Medical Policy Tumor Markers for Diagnosis and Management of Cancer Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History
• Endnotes Policy Number: 167 BCBSA Reference Number: N/A NCD/LCD: N/A Related Policies
• Analysis of Proteomic Patterns for Early Detection of Cancer #536 • CA-125 #503 • Non-BRCA Breast Cancer Risk Assessment (eg, OncoVue) #188 • Serum Biomarker Human Epididymis Protein 4 (HE4) #290 • Serum Tumor Markers for Breast and Gastrointestinal Malignancies #538 • Urinary Tumor Markers for Bladder Cancer #502 Policy1 Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

Chromogranin A (CgA) may be considered MEDICALLY NECESSARY when used to assist in the diagnosis and management of the following specific carcinoid tumors: • Malignant carcinoid tumors of the small intestine
• Malignant carcinoid tumors of the appendix, large intestine, and rectum
• Malignant carcinoid tumors of other and unspecified sites
• Benign carcinoid tumors of the small intestine.

The use of CgA is considered INVESTIGATIONAL when used in the diagnosing and management of tumors other than specific carcinoid tumors identified in the policy.

The following tumor markers described by procedure code 86316 (immunoassay for tumor antigen) are considered INVESTIGATIONAL: Exception: when used to bill for Chromogranin A (CgA) when used to assist in the diagnosis and management of specific carcinoid tumors.

CA195 CAM17-1 CAR-3 DU-PAN-2 TAG12 TAG72.3 TNF-alpha
TPS

The following tumor markers for the diagnosis, prognosis, or monitoring of treatment of patients with cancer are considered INVESTIGATIONAL:

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  Breast Cancer CA 195; CA 50; CA 549; CAM26; CAM29; CAR-3; CA-SCC; CA-SCC; CAM17-1; DMSA; Du-PAN-2; MCA; MSA; NSE; TAG 12; TAG 72.3; TNF-alpha; TPA; TPS

  Colorectal, Gastric or Pancreatic Cancer Note: See NCD 210.3 for Colorectal Cancer Screening Tests

  CA 195; CA 242; CA 50; CA 549; CA 72-4; CAM17-1; CAM-26; CAM29; CAR-3; CA- SCC; DMSA; Du-PAN-2; MCA; MCA; MSA; NSE; TAG 12; TAG 72.3; TNF-alpha; TPA; TPS Liver Cancer CA 242; CA 50; CA 72-4; TPA

  Lung Cancer

  CA-SCC; CYFRA 21-1; NSE; TPA

  Ovarian Cancer Note: See LCD L38371 • LPA • Multiplex assay that measures the concentration of six serum proteins (including but limited to tests such as OvaSure™)

  Prior Authorization Information
  Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
  Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

  Outpatient Commercial Managed Care (HMO and POS) Prior authorization is not required. Commercial PPO and Indemnity Prior authorization is not required. Medicare HMO BlueSM Prior authorization is not required. Medicare PPO BlueSM Prior authorization is not required.

  CPT Codes / HCPCS Codes / ICD Codes
  Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non- coverage as it applies to an individual member. The following codes are included below for informational purposes only; this is not an all-inclusive list.

  Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

  The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue: CPT Codes CPT codes: Code Description 86316 Immunoassay for tumor antigen, other antigen, quantitative (eg, CA 50, 72-4, 549), each The following ICD Diagnosis Codes are considered medically necessary when submitted with the CPT codes above if medical necessity criteria are met: ICD-10 Diagnosis Codes

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  ICD-10-CM diagnosis codes: Code Description C7A.019 Malignant carcinoid tumor of the small intestine, unspecified portion C7A.010 Malignant carcinoid tumor of the duodenum C7A.011 Malignant carcinoid tumor of the jejunum C7A.012 Malignant carcinoid tumor of the ileum C7A.029 Malignant carcinoid tumor of the large intestine, unspecified portion C7A.020 Malignant carcinoid tumor of the appendix C7A.021 Malignant carcinoid tumor of the cecum C7A.022 Malignant carcinoid tumor of the ascending colon C7A.023 Malignant carcinoid tumor of the transverse colon C7A.024 Malignant carcinoid tumor of the descending colon C7A.025 Malignant carcinoid tumor of the sigmoid colon C7A.026 Malignant carcinoid tumor of the rectum C7A.00 Malignant carcinoid tumor of unspecified site C7A.090 Malignant carcinoid tumor of the bronchus and lung C7A.091 Malignant carcinoid tumor of the thymus C7A.092 Malignant carcinoid tumor of the stomach C7A.094 Malignant carcinoid tumor of the foregut, unspecified C7A.095 Malignant carcinoid tumor of the midgut, unspecified C7A.096 Malignant carcinoid tumor of the hindgut, unspecified D3A.019 Benign carcinoid tumor of the small intestine, unspecified portion D3A.010 Benign carcinoid tumor of the duodenum D3A.011 Benign carcinoid tumor of the jejunum D3A.012 Benign carcinoid tumor of the ileum D3A.029 Benign carcinoid tumor of the large intestine, unspecified portion D3A.020 Benign carcinoid tumor of the appendix D3A.021 Benign carcinoid tumor of the cecum D3A.022 Benign carcinoid tumor of the ascending colon D3A.023 Benign carcinoid tumor of the transverse colon D3A.024 Benign carcinoid tumor of the descending colon D3A.025 Benign carcinoid tumor of the sigmoid colon D3A.026 Benign carcinoid tumor of the rectum D3A.090 Benign carcinoid tumor of the bronchus and lung D3A.092 Benign carcinoid tumor of the stomach D3A.094 Benign carcinoid tumor of the foregut, unspecified D3A.095 Benign carcinoid tumor of the midgut, unspecified D3A.096 Benign carcinoid tumor of the hindgut, unspecified D3A.098 Benign carcinoid tumors of other sites E34.00 Carcinoid syndrome, unspecified E34.01 Carcinoid heart syndrome E34.09 Other carcinoid syndrome

  Description A tumor marker is an indicator of a particular disease state such as the presence of cancer that can be measured. Specimens for testing may include urine, body tissues, blood or other bodily fluids. Elevated levels of a tumor marker can indicate that an individual may have cancer. However, false positives can occur.
  Summary
  Tumor markers that are described in this policy for the diagnosis, prognosis, or monitoring of treatment of patients with cancer are considered investigational because they do not meet the medical technology assessment guidelines #350.

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  Policy History Date Action 10/2024 Clarified coding information. 1/2023 Policy clarified to include reference to LCD/NCD under colorectal and ovarian cancer. 7/2022 Annual policy review. Policy reformatted. Policy statements unchanged.
  2/2018 Clarified coding information. 10/2016 Clarified coding information.
  11/2015 Medical policy ICD-10 remediation: Formatting, editing and coding updates. o Prostate Specific Antigen (PSA): Policy statements describing medically necessary indications retired. PSA is a covered test. 11/1/2015 o Prostatic Acid Phosphatase (PAP): Policy statements describing medically necessary indications retired. PAP is a covered test. 11/1/2015 o Tumor Markers for Bladder Cancer: Policy statements describing ongoing medically necessary and investigational indications transferred to medical policy #502, Urinary Tumor Markers for Bladder Cancer. 11/2015 o CA 125: Policy statements describing ongoing medically necessary and investigational indications transferred to medical policy #503, CA 125.
  11/1/2015 o CA 15-3; CA 19-9; CEA: Policy statements describing ongoing medically necessary and investigational indications transferred to medical policy #538, Serum Tumor Markers for Breast and Gastrointestinal Malignancies. 11/1/2015 o Analysis of Proteomic Patterns for Early Detection of Cancer: Policy statements describing ongoing investigational indications transferred to policy

  536, Analysis of Proteomic Patterns for Early Detection of Cancer. 11/1/2015

  o Alpha-Fetoprotein-L3 for Detection of Hepatocellular (Liver) Cancer: Policy statements describing ongoing investigational indications transferred to medical policy #504, Alpha-Fetoprotein-L3 for Detection of Hepatocellular (Liver) Cancer. 11/1/2015 Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

  Endnotes

  1 Based on expert opinion - Chromogranin A (CgA) for carcinoid tumors
  o http://www.emedicine.com/med/TOPIC2649.HTM o J Clin Lab Anal. 1999; 13(6):312-9 (ISSN: 0887-8013)
  o Schweiz Rundsch Med Prax. 2007; 96(1-2):19-28 (ISSN: 1013-2058)