Thursday, December 20, 2018

cpt 43201, 43210, 43236,43257 -Transesophageal Endoscopic Therapies

CPT Coding - Code Description

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

43210 Esophagogastroduodenoscopy, flexible, transoral; with esophagogastric fundoplasty, partial or complete, includes duodenoscopy when performed

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

43257
Esophagogastroduodenoscopy, flexible, transoral; with delivery of thermal energy tothe muscle of lower esophageal sphincter and/or gastric cardia, for treatment of gastroesophageal reflux disease

43499 Unlisted procedure, esophagus



Transesophageal Endoscopic Therapies for Gastroesophageal Reflux Disease

Introduction

GERD — gastroesophageal reflux disease — is a long-term medical condition. It’s a digestive problem that affects the ring of muscles between the esophagus (the tube that carries swallowed food to the stomach) and the stomach. When food is swallowed, the muscles at the end of the esophagus open so food can pass into the stomach. The muscles then close to prevent acid and stomach contents from backing up into the esophagus. In GERD, however, the ring of muscles is too weak, and acid can leak back up into the esophagus. GERD is usually treated with changes to lifestyle and diet, or medications, or in some cases a surgery called fundiplication. A number of other treatments have been studied. These include a procedure that is done through the mouth that wraps the upper part of the stomach around the esophagus, the use of radiofrequency energy to try to improve the barrier between the stomach and the esophagus, and the placement of implants or fillers in the esophagus. These procedures are investigational (unproven). More studies are needed to determine if they are as effective as other standard treatments.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can

be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. Policy Coverage Criteria Service Investigational

Transoral incisionless fundoplication (TIF)

Transoral incisionless fundoplication (TIF)(ie, Esophyx®) is considered investigational as a treatment of gastroesophageal reflux disease.

Transesophageal radiofrequency  Transesophageal radiofrequency to create submucosal thermal lesions of the gastroesophageal junction (ie, Stretta® procedure) is considered investigational as a treatment of gastroesophageal reflux disease.

Endoscopic submucosal implantation of a prosthesis or injection of a bulking agent

Endoscopic submucosal implantation of a prosthesis (ie, Gatekeeper™ Reflux Repair System) or injection of a bulking agent (eg, polymethylmethacrylate beads [PMMA], zirconium oxide spheres [ie, Durasphere®]) is considered investigational as a treatment of gastroesophageal reflux disease.



Evidence Review Description


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  (RF) energy, and injection/implantation of prosthetic devices or bulking agents. Background

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 10% to 20% in the Western world, with a lower prevalence in Asia.1

Pathophysiology


The pathophysiology of GERD involves excessive exposure of the esophagus 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 (eg, a hiatal hernia). Another mechanism is abnormally slow

clearance of stomach acid. 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, elevating the head of the bed, and elimination of food triggers are all recommended in recent practice guidelines.1 Proton pump inhibitors (PPIs) have been shown to be the most effective medical treatment. In a 2010 Cochrane systematic review, PPIs demonstrated superiority to H2-receptor agonists and prokinetics in both network metaanalyses and direct comparisons.

2 Surgical Treatment

The most common surgical procedure used for GERD is laparoscopic Nissen fundoplication. Fundoplication involves wrapping a portion of the gastric fundus around the distal esophagus to increase 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. Three types of procedures have been investigated.

1. Transesophageal endoscopic gastroplasty (gastroplication, TIF) can be performed as an outpatient procedure. During this 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, RF energy is applied through 4 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 ablation of the nerve pathways responsible for sphincter relaxation or may induce a tissuetightening 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®), is being evaluated.

The Gatekeeper™ Reflux Repair System (Medtronic, Shoreview, MN) uses a soft, pliable, expandable prosthesis made of a polyacrylonitrile-based hydrogel. The prosthesis is implanted into the esophageal submucosa, and with time, the prosthesis absorbs water and expands, creating bulk in the region of implantation.

U.S. Food and Drug Administration (FDA)product code: DQX. Endoscopic submucosal implantation of polymethylmethacrylate beads into the lower esophageal folds has also been investigated.

Summary of Evidence

For individuals who have GERD and hiatal hernia of 2 cm or less that is not controlled by PPIs who receive TIF (eg, EsophyX), the evidence includes 2 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, medication use, and treatment-related morbidity. The highest quality RCT (RESPECT) was a sham-controlled together 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, but the sham-controlled trial found 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 when compared with PPI therapy. Together, these trials suggest a strong placebo effect of the surgery and a modest benefit of TIF in patients whose symptoms are not controlled by PPIs. For these patients, the most appropriate comparator is laparoscopic fundoplication. Studies comparing TIF with fundoplication have limitations that include earlier TIF procedures and unequal groups at baseline and are inadequate to  determine relative efficacy. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have GERD and 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, quality of life, 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. 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 the effects of the technology on health outcomes.

For individuals who have GERD who receive endoscopic radiofrequency energy (eg, Stretta), the evidence includes 4 small RCTs, a nonrandomized comparative study, and observational studies with longer term follow-up. Relevant outcomes are symptoms, change in disease status, quality of life, medication use, and treatment-related morbidity. The RCTs report improvements in symptoms and quality of life following treatment with RF energy compared with sham controls, however, objective measures of GERD and a meta-analysis of these studies found no significant improvement in outcomes, raising questions about the mechanism of the symptom relief. Symptom relief is reported to be lower than after fundoplication, and reoperations greater. Larger RCTs with longer follow-up, preferably compared with fundoplication, are needed to better define the risks and benefits of this procedure. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have GERD who receive esophageal bulking agents, the evidence includes an RCT and case series. Relevant outcomes are symptoms, change in disease status, quality of life, medication use, and treatment-related morbidity. The RCT for a single product was  terminated early due to lack of efficacy, while other products have only case series to support use. High-quality data from large RCTs are needed to compare bulking procedures with both sham controls and with the currently accepted treatments for GERD (ie, drug therapy, laparoscopic fundoplication). Well-designed trials should use standardized outcome measures to examine whether subjective improvement (eg, discontinuation of medication therapy, GERD– Health-Related Quality of Life scores) is supported by objective improvement (eg, esophageal acid exposure). The evidence is insufficient to determine the effects of the technology on health outcomes.

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