Radiofrequency Ablation for Treatment of Tumors
DESCRIPTION
Radiofrequency ablation (RFA) involves the insertion of an electrode into the center of the tumor using a percutaneous, intraoperative or laparoscopic approach. RFA is guided by ultrasound (US) or computed tomography (CT). The tissue absorbs the radiofrequency energy emanating from the non-insulated part of the electrode. This process creates extreme heat, leading to coagulative necrosis. The goal is to destroy the entire area of the tumor, plus a margin or normal tissue, in order to control local disease, relieve symptoms and prolong survival.
POLICY
Radiofrequency ablation for the treatment of the following indications is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
primary hepatic carcinoma
hepatic metastases from colorectal cancer
hepatic metastases from neuroendocrine tumors
Radiofrequency ablation for the treatment of renal malignancy is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Radiofrequency ablation of primary hepatic carcinoma as a bridge to transplant is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Radiofrequency ablation for the palliative treatment of bone metastases when standard treatment (i.e., surgery, radiation and opioids) has failed or cannot be tolerated is considered medically necessary.
Radiofrequency ablation for the treatment of osteoid osteomas that cannot be managed successfully with medical treatment is considered medically necessary.
Radiofrequency ablation for the treatment of all other tumors, including, but not limited to, the following is considered investigational:
Abdominal/Pelvic tumors
Adrenal tumors
Breast cancer
Head and neck tumors
Initial treatment of painful bone metastases
Lung tumors, including obstructive bronchial tumors
Pancreatic tumors, including pancreatic adenocarcinoma
Primary bone tumors
Prostate cancer
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Radiofrequency ablation is considered medically appropriate if ANY ONE of the following criteria are met:
Primary and metastatic liver tumors with or without surgical resection if ALL of the following criteria are met:
Tumors are less than five (5) cm in diameter
Five (5) or less tumors exist in the liver
No evidence of extra hepatic metastases exist
As a bridge to liver transplant, if ALL of the following criteria are met:
Intent is to prevent further tumor growth
Treatment will maintain candidacy for liver transplant
Renal tumors if ALL of the following criteria are met:
Tumor is clinically localized
Tumor is radiologically indeterminant
Tumor is solid
Tumor is 4 cm or less in size
ANY ONE of the following:
Individual has only a solitary kidney
Renal insufficiency, as defined by a glomerular filtration rate (GFR) of < 60 ml/min/m2
Poor surgical candidate due to the presence of medical comorbidities
Considered a high-risk surgical candidate
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member’s health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Examples of devices used for radiofrequency ablation include: RITA®, Radionics®, and Radiotherapeutics®.
Well-designed, randomized, controlled trials with long-term follow-up are not available to determine long-term benefits of radiofrequency ablation for the treatment of certain types of cancers compared to alternative treatments.
SOURCES
Abeloff, M. D., Armitage, J. O., Niederhuber, J. E., Kastan, M. B., & McKenna, W. G. (2008). Abeloff’s Clinical Oncology (4th ed.) Philadelphia: Churchill Livingstone, an imprint of Elsevier Inc.
American Association for the Study of Liver Diseases. (2010, July). Management of hepatocellular carcinoma: An update. Retrieved January 25, 2011 from http://www.guideline.gov/popups/printView.aspx?id=23927.
American Cancer Society. (2010, August). Bone Metastasis. Retrieved January 24, 2011 from http://www.cancer.org/acs/groups/cid/documents/webcontent/003087-pdf.pdf.
American Cancer Society. (2010, August). Hyperthermia. Retrieved January 21, 2011 from http://www.cancer.org/Treatment/TreatmentsandSideEffects/TreatmentTypes/hyperthermia.
American Cancer Society. (2010, February). Bone Metastasis. Retrieved January 21, 2011 from http://www.cancer.org/Cancer/KidneyCancer/DetailedGuide/kidney-cancer-adult-treating-ablation.
American College of Radiology. (2007). Expert Panel on Interventional Radiology. Hepatic malignancy. Retrieved January 25, 2011 from http://www.guideline.gov/popups/printView.aspx?id=11558.
American College of Radiology. (2007). Expert panel on radiation oncology—Rectal/anal cancer. ACR Appropriateness Criteria® rectal cancer—metastatic disease at presentation. Retrieved January 25, 2011 from http://guideline.gov/content.aspx?id=23843&search=rectal+cancer.
American Urological Association Education and Research, Inc. (2009) Guideline for management of the clinical stage 1 renal mass. Retrieved January 25, 2011 from http://www.guideline.gov/popups/printView.aspx?id=14573.
BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2010). Radiofrequency ablation of miscellaneous solid tumors excluding liver tumors (7.01.95). Retrieved January 24, 2011 from BlueWeb. (90 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2010). Radiofrequency ablation of primary or metastatic liver tumors (7.01.91). Retrieved January 21, 2011 from BlueWeb. (53 articles and/or guidelines reviewed)
Clinics in Chest Medicine. (2010, March). Radiofrequency ablation of lung tumors. Retrieved January 25, 2011 from http://www.mdconsult.com/das/article/body/236797723-3/jorg=clinics&source=MI&sp=22936124&sid=1127560807/N/737794/1.html?issn=0272-5231. (Level 2 evidence)
ECRI Institute. Health Technology Information Service. Forecast. (2010, June). Radiofrequency ablation for breast cancer. Retrieved January 28, 2011 from ECRI Institue. (13 articles and/or guidelines reviewed)
National Cancer Institute. U. S. National Institutes of Health. (2010, August). Colon cancer treatment (PDQ®). Retrieved January 24, 2011 from http://www.cancer.gov/cancertopics/pdq/treatment/colon/healthprofessional/allpages/print.
National Cancer Institute. U. S. National Institutes of Health. (2010, July). Adult primary liver Cancer treatment (PDQ®). Retrieved January 24, 2011 from http://www.cancer.gov/cancertopics/pdq/treatment/adult-primary-liver/healthprofessional/allpages/print.
National Cancer Institute. U. S. National Institutes of Health. (2010, September). Pain (PDQ®). Retrieved January 24, 2011 from http://www.cancer.gov/cancertopics/pdq/supportivecare/pain/healthprofessional/allpages/print.
National Cancer Institute. U. S. National Institutes of Health. (2010, September). Rectal cancer treatment (PDQ®). Retrieved January 24, 2011 from http://www.cancer.gov/cancertopics/pdq/treatment/rectal/healthprofessional/allpages/print.
National Comprehensive Cancer Network. (2010, December). NCCN clinical practice guidelines in oncology™. Neuroendocrine tumors (V.2.2010). Retrieved March 4, 2011 from http://www.nccn.org/professionals/physician_gls/pdf/neuroendocrine.pdf.
National Comprehensive Cancer Network. (2011, February). NCCN clinical practice guidelines in oncology™. Kidney cancer (V.2.2011). Retrieved March 4, 2011 from http://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf.
National Comprehensive Cancer Network. (2011, February). NCCN clinical practice guidelines in oncology™. Colon cancer (V.3.2011). Retrieved March 4, 2011 from http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf.
National Comprehensive Cancer Network. (2011, February). NCCN clinical practice guidelines in oncology™. Rectal cancer (V.4.2011). Retrieved March 4, 2011 from http://www.nccn.org/professionals/physician_gls/pdf/rectal.pdf.
National Comprehensive Cancer Network. (2011, January). NCCN clinical practice guidelines in oncology™. Hepatobiliary cancers (V.1.2011). Retrieved March 4, 2011 from http://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf.
National Comprehensive Cancer Network. (2011, January). NCCN clinical practice guidelines in oncology™. Non-small cell lung cancer (V.3.2011). Retrieved March 4, 2011 from http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf.
National Institute for Health and Clinical Excellence. (2010, April). Interventional procedure guidance. Percutaneous radiofrequency ablation for primary or secondary lung cancers. Retrieved March 8, 2011 from http://www.nice.org.uk/nicemedia/live/11206/49938/49938.pdf.
National Institute for Health and Clinical Excellence. (2010, July). Interventional procedure guidance. Percutaneous radiofrequency ablation for renal cancer. Retrieved March 8, 2011 http://www.nice.org.uk/nicemedia/live/11122/49881/49881.pdf.
National Institutes of Health. Department of Health and Human Services. Clinical Center. (2009, March). Radiofrequency thermal ablation as tumor therapy. Retrieved January 24, 2011 from http://www.cc.nih.gov/drd/tumortherapy.html.
Simon, C. J., Dupuy, D. E., DiPetrillo, T. A., Safran, H. P., Grieco, C. A., Ng, T., et al. (2007). Pulmonary radiofrequency ablation: Long-term safety and efficacy in 153 patients. Radiology, 243 (1), 268-275. (Level 2 evidence)
Society of Interventional Radiology. (2009, July). Position statement on percutaneous radiofrequency ablation for the treatment of liver tumors. Retrieved January 25, 2011 from http://www.jvir.org/article/S1051-0443(09)00326-1/fulltext.
U. S. Food and Drug Administration. (2008, September). Center for Devices and Radiological Health. Alerts and Notices (Medical Devices). FDA public health notification: Radiofrequency ablation of lung tumors – clarification of regulatory status. Retrieved January 21, 2011 from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061985.htm.
Wein, A. J., Kavoussi, L. R., Novick, A. C., Partin, A. W., & Peters, C. A. (Eds.). (2007). Campbell-Walsh Urology (9th ed.). Philadelphia: Saunders Elsevier.
ORIGINAL EFFECTIVE DATE: 6/1/2000
MOST RECENT REVIEW DATE: 10/8/2011
ID_BA
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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