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Date Printed: June 25, 2017: 01:25 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-40000-26

Original Effective Date: 02/15/16

Reviewed: 02/23/17

Revised: 03/15/17

Subject: Irreversible Electroporation (IRE)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursements Program Exceptions Definitions Related Guidelines
           
Other References Updates     Previous Version
           

DESCRIPTION:

Irreversible electroporation (IRE) describes a process that uses application of brief, controlled, high-voltage direct current impulses to create multiple holes in cell membranes. This process irreversibly damages the cell's homeostasis mechanism, leading to instant cell death. IRE is most frequently performed in the liver, kidney, lung, prostate, and pancreas, and is also being used to treat metastatic disease in the liver.

The Nanoknife® Oncobionic System is a low-energy direct current thermal ablation system, which received initial Food and Drug Administration (FDA) 510K clearance in 2006, as a tissue ablation system indicated for surgical ablation of soft tissue, including cardiac and smooth muscle. Subsequent FDA clearance clarified the approved indications to "the surgical ablation of soft tissue”. It has not received clearance for the therapy or treatment of any specific disease or condition.

POSITION STATEMENT:

Irreversible electroporation (IRE), including the use of the NanoKnife® system, is considered experimental or investigational for all indications, including, but not limited to, ablation of soft tissue or of solid organs, such as the liver and pancreas.

There is insufficient clinical peer reviewed literature demonstrating the safety, efficacy, and the effects of irreversible electroporation (IRE), on long-term health outcomes.

BILLING/CODING INFORMATION:

There is no specific CPT code for irreversible electroporation.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products: The following Local Coverage Determination (LCD) was reviewed on the last guideline revised date: Noncovered Services (L33777), located at fcso.com.

DEFINITIONS:

Electroporation: a cell is subjected to a powerful electrical field using high-voltage direct current (up to 3 kV); this creates multiple holes in the cell membrane and irreversibly damages the cell's homeostasis mechanism, leading to instant cell death.

RELATED GUIDELINES:

Radiofrequency Ablation of Liver Tumors, 02-40000-23
Radiofrequency Ablation of Solid Tumors Other Than Liver Tumors, 02-99221-13

OTHER:

Index terms:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

IRE
NanoKnife®
Oncobionic System
Soft tissue ablation

REFERENCES:

  1. Akinwande O, Ahmad SS, Van Meter T, Schulz B, Martin RC. CT Findings of Patients Treated with Irreversible Electroporation for Locally Advanced Pancreatic Cancer. J Oncol. 2015;2015:680319.
  2. Chen X, et al. Electric Ablation with Irreversible Electroporation (IRE) in Vital Hepatic Structures and Follow-up Investigation. Sci Rep. 2015 Nov 9;5:16233.
  3. ClinicalTrials.gov. NCT01442324: Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma. Azienda Ospedaliera di Padova (July 2012).
  4. ClinicalTrials.gov. NCT01078415: Pilot Study of Irreversible Electroporation (IRE) to Treat Early-Stage Primary Liver Cancer (HCC). Angiodynamics, Inc. (September 2011).
  5. First Coast Service Options, Inc. (FCSO). Local Coverage Determination (LCD) 33777, Noncovered Services. 10/01/15.
  6. Narayanan G. Irreversible Electroporation for Treatment of Liver Cancer. Gastroenterol Hepatol (N Y). 2011 May; 7(5): 313–316.
  7. National Institute for Health and Care Excellence (NICE). Interventional procedure guidance 441: Irreversible electroporation for treating primary lung cancer and metastases in the lung (June 2015). Accessed at http://www.nice.org.uk/.
  8. National Institute for Health and Care Excellence (NICE). Interventional procedure guidance 442: Irreversible electroporation for treating pancreatic cancer (June 2015). Accessed at http://www.nice.org.uk/.
  9. National Institute for Health and Care Excellence (NICE). Interventional procedure guidance 443: Irreversible electroporation for treating renal cancer (June 2015). Accessed at http://www.nice.org.uk/.
  10. National Institute for Health and Care Excellence (NICE). Interventional procedure guidance 444: Irreversible electroporation for treating primary liver cancer (June 2015). Accessed at http://www.nice.org.uk/.
  11. National Institute for Health and Care Excellence (NICE). Interventional procedure guidance 445: Irreversible electroporation for treating liver metastases (June 2015). Accessed at http://www.nice.org.uk/.
  12. National Institute for Health and Care Excellence (NICE). Interventional procedure guidance 572: Irreversible electroporation for treating prostate cancer (December 2016). Accessed at http://www.nice.org.uk/.
  13. Rombouts SJ, et al. Irreversible Electroporation of the Pancreas Using Parallel Plate Electrodes in a Porcine Model: A Feasibility Study. PLoS One. 2017 Jan 4;12(1):e0169396.
  14. Scheffer HJ, et al. Colorectal liver metastatic disease: efficacy of irreversible electroporation-a single-arm phase II clinical trial (COLDFIRE-2 trial). BMC Cancer. 2015 Oct 24;15:772.
  15. Tian G, et al. Ablation of hepatic malignant tumors with irreversible electroporation: A systematic review and meta-analysis of outcomes. Oncotarget. 2016 Dec 20.
  16. U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). Oncobionic System with six probe output (Oncobionic, Inc., Rancho Santa Margarita, CA). Summary of Safety and Effectiveness. No. K080376. April 2, 2008. Accessed at http://www.accessdata.fda.gov/cdrh_docs/pdf8/K080376.pdf.
  17. U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). The NanoKnife® System (AngioDynamics, Inc. Fremont, CA). Summary of Safety and Effectiveness. No. K102329. October 24, 2011. Accessed at http://www.accessdata.fda.gov/cdrh_docs/pdf10/K102329.pdf.
  18. Wagstaff PG, et al. The efficacy and safety of irreversible electroporation for the ablation of renal masses: a prospective, human, in-vivo study protocol. BMC Cancer. 2015 Mar 22;15:165.
  19. Zager Y, et al. Optimization of Irreversible Electroporation Protocols for In-vivo Myocardial Decellularization. PLoS One. 2016 Nov 28;11(11):e0165475.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the Florida Blue Medical Policy & Coverage Committee on 02/23/17.

GUIDELINE UPDATE INFORMATION:

02/15/16

New Medical Coverage Guideline.

03/15/17

Scheduled review. Maintained position statement. Updated references.

Date Printed: June 25, 2017: 01:25 PM