Endoscopic Treatment of GERD - NONCOVERED Service

Endoscopic Treatment of GERD is not considered reasonable and necessary for the diagnosis or treatment of an injury or disease.

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:

K21.0

K21.9

T85.511A

T85.511D

T85.511S

T85.521A

T85.521D

T85.521S

T85.591A

T85.591D

T85.591S

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:

• Barnes WE, Hoddinott KM, Mundy S, Williams M. Transoral incisionless fundoplication offers high patient

   satisfaction and relief of therapy resistant typical and atypical symptoms of GERD in community practice. Surg

   Innov. 2011 Jun;18(2):119-129.

• Bell RCW, Barnes WE, Carter BJ, et al. Transoral incisionless fundoplication: 2-year results from the prospective

   multicenter U.S. study. AM Surg. 2014 Nov; 80(11);1093-1105.

• Bell RCW, Fox MA, Barnes WE, et al. Univariate and multivariate analyses of preoperative factors influencing

   symptomatic outcomes of transoral fundoplication. Surg Endosc. DOI 101007Ss00464-014-3557-z.

• Bell RCW, Freeman KD. Clinical and pH-metric outcomes of transoral esophagogastric fundoplication for the

   treatment of gastroesophageal reflux disease. Surg Endosc. 2011 Jun;25(6):1975-1984.

• Hunter JG, Kahrilas PJ, Bell RCW, et al. Efficacy of transoral fundoplication vs omeprazole for treatment of

   regurgitation in a randomized controlled trial. Gastroenterology. 2015 Feb;148(2):324-333.

• Toomey P, Teta A, Patel K. Ross S, Sukharamwala P, Rosemurgy AS. Transoral incisionless fundoplication: is it as safe

   and efficacious as a Nissen or Toupet fundoplication? AM Surg. 2014 Sep;80(9):861-867.

• Trad KS, Barnes WE, Simoni G, et al. Transoral incisionless fundoplication effective in eliminating GERD symptoms

   in partial responders to proton pump inhibitor therapy at 6 months: the TEMPO Randomized Clinical Trial. Surg

   Innov. 2015 Feb;22(1):26-40.

• Trad KS, Simoni G, Barnes WE, et al. Efficacy of transoral fundoplication for treatment of chronic gastroesophageal

   reflux disease incompletely controlled with high-dose proton-pump inhibitors therapy: a randomized, multicenter,

   open label, crossover study. BMC Gastroenterology. 2014 Oct 6;14:174.

• Trad KS, Turgeio DG, Deljkich E. Long-term outcomes after transoral incisionless fundoplication in patients with

   GERD and LPR symptoms. Surg Endosc. 2012 Mar;26(3):650-660.

• Wilson EB, Barnes WE, Mavrelis PG, et al. The effects of transoral incisionless fundoplication on chronic GERD

   patients: 12-month prospective multicenter experience. Surg Laparosc Endosc Percutan Tech. 2014 Feb;24

   (1):36-46.

• AMA CPT Copyright Statement

• CPT codes, descriptions and other data only are copyright 2015 American Medical Association (or such other date

   of publication of CPT). All Rights Reserved.

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