Irreversible Electroporation of Tumors Located in the Liver, Pancreas, Kidney, or Lung

POLICY NUMBER

A.6.01.68

DESCRIPTION

Irreversible electroporation produces high-frequency electric pulses to create an electric current that permanently damages cell membranes causing cell death due to the inability to maintain homeostasis. Irreversible electroporation produces no thermal effect and appears to preserve vessels, nerves and the extracellular matrix.

Irreversible Electroporation

Electroporation generates high-frequent electric pulses between two or more electrodes which produces an electric current that damages the cell membrane and allows molecules to pass into the cell passively. Electroporation can be temporary (reversible electroporation) or permanent (irreversible electroporation or IRE). In IRE the cell membrane is permanently damaged causing cell death due to the inability to maintain homeostasis. IRE achieves its action with no thermal effect. IRE appears to preserve vessels, nerves and the extracellular matrix.

The NanoKnife System™ (Angiodynamics) was originally cleared through the 510(k) process (K102329) in 2011 for the surgical ablation of soft tissue. NanoKnife has not received clearance for the treatment of any specific disease. FDA product code: OAB.

Related medical policies – 

• Catheter Ablation as Treatment for Atrial Fibrillation

• Stereotactic Radiosurgery and Stereotactic Body Radiotherapy

• Microwave Tumor Ablation

• Cryosurgical Ablation of Primary or Metastatic Liver Tumors

• Radiofrequency Ablation of Primary or Metastatic Liver Tumors

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

• Radiofrequency Ablation of Miscellaneous Solid Tumors Excluding Liver Tumors

• Transcatheter Arterial Chemoembolization to Treat Primary or Metastatic Liver Malignancies

• Radioembolization for Primary and Metastatic Tumors of the Liver

• Focal Treatments for Prostate Cancer

POLICY

Irreversible electroporation is considered investigational for treatment of primary or metastatic solid tumors including, but not limited to, tumors of the liver, pancreas, kidney or lung.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

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.

Other uses of Irreversible Electroporation

Pulsed field ablation is a form of irreversible electroporation energy used to treat patients with atrial fibrillation. Pulsed field ablation for atrial fibrillation is discussed in the Catheter Ablation as Treatment for Atrial Fibrillation medical policy.

Focal therapy with irreversible electroporation as a treatment for prostate cancer is addressed separately in the Focal Treatments for Prostate Cancer medical policy.

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

04/15/2025: New policy added. Approved by the Medical Policy Advisory Committee.

01/01/2026: Code Reference section updated to add new CPT code 47384.

SOURCE(S)

Blue Cross Blue Shield Association policy # 6.01.68

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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