Preauthorization required (policy M.60)

Preauthorization is required for all IRE procedures under policy M.60; providers must obtain prior authorization before performing an IRE service even though the policy states IRE is considered not reasonable and necessary for all indications.

• Policy header and M.60 identify the policy as 'Preauthorization Required'.
• Prior authorization must be requested before the service; benefits are determined by the member's benefit contract.

Obtain preauthorization prior to IRE

Preauthorization is explicitly required for IRE procedures per the policy header; submit a prior authorization request before scheduling the procedure.

• The policy heading notes Preauthorization Required for IRE procedures.
• Medical Policies do not constitute authorization of benefits; authorization is determined by the benefit contract.

Supply trial/registry evidence and rationale vs standard therapy

When requesting preauthorization, include evidence from trials or registries (when available) and a clear rationale comparing IRE to standard locoregional therapies to support the request.

• The policy requests evidence from trials or registries and rationale for use versus standard locoregional therapies.
• Documented registry or prospective study data (eg, DIRECT, AHPBA registry) are relevant to review.

Include indication, prior therapies, and follow-up in preauth

Preauthorization documentation must include the indication, tumor site, prior therapies, and the expected follow-up protocol (for example, biopsy or PSA monitoring for prostate cases).

• Include clinical indication and tumor site (eg, liver HCC/CCA, locally advanced pancreatic cancer, prostate).
• List prior systemic or locoregional therapies and planned post-procedure follow-up (eg, biopsy schedule, PSA monitoring).

Submit procedure/diagnosis code pair via Quick Code Search

Enter the proposed procedure and diagnosis code pair into the policy Quick Code Search and request review; if the code pair is not listed, the request may be held for review or denied.

• Use the Quick Code Search: input procedure code, then diagnosis code, then 'Add Code Pair'.
• If the procedure/diagnosis pair is not listed in the policy, the Quick Code Search may flag the request for review.

M.60: preauthorization required for IRE procedures

This policy (M.60) is identified as 'Preauthorization Required' for irreversible electroporation procedures; providers must secure preauthorization per the policy before performing the service.

• The policy statement and header explicitly identify preauthorization requirements for IRE under M.60.
• Authorization/benefit determination remains subject to the member's plan terms.

Document usual therapy options (NCCN‑recommended) were considered

Document that standard-of-care, NCCN-recommended approaches (surgery, transplant, systemic therapy, or standard locoregional ablation) were considered or are not feasible prior to pursuing IRE.

• Ablative strategies are potentially curative for small liver lesions (≤3 cm); NCCN recommends evaluation for curative therapies.
• For locally advanced pancreatic cancer, document systemic therapy attempts per NCCN recommendations.

Document consideration of alternative locoregional comparators

When justifying IRE, document consideration of alternative locoregional comparators such as RFA, MWA, surgical ablation, percutaneous ethanol injection, cryoablation, and arterially directed therapies.

• For liver: RFA, MWA, surgical ablation, percutaneous ethanol injection, cryoablation, embolization, and SBRT.
• For lung and prostate, list applicable standard locoregional comparators used in decision-making.

Require documentation of standard therapy consideration (comparators)

Specifically document consideration of standard locoregional therapies (eg, RFA, MWA, cryosurgery, SBRT, active surveillance) in the clinical decision-making prior to requesting IRE.

• Include why alternatives (RFA, MWA, cryosurgery, SBRT, surgery, active surveillance) are unsuitable or contraindicated.
• For pancreatic cancer, document systemic therapy alternatives and rationale for adjunctive IRE.

Record consideration of disease-specific comparators

Include documentation that alternative locoregional therapies were considered (for example prostatectomy, radiation, cryoablation, HIFU, or SBRT for prostate cases) and the clinical reasoning for selecting IRE.

• State why standard options (surgery, radiation, cryo, HIFU, SBRT) are not appropriate or feasible for the patient.
• Provide comparative rationale when IRE is proposed as an adjunct or alternative.

Provide device regulatory documentation (NanoKnife 510[k] K102329; 2024 expansion)

Document the FDA regulatory status and device identity (NanoKnife System), including that it was cleared via 510(k) K102329 and had an expanded indication in 2024 to include prostate tissue, as part of the device information submitted for review.

• NanoKnife System cleared through 510(k) K102329 for surgical ablation of soft tissue; 2024 expansion includes prostate tissue.
• Include device model and FDA clearance details when relevant to the submission.

Provide detailed IRE procedural and indication documentation

Provide detailed procedural documentation including IRE procedure details (device used, number and placement of electrodes/probes, CT guidance, ECG synchronization, anesthesia type, and percutaneous vs open approach).

• Specify number and placement of electrodes (typically 2–6), imaging guidance (CT), ECG synchronization, and general anesthesia.
• Note approach (percutaneous or open) and any probe spacers or device settings used.

Attach supporting registry/trial data and peri‑procedural outcomes

Include supporting clinical documentation such as prospective registry or study data describing IRE use (eg, enrollment, treatment arm, chemotherapy regimen) and peri-procedural morbidity/mortality when available.

• Registry or trial identifiers and results (eg, AHPBA registry, DIRECT registry) should be provided when applicable.
• Report peri-procedural adverse events, severe complications, and mortality observed.

Document procedure details and planned follow‑up

Document procedure and follow-up specifics including imaging guidance (CT), ECG synchronization, anesthesia (general), number and placement of electrodes, and pre- and post-procedure monitoring such as biopsy or PSA testing where applicable.

• Describe imaging modality used and ECG synchronization details due to risk of muscular spasms and arrhythmias.
• Provide planned follow-up monitoring (eg, biopsy schedule for prostate; imaging for local control).

Use listed CPT/HCPCS codes or appropriate unlisted codes; document coding rationale

Use the CPT/HCPCS procedure codes listed in the policy (eg, 0600T, 0601T, 47384, 47399, 48999, 53899, 55877) or appropriate unlisted procedure codes for the liver, pancreas, or urinary system when applicable; include coding rationale in the preauthorization submission.

• When applicable, provide the selected CPT/HCPCS code and justify use if choosing an unlisted code (eg, 47399, 48999, 53899).
• Enter the procedure/diagnosis code pair into Quick Code Search as part of the preauthorization workflow.

CPT coding referenced; adhere to benefit contract terms

Medical Policies reference CPT codes but do not guarantee coverage; providers must adhere to the member's benefit contract and include complete coding documentation with the prior authorization request.

• Policies reference CPT codes; benefit determination is by the applicable benefit contract.
• Include complete coding and documentation to facilitate benefit review.

High denial risk: IRE not reasonable & necessary for all indications

IRE, including NanoKnife, is considered not reasonable and necessary for all indications; requests for coverage are at high risk of denial across tumor sites unless documentation and preauthorization address the policy's concerns.

• Policy statement: IRE is not reasonable and necessary for all indications including liver, pancreas, prostate, kidneys, and cardiac ablation.
• Expect denials if requests do not sufficiently justify medical necessity or fall outside investigational/research contexts.

Risk of denial if no preauthorization or inappropriate population

Preauthorization is required and failure to obtain preauthorization or to document that the patient falls within the described intended populations (eg, nonsurgical candidates, small localized HCC/CCA, or locally advanced pancreatic cancer after systemic therapy) may result in denial.

• Document that the patient matches the policy's described populations (nonsurgical candidates, specific tumor types, lesion size where applicable).
• Lack of preauthorization or insufficient population documentation may trigger denial.

Insufficient evidence and safety concerns may lead to denial

Evidence is insufficient and safety concerns exist for IRE in pancreatic and kidney tumors; lack of RCTs and comparative data and reports of nontrivial complication and mortality rates may lead to denial for medical necessity.

• No published randomized controlled trials for pancreatic or kidney IRE; studies are predominantly single-arm.
• Reported complication rates and procedure-related mortality (eg, AHPBA registry: 18% adverse events, 2% mortality) are relevant to medical necessity review.

Denial risk for lung tumor IRE indications

For lung tumor indications, the lack of comparative evidence and high recurrence and complication rates (eg, ALICE stopped early with 61% progressive disease and high pneumothorax rate) increase the likelihood of denial.

• ALICE study stopped early (n=23) for not meeting expected efficacy; 61% progressive disease at median 12 months.
• Pneumothorax occurred in 48% with chest tubes required in 8/23, indicating substantial procedure-related morbidity.

Code pair review: unlisted or unrecognized pairs may be held/denied

If the submitted procedure and diagnosis code pair is not included in this policy, the Quick Code Search may hold the request for review or result in denial; ensure code pairs are entered and any unlisted code justifications are provided.

• Enter procedure and diagnosis code pair into Quick Code Search before request submission.
• Provide clinical justification when using unlisted procedure codes to avoid automatic denial or prolonged review.

Attach device regulatory information but note clearance ≠ coverage

Include device regulatory documentation (NanoKnife clearance) and note the policy's coverage stance; device clearance alone does not establish medical necessity for specific indications.

• NanoKnife cleared via 510(k) K102329 for surgical ablation of soft tissue with indication expansion in 2024.
• Policy states device clearance does not imply coverage for specific indications; include full device details with the request.