CLINICAL MEDICAL POLICY Upper Gastrointestinal Endoscopy and Visualization Policy Name: (L34434) Policy Number: MP-073-MC-NC Responsible Department(s): Medical Management Provider Notice Date: 07/01/2018 Issue Date: 08/01/2018 Effective Date: 08/01/2018 Annual Approval Date: 05/16/2019 Revision Date: N/A Products: North Carolina Medicare Assured All participating and nonparticipating hospitals and Application: providers Page Number(s): 1 of 22 DISCLAIMER Gateway Health℠ (Gateway) medical policy is intended to serve only as a general reference resource regarding coverage for the services described. This policy does not constitute medical advice and is not intended to govern or otherwise influence medical decisions. POLICY STATEMENT Gateway Health℠ may provide coverage under the medical-surgical benefits of the Company’s Medicare products for medically necessary Upper Gastrointestinal Endoscopy and Visualization. This policy is designed to address medical necessity guidelines that are appropriate for the majority of individuals with a particular disease, illness or condition. Each person’s unique clinical circumstances warrant individual consideration, based upon review of applicable medical records. Policy No. MP-037-MC-NC Page 1 of 22 PROCEDURES CMS NATIONAL COVERAGE POLICY Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Title XVIII of the Social Security Act §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim. Title XVIII of the Social Security Act §1862(a)(7) excludes routine physical examinations. 42 CFR 410.32(a) indicates that diagnostic tests may only be ordered by a treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements). CMS Internet-Only Manual, Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2, §100.2 CMS Internet-Only Manual, Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2, §100.4 CMS Internet-Only Manual, Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2, §100.10 1. COVERAGE GUIDANCE A. Coverage Indications, Limitations, and/or Medical Necessity Diagnostic and therapeutic esophagogastroduodenoscopy (EGD) is a common endoscopic procedure done for suspected and proven lesions of the upper gastrointestinal tract. The endoscope, a long, flexible tube-like instrument, is passed from the patient's mouth into the upper gastrointestinal tract and allows direct visualization of the entire esophagus, stomach, and up to the second portion of the duodenum and jejunum as appropriate. Using this diagnostic tool, the physician can identify sources of bleeding, tumors, or ulcers, and can obtain biopsy specimens. Therapeutic procedures, such as removal of tumors or polyps, sclerotherapy, and dilation of strictures can be performed through the scope. B. Indications which support EGD(s) for diagnostic purposes: 1) upper abdominal distress which persists despite an appropriate trial of therapy; 2) upper abdominal distress associated with symptoms and/or signs suggesting serious organic disease (e.g., anorexia and weight loss); 3) dysphagia or odynophagia; 4) esophageal reflux symptoms which are persistent or recurrent despite appropriate therapy; 5) persistent vomiting of unknown cause; 6) Cirrhosis; 7) Other symptoms of disease in which the presence of upper GI pathology might modify other planned management. Examples include patients with a history of GI bleeding who are scheduled for organ transplantation; long-term anticoagulation; and chronic non- Policy No. MP-037-MC-NC Page 2 of 22 steroidal therapy for arthritis. Other examples include patients with cirrhosis being considered for liver transplantation and those with cancer of the neck. 8) Radiologic findings of: a. A suspected neoplastic lesion, for confirmation and specific histologic diagnosis; b. A gastric or esophageal ulcer; OR c. Evidence of upper gastrointestinal tract stricture or obstruction 9) The presence of gastrointestinal bleeding: a. In most actively bleeding patients; b. when surgical therapy is contemplated; c. when rebleeding occurs after acute self-limited blood loss or after endoscopic therapy; d. when portal hypertension or aorto-enteric fistula is suspected; OR e. For presumed chronic blood loss and for iron deficiency anemia when colonoscopy is negative. 10) When sampling of duodenal or jejunal tissue or fluid is indicated; 11) To assess acute injury after caustic agent ingestion; 12) Intraoperative EGD when necessary to clarify the location or pathology of a lesion. C. Indications which support EGD(s) for therapeutic purposes: 1) Treatment of bleeding from lesions such as ulcers, tumors, vascular malformations (e.g., electrocoagulation, heater probe, laser photocoagulation or injection therapy); 2) Sclerotherapy and/or band ligation for bleeding from esophageal or proximal gastric varices or banding of varices; 3) Foreign body removal; 4) Removal of selected polypoid lesions; 5) Dilation of stenotic lesions (e.g., with transendoscopic balloon dilators or dilating systems employing guide wires); 6) Palliative therapy of stenosing neoplasms (e.g., laser, bipolar electrocoagulation, stent placement); 7) Management of achalasia (e.g., botulinum toxin, balloon dilatation). D. Non-covered Transesophageal Endoscopic Procedures for the Treatment of GERD: Some 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: Policy No. MP-037-MC-NC Page 3 of 22 1) 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. 2) 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 value enabling serosa to serosa tissue healing to prevent reflux. The procedure is performed using conscious sedation. Submucosal injection or implantation of biocompatible bulking agents or polymer prosthetics are not FDA approved for the treatment of GERD. Some of the products/procedures are currently under investigation and may be FDA approved for the treatment of GERD in the future. 3) 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. 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. 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. Once implanted, Enteryx® cannot be removed. 4) Gatekeeper ™ Reflux Repair System endoscopically introduces an expandable hydrogen prosthesis into the submucosa of the LES zone. 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. Gatekeeper can be removed if complications occur. This product is not FDA approved and is not currently available in the United States. 5) 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. This product is not FDA approved and is not currently available in the United States. 6) 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. It is currently also approved for the treatment of fecal incontinence. Durasphere® GR is a product listed as an investigational