Cryoablation of the breast using a FDA-approved cryosurgical device (code 19105) is covered when the patient has a fibroadenoma (benign neoplasm of the breast).  A core-needle biopsy is required to confirm this diagnosis.

The following criteria are necessary to establish a patient as a potential candidate for cryoablation or percutaneous excision of a fibroadenoma:

• The lesion must be sonographically visible
• The diagnosis of fibroadenoma must be confirmed histologically
• Lesions should be less than 4 cm in largest diameter

Contraindications for cryoablation or percutaneous excision of a fibroadenoma of the breast include:

• Core biopsy diagnosis suggestive of cystosarcoma phyllodes tumor or other malignancy
• Poor visualization of lesion by ultrasound
• Core biopsy diagnosis of fibroadenoma where diagnosis is thought to be discordant with findings on imaging or physical examination.

Patients undergoing cryoablation or percutaneous excision of a fibroadenoma should have clinical follow up by the treating physician.

The treatment of fibroadenomas is the only FDA approved indication at this time.  The use for any other benign condition is considered experimental/investigational and is not covered.  A participating, preferred, or network provider can bill the member for the non-covered service.

The use of cryoablation for cancerous breast tumors is considered experimental/investigational and is not covered.  A participating, preferred, or network provider can bill the member for the non-covered service.

Report code 19499 for cryoablation of the breast performed for conditions other than fibroadenoma.  When reporting unlisted code 19499, please provide a complete description of the service in the narrative field of the electronic or paper claim form.

Description

Cryoablation is a procedure that takes approximately 30 minutes in a physician’s office requiring only local anesthesia.  Ultrasound guidance is used to insert a small needle into the fibroadenoma.  Using small amounts of argon gas, the tumor is destroyed by a rapid freezing followed by a slow thawing process. This freeze-thaw cycle is repeated as needed.  The tissue is reabsorbed into the breast over the next several months.

A fibroadenoma is round, smooth and symmetrical.  This tumor responds well to the energy from the probe as the borders are defined from the breast tissue.  Cryoablation is under clinical investigation for cancerous breast tumors.  These tumors are irregular and the risk of leaving cancerous tissue behind is possible.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP.  Medical policy is not an authorization, certification, explanation of benefits, or a contract.  Benefits are determined by the Federal Employee Program.

12/2003, Cryoablation for breast fibroadenomas now eligible
12/2011, Cryoablation of the breast further defined

American Roentgen Ray Society, “Cryoablation is a Safe Procedure for Breast Cancer Patients, Early Results Indicate,” 2007 Newswise.

Bland, Keiva L, MD; Gass, Jennifer, MD; Klimberg, V Suzanne, MD; “Radiofrequency, Cryoablation and Other Modalities for Breast Cancer Ablation.”  Surgical Clinics of North America; Volume 87, Issue 2; April 2007.

Sabel, Michael A; “Ultrasound-guided Cryoablation of Breast Cancer.”  Business Briefing:  Global Surgery – Future Directions, 2005.

Pusztaszeri M, Vlastos G, Kinkel K, Pelte MF; “Histopathological Study of Breast Cancer and Normal Breast Tissue after Magnetic Resonance-guided Cryotherapy Ablation.”  Department of Clinical Pathology, Geneva University Hospitals, Switzerland; Crybiology, 2007.

Pusztaszeri M, Vlastos G, Kinkel K, Pelte MF.  Histopathological study of breast cancer and normal breast tissue after magnetic resonance-guided cryotherapy ablation.  Cryobiology, 2007 Aug;55(1):44-51.

Van Esser S, van den Bosch MA, van Diest PJ, Mali WT, Borel Rinkes IH, van Hillegersberg R. Minimally invasive ablative therapies for invasive breast carcinomas:  an overview of current literature.  World J Surg. 2007 Dec;31(12):2284-92.

Hung WK, Ying M, Chan CM, Lam HS, Mak KL. Minimally invasive technology in the management of breast disease.  Breast Cancer, 2009;16(1):23-9.

Breast Tissue Ablation Device, Journal of The American Medical Association, Vol. 287, No.1, January, 2002

Office-based Ultrasound-guided Cryoablation of Breast Fibroadenomas, The American Journal of Surgery, Vol. 184, No. 5, November, 2002

Zhao Z, Wu F. Minimally-invasive thermal ablation of early-stage breast cancer: a systemic review. Eur J Surg Oncol. 2010 Dec;36(12):1149-55.

Hahn M, Pavlista D, Danes J, et al. Ultrasound Guided Cryoablation of Fibroadenomas. Ultraschall Med. 2012 Nov 9.