Pending Policies - Surgery


Magnetic Esophageal Ring to Treat Gastroesophageal Reflux Disease (GERD)

Number:SUR709.036

Effective Date:12-01-2017

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

A laparoscopically implantable magnetic esophageal ring (LINX™ Reflux Management System) is considered medically necessary as a treatment alternative to surgical fundoplication, when the patient has chronic gastroesophageal reflux disease (GERD) symptoms (reflux symptoms that occur two or more times per week) AND are refractory to maximum medical therapy.

The safety and effectiveness of a laparoscopically implantable magnetic esophageal ring (LINX™ Reflux Management System) has not been established and/or is contraindicated and therefore considered experimental, investigational and/or unproven for patients with any other indication including but not limited to the following conditions:

Suspected or known allergies to metals such as iron, nickel, titanium, or stainless steel,

Hiatal hernias greater than 3 cm in size,

Barrett's esophagus or Grade C or D (LA classification) esophagitis,

Scleroderma,

Suspected or confirmed esophageal or gastric cancer,

Prior esophageal or gastric surgery or endoscopic intervention,

Distal esophageal motility less than 35 mmHg peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences or a known motility disorder (e g. Achalasia, Nutcracker Esophagus, and Diffuse Esophageal Spasm or Hypertensive LES),

Symptoms of dysphagia more than once per week within the last 3 months,

Esophageal stricture or gross esophageal anatomic abnormalities (Schatzki's ring, obstructive lesions, etc.),

Esophageal or gastric varices,

Lactating, pregnant or plan to become pregnant,

Morbid obesity (BMI >35), or

Age <21.

Removal of an esophageal sphincter augmentation device may be considered medically necessary when all the following criteria are met:

Patient met all the criteria for initial placement of the device, AND

Complications such as erosion, device migration, or difficulty swallowing.

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% to 20% prevalence in developed countries. The severity of GERD varies widely. 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 esophagus and esophageal cancer. For patients with severe disease, chronic treatment with acid blockers is 1 option. For some patients, medications are not adequate to control symptoms; 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 medical policy 201.016).

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 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.

Rationale:

This medical policy document was developed in February of 2016 and addresses the use of a magnetic esophageal ring to treat gastroesophageal reflux disease (GERD) previously addressed on medical policy MED201.016. A literature search was performed through February 17, 2016. The following is a summary of key literature to date.

Nonrandomized Controlled Trials

Three retrospective comparative studies have been identified on magnetic sphincter augmentation (MSA) with the LINX® device compared with laparoscopic Nissen fundoplication (LNF). The largest study is from Reynolds et al., who in 2015 reported 1-year follow-up of 50 MSA and 50 LNF patients matched for disease severity. (1) To be included in the study, patients had 1) objective evidence of GERD, defined as an abnormal pH study, presence of biopsy-proven Barrett esophagus, or esophagitis grade B or greater; 2) proton pump inhibitor (PPI) therapy for a minimum of 6 months; and 3) normal esophageal motility. Some of the patients had been included in previous reports. At 1 year after surgery, the 2 groups had similar GERD-HRQL (Health-Related Quality-of-Life) scores (MSA=4.2, LNF=4.3; maximum, 50) and PPI use (MSA=17%, LNF=8.5%). There was no difference in the number of patients reporting mild gas and bloating (MSA=27.6%, LNF=27.6%), but more LNF patients reported severe gas and bloating (10.6% vs 0%, p=0.028). More LNF patients were unable to belch (MSA=8.5%, NF=25.5%, p=0.028) or vomit when needed (MSA=4.3%, LNF=21.3%, p<0.002).

Louie at al compared outcomes from 34 patients who had MSA with 32 patients who underwent LNF. (2) 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 0% in the fundoplication group. Sheu et al. compared outcomes from 12 MSA patients with a contemporaneous case-matched cohort of patients who underwent LNF. (3) Over half of the MSA patients were self-referred, compared with none 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.

In 2015, Riegler et al. published 1-year results of an industry-sponsored multicenter registry (NCT01624506), that included a comparison with laparoscopic fundoplication. (4) The report included 202 MSA and 47 laparoscopic fundoplication (LF; Nissen or Toupet) patients from a planned enrollment of 734 patients. The choice of procedure was made by the surgeon at the time of laparoscopy, taking into account the presence of a large hiatal hernia along with other factors. In addition to having a greater frequency of large hiatal hernias (>3 cm, 45.7% vs 1.6%), the LF group was older and had a greater frequency of Barrett esophagus (19.1% vs 1.0%, p<0.001). Consistent with the greater severity of symptoms, patients who underwent LF had greater regurgitation and fewer patients who discontinued PPIs after treatment. Excessive gas and abdominal bloating (31.9% vs 10.0%) and inability to vomit (55.6% vs 8.7%) were significantly higher after LF than MSA. Improvements in GERD-HRQL scores were similar for the 2 groups. Follow-up to 3 years in a larger number of patients is ongoing.

Single-Arm Studies

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. (5) The feasibility IDE study enrolled 44 subjects at 4 clinical sites (2 U.S., 2 Europe) and has published data out to 4 years. (6, 7) The pivotal IDE study included 100 subjects from 14 clinical sites (13 U.S., 1 Europe) who had documented symptoms of GERD for more than 6 months (regurgitation or heartburn that responds to acid neutralization or suppression), required daily PPI or other antireflux 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 end point measured the rate of related device and procedure serious adverse events (SAEs). Efficacy end points were assessed off PPI therapy and measured esophageal acid exposure, total GERD-HRQL scores, and PPI usage. Subjects served as their own controls.

Results of the pivotal trial were published in 2013. (8) In this study, the primary efficacy end point of pH normalization or greater than 50% reduction in acid exposure time when off PPI was met by 64% of the subjects. Mean total acid exposure time was reduced from 11.6% at baseline to 5.1% at 12 months (56% reduction). The secondary efficacy end points 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, vs 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 an SAE including severe dysphagia and vomiting. The device was removed in 4 of these 6 patients with an SAE and in 2 additional patients for persistent reflux and chest pain.

In 2013, Bonavina et al. published longer follow-up from some patients in the pilot and multicenter registry studies. (9) This study included a consecutive series of 100 patients who received MSA for GERD at their institution and were followed for a median of 3 years (range, 378 days to 6 years). Thirty of the patients had data beyond 5 years. The median GERD-HRQL score improved from 24 off PPIs to 2 (p<0.001), and freedom from daily dependence on PPIs was achieved in 85% of patients. The time that esophageal pH was less than 4 decreased from 8.0% to 3.2% (p<0.001). Although 3 patients had the device removed for persistent GERD, odynophagia, or dysphagia, no occurrences of device migrations or erosions were observed during follow-up.

In 2015, Lipham et al. reported on adverse events for the first 1048 implanted patients (82 institutions). (10) Of these, 144 were implanted as part of premarket clinical trials (previously described), 332 had been enrolled in the postmarket registry, and 572 were implanted outside of a postmarket registry. The 3 sources 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.

Ganz et al. (2015) reported on final results of 5 years of follow-up evaluation of patients who received a magnetic device to augment lower esophageal sphincter function in patients with gastroesophageal reflux disease (GERD). (12) This prospective study of the safety and efficacy of a magnetic device was conducted in 100 adults with GERD for 6 months or more, who were partially responsive to daily proton pump inhibitors (PPIs) and had evidence of pathologic esophageal acid exposure and was conducted at 14 centers in the United States and The Netherlands. The magnetic device was placed using standard laparoscopic tools and techniques. Eighty-five subjects were followed up for 5 years to evaluate quality of life, reflux control, use of PPIs, and side effects. The GERD–health-related quality of life (GERD-HRQL) questionnaire was administered at baseline to patients on and off PPIs, and after placement of the device; patients served as their own controls. A partial response to PPIs was defined as a GERD-HRQL score of 10 or less on PPIs and a score of 15 or higher off PPIs, or a 6-point or more improvement when scores on vs off PPI were compared. Over the follow-up period, no device erosions, migrations, or malfunctions occurred. At baseline, the median GERD-HRQL scores were 27 in patients not taking PPIs and 11 in patients on PPIs; 5 years after device placement this score decreased to 4. All patients used PPIs at baseline; this value decreased to 15.3% at 5 years. Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at 5 years. All patients reported the ability to belch and vomit if needed. Bothersome dysphagia was present in 5% at baseline and in 6% at 5 years. Bothersome gas-bloat was present in 52% at baseline and decreased to 8.3% at years. The authors concluded that augmentation of the lower esophageal sphincter with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD. ClinicalTrials.gov no: NCT00776997.

UpToDate 2015

“LINX prosthesis

In 2012, the US Federal Drug Administration (FDA) approved the LINX Reflux Management System for lower esophageal sphincter augmentation. Eligible patients for the procedure include those with inadequate symptom control with acid suppression therapy, including those patients with mild to moderate GERD and a hiatal hernia less than 3 cm. The device is a ring made up of a series of rare earth magnets that have sufficient attraction to increase the LES closure pressure, but allow for food passage with swallowing. Results from early studies at four years are encouraging. Based upon a prospective study that included 44 patients, the mean total percent time pH <4 was reduced from 11.9 percent at baseline to 3.8 percent at three years (p<0.001) [67]. Most patients at ≥4 years of observation experienced improved quality of life and complete cessation of the use of PPIs.” (14)

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 1.

Table 1. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT02505945a

The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease

150

April 2017

NCT01940185a

A Post-Approval Study of the Lynx® Reflux Management System

200

September 2019

NCT: national clinical trial.

a Denotes industry-sponsored or cosponsored trial.

Practice Guidelines and Position Statements

In 2013, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Technology and Value Assessment Committee, released a technology assessment, titled TAVAC Safety and Effectiveness Analysis: LINX Reflux Management System. (11) Evidence in the feasibility and pivotal trials conducted for marketing approval was considered. The TAVAC report lists as limitations of the evidence base the lack of randomization and blinding, lack of comparative data, small case series, limited follow-up, and availability of data only from these clinical trials without evidence from routine practice. The assessment states that the available data demonstrate “reasonable assurance as to the efficacy of the LINX” (on the basis of pre- and post-treatment data of case series) and “reasonable assurance that the LINX device is safe.” In addition, the report states, “On the basis of the available evidence, the LINX device should be an option available to patients and providers for the management of medically refractory GERD.” The report concludes, “Comparative outcomes data between fundoplication and the LINX procedure are needed.”

A 2013 report on emerging technology from the American Society for Gastrointestinal Endoscopy (ASGE) concluded that long-term data about the safety and efficacy of the LINX device are needed. (13) The document indicates that the LINX band is currently being deployed laparoscopically; however, a natural orifice transluminal endoscopic surgery approach could be explored.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

43284, 43285, [Deleted 1/2017: 0392T]

HCPCS Codes

[Deleted 7/2015: C9737]

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Reynolds JL, Zehetner J, Wu P, et al. Laparoscopic Magnetic Sphincter Augmentation vs Laparoscopic Nissen Fundoplication: A Matched-Pair Analysis of 100 Patients. J Am Coll Surg. Jul 2015; 221(1):123-128. PMID 26095560

2. 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. Aug 2014; 98(2):498-504. PMID 24961840

3. Sheu EG, Nau P, Nath B, et al. A comparative trial of laparoscopic magnetic sphincter augmentation and Nissen fundoplication. Surg Endosc. Mar 2015; 29(3):505-9. PMID 25012804

4. Riegler M, Schoppman SF, Bonavina L, et al. Magnetic sphincter augmentation and fundoplication for GERD in clinical practice: one-year results of a multicenter, prospective observational study. Surg Endosc. May 2015; 29(5):1123-1129. PMID 25171881

5. U.S. Food and Drug Administration. Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee. LINX™ Reflux Management System. 2012; available at <http://www.fda.gov.> Accessed February 16, 2016.

6. 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

7. 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

8. 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

9. Bonavina L, Saino G, Bona D, et al. One hundred consecutive patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease: 6 years of clinical experience from a single center. J Am Coll Surg. Oct 2013; 217(4):577-585. PMID 23856355

10. 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. May-Jun 2015; 28(4):305-11. PMID24612509

11. Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). TAVAC Safety and Effectiveness Analysis: LINX® Reflux Management System. 2013; available at <http://www.sages.org>. Accessed June 3, 2015.

12. Ganz RA, Edmundowicz, SA, et al. Long-Term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. Clinical Gastroenterology and Hepatology 2015.

13. ASGE Technology Committee. Magnets in the GI tract. Gastrointest Endosc. Oct 2013; 78(4):561-567. PMID24054738

14. Schwaitzberg, SD, Surgical management of gastroesophageal reflux in adults. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. Topic last updated April 2014 (Accessed on February 15, 2016.)

15. Magnetic Esophageal Ring to Treat Gastroesophageal Reflux Disease (GERD). Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (August 2015) Medicine 7.01.137.

Policy History:

Date Reason
12/1/2017 Reviewed. No changes.
6/1/2017 Document updated with literature review. The following statement was added to the coverage section of the medical policy: Removal of an esophageal sphincter augmentation device may be considered medically necessary when all the following criteria are met: 1) Patient met all the criteria for initial placement of the device, AND 2) Complications such as erosion, device migration, or difficulty swallowing.
4/1/2016 New medical document originating from a topic previously addressed on medical policy MED201.016. Coverage has changed to the following: 1) A laparoscopically implantable magnetic esophageal ring (LINX™ Reflux Management System) is considered medically necessary as a treatment alternative to laparoscopic Nissen fundoplication when the patient has chronic gastroesophageal reflux disease (GERD) symptoms refractory to maximum medical therapy, 2) The safety and effectiveness of a laparoscopically implantable magnetic esophageal ring (LINX™ Reflux Management System) has not been established and/or is contraindicated and therefore considered experimental, investigational and/or unproven for patients with the following conditions: Suspected or known allergies to metals such as iron, nickel, titanium, or stainless steel; Hiatal hernias greater than 3 cm in size; Barrett's esophagus or Grade C or D (LA classification) esophagitis; Scleroderma; Suspected or confirmed esophageal or gastric cancer; Prior esophageal or gastric surgery or endoscopic intervention; Distal esophageal motility less than 35 mmHg peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences or a known motility disorder (e g. Achalasia, Nutcracker Esophagus, and Diffuse Esophageal Spasm or Hypertensive LES); Symptoms of dysphagia more than once per week within the last 3 months; Esophageal stricture or gross esophageal anatomic abnormalities (Schatzki's ring, obstructive lesions, etc.); Esophageal or gastric varices; Lactating, pregnant or plan to become pregnant; Morbid obesity (BMI >35), or Age <21.

Archived Document(s):

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