LCD/NCD Portal

L32487

 

NONCOVERED PROCEDURES - ENDOSCOPIC TREATMENT OF GASTROESOPHAGEAL

REFLUX DISEASE (GERD)

 

 

01/01/2013

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

The intent of this local coverage determination (LCD) is to communicate the non-coverage for certain procedures used for the endoscopic treatment of gastroesophageal reflux disease (GERD).

 

• Currently, the published available evidence based on peer-reviewed literature and other pertinent sources is not sufficient to establish the long-term safety and efficacy of transesophageal endoscopic anti-reflux procedures as treatment for GERD.

o Therefore, this LCD finds the transesophageal endoscopic treatment methods not reasonable and necessary and not eligible for reimbursement at this time.

 

 

Limitations of Coverage

 

Transesophageal Endoscopic Procedures

• Transesophageal endoscopic procedures for the treatment of GERD are not currently covered as the safety and efficacy of these procedures cannot be established by review of the available published peer reviewed literature.

• Several endoscopic or endoluminal procedures have been designed for the treatment of GERD. There are currently three transesophageal endoscopic approaches used to treat GERD including endoscopic plication or suturing devices; radiofrequency energy; and submucosal injection or implantation of biocompatible bulking agents or polymer prosthetics to treat GERD without surgery.

• Endoscopic plication or suturing devices that have received 510(k) marketing clearance from the Food and Drug Administration (FDA) for the treatment of GERD are all performed as outpatient procedures and include the following:

o EsophyX® is a device used in a transoral incisionless fundoplication (TIF®) procedure to repair the natural antireflux barrier and is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2cm in size.

 EsophyX® includes SerosaFuse Fasteners and consists of a flexible fastener delivery system comprised of three elements: a stylet, a pusher rod, and a delivery tube.

 The EsophyX® procedure is designed for use in transoral tissue approximation, full thickness serosa to serosa plications and to construct valves in the gastrointestinal tract which are used.

 The procedure is performed with the patient under general anesthesia.

o EndoCinch™, also titled Bard Endoscopic Suturing System (BESS), is a plication procedure using a flexible endoscope which has a device similar to a miniature sewing machine attached inside the tip of the scope.

 The scope is passed through the throat of the patient while they are under mild sedation.

 Sutures are placed on both sides of the esophagus at the junction of the esophagus and the stomach.

 The ends of the suture material are tied together to form pleats or folds which are used to prevent acid from flowing back up into the esophagus.

o Plicator™ is a device that uses an endoscope passed into the stomach in conjunction with a flexible gastroscope.

 The Plicator™ is used to grasp and fold the gastric cardia, fixating it with a pre-tied suture at the junction of the stomach and esophagus.

 This tightens the valve that provides a natural barrier to gastric reflux.

 The full thickness tissue plication restructures the gastroesophageal flap valve enabling serosa to serosa tissue healing to prevent reflux.

 The procedure is performed using conscious sedation.

o Radiofrequency (RF) energy is delivered through an endoscope as an outpatient procedure with the patient under conscious sedation.

 The FDA approved one endoscopic RF procedure in 2000.

o The Stretta® procedure uses a flexible endoscope to advance a radiofrequency (RF) delivery balloon-tipped catheter.

 The Stretta® catheter includes four sharp probes on the outside of the balloon which discharge controlled levels of RF energy into the LES muscle and the gastric cardia thereby creating thermal lesions on the targeted areas.

 The lesions heal and tighten the LES muscles decreasing the possibility of stomach acid refluxing into the stomach.

• Submucosal injection or implantation of biocompatible bulking agents or polymer prosthetics are not FDA approved for the treatment of GERD.

o Some of the products/procedures are currently under investigation and may be FDA approved for the treatment of GERD in the future.

• Enteryx® is a biocompatible nonbiodegradable liquid polymer which is implanted via injections during endoscopy into the inside muscle wall of the esophagus close to the LES.

o The liquid thickens into a sponge-like substance within the muscle enabling the sphincter to act as a barrier to reflux of the stomach acids.

o Enteryx® received premarket approval from FDA in 2003; however, Boston Scientific Corporation issued a recall of the product in 2005 due to serious adverse events prior to receiving final FDA approval.

o Once implanted, Enteryx® cannot be removed.

• Gatekeeper™ Reflux Repair System endoscopically introduces an expandable hydrogen prosthesis into the submucosa of the LES zone.

o The biocompatible material is made of a substance similar to the substance used to make contact lenses and upon insertion the prosthesis is dry but expands when it comes into contact with moisture.

o Gatekeeper can be removed if complications occur.

o This product is NOT FDA approved and is NOT currently available in the United States.

• Plexiglas Polymethuylmethacrylate (PMMA) implantation is an endoscopic procedure which involves injection of gelatinous inert polymer material in the form of beads into the submucosa of the proximal LES zone to provide bulking support to the sphincter and decrease transient relaxation of the LES.

o This product is NOT FDA approved and is not currently available in the United States.

• Durasphere® is a bulking agent made of pyrolytic carbon-coated zirconium oxide spheres which received FDA approval in 1999 for the treatment of stress urinary incontinence in women.

o It is currently also approved for the treatment of fecal incontinence.

o Duraspherereg; GR is a product listed as an investigational device by the manufacturer which is in clinical trial for use in the treatment of GERD.

 

 

Coding Information

 

Bill Type Codes

• Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.

• Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.

• Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

 

13x Hospital Outpatient

85x Critical Access Hospital

 

 

Revenue Codes

• Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service.

• In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination.

• Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

 

0360 Operating Room Services - General Classification

0361 Operating Room Services - Minor Surgery

0750 Gastro-Intestinal (GI) Services - General Classification

 

 

CPT/HCPCS Codes

 

For the physician’s services associated with the use of the endoscopic approaches including plication or suturing devices; radiofrequency energy; and submucosal injection or implantation of biocompatible bulking agents or polymer prosthetics performed to treat GERD, the unlisted procedure code 43499 should be billed. All of the services associated with these treatment procedures, such as esophagogastroduodenoscopy (EGD), are also noncovered, and should be billed and documented on the same claim. All unlisted procedure codes billed for services are subject to development and medical review.

 

NOTE: HCPCS code C9724 is only to be billed by Ambulatory Surgical Centers (ASCs).

43201 ESOPHAGOSCOPY, RIGID OR FLEXIBLE; WITH DIRECTED SUBMUCOSAL INJECTION(S), ANY SUBSTANCE

43236 UPPER GASTROINTESTINAL ENDOSCOPY INCLUDING ESOPHAGUS, STOMACH, AND EITHER THE DUODENUM AND/OR JEJUNUM AS APPROPRIATE; WITH DIRECTED SUBMUCOSAL INJECTION(S), ANY SUBSTANCE

43241 UPPER GASTROINTESTINAL ENDOSCOPY INCLUDING ESOPHAGUS, STOMACH, AND EITHER THE DUODENUM AND/OR JEJUNUM AS APPROPRIATE; WITH TRANSENDOSCOPIC INTRALUMINAL TUBE OR CATHETER PLACEMENT

43257 UPPER GASTROINTESTINAL ENDOSCOPY INCLUDING ESOPHAGUS, STOMACH, AND EITHER THE DUODENUM AND/OR JEJUNUM AS APPROPRIATE; WITH DELIVERY OF THERMAL ENERGY TO THE MUSCLE OF LOWER ESOPHAGEAL SPHINCTER AND/OR GASTRIC CARDIA, FOR TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE

43499 UNLISTED PROCEDURE, ESOPHAGUS

C9724 ENDOSCOPIC FULL-THICKNESS PLICATION OF THE STOMACH USING ENDOSCOPIC PLICATION SYSTEM (EPS); INCLUDES ENDOSCOPY

 

 

Documentation Requirements

• In order for a noncovered service/procedure listed in this LCD to be evaluated for coverage, a reconsideration request to remove the service/procedure from the list must be submitted in writing to First Coast Service Options, Inc. Medical Policy Department.

• Copies of published evidence (e.g., peer-reviewed medical literature, published studies, etc.) must also be included with the reconsideration request.

 

 

Treatment Logic:

• GERD is a condition caused by reflux of the gastric content into the esophagus which can lead to esophageal damage or serious conditions including esophagitis, strictures, Barrett’s metaplasia, and adenocarcinoma of the esophagus.

o The two main factors involved in esophageal reflux are the gastric contents and the anti-reflux mechanism, which includes the lower esophageal sphincter (LES) and the anatomic configuration of the gastroesophageal junction.

• The goal of treatment for GERD is to reduce gastroesophageal reflux. Current treatment options of GERD include lifestyle modification, and medical treatment with pharmacotherapy, and surgery.

• Lifestyle modification includes:

o Dietary change.

o Elevation of the head of the bed.

o Smoking cessation.

o Sitting upright for at least 30 minutes after eating.

• Pharmacologic acid suppression using proton pump inhibitor (PPI) therapy is widely used for patients with GERD without untoward effects and with a high level of effectiveness.

• Pharmacotherapies options include:

o Histamine type-2 receptor antagonists (H2RAs).

o Proton pump inhibitors (PPIs).

o Supplemental acid-neutralizing agents.

o Over-the-counter (OTC) remedies (antacids, combined antacid/alginic acids, H2RAs).

• When the initial treatments are not effective or not tolerated, anti-reflux surgery can be used to treat GERD.

o The current standard surgical therapy for GERD is esophagogastric fundoplasty which include procedures such as Nissen, Belsey, or Dor fundoplication, all of which are performed as laparoscopic or open inpatient surgical procedures.

o The surgical procedures reconstruct the weakened flap valve at the junction of the stomach and the esophagus.

o Esophagogastric fundoplasty is performed either as a complete (360) or partial encircling of the gastroesophageal junction.

 The fundoplication procedure involves pulling the fundus of the stomach around the lower end of the esophagus by pushing it from left to right behind the gastroesophageal junction.

• Surgical treatment options includes:

o Nissen fundoplication is a complete wrapping procedure in which the gastric fundus is sutured to itself.

o Belsey, Dor, and Toupet fundoplications are partial wrapping procedures in which the gastric fundus is sutured to the adjacent esophagus.

 

 

Sources of Information and Basis for Decision

 

Agency for Healthcare, Research and Quality. Effective health care. (AHRQ) (2005). Comparative effectiveness of management

strategies for GERD. Executive Summary. Retrieved from http://www.ahrq.gov

 

American Society of Gastrointestinal Endoscopy (ASGE) (2007). Role of endoscopy in the management of GERD. Gastrointestinal

Endoscopy 219, (66).

 

American Society of Gastrointestinal Endoscopy (ASGE) (2002). Technology status evaluation report. Gastrointestinal Endoscopy 56, (5).

 

Barnes, W. E., Hoddinott, K. M., Mundy, S., & Williams, M. (2011). Transoral incisionless fundoplication offers high patient

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

Innovation. Retrieved from http://www.sagepub.com/journalsPermission.nav

 

Bell, R. C. W., & Cadière, G. B. (2010). Transoral rotational esophogastric fundoplication: technical, anatomical, and safety

considerations. Surgical Endoscopy. Published online December 24, 2010. Retrieved from http://www.springerlink.com

 

Bell, R. C. W., & Freeman, K.D. (2010). Clinical and pH-metric outcomes of Transoral esophagogastric fundoplication for the

treatment of GERD. Surgical Endoscopy. Published online December 08, 2010. Retrieved from http://www.springerlink.com

 

Cadière, G. B., VanSante, N., Graves, J. E., Gawlicka, A. K., & Rajan, A. (2009). Two-year results of a feasibility study on antireflux

transoral incisionless fundoplication using EsophyX. Published online: in Surgical Endoscopy on March 14, 2009.

 

Cadière, G. B., Buset, M., Muls, V., Rajan, A., Rösch, T., Eckardt, A. J., Weerts, J., Bastens, B., Costamagna, G., Marchese, M., Louis, H., Mana., F., Sermon, F., Gawlicka, A. K., Daniel, M. A., & Devièr, J. (2008). Antireflux transoral incisionless

fundoplication using EsophyX: 12-Month results of a prospective multicenter study. Published 2008 World Journal

of Surgery.

 

ClinicalTrials.gov (2010). Determinants of Efficacy of EsophyX Treatment in Gastroesophageal Reflux Disease. Retrieved from

www.clinicaltrials.gov

 

ClinicalTrials.gov (2008). Endoscopic implantation of Enteryx for the treatment of GERD. Retrieved from

www.clinicaltrials.gov

 

ClinicalTrials.gov (2010). Evaluation of the Safety and Effectiveness of Tailored Transoral Incisionless Fundoplication (TIF®) Using

EsophyX® for the Treatment of GERD. Retrieved from www.clinicaltrials.gov

 

Chuttani, R. et.al. (2003). A novel endoscopic full-thickness plicator for the treatment of GERD: A pilot study, Gastrointestinal

Endoscopy 58 (5) 770-776.

 

Dolan, J. et.al. (2004). Evaluation for endoscopic full-thickness plication on anti-reflux valve competency, Gastrointestinal

Endoscopy, 59 (5), Abstract 468.

 

EndoGastric Solutions, Inc., Effective Solution for Chronic Acid Reflux. EsophyX® TIF® Package Insert for the Device. Retrieved

From EndoGastric Solutions, Inc. Web site at www.EndoGastricSolutions.com

 

FCSO LCD 32485, Noncovered Procedures - Endoscopic Treatment of Gastroesophageal Reflux Disease (GERD), 01/01/2013. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Food and Drug Administration (FDA). (N.D.) Advice for patients with Enteryx® for gastroesophageal reflux disease (1st advisory).

Retrieved from http: www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm064748.htm

 

Food and Drug Administration (FDA). Inspections, Compliance, Enforcement, and Criminal Investigations. EndoGastric Solutions,

Inc. (2010). Retrieved from www.fda.gov

 

Food and Drug Administration (FDA). Maude adverse event report: C.R. Bard endoscopic technologies EndoCinch suturing kit.

(2001). Retrieved from www.fda.gov

 

Johnson, D. A., Ganz, R., Aisenberg, J., Cohen. L. B., Deviere, J., Foley, T. R., Haber, G. B., Peters, J. H., & Lehman, G. A. (2003).

 

Endoscopic implantation of enteryx for treatment of GERD: 12 month results of a prospective, multicenter trial. American

Journal of Gastroenterology. 98(9), 1921-1930. Retrieved from http://www.ncbi.nlm.nuh.gov/pubmed/14499767

 

Laws, H. L., Clements, R. H., & Swille, C. M. (1997). A randomized comparison of Nissen fundoplication versus the Toupet

fundoplication for gastroesophageal reflux disease. Annals of Surgery. 225(6). 647-654.

 

MAUDE Adverse Event Report. EndoGastric Solutions EsophyX Device. (2010). Retrieved from www.accessdata.fda.gov

 

Mahmood, Z., McMahon, B. P., Arfin, Q., Byrne, P. J., Reynolds, J. V., Murphy, E. M., & Weir, D. G. (2003). Endocinch therapy for

gastro-esophageal reflux disease: a one year prospective follow up. Gut - an International Journal of Gastroeneterology and Hepatology.52(1), 34-39. Retrieved from http://www.ncbi.nlm.gov/pmc/articles/PMC1773510/?tool=pubmed

 

National Guideline Clearinghouse. (2009). American Gastroenterological Association medical position statement on the management

of GERD. Retrieved from http://www.guidelines.gov

 

National Guideline Clearinghouse. (2010). Agency for Healthcare Research and Quality. Gastroesophageal reflux disease (GERD).

Retrieved from http://www.ngc.gov/content.aspx?id=10631

 

Other Contractor’s LCDs.

 

Peters, J. H., DeMeester, T. R., Crookes, P., Oberg, S., de Vos Shoop, M., Hagen, J. A., & Bremner, C. G. (1998). The treatment of

gastroesophageal reflux disease with laparoscopic Nissen fundoplication. Annals of Surgery. 228(1). 40-50.

 

SAGES. (2004). Patient information for laparoscopic anti-reflux (GERD) surgery from SAGES. Retrieved from

http://www.sages.org/publication/id/PI01

 

Velanovich, V. (2010). Endoscopic, endoluminal fundoplication for gastroesophageal reflux disease: Initial experience and lesson

learned. Surgery. (148) 646-653.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

CMS LCD NONCOVERED PROCEDURES - ENDOSCOPIC TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD)