medical policy genetic testing - paramount … related to a heritable or acquired disorder. this can...

POLICY: PG0041

ORIGINAL EFFECTIVE: 01/01/12

LAST REVIEW: 01/25/18

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 genes 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 non-malignant genetic test does not always mean the patient will develop a disease. On the other hand, in some situation, a negative result does not guarantee the patient will not have a certain disorder.

POLICY 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 Breast and Ovarian Cancers (81162, 81211, 81212, 81213, 81214, 81215, 81216, 81217, 81432, 81433, 81445, 81455)

PG0125 DNA-Based Testing for Adolescent Idiopathic Scoliosis (AIS) (0004M)

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

PG0287 Cell-Free DNA Tests For Fetal Aneuploidy (81420, 81422, 81507, 0009M)

PG0296 Comparative Genomic Hybridization (CGH) (81228, 81229, S3870)

PG0298 Afirma® Thyroid FNA Analysis (81545)

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

PG0302 Genetic Testing for Colorectal Cancer (81201-81203, 81292-81301, 81317-81319, 81403)

PG0334 ThyroSeq® (81479, 81599)

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PG0336 PTEN Gene 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)

PG0360 Genetic Testing for FMR1 Mutations Including Fragile X Syndrome (81243, 81244)

PG0362 Vectra® DA (81490)

PG0363 CORUS® CAD (81493)

PG0364 Cancer Type ID (81540)

PG0367 Gene Expression Analysis for Prostate Cancer (81313, 81479, 81539, 81541, 81551, 0005U)

PG0368 GeneSight® Assay for Refractory Depression (81479)

PG0375 Molecular Cytogenetic Testing (88271)

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

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

PG0417 Proprietary Laboratory Analyses (PLA) Codes (0001U-0034U) HMO, PPO, Individual Marketplace Genetic testing codes that require prior authorization for HMO, PPO, Individual Marketplace: 81105, 81106, 81107, 81108, 81109, 81110, 81111, 81112, 81120, 81121, 81161, 81162, 81175, 81176, 81201, 81202, 81203, 81211-81217, 81225, 81226, 81227, 81228, 81229, 81235, 81238, 81242, 81243, 81244, 81247, 81248, 81249, 81251, 81258, 81259, 81269, 81283, 81287, 81288, 81292-81304, 81313, 81317-81319, 81321-81323, 81328, 81332, 81334, 81335, 81346, 81361, 81362, 81363, 81364, 81400-81408, 81413, 81414, 81420, 81432, 81435, 81436, 81439, 81445, 81448, 81450, 81455, 81479, 81504, 81509, 81519, 81599, G0452, S3865, S3866, S3870 Genetic testing codes that do not require prior authorization for HMO, PPO, Individual Marketplace: 81170, 81206-81208, 81210, 81218-81224, 81245, 81246, 81250, 81255-81256, 81261-81268, 81270, 81272, 81273, 81275, 81276, 81310, 81311, 81314-81316, 81340-81342, 81350, 81355, 81370-81383, 81437, 81528, 81545, 81595 Genetic testing codes that are non-covered for HMO, PPO, Individual Marketplace: 81200, 81205, 81209, 81230, 81231, 81232, 81240, 81241, 81252, 81253, 81254, 81257, 81260, 81290, 81291, 81324-81326, 81327, 81330, 81331, 81410, 81411, 81412, 81415-81417, 81422, 81425-81427, 81430, 81431, 81433, 81434, 81438, 81440, 81442, 81460, 81465, 81470, 81471, 81490, 81493, 81500, 81503, 81506-81512, 81525, 81535-81538, 81539, 81540, 0001M-0004M, 0006M, 0007M, 0008M, 0009M, S3800-S3853, S3854, S3861 Elite Genetic testing codes that require prior authorization for Elite: 81105, 81106, 81107, 81108, 81109, 81110, 81111, 81112, 81120, 81121, 81161, 81162, 81175, 81176, 81201, 81202, 81203, 81211-81217, 81225, 81226, 81227, 81228, 81229, 81235, 81238, 81247, 81248, 81249, 81283, 81287, 81288, 81292-81301, 81313, 81317-81319, 81321-81323, 81332, 81334, 81335, 81346, 81400-81408, 81413, 81414, 81420, 81432, 81435, 81436, 81439, 81445, 81448, 81450, 81455, 81479, 81493, 81504, 81509, 81519, 81599, 0008M, G0452, S3865, S3866, S3870 Genetic testing codes that do not require prior authorization for Elite: 81170, 81206-81208, 81210, 81218-81224, 81245, 81246, 81250, 81255-81256, 81261-81268, 81270, 81272, 81273, 81275, 81276, 81310, 81311, 81314-81316, 81340-81342, 81350, 81355, 81370-81383, 81437, 81490, 81525, 81528, 81540, 81545, 81595 Genetic testing codes that are non-covered for Elite: 81200, 81205, 81209, 81230, 81231, 81232, 81240, 81241, 81242, 81243, 81244, 81251, 81252, 81253, 81254, 81257, 81258, 81259, 81260, 81269, 81290, 81291, 81302-81304, 81324-81326, 81327, 81328, 81330, 81331, 81361, 81362, 81363, 81364, 81410, 81411, 81412, 81415-81417, 81422, 81425-81427, 81430, 81431, 81433, 81434, 81438, 81440, 81442, 81460, 81465, 81470, 81471, 81500, 81503, 81506-81512, 81535-81538, 81539, 0001M-0004M, 0006M, 0007M, 0009M, S3800-S3853, S3854, S3861 Advantage Genetic testing codes that require prior authorization for Advantage: 81105, 81106, 81107, 81108, 81109, 81110, 81111, 81112, 81120, 81121, 81161, 81162, 81175, 81176, 81200, 81201, 81202, 81203, 81205, 81209, 81211-81217, 81225, 81226, 81227, 81228, 81229, 81230, 81231, 81232, 81235, 81238, 81240, 81241, 81242, 81243, 81244, 81247, 81248, 81249, 81251, 81252, 81253, 81254, 81257,

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81258, 81259, 81260, 81269, 81283, 81287, 81288, 81290, 81291, 81292-81304, 81313, 81317-81319, 81321-81326, 81328, 81330-81332, 81334, 81335, 81346, 81361, 81362, 81363, 81364, 81400-81408, 81410, 81411, 81412, 81413, 81414, 81415-81417, 81420, 81422, 81425-81427, 81430-81436, 81438, 81439, 81440, 81442, 81445, 81448, 81450, 81455, 81460, 81465, 81470, 81471, 81479, 81509, 81519, 81539, 81599, G0452, S3854, S3865, S3866 Genetic testing codes that do not require prior authorization for Advantage: 81170, 81206-81208, 81210, 81218-81224, 81245, 81246, 81250, 81255-81256, 81261-81268, 81270, 81272, 81273, 81275, 81276, 81310, 81311, 81314-81316, 81327, 81340-81342, 81350, 81355, 81370-81383, 81437, 81528, 81545 Genetic testing codes that are non-covered for Advantage: 81490, 81493, 81500-81512, 81525, 81535-81538, 81540, 81595, 0001M-0004M, 0006M, 0007M, 0008M, 0009M, S3800-S3853, S3861, S3870 All Product Lines Cytogenetic studies (88230-88299) do not require prior authorization for all product lines. Code 88271 has a limit of 25 units per 365 days.

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:

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)

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.

Paramount covers cytogenetic studies (88230-88299) when they are reasonable and necessary for the diagnosis or treatment of the following conditions:

Genetic disorders (e.g., mongolism) in a fetus

Failure of sexual development

Chronic myelogenous leukemia

Acute leukemias lymphoid (FAB L1-L3), myeloid (FAB M0-M7), and unclassified

Mylodysplasia NOTE: Molecular cytogenetics; DNA probe each (88271) will have a limit of 25 units per 365 days. Modifier 91 will not allow for additional units.

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

Prior Authorization required


Prior Authorization

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CD61 [GPIIIa]) (eg, neonatal alloimmune thrombocytopenia [NAIT], post-transfusion purpura), gene analysis, common variant, HPA-1a/b (L33P) (Effective 01/01/2018 new code)

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) (Effective 01/01/2018 new code)



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) (Effective 01/01/2018 new code)



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) (Effective 01/01/2018 new code)



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)) (Effective 01/01/2018 new code)



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) (Effective 01/01/2018 new code)



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) (Effective 01/01/2018 new code)



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 (Effective 01/01/2018 new code)



Prior Authorization

required

81120 IDH1 (isocitrate dehydrogenase 1 [NADP+], soluble) (eg, glioma), common variants (eg, R132H, R132C) (Effective 01/01/2018 new code)



Prior Authorization

required

81121 IDH2 (isocitrate dehydrogenase 2 [NADP+], mitochondrial) (eg, glioma), common variants (eg, R140W, R172M) (Effective 01/01/2018 new code)



Prior Authorization

required

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

PG0411 Genetic Testing for 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 Breast and Ovarian Cancers

81170

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

Prior Authorization NOT required



81175 ASXL1 (additional sex combs like 1, transcriptional regulator) (eg, myelodysplastic syndrome,



Prior Authorization

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myeloproliferative neoplasms, chronic myelomonocytic leukemia), gene analysis; full gene sequence (Effective 01/01/2018 new code)

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) (Effective 01/01/2018 new code)



Prior Authorization

required

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

Non-covered 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 Colorectal Cancer

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


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)



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



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




81211

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


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


81213 BRCA1, BRCA2 (breast cancer 1 and 2) (e.g., hereditary breast and ovarian cancer) gene analysis; uncommon duplication/deletion variants


81214

BRCA1 (breast cancer 1) (e.g., hereditary breast and ovarian cancer) gene analysis; full sequence analysis and common duplication/deletion variants (i.e., exon 13 del 3.835kb, exon 13 dup 6kb, exon 14-20 del 26kb, exon 22 del 510bp, exon 8-9 del 7.1kb)


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], Prior Authorization Prior Authorization Prior

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alpha) (eg, acute myeloid leukemia), gene analysis, full gene sequence

NOT required NOT required Authorization NOT required

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)




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)



Prior Authorization

required

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)



Prior Authorization

required

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)

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) (Effective 01/01/2018 new code)



81231

CYP3A5 (cytochrome P450 family 3 subfamily A member 5) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *5 *6, *7) (Effective 01/01/2018 new code)



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)



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

81238 F9 (coagulation factor IX) (eg, hemophilia B), full gene sequence (Effective 01/01/2018 new code)



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) Prior Authorization Non-covered Prior

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

required 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 FMR1 Mutations Including Fragile X Syndrome

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 FMR1 Mutations Including Fragile X Syndrome

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-) (Effective 01/01/18 new code)



Prior Authorization

required

81248

G6PD (glucose-6-phosphate dehydrogenase)

(eg,hemolytic anemia, jaundice), gene analysis; known familial variant(s) (Effective 01/01/2018 new code)



Prior Authorization

required

81249 G6PD (glucose-6-phosphate dehydrogenase) (eg,hemolytic anemia, jaundice), gene analysis; full gene sequence (Effective 01/01/2018 new code)



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)




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


Non-covered Prior


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



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



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)



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




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)



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 (Effective 01/01/2018 new code)


Non-covered Prior


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 (Effective 01/01/2018 new code)


Non-covered Prior


81260 IKBKAP (inhibitor of kappa light polypeptide gene enhancer in B-cells, kinase complex-associated


Authorization

- 8 -



protein) (e.g., familial dysautonomia) gene analysis, common variants (e.g., 2507+6T>C, R696P)

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 (Effective 01/01/2018 new code)


Non-covered Prior


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




81272

KIT (v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog) (eg, gastrointestinal stromal tumor [GIST], acute myeloid leukemia, melanoma), gene analysis, targeted sequence analysis (eg, exons 8, 11, 13, 17, 18)




81273 KIT (v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog) (eg, mastocytosis), gene analysis, D816 variant(s)




81275 KRAS (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)




81280 Long QT syndrome gene analyses (e.g., KCNQ1, KCNH2, SCN5A, KCNE1, KCNE2, KCNJ2,

PG0280 Genetic Testing for Cardiac Conditions

- 9 -



CACNA1C, CAV3, SCN4B, AKAP, SNTA1, and ANK2); full sequence analysis (Deleted effective 12/31/2016)

81281

Long QT syndrome gene analyses (e.g., KCNQ1, KCNH2, SCN5A, KCNE1, KCNE2, KCNJ2, CACNA1C, CAV3, SCN4B, AKAP, SNTA1, and ANK2); known familial sequence variant (Deleted effective 12/31/2016)


81282

Long QT syndrome gene analyses (e.g., KCNQ1, KCNH2, SCN5A, KCNE1, KCNE2, KCNJ2, CACNA1C, CAV3, SCN4B, AKAP, SNTA1, and ANK2); duplication/deletion variants (Deleted effective 12/31/2016)


81283 IFNL3 (interferon, lambda 3) (eg, drug response), gene analysis, rs12979860 variant (Effective 01/01/2018 new code)

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

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

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



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


- 10 -



markers for mismatch repair deficiency (e.g., BAT25, BAT26), includes comparison of neoplastic and normal tissue, if performed

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


Non-covered Prior


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


Non-covered Prior


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


Non-covered Prior


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)




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


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

PG0336 PTEN Gene 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



- 11 -



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) (Effective 01/01/2018 new code)

Prior Authorization

required Non-covered

Prior Authorization

required

81330

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



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

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) (Effective 01/01/2018 new code)



Prior Authorization

required

81335 TPMT (thiopurine S-methyltransferase) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3) (Effective 01/01/2018 new code)



Prior Authorization

required

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)




81346

TYMS (thymidylate synthetase) (eg, 5-fluorouracil/5-FU drug metabolism), gene analysis, common variant(s) (eg,tandem repeat variant) (Effective 01/01/2018 new code)



Prior Authorization

required

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




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)


81361

HBB (hemoglobin, subunit beta) (eg, sickle cell anemia, beta thalassemia hemoglobinopathy); common variant(s) (eg, HbS, HbC, HbE) (Effective 01/01/2018 new code)


Non-covered Prior


81362 HBB (hemoglobin, subunit beta) (eg, sickle cell anemia, beta thalassemia hemoglobinopathy); known familial variant(s) (Effective 01/01/2018 new code)


Non-covered Prior


81363 HBB (hemoglobin, subunit beta) (eg, sickle cell anemia, beta thalassemia hemoglobinopathy); duplication/deletion variant(s) (Effective 01/01/2018


Non-covered Prior


- 12 -



new code)

81364 HBB (hemoglobin, subunit beta) (eg, sickle cell anemia, beta thalassemia hemoglobinopathy); full gene sequence (Effective 01/01/2018 new code)


Non-covered Prior


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




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 ALL REQUIRE PRIOR AUTHORIZATION

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

These genes do not meet medical necessity (this list may not be all-inclusive):

ABCC8, F1388del

ACADM, K304E

AGTR1, 1166A>C

BCKDHA, Y438n

CCR5, del

CLRN1, N48K

DPYD, IVS14+1G>A

FGFR1, P252R

FGFR3, P250R

- 13 -



FKTN, retro ins v

GNE, M712T

HPA-6

HPA-9

IVD, A282V

LCT, 13910 C>T

NEB, exon 55

PCDH15, R245X

SHOC2, S2G

SLCO1B1, V174A

SMN1, exon 7 del

SRY, fgs

TOR1A, var

81401 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) 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)



ABCC8, cv

ACADM, cv

ADRB2, cv

AFF2, detect abn

APOB, cv

APOE, cv

AR, alleles

ATN1

ATXN1

ATXN10

ATXN2

ATXN3

ATXN7

ATXN8OS

CACNA1A

CBS, cv

CFH_ARMS2, cv

CNBP

CSTB

CYP3A4, cv

CYP3A5, cv

DEK/NUP214, ta

DMPK, detect eval

EML4_ALK, ta or ia

ETV6/NTRK3

EWSR1_ATF1

FGFR3, cv

FLG, cv

FUS/DDIT3

FXN, alleles

GALC, cv

GALT, cv

H19, ma

HBB, cv

HTT, alleles

KCNQ1OT1, ma

- 14 -



LRRK2, cv

MED12, cv

MEG3_DLK1, ma

MLL_AFF1, ta qual quan

MLL_MLLT3, ta, qual quan

MT-ATP6, cv

MT-ND4, MT-ND6, cv

MT-ND5, cv

MT-RNR1, cv

MT-TK, cv

MT-TL1, cv

MT-TS1_MT-RNR1, cv

NOD2

NPM1_ALK, ta

PABPN1

PPP2R2B

PRSS1, cv

PYGM, cv

SEPT9, ma

SMN1_SMN2, dosage

SMN1_SMN2, dup_del

SS18_SSX1, ta

SS18_SSX2, ta

TBP, aa

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])



C18q

C1p-/19q, del

COL1A1/PDGFB, mbp qual quan

CYP21A2, cv

ESR1_PGR, ratio

MEFV, cv

MPL, cv

TRD, delta

UPD, str

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)



ACADS, kfv

ACADVL, kfv

ACTA2, kfv

ANG, fgs

ARX, d_d

BTD, kfv

CASR, kfv

CDH1, kfv

CEL, exon 11

COL1A2, kfv

CTNNB1, tsa

CTNNB1, tsa

CYP21A2, kfv

- 15 -



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)

DAZ_SRY, cdel

DHCR7, kfv

DLAT, kfv

DLD, kfv

DNMT3A, tsa

ENG, kfv

F12, ts ex 9

F9, kfv

FBN1, kfv

FGFR2, kfv

FGFR3, exon 7

FGFR3, kfv

FH, kfv

GAA, kfv

GALT, kfv

GJB1, fgs

GLA, kfv

GNAQ, cv

GRN, kfv

HBB, dup_del

HEXA, kfv

HRAS, exon 2

JAG1, kfv

KCNC3, tsa

KCNJ11, fgs

KCNJ2, fgs

Killer cell imm-like receptor

KRAS, exon 3

KRAS, kfv

LDLR, kfv

MAPT, kfv

MC4R, fgs

MECP2, kfv

MEFV, kfv

MEN1, kfv

MICA, cv

MMACHC, kfv

MPL, exon 10

MT-RNR1, fgs

MT-RNR1_MT-TS1, kfv

MT-TS1, fgs

NDP, d_d

NHLRC1, fgs

NR0B1, kfv

PC, kfv

PDHA1, kfv

PDHB, kfv

PDHX, kfv

PHOX2B, dup_del

PLN, fgs

PRSS1, kfv

PTPN11, kfv

- 16 -



RHD, del a

RHD, maternal

SDH, kfv

SH2D1A, dup_del

SMN1, kfv

TGFBR1, kfv

TGFBR2, kfv

TTR, kfv

TWIST, kfv

TWIST1, dup_del

UBA1, tsa

VKORC1, kfv

81404 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) 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)



ACADS, tsa

AFF2, characterize

AQP2, fgs

ARX, fgs

AVPR2, fgs

BBS10, fgs

BTD, fgs

C10orf2, fgs

CAV3, fgs

CD40LG, fgs

CLRN1, fgs

COX6B1, fgs

CPT2, fgs

CRX, fgs

CSTB, fgs

CYP1B1, fgs

DMPK, characterize alleles

EGR2, fgs

EMD, Dup_del

EPM2A, fgs

FGF23, fgs

FGFR2, tsa

FGFR3, tsa

FHL1, fgs

FKRP, fgs

FOXG1, fgs

FSHMD1A, ab a

FSHMD1A, hap

FXN, fgs

GH1, fgs

GP1BB, fgs

HBA1_HBA2, dup_del

HBB, fgs

HNF1B, dup_del

HRAS, fgs

HSD11B2, fgs

HSD3B2, fgs

- 17 -



HSPB1, fgs

INS, fgs

KCNJ1, fgs

KCNJ10, fgs

LITAF, fgs

MEFV, fgs

MEN1, dup_del

MMACHC, fgs

MPV17, dup_del

NDP, fgs

NDUFA1, fgs

NDUFAF2, fgs

NDUFS4, fgs

NIPA1, fgs

NLGN4X, dup_del

NPC2, fgs

NR0B1, fgs

PDX1, fgs

PHOX2B, fgs

PIK3CA, tsa

PLP1, Dup_del

PQBP1, Dup_del

PRNP, fgs

PROP1, fgs

PRPH2, fgs

RAF1, tsa

RHO, fgs

RP1, fgs

SCN1B, fgs

SCO2, fgs

SDHC, dup_del

SDHD, fgs

SGCG, dup_del

SH2D1A, fgs

SLC16A2, dup_del

SLC25A20, dup_del

SLC25A4, fgs

SOD1, fgs

SPINK1, fgs

STK11, dup_del

TACO1, fgs

THAP1, fgs

TOR1A, fgs

TP53, 2-5 exons

TTPA, fgs

TTR, fgs

TWIST1, fgs

TYR, fgs

USH1G, fgs

VWF, tsa

ZEB2, dup_del

ZNF41, fgs

- 18 -



81405 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) 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)



ABCD1, fgs

ACADS, fgs

ACTA2, fgs

ACTC1, fgs

ANKRD1, fgs

APTX, fgs

AR, fgs

ARSA, fgs

BCKDHA, fgs

BCS1L, fgs

BMPR2, dup_del

CASQ2, fgs

CASR, fgs

CDKL5, dup_del

CHRNA4, fgs

CHRNB2, fgs

COX10, fgs

COX15, fgs

CYP11B1, fgs

CYP17A1, fgs

CYP21A2, fgs

DBT, dup_del

DCX, fgs

DES, fgs

DFNB59, fgs

DGUOK, fgs

DHCR7, fgs

EIF2B2, fgs

EMD, fgs

ENG, dup_del

EYA1, dup_del

F9, fgs

FGFR1, fgs

FH, fgs

FKTN, fgs

FTSJ1, dup_del

GABRG2, fgs

GCH1, fgs

GDAP1, fgs

GFAP, fgs

GHR, fgs

GHRHR, fgs

GLA, fgs

HBA1_HBA2, fgs

HNF1A, fgs

HNF1B, fgs

HTRA1, fgs

IDS, fgs

IL2RG, fgs

- 19 -



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)

ISPD, fgs

KRAS, fgs

LAMP2, fgs

LDLR, dup_del

MMAA, fgs

MMAB, fgs

MPI, fgs

MPV17, fgs

MPZ, fgs

MTM1, dup_del

MYL2, fgs

MYL3, fgs

MYOT, fgs

NDUFS7, fgs

NDUFS8, fgs

NDUFV1, fgs

NEFL, fgs

NF2, dup_del

NLGN3, fgs

NLGN4X, fgs

NPHP1, dup_del

NPHS2, fgs

NSD1, dup_del

OTC, fgs

PAFAH1B1, dup_del

PARK2, dup_del

PCCA, dup_del

PCDH19, fgs

PDHA1, dup_del

PDHB, fgs

PINK1, fgs

PLP1, fgs

POU1F1, fgs

PQBP1, fgs

PRX, fgs

PSEN1, fgs

RAB7A, fgs

RAI1, fgs

REEP1, fgs

RPS19, fgs

RRM2B, fgs

SCO1, fgs

SDHB, fgs

SDHC, fgs

SGCA, fgs

SGCB, fgs

SGCD, fgs

SGCE, dup_del

SGCG, fgs

SHOC2, fgs

SHOX, fgs

SIL1, fgs

- 20 -



SLC16A2, fgs

SLC22A5, fgs

SLC25A20, fgs

SLC2A1, fgs

SMAD4, dup_del

SMN1, fgs

SPAST, dup_del

SPG7, dup_del

SPRED1, fgs

STAT3, tsa

STK11, fgs

SURF1, fgs

TARDBP, fgs

TBX5, fgs

TCF4, dup_del

TGFBR1, fgs

TGFBR2, fgs

THRB, fgs_tsa >5 exons

TK2, fgs

TNNC1, fgs

TNNI3, fgs

TP53, fgs or tsa >5 exons

TPM1, fgs

TSC1, dup_del

TYMP, fgs

WT1, fgs

ZEB2, fgs

81406 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) 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)



ACADVL, fgs

ACTN4, fgs

AFG3L2, fgs

AIRE, fgs

ALDH7A1, fgs

ANO5, fgs

APP, fgs

ASS1, fgs

ATL1, fgs

ATP1A2, fgs

ATP7B, fgs

BBS1, fgs

BBS2, fgs

BCKDHB, fgs

BEST1, fgs

BMPR2, fgs

BRAF, fgs

BSCL2, fgs

BTK, fgs

CACNB2, fgs

CAPN3, fgs

CBS, fgs

- 21 -



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)

CDH1, fgs

CDKL5, fgs

CLCN1, fgs

CLCNKB, fgs

CNTNAP2, fgs

COL6A2, dup_del

CPT1A, fgs

CRB1, fgs

CREBBP, dup_del

DBT, fgs

DLAT, fgs

DLD, fgs

DSC2, fgs

DSG2, fgs

DSP, fgs

EFHC1, fgs

EIF2B3, fgs

EIF2B4, fgs

EIF2B5, fgs

ENG, fgs

EYA1, fgs

F8, dup_del

FAH, fgs

FASTKD2, fgs

FIG4, fgs

FTSJ1, fgs

FUS, fgs

GAA, fgs

GALC, fgs

GALT, fgs

GARS, fgs

GCDH, fgs

GCK, fgs

GLUD1, fgs

GNE, fgs

GRN, fgs

HADHA, fgs

HADHB,fgs

HEXA, fgs

HLCS, fgs

HNF4A, fgs

IDUA, fgs

INF2, fgs

IVD, fgs

JAG1, dup_del

JUP, fgs

KAL1, fgs

KCNH2, fgs

KCNQ1, fgs

KCNQ2, fgs

LDB3, fgs

LDLR, fgs

- 22 -



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)

LEPR, fgs

LHCGR, fgs

LMNA, fgs

LRP5, fgs

MAP2K1, fgs

MAP2K2, fgs

MAPT, fgs

MCCC1, fgs

MCCC2, fgs

MFN2, fgs

Microarray, Neoplasia

MTM1, fgs

MUT, fgs

MUTYH, fgs

NDUFS1, fgs

NF2, fgs

NOTCH3, tsa

NPC1, fgs

NPHP1, fgs

NSD1, fgs

OPA1, dup_del

OPTN, fgs

PAFAH1B1, fgs

PAH, fgs

PALB2, fgs

PARK2, fgs

PAX2, fgs

PC, fgs

PCCA, fgs

PCCB, fgs

PCDH15, dup_del

PCSK, fgs

PDHA1, fgs

PDHX, fgs

PHEX, fgs

PKD2, fgs

PKP2, fgs

PNKD, fgs

POLG, fgs

POMGNT1, fgs

POMT1, fgs

POMT2, fgs

PRKAG2, fgs

PRKCG, fgs

PSEN2, fgs

PTPN11, fgs

PYGM, fgs

RAF1, fgs

RPE65, fgs

RYR1, tsa

SCN4A, fgs

SCNN1A, fgs

- 23 -



SCNN1B, fgs

SCNN1G, fgs

SDHA, fgs

SETX, fgs

SGCE, fgs

SH3TC2, fgs

SLC26A4, fgs

SLC37A4, fgs

SLC9A6, fgs

SMAD4, fgs

SOS1, fgs

SPAST, fgs

SPG7, fgs

STXBP1, fgs

TAZ, fgs

TCF4, fgs

TH, fgs

TMEM43, fgs

TNNT2, fgs

TRPC6, fgs

TSC1, fgs

TSC2, dup_del

UBE3A, fgs

UMOD, fgs

VWF, etsa

WAS, fgs

81407 81407

Molecular pathology procedure, Level 8 (e.g., analysis of 26-50 exons by DNA sequence analysis, mutation scanning or duplication/deletion variants of >50 exons, sequence analysis of multiple genes on one platform) SCN1A (sodium channel, voltage-gated, type 1, alpha subunit) (e.g., generalized epilepsy with febrile seizures), full gene sequence Molecular pathology procedure, Level 8 (e.g., analysis of 26-50 exons by DNA sequence analysis, mutation scanning or duplication/deletion variants of >50 exons, sequence analysis of multiple genes on one platform) SCN1A (sodium channel, voltage-gated, type 1, alpha subunit) (e.g., generalized epilepsy with febrile seizures), full gene sequence



ABCC8, fgs

AGL, fgs

AHI1, fgs

ASPM, fgs

CACNA1A, fgs

CHD7, fgs

COL4A4, fgs

COL4A5, dup_del

COL6A1, fgs

COL6A2, fgs

COL6A3, fgs

CREBBP, fgs

F8, fgs

JAG1, fgs

KDM5C, fgs

KIAA0196, fgs

L1CAM, fgs

LAMB2, fgs

MYBPC3, fgs

MYH6, fgs

MYH7, fgs

MYO7A , fgs

NOTCH1, fgs

- 24 -



NPHS1, fgs

OPA1, fgs

PCDH15, fgs

PKD1, fgs

PLCE1, fgs

SCN1A, fgs

SCN5A, fgs

SLC12A1, fgs

SLC12A3, fgs

SPG11, fgs

SPTBN2, fgs

TMEM67, fgs

TSC2, fgs

USH1C, fgs

VPS13B, dup_del

WDR62 , fgs

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



ABCA4, fgs

ATM, fgs

CDH23, fgs

CEP290, fgs

COL1A1, fgs

COL1A2, fgs

COL4A1, fgs

COL4A3, fgs

COL4A5, fgs

DMD, fgs

DYSF, fgs

FBN1, fgs

ITPR1, fgs

LAMA2, fgs

LRRK2, fgs

MYH11, fgs

NEB, fgs

NF1, fgs

PKHD1, fgs

RYR1, fgs

RYR2, fgs or tsa > 50

USH2A, fgs

VPS13B, fgs

VWF, fgs

81479

Unlisted molecular pathology procedure


These genes do not meet medical necessity (this list may not be all-inclusive): Arrhythmogenic Right Ventricular

Dysplasia/Cardiomyopathy (ARVD/C) BLUEPRINT®

HTTLPR myRisk

4q25-AF

9p21

- 25 -



81479


ABCB1, cv

ACADM, fgs

ACADM, panel

ACADVL, d_d

ACADVL, panel

ACSL4, fgs

ACVRL1, d_d

ACVRL1, ENG

ACVRL1, ENG, kfv

ACVRL1, ENG, SMAD4

ADAMTS13

ADRA2A

AFP

AGA

AGXT

ALDOB

ALG6, fgs

ALPL, fgs

ALPL, kfv

ANK3

ANKK1

APC, panel

APP, panel

ARSB, fgs

AR-V7

ARX, panel

ASHKENAZI JEWISH PNL, < 9

ASXL, dup_del

ASXL1, fgs

ASXL1, tsa

ATP7A, fgs

ATRX

AZF

BAALC

BAG3

BARD1

BCOR, tsa

BDNF

BLM, fgs

BMPR1A

BMPR2, panel

BRAF, panel

BSND, fgs

C9ORF72

CACNA1C

CALR

CAPN3, dup_del

CARD11

CASK, fgs

CBL, tsa

CC2D2A, fgs

CCM, panel

- 26 -



81479


CCM2

CCM2, panel

CCM3

CD79B

CDH1, dup_del

CDH1, panel

CDH1, tsa

CDKL5, panel

CDKN1C

CFTR, panel

CFTR, PRSS1, SPINK1

CHEK2, kfv

CHEK2, panel

CLLU1

CLN3

COL3A1, dup_del

COL3A1, fgs

COL4A5, panel

COMT

CPOX, fgs

CPOX, kfv

CRTAP, kfv

CRYAB

CSF3R, ma

CSF3R, tsa

CTRC

CTSA, fgs

CYP1A1

CYP1A2

CYP1B1, tsa

CYP21A2, panel

CYP2B6

CYP2C8

CYP3A4, CYP3A5

CYP4F2

CYP7B1, fgs

DDR2

DMD, panel

DMPK, panel

DNM2, fgs

DRD, panel

DRD1

DRD2

DRD4

EDA, tsa

EGFR, KRAS, ALK

EGFR, KRAS, BRAF

EGFR, tsa

EGFRvIII

EIF2B1, fgs

EIF2B2, panel

ELANE

- 27 -



81479


EPOR

ETV6

EZH2

F2, F5

F2, F5, MTHFR

FBN1, dup_del

FBN1, panel

FBN1, tsa

FECH, fgs

FECH, kfv

FGD1

FGD4, fgs

FGF8, fgs

FGFR panel

FKBP10, fgs

FKBP10, kfv

FKBP5

FKTN, 1167

FLCN, fgs

FMR1, panel

FOXG1, dup_del

FOXG1, panel

FUCA1, fgs

FXN, panel

G6PD

GAA, cv

GABRA6

GALC, panel

GALNS, fgs

GATA1

GBA, fgs

GCH1, del

GCK, panel

GJB, panel

GJC2, fgs

GLB1, fgs

GLI3, fgs

GNA11

GNAS

GNRH1, fgs

GNRHR, fgs

GNS, fgs

GRIK1

GRIK4

GYS2, fgs

HADHA, tsa

HAX1

HBA1, fgs

HGSNAT, fgs

HIF2A

HLA, hybrid

HNF1A, panel

- 28 -



81479


HNF1B, panel

HNF4A, panel

HOXB13

HP, panel

HP1

HSPB8, fgs

HTR2, panel

HTR2A, cv

HTR2C, cv

IFITM5, fgs

IFNL3

IGHMBP2

INSR

ITGA2

JAG1, panel

JAK2, panel

JAK3

KDM6A, fgs

KEL

KIF5A, fgs

KIF6

KISS1R, fgs

KIT, fgs

KMT2A/MLL-PTD

KMT2D, sa

KRAS, panel

KRAS, tsa

KRIT1, dup_del

KRIT1, fgs

KRIT1, panel

L1CAM, panel

LCHAD

LMNA, dup_del

LPA

LPA, ASA

MAN2B

MANBA

MCCC1, MCCC2, panel

MCM6

MCPH1, fgs

MCT8

MECP2, panel

MEF2C, del

MEF2C, fgs

MEF2C, panel

MEFV, panel

MEN1, panel

MET

Microarray, panel

MID1, fgs

MLL

MLYCD, fgs

- 29 -



81479


MLYCD, kfv

MTMR2, fgs

MUTYH, dup_del

MUTYH, panel

MYH3, exon 17

MYLK, fgs

NAA10

NAGLU, fgs

NAT2

NBN1

NCF1

NDRG1, fgs

NET

NEU1, fgs

NF1, dup_del

NF1, panel

NF2, panel

NPC1_NPC2, fgs

NPC1_NPC2, kfv

NSD1, panel

NTRK1, fgs

OPHN1, fgs

OPRD1

OPRK1

OPRM1

OTC, dup_del

OTC, panel

OXCT1, fgs

P3H1, kfv

PABP2

PALB2, panel

PARK7, dup_del

PARK7, fgs

PAX6, panel

PDCD10, dup_del

PDCD10, fgs

PDCD10, panel

PHD2

PHF6, fgs

PINK1, dup_del

PLOD1

PLOD2, fgs

PLP1, panel

PMM2, fgs

PMP22, panel

POLG, tsa

PRKG1, fgs

PROK2, fgs

PROKR2, fgs

PRRT2, fgs

PTCH

PTEN, tsa

- 30 -



81479


PTPN11, tsa

PTPN22

RAD21, tsa

RAS, panel

RASA1

RB1

REEP1, dup_del

RhCE

RPL19

RPL26

RPS6KA3, fgs

RRM1

RUNX1, tsa

SBDS

SBF2, fgs

SCA1

SCA10

SCA12

SCA13, tsa

SCA14

SCA17

SCA2

SCA5

SCA6

SCA7

SCA8

SCN1A, dup_del

SCN1A, panel

SDH, kfv

SDH, panel

SDHAF2, fgs

SDHB, panel

SDHC, panel

SDHD, panel

SEPT9, fgs

SEPT9, panel

SERPINA1, fgs

SERPINA1, panel

SERPINA10, rs2232698

SERPING1, kfv

SETBP1, tsa

SF3B1, tsa

SFTPB

SFTPC

SGCA, dup_del

SGSH, fgs

SHANK2, fgs

SHANK3

shox, panel

SLC22A5, dup_del

SLC22A5, panel

SLC25A13, fgs

- 31 -



81479


SLC47A1

SLC6A4

SLC6A8, fgs

SLCO1B1, tsa

SLCO2A1, kfv

SMAD3, fgs

SMAD3, kfv

SMAD4, kfv

SMAD4, panel

SMC1A, fgs

SMC3, tsa

SMN1_SMN2, fgs

SMN1_SMN2, panel

SMPD1, fgs

SNCA, dup_del

SNCA, fgs

SPAST, panel

SPG21, kfv

SPRED1, dup_del

SPTLC1, fgs

SPTLC2, fgs

SRSF2, tsa

STAG2, tsa

STAR

STK11, panel

STR, panel

SULT4A1

SYNGAP1, fgs

SYT, panel

SYT-SSX, ta

TACI, fgs

TACR3, fgs

TBX5, panel

TERT/TERC

TET2, fgs

TET2, tsa

TGFB2, kfv

TGFBR1/TGFBR2

TMEM216, cv

TMEM216, fgs

TP53, panel

TRB, panel

TRPV4, fgs

TSC1, TSC2

U2AF1, tsa

UBQL1

UBQLN2

UGT2B15, tsa

UGT2B7, tsa

VCP

VEGF, fgs

VEGF, tsa

- 32 -



VEGFR2

VWF, D1472H

VWF, panel

WNK1, fgs

WRAP53

WT1, tsa

YARS, fgs

ZAP70, ma

ZFYVE26, fgs

ZRSR2, tsa

Molecular Multianalyte Assays (MAA)

81410

Aortic dysfunction or dilation (eg, Marfan syndrome, Loeys Dietz syndrome, Ehler Danlos syndrome type IV, arterial tortuosity syndrome); genomic sequence analysis panel, must include sequencing of at least 9 genes, including FBN1, TGFBR1, TGFBR2, COL3A1, MYH11, ACTA2, SLC2A10, SMAD3, and MYLK



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



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 (Effective 01/01/17 new code)


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,


- 33 -



including KCNH2 and KCNQ1 (Effective 01/01/17 new code)

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



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 Cell-Free DNA Tests 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 (Effective 01/01/17 new code)


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


81433

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



- 34 -



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

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

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

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

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




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)


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



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


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) (Effective 01/01/2018 new code)

Prior Authorization

required

Prior Authorization

required

Prior Authorization

required

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



Prior Authorization

required

- 35 -



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



Non-covered

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


81508 Fetal congenital abnormalities, biochemical assays of Non-covered Non-covered Non-covered

- 36 -



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


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 (Effective 01/01/2018 new code)


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 (Effective 01/01/2018 new code)


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 PG0364 Cancer Type ID

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

81541

Oncology (prostate), mRNA gene expression profiling by real-time RT-PCR of 46 genes (31 content and 15 housekeeping), utilizing formalin-fixed paraffin embedded tissue, algorithm reported as a disease-specific mortality risk score (Effective 01/01/2018 new code)


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 (Effective 01/01/2018 new code)


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

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


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


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 Prior Authorization NOT required

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


88241 Thawing and expansion of frozen cells, each aliquot Prior Authorization NOT required

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 Prior Authorization NOT required

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


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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

Limit of 25 units/365 days


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


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


88285 Chromosome analysis; additional cells counted, each study


88289 Chromosome analysis; additional high resolution study


88291 Cytogenetics and molecular cytogenetics, interpretation and report


88299 Unlisted cytogenetic study Prior Authorization NOT required Proprietary Laboratory Analyses (PLA) Codes

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

PG0417 Proprietary Laboratory Analyses (PLA) Codes

0002U

Oncology (colorectal), quantitative assessment of three urine metabolites (ascorbic acid, succinic acid and carnitine) by liquid chromatography with tandem mass spectrometry (LC-MS/MS) using multiple reaction monitoring acquisition, algorithm reported as likelihood of adenomatous polyps


0003U

Oncology (ovarian) biochemical assays of five proteins (apolipoprotein A-1, CA 125 II, follicle stimulating hormone, human epididymis protein 4, transferrin), utilizing serum, algorithm reported as a likelihood score


0004U

Infectious disease (bacterial), DNA, 27 resistance genes, PCR amplification and probe hybridization in microarray format (molecular detection and identification of AmpC, carbapenemase and ESBL coding genes), bacterial culture colonies, report of genes detected or not detected, per isolate


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

PG0417 Proprietary Laboratory Analyses (PLA) Codes PG0367 Gene Expression Analysis for Prostate Cancer

0006U

Prescription drug monitoring, 120 or more drugs and substances, definitive tandem mass spectrometry with chromatography, urine, qualitative report of presence (including quantitative levels, when detected) or absence of each drug or substance with description and severity of potential interactions, with identified substances, per date of service


0007U

Drug test(s), presumptive, with definitive confirmation of positive results, any number of drug classes, urine, includes specimen verification including DNA authentication in comparison to buccal DNA, per date of service


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0008U

Helicobacter pylori detection and antibiotic resistance, DNA, 16S and 23S rRNA, gyrA, pbp1, rdxA and rpoB, next generation sequencing, formalin-fixed paraffin-embedded or fresh tissue, predictive, reported as positive or negative for resistance to clarithromycin, fluoroquinolones, metronidazole, amoxicillin, tetracycline and rifabutin


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


0010U Infectious disease (bacterial), strain typing by whole genome sequencing, phylogenetic-based report of strain relatedness, per submitted isolate


0011U

Prescription drug monitoring, evaluation of drugs present by LC- MS/MS, using oral fluid, reported as a comparison to an estimated steady-state range, per date of service including all drug compounds and metabolites


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)


0015U

Drug metabolism (adverse drug reactions), DNA, 22 drug metabolism and transporter genes, real-time PCR, blood or buccal swab, genotype and metabolizer status for therapeutic decision support


0016U

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


0017U

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


0018U

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


0019U

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


0020U

Drug test(s), presumptive, with definitive confirmation of positive results, any number of drug classes, urine, with specimen verification including DNA authentication in comparison to buccal DNA, per date of service


0021U

Oncology (prostate), detection of 8 autoantibodies (ARF 6, NKX3-1, 5’- UTR-BMI1, CEP 164, 3’-UTR- Ropporin, Desmocollin, AURKAIP- 1, CSNK2A2), multiplexed immunoassay and flow cytometry serum, algorithm reported as risk score


0022U Targeted genomic sequence analysis panel, non- PG0417 Proprietary Laboratory Analyses (PLA) Codes

- 40 -



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

0023U

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


0024U Glycosylated acute phase proteins (GlycA), nuclear magnetic resonance spectroscopy, quantitative


0025U Tenofovir, by liquid chromatography with tandem mass spectrometry (LC-MS/MS), urine, quantitative


0026U

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


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


0028U

CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, copy number variants, common variants with reflex to targeted sequence analysis


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)


Proprietary MAA

0001M

Infectious disease, HCV, 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


0002M

Liver disease, ten biochemical assays (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, haptoglobin, AST, glucose, total cholesterol and triglycerides) utilizing serum, prognostic algorithm reported as quantitative scores for fibrosis, steatosis and alcoholic steatohepatitis (ASH)


0003M Liver disease, ten biochemical assays (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, haptoglobin, AST, glucose, total cholesterol


- 41 -



and triglycerides) utilizing serum, prognostic algorithm reported as quantitative scores for fibrosis, steatosis and nonalcoholic steatohepatitis (NASH)

0004M Scoliosis, DNA analysis of 53 single nucleotide polymorphisms (SNPs), using saliva, prognostic algorithm reported as a risk score

PG0125 DNA-Based Testing for Adolescent Idiopathic Scoliosis (AIS)

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


0008M

Oncology (breast), mRNA analysis of 58 genes using hybrid capture, on formalin-fixed paraffin-embedded (FFPE) tissue, prognostic algorithm reported as a risk score (Deleted code effective 12/31/2017)


0009M Fetal aneuploidy (trisomy 21, and 18) DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy


0010M

Oncology (High-Grade Prostate Cancer), biochemical assay of four proteins (Total PSA, Free PSA, Intact PSA and human kallikrein 2 [hK2]) plus patient age, digital rectal examination status, and no history of positive prostate biopsy, utilizing plasma, prognostic algorithm reported as a probability score (Deleted effective 12/31/2016)


HCPCS CODES

G0452 Molecular pathology procedure; physician interpretation and report



Prior Authorization

required

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


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


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TAWG REVIEW DATES: 02/26/2016, 03/25/2016, 04/22/2016, 09/23/2016, 03/24/2017 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

- 43 -

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).

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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