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Endoscopic Radiofrequency Ablation or Cryoablation for Barrett’s Esophagus

Policy Number: MP-417

Latest Review Date: November 2024

Category: Surgery                                                                 

POLICY:

Radiofrequency ablation may be considered medically necessary for Barrett’s esophagus with dysplasia.

Radiofrequency ablation is considered investigational including, but not limited to Barrett’s esophagus without dysplasia.

Cryoablation is considered investigational for Barrett’s esophagus, with or without dysplasia.  

DESCRIPTION OF PROCEDURE OR SERVICE:

Barrett Esophagus and Risk of Esophageal Carcinoma

The esophagus is normally lined by squamous epithelium. Barrett Esophagus (BE) is a condition in which the normal squamous epithelium is replaced by specialized columnar-type epithelium, known as intestinal metaplasia, in response to irritation and injury caused by gastroesophageal reflux disease. Occurring in the distal esophagus, BE may be of any length; it may be focal or circumferential and can be seen on endoscopy as being a different color than the background squamous mucosa. Confirmation of BE requires a biopsy of the columnar epithelium and microscopic identification of intestinal metaplasia.

Intestinal metaplasia is a precursor to esophageal adenocarcinoma, which is thought to result from a stepwise accumulation of genetic abnormalities in the specialized epithelium, resulting in the phenotypic expression of histologic features from low grade dysplasia (LGD), to high-grade dysplasia (HGD), to carcinoma. Two large epidemiologic studies published in 2011 reported the risk of progression to cancer in patients with BE. One reported the rate of progression to cancer in more than 8000 patients with a mean duration of follow-up of 7 years (range, 1 to 20 years). The de novo progression to cancer from BE at 1 year was 0.13%. The risk of progression was reported as 1.4% per year in patients with LGD and 0.17% per year in patients without dysplasia. This incidence translates into a risk of 10 to 11 times that of the general population. The other study identified more than 11,000 patients with BE and, after a median follow-up of 5.2 years, it reported that the annual risk of esophageal adenocarcinoma was 0.12%. Detection of LGD on index endoscopy was associated with an incidence rate for adenocarcinoma of 5.1 cases per 1000 person-years, and the incidence rate among patients without dysplasia was 1.0 case per 1000 person-years. Risk estimates for patients with HGD were slightly higher. The reported risk of progression to cancer in BE in older studies was much higher, with an annual incidence of risk of 0.4% to 0.5% per year, with risk estimated at 30 to 40 times that of the general population. Current surveillance recommendations have been based on these higher risk estimates.

There are challenges in diagnostically differentiating between nondysplastic BE and BE with LGD; they are important when considering treatment for LGD. Both sampling bias and interobserver variability have been shown to be problematic.Therefore, analysis of progression to carcinoma in BE with intestinal metaplasia versus LGD is difficult. Initial diagnosis of BE can also be a challenge with respect to histologic grading because inflammation and LGD can share similar histologic characteristics.

One approach to risk-stratify patients with an initial diagnosis of LGD has been to use multiple pathologists, including experts in gastrointestinal histopathology, to confirm the initial diagnosis of LGD. There is a high degree of interobserver variability among the pathology readings of LGD versus inflammatory changes, and the resultant variability in pathology diagnosis may contribute to the variable rates of progression of LGD reported in the literature. Kerkhof et al (2007) reported that, in patients with an initial pathologic diagnosis of LGD, review by an expert pathologist would result in the initial diagnosis being downgraded to nondysplasia in up to 50% of cases. Curvers et al (2010) tested this hypothesis in 147 patients with BE who were given an initial diagnosis of LGD. All pathology slides were read by 2 expert gastrointestinal pathologists with extensive experience in BE; disagreements among experts in the readings were resolved by consensus. Once this process was completed, 85% of initial diagnoses of LGD were downgraded to nondysplasia, leaving 22 (15%) of 147 patients with a confirmed diagnosis of LGD. All patients were followed for a mean of 5.1 years for progression to HGD or cancer. For patients with confirmed LGD, the rate of progression was 13.4%, compared with 0.5% for patients who had been downgraded to nondysplasia.

The strategy of having LGD confirmed by expert pathologists is supported by the results of a randomized controlled trial by Phoaet al (2014), which required confirmation of LGD by a central expert panel following initial diagnosis by a local pathologist. Of 511 patients with an initial diagnosis of LGD, 264 (52%) were excluded because the central expert panel reassigned the classification of LGD, most often from LGD to indefinite or nondysplasia. These findings were further confirmed in a retrospective cohort study by Duits et al (2015) who reported on 293 BE cases with LGD diagnosed over an 11-year period and submitted for expert panel review. In this sample, 73% of subjects were downstaged.

Management of Barrett Esophagus

The management of BE includes the treatment of gastroesophageal reflux disease and surveillance endoscopy to detect progression to high-grade dysplasia (HGD) or adenocarcinoma. The finding of HGD or early-stage adenocarcinoma warrants mucosal ablation or resection (either endoscopic mucosal resection [EMR] or esophagectomy).

EMR, either focal or circumferential, provides a histologic specimen for examination and staging (unlike ablative techniques). One 2007 study provided long-term results for EMR in 100 consecutive patients with early Barrett-associated adenocarcinoma (limited to the mucosa). The 5-year overall survival was 98% and, after a mean of 36.7 months, metachronous lesions were observed in 11% of patients. In a review by Pech and Ell (2009), the authors stated that circumferential EMR of the entire segment of BE leads to a stricture rate of 50%, and recurrences occur at a rate of up to 11%.

Ablation techniques

Available mucosal ablation techniques include several thermal (multipolar electrocoagulation [MPEC], argon plasma coagulation [APC], heater probe, neodymium-doped yttrium aluminum garnet [Nd:YAG] laser, potassium titanyl phosphate [KTP]-YAG laser, diode laser, argon laser, cryoablation) or nonthermal (5-aminolevulinic acid, photodynamic therapy) techniques. In a randomized phase 3 trial reported by Overholt et al (2005), photodynamic therapy was shown to decrease significantly the risk of adenocarcinoma in BE. (PDT therapy for Barrett’s esophagus is discussed in a separate policy, MP# 337- Oncologic Applications of Photodynamic Therapy, Including Barrett’s Esophagitis).

Radiofrequency ablation affects only the most superficial layer of the esophagus (ie, the mucosa), leaving the underlying tissues unharmed. Measures of efficacy for the procedure are the eradication of intestinal metaplasia and the postablation regrowth of the normal squamous epithelium. (Note: The eradication of intestinal metaplasia does not leave behind microscopic foci). The HALO system uses radiofrequency energy and consists of 2 components: an energy generator and an ablation catheter. Reports of the efficacy of the HALO system in ablating BE have been as high as 70% (comparable with alternative methods of ablation [eg, APC, MPEC]), and even higher in some reports. The incidence of leaving behind microscopic foci of intestinal metaplasia has been reported to be between 20% and 44% with APC and 7% with MPEC; studies using the HALO system have reported 0%. Another potential advantage of the HALO system is that it is an automated process that eliminates operator-dependent error, which may be seen with APC or MPEC. Cryotherapy allows for the treatment of uneven surfaces and can be administered as either a spray therapy or a balloon catheter.

The risk of treating HGD or mucosal cancer solely with ablative techniques is undertreatment for approximately 10% of patients with undetected submucosal cancer, in whom esophagectomy would have been required.

KEY POINTS:

The most recent update covers the period through September 19, 2024.

Summary of Evidence

For individuals who have Barrett esophagus (BE) with high-grade dysplasia (HGD) who receive endoscopic radio frequency ablation (RFA), the evidence includes a randomized controlled trial (RCT) comparing radical endoscopic resection with focal endoscopic resection followed by RFA, one RCT comparing RFA with surveillance alone, and a systematic review evaluating RCTs and a number of observational studies, some of which compared RFA with other endoscopic treatment modalities. Relevant outcomes are change in disease status, morbid events, and treatment-related morbidity and mortality. The available evidence has shown that using RFA to treat BE with HGD is at least as effective in eradicating HGD as other techniques, with a lower progression rate to cancer, and may be considered an alternative to esophagectomy. Evidence from at least one RCT has demonstrated higher rates of eradication than surveillance alone. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have BE with low-grade dysplasia (LGD) who receive endoscopic RFA, the evidence includes at least RCTs comparing RFA with surveillance alone, a number of observational studies, and systematic reviews of these studies. Relevant outcomes are change in disease status, morbid events, and treatment-related morbidity and mortality. For patients with confirmed LGD, evidence suggests that RFA reduces progression to HGD and adenocarcinoma. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have BE without dysplasia who receive endoscopic RFA, the evidence includes single-arm studies reporting outcomes after RFA. Relevant outcomes are change in disease status, morbid events, and treatment-related morbidity and mortality. The available studies have suggested that nondysplastic metaplasia can be eradicated by RFA. However, the risk-benefit ratio and the net effect of RFA on health outcomes are unknown. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have BE with or without dysplasia who receive endoscopic cryoablation, the evidence includes nonrandomized studies and systematic reviews of those studies reporting outcomes after cryoablation. Relevant outcomes include change in disease status, morbid events, and treatment-related morbidity and mortality. These studies have generally demonstrated high rates of eradication of dysplasia. Recent observational studies comparing RFA with cryoablation show similar outcomes. However, there are no RCTs comparing cryoablation with surgical care or RFA. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American College of Gastroenterology

In 2022, the American College of Gastroenterology (ACG) updated guidelines for the diagnosis and management of BE, which made statements about ablation techniques. The ACG recommends ablation of remaining BE tissue when endoscopic eradication therapy is chosen for patients with LGD, HGD, or intramucosal carcinoma. Both RFA and cryoablation are discussed in the ACG guideline without a specific recommendation; however, the guideline notes the lack of randomized controlled trials (RCTs) for cryoablation methods and the more established evidence for RFA. The ACG does recommend cryotherapy as an alternative in patients unresponsive to RFA.

American Gastroenterological Association

In 2024, the American Gastroenterological Association (AGA) published clinical guideline on the role of endoscopic therapy in patients with BE and related neoplasia.

The AGA guideline made 5 recommendation for endoscopic eradication of BE:

  • "In individuals with BE with HGD, the AGA recommends EET over surveillance. (Strong recommendation, moderate certainty of evidence)"
  • "In individuals with BE with LGD, the AGA suggests for EET over surveillance. Patients who place a higher value on the well-defined harms and lower value on the benefits (which are uncertain) regarding reduction of esophageal cancer mortality would reasonably select surveillance endoscopy. (Conditional recommendation, low certainty of evidence)"
  • "In individuals with NDBE [nondysplastic BD], the AGA suggests against the routine use of EET. (Conditional recommendation, very low certainty of evidence)"
  • "In patients undergoing EET, the AGA suggests resection of visible lesions followed by ablation of the remaining BE segment over resection of the entire BE segment. (Conditional recommendation, very low certainty of evidence)"
    • "RFA is the preferred ablative modality."
  • "In individuals with BE with visible neoplastic lesions that are undergoing endoscopic resection, the AGA suggests the use of either EMR [endoscopic mucosal resection] or ESD [endoscopic submucosal resection] based on lesion characteristics. (Conditional recommendation, very low certainty of evidence)"

American Society for Gastrointestinal Endoscopy

In 2018, the American Society for Gastrointestinal Endoscopy (ASGE) issued guidelines on the role of endoscopy in BE-associated dysplasia and intramucosal cancer. These guidelines made the following recommendations on endoscopic eradication therapy, consisting of endoscopic mucosal resection of visible lesions and ablative techniques that include RFA and cryotherapy (see Table 1).

Table 1. ASGE Guidelines on Use of Endoscopy for Barrett Esophagus and Intramucosal Cancer

Recommendations

SOR

QOEa

In BE patients with LGD and HGD being considered for EET, we suggest confirmation of diagnosis by at least 1 expert GI pathologist or panel of pathologists compared with review by a single pathologist.

Conditional

Low

In BE patients with LGD, we suggest EET compared with surveillance; however, patients who place a high value on avoiding adverse events related to EET may choose surveillance as the preferred option

Conditional

Moderate

In BE patients with confirmed HGD, we recommend EET compared with surveillance

Strong

Moderate

In BE patients with HGD/IMC, we recommend against surgery compared with EET

Strong

Very low quality

In BE patients referred for EET, we recommend endoscopic resection of all visible lesions compared with no endoscopic resection of visible lesions.

Strong

Moderate

In BE patients with visible lesions who undergo endoscopic resection, we suggest ablation of the remaining Barrett’s segment compared with no ablation.

Conditional

Low

In BE patients with dysplasia and IMC referred for EET, we recommend against routine complete endoscopic resection of entire Barrett’s segment compared with endoscopic resection of visible lesion followed by ablation of remaining Barrett’s segment

Strong

Very Low

In BE patients with dysplasia and IMC who have achieved CE-IM after EET, we suggest surveillance endoscopy versus no surveillance.

Conditional

Very Low

BE: Barrett esophagus; CE-IM: complete eradication of intestinal metaplasia; EET: endoscopic eradication therapy; GI: gastrointestinal; HGD: high-grade dysplasia; IMC: intramucosal cancer; LGD: low-grade dysplasia; QOE: quality of evidence; SOR: strength of recommendation;
a Quality assessed using GRADE system.

National Comprehensive Cancer Network

National Comprehensive Cancer Network guidelines (v.4.2024) on esophageal and esophagogastric junction cancers make recommendations about BE and early-stage esophageal adenocarcinomas. For primary treatment; “The goal of endoscopic therapy, [by endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), and/or ablation] is the complete removal or eradication of early-stage disease (pTis, pT1a, and selected superficial pT1b without LVI ) and pre-neoplastic tissue (Barrett esophagus)."

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Radiofrequency ablation, Cryoablation, Barrett’s Esophagus, HALO360, CryoSpray Ablation

APPROVED BY GOVERNING BODIES:

In 2005, the HALO360 (now Barrx™ 360 RFA Balloon Catheter; Barrx Medical, Sunnyvale, CA; acquired by Covidien in 2012) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process and, in 2006, the HALO90 (now Barrx™ 90 RFA Focal Catheter) received clearance. The FDA-labeled indications are for use in coagulation of bleeding and nonbleeding sites in the gastrointestinal tract, and include the treatment of Barrett esophagus. Other focal ablation devices from Barrx include the Barrx™ 60 RFA Focal Catheter, the Barrx™ Ultra Long RFA Focal Catheter, the Barrx™ Channel RFA Endoscopic Catheter.

In December 2007, the CryoSpray Ablation™ System (formerly the SprayGenix Cryo Ablation system; CSA Medical, Lutherville, MD) was cleared for marketing by the FDA through the 510(k) process for use as a “cryosurgical tool for destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.” The CryoBalloon Ablation System has also been cleared by the FDA through the 510(k) process for use as a cryosurgical tool in surgery for endoscopic applications, including ablation of BE with dysplasia.

In July 2002, the Polar Wand® device (Chek Med Systems, Willington, CT), a cryosurgical device that uses compressed carbon dioxide, was cleared for marketing by the FDA through the 510(k) process. Indications for use are, “ablation of unwanted tissue in the fields of dermatology, gynecology, general surgery, urology, and gastroenterology.”

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

There are no specific CPT codes for radiofrequency or cryoablation of tissue in the esophagus. 

CPT Codes:

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) (includes pre- and post-dilation and guide wire passage, when performed)

43499

unlisted procedure, esophagus

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POLICY HISTORY:

Medical Policy Panel, December 2009

Medical Policy Group, March 2010 (2)

Medical Policy Administration Committee, April 2010

Available for comment April 7-May 21, 2010

Medical Policy Group, June 2010 (3)

Medical Policy Administration Committee, July 2010

Available for comment July 2-August 16, 2010

Medical Policy Group April 2011: Added 2011 Key Points and Reference

Medical Policy Group, September 2011 (1): Update to Key Points and References

Medical Policy Group, April 2012 (3): 2012 Update to Description, Key Points and References

Medical Policy Panel, April 2013

Medical Policy Group, April 2013 (3): 2013 Update to Description, Key Points and References

Medical Policy Group, December 2013 (3):  2014 Coding Update – added new codes 43229 and 43270 (effective 01/01/14); moved to previous coding 43228 and 43258 (deleted effective 01/01/14)

Medical Policy Panel, April 2014

Medical Policy Group, April 2014 (3):  2014 Update to Description, Key Points, Governing Bodies & References; no change in policy statement

Medical Policy Group, November 2014: 2015 Coding Update – Code 43257 wording change.

Medical Policy Panel, April 2015

Medical Policy Group, May 2015 (4):  Updates to Description, Policy statement, Key Points, Approved Governing Bodies, and References.  Policy statement intent did not change; clarification that all other indications of RFA for Barrett Esophagus are investigational.

Medical Policy Panel, November 2015

Medical Policy Group, November 2015 (4):  Updates to Description, Key Points, Approved by Governing Bodies and References; no change to policy statement.

Medical Policy Group, March 2016 (4): Removed CPT code 43257 from policy, as it relates to GERD treatment.

Medical Policy Panel, November 2016

Medical Policy Group, November 2016(4): Updates to Description, Key Points, and References. No change to policy statements.

Medical Policy Panel, December 2017

Medical Policy Group, December 2017 (4): Updates to Key Points and References. No change to policy statements.

Medical Policy Panel, November 2018

Medical Policy Group, December 2018 (4): Updates to Key Points and References.  No change to policy statements.

Medical Policy Panel, November 2019

Medical Policy Group, December 2019 (5): Updates to Description, Key Points, Practice Guidelines, and References. No change to Policy Statement.

Medical Policy Panel, November 2020

Medical Policy Group, November 2020 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, Approved by Governing Bodies, and References. No change to Policy Statement.

Medical Policy Panel, November 2021

Medical Policy Group, November 2021 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. Policy Statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Panel, November 2022

Medical Policy Group, November 2022 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, November 2023

Medical Policy Group, November 2023 (11): Updates to Description, Key Points, Benefit Application, and References. No change to Policy Statement.

Medical Policy Panel, November 2024

Medical Policy Group, November 2024 (11): Updates to Description, Key Points, and References. No change to Policy Statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.