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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/8:2014
Issue
8:2014
  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 

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. FDA product code: LEI


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).

Effective in 2014, there is a specific HCPCS “C” code for this procedure:

C9737 - Laparoscopy, surgical, esophageal sphincter augmentation with device (eg, magnetic band).

 


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 has been updated periodically with a literature search of the MEDLINE database. The most recent literature update was performed through July 15, 2014.

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.

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.

Nonrandomized Controlled Trials

Two retrospective comparative studies have been identified on magnetic sphincter augmentation (MSA) with the LINX® device compared with laparoscopic Nissen fundoplication (LNF). Louie at al compared outcomes from 34 patients who had MSA with 32 patients who underwent LNF.(5) Similar improvements were found for the 2 groups on the GERD-HRQL scale. The DeMeester score and pH normalized in both
groups, but these were lower (p=0.001) in the fundoplication group. MSA allowed belching in 67% of patients compared with none in the fundoplication group. Sheu et al compared outcomes from 12 MSA patients with a contemporaneous case-matched cohort of patients who underwent LNF.(6) Over half of the MSA patients were self-referred, compared with none of the patients who underwent LNF. Both procedures were effective for reflux. Severe dysphagia requiring endoscopic dilation was more frequent after MSA (50% of cases), while there was a trend for a reduction in bloating, flatulence, and diarrhea in this small retrospective study.

Observational Studies

In 2014, Lipham et al reported on adverse events for the first 1048 implanted patients (82 institutions).(7) Of these, 144 were implanted as part of premarket clinical trials (described above), 332 had been enrolled in a postmarket registry, and 572 were implanted outside of a postmarket registry. The 3 sources that were used to identify adverse events were the published clinical literature along with the device’s Summary of Safety Effectiveness Data, the FDA database for device-related complications (MAUDE database), and information provided by the manufacturer. Event rates were 0.1% intra-/perioperative complications, 1.3% hospital readmissions, 5.6% endoscopic dilations, and 3.4% reoperations for device removal. The primary reason for device removal was dysphagia. Erosion of the device occurred in 1 patient (0.1%). The median device implantation was 274 days. This study is limited by the short follow-up and the voluntary reporting of adverse events outside of the registry.

Ongoing and Unpublished Clinical Trials

An online search of www.ClinicalTrials.gov in July 2014 identified industry-sponsored observational studies of the LINX® Reflux Management System.

  • NCT01940185 is a prospective, multicenter, single-arm postapproval study to monitor the safety and efficacy of the LINX® implant procedure and device with follow-up through 5 years. The study has an estimated enrollment of 200 patients, with completion expected in 2019.
  • NCT01624506 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 of Evidence

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. Current evidence on magnetic sphincter augmentation (MSA) consists of 2 retrospective comparative cohort studies along with several case series, including 2 uncontrolled and unblinded manufacturer-sponsored studies that were submitted to the Food and Drug Administration (FDA) for device approval. The 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 comparative trials are retrospective and nonrandomized, and may be affected by selection bias. In addition, the subjective outcome measures used in these trials, such as the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scores, may be biased due to placebo effects in these nonblinded trials. The objective measure of esophageal pH shows
modest improvement compared with 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. FDA has required 5 years of follow-up on the 100 subjects in the pivotal study. Randomized comparisons of MSA with Nissen fundoplication are also needed to evaluate the relative risk-benefit of these 2 procedures. The evidence at this time is insufficient to permit conclusions concerning the effect of this device on net health outcome. It is considered investigational.

Practice Guidelines and Position Statements

In 2013, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) published a Technology and Value Assessment guideline on the safety and effectiveness of the LINX Reflux Management System.(8) SAGES Technology and Value Assessment Committee stated that safety analyses of the LINX system suggests the procedure is associated with few serious adverse events and no reported mortality, and that currently available data demonstrates a reasonable assurance as to the efficacy of the LINX Reflux Management System. The committee concluded that direct comparative studies between the LINX procedure and Nissen fundoplication will be needed, although based on the
available evidence the LINX device should be an option available to patients and providers for the management of medically refractory GERD.

A 2013 report on emerging technology from the American Society for Gastrointestinal Endoscopy concluded that long-term data about the safety and efficacy of the LINX device are needed.(9) The document indicates that the LINX band is currently being deployed laparoscopically; however, a natural orifice transluminal endoscopic surgery approach could be explored.

U.S. Preventive Services Task Force Recommendations

Use of magnetic esophageal rings is not a preventive service.

Summary

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. Current evidence on magnetic sphincter augmentation (MSA) consists of 2 retrospective comparative cohort studies along with several case series, including 2 uncontrolled and unblinded manufacturer-sponsored studies that were submitted to the U.S. Food and Drug Administration (FDA) for device approval. The 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 comparative trials are retrospective and nonrandomized and may be affected by selection bias. In addition, the subjective outcome measures used in these trials, such as the Gastroesophageal Reflux  Disease‚ÄíHealth Related Quality of Life (GERD-HRQL) scores, may be biased due to placebo effects in these nonblinded trials. The objective measure of esophageal pH shows modest improvement compared with 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. FDA has required 5 years of follow-up on the 100 subjects in the pivotal study. Randomized comparisons of MSA with Nissen fundoplication are also needed to evaluate the relative risk-benefit of these 2 procedures. 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
There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.

References:

  1. U.S. Food and Drug Administration. Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee. LINX™ Reflux Management System.2012;http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevic
    esAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM286236.pdf. Accessed June, 2014.
  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. Nov 2010;252(5):857-862. PMID 21037442
  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. Oct 2012;26(10):2944-2949. PMID 22538694
  4. Ganz RA, Peters JH, Horgan S, et al. Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med. Feb 21 2013;368(8):719-727. PMID 23425164
  5. Louie BE, Farivar AS, Shultz D, et al. Short-Term Outcomes Using Magnetic Sphincter Augmentation Versus Nissen Fundoplication for Medically Resistant Gastroesophageal Reflux Disease. Ann Thorac Surg. Jun 21 2014. PMID 24961840
  6. Sheu EG, Nau P, Nath B, et al. A comparative trial of laparoscopic magnetic sphincter augmentation and Nissen fundoplication. Surg Endosc. Jul 11 2014. PMID 25012804
  7. Lipham JC, Taiganides PA, Louie BE, et al. Safety analysis of first 1000 patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease. Dis Esophagus. Mar 11 2014. PMID 24612509
  8. Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). TAVAC Safety and Effectiveness Analysis: LINX® Reflux Management System. 2013; http://www.sages.org/publications/guidelines/tavac-safety-
    and-effectiveness-analysis-linx-reflux-management-system/. Accessed June, 2014.
  9. Asge Technology Committee. Magnets in the GI tract. Gastrointest Endosc. Oct 2013;78(4):561-567. PMID 24054738 

Codes

Number

Description

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

ICD-10-CM (effective 10/1/15)

  Investigational for all relevent diagnoses
  K21.0 and K21.9 Gastroesophageal reflux disease with and without esophagitis code range
ICD-10-PCS (effective 10/1/15)   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
12/12/13 Replace policy-coding update only New HCPCS code C9737 added.
8/14/14 Replace policy Policy updated with literature review through July 15, 2014; references 5-9 added; policy statement unchanged