Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Procedures for the Treatment of Gastroesophageal Reflux Disease (GERD)
Policy #:MA11.055c

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

SURGICAL FUNDOPLICATION

Surgical fundoplication of the lower esophageal sphincter (LES) is considered medically necessary and, therefore, covered for the treatment of gastroesophageal reflux disease (GERD) when an individual has either of the following:
  • Fails medical management with a conservative treatment approach that follows current standards of practice (e.g., lifestyle modifications, histamine2-receptor blockers, proton pump inhibitors, or promotility agents), as documented by a professional provider after a reasonable period
  • Develops comorbidities

ANTI-GASTROESOPHAGEAL REFLUX DEVICE IMPLANTATION

Surgical implantation of an anti-gastroesophageal reflux device (e.g., the Angelchik Anti-Reflux Prosthesis) is considered medically necessary and, therefore, covered for the treatment of GERD when an individual has documented severe or life-threatening GERD and conditions that have been resistant to medical treatment with histamine2-receptor blockers, proton pump inhibitors, or promotility agents, and also has any of the following:
  • Esophageal involvement with progressive systemic sclerosis
  • Foreshortening of the esophagus such that insufficient tissue exists to permit a valve reconstruction
  • High surgical risk for fundoplication procedure
  • Failed previous attempts at surgical treatment with fundoplication procedure.

Surgical implantation of the EndoStim LES Stimulation System is considered experimental/investigational and, therefore, not covered because the safety and effectiveness of this procedure cannot be established by review of the available published peer-reviewed literature.

TRANSESOPHAGEAL ENDOSCOPIC PROCEDURES

Transoral incisionless fundoplication (TIF) with EsophyX® is considered medically necessary and, therefore, covered for symptomatic chronic gastroesophageal reflux when all of the following criteria are met:
  • Symptoms of gastroesophageal reflux for more than 6 months
  • The gastroesophageal reflux symptoms are responsive to Proton Pump Inhibitors (PPIs) as measured by GERD Health-Related Quality of Life (HRQL) scores of 12 or less while on proton pump inhibitors (PPIs) and 20 or more when off PPIs for 14 days (also acceptable would be a difference of 10 or more in the GERD HRQL scores between off and on PPI therapy)
  • Hiatal hernia, if present, is 2 centimeters or less

Repeat TIF is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

A staged TIF procedure, defined as a laparoscopic esophageal, or paraesophageal diaphragmatic opening closure followed by a TIF endoscopically, is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

The following transesophageal endoscopic procedures for the treatment of GERD are considered experimental/investigational and, therefore, not covered because the safety and effectiveness of these procedures cannot be established by review of the available published peer-reviewed literature:
  • Transesophageal radiofrequency ablation, including, but not limited to:
    • Stretta® Therapy
  • Transesophageal endoscopic stapling system with MUSE™ System and Medigus SRS™ Endoscopic Stapling System
  • Transesophageal endoscopic suturing and plication, including, but not limited to:
    • Bard® EndoCinch™ Suturing System, Bard® Endoscopic Suturing System
    • NDO Surgical Endoscopic Plication System, NDO Plicator™
    • Syntheon ARD Plicator
  • Endoscopic submucosal implantation or injection of a bulking agent, including, but not limited to:
    • ethylene-vinyl alcohol (e.g., Enteryx™)
    • zirconium oxide spheres (e.g., Durasphere® GR)
    • Gatekeeper™ Reflux Repair System
    • polymethylmethacrylate (PMMA) beads

MAGNETIC ESOPHAGEAL RING IMPLANTATION

An implanted sphincter augmentation device to treat gastroesophageal reflux disease (GERD) (e.g., the LINX Reflux Management System) is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Policy Guidelines

This policy is consistent with Medicare's coverage criteria for antigastroesophageal reflux device implantation and transoral incisionless fundoplication (TIF). The Company's payment methodology may differ from Medicare.

There are no Medicare coverage determinations addressing surgical fundoplication, implanted sphincter augmentation devices, or transesophageal endoscopic procedures, other than transoral incisionless fundoplication (TIF), therefore, the Company policy is applicable.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, surgical fundoplication of the lower esophageal sphincter (LES), implantation of an anti-gastroesophageal reflux device and transesophageal endoscopic procedures covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

However, the following uses for the treatment of Gastroesophageal Reflux Disease (GERD) have been identified in this policy as experimental/investigational and are, therefore, not eligible for coverage or reimbursement by the Company:
  • Transesophageal radiofrequency ablation, including, but not limited to: Stretta® Therapy
  • Transesophageal endoscopic stapling system with MUSE™ System and Medigus SRS™ Endoscopic Stapling System
  • Transesophageal endoscopic suturing and plication, including, but not limited to: Bard® EndoCinch™ Suturing System, Bard® Endoscopic Suturing System, NDO Surgical Endoscopic Plication System, NDO Plicator™, and Syntheon ARD Plicator
  • Endoscopic submucosal implantation or injection of a bulking agent, including, but not limited to: ethylene-vinyl alcohol (e.g., Enteryx™), zirconium oxide spheres (e.g., Durasphere® GR), Gatekeeper™ Reflux Repair System, and polymethylmethacrylate (PMMA) beads
  • Surgical implantation of the EndoStim LES Stimulation System


Description

Gastroesophageal reflux disease (GERD) is a condition in which gastric content refluxes into the esophagus, causing symptoms such as chronic heartburn and/or regurgitation and mucosal damage of the esophagus, i.e., esophagitis. Some individuals may also present with extraesophageal symptoms such as asthma, hoarseness, cough, chest pain, or aspiration.

Gastric reflux can result from a number of conditions, including gastric emptying disorder, failed esophageal peristalsis, or improper closure of the lower esophageal sphincter (LES). Symptoms are caused when refluxed stomach acid comes into contact with the lining of the esophagus.

The diagnosis of GERD is made when at least one of the following is demonstrated:
  • Chronic symptoms, including persistent heartburn, acid regurgitation, and/or dysphagia
  • The presence of esophageal mucosal injury determined by photographic or histological investigation
  • Excessive acid reflux evidenced through 24-hour intraesophageal pH monitoring

The goal of treatment is to relieve and control symptoms, heal and prevent the relapse of esophagitis, and prevent long-term complications. Treatment is typically individualized based on symptoms and their severity and can include lifestyle modifications or medical interventions such as antacid or proton-pump inhibitor (PPI) medication, or corrective antireflux surgery.

MEDICAL THERAPIES FOR GERD

The first line of treatment should include lifestyle modification, antacids, and over-the-counter acid suppressants for individuals who have uncomplicated GERD, i.e., heartburn and/or regurgitation).

Diagnostic work-up and/or gastroenterology evaluation is recommended for individuals whose symptoms persist while taking over-the-counter medications or who develop warning signs of dysphagia, bleeding, unplanned weight loss, chest pain, coughing, shortness of breath, or hoarseness.

Surgical or endoscopic intervention may be another option for treating GERD in either of the following instances:
  • Medical treatment fails after a reasonable period of medical management following current standards of practice (e.g., histamine receptor blockers, proton pump inhibitors, and promotility agents).
  • An individual develops comorbidities.

SURGICAL TREATMENTS FOR GERD

Surgical therapy may be considered for individuals who experience any of the following: failed medical management; complications of GERD, such as non-healing ulcer, Barrett’s esophagus, or grade 3 or 4 erosive esophagitis; complications attributable to a large hiatal hernia, such as bleeding or dysphagia; extraesophageal symptoms, such as asthma, hoarseness, cough, chest pain, or aspiration; and documented reflux on 24-hour ambulatory intraesophageal pH monitoring.

SURGICAL FUNDOPLICATION
Surgical fundoplication is considered the gold standard surgical intervention for individuals with refractory GERD. In this procedure, a portion or all of the stomach fundus is wrapped around the lower esophagus, consequently strengthening, lengthening, and raising the pressure of the LES. Fundoplication can be performed as an open or laparoscopic procedure.

TRANSESOPHAGEAL ENDOSCOPIC TREATMENTS FOR GERD

Several minimally invasive transesophageal endoscopic treatments for GERD have been investigated. Currently, the clinical effectiveness of these treatments has not been established by review of the available published literature. These treatments include, but are not limited to, the following technologies.

TRANSESOPHAGEAL RADIOFREQUENCY ABLATION
Stretta® System

The Stretta System (Mederi Therapeutics, Greenwich, CT) uses a monopolar electrosurgical catheter along with a radiofrequency (RF) generator to treat individuals whose GERD has not responded adequately to previous medical therapy with PPIs. The catheter consists of a flexible balloon-basket assembly with 4 electrode needle sheaths. RF is delivered at different levels starting 1 cm above the squamo-columnar junction. Each application lasts 60 seconds for a total of 22 sets of needle deployments with 4 antegrade levels at the junction and two rings of cardia lesions made in pull back. The procedure is easily carried out either under conscious sedation or general anesthesia on an outpatient basis.

ENDOSCOPIC SUTURING AND PLICATION
EsophyX® System / EsophyX®2 System / EsophyX®2 HD Device / EsophyX® Z Device / StomaphyX

The EsophyX System (EndoGastric Solutions, Inc., Redmond WA) creates a transoral incisionless fundoplication (TIF). The EsophyX® device is a cylindrical tool that enables transoral modeling of the gastric cardia and fundus to the esophagus, with the placement of multiple transmural H-shaped polypropylene fasteners to fix the molded tissues in place. The device is introduced transorally over a flexible endoscope with the individual under general anesthesia. A specially designed helical retractor and tissue mold enable the surgeon to elongate the gastric cardia (TIF 1 technique) or to fold the gastric fundus around the esophagus (TIF2). With tissues held in place by the tissue mold and helical retractor, stylets are deployed from the device chassis and traverse the molded tissue. H-shaped fasteners are deployed over these stylets in a circumferential fashion to create a plication that resembles a surgical fundoplication.

Medigus Ultrasonic Surgical Endostapler or MUSE™ System (formerly the SRS™ Endoscopic Stapling System)

The MUSE System (MediGus Ltd., Omer, Israel) creates a transoral incisionless fundoplication (TIF). According to the FDA the system enables the operator to staple the fundus of the stomach to the esophagus, in two or more locations around the esophageal circumference, entirely through the mouth, without incisions. The system consists of three main parts: the endoscopic stapler, the control console and several accessories.

Bard® EndoCinch™ Suturing System / Bard® Endoscopic Suturing System

In this procedure, a metal guidewire with a spring tip is passed through the endoscope into the pylorus and the endoscope is removed. A polyvinyl dilator and overtube are passed over the guidewire. The dilator and guidewire are removed and the overtube serves as a conduit for subsequent instrument passage. Another gastroscope with the mounted sewing capsule is advanced to the level of the z line. A minimum of two plications are placed for each procedure. One or two of these plications is placed along the lesser and the other below the Z line. Stitches to form the plication are placed in a circumferential pattern.

NDO Surgical Endoscopic Plication System / NDO Plicator™

In this procedure, the Plicator and gastroscope assembly are passed into the stomach and the stomach is distended with air. The Plicator is retroflexed to within 1cm below the GE junction, and the helical tissue retractor is advanced deeply into the gastric wall. The gastric wall is retracted into the Plicator instrument arms. The arms are then closed, and the suture-implant is deployed to secure the full-thickness plication. The tissue retractor is then disengaged and the suture-implant released from the instrument. Additional sutures are placed in the same manner described above, with each additional implant placed incrementally closer to the GE junction in a linear configuration along the anterior gastric cardia. A search of online site www.ClinicalTrials.gov in December 2016 found several studies with the NDO Plicator listed as terminated, since the sponsoring company (NDO Surgical Inc.) was acquired by Johnson & Johnson and has ceased business operations.

ANTI-GASTROESOPHAGEAL REFLUX DEVICE IMPLANTATION
LINX™ Reflux Management System

The LINX™ Reflux Management System (Torax Medical, Shoreview, MN) consists of a small flexible band of 10 to 18 interlinked titanium beads with magnetic cores that is laparoscopically inserted around the esophagus at the gastroesophageal junction. The magnetic attraction between the beads is intended to help the LES resist opening due to gastric pressure, and preventing the backflow of refluxate into the esophagus. The magnetic attraction of the device also closes the LES immediately after swallowing, restoring the body’s natural barrier to stomach content reflux.

Angelchik Antireflux Prosthesis

In this procedure, a C-shaped silicon ring (i.e., Angelchik prosthesis) is surgically implanted around the esophagus at the gastroesophageal junction. It is secured in place by a circumferential tie strap. This is designed to reduce and prevent further sliding of hiatal hernias and to prevent reflux of gastric contents into the esophagus.

EndoStim LES Stimulation System

The EndoStim LES Stimulation System (EndoStim, Dallas, TX) is a minimally invasive implantable device designed to provide long-term reflux control by restoring normal esophageal function through neurostimulation. The therapy directly targets an individual's weak or dysfunctional lower esophageal sphincter (LES) muscle between the stomach and the esophagus, often the underlying cause of reflux. The EndoStim LES Stimulation System is not FDA approved for the treatment of symptomatic chronic gastroesophageal reflux disease.

INJECTION OR IMPLANTATION OF BULKING AGENTS
In these procedures, a biomaterial is injected/implanted in the submucosa of the LES augmenting the sphincter and reducing gastric reflux into the esophagus. Commonly used products include Enteryx™, Durasphere® GR, Gatekeeper™ Reflux Repair System, and plexiglas polymethylmethacrylate (PMMA) microbeads.

Enteryx™

In this procedure, a nonresorbable biocompatible polymer is endoscopically implanted in the distal esophagus and proximal gastric cardia.

Durasphere® GR

Durasphere GR (Carbon Medical Technologies, Inc., St. Paul, MN) is a bulking agent approved by the FDA for use in the treatment of adult women with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). Use of this product for the treatment of GERD would be considered an off-label use. Carbon Medical Technologies' website states that Durasphere GR is an investigational device in the United States, and is “intended to treat problems associated with Gastroesophageal Reflux Disease (GERD).”

Gatekeeper™ Reflux Repair System

The Gatekeeper™ Reflux Repair System (Medtronic, Shoreview, MN) uses 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. The Gatekeeper Reflux Repair System is not FDA approved for the treatment of symptomatic chronic gastroesophageal reflux disease.

Plexiglas Polymethylmethacrylate (PMMA) Microbeads

In this procedure, PMMA microspheres are submucosally injected in the LES. This process augments the LES and helps to reduce gastric reflux in to the esophagus.
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Hunter JG, Kahrilas PJ, Bell RC, et al. Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology. 2015;148(2):324-333 e325.

Ihde GM, Besancon K, Deljkich E. Short-term safety and symptomatic outcomes of transoral incisionless fundoplication with or without hiatal hernia in patients with chronic gastroesophageal reflux disease. Am J Surg. 2011;202(6):740-6; discussion 746-7.

Ip S, Bonis P, Tatsoni A, et al. Comparative Effectiveness of Management Strategies for Gastroesophageal Reflux Disease. Evidence Report/Technology Assessment No. 1. (Prepared by Tufts-New England Medical Center Evidence-based Practice Center). AHRQ Publication No. 06-EHC003-EF. Rockville, MD: Agency for Healthcare Research and Quality. [AHRQ Web site]. 09/23/2011. Available at: https://effectivehealthcare.ahrq.gov/topics/gerd/research. Accessed June 21, 2018.

Ip S, Chung M, Moorthy D, et al. Management strategies for gastroesophageal reflux disease: An update. Comparative effectiveness review No. 29 (Prepared by Tufts Medical Center Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). AHRQ Publication No. 11-EHC049-EF. Rockville, MD: Agency for Healthcare Research and Quality. [AHRQ Web site]. Available at: http://effectivehealthcare.ahrq.gov/ehc/products/165/781/GERD_ExecSumm.pdf. Accessed June 21, 2018.

Jobe BA, O’Rourke RW, McMahon BP, et al. Transoral Endoscopic Fundoplication in the Treatment of Gastroesophageal Reflux Disease: the anatomic and physiologic basis for reconstruction of the esophagogastric junction using a novel device. Annals of Surgery. 2008;248(1):69-76.

Kahrilas PJ, Shaheen NJ, Vaezi MF, et al. American Gastroenterological Association Medical Position Statement on the Management of Gastroesophageal Reflux Disease. Gastroenterology. 2008;135(4):1383-1391.

Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013; 108:308–328.

Kim WH, Park PW, Hahm KB, et al. Endoscopic treatment of refractory gastroesophageal reflux disease. Clinc Endosc. 2013;46(3):230-4.

Leeds S, Reavis K. Endolumenal therapies for gastroesophageal reflux disease. Gastrointest Endosc Clin N Am. 2013;23(1):41-51.

Liang WWu JHu Z. Laparoscopic Nissen fundoplication is more effective in treating patients with GERD-related chronic cough than Stretta radiofrequency. Minerva Chir.2014;69(3):121-7.

Liang WT, Wang ZG, Wang F, et al. Long-term outcomes of patients with refractory gastroesophageal reflux disease following a minimally invasive endoscopic procedure: a prospective observational study. BMC Gastroenterol. 2014;14:178.

Liang WT, Yan C, Wang ZG, et al. Early and midterm outcome after laparoscopic fundoplication and a minimally invasive endoscopic procedure in patients with gastroesophageal reflux disease: a prospective observational study. J Laparoendosc Adv Surg Tech A. 2015;25(8):657-661.

Lipham JCDeMeester TRGanz RA, et al. The LINX Reflux Management System: confirmed safety and effectiveness now at four years. Surg Endosc. 2012;26(10):2944-9.

Lipham JC, Taiganides PA, Louie BE, et al. Safety analysis of first 1000 patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease. Dis Esophagus. 2015;28(4):305-11.

Lipka S, Kumar A, Richter JE. No Evidence for Efficacy of Radiofrequency Ablation for Treatment of Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis. Clin Gastroenterol Hepatol. 2015;13(6):1058-67.

Liu HF, Zhang JG, Li J, et al. Improvement of clinical parameters in patients with gastroesophageal reflux disease after radiofrequency energy delivery. World J Gatroenterol. 2011;17(39):4429-33.

Lo WK, Mashimo H. Critical Assessment of Endoscopic Techniques for Gastroesophageal Reflux Disease. J Clin Gastroenterol. 2015;49(9):720-4.

Locke GR 3rd, Horwhat J, Mashimo H, et al. Endotherapy for and tailored approaches to treating GERD, and refractory GERD. Ann N Y Acad Sci. 2013;1300:166-86.

Louie EB, Farivar SA, Shultz D, et al. Short-term outcomes using magnetic sphincter augmentation versus Nissen fundoplication for medically resistant gastroesophageal reflux disease. Ann Thorac Surg. 2014;98(2):498-504.

Mattar SG, Qureshi F, Taylor D, et al. Treatment of refractory gastroesophageal reflux disease with radiofrequency energy (Stretta) in individuals after Roux-en-Y gastric bypass. Surg Endosc. 2006;20(6):850-4.

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Reynolds JL, Zehetner J, Bildzukewicz N, et al. Magnetic sphincter augmentation with the LINX device for gastroesophageal reflux disease after U.S. Food and Drug Administration approval. Am Surg. 2014;80(10):1034-1038.

Reynolds JL, Zehetner J, Wu P, et al. Laparoscopic Magnetic Sphincter Augmentation vs Laparoscopic Nissen Fundoplication: A Matched-Pair Analysis of 100 Patients. J Am Coll Surg. 2015;221(1):123-128.

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Schwameis K, Schwameis M, Zomer B, et al. Modern GERD treatment: feasibility of minimally invasive esophageal sphincter augmentation. AntiCancer Res. 2014;34(5):2341-2348.

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Schwartz MP, Schreinemakers JR, Smout AJ. Four-year follow-up of endoscopic gastroplication for the treatment of gastroesophageal reflux disease. World J Gastrointest Pharmacol Ther. 2013;4(4):120-6.

Schwartz MP, Wellink H, Gooszen HG, et al. Endoscopic gastroplication for the treatment of gastro-oesophageal reflux disease: a randomised, sham-controlled trial. Gut. 2007;56(1):20-8.

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Sheu EG, Nau P, Nath B, et al. A comparative trial of laparoscopic magnetic sphincter augmentation and Nissen fundoplication. Surg Endosc. 2015;29(3):505-9.

Smith CD, DeVault KR, Buchanan M. Introduction of mechanical sphincter augmentation for gastroesophageal reflux disease into practice: early clinical outcomes and keys to successful adoption. J Am Coll Surg. 2014;218(4):776-781.

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Testoni PA, Corsetti M, Di Pietro S et al. Effect of transoral incisionless fundoplication on symptoms, PPI use, and pH-impedance refluxes of GERD patients. World J Surg.
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Testoni PA, Vailati C. Transoral Incisionless Fundoplication with EsophyX® for treatment of gastroesophageal reflux disease. Dig Liver Dis. 2012;44(8):631-5.

Testoni PA, Vailati C, Testoni S, et al. Transoral incisicionless fundoplication (TIF 2.0) with EsophyX® for gastroesophageal reflux disease: long-term results and findings affecting outcome. Surg Endosc. 2012;26(5):1425-35.

Thomson M, Antao B, Hall S, et al. Medium-term outcomes of endoluminal gastroplication with the EndoCinch device in children. J Pediatr Gastroenterol Nutr. 2008;46(2):172-7.

Titus JM, Mason DP, Raymond DP, et al. Esophagopulmonary fistula and left lung abscess after transoral incisionless fundoplication. Ann Thorac Surg. 2013;96(2):689-91.

Toomey P, Teta A, Patel K, et al. Transoral incisionless fundoplication: is it as safe and efficacious as a Nissen or Toupet fundoplication? Am Surg. 2014;80(9):860-867.

Trad KSBarnes WESimoni 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;22(1):26-40.

Trad KS, Fox MA, Simoni G, et al. Transoral fundoplication offers durable symptom control for chronic GERD: 3year report from the TEMPO randomized trial with a crossover arm. Surg Endosc. 2017;31(6):2498-2508.

Trad K, Turgeon D, et al. Long term outcomes after transoral Incisionless fundoplication in individuals with GERD and LPR symptoms. Surgical Endoscopy. 2012;26:650-660.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

43210, 43280, 43285, 43325, 43327, 43328

THE FOLLOWING CODES ARE USED TO REPRESENT IMPLANTATION OF ANTI-ESOPHAGEAL REFLUX DEVICE:

43289, 43499


EXPERIMENTAL/INVESTIGATIONAL

THE FOLLOWING CODE IS USED TO REPRESENT MAGNETIC ESOPHAGEAL RING IMPLANTATION:

43284

THE FOLLOWING CODE IS USED TO REPRESENT TRANSESOPHAGEAL RADIOFREQUENCY ABLATION:

43257

THE FOLLOWING CODES ARE USED TO REPRESENT TRANSESOPHAGEAL ENDOSCOPIC SUTURING AND PLICATION:

43499, 43999

THE FOLLOWING CODES ARE USED TO REPRESENT ENDOSCOPIC SUBMUCOSAL IMPLANTATION OR INJECTION OF A BULKING AGENT:

43192, 43201

THE FOLLOWING CODE IS USED TO REPRESENT TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) DONE WITH ANY LAPAROSCOPIC REPAIR OF A LARGER HIATAL HERNIA:

43659


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

K21.0 Gastro-esophageal reflux disease with esophagitis

K21.9 Gastro-esophageal reflux disease without esophagitis



HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

Revisions from MA11.055c:
08/01/2018As of 8/01/2018, this policy has been reviewed and reissued to communicate the Company’s continuing position on procedures for the treatment of gastroesophageal reflux disease (GERD)
01/01/2017The following changes were made to this policy:
  • The following treatments for GERD were added to the policy section as Experimental/Investigational: MUSE System, Bard Endoscopic Suturing System, NDO Surgical Endoscopic Plication System, Syntheon ARD Plicator, zirconium oxide spheres (e.g., Durasphere GR), Gatekeeper Reflux Repair System, EndoStim LES Stimulation System
  • The following CPT codes have been added to this policy: 43284, 43285
  • The following CPT codes have been removed from this policy: 0392T, 0393T

Revisions from MA11.055b:
01/01/2016This policy has been identified for CPT and HCPCS code update, effective 01/01/2016.

The following CPT code has been added to this policy: 43210

The following HCPCS code has been removed from this policy: C9724

The following unlisted code has been removed from this policy for TRANSORAL INCISIONLESS FUNDOPLICATION (TIF): 43499

Revisions from MA11.055a:
09/30/2015The policy has been reviewed and reissued to communicate the Company’s continuing position on Procedures for the Treatment of Gastroesophageal Reflux Disease (GERD).
07/01/2015The following CPT codes have been added: 0392T, 0393T

The following HCPCS code has been removed: C9737

The following unlisted code has been removed for the LINX REFLUX system: 43289

Revisions from MA11.055:
01/01/2015This is a new policy.

12/15/2014: the policy in Notification was updated as follows: the Policy description section was revised to match the Medicare coverage position.




Version Effective Date: 01/01/2017
Version Issued Date: 12/30/2016
Version Reissued Date: 08/01/2018