It is the policy of health plans affiliated with Centene Corporation® that the specific genetic testing noted below is medically necessary when meeting the related criteria:
Tumor-Type Agnostic Solid Tumor Molecular Profiling Panels - I. Tumor-type agnostic solid tumor molecular profiling panels (0037U, 0048U, 0250U, 0329U, 0334U, 0379U, 0391U, 0473U, 81445, 81455, 81457, 81458, 81459) are considered medically necessary when: A. The member/enrollee meets both of the following: 1. The member/enrollee has a diagnosis of: a) Recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer, OR b) Histiocytosis, OR c) Non-small cell lung cancer (NSCLC) regardless of stage, OR d) Resectable or borderline resectable pancreatic adenocarcinoma, OR e) Central nervous system tumor; AND 2. The member/enrollee is seeking further cancer treatment (e.g., therapeutic chemotherapy). B. The member/enrollee meets one of the following: 1. The member/enrollee has a diagnosis of uterine neoplasm, AND a) The member/enrollee is undergoing initial evaluation, OR 2. The member/enrollee has a gastrointestinal stromal tumor, AND a) The tumor is negative for KIT and PDGFRA mutations. II. Repeat testing via a tumor-type agnostic solid tumor molecular profiling panel (0037U, 0048U, 0250U, 0329U, 0334U, 0379U, 0391U, 0473U, 81445, 81455, 81457, 81458, 81459) is considered medically necessary when: A. The member/enrollee has progression of: 1. Advanced or metastatic non-small cell lung cancer (NSCLC), OR 2. Advanced or metastatic gastric adenocarcinoma, OR 3. Metastatic prostate cancer. III. Tumor-type agnostic panels (codes above) are considered investigational for all other indications.
Targeted RNA Fusion Panels - I. RNA specific fusion panels with 5-50 genes performed on peripheral blood, bone marrow or solid tumors (81449) are considered medically necessary when: A. The member/enrollee has a diagnosis of, or is undergoing workup for: 1. Adult or pediatric acute lymphoblastic leukemia (ALL), OR 2. Glioma, OR 3. Histiocytosis, OR 4. Sarcoma; OR B. The member/enrollee has a gastrointestinal stromal tumor, AND 1. The tumor is negative for KIT and PDGFRA somatic mutations; OR C. The member/enrollee has non-small cell lung cancer, AND 1. DNA based NGS tumor profiling was negative for actionable mutations; OR D. The member/enrollee has a metastatic or advanced solid tumor, AND 1. There is a fusion-targeted therapy with regulatory approval for that cancer type, OR 2. DNA-based panel testing was negative for oncogenic driver mutations. II. RNA specific fusion panels (81449) are investigational for all other indications.
Broad RNA Fusion Panels - I. RNA fusion panel tests with 51 or more genes utilizing RNA analysis alone (0444U, 81456) are considered medically necessary when: A. The member/enrollee has a diagnosis of adult or pediatric acute lymphoblastic leukemia (ALL). II. RNA fusion panel tests with 51 or more genes utilizing RNA analysis alone are investigational for all other indications.
Broad Molecular Profiling Panels For Hematologic Malignancies and Myeloid Malignancy Panels - I. Broad molecular profiling panels for hematologic malignancies and myeloid malignancy panels in bone marrow or peripheral blood (81450, 81455) are considered medically necessary when: A. The member/enrollee is undergoing evaluation for acute myeloid leukemia (AML), OR B. The member/enrollee has newly diagnosed acute lymphoblastic leukemia (ALL), OR C. The member/enrollee has newly diagnosed myelodysplastic syndrome (MDS), OR D. The member/enrollee has suspected myelodysplastic syndrome (MDS) AND 1. Other causes of cytopenia(s) have been ruled out, OR E. The member/enrollee is suspected to have a myeloproliferative neoplasm (MPN), AND 1. This is the member/enrollee's initial genetic evaluation for suspected MPN, OR 2. Previous results of JAK2, CALR, and MPL analysis were negative, OR F. The member/enrollee has a diagnosis of chronic myelogenous leukemia (CML), AND 1. There has been progression to accelerated or blast phase, OR 2. Results of BCR-ABL1 kinase domain mutation analysis were negative. II. Repeat broad molecular profiling panels (81450, 81455) are considered medically necessary when: A. The member/enrollee has myelodysplastic syndrome (MDS), AND 1. The member/enrollee has relapsed after allo-HCT, OR B. The member/enrollee has acute lymphoblastic leukemia (ALL), AND 1. The member/enrollee is showing evidence of symptomatic relapse after maintenance therapy, OR C. The member/enrollee has acute myeloid leukemia (AML), AND 1. The member/enrollee has relapsed or refractory disease or progression on treatment. III. Broad molecular profiling panels for hematologic malignancies and myeloid malignancy panels are investigational for all other indications.
Colorectal Cancer Focused Molecular Profiling Panels - I. Colorectal cancer focused molecular profiling panels (81445, 81457) in solid tumors are considered medically necessary when: A. The member/enrollee has suspected or proven metastatic colorectal cancer, AND B. The panel contains, at a minimum, the following genes: KRAS, NRAS, BRAF. II. These panels are investigational for all other indications.
Lung Cancer Focused Molecular Profiling Panels - I. Lung cancer focused molecular profiling panels (0022U, 81457) are considered medically necessary when: A. The member/enrollee has a diagnosis of: 1. Advanced (stage IIIb or higher) or metastatic lung adenocarcinoma, OR 2. Advanced (stage IIIb or higher) or metastatic large cell lung carcinoma, OR 3. Advanced (stage IIIb or higher) or metastatic squamous cell lung carcinoma, OR 4. Advanced (stage IIIb or higher) or metastatic non-small cell lung cancer (NSCLC) not otherwise specified (NOS); AND B. The member/enrollee is seeking further cancer treatment (e.g., therapeutic chemotherapy). II. Repeat lung cancer-focused panels are medically necessary when the member/enrollee has progression on targeted therapy for NSCLC. III. These panels are investigational for all other indications.
Cutaneous Melanoma Focused Molecular Profiling Panels - I. Cutaneous melanoma focused molecular profiling panels (81445, 81457) are considered medically necessary when: A. The member/enrollee has a diagnosis of one of the following: 1. Stage III melanoma or higher, OR 2. Recurrent melanoma; AND B. The member/enrollee is seeking further cancer treatment (e.g., therapeutic chemotherapy); AND C. One of the following: 1. The member/enrollee has not had previous somatic testing via a multigene cancer panel for the same primary melanoma diagnosis, OR 2. The member/enrollee has had previous somatic testing via a multigene cancer panel for a primary melanoma diagnosis and has a new primary melanoma diagnosis for which this testing is being ordered. II. These panels are investigational for all other indications.
Acute Myeloid Leukemia (AML) Focused Molecular Profiling Panels - I. AML focused molecular profiling panels (0050U, 81450) for diagnosis or evaluation of AML are considered medically necessary when: A. The member/enrollee has a suspected or confirmed diagnosis of acute myeloid leukemia (AML). II. These panels are investigational for all other indications.
Myeloproliferative Neoplasms (MPNs) Panels - I. MPN molecular profiling panels (81206, 81207, 81208, 81219, 81270, 81279, 81338, 81339) are considered medically necessary when: A. The member/enrollee is suspected to have a myeloproliferative neoplasm (e.g., polycythemia vera, essential thrombocythemia, primary myelofibrosis, chronic myeloid leukemia), AND B. The panel includes, at a minimum, testing of the following genes: JAK2, CALR, and MPL. II. These panels are investigational for all other indications.
Tumor Specific BCR/ABL1 Kinase Domain Analysis - I. Tumor specific BCR/ABL1 kinase domain analysis (81170) in hematologic malignancies is considered medically necessary when: A. The member/enrollee has a diagnosis of: 1. Chronic myeloid leukemia (CML), OR 2. Ph-positive acute lymphocytic leukemia (ALL); AND B. The member/enrollee has any of the following: 1. Inadequate initial response to TKI therapy, OR 2. Loss of response to TKI therapy, OR 3. Disease progression to the accelerated or blast phase, OR 4. Relapsed/refractory disease.
Tumor Specific BCR/ABL1 FISH, Qualitative, or Quantitative Tests - I. Tumor specific BCR/ABL1 FISH, qualitative, or quantitative tests (0016U, 0040U, 81206, 81207, 81208, 81479, 88271, 88274, 88275, 88291) in hematologic malignancies are considered medically necessary when: A. The member/enrollee is suspected to have a myeloproliferative neoplasm, OR B. The member/enrollee is undergoing diagnostic workup for: 1. Acute lymphoblastic leukemia (ALL), OR 2. Acute myeloid leukemia (AML), OR 3. Chronic myeloid leukemia (CML), OR 4. B-cell lymphoma; OR C. The member/enrollee is undergoing monitoring of disease progression or minimal residual disease (MRD) monitoring using a quantitative test only for: 1. ALL, OR 2. AML, OR 3. CML, OR 4. B-cell lymphoma.
Tumor Specific BRAF Variant Analysis - I. Tumor specific BRAF variant analysis (81210) in solid tumors and hematologic malignancies is considered medically necessary when: A. The member/enrollee has a diagnosis of any of the following: 1. Suspected or proven metastatic colorectal cancer, OR 2. Advanced or metastatic non-small-cell lung cancer (NSCLC), OR 3. Stage III or stage IV cutaneous melanoma, OR 4. Indeterminate thyroid nodules requiring biopsy, OR 5. Anaplastic thyroid carcinoma, OR 6. Locally recurrent, advanced and/or metastatic papillary thyroid cancer, OR 7. Locally recurrent, advanced and/or metastatic follicular thyroid cancer, OR 8. Locally recurrent, advanced and/or metastatic Hurthle cell thyroid carcinoma, OR 9. Low-grade glioma or pilocytic astrocytoma, OR 10. Resectable or borderline resectable or locally advanced/metastatic pancreatic adenocarcinoma, OR 11. Metastatic small bowel adenocarcinoma, OR 12. Locally advanced, recurrent or metastatic esophageal or esophagogastric junction cancer, OR 13. Locally advanced, recurrent or metastatic gastric cancer; B. The member/enrollee is being evaluated for: 1. Hairy cell leukemia (for individuals without cHCL immunophenotype), OR 2. Histiocytosis (Langerhans cell histiocytosis or Erdheim-Chester disease).
Tumor Specific BRCA1/2 Variant Analysis - I. Tumor specific BRCA1/2 variant analysis (81162, 81163, 81164, 81165, 81166, 81167, 81216) in solid tumors is considered medically necessary when: A. The member/enrollee has a diagnosis of: 1. Ovarian, fallopian tube and/or primary peritoneal cancer, OR 2. Metastatic prostate cancer, OR 3. Resectable, borderline resectable, or locally advanced/metastatic pancreatic cancer.
Tumor Specific CALR Variant Analysis - I. Tumor specific CALR variant analysis (81219) is considered medically necessary when: A. The member/enrollee is suspected to have a myeloproliferative neoplasm (e.g., polycythemia vera, essential thrombocythemia, primary myelofibrosis, chronic myeloid leukemia), OR B. The member/enrollee is suspected to have a myelodysplastic syndrome (MDS).
Tumor Specific CEBPA Variant Analysis - I. Tumor specific CEBPA variant analysis (81218) in hematologic malignancies is considered medically necessary when: A. The member/enrollee is undergoing evaluation for acute myeloid leukemia (AML).
Tumor Specific EGFR Variant Analysis - I. Tumor specific EGFR variant analysis (81235) in solid tumors is considered medically necessary when: A. The member/enrollee has a diagnosis of: 1. Stage IB or higher lung adenocarcinoma, OR 2. Stage IB or higher large cell lung carcinoma, OR 3. Stage IB or higher squamous cell lung carcinoma, OR 4. Stage IB or higher non-small cell lung cancer (NSCLC) not otherwise specified (NOS).
Tumor Specific ESR1 Variant Analysis - I. Tumor specific ESR1 variant analysis (81479) in solid tumors is considered medically necessary when: A. The member/enrollee is one of the following: 1. Pre-menopausal female receiving ovarian ablation or suppression, OR 2. Postmenopausal female, OR 3. Adult male; AND B. The member/enrollee has a diagnosis of ER-positive and HER2-negative breast cancer; AND C. The member/enrollee has disease progression after one or two prior lines of endocrine therapy, including one line containing a CDK4/6 inhibitor.
Tumor Specific FLT3 Variant Analysis - I. Tumor specific FLT3 variant analysis (0023U, 0046U, 81245, 81246) in hematologic malignancies is considered medically necessary when: A. The member/enrollee has suspected or confirmed acute myeloid leukemia (AML), OR B. The member/enrollee has a diagnosis of: 1. Acute lymphocytic leukemia (ALL), OR 2. Myelodysplastic syndrome (MDS), OR 3. Myeloproliferative neoplasm.
Tumor Specific IDH1 and IDH2 Variant Analysis - I. Tumor specific IDH1 and IDH2 variant analysis (81120, 81121) in solid tumors or hematologic malignancies is considered medically necessary when: A. The member/enrollee has a diagnosis of: 1. Glioma, OR 2. Acute myeloid leukemia (AML).
Tumor Specific IGHV Somatic Hypermutation Analysis - I. Tumor specific IGHV somatic hypermutation analysis (81261, 81262, 81263) in hematologic malignancies is considered medically necessary when: A. The member/enrollee is undergoing work up for or has a diagnosis of: 1. Chronic lymphocytic leukemia (CLL), OR 2. Small lymphocytic leukemia (SLL), OR 3. Primary cutaneous B-cell lymphoma, OR 4. B-cell lymphoma.
Tumor Specific JAK2 Variant Analysis - I. Tumor specific JAK2 variant analysis (0017U, 0027U, 81270) in solid tumors or hematologic malignancies is considered medically necessary when: A. The member/enrollee is suspected to have a myeloproliferative neoplasm (MPN), OR B. The member/enrollee has acute lymphoblastic leukemia (ALL), OR C. The member/enrollee is suspected to have a myelodysplastic syndrome (MDS).
Tumor Specific KIT Variant Analysis - I. Tumor specific KIT variant analysis (81272, 81273) in solid tumors or hematologic malignancies is considered medically necessary when: A. The member/enrollee is being evaluated for systemic mastocytosis, OR B. The member/enrollee has a diagnosis of acute myeloid leukemia (AML), OR C. The member/enrollee has stage IV cutaneous melanoma, OR D. The member/enrollee has a suspected or confirmed gastrointestinal stromal tumor (GIST).
Tumor Specific KRAS Variant Analysis - I. Tumor specific KRAS variant analysis (81275, 81276) in solid tumors is considered medically necessary when: A. The member/enrollee has suspected or proven metastatic colorectal cancer, OR B. The member/enrollee is undergoing workup for metastasis of non-small cell lung cancer, OR C. The member/enrollee has resectable, borderline resectable, or locally advanced/metastatic pancreatic adenocarcinoma, OR D. The member/enrollee has unresectable or metastatic gallbladder cancer, OR E. The member/enrollee has unresectable or metastatic intrahepatic or extrahepatic cholangiocarcinoma.
Tumor Specific MGMT Methylation Analysis - I. Tumor specific MGMT promoter methylation analysis (81287) in solid tumors is considered medically necessary when: A. The member/enrollee has a diagnosis of: 1. High grade (stage III or IV) anaplastic oligodendroglioma, OR 2. High grade (stage III or IV) anaplastic astrocytoma, OR 3. High grade (stage III or IV) anaplastic glioma, OR 4. High grade (stage III or IV) glioblastoma.
Tumor Specific MLH1 Methylation Analysis - I. Tumor specific MLH1 promoter methylation analysis (81288) in solid tumors is considered medically necessary when: A. The member/enrollee has a diagnosis of any of the following: 1. Colorectal cancer, OR 2. Endometrial (uterine) cancer; AND B. Previous tumor testing showed loss of MLH1 on immunohistochemistry analysis.
Tumor Specific MPL Variant Analysis - I. Tumor specific MPL variant analysis (81338, 81339) in hematologic malignancies is considered medically necessary when: A. The member/enrollee is suspected to have a myeloproliferative neoplasm (MPN), OR B. The member/enrollee is suspected to have a myelodysplastic syndrome (MDS).
Tumor Specific Microsatellite Instability (MSI) Analysis - I. Tumor specific microsatellite instability (MSI) analysis (81301) in solid tumors is considered medically necessary when: A. The member/enrollee has a diagnosis of: 1. Colorectal cancer, OR 2. Endometrial cancer, OR 3. Gastric cancer, OR 4. Esophageal and esophagogastric junction cancer, OR 5. Recurrent, progressive or metastatic cervical carcinoma, OR 6. Testicular cancer with progression after high dose chemotherapy or third-line therapy, OR 7. Unresectable or metastatic gallbladder cancer, OR 8. Unresectable or metastatic intrahepatic or extrahepatic cholangiocarcinoma, OR 9. Unresectable or metastatic breast cancer, OR 10. Small bowel adenocarcinoma, OR 11. Resectable, borderline resectable, or metastatic pancreatic cancer, OR 12. Metastatic occult primary, OR 13. Recurrent, progressive or metastatic squamous cell carcinoma of the vulva, OR 14. Metastatic chondrosarcoma, OR 15. Metastatic chordoma, OR 16. Widely metastatic Ewing sarcoma, OR 17. Metastatic osteosarcoma, OR 18. Recurrent or metastatic vaginal cancer, OR 19. Recurrent ovarian cancer.
Tumor Specific NRAS Variant Analysis - I. Tumor specific NRAS variant analysis (81311) in solid tumors is considered medically necessary when: A. The member/enrollee has suspected or proven metastatic colorectal cancer.
Tumor Specific NPM1 Variant Analysis - I. Tumor specific NPM1 variant analysis (0049U, 81310) in hematological malignancies is considered medically necessary when: A. The member/enrollee has cytogenetically normal acute myeloid leukemia (AML).
Tumor Specific PIK3CA Variant Analysis - I. Tumor specific PIK3CA variant analysis (0155U, 81309) in solid tumors is considered medically necessary when: A. The member/enrollee has a diagnosis of recurrent or stage IV, HR positive, HER2 negative invasive breast cancer.
Tumor Specific TP53 Variant Analysis - I. Tumor specific TP53 variant analysis (81352) in bone marrow or peripheral blood is considered medically necessary when: A. The member/enrollee has a diagnosis of: 1. Acute myeloid leukemia (AML), OR 2. Chronic lymphocytic leukemia (CLL), OR 3. Small lymphocytic leukemia (SLL); AND B. The member/enrollee is undergoing diagnostic workup for mantle cell lymphoma (MCL).
HLA Typing for Transplantation - I. HLA typing for transplantation (81370, 81371, 81372, 81373, 81376, 81378, 81379, 81380, 81382) is considered medically necessary when the member/enrollee meets the following: A. The member/enrollee is being considered for any of the following: 1. Recipient of bone marrow transplantation, OR 2. Donor for bone marrow transplantation, OR 3. Recipient of solid organ transplantation, OR 4. Donor for solid organ transplantation. II. HLA typing for transplantation is investigational for all other indications.
Hematologic Minimal Residual Disease (MRD) Testing - I. Measurable (minimal) residual disease (MRD) analysis (0171U, 0364U) in bone marrow or peripheral blood is considered medically necessary when: A. The member/enrollee has a diagnosis of: 1. Acute Lymphocytic Leukemia (ALL), OR 2. Multiple Myeloma, OR 3. Chronic Lymphocytic Leukemia (CLL).
Evidence-Based Solid Tumor Minimal Residual Disease (MRD) Testing - I. MRD analysis for solid tumors using cell free DNA (0340U, 0422U, 81479) with sufficient evidence of clinical utility and validity is considered medically necessary when: A. Identification of recurrent, refractory, or progressive disease will require a change in management; AND B. The member/enrollee is not undergoing concurrent molecular laboratory testing for surveillance or monitoring for recurrent, refractory, or progressive disease; AND C. The member/enrollee meets one of the following: 1. The member/enrollee is currently being treated for cancer, AND a) The test has not previously been done for this cancer diagnosis, OR b) There is a clinical suspicion that the molecular profile of the tumor has changed, OR 2. The member/enrollee is not currently being treated for their cancer, AND a) The test has not been done in the past 12 months, OR b) There is a clinical suspicion for tumor recurrence; AND D. The member/enrollee meets one of the following test-specific conditions: 1. Guardant360 Response or Guardant Reveal for: a) Metastatic colon cancer, OR b) Colon cancer at any stage being monitored for response to immune checkpoint inhibitor therapy; OR 2. Signatera for: a) Metastatic colon cancer, OR b) Muscle invasive bladder cancer, OR c) Metastatic breast cancer, OR d) Any solid tumor being monitored for response to immune checkpoint inhibitor therapy. II. MRD analysis using solid tumor tissue is investigational for indications without demonstrated clinical utility and validity.
Emerging Evidence Solid Tumor Minimal Residual Disease (MRD) Testing - I. MRD analyses (0229U, 0306U, 0307U) with insufficient evidence of clinical validity using solid tumor tissue are considered investigational.
HPV-Related Solid Tumor Minimal Residual Disease (MRD) Testing - I. MRD analysis for HPV-related head and neck cancers using cell-free DNA (0356U) is medically necessary when: A. The member/enrollee has a personal history of HPV-driven oropharyngeal cancer; AND B. Identification of recurrence or progression will require a change in management; AND C. The member/enrollee is not undergoing concurrent surveillance or monitoring for recurrence or progression by any other method; AND D. The member/enrollee meets one of the following: 1. The member/enrollee is currently being treated for HPV-driven oropharyngeal cancer, AND a) The test has not previously been done for this cancer diagnosis, OR 2. The member/enrollee is not currently being treated for HPV-driven oropharyngeal cancer, AND a) The test has not been done in the past 12 months.
TUMOR MUTATIONAL BURDEN (TMB) - I. Tumor mutational burden (TMB) testing (81479) is considered medically necessary when: A. The member/enrollee has a diagnosis of recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; AND B. The member/enrollee has had progression of the cancer following prior treatment; AND C. The member/enrollee has no remaining satisfactory treatment options; AND D. The member/enrollee does not have central nervous system cancer.
RED BLOOD CELL GENOTYPING IN MULTIPLE MYELOMA - I. Red blood cell genotyping (0001U, 0180U, 0221U) in individuals with multiple myeloma is considered medically necessary when: A. The member/enrollee has a diagnosis of multiple myeloma; AND B. The member/enrollee is currently being treated or will be treated with either: 1. Daratumumab (Darzalex), OR 2. Isatuximab (Sarclisa); OR C. The test has not previously been done for this episode of cancer.
CANCER EXOME AND GENOME SEQUENCING - I. Cancer exome and genome sequencing in solid tumors and hematologic malignancies (0036U, 0297U, 81415, 81416, 81425, 81426) is considered investigational.