National Medical Policy
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1 National Medical Policy Subject: Policy Number: Tumor Markers for Cancer NMP522 Effective Date*: July 2013 Updated: July 2017 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State's Medicaid manual(s), publication(s), citations(s) and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link X National Coverage Determination (NCD) Carcinoembryonic Antigen; Tumor Antigen by Immunoassay - CA 125; Tumor Antigen by Immunoassay - CA 15-3/CA 27.29; Tumor Antigen by Immunoassay - CA 19-9: X National Coverage Manual Citation Local Coverage Determination (LCD)* Molecular Diagnostic Tests (MDT); MolDX: Molecular Diagnostic Tests; Bladder/Urothelial Tumor Markers; MolDx:Prolaris Prostate Cancer Genomic Assay for men with Favorable Intermediate Risk Disease;MolDx Genomic Health Oncotype DX Prostate Cancer Assay (L36153); MolDX-CDD: Decipher Prostate Cancer Classifier Assay: Article (Local)* x Other Palmetto GBA. MOLDX: sf/docscathome/moldx Tumor Markers for Cancer Jul 17 1
2 None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Health Net Inc. considers the following tumor markers medically necessary for the diagnosis and/or management of cancer (more information on each marker can be found following the table): Tumor Marker Afirma Thyroid FNA Analysis AFP (alpha-fetoprotein) AFP, lactate dehydrogenase (LDH), and beta-human chorionic gonadotropin (beta hcg) ALK Gene rearrangement B2M (beta-2 microglobulin) Bladder-tumor antigen stat test (BTA) Calcitonin CA (cancer antigen) 15-3, also known as CA or Truquant RIA CA 19.9 CA125 Carcinoembryonic antigen (CEA) Cancer Thyroid Cancer Primary hepatocellular cancer Germ cell tumors Refer to policy, Molecular Tumor Markers for Non-Small lung Cancer Multiple myeloma; Chronic lymphocytic leukemia; Some lymphomas (see below) Bladder cancer Thyroid medullary carcinoma Metastatic breast cancer Pancreatic cancer; Gallbladder cancer; Cholangiocarcinoma; Carcinoma of the ampulla of Vater Epithelial ovarian cancer; Endometrial cancer Breast Cancer: Colorectal cancer; Medullary thyroid cancer Tumor Markers for Cancer Jul 17 2
3 Tumor Marker CgA (chromogranin A) CD- 117 (C-kit) (cluster of differentiation-117) Cyclin D1 EGFR (epidermal growth factor receptor) ER/PR (estrogen receptors and progesterone receptors) 5-HIAA (5-hydrocyindoleacetic acid) HE4 (human epididymis protein 4) HER2 (human epidermal growth factor receptor 2) IDH1, IDH2 Cancer Neuroendocrine tumors (e.g., carcinoid tumors, neuroblastoma, and small cell lung cancer) Gastrointestinal stromal tumors Mantle cell lymphoma Refer to policy, Molecular Tumor Markers for Non-Small lung Cancer Breast cancer Carcinoid tumors Ovarian cancer Refer to policy, Her2/neu Gliomas ImmunoCyt/uCyte+ Janus Kinase 2 (JAK2) KRAS gene sequencing MPO (myeloperoxidase) Nuclear-Matrix Protein (NMP22) NSE (neuron-specific enolase) Placental alkaline phosphatase (PLAP) PSA (prostate-specific antigen) Thyroglobulin UroVysion Bladder cancer Polycythemia vera, differential diagnosis of essential thrombocytosis, chronic myeloproliferative disorders (CMPD) and primary myelofibrosis (PMF) in adults Refer to policy, Molecular Tumor Markers for Non-Small lung Cancer and K-RAS Mutation Analysis of Colon Cancer Acute myeloid leukemia Bladder cancer Small cell lung cancer Germ cell seminoma and non-seminoma germ cell tumors in unknown primary cancers Prostate cancer Differentiated thyroid cancer Bladder cancer Afirma Thyroid FNA The Afirma Thyroid FNA Analysis is intended for adults with thyroid nodules at least 1 centimeter in size, that are indeterminate and who are being evaluated for the possibility of a thyroid malignancy. Tumor Markers for Cancer Jul 17 3
4 AFP (alpha-fetoprotein) Hepatocellular Cancer AFP is not frequently elevated in early stage hepatocellular carcinoma (HCC) thus its utility as a screening biomarker is limited. AFP testing can be useful in conjunction with other test results to guide management of patients for whom a diagnosis of HCC is suspected. AFP is also useful in monitoring individuals with HCC. AFP, lactate dehydrogenase (LDH), and beta-human chorionic gonadotropin (beta HCG) Germ Cell Tumors AFP, LDH and beta-hcg are critical in diagnosing germ cell tumors (GCTs), determining prognosis, and assessing treatment outcome. They are useful for monitoring all stages of nonseminomas. They are useful in monitoring metastatic seminomas because elevated marker levels are early signs of relapse. B2M (beta-2 microglobulin) Multiple Myeloma The level of beta-2 microglobulin reflects the tumor mass and is considered a standard measure of the tumor burden in multiple myeloma. Chronic Lymphocytic Leukemia Elevated levels of serum beta-2microglobulin have been shown to be a strong independent prognostic indicator for treatment-free intervals, response to treatment, and overall survival, in individuals with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) Lymphomas Beta-2 microglobulin may be useful prognostic indicator in anaplastic large cell lymphoma (ALCL) Beta-2 microglobulin is useful in the initial diagnostic work-up for Follicular lymphoma (FL), Diffuse Large B-Cell Lymphoma (DLBCL) Measurement of Beta-2 microglobulin may be useful in some circumstances in the initial work-up of mantle cell lymphoma, lymphoblastic lymphoma amnd Aids related B-Cell lymphoma. Bladder-tumor antigen stat test (BTA) Bladder Cancer Per the NCCN, urine molecular tests for urothelial tumor markers are now available. Most of these tests have a better sensitivity for detecting bladder cancer than urine cytology, but specificity is lower. However, it remains unclear whether these tests offer additional information that is useful for detection and management of non-muscle-invasive bladder tumors. NCCN considers this to be a 2B recommendation (i.e., Based on lower level of evidence, there is NCCN consensus that the intervention is appropriate) Calcitonin Medullary Thyroid Cancer Basal serum calcitonin and serum carcinoembryonic antigen (CEA) are generally accepted in the preoperative work-up for medullary thyroid cancer. Calcitonin is useful for post operative management and surveillance, to evaluate effectiveness of treatment and assess for recurrence of medullary thyroid cancer. Tumor Markers for Cancer Jul 17 4
5 CA 15-3; CA Metastatic breast cancer The NCCN states that monitoring of patients symptoms and cancer burden during treatment of metastatic breast disease is important to determine whether the treatment is providing benefit and that the patient does not have toxicity from an ineffective therapy. Increasing tumor markers (CEA, CA 15-3 and CA 27.29) are findings that are concerns for progression of disease, but may also be seen in the setting of responding disease. An isolated increase in tumor markers should rarely be used to declare progression of disease. Changes in bone lesions are often difficult to assess on plain or cross-sectional radiology or on bone scan. For these reasons, patient symptoms and serum tumor markers may be more helpful in patients with bone-dominant metastatic disease. CA 19.9 Pancreatic Cancer The NCCN reports that the best validated and most clinically useful biomarker in pancreatic cancer is CA CA 19-9 is commonly expressed and shed in pancreatic and hepatobiliary disease, and in many malignancies; thus it is not tumor specific. However, the degree of increase in CA 19-9 levels may be useful in differentiating pancreatic adenocarcinoma from inflammatory conditions of the pancreas. CA 19-9 is a good diagnostic marker in symptomatic individuals, but its low predictive value makes it a poor biomarker for screening. Preoperative CA 19-9 levels correlate with both AJCC staging and resectability and thus provide additional information for staging and determining resectability, along with information from imaging, laparoscopy and biopsy. CA 19-9 seems to have value as a prognostic marker. Low post operative levels or serial decrease following surgery have been found to correlate with survival for individuals undergoing resection for pancreatic cancer. Changes in CA 19-9 levels after chemotherapy in patients with advanced disease has been shown to be a reliable predictive marker for response to treatment. CA 19-9 may be undetectable in Lewis antigen-negative individuals. CA 19-9 may be falsely positive in cases of benign or malignant biliary obstruction and do not necessarily indicate cancer or advanced disease. NCCN recommends measurement of CA 19-9 levels prior to surgery (if bilirubin levels are normal), following surgery prior to administration of adjuvant therapy or for surveillance (category 2B, i.e., based on lower level evidence, there is consensus that intervention is appropriate) Biliary Tract Cancer CA 19-9 may be considered in initial workup of individuals with a suspicion of gallbladder cancer, although the markers are NOT specific for gallbladder cancer. CA 19-9 testing can be considered after biliary decompression. CA 19-9 may be considered in initial workup of individuals with a suspicion of cholangiocarcinoma, although the markers are NOT specific for cholangiocarcinoma. Ampullary Cancer Some ampullary cancers are associated with increased serum levels of CA 19-9 and/or carcinoembryonic antigen (CEA). Serial assay of these tumor markers may be useful for posttreatment follow-up. CA 125 Ovarian Cancer Tumor Markers for Cancer Jul 17 5
6 Per the NCCN, tumor markers (including CA-125, inhibin, AFP, and beta-hcg) can be measured if clinically indicated. Per the NCCN, CA 125 and other tumor markers may be done as clinically indicated prior to each cycle of chemotherapy. After completion of primary surgery and chemotherapy in individuals with all stages of ovarian cancer who have complete response, the recommendation is observation with follow-up. If the CA 125 level was initially elevated, the measurement of a CA 125 level or other tumor markers at each follow-up evaluation is recommended. The NCCN concurs with the Society of Gynecologic Oncology (SGO) opinion which states that individuals should discuss the pros and cons of CA 125 monitoring and that the use of CA 125 levels for surveillance is optional. The FDA has approved the use of HE4 and CA 125 for estimating the risk of ovarian cancer in women with a pelvic mass. Currently, the NCCN does not recommend the use of these biomarkers for determining the status of an undiagnosed pelvic mass. Endometrial Carcinoma Per the NCCN, in individuals with extrauterine disease, a serum CA 125 assay may be helpful in monitoring clinical response. However, serum CA 125 levels may be falsely increased in women who have peritoneal inflammation/infection or radiation injury, normal in women with isolated vaginal metastases and may not predict recurrence in the absence of other clinical findings. Both NCCN and SGO recommend that CA 125 and MRI/CT may be useful before surgery to assess if extrauterine disease is present. Hereditary Breast and Ovarian Cancer Syndrome (HBOC) For individuals with HBOC who have not elected salpingo-oophorectomy, the NCCN recommends considering concurrent transvaginal ultrasound (preferably day 1-10 of menstrual cycle in premenopausal women) and CA 125 (preferably after day 5 of menstrual cycle in premenopausal women) every 6 months starting at age 30y or 5-10 years before the earliest age of the first diagnosis of ovarian cancer in the family. Carcinoembryonic antigen (CEA) Breast Cancer Increasing tumor markers (CEA, CA 15-3 and CA 27.29) are findings that are concerns for progression of disease, but may also be seen in the setting of responding disease. An isolated increase in tumor markers should rarely be used to declare progression of disease. Changes in bone lesions are often difficult to assess on plain or cross-sectional radiology or on bone scan. For these reasons, patient symptoms and serum tumor markers may be more helpful in patients with bone-dominant metastatic disease. Colorectal Cancer Testing of CEA in the initial work-up is recommended for individuals who present with invasive colon cancer appropriate for resection. CEA determination should be included in the workup for individuals with metastatic synchronous adenocarcinoma. Colorectal Cancer Surveillance CEA testing is recommended at baseline and every 3-6 months for 2 years and then every 6 months for a total of 5 years, for patient with stage III disease and those with stage II disease if the clinician determines that the individual is a potential candidate for aggressive curative surgery. Tumor Markers for Cancer Jul 17 6
7 CEA testing is also recommended every 3-6 months for 2 years and then every 6 months for a total of 5 years, for individuals with stage IV disease with no NED after curative-intent surgery and subsequent adjuvant treatment. Surveillance of are similar to those recommendations for individuals with stage II/III disease, except that certain evaluations are performed more frequently. CEA testing is recommended every 3-6 months for the first 2 years. Routine CEA monitoring and routine CT scanning are not recommended beyond 5 years Medullary Thyroid Cancer Basal serum calcitonin and serum carcinoembryonic antigen (CEA) are generally accepted in the preoperative work-up for medullary thyroid cancer. A rapidly increasing CEA level, particularly in the setting of a stable calcitonin level may be important for predicting a worse prognosis. Measurement of CEA is useful for post operative management and surveillance, to evaluate effectiveness of treatment and assess for recurrence of medullary thyroid cancer. CgA (chromogranin A) Neuroendocrine tumors Chromogranin A may be used as a tumor marker; (NCCN category 3, i.e. based on any level of evidence, there is major NCCN disagreement that the intervention is appropriate) Although not diagnostic, elevated levels have been associated with recurrence. Analysis of a large prospective database showed that CgA levels elevated twice the normal limit or higher were associated with shorter survival times for individuals with metastatic neuroendocrine tumors. CgA levels can be elevated in other conditions (e.g., renal or hepatic insufficiency, hypertension, chronic gastritis) and are also commonly also elevated in the setting of concurrent proton pump inhibitors, thus caution should be used when considering initiating new therapy based on a rising CgA level in an asymptomatic individual with a tumor that appears stable. CD-117 (C-kit) (cluster of differentiation-117) Gastrointestinal Stromal Tumors Gastrointestinal stromal tumors (GISTs) that arise in adults are characterized by the near-universal expression of the CD117 antigen. The CD117 antigen is part of the KIT transmembrane receptor tyrosine kinase that is the product of the KIT (also denoted c-kit) protooncogene Cyclin D1 Non Hodgkins Lymphoma Per the NCCN, immunophenotyping/genetic testing is useful in the differential diagnosis of mature B-cell and NK/T-cell neoplasms in conjunction with clinical and morphologic correlation. In the differential diagnosis of small cell lymphomas [i.e., Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL), Mantle Cell Lymphoma (MCL), Hairy Cell Leukemia (HCL), Splenic Marginal Zone Lymphoma (MZL), extra-nodal MZL, nodal MZL, and Follicular Lymphoma] cyclin D1 is included in the panel for immunophenotyping. Distinguishing CLL/SLL from mantle cell lymphoma is essential and cyclin D1 expression is the most reliable marker for differentiating between CLL and MCL. In select cases, the use of cyclin D1 may be useful to differenciate PC-MZL from mantle cell lymphomas. Tumor Markers for Cancer Jul 17 7
8 Cyclin D1 is also include in the immunophenotyping panel for the diagnosis of medium-sized lymphomas [Burkitt lymphoma (BL), diffuse large B-cell lymphoma (DLBCL), blastoid variant of MCL.] Cyclin D1 positively confirms the diagnosis of blastoid MCL. ER/PR (estrogen receptors and progesterone receptors) Breast Cancer Per the NCCN, the work-up of individuals with invasive breast cancer should include determination of tumor estrogen/progesterone receptor (ER/PR) status and Her2 status. ER/PR tumor status is normally determined by immunohistochemistry (IHC) testing. Per NCCN, the revised AJCC cancer staging manual recommends the collection of prognostic factors, including tumor grade, estrogen receptor (ER) content, progesterone receptor (PR) content and human epidermal growth factor receptor 2 (HER2) status, although these characteristics do not specifically influence assigned stage of disease. 5-HIAA (5-hydrocyindoleacetic acid) Carcinoid Tumor 5-hydrocyindoleascetic acid (5-HIAA), a metabolite of serotonin may also be considered as a biochemical marker in some cases, particularly in individuals with small-intestinal carcinoid tumors. Baseline levels of 5-HIAA may be considered to monitor subsequent progression of disease. HE4 (human epididymis protein 4) Per NCCN, although human epididymis protein 4 (HE4) and CA125 appear to be useful in detecting ovarian cancer, recent data showthat several markers (including CA125, HE4, etc) do not increase early enough to be useful in detecting early-stage ovarian cancer. The FDA has approved the use of HE4 and CA 125 for estimating the risk of ovarian cancer in women with a pelvic mass. Currently, the NCCN does not recommend the use of these biomarkers for determining the status of an undiagnosed pelvic mass. IDH1, IDH2 (isocitrate dehydrogenase) Gliomas Per NCCN, mutations in the IDH genes are common in patients with low-grade gliomas and are reported to be a significant marker of positive prognosis. Routine IDH testing is not recommended because its impact on treatment is still unclear, however, testing may be useful for stratification of individuals with glioma, when the results from immunohistochemistry are negative or equivocal or when the results of the genetic test will direct treatment decisions. ImmunoCyt/uCyt+ Bladder cancer May be used for detecting primary bladder cancer in patients with signs/symptoms of bladder cancer or for detecting recurrent bladder cancer in patients with a history of bladder cancer, when used as an adjunct to cystoscopy and urinary cytology Per the NCCN, urine molecular tests for urothelial tumor markers are now available. Most of these tests have a better sensitivity for detecting bladder cancer than urine cytology, but specificity is lower. However, it remains unclear whether these tests offer additional information that is useful for detection and management of non-muscle-invasive bladder tumors. NCCN considers this to be Tumor Markers for Cancer Jul 17 8
9 a 2B recommendation (i.e., Based on lower level of evidence, there is NCCN consensus that the intervention is appropriate) MPO (myeloperoxidase) Acute Myeloid Leukemia Immunohistochemical staining for myeloperoxidase is the best method for determining which cells are committed to the myeloid lineage Nuclear-Matrix Protein (NMP22) Bladder Cancer Consideration may be given to the FDA approved urinary biomarker testing by fluorescence in situ hybridization or nuclear matrix protein 22 in the monitoring for recurrence. NSE (neuron-specific enolase) Small Cell Lung Cancer (SCLC) Neuroendocrine tumors account for approximately 20% of lung cancers; most (~15%) are small cell lung cancer. Most SCLCs stain positively for markers of neuroendocrine differentiation, including chromogranin A, neuron-specific enolase, neural cell adhesion molecule and synaptophysin. Placental alkaline phosphatase (PLAP) Occult Primary (Cancer of unknown Primary) Placental alkaline phosphatase (PLAP) is mainly found in seminomas but is also expressed in some nonseminoma germ cell tumors, and genitourinary, gastrointestinal, and pulmonary carcinomas. PSA (prostate-specific antigen) Prostate Cancer The decision to participate in an early detection program for prostate cancer is complex. Factors that should be considered include patient age, life expectancy, family history, race, and previous early detection test results. Initial suspicion of prostate cancer is based on abnormal digital rectal exam (DRE) or an elevated PSA level. Prostate cancers are characterized by clinical (TMN) stage determined by DRE, Gleason score in the biopsy specimen, and serum PSA levels. NCCN guidelines incorporate a risk stratification scheme that uses a minimum of stage, grade and PSA to assign individuals to risk groups. These groups are used to select the appropriate options that should be considered for treatment and to predict the probability of biochemical failure after definitive local therapy. Biochemical progression-free survival can be reassessed post-operatively using age, serum PSA, and pathologic grade and stage. PSA levels are monitored in individuals choosing active surveillance and in individuals choosing active treatment. Many commercially available serum total PSA testing are currently available. They perform comparably, however, the levels are not interchangeable since they standardized against two different standards. An abnormal PSA result should be confirmed by retesting. Unbound or free PSA (fpsa) expressed as a ratio of total PSA has emerged as a clinically useful molecular form of PSA, with the potential to provide improvements in early detection, staging, and monitoring of prostate cancer. Studies have shown that the percentage of fpsa is significantly lower in men who have prostate cancer compared to men who have not. The US Food and Tumor Markers for Cancer Jul 17 9
10 Drug Administration (FDA) approved the use of percent-free PSA for the early detection of prostate cancer in men with PSA levels between 4-10 ng/ml. NCCN guidelines recommend the use of the percent-free PSA as an alternative in the management of patients with normal DREs and total PSA levels between 4-10ng/mL if there is a relative contraindication to biopsy. Physicians and patients electing to use percent-free PSA should be cautioned that this assay and the multi-institutional study performed to obtain its FDA approval were designed with the intention of avoiding unnecessary biopsies in men with a high likelihood of not having prostate cancer. Thyroglobulin Thyroid Cancer Thyroglobulin is most often measured in differentiated thyroid cancers (i.e., papillary, follicular, and Hurthle cell). Postoperative elevation of the thyroglobulin level above 10 nanograms per milliliter is suggestive of cancer recurrence UroVysion Bladder Cancer Per the NCCN, urine molecular tests for urothelial tumor markers are now available. Most of these tests have a better sensitivity for detecting bladder cancer than urine cytology, but specificity is lower. However, it remains unclear whether these tests offer additional information that is useful for detection and management of non-muscle-invasive bladder tumors. NCCN considers this to be a 2B recommendation (i.e., Based on lower level of evidence, there is NCCN consensus that the intervention is appropriate) Investigational Health Net Inc., considers the following tumor markers investigational, as their role in the management of various benign and cancerous conditions has not yet been demonstrated (may not be all inclusive): 1. BluePrint Molecular Subtyping Profile for Breast Cancer 2. Breast Cancer Index for Prognosis of Breast Cancer Recurrence (biotheranostics Inc.) 3. BreastNext Next-Gen Cancer Panel 4. BreastTrue High Risk Panel for Hereditary Breast Cancer (Pathway Genomics Corp). 5. BROCA Cancer Risk panel 6. CA 50 (Cancer antigen 50) 7. CA 72-4 (Cancer antigen 72-4) 8. CA 195 (Cancer antigen 195) 9. CA 549 (Cancer antigen 549) 10. CAM 17.1 (monoclonal antimucin antibody 17.1) 11. CancerNext Next-Gen Cancer Panel 12. CancerSelect (Personal Genome Diagnostics) 13. COLMOL: NGS Colon Cancer Panel 14. ColoNext 15. ColonSentry (GeneNews Ltd.) for Colorectal Cancer 16. ConfirmMDx for Prostate Cancer 17. Counsyl Universal Genetic Test 18. Decipher Prostate Cancer Classifier 19. Decision DX-GBM brain cancer assay 20. Decision DX-UM assay 21. Decision DX - Melanoma 22. Direct-to-consumer (DTC) Genetic tests (eg., 23andMe) Tumor Markers for Cancer Jul 17 10
11 23. EarlyCDT-Lung Risk Assessment Test 24. 4KScore Test (OPKO Health, Inc.) 25. FoundationOne Cancer Assay 26. HERmark breast cancer assay 27. High/Moderate Risk Panel 28. igene Cancer Panel 29. Mammastrat 30. MelanoSITE Fish Test 31. Molecular Intelligence (MI) (Caris Life Sciences) 32. Myriad MyRisk Hereditary Cancer Genetic Panel 33. Myeloma Prognostic Risk Signature (MyPRS Plus) Test for Myeloma 34. OncoType DX DCIS 35. Oncotype DX Prostate Cancer Assay 36. Ovanext 37. Ovasure 38. Panexia 39. PancNext Next-Gen Cancer Panel for Hereditary Pancreatic Cancer 40. Paradigm Cancer Diagnostic (PCDx) 41. Pathfinder TG 42. PreOvar KRAS-Variant Test for Ovarian Cancer 43. Progensa PCA3 Genetic Assay for Prostate Cancer 44. Prolaris Test for Prediction of Prostate Cancer Progression 45. ProOnc TumorSource 46. Prostate Core Mitomic Test for Prostate Cancer Diagnosis 47. ProstatePx 48. ProstRcision for prostate cancer 49. Proveri Prostate Cancer Assay (PPCA) 50. RenalNext Next-Generation Sequencing (NGS) Panel for Renal Cell Carcinoma 51. ResponseDX: Colon 52. Squamous Cell Carcinoma Antigen 53. Septin 9 (SEPT9) Methylation Analysis for Colorectal Cancer 54. SYMGENE68 NGS Cancer Panel 55. Target Now Molecular Profiling Test (Caris Life Sciences) 56. ThyGenX Thyroid Oncogene Panel/ThyraMIR [predecessor-mirinform Thyroid (Asuragen Inc)] 57. ThyroSeq v.2 Next Generation Sequencing Panel 58. Tissue of Origin Test (ResponseDX) 59. TreatmentMAP Definitions Tumor Markers for Cancer Jul 17 11
12 POC UC BC UCB AUC FNA HCC HCV HBV FFPE NPV AGEC HT TT IHC NSCLC FAP PFS GEP NGS GPS Point of care Urothelial carcinoma Bladder cancer Urothelial carcinoma bladder Area under the curve Fine needle aspiration Hepatocellular carcinoma Hepatitis C virus Hepatitis B virus Formalin-fixed, paraffin-embedded Negative predictive value Afirma gene expression classifier Hemithyroidectomy Total thyroidectomy Immunohistochemistry Non small cell lung cancer Familial adenomatous polyposis Progression free survival Gene expression profiling Next generation sequencing Genomic Prostate Score Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets. ICD-9 Codes (May not be all inclusive) Malignant neoplasm of esophagus Malignant neoplasm of stomach Malignant neoplasm of small intestine, including duodenum Malignant neoplasm of colon Malignant neoplasm of rectum, rectosigmoid junction, and anus Maligant neoplasm of liver and intrahepatic bile ducts Malignant neoplasm of gallbladder and extrahepatic bile ducts Malignant neoplasm of pancreas Malignant neoplasm of the female breast 181 Malignant neoplasm of placenta (e.g., choriocarcinoma) Malignant neoplasm of ovary and other uterine adnexa 185 Malignant neoplasm of prostate Malignant neoplasm of testis Carcinoma in situ of stomach Carcinoma in situ of colon Carcinoma in situ of other and unspecified parts of intestine Carcinoma in situ of liver and biliary system Carcinoma in situ of other and unspecified digestive system Carcinoma in situ of breast Carcinoma in situ of bladder Tumor Markers for Cancer Jul 17 12
13 Carcinoma in situ of other and unspecified female genital organs Carcinoma in situ of prostate Carcinoma in situ of other and unspecified male genital organs Neoplasm of uncertain behavior of placenta Neoplasm of uncertain behavior of ovary Neoplasm of uncertain behavior of prostate Neoplasm of uncertain behavior of bladder Neoplasm of bladder Elevated prostate specific antigen (PSA) V10.3 Personal history of malignant neoplasm of breast V10.04 Personal history of malignant neoplasm of stomach V10.05 Personal history of malignant neoplasm of large intestine V10.06 Personal history of malignant neoplasm of rectum, rectosigmoid junction, and anus V10.07 Personal history of malignant neoplasm, liver V10.09 Personal history of malignant neoplasm of gastrointestinal tract, other V10.43 Personal history of malignant neoplasm of ovary V10.46 Personal history of malignant neoplasm of prostate V10.47 Personal history of malignant neoplasm of testis V76.44 Special screening for malignant neoplasm of prostate V76.46 Family history of malignant neoplasm of ovary ICD-10 Codes C15.3-C15.9 Malignant neoplasm of esophagus C16.0-C16.9 Malignant neoplasm of stomach C17.0-C17.9 Malignant neoplasm of small intestine C18.0-C18.9 Malignant neoplasm of colon C19 Malignant neoplasm of rectosigmoid junction C22.0-C22.9 Malignant neoplasm of liver and extrahepatic bile ducts C24.0-C24.9 Malignant neoplasm of other and unspecified parts of biliary tracts C25.0-C25.9 Malignant neoplasm of pancreas C C Malignant neoplasm of breast C56.1-C56.9 Malignant neoplasm of ovary C58 Malignant neoplasm of placenta C C Malignant neoplasm of breast C61 Malignant neoplasm of prostate C62.00-C62.92 Malignant neoplasm of testis D00.2 Carcinoma in situ of stomach D01.0 Carcinoma in situ of colon D01.40-D01.49 Carcinoma in situ of other and unspecified parts of the intestine D01.7 Carcinoma in situ of other specified digestive organs D01.9 Carcinoma in situ of digestive organ, unspecified D05.90-D05.92 Unspecified type of carcinoma in situ of breast D07.30-D07.39 Carcinoma in situ of other and unspecified female genital organs D07.5 Carcinoma in situ of prostate D07.60-D07.69 Carcinoma in situ of other and unspecified male genital organs D09.0 Carcinoma in situ of bladder D39.10 Neoplasm of uncertain behavior of unspecified ovary D39.2 Neoplasm of uncertain behavior of placenta D40.0 Neoplasm of uncertain behavior of prostate D41.1 Neoplasm of uncertain behavior of bladder D49.4 Neoplasm of unspecified behavior of bladder R97.0-R97.8 Abnormal tumor markers Tumor Markers for Cancer Jul 17 13
14 Z12.5 Encounter for screening for malignant neoplasm of prostate Z12.73 Encounter for screening for malignant neoplasm of ovary Z Z Personal history of malignant neoplasm of digestive organs Z Z Personal history of malignant neoplasm of large intestine Z Z Personal history of malignant neoplasm of rectum, rectosigmoid junction, and anus Z85.05 Personal history of malignant neoplasm of liver Z Z Personal history of malignant neoplasm of small intestine Z85.07 Personal history of malignant neoplasm of pancreas Z85.09 Personal history of malignant neoplasm of other digestive organs Z85.3 Personal history of malignant neoplasm of breast Z85.43 Personal history of malignant neoplasm of ovary Z85.46 Personal history of malignant neoplasm of prostate Z85.47 Personal history of malignant neoplasm of testis CPT Codes EFGR (epidermal growth factor receptor) (e.g., non-small cell lung cancer) gene analysis, common variants (e.g., exon 19 LREA deletion, L858R, T790M, G719A, G719S, L861Q) KRAS (Kirsten rat sarcoma viral oncogene homolog) (eg, carcinoma) gene analysis, variants in exon 2 (e.g. condons 12 and 13) Oncology (high-grade prostate cancer), biochemical assay of four proteins (Total PSA, Free PSA, Intact PSA, and human kallikrein-2 [hk2]), utilizing plasma or serum, prognostic algorithm reported as a probability score Unlisted multianalyte assay with algorithmic analysis Alpha-fetoprotein (AFP); serum Beta-2 microglobulin Calcitonin Carcinoembryonic antigen (CEA) Hydrocyindoleacetic acid, 5(HIAA) Lactate dehydrogenase (LD), LDH Lactate dehydrogenase (LD), (LDH); isoenzymes, separation and quantitation Myeloperoxidase (MPO) Serum assay, Oncoprotein (HER2/neu) Prosate specific antigen (PSA); complexed (direct measurement) Prosate specific antigen (PSA); total Prosate specific antigen (PSA); free Receptor assay; estrogen Receptor assay; progesterone Thyroglobulin Gonadotropin, chorionic (hcg); quantitative Gonadotropin, chorionic (hcg); qualitative Gonadotropin, chorionic (hcg); free beta chain Unlisted chemistry procedure Immunoassay for tumor antigen, qualitative or semiqualitative (e.g., bladder tumor antigen) Immunoassay for tumor antigen, quantitative; CA 15-3 (27.29) Immunoassay for tumor antigen, quantitative; CA Immunoassay for tumor antigen, quantitative CA Human epididymis protein 4 (HE4) Tumor Markers for Cancer Jul 17 14
15 86316 Immunoassay for tumor antigen, other antigen, quantitative (e.g. CA50, 72-4, 549); each Nuclear Matrix protein 22 (NMP22), qualitative Cytopathology, in situ hybridization (e.g. FISH), urinary tract specimen with morphometric analysis, 3-5 molecular probes, each specimen; manual Cytopathology, in situ hybridization (e.g. FISH), urinary tract specimen with morphometric analysis, 3-5 molecular probes each specimen; using computer-assisted technology Molecular cytogenetics: DNA probe, each (eg FISH) Interphase in situ hybridization, analyze cells Immunohistochemistry or immunocytochemistry, per specimen; initial single antibody stain procedure In situ hybridization (eg, FISH), per specimen; initial single probe stain procedure Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), using computer-assisted technology, per specimen; initial single probe stain procedure HCPCS Codes G0103 Prostate cancer screening; prostate specific antigen test Scientific Rationale Update July 2017 Guidelines from NCCN on Prostate Cancer (2.2017) continue to state the following and remains unchanged from what was previously noted in guidelines from 03/2016: Several tissue-based molecular assays have been developed in an effort to improve decision-making in newly diagnosed men considering active surveillance and in treated men considering adjuvant therapy or treatment of recurrence. Uncertainty about the risk of disease progression can be reduced if such molecular assays can provide accurate and reproducible prognostic or predictive information beyond NCCN risk group assignment and currently available life expectancy tables and nomograms. The guidelines note that no randomized controlled trials have studied the utility of these tests. NCCN notes, Several of these assays are available, and 3 have received positive reviews by the Molecular Diagnostic Services Program (MolDX) and are likely to be covered by CMS. Several other tests are under development, and the use of these assays is likely to increase in coming years. NCCN notes further, These tests have been developed with extensive industry support, guidance, and involvement, and have been marketed under the less rigorous FDA regulatory pathway for biomarkers. Although full assessment of their clinical utility requires prospective randomized clinical trials, which are unlikely to be done, the panel believes that men with clinically localized disease may consider the use of tumor-based molecular assays at this time. Further comparative effectiveness research may allow these tests and others like them to gain additional evidence regarding their utility for better risk stratification of men with prostate cancer Scientific Rationale Update July 2016 The 4KScore test is a combination blood test that generates a risk score for the probability of finding high-grade prostate cancer, defined as a Gleason Score >7, if a prostate biopsy was performed. The intended use of the test is to aid in the decision of whether or not to proceed with a prostate biopsy. The test algorithm combines the patient age, results of the digital rectal exam (DRE), prior biopsy status, along with the measurement of four prostate-specific kallikreins (total prostate specific antigen Tumor Markers for Cancer Jul 17 15
16 (tpsa), free PSA (fpsa), intact PSA (ipsa), and human kallikrein 2 (hk2). A kallikrein is a subgroup of enzymes that cleave peptide bonds in proteins. On August 20, 2015, OPKO Health, Inc. and Bio-Reference Laboratories, Inc. announced the completion of the acquisition of Bio-Reference by OPKO. Per the OPKO BioReference website: "The 4Kscore test was developed by OPKO Health on March 31, 2014, and is performed at its CLIA-accredited and CAP-Certified whollyowned laboratories, BioReference Laboratories and GenPath Diagnostics. The biomarkers used in the 4Kscore Test are based on research conducted at Memorial Sloan Kettering Cancer Center and research centers in Europe on over 10,000 patients and a prospective, blinded clinical study by Parekh et al. (2015) and conducted at 26 urology centers in the United States on 1,012 patients. It is the most accurate test to assess a patient s risk for aggressive prostate cancer prior to a prostate biopsy. The 4Kscore Test has the potential to dramatically increase the accuracy of prostate cancer diagnosis in the United States, particularly in its most aggressive forms. Other clinical information may modify an individual patient s risk and the decision to perform a prostate biopsy should be an individual choice based upon shared decision making between physician and patient. The 4Kscore Test would benefit any patient for whom additional information about their risk or probability, of having aggressive cancer would enhance clinical decision-making before deciding to perform a prostate biopsy. The 4Kscore Test can help urologists and physicians to identify patients who can benefit from biopsy while avoiding unnecessary biopsy for low-risk patients. The result is that more of the right patients get the diagnosis and treatment they need, while unnecessary biopsy is minimized. The 4Kscore test does not provide a diagnosis of prostate cancer. Rather, it is designed to help clarify the decision on whether or not to perform a biopsy based on the probability of a patient having aggressive prostate cancer. The 4Kscore should not be used: With a previous diagnosis of prostate cancer; When DRE was done in the previous 96 hours (4 days) before phlebotomy. A DRE performed after the phlebotomy is acceptable; When 5-alpha reductase inhibitor (5-ARI) therapy, such as Avodart (dutasteride) or Proscar (finasteride), was given, within the previous six (6) months; When any procedure or therapy to treat symptomatic BPH or any invasive; urologic procedure that may be associated with a secondary PSA elevation was done, prior to phlebotomy, within the previous six (6) months". Parekh et al. (2015) completed a study with the objective to perform the first prospective evaluation of the 4Kscore test in predicting a significant Gleason score of > 7 for prostate cancer before prostate biopsy. This test was also done to validate the performance of the 4Kscore test in a total of 1012 patients who were enrolled from October 2013 to April 2014 in a blinded, prospective study at 26 urology centers in the United States. Enrollment into the study was open to all men who were scheduled for a prostate biopsy, regardless of age, PSA level, DRE or prior prostate biopsy. Each patient underwent a TRUS-guided prostate biopsy of at least 10 cores. A blinded blood sample that was collected prior to biopsy was sent to OPKO Lab for measurement of the four kallikrein markers. The results of the kallikrein markers, prostate biopsy histopathology, patient age, DRE and prior biopsy status were unblinded and analyzed. The biopsy was negative in 54% of cases (n=542), showed low-grade (all Gleason grade 6) prostatic cancer in 24% (n=239) and highgrade cancer in 23% (n=231). The statistical analysis of the 4Kscore test clinical data had an area under the receiver operating characteristic curve (AUC) of 0.82 for the detection of high-grade prostate cancer; the AUC for all patients using tpsa, age, DRE and prior biopsy was A correlation between 4KScore risk category and Gleason score was seen (P<0.1). In this study, using a threshold for biopsy of > 15 Tumor Markers for Cancer Jul 17 16
17 risk allowed for 591 biopsies to be avoided (58%), while 183 high-grade tumors were detected and 48 high-grade tumors (4.7% of the 1012 participants) were missed. Limitations of the study include lack of standard criteria for biopsy referral and lack of central laboratory used for histopathology. Borque-Fernando et al. (2015) completed a preliminary study to test the ability of the 4Kscore test to identify high-grade prostate cancer (HGPC) in prostate biopsies (Bx) and compare the test with other multivariate prognostic models such as the Prostate Cancer Prevention Trial Risk Calculator 2.0 (PCPTRC 2.0) and the European Research Screening Prostate Cancer Risk Calculator 4 (ERSPC-RC 4). Fifty-one patients underwent a prostate Bx according to standard clinical practice, with a minimum of 10 cores. The diagnosis of HGPC was agreed upon by 4 uropathologists. The authors compared the predictions from the various models by using the Mann- Whitney U test, area under the ROC curve (AUC) (DeLong test), probability density function (PDF), box plots and clinical utility curves. Forty-three percent of the patients had prostate cancer, and 23.5% had HGPC. The medians of probability for the 4Kscore test, PCPTRC 2.0 and ERSPC-RC 4 were significantly different between the patients with HGPC and those without HGPC (p.022) and were more differentiated in the case of 4Kscore test (51.5% for HGPC [25-75 percentile: %] vs. 16% [P 25-75: %] for non-hgpc; p=.002). All models presented AUCs above 0.7, with no significant differences between any of them and 4Kscore test (p.20). The PDF and box plots showed good discriminative ability, especially in the ERSPC-RC 4 and 4Kscore test models. The utility curves showed how a cutoff of 9% for 4Kscore test identified all cases of HGPC and provided a 22% savings in biopsies, which is similar to what occurs with the ERSPC-RC 4 models and a cutoff of 3%. The assessed predictive models offer good discriminative ability for HGPCs in Bx. The 4Kscore test is a good classification model as a whole, followed by ERSPC-RC 4 and PCPTRC 2.0. The clinical utility curves help suggest cutoff points for clinical decisions: 9% for 4KsT and 3% for ERSPC-RC 4. This preliminary study should be interpreted with caution due to its limited sample size. Konety et al. (2015) completed a clinical utility study to assess the influence of the 4Kscore test on the decision to perform prostate biopsies in men referred to urologists for abnormal PSA and/or DRE results. The study population included 611 patients seen by 35 academic and community urologists in the United States. Urologists ordered the 4Kscore Test as part of their assessment of men referred for abnormal PSA and/or DRE test results. Results for the patients were stratified into low risk (< 7.5%), intermediate risk (7.5%-19.9%), and high risk ( 20%) for aggressive prostate cancer. The 4Kscore test results influenced biopsy decisions in 88.7% of the men. Performing the 4Kscore rest resulted in a 64.6% reduction in prostate biopsies in patients; the actual percentage of cases not proceeding to biopsy were 94.0%, 52.9%, and 19.0% for men who had low-, intermediate-, and high-risk 4Kscore test results, respectively. A higher 4Kscore test was associated with greater likelihood of having a prostate biopsy (P < 0.001). Among the 171 patients who had a biopsy, the 4Kscore risk category is strongly associated with biopsy pathology. The 4Kscore Test, as a follow-up test for an abnormal PSA and/or DRE results, significantly influenced the physician and patient shared decision in clinical practice, which led to a reduction in prostate biopsies while increasing the probability of detecting aggressive cancer. At this time there are currently no ongoing Clinical Trials on the 4Kscore test. NCCN Guidelines (Version ) on Prostate Cancer Early Detection notes: It is well known that a negative prostate biopsy does not preclude a diagnosis of prostate cancer on subsequent biopsy. Those patients with negative biopsies Tumor Markers for Cancer Jul 17 17
18 should be followed with DRE and PSA. Tests that improve specificity in the postbiopsy state including 4Kscore, PHI, percent free PSA. PCA3 and Confirm MDXshould be considered in patients thought to be higher risk despite a negative prostate biopsy. "Follow-up for benign biopsy results, added PSA and DRE at 6-24 month interval and Consider percent-free PSA, 4KScore. PHI, PCA3, or ConfirMDX, and/or Multiparametric MRI, and/or refined prostate biopsy based on risk. A percent free PSA <10% PHI >35 or 4KScore, which provides an estimate of the probability of high grade prostate cancer, are potentially informative in patients who have never undergone biopsy or after a negative biopsy. NCCN (2016) notes that the panel consensus is that the test can be considered for patients prior to biopsy and for those with prior negative biopsy for men thought to be at higher risk for clinically significant prostate cancer. It is important for patients and their urologists to understand, however, that no cutoff threshold has been established for the 4Kscore. If a 4Kscore test is performed, the patient and his urologist should discuss the results to decide whether to proceed with a biopsy. On March 15, 2016, the European Association of Urology (EAU) Prostate Cancer Guidelines Panel began to include the 4Kscore Test in the 2016 EAU Guidelines for Prostate Cancer. The panel concluded that the 4Kscore, as a blood test with greater specificity over the PSA test, is indicated for use prior to a first prostate biopsy or after a negative biopsy to assist patients and physicians in further defining the probability of high-grade cancer. Scientific Rationale Update June 2016 The following footnote has been added to NCCN guidelines on Prostate Cancer (3.2016), Men with clinically localized disease may consider the use of tumor-based molecular assays. Retrospective case cohort studies have shown that molecular assays performed on biopsy or prostatectomy specimens provide prognostic information independent of NCCN risk groups. These include, but are not limited to, likelihood of death with conservative management, likelihood of biochemical progression after radical prostatectomy or external beam therapy, and likelihood of developing metastasis after radical prostatectomy or salvage radiotherapy. The updated guidelines note further, Several tissue-based molecular assays have been developed in an effort to improve decision-making in newly diagnosed men considering active surveillance and in treated men considering adjuvant therapy or treatment of recurrence. Uncertainty about the risk of disease progression can be reduced if such molecular assays can provide accurate and reproducible prognostic or predictive information beyond NCCN risk group assignment and currently available life expectancy tables and nomograms. The guidelines note that no randomized controlled trials have studied the utility of these tests. NCCN notes, Several of these assays are available, and 3 have received positive reviews by the Molecular Diagnostic Services Program (MolDX) and are likely to be covered by CMS. Several other tests are under development, and the use of these assays is likely to increase in coming years. NCCN notes further, These tests have been developed with extensive industry support, guidance, and involvement, and have been marketed under the less rigorous FDA regulatory pathway for biomarkers. Although full assessment of their clinical utility requires prospective randomized clinical trials, which are unlikely to be done, the panel believes that men with Tumor Markers for Cancer Jul 17 18
19 clinically localized disease may consider the use of tumor-based molecular assays at this time. Further comparative effectiveness research may allow these tests and others like them to gain additional evidence regarding their utility for better risk stratification of men with prostate cancer. Oncotype Dx Prostate Cullen et al (2015) investigated a racially diverse cohort of men (20% African American [AA]) was used to evaluate the association of the clinically validated 17- gene Genomic Prostate Score (GPS) with recurrence after radical prostatectomy and adverse pathology (AP) at surgery. Biopsies from 431 men treated for National Comprehensive Cancer Network (NCCN) very low-, low-, or intermediate-risk PCa between 1990 and 2011 at two US military medical centers were tested to validate the association between GPS and biochemical recurrence (BCR) and to confirm the association with AP. Metastatic recurrence (MR) was also evaluated. Cox proportional hazards models were used for BCR and MR, and logistic regression was used for AP. Central pathology review was performed by one uropathologist. AP was defined as primary Gleason pattern 4 or any pattern 5 and/or pt3 disease. GPS results (scale: 0-100) were obtained in 402 cases (93%); 62 men (15%) experienced BCR, 5 developed metastases, and 163 had AP. Median follow-up was 5.2 yr. GPS predicted time to BCR in univariable analysis (hazard ratio per 20 GPS units [HR/20 units]: 2.9; p<0.001) and after adjusting for NCCN risk group (HR/20 units: 2.7; p<0.001). GPS also predicted time to metastases (HR/20 units: 3.8; p=0.032), although the event rate was low (n=5). GPS was strongly associated with AP (odds ratio per 20 GPS units: 3.3; p<0.001), adjusted for NCCN risk group. In AA and Caucasian men, the median GPS was 30.3 for both, the distributions of GPS results were similar, and GPS was similarly predictive of outcome. The authors concluded the association of GPS with near- and long-term clinical end points establishes the assay as a strong independent measure of PCa aggressiveness. Tumor aggressiveness, as measured by GPS, and outcomes were similar in AA and Caucasian men in this equal-access health care system. Decipher genomic classifier Klein et al (2016) evaluated the ability of the Decipher genomic classifier in predicting metastasis from analysis of prostate needle biopsy diagnostic tumor tissue specimens. Fifty-seven patients with available biopsy specimens were identified from a cohort of 169 men treated with radical prostatectomy in a previously reported Decipher validation study at Cleveland Clinic. A Cox multivariable proportional hazards model and survival C-index were used to evaluate the performance of Decipher. With a median follow up of 8 years, 8 patients metastasized and 3 died of prostate cancer. The Decipher plus National Comprehensive Cancer Network (NCCN) model had an improved C-index of 0.88 (95% confidence interval [CI] ) compared to NCCN alone (C-index 0.75, 95% CI ). On multivariable analysis, Decipher was the only significant predictor of metastasis when adjusting for age, preoperative prostate-specific antigen and biopsy Gleason score (Decipher hazard ratio per 10% increase 1.72, 95% CI , P=.02). The authors concluded Biopsy Decipher predicted the risk of metastasis at 10 years post radical prostatectomy. While further validation is required on larger cohorts, preoperative knowledge of Decipher risk derived from biopsy could indicate the need for multimodality therapy and help set patient expectations of therapeutic burden. Glass et al (2016) examined the experience of 224 men treated with radical prostatectomy (RP) from 1997 to 2009 at Kaiser Permanente Northwest, Portland, Oregon. Study subjects had aggressive prostate cancer with at least 1 of several criteria such as preoperative prostate specific antigen 20 ng/ml or greater, pathological Gleason score 8 or greater, stage pt3 disease or positive surgical margins at prostatectomy. The primary end point was clinical recurrence or Tumor Markers for Cancer Jul 17 19
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