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DESCRIPTIONRadiofrequency 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 cm to 5 cm sphere of dead tissue. The cells killed by RFA are not removed, but are gradually replaced by fibrosis and scar tissue. If there is local recurrence, it occurs at the edge, and in some cases, may be retreated. Radiofrequency ablation may be performed percutaneously, laparoscopically, or as an open procedure.
Hepatic tumors can arise either as primary liver cancer (hepatocellular cancer [HCC]) or by metastasis to the liver from other tissues. Local therapy for hepatic metastasis may be indicated only when there is no extrahepatic disease, which rarely occurs for patients with primary cancers other than colorectal carcinoma or certain neuroendocrine malignancies. At present, surgical resection with adequate margins or liver transplantation consitutes the only treatments available with demonstrated curative potential. However, most hepatic tumors are unresectable at diagnosis, due either to their anatomic location, size, number of lesions, or underlying liver reserve.
Neuroendocrine tumors are tumors of cells that possess secretory granules and originate from the neuroectoderm. Neuroendocrine cells have roles both in the endocrine system and the nervous system. They produce and secrete a variety of regulatory hormones, or neuropeptides, which include neurotransmitters and growth factors. Overproduction of the specific neuropeptides produced by the cancerous cells causes a variety of symptoms depending on the hormone produced. They are rare, with an incidence of 2-4 per 100,000 per year. Treatment of liver metastases is undertaken to prolong survival and reduce endocrine-related symptoms as well as symptoms related to the hepatic mass.
Radiofrequency ablation (RFA) has been investigated as a treatment for unresectable hepatic tumors, both as primary treatment and as a bridge to liver transplant. In the latter setting, it is hoped that RFA will reduce the incidence of tumor progression while awaiting transplantation and thus maintain a patients's candidacy for liver transplant during the wait time for a donor organ. This issue has become less problematic with additional priority now assigned for patients with stage T2 HCC.
Various locoregional therapies for unresectable liver tumors have been investigated: radiofrequency ablation, cryosurgical ablation (cryosurgery), laser ablation, trans-hepatic arterial chemoembolization, microwave coagulation, percutaneous ethanol injection, and radioembolization (Yttrium-90 microspheres).
Radiofrequency ablation devices have been cleared through the U.S. Food and Drug Administration (FDA) 510(k) process.
Note: Radiofrequency ablation of extrahepatic tumors is addressed separately in another policy.
POLICYRadiofrequency ablation (RFA) of primary hepatocellular carcinoma (HCC) may be considered medically necessary as a primary treatment of HCC for patients who are not candidates for curative therapy (resection or transplant) when there are no more than 3 nodules and when all tumor foci can be adequately treated.
Radiofrequency ablation of primary hepatocellular carcinoma (HCC) is considered medically necessary as a bridge to transplant, where the intent is to prevent further tumor growth and to maintain a patient’s candidacy for liver transplant.
Radiofrequency ablation (RFA) of primary hepatocellular carcinoma (HCC) is considered investigational when there are more than three nodules or when not all sites of tumor foci can be adequately treated.
Radiofrequency ablation of primary hepatocellular carcinoma (HCC) is considered investigational when used to downstage (downsize) HCC in patients being considered for liver transplant.
Radiofrequency ablation may be considered medically necessary as a primary treatment of hepatic metastases 5 cm or less in diameter from colorectal cancer in the absence of extrahepatic metastatic disease if tumor foci are deemed by the attending surgeon to be technically unresectable or patients are precluded from definitive hepatic resection due to underlying condition(s) and, in either case, when all tumor foci can be adequately treated.
Radiofrequency ablation may be considered medically necessary as treatment of hepatic metastases from neuroendocrine tumors in patients with symptomatic disease when systemic therapy has failed to control symptoms.
Radiofrequency ablation for hepatic metastasis is considered investigational for the following:
POLICY GUIDELINESExplicit criteria have not been established for radiofrequency ablation of primary or metastatic hepatocellular cancer. Candidacy is based on a number of factors including number of tumor foci (nodules), size of tumor foci, and accessibility. In general, published studies have included patients with 4-5 or fewer hepatic lesions measuring 5 cm or less using current technology. Compiled evidence suggests RFA at open laparotomy may provide superior outcomes compared to the percutaneous route, but the lack of comparative trials, and patient selection bias in indirect comparisons, do not permit definitive conclusions.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good 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. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
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 HISTORY2/2000: Approved by Medical Policy Advisory Committee (MPAC)
8/2000: Reviewed by MPAC, investigational status maintained.
12/12/2000: Federal Employee Program allows coverage, see "Policy Exceptions"
5/21/2001: Codes Reference section revised
2/8/2002: Investigational definition added
3/13/2002: New 2002 codes added, CPT code 76490 added
5/2/2002: Type of Service and Place of Service deleted
6/11/2002: CPT code 47399 deleted
3/25/2004: Reviewed by MPAC, investigational status changed to medically necessary, Policy section aligned with BCBSA
5/3/2004: Code Reference section updated, CPT code 47380 "for imaging guidance, use 76490" deleted, CPT code 47382 "for imaging guidance and monitoring, see code 76490" deleted, CPT code 76490 deleted, CPT 76940 added
7/27/2006:Policy updated. Updates approved per Medical Policy Advisory Committee (MPAC)
9/1/2006: Code reference section updated. Diagnosis code 197.7 deleted from covered table.
9/22/2006: Coding updated. ICD9 2006 revisions added to policy
1/3/2007: Code reference section updated per the 2007 CPT/HCPCS revisions
6/19/2007: Policy statement updated; RFA as a primary treatment of hepatic metastases from colorectal cancer in the absence of extrahepatic metastatic disease may be considered medically necessary when the tumor cannot be removed by surgical resection, or precluded by underlying condition(s), and when all tumor foci can be treated. Added RFA for hepatic metastases from colorectal cancer that do not meet policy criteria, and from other types of cancer is considered investigational to policy statement.
12/31/2008: Policy reviewed, no changes
1/06/2009: Policy reviewed. No changes.
9/30/2009: Code reference section updated. New ICD9 procedure code 17.63 added to covered table.
01/08/2010: Code Reference Section updated. Removed deleted CPT Codes 76362 & 76394. Add the following ICD-9 Diagnosis codes: 155.2 and 197.7 (Diagnosis Code 197.7 must be billed with one of the following malignant neoplasm of colon ICD-9 Diagnosis codes: 153.0 - 153.9)
09/10/2010: Policy description updated to add information regarding neuroendocrine tumors. Added policy statement to indicate that RFA may be considered medically necessary for hepatic metastases from neuroendocrine tumors in patients with symptomatic disease when systemic therapy has failed to control symptoms. The first policy statement was revised to state that RFA of primary HCC may be considered medically necessary for patients who are not candidates for curative therapy (resection or transplant) when there are no more than 3 nodules and when all tumor foci can be adequately treated. The policy (no spelling suggestions) regarding RFA as a bridge to transplant was changed from investigational to medically necessary where the intent is to prevent further tumor growth and to maintain a patient’s candidacy for liver transplant. RFA of primary HCC remains investigational when not all sites of tumor foci can be adequately treated or when there are more than three nodules. Added ICD-9 code 209.72 to the Covered Codes table.
08/03/2011: Policy reviewed. Policy statement unchanged. Deleted outdated references from the Sources section.
09/25/2012: Policy reviewed; no changes.
11/06/2013: Policy reviewed; no changes.
09/24/2014: Policy reviewed; description updated. Added investigational statement to state that radiofrequency ablation of primary hepatocellular carcinoma (HCC) is considered investigational when used to downstage (downsize) HCC in patients being considered for liver transplant. Policy guidelines updated to add "size of tumor foci" to the factors used to determine candidacy for RFA of primary or metastatic hepatocellular cancer.
12/31/2014: Added the following new 2015 CPT code to the Code Reference section: 47383.
07/27/2015: Code Reference section updated to remove CPT code 47383.
09/01/2015: Code Reference section updated for ICD-10.
11/06/2015: Policy description updated regarding devices. Policy statements unchanged. Policy guidelines updated to add medically necessary and investigative definitions.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.91
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.