Monday, December 21, 2015

Approved Gene Testing (M00041, V14)

MolDX
Approved Gene Testing (M00041, V14)

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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. This listing has been updated with 2016 CPT codes.
#
CPT Code
Description
1.     
81170
ABL1, ga
2.     
81206
BCR_ABL1, majbp qual quant (p210)
3.     
81207
BCR_ABL1, minbp qual quant (p190)
4.     
81208
BCR_ABL1, other bp qual quant
5.     
81210
BRAF, V600E
6.     
81211
BRCA1, BRCA2, fgs cdup_del
7.     
81217
BRCA2, kfv
8.     
81218
CEBPA, fgs
9.     
81225
CYP2C19, cv
10.  
81226
CYP2D6, cv
11.  
81235
EGFR, cv
12.  
81245
FLT3, ITD
13.  
81246
FLT3, TKD
14.  
81256
HFE, cv
15.  
81261
IGH, amp
16.  
81262
IGH, dp
17.  
81263
IGH, var reg
18.  
81264
IGK, gr
19.  
81265
STR
20.  
81266
STR add  (for transplants)
21.  
81267
Chimerism, no cell
22.  
81268
Chimerism, with cell
23.  
81270
JAK2, V617F
24.  
81272
KIT, tsa
25.  
81273
KIT,  D816
26.  
81275
KRAS, codons 12 and 13
27.  
81275
KRAS, exon 1
28.  
81276
KRAS, addvar
29.  
81287
MGMT, ma
30.  
81288
MLH1, ma
31.  
81292
MLH1, fgs
32.  
81293
MLH1, kfv
33.  
81294
MLH1, dup_del
34.  
81295
MSH2, fgs
35.  
81296
MSH2, kfv
36.  
81297
MSH2, dup_del
37.  
81298
MSH6, fgs
38.  
81299
MSH6, kfv
39.  
81300
MSH6, dup_del
40.  
81301
MSI
41.  
81310
NPM1, exon 12
42.  
81311
NRAS, ex 2-3
43.  
81313
PCA3
44.  
81314
PDGFRA, tsa
45.  
81315
PML_RAR, cbp
46.  
81316
PML_RAR, sbp
47.  
81317
PMS2, fgs
48.  
81318
PMS2, kfv
49.  
81319
PMS2, dup_del
50.  
81321
PTEN, fgs
51.  
81322
PTEN, kfv
52.  
81323
PTEN, dup_del
53.  
81332
SERPINA, cv
54.  
81340
TRB, beta
55.  
81341
TRB, dp
56.  
81342
TRG, gamma
57.  
81370
HLA I-II, lr ant
58.  
81371
HLA I-II, lr verification
59.  
81372
HLA I, lr complete
60.  
81373
HLA I, lr locus ea
61.  
81374
HLA I, lr 1 ant.
62.  
81375
HLA II, lr DRB1/3/4/5, DQB1
63.  
81376
HLA II, lr locus ea
64.  
81377
HLA II, lr antigen ea
65.  
81378
HLA I-II, hr A, B, C, DRB1
66.  
81379
HLA I, hr complete
67.  
81380
HLA I, hr locus ea
68.  
81381
HLA I, hr allele ea
69.  
81382
HLA II, hr locus ea
70.  
81383
HLA II, hr allele ea
71.  
81400
ACE, idv
72.  
81400
F13B, V34L
73.  
81400
F2, 1199G>A
74.  
81400
F5, HR2
75.  
81400
F7, R353Q
76.  
81400
FGB, -455G>A
77.  
81400
HPA, panel
78.  
81400
HPA-1
79.  
81400
HPA-2
80.  
81400
HPA-3
81.  
81400
HPA-4
82.  
81400
HPA-5
83.  
81400
HPA-15
84.  
81400
IL28B, rs12979860
85.  
81400
SERPINE1, 4G
86.  
81401
ABL1, T315I
87.  
81401
CBFB_MYH11, cv
88.  
81401
CCND1_IGH, ta majbp qual qual
89.  
81401
E2A_PBX1, ta qual quan,
90.  
81401
EML4_ALK, ta
91.  
81401
ETV6_RUNX1, ta qual quan
92.  
81401
EWSR1_ERG, ta qual quan
93.  
81401
EWSR1_FLI1, ta qual quan
94.  
81401
EWSR1_WT1, ta qual quan
95.  
81401
F11, cv
96.  
81401
FIP1L1_PDGFR, qual quan
97.  
81401
FOXO1_PAX3, ta, qual quan
98.  
81401
FOXO1_PAX7, ta, qual quan
99.  
81401
IGH/BCL2, sbp
100.              
81401
MUTYH, cv
101.              
81401
PAX8_PPARG, ta
102.              
81401
RUNX1_RUNX1T1, ta qual quan
103.              
81401
TPMT, cv
104.              
81401
TYMS
105.              
81401
VWF, cv
106.              
81402
IGH_BCL2, majbpr_mcrbp qul_qun
107.              
81402
KIT, cv
108.              
81403
EPCAM, kfv
109.              
81403
F8, intron 1 and 22a
110.              
81403
HEA, gs
111.              
81403
IDH1, exon 4
112.              
81403
IDH1_ IDH2, exon 4 panel
113.              
81403
IDH2, exon 4
114.              
81403
JAK2, exon 12 and 13
115.              
81403
MUTYH, kfv
116.              
81403
 
117.              
81403
RET, kfv
118.              
81403
VHL, dup_del
119.              
81403
VWF, tsa 2A, 2B, 2M
120.              
81404
CDKN2A, fgs
121.              
81404
NRAS, exon 1, 2
122.              
81404
PRSS1, fgs
123.              
81404
RET, cv
124.              
81404
VHL, fgs
125.               
81405
MEN1, fgs
126.              
81405
RET, tsa
127.              
81405
VWF, tsa 2N
128.              
81406
RET, fgs
129.              
81445
Tsa panel, solid organ neoplasm, 5-50 genes
130.            
81450
Tsa panel, hematolymphoid neoplasm, 5-50 genes
131.             
81455
Tsa panel, solid organ or hematolymphoid neoplasm,  51 or >
132.              
81479
ALK
133.              
81479
BCR_ABL1, 210 + 190
134.              
81479
BCR_ABL1, 210 + 190 +other
135.              
 
CALR_MPL
136.              
81479
CYP2D6, CYP2C19
137.              
81479
ERBB2
138.              
81479
ERCC1
139.              
81479
FLT3, ITD + TKD
140.              
81479
HER2
141.              
81479
IGH, IGK
142.              
81479
MYD88, L265P
143.              
81479
NRAS, 2,3,4
144.              
81479
RET/PTC
145.              
81479
ROS1
146.              
81479
TRB/TRG
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
MCD #
MolDX Article #
1.   
Afirma
Veracyte
1/1/2012
81545
A523098
M00015
2.   
Allomap
XDx
2/28/2012
81595
A53099
M00016
3.   
Avise PG
Exagen Diagnostics
5/1/2012
84999
A53100
M00026
4.   
BRACAnalysis® Rearrangement Test (BART)
Myriad Genetics
12/1/2006
81213
L36082
 
5.   
BRCA1 Analysis
Myriad Genetics
12/1/2006
81214
L36082
 
6.   
BRCA1/2
Ambry
3/1/2014
81162
L36082
 
7.   
BRACAnalysis CDx
Myriad Genetics
12/19/14
81162
L36082
M00120
8.   
BRCAssureSM
LabCorp
3/1/2014
81162
L36082
 
9.   
BRCAvantage, Comprehensive
Quest
3/1/2014
81162
L36082
 
10.  
Breast Cancer Index
BioTheranostics
11/4/2014
81479
L35631
 
11.  
Cancer26
MUSC
10/3/2013
81445
NA
 
12.
CellSearch
Veridex
5/1/2012
86152 OR 86153
L35071
 
13.
cobas BRAF
Roche
9/7/2012
81210-22
A54018
M00111
14.
cobas EGFR
Roche
9/5/2013
81235-22
A54021
M00110
15.
cobas KRAS
Roche
5/7/2015
81275-22
A54472
M00121
16.  
Comprehensive BRACAnalysis®
Myriad Genetics
12/1/2006
81211
L36082
 
17.
Confirm MDx
MDx Health
11/4/2014
81479
L35632
 
18.
Corus CAD
CardioDx
7/30/2012
81493
A53102
M00009
19.
CTID
BioTheranostics
12/27/2011
81540
A53101
M00027
20.
Decipher
GenomeDX
10/01/2015
81479
L35868
 
21.
FoundationOne®
Foundation One
10/01/2015
81479
L36143
 
22.
GeneSight
Assurex Health
10/27/2014
81479
L35633
 
23.
HERmark
LabCorp
12/9/2011
81479
A53103
M00028
24.
Integrated BRAC Analysis ®
Myriad Genetics
12/1/2006
81479
L36082
 
25.
Mammaprint
Agendia
11/16/2009
81479
A53104
M00029
26.
OncotoypeDx Colon
Genomic Health
9/27/2011
81525
A53106
M00002
27.
OncotypeDX Breast
Genomic Health
3/26/2012
81479
A53105
M00003
28.
PreciseType™ HEA Bead
Immucor
6/22/2015
81403
L36074
 
29.
Progensa
Gen Probe
9/6/2012
81313
A53107
M00013
30.
Prolaris
Myriad Genetics
3/2/15
81479
L35869
 
31.
therascreen EGFR
Qiagen
9/5/2013
81235-22
A54021
M00110
32.
therascreen-Kras
Qiagen
4/30/2013
81275-22
A54472
M00121
33.
ThxID™ BRAF V600E/K Test
bioMerieux, Inc.
1/9/2014
81210-22
A54018
M00111
34.
Tissue of Origin
ResponseDx
12/22/2011
81504
A53108
M00034
35.
TRofile DNA
LabCorp
5/5/2012
87999
 
 
36.
Trofile
LabCorp
5/15/2012
87999
A53528
M00042
37.
Ventana ALK Assay
Roche
6/12/15
88342
A54656
M00122
38.
Vectra-DA
Crescendo
6/30/2012
81490
A53110
M00031
39. 
Vysis
Abbott
10/2/2012
88374 OR 88377
A54656
M00122

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