Endoscopic treatment of GERD (CPT codes 43257, 43499, 43999, 49999, and C9724) is noted as a noncovered service.

Some of the emerging techniques and associated tools are considered investigational and this LCD does NOT endorse such procedure.

 •  NOTE: An Advance Beneficiary Notice

    (ABN) is required for items and

    services not covered by Medicare

     due to being considered not medically

     reasonable and necessary.

           ◦  The beneficiary should be

               thoroughly educated about the

               benefits and risks of this item or

               service.

           ◦  If such notice is not given, providers

              may not shift financial liability for

              such items or services to beneficiaries

              should a claim for such items or

              services be denied by Medicare.

Indications:

• Benefits are not available for endoluminal

   treatment for Gastroesophageal Reflux

   Disease (GERD) using the Stretta®

   procedure, the Bard EndoCinch™ Suturing

   System, Plicator™, Enteryx®, EsophyX™ 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.
• EsophyX™ is a device for performing transoral incisionless fundoplication surgery for treating gastroesophageal reflux disease.

• This procedure reconstructs the valve at the top of the stomach that helps prevents acid reflux.

• Enteryx® is an endoscopic, minimally-invasive procedure in which an ethylene vinyl alcohol polymer solution is injected into your lower esophageal sphincter muscle using a small needle.

• This product was recalled in September 2005 due to adverse patient events.

Discussion:

• These procedures are promising for

   treatment of patients in whom proton pump

   inhibitor therapy fails.

• 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 remain 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.

CPT/HCPCS Codes:

Documentation Requirements:

• The patient's medical record must contain

   documentation that fully supports the

   medical necessity for services included

   within this LCD. (See "Indications and

   Limitations of Coverage.")

• This documentation includes, but is not

   limited to, relevant medical history, physical

   examination, and results of pertinent

   diagnostic tests or procedures.

Treatment Logic:

• Benefits are not available for endoluminal

   treatment for Gastroesophageal Reflux

   Disease (GERD) using the Stretta®

   procedure, the Bard EndoCinch™ Suturing

   System, Plicator™, Enteryx®, EsophyX™ or

   similar treatments as these procedures are

   not considered reasonable and necessary

   for the diagnosis or treatment of an injury or

   disease.

Scientific Basis Of Treatment And Bibliography: