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Clinical Policy Title: Anti-reflux devices for gastroesophageal reflux disease

Clinical Policy Number: CCP.1224

Effective Date: April 1, 2015

Initial Review Date: January 21, 2015

Most Recent Review Date: January 8, 2019

Next Review Date: January 2020

Related policies:

None.

ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas’ clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas’ clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas’ clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas’ clinical policies are not guarantees of payment.

Coverage policy

AmeriHealth Caritas considers the use of anti-reflux devices for treatment of gastroesophageal reflux

disease to be investigational and, therefore, not medically necessary. These devices or techniques

include (Food and Drug Administration, 2016; Katz, 2013; National Institutes for Health and Clinical

Excellence, 2011):

Radiofrequency ablation.

Sphincter bulking agents.

Transoral incisionless fundoplication.

Endoscopic suturing or stapling.

Magnetic sphincter augmentation.

Limitations:

All other uses of antireflux devices for the treatment of gastroesophogeal reflux disease are not

Policy contains:

Gastroesophageal reflux disease.

Radiofrequency ablation.

Injectable bulking agents.

Transoral incisionless fundoplication.

Magnetic sphincter augmentation.

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medically necessary.

Relative contraindications include:

Atypical gastroesophageal reflux disease symptoms.

Other associated foregut pathology (specifically, gastroparesis).

Psychoemotional disorders.

Functional esophageal disease.

Bleeding disorders.

Esophageal strictures/varices.

High‐grade dysplasia or cancer.

Alternative covered services (National Institute of Diabetes and Digestive and Kidney Diseases, 2014):

• Histamine 2 blockers.

• Proton pump inhibitors.

• Prokinetics (e.g., bethanechol and metoclopramide).

• Antibiotics (e.g., erythromycin).

• Open or laparoscopic Nissen fundoplication.

• Bariatric surgery (e.g., Roux-en-Y gastric bypass surgery) in obese patients.

Background

Gastroesophageal reflux disease is a common health problem for adults, affecting about 20 percent of

the U.S. population (El-Serag, 2014). Gastroesophageal reflux disease can impact quality of life and is

a risk factor for complications, such as Barrett’s esophagus and esophageal adenocarcinoma.

Gastroesophageal reflux disease results when the lower esophageal sphincter fails to function properly,

causing stomach contents to rise up into the esophagus. Obesity, smoking, anatomic abnormalities

such as hiatal hernias, pregnancy, certain medications, and inhaling secondhand smoke can contribute

to gastroesophageal reflux disease (National Institute of Diabetes and Digestive and Kidney Diseases,

2016).

The main symptom of gastroesophageal reflux disease is frequent heartburn, though some adults

with gastroesophageal reflux disease will not experience heartburn (National Institute of Diabetes and

Digestive and Kidney Diseases, 2016). Other common gastroesophageal reflux disease symptoms

include:

• A dry, chronic cough.

• Wheezing.

• Asthma and recurrent pneumonia.

• Nausea.

• Vomiting.

• A sore throat, hoarseness, or laryngitis.

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• Difficulty swallowing or painful swallowing.

• Pain in the chest or the upper part of the abdomen.

• Dental erosion and bad breath.

Lifestyle changes and anti-reflux medications are often the initial treatments for suspected

gastroesophageal reflux disease (Patti, 2016; National Institute of Diabetes and Digestive and

Kidney Diseases, undated; 2014). If symptoms improve with these treatment methods, a

gastroesophageal reflux disease diagnosis often does not require testing. Persistent symptoms and

swallowing difficulties may require testing to confirm a diagnosis. Several tests can help with

diagnosis. These include upper gastrointestinal series, esophagogastroduodenoscopy, esophageal

pH monitoring, and esophageal manometry.

Advanced treatment options:

Medical treatment involves acid suppressants. The most effective and commonly prescribed acid

suppression medications are proton pump inhibitors. Long-term use of proton pump inhibitors is

associated with increased risk of enteric infections (e.g., Clostridium difficile-associated diarrhea),

community-acquired pneumonia, bone fracture, nutritional deficiencies, and interference with

metabolism of antiplatelet agents.

Surgery may be indicated for persons with persistent symptoms who fail to respond symptomatically to

aggressive acid suppression therapy or who require high doses of proton pump inhibitors to control

symptoms, particularly in young patients who may require lifelong therapy (Kahrilas, 2008). The

primary surgical alternative is open or laparoscopic Nissen fundoplication (Society of American

Gastrointestinal and Endoscopic Surgeons, 2010). Despite the efficacy of surgery, laparoscopic Nissen

fundoplication is invasive and carries procedure morbidity, such as dysphagia, gas bloat, and modest

long-term durability. Revisional fundoplication may be required for persistent reflux symptoms,

dysphagia, or herniation; it is considerably more complicated and is associated with a higher

perioperative risk. Given these issues, there is interest in developing an intermediate option as an

alternative to chronic prescription drug use, without the morbidity related to surgery.

Endoscopic therapies have emerged to bolster the anti-reflux properties of the gastroesophageal

junction to reduce the occurrence of reflux, and several have been approved by the Food and Drug

Administration (2016). These therapies can be categorized mechanistically into four groups (Katz,

2013):

• Radiofrequency ablation to the lower esophageal sphincter.

• Injectable bulking agents into the lower esophageal sphincter.

• Endoscopic suturing.

• Transoral incisionless fundoplication, which is a suturing technique designed to create a

full thickness gastroesophageal valve from inside the stomach.

Magnetic sphincter augmentation, also referred to as magnetic esophageal ring implantation, uses a

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device constructed of magnetic titanium beads connected together with independent titanium wires

that is implanted at the lower esophageal sphincter. Each magnetic bead works independently of the

others, allowing physiological movement of the esophagus without tension. The magnetic forces of the

beads form a circular unit that holds the lower esophageal sphincter closed, and the titanium wires

allow the device to expand. Intraoperative measurements are obtained to determine device size and

resistance to expansion needed to augment lower esophageal sphincter function. Unlike other

laparoscopic anti-reflux procedures, magnetic sphincter augmentation does not alter gastric anatomy

and can be explanted if necessary. Implantation requires approximately 30 minutes and may be

performed on an outpatient basis.

Searches

AmeriHealth Caritas searched PubMed and the databases of:

UK National Health Services Centre for Reviews and Dissemination.

Agency for Healthcare Research and Quality and other evidence-based practice centers.

The Centers for Medicare & Medicaid Services.

We conducted searches on November 5, 2018. Search terms were: “GERD,” “gastroesophageal reflux

disease,” “reflux,” “anti-reflux,” “fundoplication,” “Stretta,” “esophyx,” “enteryx,” “endoscopic plication

system,” “EndoCinch,” and “transoral incisionless fundoplication.”

We included:

Systematic reviews, which pool results from multiple studies to achieve larger sample sizes

and greater precision of effect estimation than in smaller primary studies. Systematic

reviews use predetermined transparent methods to minimize bias, effectively treating the

review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies.

Guidelines based on systematic reviews.

Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple

cost studies), reporting both costs and outcomes — sometimes referred to as efficiency

studies — which also rank near the top of evidence hierarchies.

Findings

We identified two systematic reviews (Lipka, 2015; Wendling, 2013); one cost-effectiveness study (Funk,

2015); and several evidence-based guidelines for this policy. Multiple new endoluminal devices and

therapies have been developed to create a more effective antireflux barrier in patients with chronic

gastroesophageal reflux disease, who are unsatisfied or unresponsive to maximal antireflux medical

therapy or who refuse laparoscopic Nissen fundoplication. However, many devices have been

abandoned because of ineffectiveness or significant adverse effects.

The systematic reviews and meta-analyses assessed the evidence for the following Food and Drug

Administration-approved antireflux devices:

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Radiofrequency ablation using the Stretta® procedure (Mederi Therapeutics Inc., Norwalk,

Connecticut).

Sphincter bulking agents using ENTERYX® (Boston Scientific, Marlborough, Massachusetts),

subsequently withdrawn from the market.

Transoral incisionless fundoplication using EsophyX® (EndoGastric Solutions Inc., Redmond,

Washington).

Endoscopic suturing or stapling using the Medigus Ultrasonic Surgical Endostapler (MUSE™)

(Medigus USA, Danville, California)

Magnetic sphincter augmentation (LINX® Reflux Management System, Torax Medical Inc., Shoreview, Minnesota).

The safety, efficacy, durability, and cost-effectiveness of endoscopic therapies relative to conventional

pharmacologic or surgical treatment of gastroesophageal reflux disease have not been established in the

published medical literature. Current studies are generally of small to moderate size, lack adequate

control or comparison groups, and provide only short-term follow-up. The effectiveness of these devices

is modest compared with sham procedures in high-quality studies, and the risks have either been too

great or inadequately studied compared with fundoplication. Well-designed clinical trials with long-term

follow-up are required to establish that endoscopic therapies benefit health outcomes in patients with

gastroesophageal reflux disease by eliminating symptoms, preventing recurrence of symptoms or

progression of disease, healing esophagitis, and reducing or eliminating the need for pharmacologic

therapy.

Evidence-based guidance from National Institute for Health and Care Excellence (2011 and 2013); the

Society of American Gastrointestinal and Endoscopic Surgeons (Auyang, 2013); the American Society for

Gastrointestinal Endoscopy (2015); and the American College of Gastroenterology (Katz, 2013) concur

with these findings with two exceptions. The Society of American Gastrointestinal and Endoscopic

Surgeons issues a strong recommendation for using the Stretta procedure for patients with

gastroesophageal reflux disease who are ≥ 18 years of age, with persistent symptoms of heartburn,

regurgitation, or both for ≥ six months, have been partially or completely responsive to pharmacologic

therapy, and have declined laparoscopic Nissen fundoplication. The American Society for

Gastrointestinal Endoscopy suggests endoscopic antireflux therapy for selected patients with

uncomplicated gastroesophageal reflux disease, after careful discussion with the patient regarding

potential adverse effects, benefits, and other available therapeutic options.

The American Society of General Surgeons (2016) supports the use of either transoral fundoplication

using multiple fasteners or transoral incisionless fundoplication at the discretion of the general surgeon

for patients who are candidates for surgical fundoplication. Their rationale is that the transoral

procedure is a suitable minimally invasive option, as long as it adheres to the same fundamental surgical

principle of creating a full thickness esophagogastric fundoplication to correct an incompetent LES.

However, limited evidence supports their decision.

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There is insufficient evidence to support the use of magnetic sphincter augmentation for the treatment

of gastroesophageal reflux disease. The evidence consists of industry-sponsored studies of low quality

with a high risk of bias. Results suggest magnetic sphincter augmentation may effectively and safely

resolve the symptoms and be a viable alternative to laparoscopic Nissen fundoplication in certain

patients, but there is considerable uncertainty in the findings. The optimal patient selection criteria have

not been established. Study inclusion criteria were highly selective, consisting primarily of patients with

milder forms of gastroesophageal reflux disease who had at least some response to proton pump

inhibitor therapy without associated esophageal conditions, such as severe esophagitis or large hiatal

hernias. The available evidence does not support extending magnetic sphincter augmentation

application to patients with hiatal hernia larger than three centimeters.

The Food and Drug Administration mandated two post-approval studies to evaluate the long-term safety

and effectiveness of magnetic sphincter augmentation and the incidence of adverse events (2016). At

one-year follow-up, there were no device migrations or malfunctions and no events leading to long-term

complications or deaths. Device removal occurred in 3.4 percent of patients, mainly due to dysphagia

followed by recurrent symptoms of gastroesophageal reflux disease. A five-year follow-up study is

ongoing (clinicaltrials.gov identifier NCT01940185).

Evidence-based guidelines vary in their support for magnetic sphincter augmentation. The ACG found

limited evidence that magnetic sphincter augmentation provided consistent, durable symptom relief

and pH control with markedly fewer side effects than traditional laparoscopic Nissen fundoplication in

highly selected patients for up to four years (Katz, 2013). However, more data are required before

widespread usage can be recommended. The American Society of General Surgeons (2014) supports the

LINX procedure as a mechanism for controlling gastroesophageal reflux disease when it is placed by

properly trained laparoscopic surgeons with experience in foregut surgery and management of

gastroesophageal reflux disease. The Society of American Gastrointestinal and Endoscopic Surgeons

guideline (2010) makes no mention of magnetic sphincter augmentation.

Policy updates:

In December 2017, one website was added to the professional society guidelines/other category, and

seven publications were added to the peer-reviewed reference list.

In November 2018, we added one guideline/other and seven peer-reviewed publications to the policy.

No policy changes are warranted at this time. The policy ID changed from 8.03.03 to CCP.1224.

Summary of clinical evidence:

Citation Content, Methods, Recommendations

American Society of General

Surgeons (2016)

Key points:

Supports the use of either transoral fundoplication using multiple fasteners or transoral

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Citation Content, Methods, Recommendations

Position statement: transoral

fundoplication

incisionless fundoplication at the discretion of the general surgeon for patients who are

candidates for surgical fundoplication.

The transoral procedure is a nonsurgical option as long as it creates a full-thickness

esophagogastric fundoplication to correct an incompetent lower esophageal sphincter.

Based on limited evidence.

American Society of General

Surgeons (2015)

Role of endoscopy in the

management of GERD

Key points:

Committee suggests considering endoscopic antireflux therapy for selected patients

with uncomplicated gastroesophageal reflux disease after careful discussion with the

patient regarding potential adverse effects, benefits, and other available therapeutic

options.

Funk (2015)

Long-term cost-

effectiveness of medical,

endoscopic and surgical

management of

gastroesophageal reflux

disease.

Key points:

Markov model was generated from the payer's perspective using a six-month cycle and

30-year time horizon; parameters were selected using the published literature and

institutional billing data.

Four treatment strategies were analyzed: proton pump inhibitor therapy, transoral

incisionless fundoplication (EsophyX), radiofrequency ablation (Stretta), and

laparoscopic Nissen fundoplication.

Base case analysis assumed a proton pump inhibitor cost of $234 over six months ($39

per month).

Stretta and laparoscopic Nissen fundoplication were the most cost effective ($2,470.66

and $5,579.28 per quality-adjusted life-year gained, respectively).

If proton pump inhibitor therapy > $90.63 per month over 30 years, laparoscopic Nissen

fundoplication was dominant.

Laparoscopic Nissen fundoplication was more cost effective than EsophyX at all points

in time.

Lipka (2015)

No evidence for efficacy of

radiofrequency ablation for

treatment of

gastroesophageal reflux

disease: a systematic review

and meta-analysis

Key points:

Systematic review and meta-analysis of four randomized controlled trials (165 total

patients). Three trials compared Stretta versus sham, and one trial compared Stretta

versus proton pump inhibitor therapy. Overall quality: very low.

No difference between Stretta versus sham or proton pump inhibitor therapy for the

outcomes of mean time spent at a pH < 4 over a 24-hour time course, lower esophageal

sphincter pressure, ability to stop proton pump inhibitors, or health-related quality of life.

American Society of General

Surgeons (2014)

LINX Statement of Support

from ASGS

Key points:

Supports the LINX procedure as mechanism for controlling gastroesophageal reflux

disease when it is placed by properly trained laparoscopic surgeons with experience in

foregut surgery and the management of gastroesophageal reflux disease patients.

Auyang (2013) for SAGES

SAGES clinical spotlight

review: endoluminal

treatments for

gastroesophageal reflux

disease (GERD)

Key points:

EsophyX: In short-term follow-up, from six months to two years, EsophyX may be

effective in patients with hiatal hernia 2 centimeter with typical and atypical

gastroesophageal reflux disease. Long-term data are unavailable. Further studies need

to define optimal techniques, patient-selection criteria, and device/technique safety.

(Low quality of evidence; weak recommendation.)

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Citation Content, Methods, Recommendations

Stretta recommended for patients with gastroesophageal reflux disease who are ≥ 18

years of age, with persistent symptoms of heartburn, regurgitation, or both for ≥ six

months; have been partially or completely responsive to pharmacologic therapy; and

have declined laparoscopic Nissen fundoplication (high quality of evidence; strong

recommendation).

Stretta not recommended for patients with severe esophagitis, long-segment Barrett’s

esophagus, dysphagia, hiatal hernia > 2 cm, autoimmune disease, collagen vascular

disease, and/or coagulation disorders.

Katz (2013) for the

American College of

Gastroenterology

Guidelines for the diagnosis

and management of

gastroesophageal reflux

disease

Key points:

Endoscopic therapies for gastroesophageal reflux disease have not demonstrated long-

term efficacy.

Do not recommend current endoscopic therapy or transoral incisionless fundoplication

as an alternative to medical or traditional surgical therapy. (Conditional

recommendation, moderate level of evidence.)

National Institute for Health

and Care Excellence (2013)

Endoscopic radiofrequency

ablation for gastro-

oesophageal reflux disease

Key points:

Endoscopic radiofrequency ablation for gastroesophageal reflux disease is safe in the

short and medium terms, but longer-term outcomes are unclear.

Achieves symptomatic relief, but objective evidence on reduction of reflux is

inconclusive.

Procedure should only be used with special arrangements for clinical governance,

consent, and audit or research.

Wendling (2013)

Impact of transoral

incisionless fundoplication

(TIF) on subjective and

objective GERD indices: a

systematic review of the

published literature

Key points:

Systematic review of 15 studies reporting on over 550 procedures.

Transoral incisionless fundoplication significantly reduced both gastroesophageal reflux

disease-health-related quality of life scores (21.9 versus 5.9, p < 0.0001) and Reflux

Symptom Index scores (24.5 versus 5.4, p ≤ 0.0001).

Overall patient satisfaction = 72%.

Proton pump inhibitor discontinuation rate = 67%, with a mean follow-up of 8.3 months.

pH metrics were not consistently normalized.

Major complication rate = 3.2%; failure rate = 7.2%.

Transoral incisionless fundoplication effectiveness and durability, and optimal patient

population are not determined.

NICE (2011)

Endoluminal gastroplication

for gastrooesophageal reflux

disease

Key points:

No major safety concerns.

Randomized controlled trials suggest some short-term reduction in medication

requirement, but other outcomes are inconsistent, sustained improvement in

esophageal pH measurement is not demonstrated.

Transoral incisionless fundoplication should only be used with special arrangements for

clinical governance, consent, and audit or research.

References

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Professional society guidelines/other:

American Society of General Surgeons. LINX Statement of Support from ASGS [American Society of

General Surgeons]. American Society of General Surgeons website. https://theasgs.org/position-

statements/linx-statement-of-support-from-asgs/. 2014. Accessed November 5, 2018.

American Society of General Surgeons. Position Statement: Transoral Fundoplication. American Society

of General Surgeons website. https://theasgs.org/position-statements/american-society-of-general-

surgeons-asgs-position-statement-transoral-fundoplication/.2016. Accessed

November 5, 2018..

ASGE Standards of Practice Committee, Muthusamy VR, Lightdale JR, et al. The role of endoscopy in the

management of GERD. Gastrointest Endosc. 2015; 81(6): 1305-1310. doi: 10.1016/j.gie.2015.02.021.

Auyang ED, Carter P, Rauth T, Fanelli RD, Committee SG. SAGES clinical spotlight review: endoluminal

treatments for gastroesophageal reflux disease (GERD). Surg Endosc. 2013; 27(8): 2658-2672. doi:

10.1007/s00464-013-3010-8.

FDA 510(k) Premarket Notification using product code ODE. FDA website.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed December 6, 2017.

FDA Premarket Approval (PMA) database searched using PMA number P100049. FDA website.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm. Accessed November 5, 2018.

Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux

disease. Am J Gastroenterol. 2013; 108(3): 308-328; quiz 329. doi: 10.1038/ajg.2012.444.

National Institute of Diabetes and Digestive and Kidney Diseases. Acid Reflux (GER & GERD) in Adults.

National Institute of Diabetes and Digestive and Kidney Diseases website.

https://www.niddk.nih.gov/health-information/digestive-diseases/acid-reflux-ger-gerd-adults.

November 5, 2018.

National Institute of Diabetes and Digestive and Kidney Diseases. Treatment for GER and GERD. National

Institute of Diabetes and Digestive and Kidney Diseases website. November, 2014.

https://www.niddk.nih.gov/health-information/digestive-diseases/acid-reflux-ger-gerd-

adults/treatment. Accessed November 5, 2018.

National Institute for Health and Care Excellence. Endoluminal gastroplication for gastrooesophageal

reflux disease. NICE Interventional Procedure Guidance No. 404. 2011. NICE website.

https://www.nice.org.uk/guidance/ipg404. Accessed November 5, 2018.

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National Institute for Health and Care Excellence. Endoscopic radiofrequency ablation for gastro-

oesophageal reflux disease. NICE Interventional Procedure Guidance No. 461. NICE website.

https://www.nice.org.uk/guidance/ipg461. Accessed November 5, 2018.

National Institute for Health and Care Excellence. Interventional procedure overview of laparoscopic

insertion of a magnetic titanium ring for gastrooesophageal reflux disease. Interventional Procedures

Programme. November 2016. https://www.nice.org.uk/guidance/ipg585/documents/overview.

Accessed November 6, 2018.

Society of American Gastrointestinal and Endoscopic Surgeons. Guidelines for surgical treatment of

gastroesophageal reflux disease. February, 2010. Society of American Gastrointestinal and Endoscopic

Surgeons website. http://www.sages.org/publications/guidelines/guidelines-for-surgical-treatment-of-

gastroesophageal-reflux-disease-gerd/. Accessed November 5, 2018.

Peer-reviewed references:

Aiolfi A, Asti E, Bernardi D, et al. Early results of magnetic sphincter augmentation versus fundoplication

for gastroesophageal reflux disease: Systematic review and meta-analysis. Int J Surg. 2018;52:82-88. doi:

10.1016/j.ijsu.2018.02.041.

Amer MA, Smith MD, Khoo CH, Herbison GP, McCall JL. Network meta-analysis of surgical management of gastro-oesophageal reflux disease in adults. Br J Surg. 2018;105(11):1398-1407. Doi: 10.1002/bjs.10924.

Castelijns PSS, Ponten JEH, van de Poll MCG, Nienhuijs SW, Smulders JF. A collective review of biological

versus synthetic mesh-reinforced cruroplasty during laparoscopic Nissen fundoplication. Journal of

minimal access surgery. 2017. doi: 10.4103/jmas.JMAS_91_17.

Chen MY, Huang DY, Wu A, et al. Efficacy of Magnetic Sphincter Augmentation versus Nissen

Fundoplication for Gastroesophageal Reflux Disease in Short Term: A Meta-Analysis. Can J Gastroenterol

Hepatol. 2017;2017:9596342. doi: 10.1155/2017/9596342.

Du X, Wu JM, Hu ZW, et al. Laparoscopic Nissen (total) versus anterior 180 degrees fundoplication for

gastro-esophageal reflux disease: A meta-analysis and systematic review. Medicine. 2017;96(37):e8085.

doi: 10.1097/md.0000000000008085.

El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the epidemiology of gastro-oesophageal reflux

disease: a systematic review. Gut. 2014;63(6):871-80. doi: 10.1136/gutjnl-2012-304269.

Fuchs KH, Babic B, Breithaupt W, et al. EAES recommendations for the management of

gastroesophageal reflux disease. Surg Endosc. 2014; 28(6): 1753-1773. doi: 10.1007/s00464-014-3431-z.

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Funk LM, Zhang JY, Drosdeck JM, et al. Long-term cost-effectiveness of medical, endoscopic and surgical

management of gastroesophageal reflux disease. Surgery. 2015; 157(1): 126-136. doi:

10.1016/j.surg.2014.05.027.

Gerson L, Stouch B, Lobontiu A. Transoral incisionless fundoplication (TIF 2.0): a meta-analysis of three randomized, controlled clinical trials. Chirurgia. 2018;113(2):173-184. doi: 10.21614/chirurgia.113.2.173.

Huang X, Chen S, Zhao H, et al. Efficacy of transoral incisionless fundoplication (transoral incisionless

fundoplication) for the treatment of GERD: a systematic review with meta-analysis. Surg Endosc.

2017;31(3):1032-1044. doi: 10.1007/s00464-016-5111-7.

Kahrilas PJ, Shaheen NJ, Vaezi MF, et al. American Gastroenterological Association Medical Position

Statement on the management of gastroesophageal reflux disease. Gastroenterology. 2008; 135(4):

1383-1391, 1391.e1381-1385. doi: 10.1053/j.gastro.2008.08.045.

Lei X, Ren Q, Yang Y, Bai T. Outcome Evaluation of Laparoscopic and Open Nissen Fundoplication in

Children-A Systematic Review and Meta-Analysis. Am Surg. 2017;83(1):90-97. PMID: 28234132.

Lipka S, Kumar A, Richter JE. No evidence for efficacy of radiofrequency ablation for treatment of

gastroesophageal reflux disease: a systematic review and meta-analysis. Clin Gastroenterol Hepatol.

2015; 13(6): 1058-1067.e1051. doi: 10.1016/j.cgh.2014.10.013.

Patti MG. An Evidence-Based Approach to the Treatment of Gastroesophageal Reflux Disease. JAMA

Surg. 2016; 151(1): 73-78. doi: 10.1001/jamasurg.2015.4233.

Prakash D, Campbell B, Wajed S. Introduction into the NHS of magnetic sphincter augmentation: an

innovative surgical therapy for reflux - results and challenges. Ann R Coll Surg Eng. 2018;100(4):251-256.

doi: 10.1308/rcsann.2017.0224.

Richter JE, Kumar A, Lipka S, Miladinovic B, Velanovich V. Efficacy of laparoscopic Nissen fundoplication

vs transoral incisionless fundoplication or proton pump inhibitors in patients with gastroesophageal

reflux disease: a systematic review and network meta-analysis. Gastroenterol. 2018;154(5):1298-

1308.e1297. doi: 10.1053/j.gastro.2017.12.021.

Skubleny D, Switzer NJ, Dang J, et al. LINX((R)) magnetic esophageal sphincter augmentation versus

Nissen fundoplication for gastroesophageal reflux disease: a systematic review and meta-analysis.

Surgical endoscopy. 2017;31(8):3078-3084. doi: 10.1007/s00464-016-5370-3.

Stanak M, Erdos J, Hawlik K, Birsan T. Novel surgical treatments for gastroesophageal reflux disease: systematic review of magnetic sphincter augmentation and electric stimulation therapy. Gastroenterology Res. 2018;11(3):161-173. doi: 10.14740/gr1024w.

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Wendling MR, Melvin WS, Perry KA. Impact of transoral incisionless fundoplication (TIF) on subjective

and objective GERD indices: a systematic review of the published literature. Surg Endosc. 2013; 27(10):

3754-3761. doi: 10.1007/s00464-013-2961-0.

Centers for Medicaid & Medicare Services National Coverage Determinations:

100.9 National Coverage Determination (NCD) for Implantation of Anti-Gastroesophogeal Device

Local Coverage Determinations:

A54836 HCPCS local coverage determination changes.

A54837 HCPCS local coverage determination changes Part B.

A55330 Self-administered drug (SAD) list revision to the Part A and Part B article.

A55749 Response to comments: Select minimally invasive GERD procedures

A54815 Noncovered procedures – endoscopic treatment of gastroesophageal reflux disease (GERD)

A55869 Noncovered procedures – endoscopic treatment of gastroesophageal reflux disease (GERD)

REVISION TO THE Part A and Part B LCD

L34659 Endoscopic Treatment of GERD.

L35080 Select Minimally Invasive GERD Procedures.

L35008 Non-Covered Services.

L33296 Noncovered Procedures - Endoscopic Treatment of Gastroesophageal Reflux Disease (GERD).

L35094 Services That Are Not Reasonable and Necessary.

L34540 Stretta Procedure.

L34553 Stretta Procedure.

L34298 Surgery: Transoral Incisionless Fundoplication (TIF).

L34999 Transoral Incisionless Fundoplication.

Commonly submitted codes

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Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is

not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and

bill accordingly.

CPT Code Description Comments

43210 Transoral incisionless fundoplication (TIF)

43284 Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (ie, magnetic band), including cruroplasty when performed

ICD-10 Code Description Comments

K21.0 Gastro-esophageal reflux disease with esophagitis

K21.9 Gastro-esophageal reflux disease without esophagitis

HCPCS Level II Code

Description Comments

N/A