Prior authorization required for covered CPT/HCPCS when criteria apply

Selected CPT/HCPCS codes in this policy are covered only when the applicable medical necessity selection criteria are met; use of these codes may require verification of medical necessity or prior authorization before payment. Submit documentation that demonstrates the patient meets the policy's indication-specific criteria when requesting authorization for the listed procedure codes.

• Covered CPT codes are conditional on meeting the policy's selection criteria (see covered indications and size/count thresholds).
• Verification of medical necessity/prior authorization is advised prior to scheduling when coverage depends on policy criteria.

Verify code-specific coverage prior to authorization

Providers should verify coverage for the specific CPT/HCPCS and ICD-10 codes to be used prior to authorization or scheduling; certain CPT/HCPCS and ICD-10 ranges are called out in the policy as not covered for the indications listed and use of those codes may trigger denial.

• Reference the policy's code lists — some CPT/HCPCS codes are 'not covered for indications listed' and multiple ICD-10 malignant neoplasm ranges are listed as not covered for the indications in this CPB.
• Confirm code-specific coverage and whether prior authorization is required before performing the procedure.

Indication and lesion size must be documented for authorization

Prior authorization submissions must document the treated lesion’s indication and size — the policy restricts renal/adrenal masses to approximately ≤4 cm and notes size thresholds for other indications; authorization decisions will consider these size limits.

• Renal mass and adrenal gland indications: tumor size up to 4 cm is specified in the policy.
• Provide lesion location and maximal diameter as part of the request to demonstrate alignment with the policy thresholds.

Document prior therapy attempts or inoperability rationale

When conventional definitive therapy is available, prior authorization should include documentation of prior therapies attempted or a clear rationale why conventional therapy is not possible (for example, prior endoscopic resection/chemoradiation for esophageal cancer or inoperability/comorbidity indices for lung cancer).

• Document prior treatments and reasons for failure or contraindication to standard therapies.
• Include comorbidity scores or other evidence of inoperability when surgery is being declined due to risk.

Multidisciplinary review recommended for complex combined procedures

For complex combined procedures (e.g., combined cryoablation and cementoplasty for large pelvic metastases), providers should document that the case was reviewed by a multidisciplinary conference or tumor board prior to referral for the combined intervention.

• Include evidence of multidisciplinary review (participants, date, and consensus recommendation) in the authorization record.
• Explain why combined procedure is indicated and why alternative treatments are not appropriate.

Prior authorization requirements for PNN cryoablation: prior medical therapy and baseline rTNSS

Prior authorization for posterior nasal nerve (PNN) cryoablation should document prior medical management failure (minimum 4 weeks of intranasal corticosteroids per trial inclusion) and include baseline symptom scoring (e.g., rTNSS) and the intended target nerve region.

• Document failure of at least 4 weeks of intranasal corticosteroids as part of the prior medical therapy history.
• Include baseline rTNSS and planned target (PNN) in the authorization request; provide expected responder criteria if available.

Document multidisciplinary review and prior therapy for combined cryoablation + cementoplasty

When requesting authorization for combined cryoablation plus cementoplasty for large pelvic bone metastases, document multidisciplinary tumor-board review and prior failure or contraindication to surgical management or standard palliation.

• Include documentation that the patient was referred after formal multidisciplinary conference review.
• Document prior pain management attempts and rationale for choosing combined cryoablation and cementoplasty (e.g., lesion ≥5.0 cm, refractory pain).

Document prior therapies and treatment intent

Authorization requests should record prior therapies and the treatment intent (first-line vs salvage; curative vs palliative) because studies and appropriateness assessments relied on these distinctions when evaluating outcomes.

• State whether the procedure is intended as curative or palliative.
• List prior systemic, surgical, radiation, and local therapies with dates and outcomes.

Authorization must state lesion number and maximal diameter

Prior authorization must reflect lesion count and maximal lesion diameter for metastatic indications — studies enrolling pulmonary metastasis patients used explicit limits (e.g., 1–6 or 1–5 metastases and maximal diameters up to ~3.5 cm) and authorization should match those parameters.

• Provide number of lesions and the largest lesion’s diameter when requesting authorization for pulmonary metastasis cryoablation.
• Indicate performance status and whether the intent is oligometastatic-directed therapy or palliative symptom control.

Prior authorization for pulmonary metastasis cryoablation: tumor count, size, and performance status

For pulmonary metastasis cryoablation, prior authorization should include tumor count and maximal diameter (studies enrolled patients with up to 3.5 cm lesions and limited lesion counts) plus prior therapies and performance status to align with published trial inclusion criteria.

• Include the planned number of metastases to be treated and the maximal diameter of each lesion.
• Document prior systemic therapies and current ECOG/Karnofsky performance status.

Prior authorization for renal mass ablation: tumor and patient characteristics

When requesting authorization for percutaneous renal mass cryoablation, provide tumor characteristics (size, imaging visibility), patient comorbidities (e.g., GFR), and the clinical rationale for ablation versus partial nephrectomy because guidelines reserve ablation for those in whom complete ablation can be achieved and who are often higher surgical risk.

• Report tumor maximal diameter (policy specifies up to 4 cm for renal masses) and biopsy results if available.
• Provide patient's GFR and evidence of high surgical risk or solitary kidney status when applicable.

Document trial-derived clinical eligibility elements with authorization

Authorization requests for investigational or study-like indications should include the clinical eligibility elements used in trials (for example, ICE3 and meta-analyses for breast cryoablation specify tumor size limits and receptor status); document that the patient meets those trial-derived eligibility criteria when applicable.

• For breast cryoablation contexts, include tumor size, receptor status, and age criteria when claiming alignment with trial eligibility.
• Provide supporting pathology and imaging to show eligibility parallels to published cohorts.

Document eligibility for FDA-authorized breast cryoablation (ProSense)

For FDA-authorized ProSense breast cryoablation, authorization should document that the patient meets the device labeling/authorization criteria (age and biologically low‑risk tumor features) and that adjuvant endocrine therapy is planned as required by the authorization.

• Document patient age (≥70 per premarket authorization) and tumor biology (unifocal ≤1.5 cm, ER+/PR+, HER2-, Ki‑67 <15% or equivalent genomic risk profile).
• Indicate planned adjuvant endocrine therapy in the treatment plan.

Prior authorization suggested for metered cryospray in chronic bronchitis

For metered cryospray (MCS) or other chronic bronchitis cryotherapy, prior authorization may require documentation of persistent symptoms despite optimal medical therapy and adherence to the treatment protocol used in studies (three treatments spaced 4–6 weeks), including baseline and follow-up PROs.

• Document failure of optimal medical therapy for chronic bronchitis and symptom burden despite therapy.
• Indicate planned MCS treatment schedule consistent with studied protocols (three sessions 4–6 weeks apart) and provide baseline SGRQ/CAT/LCQ scores.

Reference sections contain no additional prior authorization specifics

The policy lists certain reference sections only; these reference chunks do not themselves specify prior authorization requirements — verify other policy sections for applicable authorization steps.

• Reference sections contain citations and background only and do not define prior authorization processes.
• Use the policy's prior authorization and coding sections for actionable requirements.

Renal mass permissions: cryoablation allowed for masses ≤4 cm with listed criteria

Cryoablation of renal masses is permitted when the mass is ≤4 cm and the listed renal criteria are met (high‑risk surgical candidate, GFR ≤60 mL/min/1.73 m2, or solitary kidney); authorization should reflect those size and clinical thresholds.

• Policy explicitly states renal mass cryoablation is medically necessary for masses up to 4 cm when one of the renal criteria is met.
• Include GFR, solitary kidney status, or high surgical‑risk documentation with authorization.

Consideration of standard surgical options before approving renal ablation

Authorization reviewers should confirm that standard surgical options (partial nephrectomy) were considered or that the patient is not a suitable surgical candidate before approving ablation for small renal masses.

• Document whether partial nephrectomy was considered and the rationale for selecting ablation instead.
• When active surveillance is chosen, document reasons (comorbidities, limited life expectancy) supporting that approach.

Surgical excision preferred for fit patients; document reasons for ablation

Policy notes that for stage I kidney tumors surgical excision is preferred for patients in satisfactory condition; cryoablation may be appropriate for elderly or infirm patients or when surveillance is chosen, so provide documentation of operative risk or patient preference when seeking authorization.

• Include documentation of patient fitness for surgery or reasons surgery is declined.
• State whether surveillance, ablation, or surgery is being pursued and why.

Stepwise therapy considerations: document prior standard treatments or contraindications

Prior authorization reviewers may expect stepwise therapy documentation: cryoablation is often applied after failure of conventional therapy or for medically inoperable patients, so include prior/concurrent standard‑of‑care attempts where relevant.

• For indications where conventional therapy exists, document prior unsuccessful standard treatments or contraindications.
• For PNN and chronic rhinitis, document prior medical therapy courses and their duration/outcomes.

Document failure of medical therapy (≥4 weeks INCS) before PNN cryoablation

Studies of posterior nasal nerve cryoablation required prior failure of at least 4 weeks of intranasal corticosteroids; authorization for PNN procedures should include documentation of that medical therapy failure.

• Document duration and response to intranasal corticosteroids and other nasal medications.
• Provide baseline symptom scores (rTNSS) to support medical necessity.

Step therapy consideration: require documentation of failed standard medical therapies for chronic rhinitis

Consider requiring prior use of and inadequate response to standard medical therapies for chronic rhinitis before approving cryotherapy procedures; include trial documentation in the authorization record.

• List medications tried (intranasal corticosteroids, ipratropium, antihistamines) and treatment durations/outcomes.
• Attach baseline and follow-up PRO scores where available.

Conventional surgical options should be considered before liver metastasis cryoablation

For hepatic metastases or liver cryotherapy requests, document that conventional surgical options were considered; the Cochrane review found insufficient evidence to support routine first‑line use of cryotherapy for liver metastases.

• Include documentation of multidisciplinary discussion and rationale if considering cryoablation for hepatic metastases.
• State why surgery or other standard approaches are not feasible or were unsuccessful.

Modality selection should consider prior therapies and multidisciplinary input

Selection among ablation modalities should take prior therapies into account (e.g., prior radiation) and involve multidisciplinary input; document prior local and systemic therapies when requesting approval.

• Provide history of prior radiation, systemic therapy, and any prior ablation attempts.
• Document multidisciplinary discussions influencing modality selection.

Stepwise management for small renal masses: document consideration of surveillance and partial nephrectomy

When considering cryoablation for small renal masses, include documentation that alternative conservative management (active surveillance) or partial nephrectomy were considered and why ablation is chosen given patient fitness and tumor characteristics.

• State why partial nephrectomy is not suitable or why surveillance is inappropriate for the individual patient.
• Include biopsy results when they may change management decisions.

Documentation must support selected indication and size/clinical criteria

Clinical documentation supporting authorization must demonstrate that the selected medically necessary indication and any stated size or clinical criteria (e.g., lesion size ≤4 cm; GFR threshold) are met.

• Attach imaging reports showing lesion size and location.
• Include relevant laboratory values (e.g., GFR) and pathology when available.

Imaging and biopsy documentation required to support technical success and follow-up

Provide contrast-enhanced CT or MRI imaging to document baseline lesion characteristics and, when indicated, consider biopsy when results may alter management; absence of contrast enhancement post‑ablation is used to define radiographic success in many series.

• Include pre-procedure contrast-enhanced imaging demonstrating lesion size and suitability for ablation.
• Post-procedure imaging (CE‑MRI or CT) and, when performed in studies, biopsy results demonstrating absence of viable tumor should be included in follow-up documentation.

Document post-procedure follow-up imaging and biopsy when performed

Post-procedure follow-up imaging (contrast-enhanced MRI or CT) should be documented to define radiographic success; some investigators recommend follow-up biopsy in specific circumstances to confirm absence of viable tumor.

• Report timing and findings of post-ablation contrast-enhanced imaging (commonly at ~1 month and then periodically per study protocols).
• When biopsy is performed to confirm ablation, include pathology results in the medical record.

Procedure and clinical baseline documentation required

Authorization and medical records should include procedural and baseline clinical details: tumor stage, imaging guidance used, prior treatments, comorbidity status (e.g., Charlson index), and pulmonary function when relevant for thoracic procedures.

• Provide pre-procedure performance status (ECOG/KPS), comorbidity indices, and pulmonary function test results when applicable.
• Describe imaging guidance modality and number/type of cryoprobes planned or used.

Document multidisciplinary review and non‑surgical candidacy for large pelvic metastasis procedures

For patients undergoing non-surgical interventions such as combined cryoablation and cementoplasty for large pelvic metastases, document multidisciplinary review confirming non‑surgical candidacy and the reasons surgery is not an option.

• Include tumor board notes describing deliberations and consensus.
• Attach documentation demonstrating that the patient was judged not to be a surgical candidate.

Required clinical documentation: baseline and follow-up symptom scores for PNN/chronic rhinitis

Authorization requests should include baseline and follow-up validated symptom scores (e.g., rTNSS, RQLQ, NOSE) and prespecified responder definitions for PNN or other symptom-focused cryoablation indications.

• Include baseline rTNSS and planned follow-up intervals and responder criteria (e.g., ≥30% rTNSS reduction at 90 days in RCTs).
• Provide documentation of adverse events and medication usage changes in follow-up.

Procedure and outcome documentation: include lesion, anesthesia, complications, and short‑term control

Document procedural details and outcomes when submitting claims for pulmonary or adrenal cryoablation, including lesion size, number, primary tumor type, performance status, anesthesia used, immediate complications (e.g., pneumothorax and whether chest tube/pleural catheter was required), and short‑term local control outcomes.

• Report occurrence and management of pneumothorax and other immediate complications.
• Provide short-term local control data (e.g., imaging results at 6–12 months) when available.

Document follow-up imaging schedule and results used to assess local control

Follow-up imaging intervals and content used in clinical series should be documented (for pulmonary metastases studies, CT at ~1 month and then every 3–4 months was used to assess local control); include this follow-up schedule and results when available.

• State the follow-up imaging modality and schedule used for the patient.
• Include results of each follow-up imaging encounter to support claims of local control or need for retreatment.

Include trial-relevant lesion counts and size limits when applicable

Clinical trial inclusion criteria commonly used in cryoablation studies (e.g., 1–6 pulmonary metastases, maximal diameter ≤3.5 cm) are useful guides for documentation; include these elements in authorization requests when invoking trial‑based evidence.

• When relying on trial evidence, specify how the patient meets the trial's lesion count and size eligibility.
• Provide ECOG/KPS and other trial‑relevant baseline measures if available.

Documentation for renal masses: biopsy and rationale for ablation vs surveillance/surgery

For small renal masses, include biopsy results when they may alter management decisions and document consideration of active surveillance in patients with significant comorbidities or limited life expectancy.

• Attach biopsy pathology if obtained and state whether results influenced treatment choice.
• Document rationale for ablation versus surveillance or partial nephrectomy.

Document patient selection criteria and procedural details referenced in studies

Studies and series emphasize patient selection criteria (age, tumor size, histologic features, prior treatments) — document these patient-specific factors and procedural details when requesting authorization so reviewers can assess alignment with published evidence.

• Provide age, tumor histology, receptor status (for breast), and prior treatment history in the authorization packet.
• Include procedural details such as number of freeze cycles and imaging follow‑up plan.

Document prior therapy and outcome measures for chronic bronchitis / MCS protocols

Providers should document completion of prior optimal medical therapy and outcome measures for chronic bronchitis/MCS protocols (completion of serial MCS treatments and baseline/follow-up PROs) when requesting authorization or submitting claims.

• Indicate whether the patient completed three MCS treatments and provide SGRQ/CAT/LCQ baseline and follow-up scores.
• Document adverse events and any reasons for incomplete treatment if applicable.

Use of 'not covered' CPT/HCPCS codes may trigger denial

Use of CPT/HCPCS codes that are designated 'not covered' for the policy’s listed indications may trigger claim denial; confirm the correct code group and coverage status before billing.

• Do not submit claims using codes listed as 'not covered for indications listed' in the policy for those indications.
• If uncertain, verify coding guidance with the payer prior to submission to avoid denials.

Not-covered ICD-10 malignant neoplasm ranges — risk of denial

The policy enumerates malignant neoplasm ICD-10 ranges (e.g., C00–C80.2 and related ranges) that are noted as 'not covered for indications listed' in this portion of the document; using ICD-10 codes within these ranges for the listed indications could result in denial.

• Verify that the diagnosis code you plan to bill is included in the policy’s covered ICD-10 list for the specific cryoablation indication.
• Avoid using ICD-10 codes listed as not covered for the policy’s indications to reduce claim denials.

Risk of denial for renal tumor size outside ~4 cm limit

Cryoablation for renal tumors outside the policy's recommended size limits (approximately >4 cm) lacks supportive evidence in the document; authorization for larger renal masses may be unsupported and risk denial.

• Provide strong justification and multidisciplinary review documentation if proposing ablation for renal tumors >4 cm, understanding this may be outside typical policy permissions.
• Include imaging and rationale demonstrating why alternative options are not feasible.

Incomplete treatment or follow‑up may adversely affect authorization

Incomplete courses of treatment or incomplete follow-up (as occurred in some series) may limit evidence of benefit and could affect authorization for repeat or continued procedures; include documentation of completed treatment regimen and follow-up where applicable.

• If prior series were not completed or follow-up was incomplete, explain how the current plan ensures adequate completion and follow-up.
• Attach records of completed prior treatments and follow-up imaging or symptom assessments.

Guideline divergence (e.g., metastases) may increase denial risk

Lack of guideline support for certain uses (for example, cryoablation of metastases in the NCCN kidney cancer guideline) may lead to higher scrutiny or denial for those metastatic indications; document multidisciplinary rationale and evidence when seeking approval.

• Provide guideline references and an explanation of why cryoablation is being considered despite limited guideline endorsement.
• Include tumor board recommendations and patient-specific considerations supporting the approach.

Durability evidence limitations may affect coverage decisions

Insufficient long‑term durability or limited follow-up in the evidence base may lead to coverage denial where long-term benefit is required; provide available long-term outcomes or a plan for surveillance when requesting authorization.

• When citing trial evidence, include available follow-up duration and relevant long‑term outcome data.
• If long-term data are limited, clarify how follow-up will be performed and reported.

Insufficient evidence for hepatic metastases — may lead to denial

A Cochrane review concluded there is insufficient evidence to determine benefit of cryotherapy for liver metastases compared with conventional surgery; authorization for hepatic metastasis cryoablation may therefore be denied or given higher scrutiny.

• Provide justification and multidisciplinary documentation if considering cryoablation for hepatic metastases given lack of supportive comparative evidence.
• Consider alternative standard treatments and document why they are unsuitable for the patient.

Combined-procedure evidence limitations — document rationale to support authorization

Findings from combined-procedure series (e.g., cryoablation plus cementoplasty) may be confounded by the combined intervention and retrospective designs; document the rationale, expected benefit, and multidisciplinary consensus when requesting authorization for combined approaches.

• Explain how the combined approach is expected to benefit the patient beyond single‑modality therapy.
• Attach tumor board notes and evidence supporting the combined intervention in similar clinical scenarios.

Complication documentation (e.g., pneumothorax) required — complications may affect coverage

Document and manage common procedural complications (e.g., pneumothorax requiring chest tube or pleural catheter) and include their occurrence and management in the medical record, as complications can impact post‑procedure coverage decisions.

• Report any pneumothorax, whether chest tube or pleural catheter was required, and include related inpatient or outpatient management notes.
• Include documentation of complication resolution to support ongoing coverage.

Contraindicated proximity to critical structures (within 1 cm) — do not request ablation

Ablative techniques are contraindicated when a tumor is located within 1 cm of critical structures (such as the spinal cord, major nerves, or major vessels); in such situations do not request authorization for cryoablation and document the contraindication.

• Include imaging demonstrating lesion distance from critical structures; if <1 cm, document that ablative therapy is contraindicated.
• Provide alternative management plans if ablation is contraindicated.

Evidence limitations for some indications may lead to denial or restriction

Evidence limitations (small, nonrandomized, single-arm studies and subjective outcomes) noted for several indications (e.g., metered cryospray) may trigger coverage denial or restriction; include robust objective data and multidisciplinary justification to support authorization requests for these indications.

• Provide objective outcome measures and corroborating evidence when available.
• Document prior treatment failures and detailed justification for use in the individual patient.

Documentation must verify medically necessary indication and policy thresholds

Documentation must support that the selected medically necessary indication and any stated size or clinical criteria are met when submitting CPT/ICD codes — include lesion size, number, GFR, and other policy thresholds as applicable.

• Attach imaging reports showing lesion dimensions and number.
• Include relevant labs (e.g., GFR) and notes documenting surgical risk or solitary kidney status when claimed.

Imaging and biopsy documentation — use CE imaging and include biopsy results when performed

Provide contrast-enhanced imaging and consider biopsy documentation for pre‑ and post‑procedure assessment; many series define ablation success by absence of contrast enhancement on follow‑up imaging and used biopsy selectively to confirm outcomes.

• Include pre-procedure CE‑CT or CE‑MRI and post‑procedure CE imaging reports.
• If biopsy was performed pre- or post‑ablation, include pathology results in the record.