Irreversible Electroporation (IRE) of Tumors Other Than Liver Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 06|01|2026 POLICY LAST REVIEWED: 02|18|2026 OVERVIEW Irreversible electroporation (IRE) 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. IRE produces no thermal effect and appears to preserve vessels, nerves and the extracellular matrix. This policy does not address IRE for tumors of the liver. Refer to the Related Policies section for details. MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION Medicare Advantage Plans and Commercial Products CPT Code 0601T Only Prior Authorization is required for Medicare Advantage Plans and is recommended for Commercial Products for CPT code 0601T, as this code is not specific to tumor location (e.g. liver, pancreas, kidney, lung, prostate). POLICY STATEMENT Medicare Advantage Plans and Commercial Products Irreversible electroporation (IRE) for treatment of primary or metastatic solid tumors including, but not limited to, tumors of the pancreas, kidney, lung or prostate is considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome. COVERAGE Benefits may vary between groups/contracts. Please refer to the Evidence of Coverage or Subscriber Agreement for applicable surgical benefits/coverage. BACKGROUND Irreversible Electroporation (IRE) 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 [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. Pancreatic Cancer Pancreatic ductal adenocarcinoma has a poor prognosis. The National Cancer Institute estimates that in 2025, there will be over 67,000 new cases of pancreatic cancer in the U.S. and over 51,000 pancreatic cancer deaths. Pancreatic cancer is the third-leading cause of cancer death in men and women. Risk factors for developing pancreatic cancer include: cigarette smoking, obesity, alcohol use, diabetes, pancreatitis and hereditary factors. DRAFT Medical Coverage Policy | Irreversible Electroporation (IRE) of Tumors Other Than Liver

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

Surgical resection is considered the only curative therapy although the majority of cases of pancreatic cancer are unresectable. Locally advanced pancreatic cancer accounts for 30% of newly diagnosed cases of pancreatic cancer and is usually unresectable due to local involvement of adjacent vessels. The 5-year overall survival rate is < 5% for locally advanced, unresectable disease.

The NCCN recommended treatment for patients with locally advanced pancreatic adenocarcinoma includes systemic therapy with fluorouracil + leucovorin + irinotecan + oxaliplatin (FOLFIRINOX)-based or gemcitabine-based therapy, potentially with radiation therapy, with the goal of shrinking the tumor enough for surgical resection. Individuals who are unable to undergo surgery may continue systemic therapy. Depending on the kind of cancer and the genetic makeup some individuals may be candidates for immunotherapy or poly adenosine diphosphate-ribose polymerase (PARP) inhibitors.

Thermal (radiofrequency and microwave) ablation therapies are not commonly used due to the increased risk of trauma to the adjacent major anatomical structures. IRE is being considered as an adjunct to systemic therapy because it may not cause thermal injury to nearby sensitive structures such as the superior mesenteric and portal veins, superior mesenteric and celiac arteries, bile duct adjacent nerves, or gastrointestinal structures.

Kidney Tumors The National Cancer Institute estimates that there will be over 80,000 new cases of kidney cancer and over 14,000 kidney cancer related deaths in 2025. At diagnosis, approximately 65% of disease is localized disease.

Kidney cancer is approximately 2-fold more common in males compared to females. Mortality rates are 2- foldhigher for kidney cancers in Native American people compared to White people. There are many risk factors for kidney cancer such as smoking, hypertension, obesity, chronic kidney disease, exposure to analgesics, chemotherapy and certain toxic compounds, and kidney stones.

Surgery is curative for most patients with localized kidney cancer and is therefore the preferred treatment. NCCN guidelines for kidney cancer recommend partial or radical nephrectomy for T1 kidney cancer, or ablation or active surveillance in select patients. The guidelines say that thermal ablation is an option for the management of clinical stage T1 renal lesion that are ≤3 cm and is an option for clinical T1b masses in select patients who not eligible for surgery. However, the guidelines caution that randomized phase III trials of ablative techniques with surgical resection have not been performed.

Lung Tumors The National Cancer Institute estimates that there will be over 226,000 new cases of lung cancer and over 124,000 lung cancer deaths in 2025. Lung cancer is the second most commonly diagnosed cancer and the leading cause of cancer death in both men and women.

Cigarette smoking is the leading risk factor for lung cancer, accounting for 80% to 90% of lung cancer deaths in the US. Other risk factors include radon exposure and radiation therapy to the chest. Black men are approximately 12% more likely to develop lung cancer than White men and Black women are approximately 16% less likely to develop lung cancer than White women. Women have historically had a lower risk than men, but the gap is closing.

The standard for treatment of stage I non–small cell lung cancer (NSCLC) in operable patients is surgical resection with lobectomy and systematic lymph node evaluation. However, a significant number of patients with stage I lung cancer are considered medically inoperable or high-risk surgical candidates. NCCN guidelines state that local ablative therapy with image-guided thermal ablation includes radiofrequency ablation, microwave ablation, and cryoablation, and may be considered for those patients who are deemed “high risk” (medically inoperable due to comorbidities) and is an option for the management of NSCLC lesions<3 cm. The guidelines also state that in the setting of progression at a limited number of sites

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

(oligoprogression), local ablative therapy may extend the duration of benefit of the current line of systemic therapy.

Prostate Cancer The National Cancer Institute estimates that there will be over 313,000 new cases of prostate cancer and over 35,000 prostate cancer deaths in 2025. The 5-year relative survival rate for prostate cancer is 97.9%. The most common risk factor for developing prostate cancer is increasing age. Black men are more likely to get prostate cancer compared to men of other races or ethnicities. Black men are also more than twice as likely to die from prostate cancer compared to men of other races. Genetic factors can also be a risk factor for prostate cancer, especially if a first-degree relative has had prostate cancer.

The standard for treatment of low-risk or favorable intermediate-risk prostate cancer includes active surveillance, radiation therapy, or radical prostatectomy. In patients with regional prostate cancer or higher risk groups, androgen deprivation therapy is recommended, generally in combination with radiation therapy or abiraterone. NCCN guidelines state that ablative therapy (either focal or whole gland ablative therapy) is an experimental and emerging technology for the initial treatment of localized prostate cancer that lacks randomized controlled trial evidence with long-term follow-up showing its superiority or noninferiority to current recommended management strategies. Focal therapy meets the criteria as an alternative therapy, or a non-standard treatment for initial treatment. External beam radiotherapy, brachytherapy, and cryotherapy ablation are currently US Food and Drug Administration (FDA) approved or cleared for initial treatment of prostate cancer, but randomized evidence to the superiority in long-term cancer control and/or quality of life are lacking when delivered as focal rather than whole gland therapy. Other device categories, including IRE, are noted as not currently FDA approved or cleared for the treatment of prostate cancer as focal or whole gland therapy and should only be used in the context of a clinical trial.

NCCN guidelines recommend the use of local therapy as secondary treatment in the case of biopsy-proven recurrence in the prostate after radiation therapy without distant metastatic disease. Local therapy options for patients with recurrence in the prostate include cryotherapy, IRE, high-intensity focused ultrasound, reirradation (ie, brachytherapy, sterotactic body radiotherapy), and prostatectomy plus pelvic lymph node dissection.

Regulatory Status The NanoKnife SystemTM (Angiodynamics) was originally cleared through the 510(k) process (K102329) In 2011 for the surgical ablation of soft tissue. In 2024, the indication for NanoKnife was expanded to surgical ablation of soft tissue, including prostate tissue.

For individuals with locally advanced pancreatic cancer who receive IRE , the evidence includes single-arm studies. Relevant outcomes are overall survival, disease-specific survival, symptoms, morbid events, functional outcomes, and quality of life. Thermal ablation therapies are not commonly used to treat pancreatic cancer due to the increased risk of trauma to the adjacent major anatomical structures. Irreversible electroporation may be an alternative that does not cause thermal injury to nearby sensitive structures. However, there is a lack of consensus on the optimal IRE treatment protocol. Studies of IRE for pancreatic tumors are single- arm. There are insufficient data to determine whether survival is improved with chemotherapy followed by IRE compared to chemotherapy alone. Two randomized controlled trials are underway. Prospective, single arm studies suggest a high complication rate. There are no studies reporting functional or quality of life outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals being treated with locoregional therapy for tumors in the kidneys who receive IRE , the evidence includes single-arm studies. Relevant outcomes are overall survival, disease-specific survival, symptoms, morbid events, functional outcomes, and quality of life. Studies of IRE for kidney tumors are single-arm. Only one study has included more than 10 participants. No comparative data are available.

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

Therefore, there are no data to determine how survival or adverse events compare to other methods for locoregional therapy. There are no studies reporting functional or quality of life outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals being treated with locoregional therapy for tumors in the lungs who receive IRE , the evidence includes single-arm studies. Relevant outcomes are overall survival, disease-specific survival, symptoms, morbid events, functional outcomes, and quality of life. Irreversible electroporation may be an option for locoregional therapy that is less damaging to nearby broncho vascular structures. Studies of IRE for lung tumors are single-arm. The ALICE study was a prospective, single-arm study conducted at 2 centers that was stopped early (n=23) due to failing to meet expected efficacy at an interim analysis based on high recurrence rates of 61% at a median follow-up of 1 year. No comparative data are available. Therefore, there are no data to determine how survival or adverse events compare to other methods for locoregional therapy. There are no studies reporting functional or quality of life outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals being treated with locoregional therapy for tumors in the prostate who receive IRE, the evidence includes systematic reviews of observational studies and prospective nonrandomized trials. Relevant outcomes are overall survival, disease-specific survival, symptoms, morbid events, functional outcomes, and quality of life. Irreversible electroporation is suggested as an option in clinical guidelines for secondary treatment of biopsy-proven recurrence of prostate cancer after radiation. Studies included in systematic reviews for IRE as initial therapy were too heterogeneous to conduct any pooled analyses. Across those studies, reports of biopsy-proven recurrence post-IRE ranged from 0% to 38.9%. Similarly, studies included in the systematic review for IRE as salvage therapy were also too dissimilar to conduct meta-analyses. Rates of local oncological control post-IRE varied from 67% to 77%, although the definition of control also varied across studies. In the PRESERVE study, 71% of patients had negative in-field biopsies at 12 months, which aligned with results from observational studies across systematic review. The small sample sizes, heterogeneity across studies and study populations, and observational study designs all preclude conclusions of efficacy compared to other standard treatments. No subgroup analyses have been conducted across various severities of prostate cancer. Additionally, the short follow-up times are insufficient to establish long-term oncological effects. No comparative data with guideline-recommended standard of care are available. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

CODING Medicare Advantage Plans and Commercial Products The following CPT code(s) are not covered for Medicare Advantage Plans and not medically necessary for Commercial Products: 55877 Ablation, irreversible electroporation, prostate, 1 or more tumors, including imaging guidance, percutaneous (New Code Effective 1/1/2026) 0600T Ablation, irreversible electroporation; 1 or more tumors per organ, other than liver or prostate, including imaging guidance, when performed, percutaneous (Text Revised Effective 1/1/2026)

The following CPT code(s) are not covered for Medicare Advantage Plans and not medically necessary for Commercial Products when filed for IRE of tumors other than liver. Refer to the Related Policies section for details:
0601T Ablation, irreversible electroporation; 1 or more tumors per organ, including fluoroscopic and ultrasound guidance, when performed, open

RELATED POLICIES Prior Authorization of Services, Treatments or Procedures

PUBLISHED Provider Update, April 2026

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 5 (401) 274-4848 WWW.BCBSRI.COM

REFERENCES

1. Scheltema MJ, van den Bos W, de Bruin DM, et al. Focal vs extended ablation in localized prostate cancer with irreversible electroporation; a multi-center randomized controlled trial. BMC Cancer. May 052016; 16: 299. PMID 27150293
2. Rubinsky B, Onik G, Mikus P. Irreversible electroporation: a new ablation modality--clinical implications. Technol Cancer Res Treat. Feb 2007; 6(1): 37-48. PMID 17241099
3. Davalos RV, Mir IL, Rubinsky B. Tissue ablation with irreversible electroporation. Ann Biomed Eng. Feb2005; 33(2): 223-31. PMID 15771276
4. Surveillance, Epidemiology, and End Results Program (SEER). Cancer Stat Facts. https://seer.cancer.gov/statfacts/. Accessed October 6, 2025.
5. Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024; 74(1): 12-49. PMID 38230766
6. Balaban EP, Mangu PB, Khorana AA, et al. Locally Advanced, Unresectable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. Aug 01 2016; 34(22):2654-68. PMID 27247216
7. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Pancreatic Adenocarcinoma. Version 2.2025. https://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. Accessed October 2, 2025.
8. Cheungpasitporn W, Thongprayoon C, O'Corragain OA, et al. The risk of kidney cancer in patients with kidney stones: a systematic review and meta-analysis. QJM. Mar 2015; 108(3): 205-12. PMID25208892
9. Argani P, Laé M, Ballard ET, et al. Translocation carcinomas of the kidney after chemotherapy in childhood. J Clin Oncol. Apr 01 2006; 24(10): 1529-34. PMID 16575003
10. Cho E, Curhan G, Hankinson SE, et al. Prospective evaluation of analgesic use and risk of renal cell cancer. Arch Intern Med. Sep 12 2011; 171(16): 1487-93. PMID 21911634
11. Mandel JS, McLaughlin JK, Schlehofer B, et al. International renal-cell cancer study. IV. Occupation. IntJ Cancer. May 29 1995; 61(5): 601-5. PMID 7768630
12. Lowrance WT, Ordoñez J, Udaltsova N, et al. CKD and the risk of incident cancer. J Am Soc Nephrol. Oct 2014; 25(10): 2327-34. PMID 24876115
13. Adams KF, Leitzmann MF, Albanes D, et al. Body size and renal cell cancer incidence in a large US cohort study. Am J Epidemiol. Aug 01 2008; 168(3): 268-77. PMID 18544571
14. Hidayat K, Du X, Zou SY, et al. Blood pressure and kidney cancer risk: meta-analysis of prospective studies. J Hypertens. Jul 2017; 35(7): 1333-1344. PMID 28157813
15. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Kidney Cancer. Version 1.2026. https://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf.Accessed October 4, 2025.
16. Centers for Disease Control and Prevention. Lung Cancer Risk Factors. Updated February 13, 2025. https://www.cdc.gov/lung-cancer/risk-factors/index.html. Accessed October 6, 2025.
17. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer. Version 8.2025. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed October 3, 2025.
18. Prostate cancer risk factors. Centers for Disease Control and Prevention. February 11, 2025.https://www.cdc.gov/prostate-cancer/risk-factors/index.html. Accessed October 23, 2025.
19. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology:Prostate Cancer. Version 2.2026. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf.Accessed October 23, 2025.
20. Food and Drug Administration. NanoKnife System 510(k) Summary: K183385.https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183385.pdf. Accessed October 6, 2025.
21. Geboers B, Scheffer HJ, Graybill PM, et al. High-Voltage Electrical Pulses in Oncology: Irreversible Electroporation, Electrochemotherapy, Gene Electrotransfer, Electrofusion, and Electroimmunotherapy. Radiology. May 2020; 295(2): 254-272. PMID 32208094
22. AngioDynamics. NanoKnife Patient Guide. https://nanoknife.com/resources/. Accessed October 6, 2025.

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 6 (401) 274-4848 WWW.BCBSRI.COM

23. van Roessel S, Kasumova GG, Verheij J, et al. International Validation of the Eighth Edition of the American Joint Committee on Cancer (AJCC) TNM Staging System in Patients With Resected Pancreatic Cancer. JAMA Surg. Dec 01 2018; 153(12): e183617. PMID 30285076
24. Ellis LM, Bernstein DS, Voest EE, et al. American Society of Clinical Oncology perspective: Raising the bar for clinical trials by defining clinically meaningful outcomes. J Clin Oncol. Apr 20 2014; 32(12): 1277-
25. PMID 24638016
26. Charalambous P, Moris D, Karachaliou GS, et al. The efficacy and safety of the open approach irreversible electroporation in the treatment of pancreatic cancer: A systematic review. Eur J Surg Oncol. Sep 2020; 46(9): 1565-1572. PMID 32536525
27. Martin RC, McFarland K, Ellis S, et al. Irreversible electroporation therapy in the management of locally advanced pancreatic adenocarcinoma. J Am Coll Surg. Sep 2012; 215(3): 361-9. PMID 22726894
28. Martin RC, Kwon D, Chalikonda S, et al. Treatment of 200 locally advanced (stage III) pancreatic adenocarcinoma patients with irreversible electroporation: safety and efficacy. Ann Surg. Sep 2015;262(3): 486-94; discussion 492-4. PMID 26258317
29. Månsson C, Bergenfeldt M, Brahmstaedt R, et al. Safety and preliminary efficacy of ultrasound-guided percutaneous irreversible electroporation for treatment of localized pancreatic cancer. Anticancer Res. Jan 2014; 34(1): 289-93. PMID 24403476
30. Scheffer HJ, Vroomen LG, de Jong MC, et al. Ablation of Locally Advanced Pancreatic Cancer with Percutaneous Irreversible Electroporation: Results of the Phase I/II PANFIRE Study. Radiology. Feb2017; 282(2): 585-597. PMID 27604035
31. Ruarus AH, Vroomen LGPH, Geboers B, et al. Percutaneous Irreversible Electroporation in Locally Advanced and Recurrent Pancreatic Cancer (PANFIRE-2): A Multicenter, Prospective, Single-Arm, Phase II Study. Radiology. Jan 2020; 294(1): 212-220. PMID 31687922
32. Narayanan G, Hosein PJ, Arora G, et al. Percutaneous irreversible electroporation for downstaging and control of unresectable pancreatic adenocarcinoma. J Vasc Interv Radiol. Dec 2012; 23(12): 1613-21. PMID 23177107
33. Narayanan G, Hosein PJ, Beulaygue IC, et al. Percutaneous Image-Guided Irreversible Electroporation for the Treatment of Unresectable, Locally Advanced Pancreatic Adenocarcinoma. J Vasc Interv Radiol. Mar 2017; 28(3): 342-348. PMID 27993507
34. Martin RC, McFarland K, Ellis S, et al. Irreversible electroporation in locally advanced pancreatic cancer: potential improved overall survival. Ann Surg Oncol. Dec 2013; 20 Suppl 3: S443-9. PMID23128941
35. Kluger MD, Epelboym I, Schrope BA, et al. Single-Institution Experience with Irreversible Electroporation for T4 Pancreatic Cancer: First 50 Patients. Ann Surg Oncol. May 2016; 23(5): 1736-43. PMID 26714959
36. Leen E, Picard J, Stebbing J, et al. Percutaneous irreversible electroporation with systemic treatment for locally advanced pancreatic adenocarcinoma. J Gastrointest Oncol. Apr 2018; 9(2): 275-281. PMID29755766
37. Liu S, Qin Z, Xu J, et al. Irreversible electroporation combined with chemotherapy for unresectable pancreatic carcinoma: a prospective cohort study. Onco Targets Ther. 2019; 12: 1341-1350. PMID30863100
38. Holland MM, Bhutiani N, Kruse EJ, et al. A prospective, multi-institution assessment of irreversible electroporation for treatment of locally advanced pancreatic adenocarcinoma: initial outcomes from the AHPBA pancreatic registry. HPB (Oxford). Aug 2019; 21(8): 1024-1031. PMID 30737097
39. Martin RCG, White RR, Bilimoria MM, et al. Effectiveness and Safety of Irreversible Electroporation When Used for the Ablation of Stage 3 Pancreatic Adenocarcinoma: Initial Results from the DIRECT Registry Study. Cancers (Basel). Nov 21 2024; 16(23). PMID 39682087
40. Martin RC, Durham AN, Besselink MG, et al. Irreversible electroporation in locally advanced pancreatic cancer: A call for standardization of energy delivery. J Surg Oncol. Dec 2016; 114(7): 865-871. PMID 27546233
41. Chin AI, Lam JS, Figlin RA, et al. Surveillance strategies for renal cell carcinoma patients following nephrectomy. Rev Urol. 2006; 8(1): 1-7. PMID 16985554

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 7 (401) 274-4848 WWW.BCBSRI.COM

41. Hilton A, Kourounis G, Georgiades F. Irreversible electroporation in renal tumours: A systematic review of safety and early oncological outcomes. Urologia. Aug 2022; 89(3): 329-337. PMID 35139717
42. Buijs M, Zondervan PJ, de Bruin DM, et al. Feasibility and safety of irreversible electroporation (IRE) inpatients with small renal masses: Results of a prospective study. Urol Oncol. Mar 2019; 37(3): 183.e1- 183.e8. PMID 30509869
43. Canvasser NE, Sorokin I, Lay AH, et al. Irreversible electroporation of small renal masses: suboptimal oncologic efficacy in an early series. World J Urol. Oct 2017; 35(10): 1549-1555. PMID 28255621
44. Xing M, Kokabi N, Zhang D, et al. Comparative Effectiveness of Thermal Ablation, Surgical Resection, and Active Surveillance for T1a Renal Cell Carcinoma: A Surveillance, Epidemiology, and End Results (SEER)-Medicare-linked Population Study. Radiology. Jul 2018; 288(1): 81-90. PMID 29737950
45. Thomson KR, Cheung W, Ellis SJ, et al. Investigation of the safety of irreversible electroporation in humans. J Vasc Interv Radiol. May 2011; 22(5): 611-21. PMID 21439847
46. Pech M, Janitzky A, Wendler JJ, et al. Irreversible electroporation of renal cell carcinoma: a first-in-man phase I clinical study. Cardiovasc Intervent Radiol. Feb 2011; 34(1): 132-8. PMID 20711837
47. Diehl SJ, Rathmann N, Kostrzewa M, et al. Irreversible Electroporation for Surgical Renal Masses in Solitary Kidneys: Short-Term Interventional and Functional Outcome. J Vasc Interv Radiol. Sep 2016;27(9): 1407-1413. PMID 27292599
48. Vroomen LGPH, Scheffer HJ, Melenhorst MCAM, et al. Irreversible Electroporation to Treat Malignant Tumor Recurrences Within the Pelvic Cavity: A Case Series. Cardiovasc Intervent Radiol. Oct 2017;40(10): 1631-1640. PMID 28470395
49. Liu B, Clark J, Domes T, et al. Percutaneous irreversible electroporation for the treatment of small renal masses: The first Canadian case series. Can Urol Assoc J. Sep 2019; 13(9): E263-E267. PMID30763229
50. Wendler JJ, Pech M, Fischbach F, et al. Initial Assessment of the Efficacy of Irreversible Electroporation in the Focal Treatment of Localized Renal Cell Carcinoma With Delayed-interval Kidney Tumor Resection (Irreversible Electroporation of Kidney Tumors Before Partial Nephrectomy [IRENE] Trial- An Ablate-and-Resect Pilot Study). Urology. Apr 2018; 114: 224-232. PMID 29305201
51. Wendler JJ, Pech M, Köllermann J, et al. Upper-Urinary-Tract Effects After Irreversible Electroporation (IRE) of Human Localised Renal-Cell Carcinoma (RCC) in the IRENE Pilot Phase 2a Ablate-and-Resect Study. Cardiovasc Intervent Radiol. Mar 2018; 41(3): 466-476. PMID 28929209
52. Ricke J, Jürgens JH, Deschamps F, et al. Irreversible electroporation (IRE) fails to demonstrate efficacy in a prospective multicenter phase II trial on lung malignancies: the ALICE trial. Cardiovasc Intervent Radiol. Apr 2015; 38(2): 401-8. PMID 25609208
53. Zhang K, Teoh J, Zhu G, et al. Irreversible Electroporation for the Focal Treatment of Prostate Cancer: A Systematic Review. World J Mens Health. Apr 2025; 43(2): 321-332. PMID 39028129
54. Prabhakar P, Avudaiappan AP, Sandman M, et al. Irreversible electroporation as a focal therapy for localized prostate cancer: A systematic review. Indian J Urol. 2024; 40(1): 6-16. PMID 38314081
55. George AK, Miocinovic R, Patel AR, et al. Irreversible Electroporation for Prostate Tissue Ablation in Patients with Intermediate-risk Prostate Cancer: Results from the PRESERVE Trial. Eur Urol. Jul
56. PMID 40685282
57. Yilmaz M, Karaaslan M, Şirin ME, et al. Salvage irreversible electroporation for locally recurrent prostate cancer after definitive radiotherapy: a systematic review. Prostate Cancer Prostatic Dis. Sep 2025; 28(3): 707-717. PMID 39623055
58. National Institute for Health and Care Excellence (NICE). Irreversible electroporation for treating pancreatic cancer: Interventional procedures guidance [IPG579]. 2017. https://www.nice.org.uk/guidance/ipg579. Accessed October 6, 2025.

59. National Institute for Health and Care Excellence (NICE). Irreversible electroporation for treating prostate cancer: Interventional procedures guidance [IPG768]. 2023. https://www.nice.org.uk/guidance/ipg768. Accessed October 23, 2025.

    i ii

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 8 (401) 274-4848 WWW.BCBSRI.COM

This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association.

CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS