Pathology: Molecular Pathology (path Molec)
path molec1Pathology: Molecular PathologyPage updated: August 2020This section contains information to help providers bill for clinical laboratory tests orexaminations related to molecular pathology and diagnostic services.Molecular Pathology Code ChartThe chart included later in this section correlates molecular pathology CPT and HCPCSLevel II Codes with the following: Treatment Authorization Request (TAR) and claim documentation requirements Allowable diagnosis (ICD-10-CM) codes Once-in-a-lifetime and other frequency limitations for reimbursement Select modifier and split-billing informationNote: Policy for most molecular pathology codes fits within the chart; however, some policywas too lengthy or complex for the chart and is covered outside of the chart.ModifiersFor a description of the modifiers billed with certain codes, refer to the Modifiers: ApprovedList section in this manual.Part 2 – Pathology: Molecular Pathology
path molec2Page updated: August 2020Tier 1, Molecular Pathology, Code Correlation ChartProviders should refer to the CPT code book for full descriptions of the following codes.‹‹Molecular Pathology CPT Codes, TAR and Billing Information››CPT CodeDescription81120IDH1 (isocitratedehydrogenase 1[NADP ], soluble),common variantsTARRequired TAR and/or Billing RequirementsNoOne of the following ICD-10-CMcodes is required on the claim(except with valid TAR):81121IDH2 (isocitratedehydrogenase 2[NADP ],mitochondrial),common variants81161DMD (dystrophin)deletion analysis, andduplication analysis, ifperformedNoC71.0 thru C71.9 or C92.00 thruC92.02One of the following ICD-10-CMcodes is required on the claim(except with valid 1.0 thru C71.9 or C92.00 thruC92.02NoICD-10-CM diagnosis code G71.0(muscular dystrophy) is required onthe claim.Part 2 – Pathology: Molecular PathologyOnce-in-alifetime
path molec3Page updated: August 2020‹‹Molecular Pathology CPT Codes, TAR and Billing Information (continued)››CPT CodeDescription81162BRCA1, BRCA2 geneanalysis; fullsequence analysisand fullduplication/deletionanalysisTARRequired TAR and/or Billing RequirementsYesA TAR for CPT code 81162 requiresdocumentation of one or more ofthe following numbered criteria.1. Based on 2019 U.S. PreventiveServices Task Force (USPSTF)recommendation: The patient has personal orfamily history that suggestsan inherited cancersusceptibility based on anyone of the following familialrisk assessment tools: The Ontario FamilyHistory Assessment Tool Manchester ScoringSystem Referral Screening Tool Pedigree AssessmentTool 7-Question Family HistoryScreening Tool International BreastCancer Intervention Studyinstrument Brief versions ofBRCAPRO; and The patient is willing to talkwith a health professionalwho is suitably trained toprovide genetic counselingand interpret test results;and(continued on next page)Part 2 – Pathology: Molecular PathologyFrequencyOnce-in-alifetime exceptwith valid TARoverride *
path molec4Page updated: August 2020‹‹Molecular Pathology CPT Codes, TAR and Billing Information (continued)››CPT CodeDescription81162BRCA1, BRCA2 geneanalysis; fullsequence analysisand fullduplication/deletionanalysisTARRequired TAR and/or Billing RequirementsYes The test results will aid inthe decision-making; or2. An individual from a familymember with a knowndeleterious BRCA mutation; or3. Personal history of breastcancer (invasive or ductalcarcinoma in situ) plus one ormore of the following: Diagnosed at 45 years ofage; or Diagnosed at 46 to 50 yearsof age with: An additional breastcancer primary at any age One or more close bloodrelatives with breastcancer at any age One or more close bloodrelatives with prostatecancer(Gleason score 7) An unknown or limitedfamily history; or Diagnosed at 60 years ofage with a triple negativebreast cancer; or(continued on next page)Part 2 – Pathology: Molecular PathologyFrequencyOnce-in-alifetime exceptwith valid TARoverride *
path molec5Page updated: August 2020‹‹Molecular Pathology CPT Codes, TAR and Billing Information (continued)››CPT CodeDescription81162TARRequired TAR and/or Billing RequirementsYes Diagnosed at any age with: One or more close bloodrelatives with:BRCA1, BRCA2 geneanalysis; fullsequence analysisand fullduplication/deletionanalysis Breast cancerdiagnosed at 50 yearsof age; or Ovarian carcinoma; or Male breast cancer; or Metastatic prostatecancer; or Pancreatic cancer Two or more additionaldiagnosis of breastcancer at any age inpatient and/or in closeblood relatives; or Ashkenazi Jewish ancestry;or4. Personal history of ovariancarcinoma (includes fallopiantube and primary peritonealcancers); or5. Personal history of male breastcancer; or(continued on next page)Part 2 – Pathology: Molecular PathologyFrequencyOnce-in-alifetime exceptwith valid TARoverride *
path molec6Page updated: August 2020‹‹Molecular Pathology CPT Codes, TAR and Billing Information (continued)››CPT CodeDescription81162BRCA1, BRCA2 geneanalysis; fullsequence analysisand fullduplication/deletionanalysisTARRequired TAR and/or Billing RequirementsYes6. Personal history of pancreaticcancer; or7. Personal history of metastaticprostate cancer (biopsy-provenand/or with radiographicevidence; includes distantmetastasis and regional bed ornodes; not biochemicalrecurrence); or8. Personal history of high-gradeprostate cancer (Gleason score 7) at any age with: One or more close bloodrelatives (first-, second- orthird-degree) with ovariancarcinoma, pancreaticcancer or metastaticprostate cancer at any ageor breast cancer under 50years of age; or Two or more close bloodrelatives (first-, second- orthird-degree relatives on thesame side of family) withbreast or prostate cancer(any grade) at any age; or Ashkenazi Jewish ancestry;or(continued on next page)Part 2 – Pathology: Molecular PathologyFrequencyOnce-in-alifetime exceptwith valid TARoverride *
path molec7Page updated: August 2020‹‹Molecular Pathology CPT Codes, TAR and Billing Information (continued)››CPT CodeDescription81162BRCA1, BRCA2 geneanalysis; fullsequence analysisand fullduplication/deletionanalysisTARRequired TAR and/or Billing RequirementsYes9. BRCA1/2 pathogenic/likelypathogenic variant detected bytumor profiling on any tumortype in the absence of germlinepathogenic/likely pathogenicvariant analysis; or10. For an individual without historyof breast or ovarian cancer, butwith one or more first- orsecond-degree blood relativemeeting any of the abovecriteria; or11. For BRACAnalysis CDx testingfor breast cancer, all of thefollowing TAR criteria must bemet: Patient has metastaticbreast cancer. Patient is human epidermalgrowth factor receptor 2(HER2)-negative. Patient has previously beentreated with chemotherapyin the neoadjuvant, adjuvantor metastatic setting. Patient’s additionaltreatment is contingent onthe test results.Part 2 – Pathology: Molecular PathologyFrequencyOnce-in-alifetime exceptwith valid TARoverride *
path molec8Page updated: August 2020‹‹Molecular Pathology CPT Codes, TAR and Billing Information (continued)››CPT CodeDescription81163BRCA1 (BRCA1,DNA repairassociated), BRCA2(BRCA2, DNA repairassociated) geneanalysis; fullsequence analysis81164TARRequired TAR and/or Billing RequirementsYesSee CPT code 81162 for TARcriteria and billing requirements.FrequencySee CPT code81162YesSee CPT code 81162 for TARcriteria and billing requirements.See CPT code8116281165YesBRCA1 (BRCA1,DNA repairassociated) geneanalysis; fullsequence analysis81166See CPT code 81162 for TARcriteria and billing requirements.See CPT code81162YesSee CPT code 81162 for TARcriteria and billing requirements.See CPT code81162BRCA1 (BRCA1,DNA repairassociated), BRCA2(BRCA2, DNA repairassociated) geneanalysis; fullduplication/deletionanalysisBRCA1 (BRCA1,DNA repairassociated) geneanalysis; fullduplication/deletionanalysisPart 2 – Pathology: Molecular Pathology
path molec9Page updated: December 2020Molecular Pathology CPT Codes, TAR and Billing Information (continued)CPT CodeDescription81167BRCA2 (BRCA2,DNA repairassociated) geneanalysis; ired TAR and/or Billing RequirementsYesSee CPT code 81162 for TARcriteria and billing requirements.NoCCND1/IGH(t[11;14])(eg,mantlecell lymphoma)translocationanalysis, majorbreakpoint, qualitativeand quantitative, ifperformed81170AFF2 (AF4/FMR2family, member 2[FMR2]) geneanalysis evaluation todetect abnormalallelesOnce in alifetime››C83.10 thru C83.19.YesRequires documentation on theTAR that the recipient has chronicmyeloid leukemia (CML) and failedtyrosine kinase inhibitor (TKI)therapyOnce-in-alifetimeNoOne of the following ICD-10-CMdiagnosis codes is required on theclaim (except with valid TAR):Once-in-alifetime exceptwith valid TARoverrideALB1 gene analysis,variants in the kinasedomain81171One of the following ICD-10-CMdiagnosis codes is required on theclaim:FrequencySee CPT code81162F70, F71, F80.0 thru F89, H93.25,R48.0, R62.0 thru R62.59, F82,F88, R48.2Part 2 – Pathology: Molecular Pathology
path molec10Page updated: December 2020Molecular Pathology CPT Codes, TAR and Billing Information (continued)81172AFF2 (AF4/FMR2family, member 2[FMR2]) geneanalysis;characterization ofalleles81173NoOne of the following ICD-10-CMdiagnosis codes is required on theclaim (except with valid TAR): F70, F71, F80.0 thru F89,H93.25, R48.0, R62.0 thruR62.59, F82, F88, R48.2YesAR (androgenreceptor) geneanalysis; full genesequenceOnce-in-alifetime exceptwith valid TARoverrideA TAR for CPT code 81173 requires Once-in-adocumentation of the followinglifetime exceptcriteria:with valid TARoverride The patient has clinical signsor symptoms suspicious forbulbar muscular atrophy, and The patient requires theservice as a confirmatory testfor spinal and bulbarmuscular atrophy81174AR (androgenreceptor) geneanalysis; knownfamilial variantYesA TAR for CPT code 81174 requires Once-in-adocumentation of the followinglifetime exceptcriteria:with valid TARoverride The patient has clinical signsor symptoms suspicious forbulbar muscular atrophy, and The patient requires theservice as a confirmatory testfor spinal and bulbarmuscular atrophyPart 2 – Pathology: Molecular Pathology
path molec11Page updated: December 2020Molecular Pathology CPT Codes, TAR and Billing Information (continued)CPT CodeDescription81175ASXL gene analysis,full gene sequence81176TARRequired TAR and/or Billing RequirementsNoOne of the following ICD-10-CMcodes is required on the claim(except with valid TAR):NoASXL gene analysis,targeted sequenceanalysis81177ATN1 (atrophin 1)gene analysis,evaluation to detectabnormal allelesYesC93.10 thru C93.12, D46.0 thruD46.C, D47.1One of the following ICD-10-CMcodes is required on the claim(except with valid 3.10 thru C93.12, D46.0 thruD46.C, D47.1A TAR for CPT code 81177 requires Once-in-adocumentation of the followinglifetime exceptcriteria:with valid TARoverride The patient has clinical signsor symptoms suspicious fordentatorubral pallidoluysianatrophy, and The patient requires theservice as a confirmatory testfor dentatorubralpallidoluysian atrophyPart 2 – Pathology: Molecular Pathology
path molec12Page updated: December 2020Molecular Pathology CPT Codes, TAR and Billing Information (continued)CPT CodeDescription81178ATXN1 (ataxin 1)gene analysis,evaluation to detectabnormal allelesTARRequired TAR and/or Billing RequirementsYesA TAR for CPT code 81178 requiresdocumentation of the followingcriteria: The patient has clinical signsor symptoms suspicious forspinocerebellar ataxia type 1(SCA1), andFrequencyOnce-in-alifetime exceptwith valid TARoverride The patient requires theservice as a confirmatory testfor SCA181179YesATXN2 (ataxin 2)gene analysis,evaluation to detectabnormal alleles81180ATXN3 (ataxin 3)gene analysis,evaluation to detectabnormal allelesYesA TAR for CPT code 81179 requires Once-in-adocumentation of the followinglifetime exceptcriteria:with valid TARoverride The patient has clinical signsor symptoms suspicious forspinocerebellar ataxia type 2(SCA2), and The patient requires theservice as a confirmatory testfor SCA2A TAR for CPT code 81180 requires Once-in-adocumentation of the followinglifetime exceptcriteria:with valid TARoverride The patient has clinical signsor symptoms suspicious forspinocerebellar ataxia type 3(SCA3) ,and The patient requires theservice as a confirmatory testfor SCA3Part 2 – Pathology: Molecular Pathology
path molec13Page updated: December 2020Molecular Pathology CPT Codes, TAR and Billing Information (continued)CPT CodeDescription81181ATXN7 (ataxin 7)gene analysis,evaluation to detectabnormal allelesTARRequired TAR and/or Billing RequirementsYesA TAR for CPT code 81181 requiresdocumentation of the followingcriteria: The patient has clinical signsor symptoms suspicious forspinocerebellar ataxia type 7(SCA7), andFrequencyOnce-in-alifetime exceptwith valid TARoverride The patient requires theservice as a confirmatory testfor SCA781182YesATXN8OS (ATXN8opposite strand [nonprotein coding]) geneanalysis, evaluationto detect abnormal81183ATXN10 (ataxin 10)gene analysis,evaluation to detectabnormal allelesYesA TAR for CPT code 81182 requires Once-in-adocumentation of the followinglifetime exceptcriteria:with valid TARoverride The patient has clinical signsor symptoms suspicious forspinocerebellar ataxia type 8(SCA8), and The patient requires theservice as a confirmatory testfor SCA8A TAR for CPT code 81183 requires Once-in-adocumentation of the followinglifetime exceptcriteria:with valid TARoverride The patient has clinical signsor symptoms suspicious forspinocerebellar ataxia type10 (SCA10), and The patient requires theservice as a confirmatory testfor SCA10Part 2 – Pathology: Molecular Pathology
path molec14Page updated: December 2020Molecular Pathology CPT Codes, TAR and Billing Information (continued)CPT CodeDescription81184CACNA1A (calciumvoltage-gatedchannel subunitalpha1 A) geneanalysis; evaluationto detect abnormalalleles81185TARRequired TAR and/or Billing RequirementsYesA TAR for CPT code 81184 requiresdocumentation of the followingcriteria: The patient has clinical signsor symptoms suspicious forEpisodic ataxia type 2 (EA2),and The patient requires theservice as a confirmatory testfor EA2YesCACNA1A (calciumvoltage-gatedchannel subunitalpha1 A) geneanalysis; full genesequence81186CACNA1A (calciumvoltage-gatedchannel subunitalpha1 A) geneanalysis; knownfamilial variantFrequencyOnce-in-alifetime exceptwith valid TARoverrideYesA TAR for CPT code 81185 requires Once-in-adocumentation of the followinglifetime exceptcriteria:with valid TARoverride The patient has clinical signsor symptoms suspicious forEpisodic ataxia type 2 (EA2),and The patient requires theservice as a confirmatory testfor EA2A TAR for CPT code 81186 requires Once-in-adocumentation of the followinglifetime exceptcriteria:with valid TARoverride The patient has clinical signsor symptoms suspicious forEpisodic ataxia type 2 (EA2),and The patient requires theservice as a confirmatory testfor EA2Part 2 – Pathology: Molecular Pathology
path molec15Page updated: December 2020Molecular Pathology CPT Codes, TAR and Billing Information (continued)CPT CodeDescription81187CNBP (CCHC-typezinc finger nucleicacid binding protein)gene analysis,evaluation to detectabnormal allelesTARRequired TAR and/or Billing RequirementsYesA TAR for CPT code 81187 requiresdocumentation of the followingcriteria: The patient has clinical signsor symptoms suspicious forMyotonic dystrophy type 2(MD2), andFrequencyOnce-in-alifetime exceptwith valid TARoverride The patient requires theservice as a confirmatory testfor MD281188YesCSTB (cystatin B)gene analysis;evaluation to detectabnormal alleles81189CSTB (cystatin B)gene analysis; fullgene sequenceYesA TAR for CPT code 81188 requires Once-in-adocumentation of the followinglifetime exceptcriteria:with valid TARoverride The patient has clinical signsor symptoms suspicious formyoclonic epilepsy type 1and requires the service as aconfirmatory test formyoclonic epilepsy type 1,and Treatment will be contingenton test resultsA TAR for CPT code 81189 requires Once-in-adocumentation of the followinglifetime exceptcriteria:with valid TARoverride The patient has clinical signsor symptoms suspicious formyoclonic epilepsy type 1and requires the service as aconfirmatory test formyoclonic epilepsy type 1,and Treatment will be contingenton test resultsPart 2 – Pathology: Molecular Pathology
path molec16Page updated: December 2020Molecular Pathology CPT Codes, TAR and Billing Information (continued)CPT CodeDescription81190CSTB (cystatin B)gene analysis; knownfamilial variant(s)‹‹81191NTRK1 (neurotrophicreceptor tyrosinekinase 1) (eg, solidtumors) translocationanalysisTARRequired TAR and/or Billing RequirementsYesA TAR for CPT code 81190 requiresdocumentation of the followingcriteria: The patient has clinical signsor symptoms suspicious formyoclonic epilepsy type 1and requires the service as aconfirmatory test formyoclonic epilepsy type 1,andYesFrequencyOnce-in-alifetime exceptwith valid TARoverrideTreatment will be contingent on testresultsA TAR for CPT code 81191 requires N/A››documentation of the followingcriteria:Adult and pediatric patients withsolid tumors with any one of thefollowing clinical scenario: Part 2 – Pathology: Molecular PathologyMetastatic tumor or wheresurgical resection is likely toresult in severe morbidity, orHave no satisfactoryalternative treatments orhave progressed followingtreatment
path molec17Page updated: December 2020Molecular Pathology CPT Codes, TAR and Billing Information (continued)CPT CodeDescription‹‹81192NTRK2 (neurotrophicreceptor tyrosinekinase 2)(eg, solidtumors) translocationanalysis‹‹81193TARRequired TAR and/or Billing RequirementsYesSee CPT code 81191 for TARcriteria and billing requirements.FrequencyN/A››YesSee CPT code 81191 for TARcriteria and billing requirements.N/A››YesSee CPT code 81191 for TARcriteria and billing requirements.N/A››NTRK3 (neurotrophicreceptor tyrosinekinase 3)(eg, solidtumors) translocationanalysis‹‹81194NTRK (neurotrophictropomyosin receptortyrosine kinase 1, 2,and 3) (eg, solidtumors) translocationanalysisPart 2 – Pathology: Molecular Pathology
path molec18Page updated: December 2020Molecular Pathology CPT Codes, TAR and Billing Information (continued)CPT CodeDescription81201APC gene analysis;full gene sequence81202TARRequired TAR and/or Billing RequirementsNoOne of the following ICD-10-CMcodes is required on the claim:C18.0 thru C18.9, D12.0 thru D12.9,K63.5, Z86.010YesAPC gene analysis;known familialvariants81203APC gene analysis;duplication/deletionvariants81204AR (androgenreceptor) geneanalysis;characterization ofallelesFrequencyOnce-in-alifetimeNoYesRequires documentation on theTAR of a family history of familialadenomatous polyposis thatincludes a relative with a knowndeleterious APC mutationOne of the following ICD-10-CMcodes is required on the claim:Once-in-alifetimeOnce-in-alifetimeC18.0 thru C18.9, D12.0 thru D12.9,K63.5, Z86.010A TAR for CPT code 81204 requires Once-in-adocumentation of the followinglifetime exceptcriteria:with valid TARoverride The patient has clinical signsor symptoms suspicious forbulbar muscular atrophy, and The patient requires theservice as a confirmatory testfor spinal and bulbarmuscular atrophyPart 2 – Pathology: Molecular Pathology
path molec19Page updated: December 2020Molecular Pathology CPT Codes, TAR and Billing Information (continued)CPT CodeDescription81206BCR/ABL1translocationanalysis; majorbreakpoint81207BCR/ABL1translocationanalysis; minorbreakpoint81208BCR/ABL1translocationanalysis; otherbreakpoint81210BRAF (B-Rafproto-oncogene,serine/threoninekinase), geneanalysis, V600variant(s)81212TARRequired TAR and/or Billing RequirementsNoOne of the following ICD-10-CMcodes is required on the claim:C91.00 thru C9
Pathology: Molecular Pathology Page updated: August 2020 This section contains information to help providers bill for clinical laboratory tests or examinations related to molecular pathology and diagnostic services. Molecular Pathology Code Chart The chart included later in this section correlates molecular pathology CPT and HCPCS
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pathologists combine molecular tests with conventional pathological evaluation methods, pathology laboratories should be designed and operated in accordance with the requirements of molecular testing procedures. Adequate space, appropriate equipment and qualified personnel are required to establish a molecular pathology laboratory.
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