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Endoscopic Radiofrequency Ablation or Cryoablation for Barrett’s Esophagus

Policy Number: MP-417

Latest Review Date: November 2021

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. 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, 1-20 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 personyears, 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.

Management of Barrett Esophagus

The management of Barrett esophagus includes the treatment of GERD, and surveillance endoscopy to detect progression to high-grade dysplasia or adenocarcinoma. The finding of high-grade dysplasia 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). A 2007 study published by Ell et al provided long-term results for EMR in 100 consecutive patients with early Barrett’s associated adenocarcinoma (limited to the mucosa). The five-year overall survival (OS) was 98% and metachronous lesions were observed in 11% of patients after a mean of 36.7 months. In a review by Pech et al, it is stated that circumferential EMR of the entire segment of Barrett’s leads to a stricture rate of 50%, and recurrences occur at a rate of up to 11%.

Ablation techniques

Mucosal ablation techniques that are available consist of one of 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, and cryoablation) or nonthermal (5-aminolevulinic acid [5-ALA] and photofrin photodynamic therapy [PDT]) techniques. PDT has been shown in a randomized Phase III trial, reported by Overholt et al (2005), to significantly decrease the risk of adenocarcinoma in Barrett’s esophagus. (PDT therapy for Barrett’s esophagus is discussed in a separate policy, MP# 337- Oncologic Applications of Photodynamic Therapy, Including Barrett’s Esophagitis).

The CryoSpray Ablation™ System uses a low-pressure spray for spraying liquid nitrogen through an upper endoscope. Cryotherapy allows for treatment of uneven surfaces, however, disadvantages include the uneven application inherent in spraying the cryogen.

The HALO System uses radiofrequency energy and consists of two components: an energy generator and an ablation catheter. The generator provides rapid (i.e., less than one second) delivery of a predetermined amount of radiofrequency energy to the catheter. Both the HALO90 and HALO360 are inserted into the esophagus with an endoscope, using standard endoscopic techniques. The HALO90 catheter is plate-based and used for focal ablation of areas of Barrett’s esophagus up to 3cm. The HALO360 uses a balloon catheter that is sized to fit the individual esophagus, and is inflated to allow for circumferential ablation.

Radiofrequency ablation affects only the most superficial layer of the esophagus (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).Reports of the efficacy of the HALO system in ablating Barrett’s esophagus have been as high as 70% (comparable to alternative methods of ablation [e.g., APC and MPEC]), and even higher in some reports. The incidence of leaving behind microscopic foci of intestinal metaplasia has been reported to be 20%–44% with APC and 7% with MPEC; studies using the HALO system have been 0%. Another potential advantage to the HALO system is that because it is automated, it eliminates operator-dependent error that may be seen with APC and MPEC.

The risk of treating high-grade dysplasia 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 24, 2021.

Summary of Evidence

For individuals who have Barrett Esophagus with HGD who receive endoscopic RFA, the evidence includes an RCT comparing radical endoscopic resection with focal endoscopic resection followed by RFA, an 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 ablative techniques, with a lower progression rate to cancer, and may be considered an alternative to esophagectomy. Evidence from at least 1 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 LGD who receive endoscopic RFA, the evidence includes at least 2 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 from an RCT has suggested that RFA reduces progression to HGD and adenocarcinoma. Challenges exist in differentiating between nondysplastic BE and BE with LGD; thus, a correct diagnosis has important implications for LGD treatment decisions. One of the available RCTs required that LGD be confirmed by an expert panel, which supports the use of having a gastrointestinal pathologist confirm LGD before treatment of BE with LGD can begin. 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. The relevant outcomes are change in disease status, morbid events, and treatment-related morbidity and mortality. The available studies suggest 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 noncomparative 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 generally demonstrate high rates of eradication of dysplasia. However, the available evidence does not allow comparisons 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 2016, the American College of Gastroenterology (ACG) issued guidelines for the diagnosis and management of BE, which makes statements about endoscopic therapies in general, as outlined in Table 1.

Table 1: American College of Gastroenterology Guidelines

Guidelines

Recommendation Strength

Level of Evidence

Patients with nodularity in the BE segment should undergo endoscopic mucosal resection of the nodular lesion(s) as the initial diagnostic and therapeutic maneuver…. Histologic assessment of the EMR specimen should guide further therapy. In subjects with EMR specimens demonstrating HGD, or IMC, endoscopic ablative therapy of the remaining BE should be performed.

Strong

High

In patients with EMR specimens demonstrating neoplasia at a deep margin, residual neoplasia should be assumed, and surgical, systemic, or additional endoscopic therapies should be considered

Strong

Low

Endoscopic ablative therapies should not be routinely applied to patients with nondysplastic BE because of their low risk of progression to EAC. Endoscopic eradication therapy is the procedure of choice for patients with confirmed LGD, and confirmed HGD, as noted above

Strong

Very low

In patients with T1a EAC, endoscopic therapy is the preferred therapeutic approach, being both effective and well tolerated

Strong

Moderate

In patients with T1b EAC, consultation with multidisciplinary surgical oncology team should occur before embarking on endoscopic therapy. In such patients, endoscopic therapy may be an alternative strategy to esophagectomy, especially in those with superficial (sm1) disease with a well-differentiated neoplasm lacking lymphovascular invasion, as well as those who are poor surgical candidates

Strong

Low

Routine staging of patients with nodular BE with EUS or other imaging modalities before EMR has no demonstrated benefit. Given the possibility of over- and understaging, findings of these modalities should not preclude the performance of EMR to stage-early neoplasia

Strong

Moderate

In patients with known T1b disease, EUS may have a role in assessing and sampling regional lymph nodes, given the increased prevalence of lymph node involvement in these patients compared with less advanced disease

Strong

Moderate

In patients with dysplastic BE who are to undergo endoscopic ablative therapy for nonnodular disease, radiofrequency ablation is currently the preferred endoscopic ablative therapy

Strong

Moderate

BE: Barrett esophagus; EAC: esophageal adenocarcinoma; EMR: endoscopic mucosal resection; EUS: endoscopic ultrasound; HGD: high grade dysplasia; IMC: intramucosal carcinoma; LGD: low- grade dysplasia.

American Society for Gastrointestinal Endoscopy

The American Society for Gastrointestinal Endoscopy (2018) 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 2).

Table 2. Guidelines on Use of Endoscopy for BE and IMC

Recommendations

SOR

QOE

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; HGD: high-grade dysplasia; LGD: low-grade dysplasia; IMC: intramucosal cancer; QOE: quality of evidence; SOR: strength of recommendation; a Quality assessed using GRADE system.

American Gastroenterological Association (AGA)

In 2020, the American Gastroenterological Association published a best practice clinical update on the role of endoscopic therapy in patients with BE with dysplasia and/or early cancer. This best practice document was not based on a formal systematic review; thus, no ratings for strength of recommendation and quality of evidence were not provided.

For BE with LGD, best practice advice included the following:

  • "The reading of LGD in BE should be confirmed by an experienced gastrointestinal pathologist."
  • "In BE patients with confirmed LGD, a repeat examination within 3–6 months with HD-WLE [high-definition white-light endoscopy] and preferably optical chromoendoscopy should be performed to rule out the presence of a visible lesion, which should prompt endoscopic resection (see section on HGD)."
  • "Both BET [Barrett's endoscopic therapy] and continued surveillance are reasonable options for the management of BE patients with confirmed and persistent LGD."

For BE with HGD, best practice advice included the following:

  • "The reading of HGD in BE should be confirmed by an experienced gastrointestinal pathologist."
  • "The diagnosis of flat HGD should prompt a repeat HD-WLE (6–8 weeks) to evaluate for the presence of a visible lesion; these visible lesions should be removed by EMR [endoscopic mucosal resection]."
  • "BET is the preferred treatment, over esophagectomy, for BE patients with HGD."

Society of American Gastrointestinal and Endoscopic Surgeons

In 2010, the Society of American Gastrointestinal and Endoscopic Surgeons published guidelines on the surgical treatment of GERD, which included recommendations for the treatment of BE. (see table 3)

Table 3: Guidelines on Surgical Treatment of GERD

Guidelines

Grade

HGIN and IMC can be effectively treated with endoscopic therapy including PDT, EMR, and RFA, alone or in combination

B

Antireflux surgery may be performed in a patient with non-neoplastic IM, IND, or LGIN, with or without endoscopic therapy to eradicate the Barrett’s tissue. Specifically, RFA has been shown to be safe, clinically effective, and cost-effective in these disease states and may be performed in eligible patients before, during, or after antireflux surgery

B

EMR: endoscopic mucosal resection; HGIN: high-grade dysplasia; IM: intestinal metaplasia; IMC: intramucosal carcinoma; IND: indeterminate dysplasia ;LGIN: low-grade dysplasia; PDT: photodynamic therapy; RFA: radiofrequency ablation.

National Comprehensive Cancer Network

National Comprehensive Cancer Network guidelines (v.4.2021) Esophageal and Esophagogastric 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 Barrett’s 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.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

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.

 

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.