Cryoablation of the breast using a FDA-approved cryosurgical device is covered when the patient has a fibroadenoma (benign neoplasm of the breast) (217).  A core-needle biopsy is required to confirm this diagnosis.

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 denied 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 denied service.

Report code 19499 for this procedure.  When reporting unlisted code 19499, please provide a complete description of the service in the narrative field of the electronic or paper claim form.

The allowance for procedure code 19499 includes payment for the cryoablation procedure regardless of how many lesions are treated in the same breast.

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.

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious life-threatening condition and when medically necessary and appropriate for the patient’s condition.

PRN References

12/2003, Cryoablation for breast fibroadenomas now eligible

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