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Cryosurgical ablation (hereafter referred to as cryosurgery or cryoablation) involves freezing of target tissues, most often by inserting into the tumor a probe through which coolant is circulated. Cryosurgery may be performed as an open surgical technique or as a closed procedure under laparoscopic or ultrasound guidance.
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.
Cryosurgical treatment of various tumors including renal cell carcinomas (RCC), malignant and benign breast disease, pancreatic cancer, and lung cancer has been reported in the literature.
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 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. Treatment 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. Treatment is rarely curative, but rather seeks to retard tumor growth or palliate symptoms.
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:
This policy addresses cryosurgical ablation of tumors other than liver or prostate. Related policies are -
POLICYCryosurgical 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:
Cryosurgical ablation is considered investigational as a treatment of benign or malignant tumors of the breast, lung, pancreas, or other solid tumors or metastases outside the liver and prostate, and to treat renal cell carcinomas in patients who are surgical candidates.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY11/2003: Approved by Medical Policy Advisory Committee (MPAC)
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.
11/15/2013: Added metastases to the investigational policy statement.
08/25/2014: Policy reviewed; description updated. Investigational policy statement revised to change "pancreatic cancer" to "pancreas." Intent of policy statement unchanged.
08/21/2015: Code Reference section updated for ICD-10.
11/03/2015: Policy description updated. Policy statements unchanged. Policy guidelines section updated to add medically necessary and investigative definitions.
05/31/2016: Policy number A.7.01.92 added.
09/22/2016: Policy reviewed; no changes.
SOURCE(S)Blue Cross Blue Shield Association policy #7.01.92
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.