Benefits are not available for endoluminal treatment for Gastroesophageal
Reflux Disease (GERD) using the Stretta procedure, the Bard EndoCinchTM
Suturing System, PlicatorTM, 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 EndoCinchTM Suturing System and the PlicatorTM 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. At this time, 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 TM 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 EsophyXTM. TIF using EsophyXTM 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 for TIF: June 2020**

  1. Chang CG, Thackeray L. Laparoscopic Hiatal Hernia Repair in 221 Patients: Outcomes and Experience. _JSLS_. 2016;20(1):1-7. 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).  
  

  2. 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. 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).  
  

  3. Ihde, GM, Rena,C, et al. pH Scores in Hiatal Repair with Transoral Incisionless Fundoplication. _JSLS_. 2019:23: 1-8. 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.  
  

  4. JJanu, P, Shughoury, AB, Venkat, K. Laparoscopic Hiatal Hernia Repair Followed by Transoral Incisionless Fundoplication With EsophyX Device (HH + TIF): Efficacy and Safety in Two Community Hospitals. _Surgical Innovation_. 2109. 26(6) 675-686. 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 one after the other, either with a single surgeon doing both components, or performed by a team of surgeon and 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\. Technology Coverage Statement on Minimally Invasive Surgical Options for
Gastroesophageal Reflux Disease April 2016. This is a position paper from the
American Gastrological Association based on its reviews of TIF publications.
It is strongly supportive.

2\. Bell RCW, Barnes WE, Carter BJ, et al. Transoral incisionless
fundoplication: 2-year results from the prospective multicenter U.S. study.
_AM Surg_. 2014 Nov;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 nine years
(range, one to 35 years), the median duration of PPI use was seven years
(range, one to 20 years), and 92 percent of patients had incomplete symptom
control despite maximal medical therapy. This three-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\. Hakansson B., Montgomery M., Cadiere G, et al. Randomised clinical trial:
transoral incisionless fundoplication vs. sham intervention to control chronic
GERD. Alimentary Pharmacology and Therapeutics. 2015 John Wiley & Sons Ltd.
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 of
the TIF2 procedure. No safety issues were raised. This is supportive.

4\. Hunter JG, Kahrilas PJ, Bell RCW, et al. _Gastroenterology_. 2015
Feb;148(2):324-333. The largest 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 six
months of placebo and 42 patients received sham surgery with six 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\. Clinical Spotlight Review: Endoluminal Treatments for Gastroesophageal
Reflux Disease (GERD)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, 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, 1-8\. 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 (none 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, K., & et al. (2017). Transoral fundoplication offers durable symptom
control for chronic GERD: 3-year report from the TEMPO randomized trial with a
crossover arm. Surg Endosc. 2017 Jun;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. 52 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 was
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 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.

      **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.