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1. Transesophageal endoscopic gastroplasty (or gastroplication) is an outpatient procedure that takes about 30-35 minutes and does not require general anesthesia. In the procedure, sutures are placed in the lower esophageal sphincter. The sutures are designed to strengthen and lengthen the sphincter to decrease reflux.

Currently, three endoscopic suturing devices have received FDA 510(k) marketing clearance for use in the treatment of GERD:

• EndoCinch™ (CR Bard) for partial-thickness plication, cleared in January 2001

• Plicator™ (Ethicon Endo-Surgery) for full-thickness plication, cleared in May 2003

• EsophyX™ (EndoGastric Solutions) for full-thickness plication, cleared in September 2007.

The StomaphyX device has broader FDA clearance for use in endoluminal tissue approximation and ligation in the gastrointestinal tract.

2. Radiofrequency energy has been used to produce submucosal thermal lesions at the gastroesophageal junction. (This technique has also been referred to as the Stretta procedure. The CSM Stretta® System [Conway Stuart] received 510(k) marketing clearance from the FDA in 2000 for general use in the electrosurgical coagulation of tissue and intended for use specifically in the treatment of GERD.  As of the 2009 policy update, Stretta is manufactured by Mederi Therapeutics.)  Specifically, radiofrequency energy is applied through four (4) electrodes inserted into the esophageal wall at multiple sites both above and below the squamocolumnar junction. The mechanism of action of the thermal lesions is not precisely known but may be related to ablation of the nerve pathways responsible for sphincter relaxation or may induce a tissue-tightening effect related to heat–induced collagen contraction.
3. Implantation of a polymer has also been investigated. Specifically, a biocompatible polymer is injected into the lower esophageal sphincter. On contact with the tissue, the polymer precipitates into a spongy mass. The mechanism of action in reducing reflux is not precisely known. This polymer, Enteryx^TM, received FDA approval in 2003 through the PMA process for the treatment of symptomatic gastroesophageal reflux disease.  This product was recalled from the manufacturer September 23, 2005, Boston Scientific Corporation issued a recall of Enteryx^TM  due to the device polymerizing shortly after injection into a spongy material that cannot be removed. Serious adverse events involved unrecognized transmural injections of Enteryx^TM   into structures surrounding the esophagus potentially resulting in death or serious injury.  
4. Endoscopic submucosal implantation of polymethylmethacrylate beads into the lower esophageal folds has also been investigated.

In one procedure, a biocompatible liquid polymer is injected into the lower esophageal sphincter. On contact with the tissue, the polymer precipitates into a spongy mass. The mechanism of action in reducing reflux is not precisely known. One polymer, Enteryx™, received FDA approval in 2003 through the premarket approval (PMA) process for the treatment of symptomatic GERD. However, on September 23, 2005, Boston Scientific Corporation issued a recall of Enteryx™ due to the device polymerizing shortly after injection into a spongy material that cannot be removed. Serious adverse events involved unrecognized transmural injections of Enteryx™ into structures surrounding the esophagus, potentially resulting in serious injury or death.

Another bulking agent, pyrolytic carbon-coated zirconium oxide spheres (Durasphere®), is being evaluated. Durasphere® is a bulking agent approved for treatment of urinary and fecal incontinence (see policy number 7.01.19). Use of this product for esophageal reflux would be considered off-label use. The website of Carbon Medical Technologies states that Durasphere GR is an investigational device in the U.S. “intended to treat problems associated with GERD.”

The Gatekeeper Reflux Repair System (Medtronic, Shoreview, MN) utilizes a soft, pliable, expandable prosthesis made of a polyacrylonitrile-based hydrogel. The prosthesis is implanted into the esophageal submucosa and with time the prosthesis absorbs water and expands, creating bulk in the region of implantation.

Endoscopic submucosal implantation of polymethylmethacrylate beads into the lower esophageal folds has also been investigated.

Transesophageal radiofrequency to create submucosal thermal lesions of the gastroesophageal junction (i.e., the Stretta procedure) is considered investigational as a treatment of gastroesophageal reflux disease.

Endoscopic submucosal implantation of a prosthesis or injection of a bulking agent (e.g., biocompatible liquid polymer, polymethylmethacrylate beads, zirconium oxide spheres) is considered investigational as a treatment of gastroesophageal reflux disease.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

2/11/2002: Investigational definition added

3/13/2002: New 2002 code added

4/22/2002: Type of Service and Place of Service deleted

5/7/2002: Code Reference section updated

5/2002: Reviewed by MPAC; investigational status remains, Sources updated

5/30/2002: Code Reference section updated

6/20/2002: Code Reference section updated, CPT code 43200 and 0008T deleted

8/2002: Reviewed by MPAC; investigational status remains, Sources updated

9/20/2002: HCPCS C9701 and C9703 deleted, CPT 0008T re-added

10/1/2002: Description and Policy sections revised to be consistent with BCBSA policy, Sources and Code Reference sections updated

12/17/2003: Code Reference section updated

1/27/2004: Policy reviewed, investigational status remains, "Description" and "Policy" sections aligned with BCBSA, Sources updated

3/24/2005: Code Reference section updated, CPT code 0057T with effective date of 1/1/2004, deletion date of 12/31/2004, and Note: “See CPT code 43257” added, CPT code 43257 with effective date of 1/1/2005 added, CPT code 43499 Note: “To report services on or after 1-1-2005, see CPT code 43257” added, HCPCS S2215 with effective date of 1/1/2005 added

10/17/05: Enteryx^TM notice about manufacturer recall added.

3/8/2006: Policy reviewed, no changes

3/15/2006:  Coding updated.  CPT4 2006/HCPCS 2005 revisions added to policy

6/19/2007: Policy description updated; added Plicator^TM and StomaphyX^TM devices cleared through 510(k) process. Code reference section updated per quartery HCPCS and Category III revisions

12/19/2007: Coding updated per 2008 CPT/HCPCS revisions

7/22/2008: Policy reviewed, no changes

7/9/2009: Policy reviewed, description updated, no policy changes

09/09/2010: Policy description updated regarding available devices. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. Removed deleted codes 0008T and 0133T  from the Code Reference section.

11/10/2011:  Policy description updated regarding procedures. The following policy statements were combined under a bulking agent statement and remain investigational:  1) Endoscopic submucosal implantation of a biocompatible polymer (i.e., Enteryx^TM) is considered investigational as a treatment of gastroesophageal reflux disease and 2) Endoscopic submucosal implantation of polymethylmethacrylate (PMMA) beads into the lower esophageal folds is considered investigational as a treatment of gastroesophageal reflux disease. The new statement is as follows: Endoscopic submucosal implantation of a prosthesis or injection of a bulking agent (e.g., biocompatible liquid polymer, polymethylmethacrylate beads, zirconium oxide spheres) is considered investigational as a treatment of gastroesophageal reflux disease.

01/18/2012: Policy reviewed; no changes.

02/20/2013: Policy reviewed; no changes.

Stuart Jon Spechler, MD, Long-Term Outcome of Medical and Surgical Therapies for Gastroesophageal Reflux Disease; Follow-up of a Randomized Controlled Trial. JAMA, May 9, 2001, Vol 285, No 18; 2331-2338.

Peter J . Kahrilas, MD, Surgical Therapy for Reflux Disease. JAMA , May 9, 2001, Vol 285, No 18; 2376-2378.

Bard Endoscopic Technologies packet

Hayes Medical Technology Directory

TEC, Volume 19, Number 2, July 2002

TEC, Volume 17, No. 13, October 2002

All codes billed for this procedure are considered investigational and not eligible for coverage. 

Non-Covered Codes

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