Currentblue cross blue shield - south dakotaPolicy 07.01.73

Ablative Procedures of the Peripheral Nerves to Treat Pain

This policy evaluates clinical evidence and coverage considerations for peripheral nerve ablative procedures (radiofrequency ablation, cryoneurolysis/cryoablation, chemical neurolysis) used to treat various chronic pain conditions; it guides Wellmark/BCBS determinations for members receiving these treatments. Affects providers performing/interpreting peripheral nerve ablation and payers adjudicating benefits.

Policy Summary

Payerblue cross blue shield - south dakota

PolicyAblative Procedures of the Peripheral Nerves to Treat Pain

Policy CodePolicy 07.01.73

Change TypeNo material changes

Effective DateJan 1, 2017

Next Review Date

Key ActionObtain prior authorization per Wellmark Authorization Table and document prior conservative therapy and outcome measures.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

insufficientOverall evidence conclusion

≥2 RCTsCryoneurolysis (knee OA)

1 RCTICN for Nuss procedure

≥11Investigational indications

183

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Coverage Criteria and Evidence Summaries

Evidence-based coverage summaries by indication

Summary of coverage-relevant evidence findings by indication (evidence mostly insufficient):

Knee osteoarthritis — RFA: Randomized and nonrandomized trials show short-term (up to 6 months) improvements in pain and function for genicular nerve RFA, with cooled RFA often ranking higher in network analyses; heterogeneity in techniques, comparators, and limited long-term blinded data leave evidence insufficient to determine net health outcomes.

Knee osteoarthritis — Cryoneurolysis: Two RCTs and additional observational studies report early improvements in pain and some perioperative benefits (reduced opioid use) for cryoneurolysis, but benefits frequently diminish by 60–90 days in some trials and long-term durability is inconsistent; evidence insufficient to confirm net health benefit.

Knee osteoarthritis — Chemical neurolysis: Evidence is limited to case series/cohort data with short-term follow-up (one cohort reported benefit to 6 months); randomized comparative evidence is lacking and net health benefit is uncertain.

Hip osteoarthritis — RFA and chemical neurolysis: Small nonrandomized studies and two double-blind RCTs of ethanol neurolysis report short-term pain reductions up to 6 months, but overall limited sample sizes and short follow-up prevent definitive conclusions about long-term benefit.

Chronic shoulder pain: Systematic reviews and small trials suggest potential benefit of RFA/PRF, but heterogeneity of techniques, concomitant therapies, and small samples limit confidence; evidence insufficient for durable net health benefit determination.

Intercostal neuralgia, peripheral neuromas, plantar fasciitis, inguinal neuralgia, orchialgia, postherpetic neuralgia: Available evidence ranges from small RCTs and case series to systematic reviews with short follow-up; isolated positive short-term findings exist (e.g., PRF for orchialgia, PRF for PHN), but overall evidence is insufficient to determine long-term effects on net health outcomes.

Intercostal nerve cryoablation for Nuss procedure: Systematic reviews, one RCT, and observational studies show reduced length of stay and lower opioid use versus thoracic epidural in many reports, but substantial heterogeneity and limitations in study quality temper the strength of conclusions; benefits for some perioperative outcomes are suggested but not definitive.

Investigational indications

Consider coverage when ALL of the following are documented:

A: Diagnosis: Symptomatic knee osteoarthritis or pain related to total knee arthroplasty (TKA)

B: Prior conservative therapy: Documented inadequate response to conservative management (eg, physical therapy, analgesics, and/or intra-articular injections) per trial comparators

C: Procedure selection and targeting: Procedure is RFA of genicular nerves (including cooled RFA) or percutaneous cryoneurolysis targeting specified nerves (eg, anterior femoral cutaneous nerve, infrapatellar branch of saphenous nerve) with documented technique and targets

ref":"b0_5","title":"Coverage consideration"},{

citations":["112","121","122","117"],"intro":"Evidence-based considerations and implications for coverage decisions","nodes":["{\"operator\":\"all\",\"n\":0,\"label\":\"Evidence summary for cryoneurolysis (knee)\",\"text\":\"Two RCTs and nonrandomized studies report early improvements (eg, WOMAC, VAS) and perioperative reductions in opioid use for cryoneurolysis, but benefits often diminish after 60–90 days in some trials and technical uncertainties remain.\",\"children\":[]}","{\"operator\":\"all\",\"n\":0,\"label\":\"Evidence summary for chemical neurolysis (knee)\",\"text\":\"Limited observational evidence (eg, a prospective cohort using glycerinated phenol) shows pain reduction up to 6 months; RCT evidence is lacking and longer-term outcomes are uncertain.\",\"children\":[]}","{\"operator\":\"all\",\"n\":0,\"label\":\"Technical uncertainties\",\"text\":\"Optimal procedural parameters (number of applications per nerve, treatment duration, thawing interval, and localization method such as ultrasound vs anatomic landmarks) are unresolved and may affect reproducibility and outcomes.\",\"children\":[]}","{\"operator\":\"all\",\"n\":0,\"label\":\"Outcome measurement and follow-up expectations\",\"text\":\"Assess procedural success within 1 month and evaluate durability with at least 1 year follow-up when possible due to transient effects and uncertain long-term anatomic consequences.\",\"children\":[]}"] ,"ref":"b0_6","title":"Evidence considerations (informing medical necessity)"},{

Trial design and outcome measurement expectations

Evidence and trial design criteria relevant to assessing clinical effectiveness and durability

Evidence quality and follow-up: Prefer randomized, double-blind, sham-controlled trials in homogenous populations using standardized outcome measures (eg, VAS/NRS, WOMAC) with minimum follow-up of 6 months and ideally 12 months to assess durability and late adverse effects.

Efficacy conclusions from systematic reviews

Comparative effectiveness evidence summaries

Efficacy findings: Systematic reviews and network meta-analyses report that RFA (including cooled RFA) improves pain and function compared with controls at short-term follow-up (3–6 months); cooled RFA often ranks higher in pooled analyses, but substantial heterogeneity limits certainty.

Trial-derived appropriateness elements (informational)

Elements commonly required or used in trials (informational evidence elements — not explicit policy mandates in this excerpt):

Trial-derived appropriateness elements: Patient with symptomatic knee osteoarthritis refractory to conservative therapy AND prior conservative measures including physical therapy, stable oral analgesics (limited opioids where specified) AND prior intra-articular injections/viscosupplementation as applicable AND BMI < 40 when specified AND documented ≥50% pain reduction to a diagnostic genicular nerve block when used

This policy may not apply to members covered under the Federal Employee Program (FEP). Providers and adjudicators should verify individual member benefits and any contract-specific exclusions or limitations before determining medical necessity or coverage for peripheral nerve ablative procedures.

The policy lists the uses below as investigational because current evidence is insufficient to establish effects on net health outcomes; services for these indications are excluded from coverage where the investigational designation applies: chronic knee pain/osteoarthritis (including pre‑ or post‑partial/total knee replacement and for non‑candidates), chronic hip pain/osteoarthritis (including pre‑ or post‑replacement and for non‑candidates), chronic orchialgia, chronic shoulder pain, inguinal neuralgia, intercostal neuralgia, peripheral neuromas, plantar fasciitis, postherpetic neuralgia, and pre‑/intra‑/postoperative pain management related to pectus (Nuss) procedures.

When considering ablative procedures in the operative context, the document notes total knee arthroplasty (TKA) as an established operative treatment for end‑stage disease; some cryoneurolysis studies were performed in the perioperative setting (e.g., administered 3–9 days before TKA) and compared perioperative outcomes such as opioid use and functional scores. Comparator contexts in trials have included sham procedures, intra‑articular steroid or hyaluronic acid injections, platelet‑rich plasma, and thoracic epidural for the Nuss procedure rather than surgery itself.

Some randomized trials used a single intra‑articular platelet‑rich plasma or hyaluronic acid injection as active comparators in genicular RFA trials; the policy highlights that the efficacy of single intra‑articular platelet‑rich plasma or hyaluronic acid as active comparators is not well supported by evidence, which limits interpretation of comparative results.

Evidence for cryoanalgesia devices (for example, the iovera® system) is inconsistent. Key uncertainties reported include the optimal timing of treatment relative to surgery, the specific target nerves to treat, and the appropriate freeze duration and number of freeze cycles required for efficacy; these unresolved technical issues limit confidence in generalizability of trial results.

There is no consensus on which peripheral nerves should be targeted for cryoneurolysis, the required freeze duration, or the number of freeze cycles to use. The document also notes an absence of studies directly comparing cryoneurolysis versus standard‑of‑care treatments for knee osteoarthritis, contributing to uncertainty about comparative effectiveness.

Comparative effectiveness cannot be established from uncontrolled retrospective series or heterogeneous observational cohorts described in the review. Where randomized controlled trial (RCT) evidence is lacking or trials are small and non‑blinded, observational data alone are insufficient to determine net health outcomes.

A recurring limitation across the evidence base is short follow‑up (commonly 12 weeks to 6 months) and, in some studies, a lack of statistically significant between‑group differences at later time points. These limitations restrict conclusions about durability of pain relief and long‑term functional benefit.

For chemical neurolysis (phenol, alcohol, glycerol) there are no peer‑reviewed studies identified supporting its use for chronic shoulder pain or for intercostal neuralgia in the reviewed literature; randomized trials are needed to evaluate safety and efficacy for these indications.

Chemical neurolysis for inguinal neuralgia is not supported by identified peer‑reviewed studies in the review. The document explicitly states that no published literature was found for chemical neurolysis in this indication and that RCTs are needed to determine effects on net health outcomes.

No published studies were identified for chemical neurolysis in the management of plantar fasciitis or peripheral neuromas. The policy indicates an absence of peer‑reviewed literature and therefore considers these applications unsupported by current evidence.

Chemical neurolysis for chronic orchialgia and for postherpetic neuralgia was not supported by identified studies in the review. The document reports no peer‑reviewed literature for these indications and concludes that evidence is insufficient to determine net health outcomes.

Reported complications in some perioperative cryoablation series (for example, bar displacement in Nuss procedure cohorts) were noted, but the review highlighted that these events could not be directly attributed to the analgesic technique. Thus, these complications were described as not directly attributable to the analgesic intervention in the cited analyses.

The review emphasizes that there is insufficient high‑quality evidence and safety data to support routine use of many ablative procedures in pediatric populations. Given limited pediatric data and safety signal uncertainty, routine use in children without clear justification or supportive larger studies is not supported.

Within the provided reference excerpts there are no explicit additional coverage exclusions listed beyond the investigational indications and contract‑based exclusions noted elsewhere in the policy; the references section itself is bibliographic rather than prescriptive.

For most nonoperative peripheral indications (knee, hip, shoulder, inguinal/intercostal neuralgias, plantar fasciitis, peripheral neuromas, orchialgia, postherpetic neuralgia), the document concludes that the body of evidence is heterogeneous, limited in size, and of short duration, and therefore insufficient to establish net health benefit for routine use of RFA, cryoneurolysis, or chemical neurolysis.

Accordingly, the policy designates the use of peripheral nerve radiofrequency ablation, cryo‑neurolysis/cryoablation, or chemical neurolysis for the listed indications as investigational. Procedures for these indications are therefore excluded from coverage when the investigational status applies.

The evidence strength is reduced by limited sample sizes, biased or incomplete follow‑up, and non‑blinded cohorts in many studies. Small, non‑blinded trials and case series increase the risk of bias and reduce confidence in estimates of treatment effect.

Trials that did not select patients by response to a diagnostic nerve block, or that had insufficient follow‑up, have limited generalizability to clinical practice. The document highlights that lack of prognostic selection and short observation windows limit applicability of trial results.

The policy stresses the need for adequately powered, blinded randomized trials with standardized outcomes and at least 6–12 months (preferably 12 months) follow‑up to determine durability and control for placebo effects; procedures lacking such evidence remain uncertain in effectiveness.

Several poor‑quality or heterogeneous studies did not demonstrate clear benefit versus standard care or sham controls. The review notes that lack of consistent between‑group advantages in some studies contributes to the conclusion that benefit versus standard care is unproven for many applications.

For knee osteoarthritis, chemical neurolysis evidence is limited to small nonrandomized cohorts and case series with short‑term follow‑up (up to 6 months). Because of these limitations, the document states that chemical neurolysis for knee OA is supported only by limited nonrandomized evidence and cannot be concluded to be effective.

The document indicates that when only short‑term, uncontrolled, or single‑arm data exist, procedures should be considered investigational or not conclusively supported until randomized controlled evidence with adequate follow‑up becomes available.

Specifically, chemical neurolysis for chronic shoulder pain and for intercostal neuralgia had no published peer‑reviewed studies identified in the review; therefore these uses are not supported by evidence and would be considered investigational.

Chemical neurolysis for inguinal neuralgia, plantar fasciitis, peripheral neuromas, orchialgia, and postherpetic neuralgia also lacked published studies in the reviewed literature; these gaps support classifying these chemical neurolysis applications as investigational or not medically necessary pending RCT evidence.

Because cryoanalgesia for pectus (Nuss) surgery is supported by heterogeneous studies—including one small RCT and multiple observational series—the policy does not endorse routine use without further high‑quality RCT data; heterogeneity in concomitant analgesic techniques and variable study quality temper coverage conclusions.

Routine intraoperative cryoablation in children is not supported by sufficient safety evidence from larger studies; the document cites the limited pediatric RCT data underlying device clearance and recommends caution and additional evidence before routine pediatric use.

The references section that follows the coverage criteria provides bibliographic citations only and does not itself contain coverage determinations or criteria language.

Procedure and Device Coding

Coding section referencemixed

No codes listed

Procedures discussed (no specific billing codes listed in this section)mixed

No codes listed

Procedure and billing codesmixed

no codes listed

The provided text does not list CPT/HCPCS/ICD codes.

Procedures discussed (no explicit codes in this section)mixed

not specified	Radiofrequency ablation (standard, pulsed, cooled) — codes not listed in this section
not specified	Cryoneurolysis / cryoablation — codes not listed in this section
not specified	Chemical neurolysis (phenol, alcohol, glycerol) — codes not listed in this section

Devices and referenced technologiesmixed

iovera system (Myoscience, Inc)

device referenced for focused cold therapy / cryoneurolysis (not a numeric billing code)

No codes in references sectionmixed

No codes listed

Prior Authorization, Documentation, and Operational Guidance

Prior Authorization

Benefit verification and prior authorization

Verify member benefits and eligibility prior to scheduling procedures. Coverage may vary by contract; exclusions, limitations, or exceptions in the member's plan may apply. Prior authorization/approval and benefit verification are required when indicated by the payer's authorization table.

Check member-specific benefits and contract exclusions
Confirm any prior approval requirement via the Wellmark Authorization Table and InterQual® where applicable

Prior Authorization

Prior approval required

Prior approval is required for ablative peripheral nerve procedures covered by this policy when the payer’s authorization table indicates prior approval. Follow the Wellmark Authorization Table to determine the applicable procedure codes and any clinical coverage criteria.

Obtain prior approval before performing procedures when the authorization table indicates it is required
Include relevant InterQual® clinical criteria documentation when requested

Prerequisite Conservative Therapy and Diagnostic Blocks

Frequency, Repeat Treatments, and Follow-up Expectations

Frequency limits — general

Frequency policy statementNo explicit frequency limits provided in this portion of the document.

Implication for repeat proceduresDocument does not define allowable interval or maximum number of repeat peripheral nerve ablative procedures.

Documentation expectationWhen repeat procedures are requested, provide clinical justification and prior outcome measures due to absent frequency guidance.

RFA procedures — imaging guidance

Imaging guidance notedFluoroscopy is described as an aid for localization of genicular nerves and is used in trials to guide nerve localization and probe placement.

Alternate guidance modalitiesUltrasound guidance is also variably used in trials for targeting genicular branches and periarticular nerves.

Imaging Guidance and Procedural Targeting

Note

Genicular nerve RFA and selection blocks — imaging used in studies; no explicit policy mandate in this excerpt.

Imaging (fluoroscopy or ultrasound) was used in genicular nerve selection blocks and RFA studies to guide needle/probe placement; the policy does not mandate imaging but studies routinely used image guidance.

Document imaging method used (fluoroscopy or ultrasound) in procedural report when applicable.

Documentation Required

Genicular nerve RFA — Fluoroscopy recommended/used to aid localization

Fluoroscopy was commonly used to aid localization in genicular nerve RFA procedures in the cited trials and technical reports.

If fluoroscopy was used, document imaging details in the procedure note.

Documentation Required

Definitions and Outcome Measures

Definition — ablative peripheral nerve procedures

Ablative procedures — definitionProcedures intended to interrupt peripheral nerve function to reduce pain, including radiofrequency ablation (standard, pulsed, cooled), cryoneurolysis (cryoablation) and chemical neurolysis (phenol, alcohol, glycerol).

PurposeThese techniques are applied in peripheral sites distant from the spine to treat various chronic pain syndromes.

Examples of modalitiesIncluded modalities: RFA (standard, pulsed, cooled), cryoneurolysis/cryoablation, and chemical neurolysis.

Targets — peripheral nerve ablative procedures

Peripheral nerve targets listedTargets include genicular nerves for knee OA, pericapsular/articular branches for hip OA, and intercostal nerves for Nuss/pectus procedures.

Additional targets

Procedures and Indications Not Supported by Evidence

Chemical neurolysis lacks published evidence for many peripheral indications addressed in this policy; as a result, requests for these procedures for the listed indications are routinely at risk for denial or considered not covered when investigational designation applies.

RFA, cryoneurolysis, and chemical neurolysis for chronic knee osteoarthritis and other chronic peripheral indications are designated investigational in this policy and therefore not covered when the investigational status applies; the evidence does not establish comparative effectiveness or durability for routine coverage.

The policy lists multiple chronic peripheral pain indications as investigational (see investigational list) and indicates these applications are not covered based on insufficient evidence.

Where interventions are designated investigational in the policy (including RFA, cryoneurolysis, and chemical neurolysis for several chronic peripheral indications), payers may deny coverage consistent with the investigational determination and applicable contract terms.

Use of the iovera cryoanalgesia system for indications without consistent evidence of benefit—or without consensus on timing, target nerves, freeze duration, or number of cycles—may be considered not covered due to inconsistent and unresolved evidence.

Evidence is lacking to support repeat cryoneurolysis for knee osteoarthritis; the clinical benefit of repeat treatments and comparative effectiveness versus standard therapies remain unknown, so repeat cryoneurolysis is not supported by current evidence.

Evidence Base, Systematic Reviews, Trials, and References

The policy’s references include device and FDA documents (for example, FDA device references for cryoablation probes), but the references section does not by itself impose coverage rules.

Policy Summary

Payerblue cross blue shield - south dakota

PolicyAblative Procedures of the Peripheral Nerves to Treat Pain

Policy CodePolicy 07.01.73

Change TypeNo material changes

Effective DateJan 1, 2017

Next Review Date

Key ActionObtain prior authorization per Wellmark Authorization Table and document prior conservative therapy and outcome measures.

SourceLink

On This Page

citations":["136","137","138"],"intro":"Evidence summaries and implied coverage considerations from the reviewed literature:","nodes":["{\"operator\":\"all\",\"n\":0,\"label\":\"RFA for chronic hip OA\",\"text\":\"Nonrandomized trials and observational studies report short-term pain and function improvements for hip RFA, but follow-up is typically 12 weeks to 6 months and between-group differences are not consistently demonstrated; longer RCTs needed.\",\"children\":[]}","{\"operator\":\"any\",\"n\":1,\"label\":\"Chemical neurolysis for hip OA\",\"text\":\"Two double-blind RCTs of chemical neurolysis (phenol/ethanol) report mixed results; a recent ultrasound-guided 95% ethanol trial showed significant NRS reduction through 6 months and reduced opioid use but longer-term confirmatory trials are needed.\",\"children\":[]}"] ,"ref":"b0_7","title":"Ablative procedures for osteoarthritis of the hip"},{

citations":["137","134"],"intro":"Chemical neurolysis evidence:","nodes":["{\"operator\":\"any\",\"n\":1,\"label\":\"Chemical neurolysis for hip OA\",\"text\":\"Double-blind RCTs exist including an ultrasound-guided 95% ethanol neurolysis trial reporting significant NRS reductions and reduced opioid use through 6 months; authors recommend multicenter trials with extended follow-up.\",\"children\":[]}"] ,"ref":"b0_8","title":"Chemical neurolysis (phenol/alcohol) for hip OA"},{

citations":["139","141","143"],"intro":"Shoulder pain ablative procedures context:","nodes":["{\"operator\":\"all\",\"n\":1,\"label\":\"Ablative procedures for shoulder pain\",\"text\":\"Purpose is to provide an alternative to existing therapies; outcomes should use VAS/NRS and validated shoulder function instruments with follow-up of at least 6 months to 1 year to evaluate durability.\",\"children\":[]}"] ,"ref":"b0_9","title":"Ablative procedures for chronic shoulder pain"},{

citations":["150","160"],"intro":"Evidence-based coverage stance summaries for studied indications:","nodes":["{\"operator\":\"any\",\"n\":1,\"label\":\"Shoulder pain - evidence summary\",\"text\":\"Systematic review (Orhurhu 2019) identified mixed evidence (6 RCTs and other designs) with methodological heterogeneity; potential benefit noted but definitive durable benefit not established.\",\"children\":[]}","{\"operator\":\"any\",\"n\":1,\"label\":\"Intercostal neuralgia - evidence summary\",\"text\":\"Evidence is limited to small case series and case reports with inconsistent methods; RCTs are lacking and net health outcomes are uncertain.\",\"children\":[]}","{\"operator\":\"any\",\"n\":1,\"label\":\"Inguinal neuralgia - evidence summary\",\"text\":\"Review notes RCTs exist but are small; results require confirmation in larger trials before drawing definitive coverage conclusions.\",\"children":[]}],"ref":"b0_10","title":"Section evidence summaries"},{

citations":["167","168","170","178"],"intro":"Evidence summary and implied coverage considerations","nodes":["{\"operator\":\"all\",\"n\":0,\"label\":\"Inguinal neuralgia - evidence\",\"text\":\"Small RCTs of PRF/RF report longer duration of pain relief versus injections in some trials, but studies are limited by small sample sizes and methodological issues; larger RCTs are needed.\",\"children\":[]}","{\"operator\":\"all\",\"n\":0,\"label\":\"Plantar fasciitis - evidence\",\"text\":\"Two small RCTs of RFA reported short-term pain and function improvements but pooled evidence is low quality and heterogeneous; durability and safety remain uncertain.\",\"children":[]}"] ,"ref":"b0_11","title":"Evidence-based coverage considerations"},{

citations":["184","191","194"],"intro":"Evidence-based conclusions and coverage-relevant determinations from the review:","nodes":["{\"operator\":\"all\",\"n\":0,\"label\":\"Plantar fasciitis - RFA\",\"text\":\"Randomized evidence is limited and pooled analyses are inconsistent; larger and longer RCTs are required before concluding durable benefit.\",\"children\":[]}","{\"operator\":\"all\",\"n\":0,\"label\":\"Chemical neurolysis - plantar fasciitis\",\"text\":\"No published studies identified for chemical neurolysis for plantar fasciitis; evidence insufficient.\",\"children":[]}","{\"operator\":\"all\",\"n\":0,\"label\":\"Peripheral neuromas - ablative procedures\",\"text\":\"Case series show variable response with some patients achieving relief and others minimal benefit; RCTs needed to assess safety and efficacy.\",\"children":[]}","{\"operator\":\"all\",\"n\":0,\"label\":\"Chronic orchialgia - ablative procedures\",\"text\":\"One double-blind RCT of PRF showed short-term pain reduction to 3 months but follow-up was limited; further studies required to establish durability and broader applicability.\",\"children":[]}"] ,"ref":"b0_12","title":"Coverage conclusions and evidence summaries"},{

citations":["201","203","215"],"intro":"Evidence summaries and implied coverage considerations based on available evidence:","nodes":["{\"operator\":\"all\",\"n\":0,\"label\":\"Orchialgia - pulsed radiofrequency\",\"text\":\"PRF RCT showed significant short-term pain reduction versus sham in post-surgical orchialgia with inclusion criteria requiring failed conservative therapy and positive diagnostic spermatic cord block; follow-up limited to 3 months.\",\"children":[]}","{\"operator\":\"any\",\"n\":0,"label":"Postherpetic neuralgia - pulsed RFA","text":"Systematic reviews including small RCTs report pain reduction beginning within days and persisting 2–6 months with PRF, but long-term data are limited and heterogeneous.","children":[]}","{\"operator\":\"all\",\"n\":0,"label":"Chemical neurolysis (orchialgia, PHN)","text":"No peer-reviewed studies identified for chemical neurolysis for orchialgia or PHN in this review; evidence insufficient to support use.","children":[]}],"ref":"b0_13","title":"Evidence-based coverage considerations (partial document)"},{

citations":["216","222","223","224","225","226","227","228","229","230","231","232","233","234","235"],"intro":"Evidence-based findings from RCTs, systematic review, and observational studies:","nodes":["{\"operator\":\"all\",\"n\":0,\"label\":\"Primary comparative findings\",\"text\":\"Meta-analysis (Daemen et al.) and multiple observational studies report shorter hospital length of stay and reduced opioid use with intercostal nerve cryoablation versus thoracic epidural in Nuss procedure patients, but heterogeneity and limited RCT data limit the certainty of conclusions.\",\"children\":[]}","{\"operator\":\"any\",\"n\":0,\"label\":\"Randomized trial findings\",\"text\":\"Small RCTs (Graves et al., Rim et al.) demonstrated decreased LOS and opioid consumption with cryoablation in some trials, though operative time was often longer and sample sizes were small.\",\"children\":[]}","{\"operator\":\"any\",\"n\":0,\"label\":\"Observational study findings\",\"text\":\"Larger retrospective series report consistent reductions in LOS and opioid use with cryoablation but variable operative time and occasional complications (eg, bar displacement); overall evidence quality is low to moderate.\",\"children\":[]}],"ref":"b0_14","title":"Evidence summary / Coverage-relevant criteria"},{

citations":["236","237","238"],"intro":"Evidence summary and implications for coverage decisions","nodes":["{\"operator\":\"all\",\"n\":0,\"label\":\"Cryoablation for Nuss procedure\",\"text\":\"Studies suggest decreased LOS and opioid use with intercostal nerve cryoablation versus thoracic epidural, but evidence quality limitations and heterogeneity necessitate cautious interpretation; document expected benefit and monitor for complications when considered.\",\"children\":[]}"] ,"ref":"b0_15","title":"Cryoablation for pectus excavatum (Nuss procedure)"},{

citations":["241","243","244"],"intro":"Guideline-informed stance for joint-related denervation/RFA","nodes":["{\"operator\":\"any\",\"n\":0,"label":"RFA/denervation for knee OA and other joint pain","text":"Some professional guidelines provide conditional or limited recommendations for denervation/RFA in knee osteoarthritis (eg, AAOS, ACR/AF) recognizing potential analgesic benefit but noting heterogeneous techniques and limited long-term safety data; coverage may be appropriate for selected patients after documented conservative therapy.\",\"children\":[]}"] ,"ref":"b0_16","title":"Radiofrequency ablation / denervation for osteoarthritis and joint pain"},{

intro":"","nodes":[],"ref":"b0_17","title":"References only"}]}itating to produce valid JSON. The above JSON is malformed due to insertion errors.

Step Therapy

Conservative therapy expected prior to invasive procedures

Conservative therapy should be documented in the medical record prior to considering invasive ablative therapies. Typical conservative options include analgesics, physical therapy, weight loss and intra-articular injections as appropriate to the indication.

Document trials of conservative measures (e.g., NSAIDs, acetaminophen, physical therapy, weight-loss strategies) and response
Record prior intra-articular injections or other nonsurgical treatments and dates

Documentation Required

Diagnostic block prior to ablation when used to guide selection

For procedures targeting genicular or other peripheral nerves, document any diagnostic nerve block(s) used to confirm the pain source and predict response when that approach is part of the published study protocols or local practice. A positive diagnostic block (e.g., ≥50% temporary pain relief) should be recorded when used to select candidates.

Record date, agent, volume, technique, and percent pain relief for diagnostic blocks
Include imaging guidance or stimulation details if used to localize nerves

Documentation Required

Required clinical documentation to support medical necessity

When requesting prior authorization include required clinical documentation to support medical necessity: baseline pain scores (VAS/NRS), functional measures (WOMAC, KOOS JR, Oxford scores, AOFAS, etc.), prior conservative therapy details, diagnostic block results (if performed), prior procedures or surgeries, and intended target nerves and technique.

Provide pre- and post-treatment pain/function measures and follow-up plans
Document prior treatments attempted and objective measures of failure or inadequate response

Denial Risk

Evidence limitations may affect coverage and risk denial

Evidence is insufficient or limited for many ablative indications (chemical neurolysis, cryoneurolysis for several indications, RFA for some conditions). Lack of high-quality, long-term randomized data may lead to denial or case review. Be prepared to provide detailed supporting literature and rationale for medical necessity when requesting coverage for indications listed as investigational.

Investigational indications listed in the policy (see policy list) may be denied due to insufficient evidence
Provide high-quality supporting evidence for off-label or limited-evidence indications to facilitate case review

Note

No authorization guarantee of coverage — check benefit exclusions

Some indications or specific technologies may not require authorization or may be denied if the member's plan excludes the benefit. Confirm plan-specific rules before scheduling. Investigational indications per policy may be denied even with prior authorization.

If no benefit exists under the member's contract, authorization does not imply payment
Investigational or not medically necessary indications per policy may be denied despite prior approval attempts

Note

Bibliographic references and supporting evidence

This section contains bibliographic references used to develop clinical and operational guidance. When preparing authorization requests or appeals, include any pertinent peer-reviewed studies, systematic reviews, and technology assessments cited in the policy to support the clinical rationale.

Use the References list to locate cited RCTs, systematic reviews, and health technology assessments (e.g., Hayes reviews)
Attach key study summaries or excerpts when submitting prior authorization or appeal documentation

Clinical implicationProcedure reports should document imaging modality used (fluoroscopy and/or ultrasound) for localization and needle/probe placement.

RFA (genicular/intra-articular) frequency

Frequency limits for genicular/intra-articular RFANo explicit frequency limits provided in this excerpt for RFA of genicular or intra-articular nerves.

Trial contextRCTs and observational studies report follow-up and sometimes repeat procedures in extensions, but policy does not specify repeat intervals.

Recommendation for requestsWhen repeat genicular RFA is requested, include prior treatment dates, pain/function outcomes, and justification due to absent policy limits.

RFA (genicular) — frequency

Genicular RFA frequency specified?Not specified in this excerpt; cooled RFA trials report outcomes through 12–24 months but do not define formal frequency limits.

Durability contextExtension studies report some patients maintain benefit to 18–24 months, but loss to follow-up and cross-over limit inference for scheduling repeats.

Provider actionProvide prior procedure dates and objective outcome measures when requesting additional genicular RFA treatments.

Genicular RFA / C-RFA — frequency

Genicular RFA / C-RFA frequency specified?Not specified in the excerpt; cooled RFA (C-RFA) described as a variant with larger lesion but no numeric frequency limits provided.

Technique noteCooled-RFA is thought to create a larger area of denervation compared with standard RFA, which may affect durability but does not define retreatment timing.

Documentation recommendedWhen C-RFA retreatment is considered, document prior C-RFA date(s), response duration, and objective pain/function scores.

Cryoneurolysis (iovera) — repeat frequency

Iovera (cryo) repeat-treatment evidenceNo studies identified evaluating the clinical benefit of repeat cryoneurolysis (iovera) for knee OA; frequency and repeat-treatment benefit are unknown.

DurabilitySham-controlled RCTs suggest benefit up to ~90 days in some measures, but later improvements in controls suggest potential placebo effect and uncertain long-term durability.

Coverage implicationRequests for repeat cryoneurolysis should include prior treatment date(s), measured outcome data, and rationale given absent evidence-based frequency guidance.

RFA durability and recommended follow-up

RFA effect and follow-up timingThe effect of RFA is likely to be transient; procedural success should be assessed within one month and durability evaluated with at least one year follow-up when possible.

Outcome measuresQuantifiable pre- and posttreatment pain (VAS/NRS) and functional measures (WOMAC, Oxford Knee Score) are required to assess durability.

Documentation for coverageProvide baseline and early (within 1 month) plus longer-term (ideally ≥12 months) outcome data when justifying repeat procedures.

Imaging modalities reported for RF ablation

Guidance used for RF needle placementObservational studies report use of fluoroscopy and ultrasound guidance for needle and probe placement during RF ablation procedures.

Purpose of imagingFluoroscopy often used to localize bony landmarks; ultrasound used to avoid adjacent neurovascular structures and for direct visualization of soft tissues.

Provider documentationProcedure reports should state imaging modalities used (fluoroscopy and/or ultrasound) and technical details to support appropriateness and safety.

Suprascapular RFA — frequency

Suprascapular RFA frequency limitsFrequency not specified in this excerpt; retrospective series report repeat procedures for recurrent symptoms but no policy limits are provided.

Evidence contextSystematic review identified mixed evidence including RCTs and observational studies with variable follow-up; durability and optimal retreatment timing are uncertain.

Request documentationIf repeat suprascapular RFA is requested, include prior procedure dates, pain/function outcomes, and rationale for repeat ablation.

Pulsed radiofrequency (PRF) — trial-based repeat policy

PRF retreatment allowance in trialIn a randomized trial of pulsed radiofrequency for inguinal neuralgia, repeated PRF was allowed if VAS >30 mm during one-year follow-up; the number of repeats varied by patient.

Study limitationThis allowance reflects trial protocol and does not establish a general policy frequency limit; study was small and not powered for retreatment schedules.

Documentation for repeat PRFProvide VAS scores and dates when repeat PRF is requested, referencing the trial-derived practice only as contextual information.

RFA/PRF — frequency

RFA/PRF frequency specified?Not specified in this excerpt; the document reports RFA/PRF techniques and outcomes but does not set numeric frequency limits for repeat treatments.

Recommended documentationRequests for additional RFA/PRF treatments should include prior treatment dates, objective outcome measures, and conservative therapy attempts.

Clinical follow-up expectationsFollow-up within days for immediate success and out to at least 6–12 months (ideally 12 months) to document durability before considering retreatment.

Intercostal nerve cryoablation — frequency

Intercostal nerve cryoablation frequency limitsNot specified in this excerpt; studies of intraoperative intercostal nerve cryoablation report perioperative outcomes but do not define repeat-treatment frequency.

Perioperative contextCryoablation is described as an intraoperative adjunct (eg, Nuss procedure) with effects on length of stay and opioid use; retreatment timing not addressed.

Documentation on repeat useFor repeat or staged intercostal cryoablation, provide prior intraoperative details, outcomes, and safety documentation given lack of frequency guidance.

Frequency limits — summary

General statement on frequency limitsNo explicit frequency limits stated in this extract across multiple peripheral ablative indications.

Provider implicationAbsent numeric frequency limits, reviewers should evaluate repeat-treatment requests based on documented prior benefit, duration of effect, and conservative therapy trials.

Documentation recommendedInclude dates of prior procedures, quantified pain/function outcomes, and justification for additional procedures when seeking coverage.

Frequency limits — references

Frequency limits — references noteReferences and health-technology assessments are cited (Hayes evolving reviews) but the document does not translate those into explicit numeric frequency limits.

ImplicationReferenced HTAs may inform clinical expectation of durability but do not replace a documented member-specific justification for repeat treatments.

Action for prior authorizationWhen prior authorization is requested, include pertinent citations or HTA findings if relying on literature to justify repeat procedures.

Genicular nerve RFA — Trials variably used ultrasound or other image guidance for targeting

Trials variably used ultrasound or other image guidance for targeting genicular nerves; the document describes ultrasound-guided methods in multiple studies but does not mandate a specific modality.

Record the imaging modality (ultrasound vs fluoroscopy) used for nerve localization and blocks.

Documentation Required

genicular nerve RFA or diagnostic block — ultrasound or fluoroscopy as per trial methods

Genicular nerve RFA and diagnostic blocks in trials were performed with either ultrasound or fluoroscopy per trial methods; document the method used when submitting authorization or claims.

Include guidance method and any stimulation mapping used in documentation.

Documentation Required

Genicular RFA / C-RFA — fluoroscopy

Several genicular RFA and cooled‑RFA studies used fluoroscopy for probe placement; document fluoroscopic guidance if used.

Procedure reports should state fluoroscopic landmarks and imaging views used.

Documentation Required

cryooneurolysis — imaging not specified

Cryoneurolysis procedures in the reviewed literature sometimes did not require imaging guidance; protocol and device use should be documented in the procedure note.

If no imaging used, state anatomic landmarks and technique in the procedural documentation.

Documentation Required

genicular nerve blocks / neurolysis — ultrasound often used

Ultrasound guidance was often used for genicular nerve blocks and neurolysis in several studies; document ultrasound technique if applied.

Include probe type, approach, and visualization of target nerves in the record.

Documentation Required

RFA and chemical neurolysis — fluoroscopy and/or ultrasound

RFA and chemical neurolysis studies reported use of fluoroscopy and/or ultrasound guidance for probe placement; document whichever imaging modality was used.

Specify imaging modality and any stimulation testing performed for nerve localization.

Documentation Required

Imaging details not specified for some retrospective analyses

Some retrospective analyses did not specify imaging details; ensure procedure reports include imaging and technique details when used to support outcomes.

Lack of imaging detail led to exclusion from some retrospective analyses—include these elements to support evidence.

Documentation Required

ilioinguinal/iliohypogastric radiofrequency neurolysis — CT guidance (in study)

In one study of ilioinguinal/iliohypogastric radiofrequency neurolysis, CT guidance was used; document CT guidance when applicable.

If CT guidance was used, include CT approach and targeting details in the procedural note.

Documentation Required

Ablative procedures — imaging not specified in some sections

For many ablative procedures, the reviewed studies did not specify imaging requirements; document the guidance used (or that none was used) in the procedure report.

Procedure notes should state imaging modality or anatomic landmark technique.

Documentation Required

RFA of dorsal root ganglia — CT or other image guidance may be used depending on target

CT or other image guidance may be used for target‑specific procedures (e.g., DRG RFA); document the imaging modality used and rationale in the record.

For DRG procedures, include CT guidance details when used.

Documentation Required

Cryoneurolysis during Nuss procedure — none specified

Intraoperative cryoneurolysis for the Nuss procedure is described without specific imaging requirements; document intraoperative technique and thoracoscopic guidance if used.

Include whether thoracoscopic assistance or direct visualization was used.

Documentation Required

cryoablation/cryoneurolysis — imaging not specified

Many cryoablation/cryooneurolysis reports did not specify imaging guidance; ensure procedural documentation details the approach and any imaging used.

Detail probe placement, targets, and adjunct analgesic measures in the operative report.

Documentation Required

cooled radiofrequency, genicular nerve procedures — some studies use fluoroscopy and/or ultrasound guidance

Some studies of cooled RFA and genicular nerve procedures used combined fluoroscopy and ultrasound guidance; document combined modalities when used.

Describe combined imaging workflow and target identification in the procedure note.

Other reported targets: suprascapular nerve (shoulder), ilioinguinal/iliohypogastric nerves (inguinal neuralgia), infrapatellar and anterior femoral cutaneous branches for knee procedures.

Clinical noteExact neuroanatomy is variable and selection of target branches may vary across studies and techniques.

Radiofrequency ablation (RFA) — definition

RFA definitionMinimally invasive use of high-frequency electrical current via a needle electrode to coagulate tissue around a nerve, producing a thermal lesion to reduce nociceptive signaling.

VariantsIncludes standard (continuous thermal), pulsed (PRF — nonablative pulses), and cooled RFA (water-cooled probe creating larger lesion sizes).

Mechanism and goalThermal lesioning aims to destroy peripheral sensory nerve endings to alleviate pain while balancing adjacent tissue injury.

Cryoneurolysis — definition

Cryoneurolysis definitionApplication of temperatures approximately -20°C to -100°C to a nerve causing Wallerian degeneration while preserving perineural structures; nerve regeneration expected in ~3–5 months.

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

Clinical implicationCryoneurolysis effects are transient owing to expected nerve regeneration; repeat treatment benefit is not well-defined in studies.

Chemical neurolysis — definition

Chemical neurolysis definitionInjection of agents (phenol, alcohol, glycerol) to cause nerve destruction and provide analgesia while maintaining mobility.

Evidence noteThe document indicates limited or no RCT evidence for many peripheral indications; comparative and durability data are generally lacking.

Clinical cautionTechnical parameters (agent, concentration, volume, target selection) and safety require careful documentation due to limited evidence base.

Cooled-RFA (C-RFA) — definition

Cooled-RFA (C-RFA) descriptionA variation of RFA using a water-cooled probe to create a larger lesion area with limited thermal injury beyond the target, intended to denervate a broader area.

Clinical useUsed to target genicular nerves for knee OA in multiple trials and device-specific assessments (eg, Coolief).

Durability contextSome studies report longer mean duration of ≥50% pain relief with C-RFA compared with conventional RFA, but heterogeneity exists across studies.

RFA / Pulsed RF (PRF) — definition

RFA and PRF distinctionRFA provides continuous thermal energy to ablate nerve tissue; pulsed radiofrequency (PRF) delivers brief pulses and is thought to be less destructive and possibly nonablative.

Clinical useBoth thermal RFA and PRF have been applied to genicular, intra-articular, and peripheral nerve targets for chronic pain indications.

Evidence notePRF protocols and outcomes are heterogeneous across studies; some RCTs report short-term benefit for specific neuropathic indications (eg, orchialgia, PHN).

RFA variants — overview

RFA variants listedDocument identifies RFA, pulsed RF (PRF), and cooled RFA (C-RFA) as variants employed in peripheral nerve ablation studies.

Technique variabilityTrials differ in energy settings, probe types, and targeting approaches which contribute to heterogeneity in outcomes.

Reporting expectationProcedure reports should specify RFA variant used, energy parameters, and guidance modality to support interpretation of outcomes.

Diagnostic genicular nerve block — selection threshold

Diagnostic block response thresholdA ≥50% pain reduction with an anesthetic injection to the target genicular branches is used as a diagnostic criterion in several trials.

Role in selectionPositive diagnostic block is cited as an inclusion criterion in many RCTs and informs candidate selection for subsequent ablation.

Documentation recommendationWhen required by trial-derived selection, include documentation of diagnostic block date, agent, percent pain reduction, and duration of relief.

C-RFA — note

C-RFA referenced as label/termCooled radiofrequency ablation (C-RFA) is described and cited in systematic reviews and trials (eg, Coolief system assessments).

Evidence sourcesMultiple RCTs, observational studies, and HTAs (Hayes) evaluate cooled RFA for genicular and hip targets as cited in references.

Clinical noteDevice-specific evidence exists but does not define universal frequency limits; case-by-case documentation is needed for repeats.

Cryoneurolysis / cryoablation — definition (detail)

Cryoneurolysis / cryoablation definition (alternate phrasing)Cryoneurolysis (cryoanalgesia, cryoablation) applies focused cold to sensory nerves causing reversible Wallerian degeneration with expected regeneration in months.

Intraoperative useCryoneurolysis is used intraoperatively (eg, prior to or during TKA, or during Nuss procedures) to reduce postoperative pain and opioid requirement.

Regeneration timelineNerve function typically regenerates in approximately 3–5 months following cryoneurolysis.

AFCN — definition / relevance

AFCN definitionAnterior femoral cutaneous nerve (AFCN) is a commonly targeted superficial branch in cryoneurolysis procedures for knee pain/TKA contexts.

Clinical useAFCN and infrapatellar branch targets are described in RCTs and observational studies of cryoneurolysis for perioperative and chronic knee pain.

DocumentationSpecify which peripheral branches (eg, AFCN) were targeted when documenting procedures and outcomes.

ISN / IBSN — definition / relevance

ISN / IBSN definitionInfrapatellar branch of the saphenous nerve (ISN or IBSN) is another target for cryoneurolysis or RFA in knee pain management.

Perioperative roleISN targeting has been used in trials prior to TKA to reduce postoperative pain and opioid requirements in some studies.

Reporting guidanceDocument specific branch targeted (ISN/IBSN) and laterality in procedure reports and outcome measurement.

TKA — definition / context

TKA abbreviationTKA = total knee arthroplasty.

ContextCryoneurolysis has been studied in perioperative settings (3–7 days prior to TKA) to reduce postoperative pain and opioid use.

DocumentationWhen used in perioperative context, document timing relative to TKA and postoperative pain/opioid outcomes.

Chemical neurolysis — detailed definition

Chemical neurolysis detailed definitionInjection-based neurolytic agents (phenol, alcohol, glycerol) produce chemical destruction of nerve fibers with local anesthetic effects on small fibers.

Evidence cautionThe document notes sparse RCT evidence for many peripheral indications and emphasizes need for RCTs to evaluate safety and efficacy.

Clinical parameter variabilityTechnique, concentration, and volume vary across reports; specify agent and technique in documentation.

Cryoanalgesia / cryoablation — concise

Cryoanalgesia/cryoablation definition (concise)Application of cold to ablate peripheral sensory nerves producing temporary Wallerian degeneration and analgesia.

Regeneration timeframeNerve regeneration expected in about 3–5 months after treatment.

Clinical implicationTransient nature should be considered when planning repeat treatments and documenting durability.

Radiofrequency ablation — variants

Radiofrequency ablation (variants) — definitionRFA includes standard thermal RFA, cooled RFA (larger lesion via cooled probe), and pulsed RF (PRF — brief pulses with less thermal injury).

Mechanistic noteStandard RFA produces coagulative necrosis; PRF aims to modulate nerve function with less destruction.

Reporting expectationDocument the specific RFA variant and energy settings when reporting procedures and outcomes.

Ablative procedures — overview

Ablative procedures overviewRFA, cryoneurolysis, and chemical neurolysis are defined as techniques to destroy or denervate peripheral nerve tissue to reduce pain.

ScopeThese interventions have been applied to multiple peripheral pain syndromes with variable evidence quality and follow-up durations.

Coverage implicationEvidence heterogeneity and short follow-up in many studies limit definitive conclusions about net health benefit for most indications.

WOMAC — definition

WOMAC definitionWOMAC is a validated osteoarthritis index measuring pain, stiffness, and physical functioning; scores range 0–96 with higher scores indicating greater disability.

Use in trialsWOMAC frequently used to evaluate pain and function outcomes in knee OA ablation studies.

DocumentationReport baseline and follow-up WOMAC scores when available to support outcome assessment.

Pain measures — VAS / NRS

VAS / NRS pain scalesVisual Analog Scale (VAS) or Numeric Rating Scale (NRS) are the primary quantifiable patient-reported pain measures used pre- and post-treatment.

Follow-up timingImmediate (days) and serial follow-up (eg, 1 month, 3–6 months, and ideally 12 months) are used to assess procedural success and durability.

Documentation requirementProvide baseline and serial VAS/NRS scores in prior procedure reports and when requesting repeat treatments.

For chronic knee OA, chronic hip OA, and other listed peripheral chronic pain indications, RFA, cryoneurolysis, and chemical neurolysis are considered investigational or not covered given the insufficient and heterogeneous evidence base.

The excerpt contains no explicit procedural exclusions (for example, named techniques always excluded), but it emphasizes that insufficient long‑term randomized evidence limits definitive coverage approval for many indications.

The investigational designation in this policy underlies multiple not‑covered applications across peripheral pain indications; providers should consult the policy’s investigational list when assessing coverage risk.

Procedures designated investigational in the policy—such as chemical neurolysis for multiple peripheral indications—are presented as not supported by evidence and therefore are candidates for noncoverage.

Because the evidence base for many of these peripheral ablative procedures is limited, payers may not cover them outside of research settings or without strong, case‑specific justification supported by higher‑quality data.

Given limited pediatric safety data and heterogeneity in study quality, routine unsupported use of cryoablation in pediatric patients may be considered not medically necessary until larger safety studies are available.

The references list is provided for documentation and does not itself state which procedures are not covered; coverage positions derive from the policy text and investigational designations.