218 Form

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Medical Policy Endoscopic Radiofrequency Ablation or Cryoablation for Barrett Esophagus Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 218 BCBSA Reference Number: 2.01.80 (For Plans internal use only) NCD/LCD: NA Related Policies
• Oncologic Applications of Photodynamic Therapy, Including Barrett Esophagus, #454 • Confocal Laser Endomicroscopy, #618 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

Radiofrequency ablation may be considered MEDICALLY NECESSARY for treatment of Barrett esophagus with high-grade dysplasia.

Radiofrequency ablation may be considered MEDICALLY NECESSARY for treatment of Barrett esophagus with low-grade dysplasia, when the initial diagnosis of low-grade dysplasia is confirmed by two pathologists.

Radiofrequency ablation is considered INVESTIGATIONAL for treatment of Barrett esophagus when the above criteria are not met, including but not limited to Barrett esophagus in the absence of dysplasia.

Cryoablation is considered INVESTIGATIONAL for Barrett esophagus, with or without dysplasia.

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

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Outpatient Commercial Managed Care (HMO and POS) Prior authorization is not required. Commercial PPO and Indemnity Prior authorization is not required. Medicare HMO BlueSM Prior authorization is not required. Medicare PPO BlueSM Prior authorization is not required. CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.
Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list.

The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue: CPT Codes
CPT codes:

Code Description 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) ICD-10 Diagnosis Codes ICD-10-CM Diagnosis codes: Code Description D13.0 Benign neoplasm of esophagus 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

Description 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).1, 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%.2,

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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.3,4, 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.5, 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.6, 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.7, Curvers et al (2010) tested this hypothesis in 147 patients with BE who were given an initial diagnosis of LGD.8, 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 Phoa et al (2014), which required confirmation of LGD by a central expert panel following initial diagnosis by a local pathologist.9, 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.10, 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 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).11, 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%.12, Ablative 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

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Overholt et al (2005), photodynamic therapy was shown to decrease significantly the risk of adenocarcinoma in BE.13, (Photodynamic therapy for BE is discussed in policy #454.) 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%.14, 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.12, Summary In Barrett esophagus (BE), the normal squamous epithelium is replaced by specialized columnar-type epithelium, known as intestinal metaplasia. Intestinal metaplasia is a precursor to adenocarcinoma and may be treated with mucosal ablation techniques such as radiofrequency ablation (RFA) or cryoablation. For individuals who have Barrett esophagus (BE) with high-grade dysplasia (HGD) who receive endoscopic radiofrequency ablation (RFA) , the evidence includes a randomized controlled trial (RCT) comparing radical endoscopic resection with focal endoscopic resection followed by RFA, 1 RCT comparing RFA with surveillance alone, and 2 systematic reviews 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 1 RCT has demonstrated higher rates of eradication than surveillance alone. Both systematic reviews demonstrated a more favorable safety profile for RFA compared to endoscopic mucosal resection. 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 3 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

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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. Policy History Date Action 1/2026 Annual policy review. Policy updated with literature review through September 11, 2025; references added. Policy statements unchanged. 1/2025 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2024 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2023 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2022 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2021 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2020 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2019 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2018 Annual policy review. New references added 12/2016 Annual policy review. New references added 1/2016 Annual policy review. New references added 6/2015 Annual policy review. Investigational indications clarified. Added coding language. Effective 6/1/2015. 7/2014 Annual policy review. New references added. 5/2014 Updated Coding section with ICD10 procedure and diagnosis codes. Effective 10/2015. 1/2014 Updated to add new CPT code 43229 and remove deleted code 43228 9/2012 Added coverage for RFA for treatment of Barrett’s esophagus with low-grade dysplasia.
Effective 9/1/2012. 11/2011- 4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates.
No changes to policy statements.
10/2011 Reviewed - Medical Policy Group – GI, Nutrition and Organ Transplantation. No changes to policy statements. 3/2011 Reviewed - Medical Policy Group – Allergy/Asthma/Immunology and ENT/Otolaryngology. No changes to policy statements. 8/1/2010 Medical Policy #218 effective 8/1/2010 describing covered and non-covered indications.
Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References

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2. Hvid-Jensen F, Pedersen L, Drewes AM, et al. Incidence of adenocarcinoma among patients with Barrett's esophagus. N Engl J Med. Oct 13 2011; 365(15): 1375-83. PMID 21995385

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3. Downs-Kelly E, Mendelin JE, Bennett AE, et al. Poor interobserver agreement in the distinction of high-grade dysplasia and adenocarcinoma in pretreatment Barrett's esophagus biopsies. Am J Gastroenterol. Sep 2008; 103(9): 2333-40; quiz 2341. PMID 18671819
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