Modifiedpriority healthPolicy NO. 91599

IRREVERSIBLE ELECTROPORATION(IRE)/NANOKNIFE

Policy governing coverage of irreversible electroporation (IRE), including the NanoKnife system, for ablation of soft tissue and malignant lesions for Priority Health members; applies across plan types with group-specific benefits taking precedence.

Policy Summary

Payerpriority health

PolicyIRREVERSIBLE ELECTROPORATION(IRE)/NANOKNIFE

Policy CodePolicy NO. 91599

Change TypeContent modified (added referencesremoved FDA non-approval statement)

Effective DateJun 1, 2026

Next Review Date

Key ActionIf prior authorization is required, submit documentation demonstrating medical necessity per the Priority Health Provider Manual and include recent trial evidence (e.g., PRESERVE) and indication-specific details.

SourceLink

POLICY UPDATE CHANGES

Removed statement that NanoKnife is not FDA approved for cancer treatment

Updated background and references, including information on the PRESERVE study

1policy conclusion: IRE experimental

121PRESERVE trial patients

5Not Medically Necessary codes

Deletedregulatory statement removed

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high-profile trial cited

Coverage Criteria and Policy Conclusion

Medical Necessity

Covered when ALL of the following are met

Medical Necessity Determination: Use of irreversible electroporation (IRE) or NanoKnife® for ablation of cancer is considered experimental and investigational due to insufficient evidence in the peer-reviewed literature.

This stance applies to IRE/NanoKnife procedures for oncologic indications.

Referenced clinical indications (informational)

Evidence updates and references for organ-specific use (informational)

Referenced indications: IRE is cited in the literature for hepatocellular carcinoma, pancreatic cancer, prostate cancer, and renal cell carcinoma; recent additions to the evidence base include the PRESERVE trial for intermediate-risk prostate cancer.

References include single-arm cohorts, multicenter studies, and the PRESERVE trial (2026). This information is provided for context and does not constitute coverage approval.

Use of irreversible electroporation (IRE) or NanoKnife® for ablation of cancer is considered experimental and investigational due to insufficient evidence in the peer-reviewed literature. Associated procedure codes listed as not medically necessary include 0600T, 0601T, 47384, 55877, and C8005.

The policy text previously included an explicit statement that NanoKnife is not FDA approved for cancer treatment; that statement has been removed. The background and reference list have been updated to include recent evidence such as the PRESERVE study.

Irreversible electroporation (IRE)/NanoKnife ablation for cancer is classified as experimental and investigational, and the following CPT/HCPCS codes are designated Not Medically Necessary: 0600T, 0601T, 47384, 55877, and C8005.

Early renal series report suboptimal oncologic efficacy for IRE in small renal masses; published reports include an early series noting limited oncologic outcomes for small renal tumors, which informs the policy’s assessment of limited effectiveness for renal indications.

Coding — ICD-10, CPT, HCPCS

ICD-10 supporting diagnosesICD-10

ICD-10 (unspecified list)

ICD-10 codes that may support medical necessity; 'All diagnoses are medically necessary' (document statement)

Not Medically Necessary CPT/HCPCS CodesmixedNot Covered

0600T	Ablation, irreversible electroporation; 1 or more tumors per organ, including imaging guidance, when performed, percutaneous.
0601T	Ablation, irreversible electroporation; 1 or more tumors, including fluoroscopic and ultrasound guidance, when performed, open.
47384	Ablation, irreversible electroporation, liver, 1 or more tumors, including imaging guidance, percutaneous.
55877	Ablation, irreversible electroporation, prostate, 1 or more tumors, including imaging guidance, percutaneous.
C8005	Bronchoscopy, rigid or flexible, non-thermal transbronchial ablation of lesion(s) by pulsed electric field (pef) energy, including fluoroscopic and/or ultrasound guidance, when performed, with computed tomography acquisition(s) and 3d rendering, computer-assisted, image-guided navigation, and endobronchial ultrasound (ebus) guided transtracheal and/or transbronchial sampling (e.g., aspiration[s]/biopsy[ies]) of all mediastinal and/or hilar lymph node stations or structures, and therapeutic intervention(s)

No specific codes in these chunksmixed

No codes listed

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization may be required. When prior authorization is required, providers must submit a request demonstrating that the drug, device, service, or procedure is medically necessary per plan rules and the Priority Health Provider Manual.

Refer to Priority Health Provider Manual for PA submission requirements and process.

Documentation Required

Evidence Documentation

Providers must document indication-specific evidence to support medical necessity. For prostate cancer indications, include relevant trial data such as the PRESERVE trial (George et al., 2026) and other cited studies (Blazevski 2020; de la Rosette et al. 2023; Scheltema et al. 2018, 2023) or guideline references (NCCN 2026; EAU 2026; NICE IPG768 2023) as applicable.

Include indication, tumor characteristics, prior therapies, diagnostic imaging and biopsy results, and rationale for irreversible electroporation vs alternatives.
For renal and other tumor sites, include pertinent evidence from renal studies and systematic reviews (e.g., Buijs 2017; Canvasser 2017; Yilmaz 2024).

Background and Evidence Summary

Irreversible electroporation applies direct-current electrical fields to soft tissue to create nanoscale defects in cell membranes that lead to targeted cell death without thermal energy. The technique (commercially marketed as NanoKnife®) is a non-thermal tumor ablation method that has been evaluated in registries, case series, and single-arm trials across organ sites, but available evidence remains limited and device-specific safety issues have been reported.

Organ-specific evidence is evolving but limited: prostate cancer trial data (e.g., the recently added PRESERVE study) and multiple prostate series are cited, while renal reports include studies that describe early experience and one series reporting suboptimal oncologic efficacy for small renal masses. Overall, evidence across hepatic, pancreatic, prostate, and renal indications is primarily from nonrandomized series, registries, and single-arm studies.

Definitions and Key Trial

Definition — Irreversible electroporation (IRE)

TermIrreversible electroporation (IRE)

DefinitionNon-thermal ablation technique in which direct-current electrical fields are applied to soft tissue to create nanoscale/permanent defects in cell membranes resulting in targeted cell death without drugs.

MechanismElectrical fields delivered at energy and duration that produce irreversible membrane damage (distinct from reversible electroporation/electrochemotherapy).

Clinical rationaleDoes not require chemotherapeutic drugs; proposed advantage for immunocompromised patients compared with electrochemotherapy.

PRESERVE trial — NanoKnife in intermediate‑risk prostate cancer

StudyPRESERVE trial (prospective, nonrandomized, single-arm pivotal study)

Policy Summary

Payerpriority health

PolicyIRREVERSIBLE ELECTROPORATION(IRE)/NANOKNIFE

Policy CodePolicy NO. 91599

Change TypeContent modified (added referencesremoved FDA non-approval statement)

Effective DateJun 1, 2026

Next Review Date

SourceLink

On This Page

Denial Risk

Denial Risk for Listed Ablation Codes

Providers should be aware that certain CPT/HCPCS codes for irreversible electroporation and related ablation procedures are listed as Not Medically Necessary and may be denied. If submitting for these services, supply comprehensive medical records and supporting evidence to justify medical necessity per plan criteria.

Not Medically Necessary codes at risk for denial: 0600T, 0601T, 47384, 55877, C8005.

Note

Evidence Updates and Regulatory Considerations

Updated evidence may be required as part of any prior authorization review. Recent additions to the policy include the PRESERVE trial and other updated references; providers should reference and attach pertinent publications when requesting authorization.

Policy updates removed prior statement about FDA non-approval for NanoKnife — confirm any regulatory or labeling changes in supporting documentation.
Attach copies or citations of key studies cited in the policy when clinically relevant.

Prior Authorization

Prior Authorization / Documentation Reminder

If prior authorization is required, providers must submit documentation demonstrating medical necessity consistent with the Provider Manual. Failure to provide required evidence and clinical rationale may result in denial.

Follow priority health Provider Manual instructions for required documents and timelines.
Ensure documentation includes indication, prior treatments, diagnostic results, and relevant literature or guideline support.

Population121 men with treatment‑naive, intermediate‑risk prostate cancer (age >50, organ‑confined, grade group 2–3, clinical stage ≤T2c, PSA ≤15 ng/mL or PSA density <0.15 ng/mL^2).

Primary endpointsRate of local pathological complete response (negative in-field biopsy) and incidence/type/severity of adverse events at 12 months.

Key efficacy resultNegative in-field biopsy rate at 12 months: 71% (95% CI: 62%, 79%); Delphi consensus–defined rate: 84% (95% CI: 76%, 90%).

Safety outcomes12% experienced CTCAE grade ≥3 events; three procedure‑related grade 3 adverse events reported; urinary and sexual function largely preserved at 12 months.

Irreversible electroporation (IRE) / NanoKnife — device and regulatory context

Device/SystemCommercially marketed as NanoKnife (irreversible electroporation system)

Indications in literatureEvaluated for focal ablation in solid organ tumors including liver, pancreas, prostate, and kidney in registries, case series, and single‑arm trials.

Safety evidenceReal‑world device safety analyses (e.g., MAUDE database 2025) and reported adverse events in trials/registries (including procedure‑related grade 3 events and rare complications).

Regulatory/context notePolicy text previously included a statement that NanoKnife was not FDA approved for cancer treatment; that explicit statement was removed in the current update, and device‑specific safety/reports are part of the evolving evidence base.