Surgical treatment for Gastroesophageal Reflux Disease (GERD)

may be considered medically necessary when the clinical criteria in the policy are met.

Note: Coverage for the LINX® (CPT 43284) procedure is addressed separately in Medical Policy 0191 “LINX Reflux Management System”.

Definitions:

• Achalasia - Motility disorder of the esophagus
• GERD - Gastroesophageal Reflux Disease

Description:

GERD is a condition caused by reflux of the gastric content into the esophagus, which can lead to esophageal damage, or serious conditions including esophagitis, strictures, Barrett’s metaplasia, or adenocarcinoma of the esophagus. The two main factors involved in esophageal reflux are the gastric contents and the anti-reflux mechanism, which includes the lower esophageal sphincter (LES) and the anatomic configuration of the gastroesophageal junction. The goal of treatment for GERD is to reduce gastroesophageal reflux. Current treatment options of GERD include lifestyle modification, medical treatment with pharmacotherapy, and surgery.

Lifestyle modifications include:

• Dietary change
• Elevation of the head of the bed when sleeping
• Smoking cessation
• Sitting upright for at least 30 minutes after eating

Pharmacologic acid suppression using proton pump inhibitor (PPI) therapy is widely used for patients with GERD with a high level of effectiveness. Pharmacotherapies include:

• Histamine type-2 receptor antagonists (h2ras)
• Proton pump inhibitors (ppis)
• Supplemental acid-neutralizing agents
• Over the counter (otc) remedies (antacids, combined antacid/alginic acids, h2ras)

When the initial treatments are not effective or not tolerated, anti-reflux surgery may be used to treat GERD. The current standard surgical treatment for GERD is Laparoscopic Nissen and Toupet fundoplication.

Fundoplication and Hiatal Hernia Repair by Laparoscopy applies to open fundoplication by laparotomy, open hiatal hernia repair by laparotomy, or a combined open fundoplication with hiatal hernia repair.

Hiatal hernia repair may be performed as an isolated operation, but it is more commonly performed in conjunction with fundoplication. Fundoplication procedures reinforce the gastroesophageal sphincter by wrapping the gastric fundus around the gastroesophageal junction. Fundoplication may involve the entire circumference of the sphincter (known as "Nissen" fundoplication), or may be partial, either anterior fundoplication ("Dor") or posterior fundoplication ("Toupet"). The majority of fundoplication surgery is performed laparoscopically. Fundoplication failure is uncommon, but does occur. The term “failure” is related to symptoms, surgery, or anatomy. Failure of fundoplication can manifest as persistent reflux-related symptoms, complications of the surgery, or anatomic problems such as para-esophageal hernia or migration of the wrap into the mediastinum.

Clinical Criteria:

1. GERD is considered refractory to medical management when it continues despite ALL the following conservative measures (as applicable):
   • Change of diet
   • Cessation of smoking
   • Physical exercise
   • Weight loss, or active participation in a physician supervised weight loss program
   • A trial of PPIs for a period of 3 months
2. Must be evaluated by GI Physicians for GERD and surgery would only be considered with GI Physician recommendation.
3. Anti-reflux surgery may be used to treat GERD via Fundoplication and Hiatal Hernia Repair by Laparoscopy when one or more following conditions exist:
   1. Symptomatic GERD (e.g., heartburn, regurgitation, dental erosions, cough attributable to reflux) unresponsive to, or intolerant of, medical therapy
   2. Symptomatic GERD with moderate to severe erosive esophagitis (e.g., LAgrade B or higher)
   3. GERD with development of Barrett esophagus with metaplasia or low-grade dysplasia, stricture, or esophageal ulcer
   4. Treatment of GERD after endoscopic therapy of Barrett esophagus with high- grade dysplasia, carcinoma in situ, or mucosal carcinoma
   5. In conjunction with esophageal myotomy in patient with achalasia
   6. Incarcerated or strangulated hernia
   7. Gastric volvulus
   8. Paraesophageal hernia
   9. Repeat surgery for failed previous anti-reflux or hiatal hernia procedures

Transoral Incisionless Fundoplication (TIF 2.0) EsophyX Device and SerosaFuse fasteners are used for the treatment of gastroesophageal reflux disease for which proton pump inhibitors (PPIs) have failed. This procedure uses fasteners to remodel the tissue, providing an improved esophageal barrier against reflux as well as potentially eliminating small hiatal hernias.

1. TIF 2.0 may be considered medically necessary if ALL the following exists:
   • A. Symptomatic chronic gastroesophageal reflux despite maximum PPI therapy with two different medications. Chronic is defined as greater than 6 months of symptoms and treatment AND
   • B. Symptoms must be completely unresponsive to Proton Pump Inhibitors (PPIs) as evidenced by GERD Health Related Quality of Life (HRQL) scores of less than or equal to 12 while on PPIs and greater than or equal to 20 when off PPIs for 14 days.
2. Contraindications for TIF:
   • A.

     Contraindications for TIF:

     • Hiatal hernia equal to or greater than 3 cm, if present
     • Body Mass index (BMI) Greater than 35
     • Esophagitis grade D or Barrett’s esophagitis
     • Esophageal ulcer
     • Fixed esophageal stricture or narrowing
     • Portal hypertension or varices
     • History of previous restrictive gastric or esophageal surgery, cervical spine fusion, Zenker’s diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, greater than 2 dilation for esophageal stricture, or cirrhosis
     • Gastric outlet obstruction or stenosis
     • Active esophago-gastro-duodenal ulcer disease
     • Gastric outlet obstruction or stenosis
     • Gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment
     • Prior Transoral Incisionless Fundoplication (TIF) procedure
     • Esophageal ulcer

     IV. Partial Gastrectomy as a GERD treatment may be considered medically necessary if member meets one of the following conditions:

     1. Refractory GERD along with dysphagia/esophageal dysmotility (<35 mm Hg) if fundoplication is contraindicated.

     NOTE: Partial gastrectomy with Roux en Y anastomosis (43633) is NOT considered medically necessary as a primary procedure for any other indication, including treatment of gastroparesis.

     Noncovered procedures:

     The following and similar treatments/procedures are not considered reasonable and necessary for the treatment of GERD as there is insufficient data to prove long-term effectiveness:

     1. Stretta ® procedure is a minimally invasive procedure in which a flexible tube is introduced through the mouth and down the throat to the junction of the esophagus and stomach and a low-power low-temperature radiofrequency (RF) energy is applied to the lower esophageal sphincter (LES) muscle and the gastric cardia, which thickens the muscle and increases the size and number of smooth muscle fibers in the area. Thicker LES tissue, in turn, results in restoration of the natural barrier function of the esophagogastric junction and fewer muscle relaxations that cause reflux. Benefits have not been demonstrated greater than one year post procedures.
     2. Bard EndoCinch™ Suturing System 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. Substantial peer-reviewed evidence to fully support these assumptions needs to be published.
     3. Plicator™ Endoscopically delivers full-thickness pledgeted sutures to restructure the gastroesophageal junction and the anti-reflux barrier.
     4. The LINX® Reflux Management System uses standard laparoscopic techniques, the band is placed around the esophagus at the level of the gastroesophageal junction. The magnetic attraction between the beads is intended to augment the lower esophageal sphincter to prevent gastric reflux into the esophagus without compressing the esophageal wall. Unlike the other procedures mentioned, this is extraluminal, not intraluminal.
     5. Enteryx® An endoscopic, minimally-invasive procedure in which an ethylene vinyl alcohol polymer solution is injected into one's lower esophageal sphincter muscle using a small needle. This product was recalled by the FDA in September 2005 due to adverse patient events.