Lower Esophageal Magnetic Sphincter Augmentation

Jurisdiction: JJ Part B. States: Alabama, Georgia, Tennessee. Type: Active LCD

Lower esophageal magnetic sphincter augmentation (MSA) is considered medically reasonable and necessary when all the following conditions are met: Patient is diagnosed with gastroesophageal reflux disease (GERD) defined by abnormal pH testing in which acid exposure time (AET) is greater than 6% 1 Patient has undergone appropriate endoscopic and esophageal manometric evaluation to rule out extragastrointestinal etiology of symptoms Patient has chronic GERD symptoms despite maximum medical therapy for the treatment of reflux defined as maximum (or maximum tolerated) dose of proton pump inhibitors (PPI) for at least 6 months 1 Implantation of the device is performed by a surgeon with experience in laparoscopic anti-reflux procedures and has received product specific training Because safety and efficacy has not been established, coverage is excluded for the following: Patients with suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials Patients with electrical implants such as pacemakers and defibrillators, or other metallic, abdominal implants Unrepaired hiatal hernia >3 cm or a paraesophageal hernia Barrett’s Esophagus or esophagitis Los Angeles (LA) class C or D Scleroderma Suspected or confirmed esophageal or gastric cancer Prior esophageal or gastric surgery or endoscopic intervention Distal esophageal motility less than 35mmHg peristaltic amplitude on wet swallows or Symptoms of dysphagia more than once per week within the last 3 months Esophageal stricture or gross esophageal anatomic abnormalities (Schatzki’s ring, obstructive lesions, etc.) Esophageal or gastric varices Lactating, pregnant or plan to become pregnant Morbid obesity (body mass index (BMI) >35) Age Definitions: The LA Classification of GERD 2 : Grade A-One (or more) mucosal break no longer than 5 mm that does not extend between the tops of 2 mucosal folds Grade B-One (or more) mucosal break more than 5 mm long that does not extend between the tops of 2 mucosal folds Grade C-One (or more) mucosal break that is continuous between the tops of 2 or more mucosal folds, but which involve less than 75% of the circumference Grade D-One (or more) mucosal break which involves at least 75% of the esophageal circumference