ModifiedKaiser PermanentePolicy N/A

Clinical Review Criteria — Radiofrequency Ablation

Clinical review criteria for radiofrequency ablation across indications (Barrett's esophagus, lung cancer, renal tumors, primary HCC and metastatic liver cancer, uterine fibroids) for Kaiser Foundation Health Plan of Washington members and providers.

Policy Summary

PayerKaiser Permanente

PolicyClinical Review Criteria — Radiofrequency Ablation

Policy CodePolicy N/A

Change TypeMaterial and clarifying revisions

Effective DateN/A

Next Review DateN/A

Key ActionFor non‑Medicare members, obtain histologic confirmation of low‑grade dysplasia on two endoscopies ≥3 months apart before authorizing RFA for Barrett's esophagus.

SourceLink

POLICY UPDATE CHANGES

MPC approved to maintain noncoverage position for laparoscopic RFA of uterine fibroids (CPT 58674) adopting KP criteria of insufficient evidence.

MTAC review added concluding insufficient evidence for RFVTA (Acessa) for symptomatic uterine fibroids.

Removed termed code C9771.

Removed termed code 0404T and replaced with 58580.

5primary clinical indications

1 RCTRCT for Barrett's esophagus

insufficientLung/renal evidence conclusion

58674Not Medically Necessary CPT

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Not Medically Necessary CPT

Coverage determinations and evidence conclusions

Indication-specific coverage criteria and evidence conclusions

Coverage determinations and evidence conclusions by indication

Barrett's esophagus (Non-Medicare): Radiofrequency ablation (RFA) is considered medically necessary for treatment of Barrett's esophagus in members who have histological confirmation of low-grade dysplasia by two or more endoscopies at least three months apart.two or more endoscopies >=3 months apart

Supported by randomized trial(s) and systematic reviews; MTAC conclusions vary across reviews but RFA meets clinical criteria in later appraisals (see MTAC).

Lung cancer: There is insufficient evidence in the published medical literature to show that RFA for lung cancer is as safe as standard therapies or provides better long-term outcomes; RFA for lung cancer does not meet Kaiser Permanente Medical Technology Assessment Criteria.

Evidence limited to small heterogeneous observational case series with short follow-up and variable outcomes.

Renal tumors: There is insufficient published evidence to determine the efficacy and safety of RFA for treatment of renal tumors; RFA for renal tumors does not meet Kaiser Permanente Medical Technology Assessment Criteria.

Evidence consists of small case series and case reports; no randomized trials.

Primary HCC and Metastatic Liver Cancer: RFA is commonly used for unresectable hepatic tumors, but available evidence (case series, limited controlled data) is insufficient to conclude improved survival versus alternatives for many indications; the use of RFA for primary HCC and metastatic liver cancer does not meet MTAC criteria in aggregate statements in this policy.

One nonrandomized trial and multiple case series; comparative data versus resection or other therapies are limited or absent.

Uterine fibroids / Transcervical ablation: Transcervical ablation of uterine leiomyomas (CPT 58580) is not covered per MCG criteria; laparoscopic RFA/RFVTA approaches (e.g., CPT 58674 or Acessa RFVTA) have insufficient evidence and do not meet MTAC criteria.

MCG proprietary criteria referenced for transcervical ablation noncoverage; MTAC concluded RFVTA lacks sufficient evidence for safety and durability.

Radiofrequency Ablation for Primary HCC — Insufficient / Not meeting MTAC

Evidence conclusions for hepatic RFA and PEI

RFA for primary HCC: Use of radiofrequency ablation for primary hepatocellular carcinoma (HCC) does not meet the Kaiser Permanente Medical Technology Assessment Criteria due to insufficient evidence that it improves survival compared with alternatives for many patients.

Evidence comprises case series and limited controlled trials; RFA vs PEI trials show similar complete necrosis rates with more adverse effects reported with RFA in some trials; comparative data versus resection are limited and inconsistent.

Radiofrequency Ablation for Metastatic Liver Cancer — Insufficient Evidence

Evidence conclusions for RFA in metastatic liver cancer

RFA for metastatic liver cancer: There is insufficient evidence to determine the efficacy of RFA compared with surgical resection or other treatments for metastatic liver cancer; published literature is mainly case series and cohort studies without randomized trials.

No randomized controlled trials or meta-analyses were found for metastatic liver cancer; comparative cohort data are limited and nonrandomized.

RFVTA for Uterine Fibroids — Insufficient Evidence / Not Meeting MTAC

RFVTA (Acessa) for symptomatic uterine myomas

Laparoscopic RF Volumetric Thermal Ablation (RFVTA): Insufficient published evidence demonstrates that laparoscopic ultrasound-guided RFVTA (Acessa) of symptomatic uterine myomas has superior or equivalent results compared with other uterus-conserving therapies; safety and durability of benefit are not established and MTAC concluded it does not meet Medical Technology Assessment Criteria.

Comparative studies are small or underpowered; the largest observational study (HALT) lacked a control group and showed increasing repeat surgery rates by year 3 (≈12% had repeat surgeries, most hysterectomies).

Barrett's Esophagus — Covered with Criteria

Barrett's esophagus ablation

Endoscopic ablation for Barrett's esophagus: Endoscopic ablation procedures (e.g., CPT 43229, 43270) are considered medically necessary for Barrett's esophagus when the specific criteria in this policy are met, including histologic confirmation of low-grade dysplasia by two or more endoscopies ≥3 months apart for non‑Medicare members.histologic confirmation of low-grade dysplasia by >=2 endoscopies >=3 months apart

MTAC reviews cite RCT evidence showing superiority to sham and systematic reviews supporting efficacy for dysplastic BE; documentation with appropriate diagnosis codes (K22.70 series) is required.

Transcervical ablation for uterine leiomyomas (CPT 58580) is designated as Not Medically Necessary per the referenced MCG guideline (MCG A-1039) and is therefore not covered under this policy. The policy notes that MCG criteria are proprietary; providers may request the specific MCG criteria used in an individual utilization decision by contacting Kaiser Permanente Clinical Review staff or accessing the MCG Guideline Index via the provider portal.

This policy includes several explicit Not Medically Necessary determinations. Laparoscopic radiofrequency ablation of uterine fibroids (CPT 58674), transcervical ablation of uterine fibroids (CPT 58580), and percutaneous ablation therapy for pulmonary tumors (CPT 32998) are listed as not medically necessary and may be denied. For plan- or member-specific authorization requirements, providers should verify via the Pre-authorization Code Check.

For lung cancer and renal tumors, the evidence base is limited and heterogeneous. The available literature for lung tumor RFA consists mainly of small observational case series with variable patient selection, tumor characteristics, devices, and short follow-up, yielding mixed survival and local control results; adverse events such as pneumothorax and pleural effusion are commonly reported. For renal tumors, published data are similarly limited to small case series and case reports. Kaiser MTAC concluded that RFA for these indications does not meet Medical Technology Assessment Criteria due to insufficient evidence to determine efficacy and safety.

Laparoscopic radiofrequency volumetric thermal ablation (RFVTA; e.g., Acessa system) for symptomatic uterine myomas has been reviewed and the MTAC conclusion is that there is insufficient published evidence to establish that this laparoscopic RFVTA approach provides equivalent or superior safety and durability of effect compared with alternative treatments. The policy indicates that RFVTA does not meet MTAC and that the safety and long-term effectiveness have not been established.

Transcervical ablation of uterine fibroids (CPT 58580) is specifically listed in this policy as Not Medically Necessary and is not covered under the MCG-based determination referenced in the document. Providers should anticipate possible denial for this CPT code and confirm authorization requirements before scheduling.

Ablation therapy for pulmonary tumors using percutaneous radiofrequency (CPT 32998) is considered Not Medically Necessary in this policy. The underlying evidence for RFA in lung cancer is limited to small, heterogeneous case series with short follow-up; because the effectiveness and long-term safety compared with standard therapies are not established, the procedure is not supported for routine coverage.

Procedure and diagnosis codes referenced

Uterine ablation procedure codes referencedCPT

58580	Transcervical ablation uterine ablation of leiomyomas (mentioned as not covered per MCG)
58674	Laparoscopic radiofrequency ablation of uterine fibroids (noted as insufficient evidence)

Barrett's Esophagus — Considered Medically Necessary when criteria met (procedure codes)CPTCovered

43229	Esophagoscopy, flexible, transoral; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when performed).
43270	Esophagogastroduodenoscopy, flexible, transoral; with ablation of tumor(s), polyp(s), or other lesion(s).

Lung Cancer — Considered Not Medically NecessaryCPTNot Covered

32998

Ablation therapy for reduction or eradication of 1 or more pulmonary tumor(s) percutaneous; radiofrequency (including imaging guidance when performed).

Transcervical Uterine Ablation — Not Medically NecessaryCPTNot Covered

58580

Transcervical ablation of uterine fibroid(s), including intraoperative ultrasound guidance and monitoring, radiofrequency.

Laparoscopic RFA of Uterine Fibroids — Not Medically NecessaryCPTNot Covered

58674

Laparoscopy, surgical, ablation of uterine fibroid(s) including intraoperative ultrasound guidance and monitoring, radiofrequency.

Diagnosis Codes for Barrett's EsophagusICD-10

K22.70	Barrett's esophagus without dysplasia
K22.710	Barrett's esophagus with low grade dysplasia
K22.711	Barrett's esophagus with high grade dysplasia
K22.719	Barrett's esophagus with dysplasia, unspecified

Authorization, documentation, and billing guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for endoscopic radiofrequency ablation (RFA) performed for Barrett's esophagus. Providers must verify authorization requirements for the specific CPT code and the member's plan using the Pre-authorization Code Check prior to scheduling the procedure.

Affected procedures: esophagoscopy with ablation (CPT 43229, 43270).
Use the Pre-authorization Code Check to confirm plan-specific prior authorization requirements and any plan exclusions.
Medicare vs Non‑Medicare: Where no CMS NCD/LCD applies, non‑Medicare members follow the Non‑Medicare criteria in this policy; Medicare members follow the Medicare-specific guidance noted in the policy header.

Prior Authorization

Prior Authorization — Verify via Pre-authorization Code Check

Verify prior authorization and coverage status for the relevant procedure and diagnosis codes before providing service. Use the Pre-authorization Code Check tool to confirm whether preauthorization is required and to identify any codes deemed not medically necessary under the member's plan.

Clinical background and scope

Barrett's esophagus is a metaplastic replacement of the normal squamous esophageal epithelium associated with chronic gastroesophageal reflux disease and an increased risk of progression to esophageal adenocarcinoma proportional to the grade of dysplasia. Endoscopic radiofrequency ablation (RFA) systems (e.g., HALO devices) deliver controlled thermal energy to ablate the Barrett's mucosa; when criteria are met, RFA is considered an appropriate treatment modality. For non‑Medicare members, RFA is considered medically necessary for Barrett's esophagus only when there is histologic confirmation of low‑grade dysplasia by two or more endoscopies at least three months apart. Documentation of the required histologic confirmation is necessary for authorization and coverage.

Device and technique definitions

RFA devices for Barrett's esophagus (HALO systems)

DevicesHALO360 (balloon-based circumferential ablation) and HALO90 (endoscope‑mounted focal ablation); alternative focal devices include Barrx90 ULTRA, Barrx60, and Channel RFA device.

Energy deliveryRadiofrequency energy delivered via balloon electrodes (60 tightly spaced, bipolar independent electrodes encircling the HALO360 balloon) with a preselected energy dose delivered in <1 second at 350 W.

Treatment scopeHALO360 for circumferential Barrett's mucosa; HALO90 (and other focal devices) for more focal areas of Barrett's esophagus.

SettingProcedures are ambulatory/outpatient in most cases.

PurposeThermal injury to destroy Barrett's mucosal epithelium while sparing submucosa (full‑thickness epithelial ablation without submucosal damage).

Policy Summary

PayerKaiser Permanente

PolicyClinical Review Criteria — Radiofrequency Ablation

Policy CodePolicy N/A

Change TypeMaterial and clarifying revisions

Effective DateN/A

Next Review DateN/A

Key ActionFor non‑Medicare members, obtain histologic confirmation of low‑grade dysplasia on two endoscopies ≥3 months apart before authorizing RFA for Barrett's esophagus.

SourceLink

On This Page

Pre-authorization Code Check (plan portal) — required check for CPT 43229, 43270 and related codes.

If Pre-authorization Code Check returns 'not medically necessary' for a code, obtain clinical review or denial reason before performing the procedure.

Denial Risk

Coverage Overview and Triggers for Denial

Coverage may be denied when clinical criteria are not met, documentation is incomplete, or when codes are listed as not medically necessary for the member's plan. For Medicare members, follow the Medicare section guidance; absent an NCD/LCD, Kaiser's internal clinical review criteria apply. For non‑Medicare members, RFA for Barrett's esophagus is covered only when the specific medical necessity criteria are satisfied.

Triggers for denial: lack of histologic confirmation of dysplasia, insufficient documentation of prior endoscopies, failure to demonstrate required time intervals between biopsies, or lack of pre‑ablation medical management.
Certain indications (e.g., pulmonary tumor ablation 32998, transcervical uterine ablation 58580, laparoscopic RFA of uterine fibroids 58674) are considered Not Medically Necessary and may be denied when billed for those indications.

Documentation Required

Required Diagnostic Documentation for Barrett's Esophagus

Documentation must demonstrate histologic confirmation and the timing of diagnostic procedures. For Barrett's esophagus with low-grade dysplasia, pathology confirmation should come from two or more endoscopies at least three months apart. Include all relevant operative and pathology reports, prior endoscopy reports, and documentation of medical management.

Required documentation: pathology reports confirming dysplasia, endoscopy reports (dates and findings) showing at least two endoscopies ≥3 months apart for low‑grade dysplasia.
Include documentation of prior surveillance, indication for ablation, and any prior endoscopic mucosal resection if performed.

Billing Rule

Barrett's Esophagus — Documentation and Codes

When submitting claims for RFA for Barrett's esophagus, include the appropriate procedure and diagnosis codes and ensure documentation supports the diagnosis and medical necessity. Codes listed below are associated with coverage when policy criteria are met.

Covered procedure codes when criteria met: CPT 43229, 43270.
Diagnosis codes: ICD-10 K22.70 (Barrett's esophagus without dysplasia), K22.710 (with low grade dysplasia), K22.711 (with high grade dysplasia), K22.719 (with dysplasia, unspecified).
Ensure mapping of the procedure to an appropriate Barrett's esophagus diagnosis on the claim and attach supporting clinical documentation for prior authorization and medical record review.

Note

Pre-ablation Medical Management

Before proceeding to endoscopic ablation for Barrett's esophagus, document that the member received appropriate medical management, including optimization of acid suppression with a proton pump inhibitor (PPI). Consideration of anti-reflux surgery (fundoplication) may be appropriate for PPI-refractory disease. Document prior medical therapy and response.

Pre-ablation medical management: trial and documentation of proton pump inhibitor (PPI) therapy.
Document alternative or adjunctive treatments considered (e.g., fundoplication) and rationale for ablation.
Record any use of NSAIDs/aspirin if relevant, and counsel regarding risks/benefits as part of pre-procedure planning.

Note

Provider Action Note — Unspecified Code-Specific Coverage Stances

If the policy does not explicitly specify additional code-specific coverage stances beyond the codes listed, providers must rely on the Pre-authorization Code Check and the member's plan terms. For any codes flagged as not medically necessary, obtain clinical review or alternative coverage determination prior to performing the service.

When in doubt, request clinical review and retain documentation of authorization attempts and communication with the plan.
Attach all supporting pathology and endoscopy reports to the authorization request to expedite review.

RFA for solid organ tumors — technical description

ApproachThin RF electrodes are introduced percutaneously, laparoscopically, or via open surgery under ultrasound, CT, or MRI guidance to the target lesion.

Physics and powerAlternating current of ~450–1,200 kHz is applied with power typically 5–120 W to raise tissue temperature above 70°C to induce coagulative necrosis.

Indications clearedDevices cleared by FDA for general soft tissue ablation, liver lesions, and bone metastases; not cleared for lung tumor ablation (safety and effectiveness not fully established).

Complications and limitationsPotential complications include pneumothorax, hepatic abscess, biliary injury, bleeding, diaphragmatic or visceral injury when probes are near organs; limitations treating lesions near large vessels or perihilar areas and real‑time monitoring difficulties due to heating air artifacts.

Percutaneous Ethanol Injection (PEI) — definition and context

DefinitionPercutaneous ethanol injection (PEI) is injection of absolute or 95% ethanol into tumor tissue producing coagulative necrosis via cytoplasmic dehydration, protein denaturation, and small vessel thrombosis.

Relative efficacyPEI tends to be more effective for primary hepatocellular carcinoma (HCC) in a cirrhotic liver because ethanol distribution is more uniform in 'soft' tumors within a 'hard' cirrhotic liver; less effective for metastases in normal liver tissue.

ComplicationsReported complications include hyperthermia, pain, elevated liver function tests, needle-tract seeding, pleural effusion, biliary stricture, portal vein thrombosis, and biliary tract bleeding.

Radiofrequency Ablation (RFA) — general definition

DefinitionRadiofrequency ablation (RFA) destroys tissue by applying alternating high‑frequency electric current (approximately 460–500 kHz) through an electrode placed in a lesion, producing ionic agitation and frictional heat that causes coagulative necrosis.

Thermal effectsTissue temperatures can exceed 100°C causing boiling and vapor formation; temperatures >60°C lead to protein denaturation, coagulation, and vascular thrombosis with a zone of complete ablation and peripheral partial destruction up to ~8 mm.

Delivery routesRFA may be delivered percutaneously, laparoscopically, or via open (laparotomy) approaches.

ComplicationsComplications include pleural effusion, hepatic abscess, biliary injury, liver failure, intra‑abdominal hemorrhage, pneumothorax, and hypoxemia; risk increases when probes are near diaphragm or adjacent viscera.

RF Volumetric Thermal Ablation (RFVTA) / Acessa System definition

System componentsThe Acessa RFVTA system includes an RF generator, a disposable 3.4 mm handpiece with a deployable 7‑needle electrode array, dispersive electrode pads, cables, and foot pedal; laparoscopic tower and ultrasound transducer are required for the procedure.

Mode and powerDesigned to deliver up to 200 W of RF power in three operational modes: Temperature Control, Manual Control, and Coagulation Mode.

Technique and intentUltrasound‑guided laparoscopic volumetric RF ablation (RFVTA) of uterine fibroids for outpatient treatment using a deployable multi‑needle electrode array to ablate fibroid volume.

Clinical evidence noteDescribed in small observational and feasibility studies; MTAC concluded insufficient evidence to meet Medical Technology Assessment Criteria for RFVTA (Acessa) for symptomatic uterine myomas.