Latest Review Date: December 2024

Category: Surgery                                                                 

POLICY:

Endoscopic gastroplasty (gastroplication or transoral incisionless fundoplication [TIF] eg, EsophyX, MUSE, GERDX) is considered investigational for the treatment of gastroesophageal reflux disease.

Radiofrequency to create submucosal thermal lesions of the lower esophageal sphincter (Stretta procedure) is considered investigational when used as a treatment for gastroesophageal reflux disease.

The implantation of polymers, spheres, or injection of beads into the lower esophageal sphincter is considered investigational.

The implantation of a prosthesis or hydrogel is considered investigational.

The fixation of a transmural suture-pledget (Plicator procedure) for the treatment of  gastroesophageal reflux diseases is considered investigational. 

Endoscopic closure devices (e.g. Over the Scope clip [OTSC]) are considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Transesophageal endoscopic therapies are being developed for the treatment of gastroesophageal reflux disease (GERD). A variety of procedures are being evaluated, including transesophageal (or transoral) incisionless fundoplication (TIF), application of radiofrequency energy, and injection/implantation of prosthetic devices or bulking agents.

Gastroesophageal Reflux Disease

Gastroesophageal reflux disease (GERD) is a common disorder characterized by heartburn and other symptoms related to reflux of stomach acid into the esophagus. Nearly all individuals experience such symptoms at some point in their lives; a smaller number have chronic symptoms and are at risk for complications of GERD. The prevalence of GERD has been estimated to be approximately 20% in the United States.

Pathophysiology

The pathophysiology of GERD involves excessive exposure to stomach acid, which occurs for several reasons. There can be an incompetent barrier between the esophagus and stomach, either due to dysfunction of the lower esophageal sphincter (LES) or incompetence of the diaphragm. Another mechanism is an abnormally slow clearance of stomach acid by the esophagus. A third mechanism is abnormally slow clearance of acid by the stomach. In this situation, delayed clearance leads to an increased reservoir of stomach acid and a greater tendency to reflux.

In addition to troubling symptoms, some patients will have more serious disease, which results in complications such as erosive esophagitis, dysphagia, Barrett esophagus, and esophageal carcinoma. Pulmonary complications may result from aspiration of stomach acid into the lungs and can include asthma, pulmonary fibrosis and bronchitis, or symptoms of chronic hoarseness, cough, and sore throat.

Treatment

Guidelines on the management of GERD emphasize initial medical management. Weight loss, smoking cessation, head of bed elevation, and elimination of food triggers are all recommended in recent practice guidelines. Proton pump inhibitors (PPIs) have been shown to be the most effective medical treatment. In a Cochrane systematic review, van Pinxteren et al (2010) reported that PPIs demonstrated superiority to H2-receptor agonists and prokinetics in both network meta-analyses and direct comparisons.

Surgical Treatment

The most common surgical procedure used for GERD remains laparoscopic Nissen fundoplication; however, the utilization of this procedure steadily declined between 2009 and 2013 with the advancement of novel nonmedical (endoscopic and surgical) techniques. Fundoplication involves wrapping a portion of the gastric fundus around the distal esophagus to increase lower esophageal sphincter (LES) pressure. If a hiatal hernia is present, the procedure also restores the position of the LES to the correct location. Laparoscopic fundoplication was introduced in 1991 and has been rapidly adopted because it avoids complications associated with an open procedure.

Although fundoplication results in a high proportion of patients reporting symptom relief, complications can occur, and sometimes require conversion to an open procedure. Patients who have relief of symptoms of GERD after fundoplication may have dysphagia or gas-bloat syndrome (excessive gastrointestinal gas).

Other Treatment Options

Due in part to the high prevalence of GERD, there has been interest in creating a minimally invasive transesophageal therapeutic alternative to open or laparoscopic fundoplication or chronic medical therapy. This type of procedure may be considered natural orifice transluminal surgery (NOTES). Three types of procedures have been investigated.

1. The transesophageal endoscopic gastroplasty is (also referred to as gastroplication, fundoplication or transoral incisionless fundoplication [TIF]) can be performed as an outpatient procedure. During the procedure, the fundus of the stomach is folded, and then held in place with staples or fasteners that are deployed by the device. The endoscopic procedure is designed to recreate a valve and barrier to reflux.
2. Radiofrequency (RF) energy has been used to produce submucosal thermal lesions at the gastroesophageal junction. (This technique has also been referred to as the Stretta procedure). Specifically, radiofrequency energy is applied through four electrodes inserted into the esophageal wall at multiple sites both above and below the squamocolumnar junction. The mechanism of action of the thermal lesions is not precisely known but may be related to the ablation of the nerve pathways responsible for sphincter relaxation or may induce a tissue-tightening effect related to heat-induced collagen contraction and fibrosis.
3. Submucosal injection or implantation of a prosthetic or bulking agent to enhance the volume of the lower esophageal sphincter has also been investigated. One bulking agent, pyrolytic carbon-coated zirconium oxide spheres (Durasphere®), has been evaluated. The Gatekeeper Reflux Repair System (Medtronic, Shoreview, MN) utilizes a soft, pliable, expandable prosthesis made of a polyacrylonitrile-based hydrogel. The prosthesis was implanted into the esophageal submucosa, and with time the prosthesis absorbed water and expanded, creating bulk in the region of implantation. However, the only identified RCT was terminated early due to lack of efficacy and it was voluntarily withdrawn by the manufacturer. Endoscopic submucosal implantation of polymethylmethacrylate beads into the lower esophageal folds has also been investigated.

KEY POINTS:

The most recent literature review was performed through October 18, 2024. This policy will address procedures which are currently available for use in the U.S.

Summary of Evidence

For individuals who have GERD and a hiatal hernia of 2 cm or less that is not controlled by proton pump inhibitors (PPIs) who receive TIF (eg, EsophyX), the evidence includes 2 randomized controlled trials (RCTs) comparing TIF with PPI therapy, nonrandomized studies comparing TIF with fundoplication, and case series with longer-term follow-up. Relevant outcomes are symptoms, change in disease status, quality of life (QOL), medication use, and treatment-related morbidity. The highest quality RCT (RESPECT) was sham-controlled and compared TIF with PPI therapy while the other RCT (TEMPO) compared TIF with maximum PPI therapy. Both trials found a significant benefit of TIF on the primary outcome measure in about 65% of patients. The sham-controlled trial reported improvement in 45% of the sham-controlled group and no benefit on secondary subjective outcome measures. The nonblinded RCT found significant improvements in subjective measures, but no difference in objective outcome measures compared with PPI therapy. Together, these trial results would suggest a strong placebo effect of the surgery and a modest benefit of TIF in patients whose symptoms were not controlled by PPIs. For these patients, the most appropriate comparator would be laparoscopic fundoplication. Studies comparing TIF with fundoplication have limitations that include earlier TIF procedures and unbalanced groups at baseline and are inadequate to determine relative efficacy. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have GERD and a hiatal hernia of 2 cm or less that is controlled by PPIs who receive TIF (eg, EsophyX), the evidence includes 2 RCTs and observational studies with longer-term follow-up. Relevant outcomes are symptoms, change in disease status, QOL, medication use, and treatment-related morbidity. A sham-controlled trial found that the time to resume PPI therapy was longer following TIF and the remission rate was higher, indicating that TIF is more effective than no therapy. The nonblinded RCT found a benefit of TIF compared with continued PPI therapy for subjective measures, but not for the objective measures of pH normalization and esophagitis. In addition, a single-center, double-blind RCT in individuals with GERD (using GERDX) and a hiatal hernia of 3 cm or less found improved subjective outcomes to 12 months, but objective measures such as esophageal pH control were not significantly improved. These results raise questions about a possible placebo effect for the procedure. Also, observational studies have indicated a loss of treatment effectiveness over time. Adverse events associated with the procedure (eg, perforation) may be severe. At present, the available evidence does not support the use of this intervention in patients whose symptoms are adequately controlled by medical therapy. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have GERD who receive endoscopic radiofrequency energy (eg, Stretta), the evidence includes 2 meta-analyses, a network meta-analysis, 6 small RCTs, 2 nonrandomized comparative studies, and observational studies with longer-term follow-up. Relevant outcomes are symptoms, change in disease status, QOL, medication use, and treatment-related morbidity. The RCTs reported some improvements in symptoms and QOL following treatment with radiofrequency energy compared with sham controls. However, objective measures of GERD and a meta-analysis of 4 RCTs found no significant improvements in outcomes, raising questions about the mechanism of the symptom relief. Symptom relief and clinical success is reported to be lower than after fundoplication, and reoperations and other severe adverse events greater. Larger RCTs with longer follow-up, preferably compared with fundoplication, are needed to define the risks and benefits of this procedure better. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have GERD who receive esophageal prostheses or bulking agents, the evidence includes case series. The relevant outcomes include symptoms, change in disease status, QOL, medication use, and treatment-related morbidity. High-quality data from large randomized controlled trials are needed to compare bulking procedures with both sham controls and with the currently accepted treatments for GERD, i.e., drug therapy and laparoscopic fundoplication. Well-designed trials should use standardized outcome measures to examine whether subjective improvement, such as discontinuation of medication therapy and GERD–Health-Related Quality of Life scores, is supported by objective improvement, such as esophageal acid exposure. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

The long term evidence for endoscopic suturing devices shows a progressive decline in results.  The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

American Gastroenterological Association

In 2022, the American Gastroenterological Association issued a clinical practice update on the personalized approach to the evaluation and management of GERD. The guideline stated that "transoral incisionless fundoplication is an effective endoscopic option in carefully selected patients" with proven GERD. The guideline further stated that TIF has "demonstrable value in patients with regurgitation-predominant GERD" and that "further research into risks/benefits, durability, effectiveness, and treatment outcomes will enhance optimal utilization" as part of a personalized approach to treatment.

American College of Gastroenterology

The American College of Gastroenterology (2022) guidelines on the diagnosis and management of GERD include the following statements regarding TIF and Stretta:

• We suggest consideration of TIF for patients with troublesome regurgitation or heartburn who do not wish to undergo antireflux surgery and who do not have severe reflux esophagitis (LA grade C or D) or hiatal hernias >2 cm (conditional recommendation, low level of evidence).
• Because data on the efficacy of radiofrequency energy (Stretta) as an antireflux procedure is inconsistent and highly variable, we cannot recommend its use as an alternative to medical or surgical antireflux therapies (conditional recommendation, low level of evidence).

According to the guideline methods, a conditional recommendation equates to a suggestion, and low level of evidence signifies "very little confidence in the effect estimate to support a particular recommendation, based on the risk of bias of the studies, evidence of publication bias, heterogeneity among studies, directness of the evidence, and precision of the estimate of effect." The guideline additionally noted that if TIF or Stretta is used, such use should be limited to patients with milder forms of GERD.

American Society for Gastrointestinal Endoscopy

In 2015, the American Society for Gastrointestinal Endoscopy published guidelines on endoscopic procedures for GERD. In its review of the EsophyX and Stretta procedures, the Society noted some positive findings but discrepancies between subjective and objective outcome measures or a lack of objective outcome measures in reported trials, concluding that these techniques represent “potentially new therapeutic indications for GI endoscopy”, but that prospective trials using objective measures of GERD as the primary endpoint could be useful in defining the clinical role of these procedures.

American Society of General Surgeons

The American Society of General Surgeons (2011) issued a position statement on transoral fundoplication stating that “the ASGS supports the use of transoral fundoplication by trained General Surgeons for the treatment of symptomatic chronic gastroesophageal reflux disease (GERD) in patients who fail to achieve satisfactory response to a standard dose of Proton Pump Inhibitor (PPI) therapy or for those who wish to avoid the need for a lifetime of medication dependence.”

Multi-Society Consensus Guidance on GERD

In 2023, consensus guidance was issued by the Society of American Gastrointestinal and Endoscopic Surgery, American Society for Gastrointestinal Endoscopy, American Society for Metabolic and Bariatric Surgery, European Association for Endoscopic Surgery, Society for Surgery of the Alimentary Tract, and The Society of Thoracic Surgeons on the diagnosis and treatment of GERD. The relevant questions and recommendations for TIF and Stretta are as follows:

• Should endoscopic treatment with TIF 2.0 versus fundoplication be used for patients with GERD?
  • The panel suggests that adult patients with GERD may benefit from fundoplication over TIF 2.0. (Expert Opinion recommendation; GRADE recommendation was unable to be determined due to lack of evidence).
• Should endoscopic treatment with TIF 2.0 versus medical treatment (PPI) be used for patients with GERD?
  • The panel suggests that adult patients with GERD may benefit from TIF 2.0 over continued PPI (conditional recommendation, moderate certainty of evidence).
• Should endoscopic treatment with Stretta versus fundoplication be used for patients with GERD?
  • The panel suggests that adult patients with GERD may benefit from fundoplication over Stretta. (conditional recommendation, very low certainty of evidence).
• Should endoscopic treatment with Stretta versus medical treatment (PPI) be used for patients with GERD?
  • The panel suggests that adult patients with GERD may benefit from Stretta over PPI. (conditional recommendation, low certainty of evidence).

National Institute for Health and Care Excellence

In 2013, NICE updated its guidance on endoscopic radiofrequency treatment for GERD, concluding: "The evidence on the safety of endoscopic radiofrequency ablation for gastro-esophageal reflux disease is adequate in the short and medium term, but there is uncertainty about longer‑term outcomes. With regard to efficacy, there is evidence of symptomatic relief, but objective evidence on reduction of reflux is inconclusive....." The NICE noted "concern on the part of some specialists about the possibility that symptoms may improve as a result of denervation caused by the procedure; if that were the case then failure to recognize and treat reflux might lead to complications in the long term."

In 2011, NICE issued guidance on endoluminal gastroplication for GERD, concluding that "The evidence on endoluminal gastroplication for gastroesophageal reflux disease raises no major safety concerns. Evidence from a number of RCTs [randomized controlled trials] shows a degree of efficacy in terms of reduced medication requirement in the short term, but changes in other efficacy outcomes are inconsistent, and there is no good evidence of sustained improvement in esophageal pH measurements...."

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Stretta procedure, gastroplication, Endo Cinch, treatment for gastroesophageal reflux disease, endoscopic gastroplication or gastroplasty, endoscopic gastroplasty, radiofrequency of the lower esophageal sphincter (LES), Enteryx, PMMA, Plicator, EsophyX System with SerosaFuse, EndoGastric StomaphyX, Durasphere, Gatekeeper Reflux Repair System, NDO plicator, Transoral Incisionless Fundoplication, TIF, GERD, polymethylmethacrylate beads, bulking agent, hydrogel, sphere, polymer, transesophageal radiofrequency, endoscopic closure devices, endoscopic suturing devices, Endocinch, EsophyX, Over the Scope Clips, OTSC, MUSE, Medigus Ultrasonic Surgical Endostapler, GERDX

APPROVED BY GOVERNING BODIES:

***Of Note:  Two endoscopic suturing devices and a biocompatible polymer are no longer available in the United States.

• EndoCinch was discontinued by the manufacturer, Bard
• NDO Plicator was listed as terminated in October 2013
• Enteryx® was recalled by Boston Scientific Corporation

The EsophyX® (EndoGastric Solutions) is a TIF device that was originally cleared for marketing by the FDA through the 510(k) process in 2007 and has subsequently undergone 2 evolutions: Generation 2=EsophyX2 iterations (E2-Plus, HD) and Generation 3=Z iterations (EZ/ZR, Z+). Some of the key Regulatory Status changes are summarized herein. In 2007, EsophyX® (EndoGastric Solutions, Redmond, WA) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for full-thickness plication. In 2016, EsophyX® Z Device with SerosaFuse Fasteners was cleared for marketing by the FDA through the 510(k) process for use in transoral tissue approximation, full thickness plication, ligation in the gastrointestinal tract, narrowing the gastroesophageal junction, and reduction of hiatal hernia of 2cm or less in patients with symptomatic chronic gastroesophageal reflux disease (GERD). In June 2017, EsophyX2 HD and the third-generation EsophyX Z Devices with SerosaFuse fasteners and accessories were cleared for marketing by the FDA through the 510(k) process (K171307) for expanded indications, including patients who require and respond to pharmacologic therapy and in patients with hiatal hernias larger than 2 cm when a laparoscopic hiatal hernia repair reduces a hernia to 2 cm or less. An additional FDA 510(k) clearance (K172811) occurred in October 2017 for new product specification iterations of EsophyX2 HD and EsophyX Z Devices. This clearance allows for "a moderate increase in the upper limit of the temporary Tissue Mold clamping pressure occurring during each fastener deployment." A 2024 FDA510(k) clearance (K240879) updated instructions for use and other device labeling.

The Medigus SRS Endoscopic Stapling System (MUSE, Medigus Ltd) was cleared for marketing by the FDA through the 510(k) process in 2012 (K120299) and 2014 (K132151). MUSE is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach to create anterior partial fundoplication for the treatment of symptomatic chronic GERD in patients who require and respond to pharmacologic therapy.

The GERDX-System (K233240) was cleared through the 510(k) process in 2024 (K233240). The device is intended for endoscopic full-thickness plication for chronic GERD in individuals who require and respond to pharmacological therapy. The manufacturer website includes a description for use in presence of a hiatal hernia up to 3 cm in size. The device is clinically, biologically, and technologically identical to the NDO Surgical Endoscopic Plication System (K071553) which was approved by the FDA in 2003 and has since been removed from the market due to risk of complications. Technological details of the GERDX-System have been improved from the predicate device to improve safety.

In 2000, the CSM Stretta® System was cleared for marketing by the FDA through the 510(k) process for general use in the electrosurgical coagulation of tissue and was specifically intended for use in the treatment of GERD. In 2010, Mederi Therapeutics began manufacturing the Stretta® device. Mederi was acquired by Respiratory Technology Corporation in 2018.

Durasphere® is a bulking agent approved for the treatment of urinary and fecal incontinence (see MP# 455: Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence). Use of this product for esophageal reflux would be considered off-label use. The website of Carbon Medical Technologies states that Durasphere GR “intended to treat problems associated with GERD” but is considered an investigational device in the United States.

OverStitch (Apollo Endosurgery Inc) received 510k marketing clearance from the FDA in November 2017 for endoscopic placement of suture(s) and approximation of soft tissue.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

The following CPT codes are not specific to these procedures.

For transoral incisionless fundoplication (TIF):

43210

Esophagogastroduodenoscopy, flexible, transoral; with esophagogastric fundoplasty, partial or complete, includes duodenoscopy when performed.

For radiofrequency procedure (Stretta Procedure):

43257

Esophagogastroduodenoscopy, flexible, transoral; with delivery of thermal energy to the muscle of lower esophageal sphincter and/or gastric cardia, for treatment of gastroesophageal reflux disease

For Endoscopic submucosal injection of a bulking agent:

43201	Esophagoscopy, flexible, transoral; with directed submucosal injection(s), any substance
43236	Esophagogastroduodenoscopy, flexible, transoral; with directed submucosal injections(s), any substance

For endoscopic implantation of a prosthesis:

43212	Esophagoscopy, flexible, transoral; with placement of endoscopic stent (includes pre- and post-dilation and guide wire passage, when performed)
43266	Esophagogastroduodenoscopy, flexible, transoral; with placement of endoscopic stent (includes pre- and post-dilation and guide wire passage, when performed)
43499	unlisted procedure of esophagus.

For endoscopic suturing and Plicator Procedures:

Of note, the EndoCinch Suturing System and NDO Plicator are no longer available in the U.S.A.

43999

unlisted procedure, stomach

 

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51. National Institutes of Health. Clinicaltrials.gov search results. Available at: clinicaltrials.gov/ct2/results?term=esophyx.
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53. National Institutes of Health. Clinicaltrials.gov search results. Available at: clinicaltrials.gov/ct2/results?term=durasphere.
54. Noar M, Squires P, Noar E, et al. Long-term maintenance effect of radiofrequency energy delivery for refractory GERD: a decade later. Surg Endosc. Aug 2014; 28(8):2323-2333.
55. Perry KA, Banerjee A, Melvin WS. Radiofrequency Energy Delivery to the Lower Esophageal Sphincter Reduces Esophageal Acid Exposure and Improves GERD Symptoms: A Systematic Review and Meta-analysis. Surg Laparosc Endosc Percutan Tech 2012; 22(4):283-8.
56. Rausa E, Ferrari D, Kelly ME, et al. Efficacy of laparoscopic Toupet fundoplication compared to endoscopic and surgical procedures for GERD treatment: arandomized trials network meta-analysis. Langenbecks Arch Surg. Jan 21 2023; 408(1): 52.
57. Richter JE, Kumar A, Lipka S, et al. 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. Gastroenterology. Apr 2018;154(5):1298-1308 e7.
58. Schwartz MP, Rieneke J, Schreinemakers C, et al. Four-year follow-up of endoscopic gastroplication for the treatment of gastroesophageal reflux disease. World J Gastrointest Pharmacol Ther. 2013 Nov 6; 4(4): 120-126.
59. Shaqran TM, Ismaeel MM, Alnuaman AA, et al. Epidemiology, Causes, and Management of Gastro-esophageal Reflux Disease: A Systematic Review. Cureus. Oct2023; 15(10): e47420.
60. Sharma P, Katz P. Endoscopic therapies for gastroesophageal reflux disease: back in the game? Gastroenterology. Feb 2015; 148(2):280-282.
61. Slater BJ, Collings A, Dirks R, et al. Multi-society consensus conference and guideline on the treatment of gastroesophageal reflux disease (GERD). Surg Endosc.Feb 2023; 37(2): 781-806.
62. Society of American Gastrointestinal and Endoscopic Surgeons. Clinical Spotlight Review: Endoluminal Treatments for Gastroesophageal Reflux Disease (GERD). 2017; www.sages.org/publications/guidelines/endoluminal-treatments-for-gastroesophageal-reflux-disease-gerd/.
63. Society of American Gastrointestinal and Endoscopic Surgeons. Multi-Society Consensus Conference and Guideline on the Treatment of Gastroesophageal Reflux Disease (GERD). July 2022.
64. Stefanidis G, Viazis N, Kotsikoros N, et al. Long-term benefit of transoral incisionless fundoplication using the esophyx device for the management of gastroesophageal reflux disease responsive to medical therapy. Dis Esophagus. Feb 01 2017; 30(3):1-8.
65. Testoni PA, Testoni S, Distefano G, et al. Transoral incisionless fundoplication with EsophyX for gastroesophageal reflux disease: clinical efficacy is maintained up to10 years. Endosc Int Open. May 2019; 7(5): E647-E654.
66. Testoni PA, Testoni S, Mazzoleni G, et al. Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study. Surg Endosc. Sep 2015; 29(9):2770-2780.
67. Testoni S, Hassan C, Mazzoleni G, et al. Long-term outcomes of transoral incisionless fundoplication for gastro-esophageal reflux disease: systematic-review and meta-analysis. Endosc Int Open. Feb 2021; 9(2): E239-E246.
68. Testoni SGG, Cilona MB, Mazzoleni G, et al. Transoral incisionless fundoplication with Medigus ultrasonic surgical endostapler (MUSE) for the treatment of gastro-esophageal reflux disease: outcomes up to 3 years. Surg Endosc. Jul 2022; 36(7): 5023-5031.
69. Toomey P, Teta A, Patel K, et al. Transoral incisionless fundoplication: is it as safe and efficacious as a Nissen or Toupet fundoplication? Am Surg. Sep 2014; 80(9):860-867.
70. Trad KS, Barnes WE, Prevou ER, et al. The TEMPO Trial at 5 years: transoral fundoplication (TIF 2.0) Is safe, durable, and cost-effective. Surg Innov. Apr 2018;25(2):149-157.
71. Trad KS, Barnes WE, Simoni G, et al. Transoral incisionless fundoplication effective in eliminating GERD symptoms in partial responders to proton pump inhibitor therapy at 6 months: the TEMPO Randomized Clinical Trial. Surg Innov. Feb 2015; 22(1):26-40.
72. Trad KS, Fox MA, Simoni G, et al. Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm. Surg Endosc. Jun 2017;31(6):2498-2508.
73. Trad KS, Simoni G, Barnes WE, et al. Efficacy of transoral fundoplication for treatment of chronic gastroesophageal reflux disease incompletely controlled with high-dose proton-pump inhibitors therapy: a randomized, multicenter, open label, crossover study. BMC Gastroenterol. 2014; 14:174.
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POLICY HISTORY:

Medical Review Committee, July 2000

Medical Policy Reference Manual, December 2000

Medical Review Committee, September 26, 2001

Medical Policy Group, December 2002 (3)

Medical Review Committee, December 2002

Medical Policy Group, February 2004

Available for comment February 27-April 12, 2004

Medical Policy Group, March 2005 (1)

Medical Policy Group, July 2005 (3)

Medical Policy Group, October 2006 (1)

Medical Policy Administration Committee, October 2006

Available for comment October 21-December 4, 2006

Medical Policy Group, January 2007 (3)

Medical Policy Group, January 2008 (3)

Medical Policy Group, February 2010 (1)

Medical Policy Administration Committee, February 2010

Medical Policy Group, August 2010 (3)

Medical Policy Group, August 2011 (3): Updated Policy section, Key Points, Key Words & References

Medical Policy Administration Committee, September 2011

Available for comment September 2 through October 17, 2011

Medical Policy Group, December 2011 (3): Updated Description, Key Points & References

Medical Policy Group, November 2012 (3): Updated Description, Key Points & References

Medical Policy Panel, November 2013

Medical Policy Group, December 2013 (3): Updated Description, Key Points and References; no change in policy statement

Medical Policy Group, December 2013 (3):  2014 Coding Update – added new codes 43192, 43212 and 43266 (effective 01/01/14); moved code 43219 to previous coding (deleted effective 01/01/14)

Medical Policy Group, November 2014: 2015 Coding Update – Code 43201 removed wording ‘when used to administer one of the products listed in the policy’.

Medical Policy Panel, February 2015

Medical Policy Group (4): Updates to Description, Key Points, Key Words, Approved Governing Bodies, Coding and References.  Clarified policy statements by adding “transoral incisionless fundoplication [TIF]” to first policy statement and added “to create submucosal thermal lesions” to the second policy statement- no change in policy intent to either statement. EndoCinch, Enteryx, and NDO Plicator information was removed from policy.  These are no longer available in the United States.

Medical Policy Group, November 2015: 2016 Annual Coding Update. Added CPT code 43210 to current coding.  Moved cpt code 43499 related to TIF under previous coding section.

Medical Policy Panel, November 2015.

Medical Policy Group, December 2015 (4): Updates to Description, Key Points, and References. Removed CPT code 43192 from policy, incorrect code for procedure.  No change to policy statement.

Medical Policy Panel, October 2016

Medical Policy Group, October 2016 (4): Updates to Description, Key Points, Approved Governing Bodies, and References.  No change to policy statement.  Removed deleted codes 0008T, 0133T, and S2215 from previous coding section.

Medical Policy Group, November 2016 (4): Update to Key Points and References.  No other changes made.

Medical Policy Group, December 2016 (4): updated reference #27.

Medical Policy Panel, December 2017

Medical Policy Group, January 2018 (4): Updates to Description, Key Points, Approved by Governing Bodies, and References. No change to policy statements.

Medical Policy Group, February 2018 (4): Update to Policy statements, Key Points, Key Words, and References.  Added investigational statement regarding endoscopic suturing devices.  These devices were previously considered investigational, now adding verbiage to applicable medical policy.

Medical Policy Panel, November 2018

Medical Policy Group, December 2018 (4): Updates to Key Points, Approved by Governing Bodies, Previous Coding, and References. No change to policy statement.  Removed previously deleted CPT code 43219 (deleted 1/1/14) from previous coding section.

Medical Policy Panel, November 2019

Medical Policy Group, November 2019 (5): Updates to Description, Key Points, Approved by Governing Bodies, Practice Guidelines, and References. No change to Policy Statement.

Medical Policy Panel, December 2020

Medical Policy Group, December 2020 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References.

Medical Policy Panel, December 2021

Medical Policy Group, January 2022 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, Key Words, Approved by Governing Bodies, and References. Policy Statement updated to remove “not medically necessary.” No change to policy intent.

Medical Policy Panel, December 2022

Medical Policy Group, December 2022 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No changes to Policy Statement.

Medical Policy Panel, December 2023

Medical Policy Group, December 2023 (11): Updates to Description, Key Points, Benefit Application, Current Coding and References. Removed Previous Coding Section. No changes to Policy Statement.

Medical Policy Panel, December 2024

Medical Policy Group, December 2024 (11): Updates to Description, Key Points, Key Words, Approved By Governing Bodies, and References.  Updated policy statements by adding TIF examples EsophyX, MUSE, GERDX to first policy statement. No change to policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.