNA Typing S51546 83891, 83900, 83898, 83896 (x30), 83912 81375 HLA Typing for Celiac Disease S51543 83891, 83900, 83901, 83896 (x20), 83912 81383 (x2) HLA Typing for Narcolepsy S51552 83891, 83896 (x35), 83898, 83900, 83901, 83912 81383 (x2), 81377 HLA-A High Resolution SBT Typing S51547 83891, 83900, 83904 (x6), 83912 81380 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 S51353 83891, 83896 (x90), 83900 (x3), 83912 (3) 81372 83912 81374 83891, 83900, 83904 (x6), 83912 81380 83912 81381 83912 81381 83912 81381 83912 81373 83891, 83896 (x15), 83898, 83912 81376 83891, 83900, 83896 (x15), 83912 81376 83891 (1), 83898 (2), 83904 (4), 83912 (1) 81382 83891 (1), 83898 (1), 83904 (3), 83912 (1) 81382 83891, 83898 (x2), 83894 (x2), 83912 81400 Huntington Disease Mutation S51314 83891, 83900, 83909, 83912 81401 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 S52421 83891, 83896, 83898, 83904 (x2), 83912 81270 83891, 83892(x3), 83898 EGFR 83891, 83892, 83898 (x4), (x6), 83904 (x8), 83909 83909 (x4), 83904 (x4), 83912; (x6), 83912 (x2), 88271 KRAS 81275; ALK 88271 (x2), 88275, 88291 (x2);88275; 88291 83891, 83896 (x2), 83898 (x2), 83912 81401

Quest Diagnostics Test Name Maple Syrup Disease (MSUD) Mutation (Ashkenazi Jewish) Quest Diagnostics- VALENCIA S51386 MEN2 and FMTC Mutations, Exons 10, 11, 13-16 (NY) S51812 Mucolipidosis Type IV Mutation S51588 Niemann-Pick Disease Mutation S51592 Pain Management, CYP450 2D6/2C19 GENO, QL 18946 NEW Tier Codes Effective Stacking CPT Codes 1/1/2012 83891, 83892 (x3), 83909, 83900, 83901, 83914 (x3), 83912 81205 83891 (x2), 83898 (x6), 83892 (x2), 83909 (x6), 83904 (x6), 83912 81404, 81405 83891, 83898, 83892 x2, 83909, 83914 x2, 83912 81290 83891, 83900, 83892 x2, 83909, 83914 x4, 83912 81330 83891, 83892 (x2), 83900 (x2), 83901 (x2), 88385 TC 81226, 81225 83891, 83902, 83898, 83904 (x2), 83912 81404 83891, 83898, 83892 (x3), 83909, 83914, 83912 81400 83891, 83902 (X3), 83898 (x3), 83896 (x3), 83912 81315 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 S51349 83891, 83900, 83909, 83912 81331 83891, 83892 (x2), 83909 (x6), 83894, 83898 (x6), Rett Syndrome Mutation S51295 83904 (x6), 83912 81302 Sickle Cell Anemia, DNA Probe, Fetus Tay-Sachs Disease Mutation XSense(R), Fragile X with Reflex Y Chromosome Microdeletion, DNA S51453 S51598 S51603 S51325 88235, 83891 (x2), 83892 (x4), 83909 (x2), 83898 (x2), 83912 (x2) 88235, 81401 83891, 83892, 83909, 83900, 83914 (x7), 83901 (x2), 83912 81255 83891, 83900, 83898, 83909 (x2), 83912 with reflex to southern blot 83891, 83892 (x2), 83894, 83896, 83897, 83912 81243 with reflex to 81244 83891, 83900, 83901 (x18), 83894, 83912 81403 CellSearch(R) Circulating Tumor Cells, Breast S51755 88346 (x2), 88361, 88313 0279T, 0280T CellSearch(R) Circulating Tumor Cells, Colon S52160 88346 (x2), 88361, 88313 0279T, 0280T CellSearch(R) Circulating Tumor Cells, Prostate S52159 88346 (x2), 88361, 88313 0279T, 0280T