260 Form

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Medical Policy Cryoablation of Tumors Located in the Kidney, Lung, Breast, Pancreas, or Bone Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 260 BCBSA Reference Number: 7.01.92 (For Plan internal use only)

Related Policies
• Radiofrequency Ablation of Miscellaneous Solid Tumors Excluding Liver Tumors, #259
• Cryosurgical Ablation of Primary or Metastatic Liver Tumors, #633 • Radiofrequency Ablation of Primary or Metastatic Liver Tumors, #286 • Cryoablation of Prostate Cancer, #149 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

Cryosurgical ablation may be considered MEDICALLY NECESSARY to treat localized renal cell carcinoma that is no more than 4 cm in size when either of the following criteria is met: • Preservation of kidney function is necessary (ie, the individual has 1 kidney or renal insufficiency defined by a glomerular filtration rate [GFR] of less than 60 mL/min per m2), and standard surgical approach (ie, resection of renal tissue) is likely to worsen kidney function substantially, or • The individual 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 individual has early-stage non-small cell lung cancer and is a poor surgical candidate; or
• The individual requires palliation for a central airway obstructing lesion.

Cryosurgical ablation is considered INVESTIGATIONAL as a treatment for benign or malignant tumors of the breast, lung (other than defined above), pancreas, or bone and other solid tumors or metastases outside the liver and prostate and to treat renal cell carcinomas in individuals who are surgical candidates.

Prior Authorization Information Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.

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Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) Prior authorization is not required. Commercial PPO and Indemnity Prior authorization is not required. Medicare HMO BlueSM Prior authorization is not required. Medicare PPO BlueSM Prior authorization is not required.

CPT Codes / HCPCS Codes / ICD Codes The following codes are included below for informational purposes. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue: CPT Codes CPT codes: Code Description 32994 Ablation therapy for reduction or eradication of 1 or more pulmonary tumor(s) including pleura or chest wall when involved by tumor extension, percutaneous, including imaging guidance when performed, unilateral; cryoablation 50250 Ablation, open, 1 or more renal mass lesion(s), cryosurgical, including intraoperative ultrasound guidance and monitoring, if performed 50542 Laparoscopy, surgical; ablation of renal mass lesion(s), including intraoperative ultrasound guidance and monitoring, when performed 50593 Ablation, renal tumor(s), unilateral, percutaneous, cryotherapy 76940 Ultrasound guidance for, and monitoring of, parenchymal tissue ablation 77013 Computed tomography guidance for, and monitoring of, parenchymal tissue ablation 77022 Magnetic resonance guidance for, and monitoring of, parenchymal tissue ablation

The following CPT code is considered investigational for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue: CPT Codes CPT codes: Code Description 0581T Ablation, malignant breast tumor(s), percutaneous, cryotherapy, including imaging guidance when performed, unilateral 19105 Ablation, cryosurgical, of fibroadenoma, including ultrasound guidance, each fibroadenoma 20983 Ablation therapy for reduction or eradication of 1 or more bone tumors (eg, metastasis) including adjacent soft tissue when involved by tumor extension, percutaneous, including imaging guidance when performed; cryoablation

Description 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.

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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 a 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 the 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 a more advanced local disease or metastatic disease may undergo chemotherapy with radiation following resection. Treatment focuses 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.

Summary Description 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.

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

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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 insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with solid tumors located in the breast, pancreas, or 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. 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.

Policy History Date Action 9/2025 Annual policy review. References updated. Policy statements unchanged. 9/2024 Annual policy review. Policy updated with literature review through June 3, 2024; no references added, guidelines updated. Policy statements unchanged. 9/2023 Annual policy review. References added. Policy statements unchanged. 9/2022 Annual policy review. No references added. Terminology in policy statements changed from "patients" to "individuals" for standardization; intent unchanged. 2/2022 Clarified coding information. 9/2021 Annual policy review. Title changed to "Cryoablation of Tumors Located in the Kidney, Lung, Breast, Pancreas, or Bone." Policy statement revised to align with separation of indications by tumor location - intent unchanged. 9/2020 Annual policy review. Description, summary and references updated. Policy statements unchanged. 1/2020 Clarified coding information. 9/2019 Annual policy review. Description, summary and references updated. Policy statements unchanged. 9/2018 Annual policy review. No changes to policy statements. New references added. Background and summary clarified. 4/2018 Annual policy review. Medically necessary policy statements for lung cancer added.
Clarified coding information. Effective 4/1/2018. 1/2018 Clarified coding information. 10/2016 Annual policy review. New references added. 8/2015 Annual policy review. New references added. 9/2014 Annual policy review. New references added.

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6/2014 Updated Coding section with ICD10 procedure and diagnosis codes. Effective 10/2015. 10/2013 Annual policy review. New references added. 11/2011 -4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates. No changes to policy statements.
10/2011 Reviewed - Medical Policy Group - GI, Nutrition, and Organ Transplantation. No changes to policy statements.
9/2011 Reviewed - Medical Policy Group - Urology, Obstetrics, and Gynecology. No changes to policy statements.
7/2011 Reviewed - Medical Policy Group - Hematology and Oncology. No changes to policy statements.
11/2010 Reviewed - Medical Policy Group - Gastroenterology, Nutrition, and Organ Transplantation. No changes to policy statements.
9/2010 Reviewed - Medical Policy Group - Hematology and Oncology. No changes to policy statements.
9/2010 Medical policy #260 describing covered and non-covered indications. Effective 9/2010. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References

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