Aetna Pharmacogenetic Testing coverage criteria

What this means for the claim

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

Coverage criteria

• ABCD1 gene mutation testing: medically necessary for members considering elivaldogene autotemcel (Skysona) for cerebral adrenoleukodystrophy (CALD)
• Very long chain fatty acids (VLCFA) testing: medically necessary for members considering elivaldogene autotemcel (Skysona) for cerebral adrenoleukodystrophy (CALD)
• Anaplastic lymphoma kinase (ALK) testing: ALK fusion gene for members with NSCLC being considered for crizotinib, alectinib, or ceritinib
• ALK gene rearrangement testing: for members with NSCLC being considered for pembrolizumab
• BCR/ABL mutation testing: for members with chronic myeloid leukemia being considered for nilotinib (Tasigna)
• BRAF and NRAS mutation testing: for members with colorectal cancer being considered for cetuximab or panitumumab
• BRAF gene (V600E or V600K) mutation testing: for members with unresectable/metastatic melanoma being considered for vemurafenib, dabrafenib, trametinib, cobimetinib, binimetinib, or encorafenib
• BRAF gene (V600E or V600K) mutation testing: for members with metastatic colorectal cancer being considered for encorafenib
• BRAF gene (V600E or V600K) mutation testing: for members with recurrent/metastatic NSCLC being considered for dabrafenib, pembrolizumab, or vemurafenib
• BRAF gene (V600E or V600K) mutation testing: for members with thyroid carcinoma being considered for dabrafenib or vemurafenib
• BRCA testing (olaparib) for ovarian/fallopian tube/primary peritoneal cancer: for women treated with 3+ prior chemotherapy lines OR in complete/partial response to first-line platinum-based chemotherapy
• BRCA testing (olaparib) for pancreatic carcinoma: for metastatic disease that has not progressed on first-line platinum-based treatment
• BRCA testing (olaparib) for prostate cancer: for men with advanced/recurrent/metastatic disease treated with androgen-receptor-directed therapy
• BRCA testing (olaparib or talazoparib) for breast cancer: for HER2-negative women as adjuvant therapy or after prior chemotherapy (regardless of family history)
• BRCA testing (niraparib, somatic/tumor) for ovarian/fallopian tube/primary peritoneal cancer: for members with 3+ prior chemotherapy lines OR complete/partial response to 2+ platinum-based lines
• BRCA testing (rucaparib, somatic/tumor) for ovarian/fallopian tube/primary peritoneal cancer: after 2+ prior chemotherapy lines, except if prior positive germline BRCA
• BRCA testing (rucaparib, somatic/tumor) for prostate cancer: for advanced/recurrent/metastatic disease treated with androgen-receptor therapy AND taxane-based chemotherapy
• c-KIT testing: for members with gastrointestinal stromal tumors (GIST) being considered for imatinib mesylate
• c-KIT testing: for members with aggressive systemic mastocytosis being considered for imatinib mesylate
• Claudin 18 isoform 2 (CLDN18.2) testing: for members with gastric cancer or esophagogastric junction adenocarcinoma being considered for zolbetuximab (Vyloy)
• CRCdx RAS Mutation Detection Kit: for KRAS/NRAS gene mutations for panitumumab candidates with anal adenocarcinoma, colorectal cancer, or small bowel adenocarcinoma
• CFTR gene mutation testing (specific variants G551D, G1244E, G1349D, G178R, G551S, R117H, S1251N, S1255P, S549N, S549R): for cystic fibrosis members being considered for ivacaftor (Kalydeco)
• F508del mutation (CFTR gene) testing: for members with cystic fibrosis being considered for lumacaftor/ivacaftor (Orkambi)
• Cytochrome P450 CYP2C19 testing: for members prescribed clopidogrel (Plavix); repeat testing has no proven value
• Cytochrome P450 CYP2D6 testing (tetrabenazine): for members prescribed doses greater than 50 mg daily; repeat testing has no proven value
• Cytochrome P450 CYP2D6 testing (Gaucher disease): for type 1 Gaucher disease patients being considered for eliglustat (Cerdelga); repeat testing has no proven value
• Del(17p)/TP53 mutation testing: for members with chronic lymphocytic leukemia/small lymphocytic lymphoma being considered for venetoclax (Venclexta)
• DPYD gene variant testing: for members prior to fluoropyrimidine therapy (fluorouracil or capecitabine)
• EGFR exon 19 deletions/exon 21 (L858R) substitution mutation testing: for members with NSCLC being considered for osimertinib, erlotinib, dacomitinib, gefitinib, or afatinib
• EGFR exon 19 deletions/L858R mutation testing: for members with NSCLC being considered for pembrolizumab (Keytruda)
• EGFR exon 20 insertion mutation testing: for members with NSCLC being considered for amivantamab-vmjw (Rybrevant) or mobocertinib (Exkivity)
• EGFR exon deletions/L858R mutation testing: for members with NSCLC being considered for ipilimumab (Yervoy) or nivolumab (Opdivo)
• EGFR mutation testing (general): for predicting response to EGFR-targeting tyrosine kinase inhibitors in NSCLC
• EGFR T790 mutation testing: for members with NSCLC being considered for osimertinib (Tagrisso)
• ERBB2 (HER2) amplification testing: for breast, colorectal, esophageal, gastric, gastroesophageal junction, NSCLC, salivary gland, or uterine serous cancer candidates for trastuzumab, ado-trastuzumab emtansine, or pertuzumab
• ERBB2 (HER2) mutation testing: for breast, colorectal, esophageal, gastric, gastroesophageal junction, or NSCLC candidates for fam-trastuzumab deruxtecan-nxki (Enhertu)
• Estrogen receptor 1 (ESR1) gene mutation testing: for advanced/metastatic HER2-negative, ER-positive breast cancer with progression on endocrine therapy being considered for elacestrant (Orserdu)
• EZH2 mutation testing: for members with follicular lymphoma being considered for tazemetostat (Tazverik)
• Fibroblast growth factor receptor 2 (FGFR2) mutation testing: for members with cholangiocarcinoma being considered for pemigatinib (Pemazyre)
• FGFR2 and FGFR3 mutation testing: for members with urothelial carcinoma being considered for erdafitinib (Balversa)
• Folate receptor-alpha testing: for epithelial ovarian, fallopian tube, or primary peritoneal cancer candidates for mirvetuximab soravtansine-gynx (Elahere)
• FLT3 mutation assay: for members with acute myeloid leukemia (AML) being considered for midostaurin, gilteritinib, or sorafenib
• HLA class 1 genotyping: for allopurinol hypersensitivity reaction risk prior to therapy initiation
• HLA-A*02:01 genotyping: for uveal melanoma patients before tebentafusp-tebn (Kimmtrak) treatment initiation
• HLA-B*1502 genotyping: for members of Asian ancestry before carbamazepine (Tegretol) treatment initiation
• HLA-B*5701 screening: for HIV-1 infected members before abacavir (Ziagen) treatment initiation
• HLA-B*58:01 genotyping: for Asian members prior to allopurinol therapy initiation
• IDH1/IDH2 mutation testing: for AML candidates for enasidenib mesylate (Idhifa) or ivosidenib (Tibsovo)
• KRAS G12C mutation testing: for members with NSCLC being considered for sotorasib (Lumakras) or adagrasib (Krazati)
• KRAS mutation analysis (with BRAF reflex): for predicting non-response to cetuximab/panitumumab in anal adenocarcinoma, metastatic colorectal cancer, or small bowel adenocarcinoma
• KRAS mutation analysis: for predicting non-response to erlotinib in NSCLC treatment
• Mass spectrometry/tandem mass spectrometry: for busulfan dose monitoring for Hodgkin lymphoma and multiple myeloma
• Mesenchymal-epithelial transition (MET) exon 14 skipping mutation testing: for advanced/recurrent/metastatic NSCLC candidates for capmatinib (Tabrecta)
• MGMT gene methylation assay: for glioblastoma patients to predict temozolomide (Temodar) response
• Microsatellite instability (MSI-H) and mismatch repair deficiency (dMMR) testing: for metastatic colorectal cancer candidates for ipilimumab (Yervoy)
• Microsatellite instability (MSI-H) and mismatch repair deficiency (dMMR) testing: for metastatic colorectal cancer candidates for nivolumab (Opdivo)
• Microsatellite instability (MSI-H) and mismatch repair deficiency (dMMR) testing: for unresectable/metastatic solid tumor candidates for dostarlimab-gxly (Jemperli)
• Microsatellite instability (MSI-H) and mismatch repair deficiency (dMMR) testing: for unresectable/metastatic solid tumor candidates for pembrolizumab (Keytruda)
• Neurofilament light chain testing: for ALS patients being considered for tofersen (Qalsody)
• Neurotrophic receptor tyrosine kinase (NTRK) 1/2/3 gene fusion testing: for solid tumor candidates for larotrectinib (Vitrakvi) or entrectinib (Rozlytrek)
• Neurotrophic receptor tyrosine kinase (NTRK) 1/2/3 gene fusion testing: for solid tumor candidates for larotrectinib (Vitrakvi) alone
• NS3 Q80K polymorphism testing: for hepatitis C virus genotype 1a infection candidates for simeprevir (Olysio)
• NS5A resistance-associated polymorphism testing: for HCV genotype 1, 3, or 4 infection candidates for daclatasvir (Daklinza) or elbasvir/grazoprevir (Zepatier)
• PD-L1 expression testing (Ventana PD-L1 SP263): for urothelial carcinoma candidates for durvalumab (Imfinzi)
• PD-L1 expression testing (Ventana PD-L1 SP142): for triple-negative breast carcinoma, NSCLC, or urothelial carcinoma candidates for atezolizumab (Tecentriq)
• PD-L1 expression testing (PD-L1 IHC 22C3): for NSCLC candidates for pembrolizumab (Keytruda)
• PIK3CA mutation testing: for breast cancer candidates for inavolisib (Itovebi)
• PIK3CA mutation testing: for breast cancer candidates for alpelisib (Piqray)
• PIK3CA/AKT1/PTEN alterations detection: for hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer candidates for capivasertib (Truqap) plus fulvestrant (Faslodex)
• Platelet-derived growth factor receptor-beta (PDGFRB) gene rearrangement testing: for chronic myelomonocytic leukemia and myelodysplastic syndrome/myeloproliferative disease candidates for imatinib mesylate (Gleevec)
• Praxis Extended RAS Panel: for colorectal cancer without specific RAS mutations (KRAS exons 2, 3, 4; NRAS exons 2, 3, 4) candidates for panitumumab (Vectibix)
• RET fusion testing: for NSCLC or thyroid cancer candidates for pralsetinib (Gavreto)
• RET fusion testing: for NSCLC candidates for selpercatinib (Retevmo)
• ROS1 fusion testing: for NSCLC candidates for entrectinib (Rozlytrek)
• ROS1 testing (general): for predicting crizotinib (Xalkori) response for NSCLC treatment
• Superoxide dismutase 1 (SOD1) mutation testing: for adult ALS patients being considered for tofersen (Qalsody)
• Tumor mutational burden (TMB) testing: for unresectable/metastatic solid tumors progressing on standard treatment being considered for pembrolizumab (Keytruda) as last resort
• UGT1A1 is addressed elsewhere; coverage of specific companion-diagnostic FDA-approved tests applies when tied to the listed drug and indication above

Covered codes

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

• 81210·PA verdict·Rate
• 81225·PA verdict·Rate
• 81226·PA verdict·Rate
• 81235·PA verdict·Rate
• 81162·PA verdict·Rate
• 81217·PA verdict·Rate
• 81401·PA verdict·Rate

Frequently asked questions

When does Aetna cover Pharmacogenetic Testing (CPT 81210), and what gets it denied?

Aetna CPB 0715 covers specific pharmacogenetic and pharmacodynamic tests as medically necessary only when each test is tied to a particular FDA-approved drug and indication (for example, BRCA testing for olaparib-eligible cancers, EGFR/ALK/KRAS testing to direct NSCLC targeted therapy, or HLA-B*5701 before abacavir). The key gate is that the test must be the targeted, drug-linked companion assay for an eligible member; broad multi-gene pharmacogenomic panels (e.g., GeneSight, Genomind, OneOme RightMed) are experimental and investigational, and large comprehensive panels (e.g., FoundationOne, Guardant360, oncoReveal, xT CDx) are not medically necessary when a targeted single-gene test would suffice. Coverage criteria include: ABCD1 gene mutation testing: medically necessary for members considering elivaldogene autotemcel (Skysona) for cerebral adrenoleukodystrophy (CALD); Very long chain fatty acids (VLCFA) testing: medically necessary for members considering elivaldogene autotemcel (Skysona) for cerebral adrenoleukodystrophy (CALD); Anaplastic lymphoma kinase (ALK) testing: ALK fusion gene for members with NSCLC being considered for crizotinib, alectinib, or ceritinib; ALK gene rearrangement testing: for members with NSCLC being considered for pembrolizumab; BCR/ABL mutation testing: for members with chronic myeloid leukemia being considered for nilotinib (Tasigna); BRAF and NRAS mutation testing: for members with colorectal cancer being considered for cetuximab or panitumumab; BRAF gene (V600E or V600K) mutation testing: for members with unresectable/metastatic melanoma being considered for vemurafenib, dabrafenib, trametinib, cobimetinib, binimetinib, or encorafenib; BRAF gene (V600E or V600K) mutation testing: for members with metastatic colorectal cancer being considered for encorafenib; BRAF gene (V600E or V600K) mutation testing: for members with recurrent/metastatic NSCLC being considered for dabrafenib, pembrolizumab, or vemurafenib; BRAF gene (V600E or V600K) mutation testing: for members with thyroid carcinoma being considered for dabrafenib or vemurafenib; BRCA testing (olaparib) for ovarian/fallopian tube/primary peritoneal cancer: for women treated with 3+ prior chemotherapy lines OR in complete/partial response to first-line platinum-based chemotherapy; BRCA testing (olaparib) for pancreatic carcinoma: for metastatic disease that has not progressed on first-line platinum-based treatment; BRCA testing (olaparib) for prostate cancer: for men with advanced/recurrent/metastatic disease treated with androgen-receptor-directed therapy; BRCA testing (olaparib or talazoparib) for breast cancer: for HER2-negative women as adjuvant therapy or after prior chemotherapy (regardless of family history); BRCA testing (niraparib, somatic/tumor) for ovarian/fallopian tube/primary peritoneal cancer: for members with 3+ prior chemotherapy lines OR complete/partial response to 2+ platinum-based lines; BRCA testing (rucaparib, somatic/tumor) for ovarian/fallopian tube/primary peritoneal cancer: after 2+ prior chemotherapy lines, except if prior positive germline BRCA; BRCA testing (rucaparib, somatic/tumor) for prostate cancer: for advanced/recurrent/metastatic disease treated with androgen-receptor therapy AND taxane-based chemotherapy; c-KIT testing: for members with gastrointestinal stromal tumors (GIST) being considered for imatinib mesylate; c-KIT testing: for members with aggressive systemic mastocytosis being considered for imatinib mesylate; Claudin 18 isoform 2 (CLDN18.2) testing: for members with gastric cancer or esophagogastric junction adenocarcinoma being considered for zolbetuximab (Vyloy); CRCdx RAS Mutation Detection Kit: for KRAS/NRAS gene mutations for panitumumab candidates with anal adenocarcinoma, colorectal cancer, or small bowel adenocarcinoma; CFTR gene mutation testing (specific variants G551D, G1244E, G1349D, G178R, G551S, R117H, S1251N, S1255P, S549N, S549R): for cystic fibrosis members being considered for ivacaftor (Kalydeco); F508del mutation (CFTR gene) testing: for members with cystic fibrosis being considered for lumacaftor/ivacaftor (Orkambi); Cytochrome P450 CYP2C19 testing: for members prescribed clopidogrel (Plavix); repeat testing has no proven value; Cytochrome P450 CYP2D6 testing (tetrabenazine): for members prescribed doses greater than 50 mg daily; repeat testing has no proven value; Cytochrome P450 CYP2D6 testing (Gaucher disease): for type 1 Gaucher disease patients being considered for eliglustat (Cerdelga); repeat testing has no proven value; Del(17p)/TP53 mutation testing: for members with chronic lymphocytic leukemia/small lymphocytic lymphoma being considered for venetoclax (Venclexta); DPYD gene variant testing: for members prior to fluoropyrimidine therapy (fluorouracil or capecitabine); EGFR exon 19 deletions/exon 21 (L858R) substitution mutation testing: for members with NSCLC being considered for osimertinib, erlotinib, dacomitinib, gefitinib, or afatinib; EGFR exon 19 deletions/L858R mutation testing: for members with NSCLC being considered for pembrolizumab (Keytruda); EGFR exon 20 insertion mutation testing: for members with NSCLC being considered for amivantamab-vmjw (Rybrevant) or mobocertinib (Exkivity); EGFR exon deletions/L858R mutation testing: for members with NSCLC being considered for ipilimumab (Yervoy) or nivolumab (Opdivo); EGFR mutation testing (general): for predicting response to EGFR-targeting tyrosine kinase inhibitors in NSCLC; EGFR T790 mutation testing: for members with NSCLC being considered for osimertinib (Tagrisso); ERBB2 (HER2) amplification testing: for breast, colorectal, esophageal, gastric, gastroesophageal junction, NSCLC, salivary gland, or uterine serous cancer candidates for trastuzumab, ado-trastuzumab emtansine, or pertuzumab; ERBB2 (HER2) mutation testing: for breast, colorectal, esophageal, gastric, gastroesophageal junction, or NSCLC candidates for fam-trastuzumab deruxtecan-nxki (Enhertu); Estrogen receptor 1 (ESR1) gene mutation testing: for advanced/metastatic HER2-negative, ER-positive breast cancer with progression on endocrine therapy being considered for elacestrant (Orserdu); EZH2 mutation testing: for members with follicular lymphoma being considered for tazemetostat (Tazverik); Fibroblast growth factor receptor 2 (FGFR2) mutation testing: for members with cholangiocarcinoma being considered for pemigatinib (Pemazyre); FGFR2 and FGFR3 mutation testing: for members with urothelial carcinoma being considered for erdafitinib (Balversa); Folate receptor-alpha testing: for epithelial ovarian, fallopian tube, or primary peritoneal cancer candidates for mirvetuximab soravtansine-gynx (Elahere); FLT3 mutation assay: for members with acute myeloid leukemia (AML) being considered for midostaurin, gilteritinib, or sorafenib; HLA class 1 genotyping: for allopurinol hypersensitivity reaction risk prior to therapy initiation; HLA-A*02:01 genotyping: for uveal melanoma patients before tebentafusp-tebn (Kimmtrak) treatment initiation; HLA-B*1502 genotyping: for members of Asian ancestry before carbamazepine (Tegretol) treatment initiation; HLA-B*5701 screening: for HIV-1 infected members before abacavir (Ziagen) treatment initiation; HLA-B*58:01 genotyping: for Asian members prior to allopurinol therapy initiation; IDH1/IDH2 mutation testing: for AML candidates for enasidenib mesylate (Idhifa) or ivosidenib (Tibsovo); KRAS G12C mutation testing: for members with NSCLC being considered for sotorasib (Lumakras) or adagrasib (Krazati); KRAS mutation analysis (with BRAF reflex): for predicting non-response to cetuximab/panitumumab in anal adenocarcinoma, metastatic colorectal cancer, or small bowel adenocarcinoma; KRAS mutation analysis: for predicting non-response to erlotinib in NSCLC treatment; Mass spectrometry/tandem mass spectrometry: for busulfan dose monitoring for Hodgkin lymphoma and multiple myeloma; Mesenchymal-epithelial transition (MET) exon 14 skipping mutation testing: for advanced/recurrent/metastatic NSCLC candidates for capmatinib (Tabrecta); MGMT gene methylation assay: for glioblastoma patients to predict temozolomide (Temodar) response; Microsatellite instability (MSI-H) and mismatch repair deficiency (dMMR) testing: for metastatic colorectal cancer candidates for ipilimumab (Yervoy); Microsatellite instability (MSI-H) and mismatch repair deficiency (dMMR) testing: for metastatic colorectal cancer candidates for nivolumab (Opdivo); Microsatellite instability (MSI-H) and mismatch repair deficiency (dMMR) testing: for unresectable/metastatic solid tumor candidates for dostarlimab-gxly (Jemperli); Microsatellite instability (MSI-H) and mismatch repair deficiency (dMMR) testing: for unresectable/metastatic solid tumor candidates for pembrolizumab (Keytruda); Neurofilament light chain testing: for ALS patients being considered for tofersen (Qalsody); Neurotrophic receptor tyrosine kinase (NTRK) 1/2/3 gene fusion testing: for solid tumor candidates for larotrectinib (Vitrakvi) or entrectinib (Rozlytrek); Neurotrophic receptor tyrosine kinase (NTRK) 1/2/3 gene fusion testing: for solid tumor candidates for larotrectinib (Vitrakvi) alone; NS3 Q80K polymorphism testing: for hepatitis C virus genotype 1a infection candidates for simeprevir (Olysio); NS5A resistance-associated polymorphism testing: for HCV genotype 1, 3, or 4 infection candidates for daclatasvir (Daklinza) or elbasvir/grazoprevir (Zepatier); PD-L1 expression testing (Ventana PD-L1 SP263): for urothelial carcinoma candidates for durvalumab (Imfinzi); PD-L1 expression testing (Ventana PD-L1 SP142): for triple-negative breast carcinoma, NSCLC, or urothelial carcinoma candidates for atezolizumab (Tecentriq); PD-L1 expression testing (PD-L1 IHC 22C3): for NSCLC candidates for pembrolizumab (Keytruda); PIK3CA mutation testing: for breast cancer candidates for inavolisib (Itovebi); PIK3CA mutation testing: for breast cancer candidates for alpelisib (Piqray); PIK3CA/AKT1/PTEN alterations detection: for hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer candidates for capivasertib (Truqap) plus fulvestrant (Faslodex); Platelet-derived growth factor receptor-beta (PDGFRB) gene rearrangement testing: for chronic myelomonocytic leukemia and myelodysplastic syndrome/myeloproliferative disease candidates for imatinib mesylate (Gleevec); Praxis Extended RAS Panel: for colorectal cancer without specific RAS mutations (KRAS exons 2, 3, 4; NRAS exons 2, 3, 4) candidates for panitumumab (Vectibix); RET fusion testing: for NSCLC or thyroid cancer candidates for pralsetinib (Gavreto); RET fusion testing: for NSCLC candidates for selpercatinib (Retevmo); ROS1 fusion testing: for NSCLC candidates for entrectinib (Rozlytrek); ROS1 testing (general): for predicting crizotinib (Xalkori) response for NSCLC treatment; Superoxide dismutase 1 (SOD1) mutation testing: for adult ALS patients being considered for tofersen (Qalsody); Tumor mutational burden (TMB) testing: for unresectable/metastatic solid tumors progressing on standard treatment being considered for pembrolizumab (Keytruda) as last resort; UGT1A1 is addressed elsewhere; coverage of specific companion-diagnostic FDA-approved tests applies when tied to the listed drug and indication above. Applies to 7 codes: 81210, 81225, 81226, 81235, 81162, 81217, 81401. 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: Multi-gene pharmacogenetics panels (diagnostic tests identifying genetic variations affecting drug metabolism across multiple drug classes) are experimental and investigational/unproven; Aura Genetics Pharmacogenomics (PGx) Test - experimental and investigational; EffectiveRX Comprehensive Panel - experimental and investigational; Genecept Assay - experimental and investigational; GeneSight ADHD - experimental and investigational; GeneSight Analgesic - experimental and investigational; GeneSight MTHFR - experimental and investigational; GeneSight Psychotropic - experimental and investigational; GeneSightRx - experimental and investigational; GENETWORx Neuropsychiatric Panel - experimental and investigational; Genomind Pharmacogenetics Report - experimental and investigational; INFINITI Neural Response Panel - experimental and investigational; IDgenetix - experimental and investigational; Millennium PGT - experimental and investigational; MindX One Blood Test - experimental and investigational; MyGenVar Pharmacogenomics Test - experimental and investigational; OneOme RightMed Pharmacogenomic Test - experimental and investigational; PersonaGene Genetic Panels - experimental and investigational; PersonalisedRx - experimental and investigational; Proove Profiles - experimental and investigational; Psych HealthPGx Panel by RPRD Diagnostics - experimental and investigational; RightMed Comprehensive Test - experimental and investigational; RightMed Gene Report - experimental and investigational; RightMed Gene Test Exclude F2 and F5 - experimental and investigational; RightMed Mental Health Gene Report - experimental and investigational; RightMed Mental Health Medication Report - experimental and investigational; RightMed Oncology Gene Report - experimental and investigational; RightMed Oncology Medication Report - experimental and investigational; RightMed PGx16 Test - experimental and investigational; rxSEEK Epilepsy Drug Metabolism - experimental and investigational; Tempus nP - experimental and investigational; A1555G genotyping for aminoglycoside prescribing - experimental and investigational; Aegis Drug-Drug Interaction Test - experimental and investigational; Amerigene PGT pharmacogenetic testing panels - experimental and investigational; Apolipoprotein E (Apo E) genotyping for lipid-lowering medication response - experimental and investigational; Beta adrenergic receptor genotyping (treatment-resistant asthma and other indications) - experimental and investigational; Catechol-O-Methyltransferase (COMT) Genotype, Varies Test - experimental and investigational; Circulating tumor DNA (ctDNA/liquid biopsy) for predicting immunotherapy or targeted treatment response (e.g., Guardant360 Response) - experimental and investigational; ComplyRX urine test (Claro Labs) for drug monitoring - experimental and investigational; CQuentia pharmacogenetic comprehensive panel for antidepressants and drug therapy - experimental and investigational; CYP2C19 polymorphisms testing for fluoxetine - experimental and investigational; CYP2D6 genotyping for Alzheimer's disease response to donepezil (Aricept) - experimental and investigational; CYP2C9 genotyping for coumarin derivative dosing guidance - experimental and investigational; CYP2D6 genotyping for beta blocker response prediction - experimental and investigational; CYP2D6 genotyping for opioid medications - experimental and investigational; Genotyping for other cytochrome P450 polymorphisms beyond specified covered uses (e.g., opioid analgesics, warfarin, tamoxifen, proton pump inhibitors, antipsychotics, SSRIs) - experimental and investigational; EpiSwitch CiRT (Checkpoint-inhibitor Response Test) - experimental and investigational; IL28B polymorphism genotyping for interferon therapy in hepatitis C - experimental and investigational; Interferon-lambda 3 (IFNL3) genotyping for pegylated-interferon-alpha and ribavirin response prediction - experimental and investigational; Laboratory testing for area under the curve (AUC)-targeted 5-fluorouracil dosing (e.g., Myriad Genetics OnDose) - experimental and investigational; Methotrexate polyglutamates (Avise PG test) for methotrexate response in rheumatoid arthritis - experimental and investigational; Methylenetetrahydrofolate reductase (MTHFR) genotyping for antifolate chemotherapy and antidepressant therapy - experimental and investigational; Natera Signatera Molecular Monitoring (MRD) for breast cancer - experimental and investigational; NeuroIDgenetix test for medication selection in anxiety, depression, and psychiatric disorders - experimental and investigational; OncolyticAssuranceRX (Firstox) for oral anticancer medication adherence monitoring - experimental and investigational; PGxOnePlus genetic testing for anxiety and gastroesophageal reflux disease - experimental and investigational; Pharmacogenetic studies predicting chronic kidney disease medication response - experimental and investigational; Platelet reactivity/function testing (VerifyNow P2Y12 Assay, Ultegra System Rapid Platelet Function Assay-ASA) post-percutaneous coronary intervention - experimental and investigational; rs3798220 allele testing for chronic aspirin therapy selection - experimental and investigational; Serotonin Receptor Genotype (HTR2A and HTR2C) - experimental and investigational; Signatera for stage II/III colorectal cancer adjuvant chemotherapy consideration and post-treatment relapse monitoring - experimental and investigational; Snapshot Oral Fluid Compliance (Ethos) for prescription drug adherence monitoring - experimental and investigational; Thromboxane metabolites in urine (e.g., AspirinWorks) for aspirin resistance evaluation - experimental and investigational; Thymidylate synthase genetic polymorphisms predicting 5-fluorouracil toxicity - experimental and investigational; UCSF Pharmacogenomics Panel - experimental and investigational; UGT1A1 molecular assay for irinotecan dosage screening (colorectal cancer and other cancers) - experimental and investigational; UrSure tenofovir quantification test for pre-exposure prophylaxis adherence monitoring - experimental and investigational; VKORC1 polymorphism genotyping (warfarin and vitamin K epoxide reductase complex-metabolized drugs) - experimental and investigational; FoundationOne CDx and FoundationOne Liquid CDx - not medically necessary for assessing candidacy for alectinib (Alecensa) in NSCLC (no proven advantage over targeted ALK testing or small targeted panels); FoundationOne Liquid CDx - not medically necessary for assessing candidacy for encorafenib (Braftovi) in melanoma (BRAF V600E; no proven advantage over targeted testing); FoundationOne CDx and FoundationOne Liquid CDx - not medically necessary for BRCA assessment in ovarian cancer for olaparib (no proven advantage over targeted BRCA testing); FoundationOne Liquid CDx - not medically necessary for BRCA assessment in ovarian cancer for rucaparib; Guardant360CDx testing panel - not medically necessary for EGFR assessment in NSCLC for osimertinib (Tagrisso); FoundationOne Liquid CDx - not medically necessary for EGFR testing in NSCLC for osimertinib (Tagrisso), erlotinib, or gefitinib (Iressa); oncoReveal Dx Lung and Colon Cancer Assay (O/RDx-LCCA) - not medically necessary for EGFR mutations in NSCLC for erlotinib, afatinib (Gilotrif), gefitinib (Iressa), or dacomitinib (Vizimpro); Guardant360 CDx gene panel - not medically necessary for EGFR exon 20 insertion assessment in NSCLC for amivantamab-vmjw; FoundationOne Liquid CDx gene panel - not medically necessary for EGFR exon 20 insertion assessment in NSCLC for mobocertinib; Guardant360 CDx gene panel - not medically necessary for ERBB2 mutation assessment in NSCLC for fam-trastuzumab deruxtecan-nxki (Enhertu); Guardant360 CDx gene panel - not medically necessary for KRAS G12C assessment in NSCLC for sotorasib; Agilent Resolution ctDx FIRST assay - not medically necessary for KRAS G12C assessment in NSCLC for adagrasib; FoundationOne Liquid CDx gene panel - not medically necessary for MET exon 14 skipping assessment in NSCLC for capmatinib; FoundationOne CDx and FoundationOne Liquid CDx - not medically necessary for NTRK gene fusion assessment in solid tumors for larotrectinib or entrectinib (no proven advantage over targeted NTRK testing); TruSight Oncology Comprehensive (TSO Comp) - not medically necessary for NTRK fusion assessment in solid tumors for larotrectinib (no proven advantage over targeted NTRK testing); TruSight Oncology Comprehensive (TSO Comp) - not medically necessary for RET fusion assessment in NSCLC for selpercatinib (no proven advantage over targeted RET testing); FoundationOne Liquid CDx testing panel - not medically necessary for ROS1 fusion assessment in NSCLC for entrectinib; FoundationOne CDx - not medically necessary for MSI-H/dMMR testing in solid tumors for pembrolizumab; FoundationOne CDx - not medically necessary for tumor mutational burden (TMB) testing; FoundationOne CDx testing panel - not medically necessary for PIK3CA mutation assessment in breast cancer for alpelisib (Piqray); oncoReveal CDx panel - not medically necessary for EGFR exon 19 deletions and L858R mutations in NSCLC for EGFR tyrosine kinase inhibitors (no proven advantage over targeted variant testing); oncoReveal CDx panel - not medically necessary for KRAS G12D and G13D variants in colorectal cancer for cetuximab or panitumumab (no proven advantage over targeted variant testing); oncoReveal Dx Lung and Colon Cancer Assay (O/RDx-LCCA) - not medically necessary for colorectal cancer for cetuximab (Erbitux) or panitumumab (Vectibix); xT CDx test - not medically necessary for KRAS/NRAS mutation analysis in colorectal cancer for cetuximab (Erbitux) or panitumumab (Vectibix). Claims may be denied when the requested service falls under these.

Does Aetna require prior authorization for Pharmacogenetic Testing?

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 Pharmacogenetic Testing?

Policy exclusions and limitations: Multi-gene pharmacogenetics panels (diagnostic tests identifying genetic variations affecting drug metabolism across multiple drug classes) are experimental and investigational/unproven; Aura Genetics Pharmacogenomics (PGx) Test - experimental and investigational; EffectiveRX Comprehensive Panel - experimental and investigational; Genecept Assay - experimental and investigational; GeneSight ADHD - experimental and investigational; GeneSight Analgesic - experimental and investigational; GeneSight MTHFR - experimental and investigational; GeneSight Psychotropic - experimental and investigational; GeneSightRx - experimental and investigational; GENETWORx Neuropsychiatric Panel - experimental and investigational; Genomind Pharmacogenetics Report - experimental and investigational; INFINITI Neural Response Panel - experimental and investigational; IDgenetix - experimental and investigational; Millennium PGT - experimental and investigational; MindX One Blood Test - experimental and investigational; MyGenVar Pharmacogenomics Test - experimental and investigational; OneOme RightMed Pharmacogenomic Test - experimental and investigational; PersonaGene Genetic Panels - experimental and investigational; PersonalisedRx - experimental and investigational; Proove Profiles - experimental and investigational; Psych HealthPGx Panel by RPRD Diagnostics - experimental and investigational; RightMed Comprehensive Test - experimental and investigational; RightMed Gene Report - experimental and investigational; RightMed Gene Test Exclude F2 and F5 - experimental and investigational; RightMed Mental Health Gene Report - experimental and investigational; RightMed Mental Health Medication Report - experimental and investigational; RightMed Oncology Gene Report - experimental and investigational; RightMed Oncology Medication Report - experimental and investigational; RightMed PGx16 Test - experimental and investigational; rxSEEK Epilepsy Drug Metabolism - experimental and investigational; Tempus nP - experimental and investigational; A1555G genotyping for aminoglycoside prescribing - experimental and investigational; Aegis Drug-Drug Interaction Test - experimental and investigational; Amerigene PGT pharmacogenetic testing panels - experimental and investigational; Apolipoprotein E (Apo E) genotyping for lipid-lowering medication response - experimental and investigational; Beta adrenergic receptor genotyping (treatment-resistant asthma and other indications) - experimental and investigational; Catechol-O-Methyltransferase (COMT) Genotype, Varies Test - experimental and investigational; Circulating tumor DNA (ctDNA/liquid biopsy) for predicting immunotherapy or targeted treatment response (e.g., Guardant360 Response) - experimental and investigational; ComplyRX urine test (Claro Labs) for drug monitoring - experimental and investigational; CQuentia pharmacogenetic comprehensive panel for antidepressants and drug therapy - experimental and investigational; CYP2C19 polymorphisms testing for fluoxetine - experimental and investigational; CYP2D6 genotyping for Alzheimer's disease response to donepezil (Aricept) - experimental and investigational; CYP2C9 genotyping for coumarin derivative dosing guidance - experimental and investigational; CYP2D6 genotyping for beta blocker response prediction - experimental and investigational; CYP2D6 genotyping for opioid medications - experimental and investigational; Genotyping for other cytochrome P450 polymorphisms beyond specified covered uses (e.g., opioid analgesics, warfarin, tamoxifen, proton pump inhibitors, antipsychotics, SSRIs) - experimental and investigational; EpiSwitch CiRT (Checkpoint-inhibitor Response Test) - experimental and investigational; IL28B polymorphism genotyping for interferon therapy in hepatitis C - experimental and investigational; Interferon-lambda 3 (IFNL3) genotyping for pegylated-interferon-alpha and ribavirin response prediction - experimental and investigational; Laboratory testing for area under the curve (AUC)-targeted 5-fluorouracil dosing (e.g., Myriad Genetics OnDose) - experimental and investigational; Methotrexate polyglutamates (Avise PG test) for methotrexate response in rheumatoid arthritis - experimental and investigational; Methylenetetrahydrofolate reductase (MTHFR) genotyping for antifolate chemotherapy and antidepressant therapy - experimental and investigational; Natera Signatera Molecular Monitoring (MRD) for breast cancer - experimental and investigational; NeuroIDgenetix test for medication selection in anxiety, depression, and psychiatric disorders - experimental and investigational; OncolyticAssuranceRX (Firstox) for oral anticancer medication adherence monitoring - experimental and investigational; PGxOnePlus genetic testing for anxiety and gastroesophageal reflux disease - experimental and investigational; Pharmacogenetic studies predicting chronic kidney disease medication response - experimental and investigational; Platelet reactivity/function testing (VerifyNow P2Y12 Assay, Ultegra System Rapid Platelet Function Assay-ASA) post-percutaneous coronary intervention - experimental and investigational; rs3798220 allele testing for chronic aspirin therapy selection - experimental and investigational; Serotonin Receptor Genotype (HTR2A and HTR2C) - experimental and investigational; Signatera for stage II/III colorectal cancer adjuvant chemotherapy consideration and post-treatment relapse monitoring - experimental and investigational; Snapshot Oral Fluid Compliance (Ethos) for prescription drug adherence monitoring - experimental and investigational; Thromboxane metabolites in urine (e.g., AspirinWorks) for aspirin resistance evaluation - experimental and investigational; Thymidylate synthase genetic polymorphisms predicting 5-fluorouracil toxicity - experimental and investigational; UCSF Pharmacogenomics Panel - experimental and investigational; UGT1A1 molecular assay for irinotecan dosage screening (colorectal cancer and other cancers) - experimental and investigational; UrSure tenofovir quantification test for pre-exposure prophylaxis adherence monitoring - experimental and investigational; VKORC1 polymorphism genotyping (warfarin and vitamin K epoxide reductase complex-metabolized drugs) - experimental and investigational; FoundationOne CDx and FoundationOne Liquid CDx - not medically necessary for assessing candidacy for alectinib (Alecensa) in NSCLC (no proven advantage over targeted ALK testing or small targeted panels); FoundationOne Liquid CDx - not medically necessary for assessing candidacy for encorafenib (Braftovi) in melanoma (BRAF V600E; no proven advantage over targeted testing); FoundationOne CDx and FoundationOne Liquid CDx - not medically necessary for BRCA assessment in ovarian cancer for olaparib (no proven advantage over targeted BRCA testing); FoundationOne Liquid CDx - not medically necessary for BRCA assessment in ovarian cancer for rucaparib; Guardant360CDx testing panel - not medically necessary for EGFR assessment in NSCLC for osimertinib (Tagrisso); FoundationOne Liquid CDx - not medically necessary for EGFR testing in NSCLC for osimertinib (Tagrisso), erlotinib, or gefitinib (Iressa); oncoReveal Dx Lung and Colon Cancer Assay (O/RDx-LCCA) - not medically necessary for EGFR mutations in NSCLC for erlotinib, afatinib (Gilotrif), gefitinib (Iressa), or dacomitinib (Vizimpro); Guardant360 CDx gene panel - not medically necessary for EGFR exon 20 insertion assessment in NSCLC for amivantamab-vmjw; FoundationOne Liquid CDx gene panel - not medically necessary for EGFR exon 20 insertion assessment in NSCLC for mobocertinib; Guardant360 CDx gene panel - not medically necessary for ERBB2 mutation assessment in NSCLC for fam-trastuzumab deruxtecan-nxki (Enhertu); Guardant360 CDx gene panel - not medically necessary for KRAS G12C assessment in NSCLC for sotorasib; Agilent Resolution ctDx FIRST assay - not medically necessary for KRAS G12C assessment in NSCLC for adagrasib; FoundationOne Liquid CDx gene panel - not medically necessary for MET exon 14 skipping assessment in NSCLC for capmatinib; FoundationOne CDx and FoundationOne Liquid CDx - not medically necessary for NTRK gene fusion assessment in solid tumors for larotrectinib or entrectinib (no proven advantage over targeted NTRK testing); TruSight Oncology Comprehensive (TSO Comp) - not medically necessary for NTRK fusion assessment in solid tumors for larotrectinib (no proven advantage over targeted NTRK testing); TruSight Oncology Comprehensive (TSO Comp) - not medically necessary for RET fusion assessment in NSCLC for selpercatinib (no proven advantage over targeted RET testing); FoundationOne Liquid CDx testing panel - not medically necessary for ROS1 fusion assessment in NSCLC for entrectinib; FoundationOne CDx - not medically necessary for MSI-H/dMMR testing in solid tumors for pembrolizumab; FoundationOne CDx - not medically necessary for tumor mutational burden (TMB) testing; FoundationOne CDx testing panel - not medically necessary for PIK3CA mutation assessment in breast cancer for alpelisib (Piqray); oncoReveal CDx panel - not medically necessary for EGFR exon 19 deletions and L858R mutations in NSCLC for EGFR tyrosine kinase inhibitors (no proven advantage over targeted variant testing); oncoReveal CDx panel - not medically necessary for KRAS G12D and G13D variants in colorectal cancer for cetuximab or panitumumab (no proven advantage over targeted variant testing); oncoReveal Dx Lung and Colon Cancer Assay (O/RDx-LCCA) - not medically necessary for colorectal cancer for cetuximab (Erbitux) or panitumumab (Vectibix); xT CDx test - not medically necessary for KRAS/NRAS mutation analysis in colorectal cancer for cetuximab (Erbitux) or panitumumab (Vectibix). Claims may be denied when the requested service falls under these.

Source

Related

• All Aetna coverage policies
• Aetna prior-authorization requirements — which codes need PA, by CPT