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HealthPartners

Coverage criteria policies

Genetic Testing: Molecular Profiling Assays for Cancer Management

These 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, please see the Genetic Testing for Cancer Predisposition policy.

For germline pharmacogenetic testing, please 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:
  1. The test is ordered by a board-certified pathologist; endocrinologist; geneticist; oncologist; hematologist; or advanced-practice nurse in endocrinology; genetics, oncology, or hematology who is not affiliated with the commercial testing laboratory, if applicable.
  2. The test is expected to directly impact management of one of the following specific conditions:
  • 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:
  1. The test is ordered by a board-certified pathologist; endocrinologist; geneticist; oncologist; hematologist; or advanced-practice nurse in endocrinology; genetics, oncology, or hematology who is not affiliated with the commercial testing laboratory, if applicable.
  2. The test is expected to directly impact management of one of the following specific conditions:
  • Breast Cancer
    1. EndoPredict (Myriad Genetics) is covered once per histologically-distinct tumor when all of the following criteria are met for each tumor that will be tested:
      1. The tumor is estrogen receptor positive
      2. The tumor is human epidermal growth factor receptor 2 (HER2) negative
      3. Axillary lymph nodes are negative
      4. The member is a candidate for adjuvant chemotherapy
      5. Test results will directly impact chemotherapy-related decisions
    2. MammaPrint 70-gene Breast Cancer Recurrence Assay (Agendia) is covered once per histologically-distinct tumor when all of the following criteria are met for each tumor that will be tested:
      1. The tumor is estrogen receptor positive
      2. The tumor is human epidermal growth factor receptor 2 (HER2) negative
      3. The tumor is between 0.5 cm and 2.0 cm in diameter
      4. Axillary lymph nodes are negative
      5. The member is a candidate for adjuvant chemotherapy
      6. Test results will directly impact chemotherapy-related decisions
      7. The test will be performed on fresh frozen tumor tissue rather than on formalin-fixed, paraffin-embedded tumor tissue
    3. Oncotype DX Breast (Genomic Health) is covered once per histologically-distinct tumor when all of the following criteria are met for each tumor that will be tested:
      1. The tumor is estrogen receptor or progesterone receptor positive
      2. The tumor is human epidermal growth factor receptor 2 (HER2) negative or the tumor is HER2 positive with a diameter no larger than 1cm
      3. Axillary lymph nodes are negative or there are up to three positive axillary lymph nodes
      4. There is no evidence of distant metastasis
      5. The member is a candidate for hormone therapy and adjuvant chemotherapy
  • 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:
  1. The test is ordered by a board-certified pathologist; geneticist; oncologist; hematologist; immunologist; or advanced-practice nurse in genetics, oncology, hematology, or immunology who is not affiliated with the commercial testing laboratory, if applicable.
  2. The test is expected to directly impact management of a member who has received a 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 covered

  1. Molecular profiling assays are not covered and are considered not medically necessary when test results will not directly impact cancer management 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.
  2. Repeat testing of a histologically-distinct tumor, whether at the same site or a different site, using 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.
  3. Physician interpretation and reporting for molecular profiling assays is considered integral to the primary procedure, if performed, and is not eligible for separate coverage.
  4. Short tandem repeat (STR) analysis using the know error® DNA Specimen Provenance Assay (DSPA) (Strand Diagnostics) or any other assay to confirm specimen provenance is considered integral to the primary procedure, ineligible for separate coverage, and not medically necessary because it is not within the clinically accepted practice parameters of the general medical community.
  5. Multiple-gene panels which include genes not associated with the specific condition under evaluation are considered not medically necessary because they are not considered an appropriate type of service for the member’s condition.
  6. Molecular profiling assays for management of any of the following indications are considered experimental/investigational because reliable evidence does not permit conclusions concerning safety, effectiveness, or effect on health outcomes:
  • Anal carcinoma
  • Basal cell carcinoma
  • Bladder cancer
  • Bone cancers other than Ewing sarcoma
  • Cancer of unknown primary site
  • Cervical cancer
  • Ductal carcinoma in situ (DCIS) of the breast
  • Hepatocellular carcinoma
  • Lung cancer other than non-small cell lung cancer (NSCLC)
  • Multiple myeloma
  • Ovarian cancer
  • Penile cancer
  • Prostate cancer
  • Renal cancer
  • Soft tissue sarcomas other than gastrointestinal stromal tumor (GIST)
  • Squamous cell carcinoma of the skin
  • Testicular cancer
  • Tracheal cancer
  1. All other molecular profiling assays for cancer management are considered 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 Covered
  • Topographic 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

Germline mutation is an alteration in DNA that is transmissible from parent to offspring

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

Multiple-gene molecular profiling assays analyze several genes simultaneously

Single-gene molecular profiling assays analyze only one gene

Somatic mutation (acquired mutation) is an alteration in DNA that occurs after conception and can occur in any of the cells of the body except the sperm and egg cells and are not passed on to children.

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

G0452

Molecular pathology procedure; physician interpretation and report

S3854

Gene expression profiling panel for use in the management of breast cancer treatment

0008M

Oncology (breast), mRNA analysis of 58 genes using hybrid capture, on formalin-fixed paraffin-embedded (FFPE) tissue, prognostic algorithm reported as a risk score

0005U

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

0009U

Oncology (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

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)

0014U

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

0016U

Oncology (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

0019U

Oncology, 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

0022U

Targeted 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

0023U

Oncology (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

0026U

Oncology (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

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

81176

ASXL1 (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

81211

BRCA1, 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

81228

Cytogenomic 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)

81265

Comparative 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)

81266

Comparative 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

81268

Chimerism (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

81272

KIT (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

81301

Microsatellite 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)

81315

PML/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

81316

PML/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)

81445

Targeted 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

81450

Targeted 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

81520

Oncology (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

81521

Oncology (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

81525

Oncology (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

81540

Oncology (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

81541

Oncology (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)

81551

Oncology (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

88271

Molecular cytogenetics; DNA probe, each (eg, FISH)

88274

Molecular cytogenetics; interphase in situ hybridization, analyze 25-99 cells

88275

Molecular cytogenetics; interphase in situ hybridization, analyze 100-300 cells

88291

Cytogenetics and molecular cytogenetics, interpretation and report

88363

Examination and selection of retrieved archival (ie, previously diagnosed) tissue(s) for molecular analysis (eg, KRAS mutational analysis)

88366

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

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.

References

  1. Alexander, E. K., Schorr, M., Klopper, J., Kim, C., Sipos, J., Nabhan, F., . . . Haugen, B. R. (2014). Multicenter clinical experience with the Afirma gene expression classifier. Journal of Clinical Endocrinology and Metabolism, 99, 119-125.
  2. Al-Haddad, M. A., Kowalski, T., Siddigui, A., Mertz, H. R., Mallat, D., Haddad, N., . . . Catalano, M. F. (2015). Integrated molecular pathology accurately determines the malignant potential of pancreatic cysts. Endoscopy, 47, 136-142.
  3. Ali, S. M., Sanford, E. M., Klempner, S. J., Rubinson, D. A., Wang, K., Palma, N. A., . . . Miller, V. A. (2015). Prospective comprehensive genomic profiling of advanced gastric carcinoma cases reveals frequent clinically relevant genomic alterations and new routes for targeted therapies. Oncologist, 20, 499-507.
  4. Allegra, C. J., Jessup, J. M., Somerfield, M. R., Hamilton, S. R., Hammond, E. H., Hayes, D. F., . . . Schilsky, R. L. (2009). American Society of Clinical Oncology provisional clinical opinion: testing for KRAS gene mutations in patients with metastatic colorectal carcinoma to predict response to anti-epidermal growth factor receptor monoclonal antibody therapy. Journal of Clinical Oncology, 27, 2091-2096.
  5. Alvarado, M. D., Prasad, C., Rothney, M., Cherbavaz, D. B., Sing, A. P., Baehner, F. L., . . . Markopoulos, C. J. (2015). A prospective comparison of the 21-gene recurrence score and the PAM50-based Prosigna in estrogen receptor-positive early-stage breast cancer. Advances in Therapy, 32, 1237-1247.
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  • 10/13/2015 - Date of origin
  • 07/01/2017 - Effective date
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  • 04/2017
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  • 04/05/2017

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