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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.
3
• 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
4
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:
5
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.
6
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
7
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.)
8
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
9
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.
10
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.
11
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.
12
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
13
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