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DESCRIPTIONCryosurgical ablation involves the freezing of target tissues, most often by inserting into the tumor a probe through which coolant is circulated. Cryosurgical ablation can be performed as an open surgical technique or percutaneously or laparoscopically, typically with ultrasound guidance.
Hepatic tumors can arise due to primary liver cancer or metastases to the liver from nonhepatic primary tumors. Primary liver cancer can arise from hepatocellular tissue (hepatocellular carcinoma [HCC]) or intrahepatic biliary ducts (cholangiocarcinoma). Multiple tumors metastasize to the liver, but there is particular interest in the treatment of hepatic metastases from colorectal carcinoma (CRC) given the propensity of CRC to metastasize to the liver and the high prevalence of CRC. Liver metastases from neuroendocrine tumors present a unique clinical situation. Neuroendocrine cells produce and secrete a variety of regulatory hormones, or neuropeptides, which include neurotransmitters and growth factors. Overproduction of the specific neuropeptides by cancerous cells causes various symptoms, depending on the hormone produced. Treatment of liver metastases is undertaken to reduce endocrine-related symptoms, in addition to prolonging survival and reducing symptoms related to the hepatic mass.
Surgical resection with tumor-free margins or liver transplantation are the primary treatments available that have curative potential. Many hepatic tumors are unresectable at diagnosis, due either to their anatomic location, size, number of lesions, or underlyning liver reserve. Local therapy for hepatic metastasis is indicated only when there is no extrahepatic disease, which rarely occurs for patients with primary cancers other than colorectal carcinoma or certain neuroendocrine malignancies. For liver metastases from colorectal cancer, post-surgical adjuvant chemotherapy has been reported to decrease recurrence rates and prolong time to recurrence. Combined systemic and hepatic arterial chemotherapy may increase disease-free intervals for patients with hepatic metastases from colorectal cancer, but apparently is not beneficial for those with unresectable hepatocellular carcinoma.
Various locoregional therapies for unresectable liver tumors have been evaluated: cryosurgical ablation (cryosurgery), radiofrequency ablation, laser ablation (see the Radiofrequency Ablation (RFA) of Primary or Metastatic Liver Tumors medical policy), trans-hepatic artery embolization, chemoembolization, or radioembolization with yttrium-90 microsperes; microwave coagulation, and percutaneous ethanol injection. Cryosurgical ablation occurs in tissue that has been frozen by at least three mechanisms: (1) formation of ice crystals within cells, thereby disrupting membranes and interrupting cellular metabolism among other processes; (2) coagulation of blood, thereby interrupting blood flow to the tissue, in turn causing ischemia and cell death; and (3) induction of apoptosis (cell death).
Recent studies report experience with cryosurgical and other ablative methods used in combination with subtotal resection and/or procedures such as transarterial chemoembolization.
POLICYCryosurgical ablation (cryosurgery) is considered investigational for the treatment of primary or metastatic liver tumors.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/2000: Approved by Medical Policy Advisory Committee (MPAC)
7/11/2001: Code Reference section updated
2/14/2002: Investigational definition added
3/13/2002: New 2002 codes added
4/18/2002: Type of Service and Place of Service deleted
9/17/2003: Policy reviewed, no changes, Sources updated
10/27/2004: Code Reference section updated, CPT code 47399 deleted, ICD-9 procedure code 50.99 deleted, ICD-9 procedure code 50.29 added, ICD-9 diagnosis code 155.0, 155.2, 197.7, 230.8 deleted
3/13/2006: Policy reviewed, no changes
9/13/2006: Coding updated. ICD9 2006 revisions added to policy.
8/22/2008: Policy description re-written. Policy statement unchanged
9/30/2009: Code reference section updated. New ICD-9 procedure code 17.63 added to non-covered table.
04/26/2010: Policy title changed from "Cryosurgery for Liver Tumors" to "Cryosurgical Ablation (Cryosurgery) of Primary or Metastatic Liver Tumors" to reflect the scope of the policy. Policy description updated regarding treatment approaches. Added "cryosurgical ablation" to the policy statement; intent unchanged. FEP verbiage added to the Policy Exceptions section. Deleted outdated references from the sources section.
04/20/2011: Policy reviewed; no changes.
01/18/2012: Policy reviewed; no changes.
04/02/2013: Policy reviewed; no changes.
03/07/2014: Policy reviewed; no changes.
01/23/2015: Policy reviewed; no changes.
07/27/2015: Code Reference section updated to add CPT code 47383.
08/21/2015: Code Reference section updated for ICD-10.
02/05/2016: Policy description updated regarding hepatic tumors and treatment. Policy statement unchanged. Investigative definition updated in policy guidelines section.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.75
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.