Public Statement: Medical Policy Statement:

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1 Medical Policy Title: Radiofrequency Ablation ARBenefits Approval: 10/26/2011 of Tumors Effective Date: 01/01/2012 Document: ARB0300 Revision Date: Code(s): Ablation, bone tumor(s), radiofrequency, percutaneous Laparoscopy, surgical; ablation of renal mass lesion(s), including intraoperative ultrasound guidance and monitoring, when performed Ablation, one or more renal tumor(s), percutaneous, unilateral, radiofrequency Ablation therapy for reduction or eradication of one or more pulmonary tumor(s) including pleura or chest wall when involved by tumor extension, percutaneous, radiofrequency, unilateral Transurethral resection of prostate tissue; by radiofrequency thermotherapy Public Statement: Administered by: 1. Radiofrequency ablation of tumors involves insertion of an electrode into a lesion. Radiofrequency energy emitted through the electrode generates heat to kill abnormal tissue. 2. Radiofrequency ablation is subject to review. Medical Policy Statement: 1. Percutaneous radiofrequency ablation is considered medically necessary for treatment of osteoid osteoma, as a less invasive alternative to surgical resection of the tumor. Hayes B. 2. Radiofrequency ablation is considered medically necessary for palliative treatment of osteolytic bony metastases in patients who have failed other therapies or who are poor candidates for other therapies. Page 1 of 5

2 3. Radiofrequency ablation is considered medically necessary as an alternative to surgical (cold knife) resection for debulking of primary and metastatic malignant neoplasms. 4. Radiofrequency ablation is considered medically necessary for removal of primary or metastatic malignant neoplasms, when removal of the neoplasm may be curative, and the member is unable to tolerate surgical resection. 5. Radiofrequency ablation (Transurethral needle ablation (TUNA) for the treatment of benign prostate hypertrophy (BPH) is considered medically necessary for members with benign prostatic hypertrophy as alternatives to transurethral resection of the prostate. 6. Radiofrequency ablation is considered medically necessary for lesions of Barrett s Esophagus showing dysplasia. Limits: 1. Radiofrequency ablation is considered experimental and investigational for curative treatment of primary or metastatic malignant neoplasms in persons who are able to tolerate surgical resection because the effectiveness of radiofrequency tumor ablation in improving clinical outcomes has not been established. Hayes D. 2. Radiofrequency ablation as a treatment of hepatic metastases from non-colonic primary cancers is considered experimental and investigational. 3. Radiofrequency ablation as a palliative treatment of either hepatic metastases from colorectal cancer or hepatocellular cancer is also considered experimental and investigational. 4. Radiofrequency ablation of primary or metastatic liver tumors is covered in ARB0113. Background: 1. Percutaneous radiofrequency thermal ablation has been used as a less invasive alternative to surgical resection of osteoid osteoma. The primary advantage of percutaneous radiofrequency thermal ablation is a reduction in the need for postoperative hospitalization and a reduced duration of convalescence. 2. Radiofrequency ablation has been advocated as an alternative to resection in persons with lung nodules who cannot be treated surgically because of medical problems, multiple tumors, or poor surgical risk. Satisfactory clinical results have been reported using this method for liver tumors, and several reports have been published regarding radiofrequency ablation therapy for human lung neoplasms. There are, however, no adequate prospective clinical studies that demonstrate that radiofrequency ablation of lung metastases is as effective as surgical (cold knife) resection in curative resection of malignant neoplasms. 3. Radiofrequency ablation has been used as a treatment of pancreatic cancer for a number of years in Japan. Current evidence of effectiveness of radiofrequency ablation for pancreatic cancer consists of case reports and a phase II (safety) Page 2 of 5

3 study; the latter concluded that radiofrequency ablation was a relatively safe treatment for pancreatic cancer. However, this evidence is insufficient to draw conclusions about the effectiveness of radiofrequency ablation for this indication. 4. An assessment conducted by the National Institute for Clinical Excellence (2004) reached the following conclusions about radiofrequency ablation of renal tumors: Limited evidence suggests that percutaneous radiofrequency ablation (RFA) of renal cancer brings about reduction of tumor bulk as assessed by computed tomography, and that the procedure is adequately safe. However, the procedure has not been shown to improve symptoms or survival.patient selection is important and the procedure should normally be limited to patients who are unsuitable for surgery. 5. In a review on minimally invasive therapies for BPH, Naspro et al (2005) noted that "currently, transurethral microwave thermotherapy seems to offer the soundest basis for management of the condition, providing the longest term follow up and the largest numbers of studies completed to date. References: 1. National Institute for Clinical Excellence (NICE). Percutaneous radiofrequency ablation of renal cancer. Interventional Procedure Consultation Document. London, UK: NICE; January Available at: Accessed January 6, National Institute for Clinical Excellence. Computed tomography-guided thermocoagulation of osteoid osteoma. Interventional Procedure Consultation Document. London, UK: NICE; December Available at: IP_221/ip221consultation/article.aspx. Accessed February 5, Cantwell CP, Obyrne J, Eustace S. Current trends in treatment of osteoid osteoma with an emphasis on radiofrequency ablation. Eur Radiol. 2004;14(4): Mahnken AH, Gunther RW, Tacke J. Radiofrequency ablation of renal tumors. Eur Radiol. 2004;14(8): Hinshaw JL, Lee FT Jr. Image-guided ablation of renal cell carcinoma. Magn Reson Imaging Clin N Am. 2004;12(3): , vi. 6. Posteraro AF, Dupuy DE, Mayo-Smith WW. Radiofrequency ablation of bony metastatic disease. Clin Radiol. 2004;59(9): Le QT, Petrik DW. Nonsurgical therapy for stages I and II non-small cell lung cancer. Hematol Oncol Clin North Am. 2005;19(2): , v-vi. 8. Stamatis G. Operative and interventional therapy of lung metastases. MMW Fortschr Med. 2005;147(1-2):25-26, de Baere T. Radiofrequency in cancerology. Bull Cancer. 2005;92(1): Feagins LA, Souza RF. Molecular targets for treatment of Barrett's esophagus. Dis Esophagus. 2005;18(2): Johnston MH. Technology insight: Ablative techniques for Barrett's esophagus-- current and emerging trends. Nat Clin Pract Oncol. 2005;2(8): Page 3 of 5

4 12. Yeh RW, Triadafilopoulos G. Endoscopic therapy for Barrett's esophagus. Gastrointest Endosc Clin N Am. 2005;15(3): , vii. 13. Shaheen NJ. Advances in Barrett's esophagus and esophageal adenocarcinoma. Gastroenterology. 2005;128(6): Pedrazzani C, Catalano F, Festini M, et al. Endoscopic ablation of Barrett's esophagus using high power setting argon plasma coagulation: A prospective study. World J Gastroenterol. 2005;11(12): Hage M, Siersema PD, Vissers KJ, et al. Molecular evaluation of ablative therapy of Barrett's oesophagus. J Pathol. 2005;205(1): Wolfsen HC. Endoprevention of esophageal cancer: Endoscopic ablation of Barrett's metaplasia and dysplasia. Expert Rev Med Devices. 2005;2(6): Ramon J, Lynch TH, Eardley I, et al. Transurethral needle ablation of the prostate for the treatment of benign prostate hyperplasia: A collaborative multicentre study. Br J Urol. 1997;80(1): Blute ML, Tomera KM, Hellerstein DK, et al. Transurethral microwave thermotherapy for management of benign prostatic hyperplasia. Results of the United States Prostatron cooperative study. J Urol. 1993;150(5 Pt 2): Bdesha AS, Bunce CJ, Kelleher JP, et al. Transurethral microwave treatment for benign prostatic hypertrophy. A randomized controlled trial. BMJ. 1993;306(6888): de la Rosette JJ, de Wildt MJ, Alivizatos G, et al. Transurethral microwave thermotherapy (TUMT) in benign prostatic hyperplasia: Placebo versus TUMT. Urology. 1994;44(1): Ogden CW, Reddy P, Johnson H, et al. Sham versus transurethral microwave thermotherapy in patients with symptoms of benign prostatic bladder outflow obstruction. Lancet. 1993;341(8836): Goldfarb B, Bartkiw T, Trachtenberg J. Microwave therapy of benign prostatic hyperplasia. Urol Clinics North Am. 1995;22(2): Djavan B, Madersbacher S, Klingler HC, et al. Outcome analysis of minimally invasive treatments for benign prostatic hyperplasia. Tech Urol. 1999;5(1): National Institute for Clinical Excellence (NICE). Transurethral radiofrequency needle ablation of the prostate. Interventional Procedure Guidance 15. London, UK: NICE; October Available at: National Institute for Clinical Excellence (NICE). Radiofrequency ablation of hepatocellular carcinoma. Interventional Procedure Guidance 2. London, UK: NICE; July Available at: National Institute for Clinical Excellence (NICE). Radiofrequency ablation for the treatment of colorectal metastases in the liver. Interventional Procedure Consultation Document. London, UK: NICE; January Available at: Nicholas J Shaheen et al, Radiofrequency ablation in Barrett s Esophagus with Dysplasia: NEJM May 28, 2009 Number 22 pp Page 4 of 5

5 Application to Products This policy applies to ARBenefits. Consult ARBenefits Summary Plan Description (SPD) for additional information. Last modified by: Date: Page 5 of 5