CurrentPremera BluecrossPolicy 7.01.565

Ablation of Peripheral Nerves to Treat Pain

Defines coverage stance for radiofrequency ablation, cryoneurolysis, and chemical neurolysis of peripheral nerves to treat pain for Premera Blue Cross members; intended for providers assessing medical necessity and coding.

Policy Summary

PayerPremera Bluecross

PolicyAblation of Peripheral Nerves to Treat Pain

Policy CodePolicy 7.01.565

Change TypeNo material clinical or coverage changes

Effective DateDec 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization and submit supporting clinical documentation when requesting coverage for listed ablation procedure or device codes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

investigationalInvestigational indications

mixedGenicular evidence

multipleCoding

renumberedHistory

Coverage Criteria

Investigational/Not Covered Criteria

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Investigational statements

Enumerated investigational indications: Radiofrequency ablation to treat pain associated with knee osteoarthritis or plantar fasciitis; radiofrequency ablation to treat pain associated with occipital neuralgia or cervicogenic headache; cryoneurolysis to treat pain associated with knee osteoarthritis or total knee arthroplasty; cryoneurolysis to treat pain associated with occipital neuralgia or cervicogenic headache; chemical neurolysis (e.g., alcohol, phenol, glycerol) to treat pain associated with knee osteoarthritis or plantar fasciitis; ablation of peripheral nerves to treat pain for all other peripheral nerve pain conditions (except facet joint pain per related policies).
From Policy Coverage Criteria section.

Radiofrequency ablation (RFA), cryoneurolysis, and chemical neurolysis of peripheral nerves are considered investigational for the specific indications listed in this policy and for all other peripheral nerve pain conditions not expressly enumerated. This includes, but is not limited to, treatment of pain associated with knee osteoarthritis, plantar fasciitis, occipital neuralgia, cervicogenic headache, and other peripheral pain syndromes; facet joint pain is excluded from this investigational determination and is addressed in related policies. Investigational procedures may be denied as not medically necessary when billed for these indications.

This policy’s investigational stance reflects historical and current policy iterations that have consistently treated ablative peripheral nerve procedures (cooled RFA, cryoneurolysis/cryoablation, and RFA variants) and chemical neurolysis as investigational for the listed indications; coding and statement updates over time (including addition of CPT/HCPCS codes) do not change the investigational coverage position stated here.

The policy’s administrative history documents that ablative procedures of peripheral nerves to treat pain have been evaluated and maintained as investigational across multiple reviews. Early versions (2018 onward) consolidated investigational language for cooled RFA (e.g., COOLIEF), cryoneurolysis (cryoablation), and other RFA approaches; subsequent annual reviews and coding updates have clarified scope and added relevant CPT/HCPCS codes but have not changed the investigational determination for the peripheral indications listed in the policy. Providers should note that the policy has been renumbered and updated in history entries while preserving its core investigational statements.

Specific modality-based investigational statements in this policy include: RFA of peripheral nerves to treat pain associated with knee osteoarthritis, plantar fasciitis, occipital neuralgia, or cervicogenic headache is considered investigational. Cryoneurolysis of peripheral nerves to treat pain associated with knee osteoarthritis, total knee arthroplasty, occipital neuralgia, or cervicogenic headache is considered investigational. Chemical neurolysis (eg, alcohol, phenol, glycerol) of peripheral nerves to treat pain associated with knee osteoarthritis or plantar fasciitis is considered investigational. These modality-specific statements are part of the policy’s enumerated investigational indications and apply regardless of device or technique variant unless otherwise specified in related policies.

Coding and Billing

Covered/Listed CPT Codes (procedure devices)CPT

0441T

Ablation; percutaneous, cryoablation; includes imaging guidance; lower extremity distal/peripheral nerve

Destruction by neurolytic agent CPT CodesCPT

64620	Destruction by neurolytic agent; intercostal nerve
64624	Destruction by neurolytic agent; genicular nerve branches including imaging guidance; when performed
64632	Destruction by neurolytic agent; plantar common digital nerve
64640	Destruction by neurolytic agent; other peripheral nerve or branch

HCPCS device codesHCPCS

C9808	Nerve cryoablation probe (e.g., cryoice, cryosphere), including probe and all disposable system components
C9809	Cryoablation needle (Iovera system), including needle/tip and all disposable system components

Policy-related CPT/HCPCS codes (listed in history and coding updates)mixed

C9808	HCPCS code added to policy (new)
C9809	HCPCS code added to policy (new)
64632	CPT code added to policy
64624	CPT code (added 01/01/20; referenced in history)
64620	CPT code (added 12/01/21; referenced in history)

FDA 510(k) device clearances citedmixed

K163461	FDA 510(k) clearance number for COOLIEF Cooled Radiofrequency Probe (2017)
K163236	COOLIEF Cooled Radiofrequency Kit clearance (2016) referenced in table
K133453	iovera clearance (2014) referenced in table
K111576	NeuroTherm NT 2000 clearance (2011) referenced in table
K053082	Baylis probe clearance (2005) referenced in table

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for listed procedures and device codes. Submit supporting clinical documentation (e.g., diagnosis, prior conservative therapy details, imaging, response to diagnostic nerve block) when requesting authorization.

Prior authorization required for CPT/HCPCS codes listed in the policy (see Coding section).
Include clinical rationale and all relevant records to support medical necessity.
Failure to submit required documentation may result in delayed or denied authorization.

Prior Authorization

Prior Authorization and Coding Updates

Codes added or updated in this policy must be handled per prior authorization and billing requirements. When billing, include the correct CPT and HCPCS codes and ensure coding reflects procedures performed.

Use the most current CPT/HCPCS codes for procedures and devices.
If new codes are listed in the policy update effective 2024-12-01, follow prior authorization requirements for those codes.
Confirm coding updates with the payer if there is any uncertainty prior to claim submission.

Note

Conservative Therapy Expectation

Conservative therapy is expected prior to consideration of certain neuroablative devices. Conservative treatments include appropriate medications, physical therapy, and diagnostic/therapeutic nerve blocks as described in the Treatment section.

Conservative therapy should generally be tried and documented (e.g., topical agents, systemic medications such as gabapentin, physical therapy).
Document duration and response to conservative measures.
Document results of diagnostic nerve block(s) when applicable (e.g., ≥50% pain reduction to a diagnostic genicular nerve block for cooled RF device indications).

Documentation Required

Device Clearance Documentation

Prior to billing for device-specific procedures, document the device type and FDA clearance status when applicable. Include the device name, manufacturer, 510(k) clearance number or other FDA documentation, and how the device’s labeled indication applies to the individual.

Example: For COOLIEF devices document FDA clearance (e.g., K163461/K163236) and the indication (e.g., genicular nerve lesions for management of knee pain >6 months with radiologically-confirmed osteoarthritis and positive response to diagnostic genicular nerve block).
Include device model and any supporting FDA predicate or 510(k) documentation when relevant.
If a device is being used outside of FDA-cleared indications, clearly document the rationale; such use may be subject to denial as investigational.

Documentation Required

Coding & Documentation

Include appropriate CPT and HCPCS codes and supporting clinical documentation when submitting claims or authorization requests. Provide clear operative/procedural notes, diagnostic test results, documentation of conservative therapy, and diagnostic block responses.

Report the specific CPT procedure code(s) and HCPCS device code(s) that correspond to the service provided.
Attach operative notes, imaging reports, prior conservative therapy documentation, and results of diagnostic nerve blocks as applicable.
Claims lacking adequate coding or supporting documentation may be denied or returned for additional information.

Denial Risk

Investigational Procedures Denial Risk

Investigational procedures and uses (including ablation for indications listed as investigational in the policy) are at risk for denial as not medically necessary. Device use outside FDA-cleared indications or procedures considered investigational by this policy may be denied.

Ablation of peripheral nerves for indications listed as investigational (e.g., plantar fasciitis, knee osteoarthritis in some contexts, occipital neuralgia/cervicogenic headache) may be denied.
Use of devices without appropriate FDA clearance for the intended indication, or without required prior conservative therapy and diagnostic confirmation, increases denial risk.

Background

Radiofrequency ablation (RFA), cryoneurolysis (cryoablation), and chemical neurolysis are techniques intended to interrupt peripheral nerve pain transmission by different mechanisms. RFA uses thermal coagulation to denature neural tissue and includes variants such as standard, pulsed, and cooled RFA (cooled probes produce larger lesions while limiting thermal injury). Cryoneurolysis applies extremely cold temperatures (reported in the literature down to approximately -20 to -205°C) to induce Wallerian degeneration with expected axonal regeneration over months, producing temporary interruption of nerve conduction. Chemical neurolysis (also called chemodenervation or chemical ablation) uses injected neurolytic agents (for example, alcohol or phenol) to produce longer-lasting or permanent disruption of nerve transmission. The policy’s coverage conclusions reflect the available evidence for peripheral applications, which is heterogeneous and generally judged insufficient to support these procedures for the listed peripheral indications.

Definitions

inv-19: Cooled RFA — definition and characteristics

DefinitionA variant of nerve radiofrequency ablation that uses a water-cooled probe to deliver more energy at the target while limiting heat diffusion to surrounding tissue, creating larger lesions with less off-target thermal injury.

MechanismThermal lesioning of peripheral sensory nerves by coagulation necrosis from RF energy to interrupt pain transmission.

Clinical goalAblation of targeted peripheral sensory nerves to reduce pain by destroying nerve endings in the treated region.

Distinguishing featuresDiffers from standard and pulsed RF by use of cooling to permit larger, more controlled lesions and reduce collateral tissue damage.

inv-20: Cryoneurolysis — definition and mechanism (Wallerian degeneration)

DefinitionPercutaneous application of very cold temperatures to a peripheral nerve resulting in Wallerian (anterograde axonal) degeneration with preservation of perineural and epineural structures.

Temperature range citedTemperatures as low as -205 C have been applied in investigational use.

Regeneration timelineWallerian degeneration allows complete axonal regeneration and recovery of nerve function in about three to five months.

Device exampleThe iovera cryoablation system is a portable handheld device that delivers targeted percutaneous cold to superficial peripheral nerves.

inv-21: Chemical neurolysis — definition and agents (phenol, alcohol, glycerol)

DefinitionApplication of a chemical destructive agent to a nerve to create long-lasting or permanent interruption of neural transmission (chemical neurolysis/chemodenervation).

Agents listedPhenol, ethyl alcohol (alcohol), glycerol, or hypertonic saline are named as chemical agents used for neurolysis.

Intended useUsually used to relieve pain from peripheral nerves; proposed applications include plantar fasciitis and knee osteoarthritis.

Evidence notePublished peer-reviewed evidence for some applications (e.g., plantar fasciitis) is lacking; small observational studies exist for knee OA with limited follow-up.

inv-22: COOLIEF Cooled Radiofrequency Probe indication — device-specific indication note

Device-specific indicationThe COOLIEF Cooled Radiofrequency Probe (Avanos) was cleared by FDA (K163461) for creating RF lesions of the genicular nerves for management of moderate to severe knee pain of >6 months with conservative therapy, radiologically-confirmed OA (grade 2–4), and a >50% response to a diagnostic genicular nerve block.

Regulatory statusCOOLIEF Cooled RF Probe cleared via 510(k); related COOLIEF Cooled RF Kit clearance referenced (K163236).

Clinical prerequisites per clearance>6 months of conservative therapy including medication, radiographic confirmation of osteoarthritis (grade 2–4), and >50% pain reduction to diagnostic genicular block prior to treatment (informational).

Conservative Treatment Requirements

Conservative therapy and diagnostic genicular nerve block response (informational)

Device-specific informational requirement per FDA indication (COOLIEF cooled RF probe)

COOLIEF device indication (informational): More than 6 months of conservative therapy including medication and radiologically-confirmed osteoarthritis (grade 2–4) AND a positive response (>50% reduction in pain) to a diagnostic genicular nerve block are specified by the device FDA 510(k) clearance for the COOLIEF Cooled Radiofrequency Probe.>6 months

Informational — reflects FDA-cleared indication; policy lists this as device-specific requirement.

Frequency Limits

inv-25: Cryoneurolysis or RFA — no explicit frequency limits provided in this document portion

Policy contentThis document portion does not specify numerical limits on how often cryoneurolysis or radiofrequency ablation may be repeated.

ImplicationNo explicit frequency or interval restrictions for repeat procedures are provided in the cited sections; clinical trials and technical parameters vary.

Clinical noteTechnical uncertainties (e.g., optimal number of applications, duration of treatment) are described and unresolved in the evidence base.

Imaging and Diagnostic Requirements

Note

Genicular RFA/cryoneurolysis — imaging guidance not specified

Imaging guidance requirements for genicular RFA or cryoneurolysis are not specified in this policy excerpt; the optimal guidance method (fluoroscopy vs ultrasound vs landmark) is unresolved.

Document the guidance method used (fluoroscopy, ultrasound, or anatomic landmarks) in the procedure note, since trials have used different techniques.
If a payer requests specifics, cite trial methodology or institutional protocols to support chosen guidance method.

Documentation Required

Genicular nerve ablation (per device indication) — radiograph confirming OA grade 2–4 required

Per the COOLIEF device indication, document radiographic confirmation of knee osteoarthritis grade 2–4 when performing genicular nerve ablation intended under that device's indication.

Include a radiograph report showing OA grade 2–4 in the medical record.
Also document the diagnostic genicular nerve block response (>50% pain reduction) when applicable to the device indication.

Not Covered / Exclusions

The following peripheral indications are described in the policy as investigational and therefore not covered: knee osteoarthritis (RFA, cryoneurolysis, chemical neurolysis), plantar fasciitis (RFA, chemical neurolysis), occipital neuralgia (RFA, cryoneurolysis), cervicogenic headache (RFA, cryoneurolysis), and intercostal neuralgia. The policy also states that ablation of peripheral nerves to treat pain is considered investigational for all other peripheral conditions not specifically listed (with the exception of facet joint pain, which is addressed in related policies). Providers should expect investigational determinations and potential claim denial when these procedures are billed for these indications.

Policy Summary

PayerPremera Bluecross

PolicyAblation of Peripheral Nerves to Treat Pain

Policy CodePolicy 7.01.565

Change TypeNo material clinical or coverage changes

Effective DateDec 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization and submit supporting clinical documentation when requesting coverage for listed ablation procedure or device codes.

SourceLink

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