Radiofrequency ablation or Cryoablation of Barrett’s Esophagus

Medical Policy: 02.01.44 
Original Effective Date: December 2010 
Reviewed: February 2012 
Revised:  

Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

Description: 

The esophagus is normally lined by squamous epithelium. Barrett’s esophagus 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 (GERD). Barrett’s esophagus occurs in the distal esophagus, may be of any length, focal or circumferential, and can be visualized by endoscopy as being a different color than the background squamous mucosa. Confirmation of Barrett’s esophagus requires biopsy of the columnar epithelium and microscopic identification of intestinal metaplasia.

Intestinal metaplasia is a precursor to esophageal adenocarcinoma, and patients with Barrett’s esophagus are at a 40-fold increased risk for developing this disease compared to the general population. Esophageal adenocarcinoma is thought to result from a stepwise accumulation of genetic abnormalities in the specialized epithelium, which results in the phenotypic expression of histologic features of low-grade dysplasia to high-grade dysplasia to carcinoma. Most patients with non-dysplastic Barrett’s esophagus do not progress beyond non-dysplasia. Non-dysplastic Barrett’s esophagus progresses to high-grade dysplasia at a rate of 0.9% per patient per year. Progression of low-grade to high-grade dysplasia has been reported as 6-28%. Once high-grade dysplasia is present, the risk of developing adenocarcinoma is 2-10% per patient per year, and approximately 40% of patients diagnosed with high-grade dysplasia by biopsy are found to have associated carcinoma in the resection specimen.

The current management of Barrett’s esophagus includes treatment of GERD, and surveillance endoscopy to detect progression to high-grade dysplasia or adenocarcinoma. The findings of low-grade dysplasia typically warrants only follow-up and surveillance biopsies, whereas the findings of high-grade dysplasia or early-stage adenocarcinoma warrants mucosal ablation or resection, either endoscopic mucosal resection or esophagectomy.

Endoscopic mucosal resection, either focal or circumferential, provides a histologic specimen for examination and staging. A study by Ell et al provided long-term results for endoscopic mucosal resection in 100 consecutive patients with early Barrett’s-associated adenocarcinoma (limited to the mucosa). The 5-year overall survival was 98% and metachronous lesions were observed in 11% of patients after a mean of 36.7 months. In a recent review by Pech et al, it is stated that circumferential endoscopic mucosal resection of the entire segment of Barrett’s leads to a stricture rate of 50%, and recurrences occur at a rate of up to 11%.

Available mucosal ablation techniques consist of one of several thermal (multipolar electrocoagulation, argon plasma coagulation, heater probe, Nd:YAG laser, KTP-YAG laser, diode laser, argon laser, and cryoablation) or non-thermal (5-aminolevuliniv acid [5-ALA] and photofrin photodynamic therapy [PDT] techniques. PDT has been the only therapy shown in a randomized phase III trial, conducted by Overholt et al, to significantly decrease the risk of adenocarcinoma in Barrett’s esophagus. Two hundred and eight patients with high-grade dysplasia were randomized to PDT and omeprazole versus omeprazole alone. At 24 months’ follow-up, 77% of patients treated with PDT had complete ablation of high-grade dysplasia versus 39% in the control group (p<0.0001) and occurrence of adenocarcinoma within a follow-up time of 3.6 years was 13% in the PDT group versus 20% in the control group (p<0.006). However, the use of PDT for Barrett’s esophagus with high-grade dysplasia has decreased dramatically recently, due to the fact that it is relatively expensive and associated with a high complication rate, including photosensitivity and esophageal stricture formation in up to 30% of patients treated with this method.

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

The HALO System from BARRYX Medical, Inc. uses radiofrequency energy and consists of two components: an energy generator and an ablation catheter. The generator provides rapid (i.e., less than 1 second) delivery of a predetermined amount of radiofrequency energy to the catheter. Both the HALO⁹⁰ and HALO³⁶⁰ devices are inserted into the esophagus with an endoscope, using standard endoscopic techniques. The HALO⁹⁰ catheter is used for focal ablation of areas of Barrett’s esophagus up to 3 cm. The HALO ³⁶⁰ uses a balloon catheter that is sized to fit the individual esophagus, and is inflated to allow for circumferential ablation.

The ablation with radiofrequency affects only the most superficial layer of the esophagus, leaving the underlying tissues unharmed. Efficacy measures for the procedure include eradication of intestinal metaplasia without leaving behind microscopic foci, and postablation re-growth of normal squamous epithelium. Reports of the efficacy of the HALO system in ablating Barrett’s esophagus have been as high as 70%, and even higher in some reports. The incidence of leaving behind microscopic foci of intestinal metaplasia has been reported to be 0% with the HALO system.

The HALO³⁶⁰ received U.S. Food and Drug Administration (FDA) 510(k) clearance for marketing in 2005 and the HALO⁹⁰ in 2006. The FDA-labeled indications are for use in coagulation of bleeding and nonbleeding sites in the gastrointestinal tract, and include the treatment of Barrett’s esophagus. The CryoSpray Ablation™ System received FDA 510(k) marketing clearance in December 2007 for use as a “cryosurgical tool for destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.”

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Prior Approval: 

Not applicable

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Policy: 

Radiofrequency ablation may be considered medically necessary for the treatment of Barrett’s esophagus with high-grade dysplasia.

Radiofrequency ablation is considered investigational for treatment of Barrett’s esophagus with low-grade dysplasia or Barrett’s esophagus in the absence of dysplasia.

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

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Procedure Codes and Billing Guidelines: 

• To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
• 43228: Esophagoscopy, rigid or flexible; with ablation of tumor(s), polyp(s),, or other lesion(s), not amenable to removal by hot biopsy forceps, bipolar cautery or snare technique
• 43257: Upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate; with delivery of thermal energy to the muscle of lower esophageal sphincter and/or gastric cardia, for treatment of gastroesophageal reflux disease
• 43258:  Upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate; with ablation of tumor(s), polyp(s), or other lesion(s), not amenable to removal by hot biopsy forceps, bipolar cautery or snare technique
• 43499: Unlisted procedure, esophagus

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Selected References: 

• Shaheen NJ, Sharma P, Overholt BF et al. Radiofrequency Ablation in Barrett’s Esophagus with Dysplasia. N Engl J Med 2009 May 28; 360(22):2277-88.
• Fernando HC, Murhty SC, Hofstetter W et al. The Society of Thoracic Surgeons practice guideline series: guidelines for the management of Barrett’s esophagus with high-grade dysplasia. Ann Thorac Surg 2009 Jun; 87(6): 1993-2002.
• Wang KK, Sampliner RE; Practice Parameters Committee of the American College of Gastroenterology. Updated guidelines 2008 for the diagnosis, surveillance, and therapy of Barrett’s Esophagus. Am J Gastroenterol. 2008 Mar; 103(3):788-97.
• 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):185-95.
• Pech O, Ell C. Endoscopic therapy for Barrett’s esophagus. Curr Opin Gastroenterol 2009; 25(5):405-11.
• Ell C, May A, Pech O et al. Curative endoscopic resection of early esophageal adenocarcinoma (Barrett’s cancer). Gastrointest Endosc 2007; 65(1):3-10.
• Overholt BF, Lightdale CJ, wang KK et al. Photodynamic therapy with porfimer sodium for ablation of high-grade dysplasia in Barrett’s esophagus: international, partially blinded, randomized phase III trial. Gastrointest Endosc 2005; 62(4):488-98.
• Ganz RA, Overholt BF, Sharma VK et al. Circumferential ablation of Barrett’s esophagus that contains high-grade dysplasia: a U.S. multicenter registry. Gastrointest Endosc 2008; 68(1):35-40.
• Fleischer DE, Overholt BF, Sharma VK et al. Endoscopic ablation of Barrett’s esophagus: a multicenter study with 2.5-year follow-up. Gastrointest Endosc 2008; 68(5):867-76.
• TARGET [database online]. Plymouth Meeting (PA): ECRI institute; 2009 December 29; Endoscopic radiofrequency ablation for Barrett’s esophagus. Available: http://www.ecri.org
• Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Radiofrequency ablation of nondysplastic or low-grade dysplastic Barrett’s esophagus. TEC Assessments 2010; Volume 5, No. 5.
• Greenwald BD, Dumot JA, Horwhat JD et al. Safety, tolerability, and efficacy of endoscopic low-pressure liquid nitrogen spray cryotherapy in the esophagus. Dis Esophagus 2010; 23(1):13-9.
• Shaheen NJ, Greenwald BD, Peery AF et al. Safety and efficacy of endoscopic spray cryotherapy for Barrett’s esophagus with high-grade dysplasia. Gastrointest Endosc 2010 Apr; 71(4):680-5.
• AGA Institute Medical Position Panel. American Gastroenterological Association Medical Position Statement on the Management of Barrett’s Esophagus. Gastroenterology 2011; 140:1084-1091.
• Sampliner RE. Management of Nondysplastic Barrett Esophagus with Ablation Therapy. Gastroenterol Hepatol (NY). 2011 Jul 7(7):461-4.
• Lekakos L, Karidis NP, Dimitroulis D et al. Barrett’s esophagus with high-grade dysplasia: Focus on current treatment options. World J Gastroenterol 2011 Oct 7; 17(37):4174-83.
• Wiseman EF, Ang YS. Risk factors for neoplastic progression in Barrett’s esophagus. World J Gastroenterol 2011 Aug 28; 17(32):3672-83.
• Rice TW, Goldblum JR. Management of Barrett esophagus with high-grade dysplasia. Thorac Surg Clin. 2012 Feb; 22(1):101-7, vii.
• Fleischer DE, Overholt BF, Sharma VK et al. Endoscopic radiofrequency ablation for Barrett’s esophagus: 5-year outcomes from a prospective, multicenter trial. Endoscopy 2010 Oct; 42(10): 781-9. Epub 2010 Sep 20.

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Policy History: 

Date                                        Reason                               Action

December 2010                      New topic                          New policy

March 2011                            New literature                    Policy renewed

February 2012                       Annual review                    Policy renewed

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