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 |

