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A.7.01.75
Cryosurgical ablation (CSA) involves the freezing of target tissues, often by inserting a probe through which coolant is circulated into the tumor. Cryosurgical ablationcan be performed as an open surgical technique orpercutaneously or laparoscopically, typically with ultrasound guidance.
Liver Metastases
Hepatic tumors can be due to primary liver cancer or metastases to the liver from nonhepatic primary tumors. Primary liver cancer can arise from hepatocellular tissue (hepatocellular carcinoma) or intrahepatic biliary ducts (cholangiocarcinoma). Multiple tumors metastasize to the liver, but there is particular interest in the treatment of hepatic metastases from colorectal cancer (CRC) given the propensity of CRC to metastasize to the liver and its high prevalence. 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. In the U.S, the incidence rates of liver cancer are estimated to continually increase through 2030. Some racial groups are more affected by liver cancer than others due to differences in the prevalence of risk factors and disparities in access to quality care; the mortality rate for African Americans with HCC is higher than other racial groups in the U.S.
Treatment
Surgical resection with tumor-free margins and 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, the number of lesions, or underlying 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 the 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 including: cryosurgical ablation (cryosurgery), radiofrequency ablation, laser ablation, transhepatic arterial embolization, chemoembolization, or radioembolization with yttrium-90 microspheres; 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 apoptosis; and (3) induction of apoptosis.
Some have reported on experience with cryosurgical and other ablative methods used in combination with subtotal resection and/or procedures such as transarterial chemoembolization.
Procedure-Related Complications
Cryosurgery is not a benign procedure. Treatment-related deaths occur in approximately 2% of study populations and are most often caused by cryoshock, liver failure, hemorrhage, pneumonia/sepsis, and acute myocardial infarction. Clinically significant nonfatal complication rates in the reviewed studies ranged from 0% to 83% and were generally due to the same causes as treatment-related deaths. The likelihood of complications arising from cryosurgery might be predicted, in part, by the extent of the procedure, but much of the treatment-related morbidity and mortality reflect the generally poor health status of patients with advanced hepatic disease.
Several cryosurgical devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Use includes general surgery, urology, gynecology, oncology, neurology, dermatology, ENT [ears, nose, throat], proctology, pulmonary surgery, and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures.
FDA product code: GEH.
Cryosurgical ablation of either primary or metastatic tumors in the liver is investigational.
Federal 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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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.
11/2000: 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.
09/17/2003: 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.
03/13/2006: Policy reviewed, no changes.
09/13/2006: Coding updated. ICD9 2006 revisions added to policy.
08/22/2008: Policy description re-written. Policy statement unchanged.
09/30/2009: 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.
05/31/2016: Policy number A.7.01.75 added.
07/17/2017: Policy description updated regarding devices. Policy statement unchanged.
08/09/2018: Policy description updated regarding procedure-related complications. Policy statement unchanged.
10/01/2018: Code Reference section updated to add new ICD-10 procedure codes 0F500ZF, 0F503ZF, 0F504ZF, 0F510ZF, 0F513ZF, 0F514ZF, 0F520ZF, 0F523ZF, and 0F524ZF.
11/01/2019: Policy reviewed; no changes.
10/15/2020: Policy description updated. Policy statement unchanged.
01/11/2022: Policy description updated regarding devices. Removed "cryosurgery" from the policy title and policy statement. Intent of policy statement unchanged.
09/30/2022: Code Reference section updated to add new ICD-10 procedure codes 0F500Z3, 0F510Z3, 0F520Z3, 0F503Z3, 0F513Z3, 0F523Z3, 0F504Z3, 0F514Z3, and 0F524Z3 effective 10/01/2022.
01/19/2023: Policy description updated regarding liver metastases. Policy statement re-worded. Intent unchanged. It previously stated: Cryosurgical ablation is considered investigational for the treatment of primary or metastatic liver tumors.
10/13/2023: Policy reviewed. Policy statement unchanged. Code Reference section updated to remove deleted ICD-10 procedure code DFY0KZZ.
12/05/2024: Policy description updated. Policy statement unchanged.
Blue Cross Blue Shield Association policy # 7.01.75
This may not be a comprehensive list of procedure codes applicable to this policy.
Code Number | Description | ||
CPT-4 | |||
47371 | Laparoscopy, surgical, ablation of one or more liver tumor(s); cryosurgical | ||
47381 | Ablation, open, of one or more liver tumor(s); cryosurgical | ||
47383 | Ablation, one or more liver tumor(s), percutaneous, cryoablation | ||
HCPCS | |||
ICD-9 Procedure | ICD-10 Procedure | ||
17.63 | Laser interstitial thermal therapy [LITT] of lesion or tissue of liver under guidance | 0F500Z3 | Destruction of liver using laser interstitial thermal therapy, open approach |
50.23 50.26 | Open ablation of liver lesion or tissue Other and unspecified ablation of liver lesion or tissue | 0F500ZZ | Destruction of liver, open approach |
0F510Z3 | Destruction of right lobe liver using laser interstitial thermal therapy, open approach | ||
0F510ZZ | Destruction of right lobe liver, open approach | ||
0F520Z3 | Destruction of left lobe liver using laser interstitial thermal therapy, open approach | ||
0F520ZZ | Destruction of left lobe liver, open approach | ||
0F503Z3 | Destruction of liver using laser interstitial thermal therapy, percutaneous approach | ||
50.24 | Percutaneous ablation of liver lesion or tissue | 0F503ZZ | Destruction of liver, percutaneous approach |
0F513Z3 | Destruction of right lobe liver using laser interstitial thermal therapy, percutaneous approach | ||
0F513ZZ | Destruction of right lobe liver, percutaneous approach | ||
0F523Z3 | Destruction of left lobe liver using laser interstitial thermal therapy, percutaneous approach | ||
0F523ZZ | Destruction of left lobe liver, percutaneous approach | ||
0F504Z3 | Destruction of liver using laser interstitial thermal therapy, percutaneous endoscopic approach | ||
50.25 | Laparoscopic ablation of liver lesion or tissue | 0F504ZZ | Destruction of liver, percutaneous endoscopic approach |
0F514Z3 | Destruction of right lobe liver using laser interstitial thermal therapy, percutaneous endoscopic approach | ||
0F514ZZ | Destruction of right lobe liver, percutaneous endoscopic approach | ||
0F524Z3 | Destruction of left lobe liver using laser interstitial thermal therapy, percutaneous endoscopic approach | ||
0F524ZZ | Destruction of left lobe liver, percutaneous endoscopic approach | ||
50.29 | Other destruction of lesion of liver | 0F500ZF,0F500ZZ, 0F503ZF,0F503ZZ, 0F504ZF,0F504ZZ, 0F510ZF,0F510ZZ, 0F513ZF,0F513ZZ, 0F514ZF,0F514ZZ, 0F520ZF,0F520ZZ, 0F523ZF,0F523ZZ, 0F524ZF,0F524ZZ | (See descriptions above) |
ICD-9 Diagnosis | ICD-10 Diagnosis |
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