Medical Policy


Subject:Radiofrequency Ablation to Treat Tumors Outside the Liver
Policy #:  SURG.00050Current Effective Date:  07/13/2011
Status:ReviewedLast Review Date:  05/19/2011

Description/Scope

This document 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:

Position Statement

Medically Necessary:

  1. Radiofrequency ablation of osteoid osteomas is considered medically necessary.
  2. Radiofrequency ablation of painful bony metastases is considered medically necessary in individuals who have failed or who are considered poor candidates for standard treatments such as opioids or radiation therapy.
  3. Radiofrequency ablation for clinically localized, suspected renal malignancy is considered medically necessary for individuals with peripheral lesions that are less than or equal to 4 cm in diameter and when one or more of the following criteria are met:
    1. Individual has a single kidney; or
    2. Individual has renal insufficiency as defined by a glomerular filtration rate (GFR) of less than or equal to 60mL/min/m2; or
    3. Individual is considered a high-risk surgical candidate.
  4. Radiofrequency ablation of biopsy-proven non-small cell lung cancer (NSCLC) is considered medically necessary when all of the following criteria are met:
    1. Surgical or radiation treatment with curative intent is considered appropriate based on stage of disease, however medical co-morbidity renders the individual unfit for those interventions; and
    2. No tumor has a maximum diameter of greater than 3.0 cm; and
    3. Tumors are located at least 1 cm from the trachea, main bronchi, esophagus, aorta, aortic arch branches, pulmonary artery and the heart.
  5. Radiofrequency ablation of metastatic malignant tumor(s) to the lung is considered medically necessary when all of the following criteria are met:
    1. Biopsy-proven lung metastasis(es) from an extra-pulmonary primary site; and
    2. Surgical or radiation treatment is considered appropriate based on stage of disease, however medical co-morbidity renders the individual unfit for those interventions; and
    3. There is no current active extra-pulmonary disease; and
    4. There are no more than 3 tumors per lung; and
    5. No tumor has a maximum diameter greater than 3.0 cm; and
    6. Tumors are located at least 1 cm from the trachea, main bronchi, esophagus, aorta, aortic arch branches, pulmonary artery and the heart; and
    7. If a repeat procedure, at least 12 months have elapsed since the prior ablation.

Investigational and Not Medically Necessary:

Other applications of radiofrequency ablation to treat tumors outside the liver are considered investigational and not medically necessary, including but not limited to: breast cancer, breast fibroadenomas, head and neck tumors, 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 individuals treated over an 11 year period, complete pain relief at 2-years was noted in 89% of participants (Rosenthal, 1998). Rimondi and colleagues (2005) were able to demonstrate an 85% primary success in 82 out of 97 participants. Secondary success was achieved in 15 individuals (15%). There were no treatment related complications. A smaller study by Martel (2005) reported a 97% primary success rate with RFA in 38 individuals. The secondary success rate was 100% in this study.

Painful Bony Metastases
Goetz and colleagues (2004) reported on an international study of 43 individuals 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. Selection criteria required baseline values > 4 from two or fewer painful sites. Thirty nine (91%) of the individuals 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 participants, the study population focused on those with limited other alternatives and in whom short term pain relief is an appropriate outcome (Goetz, 2004).

Renal Cell Carcinoma (RCC) and other renal tumors
The National Comprehensive Cancer Network® (NCCN) Clinical Practice Guideline in Oncology ™ for Kidney Cancer (2011) includes surgical resection as an effective therapy for clinically localized RCC, with options including radical nephrectomy and nephron-sparing surgery. Individuals with stage I through III tumors and in satisfactory medical condition are recommended to undergo surgical excision. Active surveillance or ablative techniques, such as radiofrequency ablation or cryoablation are alternative strategies for selected individuals such as the elderly and those with comorbid health risk factors.

Articles have reported RFA as promising and suggested that the procedure is relatively safe with a low complication rate and reduced tumor bulk. While no long-term, controlled clinical trials regarding RFA have been reported, case series with follow-up data up to five years are now available and have shown RFA to consistently result in ablation of tumor masses in the kidney with minimal morbidity.

The American Urological Association's (Campbell, 2009) Practice Guidelines Committee reviewed the literature and provided management guidelines for clinical T1 renal mass. The recommendations divided individuals into four indices based on tumor size. The reviewers noted "tumors >3.5 cm and those with irregular shape or infiltrative appearance may be associated with increased risk of recurrence when managed with thermal ablation". Surgical excision remained the standard of care for healthy individuals (Index 1) with T1a (≤ 4.0 cm) renal masses, and for those with increased surgical risk (Index 2). Thermal ablation as a less-invasive option is available for healthy individuals, and is recommended for high surgical risk individuals. For T1b (>4.0 cm to < 7.0 cm) healthy individuals (Index 3), standard of care is a radical nephrectomy if a normal contralateral kidney is present. The panel listed thermal ablation as an option for individuals with T1b masses.

Outcomes of 187 RFA procedures in 149 individuals were described in 6 uncontrolled studies (Farrell, 2003; Gervais, 2003; Lewin, 2004; Mayo-Smith, 2003; Pavlovich, 2002; Rendon, 2002; Zagoria, 2004). The characteristics of the individuals 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 individuals in 2 studies, including perinephric hematomas, hemorrhage, and ureteral strictures.

A study by Clark and colleagues (2006) of 22 individuals with 26 small RCC lesions had mean tumor volume decreases at a mean follow-up of 11.2 months. Although the article reported on the technical success of the procedure, 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).

The current available, peer-reviewed medical literature reveals that RFA is safe and effective for: managing small, undefined peripheral renal masses (< 4 cm); treating solitary kidneys or situations where the contra-lateral kidney is functioning poorly; and treating individuals who have significant comorbidities and cannot tolerate nephrectomy.

Pulmonary Tumors
Surgical resection is the primary standard of care for early stage, pulmonary tumors (Lencioni, 2008; NCCN, 2011). The surgical procedure is dependent on the extent of the disease, any comorbid conditions, and the individual's cardiopulmonary reserves. The NCCN clinical practice guideline also includes a recommendation for definitive chemoradiation for individuals with clinical stage II and III who are deemed medically inoperable. Surgery is rarely done for individuals with Stage IV disease.

The NCCN Clinical Practice Guideline in Oncology for Non-Small Cell Lung Cancer (2011) states,

RFA may be an option for node-negative patients who either refuse surgery or cannot tolerate surgery because of poor performance status (PS), significant cardiovascular risk, poor pulmonary function, and/or comorbidities.

Optimal candidates for RFA include patients with an isolated peripheral lesion less than 3 cm; RFA can be used for previously irradiated tissue and for palliation.

Radiofrequency ablation is being studied as a minimally invasive alternative to surgery. Most studies identified are small case series, which focused on technical feasibility and initial tumor response (Akeboshi, 2004; Belfiore, 2004; Hiraki, 2007; Jin, 2004; King, 2004; Lee, 2004; Yan, 2007; Yasui, 2004).

Lencioni and colleagues (2008) reported results from a nonrandomized, intention-to-treat, prospective, multi-center trial consisting of 106 individuals with 183 lung tumors. In the trial, proof of lung malignancy was determined from at least one tumor that was biopsy proven non-small cell lung cancer (NSCLC) or lung metastasis. Additional eligibility criteria included individuals that were rejected as surgical candidates and were ineligible for additional treatment with chemotherapy or radiation therapy. Primary study endpoints were technical success, safety and confirmed complete response (CR) of the targeted tumors. Overall survival (OS), cancer-specific survival and quality of life (QOL) were secondary endpoints. Treatment was completed in 105 of 106 participants. Technical placement and treatment of a single metastatic lesion could not be performed in one individual. 137 treatment procedures were done on 105 participants. Eighty-five (80%) of 106 participants were assessed for primary endpoints. Seventy-five (88%) of 85 participants had confirmed CR lasting at least a year in all treated tumors. Ten (12%) out of 85 participants had at least one incomplete ablation with disease progression. 20 participants died because of tumor progression. 1- and 2-year OS was 70% (95% CI 51-83%) and 48% (30-65%) in individuals with NSCLC, 89% (76-95%), 66% (53-79%) in participants with colorectal metastases, and 92% (65-99%) and 64% (43-82%) in individuals with other metastases. Large, symptomatic pneumothorax requiring drainage via a chest tube occurred in 27 procedures. Four pleural effusions requiring drainage occurred in four participants. Minor complications included pneumothorax (n=28) and pleural effusion (n=11) that did not require treatment. Three incidents of self-limiting intrapulmonary hemorrhage occurred. The median hospital stay was 3 days (range 2-12 days). Post-treatment pulmonary function tests did not show any significant changes. Individuals with NSCLC showed a slight decrease in pulmonary function which was deemed consistent with the underlying pulmonary disease. The authors noted the study population was heterogeneous, and the follow-up period may not have been long enough to detect late tumor recurrences and was not designed to provide evidence of survival benefits. Therefore, the authors concluded "a randomized controlled trial comparing RFA versus standard treatment options is now warranted to prove the clinical benefit of this approach.

In one study, Herrera (2003) reported use of RFA in 10 individuals with sarcomas and primary lung cancers and 8 individuals with metastatic tumors in the lung. All participants 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) individuals 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%.

Ambrogi and colleagues (2006) reported results from a case series of RFA of 64 pulmonary lesions in 54 individuals with primary non-small cell lung carcinoma (NSCLC) (40 cases) and metastases from other primary sites in 24 cases. Technical success was reported on all but two lesions. The mean size of the lesions was 2.4 cm. Morbidity included hematoma, pleural effusion and pneumothorax in 12.7% (10 cases). The mean follow-up period was 23.7 months. Overall complete response based on radiographs was noted in 39 of 63 lesions (61.9%). Although statistical significance was not met, RFA was better for lesions <3cm (69.7% vs 50%) and from extra-thoracic primary malignancies metastatic to the lungs (70.8% vs 56.4%). Distant recurrence occurred in 39% (21 cases) and most participants received adjuvant therapy. While the actuarial median overall survival is 28.9 months, NSCLC is lower at 18.9 months and for metastatic lesions it is not reached.

Zhu and colleagues (2008) performed a systematic review of articles on radiofrequency ablation of lung tumors published through 2006. Procedure-related morbidity and mortality ranged from 15.2% to 55.6% and 0% to 5.6%, respectively. Pneumothorax was the most frequently reported complication (4.5-61.1%). Local recurrence rates ranged from 3% to 38.1% (median = 11.2%). The median progression-free interval ranged from 15 months to 26.7 months (median = 21 months), and 1-, 2- and 3-year survival rates were 63-85%, 55-65% and 15-46%, respectively.  The authors concluded there is a growing evidence for the possible use of RFA for lung tumors. However, there was a wide range of variation in the ablation results and local recurrence rates, and estimated 3-year survival was reported in only three of the seventeen studies. The authors noted, "the relatively short follow-up in most studies may suggest that the current experience with RFA is still too immature to reliably establish its therapeutic value. RFA cannot be considered a therapeutic equivalent to surgical resection."  RFA may have a potential role in the treatment of non-resectable lung tumors, but defined, clear selection criteria have not been identified. Randomized control trials comparing RFA and systemic chemotherapy compared with chemotherapy alone would be useful.

Data from an ongoing, prospective, open-labeled trial utilizing RFA on 148 nonsurgical candidates with lung metastases were reported by Chua (2010). With a median follow-time of 29 months (range 2-103), 38 individuals had a CR while 30 other participants had a PR. Stable disease was noted in 57 individuals and progressive disease in 23 participants. Overall median PFS was 11 months (95% CI 9-14 months). The median OS was 51 months (95% CI 19-83 months). Disease progression after RFA was noted in the majority (80%) of the individuals. Local failure at the original ablation site accounted for 5%, progressive disease in other parts of the lung for 32%, in the lung and at other distant sites in 30%, and at other distant metastatic sites for 30%. Repeat RFA treatment for additional treatment or disease control was done for 28 individuals (19%). The median overall survival was 81 months from the first RFA procedure (Chua, 2010). The authors concluded the "data demonstrate that prolonged survival may be achieved after RFA of lung metastases." Recommendations also included randomized trials of concomitant RFA with systemic therapies and stringent selection criteria to further define the role for treating individuals with lung metastases.

In December 2007, the U.S. Food and Drug Administration (FDA) issued a Public Health Notification: Radiofrequency Ablation of Lung Tumors. On September 24, 2008, the FDA issued a clarification of the original notice. 

"Public health concerns:
FDA has received reports of death and serious injuries associated with the use of RF ablation devices in treatment of lung tumors. Since we have not reviewed any pre-market clinical data in support of this specific treatment use, we do not know the actual adverse event rate. Therefore, we cannot say if these deaths or injuries are occurring more frequently than with other forms of treatment for lung tumors. These adverse events could be related to a number of factors, including selection and management, technical use of the RF device, post procedural treatments, and management of complications."

The regulatory status for RFA devices also noted:

"FDA has cleared RF ablation devices for the general indication of soft tissue cutting, coagulation, and ablation by thermal coagulation necrosis. This clearance was based only on bench testing data or animal testing performance data. Under this general indication, RF ablation can be used as a tool to ablate tumors, including lung tumors.

Some RF ablation devices have been cleared for additional specific treatment indications, including partial or complete ablation of non-resectable liver lesions, and palliation of pain associated with metastatic lesions involving bone. In order for an ablation device to obtain clearance for specific treatment indications, clinical data are necessary to justify the indications by showing that the device, when used on a well-defined target population, consistently achieves the desired treatment effect.

FDA has not cleared any RF ablation devices for the specific treatment indication of partial or complete ablation of lung tumors. Manufacturers of RF ablation devices cannot legally market them for this treatment indication until they have presented to FDA clinical data sufficient to establish safety and effectiveness for this purpose. Manufacturers have asked that they be allowed to provide training for clinicians related to this ablation of pulmonary tumor use. FDA cannot permit manufacturer-sponsored training for a specific indication that has not been cleared. This does not apply to training that may be available from other sources."

Surgical resection still represents the standard of care for non-small cell lung cancer, and RFA should be reserved for select individuals who are high-risk for standard therapy. Published short-term results suggest that RFA treatment of pulmonary malignancies, when surgical resection is contraindicated, appears relatively safe, technically feasible and efficacious with the objective of improving local disease control. In addition, specialty opinion suggests that radiofrequency ablation may be used as a treatment for pulmonary tumors.

Other Malignancies 

Breast Cancer
The search identified 4 uncontrolled pilot studies with 77 individuals 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 individuals, 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 individual 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.

In a nonrandomized study by Oura and colleagues (2007), 52 individuals with small breast tumors were treated by RFA followed by radiation therapy and chemotherapy. No recurrence was reported in any of the participants at an average of 15 months post procedure. Cosmesis ratings were excellent in 43 participants, good in 6 individuals, and fair in 3 participants. However, the small trial was not controlled and the long term safety and efficacy have not been compared to standard of care. The investigators recommended further study of this novel treatment modality for small breast lesions.

Adrenal neoplasms
One case series of 13 individuals 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 individuals 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 individuals 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 other tumors and 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).

Bone metastases:  After lung and liver, bone is the third most common metastatic site and is relatively frequent among individuals 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 individuals, 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.

Breast tumors:  Early-stage primary breast tumors are typically treated surgically. The selection of lumpectomy, modified radical mastectomy, or another approach balances the individual's desire for breast conservation, the need for tumor-free margins in resected tissue, and 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. RFA is being investigated as another alternative for treatment of breast tumors and fibroadenomas.

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. The effectiveness of RFA for ablation of osteomas and pain relief has been demonstrated in clinical studies.

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. Individuals 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 health, inoperability of most metastatic lesions, and lack of evidence for benefit to the individual.

Renal cell carcinoma and other renal tumors:  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 Although long term controlled trials have not been reported, articles of case series have reported RFA as relatively safe and with low complication rate to ablate renal tumors <4 cm in diameter.

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 document 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.

Procedures
When services are Medically Necessary: 

CPT 
20982Ablation, bone tumor(s) (e.g., osteoid osteoma, metastasis) radiofrequency, percutaneous, including computed tomographic guidance
  
ICD-9 Diagnosis 
198.5Secondary malignant neoplasm of bone and bone marrow
213.0-213.9Benign neoplasm of bone and articular cartilage

When services are Investigational and Not Medically Necessary:
For the procedure code listed above for all other diagnoses; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

When services may be Medically Necessary when criteria are met: 

CPT 
32998Ablation therapy for reduction or eradication of 1 or more pulmonary tumor(s) including pleura or chest wall when involved by tumor extension, percutaneous, radiofrequency, unilateral
50542Laparoscopy, surgical; ablation of renal mass lesion(s), including intraoperative ultrasound guidance and monitoring, when performed [when specified as radiofrequency ablation]
50592Ablation, 1 or more renal tumor(s), percutaneous, unilateral, radiofrequency
  
ICD-9 Diagnosis 
 All diagnoses

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above when criteria are not met, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Guidance
When services are Medically Necessary: 

CPT 
77013Computed tomography guidance for, and monitoring of, parenchymal tissue ablation (not reportable with CPT 20982)
77022Magnetic resonance guidance for, and monitoring of, parenchymal tissue ablation
76940Ultrasound guidance for, and monitoring of, parenchymal tissue ablation (not reportable with 50542)
  
ICD-9 Procedure 
198.5Secondary malignant neoplasm of bone and bone marrow
213.0-213.9Benign neoplasm of bone and articular cartilage

When services may be Medically Necessary when criteria are met:
For the procedure codes listed above, for the following diagnoses

ICD-9 Diagnosis 
162.3-162.9Malignant neoplasm, bronchus or lung
189.0-189.1Malignant neoplasm of kidney, renal pelvis
189.8Malignant neoplasm of other specified sites of urinary organs
197.0Secondary malignant neoplasm of lung
198.0Secondary malignant neoplasm of kidney
231.2Carcinoma in situ of bronchus and lung
233.9Carcinoma in situ of other and unspecified urinary organs (specified as kidney)
236.91Neoplasm of uncertain behavior of kidney and ureter
239.5Neoplasm of unspecified nature, other genitourinary organs (specified as kidney)

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above for all other diagnoses; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Future ICD-10 coding (effective 10/01/2013)
A draft of ICD-10 Coding related to this document, as it might look today, is available for reference and comments at: Appendix 1: Future ICD-10 coding

References

Peer Reviewed Publications:

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  29. Park S, Anderson JK, Matsumoto ED, et al. Radiofrequency ablation of renal tumors: intermediate-term results. J Endourol. 2006; 20(8):569-573.
  30. 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.
  31. 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.
  32. Rimondi E, Bianchi G, Malaguti MC, et al .Radiofrequency thermoablation of primary non-spinal osteoid osteoma: optimization of the procedure. Eur Radiol. 2005; 15(7):1393-1399.
  33. 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.
  34. Sano Y, Kanazawa S, Gobara H, et al. Feasibility of percutaneous radiofrequency ablation for intrathoracic malignancies: a large single-center experience. Cancer. 2007; 109(7):1397-1405
  35. Simon CJ, Dupuy DE, DiPetrillo TA, et al. Pulmonary radiofrequency ablation: long-term safety and efficacy in 153 patients Radiology. 2007; 243(1):268-275.
  36. Singletary SE. Radiofrequency ablation of breast cancer. Am Surg. 2003; 69(1):37-40.
  37. Steinke K, Glenn D, King J, et al. Percutaneous imaging-guided radiofrequency ablation in patients with colorectal pulmonary metastases: 1-year follow-up. Ann Surg Oncol. 2004; 11(2):207-212
  38. 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.
  39. 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.
  40. Yan TD, King J, Ebrahimi A, et al. Hepatectomy and lung radiofrequency ablation for hepatic and subsequent pulmonary metastases from colorectal carcinoma. J Surg Oncol. 2007; 96(5):367-373.
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Government Agency, Medical Society, and Other Authoritative Publications:

  1. Campbell SC, Novick AC, Belldegrun A, et al; Practice Guidelines Committee of the American Urological Association. J Urol. 2009; 182(4):1271-1279.
  2. National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology™. © 2011 National Comprehensive Cancer Network, Inc. For additional information: http://www.nccn.org/. Accessed on March 23, 2011.
    • Kidney Cancer (V.2.2011). Revised March 23, 2011;
    • Non-Small Cell Lung Cancer. V.3.2011. Revised January 7, 2011;
    • Small Cell Lung Cancer (V.1.2011). Revised March 28, 2011.
  3. U.S. Food and Drug Administration. FDA Public Health Notification: Radiofrequency Ablation of Lung Tumors - Clarification of Regulatory Status. September 24, 2008 Available at: http://www.fda.gov/cdrh/safety/092408-ablation.html. Accessed on March 28, 2011.
Web Sites for Additional Information
  1. American Cancer Society. Available at: http://www.cancer.org. Accessed on March 28, 2011.
  2. National Cancer Institute. Available at: http://www.cancer.gov. Accessed on March 28, 2011.
Index

Bony Metastases, Treatment of 
Cancer
Kidney Cancer
Non-Small Cell Lung Cancer
Lung Cancer
Osteoid Osteomas
Radiofrequency Ablation (RFA)
Renal Cell Carcinoma
Solid Tumor

Document History
StatusDateAction
Reviewed05/19/2011Medical Policy & Technology Assessment Committee (MPTAC) review.
Reviewed05/18/2011Hematology/Oncology Subcommittee review. Updated Rationale, References and Websites.
 01/01/2011Updated Coding section with 01/01/2011 CPT changes.
Revised05/13/2010MPTAC review.
Revised05/12/2010Hematology/Oncology Subcommittee review. Revised criterion for renal mass diameter from 3 cm to 4 cm.  Updated Rationale, References and Websites.
Revised07/13/2009MPTAC review.
Revised06/17/2009Hematology/Oncology Subcommittee review. Clarified medically necessary criteria for lung tumors.
Revised05/21/2009MPTAC review.
Revised05/20/2009Hematology/Oncology Subcommittee review. Added medically necessary criteria for lung tumors. Rationale, references and coding updated.
Reviewed11/20/2008MPTAC review.
Reviewed11/19/2008Hematology/Oncology Subcommittee review. Updated rationale, references and websites.
Reviewed11/29/2007MPTAC review.
Reviewed11/28/2007Hematology/Oncology Subcommittee review. Rationale, coding, references and background updated. Added suspected renal malignancy as medically necessary with criteria. Clarified investigational and not medically necessary statement. The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary."
Reviewed05/17/2007MPTAC review.
Reviewed05/16/2007Hematology/Oncology Subcommittee review. References, rationale, background and coding updated. No change to position statement.
 01/01/2007Updated Coding section with 01/01/2007 CPT/HCPCS changes; removed CPT 76394 deleted 12/31/2006.
Reviewed06/08/2006MPTAC annual review.  Updated references and codes; no change to the position statement.
 01/01/2006Updated Coding section with 01/01/2006 CPT/HCPCS changes
Revised07/14/2005MPTAC review.  Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.
Pre-Merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc.

04/28/2005

SURG.00050Radiofrequency Ablation of Solid Tumors
WellPoint Health Networks, Inc.

06/24/2004

5.11.01Radiofrequency Ablation of Metastatic Lesions of the Bone as a Palliative Technique for Pain