Cryoablation of Tumors Located in the Kidney, Lung, Breast, Pancreas, or Bone

Policy Number: MA-1.088

Effective Date: 2/1/2026

Policy

Cryosurgical ablation may be considered medically necessary to treat localized renal cell carcinoma that is no more than four (4) cm in size when EITHER of the following criteria is met:

• Preservation of kidney function is necessary (i.e., the patient has one kidney or renal insufficiency defined by a glomerular filtration rate of <60 mL/min/m2) AND standard surgical approach (i.e., resection of renal tissue) is likely to worsen kidney function substantially; OR
• Patient is not considered a surgical candidate

Cryosurgical ablation may be considered medically necessary to treat lung cancer when EITHER of the following criteria is met:

• The patient has early-stage non-small cell lung cancer and is a poor surgical candidate; OR
• The patient requires palliation for a central airway-obstructing lesion

Cryosurgical ablation may be considered medically necessary to treat benign or malignant tumors of the bone when ALL the following criteria are met:

• For pain control in individuals with metastatic bone disease confirmed with imaging (e.g., CT, MRI); AND
• Individuals who have failed or are poor candidates for standard treatments such as radiation or opioids; AND
• Individuals for which surgery is not an option

Cryosurgical ablation is considered investigational as a treatment of the following:

• Benign or malignant tumors of the breast
• Benign or malignant tumors of the lung that do not meet the medically necessary criteria above
• Benign or malignant tumors of the pancreas
• Renal cell carcinomas in patients who are surgical candidates,

There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with these procedures.

Policy Guidelines

This policy is limited to treatment in adults (age 18 years and older) and does not address pediatric populations.

Individuals receiving cryosurgical ablation for benign or malignant tumors of the bone should have an estimated life expectancy sufficient to achieve benefit of the procedure.

Cross-References

• MP 1.055 Radiofrequency Ablation of Primary or Metastatic Liver Tumors.
• MP 1.084 Radiofrequency Ablation of Miscellaneous Solid Tumors Excluding Liver Tumors.
• MP 1.121 Cryosurgical Ablation of Primary or Metastatic Liver Tumors.

Product Variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO – Refer to FEP Medical Policy Manual.

Description/Background

Cryosurgical ablation (hereafter referred to as cryosurgery or cryoablation) involves freezing of target tissues; this is most often performed by inserting a coolant-carrying probe into the tumor. Cryosurgery may be performed as an open surgical technique or as a closed procedure under laparoscopic or ultrasound guidance.

Renal Tumors

Localized kidney cancer is treated with radical nephrectomy or nephron-sparing surgery. Prognosis drops precipitously if the tumor extends outside the kidney capsule because chemotherapy is relatively ineffective against metastatic renal cell carcinoma.

Lung Tumors and Lung Metastases

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

Breast Tumors

Early-stage primary breast cancers are treated surgically. The selection of lumpectomy, modified radical mastectomy, or another approach is balanced against 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 radiotherapy 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 lesion and combination chemotherapy.

Fibroadenomas are common benign tumors of the breast that can present as a palpable mass or a mammographic abnormality. These benign tumors are frequently surgically excised to rule out a malignancy.

Pancreatic Cancer

Pancreatic cancer is a relatively rare solid tumor that occurs almost exclusively in adults, and it is largely considered incurable. 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. Treatment is focused on slowing tumor growth and palliation of symptoms.

Bone Cancer and Bone Metastases

Primary bone cancers are extremely rare, accounting for less than 0.2% of all cancers. Bone metastases are more common, with clinical complications including debilitating bone pain. Treatment for bone metastases is performed to relieve local bone pain, provide stabilization, and prevent impending fracture or spinal cord compression.

Regulatory Status

Several cryoablation devices have been 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 (Endocare);
• CryoGen Cryosurgical System (Cryosurgical);
• CryoHit^® (Galil Medical) for the treatment of breast fibroadenoma;
• IceSense3™, ProSense™, and MultiSense Systems (IceCure Medical);
• SeedNet™ System (Galil Medical); and
• Visica^® System (Sanarus Medical)

Food and Drug Administration product code: GEH.

Rationale

Summary of Evidence

For individuals with early-stage kidney cancer who are surgical candidates treated with cryoablation, the evidence includes comparative observational studies and systematic reviews. Relevant outcomes are overall survival (OS), disease-specific survival, quality of life, and treatment-related morbidity. Multiple comparative observational studies and systematic reviews of these studies have compared cryoablation to partial nephrectomy for early-stage renal cancer. These studies have consistently found that partial nephrectomy is associated with better oncological outcomes than cryosurgery, but cryosurgery was associated with better perioperative outcomes, lower incidence of complications, and less decline in kidney function. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with early-stage kidney cancer who are not surgical candidates and who are treated with cryoablation, the evidence includes comparative observational studies of cryoablation compared to partial nephrectomy or other ablative techniques, systematic reviews of these studies, and case series. Relevant outcomes are OS, disease-specific survival, quality of life, and treatment-related morbidity. Although oncological outcomes were better with surgery, in comparative observational studies, cryoablation was associated with less decline in kidney function. Recent case series totaling more than 400 patients showed cryoablation was associated with good oncological outcomes and preservation of renal function. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with non-small cell lung cancer (NSCLC) who are not surgical candidates, the evidence includes uncontrolled observational studies and case series. Relevant outcomes are OS, disease-specific survival, quality of life, and treatment-related morbidity. Medically inoperable patients with early-stage primary lung tumors were treated with cryoablation in a consecutive series of 45 patients. Five-year survival was 68%; the main complications were hemoptysis in 40% of patients and pneumothorax in 51%. A prospective single arm Phase 2 study of 128 patients reported on cryoablation for treatment of metastases to the lung. Cryoablation for metastatic lung cancer was studied in a single arm trial in 40 patients. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with NSCLC who require palliation for a central airway obstructing lesion who are treated with cryoablation, the evidence includes case series. Relevant outcomes are OS, disease-specific survival, quality of life, and treatment-related morbidity. There are no comparative studies. A series of 521 consecutive patients reported improvement in symptoms in 86% of patients, but multiple study design, conduct, and relevance limitations preclude drawing conclusions about efficacy or safety of cryoablation in this population. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with NSCLC who are either poor surgical candidates or who required palliation for a lesion obstructing the central airway who receive cryoablation, clinical input supports this use provides a clinically meaningful improvement in net health outcome and indicates this use is consistent with generally accepted medical practice.

For individuals with benign or malignant tumors of the bone who are treated with cryoablation, the evidence includes uncontrolled observational studies and case series. Relevant outcomes are OS, disease-specific survival, quality of life, and treatment-related morbidity. There is a small amount of literature on cryoablation for bone cancer and bone metastases. For bone metastases, the evidence base consists of 2 single arm nonrandomized studies (N = 61 and 66) and is inadequate to determine efficacy. Studies were limited by a lack of a comparator, potential for selection bias, and lack of blinding combined with subjective outcome measures. NCCN (Version 2.2025) states that ablation techniques should be considered for local bone pain, although specific therapies are outside the scope of the guideline.

For individuals with solid tumors located in the breast or pancreas who are treated with cryoablation, the evidence includes uncontrolled observational studies and case series. Relevant outcomes are OS, disease-specific survival, quality of life, and treatment-related morbidity. Due to the lack of prospective controlled trials, it is not possible to conclude that cryoablation improves outcomes for any indication better than alternative treatments. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Definitions

N/A

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as required by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These polices are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the members’ benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding Information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement. The codes need to be in numerical order.

Cryosurgical ablation is considered investigational for treatment of benign or malignant tumors of the breast, lung (other than defined above as medically necessary), pancreas, and to treat renal cell carcinomas in patients who are surgical candidates.

Cryosurgical ablation is considered medically necessary to treat localized renal cell carcinoma, lung and bone cancer when criteria is met:

References

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Policy History

• MA 1.088
• 9/19/2025 Creation of policy.