LCD L34659

Coverage Guidance

Title XVIII of the Social Security Act, §1862(a)(1)(A). Allows coverage and payment for only those services that are considered to be reasonable and necessary.

Title XVIII of the Social Security Act, § 1833(e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Change Request 10901 Local Coverage Determinations (LCDs) Implementation date January 8, 2019.

IOM 100-08 Medicare Program Integrity Manual, Chapter 13-Local Coverage Determinations

Indications and Limitations of Coverage

Benefits are not available for endoluminal treatment for Gastroesophageal Reflux Disease (GERD) using the Stretta® procedure, the Bard EndoCinch™ Suturing System, Plicator™, or similar treatments as these procedures are not considered reasonable and necessary for the diagnosis or treatment of an injury or disease.

Currently, these procedures are considered non-covered due to the fact that current peer-reviewed literature does not support the efficacy of the services. Claims will be denied as "not proven effective."

The Stretta® procedure is an endoluminal treatment for GERD in which radiofrequency energy is delivered to smooth muscle of the lower esophageal sphincter (LES). A flexible catheter equipped with special needle electrodes for precise energy delivery is placed by mouth into the esophagus and carefully controlled radiofrequency energy is then delivered to the LES and gastric cardia, creating thermal lesions. The manufacturer maintains that the changes that occur immediately, and over time, result in a "tighter" LES and a less compliant gastric cardia. Additionally, the interruption of nerve pathways in the LES area is believed to reduce the incidence of inappropriate LES "relaxations," leading to an improvement in GERD symptoms. Substantial peer-reviewed evidence to fully support these assumptions remains to be published.

The Bard EndoCinch™ Suturing System and the Plicator™ are intended for use in endoscopic placement of suture(s) in the soft tissue of the esophagus and stomach and for approximation of tissue for treatment of symptomatic gastroesophageal reflux disease.

Clinical data from various studies are emerging. Currently, open-label studies or patient registries with short-term follow-ups are the dominant source of data. The overwhelming preponderance of reviewers remains equivocal in their support and have called for randomized controlled trials with long-term follow-ups. In the absence of evidence from such studies, and in the absence of wide acceptance, endoscopic treatments for GERD are not proven effective.

Therefore, they are not reimbursable even though some of the treatments may have associated CPT™ or OPPS codes.

Coverage for the TIF (Transoral Incisionless Fundoplication) procedure is for treatment of patients in whom proton pump inhibitor therapy fails. An example of the device used in TIF is EsophyX™. TIF using EsophyX™ for performing surgery for treating gastroesophageal reflux disease (GERD) reconstructs the valve at the top of the stomach that helps prevents acid reflux.

Indications

Coverage is appropriate for TIF if done by a well-trained surgeon for the following indications:

1. Symptomatic chronic gastroesophageal reflux (chronic being defined as > 6 months of symptoms), and

2. Symptoms must not be completely responsive to Proton Pump Inhibitors (PPIs) as judged by GERD HRQL scores of < or equal to 12 while on PPIs and > or equal to 20 when off for 14 days (also acceptable would be the difference of > or equal to 10 of the scores between off and on therapy), and

3. Hiatal hernia < or equal to 2 cm, including where the hernia has been reduced to 2 cm or less by a successful laparoscopic hernia reduction procedure prior to the TIF procedure. (Based on (FDA) approval).

Limitations

Coverage is not extended:

1. For those patients who may have recurrent symptoms or may fail this procedure. No literature has been submitted for repeat TIF use. These procedures (repeat TIF) would be considered investigational at this time.

Summary of Evidence

Summary of evidence for TIF: June 2020

• Chang CG, Thackeray L. Laparoscopic Hiatal Hernia Repair in 221 Patients: Outcomes and Experience. JSLS. 2016;20(1):e2015.00104. doi:10.4293/JSLS.2015.00104. The article addresses the common condition of hiatal hernia, which is often associated with symptomatic gastroesophageal reflux disease (GERD). The article supported the studies outcomes of the efficacy and safety of laparoscopic hiatal hernia repair (LHHR) with biologic mesh to reduce and/or alleviate GERD symptoms and associated hiatal hernia recurrence. The greatest GERD-HRQL score decrease (20.5 ± 13.4) was observed in patients who underwent LHHR with a fundoplication procedure (Nissen/TIF).

• Ihde GM, Besancon K, Deljkich E. Short-term safety and symptomatic outcomes of transoral incisionless fundoplication with or without hiatal hernia repair in patients with chronic gastroesophageal reflux disease. Am J Surg. 2011; 202(6):740-747. doi:10.1016/j.amjsurg.2011.06.035. The study supports the safety of TIF and the procedure’s ability to significantly reduce the symptoms. The technology represents a suitable alternative treatment option to patients with chronic GERD not satisfied with their current management of the disease. The use of laparoscopic HHR can augment the use of transoral fundoplication without introducing the side effects of laparoscopic Nissen fundoplication (LNF).

• Ihde GM 2nd, Pena C, Scitern C, Brewer S. pH Scores in Hiatal Repair with Transoral Incisionless Fundoplication. JSLS. 2019;23(1):e2018.00087. doi:10.4293/JSLS.2018.00087. This article supports that hiatal hernia repair combined with transoral incisionless fundoplication significantly improved outcomes in patients with gastroesophageal reflux disease in both subjective Gastroesophageal Reflux Disease Health Related Quality of Life and Reflux Symptom Index measurements as well as in objective pH scores.

• Janu P, Shughoury AB, Venkat K, et al. Laparoscopic Hiatal Hernia Repair Followed by Transoral Incisionless Fundoplication With EsophyX Device (HH + TIF): Efficacy and Safety in Two Community Hospitals. Surg Innov. 2019;26(6):675-686. doi:10.1177/1553350619869449. This study was to assess the safety and efficacy of a HH + TIF procedure among a cohort of GERD patients with hiatal hernias. Based on the findings, the procedures can be safely performed 1 after the other, either with a single surgeon doing both components, or performed by a team of a surgeon and a gastroenterologist.

Summary of Evidence for TIF: September 2017

As noted above, transoral incisionless fundoplication surgery is a method for treating gastroesophageal reflux disease. This procedure reconstructs the valve at the top of the stomach that helps prevent acid reflux.

1. Donovan D. American Gastroenterological Association releases Technology Coverage statement on minimally invasive surgical options for GERD. EndoGastric Solutions. Published June 17, 2016. Accessed June 25, 2026. https://www.endogastricsolutions.com/2016/06/american-gastroenterological-association-releases-technology-coverage-statement-on-minimally-invasive-surgical-options-for-gerd/ . This is a position paper from the American Gastrological Association based on its reviews of TIF publications. It is strongly supportive.

2. Bell RC, Barnes WE, Carter BJ, et al. Transoral incisionless fundoplication: 2-year results from the prospective multicenter U.S. study. Am Surg. 2014;80(11):1093-1105. This 24-month follow-up has been reported from a prospective multicenter registry of patients with chronic GERD who received transoral fundoplication using the ESOPHYX2 system with SerosaFuse fasteners. For the 100 consecutive patients who were treated in this community-based study, the median GERD symptom duration was 9 years (range, 1 to 35 years), the median duration of PPI use was 7 years (range, 1 to 20 years), and 92% of patients had incomplete symptom control despite maximal medical therapy. This 3-year study provides evidence to demonstrate sustainable improvement in health outcomes, symptom relief, decrease in PPI utilization and improvement in esophageal pH with transoral fundoplication. This is supportive.

3. Håkansson B, Montgomery M, Cadiere GB, et al. Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD. Aliment Pharmacol Ther. 2015;42(11-12):1261-1270. doi:10.1111/apt.13427. This publication is indexed in the U.S. National Library of Medicine of the National Institutes. The study was blinded and divided equally into TIF and sham procedures. The follow up period was only 6 months, the time (average days) in remission offered by the TIF procedure (197) was significantly longer compared to those submitted to the sham intervention (107), P < 0.001. After 6 months 13/22 (59%) of the chronic GERD patients remained in clinical remission after the active intervention. The secondary outcome measures were all in favor of the TIF2 procedure. No safety issues were raised. This is supportive.

4. Hunter JG, Kahrilas PJ, Bell RC, et al. Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology. 2015;148(2):324-333.e5. doi:10.1053/j.gastro.2014.10.009. The largest randomized controlled trial (RCT) with the lowest risk of bias is an industry-sponsored double-blind sham controlled multicenter study (RESPECT) that evaluated transoral fundoplication in patients whose symptoms were not well-controlled on proton pump inhibitors (PPIs). Out of 696 patients screened, 129 met inclusion and exclusion criteria and were randomized in a 2:1 ratio; 87 patients received transoral fundoplication combined with 6 months of placebo and 42 patients received sham surgery with 6 months of daily PPI therapy (sham/PPI). Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P < .001), but not after sham surgery (mean 8.6% before and 8.9% after). This is supportive.

5. Society of American Gastrointestinal and Endoscopic Surgeons. Clinical Spotlight Review: Endoluminal Treatments for Gastroesophageal Reflux Disease (GERD). Sages.org. March 2017. https://www.sages.org/publications/guidelines/endoluminal-treatments-for-gastroesophageal-reflux-disease-gerd/. This is a statement from the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in Mar 2017. The recommendation is: Based on existing evidence, TIF can be performed with an acceptable safety risk in appropriately selected patients. The procedure leads to better control of GERD symptoms compared with PPI treatment in the short term (6 months), but appears to lose effectiveness during longer term follow-up and is associated with moderate patient satisfaction scores. Objective GERD measures improve similarly after TIF 2.0 compared with PPI. No comparative, controlled trials exist between TIF and surgical fundoplication, but preliminary evidence suggests that the latter can be used safely after TIF failure. (Per SAGES, this is level of evidence +++, strong recommendation).

6. 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. 2017;30(3):1-8. doi:10.1111/dote.12525. This publication is indexed in the U.S. National Library of Medicine of the National Institutes of Health. The study initially had 45 patients who had the TIF procedure and were followed for a mean of 59 months (range 36–75). One patient had a complication during surgery and thus was excluded. The 44 patients had follow-up upper endoscopy at 6 months, 1 year, and 3–5 years postoperatively (72.7%) that completed the study follow up, reported elimination of their main symptom without the need for PPI administration (no PPI usage). Six patients (13.6%), 5 with heartburn, and 1 with regurgitation reported half PPI dose taken for <50% of the preceding follow up period (occasional PPI usage), 6 more patients (4 with heartburn, 1 with regurgitation, and 1 with chest pain) reported full or half PPI dose taken for more than 50% of the preceding follow up period (daily PPI usage). This is supportive.

7. 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. 2017;31(6):2498-2508. doi:10.1007/s00464-016-5252-8. The TF EsophyX vs. Medical PPI Open Label Trial was conducted in 7 sites. Patients were enrolled with < 2 cm or absent hiatal hernia who suffered from GERD symptoms while on PPI treatment for at least 6 months and had abnormal esophageal acid exposure (EAE). Patients were randomized to TIF group or PPI group. At 6 months, all remaining PPI patients elected to undergo crossover to TIF. Fifty-two patients were assessed at 3 years for GERD symptom resolution, healing of esophagitis using endoscopy, EAE using 48-hour Bravo testing and discontinuation of PPI use. At 3-year follow-up, elimination of troublesome regurgitation and all atypical symptoms were reported by 90 % (37/41) and 88 % (42/48) of patients, respectively. The mean Reflux Symptom Index score improved from 22.2 (9.2) on PPIs at screening to 4 (7.1) off PPIs 3 years post-TF, p\0.0001. The mean total % time pH \4 improved from 10.5 (3.5) to 7.8 (5.7), p = 0.0283. Esophagitis was healed in 86 % (19/22) of patients. At the end of the study, 71 % (37/52) of patients had discontinued PPI therapy. All outcome measures remained stable between 1-, 2-, and 3-year follow-ups post-TF, p\0.0001. This study demonstrated TIF can be used to achieve long term control of chronic GERD symptoms, healing esophagitis and improvement of EAE. This is supportive.

Analysis of Evidence

TIF Reconsideration June 2020

The evidence reviewed is sufficient to demonstrate that hiatal hernia repair, where the size has been reduced to 2 cm or less by laparoscopic technique, can be used safely and efficaciously prior to TIF procedure.

TIF Reconsideration September 2017

While most patients with GERD can be managed non-operatively with pharmacologic therapy, advancements in endoscopic and laparoscopic surgery have expanded the options for patients with GERD who are referred for surgical/endoscopic intervention. Surgical and endoscopic intervention should be entertained only after considerable initial evaluation and medical therapy by primary care and specialty physicians. For patients who have 1) failed medical management, 2) have complications of GERD, or 3) have extra-esophageal manifestations (asthma, hoarseness, cough, chest pain, aspiration), anti-reflux surgery may be an appropriate option.

The evidence reviewed is sufficient to demonstrate sustainable improvement in health outcomes, symptom relief, decrease in PPI utilization and improvement in esophageal pH with transoral fundoplication. This option should be considered in patients not responding to PPI therapy (symptoms of regurgitation) who have documented objective evidence of GERD (pathologic acid exposure on pH testing (both off and on medication)) or esophagitis. Transoral fundoplication should be covered and reimbursed for appropriate patients who meet the selection criteria as described.

Associated Information

Documentation Requirements

The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD. (See the Coverage Indications, Limitations and/or Medical Necessity). This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures, and any other records that describe or support the evaluation and treatment of the patient. Documentation should be available to the Contractor upon request.

Bibliography

• Cadière GB, Van Sante N, Graves JE, Gawlicka AK, Rajan A. Two-year results of a feasibility study on antireflux transoral incisionless fundoplication using EsophyX. Surg Endosc. 2009;23(5):957-964. doi:10.1007/s00464-009-0384-8

• Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease [published correction appears in Am J Gastroenterol. 2013 Oct;108(10):1672]. Am J Gastroenterol. 2013;108(3):308-329. doi:10.1038/ajg.2012.444

• 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.e13915. doi:10.1053/j.gastro.2008.08.045

• Kahrilas PJ, Shaheen NJ, Vaezi MF; American Gastroenterological Association Institute; Clinical Practice and Quality Management Committee. American Gastroenterological Association Institute technical review on the management of gastroesophageal reflux disease. Gastroenterology. 2008;135(4):1392-1413.e14135.

• Repici A, Fumagalli U, Malesci A, Barbera R, Gambaro C, Rosati R. Endoluminal fundoplication (ELF) for GERD using EsophyX: a 12-month follow-up in a single-center experience. J Gastrointest Surg. 2010;14(1):1-6. doi:10.1007/s11605-009-1077-2

Sources reviewed for reconsideration request received for June 2020:

• Chang CG, Thackeray L. Laparoscopic Hiatal Hernia Repair in 221 Patients: Outcomes and Experience. JSLS. 2016;20(1):e2015.00104. doi:10.4293/JSLS.2015.00104

• Ihde GM, Besancon K, Deljkich E. Short-term safety and symptomatic outcomes of transoral incisionless fundoplication with or without hiatal hernia repair in patients with chronic gastroesophageal reflux disease. Am J Surg. 2011;202(6):740-747. doi:10.1016/j.amjsurg.2011.06.035

Additional Sources reviewed

• Ihde GM 2nd, Pena C, Scitern C, Brewer S. pH Scores in Hiatal Repair with Transoral Incisionless Fundoplication. JSLS. 2019;23(1):e2018.00087. doi:10.4293/JSLS.2018.00087

• Janu P, Shughoury AB, Venkat K, et al. Laparoscopic Hiatal Hernia Repair Followed by Transoral Incisionless Fundoplication With EsophyX Device (HH + TIF): Efficacy and Safety in Two Community Hospitals. Surg Innov. 2019;26(6):675-686. doi:10.1177/1553350619869449

Sources reviewed for reconsideration request received in September 2017:

• American Gastroenterological Association: AGA Institute April 2016. Technology Coverage Statement on Minimally Invasive Surgical Options for Gastroesophageal Reflux Disease. Published online 2016:1-6.

• Bell RCW, Barnes WE, Carter BJ, et al. Transoral incisionless fundoplication: 2-year results from the prospective multicenter U.S. study. Am Surg. 2014;80(11):1093-1105. doi:10.1177/000313481408001124

• Håkansson B, Montgomery M, Cadiere GB, et al. Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD. Aliment Pharmacol Ther. 2015;42(11-12):1261-1270. doi:10.1111/apt.13427

• Hunter JG, Kahrilas PJ, Bell RCW, et al. Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology. 2015;148(2):324-333.e5. doi:10.1053/j.gastro.2014.10.009

• Society of American Gastrointestinal and Endoscopic Surgeons: Board of Governors of the SAGES. Clinical Spotlight Review. Published online 2017:1-12.

• 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: Esophyx for GERD. Dis Esophagus. Published online 2016. doi:10.1111/dote.12525

• 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. 2017;31(6):2498-2508. doi:10.1007/s00464-016-5252-8