Aetna · Clinical coverage policy

Aetna Tumor Markers coverage criteria

Aetna CPB 0352 covers a large catalog of tumor markers (serum proteins, immunohistochemistry/expression markers, somatic gene mutations and rearrangements, MSI/mismatch-repair testing, and named molecular panels) as medically necessary only when matched to a specific listed cancer type and clinical use (e.g., AFP for hepatocellular carcinoma, CA-125 for ovarian masses, BCR/ABL for CML, MSI/dMMR for the enumerated cancers, and breast/prostate genomic risk tests under defined receptor-status and risk criteria). The gate is strict marker-to-indication matching plus, for breast and prostate genomic tests, limits on using more than one test type or repeat testing; a long list of named assays and circulating markers (including multi-cancer early detection and most liquid biopsies outside small NSCLC panels) is considered experimental, investigational, or unproven.

Policy CPB 0352 · Effective · Verify against the current Aetna policy before submitting — view source policy.

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Aetna

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CPB 0352

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Effective

January 1, 2026

This page reflects the coverage criteria captured from Aetna policy CPB 0352 and may not include every criterion, exception, or code — verify the complete bulletin before submitting.

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The covered path, the next step to get it approved, and the specific way it denies — built only from this policy.

When does Aetna cover Tumor Markers (CPT 84152), and what gets it denied?

Path
Aetna CPB 0352 covers a large catalog of tumor markers (serum proteins, immunohistochemistry/expression markers, somatic gene mutations and rearrangements, MSI/mismatch-repair testing, and named molecular panels) as medically necessary only when matched to a specific listed cancer type and clinical use (e.g., AFP for hepatocellular carcinoma, CA-125 for ovarian masses, BCR/ABL for CML, MSI/dMMR for the enumerated cancers, and breast/prostate genomic risk tests under defined receptor-status and risk criteria). The gate is strict marker-to-indication matching plus, for breast and prostate genomic tests, limits on using more than one test type or repeat testing; a long list of named assays and circulating markers (including multi-cancer early detection and most liquid biopsies outside small NSCLC panels) is considered experimental, investigational, or unproven. Coverage criteria include: 1p19q codeletion: medically necessary for astrocytomas and gliomas; ALK expression: medically necessary for pancreatic adenocarcinoma, pediatric Hodgkin's lymphoma, inflammatory myofibroblastic tumor (IMT) with ALK translocation, breast implant-associated ALCL, peripheral T-cell lymphoma, uterine sarcoma; ALK gene fusion: medically necessary as a biomarker in non-small cell lung cancer; ALK gene rearrangement: medically necessary for diffuse large B cell lymphoma, anaplastic thyroid carcinoma, primary cutaneous CD30+ T-cell lymphoproliferative disorders, post-transplant lymphoproliferative disorder, non-small cell lung cancer; BCR/ABL: medically necessary for acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), B-cell lymphoblastic lymphoma, chronic myelogenous leukemia (CML), suspected myeloproliferative neoplasm; CBFB: medically necessary for acute myeloid leukemia; FIP1L1-PDGFRA fusion oncogene: medically necessary for systemic mastocytosis with peripheral blood eosinophilia; FIP1L1-PDGFRA gene rearrangements: medically necessary for myeloid/lymphoid neoplasms with peripheral blood eosinophilia and tyrosine kinase fusion genes; PML/RARA: medically necessary for acute promyelocytic leukemia; APC: medically necessary for familial adenomatous polyposis (when criteria met) and desmoid fibromatosis; BRAF V600 mutation: medically necessary for indeterminate thyroid nodules, hairy cell leukemia, gastrointestinal stromal tumors, colorectal cancer, Lynch syndrome, non-small cell lung cancer, thyroid carcinoma, infiltrative glioma, pancreatic adenocarcinoma, melanoma; CALR (calreticulin): medically necessary for chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndrome, myeloproliferative neoplasms; EZH2: medically necessary for myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN) to evaluate for higher-risk mutations in primary myelofibrosis (PMF); FLT3 gene mutation: medically necessary for acute lymphoblastic leukemia, acute myeloid leukemia (AML), myelodysplastic syndromes, myeloproliferative neoplasms, myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase fusion genes; IDH1 and IDH2: medically necessary for acute myeloid leukemia (AML), chondrosarcoma, chronic myeloid leukemia (CML), glioma or glioblastoma, myelodysplastic syndromes, myeloproliferative neoplasms; IDH1, IDH2, and TERT mutation analysis: medically necessary for glioma or myelodysplastic syndrome (MDS); KRAS: medically necessary for metastatic colorectal cancer, myelodysplastic syndromes, non-small cell lung cancer, pancreatic adenocarcinoma, uterine sarcoma; MDM2 (murine double minute 2): medically necessary for uterine sarcoma and soft tissue sarcoma; MLH1 tumor promoter hypermethylation: medically necessary for endometrial cancer; MPL: medically necessary for chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndromes, myeloproliferative neoplasms; NPM1: medically necessary for acute myeloid leukemia (AML), chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndromes, myeloproliferative neoplasms; NRAS: medically necessary for colorectal cancer, myelodysplastic syndrome, blastic plasmacytoid dendritic cell neoplasm (BPDCN); NTRK: medically necessary for all solid tumors; PTEN: medically necessary for uterine sarcoma and persons meeting Cowden syndrome criteria; RUNX1: medically necessary for acute myeloid leukemia, myelodysplastic syndrome, systemic mastocytosis; SF3B1: medically necessary for chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndromes, myeloproliferative neoplasms, uveal melanoma; SRSF2: medically necessary for chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndromes, myeloproliferative neoplasms, systemic mastocytosis; TP53: medically necessary for acute myeloid leukemia, adult medulloblastoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, chronic myeloid leukemia (chronic phase, adult), endometrial carcinoma, malignant peritoneal or pleural mesothelioma, mantle cell lymphoma, myelodysplastic syndromes, myeloproliferative neoplasms, occult primary, pediatric acute lymphoblastic leukemia, peripheral T-cell lymphomas, splenic marginal zone lymphoma, uterine sarcoma, well-differentiated grade 3 neuroendocrine tumors; U2AF1: medically necessary for blastic plasmacytoid dendritic cell neoplasm (BPDCN), chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndromes, myeloproliferative neoplasms; ZRSR2: medically necessary for chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndromes; BCL2 and BCL6: medically necessary for non-Hodgkin's lymphoma and Castleman's disease; Beta-2 microglobulin (B2M): medically necessary for multiple myeloma, non-Hodgkin's lymphoma, Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma; BIRC3 and MALT1: medically necessary for gastric MALT lymphoma, non-gastric MALT lymphoma, nodal marginal zone lymphoma, splenic marginal zone lymphoma; BTK (Bruton's tyrosine kinase): medically necessary for chronic lymphocytic leukemia/small lymphocytic lymphoma; CALB2 (calretinin): medically necessary for lung cancer and occult primary; CALCA (calcitonin): medically necessary for medullary thyroid cancer or adenocarcinoma or anaplastic/undifferentiated tumors of head and neck; CCND1 (cyclin D1): medically necessary for B-cell lymphomas, primary cutaneous B-cell lymphomas, chronic lymphocytic leukemia/small lymphocytic lymphoma, hairy cell leukemia; CD20: medically necessary for determining eligibility for anti-CD20 treatment (rituximab); CD25: medically necessary for determining eligibility for denileukin diftitox (Ontak) treatment; CD31 immunostaining: medically necessary for diagnosis of angiosarcoma; CD33: medically necessary for lymphoblastic lymphoma and determining eligibility for anti-CD33 treatment; CD52: medically necessary for post-transplant lymphoproliferative disorder, T-cell prolymphocytic leukemia, and determining eligibility for anti-CD52 treatment; CD117 (c-kit): medically necessary for acute myeloid leukemia, cutaneous melanoma, gastrointestinal stromal tumors, systemic mastocytosis; CHGA (chromogranin A): medically necessary for neuroendocrine tumors, non-small cell lung cancer, small cell lung cancer, Merkel cell carcinoma, occult primary; INHA (inhibin): medically necessary for ovarian cancer or pelvic mass; Estrogen receptors (ESR1): medically necessary for breast cancer, endometrial carcinoma, non-small cell lung cancer, occult primary, ovarian cancer, uterine sarcoma; Progesterone receptors (PGR): medically necessary for breast cancer, non-small cell lung cancer, occult primary, uterine sarcoma; MYD88: medically necessary to differentiate Waldenstrom's macroglobulinemia (WM) versus marginal zone lymphoma (MZL) if plasmacytic differentiation present; and for gastric MALT lymphoma, nodal marginal zone lymphoma, nongastric MALT lymphoma, splenic marginal zone lymphoma, multiple myeloma; Myeloperoxidase (MPO) immunostaining, CEBPA mutation, and KIT mutation: medically necessary for acute myeloid leukemia diagnosis; PLCG2 (phospholipase C gamma 2): medically necessary for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); Steroid hormone receptor status in pre-menopausal and post-menopausal members: medically necessary to identify individuals for endocrine adjuvant therapy; Thyroglobulin antibodies: medically necessary for thyroid cancer; Thyroglobulin (TG): medically necessary for thyroid cancer, occult primary, adenocarcinoma or anaplastic/undifferentiated tumors of head and neck; Thyroid transcription factor-1 (TTF-1): medically necessary for lung cancer or neuroendocrine tumors; Thymidine kinase: medically necessary for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); Vascular endothelial growth factor (VEGF): medically necessary for Castleman's disease; WT-1 gene expression: medically necessary for desmoplastic round cell tumors, ovarian clear cell carcinomas, non-small cell lung cancer, occult primary; ZAP-70: medically necessary for assessing prognosis and need for aggressive therapy in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); 5-hydroxyindoleacetic acid (5-HIAA): medically necessary for neuroendocrine tumors; Alpha fetoprotein (AFP): medically necessary for testing hepatocellular carcinoma in hepatitis B carriers or persons with cirrhosis with specific risk factors; Alpha fetoprotein (AFP): medically necessary for hepatocellular carcinoma, mediastinal mass, ovarian cancer, pelvic mass, testicular cancer, testicular mass, thymic carcinoma, thymoma; Alpha fetoprotein (AFP) serial measurements: medically necessary to diagnose germ cell tumors in members with adenocarcinoma or carcinoma not otherwise specified involving mediastinal nodes, or for diagnosis and monitoring of hepatocellular carcinoma; CA 15-3 serial measurements: medically necessary in following course of treatment in women with breast cancer, especially advanced metastatic breast cancer; CA 19-9: medically necessary to monitor clinical response to therapy or detect early recurrence in gastric cancer, pancreatic cancer, gallbladder cancer, cholangiocarcinoma, ovarian cancer, small bowel adenocarcinoma, adenocarcinoma of ampulla of Vater; CA 19-9: medically necessary to rule out cholangiocarcinoma in persons with primary sclerosing cholangitis undergoing liver transplantation; CA 19-9: medically necessary for evaluation of jaundice, abnormal liver function tests (LFTs), hepatobiliary obstruction/abnormality on abdominal imaging; CA 19-9: medically necessary for initial work-up and surveillance for recurrence of ovarian masses; CA 19-9: medically necessary as a tumor marker for mucinous appendiceal carcinoma; Cancer antigen 125 (CA 125): medically necessary as a preoperative diagnostic aid in women with ovarian masses suspected malignant; Cancer antigen 125 (CA 125): medically necessary as a screening test for ovarian cancer with family history of hereditary ovarian cancer syndrome (performed concurrently with transvaginal ultrasound); Cancer antigen 125 (CA 125): medically necessary for diagnosis in women with new symptoms (bloating, pelvic/abdominal pain, difficulty eating, urinary frequency/urgency) persisting 3 weeks or more; Cancer antigen 125 (CA 125): medically necessary in members with adenocarcinoma of unknown primary to rule out ovarian cancer; Cancer antigen 125 (CA 125): medically necessary in members with known ovarian cancer as an aid in disease monitoring, response to treatment, recurrent disease detection, assessing second-look surgery value; Carcinoembryonic antigen (CEA): medically necessary as a preoperative prognostic indicator in members with known colorectal carcinoma or mucinous appendiceal carcinoma; Carcinoembryonic antigen (CEA) pancreatic cyst fluid: medically necessary to distinguish mucinous from non-mucinous malignant cysts; Carcinoembryonic antigen (CEA): medically necessary to detect asymptomatic recurrence of colorectal cancer after treatment; Carcinoembryonic antigen (CEA): medically necessary to monitor response to treatment for metastatic colorectal cancer; Carcinoembryonic antigen (CEA): medically necessary for cholangiocarcinoma, gallbladder cancer, lung cancer, medullary thyroid cancer, metastatic breast cancer, mucinous ovarian cancer, occult primary; Carcinoembryonic antigen (CEA): medically necessary for evaluation of jaundice, abnormal liver function tests, bile duct obstruction/abnormality on imaging; Human chorionic gonadotropin (HCG) serial measurement: medically necessary to diagnose germ cell tumors in members with adenocarcinoma or carcinoma not otherwise specified involving mediastinal nodes; Human chorionic gonadotropin (HCG) serial measurement: medically necessary to monitor treatment in members with trophoblastic tumors and germinal cell tumors; Human chorionic gonadotropin, beta (beta-HCG): medically necessary for mediastinal mass, ovarian cancer, pelvic mass, testicular mass, testicular cancer, thymoma, thymic carcinoma; Lactate dehydrogenase (LDH): medically necessary for acute lymphoblastic leukemia (ALL), bone cancer, kidney cancer, kidney mass, lung cancer, multiple myeloma, non-Hodgkin's lymphoma, pelvic mass, ovarian cancer, testicular cancer, testicular mass; Placental alkaline phosphatase (PLAP): medically necessary to diagnose germ cell seminoma and non-seminoma germ cell tumors in unknown primary cancers; Prostate-specific antigen (PSA): medically necessary for prostate cancer screening, staging, monitoring response to therapy, detecting disease recurrence; Copy number alterations molecular testing: medically necessary for pediatric diffuse high-grade glioma; IGH@ (immunoglobulin heavy chain locus) gene rearrangement analysis: medically necessary to detect abnormal clonal population(s) in non-Hodgkin's lymphomas, chronic lymphocytic leukemia, hairy cell leukemia, post-transplant lymphoproliferative disorder; IGK@ (immunoglobulin kappa light chain locus) gene rearrangement analysis: medically necessary for non-Hodgkin's lymphoma, systemic light chain amyloidosis; Microsatellite instability (MSI) molecular testing: medically necessary for adrenal gland tumor (incl. adrenocortical carcinoma); biliary tract cancers (extrahepatic cholangiocarcinoma, gallbladder cancer, intrahepatic cholangiocarcinoma); bone cancer (chondrosarcoma, chordoma, Ewing sarcoma, osteosarcoma); invasive breast cancer; cervical cancer; colon cancer (incl. appendiceal adenocarcinoma); esophageal and esophagogastric junction cancers; gastric cancer; head and neck cancer (incl. salivary gland tumors); Lynch syndrome; neuroendocrine tumors; occult primary; ovarian/fallopian tube/primary peritoneal cancer; penile cancer; prostate cancer; rectal cancer; small bowel adenocarcinoma; testicular cancer (nonseminoma, seminoma); thyroid carcinoma (anaplastic, follicular, oncocytic, papillary); upper genitourinary tract tumors; uterine neoplasms (endometrial carcinoma, uterine sarcoma); vulvar cancer (squamous cell carcinoma); Mismatch repair (MSI/dMMR: MLH1, MSH2, MSH6, PMS2) tumor testing: medically necessary for breast cancer, ovarian cancer, colorectal cancer, small bowel adenocarcinoma, esophageal cancer, esophagogastric junction cancer, gastric cancer, pancreatic cancer, cholangiocarcinoma, gallbladder cancer, pancreatic adenocarcinoma, cervical cancer, uterine cancer, prostate cancer, testicular cancer, penile cancer, myelodysplastic syndromes, Ewing sarcoma, occult primary; PCR for T-cell receptor gamma chain gene rearrangement: medically necessary for mycosis fungoides diagnosis; Next generation sequencing of tumor DNA to detect or quantify minimal residual disease (MRD): medically necessary for acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), multiple myeloma; Targeted hematologic genomic sequencing panel (5-50 genes): medically necessary for acute lymphocytic leukemia, acute myeloid leukemia, chronic myelogenous leukemia, myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN); Targeted solid organ genomic sequencing panel (5-50 genes): medically necessary for advanced esophageal and esophagogastric junction cancer; advanced gastric cancer; colorectal cancer; cutaneous melanoma; non-small cell lung cancer; ovarian cancer; pancreatic cancer; prostate cancer; stage IV or recurrent unresectable breast cancer; T-cell receptor gene rearrangements (TRA@, TRB@, TRD@, TRG@): medically necessary for T-cell prolymphocytic leukemia, T-cell large granular lymphocytic leukemia, nasal type extranodal NK/T-cell lymphoma, hepatosplenic gamma-delta T-cell lymphoma, peripheral T-cell lymphoma, primary cutaneous CD30+ T-cell lymphoproliferative disorders, myelodysplastic syndromes, Castleman's disease, mycosis fungoides/Sezary syndrome, myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase fusion genes; TERT (telomerase reverse transcriptase): medically necessary for gliomas (infiltrative supratentorial astrocytoma/oligodendroglioma, anaplastic gliomas/glioblastoma) and myelodysplastic syndrome (MDS); Androgen receptor splice variant 7 (AR-V7) in circulating tumor cells (CTC): medically necessary to select therapy in metastatic castrate-resistant prostate cancer after progression on abiraterone or enzalutamide; Somatic genomic testing for JAK2 mutations: medically necessary for (a) qualitative assessment of JAK2-V617F sequence variant using detection thresholds up to 5% for initial diagnostic assessment in adults with chronic myeloproliferative disorder (CMPD) symptoms; (b) diagnostic assessment of polycythemia vera in adults; (c) differential diagnosis of essential thrombocytosis and primary myelofibrosis from reactive conditions in adults; Liquid biopsy (up to 50 genes): medically necessary for non-small cell lung cancer in members not medically fit for invasive sampling or with insufficient tissue for molecular analysis; PIK3CA: medically necessary for breast cancer and uterine sarcoma; PDGFRA: medically necessary for gastrointestinal stromal tumors (GIST), pediatric acute lymphoblastic leukemia; PDGFRB testing: medically necessary for myelodysplastic syndromes (MDS), dermatofibrosarcoma protuberans, acute lymphoblastic leukemia, myeloid/lymphoid neoplasms with peripheral blood eosinophilia and tyrosine kinase fusion genes; Afirma Thyroid FNA analysis: medically necessary for assessing fine needle aspiration samples from thyroid nodules that are indeterminate; Quest Diagnostics Thyroid Cancer Mutation Panel: medically necessary for indeterminate thyroid nodule fine needle aspiration samples; ThyGeNEXT Thyroid Oncogene Panel and ThyraMIR microRNA Classifier: medically necessary for indeterminate thyroid nodule fine needle aspiration samples; ThyroSeq: medically necessary for indeterminate thyroid nodule fine needle aspiration samples; Human epidermal growth factor receptor 2 (HER2/ERBB2) evaluation: medically necessary in biliary tract, bladder, breast, cervical, colorectal, esophageal, esophageal gastric junction, gastric, non-small cell lung cancer (NSCLC), ovarian/fallopian tube, salivary gland tumors; Human papillomavirus (HPV) tumor testing (p16): medically necessary for head and neck cancer (incl. oropharynx cancer) or occult primary cancers; Breast Cancer Index (BCI): medically necessary (when all criteria met) to assess necessity of adjuvant chemotherapy or adjuvant endocrine therapy in nonmetastatic (node negative) or 1-3 involved ipsilateral axillary lymph nodes, estrogen/progesterone receptor positive, HER2 negative breast cancer; also for HER2-negative breast cancer with 0-3 positive nodes after 5 years endocrine therapy without recurrence; EndoPredict (12-gene score): medically necessary (when all criteria met) to assess necessity of adjuvant chemotherapy in nonmetastatic (node negative) or 1-3 involved ipsilateral axillary lymph nodes, estrogen receptor positive, HER2 negative breast cancer; Mammaprint: medically necessary (when all criteria met) to assess necessity of adjuvant chemotherapy in nonmetastatic (node negative) or 1-3 involved ipsilateral axillary lymph nodes, estrogen/progesterone receptor positive, HER2 negative breast cancer with high clinical risk; Oncotype Dx Breast (21 gene RT-PCR): medically necessary (when all criteria met) to assess necessity of adjuvant chemotherapy in nonmetastatic (node negative) or 1-3 involved ipsilateral axillary lymph nodes, estrogen receptor positive, HER2 negative (or HER2 positive <1 cm) breast cancer; PAM50 Risk of Recurrence (ROR) Score (Prosigna): medically necessary (when all criteria met) to assess necessity of adjuvant chemotherapy in nonmetastatic (node negative), estrogen receptor positive, HER2 negative breast cancer; Urokinase plasminogen activator (uPA) and plasminogen activator inhibitor 1 (PAI-1): medically necessary to assess necessity of adjuvant chemotherapy in nonmetastatic (node negative), estrogen receptor positive, HER2 negative breast cancer; also for prognosis determination in newly diagnosed, node negative breast cancer; Decipher: medically necessary for NCCN very-low, low, or favorable intermediate-risk prostate cancer with >10 year life expectancy not yet treated and candidates for active surveillance/definitive therapy; OR intermediate-risk prostate cancer when deciding whether to add androgen-deprivation therapy to radiation; OR undetectable PSA after prostatectomy to determine adjuvant vs salvage radiation or initiate systemic therapies; DecisionDx-UM (Castle Biosciences): medically necessary for risk stratification of localized uveal melanoma; Oncotype DX Prostate: medically necessary for NCCN very-low, low, or favorable intermediate-risk prostate cancer with >10 year life expectancy not yet treated and candidates for active surveillance/definitive therapy; OR intermediate-risk prostate cancer when deciding whether to add androgen-deprivation therapy to radiation; Prolaris: medically necessary for NCCN very-low, low, or favorable intermediate-risk prostate cancer with >10 year life expectancy not yet treated and candidates for active surveillance/definitive therapy; OR intermediate-risk prostate cancer when deciding whether to add androgen-deprivation therapy to radiation; ProMark: medically necessary for NCCN very-low, low, or favorable intermediate-risk prostate cancer with >10 year life expectancy not yet treated and candidates for active surveillance/definitive therapy; OR intermediate-risk prostate cancer when deciding whether to add androgen-deprivation therapy to radiation; Fluorescence immunocytology (e.g., ImmunoCyt/uCyt): medically necessary as an adjunct to cystoscopy or cytology in monitoring persons with bladder cancer; Urinary biomarkers (bladder tumor antigen [BTA]; nuclear matrix protein [NMP22]; fibrin/fibrinogen degradation products [FDP]; fluorescence in situ hybridization [FISH]): medically necessary for follow-up of bladder cancer treatment; monitoring for eradication; and recurrences after eradication; Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS or MASS-FIX) and immunoprecipitation: medically necessary for detection and isotyping of immunoglobulin paraprotein (M-protein) in plasma cell dyscrasia evaluation and management; Veristrat proteomic testing: medically necessary for advanced NSCLC without EGFR/ALK mutations, progressed after one or more chemotherapy regimens, considered for erlotinib treatment. Applies to 13 codes: 84152, 84153, 84154, 82378, 86300, 86301, 86304, 83950, 81206, 81207, 81208, 81301, G0103.
Action
Confirm prior-authorization status with Aetna before scheduling — it is code- and plan-specific, and this policy is not an exact authorization source.
Trap
Policy exclusions and limitations: More than one type of breast adjuvant-therapy test (among Oncotype Dx Breast, Breast Cancer Index, EndoPredict, PAM50, Mammaprint, or uPA and PAI-1): experimental/investigational/unproven (EXCEPTION: more than one Oncotype Dx test may be medically necessary for persons with two or more histologically distinct tumors meeting criteria); Repeat Oncotype Dx testing or testing of multiple tumor sites in the same person: no proven value for other indications; Oncotype Dx for ductal carcinoma in situ (OncotypeDx DCIS), colon cancer (OncotypeDx Colon), and all other indications: experimental; Repeat testing or use of more than one type of prostate cancer progression-risk test (Oncotype Dx Prostate, Decipher, Prolaris, or ProMark): experimental/investigational/unproven; Various thyroid (Afirma, Quest, ThyGeNEXT, ThyroSeq) and genomic sequencing tests: not covered for repeat testing within 60 days of prior panel testing for the same indication; JAK2: experimental for quantitative allele burden assessment and pediatric myeloproliferative disorder diagnosis; ImmunoCyt/uCyt: experimental for hematuria evaluation, bladder cancer diagnosis, or screening asymptomatic persons; Urinary biomarkers (BTA, NMP22, FDP, FISH): experimental for bladder cancer screening, hematuria evaluation, symptomatic individual diagnosis, and all other indications; AFP: experimental for trophoblastic tumor diagnosis and oncologic indications beyond those listed in the medically necessary section; CA 125: experimental for screening colorectal or ovarian cancer (except as stated) and for differential diagnosis of colonic disease symptoms; CA 19-9: experimental for breast, colorectal, esophageal, gastro-esophageal, liver, uterine cancer; NUT midline carcinoma; prognosis/treatment prediction in bladder cancer; screening primary sclerosing cholangitis; CEA: experimental for colorectal cancer screening; as a sole adjuvant/systemic therapy determinant; esophageal carcinoma diagnosis; gastric cancer screening/diagnosis/staging/surveillance; PSA: experimental for breast cancer screening or differentiating benign versus malignant breast mass; PIK3CA: experimental for metastatic colorectal cancer/EGFR antagonist prediction (outside breast and uterine sarcoma indications); PLCG2: experimental for indications outside chronic lymphocytic leukemia (CLL); Vascular endothelial growth factor (VEGF): experimental except for Castleman's disease; NRAS mutation: experimental for metastatic colorectal cancer with anti-VEGF therapy prediction, and for melanoma prognosis/tyrosine kinase inhibitor selection; Ras oncogenes (except KRAS, NRAS, BRAF): experimental; 3D Predict Ovarian Doublet Panel: experimental; 3D Predict Ovarian PARP Panel: experimental; 4Kscore: experimental; Afirma Xpression Atlas: experimental; AidaBreast: experimental; AMBLor Melanoma Prognostic Test: experimental; ArteraAI Prostate Test: experimental; Assaying for loss of heterozygosity (LOH) on chromosome 18 (18q-LOH/DCC) for colorectal cancer: experimental; AssureMDx: experimental; Augusta Hematology Optical Genome Mapping: experimental; Auria for breast cancer screening: experimental; Avantect Ovarian Cancer Test: experimental; Avantect Pancreatic Cancer Test: experimental; Aventa FusionPlus: experimental; Aventa Lymphoma: experimental; BBDRisk Dx: experimental; Biodesix BDX-XL2, Nodify CDT, Nodify Lung, Nodify XL2 for distinguishing benign from malignant lung nodules: experimental; Biomarker Translation (BT) test for breast cancer: experimental; BioSpeciFx, including Comprehensive Tumor Profiling: experimental; Bladder CARE: experimental; BostonGene Tumor Portrait Test: experimental; BRAF and EGFR for esophageal carcinoma: experimental; Breast Cancer Gene Expression Ratio (HOXB13:IL17BR): experimental; BreastSentry: experimental; BTG Early Detection of Pancreatic Cancer: experimental; Cancerguard: experimental; Carcinoembryonic antigen cell adhesion molecule 6 (CEACAM6) for breast atypical hyperplasia, breast cancer risk prediction: experimental; Carcinoembryonic antigen cellular adhesion molecule-7 (CEACAM-7) as predictive marker for rectal cancer recurrence: experimental; Caris Molecular Intelligence/Target Now Molecular Profiling: experimental; Castle Biosciences myPath Melanoma: experimental; CDH1 for ovarian cancer: experimental; CDX2 as prognostic biomarker for colon cancer: experimental; Circulating cell-free nucleic acids (liquid biopsy) for colorectal cancer: experimental; Circulating tumor cell (CTC) assays for metastatic breast, colorectal, melanoma, prostate cancers (incl. CellMax Life, CELLSEARCH variants, FirstSightCRC): experimental; Circulating tumor DNA (ctDNA/liquid biopsy) for indications beyond small <50 gene panels for NSCLC (incl. CancerIntercept, Caris Assure, Colvera, DefineMBC, GeneStrat, FoundationACT, FoundationOne Liquid, Guardant Reveal, Guardant360, HPV-SEQ, LiquidHALLMARK, NEO PanTracer, Neolab Prostate, Northstar Response, Oncodetect, OptiSeq, Signatera, Tempus xF/xF+): experimental; CK5, CK14, p63, Racemase P504S for prostate cancer: experimental; ClarityDx Prostate: experimental; c-Met expression for advanced NSCLC, colorectal cancer prognosis prediction: experimental; Cyfra21-1, p53, squamous cell carcinoma antigen (SCC-Ag), VEGF-C for esophageal carcinoma: experimental; Cofilin (CFL1) in non-small cell lung cancer: experimental; ColonSentry: experimental; ColoPrint, CIMP, LINE-1 hypomethylation, immune cells for colon cancer: experimental; Colorectal Cancer DSA: experimental; ColoScape, ColoScape PLUS: experimental; ConfirmMDx for prostate cancer: experimental; Cxbladder tests (Detect+, Resolve, Triage) for microhematuria/bladder cancer: experimental; Cyclin D1 and FADD for head and neck squamous cell carcinoma: experimental; CyPath Lung: experimental; DAWN IO Melanoma: experimental; DCIS Recurrence Score: experimental; DCISionRT: experimental; Decipher Bladder: experimental; DecisionDx DiffDx-Melanoma: experimental; DecisionDx-Melanoma: experimental; DecisionDx-SCC: experimental; Des-gamma-carboxy prothrombin (DCP/PIVKA II) for hepatocellular carcinoma diagnosis/monitoring: experimental; DetermaRx: experimental; DiviTum TKa: experimental; EarlyCDT-Lung: experimental; EarlyDx: experimental; EarlyTect Bladder Cancer Detection (EarlyTect BCD): experimental; EGFR gene expression for transitional (urothelial) cell cancer: experimental; EGFRVIII for glioblastoma multiforme: experimental; EML4-ALK as diagnostic tool for stage IV NSCLC: experimental; Endeavor Comprehensive Genomic Profiling: experimental; Envisia Genomic Classifier: experimental; Epignostix CNS Tumor Methylation Classifier: experimental; Episeek Malignant Pleural Effusion (MPE): experimental; Excision repair cross-complementation group 1 protein (ERCC1) for NSCLC, colon, gastric cancer: experimental; ExoDx Prostate/ExosomeDx Prostate (IntelliScore): experimental; F2RL1 as biomarker in cervical cancer diagnosis/prognosis: experimental; Fibrin/fibrinogen degradation products (FDP) (DR-70, Onko-Sure) for colorectal cancer: experimental; FoundationOne, FoundationOne CDx, FoundationOne Heme, FoundationOne RNA (certain exceptions noted): experimental; Galectin-3 for breast, myelodysplastic syndrome, osteosarcoma, ovarian, pancreatic, prostate cancers: experimental; Gene hypermethylation for prostate cancer: experimental; GeneKey: experimental; GeneSearch Breast Lymph Node (BLN): experimental; Glutathione-S-transferase P1 (GSTP1) for prostate cancer screening/detection/management: experimental; GlycoKnow Ovarian: experimental; Grail Galleri Test: experimental; Guanylyl cyclase c (GCC/GUCY2C/Previstage GCC) for colorectal cancer: experimental; Guardant360 TissueNext: experimental; Haystack MRD Baseline and Haystack MRD Monitoring: experimental; HelioLiver: experimental; HeproDx: experimental; HER2 testing of appendiceal cancer: experimental; HERmark for breast cancer: experimental; HMGB1 and RAGE in cutaneous malignancy (basal cell carcinoma, melanoma, squamous cell carcinoma): experimental; Human epididymis protein 4 (HE4) for endometrial cancer, ovarian cancer, pelvic mass evaluation: experimental; Human papillomavirus 16 (HPV16) L1 gene as biomarker in cervical cancer: experimental; HC4 (NexCourse IHC4) for breast cancer: experimental; IGoCheck: experimental; IMMray PanCan-d for pancreatic ductal adenocarcinoma: experimental; Immunoassay using magnetic nanosensor for lung cancer diagnosis: experimental; Immunoscore for colon cancer recurrence risk/adjuvant therapy: experimental; Insight DX Breast Cancer Profile: experimental; Insight TNBCtype: experimental; Invitae PCM MRD Monitoring: experimental; Invitae PCM Tissue Profiling and MRD Baseline: experimental; IsoPSA: experimental; Ki67 for breast cancer: experimental; Ki-67 in upper tract urinary carcinoma: experimental; Labcorp Plasma Complete: experimental; Lectin-reactive alpha-fetoprotein (AFP-L3) for liver cancer: experimental; Long non-coding RNA in gallbladder cancer: experimental; LungLB, LungLife AI: experimental; LungOI: experimental; Lymph2CX, Lymph3Cx Lymphoma Molecular Classification: experimental; MammoCheck: experimental; Mammostrat: experimental; Mass spectrometry-based proteomic profiling for indeterminate pulmonary nodules: experimental; MatePair targeted rearrangements for hematolymphoid/solid organ neoplasia: experimental; Mayo Clinic Urinary Steroid Profile for adrenal malignancy management: experimental; MelaNodal Predict for cutaneous melanoma: experimental; Merkel SmT Oncoprotein Antibody Titer: experimental; Merkel Virus VP1 Capsid Antibody: experimental; Merlin Test (SkylineDx): experimental; MI Cancer Seek: experimental; MiCheck Prostate: experimental; Microarray-based gene expression (MyPRS) for multiple myeloma: experimental; Micro-RNAs (miRNAs) miRview mets, miRview mets2: experimental; M-inSight Patient Definition/Follow-Up Assessment: experimental; miR-31now: experimental; miR Sentinel Prostate Cancer: experimental; Molecular Intelligence Services/MI Profile/MI Profile X: experimental; Molecular subtyping profile (BluePrint) for breast cancer: experimental; mRNA gene expression profiling for cutaneous melanoma: experimental; mRNA sequence analysis: experimental; MSK-IMPACT: experimental; MUC1 in gastric cancer: experimental; Mucin 4 expression in colorectal cancer: experimental; Mucin 5AC (MUC5AC) for biliary tract cancer: experimental; My Prognostic Risk Signature (MyPRS): experimental; MyAML Next Generation Sequencing Panel: experimental; MyMRD Gene Panel: experimental; MyProstateScore (formerly Mi-Prostate Score), TMPRSS2:ERG, PCA3, PSA: experimental; MyProstateScore 2.0: experimental; NantHealth GPS Cancer Panels: experimental; NavDx: experimental; Neo Comprehensive - Heme Cancers: experimental; Neo Comprehensive - Myeloid Disorders: experimental; NeoTYPE Breast Tumor Profile: experimental; NeoTYPE Endometrial Tumor Profile: experimental; NETest: experimental; NeXT DX tumor profiling for breast cancer: experimental; NF1, RET, SDHB for ovarian cancer: experimental; Northstar Select: experimental; OmniSeq Advance DNA/RNA sequencing: experimental; OncInsights: experimental; OncoAssure Prostate: experimental; OncobiotaLUNG: experimental; Oncomap ExTra (formerly Oncotype MAP): experimental; OncoOmicDx Targeted Proteomic: experimental; OncoSignal: experimental; OncoTarget/OncoTreat: experimental; Oncotype MAP PanCancer Tissue: experimental; OncoVantage: experimental; Oncuria Detect, Oncuria Monitor, Oncuria Predict for bladder cancer: experimental; OptiSeq Dual Cancer Panel: experimental; OVA1/Overa: experimental; OvaCheck: experimental; OvaSure: experimental; OvaWatch: experimental; PancreaSeq Genomic Classifier: experimental; PancreaSure: experimental; PanCystPro Panel: experimental; PanGIA Prostate: experimental; Pathwork Tissue of Origin/ResponseDx Tissue of Origin: experimental; Percepta Bronchial Genomic Classifier: experimental; PGDx elio tissue complete for tumor mutation profiling: experimental; Pharmaco-oncologic Algorithm Treatment Ranking Service: experimental; Praxis Somatic Combined Whole Genome/Optical Genome Mapping: experimental; Praxis Somatic Optical Genome Mapping: experimental; Praxis Somatic Transcriptome: experimental; Praxis Somatic Whole Genome: experimental; Precise Tumor Molecular Profile (Myriad): experimental; PreciseDx Breast Cancer: experimental; PreOvar test for KRAS-variant ovarian cancer risk: experimental; ProOnc TumorSourceDx to identify tissue of origin: experimental; Prostate core mitotic: experimental; Prostate Px, Post-Op Px for prostate cancer recurrence: experimental; Prostate Cancer Risk Panel (FISH analysis): experimental; ProsTAV telomere-based biomarker for prostate cancer: experimental; Proveri prostate cancer assay (PPCA): experimental; PTEN gene expression for NSCLC: experimental; PurISTS Test: experimental; QuantiDNA Colorectal Cancer Triage: experimental; RadTox cfDNA: experimental; ResponseDx Colon: experimental; Ribonucleotide reductase subunit M1 (RRM1) for NSCLC/gemcitabine-based chemotherapy: experimental; RNA gene expression profiling for hematolymphoid/solid organ neoplasm: experimental; RNA Salah Targeted Expression Panel (RNA STEP): experimental; ROMA (Risk of Ovarian Malignancy Algorithm): experimental; Rotterdam Signature 76-gene panel: experimental; Salivary metatranscriptome analysis for oral cancers: experimental; SelectMDx for prostate cancer: experimental; Sentinel Prostate Test for screening/risk determination: experimental; Serum amyloid A for endometrial endometrioid carcinoma recurrence/therapy response: experimental; Solid Tumor Expanded Panel (Quest): experimental; Strata Select: experimental; TargetPrint gene expression for estrogen/progesterone/HER2 receptor status in breast cancer: experimental; Tempus p-MSI: experimental; Tempus p-Prostate: experimental; Tempus Tumor Origin (TO): experimental; Tempus xR: experimental; 41-gene signature assay: experimental; Theros CancerType ID: experimental; Thymidylate synthase: experimental; Thyroid GuidePx: experimental; ThyroSeq CRC for thyroid cancer: experimental; TMPRSS fusion genes for prostate cancer: experimental; Topographic genotyping (Pancragen/PathFinderTG): experimental; Total (whole) gene sequencing for cancer: experimental; TP53 mutation analysis for ovarian cancer: experimental; UriFind Blood Cancer for bladder cancer: experimental; UroAmp MRD for bladder cancer: experimental; UroCor cytology panels (DD23, P53) for bladder cancer: experimental; Vascular endothelial growth factor receptor 2 (VEGFR2) expression for colorectal cancer VEGF inhibition response prediction: experimental; Vesta AI Pathology for non-muscle invasive bladder cancer: experimental; Whole exome sequencing (somatic mutations) for cancer: experimental; The following circulating tumor markers are experimental for screening asymptomatic members, cancer diagnosis, staging, routine surveillance, and monitoring treatment response: a2-PAG; CA-SCC; MAM-6; TAG12; AMACR; Cathepsin-D; Cathepsin-L; Motility-related protein (MRP); TAG72; Cyclin E (fragments/whole); Multidrug resistance glycoprotein (Mdr1); TAG72.3; BCM; DU-PAN-2; TAG72.5; CA195; Early prostate cancer antigen (EPCA); NSE; TATI; CA242; Guanylyl cyclase C (Previstage GCC molecular); Thrombospondin-1 (THBS-1); CA50; Hepsin; PCA3 (DD3)/UpM3; Thymosin B15; CA549; Human kallikrein 2 (HK2); PNA/ELLA; TNF-alpha; CA72-4; LASA; Prostate stem cell antigen (PSCA); Topoisomerase II Alpha (TOP2A); CAM17-1; LPA; SCC; TPA; CAM26; M 26; SLEX; CAM29; M 29; SPAN-1; Nuclear Matrix Protein 66 (NMP66); CAR-3; MSA; SLX; Anti-malignin antibody screen (AMAS); CYFRA21-1; MCA; ST-439. Claims may be denied when the requested service falls under these. Some of these are conditional (note the stated exceptions) — confirm specifics against the bulletin.

Source: Aetna CPB 0352 — Tumor Markers

Coverage criteria

  • 1p19q codeletion: medically necessary for astrocytomas and gliomas
  • ALK expression: medically necessary for pancreatic adenocarcinoma, pediatric Hodgkin's lymphoma, inflammatory myofibroblastic tumor (IMT) with ALK translocation, breast implant-associated ALCL, peripheral T-cell lymphoma, uterine sarcoma
  • ALK gene fusion: medically necessary as a biomarker in non-small cell lung cancer
  • ALK gene rearrangement: medically necessary for diffuse large B cell lymphoma, anaplastic thyroid carcinoma, primary cutaneous CD30+ T-cell lymphoproliferative disorders, post-transplant lymphoproliferative disorder, non-small cell lung cancer
  • BCR/ABL: medically necessary for acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), B-cell lymphoblastic lymphoma, chronic myelogenous leukemia (CML), suspected myeloproliferative neoplasm
  • CBFB: medically necessary for acute myeloid leukemia
  • FIP1L1-PDGFRA fusion oncogene: medically necessary for systemic mastocytosis with peripheral blood eosinophilia
  • FIP1L1-PDGFRA gene rearrangements: medically necessary for myeloid/lymphoid neoplasms with peripheral blood eosinophilia and tyrosine kinase fusion genes
  • PML/RARA: medically necessary for acute promyelocytic leukemia
  • APC: medically necessary for familial adenomatous polyposis (when criteria met) and desmoid fibromatosis
  • BRAF V600 mutation: medically necessary for indeterminate thyroid nodules, hairy cell leukemia, gastrointestinal stromal tumors, colorectal cancer, Lynch syndrome, non-small cell lung cancer, thyroid carcinoma, infiltrative glioma, pancreatic adenocarcinoma, melanoma
  • CALR (calreticulin): medically necessary for chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndrome, myeloproliferative neoplasms
  • EZH2: medically necessary for myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN) to evaluate for higher-risk mutations in primary myelofibrosis (PMF)
  • FLT3 gene mutation: medically necessary for acute lymphoblastic leukemia, acute myeloid leukemia (AML), myelodysplastic syndromes, myeloproliferative neoplasms, myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase fusion genes
  • IDH1 and IDH2: medically necessary for acute myeloid leukemia (AML), chondrosarcoma, chronic myeloid leukemia (CML), glioma or glioblastoma, myelodysplastic syndromes, myeloproliferative neoplasms
  • IDH1, IDH2, and TERT mutation analysis: medically necessary for glioma or myelodysplastic syndrome (MDS)
  • KRAS: medically necessary for metastatic colorectal cancer, myelodysplastic syndromes, non-small cell lung cancer, pancreatic adenocarcinoma, uterine sarcoma
  • MDM2 (murine double minute 2): medically necessary for uterine sarcoma and soft tissue sarcoma
  • MLH1 tumor promoter hypermethylation: medically necessary for endometrial cancer
  • MPL: medically necessary for chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndromes, myeloproliferative neoplasms
  • NPM1: medically necessary for acute myeloid leukemia (AML), chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndromes, myeloproliferative neoplasms
  • NRAS: medically necessary for colorectal cancer, myelodysplastic syndrome, blastic plasmacytoid dendritic cell neoplasm (BPDCN)
  • NTRK: medically necessary for all solid tumors
  • PTEN: medically necessary for uterine sarcoma and persons meeting Cowden syndrome criteria
  • RUNX1: medically necessary for acute myeloid leukemia, myelodysplastic syndrome, systemic mastocytosis
  • SF3B1: medically necessary for chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndromes, myeloproliferative neoplasms, uveal melanoma
  • SRSF2: medically necessary for chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndromes, myeloproliferative neoplasms, systemic mastocytosis
  • TP53: medically necessary for acute myeloid leukemia, adult medulloblastoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, chronic myeloid leukemia (chronic phase, adult), endometrial carcinoma, malignant peritoneal or pleural mesothelioma, mantle cell lymphoma, myelodysplastic syndromes, myeloproliferative neoplasms, occult primary, pediatric acute lymphoblastic leukemia, peripheral T-cell lymphomas, splenic marginal zone lymphoma, uterine sarcoma, well-differentiated grade 3 neuroendocrine tumors
  • U2AF1: medically necessary for blastic plasmacytoid dendritic cell neoplasm (BPDCN), chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndromes, myeloproliferative neoplasms
  • ZRSR2: medically necessary for chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndromes
  • BCL2 and BCL6: medically necessary for non-Hodgkin's lymphoma and Castleman's disease
  • Beta-2 microglobulin (B2M): medically necessary for multiple myeloma, non-Hodgkin's lymphoma, Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma
  • BIRC3 and MALT1: medically necessary for gastric MALT lymphoma, non-gastric MALT lymphoma, nodal marginal zone lymphoma, splenic marginal zone lymphoma
  • BTK (Bruton's tyrosine kinase): medically necessary for chronic lymphocytic leukemia/small lymphocytic lymphoma
  • CALB2 (calretinin): medically necessary for lung cancer and occult primary
  • CALCA (calcitonin): medically necessary for medullary thyroid cancer or adenocarcinoma or anaplastic/undifferentiated tumors of head and neck
  • CCND1 (cyclin D1): medically necessary for B-cell lymphomas, primary cutaneous B-cell lymphomas, chronic lymphocytic leukemia/small lymphocytic lymphoma, hairy cell leukemia
  • CD20: medically necessary for determining eligibility for anti-CD20 treatment (rituximab)
  • CD25: medically necessary for determining eligibility for denileukin diftitox (Ontak) treatment
  • CD31 immunostaining: medically necessary for diagnosis of angiosarcoma
  • CD33: medically necessary for lymphoblastic lymphoma and determining eligibility for anti-CD33 treatment
  • CD52: medically necessary for post-transplant lymphoproliferative disorder, T-cell prolymphocytic leukemia, and determining eligibility for anti-CD52 treatment
  • CD117 (c-kit): medically necessary for acute myeloid leukemia, cutaneous melanoma, gastrointestinal stromal tumors, systemic mastocytosis
  • CHGA (chromogranin A): medically necessary for neuroendocrine tumors, non-small cell lung cancer, small cell lung cancer, Merkel cell carcinoma, occult primary
  • INHA (inhibin): medically necessary for ovarian cancer or pelvic mass
  • Estrogen receptors (ESR1): medically necessary for breast cancer, endometrial carcinoma, non-small cell lung cancer, occult primary, ovarian cancer, uterine sarcoma
  • Progesterone receptors (PGR): medically necessary for breast cancer, non-small cell lung cancer, occult primary, uterine sarcoma
  • MYD88: medically necessary to differentiate Waldenstrom's macroglobulinemia (WM) versus marginal zone lymphoma (MZL) if plasmacytic differentiation present; and for gastric MALT lymphoma, nodal marginal zone lymphoma, nongastric MALT lymphoma, splenic marginal zone lymphoma, multiple myeloma
  • Myeloperoxidase (MPO) immunostaining, CEBPA mutation, and KIT mutation: medically necessary for acute myeloid leukemia diagnosis
  • PLCG2 (phospholipase C gamma 2): medically necessary for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
  • Steroid hormone receptor status in pre-menopausal and post-menopausal members: medically necessary to identify individuals for endocrine adjuvant therapy
  • Thyroglobulin antibodies: medically necessary for thyroid cancer
  • Thyroglobulin (TG): medically necessary for thyroid cancer, occult primary, adenocarcinoma or anaplastic/undifferentiated tumors of head and neck
  • Thyroid transcription factor-1 (TTF-1): medically necessary for lung cancer or neuroendocrine tumors
  • Thymidine kinase: medically necessary for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
  • Vascular endothelial growth factor (VEGF): medically necessary for Castleman's disease
  • WT-1 gene expression: medically necessary for desmoplastic round cell tumors, ovarian clear cell carcinomas, non-small cell lung cancer, occult primary
  • ZAP-70: medically necessary for assessing prognosis and need for aggressive therapy in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
  • 5-hydroxyindoleacetic acid (5-HIAA): medically necessary for neuroendocrine tumors
  • Alpha fetoprotein (AFP): medically necessary for testing hepatocellular carcinoma in hepatitis B carriers or persons with cirrhosis with specific risk factors
  • Alpha fetoprotein (AFP): medically necessary for hepatocellular carcinoma, mediastinal mass, ovarian cancer, pelvic mass, testicular cancer, testicular mass, thymic carcinoma, thymoma
  • Alpha fetoprotein (AFP) serial measurements: medically necessary to diagnose germ cell tumors in members with adenocarcinoma or carcinoma not otherwise specified involving mediastinal nodes, or for diagnosis and monitoring of hepatocellular carcinoma
  • CA 15-3 serial measurements: medically necessary in following course of treatment in women with breast cancer, especially advanced metastatic breast cancer
  • CA 19-9: medically necessary to monitor clinical response to therapy or detect early recurrence in gastric cancer, pancreatic cancer, gallbladder cancer, cholangiocarcinoma, ovarian cancer, small bowel adenocarcinoma, adenocarcinoma of ampulla of Vater
  • CA 19-9: medically necessary to rule out cholangiocarcinoma in persons with primary sclerosing cholangitis undergoing liver transplantation
  • CA 19-9: medically necessary for evaluation of jaundice, abnormal liver function tests (LFTs), hepatobiliary obstruction/abnormality on abdominal imaging
  • CA 19-9: medically necessary for initial work-up and surveillance for recurrence of ovarian masses
  • CA 19-9: medically necessary as a tumor marker for mucinous appendiceal carcinoma
  • Cancer antigen 125 (CA 125): medically necessary as a preoperative diagnostic aid in women with ovarian masses suspected malignant
  • Cancer antigen 125 (CA 125): medically necessary as a screening test for ovarian cancer with family history of hereditary ovarian cancer syndrome (performed concurrently with transvaginal ultrasound)
  • Cancer antigen 125 (CA 125): medically necessary for diagnosis in women with new symptoms (bloating, pelvic/abdominal pain, difficulty eating, urinary frequency/urgency) persisting 3 weeks or more
  • Cancer antigen 125 (CA 125): medically necessary in members with adenocarcinoma of unknown primary to rule out ovarian cancer
  • Cancer antigen 125 (CA 125): medically necessary in members with known ovarian cancer as an aid in disease monitoring, response to treatment, recurrent disease detection, assessing second-look surgery value
  • Carcinoembryonic antigen (CEA): medically necessary as a preoperative prognostic indicator in members with known colorectal carcinoma or mucinous appendiceal carcinoma
  • Carcinoembryonic antigen (CEA) pancreatic cyst fluid: medically necessary to distinguish mucinous from non-mucinous malignant cysts
  • Carcinoembryonic antigen (CEA): medically necessary to detect asymptomatic recurrence of colorectal cancer after treatment
  • Carcinoembryonic antigen (CEA): medically necessary to monitor response to treatment for metastatic colorectal cancer
  • Carcinoembryonic antigen (CEA): medically necessary for cholangiocarcinoma, gallbladder cancer, lung cancer, medullary thyroid cancer, metastatic breast cancer, mucinous ovarian cancer, occult primary
  • Carcinoembryonic antigen (CEA): medically necessary for evaluation of jaundice, abnormal liver function tests, bile duct obstruction/abnormality on imaging
  • Human chorionic gonadotropin (HCG) serial measurement: medically necessary to diagnose germ cell tumors in members with adenocarcinoma or carcinoma not otherwise specified involving mediastinal nodes
  • Human chorionic gonadotropin (HCG) serial measurement: medically necessary to monitor treatment in members with trophoblastic tumors and germinal cell tumors
  • Human chorionic gonadotropin, beta (beta-HCG): medically necessary for mediastinal mass, ovarian cancer, pelvic mass, testicular mass, testicular cancer, thymoma, thymic carcinoma
  • Lactate dehydrogenase (LDH): medically necessary for acute lymphoblastic leukemia (ALL), bone cancer, kidney cancer, kidney mass, lung cancer, multiple myeloma, non-Hodgkin's lymphoma, pelvic mass, ovarian cancer, testicular cancer, testicular mass
  • Placental alkaline phosphatase (PLAP): medically necessary to diagnose germ cell seminoma and non-seminoma germ cell tumors in unknown primary cancers
  • Prostate-specific antigen (PSA): medically necessary for prostate cancer screening, staging, monitoring response to therapy, detecting disease recurrence
  • Copy number alterations molecular testing: medically necessary for pediatric diffuse high-grade glioma
  • IGH@ (immunoglobulin heavy chain locus) gene rearrangement analysis: medically necessary to detect abnormal clonal population(s) in non-Hodgkin's lymphomas, chronic lymphocytic leukemia, hairy cell leukemia, post-transplant lymphoproliferative disorder
  • IGK@ (immunoglobulin kappa light chain locus) gene rearrangement analysis: medically necessary for non-Hodgkin's lymphoma, systemic light chain amyloidosis
  • Microsatellite instability (MSI) molecular testing: medically necessary for adrenal gland tumor (incl. adrenocortical carcinoma); biliary tract cancers (extrahepatic cholangiocarcinoma, gallbladder cancer, intrahepatic cholangiocarcinoma); bone cancer (chondrosarcoma, chordoma, Ewing sarcoma, osteosarcoma); invasive breast cancer; cervical cancer; colon cancer (incl. appendiceal adenocarcinoma); esophageal and esophagogastric junction cancers; gastric cancer; head and neck cancer (incl. salivary gland tumors); Lynch syndrome; neuroendocrine tumors; occult primary; ovarian/fallopian tube/primary peritoneal cancer; penile cancer; prostate cancer; rectal cancer; small bowel adenocarcinoma; testicular cancer (nonseminoma, seminoma); thyroid carcinoma (anaplastic, follicular, oncocytic, papillary); upper genitourinary tract tumors; uterine neoplasms (endometrial carcinoma, uterine sarcoma); vulvar cancer (squamous cell carcinoma)
  • Mismatch repair (MSI/dMMR: MLH1, MSH2, MSH6, PMS2) tumor testing: medically necessary for breast cancer, ovarian cancer, colorectal cancer, small bowel adenocarcinoma, esophageal cancer, esophagogastric junction cancer, gastric cancer, pancreatic cancer, cholangiocarcinoma, gallbladder cancer, pancreatic adenocarcinoma, cervical cancer, uterine cancer, prostate cancer, testicular cancer, penile cancer, myelodysplastic syndromes, Ewing sarcoma, occult primary
  • PCR for T-cell receptor gamma chain gene rearrangement: medically necessary for mycosis fungoides diagnosis
  • Next generation sequencing of tumor DNA to detect or quantify minimal residual disease (MRD): medically necessary for acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), multiple myeloma
  • Targeted hematologic genomic sequencing panel (5-50 genes): medically necessary for acute lymphocytic leukemia, acute myeloid leukemia, chronic myelogenous leukemia, myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN)
  • Targeted solid organ genomic sequencing panel (5-50 genes): medically necessary for advanced esophageal and esophagogastric junction cancer; advanced gastric cancer; colorectal cancer; cutaneous melanoma; non-small cell lung cancer; ovarian cancer; pancreatic cancer; prostate cancer; stage IV or recurrent unresectable breast cancer
  • T-cell receptor gene rearrangements (TRA@, TRB@, TRD@, TRG@): medically necessary for T-cell prolymphocytic leukemia, T-cell large granular lymphocytic leukemia, nasal type extranodal NK/T-cell lymphoma, hepatosplenic gamma-delta T-cell lymphoma, peripheral T-cell lymphoma, primary cutaneous CD30+ T-cell lymphoproliferative disorders, myelodysplastic syndromes, Castleman's disease, mycosis fungoides/Sezary syndrome, myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase fusion genes
  • TERT (telomerase reverse transcriptase): medically necessary for gliomas (infiltrative supratentorial astrocytoma/oligodendroglioma, anaplastic gliomas/glioblastoma) and myelodysplastic syndrome (MDS)
  • Androgen receptor splice variant 7 (AR-V7) in circulating tumor cells (CTC): medically necessary to select therapy in metastatic castrate-resistant prostate cancer after progression on abiraterone or enzalutamide
  • Somatic genomic testing for JAK2 mutations: medically necessary for (a) qualitative assessment of JAK2-V617F sequence variant using detection thresholds up to 5% for initial diagnostic assessment in adults with chronic myeloproliferative disorder (CMPD) symptoms; (b) diagnostic assessment of polycythemia vera in adults; (c) differential diagnosis of essential thrombocytosis and primary myelofibrosis from reactive conditions in adults
  • Liquid biopsy (up to 50 genes): medically necessary for non-small cell lung cancer in members not medically fit for invasive sampling or with insufficient tissue for molecular analysis
  • PIK3CA: medically necessary for breast cancer and uterine sarcoma
  • PDGFRA: medically necessary for gastrointestinal stromal tumors (GIST), pediatric acute lymphoblastic leukemia
  • PDGFRB testing: medically necessary for myelodysplastic syndromes (MDS), dermatofibrosarcoma protuberans, acute lymphoblastic leukemia, myeloid/lymphoid neoplasms with peripheral blood eosinophilia and tyrosine kinase fusion genes
  • Afirma Thyroid FNA analysis: medically necessary for assessing fine needle aspiration samples from thyroid nodules that are indeterminate
  • Quest Diagnostics Thyroid Cancer Mutation Panel: medically necessary for indeterminate thyroid nodule fine needle aspiration samples
  • ThyGeNEXT Thyroid Oncogene Panel and ThyraMIR microRNA Classifier: medically necessary for indeterminate thyroid nodule fine needle aspiration samples
  • ThyroSeq: medically necessary for indeterminate thyroid nodule fine needle aspiration samples
  • Human epidermal growth factor receptor 2 (HER2/ERBB2) evaluation: medically necessary in biliary tract, bladder, breast, cervical, colorectal, esophageal, esophageal gastric junction, gastric, non-small cell lung cancer (NSCLC), ovarian/fallopian tube, salivary gland tumors
  • Human papillomavirus (HPV) tumor testing (p16): medically necessary for head and neck cancer (incl. oropharynx cancer) or occult primary cancers
  • Breast Cancer Index (BCI): medically necessary (when all criteria met) to assess necessity of adjuvant chemotherapy or adjuvant endocrine therapy in nonmetastatic (node negative) or 1-3 involved ipsilateral axillary lymph nodes, estrogen/progesterone receptor positive, HER2 negative breast cancer; also for HER2-negative breast cancer with 0-3 positive nodes after 5 years endocrine therapy without recurrence
  • EndoPredict (12-gene score): medically necessary (when all criteria met) to assess necessity of adjuvant chemotherapy in nonmetastatic (node negative) or 1-3 involved ipsilateral axillary lymph nodes, estrogen receptor positive, HER2 negative breast cancer
  • Mammaprint: medically necessary (when all criteria met) to assess necessity of adjuvant chemotherapy in nonmetastatic (node negative) or 1-3 involved ipsilateral axillary lymph nodes, estrogen/progesterone receptor positive, HER2 negative breast cancer with high clinical risk
  • Oncotype Dx Breast (21 gene RT-PCR): medically necessary (when all criteria met) to assess necessity of adjuvant chemotherapy in nonmetastatic (node negative) or 1-3 involved ipsilateral axillary lymph nodes, estrogen receptor positive, HER2 negative (or HER2 positive <1 cm) breast cancer
  • PAM50 Risk of Recurrence (ROR) Score (Prosigna): medically necessary (when all criteria met) to assess necessity of adjuvant chemotherapy in nonmetastatic (node negative), estrogen receptor positive, HER2 negative breast cancer
  • Urokinase plasminogen activator (uPA) and plasminogen activator inhibitor 1 (PAI-1): medically necessary to assess necessity of adjuvant chemotherapy in nonmetastatic (node negative), estrogen receptor positive, HER2 negative breast cancer; also for prognosis determination in newly diagnosed, node negative breast cancer
  • Decipher: medically necessary for NCCN very-low, low, or favorable intermediate-risk prostate cancer with >10 year life expectancy not yet treated and candidates for active surveillance/definitive therapy; OR intermediate-risk prostate cancer when deciding whether to add androgen-deprivation therapy to radiation; OR undetectable PSA after prostatectomy to determine adjuvant vs salvage radiation or initiate systemic therapies
  • DecisionDx-UM (Castle Biosciences): medically necessary for risk stratification of localized uveal melanoma
  • Oncotype DX Prostate: medically necessary for NCCN very-low, low, or favorable intermediate-risk prostate cancer with >10 year life expectancy not yet treated and candidates for active surveillance/definitive therapy; OR intermediate-risk prostate cancer when deciding whether to add androgen-deprivation therapy to radiation
  • Prolaris: medically necessary for NCCN very-low, low, or favorable intermediate-risk prostate cancer with >10 year life expectancy not yet treated and candidates for active surveillance/definitive therapy; OR intermediate-risk prostate cancer when deciding whether to add androgen-deprivation therapy to radiation
  • ProMark: medically necessary for NCCN very-low, low, or favorable intermediate-risk prostate cancer with >10 year life expectancy not yet treated and candidates for active surveillance/definitive therapy; OR intermediate-risk prostate cancer when deciding whether to add androgen-deprivation therapy to radiation
  • Fluorescence immunocytology (e.g., ImmunoCyt/uCyt): medically necessary as an adjunct to cystoscopy or cytology in monitoring persons with bladder cancer
  • Urinary biomarkers (bladder tumor antigen [BTA]; nuclear matrix protein [NMP22]; fibrin/fibrinogen degradation products [FDP]; fluorescence in situ hybridization [FISH]): medically necessary for follow-up of bladder cancer treatment; monitoring for eradication; and recurrences after eradication
  • Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS or MASS-FIX) and immunoprecipitation: medically necessary for detection and isotyping of immunoglobulin paraprotein (M-protein) in plasma cell dyscrasia evaluation and management
  • Veristrat proteomic testing: medically necessary for advanced NSCLC without EGFR/ALK mutations, progressed after one or more chemotherapy regimens, considered for erlotinib treatment

Covered codes

Codes listed in this Aetna policy. Check each one's prior-authorization verdict and Medicare rate:

Frequently asked questions

When does Aetna cover Tumor Markers (CPT 84152), and what gets it denied?
Aetna CPB 0352 covers a large catalog of tumor markers (serum proteins, immunohistochemistry/expression markers, somatic gene mutations and rearrangements, MSI/mismatch-repair testing, and named molecular panels) as medically necessary only when matched to a specific listed cancer type and clinical use (e.g., AFP for hepatocellular carcinoma, CA-125 for ovarian masses, BCR/ABL for CML, MSI/dMMR for the enumerated cancers, and breast/prostate genomic risk tests under defined receptor-status and risk criteria). The gate is strict marker-to-indication matching plus, for breast and prostate genomic tests, limits on using more than one test type or repeat testing; a long list of named assays and circulating markers (including multi-cancer early detection and most liquid biopsies outside small NSCLC panels) is considered experimental, investigational, or unproven. Coverage criteria include: 1p19q codeletion: medically necessary for astrocytomas and gliomas; ALK expression: medically necessary for pancreatic adenocarcinoma, pediatric Hodgkin's lymphoma, inflammatory myofibroblastic tumor (IMT) with ALK translocation, breast implant-associated ALCL, peripheral T-cell lymphoma, uterine sarcoma; ALK gene fusion: medically necessary as a biomarker in non-small cell lung cancer; ALK gene rearrangement: medically necessary for diffuse large B cell lymphoma, anaplastic thyroid carcinoma, primary cutaneous CD30+ T-cell lymphoproliferative disorders, post-transplant lymphoproliferative disorder, non-small cell lung cancer; BCR/ABL: medically necessary for acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), B-cell lymphoblastic lymphoma, chronic myelogenous leukemia (CML), suspected myeloproliferative neoplasm; CBFB: medically necessary for acute myeloid leukemia; FIP1L1-PDGFRA fusion oncogene: medically necessary for systemic mastocytosis with peripheral blood eosinophilia; FIP1L1-PDGFRA gene rearrangements: medically necessary for myeloid/lymphoid neoplasms with peripheral blood eosinophilia and tyrosine kinase fusion genes; PML/RARA: medically necessary for acute promyelocytic leukemia; APC: medically necessary for familial adenomatous polyposis (when criteria met) and desmoid fibromatosis; BRAF V600 mutation: medically necessary for indeterminate thyroid nodules, hairy cell leukemia, gastrointestinal stromal tumors, colorectal cancer, Lynch syndrome, non-small cell lung cancer, thyroid carcinoma, infiltrative glioma, pancreatic adenocarcinoma, melanoma; CALR (calreticulin): medically necessary for chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndrome, myeloproliferative neoplasms; EZH2: medically necessary for myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN) to evaluate for higher-risk mutations in primary myelofibrosis (PMF); FLT3 gene mutation: medically necessary for acute lymphoblastic leukemia, acute myeloid leukemia (AML), myelodysplastic syndromes, myeloproliferative neoplasms, myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase fusion genes; IDH1 and IDH2: medically necessary for acute myeloid leukemia (AML), chondrosarcoma, chronic myeloid leukemia (CML), glioma or glioblastoma, myelodysplastic syndromes, myeloproliferative neoplasms; IDH1, IDH2, and TERT mutation analysis: medically necessary for glioma or myelodysplastic syndrome (MDS); KRAS: medically necessary for metastatic colorectal cancer, myelodysplastic syndromes, non-small cell lung cancer, pancreatic adenocarcinoma, uterine sarcoma; MDM2 (murine double minute 2): medically necessary for uterine sarcoma and soft tissue sarcoma; MLH1 tumor promoter hypermethylation: medically necessary for endometrial cancer; MPL: medically necessary for chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndromes, myeloproliferative neoplasms; NPM1: medically necessary for acute myeloid leukemia (AML), chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndromes, myeloproliferative neoplasms; NRAS: medically necessary for colorectal cancer, myelodysplastic syndrome, blastic plasmacytoid dendritic cell neoplasm (BPDCN); NTRK: medically necessary for all solid tumors; PTEN: medically necessary for uterine sarcoma and persons meeting Cowden syndrome criteria; RUNX1: medically necessary for acute myeloid leukemia, myelodysplastic syndrome, systemic mastocytosis; SF3B1: medically necessary for chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndromes, myeloproliferative neoplasms, uveal melanoma; SRSF2: medically necessary for chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndromes, myeloproliferative neoplasms, systemic mastocytosis; TP53: medically necessary for acute myeloid leukemia, adult medulloblastoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, chronic myeloid leukemia (chronic phase, adult), endometrial carcinoma, malignant peritoneal or pleural mesothelioma, mantle cell lymphoma, myelodysplastic syndromes, myeloproliferative neoplasms, occult primary, pediatric acute lymphoblastic leukemia, peripheral T-cell lymphomas, splenic marginal zone lymphoma, uterine sarcoma, well-differentiated grade 3 neuroendocrine tumors; U2AF1: medically necessary for blastic plasmacytoid dendritic cell neoplasm (BPDCN), chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndromes, myeloproliferative neoplasms; ZRSR2: medically necessary for chronic myeloid leukemia (chronic phase, adult), myelodysplastic syndromes; BCL2 and BCL6: medically necessary for non-Hodgkin's lymphoma and Castleman's disease; Beta-2 microglobulin (B2M): medically necessary for multiple myeloma, non-Hodgkin's lymphoma, Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma; BIRC3 and MALT1: medically necessary for gastric MALT lymphoma, non-gastric MALT lymphoma, nodal marginal zone lymphoma, splenic marginal zone lymphoma; BTK (Bruton's tyrosine kinase): medically necessary for chronic lymphocytic leukemia/small lymphocytic lymphoma; CALB2 (calretinin): medically necessary for lung cancer and occult primary; CALCA (calcitonin): medically necessary for medullary thyroid cancer or adenocarcinoma or anaplastic/undifferentiated tumors of head and neck; CCND1 (cyclin D1): medically necessary for B-cell lymphomas, primary cutaneous B-cell lymphomas, chronic lymphocytic leukemia/small lymphocytic lymphoma, hairy cell leukemia; CD20: medically necessary for determining eligibility for anti-CD20 treatment (rituximab); CD25: medically necessary for determining eligibility for denileukin diftitox (Ontak) treatment; CD31 immunostaining: medically necessary for diagnosis of angiosarcoma; CD33: medically necessary for lymphoblastic lymphoma and determining eligibility for anti-CD33 treatment; CD52: medically necessary for post-transplant lymphoproliferative disorder, T-cell prolymphocytic leukemia, and determining eligibility for anti-CD52 treatment; CD117 (c-kit): medically necessary for acute myeloid leukemia, cutaneous melanoma, gastrointestinal stromal tumors, systemic mastocytosis; CHGA (chromogranin A): medically necessary for neuroendocrine tumors, non-small cell lung cancer, small cell lung cancer, Merkel cell carcinoma, occult primary; INHA (inhibin): medically necessary for ovarian cancer or pelvic mass; Estrogen receptors (ESR1): medically necessary for breast cancer, endometrial carcinoma, non-small cell lung cancer, occult primary, ovarian cancer, uterine sarcoma; Progesterone receptors (PGR): medically necessary for breast cancer, non-small cell lung cancer, occult primary, uterine sarcoma; MYD88: medically necessary to differentiate Waldenstrom's macroglobulinemia (WM) versus marginal zone lymphoma (MZL) if plasmacytic differentiation present; and for gastric MALT lymphoma, nodal marginal zone lymphoma, nongastric MALT lymphoma, splenic marginal zone lymphoma, multiple myeloma; Myeloperoxidase (MPO) immunostaining, CEBPA mutation, and KIT mutation: medically necessary for acute myeloid leukemia diagnosis; PLCG2 (phospholipase C gamma 2): medically necessary for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); Steroid hormone receptor status in pre-menopausal and post-menopausal members: medically necessary to identify individuals for endocrine adjuvant therapy; Thyroglobulin antibodies: medically necessary for thyroid cancer; Thyroglobulin (TG): medically necessary for thyroid cancer, occult primary, adenocarcinoma or anaplastic/undifferentiated tumors of head and neck; Thyroid transcription factor-1 (TTF-1): medically necessary for lung cancer or neuroendocrine tumors; Thymidine kinase: medically necessary for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); Vascular endothelial growth factor (VEGF): medically necessary for Castleman's disease; WT-1 gene expression: medically necessary for desmoplastic round cell tumors, ovarian clear cell carcinomas, non-small cell lung cancer, occult primary; ZAP-70: medically necessary for assessing prognosis and need for aggressive therapy in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); 5-hydroxyindoleacetic acid (5-HIAA): medically necessary for neuroendocrine tumors; Alpha fetoprotein (AFP): medically necessary for testing hepatocellular carcinoma in hepatitis B carriers or persons with cirrhosis with specific risk factors; Alpha fetoprotein (AFP): medically necessary for hepatocellular carcinoma, mediastinal mass, ovarian cancer, pelvic mass, testicular cancer, testicular mass, thymic carcinoma, thymoma; Alpha fetoprotein (AFP) serial measurements: medically necessary to diagnose germ cell tumors in members with adenocarcinoma or carcinoma not otherwise specified involving mediastinal nodes, or for diagnosis and monitoring of hepatocellular carcinoma; CA 15-3 serial measurements: medically necessary in following course of treatment in women with breast cancer, especially advanced metastatic breast cancer; CA 19-9: medically necessary to monitor clinical response to therapy or detect early recurrence in gastric cancer, pancreatic cancer, gallbladder cancer, cholangiocarcinoma, ovarian cancer, small bowel adenocarcinoma, adenocarcinoma of ampulla of Vater; CA 19-9: medically necessary to rule out cholangiocarcinoma in persons with primary sclerosing cholangitis undergoing liver transplantation; CA 19-9: medically necessary for evaluation of jaundice, abnormal liver function tests (LFTs), hepatobiliary obstruction/abnormality on abdominal imaging; CA 19-9: medically necessary for initial work-up and surveillance for recurrence of ovarian masses; CA 19-9: medically necessary as a tumor marker for mucinous appendiceal carcinoma; Cancer antigen 125 (CA 125): medically necessary as a preoperative diagnostic aid in women with ovarian masses suspected malignant; Cancer antigen 125 (CA 125): medically necessary as a screening test for ovarian cancer with family history of hereditary ovarian cancer syndrome (performed concurrently with transvaginal ultrasound); Cancer antigen 125 (CA 125): medically necessary for diagnosis in women with new symptoms (bloating, pelvic/abdominal pain, difficulty eating, urinary frequency/urgency) persisting 3 weeks or more; Cancer antigen 125 (CA 125): medically necessary in members with adenocarcinoma of unknown primary to rule out ovarian cancer; Cancer antigen 125 (CA 125): medically necessary in members with known ovarian cancer as an aid in disease monitoring, response to treatment, recurrent disease detection, assessing second-look surgery value; Carcinoembryonic antigen (CEA): medically necessary as a preoperative prognostic indicator in members with known colorectal carcinoma or mucinous appendiceal carcinoma; Carcinoembryonic antigen (CEA) pancreatic cyst fluid: medically necessary to distinguish mucinous from non-mucinous malignant cysts; Carcinoembryonic antigen (CEA): medically necessary to detect asymptomatic recurrence of colorectal cancer after treatment; Carcinoembryonic antigen (CEA): medically necessary to monitor response to treatment for metastatic colorectal cancer; Carcinoembryonic antigen (CEA): medically necessary for cholangiocarcinoma, gallbladder cancer, lung cancer, medullary thyroid cancer, metastatic breast cancer, mucinous ovarian cancer, occult primary; Carcinoembryonic antigen (CEA): medically necessary for evaluation of jaundice, abnormal liver function tests, bile duct obstruction/abnormality on imaging; Human chorionic gonadotropin (HCG) serial measurement: medically necessary to diagnose germ cell tumors in members with adenocarcinoma or carcinoma not otherwise specified involving mediastinal nodes; Human chorionic gonadotropin (HCG) serial measurement: medically necessary to monitor treatment in members with trophoblastic tumors and germinal cell tumors; Human chorionic gonadotropin, beta (beta-HCG): medically necessary for mediastinal mass, ovarian cancer, pelvic mass, testicular mass, testicular cancer, thymoma, thymic carcinoma; Lactate dehydrogenase (LDH): medically necessary for acute lymphoblastic leukemia (ALL), bone cancer, kidney cancer, kidney mass, lung cancer, multiple myeloma, non-Hodgkin's lymphoma, pelvic mass, ovarian cancer, testicular cancer, testicular mass; Placental alkaline phosphatase (PLAP): medically necessary to diagnose germ cell seminoma and non-seminoma germ cell tumors in unknown primary cancers; Prostate-specific antigen (PSA): medically necessary for prostate cancer screening, staging, monitoring response to therapy, detecting disease recurrence; Copy number alterations molecular testing: medically necessary for pediatric diffuse high-grade glioma; IGH@ (immunoglobulin heavy chain locus) gene rearrangement analysis: medically necessary to detect abnormal clonal population(s) in non-Hodgkin's lymphomas, chronic lymphocytic leukemia, hairy cell leukemia, post-transplant lymphoproliferative disorder; IGK@ (immunoglobulin kappa light chain locus) gene rearrangement analysis: medically necessary for non-Hodgkin's lymphoma, systemic light chain amyloidosis; Microsatellite instability (MSI) molecular testing: medically necessary for adrenal gland tumor (incl. adrenocortical carcinoma); biliary tract cancers (extrahepatic cholangiocarcinoma, gallbladder cancer, intrahepatic cholangiocarcinoma); bone cancer (chondrosarcoma, chordoma, Ewing sarcoma, osteosarcoma); invasive breast cancer; cervical cancer; colon cancer (incl. appendiceal adenocarcinoma); esophageal and esophagogastric junction cancers; gastric cancer; head and neck cancer (incl. salivary gland tumors); Lynch syndrome; neuroendocrine tumors; occult primary; ovarian/fallopian tube/primary peritoneal cancer; penile cancer; prostate cancer; rectal cancer; small bowel adenocarcinoma; testicular cancer (nonseminoma, seminoma); thyroid carcinoma (anaplastic, follicular, oncocytic, papillary); upper genitourinary tract tumors; uterine neoplasms (endometrial carcinoma, uterine sarcoma); vulvar cancer (squamous cell carcinoma); Mismatch repair (MSI/dMMR: MLH1, MSH2, MSH6, PMS2) tumor testing: medically necessary for breast cancer, ovarian cancer, colorectal cancer, small bowel adenocarcinoma, esophageal cancer, esophagogastric junction cancer, gastric cancer, pancreatic cancer, cholangiocarcinoma, gallbladder cancer, pancreatic adenocarcinoma, cervical cancer, uterine cancer, prostate cancer, testicular cancer, penile cancer, myelodysplastic syndromes, Ewing sarcoma, occult primary; PCR for T-cell receptor gamma chain gene rearrangement: medically necessary for mycosis fungoides diagnosis; Next generation sequencing of tumor DNA to detect or quantify minimal residual disease (MRD): medically necessary for acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), multiple myeloma; Targeted hematologic genomic sequencing panel (5-50 genes): medically necessary for acute lymphocytic leukemia, acute myeloid leukemia, chronic myelogenous leukemia, myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN); Targeted solid organ genomic sequencing panel (5-50 genes): medically necessary for advanced esophageal and esophagogastric junction cancer; advanced gastric cancer; colorectal cancer; cutaneous melanoma; non-small cell lung cancer; ovarian cancer; pancreatic cancer; prostate cancer; stage IV or recurrent unresectable breast cancer; T-cell receptor gene rearrangements (TRA@, TRB@, TRD@, TRG@): medically necessary for T-cell prolymphocytic leukemia, T-cell large granular lymphocytic leukemia, nasal type extranodal NK/T-cell lymphoma, hepatosplenic gamma-delta T-cell lymphoma, peripheral T-cell lymphoma, primary cutaneous CD30+ T-cell lymphoproliferative disorders, myelodysplastic syndromes, Castleman's disease, mycosis fungoides/Sezary syndrome, myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase fusion genes; TERT (telomerase reverse transcriptase): medically necessary for gliomas (infiltrative supratentorial astrocytoma/oligodendroglioma, anaplastic gliomas/glioblastoma) and myelodysplastic syndrome (MDS); Androgen receptor splice variant 7 (AR-V7) in circulating tumor cells (CTC): medically necessary to select therapy in metastatic castrate-resistant prostate cancer after progression on abiraterone or enzalutamide; Somatic genomic testing for JAK2 mutations: medically necessary for (a) qualitative assessment of JAK2-V617F sequence variant using detection thresholds up to 5% for initial diagnostic assessment in adults with chronic myeloproliferative disorder (CMPD) symptoms; (b) diagnostic assessment of polycythemia vera in adults; (c) differential diagnosis of essential thrombocytosis and primary myelofibrosis from reactive conditions in adults; Liquid biopsy (up to 50 genes): medically necessary for non-small cell lung cancer in members not medically fit for invasive sampling or with insufficient tissue for molecular analysis; PIK3CA: medically necessary for breast cancer and uterine sarcoma; PDGFRA: medically necessary for gastrointestinal stromal tumors (GIST), pediatric acute lymphoblastic leukemia; PDGFRB testing: medically necessary for myelodysplastic syndromes (MDS), dermatofibrosarcoma protuberans, acute lymphoblastic leukemia, myeloid/lymphoid neoplasms with peripheral blood eosinophilia and tyrosine kinase fusion genes; Afirma Thyroid FNA analysis: medically necessary for assessing fine needle aspiration samples from thyroid nodules that are indeterminate; Quest Diagnostics Thyroid Cancer Mutation Panel: medically necessary for indeterminate thyroid nodule fine needle aspiration samples; ThyGeNEXT Thyroid Oncogene Panel and ThyraMIR microRNA Classifier: medically necessary for indeterminate thyroid nodule fine needle aspiration samples; ThyroSeq: medically necessary for indeterminate thyroid nodule fine needle aspiration samples; Human epidermal growth factor receptor 2 (HER2/ERBB2) evaluation: medically necessary in biliary tract, bladder, breast, cervical, colorectal, esophageal, esophageal gastric junction, gastric, non-small cell lung cancer (NSCLC), ovarian/fallopian tube, salivary gland tumors; Human papillomavirus (HPV) tumor testing (p16): medically necessary for head and neck cancer (incl. oropharynx cancer) or occult primary cancers; Breast Cancer Index (BCI): medically necessary (when all criteria met) to assess necessity of adjuvant chemotherapy or adjuvant endocrine therapy in nonmetastatic (node negative) or 1-3 involved ipsilateral axillary lymph nodes, estrogen/progesterone receptor positive, HER2 negative breast cancer; also for HER2-negative breast cancer with 0-3 positive nodes after 5 years endocrine therapy without recurrence; EndoPredict (12-gene score): medically necessary (when all criteria met) to assess necessity of adjuvant chemotherapy in nonmetastatic (node negative) or 1-3 involved ipsilateral axillary lymph nodes, estrogen receptor positive, HER2 negative breast cancer; Mammaprint: medically necessary (when all criteria met) to assess necessity of adjuvant chemotherapy in nonmetastatic (node negative) or 1-3 involved ipsilateral axillary lymph nodes, estrogen/progesterone receptor positive, HER2 negative breast cancer with high clinical risk; Oncotype Dx Breast (21 gene RT-PCR): medically necessary (when all criteria met) to assess necessity of adjuvant chemotherapy in nonmetastatic (node negative) or 1-3 involved ipsilateral axillary lymph nodes, estrogen receptor positive, HER2 negative (or HER2 positive <1 cm) breast cancer; PAM50 Risk of Recurrence (ROR) Score (Prosigna): medically necessary (when all criteria met) to assess necessity of adjuvant chemotherapy in nonmetastatic (node negative), estrogen receptor positive, HER2 negative breast cancer; Urokinase plasminogen activator (uPA) and plasminogen activator inhibitor 1 (PAI-1): medically necessary to assess necessity of adjuvant chemotherapy in nonmetastatic (node negative), estrogen receptor positive, HER2 negative breast cancer; also for prognosis determination in newly diagnosed, node negative breast cancer; Decipher: medically necessary for NCCN very-low, low, or favorable intermediate-risk prostate cancer with >10 year life expectancy not yet treated and candidates for active surveillance/definitive therapy; OR intermediate-risk prostate cancer when deciding whether to add androgen-deprivation therapy to radiation; OR undetectable PSA after prostatectomy to determine adjuvant vs salvage radiation or initiate systemic therapies; DecisionDx-UM (Castle Biosciences): medically necessary for risk stratification of localized uveal melanoma; Oncotype DX Prostate: medically necessary for NCCN very-low, low, or favorable intermediate-risk prostate cancer with >10 year life expectancy not yet treated and candidates for active surveillance/definitive therapy; OR intermediate-risk prostate cancer when deciding whether to add androgen-deprivation therapy to radiation; Prolaris: medically necessary for NCCN very-low, low, or favorable intermediate-risk prostate cancer with >10 year life expectancy not yet treated and candidates for active surveillance/definitive therapy; OR intermediate-risk prostate cancer when deciding whether to add androgen-deprivation therapy to radiation; ProMark: medically necessary for NCCN very-low, low, or favorable intermediate-risk prostate cancer with >10 year life expectancy not yet treated and candidates for active surveillance/definitive therapy; OR intermediate-risk prostate cancer when deciding whether to add androgen-deprivation therapy to radiation; Fluorescence immunocytology (e.g., ImmunoCyt/uCyt): medically necessary as an adjunct to cystoscopy or cytology in monitoring persons with bladder cancer; Urinary biomarkers (bladder tumor antigen [BTA]; nuclear matrix protein [NMP22]; fibrin/fibrinogen degradation products [FDP]; fluorescence in situ hybridization [FISH]): medically necessary for follow-up of bladder cancer treatment; monitoring for eradication; and recurrences after eradication; Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS or MASS-FIX) and immunoprecipitation: medically necessary for detection and isotyping of immunoglobulin paraprotein (M-protein) in plasma cell dyscrasia evaluation and management; Veristrat proteomic testing: medically necessary for advanced NSCLC without EGFR/ALK mutations, progressed after one or more chemotherapy regimens, considered for erlotinib treatment. Applies to 13 codes: 84152, 84153, 84154, 82378, 86300, 86301, 86304, 83950, 81206, 81207, 81208, 81301, G0103. Confirm prior-authorization status with Aetna before scheduling — it is code- and plan-specific, and this policy is not an exact authorization source. Policy exclusions and limitations: More than one type of breast adjuvant-therapy test (among Oncotype Dx Breast, Breast Cancer Index, EndoPredict, PAM50, Mammaprint, or uPA and PAI-1): experimental/investigational/unproven (EXCEPTION: more than one Oncotype Dx test may be medically necessary for persons with two or more histologically distinct tumors meeting criteria); Repeat Oncotype Dx testing or testing of multiple tumor sites in the same person: no proven value for other indications; Oncotype Dx for ductal carcinoma in situ (OncotypeDx DCIS), colon cancer (OncotypeDx Colon), and all other indications: experimental; Repeat testing or use of more than one type of prostate cancer progression-risk test (Oncotype Dx Prostate, Decipher, Prolaris, or ProMark): experimental/investigational/unproven; Various thyroid (Afirma, Quest, ThyGeNEXT, ThyroSeq) and genomic sequencing tests: not covered for repeat testing within 60 days of prior panel testing for the same indication; JAK2: experimental for quantitative allele burden assessment and pediatric myeloproliferative disorder diagnosis; ImmunoCyt/uCyt: experimental for hematuria evaluation, bladder cancer diagnosis, or screening asymptomatic persons; Urinary biomarkers (BTA, NMP22, FDP, FISH): experimental for bladder cancer screening, hematuria evaluation, symptomatic individual diagnosis, and all other indications; AFP: experimental for trophoblastic tumor diagnosis and oncologic indications beyond those listed in the medically necessary section; CA 125: experimental for screening colorectal or ovarian cancer (except as stated) and for differential diagnosis of colonic disease symptoms; CA 19-9: experimental for breast, colorectal, esophageal, gastro-esophageal, liver, uterine cancer; NUT midline carcinoma; prognosis/treatment prediction in bladder cancer; screening primary sclerosing cholangitis; CEA: experimental for colorectal cancer screening; as a sole adjuvant/systemic therapy determinant; esophageal carcinoma diagnosis; gastric cancer screening/diagnosis/staging/surveillance; PSA: experimental for breast cancer screening or differentiating benign versus malignant breast mass; PIK3CA: experimental for metastatic colorectal cancer/EGFR antagonist prediction (outside breast and uterine sarcoma indications); PLCG2: experimental for indications outside chronic lymphocytic leukemia (CLL); Vascular endothelial growth factor (VEGF): experimental except for Castleman's disease; NRAS mutation: experimental for metastatic colorectal cancer with anti-VEGF therapy prediction, and for melanoma prognosis/tyrosine kinase inhibitor selection; Ras oncogenes (except KRAS, NRAS, BRAF): experimental; 3D Predict Ovarian Doublet Panel: experimental; 3D Predict Ovarian PARP Panel: experimental; 4Kscore: experimental; Afirma Xpression Atlas: experimental; AidaBreast: experimental; AMBLor Melanoma Prognostic Test: experimental; ArteraAI Prostate Test: experimental; Assaying for loss of heterozygosity (LOH) on chromosome 18 (18q-LOH/DCC) for colorectal cancer: experimental; AssureMDx: experimental; Augusta Hematology Optical Genome Mapping: experimental; Auria for breast cancer screening: experimental; Avantect Ovarian Cancer Test: experimental; Avantect Pancreatic Cancer Test: experimental; Aventa FusionPlus: experimental; Aventa Lymphoma: experimental; BBDRisk Dx: experimental; Biodesix BDX-XL2, Nodify CDT, Nodify Lung, Nodify XL2 for distinguishing benign from malignant lung nodules: experimental; Biomarker Translation (BT) test for breast cancer: experimental; BioSpeciFx, including Comprehensive Tumor Profiling: experimental; Bladder CARE: experimental; BostonGene Tumor Portrait Test: experimental; BRAF and EGFR for esophageal carcinoma: experimental; Breast Cancer Gene Expression Ratio (HOXB13:IL17BR): experimental; BreastSentry: experimental; BTG Early Detection of Pancreatic Cancer: experimental; Cancerguard: experimental; Carcinoembryonic antigen cell adhesion molecule 6 (CEACAM6) for breast atypical hyperplasia, breast cancer risk prediction: experimental; Carcinoembryonic antigen cellular adhesion molecule-7 (CEACAM-7) as predictive marker for rectal cancer recurrence: experimental; Caris Molecular Intelligence/Target Now Molecular Profiling: experimental; Castle Biosciences myPath Melanoma: experimental; CDH1 for ovarian cancer: experimental; CDX2 as prognostic biomarker for colon cancer: experimental; Circulating cell-free nucleic acids (liquid biopsy) for colorectal cancer: experimental; Circulating tumor cell (CTC) assays for metastatic breast, colorectal, melanoma, prostate cancers (incl. CellMax Life, CELLSEARCH variants, FirstSightCRC): experimental; Circulating tumor DNA (ctDNA/liquid biopsy) for indications beyond small <50 gene panels for NSCLC (incl. CancerIntercept, Caris Assure, Colvera, DefineMBC, GeneStrat, FoundationACT, FoundationOne Liquid, Guardant Reveal, Guardant360, HPV-SEQ, LiquidHALLMARK, NEO PanTracer, Neolab Prostate, Northstar Response, Oncodetect, OptiSeq, Signatera, Tempus xF/xF+): experimental; CK5, CK14, p63, Racemase P504S for prostate cancer: experimental; ClarityDx Prostate: experimental; c-Met expression for advanced NSCLC, colorectal cancer prognosis prediction: experimental; Cyfra21-1, p53, squamous cell carcinoma antigen (SCC-Ag), VEGF-C for esophageal carcinoma: experimental; Cofilin (CFL1) in non-small cell lung cancer: experimental; ColonSentry: experimental; ColoPrint, CIMP, LINE-1 hypomethylation, immune cells for colon cancer: experimental; Colorectal Cancer DSA: experimental; ColoScape, ColoScape PLUS: experimental; ConfirmMDx for prostate cancer: experimental; Cxbladder tests (Detect+, Resolve, Triage) for microhematuria/bladder cancer: experimental; Cyclin D1 and FADD for head and neck squamous cell carcinoma: experimental; CyPath Lung: experimental; DAWN IO Melanoma: experimental; DCIS Recurrence Score: experimental; DCISionRT: experimental; Decipher Bladder: experimental; DecisionDx DiffDx-Melanoma: experimental; DecisionDx-Melanoma: experimental; DecisionDx-SCC: experimental; Des-gamma-carboxy prothrombin (DCP/PIVKA II) for hepatocellular carcinoma diagnosis/monitoring: experimental; DetermaRx: experimental; DiviTum TKa: experimental; EarlyCDT-Lung: experimental; EarlyDx: experimental; EarlyTect Bladder Cancer Detection (EarlyTect BCD): experimental; EGFR gene expression for transitional (urothelial) cell cancer: experimental; EGFRVIII for glioblastoma multiforme: experimental; EML4-ALK as diagnostic tool for stage IV NSCLC: experimental; Endeavor Comprehensive Genomic Profiling: experimental; Envisia Genomic Classifier: experimental; Epignostix CNS Tumor Methylation Classifier: experimental; Episeek Malignant Pleural Effusion (MPE): experimental; Excision repair cross-complementation group 1 protein (ERCC1) for NSCLC, colon, gastric cancer: experimental; ExoDx Prostate/ExosomeDx Prostate (IntelliScore): experimental; F2RL1 as biomarker in cervical cancer diagnosis/prognosis: experimental; Fibrin/fibrinogen degradation products (FDP) (DR-70, Onko-Sure) for colorectal cancer: experimental; FoundationOne, FoundationOne CDx, FoundationOne Heme, FoundationOne RNA (certain exceptions noted): experimental; Galectin-3 for breast, myelodysplastic syndrome, osteosarcoma, ovarian, pancreatic, prostate cancers: experimental; Gene hypermethylation for prostate cancer: experimental; GeneKey: experimental; GeneSearch Breast Lymph Node (BLN): experimental; Glutathione-S-transferase P1 (GSTP1) for prostate cancer screening/detection/management: experimental; GlycoKnow Ovarian: experimental; Grail Galleri Test: experimental; Guanylyl cyclase c (GCC/GUCY2C/Previstage GCC) for colorectal cancer: experimental; Guardant360 TissueNext: experimental; Haystack MRD Baseline and Haystack MRD Monitoring: experimental; HelioLiver: experimental; HeproDx: experimental; HER2 testing of appendiceal cancer: experimental; HERmark for breast cancer: experimental; HMGB1 and RAGE in cutaneous malignancy (basal cell carcinoma, melanoma, squamous cell carcinoma): experimental; Human epididymis protein 4 (HE4) for endometrial cancer, ovarian cancer, pelvic mass evaluation: experimental; Human papillomavirus 16 (HPV16) L1 gene as biomarker in cervical cancer: experimental; HC4 (NexCourse IHC4) for breast cancer: experimental; IGoCheck: experimental; IMMray PanCan-d for pancreatic ductal adenocarcinoma: experimental; Immunoassay using magnetic nanosensor for lung cancer diagnosis: experimental; Immunoscore for colon cancer recurrence risk/adjuvant therapy: experimental; Insight DX Breast Cancer Profile: experimental; Insight TNBCtype: experimental; Invitae PCM MRD Monitoring: experimental; Invitae PCM Tissue Profiling and MRD Baseline: experimental; IsoPSA: experimental; Ki67 for breast cancer: experimental; Ki-67 in upper tract urinary carcinoma: experimental; Labcorp Plasma Complete: experimental; Lectin-reactive alpha-fetoprotein (AFP-L3) for liver cancer: experimental; Long non-coding RNA in gallbladder cancer: experimental; LungLB, LungLife AI: experimental; LungOI: experimental; Lymph2CX, Lymph3Cx Lymphoma Molecular Classification: experimental; MammoCheck: experimental; Mammostrat: experimental; Mass spectrometry-based proteomic profiling for indeterminate pulmonary nodules: experimental; MatePair targeted rearrangements for hematolymphoid/solid organ neoplasia: experimental; Mayo Clinic Urinary Steroid Profile for adrenal malignancy management: experimental; MelaNodal Predict for cutaneous melanoma: experimental; Merkel SmT Oncoprotein Antibody Titer: experimental; Merkel Virus VP1 Capsid Antibody: experimental; Merlin Test (SkylineDx): experimental; MI Cancer Seek: experimental; MiCheck Prostate: experimental; Microarray-based gene expression (MyPRS) for multiple myeloma: experimental; Micro-RNAs (miRNAs) miRview mets, miRview mets2: experimental; M-inSight Patient Definition/Follow-Up Assessment: experimental; miR-31now: experimental; miR Sentinel Prostate Cancer: experimental; Molecular Intelligence Services/MI Profile/MI Profile X: experimental; Molecular subtyping profile (BluePrint) for breast cancer: experimental; mRNA gene expression profiling for cutaneous melanoma: experimental; mRNA sequence analysis: experimental; MSK-IMPACT: experimental; MUC1 in gastric cancer: experimental; Mucin 4 expression in colorectal cancer: experimental; Mucin 5AC (MUC5AC) for biliary tract cancer: experimental; My Prognostic Risk Signature (MyPRS): experimental; MyAML Next Generation Sequencing Panel: experimental; MyMRD Gene Panel: experimental; MyProstateScore (formerly Mi-Prostate Score), TMPRSS2:ERG, PCA3, PSA: experimental; MyProstateScore 2.0: experimental; NantHealth GPS Cancer Panels: experimental; NavDx: experimental; Neo Comprehensive - Heme Cancers: experimental; Neo Comprehensive - Myeloid Disorders: experimental; NeoTYPE Breast Tumor Profile: experimental; NeoTYPE Endometrial Tumor Profile: experimental; NETest: experimental; NeXT DX tumor profiling for breast cancer: experimental; NF1, RET, SDHB for ovarian cancer: experimental; Northstar Select: experimental; OmniSeq Advance DNA/RNA sequencing: experimental; OncInsights: experimental; OncoAssure Prostate: experimental; OncobiotaLUNG: experimental; Oncomap ExTra (formerly Oncotype MAP): experimental; OncoOmicDx Targeted Proteomic: experimental; OncoSignal: experimental; OncoTarget/OncoTreat: experimental; Oncotype MAP PanCancer Tissue: experimental; OncoVantage: experimental; Oncuria Detect, Oncuria Monitor, Oncuria Predict for bladder cancer: experimental; OptiSeq Dual Cancer Panel: experimental; OVA1/Overa: experimental; OvaCheck: experimental; OvaSure: experimental; OvaWatch: experimental; PancreaSeq Genomic Classifier: experimental; PancreaSure: experimental; PanCystPro Panel: experimental; PanGIA Prostate: experimental; Pathwork Tissue of Origin/ResponseDx Tissue of Origin: experimental; Percepta Bronchial Genomic Classifier: experimental; PGDx elio tissue complete for tumor mutation profiling: experimental; Pharmaco-oncologic Algorithm Treatment Ranking Service: experimental; Praxis Somatic Combined Whole Genome/Optical Genome Mapping: experimental; Praxis Somatic Optical Genome Mapping: experimental; Praxis Somatic Transcriptome: experimental; Praxis Somatic Whole Genome: experimental; Precise Tumor Molecular Profile (Myriad): experimental; PreciseDx Breast Cancer: experimental; PreOvar test for KRAS-variant ovarian cancer risk: experimental; ProOnc TumorSourceDx to identify tissue of origin: experimental; Prostate core mitotic: experimental; Prostate Px, Post-Op Px for prostate cancer recurrence: experimental; Prostate Cancer Risk Panel (FISH analysis): experimental; ProsTAV telomere-based biomarker for prostate cancer: experimental; Proveri prostate cancer assay (PPCA): experimental; PTEN gene expression for NSCLC: experimental; PurISTS Test: experimental; QuantiDNA Colorectal Cancer Triage: experimental; RadTox cfDNA: experimental; ResponseDx Colon: experimental; Ribonucleotide reductase subunit M1 (RRM1) for NSCLC/gemcitabine-based chemotherapy: experimental; RNA gene expression profiling for hematolymphoid/solid organ neoplasm: experimental; RNA Salah Targeted Expression Panel (RNA STEP): experimental; ROMA (Risk of Ovarian Malignancy Algorithm): experimental; Rotterdam Signature 76-gene panel: experimental; Salivary metatranscriptome analysis for oral cancers: experimental; SelectMDx for prostate cancer: experimental; Sentinel Prostate Test for screening/risk determination: experimental; Serum amyloid A for endometrial endometrioid carcinoma recurrence/therapy response: experimental; Solid Tumor Expanded Panel (Quest): experimental; Strata Select: experimental; TargetPrint gene expression for estrogen/progesterone/HER2 receptor status in breast cancer: experimental; Tempus p-MSI: experimental; Tempus p-Prostate: experimental; Tempus Tumor Origin (TO): experimental; Tempus xR: experimental; 41-gene signature assay: experimental; Theros CancerType ID: experimental; Thymidylate synthase: experimental; Thyroid GuidePx: experimental; ThyroSeq CRC for thyroid cancer: experimental; TMPRSS fusion genes for prostate cancer: experimental; Topographic genotyping (Pancragen/PathFinderTG): experimental; Total (whole) gene sequencing for cancer: experimental; TP53 mutation analysis for ovarian cancer: experimental; UriFind Blood Cancer for bladder cancer: experimental; UroAmp MRD for bladder cancer: experimental; UroCor cytology panels (DD23, P53) for bladder cancer: experimental; Vascular endothelial growth factor receptor 2 (VEGFR2) expression for colorectal cancer VEGF inhibition response prediction: experimental; Vesta AI Pathology for non-muscle invasive bladder cancer: experimental; Whole exome sequencing (somatic mutations) for cancer: experimental; The following circulating tumor markers are experimental for screening asymptomatic members, cancer diagnosis, staging, routine surveillance, and monitoring treatment response: a2-PAG; CA-SCC; MAM-6; TAG12; AMACR; Cathepsin-D; Cathepsin-L; Motility-related protein (MRP); TAG72; Cyclin E (fragments/whole); Multidrug resistance glycoprotein (Mdr1); TAG72.3; BCM; DU-PAN-2; TAG72.5; CA195; Early prostate cancer antigen (EPCA); NSE; TATI; CA242; Guanylyl cyclase C (Previstage GCC molecular); Thrombospondin-1 (THBS-1); CA50; Hepsin; PCA3 (DD3)/UpM3; Thymosin B15; CA549; Human kallikrein 2 (HK2); PNA/ELLA; TNF-alpha; CA72-4; LASA; Prostate stem cell antigen (PSCA); Topoisomerase II Alpha (TOP2A); CAM17-1; LPA; SCC; TPA; CAM26; M 26; SLEX; CAM29; M 29; SPAN-1; Nuclear Matrix Protein 66 (NMP66); CAR-3; MSA; SLX; Anti-malignin antibody screen (AMAS); CYFRA21-1; MCA; ST-439. Claims may be denied when the requested service falls under these. Some of these are conditional (note the stated exceptions) — confirm specifics against the bulletin.
Does Aetna require prior authorization for Tumor Markers?
Confirm prior-authorization status with Aetna before scheduling — it is code- and plan-specific, and this policy is not an exact authorization source.
What does Aetna exclude for Tumor Markers?
Policy exclusions and limitations: More than one type of breast adjuvant-therapy test (among Oncotype Dx Breast, Breast Cancer Index, EndoPredict, PAM50, Mammaprint, or uPA and PAI-1): experimental/investigational/unproven (EXCEPTION: more than one Oncotype Dx test may be medically necessary for persons with two or more histologically distinct tumors meeting criteria); Repeat Oncotype Dx testing or testing of multiple tumor sites in the same person: no proven value for other indications; Oncotype Dx for ductal carcinoma in situ (OncotypeDx DCIS), colon cancer (OncotypeDx Colon), and all other indications: experimental; Repeat testing or use of more than one type of prostate cancer progression-risk test (Oncotype Dx Prostate, Decipher, Prolaris, or ProMark): experimental/investigational/unproven; Various thyroid (Afirma, Quest, ThyGeNEXT, ThyroSeq) and genomic sequencing tests: not covered for repeat testing within 60 days of prior panel testing for the same indication; JAK2: experimental for quantitative allele burden assessment and pediatric myeloproliferative disorder diagnosis; ImmunoCyt/uCyt: experimental for hematuria evaluation, bladder cancer diagnosis, or screening asymptomatic persons; Urinary biomarkers (BTA, NMP22, FDP, FISH): experimental for bladder cancer screening, hematuria evaluation, symptomatic individual diagnosis, and all other indications; AFP: experimental for trophoblastic tumor diagnosis and oncologic indications beyond those listed in the medically necessary section; CA 125: experimental for screening colorectal or ovarian cancer (except as stated) and for differential diagnosis of colonic disease symptoms; CA 19-9: experimental for breast, colorectal, esophageal, gastro-esophageal, liver, uterine cancer; NUT midline carcinoma; prognosis/treatment prediction in bladder cancer; screening primary sclerosing cholangitis; CEA: experimental for colorectal cancer screening; as a sole adjuvant/systemic therapy determinant; esophageal carcinoma diagnosis; gastric cancer screening/diagnosis/staging/surveillance; PSA: experimental for breast cancer screening or differentiating benign versus malignant breast mass; PIK3CA: experimental for metastatic colorectal cancer/EGFR antagonist prediction (outside breast and uterine sarcoma indications); PLCG2: experimental for indications outside chronic lymphocytic leukemia (CLL); Vascular endothelial growth factor (VEGF): experimental except for Castleman's disease; NRAS mutation: experimental for metastatic colorectal cancer with anti-VEGF therapy prediction, and for melanoma prognosis/tyrosine kinase inhibitor selection; Ras oncogenes (except KRAS, NRAS, BRAF): experimental; 3D Predict Ovarian Doublet Panel: experimental; 3D Predict Ovarian PARP Panel: experimental; 4Kscore: experimental; Afirma Xpression Atlas: experimental; AidaBreast: experimental; AMBLor Melanoma Prognostic Test: experimental; ArteraAI Prostate Test: experimental; Assaying for loss of heterozygosity (LOH) on chromosome 18 (18q-LOH/DCC) for colorectal cancer: experimental; AssureMDx: experimental; Augusta Hematology Optical Genome Mapping: experimental; Auria for breast cancer screening: experimental; Avantect Ovarian Cancer Test: experimental; Avantect Pancreatic Cancer Test: experimental; Aventa FusionPlus: experimental; Aventa Lymphoma: experimental; BBDRisk Dx: experimental; Biodesix BDX-XL2, Nodify CDT, Nodify Lung, Nodify XL2 for distinguishing benign from malignant lung nodules: experimental; Biomarker Translation (BT) test for breast cancer: experimental; BioSpeciFx, including Comprehensive Tumor Profiling: experimental; Bladder CARE: experimental; BostonGene Tumor Portrait Test: experimental; BRAF and EGFR for esophageal carcinoma: experimental; Breast Cancer Gene Expression Ratio (HOXB13:IL17BR): experimental; BreastSentry: experimental; BTG Early Detection of Pancreatic Cancer: experimental; Cancerguard: experimental; Carcinoembryonic antigen cell adhesion molecule 6 (CEACAM6) for breast atypical hyperplasia, breast cancer risk prediction: experimental; Carcinoembryonic antigen cellular adhesion molecule-7 (CEACAM-7) as predictive marker for rectal cancer recurrence: experimental; Caris Molecular Intelligence/Target Now Molecular Profiling: experimental; Castle Biosciences myPath Melanoma: experimental; CDH1 for ovarian cancer: experimental; CDX2 as prognostic biomarker for colon cancer: experimental; Circulating cell-free nucleic acids (liquid biopsy) for colorectal cancer: experimental; Circulating tumor cell (CTC) assays for metastatic breast, colorectal, melanoma, prostate cancers (incl. CellMax Life, CELLSEARCH variants, FirstSightCRC): experimental; Circulating tumor DNA (ctDNA/liquid biopsy) for indications beyond small <50 gene panels for NSCLC (incl. CancerIntercept, Caris Assure, Colvera, DefineMBC, GeneStrat, FoundationACT, FoundationOne Liquid, Guardant Reveal, Guardant360, HPV-SEQ, LiquidHALLMARK, NEO PanTracer, Neolab Prostate, Northstar Response, Oncodetect, OptiSeq, Signatera, Tempus xF/xF+): experimental; CK5, CK14, p63, Racemase P504S for prostate cancer: experimental; ClarityDx Prostate: experimental; c-Met expression for advanced NSCLC, colorectal cancer prognosis prediction: experimental; Cyfra21-1, p53, squamous cell carcinoma antigen (SCC-Ag), VEGF-C for esophageal carcinoma: experimental; Cofilin (CFL1) in non-small cell lung cancer: experimental; ColonSentry: experimental; ColoPrint, CIMP, LINE-1 hypomethylation, immune cells for colon cancer: experimental; Colorectal Cancer DSA: experimental; ColoScape, ColoScape PLUS: experimental; ConfirmMDx for prostate cancer: experimental; Cxbladder tests (Detect+, Resolve, Triage) for microhematuria/bladder cancer: experimental; Cyclin D1 and FADD for head and neck squamous cell carcinoma: experimental; CyPath Lung: experimental; DAWN IO Melanoma: experimental; DCIS Recurrence Score: experimental; DCISionRT: experimental; Decipher Bladder: experimental; DecisionDx DiffDx-Melanoma: experimental; DecisionDx-Melanoma: experimental; DecisionDx-SCC: experimental; Des-gamma-carboxy prothrombin (DCP/PIVKA II) for hepatocellular carcinoma diagnosis/monitoring: experimental; DetermaRx: experimental; DiviTum TKa: experimental; EarlyCDT-Lung: experimental; EarlyDx: experimental; EarlyTect Bladder Cancer Detection (EarlyTect BCD): experimental; EGFR gene expression for transitional (urothelial) cell cancer: experimental; EGFRVIII for glioblastoma multiforme: experimental; EML4-ALK as diagnostic tool for stage IV NSCLC: experimental; Endeavor Comprehensive Genomic Profiling: experimental; Envisia Genomic Classifier: experimental; Epignostix CNS Tumor Methylation Classifier: experimental; Episeek Malignant Pleural Effusion (MPE): experimental; Excision repair cross-complementation group 1 protein (ERCC1) for NSCLC, colon, gastric cancer: experimental; ExoDx Prostate/ExosomeDx Prostate (IntelliScore): experimental; F2RL1 as biomarker in cervical cancer diagnosis/prognosis: experimental; Fibrin/fibrinogen degradation products (FDP) (DR-70, Onko-Sure) for colorectal cancer: experimental; FoundationOne, FoundationOne CDx, FoundationOne Heme, FoundationOne RNA (certain exceptions noted): experimental; Galectin-3 for breast, myelodysplastic syndrome, osteosarcoma, ovarian, pancreatic, prostate cancers: experimental; Gene hypermethylation for prostate cancer: experimental; GeneKey: experimental; GeneSearch Breast Lymph Node (BLN): experimental; Glutathione-S-transferase P1 (GSTP1) for prostate cancer screening/detection/management: experimental; GlycoKnow Ovarian: experimental; Grail Galleri Test: experimental; Guanylyl cyclase c (GCC/GUCY2C/Previstage GCC) for colorectal cancer: experimental; Guardant360 TissueNext: experimental; Haystack MRD Baseline and Haystack MRD Monitoring: experimental; HelioLiver: experimental; HeproDx: experimental; HER2 testing of appendiceal cancer: experimental; HERmark for breast cancer: experimental; HMGB1 and RAGE in cutaneous malignancy (basal cell carcinoma, melanoma, squamous cell carcinoma): experimental; Human epididymis protein 4 (HE4) for endometrial cancer, ovarian cancer, pelvic mass evaluation: experimental; Human papillomavirus 16 (HPV16) L1 gene as biomarker in cervical cancer: experimental; HC4 (NexCourse IHC4) for breast cancer: experimental; IGoCheck: experimental; IMMray PanCan-d for pancreatic ductal adenocarcinoma: experimental; Immunoassay using magnetic nanosensor for lung cancer diagnosis: experimental; Immunoscore for colon cancer recurrence risk/adjuvant therapy: experimental; Insight DX Breast Cancer Profile: experimental; Insight TNBCtype: experimental; Invitae PCM MRD Monitoring: experimental; Invitae PCM Tissue Profiling and MRD Baseline: experimental; IsoPSA: experimental; Ki67 for breast cancer: experimental; Ki-67 in upper tract urinary carcinoma: experimental; Labcorp Plasma Complete: experimental; Lectin-reactive alpha-fetoprotein (AFP-L3) for liver cancer: experimental; Long non-coding RNA in gallbladder cancer: experimental; LungLB, LungLife AI: experimental; LungOI: experimental; Lymph2CX, Lymph3Cx Lymphoma Molecular Classification: experimental; MammoCheck: experimental; Mammostrat: experimental; Mass spectrometry-based proteomic profiling for indeterminate pulmonary nodules: experimental; MatePair targeted rearrangements for hematolymphoid/solid organ neoplasia: experimental; Mayo Clinic Urinary Steroid Profile for adrenal malignancy management: experimental; MelaNodal Predict for cutaneous melanoma: experimental; Merkel SmT Oncoprotein Antibody Titer: experimental; Merkel Virus VP1 Capsid Antibody: experimental; Merlin Test (SkylineDx): experimental; MI Cancer Seek: experimental; MiCheck Prostate: experimental; Microarray-based gene expression (MyPRS) for multiple myeloma: experimental; Micro-RNAs (miRNAs) miRview mets, miRview mets2: experimental; M-inSight Patient Definition/Follow-Up Assessment: experimental; miR-31now: experimental; miR Sentinel Prostate Cancer: experimental; Molecular Intelligence Services/MI Profile/MI Profile X: experimental; Molecular subtyping profile (BluePrint) for breast cancer: experimental; mRNA gene expression profiling for cutaneous melanoma: experimental; mRNA sequence analysis: experimental; MSK-IMPACT: experimental; MUC1 in gastric cancer: experimental; Mucin 4 expression in colorectal cancer: experimental; Mucin 5AC (MUC5AC) for biliary tract cancer: experimental; My Prognostic Risk Signature (MyPRS): experimental; MyAML Next Generation Sequencing Panel: experimental; MyMRD Gene Panel: experimental; MyProstateScore (formerly Mi-Prostate Score), TMPRSS2:ERG, PCA3, PSA: experimental; MyProstateScore 2.0: experimental; NantHealth GPS Cancer Panels: experimental; NavDx: experimental; Neo Comprehensive - Heme Cancers: experimental; Neo Comprehensive - Myeloid Disorders: experimental; NeoTYPE Breast Tumor Profile: experimental; NeoTYPE Endometrial Tumor Profile: experimental; NETest: experimental; NeXT DX tumor profiling for breast cancer: experimental; NF1, RET, SDHB for ovarian cancer: experimental; Northstar Select: experimental; OmniSeq Advance DNA/RNA sequencing: experimental; OncInsights: experimental; OncoAssure Prostate: experimental; OncobiotaLUNG: experimental; Oncomap ExTra (formerly Oncotype MAP): experimental; OncoOmicDx Targeted Proteomic: experimental; OncoSignal: experimental; OncoTarget/OncoTreat: experimental; Oncotype MAP PanCancer Tissue: experimental; OncoVantage: experimental; Oncuria Detect, Oncuria Monitor, Oncuria Predict for bladder cancer: experimental; OptiSeq Dual Cancer Panel: experimental; OVA1/Overa: experimental; OvaCheck: experimental; OvaSure: experimental; OvaWatch: experimental; PancreaSeq Genomic Classifier: experimental; PancreaSure: experimental; PanCystPro Panel: experimental; PanGIA Prostate: experimental; Pathwork Tissue of Origin/ResponseDx Tissue of Origin: experimental; Percepta Bronchial Genomic Classifier: experimental; PGDx elio tissue complete for tumor mutation profiling: experimental; Pharmaco-oncologic Algorithm Treatment Ranking Service: experimental; Praxis Somatic Combined Whole Genome/Optical Genome Mapping: experimental; Praxis Somatic Optical Genome Mapping: experimental; Praxis Somatic Transcriptome: experimental; Praxis Somatic Whole Genome: experimental; Precise Tumor Molecular Profile (Myriad): experimental; PreciseDx Breast Cancer: experimental; PreOvar test for KRAS-variant ovarian cancer risk: experimental; ProOnc TumorSourceDx to identify tissue of origin: experimental; Prostate core mitotic: experimental; Prostate Px, Post-Op Px for prostate cancer recurrence: experimental; Prostate Cancer Risk Panel (FISH analysis): experimental; ProsTAV telomere-based biomarker for prostate cancer: experimental; Proveri prostate cancer assay (PPCA): experimental; PTEN gene expression for NSCLC: experimental; PurISTS Test: experimental; QuantiDNA Colorectal Cancer Triage: experimental; RadTox cfDNA: experimental; ResponseDx Colon: experimental; Ribonucleotide reductase subunit M1 (RRM1) for NSCLC/gemcitabine-based chemotherapy: experimental; RNA gene expression profiling for hematolymphoid/solid organ neoplasm: experimental; RNA Salah Targeted Expression Panel (RNA STEP): experimental; ROMA (Risk of Ovarian Malignancy Algorithm): experimental; Rotterdam Signature 76-gene panel: experimental; Salivary metatranscriptome analysis for oral cancers: experimental; SelectMDx for prostate cancer: experimental; Sentinel Prostate Test for screening/risk determination: experimental; Serum amyloid A for endometrial endometrioid carcinoma recurrence/therapy response: experimental; Solid Tumor Expanded Panel (Quest): experimental; Strata Select: experimental; TargetPrint gene expression for estrogen/progesterone/HER2 receptor status in breast cancer: experimental; Tempus p-MSI: experimental; Tempus p-Prostate: experimental; Tempus Tumor Origin (TO): experimental; Tempus xR: experimental; 41-gene signature assay: experimental; Theros CancerType ID: experimental; Thymidylate synthase: experimental; Thyroid GuidePx: experimental; ThyroSeq CRC for thyroid cancer: experimental; TMPRSS fusion genes for prostate cancer: experimental; Topographic genotyping (Pancragen/PathFinderTG): experimental; Total (whole) gene sequencing for cancer: experimental; TP53 mutation analysis for ovarian cancer: experimental; UriFind Blood Cancer for bladder cancer: experimental; UroAmp MRD for bladder cancer: experimental; UroCor cytology panels (DD23, P53) for bladder cancer: experimental; Vascular endothelial growth factor receptor 2 (VEGFR2) expression for colorectal cancer VEGF inhibition response prediction: experimental; Vesta AI Pathology for non-muscle invasive bladder cancer: experimental; Whole exome sequencing (somatic mutations) for cancer: experimental; The following circulating tumor markers are experimental for screening asymptomatic members, cancer diagnosis, staging, routine surveillance, and monitoring treatment response: a2-PAG; CA-SCC; MAM-6; TAG12; AMACR; Cathepsin-D; Cathepsin-L; Motility-related protein (MRP); TAG72; Cyclin E (fragments/whole); Multidrug resistance glycoprotein (Mdr1); TAG72.3; BCM; DU-PAN-2; TAG72.5; CA195; Early prostate cancer antigen (EPCA); NSE; TATI; CA242; Guanylyl cyclase C (Previstage GCC molecular); Thrombospondin-1 (THBS-1); CA50; Hepsin; PCA3 (DD3)/UpM3; Thymosin B15; CA549; Human kallikrein 2 (HK2); PNA/ELLA; TNF-alpha; CA72-4; LASA; Prostate stem cell antigen (PSCA); Topoisomerase II Alpha (TOP2A); CAM17-1; LPA; SCC; TPA; CAM26; M 26; SLEX; CAM29; M 29; SPAN-1; Nuclear Matrix Protein 66 (NMP66); CAR-3; MSA; SLX; Anti-malignin antibody screen (AMAS); CYFRA21-1; MCA; ST-439. Claims may be denied when the requested service falls under these. Some of these are conditional (note the stated exceptions) — confirm specifics against the bulletin.

Source

Aetna CPB 0352 — Tumor Markers

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This page summarizes Aetna clinical-coverage criteria extracted from policy CPB 0352 for educational purposes. Coverage policies change and vary by individual plan. Always verify against Aetna's current policy before performing a procedure or submitting a claim. d3rx is not responsible for claim denials or reimbursement issues.