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

POLICY NUMBER

A.7.01.92

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.

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 a 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.

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 or 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.

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 by Endocare;

• CryoGen Cryosurgical System by Cryosurgical;

• CryoHit® by Galil Medical for the treatment of breast fibroadenoma;

• IceSense3™, ProSense™, and MultiSense Systems (IceCure Medical);

• SeedNet™ System by Galil Medical; and

• Visica® System by Sanarus Medical.

Related policies are -

• Cryosurgical Ablation (Cryosurgery) of Primary or Metastatic Liver Tumors

• Whole Gland Cryoablation of Prostate Cancer

POLICY

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 (i.e., the individual has one kidney or renal insufficiency defined by a glomerular filtration rate of less than 60 mL/min per m²), and standard surgical approach (i.e., 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 to treat renal cell carcinomas in individuals who are surgical candidates.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

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

This policy does not address pediatric indications.

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 Mental Health Disorders, 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 medical necessity, “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 HISTORY

11/2003: 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.

02/22/2018: Policy description updated. Added policy statement that cryosurgical ablation may be considered medically necessary to treat lung cancer when certain criteria are met. Investigational statement updated to include bone tumors and to clarify that cryosurgical ablation is investigational as a treatment of benign or malignant tumors of the lung "other than defined above." Code Reference section updated to add ICD-10 diagnosis codes C34.00 - C34.02, C34.10 - C34.12, C34.2, C34.30 - C34.32, C34.80 - C34.82, and C34.90 - C34.92.

06/01/2019: Policy description updated regarding cryosurgical treatment. Policy statements unchanged. Code Reference section updated to add CPT code 32994 and ICD-10 procedure codes 0B5C3ZZ, 0B5D3ZZ, 0B5F3ZZ, 0B5G3ZZ, 0B5J3ZZ, 0B5H3ZZ, 0B5K3ZZ, 0B5L3ZZ, 0B5M3ZZ, 0B5N3ZZ, and 0B5P3ZZ as covered. Added CPT code 20983 as investigational.

08/14/2019: Policy description updated. Policy statements unchanged.

09/30/2019: Code Reference section updated regarding deleted ICD-10 procedure codes.

12/20/2019: Code Reference section updated to add new CPT code 0581T effective 01/01/2020.

08/18/2020: Policy description updated regarding devices. Policy statements unchanged.

02/22/2022: Policy title changed from "Cryosurgical Ablation of Miscellaneous Solid Tumors Other Than Liver, Prostate, or Dermatologic Tumors" to "Cryoablation of Tumors Located in the Kidney, Lung, Breast, Pancreas, or Bone." Policy description updated regarding renal tumors, lung tumors and lung metastases, bone cancer, and bone metastases. Investigational policy statement updated to align with the separation of indications by tumor location. Policy intent unchanged. Policy Guidelines updated to state that this policy does not address pediatric indications. Code Reference section updated to remove deleted ICD-10 procedure codes 0H5TXZZ, 0H5UXZZ, and 0H5VXZZ.

08/11/2022: Policy reviewed. Policy statements updated to change "patient" to "individual."

08/10/2023: Policy reviewed; no changes.

08/14/2024: Policy reviewed; no changes.

09/12/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.92

CODE REFERENCE

This 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. 

Covered Codes

Investigational Codes

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