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    MolDx
    Approved Gene Testing (M00041, V12)

    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
    1.
    81206
    BCR_ABL1, majbp qual quant (p210)
    2.
    81207 
    BCR_ABL1, minbp qual quant (p190)
    3.
    81208 
    BCR_ABL1, other bp qual quant
    4.
    81210 
    BRAF, V600E
    5.
    81225 
    CYP2C19, cv
    6.
    81226 
    CYP2D6, cv
    7.
    81235 
    EGFR, cv
    8.
    81245 
    FLT3, ITD
    9.
    81246 
    FLT3, TKD
    10.
    81256 
    HFE, cv
    11.
    81261 
    IGH, amp
    12.
    81262 
    IGH, dp
    13.
    81263
    IGH, var reg
    14.
    81264 
    IGK, gr
    15.
    81265 
    STR
    16.
    81266
    STR add  (for transplants)
    17.
    81267 
    Chimerism, no cell
    18.
    81268 
    Chimerism, with cell
    19.
    81270 
    JAK2, V617F
    20.
    81275 
    KRAS, codons 12 and 13
    21.
    81275 
    KRAS, exon 1
    22.
    81287 
    MGMT, ma
    23.
    81288 
    MLH1, ma
    24.
    81292 
    MLH1, fgs
    25.
    81293 
    MLH1, kfv
    26.
    81294 
    MLH1, dup_del
    27.
    81295 
    MSH2, fgs
    28.
    81296 
    MSH2, kfv
    29.
    81297 
    MSH2, dup_del
    30.
    81298 
    MSH6, fgs
    31.
    81299
    MSH6, kfv
    32.
    81300 
    MSH6, dup_del
    33.
    81301 
    MSI
    34.
    81310 
    NPM1, exon 12
    35.
    81315 
    PML_RAR, cbp
    36.
    81316 
    PML_RAR, sbp
    37.
    81317 
    PMS2, fgs
    38.
    81318 
    PMS2, kfv
    39.
    81319 
    PMS2, dup_del
    40.
    81321 
    PTEN, fgs
    41.
    81322 
    PTEN, kfv
    42.
    81323 
    PTEN, dup_del
    43.
    81332 
    SERPINA, cv
    44.
    81340 
    TRB, beta
    45.
    81341 
    TRB, dp
    46.
    81342 
    TRG, gamma
    47.
    81370 
    HLA I-II, lr ant
    48.
    81371
    HLA I-II, lr verification
    49.
    81372 
    HLA I, lr complete
    50.
    81373 
    HLA I, lr locus ea
    51.
    81374 
    HLA I, lr 1 ant.
    52.
    81375 
    HLA II, lr DRB1/3/4/5, DQB1
    53.
    81376 
    HLA II, lr locus ea
    54.
    81377 
    HLA II, lr antigen ea
    55
    81378 
    HLA I-II, hr A, B, C, DRB1
    56.
    81379 
    HLA I, hr complete
    57.
    81380 
    HLA I, hr locus ea
    58.
    81381 
    HLA I, hr allele ea
    59.
    81382 
    HLA II, hr locus ea
    60.
    81383 
    HLA II, hr allele ea
    61.
    81400
     
    ACE, idv
    62. 81400 
    F13B, V34L
    63.
    81400 
    F2, 1199G>A
    64.
    81400 
    F5, HR2
    65.
    81400 
    F7, R353Q
    66.
    81400 
    FGB, -455G>A
    67.
    81400 
    HPA, panel
    68.
    81400 
    HPA-1
    69.
    81400 
    HPA-15
    70.
    81400 
    HPA-2
    71.
    81400 
    HPA-3
    72.
    81400 
    HPA-4
    73.
    81400 
    IL28B, rs12979860
    74.
    81400 
    SERPINE1, 4G
    75.
    81401 
    ABL1, T315I
    76.
    81401 
    CBFB_MYH11, cv
    77.
    81401 
    CCND1_IGH, ta majbp qual qual
    78.
    81401 
    E2A_PBX1, ta qual quan,
    79.
    81401
    EML4_ALK, ta
    80.
    81401 
    ETV6_RUNX1, ta qual quan
    81.
    81401 
    EWSR1_ERG, ta qual quan
    82.
    81401
    EWSR1_FLI1, ta qual quan
    83.
    81401 
    EWSR1_WT1, ta qual quan
    84.
    81401
    F11, cv
    85.
    81401 
    FIP1L1_PDGFR, qual quan
    86.
    81401 
    FOXO1_PAX3, ta, qual quan
    87.
    81401 
    FOXO1_PAX7, ta, qual quan
    88.
    81401 
    MUTYH, cv
    89.
    81401 
    PAX8_PPARG, ta
    90.
    81401
    RUNX1_RUNX1T1, ta qual quan
    91.
    81401 
    TPMT, cv
    92.
    81401
    TYMS
    93.
    81401 
    VWF, cv
    94.
    81402 
    IGH_BCL2, majbpr_mcrbp qul_qun
    95.
    81402 
    KIT, cv
    96.
    81403 
    ABL1
    97.
    81403 
    CEBPA, fgs
    98.
    81403 
    EPCAM, kfv
    99.
    81403 
    F8, intron 1 and 22a
    100.
    81403 
    IDH1, exon 4
    101.
    81403
    MUTYH, kfv 
    102.
    81403 
    IDH1_ IDH2, exon 4 panel
    103.
    81403 
    IDH2, exon 4
    104.
    81403 
    JAK2, exon 12 and 13
    105.
    81403 
    RET, kfv
    106.
    81403 
    VHL, dup_del
    107.
    81403 
    VWF, tsa 2A, 2B, 2M
    108.
    81404 
    CDKN2A, fgs
    109.
    81404 
    KIT, tga
    110.
    81404 
    NRAS, exon 1, 2
    111.
    81404 
    PDGFRA, tsa
    112.
    81404 
    PRSS1, fgs
    113.
    81404 
    RET, cv
    114.
    81404 
    VHL, fgs
    115.
    81405 
    MEN1, fgs
    116.
    81405 
    RET, tsa
    117.
    81405 
    VWF, tsa 2N
    118.
    81406 
    RET, fgs
    119.
    81479 
    FLT3, ITD + TKD
    120.
    81479 
    MYD88, L265P
    121. 
    81479 
    ROS1 

    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 #
    1.
    Afirma 
    Veracyte
    1/1/2012
    81479
    A52541
    M00015
    2.
    Allomap 
    XDx
    2/28/2012
    81479
    A52542
    M00016
    3.
    Avise PG
    Exagen Diagnostics
    5/1/2012
    84999
    A52543
    M00026
    4.
    BRACAnalysis® Rearrangement Test (BART) 
    Myriad Genetics
    12/1/2006
    81213
    L24308
     
    5.
    BRCA1 Analysis
    Myriad Genetics
    12/1/2006
    81214
    L24308
     
    6. BRCA1/2   Ambry 

     3/1/2014

    81479     
    7. BRCAssureSM   LabCorp 

     3/1/2014

    81479     
    8. BRCAvantage, Comprehensive   Quest 

     3/1/2014

    81479     
    9.
    Breast Cancer Index 
    BioTheranostics
    11/4/2014
    81479
    L35294
     
    10.
    Cancer26 
    MUSC
    10/3/2013
    81479
    NA
     
    11.
    CellSearch
    Veridex
    5/1/2012
    86152 OR 86153
    L34631
     
    12.
    cobas BRAF 
    Roche
    9/7/2012
    81210-22
    A54017
    M00111
    13.
    cobas EGFR 
    Roche
    9/5/2013
    81235-22
    A54020
    M00110
    14.
    cobas KRAS 
    Roche 

     5/7/2015

    81275-22

    A54471  M00120
    15.
    Comprehensive BRACAnalysis® 
    Myriad Genetics
    12/1/2006
    81211
    L24308
     
    16. BRACAnalysis CDx   Myriad Genetics 

     12/19/14

    81479  A54339  M00120 
    17.
    Confirm MDx 
    MDx Health
    11/4/2014
    81479
    L35368
     
    18.
     
    Corus CAD
    CardioDx
    7/30/2012
    81479
    A51927
    M00009
    19.
    CTID 
    BioTheranostics
    12/27/2011
    81479
    A52544
    M00027
    20.
    Decipher 
    GenomeDX
    LCD pending
    81479
    L35650
     
    21.
    GeneSight 
    Assurex Health
    10/27/2014
    81479
    L35430
     
    22.
    HERmark 
    LabCorp
    12/9/2011
    81479
    A52551
    M00028
    23.
    Integrated BRAC Analysis ® 
    Myriad Genetics
    12/1/2006
    81479
    L24308
     
    24.
    Mammaprint
     
    Agendia
    11/16/2009
    81479
    A52557
    M00029
    25.
    OncotoypeDx Colon 
    Genomic Health
    9/27/2011
    81479
    A51724
    M00002
    26.
    OncotypeDX Breast 
    Genomic Health
    3/26/2012
    81479
    A51726
    M00003
    27. PreciseType™ HEA Bead   Immucor 

     6/22/2015

    81403  L35827   
    28.
     
    Progensa
    Gen Probe
    9/6/2012
    81479
    A51964
    M00013
    29.
    Prolaris 
    Myriad Genetics
    3/2/2015
    81479
    L35629
     
    30.
    therascreen EGFR
    Qiagen
    9/5/2013
    81235-22
    A54020
    M00110
    31.
    therascreen-Kras
    Qiagen
    4/30/2013
    81275-22
    A54472
    M00030
    32.
    ThxID™ BRAF V600E/K Test 
    bioMerieux, Inc.
    1/9/2014
    81210-22
    A54017
    M00111
    33.
    Tissue of Origin 
    ResponseDx
    12/22/2011
    81479
    A53091
    M00034
    34. TRofile DNA   LabCorp 

     5/5/2012

    87999     
    35.
    Trofile 
    LabCorp
    5/15/2012
    87999
    A53530
    M00042
    36. 
    Ventana ALK Assay
     
    Roche 

       6/12/2015

    88342  A52568  M00122 
    37.
    Vectra-DA  
    Crescendo
    6/30/2012
    81479
    A52567
    M00031
    38.
    Vysis
    Abbott
    10/2/2012
    88374 OR 88377
    A52568
    M00122

     

    last updated on 08/17/2015
    ver 1.0.0