Select Minimally Invasive GERD Procedures

Jurisdiction: JK MAC Part B. States: Connecticut, Maine, Massachusetts, New Hampshire, New York, Rhode Island, Vermont. Type: Active LCD

Indications: EsophyX™ is a device for performing transoral incisionless fundoplication surgery (TIF) for treating gastroesophageal reflux disease. This procedure reconstructs the valve at the top of the stomach that helps prevent acid reflux. Benefits are not available for endoluminal treatment for Gastroesophageal Reflux Disease (GERD) using the Stretta® procedure, the Bard EndoCinch™ Suturing System, Plicator™, Enteryx® or similar treatments as these procedures are not considered reasonable and necessary for the diagnosis or treatment of an injury or disease. Coverage is not available for LINX® Reflux Management System, which is not a true endoluminal treatment but is also not considered reasonable and necessary for the diagnosis or treatment of an injury or disease. Currently, these procedures other than TIF are considered non-covered due to the fact that current peer-reviewed literature does not support the long-term efficacy and long-term safety of the services. Claims will be denied as "not proven effective." Limitations: For TIF, Coverage is not extended to: any patient who has recurrent symptoms or other evidence of failure following a prior TIF. These procedures (repeat TIF) would be considered investigational at this time. any patient with a hiatal hernia greater than 2 cm, except 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). any GERD patients with BMI > 35, esophagitis LA grade >B, Barrett’s esophagus > 2 cm, and presence of achalasia or esophageal ulcer or has not been on an appropriate trial of proton pump inhibitors.