Cryoanalgesia and Therapeutic Cold
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This policy governs the medical necessity and coverage stance for cryoanalgesia and therapeutic cold devices and procedures, specifying covered indications (e.g., trigeminal neuralgia, perioperative cryoanalgesia for Nuss/Ravitch, and certain passive cold compression DME) and investigational or not covered uses.
No material clinical or coverage changes in this revision.
Coverage Determinations and Evidence Summary
Coverage and Experimental/Investigational
Aetna considers the following medically necessary or experimental/investigational:
See Appendix for TN selection criteria.
Lists examples and device models.
Cryoanalgesia for pectus excavatum (Nuss/MIRPE)
Evidence and outcomes reported in the literature (informational):
Level of Evidence includes I-II-III across studies
Intra-operative cryoanalgesia for tonsillectomy
Systematic review findings:
Trials used cryotherapy probe or ice-water cooling
Cold therapy units and hot/ice machines
Cold therapy device evidence summary:
Document cites lack of evidence for superiority of complex active units
Evidence-based indications and limitations
Evidence-summary based stance for specific indications
See systematic review Raggio et al (2018).
Cooper et al (2018).
Kvarstein et al (2019).
Concussion management — investigational/limited evidence
Selective head–neck cooling (concussion) evidence and regulatory status
Gard et al (2021), Congeni et al (2022), Al-Husseini (2022).
TecTraum/pro2cool status described in document.
Cryoneurolysis for post-operative and cancer pain — preliminary evidence
Percutaneous cryoneurolysis for post-operative and cancer pain
Gabriel et al (2020).
Parrado et al (2019).
Filippiadis et al (2021).
Trigeminal neuralgia — medically necessary criteria
Selection criteria for cryoanalgesia in trigeminal neuralgia
Repeat cryoanalgesia may be medically necessary every 6 months.
The policy lists several specific indications and device categories as experimental/investigational and therefore not established for routine coverage. Examples include cryo neurolysis for abdominal pain related to pancreatic cancer, peripheral neuropathic pain, phantom limb pain, post-herpetic neuralgia, and intra‑operative or post‑operative cryoanalgesia for post‑thoracotomy or post‑tonsillectomy pain. Also designated investigational are devices that deliver both hot and cold therapy and passive cold compression units for indications other than those explicitly listed as medically necessary.
Available studies do not demonstrate that complex active cold therapy systems with mechanical pumps or refrigeration confer additional clinical benefit compared with simpler passive devices such as the Cryo/Cuff or conventional ice packs. The document states there is no evidence that these more complicated cold therapy units provide any additional benefit over the CryoCuff or conventional ice bags or packs, and notes alignment with Medicare DME MAC policy regarding mechanical cold therapy pumps.
The policy identifies several devices or device families that currently lack adequate evidence of safety and effectiveness or FDA marketing clearance for the listed indications. Examples called out include Kinex ThermoComp and VascuTherm2 (solid‑state continuous cold/compression systems) and other combinations of heating/cooling systems referenced in the scope (e.g., Aqua Relief System, ThermoPlus). Use of such devices for the described pain indications is considered investigational pending stronger evidence or regulatory authorization.
Many of the clinical reports and series cited in the policy have methodological limitations that restrict generalizability. Common limitations include uncontrolled or unblinded designs, small sample sizes, single‑center or retrospective cohorts, and heterogeneity in patient selection and procedural technique. The policy therefore cautions that preliminary positive findings should be interpreted carefully and validated in randomized, adequately powered, and well‑controlled studies before broad adoption.
This Clinical Policy Bulletin is developed to assist in the administration of plan benefits and is not an offer of coverage or medical advice. It provides a general summary of clinical evidence and coverage stance and does not constitute a contract; treating providers retain responsibility for clinical care decisions.
The policy explicitly lists applications of therapeutic hypothermia and intra‑brain cooling that are not supported for routine use, including therapeutic induction of intra‑brain hypothermia (e.g., pro2cool), prophylactic hypothermia for traumatic brain injury, and therapeutic hypothermia for hemorrhagic stroke. These techniques are considered not established for the specified neurologic indications.
Continuous cold therapy systems or Hot/Ice Machines have not been shown consistently to provide superior postoperative outcomes compared with standard cryotherapy (ice packs) or simpler passive units. The policy cites studies that failed to demonstrate consistent benefit and notes that routine use of continuous cold or Hot/Ice Machines for all post‑operative patients is not supported by the available data.
Large randomized evidence does not support early prophylactic hypothermia for severe traumatic brain injury. The POLAR‑RCT (n=511) found no improvement in 6‑month neurologic outcomes with early prophylactic hypothermia compared with normothermia, and therefore early routine prophylactic hypothermia for severe TBI is not recommended.
A double‑blind RCT of occipital cryoneurolysis for cervicogenic headache (n=52) demonstrated substantial but transient pain reductions that were not statistically different from corticosteroid plus local anesthetic injections. The authors concluded occipital cryoneurolysis may be considered only after positive diagnostic blocks and when less invasive therapies have been insufficient, and they raised concerns about potential local scar or neuroma formation with repeated procedures.
CPT, HCPCS, and ICD-10 Codes
| 0440T | Ablation, percutaneous, cryoablation, includes imaging guidance; upper extremity distal/peripheral nerve. |
| 0441T | Ablation, percutaneous, cryoablation, includes imaging guidance; lower extremity distal/peripheral nerve. |
| 0442T | Ablation, percutaneous, cryoablation, includes imaging guidance; nerve plexus or other truncal nerve (eg, brachial plexus, pudendal nerve). |
| 0776T | Therapeutic induction of intra-brain hypothermia, including placement of a mechanical temperature-controlled cooling device to the neck over carotids and head, including monitoring (eg, vital signs and sport concussion assessment tool 5 [SCAT5]), 30 minutes of treatment. |
| 64605 | Destruction by neurolytic agent, trigeminal nerve; second and third division branches at foramen ovale. |
| 64640 | Destruction by neurolytic agent; other peripheral nerve or branch. |
| 19301-19307 | Mastectomy. |
| 21740-21743 | Reconstructive repair of pectus excavatum or carinatum. |
| 27447 | Arthroplasty, knee, condyle and plateau; medial AND lateral compartments with or without patella resurfacing. |
| 27486-27487 | Revision of total knee arthroplasty, with or without allograft; 1 component (27486) and femoral and entire tibial component (27487). |
| 64400 | Injection, anesthetic agent; trigeminal nerve, any division or branch. |
| 64420 | Intercostal nerve, single. |
| 64421 | Intercostal nerves, multiple, regional block. |
| A9273 | Hot water bottle, ice cap or collar, heat and/or cold wrap, any type. |
| E0217 | Water circulating heat pad with pump. |
| E0218 | Water circulating cold pad with pump. |
| E0236 | Pump for water circulating pad. |
| E0249 | Pad for water circulating heat unit. |
| E0650 | Pneumatic compressor; non-segmental home. |
| E0651 | Pneumatic compressor, segmental home model without calibrated gradient pressure. |
| E0652 | Pneumatic compressor, segmental home model with calibrated gradient pressure. |
| E0671 | Segmental gradient pressure pneumatic appliance; full leg. |
| E0673 | Segmental gradient pressure pneumatic appliance, half leg. |
| G50.0 | Trigeminal neuralgia. |
| G54.6 | Phantom limb syndrome with pain. |
| M17.0-M17.9 | Osteoarthritis of knee. |
| R52 | Pain, unspecified. |
Authorization, Documentation, and Provider Requirements
Prior Authorization Alignment and Guidance
Prior authorization may be required for certain devices or procedures referenced in this policy. Aetna’s approach to mechanical cold therapy pumps is aligned with Medicare DME MAC policy; prior authorization requirements and coverage determinations for these devices will follow that guidance. Prior authorization may also be required for home therapeutic cold devices or novel head–neck cooling systems that lack sufficient evidence or FDA clearance.
- Prior authorization follows Medicare DME MAC policy for mechanical cold therapy pumps.
- Active cold units with mechanical pumps and combined heat/cold devices may require prior authorization and are generally considered experimental/investigational for many indications.
Trigeminal Neuralgia: Selection Criteria and Repeat Interval
For cryoanalgesia to treat trigeminal neuralgia, members must meet selection criteria: symptoms present for at least 6 months and a documented trial of, and failure of, appropriate pharmacotherapies (e.g., carbamazepine, baclofen, phenytoin) or documented intolerance to them. Repeat cryoanalgesia may be considered medically necessary no more often than every 6 months.
- Pain duration ≥ 6 months.
- Documented trial and failure of, or intolerance to, pharmacotherapies (e.g., carbamazepine, baclofen, phenytoin).
- Repeat treatments: minimum 6-month interval between procedures.
Evidence-Based Coverage Implication for Mechanical Cold Therapy Pumps
Active cold therapy pumps and more complicated circulating units have not been shown to provide added clinical benefit over passive cold compression therapy. As a result, claims for active cold units with mechanical pumps or combined heat/cold systems may be considered experimental/investigational or not covered for many indications.
- Mechanical circulating units with pumps lack evidence of superiority to passive hot/cold therapy.
- Examples of active/complex systems: IceMan, Game Ready, AutoChill, BioCryo, VPULSE, Hilotherm.
Evidence and Safety Risks
Use of devices or procedures without adequate clinical evidence or demonstrated safety/effectiveness may be unsupported and subject to denial. Documented clinical rationale, relevant evidence, and justification for use of novel or less-established devices should be provided when seeking coverage.
- Devices lacking peer-reviewed evidence of safety/effectiveness carry increased denial risk.
- Provide clinical rationale and cite supportive literature when requesting coverage for novel devices.
Regulatory Status Risk
When a device is not cleared or authorized by the FDA for the requested indication, lack of regulatory clearance increases the risk that coverage will be denied. The pro2cool system (example) was not cleared by the FDA at the time of documentation and lacks market authorization, which should be noted in submissions.
- If device is not FDA-cleared for the indication, include rationale and supporting evidence; coverage may be denied.
- Example: pro2cool lacked FDA marketing authorization at the time of the referenced documentation.
No Additional Explicit Prior Authorization or Denial Triggers
There are no additional explicit prior authorization requirements or automatic denial triggers specified beyond those described above; determinations will be made based on the clinical indications, evidence, and existing coverage rules.
- Absence of an explicit PA requirement in this section does not preclude case-by-case review.
- Providers should verify member-specific benefits and PA rules.
Clinical Documentation and Evidence
Submit comprehensive clinical documentation to support the medical necessity of devices or procedures. Include the clinical rationale, prior conservative therapies tried, diagnostic test results, and citations to relevant peer-reviewed evidence when applicable.
- Document clinical rationale and reference supporting evidence or literature.
- Include prior conservative treatments and results of diagnostic/test blocks when applicable.
Required Documentation
Required documentation must be included with requests or claims: device model and manufacturer, indication for use, detailed treatment parameters (e.g., temperature, duration, compression settings), and FDA clearance status when applicable.
- Device model and manufacturer.
- Indication and clinical rationale.
- Treatment parameters (temperature, duration, compression settings).
- FDA clearance/authorization status if applicable.
Required Clinical Documentation
Include the following clinical details in chart notes and prior authorization submissions when relevant: indication (e.g., cervicogenic headache, occipital neuralgia, peripheral neuropathic pain, pre-op for TKA), results of diagnostic or prognostic test blocks, prior treatments and responses, and anticipated benefit.
- Clearly state the indication (diagnosis code) and how selection criteria are met.
- Provide results of diagnostic blocks or other objective assessments.
- List prior therapies and response/tolerance.
- Describe expected benefit and treatment plan.
Policy References and Administrative Information
This section of the policy contains references, policy history, and administrative information. Providers should consult the policy history and related policy links for updates and confirm the effective date and next review date when interpreting coverage.
- Effective date: 1998-10-13; Next review date listed in policy header.
- Review policy history and related CPBs for context and updates.
Step Therapy Consideration
Step therapy considerations: when evidence is limited for a procedure (e.g., occipital cryoneurolysis), consider requiring less invasive or more established diagnostic/therapeutic steps first (for example, diagnostic nerve blocks or conservative medical management) prior to approving cryoneurolysis.
- Recommend diagnostic/test blocks and conservative therapies before approving cryoneurolysis for cervicogenic headache or occipital neuralgia.
- Document responses to these prior steps in the medical record.
Clinical Background and Definitions
Active cold compression therapy units that incorporate mechanical pumps or refrigeration (for example, Game Ready, Breg Polar Care Cube, and similar systems) are listed as not covered for the indications described in the policy. The policy also lists devices that deliver both hot and cold therapy and other named systems in the scope as investigational or excluded from routine coverage for the listed pain and postoperative uses.
Prior Treatments and Diagnostic Requirements
Failure or intolerance of medications required prior to cryoanalgesia.
Failure or intolerance of medications required prior to cryoanalgesia.
See Appendix selection criteria; repeat procedures may be considered every 6 months.
Treatment Frequency and Repeat Intervals
Imaging and Procedural Guidance
Imaging Guidance for Percutaneous Cryoablation Codes
Imaging guidance is implied or required by CPT descriptions for percutaneous cryoablation codes (0440T–0442T); use imaging as documented in code descriptions when performing percutaneous cryoablation.
- Ensure procedural documentation includes the imaging modality used consistent with code descriptors.
Technical Notes — Intra-operative Cryoanalgesia for Nuss
Intra-operative cryoanalgesia for the Nuss procedure uses thoracoscopic transthoracic or modified probe techniques; providers should follow the procedural methods described in the literature when performing these intra-operative techniques.
- Techniques described include probe modification (insulation) to allow ipsilateral nerve ablation and approaches that avoid additional thoracoscopic ports.
CT Guidance for Splanchnic Nerve Cryoneurolysis
Percutaneous cryoneurolysis of the splanchnic nerves in reported series was performed under CT guidance; document imaging modality when claiming these procedures.
- Report use of CT guidance and procedural details (posterolateral paravertebral approach, cryoprobe gauge).
Ultrasound Guidance for Intercostal Cryoneurolysis
Ultrasound guidance was used for percutaneous intercostal nerve cryoneurolysis in reported mastectomy case reports; document use of ultrasound if applicable.
- Include US-guided localization technique and outcomes in procedural documentation.
Imaging Guidance for Percutaneous Cryoneurolysis
When percutaneous cryoneurolysis is performed in study protocols or for improved accuracy, use and document appropriate imaging guidance (ultrasound or CT) as reported in the literature.
- Document imaging modality, localization technique (nerve stimulation/US), and procedural parameters in the record.
Imaging Note — Intraoperative Intercostal Cryoablation
References describing intraoperative intercostal cryoablation techniques for thoracic procedures do not specify imaging requirements in the cited excerpts; follow institution-specific standards and document the approach used.
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