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 |