Rule Category: Medical Ref: No: 2013-MN-0008 ` Version Control: Version No.1.1 Effective Date: 15 May 2013 Revision Date: 15 May 2014 Tumor Markers Indications Adjudication Rule Table of content Abstract Scope Page 1 Page Adjudication Policy Page 2 Adjudication examples Page 4 Denial codes Page 5 Appendices Page 5 Approved by: Daman Abstract Responsible: Medical Strategy & Development Department For Members Tumor markers are substances found in the blood, urine, stool, other bodily fluids, or tissues of some patients with cancer. Tumor markers may be used to help diagnose cancer, predict a patient’s response to certain cancer therapies, check a patient’s response to treatment, or determine whether cancer has returned. More than 20 tumor markers are currently in use. Related Adjudication Rules: None System Rules: None Daman covers tumor markers if medically justified as per the best international medical practice and as per the policy terms and conditions of each Health Insurance Plan administered by Daman. For Medical Professionals Tumor markers are measurable biochemicals that are associated with a malignancy. They are either produced by tumor cells (tumor-derived) or by the body in response to tumor cells (tumor-associated). They include a variety of substances like cell surface antigens, cytoplasmic proteins, enzymes, hormones, oncofetal antigens, receptors, oncogenes and their products. The various tumor markers differ in their usefulness for screening, diagnosis, prognosis, assessing therapeutic response, and detecting recurrence. As no tumor marker (except PSA) is proved to be ideal to be highly specific and sensitive, so they cannot be constructed as primary for the diagnosis of cancer. The main use of tumor marker in clinical medicine is as a supportive laboratory test for diagnosis or in follow up of a patient being treated for malignancy. Daman covers the tumor markers for cancer management if medically necessary, for all plans administered by Daman as per the policy terms and conditions of each plan. For screening purpose, Daman covers only PSA (Prostate specific antigen) tumor marker for prostate cancer screening as per the policy terms and conditions. Disclaimer By accessing Daman Adjudication Rules, you acknowledge that you have read and understood the terms of use set out in the disclaimer below: Daman Adjudication Rules are intended to outline the procedures in adjudication as applied by the National Health Insurance Company – Daman PJSC (hereinafter “Daman”). The Daman Adjudication Rules are not intended to be fully comprehensive and are not intended to grant rights or impose obligations on Daman. The Daman Adjudication Rules are not recommendations for treatment and should never be used as treatment guidelines. Daman shall not be liable for any direct, indirect, incidental or consequential damages, costs, losses or liabilities whatsoever arising out of the use of, access to, or inability to use or access the Daman Adjudication Rules or reliance on any information provided on this website. Any information provided herein is general and is not intended to replace or supersede any laws or regulations related to the Adjudication Rules as enforced in the United Arab Emirates or any other written document governing the relationship between Daman and its contracting parties. National Health Insurance Company – Daman (PJSC) (P.O. Box 128888, Abu Dhabi, U.A.E. Tel No. +97126149555 Fax No. +97126149550) Doc Ctrl No.: TEMP/MSD-008 Version No.: 1 Revision No.: 0 Date of Issue: 08.05.2013 Page No(s).: 1 of 4 Tumor Markers Indications Scope tumor associated antigen (BTA) This guideline aims to specify all coverage details of tumor markers for all health insurance plans administered by Daman as per policy terms and conditions and as per best International medical practice. Adjudication Policy Eligibility / Coverage Criteria Tumor markers are covered as per best clinical practice and as per the plan wise coverage criteria for all health insurance plans administered by Daman. For screening purpose, Daman covers only PSA (Prostate Specific Antigen) tumor marker for prostate cancer screening for all those health insurance plans, having this screening coverage benefit. Daman covers all the tumor markers given below with cancer types mentioned for uses including but not limited to the following Tumor Markers AFP + bHCG Levels raised in Cancer Types Non-seminoma germ cell testicular and ovarian tumors Uses ALK gene rearrangem ents Non-small cell lung cancer and anaplastic large cell lymphoma For treatment and prognosis Alphafetoprotein (AFP) Hepatocellular carcinoma, nonseminomatous germ cell tumors To help diagnose and follow response to treatment BCR-ABL fusion gene Chronic Myeloid Leukemia To confirm diagnosis and monitor disease status Beta-2microglobul in (B2M) Multiple Myeloma To determine prognosis and follow response to treatment Betahuman chorionic gonadotropi n (BetahCG) Trophoblastic Ovarian and Testicular Cancer Bladder- Bladder Cancer BRAF mutation V600E Cutaneous Melanoma and Colorectal Cancer To predict response to targeted therapies CA (cancer antigen)153/ CA27.29 Breast Cancer To assess whether treatment is working or disease has recurred CA-125 Ovarian Cancer To help in diagnosis, assessment of response to treatment, and evaluation of recurrence CA19-9 Pancreatic Cancer (more specific) and Biliary Tract Cancers To monitor response to treatment and early recurrence Calcitonin Medullary Thyroid Cancer To aid in diagnosis, check whether treatment is working, and assess recurrence Colorectal Cancer (Primary tumor) and Breast Cancer To check whether colorectal cancer has spread; to look for breast cancer recurrence and assess response to treatment CD20 Non-Hodgkin Lymphoma To determine whether treatment with a targeted therapy is appropriate Chromogra nin A (CgA) Neuroendocrine Tumors (e.g. carcinoid tumors, neuroblastoma and small cell lung cancer) To help in diagnosis, assessment of treatment response, and evaluation of recurrence Cytokeratin fragments 21-1 Non-Small Cell Lung Cancer To help in monitoring for recurrence and differential diagnosis of suspicious lung masses EGFR (Epidermal growth factor receptor) mutation analysis Non-Small Cell Lung Cancer To help determine treatment and prognosis Breast Cancer To determine whether treatment with hormonal therapy (such as Carcinoemb ryonic antigen (CEA) To assess stage, prognosis, and response to treatment of nonseminoma testicular and ovarian germ cell tumors and undiagnosed pelvic mass To assess stage, prognosis, and response to treatment Estrogen receptor (ER)/proge sterone Follow up treatment for bladder cancer or, monitoring for eradication of bladder cancer or, recurrences after eradication National Health Insurance Company – Daman (PJSC) (P.O. Box 128888, Abu Dhabi, U.A.E. Tel No. +97126149555 Fax No. +97126149550) Doc Ctrl No.: TEMP/MSD-008 Version No.: 1 Revision No.: 0 Date of Issue: 08.05.2013 Page No(s).: 2 of 4 Tumor Markers Indications receptor (PR) Fibrin/fibrin ogen HE4 HER2 (human epidermal growth factor receptor 2) tamoxifen) is appropriate To monitor progression and response to treatment Bladder Cancer Ovarian Cancer To assess disease progression and monitor for recurrence Breast Cancer, Gastric Cancer, and Esophagogastric Junction Adenocarcinoma To determine whether treatment with trastuzumab is appropriate in inoperable, locally advanced and recurrent or metastatic disease when transtuzumab therapy is considered and there is no history of prior treatment for metastatic disease. Multiple Myeloma and Waldenströmmacro globulinemia To help diagnose disease, assess response to treatment, and look for recurrence Gastrointestinal Stromal Tumor To help in diagnosing and determining treatment KRAS mutation analysis Colorectal Cancer Metastatic To determine whether treatment with a particular type of targeted therapy is appropriate Lactate dehydrogen ase Germ Cell Tumors To assess stage, prognosis, and response to treatment MPO (myelopero xidase) Acute Myeloid Leukemia Diagnosis of Acute Myeloid Leukemia Nuclear matrix protein 22 Bladder Cancer To monitor response to treatment. Metastatic Germ Cell Tumors To diagnose germ cell seminoma and non-seminoma germ cell tumors in unknown primary cancers Immunoglo bulins KIT PLAP (placental Alkaline Phosphatas e) Prostatespecific antigen (PSA) Prostate Cancer Thyroid Cancer To help in diagnosis, assess response to treatment, and look for recurrence Breast Cancer To determine aggressiveness of cancer and guide treatment for lymph node negative breast cancer patients who are unlikely to benefit from adjuvant chemotherapy. UroVysion Bladder Cancer Follow up treatment for bladder cancer or, monitoring for eradication of bladder cancer or, recurrences after eradication 21-Gene signature (Oncotype DX) Breast Cancer To evaluate risk of recurrence 5-Protein signature (Ova1) Ovarian Cancer To pre-operatively assess pelvic mass for suspected ovarian cancer 70-Gene signature (Mammapri nt) Breast Cancer To evaluate risk of recurrence Thyroglobul in Urokinase plasminoge n activator (uPA) and plasminoge n activator inhibitor (PAI-1) Requirements for Coverage ICD and CPT codes must be coded to the highest level of specificity. Non-Coverage Daman does not cover tumor markers for the Visitor’s Plan. Daman does not cover any of the diagnosis and services considered to be experimental or unproven for doing tumor markers. Daman does not cover any of the tumor markers which are considered to be experimental or unproven. Payment and Coding Rules Please apply HAAD payment rules and regulations and relevant coding manuals for ICD, CPT, etc. To help in diagnosis, assess response to treatment, and look for recurrence. Screening for prostate cancer (as per the policy terms and conditions) National Health Insurance Company – Daman (PJSC) (P.O. Box 128888, Abu Dhabi, U.A.E. Tel No. +97126149555 Fax No. +97126149550) Doc Ctrl No.: TEMP/MSD-008 Version No.: 1 Revision No.: 0 Date of Issue: 08.05.2013 Page No(s).: 3 of 4 Tumor Markers Indications Adjudication Examples 3. American Society of Clinical Oncology. (Feb 2, 2010). Understanding Tumor Markers. Available: http://www.cancer.net/patient/All+About+Canc er/Cancer.Net+Feature+Articles/Treatments%2 C+Tests%2C+and+Procedures/Understanding+ Tumor+Markers. Last accessed August 2, 2012. Example 1 Question: A 35 years old female holding Basic card with the H/O malignant neoplasm of ovary and had taken her chemotherapy treatment. Doctor wants to check the response to therapy and is claiming for a test for CA 125. Will this case be paid? 4. Greg L. Perkins, M.D., Evan D. SLATER, M.D., Georganne K. Sanders, M.D. (September 2003). Serum Tumor Markers. AMERICAN FAMILY PHYSICIAN. 68 (6), p 1-7. 5. Catharine Sturgeon. (2002). Practice Guidelines for Tumor Marker Use in the Clinic. Clinical Chemistry by the American Association. 48 (8), p 1-9. Answer: Yes, the claim will be paid Example 2 6. N. Lynn Henry, Daniel F. Hayes. (2006). Uses and Abuses of Tumor Markers in the Diagnosis, Monitoring, and Treatment of Primary and Metastatic Breast Cancer. The Oncologist by Department of Internal Medicine, Breast Oncology Program, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, USA. 11 (1), p 1-13. Question: A 40 year old female holding Thiqa card with family H/O breast malignancy. Doctor is claiming for CA 15-3 to screen for breast cancer for her. Will this claim be paid? Answer: No, the claim will be rejected with NCOV003 as no tumor marker is proved to be used for screening except PSA. 7. M.J. Duffy and P. McGing on behalf of the Scientific Committee of the Association of Clinical Biochemists in Ireland (ACBI). (2005). Guidelines for the Use of Tumour Markers. The Scientific Committee of the Association of Clinical Biochemists in Ireland (ACBI). 3 (1), p 1-15. Denial codes Code Code description MNEC-003 Service is not clinically indicated based on good clinical practice. MNEC-004 Service is not clinically indicated based on good clinical practice, without additional supporting diagnosis/activities. NCOV-003 Service(s) is (are) not covered. MNEC-003 Service is not clinically indicated based on good clinical practice. MNEC-003 Service is not clinically indicated based on good clinical practice. 8. American Society of Hematology. (1993). The ABL-BCR fusion gene is expressed in chronic myeloid leukemia. Blood. 81 (1), p 158-165. 9. Harbeck N, Kates RE, Gauger K, Willems A, Kiechle M, Magdolen V, Schmitt M.. (2004). Urokinase-type plasminogen activator (uPA) and its inhibitor PAI-I: novel tumor-derived factors with a high prognostic and predictive impact in breast cancer. PUB Med, US National Library of Medicine, National Institute of Health. 91 (3), p 1. 10.National Institute for Health and Clinical Excellence. (July 2010). Diagnosis and management of metastatic malignant disease of unknown primary origin. NICE Clinical Guideline 104. 1 (1), p 1-34 Appendices Revision History Reference 1. National Cancer Institute. (July 7, 2011). Tumor Markers. Available: http://www.cancer.gov/cancertopics/factsheet/ detection/tumor-markers. Last accessed August 2, 2012. Date 01-07-13 Change V 1.1: New template 2. The National Academy of Clinical Biochemistry. (2009). Use of Tumor Markers in Clinical Practice: Quality Requirements. Laboratory Medicine Practice Guidelines. 1 (1), page 1-37. National Health Insurance Company – Daman (PJSC) (P.O. Box 128888, Abu Dhabi, U.A.E. Tel No. +97126149555 Fax No. +97126149550) Doc Ctrl No.: TEMP/MSD-008 Version No.: 1 Revision No.: 0 Date of Issue: 08.05.2013 Page No(s).: 4 of 4