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The hypothesized advantages of cryosurgery include improved local control and benefits common to any minimally invasive procedure (e.g., preserving normal organ tissue, decreasing morbidity, decreasing length of hospitalization). Potential complications of cryosurgery include those caused by hypothermic damage to normal tissue adjacent to the tumor, structural damage along the probe track and secondary tumors, if cancerous cells are seeded during probe removal.

Recent publications report use of cryosurgery to treat renal cell carcinomas, breast cancer, or pancreatic cancer.

Breast tumors - Early-stage primary breast tumors are treated surgically. The selection of lumpectomy, modified radical mastectomy or another approach balances the patient's desire for breast conservation, the need for tumor-free margins in resected tissue, and the patient's age, hormone receptor status and other factors. Adjuvant radiation therapy decreases local recurrences, particularly for those who select lumpectomy. Adjuvant hormonal therapy and/or chemotherapy are added, depending on presence and number of involved nodes, hormone receptor status, and other factors. Treatment of metastatic disease includes surgery to remove the primary lesion and combination chemotherapy. Fibroadenomas are common, benign tumors of the breast that can either present as a palpable mass or a mammographic abnormality. These benign tumors are frequently surgically excised in order to rule out a malignancy.

Lung tumors - Early stage lung tumors are typically treated surgically. Patients with early stage lung cancer who are not surgical candidates may be candidates for radiation treatment with curative intent. Cryoablation is being investigated in patients who are medically inoperable, with small primary lung cancers or lung metastases. Patients with more advanced local disease or metastatic disease may undergo chemotherapy with radiation following resection. This is rarely curative but rather seeks to retard tumor growth or palliate symptoms.

Renal cell carcinoma - Localized renal cell carcinoma (RCC) is treated by radical nephrectomy or nephron-sparing surgery. Prognosis drops precipitously if the tumor extends outside the kidney capsule, since chemotherapy is relatively ineffective against metastatic RCC.

Pancreatic cancer - Pancreatic cancer is a relatively rare solid tumor that occurs almost exclusively in adults and is almost always fatal. Surgical resection of tumors contained entirely within the pancreas is currently the only potentially curative treatment. However the nature of the cancer is such that few tumors are found at such an early and potentially curable stage. Patients with more advanced local disease or metastatic disease may undergo chemotherapy with radiation following resection. This is rarely curative but rather seeks to retard tumor growth or palliate symptoms.

There are several cryoablation devices cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for use in open, minimally invasive or endoscopic surgical procedures in the areas of general surgery, urology, gynecology, oncology, neurology, dermatology, proctology, thoracic surgery and ear, nose and throat. Examples include:

• Cryocare Surgical System by Endocare;
• CryoGen Cryosurgical System by Cryosurgical, Inc.;
• CryoHit by Galil Medical for the treatment of breast fibroadenoma;
• SeedNet System by Galil Medical; and
• Visica System by Sanarus Medical

This policy addresses cryosurgical ablation of tumors other than liver or prostate. See also Cryosurgical Ablation of Liver Tumors, Cryosurgical Ablation of Prostate Cancer.

• Preservation of kidney function is necessary (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) and standard surgical approach (i.e., resection of renal tissue) is likely to substantially worsen kidney function; or
• Patient is not considered a surgical candidate.

Cryosurgical ablation is considered investigational as a treatment of benign or malignant tumors of the breast, lung, pancreatic cancer and renal cell carcinomas in patients who are surgical candidates, or other solid tumors outside the liver and prostate.

None

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

1/21/2004: Code Reference section completed

3/13/2006: Coding updated. CPT4 2006 revisions added to policy 

3/20/2006: Policy reviewed, no changes

12/27/2006: Code Reference section updated per the 2007 CPT revisions

8/2/2007: Policy reviewed, no changes to policy statement. Added "Dermatologic" to policy title

12/17/2007: Coding updated. CPT/HCPCS 2008 revisions added to policy

6/1/2009: Policy statement updated to include medically necessary indications for renal cell carcinoma. Coding section updated: CPT codes 50250, 50593 moved to the covered table. ICD-9 procedure codes 55.32, 55.33, 55.34, 55.35 added to the covered table. ICD-9 diagnosis code range 189.0-189.9 added to the covered table. ICD9-procedure code 85.20 added to non-covered table.Code 0135T deleted from the policy due to it is code which was deleted on 12-31-07. 0120T deleted from the policy due to it is code which was deleted on 12-31-2006.

07/15/2010:  Policy reviewed; no changes.

08/03/2011: Policy description updated regarding available devices. Policy statement unchanged.

09/25/2012: Policy description updated to add information regarding lung tumors. Added lung cancer to the investigational policy statement.

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document. 

Covered Codes

This is not an all-inclusive list of non-covered procedure codes.

The code(s) listed below and ANY code not listed in the previous section are considered non-covered for this procedure. 

Non-Covered Codes