Coverage Policy Manual
Policy #: 2004007
Category: Surgery
Initiated: January 2004
Last Review: July 2018
  Radiofrequency Ablation, Renal Tumors

Description:
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:
    • controlling local tumor growth and preventing recurrence;
    • palliating symptoms; and
    • 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, laparoscopic ally, 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), 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. For some of these, 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 (preserving normal organ tissue, decreasing morbidity, decreasing length of hospitalization, etc).
 
Localized renal cell carcinoma (RCC) is treated by radical nephrectomy or nephron-sparing surgery. Prognosis drops precipitously if the tumor extends outside the kidney capsule, since chemotherapy is relatively ineffective against metastatic RCC.
 
CPT 50542 may be used to report laparoscopic cryoablation or radiofrequency ablation of renal tumors.  Cryoablation of renal tumors is addressed in policy # 2000041.
 
RELATED POLICIES:
2012062 - Radiofrequency Ablation of Primary or Metastic Liver Tumors
2000041 - Cryosurgical Ablation of Renal Tumors
 

Policy/
Coverage:
Effective, November 2010
Radiofrequency ablation of neoplastic renal tumors in patients who are unable to tolerate nephron-sparing surgery or nephrectomy meets primary coverage criteria for effectiveness in improving health outcomes when:
 
        • the tumor is 4.0 cm  or less in size
        • the tumor is not in the medullary portion of the kidney, and
        • the tumor is not adjacent to a significant vessel.  
 
The use of radiofrequency ablation of renal tumors in any circumstance other than that described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, the use of radiofrequency ablation of renal tumors in any circumstance other than that described above is considered investigational and is not covered.  Investigational services are an exclusion in the member certificate of coverage.
 
Effective, December 2005 through October 2010
Radiofrequency ablation of neoplastic renal tumors in patients who are unable to tolerate nephron-sparing surgery or nephrectomy meets primary coverage criteria for effectiveness in improving health outcomes when:
    • the tumor is < 4.0 cm in size
    • the tumor is not in the medullary portion of the kidney, and
    • the tumor is not adjacent to a significant vessel.  
 
The use of radiofrequency ablation of renal tumors in any circumstance other than that described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, the use of radiofrequency ablation of renal tumors in any circumstance other than that described above is considered investigational and is not covered.  Investigational services are an exclusion in the member certificate of coverage.
 
Effective, January 2004
Radiofrequency ablation of renal cell carcinoma is considered investigational and is not covered.
 

Rationale:
This section summarizes  the evidence for RFA for renal tumors with evidence available from at least 1 case series of 10 or more patients.  Outcome of 187 RFA procedures in 149 patients were described in 6 uncontrolled studies.  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%–10% of patients in 2 studies, including perinephric hematomas, hemorrhage, and ureteral strictures. Data were 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.
 
In reporting the results of 100 tumor ablations in 85 patients Gervais et al. used multivariate analysis to assess tumor size and location as independent predictors of results of radiofrequency ablation.  Ablations was considered successful if it resulted in complete necrosis.  They concluded RFA of renal tumors is most effective for small tumors, 3 cm or less, though complete ablation in larger tumors is possible with multiple ablation sessions.  Tumors in noncentral locations were more often successfully ablated.
 
2008–2009 Update
Stern and colleagues retrospectively compared patients with stage T1a renal tumors, confirmed by pathology to be renal cell carcinoma, treated with either partial nephrectomy (n=34) or RFA (n=34) (Stern, 2007). The mean follow-up for the partial nephrectomy group was 47 months and for the RFA group 30 months. Three-year recurrence-free survival rate was 95.2% for partial nephrectomy and 91.4% for RFA. There were no disease-specific deaths in either group. In this small study, intermediate outcomes for patients with T1a renal cell carcinomas were similar whether treated with partial nephrectomy or RFA.
 
A review article summarizes the literature from the last 5 years, which includes 713 patients who underwent RFA of 866 renal tumors with an average follow-up of 12.6 months (Abdellaoui , 2008).  The average tumor-free survival rate was 85.4%. The author notes that across different study reports there are significant variations in the practice of RFA for kidney tumors, including the types of devices used, imaging modality and performance experience, making it difficult to compare results across studies. Additionally, the article points out that the longest average follow-up of published studies of RFA and kidney tumors is 28 months, and that long-term follow-up data are necessary to validate the use of this technique.
 
Kunkle and Uzzo conducted a comparative meta-analysis evaluating cryoablation and RFA as primary treatment for small renal masses (Kunklo, 2008).  Forty-seven case series representing 1375 renal tumors were analyzed. Of 600 lesions treated with cryoablation, 494 were biopsied before treatment vs 482 of 775 treated with RFA. The incidence of RCC with known pathology was 71.7% in the cryoablation group and 90% in the RFA group. The mean duration of follow-up after RFA was 15.8 months.  Local tumor progression was reported in 31 of 600 lesions after cryoablation and in 100 of 775 lesions after RFA, a difference that was significant.  Progression to metastatic disease was described in 6 of 600 lesions after cryoablation vs 19 of 775 after RFA. The authors caution that minimally invasive ablation generally has been performed selectively on older patients with smaller tumors possibly resulting in selection bias, series of ablated lesions tend to have shorter post-treatment follow-up compared with tumors managed by surgical excision or active surveillance, and treatment efficacy may be overestimated in series that include tumors with unknown pathology.
 
Updated NCCN guidelines have added the statement that ”emerging energy ablative techniques (e.g., cryosurgery or radiofrequency ablation) are currently considered an option by some experts for selected small tumors although a rigorous comparison with surgical resection (i.e., total or partial nephrectomy by open or laparoscopic techniques) has not been done.”
 
In summary, data from these most recent publications and the updated NCCN guidelines supports the current coverage statement and does not provide any evidence to prompt a change in coverage.
 
2010 Update
A search of the MEDLINE database through October 2010 identified no published literature that would prompt a change in the coverage statement.
 
One Phase II/III trial is identified as ongoing comparing surgery and RFA for the treatment of renal tumors (NCT00221728). The study design is open label and randomized with expected enrollment of 180 patients from 9 centers. Patients are eligible if they have a kidney tumor smaller than 4 cm, confined to the kidney (T1a). Principal outcome is 5-year efficacy measured as no residual tumor and no recurrence at the site of treatment. The estimated study completion date is April 2011.
 
2012 Update
A search of the MEDLINE database through September 2012 identified no published literature that would prompt a change in the coverage statement.
 
Salas and colleagues (2010) reviewed 17 studies identified from literature published between 2003 and 2009.  The authors found RFA has proven to demonstrate oncologic outcomes that are almost equivalent to surgical resection when treating renal tumors with a mean size less than 4.0 cm. Renal function also declines minimally and is significantly lower than surgical resection.  Van Poppel and colleagures (2011) also conducted a review of the literature published between 2004 and May 2011. In this review, the authors concluded RFA is a reasonable treatment option for most low-grade renal tumors less than 4 cm in patients who are not candidates for surgical resection or active surveillance. The authors noted the need for long-term prospective studies to compare ablative techniques for renal ablation, such as RFA versus cryoablation.
 
Summary
Based on the scientific data (large numbers of patients treated with follow-up) and the clinical input  received, radiofrequency ablation of small (i.e., 4 cm or less) renal cancers may be considered medically necessary in those patients who are not surgical candidates due to comorbid conditions or who have baseline renal insufficiency such that standard surgical procedures would impair their kidney function.
National Comprehensive Cancer Network (NCCN) Guidelines
Updated NCCN guidelines (v2.2011) indicate RFA is a thermal ablation option for the treatment of kidney cancer in select patients such as elderly patients and others with competing health risks.  
 
There are six clinical trials listed on the www.clinicaltrials.gov site for radiofrequency ablation of renal tumors.  The status for the studies includes two that have been completed, but no results have been published, one is still recruiting and two that have not yet started recruiting. The others are listed as terminated or unknown.
 
 
The completed studies are:
    1. NCT00006255 – (A Phase II Study of Magnetic Resonance Guided and Monitored Interstitial Thermal Radiofrequency Ablation of Primary Renal Cell Carcinoma, Hepatic Metastasis, and Other Sites of Solid Organ Tumor and Metastases) The purpose of this trial was to study the effectiveness of magnetic-resonance-guided radiofrequency ablation in treating patients who have primary kidney cancer, liver metastases, or other solid tumors.
    2. NCT00019955 –(A Phase II Study to Evaluate Radiofrequency Ablation of Renal Cancer)
This trial studied radiofrequency interstitial tissue ablation to see how well it works in treating patients with localized renal cell carcinoma.
   
NCT00221728 was terminated due to lack of patients.
 
2013 Update
A literature search of PubMed and NCI clinical trials database was conducted through September 2013. There was no new literature identified that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
 
In 2012, El Dib and colleagues conducted a meta-analysis evaluating RFA and cryoablation for small renal masses Eel Dib, 2012). Included in the review were 11 RFA case series (totaling 426 patients) and 20 cryoablation case series (totaling 457 patients) published through January 2011. Mean tumor size was 2.7 cm (range from 2 to 4.3 cm) in the RFA group and 2.5 cm (range from 2 to 4.2 cm) in the cryoablation group. Mean follow-up times for the RFA and cryoablation groups were 18.1 and 17.9 months, respectively. Clinical efficacy, defined as cancer-specific survival rate, radiographic success, no evidence of local tumor progression, or distant metastases, was not significantly different between groups. The pooled proportion of clinical efficacy for RFA was 90% (95% CI: 0.86–0.93) and 89% (95% confidence interval [CI]: 0.83–0.94) for cryoablation.
 
National Cancer Institute Clinical Trials Database (PDQ®)
A search of the online clinical trials database at ClinicalTrials.org on September 21, 2013 identified one ongoing randomized controlled trials. In NCT01838720, 90 patients will be randomized to compare laparoscopic RFA to laparoscopic partial nephrectomy for stage T1a renal cell carcinoma tumor removal.
 
2014 Update
A literature search conducted through June 2014 did not reveal any new information that would prompt a change in the coverage statement.
 
2015 Update
A literature search conducted through May 2015 did not reveal any new information that would prompt a change in the coverage statement.  The key identified literature is summarized below.
 
Osteoid Tumors
Lanza and colleagues reported on a systematic review of percutaneous thermal ablation for osteoid osteomas in 2014 (Lanza, 2013). Included in the review were 23 articles on RFA, 3 on interstitial laser ablation and 1 with a combination of ablation techniques, totaling 27 articles and 1,772 patients. Technical success was a mean of 100% and clinical success, defined as being pain free, ranged from 94-98% depending on length of follow-up. Complications occurred in 2% of patients and included skin or muscle burn in 9 patients, 4 infections, nerve lesions or tool breakage in 3 patients each, delayed skin healing, hematoma, and failure to reach target temperature in 2 patients each and fracture, pulmonary aspiration, thrombophlebitis and cardiac arrest in 1 patient each. Eighty-six patients had tumor recurrence.
 
In 2014 Wang and colleagues reported on a systematic review and meta-analysis of studies on RFA and partial nephrectomy for stage 1 renal tumors (Wang, 2014).  Included in the review were 166 studies with a total of 9565 patients. The rate of local progression was greater with RFA than laparoscopic/robotic or open partial nephrectomy (4.6%, 1.2% and 1.9%, respectively; p<0.001.) RFA had more frequent minor complications than laparoscopic/robotic or open partial nephrectomy (13.8%, 7.5% and 9.5%, respectively; p<0.001). However, the rate of major complications was greater with open partial nephrectomy than laparoscopic/robotic partial nephrectomy or RFA (7.9%, 7.9% and 3.1%, respectively, p<0.001).
 
In another 2014 systematic review and meta-analysis, Katsanos and colleagues reviewed 1 RCT and 5 cohort studies (N=587) on thermal ablation (RFA or microwave) or nephrectomy for small renal tumors with a mean size of 2.5 cm (Katsanos, 2014). The local recurrence rate was 3.6% in both groups [risk ratio (RR): 0.92, 95% CI: 0.4 to 2.14, p=0.79]. Disease-free survival was also similar in both groups up to 5 years (hazard ratio: 1.04, 95% CI: 0.48 to 2.24, p=0.92). However, the overall rate of complications was significantly lower in the ablation patients than nephrectomy (7.4 vs. 11.1 %; pooled RR: 0.55, 95 % CI: 0.31 to 0.97, p = 0.04.
 
Thyroid Tumors
In 2014 Fuller et al reported on a systematic review and meta-analysis of studies on RFA for benign thyroid tumors.47 Included in the review were 9 studies (5 observational studies and 4 randomized studies) totaling 306 treatments. After RFA, statistically significant improvements were reported in nodule size reduction (29.77 ml, 95% CI: -13.83 to -5.72), combined symptom improvement and cosmetic scores on the 0 to 6 scale (mean of -2.96, 95% CI: -2.66 to -3.25) and withdrawal from methimazole (OR of 40.34, 95% CI: 7.78 to 209.09) . Twelve adverse events were reported of which 2 were considered significant but did not require hospitalization.
 
Bone metastases: Case series have included a limited number of cases of RFA for palliation of pain from bone metastasis. However, the patient populations comprised individuals with limited or no treatment options, for whom short-term pain relief is an appropriate outcome. Therefore, the use of RFA as palliative therapy in patients with painful metastatic bone lesions may be considered medically necessary. Because data are unavailable on use of RFA as initial therapy for pain from bone metastases, this indication remains investigational.
 
Osteoid osteomas: There are no randomized trials for RFA for osteoid osteomas, however, uncontrolled studies have demonstrated RFA can provide adequate pain relief with minimal complications. Therefore, the use of RFA for the treatment of osteoid osteomas that cannot be successfully treated with medical treatment may be considered medically necessary.
 
Renal cell carcinoma: Based on the scientific data (large numbers of patients treated with follow-up) and The clinical input received, radiofrequency ablation of small (i.e. 4 cm) renal cancers may be considered medically necessary in those patients who are not surgical candidates due to comorbid conditions or who have baseline renal insufficiency such that standard surgical procedures would impair their kidney function.
 
Pulmonary tumors: While available studies are limited by study design, accumulating evidence from case series suggests that RFA may be a treatment option in selected patients with primary, non-small cell lung cancer and metastatic pulmonary tumors. Although complications have been reported with the use of RFA in the lung, evidence suggests RFA may have survival rates and have rates of procedure-related complications and mortality similar to surgery. Surgical resection remains the treatment of choice, but in patients unable to tolerate surgery due to medical comorbidities, RFA may be considered a treatment option.
 
Breast tumors: Studies on RFA for breast tumors have reported varied and incomplete ablation rates with concerns about post ablation tumor cell viability. Long-term improvements in health outcomes have not been demonstrated. Additionally, available studies do not allow comparisons to conventional breast-conserving procedures. Further studies, with long-term follow-up, are needed to determine whether RFA for small breast cancers can provide local control and survival rates comparable to conventional breas conserving treatment. Therefore, RFA in the treatment of breast cancer is considered investigational.
 
Head and neck tumors: The evidence for RFA in head and neck tumors is limited to small case series. While RFA may have a role in palliation, complications are common and severe. Therefore, RFA for the treatment of head and neck tumors is considered investigational.
 
Thyroid tumors: The evidence for RFA in thyroid tumors is primarily limited to case series and uncontrolled studies. While RFA has been shown to reduce thyroid tumor volume and improve clinical symptoms, complications can be common and available evidence is insufficient to determine the impact of RFA on net health outcomes. Therefore, RFA for the treatment of thyroid tumors is considered investigational.
 
Miscellaneous tumors: Numerous small case series have been reported on RFA for a variety of miscellaneous tumors including adrenal, soft tissue neoplasms, solid malignancies, pancreas, hamartoma, rectosigmoid, rectal and colorectal tumors. Due to the limited available evidence, RFA for these and any other miscellaneous tumors is considered investigational.
 
National Comprehensive Cancer Network (NCCN) Guidelines
NCCN practice guidelines for the treatment of colon cancer67 state that ablative techniques may be considered alone or in conjunction with resection. All original sites of disease need to be amenable to ablation or resection.
 
NCCN guidelines for thyroid carcinoma indicate ablation techniques such as radiofrequency may be considered for palliative resection of symptomatic distant metastases.68 Ablation may also be considered for asymptomatic distant metastases when there is progressive disease.
 
NCCN guidelines69 indicate RFA is a thermal ablation option for the treatment of kidney cancer in select patients with clinical stage T1 lesions who are not candidates for surgery. RFA is also an option in select patients such as elderly patients and others with competing health risks.
 
NCCN guidelines do not address the use of RFA in head and neck cancer.
 
NCCN guidelines do not address RFA in the management of breast cancer.
 
2016 Update
A literature search conducted through April 2016 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
A literature search was conducted through June 2018.  There was no new information identified that would prompt a change in the coverage statement.  

CPT/HCPCS:
50542Laparoscopy, surgical; ablation of renal mass lesion(s), including intraoperative ultrasound guidance and monitoring, when performed
50592Ablation, 1 or more renal tumor(s), percutaneous, unilateral, radiofrequency
76940Ultrasound guidance for, and monitoring of, parenchymal tissue ablation
77013Computed tomography guidance for, and monitoring of, parenchymal tissue ablation
77022Magnetic resonance guidance for, and monitoring of, parenchymal tissue ablation

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Abdellaoui A, Watkinson AF.(2008) Radiofrequency ablation of renal tumors. Future Oncol 2008; 4(1):103-11.

Aron M, Gill IS.(2007) Minimally invasive nephron-sparing surgery (MINSS) for renal tumours. Part II: probe ablative therapy. Eur Urol 2007; 51(2):348-57.

Comparison between surgery and radiofrequency for treatment of renal tumors. http://clinicaltrials.gov/ct2/show/NCT00221728?term=NCT00221728&rank=1. Last accessed September 2009.

El Dib R, Touma NJ, Kapoor A.(2012) Cryoablation vs radiofrequency ablation for the treatment of renal cell carcinoma: a meta-analysis of case series studies. BJU Int 2012; 110(4):510-6.

Farrell MA, Charboneau WJ, DiMarco DS, et al.(2003) Image-guided radiofrequency ablation of solid renal tumors. Am J Roentgenol 2003; 180(6):1509-13.

Finelli A, Rewcastle JC, Jewett MA.(2003) Cryotherapy and radiofrequency ablation: pathophysiologic basis and laboratory studies. Curr Opin Urol May 2003; 13(3): 187-91.

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Gervais DA, Arellano RS, et al.(2005) Radiofrequency ablation of renal cell carcinoma: Part 2, lessons learned with ablation of 100 tumors. Am J Roentgenol 2005; 185:72-80.

Gervais DA, McGovern FJ, Arellano RS, et al.(2003) Renal cell carcinoma: clinical experience and technical success with radio-frequency ablatin of 42 tumors. Radiology 2003; 226(2):417-24.

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