Medical Policy



Subject: Ablative Techniques as a Treatment for Barrett's Esophagus
Document #: SURG.00106 Current Effective Date:    03/29/2017
Status: Reviewed Last Review Date:    02/02/2017

Description/Scope

This document addresses the use of the following ablative techniques for treating Barrett's esophagus: radiofrequency ablation, cryoablation, laser ablation, argon plasma coagulation, and electrocoagulation.

Position Statement

Medically Necessary:

Radiofrequency ablation, as an alternative to esophagectomy, is considered medically necessary in individuals with:

Radiofrequency ablation is considered medically necessary in individuals with Barrett's esophagus with low-grade dysplasia (LGD) on biopsy with confirmation of the biopsy finding of LGD by two independent physicians.**

**Note: The American Gastroenterological Association recommends that LGD should be confirmed by two pathologists since published studies have reported higher rates of progression of LGD when initial readings have been confirmed by expert pathologists, thereby eliminating or minimizing the rate of false positive diagnoses of LGD.

Investigational and Not Medically Necessary:

Radiofrequency ablation as a treatment for Barrett's esophagus is considered investigational and not medically necessary for all other indications.

Cryoablation as a treatment for Barrett's esophagus is considered investigational and not medically necessary.

Laser ablation as a treatment for Barrett's esophagus is considered investigational and not medically necessary.

Argon plasma coagulation as a treatment for Barrett's esophagus is considered investigational and not medically necessary.

Electrocoagulation as a treatment for Barrett's esophagus is considered investigational and not medically necessary.

Rationale

Barrett's esophagus is defined as metaplasia of the esophageal epithelium, with normal squamous epithelium replaced by columnar epithelium containing goblet cells, also known as intestinal metaplasia. This change is associated with gastroesophageal reflux disease. Approximately 10% of individuals with chronic reflux have Barrett's esophagus, and the prevalence of the condition in a recent population study was 1.6%. The condition is associated with an increased risk of esophageal adenocarcinoma. The incidence of this once rare cancer has increased by more than 500% since the 1970s. The cancer remains highly lethal, with a 5-year survival rate of less than 15% (Shaheen, 2009).

The National Comprehensive Cancer Network® guidelines on Esophageal and Esophagogastric Junction Cancers (2016) indicate that radiofrequency ablation is the preferred treatment for those individuals with Barrett's esophagus and high-grade dysplasia (HGD). Cryoablation and photodynamic therapy can be alternative therapies.

Barrett's esophagus is an important risk factor in the development of adenocarcinoma of the esophagus. Standard surgical treatment for Barrett's esophagus with HGD or adenocarcinoma includes, but is not necessarily limited to esophageal resection (esophagectomy). Esophagectomy, although almost always curative of HGD and adenocarcinoma of the esophagus, can be associated with significant mortality and morbidity. Because the incidence of HGD and cancer increases with age, it is reasonable to assume that the probability of comorbid illness in older individuals might further increase the morbidity and mortality associated with esophagectomy. Due to the morbidity and mortality associated with this procedure, as well as the fact that some individuals are not surgical candidates, less invasive treatment options, including various ablative techniques, are being investigated.

A meta-analysis and systematic review by Wani and colleagues (2009) reports on the incidence of esophageal cancer in those individuals with Barrett's esophagus after ablative therapy compared to those individuals with Barrett's esophagus who have not received ablative therapy. Three diagnoses were reported: individuals with non-dysplastic Barrett's esophagus, individuals with LGD, and individuals with HGD. In individuals with non-dysplastic Barrett's esophagus, the incidence of cancer in the surveillance group was 5.98 per 1000 patient-years, the ablative group was 1.63 per 1000 patient-years. For those with LGD in the surveillance group the incidence of cancer was 16.98 per 1000 patient-years, the ablative group showed 1.58 per 1000 patient-years. HGD surveillance individuals had an incidence of cancer of 65.8 per 1000 patient-years while the ablative group had an incidence of 16.76 per 1000 patient-years. Some limitations to the review are the inclusion of cohort studies instead of randomized trials, there is potential for publication bias in the reported studies, and potential complications were not assessed. The review suggests that ablation is associated with lower rates of progression to cancer when compared to surveillance only. The authors do note that spontaneous regression of LGD has been reported and most of the individuals with non-dysplastic Barrett's esophagus and LGD won't benefit from ablation. Those with HGD appear to achieve the highest benefit from ablation.

In 2011, Hvid-Jensen reported on a cohort study which analyzed the data of 11,028 individuals with Barrett's esophagus for a median of 5.2 years. The authors sought to determine the incidence of esophageal adenocarcinoma and HGD among individuals with Barrett's esophagus. After initial endoscopy and within the first year, 131 new cases of adenocarcinoma were diagnosed. During the subsequent years, 66 new cases of adenocarcinoma were diagnosed showing an incidence rate for adenocarcinoma to be 1.2 cases per 1000 person-years. Detection of LGD was determined to be 5.1 cases per 1000 person-years. The authors found that while Barrett's esophagus is a risk factor for esophageal carcinoma, the absolute annual risk was 0.12% which is lower than the assumed risk of 0.5%. The authors concluded that "the risk of esophageal adenocarcinoma among patients with Barrett's esophagus is so minor that in the absence of dysplasia, routine surveillance of such patients is of doubtful value."

Radiofrequency Ablation
Shaheen and colleagues (2009) conducted a multicenter, sham-controlled trial, in which 127 individuals with dysplastic Barrett's esophagus were randomly assigned in a 2:1 ratio to receive either radiofrequency ablation or a sham procedure (control group). Participants were randomized according to the length of Barrett's esophagus and the grade of dysplasia. In the intention-to-treat analyses, among individuals with HGD, complete eradication occurred in 81.0% of those in the ablation group, compared to 19.0% of those in the control group (p<0.001). Among participants with LGD, complete eradication of dysplasia occurred in 90.5% of those in the ablation group, compared to 22.7% of those in the control group (p<0.001). Participants in the ablation group experienced complete eradication of intestinal metaplasia at a rate of 77.4% versus 2.3% of those in the control group (p<0.001). Participants in the ablation group had a lesser amount of disease progression (3.6% vs. 16.3%, p=0.03) and a smaller incidence of cancers (1.2% vs. 9.3%, p=0.045). The number of sessions of radiofrequency ablation varies among individuals. Typically sessions are repeated until eradication of Barrett's esophagus is complete. Chest pain was reported more frequently after the ablation procedure than after the sham procedure. In the ablation group, 5 subjects (6.0%) had esophageal stricture and there was 1 incident of upper gastrointestinal hemorrhage. The authors concluded that in individuals with dysplastic Barrett's esophagus, radiofrequency ablation was associated with a reduced risk of disease progression and a high rate of complete eradication of both dysplasia and intestinal metaplasia. With regard to effectiveness of radiofrequency ablation in LGD vs. HGD, Shaheen (2009) demonstrated the ability of radiofrequency ablation to eradicate dysplasia and intestinal metaplasia over the course of 12 months in participants with LGD as well as HGD. However, the study authors were cautious in automatically generalizing the study's results to all participants with LGD. In summary, while the risk-benefit calculus on the use of radiofrequency ablation in participants with Barrett's esophagus and HGD may suggest incremental benefit in terms of both potentially reducing need for esophagectomy and progression to cancer, the evidence at this time seems less compelling in participants with LGD, who have a 10 times lesser chance of progression to cancer and for whom frequent endoscopic surveillance remains standard treatment practice.

A multicenter randomized trial by Phoa and colleagues (2014) looked at 136 participants with confirmed diagnosis of Barrett's esophagus with LGD. The participants were randomized to radiofrequency ablation (n=68) or endoscopic surveillance (n=68) (control group). Using a 3-year follow-up period, the participants were followed to determine whether there was neoplastic progression to HGD or adenocarcinoma. Of the participants in the ablation group, complete eradication of dysplasia occurred in 92.6% and 27.9% in the control group. 

A recent study by Haidry and colleagues (2015) looked at 508 individuals with Barrett's esophagus who received radiofrequency ablation and/or endoscopic mucosal resection. Outcomes included the clearance of dysplasia as evidenced by no biopsy-proven residual dysplasia and no evidence of intestinal metaplasia on biopsy at the end of treatment. The participants were assessed over two time periods (2008-2010 and 2011-2013). A total of 266 participants were assessed at the end of the first time period and 77% of participants achieved clearance of dysplasia while 57% of participants achieved reversal of intestinal metaplasia. By the 12-month follow-up period, 9 participants progressed to invasive cancer and 18 more participants developed invasive cancer by the median follow-up period of 31 months. For the second time period, 242 participants were treated. At the 12-month follow-up, 92% of participants achieved complete reversal of dysplasia and 83% of participants achieved complete reversal of intestinal metaplasia and 2.1% of participants progressed to invasive cancer. While surgical resection is an option, this study supports the use of radiofrequency ablation as an alternative to more invasive surgery with improvements in outcome over time due to improved imaging and skill levels.

In 2011, the American Gastroenterological Association (AGA) released its medical position statement on the management of Barrett's esophagus. They note that there is difficulty distinguishing an accurate degree of dysplasia (low-grade, high-grade, or nondysplastic Barrett's esophagus) due to the architecture and aberrancies of the esophagus and that there are no well-defined cut-off points that separate LGD from HGD. The risk of progression from LGD to HGD or adenocarcinoma is not well-known and varies greatly. Rates of progression have been reported as low as 0.22% per year (Bhat, 2011) to 13.4% (AGA, 2011). Despite some variations in determining the risk of progression from LGD to HGD, the AGA report concludes that radiofrequency ablation should be a therapeutic option for those with confirmed LGD in Barrett's esophagus. Radiofrequency ablative therapy for those individuals with Barrett's esophagus with LGD leads to reversion to normal-appearing squamous epithelium in greater than 90% of cases and the reversion to squamous epithelium can persist for up to 5 years.

According to the American College of Gastroenterology (Shaheen, 2016), endoscopic ablative therapy would be recommended for those individuals with Barrett's esophagus and for those with LGD.

Cryoablation
Cryoablation involves the use of extreme cold to destroy diseased tissue. Johnston (2005) reported on a pilot study for a new modality using low-pressure spray cryoablation with endoscopy for individuals with Barrett's esophagus. Eleven participants with Barrett's esophagus were treated with cryoablation. Nine out of the 11 participants completed the protocol and reversal of Barrett's esophagus was achieved in all 9 individuals with cryoablation and high-dose proton pump inhibitor. During the 6-month follow-up surveillance endoscopy, 2 of the 9 participants developed fragments of intestinal metaplasia. Eradication of the Barrett's esophagus was achieved in 7 of the 9 participants (78%) who completed the protocol. With intention-to-treat analysis, eradication of Barrett's esophagus was achieved in 64% of participants. It must be noted that the primary author of this study is the inventor of the described device.

In 2009, Dumot and colleagues published the results of an open-label prospective study of cryoablation for Barrett's esophagus. The purpose of the study was to 1) determine whether cryoablation is safe for the treatment of Barrett's esophagus with dysplasia and neoplasia and 2) determine whether efficacy is sufficient enough to warrant investigation in larger studies. Thirty participants received cryoablation for treatment of high-grade dysplasia Barrett's esophagus or intramucosal carcinoma. Responses were achieved in 27 of the 30 participants (90%). With a median follow-up of 12 months, 68% of participants with HGD and 80% of participants with intramural carcinoma had persistent responses to treatment. The authors concluded that "further study with long-term follow-up is necessary and is currently under way to determine the role of cryoablation in the endoscopists' armamentarium."

In a prospective study, Greenwald (2010) reports on the safety, tolerability and efficacy of cryoablation. A total of 77 individuals were enrolled and received cryoablation for diagnoses of metaplasia, LGD, HGD, intramucosal carcinoma, invasive carcinoma, and severe squamous dysplasia. Of the 17 individuals with HGD who had completed therapy, 94% had complete eradication. Overall the cryoablation was well tolerated. The most common complaint was mild chest pain or discomfort (reported in 13.9% of the procedures). Other complaints included severe chest pain (3.7%), dysphagia (13.3%), odynophagia (12.1%) and sore throat (9.6%).

Shaheen (2010) reported on a retrospective analysis of 98 subjects who underwent cryoablation for Barrett's esophagus and HGD. Of the 98 subjects enrolled in the study, 60 completed all planned cryoablation treatments. Fifty-eight participants (97%) had complete eradication of HGD. No serious adverse events or perforations were reported. The study is limited by short follow-up of 10.5 months, no randomization and retrospective nature without a control group.

While cryoablation shows promise for the treatment of dysplasia and neoplasm of the esophagus, studies are limited to short-term follow-up and the evidence appears incomplete. Additional long-term studies are needed to determine the effectiveness, safety and tolerability.

Laser Ablation
Weston and colleagues (2002) reported on the safety and efficacy of laser ablation of Barrett's esophagus and HGD. Seventeen participants received laser ablation therapy for high-grade dysplasia. Three participants exited the study. Of the 14 participants who remained in the study, all had successful eradication of their HGD and/or cancer. Also 11 participants achieved histologic and endoscopic ablation of all Barrett's esophageal tissue. Seven of the 11 participants with complete ablation had subsequent follow-up ranging from 2-36 months. Four of the 7 participants demonstrated regrowth, 2 have been successfully treated with an electrosurgical generator and 2 have been successfully treated with laser ablation. While treatment appears promising, the authors conclude "there is a need for additional controlled trials with a larger number of patients and longer follow-up, as well as for consideration of a head-to-head trial with Photofrin PDT."

In 2004, Norberto and colleagues reported on 15 individuals with Barrett's esophagus who underwent laser ablation treatment. The individuals received laser therapy sessions for the first 3 months then every 3 months during the first year of treatment. Therapy continued until the Barrett's esophagus was completely eradicated. Follow-up ranged from 7-61 months. Complete regression was achieved in 6 of the 15 individuals (40%).

Argon Plasma Coagulation
Argon plasma coagulation involves the use of ionized argon gas to deliver a high-frequency current to destroy diseased tissue. In 2007, Mork and colleagues reported on 25 individuals who received argon plasma coagulation and a proton-pump inhibitor prior to and following the ablation procedure. The individuals received endoscopic surveillance every 3 months during the first year following complete eradication of the glandular epithelium. Follow-up was 51 months and recurrence of Barrett's esophagus was detected in 14 of the 25 individuals. Four individuals were lost during the study: 1 was excluded for compliance issues, 1 refused further argon plasma coagulation sessions and 2 others had only incomplete squamous restoration after 3 and 4 treatment sessions. One individual had relapse of Barrett's esophagus 3 times and was treated by argon plasma coagulation 11 times. This individual eventually had laparoscopic fundoplication. Seven individuals had no recurrence during the follow-up period. Seven individuals had the first recurrence of Barrett's esophagus detectable by microscope. Seven individuals had relapse detectable endoscopically and histologically during the same endoscopy. This study shows a relapse rate of approximately two-thirds after eradication of Barrett's esophagus after argon plasma coagulation. Success rates may be dependent on the thermic energy applied and the proton pump inhibitor schedule. Higher energy may carry more risks, but no standards have been established for this procedure yet.

Formentini (2007) reported on a retrospective analysis of the efficacy of ablation of Barrett's esophagus using argon plasma coagulation followed by fundoplication. Twenty-one individuals met study criteria and were the population. All individuals received argon plasma coagulation treatments approximately every 4-6 weeks until the metaplastic epithelium was completely ablated. Then all individuals underwent Nissen fundoplication. Response to treatment was measured with endoscopy every 6-12 months. Postoperatively 17 out of 21 participants had at least 1 endoscopic control. Recurrence of Barrett's esophagus was observed in 6 of the 17 participants. Five of the 6 participants had ablation by argon plasma coagulation (one participant refused) and were disease-free at the writing of this article. The authors acknowledge that "further studies are required to clarify the role of ablation's procedure in the treatment of BE."

Bright (2009) reported on a randomized controlled trial which compared 57 participants with Barrett's esophagus to undergo argon plasma coagulation or annual endoscopic surveillance. Another endoscopy was scheduled at 12 months for both groups of participants and biopsies were taken. The biopsies were examined by a pathologist who was unaware of the previous treatment (argon plasma coagulation or surveillance). At 12 months, 14 out of 23 participants who had received argon plasma coagulation showed at least 95% ablation of the metaplastic mucosa and 9 participants had complete regression of Barrett's esophagus. None of the individuals who had surveillance endoscopy had more than 95% regression. While these results look promising, ablation with argon plasma coagulation is more time-consuming than routine surveillance endoscopy, participants who have had argon plasma coagulation still need endoscopic surveillance and in this particular study, at least some of the metaplastic columnar mucosa recurred during the first 12 months. While the recurrences were small, it is not possible to predict which individuals will have recurrence and the outcomes at 12 months were not as good as immediately following the treatment. The authors have concluded that argon plasma coagulation "should probably remain within clinical trials."

Manner and colleagues (2014) reported on 63 participants who had been curatively resected of Barrett's neoplasia by endoscopy and were randomized to receive either argon plasma coagulation (n=33) or surveillance only (n=30). The primary outcome was recurrence-free survival. During the follow-up period of 2 years, in the ablation group 1 secondary lesion was found and 11 secondary lesions were found in the surveillance group. While the results showed fewer secondary lesions following argon plasma coagulation, this study was limited by its small group size and according to the authors a "limited follow-up of 2 years."

Electrocoagulation
In 1999, Sharma and colleagues reported on 6 individuals with Barrett's esophagus who received laser treatment and electrocoagulation. The number of electrocoagulation sessions ranged from 1-5. Follow-up ranged from 9-86 months. Complete ablation was achieved. However, the authors concluded that "Despite the success achieved in this group of patients, the use of such therapy as an alternative to surgery in all patients with early Barrett's cancer is not currently recommended."

At this time, the key gastroenterological societies (American College of Gastroenterology, AGA and American Society of Gastrointestinal Endoscopy) do not have any guidelines or position statements endorsing laser ablation, argon plasma ablation or electrocoagulation as a treatment for Barrett's esophagus. Current literature consists primarily of uncontrolled studies with small group sizes, with only a limited number of randomized controlled trials comparing treatments for Barrett's esophagus. While these endoscopic techniques are promising in terms of treating Barrett's esophagus, few long-term results are available (Li, 2008). The authors of a Cochrane review in 2010 concluded that ablative therapies have a role in the management of Barrett's esophagus, however; "more clinical trial data and in particular randomized controlled trials are required to assess whether or not the cancer risk is reduced in routine clinical practice."

Devices 
At least two radiofrequency devices have been approved by the Food and Drug Administration (FDA). The HALO360 Coagulation Catheter (BARRX Medical Inc., Sunnyvale, CA) is marketed to be used in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract. Clinical indications include but are not limited to Barrett's esophagus. The HALO System is reported to provide uniform and controlled heat therapy which removes the thin layer of diseased esophageal tissue. The HALO360 Ablation Catheter can provide radiofrequency energy fully around the esophageal circumference, as well as in smaller areas of the esophagus. The HALO90 ablation catheter (BARRX Medical Inc., Sunnyvale, CA) is a similar device but does not deliver energy circumferentially and is generally used to treat smaller areas. The procedure is typically carried out in the outpatient setting with the individual undergoing conscious sedation during endoscopy. According to the manufacturer's website, the HALO360 is now known as the Barrx RFA Balloon Catheter and the HALO90 is now known as the Barrx 90 RFA Focal Catheter.

In 2007, the FDA gave 510(k) clearance for marketing of a cryosurgical tool to destroy unwanted tissue, specifically for endoscopic applications. Since that time additional devices have also received 510(k) clearance.

For argon plasma coagulation, the FDA has given 510(k) clearance to several devices, one of which includes the ERBE VI0 APC (Model APC 2) (ERBE USA, Inc, Marietta, GA). Its intended use is to deliver argon gas for argon plasma coagulation of tissue.

Background/Overview

Barrett's esophagus is a precancerous condition in which a thin layer of tissue lining the lower esophagus is damaged due to chronic acid reflux. The presence of Barrett's esophagus is associated with an increased risk of developing cancer of the esophagus. Surgical treatment options for Barrett's esophagus include but are not necessarily limited to esophagectomy and endoscopic mucosal resection.

Barrett's esophagus occurs as a result of chronic gastroesophageal acid reflux (GERD), a condition that affects approximately 20% of the adult population in the United States. Esophageal cancer frequently arises from untreated Barrett's esophagus. Generally speaking, once precancerous changes are discovered, the lower esophagus is either surgically removed or the lining of the esophagus must be destroyed using endoscopic ablative techniques. Ablative techniques have been developed in an attempt to reverse Barrett's esophagus. Ablative techniques can be categorized as heat or cold injury such as electrocoagulation, argon plasma coagulation, radiofrequency ablation, cryoablation and laser ablation (neodymium-yttrium aluminum garnet [Nd-YAG] and potassium titanium phosphate [KTP]) and photochemical injury such as photodynamic therapy.

Radiofrequency ablation is a procedure that uses radio waves and heat to destroy abnormal cells. During radiofrequency ablation, the physician uses a three component system of a sizing balloon, an ablative energy generator and an ablation catheter. The balloon catheter is placed into the esophagus during endoscopy. After the balloon is inflated, radiofrequency energy is delivered, purportedly removing the diseased tissue lining the esophagus. The HALO System is being investigated as a less invasive treatment for Barrett's esophagus, providing uniform and controlled heat therapy to remove the thin layer of abnormal esophageal tissue.

Cryoablation is being investigated as another treatment for Barrett's esophagus. This involves the use of low-pressure liquid nitrogen spray being administered through a standard endoscopy to the diseased tissue.

Laser ablation involves the use of high-intensity light to treat cancer. For the esophagus, Nd:YAG lasers are applied through an endoscope, the light is precisely aimed at the diseased tissue, which is destroyed.

Argon plasma coagulation is a non-contact thermal method of delivering an electrical current by way of argon gas to the targeted tissue. The argon gas flows through a catheter that is passed through an endoscope. When the argon gas flows over the electrode it becomes ionized. A spark ionizes the argon gas as it is sprayed from the tip of the catheter in the direction of the targeted tissue and produces tissue coagulation. Argon plasma coagulation allows for treatment of a large surface area.

Electrocoagulation uses a fine wire probe to deliver radio waves to tissues near the probe. The radio waves cause the tissue to vibrate which increases temperature causing coagulation and leading to destruction of the tissue. Electrocoagulation can be either monopolar or bipolar. For individuals with an implantable device such as a pacemaker or automatic defibrillator, bipolar is the preferred method because the electrical current does not travel beyond the depth of thermal injury and disrupt the programming of these devices.

Definitions

Argon plasma coagulation: A non-contact thermal technique which uses ionized argon gas to deliver a high-frequency current which coagulates tissue.

Barrett's esophagus: A complication due to chronic severe gastroesophageal reflux disease (GERD), in which the cells that line the esophagus near the stomach become pre-cancerous; resulting in an increased risk of cancer of the esophagus (adenocarcinoma).

Cryoablation: A technique which removes cancerous tissue by killing it with extreme cold.

Electrocoagulation: The use of thermal energy to destroy abnormal tissue.

Endoscopic mucosal resection (EMR): A surgical technique in which fluid is injected into the submucosa, (the layer of the gastrointestinal tract immediately below the mucosa), to elevate the mucosa and allow it to be grabbed with a snare.

Esophagectomy: The surgical removal of a portion of the esophagus; the remaining esophagus is reattached to the stomach so the individual can still swallow.

Laser ablation: The use of high intensity light to treat cancer and other illnesses.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

CPT  
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) [when specified as radiofrequency ablation]
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) [when specified as radiofrequency ablation]
   
ICD-10 Procedure  
  For the following codes when specified as radiofrequency ablation:
0D514ZZ Destruction of upper esophagus, percutaneous endoscopic approach
0D518ZZ Destruction of upper esophagus, via natural or artificial opening endoscopic
0D524ZZ Destruction of middle esophagus, percutaneous endoscopic approach
0D528ZZ Destruction of middle esophagus, via natural or artificial opening endoscopic
0D534ZZ Destruction of lower esophagus, percutaneous endoscopic approach
0D538ZZ Destruction of lower esophagus, via natural or artificial opening endoscopic
0D544ZZ Destruction of esophagogastric junction, percutaneous endoscopic approach
0D548ZZ Destruction of esophagogastric junction, via natural or artificial opening endoscopic
0D554ZZ Destruction of esophagus, percutaneous endoscopic approach
0D558ZZ Destruction of esophagus, via natural or artificial opening endoscopic
   
ICD-10 Diagnosis  
K22.710-K22.719 Barrett's esophagus with dysplasia

When services are Investigational and Not Medically Necessary:
For the procedure and diagnosis codes listed above when criteria are not met, for the following diagnosis code, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

ICD-10 Diagnosis  
K22.70 Barrett's esophagus without dysplasia

When services are also Investigational and Not Medically Necessary:

CPT  
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) [when specified as cryoablation, laser ablation, electrocoagulation or argon plasma coagulation]
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) [when specified as cryoablation, laser ablation, electrocoagulation or argon plasma coagulation]
   
ICD-10 Procedure  
  For the following codes when specified as cryoablation, laser ablation, electrocoagulation or argon plasma coagulation:
0D514ZZ Destruction of upper esophagus, percutaneous endoscopic approach
0D518ZZ Destruction of upper esophagus, via natural or artificial opening endoscopic
0D524ZZ Destruction of middle esophagus, percutaneous endoscopic approach
0D528ZZ Destruction of middle esophagus, via natural or artificial opening endoscopic
0D534ZZ Destruction of lower esophagus, percutaneous endoscopic approach
0D538ZZ Destruction of lower esophagus, via natural or artificial opening endoscopic
0D544ZZ Destruction of esophagogastric junction, percutaneous endoscopic approach
0D548ZZ Destruction of esophagogastric junction, via natural or artificial opening endoscopic
0D554ZZ Destruction of esophagus, percutaneous endoscopic approach
0D558ZZ Destruction of esophagus, via natural or artificial opening endoscopic
   
ICD-10 Diagnosis  
K22.70-K22.719 Barrett's esophagus
   
References

Peer Reviewed Publications:

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  25. Sharma P, Jaffe PE, Bhattacharyya A, Sampliner RE. Laser and multipolar electrocoagulation ablation of early Barrett's adenocarcinoma: long-term follow-up. Gastrointest Endosc. 1999; 49(4 Pt 1):442-446.
  26. Sharma VK, Wang KK, Overholt BF, et al. Balloon-based, circumferential, endoscopic radiofrequency ablation of Barrett's esophagus: 1-year follow-up of 100 patients. Gastrointest Endosc. 2007; 65(2):185-195.
  27. Sharma P, Wani S, Weston AP, et al. A randomised controlled trial of ablation of Barrett's oesophagus with multipolar electrocoagulation versus argon plasma coagulation in combination with acid suppression: long term results. Gut. 2006; 55(9):1233-1239.
  28. Smith CD, Bejarano PA, Melvin WS, et al. Endoscopic ablation of intestinal metaplasia containing high-grade dysplasia in esophagectomy patients using a balloon-based ablation system. Surg Endosc. 2007; 21(4):560-569.
  29. Wani S, Puli SR, Shaheen NJ, et al. Esophageal adenocarcinoma in Barrett's esophagus after endoscopic ablative therapy: a meta-analysis and systematic review. Am J Gastroenterol. 2009; 104(2):502-513.
  30. Wani S, Sayana H, Sharma P. Endoscopic eradication of Barrett's esophagus. Gastrointest Endosc. 2010; 71(1):147-166.
  31. Weston AP, Sharma P. Neodymium:yttrium-aluminum garnet contact laser ablation of Barrett's high grade dysplasia and early adenocarcinoma. Am J Gastroenterol. 2002; 97(12):2998-3006.
  32. Wolfsen HC. Endoprevention of esophageal cancer: endoscopic ablation of Barrett's metaplasia and dysplasia. Expert Rev Med Devices. 2005; 2(6):713-723.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Gastroenterological Association, Spechler SJ, Sharma P, et al. American Gastroenterological Association medical position statement on the management of Barrett's esophagus. Gastroenterology. 2011; 140(3):1084-1091.
  2. American Society for Gastrointestinal Endoscopy. Technology status evaluation report: Mucosal ablation devices. 2008. Available at: http://www.asge.org/clinicalpractice/clinical-practice.aspx?id=358. Accessed on December 20, 2016.
  3. Blue Cross Blue Shield Association. Radiofrequency ablation of nondysplastic and low-grade dysplastic Barrett's esophagus. TEC Assessment, 2010; 27(3).
  4. National Institute for Health and Clinical Excellence. Clinical guideline 106. Barrett's oesophagus: Ablative therapy for the treatment of Barrett's oesophagus. August 2010. Available at: http://guidance.nice.org.uk/CG106. Accessed on December 20, 2016.
  5. NCCN Clinical Practice Guidelines in Oncology ™ © 2016 National Comprehensive Cancer Network, Inc. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on December 20, 2016. 
    • Esophageal and Esophagogastric Junction Cancers (V.2.2016). Revised July 7, 2016.
  6. Rees JRE, Lao-Sirieix P, Wong A, Fitzgerald RC. Treatment for Barrett's oesophagus. Cochrane Database Syst Rev. 2013;(6):CD004060.
  7. Shaheen NJ, Falk GW, Iyer PG, et al. ACG Clinical Guideline: diagnosis and management of Barrett's esophagus. Am J Gastroenterol. 2016; 111(1):30-50. Available at: http://gi.org/guideline/diagnosis-and-management-of-barretts-esophagus/. Accessed on December 20, 2016.
  8. U.S. Food and Drug Administration 510(k) Premarket Notification Database. HALO90 Coagulation System Summary of Safety and Effectiveness. No. K062441. Rockville, MD: FDA. November 14, 2006. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062441.pdf. Accessed on December 20, 2016.
  9. U.S. Food and Drug Administration 510(k) Premarket Notification Database. HALO360 Energy Generator Summary of Safety and Effectiveness. No. K082202. Rockville, MD: FDA. October 08, 2008. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/K082202.pdf. Accessed on December 20, 2016.
  10. U.S. Food and Drug Administration 510(k) Premarket Notification Database. ERBE VI0 APC (Model APC 2) with Accessories. Summary of Safety and Effectiveness. No. K024047. Rockville, MD: FDA. January 8, 2003. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/k024047.pdf. Accessed on , 2016.
Index

Argon plasma coagulation
Barrett's esophagus
Barrx 360 RFA Balloon Catheter
Barrx 90 RFA Focal Catheter
Cryoablation
Electrocoagulation
Laser ablation
Radiofrequency ablation

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Reviewed 02/02/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Rationale and References sections.
Reviewed 02/04/2016 MPTAC review. Updated Rationale and Reference sections. Removed ICD-9 codes from Coding section.
Reviewed 02/05/2015 MPTAC review. Updated Description/Scope, Rationale, Background/Overview, and References sections.
  01/01/2015 Updated Coding section with 01/01/2015 CPT changes; removed 43216, 43250 (no longer applicable).
Reviewed 02/13/2014 MPTAC review. Updated Rationale, Background/Overview, References, and Index sections.
  01/01/2014 Updated Coding section with 01/01/2014 CPT changes; removed 43228, 43258, deleted 12/31/2013.
Reviewed 02/14/2013 MPTAC review. Updated Rationale, References, and Index.
Revised 02/16/2012 MPTAC review. Addition of low-grade dysplasia to medically necessary statement. Updated Rationale and Coding sections.
Reviewed 08/18/2011 MPTAC review. Updated Rationale and References.
Revised 02/17/2011 MPTAC review. Addition of laser ablation, argon plasma coagulation and electrocoagulation to investigational and not medically necessary statement. Updated Description/Scope, Rationale, Background/Overview, Definitions, Coding, References and Index.
Revised 11/18/2010 MPTAC review. Title changed to "Ablative Techniques as a Treatment for Barrett's Esophagus." Added the use of cryoablation to investigational and not medically necessary statement. Updated Description/Scope, Rationale, Background/Overview, Definitions, Coding, References and Index.
Revised 11/19/2009 MPTAC review. In the medically necessary statement, removed the criteria that two separate endoscopies be performed. Updated review date, References and History sections of the document.
Revised 08/27/2009 MPTAC review. Position statement revised to consider radiofrequency ablation medically necessary in patients with: (1) Barrett's esophagus with high grade dysplasia which has been confirmed by two separate endoscopies; and (2 life expectancy of one year or greater. Updated review date, Rationale, Definitions, Coding, References and History sections of the document.
New 08/28/2008 MPTAC review. Initial document development.