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 miscellaneous solid tumors, including, but not limited to, the following: liver, pancreas, breast and breast fibroadenomas is considered investigational.
Policies with similar titles:
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.
ADDITIONAL INFORMATION
Scientific evidence in the form of published articles in peer-reviewed journals addressing the long term outcomes of cryosurgical ablation is lacking. The available literature does not validate the safety and efficacy of this technology for the treatment of those diagnoses listed in the investigational statement.
SOURCES
Atwell, T., Farrell, M., Callstrom, M., Charboneau, J., Leibovich, B., Patterson, D., et al. (2007). Percutaneous cryoablation of 40 solid renal tumors with US guidance and CT monitoring: initial experience. Radiology, 243 (1), 276 - 283. (Level 4 Evidence)
Bland, K. L., Gass, J., & Klimberg, V. S. (2007). Radiofrequency, cryoablation, and other modalities for breast cancer ablation. Surgical Clinics of North America, 87, (2), 539 - 550. (Level 5 Evidence)
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2009). Cryosurgical ablation of miscellaneous solid tumors other than liver, prostate, or dermatologic tumors (7.01.92). Retrieved December 17, 2009 from BlueWeb. (33 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2008). Cryosurgical ablation of primary or metastatic liver tumors (7.01.75). Retrieved December 17, 2009 from BlueWeb. (20 articles and/or guidelines reviewed)
Davol, P. E., Fulmer, B. R., & Rukstalis, D. B. (2006). Long-term results of cryoablation for renal cancer and complex renal masses. Urology, 68 (Suppl. 1A), 2 - 6. (Level 5 Evidence)
Gage, A. A, & Baust, J. G. (2007). Cryosurgery for tumors. Journal of the American College of Surgeons, 205 (2), 342 - 356. (Level 5 Evidence)
Hayes. Medical Technology Directory. (2007, January). Cryoablation for treatment of breast fibroadenomas. Retrieved August 28, 2007 from www.Hayesinc.com/subscribers. (22 articles and/or guidelines reviewed)
Nurko, J., Mabry, C. D., Whitworth, P., Jarowenko, D., Oetting, L., Potruch, T., et al. (2005). Interim results from the fibroadenoma cryoablation treatment registry. The American Journal of Surgery, 190 (4), 647 - 651. (Level 4 Evidence)
Tafra, L., Fine, R., Whitworth, P., Berry, M., Woods, J., Ekbom, G., et al. (2006). Prospective randomized study comparing cryo-assisted and needle-wire localization of ultrasound-visible breast tumors. American Journal of Surgery, 192 (4), 462 - 470. (Level 2 Evidence)
U. S. Department of Health & Human Services. Centers for Medicare & Medicaid Services. LMRP for CIGNA Government Services. (1998, March). Cryosurgery for liver tumors. Retrieved December 18, 2009 from http://www.cignagovernmentservices.com/partb/pubs/mb/1998/gr98_1/tn/cryosurgery_for_liver_tumors_LMR_policy_97-26.html.
U. S. Food and Drug Administration. (2005, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K050347. Retrieved December 18, 2009 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=17546.
U. S. Food and Drug Administration. (2005, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K052530. Retrieved December 18, 2009 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=19466.
U. S. Food and Drug Administration. (2007, January). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K062896. Retrieved December 18, 2009 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=22902.
U. S. National Institutes of Health. National Cancer Institute. (2008, October). Islet cell carcinoma (endocrine pancreas) (PDQ®): Treatment. Retrieved December 18, 2009 from http://www.cancer.gov/cancertopics/pdq/treatment/isletcell/healthprofessional/allpages.
U. S. National Institutes of Health. National Cancer Institute. (2009, May). Adult primary liver cancer treatment (PDQ®): Treatment. Health professional version. Retrieved December 18, 2009 from http://www.cancer.gov/cancertopics/pdq/treatment/adult-primary-liver/HealthProfessional/page1/print.
U. S. National Institutes of Health. National Cancer Institute. (2003, September). Cryosurgery in cancer treatment: Question and answers. Retrieved December 18, 2009 from http://www.cancer.gov/images/Documents/c36af201-3ca4-4c4a-b8fc-df5499d54f50/fs7_34.pdf.
ORIGINAL EFFECTIVE DATE: 3/1/2000
MOST RECENT REVIEW DATE: 2/11/2010
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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