National Medical Policy

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1 National Medical Policy Subject: Policy Number: Cryosurgical Ablation of Renal Tumors NMP314 Effective Date*: January 2007 Updated: March 2016 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State s Medicaid manual(s), publication(s), citation(s), and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link National Coverage Determination (NCD) National Coverage Manual Citation X Local Coverage Determination (LCD)* Ablative Therapy: Article (Local)* Other None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. Cryosurgical Ablation of Renal Tumors Mar 16 1

2 If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Health Net, Inc. considers cryosurgical ablation of renal tumors, up to approximately 4 cm in size, medically necessary in a select group of patients who meet any of the following criteria: 1. Patients with a solitary kidney; or 2. Patient is at high risk for surgical resection due to poor clinical status; or 3. Patients with compromised renal function, as defined by as defined by a glomerular filtration rate of less than or equal to 60 ml/min/m2, in whom preservation of renal function is necessary. Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets. ICD-9 Codes Malignant neoplasm of kidney, except pelvis Secondary malignant neoplasm of kidney ICD-10 Codes C64- C64.9 Malignant neoplasm of kidney, except renal pelvis C65- C65.9 Malignant neoplasm of renal pelvis C79.0- C79.02 Secondary malignant neoplasm of kidney and renal pelvis CPT Codes Ablation, open, one or more renal mass lesion(s), cryosurgical, including intraoperative ultrasound guidance and monitoring, if performed Laparoscopy, surgical; ablation of renal mass lesion(s) including intraoperative ultrasound guidance and monitoring, if performed Ablation, renal tumor(s), unilateral, percutaneous, cryotherapy HCPCS Codes N/A Scientific Rationale Update March 2016 National Comprehensive Cancer Network (NCCN, Version ) Clinical Practice Guidelines on Kidney Cancer notes: Cryosurgical Ablation of Renal Tumors Mar 16 2

3 Observation or ablative techniques (eg, cryosurgery, radiofrequency ablation): Can be considered for patients with Clinical Stage T1 renal lesions who are not surgical candidates. Biopsy of small lesions may be considered to obrain or confirm a diagnosis of malignancy and guide surveillance, cryosurgery, and radiofrequency ablation strategies. Randomized Phase lll comparison with surgical resection (i.e., radical or partial nephrectomy by open laparoscopic techniques) has not been done. Ablative techniques are associated with a higher local recurrence rate than conventional surgery. Zagar et al. (2015) analyzed their 15-year experience with small renal masses ablation and present oncologic and functional outcomes of laparoscopic cryoablation (LCA) and percutaneous cryoablation (PCA). The authors identified patients who underwent LCA (n = 275) or PCA (n = 137) for small renal masses between 1997 and Differences in overall survival (OS) and recurrence-free survival (RFS) were analyzed using a log-rank test. Cox proportional hazard ratios model was used to determine factors that predicted OS. Fit proportional hazard risk ratios were also calculated to determine if there were any factors that affected tumor recurrence. Tumor sizes were equal between the 2 groups; however, tumors in the PCA group were more complex. The overall (7.27% and 7.29%) and major complications (0.7%) and 3.6%) were similar. The estimated probability of 5-year OS for LCA and PCA was 89% and 82%, respectively. The estimated probability of the 5-year RFS for LCA and PCA was 79% and 80%, respectively. Heart disease (hazard ratio, 2.15; 95% confidence interval, ; P =.001) and history of disease recurrence (hazard ratio, 2.49; 95% confidence interval, ; P =.001; P <.0001) were predictors of death. The median follow-up time for the LCA group (4.41 years [ years]) was longer than the PCA group (3.15 years [ years]; P =.0001). The authors found no significant difference in OS or RFS at 5 years between the 2 groups. Tumor size and anterior location affected local recurrence rates, and these factors should be taken into consideration when choosing the appropriate treatment plan. Renal nephrometry score or type of cryoablation was not associated with tumor recurrence. Scientific Rationale Update March 2015 According to NCCN guidelines on Kidney Cancer (3.2015), surgical resection remains an effective therapy for clinically localized renal cell carcinoma (RCC), with options including radical nephrectomy and nephron-sparing surgery. Each modality is associated with their own risks and benefits, the balance of which should optimize long-term renal function and expected cancer-free survival. NCCN notes that elderly individuals and those with small renal masses and other comorbidities often have a low RCC-specific mortality. Active surveillance and ablative techniques such as cryoor radiofrequency ablation are alternative strategies for selected patients, particularly the elderly and those with competing health risks. They do note however, ablative techniques are associated with a higher local recurrence rate than conventional surgery. The also note that randomized phase III comparison of ablative techniques with surgical resection have not been performed. Miller et al (2014) sought to evaluate outcomes of percutaneous ablation of small renal tumors in the elderly population. Using their tumor ablation database, the authors searched for percutaneous ablation procedures for clinical T1a renal masses in octogenarians and nonagenarians between June 2001 and May Altogether, 105 tumors from 99 procedures among 95 patients (mean age 84.0±3.0 years, Cryosurgical Ablation of Renal Tumors Mar 16 3

4 range 80-92) were identified. Oncologic outcomes and major complications were evaluated. Assessment also included patient hospital stays and renal functional outcomes. Technical success was achieved in 60/61 (98.4%) tumors managed with cryoablation and 43/44 (97.7%) after radiofrequency ablation (RFA). Of 87 renal tumors with at least 3 months imaging follow-up, 2 (5.4%) tumors progressed at 1.2 and 2.2 years after RFA. None recurred after cryoablation. Estimated progressionfree survival rates at 1, 3, and 5 years after ablation were 99%, 97%, and 97%, respectively. Thirty-four patients died at a mean of 3.7 years after ablation (median 3.7; range ). Estimated overall survival rates were 98%, 83%, and 61%, respectively. Among 33 patients with sporadic, biopsy-proven renal-cell carcinoma, estimated cancer-specific survival rates were 100%, 100%, and 86%, respectively. Five (8.6%) major complications developed after renal cryoablation with no (0%) major complication after RFA. Mean decrease in serum creatinine level within 1 week after ablation was 0.1mg/dL. Mean hospitalization was 1.2 days. The authors concluded percutaneous thermal ablation is safe and effective in the active management of clinical T1a renal masses in elderly patients. These results should help urologists appropriately assess expected outcomes when counseling octogenarian and nonagenarian patients. Larcher et al (2015) hypothesized that laparoscopic renal cryoablation (LRC) might provide an effective long-term cancer control in patients with a single ct1a SRM without a previous history of renal cell carcinoma (RCC). The study design was a retrospective analysis of 174 consecutive patients who received LRC as first treatment for a single computed tomography or magnetic resonance imaging contrast-enhancing ct1a SRM between 2000 and Patients with a previous history of RCC were excluded. Treatment failure was evaluated 1 day after surgery. Local recurrence, metachronous SRM, systemic progression, disease relapse, cancerspecific mortality, and all-cause mortality were evaluated 10 years after surgery. Kaplan-Meier plots were used to depict outcome-free survival rate. Median patient age was 66 years. Median tumor size was 20mm. Median follow-up was 48 months. Among patients with biopsy-proven RCC (63%, n = 109), the treatment failure-free rate was 98%. The 10-year recurrence-free survival rate was 95% and the 10-year metachronous SRM-free survival rate was 87%. The 10-year systemic progressionfree survival rate was 100% and the 10-year disease relapse-free survival rate was 81%. The cancer-specific mortality-free survival rate was 100%, and the all-cause mortality-free survival rate was 61%. The authors concluded LRC provides safe long-term cancer control in patients newly diagnosed with a single ct1a SRM. Treatment failure and local recurrence are uncommon. Systemic progression-free survival and cancer-specific-free survival are optimal. Johnson et al (2014) reported the long-term oncologic outcomes of laparoscopic cryoablation for clinical stage T1 renal masses at the Medical College of Wisconsin. A retrospective chart review was performed evaluating patients who underwent laparoscopic cryoablation for renal masses at the Medical College of Wisconsin between February 2000 and October A total of 171 renal masses in 144 patients were treated by laparoscopic cryoablation during the study period. After excluding patients with <5 years follow-up and those with >clinical stage I disease, 112 renal masses treated in 92 patients remained for analysis. Mean patient age was 59.6 years (standard deviation [SD], 12.5 years). Mean lesion size was 2.3 cm (SD, 0.94 cm). Mean age adjusted Charlson comorbidity index was 4.55 (SD, 1.69). Mean follow-up was 97.9 months (SD, 24.8 months). Overall survival among all patients was 80.9%. Lesions were biopsy proven to be malignant in 70 patients (76.3%). Of those with biopsy-proven malignancy, there were 6 recurrences, 14 non-cancer- Cryosurgical Ablation of Renal Tumors Mar 16 4

5 related deaths, and 1 cancer-related death, leading to an overall survival of 77.6%, progression-free survival of 91.0%, and cancer-specific survival of 98.5%.The authors concluded this series indicates that laparoscopic cryoablation is both an efficacious treatment for clinical stage T1 renal masses and provides excellent longterm oncologic outcomes. Georgiades and Rodriguez (2014) presented the 5-year oncologic outcomes of a prospective trial of percutaneous cryoablation in the treatment of RCC. Over a 5- year period, we treated 134 consecutive patients with biopsy-proven RCC with CTguided percutaneous cryoablation. All were treated while under conscious sedation. Technical objective was for the ice ball to cover the lesion plus a 5-mm margin. Hydro- or air dissection was utilized to aid in technical success as needed. Efficacy was defined as the lack of enhancement and/or enlargement of a previously enhancing lesion on follow-up imaging. Safety was assessed by the common terminology criteria for adverse events (CTCAE), version 4.0. The 1-, 2-, 3-, 4-, and 5-year efficacy of percutaneous cryoablation for RCC was 99.2, 99.2, 98.9, 98.5, and 97.0%, respectively. Median tumor size was 2.8 ± 1.4 cm. All-cause mortality during the study period was 3 (none from RCC), yielding an overall 5-year survival of 97.8%. The cancer-specific 5-year survival was 100%. No patient developed metastatic disease during the follow-up period. The overall significant CTCAE version 4.0 complication rate was 6%, with the most frequent being transfusion-requiring hemorrhage, at 1.6%. There was one 30-day mortality unrelated to the procedure. The authors concluded CT-guided percutaneous cryoablation for renal cancer offers very high efficacy, approaching that of the gold standard, with a more favorable safety profile. Scientific Rationale Update March 2014 Georgiades and Rodriguez (2014) presented the 5-year oncologic outcomes of a prospective trial evaluating percutaneous cryoablation as a treatment option for renal cell carcinoma (RCC). Over a 5-year period, 134 consecutive patients with biopsyproven RCC were treated with CT-guided percutaneous cryoablation. All were treated while under conscious sedation. Technical objective was for the ice ball to cover the lesion plus a 5-mm margin. Hydro- or air dissection was utilized to aid in technical success as needed. Efficacy was defined as the lack of enhancement and/or enlargement of a previously enhancing lesion on follow-up imaging. Safety was assessed by the common terminology criteria for adverse events (CTCAE), version 4.0. The 1-, 2-, 3-, 4-, and 5-year efficacy of percutaneous cryoablation for RCC was 99.2, 99.2, 98.9, 98.5, and 97.0 %, respectively. Median tumor size was 2.8 ± 1.4 cm. All-cause mortality during the study period was 3 (none from RCC), yielding an overall 5-year survival of 97.8 %. The cancer-specific 5-year survival was 100 %. No patient developed metastatic disease during the follow-up period. The overall significant CTCAE version 4.0 complication rate was 6 %, with the most frequent being transfusion-requiring hemorrhage, at 1.6 %. There was one 30-day mortality unrelated to the procedure. Investigators concluded CT-guided percutaneous cryoablation for renal cancer offers very high efficacy, approaching that of the gold standard, with a more favorable safety profile. Martin and Athreya (2013) compared local and metastatic recurrence of small renal masses primarily treated by cryoablation or microwave ablation in a meta-analysis. The MEDLINE, CINAHL, and PUBMED databases were searched to review the treatment of small renal masses with cryoablation or microwave ablation. Fifty-one studies met the inclusion criteria. Fifty-one studies representing 3950 kidney lesions were analyzed. No differences were detected in the mean patient age (P = 0.150) or Cryosurgical Ablation of Renal Tumors Mar 16 5

6 duration of follow-up (P = 0.070). The mean tumor size was significantly larger in the microwave ablation group compared with the cryoablation group (P = 0.030). There was no difference between microwave ablation and cryoablation groups in terms of primary effectiveness (93.75% vs %, respectively; P = 0.400), cancer-specific survival (98.27% vs. 96.8%, respectively; P = 0.470), local tumor progression (4.07% vs. 2.53%, respectively; P = 0.460), or progression to metastatic disease (0.8% vs. 0%, respectively; P = 0.120). Patient age was predictive of overall complications in the multivariate analysis (P = 0.020). Local tumor progression with cryoablation was predicted by the mean follow-up duration using univariate (P = 0.009) and multivariate regression (P = 0.003). Clear cell and angiomyolipoma were more frequent in the microwave ablation group (P < and P = , respectively), and papillary, chromophobe, and oncocytoma were more frequent in the cryoablation group (P < , P < , and P = , respectively). Open access was used more often in the microwave ablation group than in the cryoablation group (12.20% vs. 1.04%, respectively; P < ), and percutaneous access was used more frequently in the cryoablation group than in the microwave ablation group (88.64% vs %, respectively; P = ). Reviewers concluded there is no difference in local or metastatic recurrence between cryoablation- and microwave ablation-treated small renal masses. Breen et al (2013) evaluated the technical and oncological efficacy of an imageguided cryoablation program for renal tumors. A prospective analysis of technical and radiological outcomes was undertaken after treatment of 171 consecutive tumors in 147 patients. Oncological efficacy in a subset of 125 tumors in 104 patients with >6 months' radiological follow-up and a further subset of 62 patients with solitary, biopsy-proven renal carcinoma was also analyzed. Factors influencing technical success, as determined by imaging follow-up, and complication rates were statistically analyzed using a statistics software package and logistic regression analyses. No variables were found to predict subtotal treatment, although gender (P = 0.08), tumor size of >4cm (P = 0.09) and central location of tumor (P = 0.07) approached significance. Upper pole location was the single variable that was found to predict complications (P = 0.006). Among the 104 patients (125 tumors), radiologically assessed at 6 months and with a mean radiological follow-up of 20.1 months, we found a single case of unexpected late local recurrence. Authors concluded percutaneous image-guided cryoablation, at a mean of 20.1 months' follow-up, appears to provide a safe and effective treatment option with a low complication rate. Anteriorly sited tumors should not be considered a contraindication for percutaneous image-guided cryoablation. Scientific Rationale Update October 2009 Factors affecting the surgical approach for the treatment of a renal tumor include the size and location of the tumor, whether other tumors exist, the presence of a solitary kidney, underlying kidney function and the risk of chronic kidney disease and the individuals clinical status. Partial nephrectomy, a nephron-sparing approach, is an acceptable alternative to radical nephrectomy for patients small renal masses. Partial nephrectomy has demonstrated oncological results similar to radical nephrectomy. Radiofrequency ablation (RFA) and cryoablation are gaining acceptance in the treatment of carefully selected patients with small renal cell carcinomas (RCCs). Although these approaches offer some significant advantages, long-term efficacy data are lacking. Cryosurgical Ablation of Renal Tumors Mar 16 6

7 According to the National Comprehensive Cancer Network (NCCN), patients in satisfactory medical condition should undergo surgical excision of stage I- III tumors. However, a small set of elderly or infirm patients with small tumors may be offered surveillance alone or energy ablative minimally invasive techniques such as RFA or cryoablation. According to the 2009 guidelines on management of the Clinical Stage I Renal mass from the American Urological Association, "Cryoablation and RFA represent valid treatment alternatives for many older patients or those with substantial comorbidities, presuming judicious patient selection and thorough patient counseling. Renal cryoablation may be a treatment option for the patient at high surgical risk who is not a candidate for observation or who wants proactive treatment, and who accepts with full understanding the need for lifelong radiographic surveillance and repeat biopsy after treatment." They state further, "RFA is a minimally invasive treatment option for localized renal masses, especially for patients who represent a high surgical risk. Standard technique is lacking in the current literature, and followup criteria are not well defined." The National Institute of Clinical Excellence (NICE) issued a guidance Jan 2007 on cryotherapy for renal cancer. Per NICE, The current evidence suggests that cryotherapy for renal cancer ablates tumor tissue and that its safety is adequate. However, the evidence about its effect on long-term local control and survival is not yet adequate to support the use of this procedure without special arrangements for consent and for audit or research. Turna et al (2009) compared perioperative, oncologic and functional outcomes of individuals with tumors in a solitary kidney. 36, 36 and 29 individuals underwent laparoscopic partial nephrectomy, cryoablation and radio frequency ablation, respectively. On multivariate analysis tumor size, aspect and remnant kidney status were independent predictors of treatment selection. Cancer specific and overall survival at 2 years was 100% and 91.2% for laparoscopic partial nephrectomy, 88.5% and 88.5% for cryoablation, and 83.9% and 83.9% for radio frequency ablation, respectively. Disease-free survival was significantly better for laparoscopic partial nephrectomy than for cryoablation and radio frequency ablation (100% vs 69.6% and 33.2%, respectively). The mean estimated glomerular filtration rate change for laparoscopic partial nephrectomy, cryoablation and radio frequency ablation of 17, 3 and 7 ml per minute per 1.73 m(2) reflected a 26%, 6% and 13% decrease from baseline, respectively, which was statistically significant. The investigators concluded that laparoscopic partial nephrectomy and probe ablative procedures can be safely and efficiently done for renal tumor in patients with a solitary kidney. Intermediate term oncological outcomes are superior for laparoscopic partial nephrectomy despite somewhat poorer renal function outcomes than those of cryoablation and radio frequency ablation. Kunckle and Uzzo (2008) performed a comparative meta-analysis evaluating cryoablation and RFA as primary treatment for small renal masses (SRMs). Fortyseven studies representing 1375 kidney lesions treated by cryoablation or RFA were analyzed. No differences were detected between ablation modalities with regard to mean patient age, tumor size, or duration of follow-up. Pretreatment biopsy was performed more often for cryoablated lesions (82.3%) than for RFA (62.2%). Unknown pathology occurred at a significantly higher rate for SRMs that underwent RFA (40.4%) versus cryoablation (24.5%). Repeat ablation was performed more often after RFA (8.5% vs 1.3%), and the rates of local tumor progression were Cryosurgical Ablation of Renal Tumors Mar 16 7

8 significantly higher for RFA (12.9% vs 5.2%) compared with cryoablation. The higher incidence of local tumor progression was found to be correlated significantly with treatment by RFA on univariate analysis and on multivariate regression analysis. Metastasis was reported less frequently for cryoablation (1.0%) versus RFA (2.5%). Cryoablation usually was performed laparoscopically (65%), whereas 94% of lesions that were treated with RFA were approached percutaneously. The reviewers concluded that ablation of SRMs is a viable strategy based on short-term oncologic outcomes. Although extended oncologic efficacy remains to be established for ablation modalities, the current data suggest that cryoablation results in fewer retreatments and improved local tumor control, and it may be associated with a lower risk of metastatic progression compared with RFA. Atwell et al (2008) performed a retrospective review of 115 renal tumors in 110 patients treated with percutaneous cryoablation. Specific attention was directed to tumor characteristics, hospital course, complications, technical success and treatment success based on followup imaging. Mean tumor size was 3.3 cm (range 1.5 to 7.3), including 29 tumors 4.0 cm or larger and 21 tumors in the anterior kidney. Of 90 renal mass biopsies performed 52 (58%) showed renal cell carcinoma. All patients were admitted to the hospital following cryoablation and most (87%) were discharged home the next day (range 1 to 12 days). There were 7 major complications associated with the 113 cryoablation procedures (6%). Technical success was achieved in 112 of the 115 (97%) treated tumors and 3 residual tumors were seen on 3-month follow-up imaging. There has been no local progression in 80 tumors (100% treatment success) followed 3 months or longer (mean 13.3 months). The reviewers concluded that percutaneous renal cryoablation is technically feasible and relatively safe. With experience many anterior tumors and tumors larger than 4 cm can be successfully treated. Long-term follow-up remains necessary to prove treatment durability. Scientific Rationale Initial Renal cell carcinoma (RCC), also referred to as renal adenocarcinoma, comprises approximately 2% of all malignancies. 90% of renal tumors are of the renal cell carcinoma (RCC) type. Renal cancer can occur in one or both kidneys. Smaller tumors (<4 cm) have a better prognosis and sometimes can be treated with nephron-sparing surgery. When patients present with localized disease, surgical resection can be curative. When the diagnosis is not made until disease is either locally advanced and unresectable or metastatic, the prognosis is generally poor. The staging system for renal cell cancer is based on the degree of tumor spread beyond the kidney. Surgical resection is the mainstay of treatment in renal cell cancer stage I-III. Tumor size, location, and patient characteristics determine the type of excision (e.g., radical or partial nephrectomy) and approach (e.g., open or laparoscopic approach.) Careful surveillance following surgical resection is important as 20% to 30% of patients with localized tumors experience relapse after surgical excision. The median time to relapse after surgery is 1 to 2 years, with most relapses occurring within 3 years. Lung metastasis is the most common site of distant recurrence. In patients with disseminated tumor (e.g., stage IV) although not usually curative, locoregional forms of therapy can aid in palliating symptoms of the primary tumor or related ectopic hormone production. Systemic therapy has demonstrated only limited effectiveness. Cryosurgical Ablation of Renal Tumors Mar 16 8

9 Elderly patients and those patients with significant comorbidity may not be candidates for surgical resection. Cryotherapy also referred to as cryoablation, has been investigated as an alternative treatment option for these patients. Cryotherapy is also suggested for patients with renal cancer in whom preservation of renal function is desired in as much as it is possible, for example, in patients with a solitary kidney, or with compromised renal function. Cryosurgery is a minimally invasive, nephron-sparing procedure developed as an alternative to open or laparoscopic partial nephrectomy. The maximum recommended lesion size for cryosurgery is 4.0 cm, (i.e., small, stage I tumors.) Lesions this size or smaller can be treated with a single probe, which causes less morbidity than multiple probe use. Cryosurgery is not recommended if lesions are near the center of the kidney, as it is not known whether they can be treated successfully because of the heat from large renal vessels and the potential for urinary fistula and obstruction if the renal pelvis is damaged. Cryosurgery is most commonly performed under anesthesia via a laparoscopic or percutaneous approach, with imaging guidance to monitor probe placement. A probe is inserted into the tumor that delivers a coolant at subfreezing temperatures, with the tip of the probe acting as the site of freezing. An ice ball is created around the tip of the probe, destroying cells through direct freezing, dehydration and hypoxia. Each freeze cycle is followed by a heat (thaw) cycle to allow removal of the probe. A double freeze-thaw cycle is usually performed to ablate the tumor, with the aim of extending the ice ball approximately 1 cm beyond the tumor margins. Additional freeze/thaw cycles may be repeated if necessary, and more than one freezing probes could be used. Lawatsch et al. (2006) reported a retrospective chart review of patients with small renal tumors (median tumor size was 2.5 cm) treated with laparoscopic cryoablation. 81 renal tumors were cryoablated. Conversion to open surgery occurred in 2 patients. Nephrectomy for bleeding occurred in 1 patient. Median follow-up was 26.8 months. Two recurrences were identified after laparoscopic cryoablation. The author concluded that laparoscopic cryoablation appears to be an alternative to open or laparoscopic partial nephrectomy for small renal tumors as tumor recurrence rates in the studies published to date are comparable to those of partial nephrectomy, however, longer follow up is necessary. Bolte et al. (2006) reported on magnetic resonance imaging findings after laparoscopic renal cryoablation. 33 patients underwent laparoscopic cryoablation of 34 renal masses, 24 were followed up with MRI postoperatively. Size of tumor ranged 1.5 to 3.7 cm, mean 2.4. Postoperative MRI was done at 1, 3, and 6 months after ablation and every 6 months thereafter. Patient follow-up data were available for at least 6 months and up to 48 months for 18 patients. On the first follow-up MRI study, six lesions had increased in size, five had decreased in size, and seven showed no change. Of the 18 patients, 7 had peripheral rim enhancement within 3 months of follow-up. Four resolved. One patient developed rim enhancement at 7 months postoperatively. Subsequent images revealed lesion enlargement with heterogeneous enhancement. Biopsy was positive for renal cell carcinoma. One patient developed nodular enhancement at 10 months with a decrease in lesion size. Watchful waiting was chosen because the patient had significant medical comorbidities. The author concluded that peripheral rim enhancement is a common finding on MRI immediately after laparoscopic renal cryoablation. Rim enhancement with an increase in lesion size or nodular enhancement is of more concern than rim Cryosurgical Ablation of Renal Tumors Mar 16 9

10 enhancement alone. More data are necessary to understand the progression of renal lesions after cryoablation. Permpongkosol et al. (2006) investigated outcomes in patients undergoing ablation who had nondiagnostic biopsies at the time of the procedure. 79 patients (88 renal masses) underwent percutaneous CT guided biopsy and ablation of a renal mass. Patients with nondiagnostic biopsies were identified and the medical records were reviewed retrospectively. All patients had an enhancing renal mass on preoperative computerized tomography or magnetic resonance imaging and all underwent postoperative contrast imaging to evaluate persistent viable tumor. A total of 19 patients (20 tumors) with nondiagnostic percutaneous biopsy were included in the study. Tumors were treated with frequency ablation (12) or cryoablation (7). In 17 patients (89.5%) post-procedure imaging confirmed the absence of contrast enhancement at a median follow-up of 27.3 months. In 2 cases, post-procedure imaging showed a residual renal mass or recurrence with enhancement, suggesting that the original percutaneous biopsy result was false negative. In 1 patient residual tumor was identified on initial post-ablation imaging and the patient underwent laparoscopic partial nephrectomy. In another patient recurrence was diagnosed 30 months after ablation and the patient underwent laparoscopic radical nephrectomy. Although there was a nondiagnostic percutaneous biopsy in each case, pathological findings in the subsequent surgical specimen confirmed renal cell carcinoma. The investigator concluded that nondiagnostic percutaneous biopsy at renal tumor ablation does not obviate the need for standard post-procedure imaging follow-up. Of patients with nondiagnostic biopsies in this series 10.5% still harbored viable renal cell carcinoma after percutaneous ablation. Davol et al. (2006) reported on a retrospective review of 48 patients following cryosurgical ablation of renal neoplasm (median lesion size was 2.6 cm (range, cm). After a median follow-up of 64 months (range, months), an overall survival rate of 89.5% were identified. A total of 12.5% patients were diagnosed with persistent disease during the follow-up period. The cancer-specific survival rate was 100%, and the cancer-free survival rate after a single cryoablation procedure was 87.5%. This improved to 97.5% after a repeat procedure. No major complications were observed. The author reported that radiologic follow-up strategies are crucial in monitoring treatment success and identifying those who may require a secondary salvage procedure. In a retrospective review, Hegarty et al. (2006) compared 164 laparoscopic cryoablations and 82 percutaneous radiofrequency ablations in terms of complications, impact on renal function, follow-up imaging, and oncologic outcomes. The mean tumor size was similar (2.56 cm vs 2.51 cm); however, the cryoablation group had a greater number of anteriorly located tumors (39% vs 10%), as well as fewer central tumors (6% vs 37%) and fewer solitary kidneys (24% vs 49%). Cancer-specific survival following cryotherapy was 98% at a median follow-up of 3 years and 100% for RFA at 1-year median follow-up. The investigator concluded that early results are encouraging in terms of early oncologic control, preservation of renal function, and low complication rates, however, longer-term oncologic data are necessary so that the true value of these treatment modalities can be determined. A retrospective review reported by Powell et al (2005) concluded that renal cryotherapy appears to be a viable alternative for small, peripheral, renal lesions, especially in patients who are not considered good candidates for open surgical Cryosurgical Ablation of Renal Tumors Mar 16 10

11 approach, however, longer follow up data is necessary. In this review, 25 patients treated with transperitoneal laparoscopic cryotherapy by a single surgeon, for small peripheral renal lesions (mean tumor size was 2.4 cm.) Three cases were converted to open; two complications included transfusion and hydronephrosis, both managed conservatively. Mean follow-up is 16.2 months (range 6-36 months). There have been no recurrences to date despite a rigorous surveillance protocol. Outcomes of 56 patients treated with laparoscopic renal cryoalation at 3 years were reported by Gill et al. (2005.) Serial magnetic resonance imaging (MRI) were performed at 1 day, months 1, 3, 6, 12, 18 and 24, and yearly thereafter for 5 years. Computerized tomography guided needle biopsy of the cryolesion was performed 6 months postoperatively and repeated if MRI findings were abnormal. Follow-up data were obtained prospectively. For a mean renal tumor size of 2.3 cm mean intraoperative size of the created cryolesion was 3.6 cm. Sequential mean cryolesion size on MRI on postoperative 1 day and at 3 and 6 months, was 3.7, 2.8, 2.3. At 1, 2 and 3 years, mean cryolesion size was, 1.7, 1.2 and 0.9 cm, representing a 26%, 39%, 56%, 69% and 75% percent reduction in cryolesion size at 3 and 6 months, and 1, 2 and 3 years, respectively. At 3 years 17 cryolesions (38%) had completely disappeared on MRI. Postoperative needle biopsy identified locally persistent/recurrent renal tumor in 2 patients. In the 51 patients undergoing cryotherapy for a unilateral, sporadic renal tumor 3-year cancer specific survival was 98%. The author concluded that although 3 year outcomes were encouraging, longer (5-year) data is needed to determine the proper place of renal cryotherapy among minimally invasive, nephron sparing options. Lee et al. reported on 2+ years results in 20 patients with small renal masses who were treated with laparoscopic renal cryosurgery. Renal biopsies revealed renal cell carcinoma in 11 of the 20 patients. Of these 11 patients, none had evidence of recurrent disease at last follow-up, and follow-up scans showed no enhancement of any lesions. Of the 8 patients with follow-up of 2 years or greater, 4 had complete resolution of the renal lesions. The remainder had lesions that were reduced and stable in size. This investigator also concluded that data from longer term studies were needed to determine long-term efficacy. Renal cryoablation shows considerable promise for select renal tumors, however, the ideal candidates for this procedure still needs to be determined. Renal cryoablation should be reserved for carefully selected patients, such as patients with renal tumors < 4 cm with significant comorbidity that preclude surgical resection or in patients with a solitary kidney, or compromised renal function. Intermediate-term data are encouraging but there is a lack of long-term data in large controlled clinical studies, as well as lack of comparative studies between cryosurgery and conventional treatments such as partial or complete nephrectomy. Review History January 2007 Medical Advisory Council, initial approval October 2009 Update no revisions. Code updates. March 2011 Update. Added Medicare Table. Added 2011 CPT Code revisions. No policy revisions. March 2012 Update - no revisions. March 2013 Update no revisions. Code updates. March 2014 Update no revisions March 2015 Update no revisions Cryosurgical Ablation of Renal Tumors Mar 16 11

12 March 2016 Update no revisions. Code updates. This policy is based on the following evidence-based guidelines: 1. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology Kidney Cancer. V.I Updated Version Update version Update Version Update version Update Updated Version U.S. National Institute of Health. National Cancer Institute. Renal Cell Cancer (PDQ):Treatment. Last modified 5/4/2006. Available at: 3. National Institute for Health and Clinical Excellence. Cyrotherapy for renal cancer (interventional procedures overview) May Update Jan Hayes Alert. Technology Assessment Brief. Cryosurgery for Renal Masses Volume VII, Number 3 - March American Urological Association. Management of the Clinical Stage 1 Renal Mass (2009). Reaffirmed 2010 Available at: 6. National Institute for Health and Clinical Excellence (NICE). (2011, January). Interventional procedure overview of laparoscopic cryotherapy for renal cancer. 9. Hayes Health Technology Brief. Percutaneous Cryoablation for Treatment of Renal Cell Cancer. Nov Archived Dec Hayes Search and Summary. Percutaneous Cryoablation for Treatment of Renal Cell Cancer in Adult Patients. Feb Updated June 22, References Update March Krummel T, Garnon J, Lang H, et al. Percutaneous cryoablation for tuberous sclerosis-associated renal angiomyolipoma with neoadjuvant mtor inhibition. BMC Urol. 2014;14(1): Tang, K, Yao, W, Li, H, et al. Laparoscopic renal cryoablation versus laparoscopic partial nephrectomy for the treatment of small renal masses: a systematic review and meta-analysis of comparative studies. Journal of laparoendoscopic & advanced surgical techniques Part A Jun;24(6): Wolff RF, Ryder S, Bossi A, et al. A systematic review of randomised controlled trials of radiotherapy for localised prostate cancer. Eur J Cancer Nov;51(16): Zargar H, Samarasekera D, Khalifeh A, et al. Laparoscopic vs percutaneous cryoablation for the small renal mass: 15-year experience at a single center. Urology Apr;85(4): doi: /j.urology Epub 2015 Feb 18. References Update March Georgiades CS, Rodriguez R. Efficacy and safety of percutaneous cryoablation for stage 1A/B renal cell carcinoma: results of a prospective, single-arm, 5-year study. Cardiovasc Intervent Radiol Dec;37(6): Johnson S, Pham KN, See W, et al. Laparoscopic cryoablation for clinical stage T1 renal masses: long-term oncologic outcomes at the Medical College of Wisconsin. Urology Sep;84(3): Kapoor A, Wang Y, Dishan B, Pautler SE. Update on cryoablation for treatment of small renal mass: oncologic control, renal function preservation, and rate of complications. Curr Urol Rep Apr;15(4):396. Cryosurgical Ablation of Renal Tumors Mar 16 12

13 4. Kim DY, Wood CG, Karam JA. Treating the two extremes in renal cell carcinoma: management of small renal masses and cytoreductive nephrectomy in metastatic disease. Am Soc Clin Oncol Educ Book. 2014:e Klatte T, Kroeger N, Zimmermann U, et al. The contemporary role of ablative treatment approaches in the management of renal cell carcinoma (RCC): focus on radiofrequency ablation (RFA), high-intensity focused ultrasound (HIFU), and cryoablation. World J Urol Jun;32(3): Larcher A, Fossati N, Mistretta F, et al. Long-term oncologic outcomes of laparoscopic renal cryoablation as primary treatment for small renal masses. Urol Oncol Jan;33(1):22.e Miller JM, Julien P, Wachsman A, et al. The role of embolization in reducing the complications of cryoablation in renal cell carcinoma. Clin Radiol Oct;69(10): Miller AJ, Kurup AN, Schmit GD, et al. Percutaneous Clinical T_1a Renal Mass Ablation in the Octogenarian and Nonagenarian: Oncologic Outcomes and Morbidity. J Endourol Nov 11. References Update March Atwell TD, Schmit GD, Boorjian SA, et al. Percutaneous ablation of renal masses measuring 3.0 cm and smaller: comparative local control and complications after radiofrequency ablation and cryoablation. AJR Am J Roentgenol Feb;200(2): Breen DJ, Bryant TJ, Abbas A, et al. Percutaneous cryoablation of renal tumours: outcomes from 171 tumours in 147 patients. BJU Int Oct;112(6): Castro A Jr, Jenkins LC, Salas N, et al. Ablative therapies for small renal tumours. Nat Rev Urol May;10(5): Cordeiro ER, Barwari K, Anastasiadis A, et al. Laparoscopic cryotherapy for small renal masses: Current State. Arch Esp Urol Jan-Feb;66(1): Georgiades CS, Rodriguez R. Efficacy and Safety of Percutaneous Cryoablation for Stage 1A/B Renal Cell Carcinoma: Results of a Prospective, Single-Arm, 5- Year Study. Cardiovasc Intervent Radiol Jan 3. [ 6. Georgiades C, Rodriguez R. Renal tumor ablation. Tech Vasc Interv Radiol Dec;16(4): Khoder WY, Siegert S, Stief CG, et al. Results of a prospective study comparing the clinical efficacy of cryoablation of renal cell cancer followed by immediate partial nephrectomy. Eur J Surg Oncol Jan;40(1): Martin J, Athreya S. Meta-analysis of cryoablation versus microwave ablation for small renal masses: is there a difference in outcome? Diagn Interv Radiol Nov-Dec;19(6): Morgan MA, Roberts NR, Pino LA, et al..percutaneous cryoablation for recurrent low grade renal cell carcinoma after failed nephron-sparing surgery. Can J Urol Oct;20(5): Schmit GD, Thompson RH, Boorjian SA, et al. Percutaneous renal cryoablation in obese and morbidly obese patients. Urology Sep;82(3): References Update March Atkins MB. Diagnostic approach, differential diagnosis, and treatment of a solid renal mass. UpToDate. October 16, El Dib R, Touma NJ, Kapoor A. Cryoablation vs radiofrequency ablation for the treatment of renal cell carcinoma: a meta-analysis of case series studies. BJU Int 2012; 110:510. Cryosurgical Ablation of Renal Tumors Mar 16 13

14 3. Hines-Peralta A, Nahum Goldberg S. Radiofrequency ablation and cryoablation for renal cell carcinoma. UpToDate. July 18, Ritchie JP. Surgical management of localized renal cell carcinoma. UpToDate. March 13, References Update March Allen, B.C., Remer, E.M., (2010, Jul-Aug). Percutaneous cryoablation of renal tumors: patient selection, technique, and postprocedural imaging. Radiographics,30(4): Chalasani V, Martinez CH, Abdelhady M, et al. Surgical cryoablation as an option for small renal masses in patients who are not ideal partial nephrectomy candidates: intermediate-term outcomes. (2010). Can Urol Assoc J, 4(6): References Update March Laguna MP, Beemster P, Kumar P, et al Perioperative morbidity of laparoscopic cryoablation of small renal masses with ultrathin probes: a European multicentre experience. Eur Urol. 2009;56(2): Gontero P, Joniau S, Zitella A, et al. Ablative therapies in the treatment of small renal tumors: how far from standard of care? Urol Oncol May- Jun;28(3): Epub 2009 Nov Malcolm JB, Logan JE, Given RW, et al. Renal functional outcomes after cryoablation of small renal masses. J Endourol Mar;24(3): References Update October Berger A, Crouzet S, Canes D, et al. Minimally invasive nephron-sparing surgery. Curr Opin Urol Sep;18(5): Goel RK, Kaouk JH. Probe ablative treatment for small renal masses: cryoablation vs. radio frequency ablation. Curr Opin Urol Sep;18(5): Hayes Technology Brief. Percutaneous Cryoablation for Treatment of Renal Cell Cancer. Nov Hinshaw JL, Shadid AM, Nakada SY et al. Comparison of percutaneous and laparoscopic cryoablation for the treatment of solid renal masses. AJR Am J Roentgenol Oct;191(4): Hiraoka K, Kawauchi A, Nakamura T et al. Radiofrequency ablation for renal tumors: Our experience. Int J Urol Sep Kunkle DA, Uzzo RG. Cryoablation or radiofrequency ablation of the small renal mass : a meta-analysis. Cancer Nov 15;113(10): Kutikov A, Kunkle DA, Uzzo RG. Focal therapy for kidney cancer: a systematic review. Curr Opin Urol Mar;19(2): Turna B, Kaouk JH, Frota R et al. Minimally Invasive Nephron Sparing Management for Renal Tumors in Solitary Kidneys. J Urol Sep 14 References 1. Aron M, Gill IS. Minimally Invasive Nephron-Sparing Surgery (MINSS) for Renal Tumours Part II: Probe Ablative Therapy. Eur Urol Feb;51(2): Bolte SL, Ankem MK, Moon TD, et al. Magnetic resonance imaging findings after laparoscopic renal cryoablation. Urology Mar;67(3): Davol PE, Fulmer BR, Rukstalis DB. Long-term results of cryoablation for renal cancer and complex renal masses. Urology Jul;68(1 Suppl):2-6. Cryosurgical Ablation of Renal Tumors Mar 16 14

15 4. Hegarty NJ, Gill IS, Desai MM, Remer EM, O'Malley CM, Kaouk JH. Probe-ablative nephron-sparing surgery: cryoablation versus radiofrequency ablation. Urology Jul;68(1 Suppl): Kaouk JH, Aron M, Rewcastle JC, Gill IS. Cryotherapy: clinical end points and their experimental foundations. Urology Jul;68(1 Suppl): Lawatsch EJ, Langenstroer P, Byrd GF, et al. Intermediate results of laparoscopic cryoablation in 59 patients at the Medical College of Wisconsin. J Urol Apr;175(4): Miki K, Shimomura T, Yamada H, et al. Percutaneous cryoablation of renal cell carcinoma guided by horizontal open magnetic resonance imaging. Int J Urol Jul;13(7): Permpongkosol S, Bagga HS, Romero FR, et al. Trends in the operative management of renal tumors over a 14-year period. BJU Int Oct;98(4): Permpongkosol S, Link RE, Solomon SB, Kavoussi LR. Results of computerized tomography guided percutaneous ablation of renal masses with nondiagnostic pre-ablation pathological findings. J Urol Aug;176(2): Schwartz BF, Rewcastle JC, Powell T, et al. Cryoablation of small peripheral renal masses: a retrospective analysis. Urology Jul;68(1 Suppl): Warlick CA, Lima GC, Allaf ME, et al. Clinical sequelae of radiographic iceball involvement of collecting system during computed tomography-guided percutaneous renal tumor cryoablation. Urology May;67(5): Wink MH, Lagerveld BW, Laguna MP, et al. Cryotherapy for renal-cell cancer: diagnosis, treatment, and contrast-enhanced ultrasonography for follow-up. J Endourol Jul;20(7):456-8; discussion Bachmann A, Sulser T, Jayet C, et al. Retroperitoneoscopy-assisted cryoablation of renal tumors using multiple 1.5 mm ultrathin cryoprobes: a preliminary report. Eur Urol Apr;47(4): Desai MM, Aron M, Gill IS. Laparoscopic partial nephrectomy versus laparoscopic cryoablation for the small renal tumor. Urology Nov;66(5 Suppl): Gill IS, Remer EM, Hasan WA, et al. Renal cryoablation: outcome at 3 years. J Urol Jun;173(6): Gore JL, Kim HL, Schulam P. Initial experience with laparoscopically assisted percutaneous cryotherapy of renal tumors. J Endourol May;19(4): Jang TL, Wang R, Kim SC, et al. Histopathology of human renal tumors after laparoscopic renal cryosurgery. J Urol Mar;173(3): Powell T, Whelan C, Schwartz BF. Laparoscopic renal cryotherapy: biology, techniques and outcomes. Minerva Urol Nefrol Jun;57(2): Cestari A, Guazzoni G, dell'acqua V, et al. Laparoscopic cryoablation of solid renal masses: intermediate term followup. J Urol Oct;172(4 Pt 1): Johnson DB, Solomon SB, Su LM, et al. Defining the complications of cryoablation and radio frequency ablation of small renal tumors: a multiinstitutional review. J Urol Sep;172(3): Abreu SC, Gill IS. Renal cell carcinoma: modern surgical approach. Curr Opin Urol Nov;13(6): Derweesh IH, Novick AC. Small renal tumors: natural history, observation strategies and emerging modalities of energy based tumor ablation. Can J Urol Jun;10(3): Lee DI, McGinnis DE, Feld R, Strup SE. Retroperitoneal laparoscopic cryoablation of small renal tumors: intermediate results. Urology Jan;61(1): Nadler RB, Kim SC, Rubenstein JN, et al. Laparoscopic renal cryosurgery: the Northwestern experience. J Urol Oct;170(4 Pt 1): Cryosurgical Ablation of Renal Tumors Mar 16 15

16 25. Shingleton WB, Sewell PE Jr. Cryoablation of renal tumours in patients with solitary kidneys. BJU Int Aug;92(3): Steinberg AP, Abreu SC, Desai MM, et al. Laparoscopic nephron-sparing surgery in the presence of renal artery disease. Urology Nov;62(5): Janzen N, Zisman A, Pantuck AJ, et al. Minimally invasive ablative approaches in the treatment of renal cell carcinoma. Curr Urol Rep Feb;3(1): Harada J, Dohi M, Mogami T, et al. Initial experience of percutaneous renal cryosurgery under the guidance of a horizontal open MRI system. Radiat Med Nov-Dec;19(6): Shingleton WB, Sewell PE Jr. Percutaneous renal cryoablation of renal tumors in patients with von Hippel-Lindau disease. J Urol Mar;167(3): Rukstalis DB, Khorsandi M, Garcia FU, et al. Clinical experience with open renal cryoablation. Urology Jan;57(1): Edmunds TB Jr, Schulsinger DA, Durand DB, Waltzer WC. Acute histologic changes in human renal tumors after cryoablation. J Endourol Mar;14(2): Gill IS, Novick AC, Meraney AM, et al. Laparoscopic renal cryoablation in 32 patients. Urology Nov 1;56(5): Remer EM, Weinberg EJ, Oto A, et al. MR imaging of the kidneys after laparoscopic cryoablation. AJR Am J Roentgenol Mar;174(3): Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. Cryosurgical Ablation of Renal Tumors Mar 16 16

17 The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Cryosurgical Ablation of Renal Tumors Mar 16 17