Radiofrequency ablation (RFA) is a procedure in which a probe is inserted into the center of a tumor and heated locally by a high frequency, alternating current that flows from electrodes. The local heat treats the tissue adjacent to the probe, resulting in a 3-5 cm sphere of dead tissue. The cells killed by RFA are not removed but are gradually replaced by fibrosis and scar tissue. RFA may be performed percutaneously, laparoscopically, or as an open procedure.

Cryosurgical ablation involves the freezing of target tissues, most often by inserting a probe into the tumor where coolant is circulated. Cryosurgical ablation can be performed as an open surgical technique or percutaneously or laparoscopically, typically with ultrasound guidance.

RFA of primary or metastatic hepatocellular carcinoma (HCC) may be considered medically necessary when ANY of following are met: 

• There are no more than three (3) nodules and all tumor foci can be adequately treated; or
• As a bridge to transplant when ALL of the following criteria have been met:
  • Preserved liver function defined as Child-Pugh Class A or B; and
  • Single  tumors less than or equal to 6.5 cm in diameter, or no more than three (3) lesions less than or equal to 4.5 cm in diameter, and total tumor diameter less than or equal to 8 cm ; and
  • No evidence of extra-hepatic metastases; and
  • No evidence of severe renal function impairment; and
  • No evidence of portal vein occlusion; or
• Primary or metastatic treatment of hepatic metastases 5 cm or less in diameter from colorectal cancer in the absence of extrahepatic metastatic disease when all tumor foci can be adequately treated; or
• Treatment of hepatic metastases from neuroendocrine tumors in patients with symptomatic disease when systemic therapy has failed to control symptoms; or
• As a repeat procedure when at least six (6) months have elapsed since the prior surgical resection or ablation.

RFA for hepatic metastasis is considered experimental/investigational for the following:

• Hepatic metastases from colorectal cancer or neuroendocrine tumors that do not meet the criteria above; and
• Hepatic metastases from other types of cancer with the exception of colorectal cancer or neuroendocrine tumors.

RFA of liver tumors is considered experimental/investigational for all other indications due to the lack of scientific evidence to support efficacy and safety and therefore non-covered.

Cryosurgery of the liver, using a FDA-approved cryosurgical device, may be considered medically necessary for select individuals with unresectable liver tumors or for patients whose liver tumors are not totally resectable when ALL of the following criteria are met:

• Proven primary or secondary malignant tumor by biopsy, tumor markers, MRI, CT scan or ultrasound; and
• The lesion(s) must be unresectable, whether on the basis of size, location, (proximity to major structures) bilobar involvement, or underlying liver disease (such as cirrhosis); and
• For individuals with metastatic disease there must be no residual tumor at the primary site; and
• There must be no evidence of extrahepatic malignancy; and 
• All visible tumors (visible by imaging study including intraoperative ultrasound) must be eradicable; and
• Lesion measures no more than 4 cm in diameter; and
• Lesions must be either a primary hepatocellular carcinoma or hepatic metastases from either primary colorectal cancer or neuroendocrine cancer. 

The following uses of cryosurgery of the liver are considered experimental/investigational:

• When policy criteria have not been met; or
• Metastatic lesions of the liver are from tumor primaries other than colorectal or neuroendocrine cancer.

Cryosurgery for liver tumors is considered experimental/investigational for all other indications due to the lack of scientific evidence to support efficacy and safety and is therefore non-covered.