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Transesophageal endoscopic therapies are being developed for the treatment of gastroesophageal reflux disease (GERD). A variety of procedures are being evaluated, including transesophageal (or transoral) incisionless fundoplication (TIF), application of radiofrequency (RF) energy, and injection/implantation of prosthetic devices or bulking agents.
Due 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. This type of procedure may be considered natural orifice transluminal surgery. Three types of procedures have been investigated.
One bulking agent, pyrolytic carbon-coated zirconium oxide spheres (Durasphere®), is being evaluated.
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.
EsophyX® (EndoGastric Solutions, Redmond, WA) received 510(k) marketing clearance in 2007 for full-thickness plication. The Medigus SRS Endoscopic Stapling System (MUSE, Medigus Ltd) received marketing clearance in 2012 (K120299) and 2014 (K132151). MUSE is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach to create anterior partial fundoplication for treatment of symptomatic chronic GERD in patients who require and respond to pharmacologic therapy.
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. Stretta® is currently manufactured by Mederi Therapeutics (Greenwich, CT).
Durasphere® is a bulking agent approved for treatment of urinary and fecal incontinence (see Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence medical policy). 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.”
POLICYTransoral incisionless fundoplication (TIF) (ie, Esophyx®) is considered investigational as a treatment of gastroesophageal reflux disease.
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., 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 is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
03/25/2014: Policy reviewed; no changes to policy statement. Deleted outdated references from Sources section. Updated description of CPT code 43257.
05/19/2015: Policy description updated regarding procedures and devices. Removed NDO Plicator, EndoCinch, and Enteryx from the policy. First investigational policy statement revised to change "Transesophageal endoscopic gastroplasty" to "Transoral incisionless fundoplication (TIF)." Third investigational policy statement updated to remove "biocompatible liquid polymer" as an example of a bulking agent. Policy guidelines updated to revise investigational definition. Removed ICD-9 procedure code 42.23 from the Code Reference section.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.01.38
This may not be a comprehensive list of procedure codes applicable to this policy.