Humana Diagnostic Esophagogastroduodenoscopy or Esophagoscopy - Medicare Advantage Form

Please refer to CMS website for the most current applicable National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/CMS Online Manual System/Transmittals. Diagnostic Esophagogastroduodenoscopy or Esophagoscopy Page: 2 of 12 Type Title NCD Endoscopy ID Number 100.2 Jurisdiction Medicare Administrative Contractors (MACs) Applicable States/Territories LCD LCA LCD LCA Upper Gastrointestinal Endoscopy (Diagnostic and Therapeutic) L35350 A57414 JH – JL Novitas Solutions, Inc. (Part A/B MAC) AR, CO, DC, DE, MD, NJ, NM, OK, PA, TX, LA, MS Upper Gastrointestinal Endoscopy and Visualization L34434 A56389 JJ – JM Palmetto GBA (Part A/B MAC) AL, GA, NC, SC, TN, VA, WV Description This medical coverage policy is intended for diagnostic esophagogastroduodenoscopy (EGD) or esophagoscopy only. Criteria for screening, surveillance or therapeutic EGD or esophagoscopy are not addressed in this policy. Esophagogastroduodenoscopy (EGD), also known as upper gastrointestinal (GI) endoscopy, is used for real- time visualization of the throat, esophagus, stomach and proximal duodenum for assessment and interpretation of the findings encountered. During the procedure, a thin, flexible fiberoptic tube with a high-definition white light and camera is passed through the mouth and upper GI tract displaying images on a video monitor. Additionally, the EGD may be used to dilate (stretch) a narrow area, obtain a biopsy (small tissue sample), perform a cytology test (the collection of cells for testing), remove polyps or treat bleeding. An esophagoscopy is the examination of the esophagus or the first portion of the EGD, which visualizes the esophageal mucosa from the upper esophageal sphincter to the esophagogastric junction where the esophageal mucosa ends and the stomach mucosa begins. The esophagoscopy procedure is one of several procedures that fall under the category of upper endoscopy, including gastroscopy, EGD, and enteroscopy. Esophagoscopy alone is uncommon; it is generally performed as part of a more complete upper endoscopic procedure in which the esophagus, stomach, and portions of the small intestine are explored endoscopically. Esophagoscopy can be performed via the transnasal or transoral route. Transnasal EGD is proposed as an alternative to the transnasal approach and uses a flexible ultrathin tube. This approach reportedly does not require sedation and has been suggested for use in an individual who may have anxiety of sedation or at high risk of cardiopulmonary complications. Diagnostic Esophagogastroduodenoscopy or Esophagoscopy Page: 3 of 12 Transoral esophageal mucosal integrity testing by electrical impedance (eg, MiVu) is being studied to aid in the diagnosis of gastroesophageal reflux disease (GERD). This testing is performed during routine endoscopy and reportedly gives real time measurements of esophageal epithelial impedance values. Coverage Determination Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare. In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the criteria contained in the following: Transoral diagnostic EGD or transnasal or transoral esophagoscopy is considered medically reasonable and necessary when the following requirements are met: • Evaluation of dyspepsia or GERD with ANY of the following: o Family history of upper GI cancer in first-degree relative; OR o Lymphadenopathy (eg, left supraclavicular or periumbilical); OR o Palpable abdominal mass (eg, hepatoma); OR o Progressive dysphagia; OR o Unexplained iron deficiency anemia; OR • Evaluation of persistent dyspepsia symptoms (eg, epigastric pain, fullness, heartburn, nausea, vomiting) after an appropriate trial of a proton pump inhibitor (PPI) therapy (appropriate trial of therapy is a 2-to- 4-week course of standard dose, once daily PPI); OR • Evaluation of GERD reflux symptoms (eg, acid reflux, heartburn) that are persistent or recurrent despite standard dosing of a trial of PPI (eg, Dexilant [dexlansoprazole]) for 2 months or greater; OR • Assess acute injury after caustic ingestion; OR • Atypical chest pain after cardiac disease has been ruled out; OR • Clinically significant unintentional weight loss (eg, anorexia) (greater than 5 percent usual body weight over 6 to 12 months); OR • Confirmation and specific histologic diagnosis of radiologically demonstrated findings (eg, lesions, strictures) including, but not limited to: o Gastric or esophageal lesion; OR o Suspected neoplastic lesion; OR o Upper tract obstruction or stricture; OR Diagnostic Esophagogastroduodenoscopy or Esophagoscopy Page: 4 of 12 • Evaluation of esophageal masses and for directing biopsies to rule out esophageal cancer; OR • Evaluation of familial adenomatous polyposis syndromes; OR • Evaluation of an individual with findings on an esophagram suggestive of achalasia; OR • Evaluation of an individual with signs or symptoms of locoregional recurrence after resection of esophageal cancer; OR • Evaluation of an individual with suspected portal hypertension to document esophageal varices; OR • Evaluation of lower abdominal symptoms such as diarrhea in an individual suspected of having small bowel disease to identify an upper GI etiology (eg, celiac disease); OR • Evaluation of other diseases in which the presence of upper GI pathology might modify other planned management (eg, an individual with a history of ulcer or GI bleeding who is scheduled for organ transplantation, long-term anticoagulation or chronic nonsteroidal anti-inflammatory drug [NSAID] therapy for arthritis and in an individual with cancer of the head or neck); OR • GI bleeding and at least 1 of the following: o For presumed chronic blood loss and for iron deficiency anemia when colonoscopy is negative; OR o In most actively bleeding patients or those recently stopped; OR o When portal hypertension or aortoenteric fistula is suspected; OR o When re-bleeding occurs after acute self-limited blood loss or after endoscopic therapy; OR o When surgical therapy is contemplated; OR • Odynophagia (painful swallowing); OR • Persistent vomiting of unknown cause The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy. In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider MCG Guidelines. Coverage Limitations US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage Diagnostic Esophagogastroduodenoscopy or Esophagoscopy Page: 5 of 12 Diagnostic EGD or Esophagoscopy will not be considered medically reasonable and necessary for the following: • Individual with an asymptomatic upper GI tract (eg, prior to bariatric surgery) Transoral esophageal mucosal integrity testing by electrical impedance (eg, MiVu) will not be considered medically reasonable and necessary. A review of the current medical literature shows that the evidence is insufficient to determine that this service is standard medical treatment. There remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of this service in clinical management. Summary of Evidence A review of the current medical literature demonstrates a lack of evidence or an unclear utility of transoral esophageal mucosal integrity testing by electrical impedance (eg, MiVu). No studies reported clinical utility outcomes and the studies were considered to be of very poor quality. One systematic review was identified, which did not report advantages of this test versus standard diagnostic methods.35