Thursday, November 2, 2017

MolDX Approved Genetic Tests (Table) M00041 V16 (1/27/2016)

Approved Gene Testing (M00041, V16)

     
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.     
81162
BRCA1, BRCA2, fgs cdup_del
2.     
81170
ABL1, ga
3.     
81206
BCR_ABL1, majbp qual quant (p210)
4.     
81207
BCR_ABL1, minbp qual quant (p190)
5.     
81208
BCR_ABL1, other bp qual quant
6.     
81210
BRAF, V600E
7.     
81211
BRCA1, BRCA2, fgs cdup_del
8.     
81212
BRCA1, BRCA2, 185delAG, 5385insC, 6174delT
9.     
81213
BRCA1, BRCA2, uncom dup_del
10.  
81214
BRCA1, fgs cdup_del
11.  
81215
BRCA1, fgs, kfv
12.  
81216
BRCA2, fgs
13.  
81217
BRCA2, kfv
14.  
81218
CEBPA, fgs
15.  
81225
CYP2C19, cv
16.  
81226
CYP2D6, cv
17.  
81235
EGFR, cv
18.  
81245
FLT3, ITD
19.  
81246
FLT3, TKD
20.  
81256
HFE, cv
21.  
81261
IGH, amp
22.  
81262
IGH, dp
23.  
81263
IGH, var reg
24.  
81264
IGK, gr
25.  
81265
STR
26.  
81266
STR add  (for transplants)
27.  
81267
Chimerism, no cell
28.  
81268
Chimerism, with cell
29.  
81270
JAK2, V617F
30.  
81272
KIT, tsa
31.  
81273
KIT,  D816
32.  
81275
KRAS, codons 12 and 13
33.  
81276
KRAS, addvar
34.  
81287
MGMT, ma
35.  
81288
MLH1, ma
36.  
81292
MLH1, fgs
37.  
81293
MLH1, kfv
38.  
81294
MLH1, dup_del
39.  
81295
MSH2, fgs
40.  
81296
MSH2, kfv
41.  
81297
MSH2, dup_del
42.  
81298
MSH6, fgs
43.  
81299
MSH6, kfv
44.  
81300
MSH6, dup_del
45.  
81301
MSI
46.  
81310
NPM1, exon 12
47.  
81311
NRAS, ex 2-3
48.  
81313
PCA3
49.  
81314
PDGFRA, tsa
50.  
81315
PML_RAR, cbp
51.  
81316
PML_RAR, sbp
52.  
81317
PMS2, fgs
53.  
81318
PMS2, kfv
54.  
81319
PMS2, dup_del
55.  
81321
PTEN, fgs
56.  
81322
PTEN, kfv
57.  
81323
PTEN, dup_del
58.  
81332
SERPINA, cv
59.  
81340
TRB, beta
60.  
81341
TRB, dp
61.  
81342
TRG, gamma
62.  
81370
HLA I-II, lr ant
63.  
81371
HLA I-II, lr verification
64.  
81372
HLA I, lr complete
65.  
81373
HLA I, lr locus ea
66.  
81374
HLA I, lr 1 ant.
67.  
81375
HLA II, lr DRB1/3/4/5, DQB1
68.  
81376
HLA II, lr locus ea
69.  
81377
HLA II, lr antigen ea
70.  
81378
HLA I-II, hr A, B, C, DRB1
71.  
81379
HLA I, hr complete
72.  
81380
HLA I, hr locus ea
73.  
81381
HLA I, hr allele ea
74.  
81382
HLA II, hr locus ea
75.  
81383
HLA II, hr allele ea
76.  
81400
ACE, idv
77.  
81400
F13B, V34L
78.  
81400
F2, 1199G>A
79.  
81400
F5, HR2
80.  
81400
F7, R353Q
81.  
81400
FGB, -455G>A
82.  
81400
HPA-1
83.  
81400
HPA-2
84.  
81400
HPA-3
85.  
81400
HPA-4
86.  
81400
HPA-5
87.  
81400
HPA-6
88.  
81400
HPA-15
89.  
81400
IL28B, rs12979860
90.  
81400
SERPINE1, 4G
91.  
81401
ABL1, T315I
92.  
81401
CBFB_MYH11, cv
93.  
81401
CCND1_IGH, ta majbp qual qual
94.  
81401
E2A_PBX1, ta qual quan,
95.  
81401
EML4_ALK, ta
96.  
81401
ETV6_RUNX1, ta qual quan
97.  
81401
EWSR1_ERG, ta qual quan
98.  
81401
EWSR1_FLI1, ta qual quan
99.  
81401
EWSR1_WT1, ta qual quan
100.            
81401
F11, cv
101.            
81401
FIP1L1_PDGFR, qual quan
102.            
81401
FOXO1_PAX3, ta, qual quan
103.            
81401
FOXO1_PAX7, ta, qual quan
104.            
81401
IGH/BCL2, sbp
105.            
81401
MUTYH, cv
106.             
81401
PAX8_PPARG, ta
107.              
81401
RUNX1_RUNX1T1, ta qual quan
108.              
81401
TPMT, cv
109.             
81401
TYMS
110.             
81401
VWF, cv
111.              
81402
IGH_BCL2, majbpr_mcrbp qul_qun
112.              
81402
KIT, cv
113.              
81403
EPCAM, kfv
114.              
81403
F8, intron 1 and 22a
115.              
81403
HEA, gs
116.              
81403
IDH1, exon 4
117.             
81403
IDH2, exon 4
118.             
81403
JAK2, exon 12 and 13
119.             
81403
MUTYH, kfv
120.             
81403
RET, kfv
121.            
81403
VHL, dup_del
122.             
81403
VWF, tsa 2A, 2B, 2M
123.             
81404
CDKN2A, fgs
124.             
81404
NRAS, exon 1, 2
125.             
81404
PRSS1, fgs
126.            
81404
RET, cv
127.             
81404
VHL, fgs
128.             
81405
MEN1, fgs
129.             
81405
RET, tsa
130.             
81405
VWF, tsa 2N
131.             
81406
RET, fgs
132.             
81432
HereditaryCA panel
133.     
81445
Tsa panel, solid organ neoplasm, 5-50 genes
134.      
81450
Tsa panel, hematolymphoid neoplasm, 5-50 genes
135.        
81455
Tsa panel, solid organ or hematolymphoid neoplasm, 51 or >
136.           
81479
ALK
137.            
81479
BCR_ABL1, 210 + 190
138.             
81479
BCR_ABL1, 210 + 190 +other
139.            
81479
CYP2D6, CYP2C19
140.            
81479
ERBB2
141.             
81479
ERCC1
142.             
81479
FLT3, ITD + TKD
143.            
81479
HER2
144.            
81479
IGH, IGK
145.            
81479
MLH1 panel, (fgs + d_d)
146.             
81479
MSH2, panel (fgs + d_d)
147.             
81479
MSH6, panel (fgs + d_d)
148.            
81479
MYD88, L265P
149.             
81479
NRAS, 2,3,4
150.             
81479
RET/PTC
151.             
81479
ROS1
152.             
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
A53098
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
81479
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
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
81162
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.
Prosigna
Nanostring
10/01/2015
0008M
L36125
 
32.
therascreen EGFR
Qiagen
9/5/2013
81235-22
A54021
M00110
33.
therascreen-Kras
Qiagen
4/30/2013
81275-22
A54472
M00121
34.
ThxID™ BRAF V600E/K Test
bioMerieux, Inc.
1/9/2014
81210-22
A54018
M00111
35.
Tissue of Origin
ResponseDx
12/22/2011
81504
A53108
M00034
36.
TRofile DNA
LabCorp
5/5/2012
87999
 
 
37.
Trofile
LabCorp
5/15/2012
87999
A53528
M00042
38.
Ventana ALK Assay
Roche
6/12/15
88342
A54656
M00122
39.
Vectra-DA
Crescendo
6/30/2012
81490
A53110
M00031
40.
Vysis
Abbott
10/2/2012
88374 OR 88377
A54656
M00122
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