![]() | Medical Policy |
| Subject: | Cryosurgical Ablation of Solid Tumors Outside the Liver | ||
| Policy #: | SURG.00025 | Current Effective Date: | 07/13/2011 |
| Status: | Reviewed | Last Review Date: | 05/19/2011 |
| Description/Scope |
Cryosurgical ablation (cryosurgery) involves freezing of target tissues, most often by inserting into the tumor a probe through which coolant is circulated. This document focuses on the use of cryosurgery as a treatment of prostate cancer, renal tumors and other solid tumors outside the liver.
Note: For additional information, see the following:
| Position Statement |
Medically Necessary:
Cryosurgical ablation of the prostate is considered medically necessary as a treatment of prostate cancer.
Cryosurgical 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 when one or more of the following criteria are met:
Investigational and Not Medically Necessary:
Cryosurgical ablation of tumors outside the liver is considered investigational and not medically necessary when the above criteria are not met and for all other indications including but not limited to benign or malignant breast tumors and pancreatic cancer.
| Rationale |
Prostate cancer
Cryosurgical ablation for treatment of prostate cancer has been demonstrated to be a safe and effective treatment modality. Data from many small non-randomized uncontrolled trials have established that cryoablation of prostate tumors demonstrates similar complication rates in terms of erectile dysfunction, obstruction, incontinence, and urethral stricture as does external beam radiation therapy. The efficacy of cryoablation, as noted by post-operative biopsy results and recurrence rates, is similar to external beam radiation when treating prostate cancer. The American Urological Association (AUA) issued a Best Practice Guideline on cryosurgery for treatment of prostate cancer which is based on expert consensus and a review of the literature (2008). Biochemical disease free survival (DFS) for low-risk cases were 65% -92%, and for intermediate– and high-risk cases DFS ranged from 69%-89% and 48%- 89%, respectively.
Breast cancer and breast fibroadenomas:
Three studies described the outcome of cryosurgery for advanced primary or recurrent breast cancer in 72 individuals. Cryosurgery was performed percutaneously with ultrasound guidance (n=15) or during an open surgical procedure (n=57). Individuals were treated for advanced primary disease (44%) or recurrent tumors (56%). Tanaka reported the largest retrospective series: 9 individuals with advanced primary tumors and 40 with recurrent disease. The author reported 44% survival of individuals with primary breast cancer (n=9) at 3 and 5 years, but did not report survival duration or other outcome for those with recurrent or metastatic disease. The report also did not adequately describe selection criteria for those enrolled in the study, details of the procedure, and procedure-related adverse events. The other studies were smaller series and also were inadequate with respect to study design, analysis, and reporting of results. Furthermore, the study by Pfleiderer (2002) was a pilot trial to evaluate technical limitations of the procedure. Tumors were excised and evaluated by pathology days to weeks after cryosurgery and the authors reported incomplete necrosis in tumors greater than 23mm in diameter. Because of these limitations, studies published to date do not permit conclusions regarding the effects of cryosurgery on health outcomes of individuals with breast cancer.
One study described the use of office-based ultrasound-guided cryoablation as a treatment of breast fibroadenomas in 57 individuals in whom a prior biopsy had confirmed the presence of a fibroadenoma. While this study reported that the procedure was technically feasible, only 20 of the 57 individuals treated were followed up for 6 months after cryosurgery and only 3 were followed up for 12 months. Thus, longer follow-up and further studies are required. Additionally, uncontrolled case series published in 2004 (and funded by the device manufacturer) suggested that cryoablation may be safe and initially effective in treating breast fibroadenomas (Edwards, 2004; Kaufman 2005). However, a 2005 analysis of 444 treated fibroadenomas from a multi-center registry cautioned that palpability of the treated site may persist for months after the procedure in a significant percentage of individuals, and urged that surgeons, especially in individuals with larger fibroadenomas, consider this factor carefully when deciding between cryoablation and open surgical removal of the lesion. The paper cautions that, even though individual satisfaction with the cosmetic outcome of the procedure appeared generally high, longer term follow-up is necessary to better understand the time course for resolution of both radiographic and physical findings in such individuals (Nurko, 2005).
Littrup and colleagues (2009) reported results from a feasibility nonrandomized study investigating multiprobe cryoablation as a treatment of 22 breast cancer lesions in 11 individuals who refused surgery. Participants consented to subsequent therapy with radiation therapy and/or chemotherapy with or without hormone therapy. Mean pretreatment tumor diameter was 1.7 cm (range, 0.5 – 5.8 cm). Average clinical follow-up was 22.8 months and average imaging follow-up was 17.5 months. Three participants were lost to follow-up. Two individuals had post procedure biopsies confirming no local recurrence. One participant had a distant malignant lesion develop. Local success rate at 18 months was 100%. Although technical feasibility of cryoablation as a treatment of breast cancer appears promising, there is a lack of long term (greater than 5 years) outcomes from studies.
The NCCN Breast Cancer Clinical Practice Guidelines (2011) do not include cryoablation as a modality to treat breast cancer.
The American Society of Breast Surgeons (2008) has provided recommendations for cryoablation or percutaneous excision of fibroadenoma based on the data of 4-year outcomes.
The use of cryosurgery as a treatment for breast fibroadenomas has been reported in small case series. Although technical feasibility of cryoablation appears promising, there is a lack of long-term (greater than 5-years) outcomes from studies. There have not been any prospective studies comparing the safety and efficacy of cryoablation versus surgical excision.
Renal cell carcinoma and other renal tumors:
Surgical excision of small renal masses remains the standard of care with 5-year survival approaching 97%. The use of minimally invasive techniques such as cryoablation and radiofrequency ablation continues to increase (Kunkle, 2008; Kutikov, 2009).
Three reports described results of cryosurgery in 61 individuals with renal cell carcinoma. For half of these individuals, cryosurgery was performed laparoscopically and for half during an open procedure. With a median follow-up of 16 months, 91% of the 29 individuals treated by Rukstalis (2001) reportedly had complete radiographic responses, but the authors did not report data on long-term outcomes (e.g., survival). The study cites "five serious adverse events" with one considered directly related to the procedure, a persistent renal cell carcinoma. The other adverse events included congestive heart failure in one individual and chronic renal failure requiring dialysis in three.
The other studies reported outcomes for a series of individuals treated at two Cleveland Clinic hospitals: an initial report on a series of 10 individuals and a later report with longer term outcomes on 32 individuals that likely included the original 10 (Rodriguez, 2000; Gill, 2000). Results of cryosurgery were reported as (a) MRI response in 20 individuals with one or more years of follow-up, and (b) as histologic analyses of biopsies on 23 individuals obtained 3 to 6 months post-procedure. The report did not indicate whether these were overlapping groups or the number of individuals who underwent MRI but not biopsy or vice versa. Based on MRI, the cryoablated lesion fully resolved in 25% of the individuals examined. For the remaining 15, the cryoablated lesions decreased a mean 66% in size. Biopsy results showed no evidence of viable tumor in any lesion. However, needle biopsies before cryosurgery confirmed the diagnosis of renal cell carcinoma in only 13 of these individuals. Thus, it is unclear whether these individuals were tumor-free or the post-procedure biopsy missed residual tumor. Postoperative adverse effects included herpes esophagitis in one individual and spontaneously resolving perirenal hemorrhage in another. The authors did not indicate whether these were specifically related to the cryosurgery procedure.
In articles published in 2005 and 2006, the initial or short-term data on laparoscopic renal cryoablation was reported 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 cryosurgery have been reported, case series with follow-up data up to five years are now available and have shown cryoablation to consistently result in ablation of tumor masses in the kidney with minimal morbidity (Stein 2007). In a meta-analysis (Kunkle, 2008), 1375 renal masses were ablated by cryoablation (n= 600) or radiofrequency ablation (RFA, n= 775) in 47 studies. Renal cell carcinoma (RCC) was confirmed in 53.9% of all ablated lesions. Local tumor progression was significantly less with cryoablation 5.2% (31/600 lesions) versus 12.9% (100/775 lesions) with RFA (P<0.0001).
The current available, peer-reviewed medical literature reveals that cryoablation is safe and effective for: managing small, undefined peripheral renal masses (less than 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.
The primary drawback remains the lack of long-term oncologic outcome data (Desai, 2005). In several studies, (Aron, 2005; Hegarty, 2006; Kaouk, 2006; Kunkle, 2008; Schwartz, 2006) the authors concluded that long-term radiologic and histologic data are needed to determine the most appropriate candidates for renal cryoablation; the optimal modality for tumor targeting and monitoring therapy; the appropriate follow-up strategy and to confirm the durability of the results. This data must be compared with outcomes after partial nephrectomy, which remains the "gold standard" treatment. Hafron (2007) reported that cryoablation has evolved as a valid treatment option for small renal masses in select individuals; however, longer-term oncologic data are needed before it can be considered as a primary treatment modality for all renal cancer individuals.
The National Comprehensive Cancer Network's Clinical Practice Guideline 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.
The National Institute for Health and Clinical Excellence (NICE, 2007) guidance on cryoablation for renal cancer states that current evidence suggests that cryotherapy for renal cancer ablates tumor tissue and that its safety is adequate. Cryoablation is described as a possible treatment option for small tumors (less than 4 cm), for maximum preservation of renal function in individuals with a solitary kidney or compromised renal function or for those unfit for or unwilling to undergo major surgery.
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.
Pancreatic cancer:
Kovach (2002) reported 10 cryosurgical ablations in 9 individuals with unresectable pancreatic cancer using intraoperative ultrasound guidance during laparotomy. The authors report no intraoperative morbidity or mortality and that all individuals had adequate pain control postoperatively. At the time of publication, all individuals had expired at an average of 5 months postoperatively (range: 1–11 months). Because this pilot feasibility study did not include a control group or compare outcomes of cryosurgery to alternative strategies for managing similar individuals, no conclusions are possible on effects of cryosurgery for pancreatic cancer.
| Background/Overview |
Cryosurgery, also called cryotherapy or cryosurgical ablation, is the use of extreme cold produced by liquid nitrogen (or argon gas) to destroy abnormal tissue. Cryosurgery may be used to treat tumors on the skin (external tumors), such as basal cell carcinoma, or tumors inside the body (internal tumors), such as prostate cancer.
When cryosurgery is used to treat tumors inside the body, liquid nitrogen or argon gas is circulated through a hollow instrument called a cryoprobe, which is placed in contact with the tumor. The doctor uses imaging procedures such as ultrasound or MRI to guide the cryoprobe to the tumor location and monitor the freezing process. The monitoring process is important so freezing of the cells is limited to the tumor and its immediate area, limiting the amount of damage to nearby healthy tissue. The cryoprobe may be inserted into the tumor during an open or laparoscopic surgical procedure or may be inserted through the skin (percutaneously) and guided to the tumor using an imaging technique. During a cryosurgical procedure a ball of ice crystals forms around the probe, freezing nearby cells and killing them. The probe is then removed from the tumor and the frozen tissue thaws. The dead tissue is then naturally absorbed by the body. Sometimes more than one probe is used to deliver the liquid nitrogen to various parts of the tumor.
Cryosurgery does have side effects; however, they may be less severe than those associated with conventional surgery or radiation therapy. The effects depend on the location of the tumor but may include bleeding, and in the case of treatment for prostate cancer, incontinence and urinary retention. In rare cases, cryosurgery may interact adversely with certain types of chemotherapy.
Cryosurgery may offer advantages over other methods of cancer treatment. It is less invasive than surgery, involving only a small incision or insertion of the cryoprobe through the skin. Consequently, complications of surgery such as pain and bleeding may be minimized. Cryosurgery may require a shorter recovery time and a shorter hospital stay, or no hospital stay at all. Sometimes cryosurgery can be done using only local anesthesia.
Because physicians can focus cryosurgical treatment on a limited area, they may be able to avoid the destruction of nearby healthy tissue. The treatment may be safely repeated and may be used along with standard treatments such as surgery, chemotherapy, hormone therapy, and radiation. Cryosurgery may offer an option for treating cancers that are considered inoperable or that do not respond to standard treatments. Furthermore, it may be used for individuals who are not good candidates for conventional surgery because of their age or other medical conditions.
Cryosurgery of prostate cancer:
Treatment options for prostate cancer include watchful waiting, surgical prostatectomy, various forms of radiation therapy and cryosurgery. Cryosurgery of the prostate is a minimally invasive alternative for the management of prostate cancer. The goal of prostate cryoablation is the destruction of the entire gland.
Cryosurgery for breast fibroadenomas:
Fibroadenomas of the breast are a common benign tumor, which may be palpated or discovered by imaging techniques. Fibroadenomas are typically observed or may be surgically excised if causing concern or discomfort. Cryosurgery has been proposed as a surgical alternative.
Cryosurgery for renal cell carcinoma or other renal tumors:
Localized renal cell carcinoma (RCC) is treated by radical nephrectomy or nephron-sparing surgery. Cryosurgery has been proposed as an alternative to surgical excision, with the potential advantage of preserving functioning renal tissue.
| Definitions |
Cryosurgical ablation (cryotherapy or cryoablation): A surgical procedure where cancerous or diseased cells are destroyed using extreme cold.
Solid tumors: Tumors that appear in body tissues other than blood, bone marrow, or the lymphatic system; examples include tumors of the liver, lung, or colon.
Tumor: An abnormal mass of tissue that results from excessive cell division that is uncontrolled and progressive, also called a neoplasm.
Unresectable: A property of a tumor that makes it unable to be removed surgically.
| 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 | |
| 55873 | Cryosurgical ablation of the prostate (includes ultrasonic guidance and monitoring) |
| ICD-9 Procedure | |
| 60.62 | Perineal prostatectomy |
| ICD-9 Diagnosis | |
| 185 | Malignant neoplasm of prostate |
| 198.82 | Secondary malignant neoplasm of genital organs |
| 233.4 | Carcinoma in situ of prostate |
When services are Investigational and Not Medically Necessary:
For the procedure codes listed above, for all other diagnoses not listed; 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 | |
| 50250 | Ablation, open, 1 or more renal mass lesion(s), cryosurgical, including intraoperative ultrasound guidance and monitoring, if performed |
| 50542 | Laparoscopy, surgical; ablation of renal mass lesion(s), including intraoperative ultrasound guidance and monitoring, when performed [when specified as cryosurgical ablation] |
| 50593 | Ablation, renal tumor(s), unilateral, percutaneous, cryotherapy |
| 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.
When services are also Investigational and Not Medically Necessary:
| CPT | |
| 19105 | Ablation, cryosurgical, of fibroadenoma, including ultrasound guidance, each fibroadenoma |
| ICD-9 Diagnosis | |
| All diagnoses |
Guidance
When services may be Medically Necessary when criteria are met:
| CPT | |
| When specified as guidance for cryoablation: | |
| 77013 | Computed tomography guidance for, and monitoring of, parenchymal tissue ablation |
| 77022 | Magnetic resonance guidance for, and monitoring of, parenchymal tissue ablation |
| 76940 | Ultrasound guidance for, and monitoring of, parenchymal tissue ablation |
| ICD-9 Diagnosis | |
| 189.0-189.1 | Malignant neoplasm of kidney, renal pelvis |
| 189.8 | Malignant neoplasm of other specified sites of urinary organs |
| 198.0 | Secondary malignant neoplasm of kidney |
| 233.9 | Carcinoma in situ of other and unspecified urinary organs [specified as kidney] |
| 236.91 | Neoplasm of uncertain behavior of kidney and ureter |
| 239.5 | Neoplasm of unspecified nature, other genitourinary organs [specified as kidney] |
When services are Investigational and Not Medically Necessary:
For the procedure codes listed above when specified as guidance for cryoablation, for all other diagnoses; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.
Note: See also SURG.00050 and SURG.00065 for other medically necessary indications for parenchymal tissue ablation guidance.
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:
Government Agency, Medical Society, and Other Authoritative Publications:
| Web Sites for Additional Information |
| Index |
Breast Cancer
Cancer
Cryoablation
Cryosurgery
Cryosurgical Ablation
Pancreatic Cancer
Prostate Cancer
Renal Cell Carcinoma
Solid Tumor
| Document History |
Status | Date | Action |
| Reviewed | 05/19/2011 | Medical Policy & Technology Assessment Committee (MPTAC) review. |
| Reviewed | 05/18/2011 | Hematology/Oncology Subcommittee review. Updated Rationale, References and Websites. |
| 01/01/2011 | Updated Coding section with 01/01/2011 CPT code descriptor changes. | |
| Revised | 05/13/2010 | MPTAC review. |
| Revised | 05/12/2010 | Hematology/Oncology Subcommittee review. Revised criteria for prostate cancer. Revised criterion for renal mass diameter from 3 cm to 4 cm. Updated Rationale, References and Websites. |
| Reviewed | 11/19/2009 | MPTAC review. |
| Reviewed | 11/18/2009 | Hematology/Oncology Subcommittee review. Updated rationale, references and websites. Updated coding section with 01/01/2010 CPT changes. |
| Reviewed | 11/20/2008 | MPTAC review. |
| Reviewed | 11/19/2008 | Hematology/Oncology Subcommittee review. Updated rationale, references and websites. |
| Revised | 11/29/2007 | MPTAC review. |
| Revised | 11/28/2007 | Hematology/Oncology Subcommittee review. Title updated to clarify policy addresses solid tumors outside the liver. Added suspected renal malignancy as medically necessary with criteria. Clarified investigational and not medically necessary statement. References updated. Updated coding section to include 01/01/2008 CPT changes; removed CPT 0135T deleted 12/31/2007. The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." |
| Reviewed | 05/17/2007 | MPTAC review. |
| Reviewed | 05/16/2007 | Hematology/Oncology Subcommittee review. References updated. |
| Reviewed | 12/07/2006 | MPTAC review. |
| Reviewed | 12/06/2006 | Hematology/Oncology Subcommittee review. Rationale and references updated. |
| 01/01/2007 | Updated Coding section with 01/01/2007 CPT/HCPCS changes; removed CPT 0120T deleted 12/31/2006, HCPCS S2090, S2091 deleted 12/31/2005. | |
| Reviewed | 06/08/2006 | MPTAC review. Updated references, coding, rationale |
| 01/01/2006 | Updated Coding section with 01/01/2006 CPT/HCPCS changes | |
| 11/17/2005 | Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD). | |
| Revised | 07/14/2005 | MPTAC 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.00025 | Cryosurgical Ablation of Solid Tumors |
| WellPoint Health Networks, Inc. | 12/02/2004 | 3.08.01 | Cryosurgery for Cancer of the Prostate |
12/02/2004 | 3.01.31 | Cryosurgical Ablation of Miscellaneous Extrahepatic Solid Tumors |