Genetic Testing: Molecular Profiling Assays for Cancer ManagementThese services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Prior authorization is required for molecular profiling assays for cancer management.

For genetic testing for predisposition to cancer, see the Genetic Testing for Cancer Predisposition policy.

For germline pharmacogenetic testing, see the Genetic Testing: Pharmacogenetics policy.

Coverage

Indications that are covered

Somatic genetic testing using single-gene analysis, microsatellite instability (MSI) analysis, mismatch repair (MMR) analysis, tumor karyotyping, and fluorescence in situ hybridization (FISH) for cancer management is covered when criteria 1 and 2 listed below are met:

The test is ordered by a board-certified pathologist; endocrinologist; geneticist; oncologist; 1.hematologist; or advanced-practice nurse in endocrinology; genetics, oncology, or hematology who is not affiliated with the commercial testing laboratory, if applicable.

The test is expected to directly impact management of one of the following specific conditions:2.Breast cancer (excluding ductal carcinoma in situ [DCIS] of the breast)•Colorectal cancer•Esophageal cancer•Ewing sarcoma•Gastrointestinal stromal tumor (GIST)•Glioblastoma multiforme•Lung cancer•Leukemias/Lymphomas•Melanoma•Thyroid Carcinoma•Other hematololgical malignancies, lymphoproliferative disorders, and •

myelodysplastic/myeloproliferative conditions

Somatic multiple-gene molecular profiling panels and gene expression classifiers using the specific assays listed below, if any, are covered when criteria 1 and 2 listed below are met and any additional condition-specific criteria listed below are also met:

The test is ordered by a board-certified pathologist; endocrinologist; geneticist; oncologist; 1.hematologist; or advanced-practice nurse in endocrinology; genetics, oncology, or hematology who is not affiliated with the commercial testing laboratory, if applicable.

The test is expected to directly impact management of one of the following specific conditions:2.Breast Cancer•

EndoPredict (Myriad Genetics) is covered once per histologically-distinct tumor when all of A.the following criteria are met for each tumor that will be tested:

The tumor is estrogen receptor positivei.The tumor is human epidermal growth factor receptor 2 (HER2) negativeii.Axillary lymph nodes are negativeiii.The member is a candidate for adjuvant chemotherapyiv.Test results will directly impact chemotherapy-related decisionsv.

MammaPrint 70-gene Breast Cancer Recurrence Assay (Agendia) is covered once per B.histologically-distinct tumor when all of the following criteria are met for each tumor that will be tested:

The tumor is estrogen receptor positivei.The tumor is human epidermal growth factor receptor 2 (HER2) negativeii.The tumor is between 0.5 cm and 2.0 cm in diameteriii.

Axillary lymph nodes are negativeiv.The member is a candidate for adjuvant chemotherapyv.Test results will directly impact chemotherapy-related decisionsvi.The test will be performed on fresh frozen tumor tissue rather than on formalin-vii.

fixed, paraffin-embedded tumor tissue Oncotype DX Breast (Genomic Health) is covered once per histologically-distinct tumor C.

when all of the following criteria are met for each tumor that will be tested:The tumor is estrogen receptor or progesterone receptor positivei.The tumor is human epidermal growth factor receptor 2 (HER2) negative or the ii.

tumor is HER2 positive with a diameter no larger than 1cmAxillary lymph nodes are negative or there are up to three positive axillary lymph iii.

nodesThere is no evidence of distant metastasisiv.The member is a candidate for hormone therapy and adjuvant chemotherapyv.

Colorectal Cancer: Targeted molecular profiling panels limited to analysis of BRAF, KRAS, and/or •NRAS gene mutations are covered for members with metastatic colorectal cancer.

Gastrointestinal Stromal Tumor (GIST): Targeted molecular profiling panels limited to analysis of •BRAF, KIT, PDGFRA, and/or SDH gene mutations are covered for members with GIST.

Non-Small Cell Lung Cancer (NSCLC): Targeted molecular profiling panels limited to analysis of •ALK, EGFR, and/or KRAS gene mutations are covered for members with NSCLC.

Melanoma: Targeted molecular profiling panels limited to analysis of BRAF and KIT gene mutations •are covered for members with metastatic melanoma.

Thyroid Carcinoma: Afirma® Thyroid FNA Analysis (Veracyte) is covered for adults with •cytologically-indeterminate thyroid nodules >1 cm in diameter.

Short tandem repeat (STR) analysis and single nucleotide polymorphism (SNP) analysis are covered when criteria 1-2 listed below are met:

The test is ordered by a board-certified pathologist; geneticist; oncologist; hematologist; 1.immunologist; or advanced-practice nurse in genetics, oncology, hematology, or immunology who is not affiliated with the commercial testing laboratory, if applicable.

The test is expected to directly impact management of a member who has received a 2.hematopoietic stem cell transplantation, transfusion of donor lymphocytes, administration of immunomodulatory cytokines, or other cellular therapy or is planning to receive one of these therapies in the immediate future.

Indications that are not coveredMolecular profiling assays are not covered and are considered not medically necessary when test 1.

results will not directly impact the treatment or management of a condition or provide a unifying diagnosis for a previously unidentified condition because the testing is not expected to restore or maintain the member’s health, prevent deterioration of the member’s condition, nor prevent the reasonably likely onset of a health problem or detect an incipient problem.

The following services are not covered and are considered not medically necessary because they 2.are not within the practice parameters of the general medical community:

Comparative analysis using short tandem repeat (STR) markers, using the know error® A.DNA Specimen Provenance Assay (DSPA) (Strand Diagnostics) or any other assay to confirm specimen provenance or for any other indication except as described under Indications that are Covered, is considered integral to the primary procedure and ineligible for separate coverage

Direct-to-consumer genetic testingB.Genetic testing for acquired disorders (those of non-genetic etiology, such as a condition C.

caused by an identified environmental factor).Genetic testing which was not ordered by a licensed healthcare provider or physician (see D.

Definitions) who has established a direct patient care relationship with the member to be tested.Genetic testing that is provided solely to satisfy data collection and analysis needs and E.

that will not be used in direct clinical management.Repeat testing of a histologically-distinct tumor, whether at the same site or a different site, using 3.

the same or a similar molecular profiling assay or gene expression classifier, is not covered and is considered not medically necessary because it is not considered an appropriate frequency of care.

Multiple-gene panels which include genes not associated with the specific condition, features, 4.characteristics, or symptoms under evaluation, or including genes not associated with conditions within the ordering provider’s differential diagnosis list for the affected member, are not covered and are considered not medically necessary because they are not considered an appropriate type of service for the member’s condition.

Molecular profiling assays for management of any of the following indications are considered 5.

experimental/investigational because reliable evidence does not permit conclusions concerning safety, effectiveness, or effect on health outcomes:

Anal carcinomaA.Basal cell carcinomaB.Bladder cancerC.Bone cancers other than Ewing sarcomaD.Cancer of unknown primary siteE.Cervical cancerF.Ductal carcinoma in situ (DCIS) of the breastG.Hepatocellular carcinomaH.Lung cancer other than non-small cell lung cancer (NSCLC)I.Multiple myelomaJ.Ovarian cancerK.Penile cancerL.Prostate cancerM.Renal cancerN.Soft tissue sarcomas other than gastrointestinal stromal tumor (GIST)O.Squamous cell carcinoma of the skinP.Testicular cancerQ.Tracheal cancer R.

All other molecular profiling assays for cancer management are considered 6.experimental/investigational because reliable evidence does not permit conclusions concerning safety, effectiveness, or effect on health outcomes. These services include, but are not limited to:

Analysis of proteomic patterns/proteomic profiling•Detection and/or analysis of cell-free DNA or circulating tumor cells•Genomic microarray testing for hematological malignancies•Liquid biopsy•MicroRNA analysis•Single nucleotide polymorphism (SNP) analysis except as specified under Indications that are •

CoveredTopographic genotyping•Whole exome and whole genome sequencing•50SEQ (med fusion)•BluePrint Molecular Subtyping Profile (Agendia)•Breast Cancer Index (BCI) (Biotheranostics)•CancerIntercept Detect (Pathway Genomics)•CancerIntercept Monitor (Pathway Genomics)•CancerTYPE ID (Biotheranostics)•clonoSEQ (Adaptive Biotechnologies)•ColonSentry (Innovative Diagnostic Laboratory)•ColonSEQ (med fusion)•ColonSEQPlus (med fusion)•ColoPrint (Agendia)•ColoVantage•ConfirmMDx (MDxHealth)•Cxbladder (Pacific Edge)•Decipher Prostate Cancer Classifier (GenomeDx Biosciences)•DecisionDX-Melanoma (Castle Biosciences)•DecisionDX-UM (Castle Biosciences)•Epi proColon (Epigenomics)•FoundationOne (Foundation Medicine)•FoundationOne Heme (FoundationMedicine)•GeneKey•GeneStrat (biodesix)•Guardant360 (Guardant Health)•Lung Molecular Profile (Genoptix)•LungSEQ (med fusion)•Lymphoid Molecular Profile (Genoptix)•Melanoma Molecular Profile (Genoptix)•MelanomaSEQ (med fusion)•Molecular Intelligence (Caris Life Sciences)•Myeloid Molecular Profile (Genoptix)•myPath Melanoma (Myriad Genetics)•

MyPRS (Signal Genetics)•NeoType tumor profiles (NeoGenomics Laboratories)•NexCourse Complete (Genoptix)•NexCourse Solid (Genoptix)•Omniseq Comphrehensive (OmniSeq)•Oncofocus (Oncologia)•OncoGxLung (Rosetta Genomics)•OncoGxOne (Rosetta Genomics)•OncotypeDX™ Colon Cancer Assay (Genomic Health, Inc.)•OncotypeDX™ DCIS Breast Cancer Assay (Genomic Health, Inc.)•OncotypeDX™ Prostate Score (GPS) Assay (Genomic Health, Inc.)•PancraGEN (Interpace Diagnostics)•Paradigm Cancer Diagnostic (PCDx) (Paradigm)•Prolaris (Myriad Genetics)•ProstaVysion (Bostwick Laboratories)•ResponseDX Colon (Response Genetics, Inc.)•ResponseDX Tissue of Origin (Response Genetics, Inc.)•RosettaGX Cancer Origin and CORE Cancer Origin Reflex (Rosetta Genomics)•RosettaGX Reveal (Rosetta Genomics)•RosettaGxBladder (Rosetta Genomics)•RosettaGxKidney (Rosetta Genomics)•RosettaGxLung (Rosetta Genomics)•RosettaGxProstate (Rosetta Genomics)•SelectMDx (MDxHealth)•TheraLink HER Family Assay (Theranostics Health)•ThyGenX (Interpace Diagnostics)•ThyraMIR (Interpace Diagnostics)•ThyroSeq (CBLPath)•UroGenRA Kidney Array CGH (Cancer Genetics)•Urovysion•Veristrat Proteomic Testing (biodesix)•Xpresys Lung (Integrated Diagnostics)•

Definitions

Healthcare provider is any licensed non-physician (excluding naturopathic providers).

Molecular profiling analyzes samples of tissue or fluid to detect somatic mutations.

Physician is a licensed medical doctor or doctor of osteopathy.

Codes

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

Codes

Description

0005U Oncology (prostate) gene expression profile by real-time RT-PCR of 3 genes (ERG, PCA3, and SPDEF), urine, algorithm reported as risk score

0006M

Oncology (hepatic), mRNA expression levels of 161 genes, utilizing fresh hepatocellular carcinoma tumor tissue, with alpha-fetoprotein level, algorithm reported as a risk classifier

0007M

Oncology (gastrointestinal neuroendocrine tumors), real-time PCR expression analysis of 51 genes, utilizing whole peripheral blood, algorithm reported as a nomogram of tumor disease index

0009UOncology (breast cancer), ERBB2 (HER2) copy number by FISH, tumor cells from formalin-fixed paraffin-embedded tissue isolated using image-based dielectrophoresis (DEP) sorting, reported as ERBB2 gene amplified or non-amplified

0011M

Oncology, prostate cancer, mRNA expression assay of 12 genes (10 content and 2 housekeeping), RT-PCR test utilizing blood plasma and/or urine, algorithms to predict high-grade prostate cancer risk

0012M

Oncology (urothelial), mRNA, gene expression profiling by real-time quantitative PCR of five genes (MDK, HOXA13, CDC2 [CDK1], IGFBP5, and XCR2), utilizing urine, algorithm reported as a risk score for having urothelial carcinoma

0013M

Oncology (urothelial), mRNA, gene expression profiling by real-time quantitative PCR of five genes (MDK, HOXA13, CDC2 [CDK1], IGFBP5, and CXCR2), utilizing urine, algorithm reported as a risk score for having recurrent urothelial carcinoma

0013U Oncology (solid organ neoplasia), gene rearrangement detection by whole genome next-generation sequencing, DNA, fresh or frozen tissue or cells, report of specific gene rearrangement(s)

0014UHematology (hematolymphoid neoplasia), gene rearrangement detection by whole genome next-generation sequencing, DNA, whole blood or bone marrow, report of specific gene rearrangement(s)

0016UOncology (hematolymphoid neoplasia), RNA, BCR/ABL1 major and minor breakpoint fusion transcripts, quantitative PCR amplification, blood or bone marrow, report of fusion not detected or detected with quantitation

0017U Oncology (hematolymphoid neoplasia), JAK2 mutation, DNA, PCR amplification of exons 12-14 and sequence analysis, blood or bone marrow, report of JAK2 mutation not detected or detected

0018U Oncology (thyroid), microRNA profiling by RT-PCR of 10 microRNA sequences, utilizing fine needle aspirate, algorithm reported as a positive or negative result for moderate to high risk of malignancy

0019UOncology, RNA, gene expression by whole transcriptome sequencing, formalin-fixed paraffin embedded tissue or fresh frozen tissue, predictive algorithm reported as potential targets for therapeutic agents

0022UTargeted genomic sequence analysis panel, non-small cell lung neoplasia, DNA and RNA analysis, 23 genes, interrogation for sequence variants and rearrangements, reported as presence/absence of variants and associated therapy(ies) to consider

0023UOncology (acute myelogenous leukemia), DNA, genotyping of internal tandem duplication, p.D835, p.I836, using mononuclear cells, reported as detection or nondetection of FLT3 mutation and indication for or against the use of midostaurin

0026UOncology (thyroid), DNA and mRNA of 112 genes, next-generation sequencing, fine needle aspirate of thyroid nodule, algorithmic analysis reported as a categorical result ("Positive, high probability of malignancy" or "Negative, low probability of malignancy")

0027U JAK2 (Janus kinase 2) (eg, myeloproliferative disorder) gene analysis, targeted sequence analysis exons 12-15

0036U Exome (ie, somatic mutations), paired formalin-fixed paraffin-embedded tumor tissue and normal specimen, sequence analyses

0037UTargeted genomic sequence analysis, solid organ neoplasm, DNA analysis of 324 genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability and tumor mutational burden

0045UOncology (breast ductal carcinoma in situ), mRNA, gene expression profiling by real-time RT-PCR of 12 genes (7 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as recurrence score

0046U FLT3 (fms-related tyrosine kinase 3) (eg, acute myeloid leukemia) internal tandem duplication (ITD) variants, quantitative

0047U Oncology (prostate), mRNA, gene expression profiling by real-time RT-PCR of 17 genes (12 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a risk score

0048UOncology (solid organ neoplasia), DNA, targeted sequencing of protein-coding exons of 468 cancer-associated genes, including interrogation for somatic mutations and microsatellite instability, matched with normal specimens, utilizing formalin-fixed paraffin-embedded tumor tissue, report of clinically significant mutation(s)

0049U NPM1 (nucleophosmin) (eg, acute myeloid leukemia) gene analysis, quantitative

0050U Targeted genomic sequence analysis panel, acute myelogenous leukemia, DNA analysis, 194 genes, interrogation for sequence variants, copy number variants or rearrangements

0053U Oncology (prostate cancer), FISH analysis of 4 genes (ASAP1, HDAC9, CHD1 and PTEN), needle biopsy specimen, algorithm reported as probability of higher tumor grade

0056U Hematology (acute myelogenous leukemia), DNA, whole genome next-generation sequencing to detect gene rearrangement(s), blood or bone marrow, report of specific gene rearrangement(s)

0057UOncology (solid organ neoplasia), mRNA, gene expression profiling by massively parallel sequencing for analysis of 51 genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a normalized percentile rank

81170 ABL1 (ABL proto-oncogene 1, non-receptor tyrosine kinase) (eg, acquired imatinib tyrosine kinase inhibitor resistance), gene analysis, variants in the kinase domain

81175 ASXL1 (additional sex combs like 1, transcriptional regulator) (eg, myelodysplastic syndrome, myeloproliferative neoplasms, chronic myelomonocytic leukemia), gene analysis; full gene sequence

81176ASXL1 (additional sex combs like 1, transcriptional regulator) (eg, myelodysplastic syndrome, myeloproliferative neoplasms, chronic myelomonocytic leukemia), gene analysis; targeted sequence analysis (eg, exon 12)

81201 APC (adenomatous polyposis coli) (eg, familial adenomatosis polyposis [FAP], attenuated FAP) gene analysis; full gene sequence

81202 APC (adenomatous polyposis coli) (eg, familial adenomatosis polyposis [FAP], attenuated FAP) gene analysis; known familial variants

81203 APC (adenomatous polyposis coli) (eg, familial adenomatosis polyposis [FAP], attenuated FAP) gene analysis; duplication/deletion variants

81206 BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; major breakpoint, qualitative or quantitative

81207 BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; minor breakpoint, qualitative or quantitative

81208 BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; other breakpoint, qualitative or quantitative

81210 BRAF (v-raf murine sarcoma viral oncogene homolog B1) (eg, colon cancer), gene analysis, V600E variant

81211BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis and common duplication/deletion variants in BRCA1 (ie, exon 13 del 3.835kb, exon 13 dup 6kb, exon 14-20 del 26kb, exon 22 del 510bp, exon 8-9 del 7.1kb)

81218 CEBPA (CCAAT/enhancer binding protein [C/EBP], alpha) (eg, acute myeloid leukemia), gene analysis, full gene sequence

81219 CALR (calreticulin) (eg, myeloproliferative disorders), gene analysis, common variants in exon 9

81228Cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number variants (eg, bacterial artificial chromosome [BAC] or oligo-based comparative genomic hybridization [CGH] microarray analysis)

81229 Cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number and single nucleotide polymorphism (SNP) variants for chromosomal abnormalities

81235 EGFR (epidermal growth factor receptor) (eg, non-small cell lung cancer) gene analysis, common variants (eg, exon 19 LREA deletion, L858R, T790M, G719A, G719S, L861Q)

81242 FANCC (Fanconi anemia, complementation group C) (eg, Fanconi anemia, type C) gene analysis, common variant (eg, IVS4+4A>T)

81245 FLT3 (fms-related tyrosine kinase 3) (eg, acute myeloid leukemia), gene analysis; internal tandem duplication (ITD) variants (ie, exons 14, 15)

81246 FLT3 (fms-related tyrosine kinase 3) (eg, acute myeloid leukemia), gene analysis; tyrosine kinase domain (TKD) variants (eg, D835, I836)

81261 IGH@ (Immunoglobulin heavy chain locus) (eg, leukemias and lymphomas, B-cell), gene rearrangement analysis to detect abnormal clonal population(s); amplified methodology (eg, polymerase chain reaction)

81262 IGH@ (Immunoglobulin heavy chain locus) (eg, leukemias and lymphomas, B-cell), gene rearrangement analysis to detect abnormal clonal population(s); direct probe methodology (eg, Southern blot)

81263 IGH@ (Immunoglobulin heavy chain locus) (eg, leukemia and lymphoma, B-cell), variable region somatic mutation analysis

81264 IGK@ (Immunoglobulin kappa light chain locus) (eg, leukemia and lymphoma, B-cell), gene rearrangement analysis, evaluation to detect abnormal clonal population(s)

81265Comparative analysis using Short Tandem Repeat (STR) markers; patient and comparative specimen (eg, pre-transplant recipient and donor germline testing, post-transplant non-hematopoietic recipient germline [eg, buccal swab or other germline tissue sample] and donor testing, twin zygosity testing, or maternal cell contamination of fetal cells)

81266Comparative analysis using Short Tandem Repeat (STR) markers; each additional specimen (eg, additional cord blood donor, additional fetal samples from different cultures, or additional zygosity in multiple birth pregnancies) (List separately in addition to code for primary procedure)

81267 Chimerism (engraftment) analysis, post transplantation specimen (eg, hematopoietic stem cell), includes comparison to previously performed baseline analyses; without cell selection

81268Chimerism (engraftment) analysis, post transplantation specimen (eg, hematopoietic stem cell), includes comparison to previously performed baseline analyses; with cell selection (eg, CD3, CD33), each cell type

81270 JAK2 (Janus kinase 2) (eg, myeloproliferative disorder) gene analysis, p.Val617Phe (V617F) variant

81272KIT (v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog) (eg, gastrointestinal stromal tumor [GIST], acute myeloid leukemia, melanoma), gene analysis, targeted sequence analysis (eg, exons 8,

11, 13, 17, 18)81273 KIT (v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog) (eg, mastocytosis), gene analysis,

D816 variant(s)

81275 KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene) (eg, carcinoma) gene analysis, variants in codons 12 and 13

81276 KRAS (Kirsten rat sarcom viral oncogene homolog) (eg, carcinoma) gene analysis; additional variant(s) (eg, codon 61, codon 146)

81287 MGMT (O-6-methylguanine-DNA methyltransferase) (eg, glioblastoma multiforme), methylation analysis

81288 MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; promoter methylation analysis

81292 MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; full sequence analysis

81293 MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; known familial variants

81294 MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; duplication/deletion variants

81295 MSH2 (mutS homolog 2, colon cancer, nonpolyposis type 1) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; full sequence analysis

81296 MSH2 (mutS homolog 2, colon cancer, nonpolyposis type 1) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; known familial variants

81297 MSH2 (mutS homolog 2, colon cancer, nonpolyposis type 1) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; duplication/deletion variants

81298 MSH6 (mutS homolog 6 [E. coli]) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; full sequence analysis

81299 MSH6 (mutS homolog 6 [E. coli]) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; known familial variants

81300 MSH6 (mutS homolog 6 [E. coli]) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; duplication/deletion variants

81301Microsatellite instability analysis (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) of markers for mismatch repair deficiency (eg, BAT25, BAT26), includes comparison of neoplastic and normal tissue, if performed

81310 NPM1 (nucleophosmin) (eg, acute myeloid leukemia) gene analysis, exon 12 variants

81311 NRAS (neuroblastoma RAS viral [v-ras] oncogene homolog) ( eg, colorectal carcinoma), gene analysis , variants in exon 2 (eg, codons 12 and 13) and exon 3 (eg,

81313 PCA3/KLK3 (prostate cancer antigen 3 [non-protein coding]/kallikrein-related peptidase 3 [prostate specific antigen]) ratio (eg, prostate cancer)

81314 PDGFRA (platelet-derived growth factor receptor, alpha polypeptide) (eg, gastrointestinal stromal tumor [GIST]) gene analysis, targeted sequence analysis (eg, exons 12, 18)

81315PML/RARalpha, (t(15;17)), (promyelocytic leukemia/retinoic acid receptor alpha) (eg, promyelocytic leukemia) translocation analysis; common breakpoints (eg, intron 3 and intron 6), qualitative or quantitative

81316PML/RARalpha, (t(15;17)), (promyelocytic leukemia/retinoic acid receptor alpha) (eg, promyelocytic leukemia) translocation analysis; single breakpoint (eg, intron 3, intron 6 or exon 6), qualitative or quantitative

81317 PMS2 (postmeiotic segregation increased 2 [S. cerevisiae]) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; full sequence analysis

81318 PMS2 (postmeiotic segregation increased 2 [S. cerevisiae]) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; known familial variants

81319 PMS2 (postmeiotic segregation increased 2 [S. cerevisiae]) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; duplication/deletion variants

81321 PTEN (phosphatase and tensin homolog) (eg, Cowden syndrome, PTEN hamartoma tumor syndrome) gene analysis; full sequence analysis

81322 PTEN (phosphatase and tensin homolog) (eg, Cowden syndrome, PTEN hamartoma tumor syndrome) gene analysis; known familial variant

81323 PTEN (phosphatase and tensin homolog) (eg, Cowden syndrome, PTEN hamartoma tumor syndrome) gene analysis; duplication/deletion variant

81327 SEPT9 (Septin9) (eg, colorectal cancer) methylation analysis

81334 RUNX1 (runt related transcription factor 1) (eg, acute myeloid leukemia, familial platelet disorder with associated myeloid malignancy), gene analysis, targeted sequence analysis (eg, exons 3-8)

81340 TRB@ (T cell antigen receptor, beta) (eg, leukemia and lymphoma), gene rearrangement analysis to detect abnormal clonal population(s); using amplification methodology (eg, polymerase chain reaction)

81341 TRB@ (T cell antigen receptor, beta) (eg, leukemia and lymphoma), gene rearrangement analysis to detect abnormal clonal population(s); using direct probe methodology (eg, Southern blot)

81342 TRG@ (T cell antigen receptor, gamma) (eg, leukemia and lymphoma), gene rearrangement analysis, evaluation to detect abnormal clonal population(s)

81445Targeted genomic sequence analysis panel, solid organ neoplasm, DNA analysis, and RNA analysis when performed, 5-50 genes (eg, ALK, BRAF, CDKN2A, EGFR, ERBB2, KIT, KRAS, NRAS, MET, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed

81450Targeted genomic sequence analysis panel, hematolymphoid neoplasm or disorder, DNA analysis, and RNA analysis when performed, 5-50 genes (eg, BRAF, CEBPA, DNMT3A, EZH2, FLT3, IDH1, IDH2, JAK2, KRAS, KIT, MLL, NRAS, NPM1, NOTCH1), interrogation for sequence variants, and copy number variants or rearrangements, or isoform expression or mRNA expression levels, if performed

81455

Targeted genomic sequence analysis panel, solid organ or hematolymphoid neoplasm, DNA and RNA analysis when performed, 51 or greater genes (eg, ALK, BRAF, CDKN2A, CEBPA, DNMT3A, EGFR, ERBB2, EZH2, FLT3, IDH1, IDH2, JAK2, KIT, KRAS, MLL, NPM1, NRAS, MET, NOTCH1, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed

81504 Oncology (tissue of origin), microarray gene expression profiling of > 2000 genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as tissue similarity scores

81519 Oncology (breast), mRNA, gene expression profiling by real-time RT-PCR of 21 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as recurrence score

81520Oncology (breast), mRNA gene expression profiling by hybrid capture of 58 genes (50 content and 8 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a recurrence risk score

81521Oncology (breast), mRNA, microarray gene expression profiling of 70 content genes and 465 housekeeping genes, utilizing fresh frozen or formalin-fixed paraffin-embedded tissue, algorithm reported as index related to risk of distant metastasis

81525Oncology (colon), mRNA, gene expression profiling by real-time RT-PCR of 12 genes (7 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a recurrence score

81540Oncology (tumor of unknown origin), mRNA, gene expression profiling by real-time RT-PCR of 92 genes (87 content and 5 housekeeping) to classify tumor into main cancer type and subtype, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a probability of a predicted main cancer type and subtype

81541Oncology (prostate), mRNA gene expression profiling by real-time RT-PCR of 46 genes (31 content and 15 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a disease-specific mortality risk score

81545 Oncology (thyroid), gene expression analysis of 142 genes, utilizing fine needle aspirate, algorithm reported as a categorical result (eg, benign or suspicious)

81551Oncology (prostate), promoter methylation profiling by real-time RT-PCR of 3 genes (GSTP1, APC, RASSF1), utilizing formalin-fixed, paraffin-embedded tissue, algorithm reported as a likelihood of prostate cancer detection on repeat biopsy

81599 Unlisted multianalyte assay with algorithmic analysis

88120 Cytopathology, in situ hybridization (eg, FISH), urinary tract specimen with morphometric analysis, 3-5 molecular probes, each specimen; manual

88121 Cytopathology, in situ hybridization (eg, FISH), urinary tract specimen with morphometric analysis, 3-5 molecular probes, each specimen; using computer-assisted technology

88182 Flow cytometry, cell cycle or DNA analysis88271 Molecular cytogenetics; DNA probe, each (eg, FISH)88274 Molecular cytogenetics; interphase in situ hybridization, analyze 25-99 cells88275 Molecular cytogenetics; interphase in situ hybridization, analyze 100-300 cells88291 Cytogenetics and molecular cytogenetics, interpretation and report88358 Morphometric analysis; tumor (eg, DNA ploidy)

88364 In situ hybridization (eg, FISH), per specimen; each additional single probe stain procedure (List separately in addition to code for primary procedure)

88365 In situ hybridization (eg, FISH), per specimen; initial single probe stain procedure88366 In situ hybridization (eg, FISH), per specimen; each multiplex probe stain procedure

88367 Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), using computer-assisted technology, per specimen; initial single probe stain procedure

88368 Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), manual, per specimen; initial single probe stain procedure

88369 Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), manual, per specimen; each additional single probe stain procedure (List separately in addition to code for primary procedure)

88373Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), using computer-assisted technology, per specimen; each additional single probe stain procedure (List separately in addition to code for primary procedure)

88374 Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), using computer-assisted technology, per specimen; each multiplex probe stain procedure

88377 Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), manual, per specimen; each multiplex probe stain procedure

G9840 RAS (KRAS and NRAS) gene mutation testing performed before initiation of anti-EGFR MoAbS3854 Gene expression profiling panel for use in the management of breast cancer treatment

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

Approved Medical Director Committee 10/13/2015; Revised 3/2016, 10/2016, 1/5/2017, 4/5/2017, 7/1/2018, 7/19/2018; Annual Review 10/2016, 4/2017, 4/2018

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