Anthem Blue Cross Connecticut CG-SURG-78 Locoregional Techniques for Treating Primary and Metastatic Liver Malignancies Form

This document addresses locoregional therapies to treat primary or metastatic cancer of the liver. Treatment goals  can be curative,  palliative, as a bridge to liver transplantation or downstaging (become eligible for liver transplantation following initial treatment). Locoregional therapies may include any of the following ablative and arterially directed therapies:

• Ablative Therapy
  • Cryosurgical ablation, or cryotherapy
  • Microwave ablation (MWA)
  • Percutaneous ethanol injection (PEI)
  • Radiofrequency ablation (RFA)
  • Histotripsy
• Arterially directed therapy
  • Selective internal radiation therapy (SIRT); also known as transarterial radioembolization (TARE)
  • Transcatheter arterial chemoembolization (TACE)
  • Transcatheter arterial embolization (TAE)
  • Immunoembolization

Note: For related topics, please see the following:

• CG-SURG-61 Cryosurgical, Radiofrequency, Microwave or Laser Ablation to Treat Solid Tumors Outside the Liver
• RAD.00059 Catheter-based Embolization Procedures for Malignant Lesions Outside the Liver
• SURG.00126 Irreversible Electroporation
• TRANS.00008 Liver Transplantation

Clinical Indications

Medically Necessary:

1. Treatment of Hepatic Tumors (Primary or Metastatic)
   1. Any of the following locally ablative techniques are considered medically necessary for individuals with any of the following conditions when all of the criteria below have been met:
      1. Techniques
         1. Cryosurgical ablation; or
         2. Microwave ablation (MWA); or
         3. Percutaneous ethanol injection (PEI); or
         4. Radiofrequency (RFA)
            and
      2. Conditions
         1. Hepatocellular carcinoma; or
         2. Liver metastases from colorectal cancer; or
         3. Functioning neuroendocrine tumors
            and
      3. Criteria
         1. A poor candidate for surgical resection or unwilling to undergo surgical resection; and
         2. Each lesion measures no more than 5 cm in diameter; and
         3. No or minimal extra-hepatic metastases; and
         4. All foci of disease are amenable to ablative therapy or surgical resection.
   2. Any of the following arterially directed techniques are considered medically necessary for individuals when any of the following conditions/criteria below have been met:
      1. Techniques:
         1. TACE*; or
         2. TAE; or
         3. SIRT/TARE
            * For TACE using chemotherapy-loaded microspheres or immunoembolization, see the Not Medically Necessary section statement.
            and
      2. Conditions and Criteria:
         1. Treatment for surgically unresectable primary hepatocellular carcinoma (HCC) when all of the following criteria are met:
            1. Preserved liver function defined as Childs-Turcotte-Pugh Class A or B; and
            2. No or minimal extra-hepatic metastases;
               or
         2. Treatment for individuals with liver-only metastasis from uveal (ocular) melanoma; or
         3. Palliative treatment of symptoms associated with neuroendocrine (carcinoid or non-carcinoid) tumors; or
         4. Palliative treatment of liver-related symptoms due to tumor bulk (for example, pain) from a primary or metastatic tumor.
   3. SIRT/TARE is considered medically necessary as a secondary treatment of chemotherapy resistant or refractory colorectal cancer with liver dominant metastases.
2. Bridge to Liver Transplantation
   1. SIRT/TARE, TACE, TAE, PEI, RFA, or microwave ablation is considered medically necessary as a bridge to liver transplantation, when all of the following criteria are met:
      1. Preserved liver function defined as Childs-Turcotte-Pugh Class A or B; and
      2. Three or fewer encapsulated nodules and each nodule is less than or equal to 5 centimeters in diameter; and
      3. No evidence of extra-hepatic metastases; and
      4. No evidence of portal vein occlusion.
3. Hepatocellular Carcinoma in Individuals Who May Become Eligible for Liver Transplantation (Downstaging)
   PEI, RFA, TACE, TAE, or SIRT/TARE is considered medically necessary for the treatment of an individual when both of the following criteria are met:
   1. May become eligible for liver transplantation except that the hepatic lesion(s) size is greater than 5 centimeters in maximal diameter; and
   2. It can be reasonably expected that treatment will result in tumor size reduction to less than or equal to 5 centimeters in maximal diameter.

Not Medically Necessary:

Histotripsy is considered not medically necessary for the treatment of primary and metastatic liver malignancies.

Locally ablative techniques are considered not medically necessary when the criteria above are not met.

Arterially directed techniques are considered not medically necessary when the criteria above are not met.

TACE using the following techniques are considered not medically necessary for any indication:

1. Drug-eluting beads (DEB-TACE) (also known as drug-loaded microspheres); or
2. Immunoembolization (for example, granulocyte-macrophage colony-stimulating factor [GM-CSF]).