This policy addresses the use of radiofrequency ablation (RFA) as a treatment for primary or secondary malignancies outside the liver. 

Note: For additional information see the following topics:

• SURG.00065 Locally Ablative Techniques for Treating Primary and Metastatic Liver Malignancies
• SURG.00025 Cryosurgical Ablation of Solid Tumors

Medically Necessary:

Radiofrequency ablation of osteoid osteomas is considered medically necessary.

Radiofrequency ablation of painful bony metastases is considered medically necessary in patients who have failed or who are considered poor candidates for standard treatments such as opioids or radiation therapy.

Investigational/Not Medically Necessary:

Other applications of radiofrequency ablation to treat tumors outside the liver are considered investigational/not medically necessary, including but not limited to: renal cell cancer, breast cancer, breast fibroadenomas, tumors of the lung, head and neck, adrenal cancer, chordoma, ovarian cancer, and pelvic/abdominal metastases of unspecified origin.

Rationale

Osteoid Osteoma
The use of radiofrequency ablation has been demonstrated in several case series to be an effective treatment of osteoid osteoma.  In the largest case series of 126 patients treated over an 11 year period, the 2 year, complete pain relief was noted in 89% of patients. (Rosenthal, 1998).

Painful Bony Metastases
Goetz and colleagues (2004) reported on an international study of 43 patients with painful bony metastases treated at nine centers. The study’s primary outcome measure was the Brief pain Inventory-Short Form, a validated scale from 0 for no pain to 10 for worst pain imaginable. Patient eligibility required baseline values >= 4 from two or fewer painful sites. Thirty nine (91%) of the patients had previously received opioids to control pain and 32 (74%) had prior radiation therapy to the same lesion. Mean pain score at baseline was 7.9. At 4, 12 and 24 weeks after RFA, average pain score decreased to 4.5, 3.0 and 1.4, respectively. While this uncontrolled study includes a limited number of patients, the patient population focused on those with limited other alternatives and in whom short term pain relief is an appropriate outcome (Goetz,2004).

Other Malignancies
Renal Cell Carcinoma (RCC): Outcome of 187 RFA procedures in 149 patients was described in 6 uncontrolled studies (Farrell, 2003; Gervais, 2003; Lewin, 2004; Mayo-Smith, 2003; Pavlovich, 2002; Rendon, 2002; Zagoria, 2004). The characteristics of the patients and RFA procedures varied widely within and across the 6 studies in terms of tumor type (e.g., exophytic, parenchymal, central, with or without history of von Hipple-Lindau disease), tumor size (from <1 cm to >5 cm), length of follow-up (from <1 month to >36 months), imaging modality used for guidance, and reason for using RFA. Overall, 88% of procedures were considered successful shortly after 1 or 2 ablations (i.e., no signs of residual tumor by histologic analysis after excision or by post-RFA radiologic imaging). Significant but nonfatal complications were reported in 8% to 10% of patients in 2 studies, including perinephric hematomas, hemorrhage, and ureteral strictures. Data was unavailable or lacked appropriate statistical analyses concerning duration of survival or quality of life. Thus, available evidence did not permit conclusions on net health outcomes of RFA for renal cancers. A study by Clark and colleagues (2006) of 22 patients with 26 small RCC lesions had mean tumor volume decreases at a mean followup of 11.2 months. However, with the short term follow up, progression-free and overall survival data were not provided. In 2006, Lam and colleagues concluded there were conflicting outcomes from RFA trials. Additional clinical data was needed about RFA “before its true clinical efficacy and renal applicability can be determined.” The recommendation for additional randomized controlled, long term clinical trials was also noted by Veltri (2006) and Park (2006).

Breast Cancer
The search identified 4 uncontrolled pilot studies with 77 patients given RFA to treat primary breast cancer (Fornage, 2004; Hayashi, 2003; Izzo, 2001; Singletary, 2003). One of these reported preliminary data from an ongoing trial Hayashi (2003). In each study, RFA was performed no more than 2 weeks before definitive surgery (e.g., lumpectomy, quadrantectomy, and modified radical mastectomy). In many patients, RFA was performed immediately before surgery (Izzo,2001). Complete coagulation necrosis was reported in 90% of the excised tumors, with no reported complications from RFA. None of the studies reported that presurgical RFA altered surgical decisions of either the patient or surgeon.  Investigators of each study acknowledged the preliminary nature of their reports and the pilot status of their studies on effectiveness of RFA as a potential alternative to excision.

Pulmonary Tumors 
One study Herrera (2003) reported use of RFA in 10 patients with sarcomas and primary lung cancers and 8 patients with metastatic tumors in the lung. All patients had potentially resectable disease after failing previous nonoperative treatment, but were not considered surgical candidates because of “poor physiological reserve or patient refusal.” With mean follow-up of 6 months, RFA fully ablated tumors in 66% (8 of 12) patients with tumors smaller than 5 cm, compared with 33% in larger tumors (2 of 6). Complications were common, including 1 fatality from massive hemoptysis and 1 case of transient acute respiratory failure. Nonfatal complications included pleural effusion in 50%, pneumothorax in 54% (all CT-guided group), thoracocentesis in 11%, and pneumonia/pneumonitis in 22%. The updated literature search revealed ongoing interest in using RFA in pulmonary tumors. However, the additional identified studies are all small case series, which focused on technical feasibility and initial tumor response (Akebosh, 2004; Belfiore, 2004; Jin, 2004; King, 2004; Lee, 2004; Yasui, 2004).

Miscellaneous
One case series of 13 patients with adrenal neoplasms treated with RF ablation was identified. Eleven of the 13 lesions were treated successfully with RF ablation, defined by follow up CT scans, and normalization of preprocedural biochemical abnormalities (Mayo-Smith, 2004). 

Background/Overview

Radiofrequency ablation (RFA) is used to treat inoperable tumors or to treat patients ineligible for surgery due to age, presence of comorbidities, or poor general health. Goal(s) of RFA may include 1) controlling local tumor growth and preventing recurrence; 2) palliating symptoms; and 3) extending survival duration for patients with certain tumors. The procedure kills cells (cancerous and normal) by applying a heat-generating rapidly alternating current through probes inserted into the tumor. The effective volume of RFA depends on the frequency and duration of applied current, local tissue characteristics, and probe configuration (e.g., single versus multiple tips). RFA can be performed as an open surgical procedure, laparoscopically, or percutaneously with ultrasound or computed tomography (CT) guidance.

Potential complications associated with RFA include those caused by heat damage to normal tissue adjacent to the tumor (e.g., intestinal damage during RFA of kidney), structural damage along the probe track (e.g., pneumothorax as a consequence of procedures on the lung), hemorrhage, abscess formation, infection, or secondary tumors if cells seed during probe removal.

RFA was developed initially to treat inoperable tumors of the liver. Recently, reports have been published on use of RFA to treat renal cell carcinomas, breast cancer, pulmonary (primary lung cancers or metastatic tumors), bone, and other tumors. In some cases, RFA is being investigated as an alternative to surgery for operable tumors. Well-established local or systemic treatment alternatives are available for each of these malignancies. The hypothesized advantages of RFA for these cancers include improved local control and those common to any minimally invasive procedure (e.g., preserving normal organ tissue, decreasing morbidity, decreasing length of hospitalization).

Renal cell carcinoma:  Localized renal cell carcinoma (RCC) is treated by radical nephrectomy or nephron-sparing surgery. Based on staging results, adjuvant immunotherapy or chemotherapy may be utilized. Zisman and colleagues (2002) reported the natural progression of RCC is influenced by many variables in addition to the pathology. As such, alternative staging systems are being investigated to improve identification and stratification of risk factors correlated with prognoses to facilitate treatment decisions.

Breast tumors:  Early-stage primary breast tumors are treated surgically. The selection of lumpectomy, modified radical mastectomy, or another approach balances the patient’s desire for breast conservation, the need for tumor-free margins in resected tissue, and the patient’s age, hormone receptor status, and other factors. Adjuvant radiation therapy decreases local recurrences, particularly for those who select lumpectomy. Adjuvant hormonal therapy and/or chemotherapy are added, depending on presence and number of involved nodes, hormone receptor status, and other factors. Fibroadenomas are benign tumors of the breast, which may present as a palpable mass or a mammographic abnormality. Fibroadenomas are typically surgically excised.

Pulmonary tumors:  Primary lung cancers are resected if they are small, solitary masses. Adjuvant radiation and chemotherapy usually are added, most often using a platinum compound combined with one or more other drugs such as a taxane, alkylating agent, vinca alkaloid, or topoisomerase inhibitor. The preferred regimen depends on histologic type. Patients with metastatic pulmonary lesions are also treated with chemotherapy, but with palliative intent or to relieve symptoms. Surgical resection of isolated metastatic lung lesions is an option, but is not used very often due to generally poor patient health, inoperability of most metastatic lesions, and lack of evidence for benefit to patients. 

Osteoid osteomas:  Osteomas are benign tumors of the bone typically seen in children and young adults. They cause inflammation, local effects on normal tissue from tumor expansion, and secondary effects and complications (e.g., scoliosis, osteoarthritis). Open excision is the accepted treatment and is generally successful. However, it is associated with increased risk of fracture, recurrence of larger tumors, and incomplete resection of anatomically inaccessible tumors. 

Bone metastases:  After lung and liver, bone is the third most common metastatic site and is relatively frequent among patients with primary malignancies of the breast, prostate, and lung. Bone metastases often cause osteolysis (bone breakdown), resulting in pain, fractures, decreased mobility, and reduced quality of life. External beam irradiation often is the initial palliative therapy for osteolytic bone metastases. However, pain from bone metastases is refractory to radiation therapy in 20% to 30% of patients, while recurrent pain at previously irradiated sites may be ineligible for additional radiation due to risks of normal tissue damage. Other alternatives include hormonal therapy, radiopharmaceuticals such as strontium-89, and bisphosphonates. Less often, surgery or chemotherapy may be used for palliation and intractable pain may require opioid medications.  RFA has been investigated as another alternative for palliating pain from bone metastases.  

Definitions

Ablation: the destruction of a body part or tissue or its function; may be achieved by surgery, hormones, drugs, radiofrequency, heat, or other methods

Metastasis: the spread of cancer from one part of the body to another; a metastatic tumor contains cells that are like those in the original (primary) tumor and have spread

Osteoid osteoma: a benign skeletal tumor of unknown etiology that can occur in any bone

Radiofrequency ablation (RFA): a surgical procedure where cancerous or diseased cells are destroyed using heat produced by high-frequency radio waves

Unresectable: refers to a tumor that cannot safely be removed surgically due to size or location

Coding

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Medically Necessary:

CPT

ICD-9 Diagnosis

When services are Investigational/Not Medically Necessary:

For the procedure codes listed above for all other diagnosis; or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.

Services are also Investigational/Not Medically Necessary:

CPT

ICD-9 Diagnosis

References

Peer Reviewed Publications:

1. Akeboshi M, Yamakado K, Nakatsuka A, et al. Percutaneous radiofrequency ablation of lung neoplasms: Initial therapeutic response. J Vasc Interv Radiol. 2004; 15:463-470.
2. Ambrogi MC, Lucchi M, Dini P, et al. Percutaneous radiofrequency ablation of lung tumors: results in the mid-term. Eur J Cardiothorac Surg. 2006; (1):177-183.
3. Belfiore G, Moggio G, Tedeschi E, et al. CT-guided radiofrequency ablation: a potential complementary therapy for patients with unresectable primary lung cancer – a preliminary report of 33 patients. AJR. 2004; 183:1003-1011.
4. Clark TWI, Malkowicz B, Stavropoulos W, et al. Radiofrequency ablation of small renal cell carcinomas using multitined expandable electrodes: preliminary experience. J Vasc Interv Radiol. 2006; 17(3):513-519.
5. Farrell MA, Charboneau WJ, DiMarco DS, et al. Image-guided radiofrequency ablation of solid renal tumors. AJR Am J Roentgenol. 2003; 180(6):1509-1513.
6. Fornage BD, Sneige N, Ross MI, et al. Small breast cancer treated with US guided radiofrequency ablation. Feasibility study. Radiology. 2004; 231:215-224.
7. Gervais DA, McGovern FJ, Arellano RS, et al. Renal cell carcinoma: clinical experience and technical success with radio-frequency ablation of 42 tumors. Radiology. 2003; 226(2):417-424.
8. Gervais DA, Arellano RS, McGovern FJ, et al. Radiofrequency ablation of renal cel carcinoma: part 2, lessons learned with ablation of 100 tumors. AJR. 2005; 185:72-80.
9. Gervais DA, McGovern FJ, Arellano RS, et al. Radiofrequency ablation of renal cell carcinoma: part 1, indications, results, and role in patient management over a 6-year period and ablation of 100 tumors. AJR. 2005; 185:64-71. 
10. Goetz MP, Callstrom MR, Charboneau JW et al. Percutaneous image-guided radiofrequency ablation of painful metastases involving bone: a multicenter study. J Clin Oncol. 2004; 22(2):300-306. 
11. Hayashi AH, Silver SF, van der Westhuizen NG, et al.  Treatment of invasive breast carcinoma with ultrasound-guided radiofrequency ablation. Am J Surg. 2003; 185(5):429-435.
12. Herrera LJ, Fernando HC, Perry Y, et al. Radiofrequency ablation of pulmonary malignant tumors in nonsurgical candidates. J Thorac Cardiovasc Surg. 2003; 125(4):929-936.
13. Izzo F, Thomas R, Delrio P, et al. Radiofrequency ablation in patients with primary breast carcinoma: a pilot study in 26 patients. Cancer. 2001; 92(8):2036-2044.
14. Jin GY, Lee JM, Lee YC, et al. Primary and secondary lung malignancies treated with percutaneous radiofrequency ablation: evaluation with follow-up helical CT. AJR. 2004; 183:1013-1020. 
15. King J, Glenn D, Clark W, et al. Percutaneous radiofrequency ablation of pulmonary metastases in patients with colorectal cancer. Br J Surg. 2004; 91:217-223.
16. Lam JS, Breda A, Belldegrun A, Figlin RA. Evolving principles of surgical management and prognostic factors for outcome in renal cell carcinoma. J Clin Oncol. 2006; 24(35):5565-5575.
17. Lee JM, Hin GY, Goldberg SN, et al. Percutaneous radiofrequency ablation for inoperable non-small cell lung cancer and metastases: Preliminary report. Radiology. 2004; 230:125-134.
18. Lewin JS, Nour SG, Connell CF, et al. Phase II clinical trial of interactive MR imaging-guided interstitial radiofrequency thermal ablation of primary kidney tumors: Initial experience. Radiology 2004; 232:835-845.
19. Mayo-Smith WW, Dupuy DE, Parikh PM, et al. Imaging-guided percutaneous radiofrequency ablation of solid renal masses: techniques and outcomes of 38 treatment sessions in 32 consecutive patients. AJR Am J Roentgenol. 2003; 180(6):1503-1508.
20. Mayo-Smith WW, Dupuy DE. Adrenal neoplasms: CT-guided radiofrequency ablation – preliminary results. Radiology. 2004; 231:225-230.
21. Park S, Anderson JK, Matsumoto ED, et al. Radiofrequency ablation of renal tumors: intermediate-term results. J Endourol. 2006 Aug; 20(8):569-573. 
22. Pavlovich CP, Walther MM, Choyke PL, et al. Percutaneous radio frequency ablation of small renal tumors: initial results. J Urol. 2002; 167(1):10-15.
23. Rendon RA, Kachura JR, Sweet JM, et al. The uncertainty of radio frequency treatment of renal cell carcinoma: findings at immediate and delayed nephrectomy. J Urol. 2002; 167(4):1587-1592.
24. Rosenthal DI, Hornicek FJ, Wolfe MW, et al. Percutaneous radiofrequency coagulation of osteoid osteoma compared with operative treatment. J Bone Joint Surg Am. 1998; 80(6):815-821.
25. Singletary SE. Radiofrequency ablation of breast cancer. Am Surg. 2003; 69(1):37-40.
26. Veltri A, Calvo A, Tosetti I, et al. Experiences in US-Guided Percutaneous Radiofrequency Ablation of 44 Renal Tumors in 31 Patients: Analysis of Predictors for Complications and Technical Success. Cardiovasc Intervent Radiol. 2006; 29(5):811-818.
27. Wah TM, Arellano RS, Gervais DA, et al. Image-guided percutaneous radiofrequency ablation and incidence of post-radiofrequency ablation syndrome: prospective survey. Radiology. 2005; 237(3):1097-1102.
28. Yasui K, Kanazawa S, Sano Y, et al. Thoracic tumors treated with CT-guided radiofrequency ablation: Initial experience. Radiology. 2004;231:850-857. 
29. Zagoria RJ, Hawkins AD, Clark PE, et al. Percutaneous CT-guided radiofrequency ablation of renal neoplasms: Factors influencing success. AJR. 2004; 183:201-207.
30. Zisman A, Pantuck AJ, Wieder J, et al. Risk group assessment and clinical outcome algorithm to predict the natural history of patients with surgically resected renal cell carcinoma. J Clin Oncol. 2002; 20(23):4559-4566.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Cancer Society. Available at: http://www.cancer.org. Accessed on April 17, 2007.
2. Hayes, Inc. Hayes Medical Technology Directory. Radiofrequency Ablation for Osteoid Osteoma. Lansdale, PA: Hayes Inc.; March 2004. Search updated May 3, 2006. 
3. Hayes, Inc. Health Technology Brief. Radiofrequency Ablation for Renal Tumors. Lansdale, PA: Hayes, Inc: November 2, 2005. Updated December 6, 2005. \
4. National Cancer Institute. Renal Cell Cancer (PDQ®): Treatment. Last modified April 6, 2007. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/renalcell/healthprofessional. Accessed on April 20, 2007.
5. National Comprehensive Cancer Network® (NCCN) V.2.2007. Kidney Cancer. January 16, 2007. Available at: http://www.nccn.org/professionals/physician_gls/PDF/kidney.pdf. Accessed on March 17, 2007. 

Index

Policy History

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

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