Coding Code Description CPT
0340T Ablation, pulmonary tumor(s), including pleura or chest wall when involved by tumor extension, percutaneous, cryoablation, unilateral, includes imaging guidance (code terminated 1/1/18, replaced by 32994)
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
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 (new code effective 1/1/18)
50250 Ablation, open, one 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
Introduction
Cryosurgical ablation uses extreme cold to destroy certain types of tumors. A probe is inserted into the tumor and an extremely cold liquid is circulated through the probe. An icy ball forms around the probe to freeze part or all of the tumor. The probe can be positioned in such a way as to maximize harm to the tumor while sparing nearby health tissue. The frozen area thaws, allowing the body to absorb the treated tissue. The policy discusses when this technique is considered medically necessary for specific breast and kidney tumors. It’s also been tried for other kinds of tumors. Because larger and longer medical studies are needed, this technique is considered investigational (unproven) for other types of tumors.
This policy informs them about when a service may be covered. Service Medical Necessity Cryosurgical ablation of benign breast fibroadenomas Cryosurgical ablation of benign breast fibroadenomas may be considered medically necessary when ALL of the following criteria are met:
* The lesion must be sonographically visible AND
* The diagnosis of fibroadenoma is confirmed histologically AND
* The lesion(s) is less than 3 cm in largest diameter AND
* There are none of the following contraindications in existence:
o Large core biopsy diagnosis suggestive of cystosarcoma phyllodes tumor or other malignancy
o Poor visualization of lesion by ultrasound
o Large core biopsy diagnosis of fibroadenoma where diagnosis is thought to be non-concordant with findings on imaging or physical examination Cryosurgical ablation, localized renal cell carcinoma
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 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 (ie, resection of renal tissue) is likely to substantially worsen kidney function OR
* Patient is not considered a surgical candidate Lung cancer 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.
Service Investigational Cryosurgical ablation, malignant tumors
Cryosurgical ablation is considered investigational to treat individuals with ANY of the following:
* Bone cancer
* Lung cancer (other than defined above)
* Malignant tumors of the breast
* Other solid tumors or metastases outside the liver and prostate
* Pancreatic cancers
* Renal cell carcinomas in patients who are surgical candidates
Documentation Requirements
The patient’s medical records submitted for review for all conditions should document that medical necessity criteria are met. The record should include the following:
* For cryosurgical ablation of benign breast fibroadenomas, clinical documentation that includes:
o Lesion that is visible on an ultrasound
o Histological result confirming the diagnosis of fibroadenoma
o Size of the lesion
o And none of the following contraindications:
* Large core biopsy diagnosis that is suggestive of cystosarcoma phyllodes tumor or other malignancy
* Poor visualization of lesion by ultrasound
* Large core biopsy diagnosis of fibroadenoma where diagnosis is thought to be inconsistent with findings on imaging or physical examination
* For cryosurgical ablation of localized renal cell carcinoma, documentation of:
o The need to preserve the kidney because:
* Patient has one kidney OR
* Patient has renal insufficiency as defined by a glomerular filtration rate (GFR) of less than or equal to 60 mL/min/m, and standard surgical approach (ie, resection of renal tissue) is likely to substantially worsen kidney function OR
o Patient is considered not a surgical candidate
* For lung cancer, documentation of:
o Patient has early-stage non-small cell lung cancer and is a poor surgical candidate OR
Documentation Requirements
o The patient requires palliation for a central airway obstructing lesion
Evidence Review 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.
Background
Breast Tumors
Early-stage primary breast tumors 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 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 have been frequently surgically excised 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 radiotherapy 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 metastaticdisease may undergo chemotherapy with radiation following resection. Treatment is rarely curative:rather, it seeks to retard tumor growth or palliate symptoms.
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 focuses on slowing tumor growth and palliation of symptoms.
Renal Cell Carcinoma (RCC)
Localized renal cell carcinoma is treated with radical nephrectomy or nephron-sparing surgery. Prognosis drops precipitously if the tumor extends outside the kidney because chemotherapy is relatively ineffective against metastatic renal cell carcinoma.
Cryosurgical Treatment
Cryosurgical treatment of various tumors including malignant and benign breast disease, lung cancer, pancreatic cancer, and renal cell carcinoma has been reported in the literature. The hypothesized advantages of cryosurgery include improved local control and benefits common to any minimally invasive procedure (eg, preserving normal organ tissue, decreasing morbidity, decreasing length of hospitalization).
Summary of Evidence
For individuals who have solid tumors (located in areas of the breast, lung, pancreas, kidney, or bone) who receive cryosurgical ablation, the evidence includes nonrandomized comparative studies, case series, and systematic reviews of these nonrandomized studies. Relevant outcomes are overall survival, disease-specific survival, quality of life, and treatment-related morbidity.
There is a lack of randomized controlled trials and high-quality comparative studies to determine the efficacy and comparative effectiveness of cryoablation. The largest amount of evidence assesses renal cell carcinoma in select patients (ie, those with small tumors who are not surgical candidates, or those who have baseline renal insufficiency of such severity that standard
surgical procedures would impair their kidney function). Cryoablation results in short-term tumor control and less morbidity than surgical resection, but long-term outcomes may be inferior to surgery. For other indications, there is less evidence, with single-arm series reporting high rates of local control. Due to the lack of prospective controlled trials, it is difficult to conclude that cryoablation improves outcomes for any indication better than alternative treatments. The evidence is insufficient to determine the effects of the technology on health outcomes. However, based on clinical input, cryosurgical ablation of benign breast fibroadenomas is considered medically necessary when criteria are met.
