CurrentKaiser PermanentePolicy N/A

Clinical Review Criteria Radiofrequency Ablation

Kaiser Permanente Clinical Review Criteria for radiofrequency ablation across multiple indications (Barrett's esophagus, lung cancer, renal tumors, primary HCC and metastatic liver cancer, uterine fibroids) describing medical necessity positions, evidence summaries, and guidance for Medicare vs non-Medicare members.

Policy Summary

PayerKaiser Permanente

PolicyClinical Review Criteria Radiofrequency Ablation

Policy CodePolicy N/A

Change TypeMixed (coverage positions updated; some noncoverage maintained)

Effective DateN/A

Next Review DateN/A

Key ActionUse KPWA Clinical Review Criteria for Medicare members when CMS guidance is absent.

POLICY UPDATE CHANGES

08/09/2024 - Removed termed code C9771.

04/17/2024 - Removed termed code 0404T and replaced with 58580.

10/03/2023 - MPC approved to maintain a position of noncoverage for Laparoscopic RFA by adopting KP criteria of insufficient evidence (CPT 58674); 60-day notice not required.

04/05/2022 - MPC approved to adopt MCG A-1039 Transcervical Uterine Ablation of Leiomyomas; service continues to be considered not medically necessary.

5Indications addressed in this part

1Indication with explicit medically necessary criteria (BE LGD)

3Indications with insufficient evidence / not meeting MTAC

1Procedures not covered per MCG

Repeat surgery rate at 3 years (HALT trial)

Coverage Summary

Scope: This policy covers Kaiser Permanente Clinical Review Criteria for radiofrequency ablation (RFA) across multiple indications including Barrett's esophagus, lung cancer, renal tumors, primary HCC and metastatic liver cancer, and uterine fibroids. Coverage stance is mixed: some indications have explicit medically necessary criteria while others are considered not medically necessary or lack sufficient evidence.

Key highlights: RFA for Barrett's esophagus with dysplasia is considered medically necessary when specific criteria are met (histological confirmation of low-grade dysplasia by two or more endoscopies at least three months apart). Laparoscopic RFA of uterine fibroids (CPT 58674) and transcervical uterine ablation (CPT 58580) are not medically necessary (transcervical ablation per proprietary MCG A-1039). Percutaneous pulmonary tumor RFA (CPT 32998) is considered not medically necessary for lung cancer due to insufficient evidence.

High-level counts and thresholds

Indications addressed5

Indication with explicit medically necessary criteria1 (Barrett's esophagus LGD with histological confirmation by two or more endoscopies ≥3 months apart)

Indications with insufficient evidence3 (Lung cancer; Renal tumors; Primary HCC and metastatic liver cancer)

Procedures not covered per MCG1 (Transcervical ablation CPT 58580 - not covered per MCG A-1039)

Barrett's esophagus histology confirmation interval thresholdTwo or more endoscopies at least three months apart

Medical-Necessity Criteria

For Non-Medicare Members - Barrett's Esophagus

RFA is considered medically necessary when ALL criteria are met:

ALL of the following

Histologic confirmation of Barrett's esophagus with low-grade dysplasia (LGD) by endoscopy and biopsy.
Confirmation of LGD on at least two separate endoscopic examinations performed at least three months apart.
Patient is an adult for whom endoscopic therapy is appropriate and who has been counseled on risks, benefits, and alternatives to RFA.
RFA is performed using an FDA-cleared device and by a provider credentialed to perform endoscopic ablation procedures.

Coding

Referenced CPT codes / procedures mentionedCPT

58580	Transcervical ablation Uterine Abla tion of Leiomyomas (mentioned - not covered per MCG)
58674	Laparoscopic Radiofrequency Ablation of Uterine Fibroids (mentioned - insufficient evidence)

Laparoscopic RFA - Not Medically NecessaryCPTNot Covered

58674

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

Transcervical Uterine Ablation - Not Medically NecessaryCPTNot Covered

58580

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

Barrett's Esophagus - Considered Medically Necessary when criteria metCPT|ICD-10Covered

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

Pulmonary Tumor Ablation - Not Medically NecessaryCPTNot Covered

32998

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

Provider Actions

Prior Authorization

Use KPWA Clinical Review Criteria for Medicare members when CMS guidance absent

For Medicare members, KPWA applies its own Clinical Review Criteria (Non‑Medicare criteria) for medical necessity determinations when no CMS NCD, LCD, or coverage article exists. Use the KPWA Clinical Review Criteria for Radiofrequency Ablation to guide prior authorization decisions for Medicare beneficiaries.

Documentation Required

Documentation for Barrett's esophagus RFA

To support medical necessity for RFA for Barrett's esophagus with low‑grade dysplasia, provide histological confirmation of low‑grade dysplasia by two or more endoscopies performed at least three months apart.

Background & Evidence Summary

Background: This document provides Kaiser Permanente's Clinical Review Criteria and Medical Technology Assessment Committee (MTAC) evidence summaries for radiofrequency ablation across multiple indications. It summarizes literature searches, MTAC reviews, critical appraisals and evidence conclusions about efficacy and safety compared with alternatives and notes limitations of FDA clearance for some uses.

The evidence sections referenced include MTAC reviews and supporting source documents for RFA in Barrett's esophagus, lung cancer, renal tumors, liver cancer, and laparoscopic RFVTA of uterine fibroids (Acessa system). The policy history records committee decisions, code updates, and adoption of MCG criteria where applicable.

MTAC evidence conclusions

MTAC - Barrett's esophagusFair evidence from an RCT shows RFA superior to sham for BE with dysplasia; insufficient evidence on long‑term outcomes or cancer risk reduction

MTAC - Lung cancerLimited evidence; insufficient published evidence to determine efficacy and safety for lung cancer

MTAC - Renal tumorsInsufficient published evidence to determine efficacy and safety for renal tumors

MTAC - Primary HCC & metastatic liver

Medicare Determinations

Medicare determinations: No National Coverage Determinations (NCDs) or Local Coverage Determinations (LCDs) were identified for these indications in this document (listed as 'None identified'), however LCD references L34886 and L35008 are noted in the record as referenced non-covered services. For Medicare members, because CMS coverage manuals, NCDs, and LCDs are absent, KPWA will apply its own Clinical Review Criteria (Non‑Medicare criteria) for medical necessity determinations.

Revision History

10/03/2023material revision

MPC approved to maintain a position of noncoverage for Laparoscopic RFA by adopting KP criteria of insufficient evidence for CPT 58674 (material). 60-day notice not required.

04/05/2022material added

MPC approved to adopt MCG A-1039 Transcervical Uterine Ablation of Leiomyomas; service continues to be considered not medically necessary (material).

04/17/2024non-material revised

Non-material revision: termed code 0404T removed and replaced with CPT 58580.

Policy Summary

PayerKaiser Permanente

PolicyClinical Review Criteria Radiofrequency Ablation

Policy CodePolicy N/A

Change TypeMixed (coverage positions updated; some noncoverage maintained)

Effective DateN/A

Next Review DateN/A

Key ActionUse KPWA Clinical Review Criteria for Medicare members when CMS guidance is absent.

On This Page

For Medicare Members

In the absence of CMS coverage guidance, KPWA will apply the Non-Medicare criteria above for Medicare members.

ALL of the following

CMS Coverage Manuals: None.
National Coverage Determinations (NCD): None.
Local Coverage Determinations (LCD): None.
Local Coverage Articles: None.
Due to the absence of NCD/LCD/other guidance, KPWA will use its Clinical Review Criteria for Radiofrequency Ablation and apply the Non-Medicare criteria.

RFA for Barrett's Esophagus

RFA for Barrett's esophagus is covered when the applicable criteria in this policy (e.g., the Barrett's Esophagus criteria above) are met.

ALL of the following

All applicable policy criteria for the specific indication (e.g., Barrett's esophagus) must be satisfied prior to considering RFA.
Documentation of histology, prior endoscopic evaluations, and counseling must be available in the medical record.

RFA for Pulmonary Tumors / Lung Cancer

Coverage determination summary for pulmonary tumors / primary lung cancer:

ALL of the following

Use of CPT 32998 (percutaneous image-guided ablation, radiofrequency) for primary lung cancer or pulmonary tumors is considered not medically necessary.

Transcervical / Uterine Ablation of Leiomyomas (58580) and Laparoscopic RFA of Uterine Fibroids (58674)

Transcervical and laparoscopic RFA for uterine leiomyomas/fibroids — summary:

ALL of the following

Transcervical uterine ablation of leiomyomas (CPT 58580) is not covered per MCG A-1039.
Laparoscopic radiofrequency ablation of uterine fibroids (CPT 58674) has insufficient evidence and is considered not medically necessary.

For Non-Medicare Members - Lung Cancer

For Non-Medicare Members - Lung Cancer:

ALL of the following

There is insufficient evidence in the published medical literature to demonstrate that RFA for lung cancer or pulmonary tumors is as safe and effective as standard therapies or provides superior long-term outcomes; therefore it is considered not medically necessary or investigational for this indication.

Laparoscopic Radiofrequency Volumetric Thermal Ablation (RFVTA) of Uterine Fibroids

Laparoscopic radiofrequency volumetric thermal ablation (RFVTA) of uterine fibroids (Acessa System) coverage determination:

ALL of the following

The published evidence is insufficient to show that RFVTA provides outcomes equivalent to or better than standard surgical therapies; therefore RFVTA is considered not medically necessary/experimental for treatment of uterine fibroids.

Transcervical Uterine Ablation of Leiomyomas (Transcervical RFA)

Transcervical RFA of leiomyomas coverage determination:

ALL of the following

Transcervical radiofrequency ablation of uterine leiomyomas (CPT 58580) is considered not medically necessary.

For Non-Medicare Members - Renal Tumors; Primary HCC and Metastatic Liver Cancer

The following additional non-Medicare criteria groups are included and must be met when applicable:

ALL of the following

Renal Tumors: Radiofrequency ablation for renal (kidney) tumors is considered investigational/ not medically necessary when not meeting established image-guided ablation criteria; patient selection should follow multidisciplinary review and documented rationale for ablation versus partial nephrectomy or other standard treatments.
Primary HCC and Metastatic Liver Cancer: Radiofrequency ablation for primary hepatocellular carcinoma (HCC) and for metastatic liver tumors may be considered when performed according to accepted liver tumor ablation guidelines (e.g., tumor size, number, location criteria) and when documentation demonstrates that the patient is a candidate for ablation as an alternative to resection or transplantation; medical necessity review is not required per policy statement only when the service is performed in accordance with plan-specified criteria and institutional protocols.

Documentation Required

MCG criteria access for transcervical ablation

MCG A-1039 is the proprietary guideline used for transcervical uterine ablation (CPT 58580). Providers may request the specific MCG criteria by calling Kaiser Permanente Clinical Review staff or accessing the MCG Guideline Index via the provider portal.

Documentation Required

Use applicable policy criteria for Barrett's esophagus

When billing for endoscopic ablation for Barrett's esophagus (e.g., CPT 43229 or 43270), document and apply the applicable Barrett's esophagus medical necessity criteria. Relevant diagnosis and procedure codes include 43229, 43270, K22.70, K22.710, K22.711, and K22.719.

Billing Rule

Pre-authorization check for codes

Verify authorization requirements for a specific code by plan type before performing the service. Use the Pre-authorization Code Check to determine whether prior authorization is required for the planned procedure.

Denial Risk

Noncoverage of uterine RFA and pulmonary RFA

Claims for certain uterine and pulmonary RFA procedures are considered not medically necessary and are at risk for denial. Specifically, CPT 58674 (laparoscopic RFA of uterine fibroids), CPT 58580 (transcervical ablation of uterine fibroids), and CPT 32998 (percutaneous pulmonary tumor RFA) are listed as not covered per policy and MCG.

Mixed/fair evidence for small solitary HCC (<5 cm) vs resection; overall evidence insufficient to meet MTAC criteria

MTAC - RFVTA (uterine fibroids) and HALT trialInsufficient evidence for laparoscopic RFVTA (Acessa); HALT trial showed benefit up to 3 years but increasing repeat surgeries (12% by year 3; 79% of repeats were hysterectomies)

Overall evidence qualityGenerally insufficient for several indications (small, observational studies; limited follow-up); does not meet MTAC criteria for many uses

Definitions: Radiofrequency ablation (RFA) — thermal destruction of tissue via alternating high-frequency electric current delivered through electrodes (used for mucosal and soft-tissue ablation and solid tumor destruction).

Radiofrequency volumetric thermal ablation (RFVTA, Acessa system) — a laparoscopic, ultrasound-guided RFA technique for uterine fibroids using a handpiece with deployable electrodes designed to deliver up to 200 W for volumetric myoma ablation.

Medical Technology Assessment Committee (MTAC) — Kaiser Permanente committee that evaluates the evidence and issues MTAC reviews and conclusions used to support these criteria.

MCG A-1039 — proprietary MCG clinical guideline referenced for transcervical uterine ablation determinations; MCG criteria are proprietary and may be requested via the provider portal or Kaiser Permanente Clinical Review staff.

08/09/2024non-material clarifiedLatest

Non-material clarification: removed termed code C9771.