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    MolDx
    Approved Gene Testing (M00041, V8)

    After a review of the current available literature, the MolDX Program has determined that testing for the following genes/gene components meets the Medicare criteria for a covered service.

    CPT Code
    Description
    81206
    BCR_ABL1, majbp qual quant (p210)
    81207
    BCR_ABL1, minbp qual quant (p190)
    81208
    BCR_ABL1, other bp qual quant
    81210
    BRAF, V600E
    81225
    CYP2C19, cv
    81226
    CYP2D6, cv
    81235
    EGFR, cv
    81240
    F2, 20210G>A
    81241
    F5, Leiden  (1691G>A)
    81245
    FLT3, ITD
    81246
    FLT3, TKD
    81256
    HFE, cv
    81261
    IGH, amp
    81262
    IGH, dp
    81263
    IGH, var reg
    81264
    IGK, gr
    81265
    STR
    81266
    STR add  (for transplants)
    81267
    Chimerism, no cell
    81268
    Chimerism, with cell
    81270
    JAK2, V617F
    81275
    KRAS, codons 12 and 13
    81275
    KRAS, exon 1
    81287
    MGMT, ma
    81288
    MLH1, ma
    81291
    MTHFR, cv
    81292
    MLH1, fgs
    81293
    MLH1, kfv
    81294
    MLH1, dup_del
    81295
    MSH2, fgs
    81296
    MSH2, kfv
    81297
    MSH2, dup_del
    81298
    MSH6, fgs
    81299
    MSH6, kfv
    81300
    MSH6, dup_del
    81301
    MSI
    81310
    NPM1, exon 12
    81315
    PML_RAR, cbp
    81316
    PML_RAR, sbp
    81317
    PMS2, fgs
    81318
    PMS2, kfv
    81319
    PMS2, dup_del
    81321
    PTEN, fgs
    81322
    PTEN, kfv
    81323
    PTEN, dup_del
    81332
    SERPINA, cv
    81340
    TRB, beta
    81341
    TRB, dp
    81342
    TRG, gamma
    81370
    HLA I-II, lr ant
    81371
    HLA I-II, lr verification
    81372
    HLA I, lr complete
    81373
    HLA I, lr locus ea
    81374
    HLA I, lr 1 ant.
    81375
    HLA II, lr DRB1/3/4/5, DQB1
    81376
    HLA II, lr locus ea
    81377
    HLA II, lr antigen ea
    81378
    HLA I-II, hr A, B, C, DRB1
    81379
    HLA I, hr complete
    81380
    HLA I, hr locus ea
    81381
    HLA I, hr allele ea
    81382
    HLA II, hr locus ea
    81383
    HLA II, hr allele ea
    81400
    ACE, idv
    81400
    F13B, V34L
    81400
    F2, 1199G>A
    81400
    F5, HR2
    81400
    F7, R353Q
    81400
    FGB, -455G>A
    81400
    HPA, panel
    81400
    HPA-1
    81400
    HPA-15
    81400
    HPA-2
    81400
    HPA-3
    81400
    HPA-4
    81400
    IL28B, rs12979860
    81400
    SERPINE1, 4G
    81401
    ABL1, T315I
    81401
    CBFB_MYH11, cv
    81401
    CCND1_IGH, ta majbp qual qual
    81401
    E2A_PBX1, ta qual quan,
    81401
    EML4_ALK, ta
    81401
    ETV6_RUNX1, ta qual quan
    81401
    EWSR1_ERG, ta qual quan
    81401
    EWSR1_FLI1, ta qual quan
    81401
    EWSR1_WT1, ta qual quan
    81401
    F11, cv
    81401
    FIP1L1_PDGFR, qual quan
    81401
    FOXO1_PAX3, ta, qual quan
    81401
    FOXO1_PAX7, ta, qual quan
    81401
    MUTYH, cv
    81401
    PAX8_PPARG, ta
    81401
    RUNX1_RUNX1T1, ta qual quan
    81401
    TPMT, cv
    81401
    TYMS
    81401
    VWF, cv
    81402
    IGH_BCL2, majbpr_mcrbp qul_qun
    81402
    KIT, cv
    81403
    ABL1
    81403
    CEBPA, fgs
    81403
    EPCAM, kfv
    81403
    F8, intron 1 and 22a
    81403
    IDH1, exon 4
    81403
    IDH1_ IDH2, exon 4 panel
    81403
    IDH2, exon 4
    81403
    JAK2, exon 12 and 13
    81403
    RET, kfv
    81403
    VHL, dup_del
    81403
    VWF, tsa 2A, 2B, 2M
    81404
    CDKN2A, fgs
    81404
    KIT, tga
    81404
    NRAS, exon 1, 2
    81404
    PDGFRA, tsa
    81404
    PRSS1, fgs
    81404
    RET, cv
    81404
    VHL, fgs
    81405
    MEN1, fgs
    81405
    RET, tsa
    81405
    VWF, tsa 2N
    81406
    CAPN3, fgs
    81406
    RET, fgs
    81479
    FLT3, ITD + TKD
    81479
    MYD88, L265P

    The following tests have completed the MolDX Technical Assessment Process and limited coverage has been established.  Please review the companion policy and/or article for test specific information.

    Proprietary Test Name
    Manufacturer
    Effective Date
    CPT Code
    MCD #
    MolDX Article #
    Afirma
    Veracyte
    1/1/2012
    81479
    A52541
    M00015
    Allomap
    XDx
    2/28/2012
    81479
    A52542
    M00016
    Avise PG
    Exagen Diagnostics
    5/1/2012
    84999
    A52543
    M00026
    BRACAnalysis® Rearrangement Test (BART)
    Myriad Genetics
    12/1/2006
    81213
    L24308
     
    BRCA1 Analysis
    Myriad Genetics
    12/1/2006
    81214
    L24308
     
    Breast Cancer Index
    BioTheranostics
    11/4/2014
    81479
    L35294
     
    Cancer26
    MUSC
    10/3/2013
    81479
    NA
     
    CellSearch
    Veridex
    5/1/2012
    86152 OR 86153
    L34631
     
    cobas BRAF
    Roche
    9/7/2012
    81210-22
    A54017
    M00111
    cobas EGFR
    Roche
    9/5/2013
    81235-22
    A54020
    M00110
    Comprehensive BRACAnalysis®
    Myriad Genetics
    12/1/2006
    81211
    L24308
     
    Confirm MDx
    MDx Health
    11/4/2014
    81479
    L35368
     
    Corus CAD
    CardioDx
    7/30/2012
    81479
    A51927
    M00009
    CTID
    BioTheranostics
    12/27/2011
    81479
    A52544
    M00027
    Decipher
    GenomeDX
    LCD pending
    81479
    L35650
     
    GeneSight
    Assurex Health
    10/27/2014
    81479
    L35430
     
    HERmark
    LabCorp
    12/9/2011
    81479
    A52551
    M00028
    Integrated BRAC Analysis ®
    Myriad Genetics
    12/1/2006
    81479
    L24308
     
    Mammaprint
    Agendia
    11/16/2009
    81479
    A52557
    M00029
    OncotoypeDx Colon
    Genomic Health
    9/27/2011
    81479
    A51724
    M00002
    OncotypeDX Breast
    Genomic Health
    3/26/2012
    81479
    A51726
    M00003
    Progensa
    Gen Probe
    9/6/2012
    81479
    A51964
    M00013
    Prolaris
    Myriad Genetics
    LCD pending
    81479
    L35629
     
    therascreen EGFR
    Qiagen
    9/5/2013
    81235-22
    A54020
    M00110
    therascreen-Kras
    Qiagen
    4/30/2013
    81275-22
    A52559
    M00030
    ThxID™ BRAF V600E/K Test
    bioMerieux, Inc.
    1/9/2014
    81210-22
    A54017
    M00111
    Tissue of Origin
    ResponseDx
    12/22/2011
    81479
    A53091
    M00034
    Trofile
    LabCorp
    5/15/2012
    87999
    A53530
    M00042
    Vectra-DA
    Crescendo
    6/30/2012
    81479
    A52567
    M00031
    Vysis
    Abbott
    10/2/2012
    88367 OR 88368
    A52568
    M00032

     

    last updated on 01/30/2015
    ver 1.0.0