About this policy
Jurisdiction: J8 MAC Part B. States: Indiana, Michigan. Type: Active LCD
Coverage indications
Benefits are not available for endoluminal treatment for Gastroesophageal Reflux Disease (GERD) using the Stretta® procedure, the Bard EndoCinch™ Suturing System, Plicator™, or similar treatments as these procedures are not considered reasonable and necessary for the diagnosis or treatment of an injury or disease. Currently, these procedures are considered non-covered due to the fact that current peer-reviewed literature does not support the efficacy of the services. Claims will be denied as "not proven effective." The Stretta® procedure is an endoluminal treatment for GERD in which radiofrequency energy is delivered to smooth muscle of the lower esophageal sphincter (LES). A flexible catheter equipped with special needle electrodes for precise energy delivery is placed by mouth into the esophagus and carefully controlled radiofrequency energy is then delivered to the LES and gastric cardia, creating thermal lesions. The manufacturer maintains that the changes that occur immediately, and over time, result in a "tighter" LES and a less compliant gastric cardia. Additionally, the interruption of nerve pathways in the LES area is believed to reduce the incidence of inappropriate LES "relaxations," leading to an improvement in GERD symptoms. Substantial peer-reviewed evidence to fully support these assumptions remains to be published. The Bard EndoCinch™ Suturing System and the Plicator™ are 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. Clinical data from various studies are emerging. At this time, open-label studies or patient registries with short term follow-ups are the dominant source of data. The overwhelming preponderance of reviewers remains equivocal in their support and have called for randomized controlled trials with long-term follow-ups. In the absence of evidence from such studies, and in the absence of wide acceptance, endoscopic treatments for GERD are not proven effective. Therefore, they are not reimbursable even though some of the treatments may have associated CPT™ or OPPS codes. Coverage for the TIF (Transoral Incisionless Fundoplication) procedure is for treatment of patients in whom proton pump inhibitor therapy fails. An example of the device used in TIF is EsophyX™. TIF using EsophyX™ for performing surgery for treating gastroesophageal reflux disease (GERD) reconstructs the valve at the top of the stomach that helps prevents acid reflux. Indications Coverage is appropriate for TIF if done by a well-trained surgeon for the following indications: 1. Symptomatic chronic gastroesophageal reflux (chronic being defined as > 6 months of symptoms), and 2. Symptoms must not be completely responsive to Proton Pump Inhibitors (PPIs) as judged by GERD HRQL scores of or equal to 20 when off for 14 days (also acceptable would be the difference of > or equal to 10 of the scores between off and on therapy), and 3. Hiatal hernia TIF procedure. (Based on (FDA) approval). Limitations Coverage is not extended: 1. For those patients who may have recurrent symptoms or may fail this procedure. No literature has been submitted for repeat TIF use. These procedures (repeat TIF) would be considered investigational at this time.
Codes in this policy
Code numbers and each code’s status as the policy records it. CPT code descriptions are left out of this page, as are the passages that cite CPT codes; the official document has them.