Transcatheter Arterial Chemoembolization for Liver Tumors
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This policy governs when transcatheter hepatic arterial chemoembolization may be considered medically necessary or investigational for primary liver cancer and hepatic metastases.
No material clinical or coverage changes in this revision.
Medical Necessity and Investigational Use
Medical Necessity
Transcatheter hepatic arterial chemoembolization may be considered medically necessary when ANY ONE of the following conditions is met:
ANY of the following
Hepatocellular cancer
- Hepatocellular cancer is unresectable but confined to the liver.
- The hepatocellular cancer is not associated with portal vein thrombosis.
- Liver function is not characterized as Child-Pugh class C.
See Related Information for Child-Pugh Classification.
Bridge to liver transplant
- The individual has hepatocellular cancer and treatment is intended to prevent further tumor growth and maintain candidacy for liver transplantation.
Tumor burden
- A single tumor is present.< 5 cm
- No more than 3 tumors are present, with each tumor meeting the size criterion.Each < 3 cm
- Absence of extrahepatic disease or vascular invasion.
- Child-Pugh class A or B.
See Related Information for Child-Pugh Classification.
Symptomatic metastatic neuroendocrine tumor
- Liver metastases from a metastatic neuroendocrine tumor are present.
- Symptoms persist despite systemic therapy.
- The individual is not a candidate for surgical resection.
- Liver-dominant metastatic uveal melanoma.
Investigational Indications
Transcatheter hepatic arterial chemoembolization is considered investigational when ANY ONE of the following conditions applies:
ANY of the following
- Use as neoadjuvant or adjuvant therapy in resectable hepatocellular cancer.
- Use in combination with radiofrequency ablation (RFA) to treat resectable or unresectable hepatocellular carcinoma.
- Treatment of unresectable cholangiocarcinoma.
- Treatment of recurrent hepatocellular carcinoma or hepatocellular cancer that does not meet the medical-necessity criteria above.
Treatment of hepatocellular tumors prior to liver transplantation is considered investigational, except when the bridge-to-transplant medical-necessity criteria are met. The exception applies when the intent is to prevent further tumor growth and maintain the individual's candidacy for liver transplantation, with a single tumor less than 5 cm or no more than 3 tumors each less than 3 cm, absence of extrahepatic disease or vascular invasion, and Child-Pugh class A or B.
Treatment of liver metastases from tumors outside the covered symptomatic metastatic neuroendocrine tumor indication is considered investigational. This includes treatment of liver metastases from other tumor types when the medical-necessity criteria for symptomatic metastatic neuroendocrine tumor are not met.
Codes and Clinical Classification
| 37243 | Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia, or infarction. |
| 75894 | Transcatheter therapy, embolization, any method, radiological supervision and interpretation |
Documentation and Coverage Decision Risks
Medical Records and Office Notes Required
Submit medical records demonstrating that the applicable medical-necessity criteria are met. Documentation should include office visit notes with the relevant history and physical examination for the condition being treated, along with clinical support for medical necessity.
- Unresectable primary liver cancer confined to the liver without portal vein thrombosis or narrowing.
- Bridge to liver transplantation: a single tumor less than 5 cm, or no more than 3 tumors each less than 3 cm; no extrahepatic disease or vascular invasion; and Child-Pugh class A or B.
- Symptomatic neuroendocrine liver metastases that persist despite systemic therapy when the individual is not a candidate for surgical resection.
- Liver-dominant metastatic uveal melanoma.
Investigational Uses
Transcatheter hepatic arterial chemoembolization (TACE) is considered investigational for the uses listed below and may not be covered under this policy.
- Neoadjuvant or adjuvant therapy for resectable hepatocellular cancer.
- Combination treatment with radiofrequency ablation (RFA) for resectable or unresectable hepatocellular carcinoma.
- Treatment of unresectable cholangiocarcinoma.
- Treatment of liver metastases from any other primary tumor, or treatment of hepatocellular cancer that does not meet the medical-necessity criteria, including recurrent hepatocellular carcinoma.
- Treatment of hepatocellular tumors before liver transplantation, except when the stated bridge-to-transplant criteria are met.
Insufficient Evidence for Most Non-Uveal Hepatic Metastases
Evidence is insufficient to determine that TACE improves net health outcomes for unresectable hepatic metastases from primary tumors other than the covered uveal melanoma and neuroendocrine tumor indications. For colorectal cancer, studies show variable disease stabilization and some response or progression-free-survival findings, but a prolonged survival benefit over systemic chemotherapy remains uncertain; evidence for other cancers, including breast cancer, is extremely limited.
- Applies to unresectable hepatic metastases from other primary tumors, including colorectal and breast cancer.
- Studies are limited by small populations, variable individual-selection criteria, and differing treatment regimens.
- Insufficient evidence supports a conclusion of improved overall survival, disease-specific survival, quality of life, or treatment-related morbidity and mortality.
Criteria Not Met
TACE is considered investigational when the policy medical-necessity criteria are not met, including treatment of hepatocellular cancer outside the specified eligible indications.
- Verify that the diagnosis, disease extent, liver function, transplant-bridging criteria, and other applicable requirements are documented before submission.
- Failure to satisfy or document the criteria creates a coverage denial risk.
Clinical Background and Evidence
Transcatheter arterial chemoembolization (TACE) is a minimally invasive, liver-directed procedure. A catheter is advanced through the arterial system into the hepatic artery to deliver concentrated chemotherapy to the tumor-bearing region, followed by infusion of embolic material that restricts tumor blood flow. This produces ischemia and necrosis while prolonging local drug retention.
Key Terms
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