Summary Of Evidence

In 2000 and 2012, the American Society of Gastrointestinal Endoscopy (ASGE) issued guidelines regarding the performance of upper GI endoscopy.^1,3 The ASGE recommends upper endoscopy if the results are likely to influence management of the patient, if empiric treatment for a suspected benign disorder has been unsuccessful, if the procedure can be used as an alternative to radiographic evaluation, or if a therapeutic maneuver may be needed. Also, upper endoscopy is indicated if the results would affect the management of other diseases. ERCP uses endoscopy to identify the major and minor papillae. The biliary and pancreatic ductal systems are cannulated and opacified with contrast to aid in establishing a diagnosis. Therapeutic interventions during ERCP include endoscopic sphincterotomy with or without stent placement, removal of choledocholithiasis, and other techniques for the treatment of pancreatic and biliary duct conditions. Endoscopic ultrasound uses an ultrasound transducer incorporated into the tip of the endoscope, or a probe is passed through the channel of the endoscope. The ultrasound produces high-resolution images of the GI wall and adjacent structures. Procedures can be conducted with ultrasound guidance to obtain tissue samples and perform therapy.

The ASGE issued an additional guideline in 2015 specifically addressing the role of upper endoscopy for patients with GERD.⁴ Included in this guideline, the authors concluded that endoscopic anti-reflux therapy be considered for selected patients with uncomplicated GERD following discussion with the patient regarding potential adverse effects, benefits, and other available therapeutic options. Several devices and/or techniques have shown insufficient evidence for efficacy or durability or for safety. Endoluminal GERD therapies in the U.S. include the Stretta procedure and TIF. In patients with GERD, EGD may be necessary to evaluate for GERD symptoms that are persistent or progressive despite appropriate medical therapy, dysphagia/odynophagia, involuntary weight loss, evidence of a GI bleed or anemia, follow-up of Barrett’s esophagus in selected patients, or persistent vomiting. Endoscopy is often performed in the evaluation of patients with suspected extraesophageal manifestations of GERD (e.g., choking, coughing, hoarseness, asthma, laryngitis, chronic sore throat, or dental erosions). Given that most of these patients will not have endoscopic evidence of erosive esophagitis, especially when taking empiric medical therapy for GERD, the routine use of EGD to evaluate extraesophageal symptoms of GERD is not recommended. Evidence is also insufficient to support the routine use of EGD in patients with uncomplicated GERD who are responsive to medical therapy.

In 2010, the ASGE issued a technical status evaluation describing the use of narrow-caliber endoscopes, or ultrathin (UT) endoscopes, that allow for passage of the scope through the nose or mouth.⁵ These types of scopes have made it possible to perform unsedated transnasal EGD. The indications for ultrathin EGD (UT-EGD) with or without sedation are the same as for standard EGD. Unsedated transnasal UT-EGD is often preferred in patients who refuse sedation or cannot tolerate it because of cardiopulmonary disease, or in patients who cannot tolerate the scope being passed orally. The UT endoscope is also useful for navigating very narrow strictures in the GI tract that preclude passage of a standard-caliber endoscope.

Analysis of Evidence

The available evidence suggests that EGD, ERCP, and endoscopic ultrasound are safe and effective for many diagnostic and therapeutic indications that affect the upper GI tract as outlined in this LCD. Also, in a select group of patients, literature supports the use of UT-EGD for the same indications as standard EGD.

Endoluminal therapies for GERD have been used for more than a decade. Endoluminal GERD therapies in the U.S. include the Stretta procedure (limited coverage for this procedure is outlined in this A/B MAC's Stretta Procedure L34553 LCD) and TIF (covered under this A/B MAC LCD). Current published peer reviewed literature supports the safety and efficacy of the EsophyX^® device used in this procedure.

Diagnostic and therapeutic esophagogastroduodenoscopy (EGD) is a common endoscopic procedure done for suspected and proven lesions of the upper gastrointestinal (GI) tract.^1,3 The endoscope, a long, flexible tube-like instrument, is passed either peroral or transnasal⁵ into the upper GI tract and allows direct visualization of the entire esophagus, stomach, and up to the second portion of the duodenum and jejunum as appropriate. Using this diagnostic tool, the physician can identify sources of bleeding, tumors, or ulcers, and can obtain biopsy specimens. Therapeutic procedures, such as removal of tumors or polyps, sclerotherapy, and dilation of strictures can be performed through the scope.

A. Indications which support EGD(s) for diagnostic purposes:^1,3

• upper abdominal distress which persists despite an appropriate trial of therapy;
• upper abdominal distress associated with symptoms and/or signs suggesting serious organic disease (e.g., anorexia and weight loss);
• dysphagia or odynophagia;
• esophageal reflux symptoms which are persistent or recurrent despite appropriate therapy;
• persistent vomiting of unknown cause;
• cirrhosis;
• other symptoms of disease in which the presence of upper GI pathology might modify other planned management. Examples include patients with a history of GI bleeding who are scheduled for organ transplantation; long-term anticoagulation; and chronic non-steroidal therapy for arthritis. Other examples include patients with cirrhosis being considered for liver transplantation and those with cancer of the neck.

      Radiologic findings of:

• a suspected neoplastic lesion, for confirmation and specific histologic diagnosis;
• gastric or esophageal ulcer; or
• evidence of upper GI tract stricture or obstruction.

      The presence of GI bleeding:

• in most actively bleeding patients;
• when surgical therapy is contemplated;
• when rebleeding occurs after acute self-limited blood loss or after endoscopic therapy;
• when portal hypertension (HTN) or aorto-enteric fistula (AEF) is suspected; or
• for presumed chronic blood loss and for iron deficiency anemia when colonoscopy is negative.¹⁰

• when sampling of duodenal or jejunal tissue or fluid is indicated;
• to assess acute injury after caustic agent ingestion;
• to assess diarrhea in patients suspected of having small-bowel disease (e.g., celiac disease);
• intraoperative EGD when necessary to clarify the location or pathology of a lesion.

B. Indications which support EGD(s) for therapeutic purposes:^1,3

• treatment of bleeding from lesions such as ulcers, tumors, vascular malformations (e.g., electrocoagulation, heater probe, laser photocoagulation or injection therapy);
• sclerotherapy and/or band ligation for bleeding from esophageal or proximal gastric varices or banding of varices;
• foreign body removal;
• removal of selected polypoid lesions;
• dilation of stenotic lesions (e.g., with transendoscopic balloon dilators or dilating systems employing guide wires);
• palliative therapy of stenosing neoplasms (e.g., laser, bipolar electrocoagulation, stent placement);
• management of achalasia (e.g., botulinum toxin, balloon dilatation);
• endoscopic therapy of intestinal metaplasia;
• management of operative complications (e.g., dilation of anastomotic strictures, stenting of anastomotic disruption, fistula, or leak in selected circumstances).

C. Noncovered Transesophageal Endoscopic Procedures for the Treatment of Gastroesophageal Reflux Disease (GERD)

Some transesophageal endoscopic procedures for the treatment of GERD are not currently covered as the safety and efficacy of these procedures cannot be established by review of the available published peer reviewed literature.

Several endoscopic or endoluminal procedures have been designed for the treatment of GERD. There are currently 3 transesophageal endoscopic approaches used to treat GERD including endoscopic plication or suturing devices; radiofrequency energy; and submucosal injection or implantation of biocompatible bulking agents or polymer prosthetics to treat GERD without surgery.

Endoscopic plication or suturing devices that have received 510(k) marketing clearance from the Food and Drug Administration (FDA) for the treatment of GERD are all performed as outpatient procedures and include the following:

• EndoCinch^®, also titled Bard Endoscopic Suturing System (BESS), is a plication procedure using a flexible endoscope which has a device similar to a miniature sewing machine attached inside the tip of the scope. The scope is passed through the throat of the patient while they are under mild sedation. Sutures are placed on both sides of the esophagus at the junction of the esophagus and the stomach. The ends of the suture material are tied together to form pleats or folds which are used to prevent acid from flowing back up into the esophagus.
• Plicator^® is a device that uses an endoscope passed into the stomach in conjunction with a flexible gastroscope. The Plicator^® is used to grasp and fold the gastric cardia, fixating it with a pre-tied suture at the junction of the stomach and esophagus. This tightens the valve that provides a natural barrier to gastric reflux. The full thickness tissue plication restructures the gastroesophageal flap value enabling serosa to serosa tissue healing to prevent reflux. The procedure is performed using conscious sedation.

Submucosal injection or implantation of biocompatible bulking agents or polymer prosthetics are not FDA approved for the treatment of GERD. Some of the products/procedures are currently under investigation and may be FDA approved for the treatment of GERD in the future.

• Enteryx is a biocompatible nonbiodegradable liquid polymer which is implanted via injections during endoscopy into the inside muscle wall of the esophagus close to the lower esophageal sphincter (LES). The liquid thickens into a sponge-like substance within the muscle enabling the sphincter to act as a barrier to reflux of the stomach acids. Enteryx received premarket approval from FDA in 2003, however, Boston Scientific Corporation issued a recall of the product in 2005 due to serious adverse events prior to receiving final FDA approval. Once implanted, Enteryx cannot be removed.
• Gatekeeper Reflux Repair System endoscopically introduces an expandable hydrogen prosthesis into the submucosa of the LES zone. The biocompatible material is made of a substance similar to the substance used to make contact lenses and upon insertion the prosthesis is dry but expands when it comes into contact with moisture. Gatekeeper can be removed if complications occur. This product is not FDA approved and is not currently available in the United States.
• Plexiglas Polymethylmethacrylate (PMMA) implantation is an endoscopic procedure which involves injection of gelatinous inert polymer material in the form of beads into the submucosa of the proximal LES zone to provide bulking support to the sphincter and decrease transient relaxation of the LES. This product is not FDA approved and is not currently available in the United States.
• Durasphere is a bulking agent made of pyrolytic carbon-coated zirconium oxide spheres which received FDA approval in 1999 for the treatment of stress urinary incontinence in women. It is currently also approved for the treatment of fecal incontinence. Durasphere GR is a product listed as an investigational device by the manufacturer which is in clinical trial for use in the treatment of GERD.

All of the ancillary procedures and services associated with the treatment procedures described above, such as EGD, are also noncovered when performed in conjunction with any of the procedures listed above, and should be billed and documented on the same claim as the non-covered procedure.

D. Covered Transesophageal Endoscopic Procedure for the Treatment of GERD

Transoral incisionless fundoplication (TIF) is a transesophageal endoscopic procedure for the treatment of GERD that is covered under this Local Coverage Determination (LCD).⁴ Current published peer reviewed literature supports the safety and efficacy of the EsophyX^® device used in this procedure.⁹

• EsophyX^® is a device used in a TIF procedure to repair the natural antireflux barrier and is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2 cm in size. EsophyX^® includes SerosaFuse^® Fasteners and consists of a flexible fastener delivery system comprised of 3 elements: a stylet, a pusher rod, and a delivery tube. The EsophyX^® procedure is designed for use in transoral tissue approximation, full thickness serosa to serosa plications and to construct valves in the GI tract which are used. The procedure is performed with the patient under general anesthesia.

E. Sequential or periodic diagnostic EGD may be indicated for an appropriate number of procedures for active or symptomatic conditions:

• follow-up of selected esophageal, gastric or stomal ulcers to demonstrate healing (frequency of follow-up EGD is variable, but every 2 to 4 months until healing is demonstrated is reasonable);
• follow-up in patients with prior adenomatous gastric polyps (approximate frequency of follow-up EGD's would be every 1 to 4 years depending on the clinical circumstances, with occasional patients with sessile polyps requiring every 6-month surveillance initially);
• follow-up for adequacy of prior sclerotherapy and/or band ligation of esophageal varices (approximate frequency of follow-up EGD's is variable depending on the state of the patient but every 6 to 24 months is reasonable after the initial sclerotherapy/banding sessions are completed);
• follow-up of Barrett’s esophagus (approximate frequency of follow-up EGD's is 1 to 2 years with biopsies, unless dysplasia or atypia is demonstrated, in which case a repeat biopsy in 2 to 3 months might be indicated); or
• follow-up in patients with familial adenomatous polyposis (FAP) (approximate frequency of follow-up EGD's would be every 2 to 4 years, but might be more frequent, such as every 6 to 12 months if gastric adenomas or adenomas of the duodenum were demonstrated).

F. Endoscopic retrograde cholangiopancreatography (ERCP) is generally indicated for certain biliary and pancreatic conditions:^1,3

• ERCP may be useful in traumatic pancreatitis to accurately localize the injury and provide endoscopic drainage;
• ERCP may be useful in pancreatic duct stricture evaluation;
• ERCP may be useful for the extraction of bile duct stones in severe gallstone induced pancreatitis;
• ERCP may be useful in detecting pancreatic ductal changes in chronic pancreatitis and also the presence of calcified stones in the ductal system. A pancreatogram may be performed and is likely to be abnormal in chronic alcoholic pancreatitis but less so in non-alcoholic induced types;
• ERCP may be useful in detecting gallstones in symptomatic patients whose oral cholecystogram and gallbladder ultrasonograms are normal; and
• ERCP may be indicated in patients with radiologic imaging suggestive of common bile duct stones or other potential hepatobiliary pathology.

• ERCP is generally NOT indicated for the diagnosis of pancreatitis except for gallstone pancreatitis.
• ERCP is NOT usually indicated in early stages or in acute pancreatitis and could possibly exacerbate this condition.

G. Indications for endoscopic ultrasound:^1,3

• staging tumors of the GI tract, pancreas, and bile ducts;
• evaluating abnormalities of the GI tract wall or adjacent structures;
• tissue sampling of lesions within, or adjacent to, the wall of the GI tract;
• evaluation of abnormalities of the pancreas, including masses, pseudocysts and chronic pancreatitis;
• evaluation of abnormalities of the biliary tree;
• providing endoscopic therapy of the GI tract under ultrasonographic guidance;
• staging of tumors shown to be metastatic only when the results are the basis for therapeutic decision;
• providing access into the bile ducts or pancreatic duct, either independently or as an adjunct to ERCP.