DESCRIPTION
Cryosurgical ablation (cryoablation or cryosurgery) involves exposing tissues to extreme cold in order to produce well-demarcated areas of cell injury and destruction. The tissue is usually cooled below -20 degrees C. The cold is usually produced by use of a probe containing liquid nitrogen. Cryosurgical ablation may be performed as an open surgical technique, percutaneously, or laparoscopically with ultrasound, magnetic resonance imaging (MRI), or computed tomography (CT) guidance.
POLICY
Cryosurgical ablation for the treatment of renal tumors is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
Policies with similar titles:
MEDICAL APPROPRIATENESS
Cryosurgical ablation for the treatment of renal tumors is considered medically appropriate if ALL of the following criteria are met:
Renal tumors are 4 cm or less in size
ANY ONE of the following criteria are met:
To preserve kidney function (i.e., the patient has one kidney or renal insufficiency defined by a glomerular filtration rate [GFR] of less than 60 mL/min per m2)
Standard surgical approach (i.e., resection of renal tissue) is likely to substantially worsen kidney function
The individual is not considered a surgical candidate
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
SOURCES
American Urological Association. (2009) Guideline for management of the clinical stage 1 renal mass. Retrieved June 8, 2009 from http://www.auanet.org/content/guidelines-and-quality-care/policy-statements/a/ablation-of-renal-masses.cfm.
Atwell, T. D., Farrell, M. A., Callstrom, M., R., Charboneau, J. W., Leibovich, B. C., Frank, I., et al. (2007). Percutaneous cryoablation of large renal masses: Technical feasibility and short-term outcome. American Journal of Roentgenology, 188 (5), 1195-1200. (Level 4 Evidence - Independent study)
Bandi, G., Wen, C. C., Hedican, S. P., Moon, T. D., Lee, F. T., & Nakada, S. Y. (2007). Cryoablation of small renal masses: Assessment of the outcome at one institution. BJU International, 100 (4 ), 798-801.
BlueCross BlueShield Association. Medical Policy Reference Manual. (6:2010). Cryosurgical ablation of miscellaneous solid tumors other than liver, prostate, or dermatologic tumors (7.01.92). Retrieved June 30, 2011 from BlueWeb. (33 articles and/or guidelines reviewed)
Gage, A. A, & Baust, J. G. (2007). Cryosurgery for tumors. Journal of the American College of Surgeons, 205 (2), 342-356.
Georgiades, C. S., Hong, K., Bizzell, C., Geschwind, J. F., & Rodriquez, R. (2008). Safety and efficacy of CT-guided percutaneous cryoablation for renal cell carcinoma. Journal of Vascular and Interventional Radiology, 19 (9), 1302-1310.
Hafron, J., & Kaouk, J. H. (2007). Cryosurgical ablation of renal cell carcinoma. Cancer Control, 14 (3), 211-217.
Littrup, P. J., Ahmed, A., Aoun, H. D., Noujaim, D. L., Harb, T., Nakat, S., et al. (2007). CT-guided percutaneous cryotherapy of renal masses. Journal of Vascular and Interventional Radiology, 18 (3), 383-392.
National Comprehensive Cancer Network (NCCN). (2011, February). NCCN clinical practice guidelines in oncology™. Kidney cancer. (V.2.2011). Retrieved June 30, 2011 from http://www.nccn.org/professionals/physician_gls/PDF/kidney.pdf.
National Institute for Health and Clinical Excellence (NICE). (2007, January). Cryotherapy for renal cancer. Retrieved April 23, 2009 from http://www.nice.org.uk/nicemedia/pdf/IPG207guidance.pdf.
National Institute for Health and Clinical Excellence (NICE). (2011, January). Interventional procedure overview of laparoscopic cryotherapy for renal cancer. Retrieved June 30, 2011 from http://www.nice.org.uk/nicemedia/live/11269/53774/53774.pdf.
Nguyen, C. T., Campbell, S. C., & Novick, A. C. (2008). Choice of operation for clinically localized renal tumor. The Urologic Clinics of North America, 35 (4), 645-655.
Weld, K. J., Figenshau, R. S., Venkatesh, R., Bhayani, S. B., Ames, C. D., Clayman, R. V., et al. (2007). Laparoscopic cryoablation for small renal masses: Three-year follow-up. Urology, 69 (3), 448-451. (Level 2 Evidence - Industry sponsored)
MOST RECENT REVIEW DATE: 8/11/2011
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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