Intragastric devices may be of benefit to patients who are unable to achieve weight loss through lifestyle modification and pharmaceuticals. With the help of every member of a multidisciplinary team and ongoing commitment from patients, small, practical steps and goals can lead to long-lasting, healthy weight loss.
Key points
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Intragastric devices may be of benefit to patients who are unable to achieve weight loss through lifestyle modification and pharmaceuticals.
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With the help of every member of a multidisciplinary team and ongoing commitment from patients, small, practical steps and goals can lead to long-lasting, healthy weight loss.
There has been increasing interest in new payment and delivery models designed to improve the effectiveness and efficiency of clinical care. Although efforts have typically focused on improving the management of conditions at a primary care level, there has also been interest in improving care provided by specialists. Over the past several decades, there has been a heightened awareness of the epidemic of obesity. The United States Preventive Service Task Force (USPSTF) recommends screening all adults for obesity. Clinicians should offer or refer patients with a body mass index (BMI) of 30 kg/m 2 or higher to intensive multicomponent behavioral interventions. The USPSTF recommends that clinicians screen children age 6 years and older for obesity and offer or refer them to comprehensive, intensive behavioral interventions to promote improvement in weight status.
Endoscopic or surgical approaches should not be a sole solution to the management of patients with obesity. They are components of a framework that support a multidisciplinary approach to the management of each patient. Providing bariatric endoscopy in the absence of a comprehensive obesity management program benefits no one; not the patient, the patient’s family, employer, purchaser, or payer. Thus, it is crucial for practices that wish to provide bariatric endoscopic services to ensure that the patients have access to other services across multiple disciplines that, taken together, support the management of obesity, which is a chronic disease.
Coding endoscopic placement and removal of gastric devices for the management of obesity
Available clinical data and manufacturer recommendations indicate 6 months to be the current standard duration of therapy for the intragastric balloon (IGB) devices approved by the US Food and Drug Administration (FDA) as of January 1, 2017.
The ORBERA Intragastric Balloon System is indicated for use as an adjunct to weight reduction for adults with obesity with a BMI of greater than or equal to 30 and less than or equal to 40 kg/m 2 and is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of significant long-term weight loss and maintenance of that weight loss. ORBERA is indicated for adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise, and behavior modification programs.
The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise in patients with a BMI of 30 to 40 kg/m 2 and 1 or more obesity-related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.
The Obalon Balloon System is a swallowable intragastric balloon system indicated for temporary use to facilitate weight loss in adults with obesity (BMI of 30–40 kg/m 2 ) who have failed to lose weight through diet and exercise. The system is intended to be used as an adjunct to a moderate-intensity diet and behavior modification program.
At present, there are no CPT (Current Procedural Terminology) or HCPCS (Healthcare Common Procedural Coding System) codes for the endoscopic placement of intragastric space-occupying or gastric pacing devices for the management of obesity. Endoscopic placement should be reported using code 43999 (unlisted procedure, stomach). Nonendoscopic placement of an intragastric space-occupying device should be reported using code 99199 (unlisted special service, procedure, or report). Endoscopic removal of a foreign body from the stomach should be reported using code 43247 (esophagogastroduodenoscopy, flexible, transoral; with removal of foreign body or bodies).
The AspireAssist is intended to assist in weight reduction of patients with obesity. It is indicated for use in adults aged 22 years or older with a BMI of 35.0 to 55.0 kg/m 2 who have failed to achieve and maintain weight loss with nonsurgical weight loss therapy. The AspireAssist is intended for a long-term duration of use in conjunction with lifestyle therapy and continuous medical monitoring.
Endoscopic placement of a percutaneous gastrostomy-type device for the management of obesity should be reported using code 43246 (esophagogastroduodenoscopy, flexible, transoral; with directed placement of percutaneous gastrostomy tube). If the device is placed under fluoroscopic guidance without endoscopic visualization, the service would be reported using code 49440 (insertion of gastrostomy tube, percutaneous, under fluoroscopic guidance including contrast injections, image documentation, and report).
Endoscopic removal of a percutaneous gastrostomy-type device for the management of obesity should be reported using code 43247. If the device is removed as part of an evaluation and management (EM) visit, only the EM code is reported. If the device is removed endoscopically and replaced endoscopically, then code 43247 should be used to report removal, and code 43246 to report endoscopic placement of a subsequent percutaneous gastrostomy-type device. If the device is replaced without imaging or endoscopic guidance, then code 43760 (percutaneous change of gastrostomy tube without imaging or endoscopic guidance) is appropriate. If the device is replaced under fluoroscopic guidance, then code 49450 (replacement of gastrostomy under fluoroscopic guidance) is appropriate.
The manufacturers of the endoscopic devices require the endoscopist to participate in an endoscopic-skills training program before the company will sell the device to the physician. The physician must show advanced upper endoscopy skill and experience by possession of interventional endoscopy privileges granted locally by the participating hospital or ambulatory facility. Physicians are required to use the device as a component of a multidisciplinary weight management practice that provides appropriate endoscopy facilities, nutrition and exercise counseling, psychological and radiological support, and long-term support and follow-up.
There are no requirements specifying that placement and/or removal of endoscopic devices for obesity always require general anesthesia and/or intubation. Orotracheal intubation is recommended in patients with BMI greater than 40 kg/m 2 , and in those with obstructive sleep apnea or chronic obstructive pulmonary disease. Some endoscopists elect to perform the initial placement of the device using general anesthesia and airway intubation. Endoscopic removal of IGB devices must be completed in the presence of an empty stomach, and patients should be nil per os (NPO) for a minimum of 12 hours before removal. A strict gastric emptying protocol is recommended 48 hours before the patient is due to undergo the balloon removal procedure. Some experienced endoscopists recommend that the airway be protected from aspiration of acid or gastric contents dripping from the IGB for the first several balloon removals, especially if the endoscopist does not frequently remove large foreign bodies from the stomach. If food is found in the stomach on endoscopic examination, then measures (aspiration of stomach contents, endotracheal intubation, or delay of procedure) must be taken to protect the airway. Risks, potential complications, and side effects of intragastric devices should be discussed with the patient before proceeding with placement.
Coding endoscopic placement and removal of gastric devices for the management of obesity
Available clinical data and manufacturer recommendations indicate 6 months to be the current standard duration of therapy for the intragastric balloon (IGB) devices approved by the US Food and Drug Administration (FDA) as of January 1, 2017.
The ORBERA Intragastric Balloon System is indicated for use as an adjunct to weight reduction for adults with obesity with a BMI of greater than or equal to 30 and less than or equal to 40 kg/m 2 and is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of significant long-term weight loss and maintenance of that weight loss. ORBERA is indicated for adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise, and behavior modification programs.
The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise in patients with a BMI of 30 to 40 kg/m 2 and 1 or more obesity-related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.
The Obalon Balloon System is a swallowable intragastric balloon system indicated for temporary use to facilitate weight loss in adults with obesity (BMI of 30–40 kg/m 2 ) who have failed to lose weight through diet and exercise. The system is intended to be used as an adjunct to a moderate-intensity diet and behavior modification program.
At present, there are no CPT (Current Procedural Terminology) or HCPCS (Healthcare Common Procedural Coding System) codes for the endoscopic placement of intragastric space-occupying or gastric pacing devices for the management of obesity. Endoscopic placement should be reported using code 43999 (unlisted procedure, stomach). Nonendoscopic placement of an intragastric space-occupying device should be reported using code 99199 (unlisted special service, procedure, or report). Endoscopic removal of a foreign body from the stomach should be reported using code 43247 (esophagogastroduodenoscopy, flexible, transoral; with removal of foreign body or bodies).
The AspireAssist is intended to assist in weight reduction of patients with obesity. It is indicated for use in adults aged 22 years or older with a BMI of 35.0 to 55.0 kg/m 2 who have failed to achieve and maintain weight loss with nonsurgical weight loss therapy. The AspireAssist is intended for a long-term duration of use in conjunction with lifestyle therapy and continuous medical monitoring.
Endoscopic placement of a percutaneous gastrostomy-type device for the management of obesity should be reported using code 43246 (esophagogastroduodenoscopy, flexible, transoral; with directed placement of percutaneous gastrostomy tube). If the device is placed under fluoroscopic guidance without endoscopic visualization, the service would be reported using code 49440 (insertion of gastrostomy tube, percutaneous, under fluoroscopic guidance including contrast injections, image documentation, and report).
Endoscopic removal of a percutaneous gastrostomy-type device for the management of obesity should be reported using code 43247. If the device is removed as part of an evaluation and management (EM) visit, only the EM code is reported. If the device is removed endoscopically and replaced endoscopically, then code 43247 should be used to report removal, and code 43246 to report endoscopic placement of a subsequent percutaneous gastrostomy-type device. If the device is replaced without imaging or endoscopic guidance, then code 43760 (percutaneous change of gastrostomy tube without imaging or endoscopic guidance) is appropriate. If the device is replaced under fluoroscopic guidance, then code 49450 (replacement of gastrostomy under fluoroscopic guidance) is appropriate.
The manufacturers of the endoscopic devices require the endoscopist to participate in an endoscopic-skills training program before the company will sell the device to the physician. The physician must show advanced upper endoscopy skill and experience by possession of interventional endoscopy privileges granted locally by the participating hospital or ambulatory facility. Physicians are required to use the device as a component of a multidisciplinary weight management practice that provides appropriate endoscopy facilities, nutrition and exercise counseling, psychological and radiological support, and long-term support and follow-up.
There are no requirements specifying that placement and/or removal of endoscopic devices for obesity always require general anesthesia and/or intubation. Orotracheal intubation is recommended in patients with BMI greater than 40 kg/m 2 , and in those with obstructive sleep apnea or chronic obstructive pulmonary disease. Some endoscopists elect to perform the initial placement of the device using general anesthesia and airway intubation. Endoscopic removal of IGB devices must be completed in the presence of an empty stomach, and patients should be nil per os (NPO) for a minimum of 12 hours before removal. A strict gastric emptying protocol is recommended 48 hours before the patient is due to undergo the balloon removal procedure. Some experienced endoscopists recommend that the airway be protected from aspiration of acid or gastric contents dripping from the IGB for the first several balloon removals, especially if the endoscopist does not frequently remove large foreign bodies from the stomach. If food is found in the stomach on endoscopic examination, then measures (aspiration of stomach contents, endotracheal intubation, or delay of procedure) must be taken to protect the airway. Risks, potential complications, and side effects of intragastric devices should be discussed with the patient before proceeding with placement.
Complications related to gastric devices for the management of obesity
Risks, potential complications, and side effects of intragastric devices should be discussed with the patient before proceeding with placement. The manufacturers of the space-occupying devices have noted 2 absolute contraindications to the use of these devices:
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The presence of more than 1 intragastric device at the same time.
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Prior open or laparoscopic stomach or bariatric surgery.
In addition, there are several relative contraindications to be considered when considering placement of an IGB:
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Any inflammatory disease of the gastrointestinal tract, including esophagitis, gastric ulceration, duodenal ulceration, cancer, or specific inflammation, such as Crohn disease.
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Potential upper gastrointestinal bleeding conditions, such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia, or other congenital anomalies of the gastrointestinal tract, such as atresias or stenoses.
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A large hiatal hernia or greater than 5-cm hernia or less than or equal to 5 cm with associated severe or intractable gastroesophageal reflux symptoms.
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A structural abnormality in the esophagus or pharynx, such as a stricture or diverticulum that could impede passage of the delivery catheter and/or an endoscope.
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Achalasia or any other severe motility disorder that may pose a safety risk during removal of the device.
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Gastric mass.
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Severe coagulopathy.
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Hepatic insufficiency or cirrhosis.
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Patients who are known or suspected to have an allergic reaction to materials contained in the intragastric device.
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Any other medical condition that would not permit elective endoscopy, such as poor general health or history and/or symptoms of severe renal, hepatic, cardiac, and/or pulmonary disease.
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Uncontrolled mental disorder or a neurodevelopmental disorder that could compromise patient understanding of, or compliance with, follow-up visits and removal of the device after 6 months.
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Recent or current eating disorder, including but not limited to self-induced vomiting.
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Recent or current substance use disorder.
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Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
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Patients unwilling to participate in an established medically supervised diet and behavior modification program, with routine medical follow-up.
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Patients receiving aspirin, antiinflammatory agents, anticoagulants, or other gastric irritants, not under medical supervision.
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Patients who are known to be pregnant or breast feeding.
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Patients who lack a general understanding about the procedure, risks, benefits, expected outcomes, and the necessary lifestyle changes recommended.
For patients considering IGB devices that contain methylene blue, patients receiving serotonergic drugs, including selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, and other prescription and over-the-counter drugs, should be cautioned about the possibility of developing serotonin syndrome because of the combination of these medications and the release of methylene blue (in the event of balloon rupture). Patients should immediately seek medical attention if they develop any symptoms of confusion, headache, nausea and vomiting, rapid heart rate, or severe sweating.
The risk of obstructions may be higher in patients who have diabetes, a dysmotility disorder, or who have had prior abdominal or gynecologic surgery. Patients with known abdominal adhesions or who have had prior abdominal surgery or any signs or symptoms of a bowel obstruction should be carefully evaluated before use of these devices in relation to possible intestinal obstruction should the device deflate or pass into the intestines. Bowel obstructions have been reported to be caused by deflated balloons passing into the intestines and have required surgical removal. The patient’s clinical history should be considered when assessing the suitability of the patient and the risk of the procedure.
To prevent ulcers, it is recommended that the patient start a program of oral proton pump inhibitors (PPIs) for approximately 3 to 5 days before placement so that a maximal gastric acid suppression effect will be present on the day of placement. It is recommended that the PPI dose be given sublingually if nausea and/or vomiting are present. An oral PPI with the highest recommended starting dose (eg, omeprazole 40 mg daily or equivalent) should be continued as long as the device is in place.
It is recommended that no food or liquid is present in the stomach at the time of the insertion procedure. Representative preprocedure diet instructions include:
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Forty-eight hours before the procedure: soft food only, no meat in any form
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Twenty-four hours before the procedure: clear liquids only
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Twelve hours before the procedure: no food or liquids by mouth
For removal, clear liquids for a minimum of 24 hours, and preferably 48 hours, is recommended, because there is significant documented delay in gastric emptying with the IGB device in place. Several experienced gastroenterologists also recommend ingestion of a clear, carbonated, low-calorie beverage between 12 and 24 hours before the procedure to clean the surface of the balloon before removal.
Endoscopic removal of IGB devices must be completed in the presence of an empty stomach. Patients should be NPO for a minimum of 12 hours before removal. If food is found in the stomach on endoscopic examination, then measures (aspiration of stomach contents, endotracheal intubation, or delay of procedure) must be taken to protect the airway. In the event of an emergency removal by a physician untrained in the procedure, endotracheal intubation of the patient is recommended to reduce the risk of aspiration, because the risk of aspiration of gastric contents into the patient’s lungs is serious and may lead to death.
Patients reporting loss of satiety, increased hunger, and/or weight gain should be evaluated expeditiously because this may indicate a balloon deflation. Physical examination, plain abdominal radiograph, upper gastrointestinal examination, and endoscopy can be helpful in confirming the diagnosis. Deflated devices should be removed promptly. Patients should be advised that balloon deflation may lead to serious adverse events, including bowel obstruction and need for emergency surgery.
Possible complications of IGB placement include:
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Intestinal obstruction by the balloon.
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Death caused by complications related to intestinal obstruction.
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Esophageal obstruction.
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Gastric outlet obstruction.
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Injury to the digestive tract during placement of the balloon in an improper location, such as in the esophagus or duodenum.
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Insufficient or no weight loss.
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Adverse health consequences resulting from weight loss.
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Gastric discomfort and feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.
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Continuing nausea and vomiting.
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Abdominal or back pain, either steady or cyclic.
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Gastroesophageal reflux.
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Influence on digestion of food.
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Blockage of food entering into the stomach.
The percutaneous gastric aspiration device has a unique set of contraindications and complications. Contraindications include:
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Previous abdominal surgery that significantly increases the medical risks of gastrostomy tube placement.
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Esophageal stricture, pseudo-obstruction, severe gastroparesis, or gastric outlet obstruction.
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Inflammatory bowel disease.
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History of refractory gastric ulcers.
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Ulcers, bleeding lesions, or tumors discovered during endoscopic examination.
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Uncontrolled hypertension (blood pressure >160/100 mm Hg).
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History or evidence of serious pulmonary or cardiovascular disease, including acute coronary syndrome, heart failure requiring medications, or New York Heart Association (NYHA) class III or IV.
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Coagulation disorders (platelet count <50,000/μL, prothrombin time >2 seconds more than control, or International Normalized Ratio >1.5).
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Anemia (hemoglobin level <8.0 g/dL in women and <10.0 g/dL in men).
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Pregnant or lactating.
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Diagnosed bulimia or diagnosed binge-eating disorder (using Diagnostic and Statistical Manual of Mental Disorders criteria).
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Night eating syndrome.
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Chronic abdominal pain that would potentially complicate the management of the device.
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Physical or mental disability, or psychological illness that could interfere with compliance with the therapy.
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At high risk of having a medical complication from the endoscopic procedure or a weight loss program for any reason, including poor general health or severe organ dysfunction such as cirrhosis or renal dysfunction.
Possible adverse events of the gastrostomy tube device include:
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Peristomal granulation tissue
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Abdominal pain and discomfort after device placement
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Nausea, vomiting
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Dyspepsia, acid reflux, heartburn, hiccups, belching
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Peristomal irritation, inflammation, discharge
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Peristomal bacterial or fungal infection
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Peristomal bleeding
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Hypokalemia
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Change in bowel habits, constipation, diarrhea
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Accidental dislodgement or trauma to the device
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