Prior approval and benefit verification

Prior approval is listed as “Not applicable.” Verify member benefits and contract-specific exclusions or limitations at time of service to confirm coverage and any prior authorization requirements.

• Benefit determinations are based on the applicable contract language in effect at the time the services were rendered.
• Exclusions, limitations, or exceptions may apply; individual member benefits must be verified.

Prior authorization should document clinical justification

When requesting prior authorization, document clinical justification that addresses limited comparative evidence and any elevated complication signals (notably in pancreatic studies) and include tumor stage, prior systemic therapies, and why standard locoregional options are not appropriate.

• Studies for pancreatic, liver, kidney, and lung indications are primarily single-arm and lack comparative RCT evidence.
• Document prior systemic therapy, tumor stage, and rationale for using IRE instead of standard therapies.

Prior authorization for IRE procedures (device / procedural planning confirmation)

Prior authorization should confirm planned use of the NanoKnife IRE system and that procedural planning includes CT guidance, electrocardiography synchronization, general anesthesia, and electrode placement to bracket the targeted tissue.

• NanoKnife System described as the IRE device cleared for surgical ablation of soft tissue.
• Procedure is performed under CT guidance and ECG synchronization and under general anesthesia.
• Physician places 2–6 electrodes to bracket the targeted tissue.

Prior authorization and billing codes

Bill IRE procedures using the CPT codes listed in the policy: 0600T, 0601T, and 47384; ensure the claim includes the appropriate place of service and type-of-service fields per payer requirements.

• 0600T — Ablation, IRE; percutaneous for organs other than liver or prostate.
• 0601T — Ablation, IRE; open approach.
• 47384 — Ablation, IRE; liver, percutaneous.

Alternative locoregional therapy options

Consider established locoregional alternatives (e.g., radiofrequency ablation, microwave ablation, cryoablation, percutaneous ethanol injection, arterial embolization, and radiotherapy including SBRT) before IRE when clinically appropriate.

• NCCN lists microwave/RFA, surgical or percutaneous ethanol injection and arterial embolization and radiotherapy as locoregional options for hepatic tumors.
• Thermal ablation and other established ablative procedures are alternatives for small renal masses.

Systemic therapy precedes local ablation for pancreas (NCCN context)

For locally advanced pancreatic adenocarcinoma, document that appropriate systemic therapy (e.g., FOLFIRINOX or gemcitabine-based regimens) with or without radiation was given per NCCN recommendations prior to considering local ablation.

• NCCN recommended initial approach for locally advanced pancreatic cancer is systemic therapy, potentially with radiation, to attempt downstaging.
• There is insufficient data to determine whether chemotherapy followed by IRE improves survival compared with chemotherapy alone; RCTs are ongoing.

Consider standard ablative or surveillance options first

Document consideration of standard ablative approaches or active surveillance for small renal masses before IRE; NCCN guidance supports thermal ablation or surveillance for selected small renal tumors.

• NCCN states thermal ablation (cryo, RFA, microwave) and active surveillance are options for certain small renal masses (<3 cm, T1a).
• IRE evidence for kidney tumors is limited to small, single-arm studies with no comparative data.

Step therapy (informational)

No explicit step therapy mandate is specified in this policy; the guidance notes IRE is an emerging modality and not currently recommended by some guidelines for several indications.

• NCCN describes IRE as an emerging modality and the Panel does not currently recommend IRE for locally advanced pancreatic cancer due to concerns about complications and technical expertise.
• No formal step-wise requirement (e.g., mandatory prior-line therapies) is specified in this segment.

Documentation and benefit verification (refer to policy and codes table)

Refer to the policy text and the Codes table when preparing authorization requests and claims; verify member benefits and applicable contract language at the time of service.

• Policy states to use appropriate CPT/HCPCS and diagnosis codes per Codes table.
• Benefit determinations depend on the member’s contract and may vary.

Procedural documentation details

Include procedural details in the medical record and authorization request: device used (NanoKnife), number and placement of electrodes (2–6), imaging guidance (CT), ECG synchronization, anesthesia type, pulse settings, and perioperative monitoring for arrhythmia/muscle contractions.

• NanoKnife System details and that voltage is applied between probe pairs in pulses.
• Procedure performed under CT guidance and ECG synchronization; physician places 2–6 electrodes.
• Document pulse settings and perioperative monitoring due to risk of muscular spasms and arrhythmia.

Procedure documentation (NanoKnife specifics, electrode details, CT/ECG guidance)

For NanoKnife procedures, document the specific device (NanoKnife System), electrode count and configuration (typically 2–6 electrodes to bracket tissue), CT imaging guidance, and ECG synchronization used during energy delivery.

• NanoKnife System is a software-controlled direct-current generator with single electrode probes and optional spacer.
• Physician places 2–6 electrodes and applies a series of electrical pulses.
• Procedure performed under CT guidance and electrocardiography synchronization.

Required claim documentation (applicable CPT codes)

Claims must include the applicable CPT code from the policy (0600T, 0601T, or 47384) and appropriate place-of-service and type-of-service fields to reduce claim denials.

• 0600T for percutaneous IRE (non-liver/prostate).
• 0601T for open IRE procedures.
• 47384 for percutaneous liver IRE.

Investigational designation may trigger denial

Because IRE for liver, pancreas, kidney, or lung tumors is designated investigational by this policy, lack of coverage may result in claim denial unless the service is part of an approved clinical trial or meets any narrow, documented exception.

• Policy states IRE is considered investigational for treatment of primary or metastatic solid tumors including liver, pancreas, kidney, or lung.
• Investigational services may be denied.

Lung study outcomes may trigger denial (ALICE trial results)

Document and anticipate possible denial for lung IRE based on ALICE trial outcomes: the multicenter ALICE study was stopped early (n=23) for lack of efficacy with 61% progressive disease at ~1 year and high pneumothorax rates (48%).

• ALICE study stopped early (planned n=36, stopped at n=23) with 61% progressive disease at median 12 months.
• Pneumothorax occurred in 48% with chest tubes required in 8 participants.

Coding-related denial risk (failure to use specified CPT codes)

Use the CPT codes specified in the policy (0600T, 0601T, 47384) when reporting IRE; failure to use these codes or to include the correct place/type-of-service may result in claim denial.

• Policy lists CPT 0600T, 0601T, and 47384 for reporting IRE procedures.
• Claims should include appropriate place-of-service and type-of-service fields.