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DESCRIPTIONDue in part to the prevalence of gastroesophageal reflux disease (GERD), there has been interest in creating a minimally invasive transesophageal therapeutic alternative to open or laparoscopic fundoplication or chronic medical therapy. Four different procedures have 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.
POLICYTransesophageal endoscopic gastroplasty is considered investigational as a treatment of gastroesophageal reflux disease (i.e., the EndoCinch™, NDO Plicator™, or EsophyX™ procedures).
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.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY5/2001: Approved by Medical Policy Advisory Committee (MPAC)
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: EnteryxTM 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 PlicatorTM and StomaphyXTM 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., EnteryxTM) 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.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.01.38
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
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.