medical policy genetic testing · research genetic testing (used to help with research and...

POLICY: PG0041

ORIGINAL EFFECTIVE:01/01/12

LAST REVIEW:04/01/2020

MEDICAL POLICY Genetic Testing

GUIDELINES This policy does not certify benefits or authorization of benefits, which is designated by each individual policyholder contract. Paramount applies coding edits to all medical claims through coding logic software to evaluate the accuracy and adherence to accepted national standards. This guideline is solely for explaining correct procedure reporting and does not imply coverage and reimbursement.

DESCRIPTION A genetic test is the analysis of human DNA, RNA, chromosomes, proteins, or certain metabolites in order to detect alterations related to a heritable or acquired disorder. This can be accomplished by directly examining the DNA or RNA that makes up a gene (direct testing), looking at markers co-inherited with a disease-causing gene (linkage testing), assaying certain metabolites (biochemical testing), or examining the chromosomes (cytogenetic testing). Clinical genetic tests are those in which specimens are examined and results reported to the provider or patient for the purpose of diagnosis, prevention or treatment in the care of individual patients. Genetic testing is performed for a variety of intended uses:

Diagnostic testing (to diagnose disease)

Predictive testing (generally performed to gather genetic data that can assist in clinical management, including therapeutic decision for an individual.

Pre-symptomatic genetic testing (to predict future disease)

Carrier testing (to identify carriers of genetic mutations)

Prenatal testing (offered during pregnancy to identify fetuses that have certain diseases)

Pre-implantation genetic testing (done in conjunction with invitro fertilization to determine whether embryos for implantation carry a gene mutation that could cause disease)

Newborn screening (to test newborns shortly after birth to determine whether they have certain diseases known to cause problems with health and development)

Pharmacogenetic testing (to determine the likelihood of an individual being responsive to a particular drug and/or to predict serious toxicity from a drug in order to optimize drug selection or drug dosage)

Research genetic testing (used to help with research and development of gene-based therapy) Several hundred genetic tests are currently in use, and more are being developed. Although genetic testing can provide helpful information for diagnosing, treating, and preventing illness, there are limitations. For example, in a healthy patient, a positive result from a genetic test does not always mean the patient will develop a disease. On the other hand, in some situations, a negative result does not guarantee the patient will not have a certain disorder.

POLICY Paramount does not cover investigational or experimental medical or surgical procedures that are not medically necessary and have not been strongly supported in research and for which there is a safe and medically accepted alternative available. Prior authorization is required for genetic testing unless otherwise noted in one of our policies. Some genetic testing requires prior authorization or may be non-covered. A provider must refer to the Paramount prior authorization list and specific medical policy in reference to specific tests for coverage determinations (this list may not be all-inclusive):

PG0065 Colorectal Cancer Screening (81327, 81401, 81528)

PG0067 Genetic Testing for Hereditary Breast and Ovarian Cancer Syndrome (HBOC) (81162, 81212, 81215, 81216, 81217, 81432, 81433)

PG0280 Genetic Testing for Cardiac Conditions (81413, 81414, 81439, S3861-S3866)

PG0287 Non-Invasive Prenatal Screening (NIPS)/Cell-Free DNA Tests For Fetal Aneuploidy (81420, 81422, 81507, 0009M)

PG0296 Comparative Genomic Hybridization (CGH)/Chromosomal Microarray Analysis (CMA) (81228, 81229, S3870)

PG0298 Molecular Markers in Fine Needle Aspirates of Thyroid Nodules (81545)

PG0301 Genetic Expression Assays for Breast Cancer Prognosis (81479, 81519, 81520, 81521, 0008M, S3854)

PG0302 Genetic Testing for Lynch Syndrome and Polyposis Syndromes (81201-81203, 81288, 81292-81301, 81317-81319, 81401, 81403, 81406, 81435, 81436)

PG0336 PTEN Genetic Testing (81321-81323)

PG0340 AlloMap™ Molecular-Expression Blood Test (81595)

PG0355 Genetic Testing for Hereditary Thrombophilia (81240, 81241, 81291)

PG0357 Gene Expression Profiling for Colorectal Cancer (81525)

PG0358 Genetic Counseling

PG0360 Genetic Testing for Fragile X-Related Disorders (81243, 81244)

PG0362 Vectra® DA (81490)

PG0363 CORUS® CAD (81493)

PG0364 Gene Expression Profiling for Cancers of Unknown Primary Site (81504, 81540)

PG0367 Gene Expression Analysis for Prostate Cancer (81313, 81479, 81539, 81541, 81551)

PG0368 GeneSight® Assay for Refractory Depression (81479)

PG0375 Molecular Cytogenetic Testing (88230, 88233, 88235, 88237, 88239-88241, 88245, 88248,

88249, 88261-88264, 88267, 88269, 88271-88275, 88280, 88283, 88285, 88289, 88291, 88299)

PG0387 Genetic Testing for Cystic Fibrosis (81220-81224)

PG0390 Genetic Testing for Warfarin Dose (G9143, 81227, 81355)

PG0391 UGT1A1 Targeted Mutation Analysis for Irinotecan Response (81350)

PG0398 Genetic Testing for Spinal Muscular Atrophy (81329, 81336, 81337)

PG0411 Genetic Testing for Dystrophinopathies (Duchenne and Becker Muscular Dystrophy) (81161, 81408)

PG0412 Genetic Testing for Age-Related Macular Degeneration (81401, 81405, 81408, 81479, 81599)

PG0417 Proprietary Laboratory Analyses (PLA) Codes (0001U-0061U)

PG0436 CYP2C19 & CYP2D6 Pharmacogenetic Testing (81225, 81226)

PG0437 HLA-B1502 & HLA-B5701 Pharmacogenetic Testing (81381)

PG0438 Next Generation Sequencing (NGS) Tests for Advanced Cancer (81455, 81479)

PG0442 Carrier Screening for Genetic Diseases (81200, 81205, 81209, 81220, 81242, 81250, 81251-

81255, 81257-81260, 81265, 81266, 81269, 81290, 81330, 81361, 81362-81364, 81400, 81401, 81403,

81404, 81406, 81412, 81443, 81479)

PG0453 Germline Multi-Gene Panel Genetic Testing (81410-81414, 81430-81440, 81442, 81443, 81448,

81460, 81465, 81470, 81471, 81479)

PG0467 Genetic Testing for Epilepsy (81188, 81189, 81190, 81401, 81403, 81404, 81405, 81406, 81407,

81479)

PG0468 Whole Exome Sequencing (WES) and Whole Genome Sequencing (WGS) (81415, 81416,

81417, 81425, 81426, 81427) Refer to CODING/BILLING INFORMATION below for coverage determination.

HMO, PPO, Individual Marketplace, Elite, Advantage Coverage and authorization for genetic testing is determined by review. The testing must have direct effect on the management and clinical care of the individual being tested, and must contain all of the following criteria:

Individual has not previously received genetic testing for the disorder. In general, genetic testing for a particular disorder should be performed once per lifetime; however, there are rare instances in which testing may be performed more than once in a lifetime (e.g., previous testing methodology is inaccurate, a new discovery has added significant relevant mutations for a disease, significant changes in technology or treatments indicate that test results or outcomes may change as a result of repeat testing)

The genetic disorder is associated with a significant disability or has a lethal natural history

The risk of the significant disability or lethality from the genetic disorder cannot be determined through other diagnostic testing

A specific mutation, or set of mutations, has been proven valid in the scientific literature to be reliable, associated with the disease

The results of the genetic test could impact the medical management of the individual being tested

The genetic test will likely result in an anticipated improvement in net health outcomes for the individual being tested (i.e., the disease is treatable or preventable)

Panels including, but may not limited to, multiple genes or multiple conditions, and in cases where a tiered approach/method is clinically available, may be covered ONLY for the number of genes or tests deemed medically necessary to establish a diagnosis

When requesting prior authorization review, the patient’s medical history/record and details of the lab facility providing the requested service must be provided. An approved request will only be given to a specific lab for a specific provider for a specific service. Genetic testing may be denied as experimental or not medically necessary based on the information submitted.

The physician, lab or facility ordering the service will be financially responsible if prior authorization is not obtained. Members who choose to precede with unauthorized genetic testing bear the responsibility for the cost. The provider should always secure a Waiver of Responsibility prior to providing the testing to assure member understanding of their financial responsibility.

CODING/BILLING INFORMATION The appearance of a code in this section does not necessarily indicate coverage. Codes that are covered may have selection criteria that must be met. Payment for supplies may be included in payment for other services rendered.

CPT CODES HMO, PPO, Individual

Marketplace Elite Advantage

Tier 1 Molecular Pathology Procedures

81105

Human Platelet Antigen 1 genotyping (HPA-1), ITGB3 (integrin, beta 3 [platelet glycoprotein IIIa], antigen CD61 [GPIIIa]) (eg, neonatal alloimmune thrombocytopenia [NAIT], post-transfusion purpura), gene analysis, common variant, HPA-1a/b (L33P)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81106

Human Platelet Antigen 2 genotyping (HPA-2), GP1BA (glycoprotein Ib [platelet], alpha polypeptide [GPIba]) (eg, neonatal alloimmune thrombocytopenia [NAIT], posttransfusion purpura), gene analysis, common variant, HPA-2a/b (T145M)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81107

Human Platelet Antigen 3 genotyping (HPA-3), ITGA2B (integrin, alpha 2b [platelet glycoprotein IIb of IIb/IIIa complex], antigen CD41 [GPIIb]) (eg, neonatal alloimmune thrombocytopenia [NAIT], post- transfusion purpura), gene analysis, common variant, HPA-3a/b (I843S)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81108

Human Platelet Antigen 4 genotyping (HPA-4), ITGB3 (integrin, beta 3 [platelet glycoprotein IIIa], antigen CD61 [GPIIIa]) (eg, neonatal alloimmune thrombocytopenia [NAIT], post-transfusion purpura), gene analysis, common variant, HPA-4a/b (R143Q)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81109

Human Platelet Antigen 5 genotyping (HPA-5), ITGA2 (integrin, alpha 2 [CD49B, alpha 2 subunit of VLA-2 receptor] [GPIa]) (eg, neonatal alloimmune thrombocytopenia [NAIT], post-transfusion purpura), gene analysis, common variant (eg, HPA-5a/b (K505E))

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81110

Human Platelet Antigen 6 genotyping (HPA-6w), ITGB3 (integrin, beta 3 [platelet glycoprotein IIIa, antigen CD61] [GPIIIa]) (eg, neonatal alloimmune thrombocytopenia [NAIT], post-transfusion purpura), gene analysis, common variant, HPA-6a/b (R489Q)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81111

Human Platelet Antigen 9 genotyping (HPA-9w), ITGA2B (integrin, alpha 2b [platelet glycoprotein IIb of IIb/IIIa complex, antigen CD41] [GPIIb]) (eg, neonatal alloimmune thrombocytopenia [NAIT], post- transfusion purpura), gene analysis, common variant, HPA-9a/b (V837M)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81112

Human Platelet Antigen 15 genotyping (HPA-15), CD109 (CD109 molecule) (eg, neonatal alloimmune thrombocytopenia [NAIT], post-transfusion purpura), gene analysis, common variant, HPA-15a/b

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81120 IDH1 (isocitrate dehydrogenase 1 [NADP+], soluble) (eg, glioma), common variants (eg, R132H, R132C)

Prior Authorization Not required



81121 IDH2 (isocitrate dehydrogenase 2 [NADP+], mitochondrial) (eg, glioma), common variants (eg, R140W, R172M)




81161 DMD (dystrophin) (e.g., Duchenne/Becker muscular dystrophy) deletion analysis, and duplication analysis, if performed

PG0411 Genetic Testing for Dystrophinopathies (Duchenne and Becker Muscular Dystrophy)

81162 BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis and full duplication/deletion analysis

PG0067 Genetic Testing for Hereditary Breast and Ovarian Cancer syndrome (HBOC)

81163 BRCA1 (BRCA1, DNA repair associated), BRCA2 (BRCA2, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis


81164 BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis


81165 BRCA1 (BRCA1, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis

PG0067 Genetic Testing for Hereditary Breast and Ovarian Cancer syndrome (HBOC))

81166

BRCA1 (BRCA1, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full duplication/deletion analysis (ie, detection of large gene rearrangements)


81167

BRCA2 (BRCA2, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full duplication/deletion analysis (ie, detection of large gene rearrangements)


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




81171 AFF2 (AF4/FMR2 family, member 2 [FMR2]) gene analysis; evaluation to dtect abnormal (eg, expanded) alleles

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81172

AFF2 (AF4/FMR2 family, member 2 [FMR2]) (eg, fragile X mental retardation 2 [FRAXE]) gene analysis; characterization of alleles (eg, expanded size and methylation status)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81173 AR (androgen receptor) (eg, spinal and bulbar muscular atrophy, Kennedy disease, X chromosome inactivation) gene analysis; full gene sequence

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81174

AR (androgen receptor) (eg, spinal and bulbar muscular atrophy, Kennedy disease, X chromosome inactivation) gene analysis; known familial variant

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81175

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

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

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)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81177 ATN1 (atrophin 1) (eg, dentatorubral-pallidoluysian atrophy) gene analysis, evaluation to detect abnormal (eg, expanded) alleles

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81178 ATXN1 (ataxin 1) (eg, spinocerebellar ataxia) gene analysis, evaluation to detect abnormal (eg, expanded) alleles

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required


Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81180 ATXN3 (ataxin 3) (eg, spinocerebellar ataxia, Machado-Joseph disease) gene analysis, evaluation to detect abnormal (eg, expanded)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required


Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81182 ATXN8OS (ATXN8 opposite strand [non-protein coding]) (eg, spinocerebellar ataxia) gene analysis, evaluation to detect abnormal (eg, expanded) alleles

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required


Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81184 CACNA1A (calcium voltage-gated channel subunit alpha1 A) (eg, spinocerebellar ataxia) gene analysis; evaluation to detect abnormal (eg, expanded) alleles

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81185 CACNA1A (calcium voltage-gated channel subunit alpha1 A) (eg, spinocerebellar ataxia) gene analysis; full gene sequence

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81186 CACNA1A (calcium voltage-gated channel subunit alpha1 A) (eg, spinocerebellar ataxia) gene analysis; known familial variant

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81187 CNBP (CCHC-type zinc finger nucleic acid binding protein) (eg, myotonic dystrophy type 2) gene analysis, evaluation to detect abnormal (eg, expanded) alleles

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81188 CSTB (cystatin B) (eg, Unverricht-Lundborg disease) gene analysis; evaluation to detect abnormal (eg, expanded) alleles

Prior Authorization required PG0467 Genetic Testing for Epilepsy

81189 CSTB (cystatin B) (eg, Unverricht-Lundborg disease) gene analysis; full gene sequence


81190 CSTB (cystatin B) (eg, Unverricht-Lundborg disease) gene analysis; known familial variant(s)


81200 ASPA (aspartoacylase) (e.g., Canavan disease) gene analysis, common variants (e.g., E285A, Y231X)

Prior Authorization

required Non-Covered

Prior Authorization

required

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

PG0302 Genetic Testing for Lynch Syndrome and Polyposis Syndromes

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


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


81204

AR (androgen receptor) (eg, spinal and bulbar muscular atrophy, Kennedy disease, X chromosome inactivation) gene analysis; characterization of alleles (eg, expanded size or methylation status)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81205 BCKDHB (branched-chain keto acid dehydrogenase E1, beta polypeptide) (e.g., Maple syrup urine disease) gene analysis, common variants (e.g., R183P, G278S, E422X)

Prior Authorization


Prior Authorization

required

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




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




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




81209 BLM (Bloom syndrome, RecQ helicase-like) (e.g., Bloom syndrome) gene analysis, 2281del6ins7 variant

Prior Authorization


Prior Authorization

required

81210 BRAF (B-Raf proto-oncogene, serine/threonine kinase) (e.g., colon cancer, melanoma), gene analysis, V600 variant(s)




81212 BRCA1, BRCA2 (breast cancer 1 and 2) (e.g., hereditary breast and ovarian cancer) gene analysis; 185delAG, 5385insC, 6174delT variants

PG0067 Genetic Testing for Hereditary Breast and Ovarian Cancer Syndrome

81215 BRCA1 (breast cancer 1) (e.g., hereditary breast and ovarian cancer) gene analysis; known familial variant


81216 BRCA2 (breast cancer 2) (e.g., hereditary breast and ovarian cancer) gene analysis; full sequence analysis


81217 BRCA2 (breast cancer 2) (e.g., hereditary breast and ovarian cancer) gene analysis; known familial variant


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




81220 CFTR (cystic fibrosis transmembrane conductance regulator) (e.g., cystic fibrosis) gene analysis; common variants (e.g., ACMG/ACOG guidelines)

PG0387 Genetic Testing for Cystic Fibrosis

81221 CFTR (cystic fibrosis transmembrane conductance regulator) (e.g., cystic fibrosis) gene analysis; known familial variants


81222 CFTR (cystic fibrosis transmembrane conductance regulator) (e.g., cystic fibrosis) gene analysis; duplication/deletion variants


81223 CFTR (cystic fibrosis transmembrane conductance regulator) (e.g., cystic fibrosis) gene analysis; full gene sequence


81224 CFTR (cystic fibrosis transmembrane conductance regulator) (e.g., cystic fibrosis) gene analysis; intron 8 poly-T analysis (e.g., male infertility)


81225 CYP2C19 (cytochrome P450, family 2, subfamily C, polypeptide 19) (e.g., drug metabolism), gene analysis, common variants (e.g., *2, *3, *4, *8, *17)

PG0436 CYP2C19 & CYP2D6 Pharmacogenetic Testing

81226

CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (e.g., drug metabolism), gene analysis, common variants (e.g., *2, *3, *4, *5, *6, *9, *10, *17, *19, *29, *35, *41, *1XN, *2XN, *4XN)

PG0436 CYP2C19 & CYP2D6 Pharmacogenetic Testing

81227 CYP2C9 (cytochrome P450, family 2, subfamily C, polypeptide 9) (e.g., drug metabolism), gene analysis, common variants (e.g., *2, *3, *5, *6)

PG0390 Genetic Testing for Warfarin Dose

81228

Cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number variants (e.g., Bacterial Artificial Chromosome [BAC] or oligo-based comparative genomic hybridization [CGH] microarray analysis)

PG0296 Comparative Genomic Hybridization (CGH)/Chromosomal Microarray Analysis (CMA)

81229

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


81230 CYP3A4 (cytochrome P450 family 3 subfamily A member 4) (eg, drug metabolism), gene analysis, common variant(s) (eg, *2, *22)

Non-Covered Non-Covered Prior

Authorization required

81231 CYP3A5 (cytochrome P450 family 3 subfamily A member 5) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *5 *6, *7)



81232

DPYD (dihydropyrimidine dehydrogenase) (eg, 5- fluorouracil/5-FU and capecitabine drug metabolism), gene analysis, common variant(s) (eg, *2A, *4, *5, *6) (Effective 01/01/2018 new code)



81233 BTK (Bruton's tyrosine kinase) (eg, chronic lymphocytic leukemia) gene analysis, common variants (eg, C481S, C481R, C481F)




81234 DMPK (DM1 protein kinase) (eg, myotonic dystrophy type 1) gene analysis; evaluation to detect abnormal (expanded) alleles

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81235

EGFR (epidermal growth factor receptor) (e.g., non- small cell lung cancer) gene analysis, common variants (e.g., exon 19 LREA deletion, L858R, T790M, G719A, G719S, L861Q) (LCD L32288)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81236 EZH2 (enhancer of zeste 2 polycomb repressive complex 2 subunit) (eg, myelodysplastic syndrome, myeloproliferative neoplasms) gene analysis, full gene sequence




81237 EZH2 (enhancer of zeste 2 polycomb repressive complex 2 subunit) (eg, diffuse large B-cell lymphoma) gene analysis, common variant(s) (eg, codon 646)




81238 F9 (coagulation factor IX) (eg, hemophilia B), full gene sequence

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81239 DMPK (DM1 protein kinase) (eg, myotonic dystrophy type 1) gene analysis; characterization of alleles (eg, expanded size)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81240 F2 (prothrombin, coagulation factor II) (e.g., hereditary hypercoagulability) gene analysis, 20210G>A variant

PG0355 Genetic Testing for Hereditary Thrombophilia

81241 F5 (coagulation Factor V) (e.g., hereditary hypercoagulability) gene analysis, Leiden variant


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

Prior Authorization


Prior Authorization

required

81243 FMR1 (Fragile X mental retardation 1) (e.g., fragile X mental retardation) gene analysis; evaluation to detect abnormal (e.g., expanded) alleles

PG0360 Genetic Testing for Fragile X-Related Disorders

81244 FMR1 (Fragile X mental retardation 1) (e.g., fragile X mental retardation) gene analysis; characterization of alleles (e.g., expanded size and methylation status)

PG0360 Genetic Testing for Fragile X-Related Disorders

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




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




81247 G6PD (glucose-6-phosphate dehydrogenase) (eg,hemolytic anemia, jaundice), gene analysis; common variant(s) (eg, A, A-)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81248 G6PD (glucose-6-phosphate dehydrogenase) (eg,hemolytic anemia, jaundice), gene analysis; known familial variant(s)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81249 G6PD (glucose-6-phosphate dehydrogenase) (eg,hemolytic anemia, jaundice), gene analysis; full gene sequence

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81250 G6PC (glucose-6-phosphatase, catalytic subunit) (e.g., Glycogen storage disease, Type 1a, von Gierke disease) gene analysis, common variants (e.g., R83C, Q347X)

Prior Authorization


Prior Authorization

required

81251 GBA (glucosidase, beta, acid) (e.g., Gaucher disease) gene analysis, common variants (e.g., N370S, 84GG, L444P, IVS2+1G>A)

Prior Authorization


Prior Authorization

required

81252 GJB2 (gap junction protein, beta 2, 26kDa, connexin 26) (e.g., nonsyndromic hearing loss) gene analysis; full gene sequence (LCD L32288)

Prior Authorization


Prior Authorization

required

81253 GJB2 (gap junction protein, beta 2, 26kDa; connexin 26) (e.g., nonsyndromic hearing loss) gene analysis; known familial variants (LCD L32288)

Prior Authorization


Prior Authorization

required

81254

GJB6 (gap junction protein, beta 6, 30kDa, connexin 30) (e.g., nonsyndromic hearing loss) gene analysis, common variants (e.g., 309kb [del(GJB6- D13S1830)] and 232kb [del(GJB6-D13S1854)]) (LCD L32288)

Prior Authorization


Prior Authorization

required

81255 HEXA (hexosaminidase A [alpha polypeptide]) (e.g., Tay-Sachs disease) gene analysis, common variants(e.g., 1278insTATC, 1421+1G>C, G269S)

Prior Authorization


Prior Authorization

required

81256 HFE (hemochromatosis) (e.g., hereditary hemochromatosis) gene analysis, common variants (e.g., C282Y, H63D)




81257

HBA1/HBA2 (alpha globin 1 and alpha globin 2) (e.g., alpha thalassemia, Hb Bart hydrops fetalis syndrome, HbH disease), gene analysis; common deletions or variant (e.g., Southeast Asian, Thai, Filipino, Mediterranean, alpha3.7, alpha4.2, alpha20.5, and Constant Spring)

Prior Authorization


Prior Authorization

required

81258 HBA1/HBA2 (alpha globin 1 and alpha globin 2) (e.g., alpha thalassemia, Hb Bart hydrops fetalis syndrome, HbH disease), gene analysis; known familial variant

Prior Authorization


Prior Authorization

required

81259 HBA1/HBA2 (alpha globin 1 and alpha globin 2) (e.g., alpha thalassemia, Hb Bart hydrops fetalis syndrome, HbH disease), gene analysis; full gene sequence

Prior Authorization


Prior Authorization

required

81260

IKBKAP (inhibitor of kappa light polypeptide gene enhancer in B-cells, kinase complex-associated protein) (e.g., familial dysautonomia) gene analysis, common variants (e.g., 2507+6T>C, R696P)

Prior Authorization


Prior Authorization

required

81261

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




81262

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




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




81264 IGK@ (Immunoglobulin kappa light chain locus) (e.g., 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 (e.g., pre-transplant recipient and donor germline testing, post-transplant non-hematopoietic recipient germline [e.g., 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 (e.g., 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 (e.g., hematopoietic stem cell), includes comparison to previously performed baseline analyses; without cell selection




81268

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




81269 HBA1/HBA2 (alpha globin 1 and alpha globin 2) (eg, alpha thalassemia, Hb Bart hydrops fetalis syndrome, HbH disease), gene analysis duplication/deletion variants

Prior Authorization


Prior Authorization

required

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

Prior Authorization NOT required



81271 HTT (huntingtin) (eg, Huntington disease) gene analysis; evaluation to detect abnormal (eg, expanded) alleles Non-Covered Non-Covered

Prior Authorization

required

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)




81274 HTT (huntingtin) (eg, Huntington disease) gene analysis; characterization of alleles (eg, expanded size) Non-Covered Non-Covered

Prior Authorization

required

81275 KRAS (Kirsten rat sarcoma viral oncogene homolog) (e.g., carcinoma) gene analysis, variants in exon 2 (eg, codons 12 and 13)




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




81277 Cytogenomic neoplasia (genome-wide) microarray analysis, interrogation of genomic regions for copy number and loss-of-heterozygosity variants for chromosomal abnormalities

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81283 IFNL3 (interferon, lambda 3) (eg, drug response), gene analysis, rs12979860 variant

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81284 FXN (frataxin) (eg, Friedreich ataxia) gene analysis; evaluation to detect abnormal (expanded) alleles

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81285 FXN (frataxin) (eg, Friedreich ataxia) gene analysis; characterization of alleles (eg, expanded size)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81286 FXN (frataxin) (eg, Friedreich ataxia) gene analysis; full gene sequence

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81287 MGMT (O-6-methylguanine-DNA methyltransferase) (e.g., glioblastoma multiforme), methylation analysis

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81288 LH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; promoter methylation analysis

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81289 FXN (frataxin) (eg, Friedreich ataxia) gene analysis; known familial variant(s)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81290 MCOLN1 (mucolipin 1) (e.g., Mucolipidosis, type IV) gene analysis, common variants (e.g., IVS3-2A>G, del6.4kb)

Prior Authorization


Prior Authorization

required

81291

MTHFR (5,10-methylenetetrahydrofolate reductase) (e.g., hereditary hypercoagulability) gene analysis, common variants (e.g., 677T, 1298C)


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


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


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


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


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


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


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


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


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


81301

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

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81302 MECP2 (methyl CpG binding protein 2) (e.g., Rett syndrome) gene analysis; full sequence analysis

Prior Authorization


Prior Authorization

required

81303 MECP2 (methyl CpG binding protein 2) (e.g., Rett syndrome) gene analysis; known familial variant

Prior Authorization


Prior Authorization

required

81304 MECP2 (methyl CpG binding protein 2) (e.g., Rett syndrome) gene analysis; duplication/ deletion variants

Prior Authorization


Prior Authorization

required

81305 MYD88 (myeloid differentiation primary response 88) (eg, Waldenstrom's macroglobulinemia, lymphoplasmacytic leukemia) gene analysis, p.Leu265Pro (L265P) variant

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81306 NUDT15 (nudix hydrolase 15) (eg, drug metabolism) gene analysis, common variant(s) (eg, *2, *3, *4, *5, *6)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81307 PALB2 (partner and localizer of BRCA2) (eg, breast and pancreatic cancer) gene analysis; full gene sequence

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81308 PALB2 (partner and localizer of BRCA2) (eg, breast and pancreatic cancer) gene analysis; known familial variant

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81309

PIK3CA (phosphatidylinositol-4, 5-biphosphate 3-kinase, catalytic subunit alpha) (eg, colorectal and breast cancer) gene analysis, targeted sequence analysis (eg, exons 7, 9, 20)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81310 NPM1 (nucleophosmin) (e.g., 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, codon 61)




81312 PABPN1 (poly[A] binding protein nuclear 1) (eg, oculopharyngeal muscular dystrophy) gene analysis, evaluation to detect abnormal (eg, expanded) alleles

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

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

PG0367 Gene Expression Analysis for 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) (e.g., promyelocytic leukemia) translocation analysis; common breakpoints (e.g., intron 3 and intron 6), qualitative or quantitative




81316

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




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


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


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


81320 PLCG2 (phospholipase C gamma 2) (eg, chronic lymphocytic leukemia) gene analysis, common variants (eg, R665W, S707F, L845F)




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

PG0336 PTEN Genetic Testing

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


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


81324 PMP22 (peripheral myelin protein 22) (e.g., Charcot- Marie-Tooth, hereditary neuropathy with liability to pressure palsies) gene analysis; duplication/deletion analysis



81325 PMP22 (peripheral myelin protein 22) (e.g., Charcot- Marie-Tooth, hereditary neuropathy with liability to pressure palsies) gene analysis; full sequence analysis



81326 PMP22 (peripheral myelin protein 22) (e.g., Charcot- Marie-Tooth, hereditary neuropathy with liability to pressure palsies) gene analysis; known familial variant



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

PG0065 Colorectal Cancer Screening

81328 SLCO1B1 (solute carrier organic anion transporter family, member 1B1) (eg, adverse drug reaction), gene analysis, common variant(s) (eg, *5)

Prior Authorization


Prior Authorization

required

81329

SMN1(survival of motor neuron 1, telomeric) (eg, spinal muscular atrophy) gene analysis; dosage/deletion analysis (eg, carrier testing), includes SMN2 (survival of motor neuron 2, centromeric) analysis , if performed

PG0398 Genetic Testing for Spinal Muscular Atrophy

81330 SMPD1(sphingomyelin phosphodiesterase 1, acid lysosomal) (e.g., Niemann-Pick disease, Type A) gene analysis, common variants (e.g., R496L, L302P, fsP330)

Prior Authorization


Prior Authorization

required

81331

SNRPN/UBE3A (small nuclear ribonucleoprotein polypeptide N and ubiquitin protein ligase E3A) (e.g., Prader-Willi syndrome and/or Angelman syndrome), methylation analysis



81332

SERPINA1 (serpin peptidase inhibitor, clade A, alpha-1 antiproteinase, antitrypsin, member 1) (e.g., alpha-1-antitrypsin deficiency), gene analysis, common variants (e.g., *S and *Z)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81333 TGFBI (transforming growth factor beta-induced) (eg, corneal dystrophy) gene analysis, common variants (eg, R124H, R124C, R124L, R555W, R555Q)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

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)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81335 TPMT (thiopurine S-methyltransferase) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81336 SMN1(survival of motor neuron 1, telomeric) (eg, spinal muscular atrophy) gene analysis; full gene sequence


81337 SMN1(survival of motor neuron 1, telomeric) (eg, spinal muscular atrophy) gene analysis; known familial sequence variant(s)


81340

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




81341

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




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




81343 PPP2R2B (protein phosphatase 2 regulatory subunit Bbeta) (eg, spinocerebellar ataxia) gene analysis, evaluation to detect abnormal (eg, expanded) alleles

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81344 TBP (TATA box binding protein) (eg, spinocerebellar ataxia) gene analysis, evaluation to detect abnormal (eg, expanded) alleles

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81345 TERT (telomerase reverse transcriptase) (eg, thyroid carcinoma, glioblastoma multiforme) gene analysis, targeted sequence analysis (eg, promoter region)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81346 TYMS (thymidylate synthetase) (eg, 5-fluorouracil/5- FU drug metabolism), gene analysis, common variant(s) (eg,tandem repeat variant)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81350 UGT1A1 (UDP glucuronosyltransferase 1 family, polypeptide A1) (e.g., irinotecan metabolism), gene analysis, common variants (e.g., *28, *36, *37)

PG0391 UGT1A1 Targeted Mutation Analysis for Irinotecan Response

81355 VKORC1 (vitamin K epoxide reductase complex, subunit 1) (e.g., warfarin metabolism), gene analysis, common variant(s) (e.g., -1639G>A, c.173+1000C>T)

PG0390 Genetic Testing for Warfarin Dose

81361 HBB (hemoglobin, subunit beta) (eg, sickle cell anemia, beta thalassemia hemoglobinopathy); common variant(s) (eg, HbS, HbC, HbE)

Prior Authorization


Prior Authorization

required

81362 HBB (hemoglobin, subunit beta) (eg, sickle cell anemia, beta thalassemia hemoglobinopathy); known familial variant(s)

Prior Authorization


Prior Authorization

required

81363 HBB (hemoglobin, subunit beta) (eg, sickle cell anemia, beta thalassemia hemoglobinopathy); duplication/deletion variant(s)

Prior Authorization


Prior Authorization

required

81364 HBB (hemoglobin, subunit beta) (eg, sickle cell anemia, beta thalassemia hemoglobinopathy); full gene sequence

Prior Authorization


Prior Authorization

required

81370 HLA Class I and II typing, low resolution (e.g., antigen equivalents); HLA-A, -B, -C, -DRB1/3/4/5, and -DQB1




81371 HLA Class I and II typing, low resolution (e.g., antigen equivalents); HLA-A, -B, and -DRB1/3/4/5 (e.g., verification typing)




81372 HLA Class I typing, low resolution (e.g., antigen equivalents); complete (i.e., HLA-A, -B, and -C)




81373 HLA Class I typing, low resolution (e.g., antigen equivalents); one locus (e.g., HLA-A, -B, or -C), each




81374 HLA Class I typing, low resolution (e.g., antigen equivalents); one antigen equivalent (e.g., B*27), each




81375 HLA Class II typing, low resolution (e.g., antigen equivalents); HLA-DRB1/3/4/5 and -DQB1




81376 HLA Class II typing, low resolution (e.g., antigen equivalents); one locus (e.g., HLA-DRB1/3/4/5, - DQB1, -DQA1, -DPB1, or -DPA1), each




81377 HLA Class II typing, low resolution (e.g., antigen equivalents); one antigen equivalent, each




81378 HLA Class I typing, high resolution (i.e., alleles or allele groups); complete (i.e., HLA-A, -B, and -C)




81379 HLA Class I typing, high resolution (i.e., alleles or allele groups); complete (i.e., HLA-A, -B, and -C)




81380 HLA Class I typing, high resolution (i.e., alleles or allele groups); one locus (e.g., HLA-A, -B, or -C), each




81381 HLA Class I typing, high resolution (i.e., alleles or allele groups); one allele or allele group (e.g., B*57:01P), each

PG0437 HLA-B1502 & HLA-B5701 Pharmacogenetic Testing

81382

HLA Class II typing, high resolution (i.e., alleles or allele groups); one locus (e.g., HLA-DRB1, -DRB3, - DRB4, -DRB5, -DQB1, -DQA1, -DPB1, or -DPA1), each




81383 HLA Class II typing, high resolution (i.e., alleles or allele groups); one allele or allele group (e.g., HLA- DQB1*06:02P), each




Tier 2 Molecular Pathology Procedures

81400

Molecular pathology procedure, Level 1 analysis)(e.g., identification of single germline variant [e.g., SNP] by techniques such as restriction enzyme digestion or melt curve analysis)

Prior Authorization required for all product lines

81401

Molecular pathology procedure, Level 2 (e.g., 2-10 SNPs, 1 methylated variant, or 1 somatic variant [typically using nonsequencing target variant analysis], or detection of a dynamic mutation disorder/triplet repeat)


81402

Molecular pathology procedure, Level 3 (eg, >10 SNPs, 2-10 methylated variants, or 2-10 somatic variants [typically using non-sequencing target variant analysis], immunoglobulin and T-cell receptor gene rearrangements, duplication/deletion variants of 1 exon, loss of heterozygosity [LOH], uniparental disomy [UPD])


81403

Molecular pathology procedure, Level 4 (eg, analysis of single exon by DNA sequence analysis, analysis of >10 amplicons using multiplex PCR in 2 or more independent reactions, mutation scanning or duplication/deletion variants of 2-5 exons)


81404

Molecular pathology procedure, Level 5 (eg, analysis of 2-5 exons by DNA sequence analysis, mutation scanning or duplication/deletion variants of 6-10 exons, or characterization of a dynamic mutation disorder/triplet repeat by Southern blot analysis)


81405

Molecular pathology procedure, Level 6 (eg, analysis of 6-10 exons by DNA sequence analysis, mutation scanning or duplication/deletion variants of 11-25 exons, regionally targeted cytogenomic array analysis)


81406

Molecular pathology procedure, Level 7 (e.g., analysis of 11-25 exons by DNA sequence analysis, mutation scanning or duplication/deletion variants of 26-50 exons, cytogenomic array analysis for neoplasia)


81407 Molecular pathology procedure, Level 8 (e.g., analysis of 26-50 exons by DNA sequence analysis, mutation scanning or duplication/deletion variants of


81408

Molecular pathology procedure, Level 9 (e.g., analysis of >50 exons in a single gene by DNA sequence analysis) FBN1 (fibrillin 1) (e.g., Marfan syndrome), full gene sequence NF1 (neurofibromin 1) (e.g., neurofibromatosis, type 1), full gene sequence RYR1 (ryanodine receptor 1, skeletal) (e.g., malignant hyperthermia), full gene sequence VWF (von Willebrand factor) (e.g., von Willebrand disease types 1 and 3), full gene sequence


81479 Unlisted molecular pathology procedure Prior Authorization required for all product lines

Molecular Multianalyte Assays (MAA)

81410

Aortic dysfunction or dilation (eg, Marfan syndrome, Loeys Dietz syndrome, Ehler Danlos syndrome type IV, arterial tortuosity syndrome); duplication/deletion analysis panel, must include analyses for TGFBR1, TGFBR2, MYH11, and COL3A1

PG0453 Germline Multi-Gene Panel Testing

81411

Aortic dysfunction or dilation (eg, Marfan syndrome, Loeys Dietz syndrome, Ehler Danlos syndrome type IV, arterial tortuosity syndrome); duplication/deletion analysis panel, must include analyses for TGFBR1, TGFBR2, MYH11, and COL3A1


81412

Ashkenazi Jewish associated disorders (eg, Bloom syndrome, Canavan disease, cystic fibrosis, familial dysautonomia, Fanconi anemia group C, Gaucher disease, Tay-Sachs disease), genomic sequence analysis panel, must include sequencing of at least 9 genes, including ASPA, BLM, CFTR, FANCC, GBA, HEXA, IKBKAP, MCOLN1, and SMPD1

PG0453 Germline Multi-Gene Panel Testing/PG0442 Carrier Screening for Genetic

Diseases

81413

Cardiac ion channelopathies (eg, Brugada syndrome, long QT syndrome, short QT syndrome, catecholaminergic polymorphic ventricular tachycardia); genomic sequence analysis panel, must include sequencing of at least 10 genes, including ANK2, CASQ2, CAV3, KCNE1, KCNE2, KCNH2, KCNJ2, KCNQ1, RYR2, and SCN5A

PG0453 Germline Multi-Gene Panel Testing/PG0280 Genetic Testing for Cardiac

Conditions

81414

Cardiac ion channelopathies (eg, Brugada syndrome, long QT syndrome, short QT syndrome, catecholaminergic polymorphic ventricular tachycardia); duplication/deletion gene analysis panel, must include analysis of at least 2 genes, including KCNH2 and KCNQ1

PG0453 Germline Multi-Gene Panel Testing/PG0280 Genetic Testing for Cardiac

Conditions

81415 Exome (eg, unexplained constitutional or heritable disorder or syndrome); sequence analysis

PG0468 Whole Exome Sequencing (WES) and Whole Genome Sequencing (WGS)

81416

Exome (eg, unexplained constitutional or heritable disorder or syndrome); sequence analysis, each comparator exome (eg, parents, siblings) (List separately in addition to code for primary procedure)


81417

Exome (eg, unexplained constitutional or heritable disorder or syndrome); re-evaluation of previously obtained exome sequence (eg, updated knowledge or unrelated condition/syndrome)


81420

Fetal chromosomal aneuploidy (eg, trisomy 21, monosomy X) genomic sequence analysis panel, circulating cell-free fetal DNA in maternal blood, must include analysis of chromosomes 13, 18, and 21

PG0287 Non-Invasive Prenatal Screening (NIPS)/Cell-Free DNA Screening for Fetal

Aneuploidy

81422 Fetal chromosomal microdeletion(s) genomic sequence analysis (eg. DiGeorge syndrome, Cri-du- chat syndrome), circulating cell-free fetal DNA in maternal blood


Aneuploidy

81425 Genome (eg, unexplained constitutional or heritable disorder or syndrome); sequence analysis


81426

Genome (eg, unexplained constitutional or heritable disorder or syndrome); sequence analysis, each comparator genome (eg, parents, siblings) (List separately in addition to code for primary procedure)


81427

Genome (eg, unexplained constitutional or heritable disorder or syndrome); re-evaluation of previously obtained genome sequence (eg, updated knowledge or unrelated condition/syndrome)


81430

Hearing loss (eg, nonsyndromic hearing loss, Usher syndrome, Pendred syndrome); genomic sequence analysis panel, must include sequencing of at least 60 genes, including CDH23, CLRN1, GJB2, GPR98, MTRNR1, MYO7A, MYO15A, PCDH15, OTOF, SLC26A4, TMC1, TMPRSS3, USH1C, USH1G, USH2A, and WFS1


81431

Hearing loss (eg, nonsyndromic hearing loss, Usher syndrome, Pendred syndrome); duplication/deletion analysis panel, must include copy number analyses for STRC and DFNB1 deletions in GJB2 and GJB6 genes


81432

Hereditary breast cancer-related disorders (eg, hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer); genomic sequence analysis panel, must include sequencing of at least 10 genes, always including BRCA1, BRCA2, CDH1, MLH1, MSH2, MSH6, PALB2, PTEN, STK11, and TP53

PG0067 Genetic Testing for Breast and Ovarian Cancers/PG0453 Germline Multi-Gene Panel

Testing

81433 Hereditary breast cancer-related disorders (eg, hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer); duplication/deletion analysis panel,

PG0067 Genetic Testing for Breast and Ovarian Cancers/PG0453 Germline Multi-Gene Panel

Testing

must include analyses for BRCA1, BRCA2, MLH1, MSH2, and STK11

81434

Hereditary retinal disorders (eg, retinitis pigmentosa, Leber congenital amaurosis, cone-rod dystrophy), genomic sequence analysis panel, must include sequencing of at least 15 genes, including ABCA4, CNGA1, CRB1, EYS, PDE6A, PDE6B, PRPF31, PRPH2, RDH12, RHO, RP1, RP2, RPE65, RPGR, and USH2A


81435

Hereditary colon cancer disorders (eg, Lynch syndrome, PTEN hamartoma syndrome, Cowden syndrome, familial adenomatosis polyposis); genomic sequence analysis panel, must include analysis of at least 10 genes, including APC, BMPR1A, CDH1, MLH1, MSH2, MSH6, MUTYH, PTEN, SMAD4 and STK11

PG0302 Genetic Testing for Lynch Syndrome and Polyposis Syndromes/PG0453 Germline Multi-

Gene Panel Testing

81436

Hereditary colon cancer disorders (eg, Lynch syndrome, PTEN hamartoma syndrome, Cowden syndrome, familial adenomatosis polyposis); duplication/deletion gene analysis panel, must include analysis of at least 5 genes, including MLH1, MSH2, EPCAM, SMAD4, and STK11

PG0302 Genetic Testing for Lynch Syndrome and Polyposis Syndromes/PG0453 Germline Multi-

Gene Panel Testing

81437

Hereditary neuroendocrine tumor disorders (eg, medullary thyroid carcinoma, parathyroid carcinoma, malignant pheochromocytoma or paraganglioma; genomic sequence analysis panel, must include sequencing of at least 6 genes, including MAX, SDHB, SDHC, SDHD, TMEM127, and VHL

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81438

Hereditary neuroendocrine tumor disorders (eg, medullary thyroid carcinoma, parathyroid carcinoma, malignant pheochromocytoma or paraganglioma; duplication/deletion analysis panel, must include analyses for SDHB, SDHC, SDHD, and VHL


81439

Hereditary cardiomyopathy (eg, hypertrophic cardiomyopathy, dilated cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy), genomic sequence analysis panel, must include sequencing of at least 5 cardiomyopathy-related genes (eg, DSG2, MYBPC3, MYH7, PKP2, TTN)

PG0280 Genetic Testing for Cardiac Conditions/PG0453 Germline Multi-Gene Panel

Testing

81440

Nuclear encoded mitochondrial genes (eg, neurologic or myopathic phenotypes), genomic sequence panel, must include analysis of at least 100 genes, including BCS1L, C10orf2, COQ2, COX10, DGUOK, MPV17, OPA1, PDSS2, POLG, POLG2, RRM2B, SCO1, SCO2, SLC25A4, SUCLA2, SUCLG1, TAZ, TK2, and TYMP


81442

Noonan spectrum disorders (eg, Noonan syndrome, cardio-facio-cutaneous syndrome, Costello syndrome, LEOPARD syndrome, Noonan-like syndrome), genomic sequence analysis panel, must include sequencing of at least 12 genes, including BRAF, CBL, HRAS, KRAS, MAP2K1, MAP2K2, NRAS, PTPN11, RAF1, RIT1, SHOC2, and SOS1


81443

Genetic testing for severe inherited conditions (eg, cystic fibrosis, Ashkenazi Jewish-associated disorders [eg, Bloom syndrome, Canavan disease, Fanconi anemia type C, mucolipidosis type VI, Gaucher disease, Tay-Sachs disease], beta hemoglobinopathies, phenylketonuria, galactosemia), genomic sequence analysis panel, must include sequencing of at least 15 genes (eg ACADM, ARSA, ASPA, ATP7B, BCKDHA, BCKDHB, BLM, CFTR, DHCR7, FANCC, G6PC, GAA, GALT, GB1, GBE1, HBB, HEXA, IKBKAP, MCOLN1, PAH)


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

PG0438 Next Generation Sequencing (NGS) Tests for Advanced Cancer

81448

Hereditary peripheral neuropathies (eg, Charcot- Marie-Tooth, spastic paraplegia), genomic sequence analysis panel, must include sequencing of at least 5 peripheral neuropathy-related genes (eg, BSCL2, GJB1, MFN2, MPZ, REEP1, SPAST, SPG11, SPTLC1)


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 analysis, 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


81460

Whole mitochondrial genome (eg, Leigh syndrome, mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes [MELAS], myoclonic epilepsy with ragged-red fibers [MERFF], neuropathy, ataxia, and retinitis pigmentosa [NARP], Leber hereditary optic neuropathy [LHON]), genomic sequence, must include sequence analysis of entire mitochondrial genome with heteroplasmy detection


81465

Whole mitochondrial genome large deletion analysis panel (eg, Kearns-Sayre syndrome, chronic progressive external ophthalmoplegia), including heteroplasmy detection, if performed


81470

X-linked intellectual disability (XLID) (eg, syndromic and non-syndromic XLID); genomic sequence analysis panel, must include sequencing of at least 60 genes, including ARX, ATRX, CDKL5, FGD1, FMR1, HUWE1, IL1RAPL, KDM5C, L1CAM, MECP2, MED12, MID1, OCRL, RPS6KA3, and SLC16A2


81471

X-linked intellectual disability (XLID) (eg, syndromic and non-syndromic XLID); duplication/deletion gene analysis, must include analysis of at least 60 genes, including ARX, ATRX, CDKL5, FGD1, FMR1, HUWE1, IL1RAPL, KDM5C, L1CAM, MECP2, MED12, MID1, OCRL, RPS6KA3, and SLC16A2


Multianalyte Assays with Algorithmic Analyses (MAAA)

81490 Autoimmune (rheumatoid arthritis), analysis of 12 biomarkers using immunoassays, utilizing serum, prognostic algorithm reported as a disease activity score

PG0362 Vectra® DA

81493 Coronary artery disease, mRNA, gene expression profiling by real-time RT-PCR of 23 genes, utilizing whole peripheral blood, algorithm reported as a risk score

PG0363 CORUS®CAD

81500 Oncology (ovarian), biochemical assays of two proteins (CA-125 and HE-4), utilizing serum, with menopausal status, algorithm reported as a risk score

Non-Covered Non-Covered Non-Covered

81503

Oncology (ovarian), biochemical assays of five proteins (CA-125, apolipoprotein A1, beta-2 microglobulin, transferring, and pre-albumin), utilizing serum, algorithm reported as a risk score


81504

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

PG0364 Gene Expression Profiling for Cancers of Unknown Primary Site

81506

Endocrinology (type 2 diabetes), biochemical assays of seven analytes (glucose, HbA1c, insulin, hs-CRP, adiponectin, ferritin, interleukin 2-receptor alpha), utilizing serum or plasma, algorithm reporting a risk score


81507 Fetal aneuploidy (trisomy 21, 18, and 13) DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy


Aneuploidy

81508 Fetal congenital abnormalities, biochemical assays of two proteins (PAPP-A, hCG [any form]), utilizing maternal serum, algorithm reported as a risk score


81509 Fetal congenital abnormalities, biochemical assays of three proteins (PAPP-A, hCG [any form], DIA), utilizing maternal serum, algorithm reported as a risk score


81510 Fetal congenital abnormalities, biochemical assays of three analytes (AFP, uE3, hCG [any form]), utilizing maternal serum, algorithm reported as a risk score)


81511

Fetal congenital abnormalities, biochemical assays of four analytes (AFP, uE3, hCG [any form], DIA) utilizing maternal serum, algorithm reported as a risk score (may include additional results from previous biochemical testing)


81512 Fetal congenital abnormalities, biochemical assays of five analytes

(AFP, uE3, total hCG, hyperglycosylated hCG, DIA) utilizing

maternal serum, algorithm reported as a risk score Non-Covered Non-Covered Non-Covered

81518

Oncology (breast), mRNA, gene expression profiling by real-time RT-PCR of 11 genes (7 content and 4 housekeeping), utilizing formalin- fixed paraffin embedded tissue, algorithms reported as percentage risk for metastatic recurrence and likelihood of benefit from extended endocrine therapy

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

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

PG0301 Genetic Expression Assays for Breast Cancer Prognosis

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


81522

Oncology (breast), mRNA, gene expression profiling by RT-PRC of 12 genes (8 content and 4 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as recurrence risk score

Prior Authorization required



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

PG0357 Gene Expression Profiling for Colorectal Cancer

81528

Oncology (colorectal) screening, quantitative real- time target and signal amplification of 10 DNA markers (KRAS mutations, promoter methylation of NDRG4 and BMP3) and fecal hemoglobin, utilizing stool, algorithm reported as a positive or negative result

PG0065 Colorectal Cancer Screening

81535

Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by DAPI stain and morphology, predictive algorithm reported as a drug response score; first single drug or drug combination

PG0122 In Vitro Chemoresistance and Chemosensitivity Assays

81536

Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by DAPI stain and morphology, predictive algorithm reported as a drug response score; each additional single drug or drug combination (List separately in addition to code for primary procedure)

PG0122 In Vitro Chemoresistance and Chemosensitivity Assays

81538

Oncology (lung), mass spectrometric 8-protein signature, including amyloid A, utilizing serum, prognostic and predictive algorithm reported as good versus poor overall survival

PG0111 VeriStrat®

81539

Oncology (high-grade prostate cancer), biochemical assay of four proteins (Total PSA, Free PSA, Intact PSA and human kallikrein-2 [hK2]), utilizing plasma or serum, prognostic algorithm reported as a probability 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

PG0364 Gene Expression Profiling for Cancers of Unknown Primary Site

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


81542 Oncology (prostate), mRNA, microarray gene expression profiling of 22 content genes, utilizing formalin-fixed paraffin-

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

embedded tissue, algorithm reported as metastasis 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)

PG0298 Afirma® Thyroid FNA Analysis

81551

Oncology (prostate), promoter methylation profiling by real-time 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


81552

Oncology (uveal melanoma), MRNA, gene expression profiling by real-time RT-PRC or 15 genes (12 content and 3 housekeeping), utilizing fine needle aspirate or formalin-fixed paraffin-embedded tissue, algorithm reported as risk of metastasis

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81595

Cardiology (heart transplant), mRNA, gene expression profiling by real-time quantitative PCR of 20 genes (11 content and 9 housekeeping), utilizing subfraction of peripheral blood, algorithm reported as a rejection risk score

PG0340 AlloMap™ Molecular-Expression Blood Test

81596

Infectious disease, chronic hepatitis C virus (HCV) infection, six biochemical assays (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, and haptoglobin) utilizing serum, prognostic algorithm reported as scores for fibrosis and necroinflammatory activity in liver

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

81599 Unlisted multianalyte assay with algorithmic analysis

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

Cytogenetic Studies

88230 Tissue culture for non-neoplastic disorders; lymphocyte PG0375 Molecular Cytogenetic Testing

88233 Tissue culture for non-neoplastic disorders; skin or other solid tissue biopsy

PG0375 Molecular Cytogenetic Testing

88235 Tissue culture for non-neoplastic disorders; amniotic fluid or chorionic villus cells


88237 Tissue culture for neoplastic disorders; bone marrow, blood cells


88239 Tissue culture for neoplastic disorders; solid tumor PG0375 Molecular Cytogenetic Testing

88240 Cryopreservation, freezing and storage of cells, each cell line


88241 Thawing and expansion of frozen cells, each aliquot PG0375 Molecular Cytogenetic Testing

88245 Chromosome analysis for breakage syndromes; baseline Sister Chromatid Exchange (SCE), 20-25 cells


88248 Chromosome analysis for breakage syndromes; baseline breakage, score 50-100 cells, count 20 cells, 2 karyotypes (eg, for ataxia telangiectasia, Fanconi anemia, fragile X)


88249 Chromosome analysis for breakage syndromes; score 100 cells, clastogen stress (eg, diepoxybutane, mitomycin C, ionizing radiation, UV radiation)


88261 Chromosome analysis; count 5 cells, 1 karyotype, with banding


88262 Chromosome analysis; count 15-20 cells, 2 karyotypes, with banding


88263 Chromosome analysis; count 45 cells for mosaicism, 2 karyotypes, with banding


88264 Chromosome analysis; analyze 20-25 cells PG0375 Molecular Cytogenetic Testing

88267 Chromosome analysis, amniotic fluid or chorionic villus, count 15 cells, 1 karyotype, with banding


88269 Chromosome analysis, in situ for amniotic fluid cells, count cells from 6-12 colonies, 1 karyotype, with banding


88271 Molecular cytogenetics; DNA probe, each (eg, FISH) PG0375 Molecular Cytogenetic Testing

88272 Molecular cytogenetics; chromosomal in situ hybridization, analyze 3-5 cells (eg, for derivatives and markers)


88273 Molecular cytogenetics; chromosomal in situ hybridization, analyze 10-30 cells (eg, for microdeletions)


88274 Molecular cytogenetics; interphase in situ hybridization, analyze 25-99 cells


88275 Molecular cytogenetics; interphase in situ hybridization, analyze 100-300 cells


88280 Chromosome analysis; additional karyotypes, each study PG0375 Molecular Cytogenetic Testing

88283 Chromosome analysis; additional specialized banding technique (eg, NOR, C-banding)


88285 Chromosome analysis; additional cells counted, each study PG0375 Molecular Cytogenetic Testing

88289 Chromosome analysis; additional high resolution study PG0375 Molecular Cytogenetic Testing

88291 Cytogenetics and molecular cytogenetics, interpretation and report


88299 Unlisted cytogenetic study PG0375 Molecular Cytogenetic Testing

Proprietary MAA

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


0011M

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


0012M

Oncology (urothelial), mRNA, gene expression profiling by real-hyphentime 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-hyphentime 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


Proprietary Laboratory Analyses

0001U Red blood cell antigen typing, DNA, human erythrocyte antigen gene analysis of 35 antigens from 11 blood groups, utilizing whole blood, common RBC alleles reported

Non-Covered

Prior Authorization


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


0012U Germline disorders, gene rearrangement detection by whole genome next-generation sequencing, DNA, whole blood, report of specific gene rearrangement(s)


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

Prior Authorization

required Non-Covered Non-Covered

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

Prior Authorization


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

Non-Covered Prior


Non-Covered

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

Prior Authorization

required

Prior Authorization


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

Prior Authorization


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")

Non-Covered Prior


Non-Covered

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

Prior Authorization


0029U Drug metabolism (adverse drug reactions and drug response), targeted sequence analysis (ie, CYP1A2, CYP2C19, CYP2C9, CYP2D6, CYP3A4, CYP3A5, CYP4F2, SLCO1B1, VKORC1 and rs12777823)


0030U Drug metabolism (warfarin drug response), targeted sequence analysis (ie, CYP2C9, CYP4F2, VKORC1, rs12777823)


0031U CYP1A2 (cytochrome P450 family 1, subfamily A, member 2)(eg, drug metabolism) gene analysis, common variants (ie, *1F, *1K, *6, *7)


0032U COMT (catechol-O-methyltransferase)(drug metabolism) gene analysis, c.472G>A (rs4680) variant


0033U HTR2A (5-hydroxytryptamine receptor 2A), HTR2C (5- hydroxytryptamine receptor 2C) (eg, citalopram metabolism) gene analysis, common variants (ie, HTR2A rs7997012 [c.614-2211T>C], HTR2C rs3813929 [c.-759C>T] and rs1414334 [c.551-3008C>G])


0034U TPMT (thiopurine S-methyltransferase), NUDT15 (nudix hydroxylase 15)(eg, thiopurine metabolism), gene analysis, common variants (ie, TPMT *2, *3A, *3B, *3C, *4, *5, *6, *8, *12; NUDT15 *3, *4, *5)


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


0037U Targeted 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

Prior Authorization

required

Prior Authorization


0040U BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis, major breakpoint, quantitative

Prior Authorization


0045U Oncology (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

Non-Covered Prior


Non-Covered

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

Prior Authorization


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

Non-Covered Prior


Non-Covered

0048U Oncology (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)

Prior Authorization

required

Prior Authorization


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

Prior Authorization


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

Prior Authorization


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


0055U Cardiology (heart transplant), cell-free DNA, PCR assay of 96 DNA target sequences (94 single nucleotide polymorphism targets and two control targets), plasma


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)


0060U Twin zygosity, genomic targeted sequence analysis of chromosome 2, using circulating cell-free fetal DNA in maternal blood


0069U Oncology (colorectal), microRNA, RT-PCR expression profiling of miR-31-3p, formalin-fixed paraffin-embedded tissue,

algorithm reported as an expression score


0070U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, common and select rare variants (ie, *2, *3, *4, *4N, *5, *6, *7, *8, *9, *10, *11, *12, *13, *14A, *14B, *15, *17, *29, *35, *36, *41, *57, *61, *63, *68, CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, full gene sequence

Prior Authorization

required

Prior Authorization


0071U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, full gene sequence (List separately in addition to code for primary procedure) (Use 0071U in conjunction with 0070U)

Prior Authorization

required

Prior Authorization


0072U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, CYP2D6-2D7 hybrid gene) (List separately in addition to code for primary procedure) (Use 0072U in conjunction with 0070U)

Prior Authorization

required

Prior Authorization


0073U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, CYP2D7-2D6 hybrid gene) (List separately in addition to code for primary procedure) (Use 0073U in conjunction with 0070U)

Prior Authorization

required

Prior Authorization


0074U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, non-duplicated gene when duplication/multiplication is trans) (List separately in addition to code for primary procedure) (Use 0074U in conjunction with 0070U)

Prior Authorization

required

Prior Authorization


0075U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, 5’ gene duplication/multiplication) (List separately in addition to code for primary procedure) (Use 0075U in conjunction with 0070U)

Prior Authorization

required

Prior Authorization


0076U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, 3’ gene duplication/multiplication) (List separately in addition to code for primary procedure) (Use 0076U in conjunction with 0070U)

Prior Authorization

required

Prior Authorization


0078U Pain management (opioid-use disorder) genotyping panel, 16 common variants (ie, ABCB1, COMT, DAT1, DBH, DOR, DRD1, DRD2, DRD4, GABA, GAL, HTR2A, HTTLPR, MTHFR, MUOR, OPRK1, OPRM1), buccal swab or other germline tissue sample, algorithm reported as

positive or negative risk of opioid-use disorder


0079U Comparative DNA analysis using multiple selected single-nucleotide polymorphisms (SNPs), urine and buccal DNA, for

specimen identity verification


0084U Red blood cell antigen typing, DNA, genotyping of 10 blood groups with phenotype prediction of 37 red blood cell antigens


0087U Cardiology (heart transplant), mRNA gene expression profiling by microarray of 1283 genes, transplant biopsy tissue, allograft rejection and injury algorithm reported as a

probability score


0088U Transplantation medicine (kidney allograft rejection), microarray gene expression profiling of 1494 genes, utilizing transplant biopsy tissue, algorithm reported as a probability score for rejection


0089U Oncology (melanoma), gene expression profiling by RTqPCR, PRAME and LINC00518, superficial collection using adhesive patch(es)

Non-Covered Prior


Non-Covered

0090U Oncology (cutaneous melanoma), mRNA gene expression profiling by RT-PCR of 23 genes (14 content and 9 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a categorical

Prior Authorization

required

Prior Authorization


0094U Genome (eg, unexplained constitutional or heritable disorder or syndrome), rapid sequence analysis


0101U Hereditary colon cancer disorders (eg, Lynch syndrome, PTEN hamartoma syndrome, Cowden syndrome, familial adenomatosis polyposis), genomic sequence analysis panel utilizing a combination of NGS, Sanger, MLPA, and array CGH, with MmRNA analytics to resolve variants of unknown significance when indicated (15 genes [sequencing and deletion/duplication], EPCAM an GREM1 [deletion/duplication only])

Prior Authorization

required

Prior Authorization


0102U hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer), genomic sequence analysis panel utilizing a combination of NGS, Sanger, MLPA, and array CGH, with MmRNA analytics to resolve variants of unknown significance when indicated (17 genes [sequencing and deletion/duplication])

Prior Authorization

required

Prior Authorization


0103U Hereditary ovarian cancer (eg, hereditary ovarian cancer, hereditary endometrial cancer), genomic sequence analysis panel utilizing a combination of NGS, Sanger,,MLPA, and array CGH, with MmRNA

analytics to resolve variants of unknown significance when indicated (24 genes [sequencing and deletion/duplication], EPCAM [deletion/duplication only])

Prior Authorization

required

Prior Authorization


0111U Oncology (colon cancer), targeted KRAS (codons 12, 13, and 61) and NRAS (codons 12, 13, and 61) gene analysis utilizing formalin-fixed paraffin-embedded tissue

Prior Authorization


0118U Transplantation medicine, quantification of donor-derived cell-free DNA using whole genome next-generation sequencing, plasma, reported as percentage of donor-derived cell-free DNA in the total cell-free DNA


0120U Oncology (B-cell lymphoma classification), mRNA, gene expression profiling by fluorescent probe hybridization of 58 genes (45 content and 13 housekeeping genes), formalin-fixe paraffin-embedded tissue, algorithm reported as likelihood for primary mediastinal B-cell lymphoma (PMBCL) and diffuse large B-cell lymphoma (DLBCL) with cell of origin subtyping in the latter


0129U Hereditary breast cancer–related disorders (eg, hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer), genomic sequence analysis and deletion/duplication analysis panel (ATM, BRCA1, BRCA2, CDH1, CHEK2, PALB2,

PTEN, and TP53)

Prior Authorization

required

Prior Authorization


0130U Hereditary colon cancer disorders (eg, Lynch syndrome, PTEN hamartoma syndrome, Cowden syndrome, familial adenomatosis polyposis), targeted mRNA sequence analysis panel (APC, CDH1, CHEK2, MLH1, MSH2, MSH6, MUTYH, PMS2, PTEN, and TP53) (List separately in addition to code for primary procedure) (Use 0130U in conjunction with 81435, 0101U)


0131U Hereditary breast cancer–related disorders (eg, Non-Covered Non-Covered Non-Covered

hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer), targeted mRNA

sequence analysis panel (13 genes)

0132U Hereditary ovarian cancer–related disorders (eg, hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer), targeted mRNA



0133U Hereditary prostate cancer–related disorders, targeted mRNA sequence analysis panel (11 genes)


0134U Hereditary pan cancer (eg, hereditary breast and ovarian cancer, hereditary endometrial cancer, hereditary colorectal cancer), targeted mRNA



0135U Hereditary gynecological cancer (eg, hereditary breast and ovarian cancer, hereditary endometrial

cancer, hereditary colorectal cancer), targeted mRNA sequence analysis panel (12 genes)


0136U ATM (ataxia telangiectasia mutated) (eg, ataxia telangiectasia) mRNA sequence analysis


0137U PALB2 (partner and localizer of BRCA2) (eg, breast and pancreatic cancer) mRNA sequence analysis


0138U BRCA1 (BRCA1, DNA repair associated), BRCA2 (BRCA2, DNA repair associated) (eg, hereditary

breast and ovarian cancer) mRNA sequence analysis


0153U Oncology (breast), mRNA, gene expression profiling by next-generation sequencing of 101 genes, utilizing formalin-fixed paraffin-embedded tissue,

algorithm reported as a triple negative breast cancer clinical subtype(s) with information on immune cell involvement


0154U Oncology (urothelial cancer), RNA, analysis by real-time RT-PCR of the FGFR3 (fibroblast growth factor receptor 3) gene analysis (ie, p.R248C [c.742C>T], p.S249C [c.746C>G], p.G370C [c.1108G>T], p.Y373C [c.1118A>G], FGFR3-TACC3v1, and FGFR3-TACC3v3)

Prior Authorization


0155U Oncology (breast cancer), DNA, PIK3CA (phosphatidylinositol-4,5-bisphosphate 3- kinase, catalytic subunit alpha) (eg, breast cancer) gene analysis (ie, p.C420R, p.E542K, p.E545A, p.E545D [g.1635G>T only], p.E545G, p.E545K, p.Q546E, p.Q546R, p.H1047L, p.H1047R,

Prior Authorization

required

Prior Authorization


0156U Copy number (eg, intellectual disability, dysmorphology), sequence analysis


0157U APC (APC regulator of WNT signaling pathway) (eg, familial adenomatosis polyposis [FAP]) mRNA sequence analysis


0158U MLH1 (mutL homolog 1) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) mRNA sequence analysis (List separately in addition to code for primary procedure)


0159U MSH2 (mutS homolog 2) (eg, hereditary colon cancer, Lynch syndrome) mRNA sequence analysis (List separately in addition to code for primary procedure)


0160U MSH6 (mutS homolog 6) (eg, hereditary colon cancer, Lynch syndrome) mRNA sequence analysis (List separately in addition to code for primary procedure


0161U PMS2 (PMS1 homolog 2, mismatch repair system component) (eg, hereditary nonpolyposis colorectal cancer, Lynch syndrome) mRNA sequence analysis (List separately in addition to code for primary

procedure)


0162U Hereditary colon cancer (Lynch syndrome), targeted mRNA sequence analysis panel (MLH1, MSH2, MSH6, PMS2) (List separately in addition to code

for primary procedure)


0168U Fetal aneuploidy (trisomy 21, 18, and 13) DNA sequence analysis of selected regions using maternal plasma without fetal fraction cutoff, algorithm reported as a risk score for each trisomy


0169U NUDT15 (nudix hydrolase 15) and TPMT (thiopurine S-methyltransferase) (eg, drug metabolism) gene analysis, common variants


0170U Neurology (autism spectrum disorder [ASD]), RNA, next-generation sequencing, saliva, algorithmic analysis, and results reported as predictive probability of ASD diagnosis


0171U Targeted genomic sequence analysis panel, acute myeloid leukemia, myelodysplastic syndrome, and myeloproliferative neoplasms, DNA analysis, 23 genes, interrogation for sequence variants, rearrangements and


HCPCS CODES

G0452 Molecular pathology procedure; physician interpretation and report Non-Covered

Prior Authorization


G9143 Warfarin responsiveness testing by genetic technique using any method, any number of specimen(s)


S3800 Genetic testing for amyotrophic lateral sclerosis (ALS) Non-Covered Non-Covered Non-Covered

S3840 DNA analysis for germline mutations of the RET proto-oncogene for susceptibility to multiple endocrine neoplasia type 2


S3841 Genetic testing for retinoblastoma Non-Covered Non-Covered Non-Covered

S3842 Genetic testing for von Hippel-Lindau disease Non-Covered Non-Covered Non-Covered

S3844 DNA analysis of the connexin 26 gene (GJB2) for susceptibility to congenital, profound deafness


S3845 Genetic testing for alpha-thalassemia Non-Covered Non-Covered Non-Covered

S3846 Genetic testing for hemoglobin E beta-thalassemia Non-Covered Non-Covered Non-Covered

S3849 Genetic testing for Niemann-Pick diseases Non-Covered Non-Covered Non-Covered

S3850 Genetic testing for sickle cell anemia Non-Covered Non-Covered Non-Covered

S3852 DNA analysis for APOE epsilon 4 allele for susceptibility to Alzheimer's disease


S3853 Genetic testing for myotonic muscular dystrophy Non-Covered Non-Covered Non-Covered

S3854

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


S3861 Genetic testing, sodium channel, voltage-gated, type V, alpha subunit (SCN5A) and variants for suspected Brugada Syndrome

PG0280 Genetic Testing for Cardiac Conditions

S3865 Comprehensive gene sequence analysis for hypertrophic cardiomyopathy


S3866 Genetic analysis for a specific gene mutation for hypertrophic cardiomyopathy (HCM) in an individual with a known HCM mutation in the family


S3870 Comparative genomic hybridization (CGH) microarray testing for developmental delay, autism spectrum disorder and/or mental retardation


REVISION HISTORY EXPLANATION 01/01/13: Updated 07/08/13: Per Medical Director Review, genetic subcommittee, the following genetic codes will not require a prior

authorization; 81206-81208, 81210, 81220-81223, 81240-81245, 81250-81251, 81255-81256, 81261-81268, 81270, 81275, 81291, 81310, 81315-81316, 81340-81342, 81350, 81355, 81378-81383. 12/31/13: Per 2014 new code review, updated the configuration code sets to include procedures G0452 and 81287

to require prior authorization, and procedures 81504 and 81507 to be denied as non-covered. 05/13/14: Added codes 81161, 84999, 85999, 86849, 87999, 88199, 88299, 88380, 88381, 88399, 89398. Removed code S3870. Changed title of medical policy from Genetic and Experimental Laboratory Services to Genetic Testing. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee.

01/13/15: Added reference to PG0296 Comparative Genomic Hybridization (CGH) for codes 81228 & 81229 per Medical Policy Steering Committee. 06/09/15: Added code effective 1/1/15: 81246, 81288, 81313, 81410, 81411, 81415-81417, 81420, 81425-81427,

81430, 81431, 81435, 81436, 81440, 81445, 81450, 81455, 81460, 81465, 81470, 81471, 81519. Updated descriptions for revised codes effective 1/1/15: 81402-81405. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 10/26/15: For multianalyte assay with algorithmic analyses code 81519 refer to PG0301 Genetic Expression Assays for Breast Cancer Prognosis for coverage determination. 02/26/16: Added effective 1/1/16 new codes 81162, 81432, 81433, 81434 that require prior authorization; 81170,

81218, 81219, 81272, 81273, 81276, 81311, 81314, 81412, 81437, 81438, 81442, 81528, 81545, 81595 that do not require prior authorization; and 81490, 81493, 81525, 81535, 81536, 81538, 81540 that are non-covered. Updated effective 1/1/16 revised codes 81210, 81275, 81355, 81435, 81436, 81445, 81450, & 81455. Added codes 88230-88299, and 0001M-0010M. Code 88271 has a limit of 25 units per 365 days. Removed codes 88380 & 88381. Policy reviewed and updated to reflect most current clinical evidence per The Technology Assessment Working Group (TAWG). 03/25/16: Coverage changes made per CMS guidelines: Non-covered for all product lines - 81161, 81507, 0009M;

Non-covered for HMO, PPO, Individual Marketplace, Elite and covered with prior authorization for Advantage - 81200. 81205, 81209, 81224, 81252, 81253, 81254, 81257, 81260, 81290, 81324, 81325, 81326, 81330, 81331, 81410, 81411, 81412, 81415, 81416, 81417, 81425, 81426, 81427, 81430, 81431, 81433, 81434, 81438, 81440, 81442, 81460, 81465, 81470, 81471; Covered with prior authorization for HMO, PPO, Individual Marketplace, Elite and Non-covered for Advantage - 81490, 81504, 81525, 81540; Covered with prior authorization for Elite and Non- covered for HMO, PPO, Individual Marketplace, Advantage – 81493. Policy reviewed and updated to reflect most current clinical evidence per TAWG. 04/22/16: Codes 81242, 81251, 81302, 81303, 81304 are covered with prior authorization for HMO, PPO, Individual Marketplace, & Advantage and are non-covered for Elite per CMS guidelines. Added specific non- covered genes/gene components determination for 81400-81408, & 81479 per CMS guidelines as non-covered for all product lines. Added myRisk test (81479) as non-covered for all product lines per CMS guidelines. Added reference to new policies: PG0355 Genetic Testing for Hereditary Thrombophilia (81240, 81241, 81291), PG0357 Gene Expression Profiling for Colorectal Cancer (81525), PG0360 Genetic Testing for FMR1 Mutations Including Fragile X Syndrome (81243, 81244), PG0363 CORUS® CAD (81493), PG0364 Cancer Type ID (81540), & PG0368 GeneSight® Assay for Refractory Depression (81479). Policy reviewed and updated to reflect most current clinical evidence per TAWG. 6/24/16: Policy updated per TAWG determination for PG0298 Afirma® Thyroid FNA Analysis, PG0334 ThyroSeq® v.2 Next Generation Sequencing, and PG0367 Gene Expression Analysis for Prostate Cancer. 10/28/16: CPT code 81224 is now covered without prior authorization for HMO, PPO, Individual Marketplace, & Elite, in addition, to Advantage. Policy reviewed and updated to reflect most current clinical evidence per TAWG. 03/24/17: Added effective 01/01/17 new CPT code 81327 per PG0065 Colorectal Cancer Screening. Added effective 01/01/17 new CPT codes 81413, 81414, 81439 per PG0280 Genetic Testing for Cardiac Conditions. Added effective 01/01/17 new CPT code 81422 per PG0287 Cell-Free DNA Tests For Fetal Aneuploidy. Added CPT code S3854 per PG0301 Genetic Expression Assays for Breast Cancer Prognosis. Added CPT codes S3861- S3866 per PG0280 Genetic Testing for Cardiac Conditions. Added CPT code S3870 per PG0296 Comparative

Genomic Hybridization (CGH). Added effective 01/01/17 new CPT codes 81539 as requires prior authorization for Advantage & non-covered for HMO, PPO, Individual Marketplace, & Elite. Added CPT codes S3800-S3853 as non- covered for all product lines. Deleted effective 12/31/16 CPT code 0010M (replaced by 81539). Deleted effective 12/31/16 CPT codes 81280-81282 per PG0280 Genetic Testing for Cardiac Conditions. Effective 01/01/17 code 81595 is now non-covered for Advantage per ODM guidelines (continues to be covered without prior authorization for HMO, PPO, Individual Marketplace, & Elite) for PG0340 AlloMap™ Molecular-Expression Blood Test. Policy reviewed and updated to reflect most current clinical evidence per The Technology Assessment Working Group (TAWG). 01/25/18: Added effective 01/01/18 new CPT codes 81520 & 81521 per PG0301 Genetic Expression Assays for Breast Cancer Prognosis. Added effective 01/01/18 new CPT codes 81541 & 81551 per PG0367 Gene Expression Analysis for Prostate Cancer. Effective 12/31/17 deleted code 0008M (replaced by 81520) per PG0301 Genetic Expression Assays for Breast Cancer Prognosis. Added Proprietary Laboratory Analyses (PLA) Codes 0001U- 0034U per PG0417 Proprietary Laboratory Analyses (PLA) Codes & PG0367 Gene Expression Analysis for Prostate Cancer. Revised effective 01/01/18 codes 81257, 81432, & 81439. Added effective 01/01/18 new codes 81105, 81106, 81107, 81108, 81109, 81110, 81111, 81112, 81120, 81121, 81175, 81176, 81238, 81247, 81248,

81249, 81283, 81334, 81335, 81346, 81448 as covered with prior authorization for all product lines per CMS & ODM guidelines. Added effective 01/01/18 new codes 81230, 81231, 81232 as covered with prior authorization for Advantage per ODM guidelines and non-covered for HMO, PPO, Individual Marketplace, & Elite per CMS guidelines. Added effective 01/01/18 new codes 81258, 81259, 81269, 81328, 81361, 81362, 81363, 81364 as covered with prior authorization for HMO, PPO, Individual Marketplace, & Advantage and non-covered for Elite per CMS guidelines. Added code G9143 per PG0390 Genetic Testing for Warfarin Dose. Refer to PG0390 Genetic Testing for Warfarin Dose for coverage determination of codes G9143, 81227 & 81355. Refer to PG0367 Gene Expression Analysis for Prostate Cancer for coverage determination of codes 81313 & 81539. Refer to PG0375 Molecular Cytogenetic Testing for coverage determination of code 88271. Refer to PG0411 Genetic Testing for Duchenne and Becker Muscular Dystrophy for coverage determination of codes 81161 & 81408. Codes 81432, 81435, 81436, 81445, 81455 removed from PG0336 PTEN Hamartoma Tumor Syndrome. Policy reviewed and updated to reflect most current clinical evidence per The Technology Assessment Working Group (TAWG). 08/23/18: Added reference to these genetic policies: PG0358 Genetic Counseling; PG0364 Gene Expression Profiling for Cancers of Unknown Primary Site (81504, 81540); PG0374 Verifi Prenatal Test (81420, 81507, 0009M); PG0387 Genetic Testing for Cystic Fibrosis (81220-81224); PG0391 UGT1A1 Targeted Mutation Analysis for Irinotecan Response (81350); PG0398 Genetic Testing for Spinal Muscular Atrophy (81400, 81401, 81403, 81405); PG0412 Genetic Testing for Macular Degeneration (81401, 81405, 81408); PG0436 CYP2C19 & CYP2D6 Pharmacogenetic Testing (81225, 81226); PG0437 HLA-B1502 & HLA-B5701 Pharmacogenetic Testing (81381); & PG0438 Next Generation Sequencing (NGS) Tests for Advanced Cancer (81455, 81479); PG0442 Carrier Screening for Genetic Diseases. Updated title PG0298 from Afirma® Thyroid FNA Analysis to Molecular Markers in Fine Needle Aspirates of Thyroid Nodules. Removed PG0334 ThyroSeq® v.2 Next Generation Sequencing (added to PG0298). Removed Proprietary Laboratory Analyses (PLA) Codes (0001U-0044U) from this policy, refer to PG0417 Proprietary Laboratory Analyses (PLA) Codes. Added effective 1/1/18 new Proprietary MAA code 0011M as non-covered for all product lines. Added effective 4/1/18 new Proprietary MAA codes 0012M & 0013M as non- covered for all product lines. Codes 81250 & 81255 are now non-covered for Elite per CMS guidelines. Code 81438 is now covered with prior authorization for Elite per CMS guidelines. Policy reviewed and updated to reflect most current clinical evidence per The Technology Assessment Working Group (TAWG). 7/22/19: Added reference to genetic policy PG0453 Germline Multi-Gene Panel Testing. Updated references to the following genetic policies: PG0296 Comparative Genomic Hybridization (CGH)/Chromosomal Microarray Analysis (CMA), PG0067 Genetic Testing for Hereditary Breast and Ovarian Cancer syndrome (HBOC), PG0302 Genetic Testing for Lynch syndrome/Polyposis Syndromes, PG0336 PTEN Genetic Testing, PG0287 Non-Invasive Prenatal Screening (NIPS)/Cell-Free Screening for Fetal Aneuploidy, PG0387 Cystic Fibrosis Genetic Testing, PG0398 Genetic Testing for Spinal Muscular Atrophy, PG0360 Fragile X-Related Disorders, PG0411 Genetic Testing for Dystriphinopathies (Duchenne and Becker Muscular Dystrophy), PG0375 Molecular Cytogenetic Testing, and PG0442 Carrier Screening for Genetic Disease. Deleted specific gene names under 81400-81408, 81479 that were listed as not meeting medical necessity. Added CPT codes 81163-81167, 81329, 81336, and 81337 which all require prior authorization. Deleted CPT codes 81211, 81213, and 81214 to reflect changes in the CPT Coding Expert Manual. CPT codes 81410, 81412, 81430-81436, 81438, 81440, 81442, 81460, 81465, 81470, 81471 were Previously non-covered for HMO, PPO, Individual, Marketplace, and Elite plans. The policy was updated to reference PG0453 Germline Multi-Gene Panel Testing. Deleted reference to 0004M as medical policy PG0125 has been retired.

4/1/2020: Updated policy with all active genetic codes related to the policy, including CPT genetic PLA U-codes.

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REFERENCES/RESOURCES:

Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and services Ohio Department of Medicaid http://jfs.ohio.gov/ American Medical Association, Current Procedural Terminology (CPT®) and associated publications and services

Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System, HCPCS Release and Code Sets Industry Standard Review Hayes, Inc.

http://jfs.ohio.gov/

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