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September 22, 2015 - Updated 10.27.16

Approved Gene Testing (CM0007, V2)

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. 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, ex2-3
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 MUTYH, kfv
118. 81403 IDH2, exon 4
119. 81403 JAK2, exon 12 and 13
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 HereditaryCApanel
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 Code MCD # MolDX Article #
1. Afirma Veracyte 1/1/2012 81479 A54185 CM00014
2. Allomap XDx 2/28/2012 81479 A54186 CM00023
3. Avise PG Exagen Diagnostics 5/1/2012 84999 A54187 CM00025
4. BRACAnalysis® Rearrangement Test (BART) Myriad Genetics 12/1/2006 81213
5. BRCA1 Analysis Myriad Genetics 12/1/2006 81214
6. BRCA1/2 Ambry 3/1/2014 81479
7.   BRCAnalysis CDx 12/19/2014 81479 CM00028
8. BRCAssureSM LabCorp 3/1/2014 81479
9. BRCAvantage, Comprehensive Quest 3/1/2014 81479
10. Breast Cancer Index BioTheranostics 11/4/2014 81479 L36004
11. Cancer26 MUSC 10/3/2013 81479 NA
12. CellSearch Veridex 5/1/2012 86152 OR 86153 L32301
13. cobas BRAF Roche 9/7/2012 81210-22 A54238 CM00029
14. cobas EGFR Roche 9/5/2013 81235-22 A54189 CM00092
15. cobas KRAS Roche 5/7/2015 81275-22
16. Comprehensive BRACAnalysis® Myriad Genetics 12/1/2006 81211
17. Confirm MDx MDx Health 11/4/2014 81479 L36006
18. Corus CAD CardioDx 7/30/2012 81479 A54190 CM00021
19. CTID BioTheranostics 12/27/2011 81479 A54188 CM00015
20. FoundationOne® Foundation one 10/01/2015 81479  
21. GeneSight Assurex Health 10/27/2014 81479 L35443
22. HERmark LabCorp 12/9/2011 81479 A54193 CM00016
23. Integrated BRAC Analysis ® Myriad Genetics 12/1/2006 81162
24. Mammaprint Agendia 11/16/2009 81479 A54194 CM00017
25. OncotoypeDx Colon Genomic Health 9/27/2011 81479 A54196 CM00026
26. OncotypeDX Breast Genomic Health 3/26/2012 81479 A54195 CM00024
27. PreciseType™ HEA Bead Immucor 6/22/2015 81403 L36011
28. Progensa Gen Probe 9/6/2012 81479 A54197 CM00018
29. Prolaris Myriad Genetics 3/2/2015 81479 L36002
30. Prosigna Nanostring 10/01/2015 0008M L36425
31. therascreen EGFR Qiagen 9/5/2013 81235-22 A54199 CM00092
32. therascreen-Kras Qiagen 4/30/2013 81275-22 A54200 CM00027
33. ThxID™ BRAF V600E/K Test bioMerieux, Inc. 1/9/2014 81210-22 A54239 CM00029
34. Tissue of Origin ResponseDx 12/22/2011 81479 A54198 CM00030
35. TRofile DNA LabCorp 5/5/2012 87999
36. Trofile LabCorp 5/15/2012 87999 A54287 TBA
37. Ventana ALK Assay Roche 6/12/2015 88342 A54598 CM00022
38. Vectra-DA Crescendo 6/30/2012 81490 A54201 CM00019
39. Vysis Abbott 10/2/2012 88374 OR 88377 A54598 TBA

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