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MP 7.01.137 Magnetic Esophageal Ring to Treat Gastroesophageal Reflux Disease (GERD)

Medical Policy    
Section
Surgery
 
Original Policy Date
August 2012
Last Review Status/Date
Reviewed with literature search/8:2013
Issue
8:2013
  Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.


Description  

A laparoscopically implanted ring composed of interlinked titanium beads with magnetic cores has been developed for the treatment of gastroesophageal reflux disease (GERD). The device is placed around the esophagus at the level of the gastroesophageal junction and is being evaluated in patients who have GERD symptoms despite maximum medical therapy.

Background

Gastroesophageal reflux disease (GERD) is defined as reflux of stomach acid into the esophagus that causes symptoms and/or mucosal injury. GERD is a common medical disorder, with estimates of 10-20% prevalence in developed countries. The severity of GERD is widely variable. Many patients have mild, intermittent symptoms that do not require treatment or only require episodic use of medications. Other patients have chronic, severe GERD that can lead to complications such as Barrett’s esophagus and esophageal cancer. For patients with severe disease, chronic treatment with acid blockers is one option. For some patients, medications are not adequate to control symptoms, and other patients prefer to avoid the use of indefinite, possibly lifelong medications. Surgical treatments are available for these patients, primarily a Nissen fundoplication performed either laparoscopically or by open surgery. A number of less invasive procedures are also being evaluated as an intermediate option between medical therapy and surgery (see policy 2.01.38 on endoscopic procedures).

The LINX™ Reflux Management System (Torax Medical) is composed of a small flexible band of 10 to 18 interlinked titanium beads with magnetic cores. Using standard laparoscopic techniques, the band is placed around the esophagus at the level of the gastroesophageal junction. The magnetic attraction between the beads is intended to augment the lower esophageal sphincter to prevent gastric reflux into the esophagus, without compressing the esophageal wall. It is proposed that swallowing food or liquids creates sufficient pressure to overcome the magnetic bond between the beads, allowing the beads to separate and temporarily increase the size of the ring. The target population is patients who have GERD symptoms despite maximum medical therapy (e.g., proton pump inhibitors) but who do not want to risk the adverse effects of a surgical procedure like Nissen fundoplication. Adverse events of the LINX™ Reflux Management System may include dysphagia or odynophagia. The device can be removed by a laparoscopic procedure if severe adverse events occur or if magnetic resonance imaging (MRI) is needed for another condition.

Regulatory Status

The LINX™ Reflux Management System was approved by the U.S. Food and Drug Administration (FDA) in 2012. The LINX™ device is indicated for patients diagnosed with GERD, as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum therapy for the treatment of reflux. The FDA has required 5-year follow-up of 100 patients from the investigational device exemption (IDE) pivotal study to evaluate safety and efficacy of the device.


Policy 

An implantable magnetic esophageal ring to treat gastroesophageal reflux disease (GERD) is investigational.


Policy Guidelines 

There is no specific CPT code for this procedure. It would likely be reported with the unlisted laparoscopy procedure, esophagus code 43289.

The Medicare carrier Novitas Solutions posted a provider bulletin in June 2013 which states that code 43280 has been incorrectly reported for this procedure and that the unlisted code 43289 should be used (https://www.novitas-solutions.com/bulletins/all/news-06192013.html). 


Benefit Application
BlueCard/National Account Issues

State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only on the basis of their medical necessity.


Rationale

This policy was created in 2012 and updated on July 1, 2013 with a literature search of the MEDLINE database.

Randomized, controlled trials are necessary to establish the efficacy of treatments for gastroesophageal reflux disease (GERD). GERD has a variable natural history, with exacerbations and remissions, and as a result, a control group is required to differentiate improvements in symptoms from the natural history of the disorder. A placebo control is optimal due to the subjective nature of the patient-reported outcome measures, which are prone to bias if the patient is not blinded to treatment assignment. Random assignment is important because of the multiple potential confounders of GERD outcomes, such as diet, smoking and obesity. Randomization minimizes the chance that these confounders will be distributed unequally among treatment groups.

Single-arm series are of limited usefulness for determining treatment efficacy. Improvements in symptoms in single-arm studies may be due to the variable natural history of GERD, and/or bias from the placebo and other non-specific effects. Single-arm series can demonstrate the feasibility and potential benefit of this procedure and can be used to determine rates of adverse events. It is also important to determine comparative efficacy of treatments for GERD, since there are numerous medical and surgical treatments that are effective. Single-arm series are inadequate for determining comparative effectiveness of different treatment options; controlled trials with active comparators are required for this.

Literature Review

Data submitted to the U.S. Food and Drug Administration (FDA) for the LINX® Reflux Management System included 2 single-arm FDA-regulated investigational device exemption (IDE) trials with a total of 144 subjects and follow-up data between 2 and 4 years. (1) The feasibility IDE study enrolled 44 subjects at 4 clinical sites (2 U.S. and 2 Europe) and has published data out to 4 years. (2, 3) The pivotal IDE study included 100 subjects from 14 clinical sites (13 U.S. and 1 Europe) who had documented symptoms of gastroesophageal reflux disease for longer than 6 months (regurgitation or heartburn that responds to acid neutralization or suppression), required daily proton pump inhibitor (PPI) or other anti-reflux drug therapy, had symptomatic improvement on PPI therapy, and had a total distal ambulatory esophageal pH less than 4 for 4.5% or more of the time when off GERD medications. The primary safety endpoint measured the rate of related device and procedure serious adverse events (SAEs). Efficacy endpoints were assessed off PPI therapy and measured esophageal acid exposure, total GERD-Health Related Quality of LIFE (HRQL) scores, and PPI usage. Subjects served as their own controls.

A total of 24/44 (54.5%) subjects in the feasibility study experienced adverse events related to the device and/or procedure, and 2 subjects experienced SAEs. The most common adverse event was dysphagia (22 events in 20 subjects, which resolved in 90 days). No SAEs related to the device or procedure occurred after the first year. In the pivotal study, dysphagia was commonly observed, occurring in 68% of patients (49% mild, 16% moderate, and 5% severe), and an SAE related to the device or implantation procedure occurred in 6% (8/144) of subjects. Most cases of dysphagia self-improved or improved with endoscopic esophageal balloon dilation. Three subjects underwent device removal for severe dysphagia and/or odynophagia. Three subjects were hospitalized for nausea and/or vomiting. One subject reported the inability to vomit. No device migration was observed on radiographs taken at 12 months.

Success on the subject level was defined as normalization of acid (pH <4 for ≤4.5% of time) or reduced total time (pH <4) by at least 50% relative to baseline measurements. In the feasibility study, esophageal pH testing was performed out to 36 months in only 1 of the 4 centers. The percentage of subjects who achieved success was 79.5% (31/39) at 12 months, 90% (18/20) at 24 months, and 85% (17/20) at 36 months. The proportion of patients with reduction in PPI therapy by 50% or more was 89.7% (35/39) at 12 months, 82.9% (29/35) at 24 months, and 87.5% (28/32) at 36 months. Improvement in GERD-HRQL scores by more than 50% occurred in 97.4% (38/39) of subjects at 12 months, 88.6% (31/35) at 24 months and 96.3% (26/27) at 36 months.

Results of the pivotal trial were published in 2013. (4) In this study, the primary efficacy endpoint of pH normalization or greater than 50% reduction in acid exposure time when off PPI was met by 64% of the subjects. The mean total acid exposure time was reduced from 11.6% at baseline to 5.1% at 12 months (56% reduction). The secondary efficacy endpoints met the study success criteria. Ninety-two percent of subjects had at least a 50% improvement in GERD-HRQL symptom score (the mean GERD-HRQL total score decreased from 28.4 at baseline to 5.9 and 5.5 at 12 and 24 months, respectively), and 93% had reduced PPI use (79% and 83% of subjects were free from daily dependence at 12 and 24 months, respectively, compared with 0% at baseline). Dysphagia was observed in 68% of patients postoperatively, in 11% at 1 year, and in 4% at 3 years. Nineteen patients underwent esophageal dilation for dysphagia. Six patients (6%) experienced a serious adverse event (SAE) including severe dysphagia and vomiting. The device was removed in 4 of these 6 patients with a SAE and in 2 additional patients for persistent reflux and chest pain.

Ongoing Clinical Trials

A search of the online site www.clinicaltrials.gov in July 2013 identified an industry-sponsored observational study of the LINX® Reflux Management System (NCT01624506). This is a registry to track and monitor patients treated with either the LINX® device or fundoplication in clinical practice. It began in 2010 and has an estimated enrollment of 800 patients, with completion anticipated in 2016.

Summary

A laparoscopically-implanted magnetic esophageal ring is being evaluated for the treatment of gastroesophageal reflux disease (GERD). Current evidence consists of 2 uncontrolled and unblinded manufacturer-sponsored studies that were submitted to the FDA for device approval. These single-arm series are of limited usefulness for determining treatment efficacy and provide no information on the comparative efficacy of this procedure with other GERD treatments. The subjective outcome measures used in these two trials, such as the GERD-HRQL (Health Related Quality of Life, scores may be biased due to placebo effects with this study design. The objective measure of esophageal pH shows modest improvement compared to baseline, but this is a physiologic measure with uncertain clinical significance. Dysphagia was common in treated patients, although serious adverse events were less common, and the smaller feasibility study did not identify any serious safety concerns at up to 4 years of follow-up. The FDA has required 4 years of follow-up on the 100 subjects in the pivotal study. Independent assessment of the device by non-industry sources would also allow greater certainty. The evidence at this time is insufficient to permit conclusions concerning the effect of this device on net health outcome. It is considered investigational.

Medicare National Coverage

No national coverage decisions were identified for the LINX® Reflux Management System.

References:

  1.  
    1. LINX™ Reflux Management System. Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee 2012. Available online at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM286236.pdf. Last accessed July, 2012.
    2. Bonavina L, DeMeester T, Fockens P et al. Laparoscopic sphincter augmentation device eliminates reflux symptoms and normalizes esophageal acid exposure: one- and 2-year results of a feasibility trial. Ann Surg 2010; 252(5):857-62.
    3. Lipham JC, DeMeester TR, Ganz RA et al. The LINX(R) reflux management system: confirmed safety and efficacy now at 4 years. Surg Endosc 2012; 26(10):2944-9.
    4. Ganz RA, Peters JH, Horgan S et al. Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med 2013; 368(8):719-27.

 

Codes

Number

Description

CPT    See policy guidelines
ICD-9 Diagnosis   Investigational for all relevent diagnoses

ICD-10-CM (effective 10/1/14)

  Investigational for all relevent diagnoses
  K21.0 and K21.9 Gastroesophageal reflux disease with and without esophagitis code range
ICD-10-PCS (effective 10/1/14)   ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for this procedure.
  0DV44CZ Surgical, gastrointestinal system, restriction, gastroesophageal junction, percutaneous endoscopic, extraluminal device


Index 

Gastroesophageal Reflux
GERD


Policy History  

Date

Action

Reason

08/09/12

Add to Surgery section

Policy created with literature review through June 2012; considered investigational

8/08/13 Replace policy Policy updated with literature review through July 1, 2013; reference 4 added; policy statement unchanged