Medical Policy: 02.01.56
Original Effective Date: December 2015
Reviewed: July 2021
Revised: July 2021
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Bariatric surgery is performed to treat morbid (clinically severe) obesity. Morbid obesity is defined as a body mass index (BMI) greater than 40 kg/m2 or a BMI greater than 35 kg/m2 with associated complications including, but not limited to, diabetes, hypertension, or obstructive sleep apnea. Morbid obesity results in a very high-risk for weight-related complications, such as diabetes, hypertension, obstructive sleep apnea, and various types of cancers (for men: colon, rectal, prostate; for women: breast, uterine, ovarian), and a shortened lifespan. A morbidly obese man at age 20 can expect to live 13 fewer years than his counterpart with a normal BMI, which equates to a 22% reduction in life expectancy.
The first treatment of morbid obesity is dietary and lifestyle changes. Although this strategy may be effective in some patients, only a few morbidly obese individuals can reduce and control weight through diet and exercise. Most patients find it difficult to comply with these lifestyle modifications on a long-term basis. When conservative measures fail, some patients may consider surgical approaches and there are numerous gastric and intestinal surgical techniques available. This medical policy addresses the following miscellaneous bariatric procedures for the treatment of obesity that are considered investigational because the evidence is insufficient to determine the effects of the technology on net health outcomes.
The Intragastric balloon (also known as the silicone intragastric balloon or SIB) has been developed as a temporary aid for obese patients who have had unsatisfactory results in their clinical treatment for obesity. Intragastric balloon is intended to reduce gastric capacity, causing satiety, making it easier for patients to take smaller amounts of food.
Other balloons being investigated include the SatiSphere (Endosphere, Columbus, OH), Spatz Adjustable Balloon System (Spatz Medical, NY, USA), Elipse (Allurion Technologies, Wellesley, M)A, Full Sense Bariatric Device (Baker, Foote, Kemmeter, Walburn [BFKW] LLC, Grand Rapids, MI), Heliosphere® (Helioscopie Medical Implants, Vienne, France), Silimed Gastric Balloon (Silimed, Rio de Janeiro, Brazil) and the Ullorex® Oral Intragastric Balloon (Phagia Technologies, Inc., Fort Lauderdale, FL). These devices are currently not FDA approved for use in the United States.
The FDA has received reports of unanticipated patient deaths related to liquid-filled intragastric balloon systems for treating obesity. The reports involved Apollo Endosurgery's (Austin, TX, USA) Orbera® Intragastric Balloon System, and ReShape Medical Inc.'s (San Clemente, CA, USA) ReShape® Integrated Dual Balloon System. All reported patients died within a month or less of receiving the balloon.
On August 10, 2017, FDA released an updated letter to alert healthcare providers of additional information regarding these adverse events (AEs). The letter discusses that FDA still does not know the root cause and incidence rate of patient deaths in relation to liquid-filled intragastric balloons and has not been able to definitively attribute the deaths to the actual devices or device insertion procedures (e.g., gastric and esophageal perforation, intestinal obstruction).
The Transpyloric Shuttle/TransPyloric Shuttle Delivery Device (TPS) (BAROnove, Inc. San Carols, CA) was FDA PMA approved for obese adult patients with a Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with an associated medical condition who have been unable to lose weight on a diet and behavior modification program and exercise. It is intended to be used while a patient participates in a diet and exercise plan supervised by a health care provider (FDA, 2019). The TPS is placed into the stomach through the mouth during an endoscopic procedure. Once in place, the TPS is formed, using the TPS Delivery Device, into a smooth large bulb connected to a smaller bulb by a flexible silicone tether. The large bulb remains in the stomach. The smaller bulb can remain in the stomach or cross the stomach into the small intestine to slow the time it takes for food to leave the stomach and enter the small intestine (gastric emptying). The TPS remains in the stomach for up to 12 months to help patients lose weight (FDA, 2019).
Vertical banded gastroplasty (VBG), also known as stomach stapling. In this procedure the upper stomach near the esophagus is stapled vertically to create a small pouch along the inner curve of the stomach. The outlet from the pouch to the rest of the stomach is restricted by a band made of special material. The band delays the emptying of food from the pouch, causing a feeling of fullness. The percentage of reoperations necessary with vertical banded gastroplasty is increased from all other approved procedures. This procedure is no longer the standard of care.
Intestinal Bypass, (e.g., jejunoileal) bypass is created by dividing the small bowel 30 cm distal to the ligament of Treitz. The proximal cut end of the small bowel is anastomosed to the terminal ileum 50 cm proximal to the ileocecal valve. The rest of the small bowel remains a blind loop.
The Mini gastric bypass or Single-Anastomosis Gastric Bypass (similar to the Billroth II operation, can also be called Gastrojejunostomy intestinal anastomosis) mini-gastric bypass is a variation of the gastric bypass. Using a laparoscopic approach, the stomach is segmented, similar to a traditional gastric bypass, but instead of creating a Roux-en-Y anastomosis, the jejunum is anastomosed directly to the stomach.
The long-limb gastric bypass differs from the conventional gastric bypass only in the length of defunctionalized jejunum. The long-limb gastric bypass was designed to induce greater malabsorption by diverting bile and pancreatic secretions distally in the digestive tract. This was felt to produce a greater malabsorption of fats without the protein malabsorption associated with intestinal bypass.
Gastrointestinal liners including (e.g., EndoBarrier ValenTxEndo Bypass System), an endoscopically delivered duodeno-jejunal bypass liner (DJBL), is a plastic flexible tube that is placed in the duodenal bulb, directly behind the pylorus. It extends from the duodenum to the proximal jejunum.
Transoral gastroplasty (TG) is a minimally invasive, incisionless, reversible weight-loss procedure in which the stomach size is restricted with staples or sutures by using endoscopic surgical tools guided through the mouth and esophagus into the stomach. Two examples of this procedure that are proposed for revisions of standard weight loss surgery are Stomaphyx and the ROSE procedure. This may also be referred to as endoscopic sleeve gastroplasty. Newly approved to assist in transoral procedures. The OverStitch™ Endoscopic Suturing System allows placement of full-thickness sutures through a flexible endoscope during bariatric and gastrointestinal surgeries. It allows deployment of both running and interrupted sutures, has a curved needle design to control suture depth, and allows knotless fixation.
In a traditional gastric bypass procedure, surgeons create a smaller stomach by stapling off a large section. A problem with the traditional procedure is that the staples can break down, causing the stomach to regain its original shape -- and patients to start gaining weight again. Also, the stomach opening that leads into the intestines, which in surgery is made smaller to allow less food to pass through, often stretches as the years go by. With the Fobi pouch, there is no use of staples; rather, the stomach is bisected and hand-sewn to maintain the separation. A synthetic band is placed around the stomach opening to keep it from stretching. This has not been fully endorsed by the American Society for Metabolic and Bariatric Surgery (ASMBS) as a primary weight loss procedure.
This procedure is intended to provide control of calorie consumption to those with BMI 35-55 kg/m² who have been unsuccessful in weight loss through non-surgical means. To place the device, surgeons insert a tube in the stomach with an endoscope via a small incision in the abdomen. A disk-shaped port valve that lies outside the body, flush against the skin of the abdomen, is connected to the tube and remains in place. Approximately 20 to 30 minutes after meal consumption, the patient attaches the device’s external connector and tubing to the port valve, opens the valve and drains the contents. Once opened, it takes approximately five to 10 minutes to drain food matter through the tube and into the toilet. The device removes approximately 30 percent of the calories consumed. Only 1 randomized control trial has been initiated, with no literature available on the long-term effects of therapy on health outcomes. With no completed randomized control trials the evidence is lacking that proves device use shows an improvement in net health outcomes or that the service is as beneficial as any established alternative service.
During this procedure a small catheter is passed through the radial artery in the wrist or the femoral artery in the groin and utilize live x-ray imaging to guide the catheter to the artery that supplies blood to the left side of the stomach. Here the physician injects tiny particles that are just large enough to block and kill the cells that make the appetite hormone ghrelin.
Hydrogel capsules (i.e., Gelesis100) are pills that are designed to treat the physiological symptoms of hunger without surgery, other invasive procedures or systemically absorbed drugs. Twenty minutes before a meal, a patient swallows capsules containing hydrogel particles. Once in the stomach, these particles are released from the capsules and rapidly absorb water, hydrating to approximately one hundred times their dry weight. The particles will pass through the digestive tract and be excreted from the body.
In 2018, the ASMBS released an addendum to their intragastric balloon therapy position statement in response to the FDA’s warnings on complications not identified during initial clinical trials, and worldwide mortalities associated with intragastric balloons. They recommend that: As with all procedures, it is important that patients give informed consent and are aware of potential adverse events. Laypeople may need to be counseled to correct a misperception that endoluminal treatments are nonsurgical and thus risk-free. When less powerful treatments are chosen, behavioral modification increases in importance and there is risk of weight regain after the device is retrieved. The ASMBS routinely advocates for multidisciplinary care and support of the weight loss patient, and this recommendation is even more crucial for intragastric balloon recipients.
In 2016, the American Society for Metabolic and Bariatric Surgery provided the following guideline: single anastomosis duodenal switch procedures are considered investigational at present and should be performed under a study protocol with third-party oversight to ensure continuous evaluation of patient safety and to review adverse events and outcomes.
A 2016 NICE guidance on single-anastomosis duodeno-ileal bypass with sleeve gastrectomy for treating morbid obesity stated that the current evidence on the safety shows that there are well-recognized complications. Evidence on efficacy is limited in both quality and quantity. Therefore, the procedure should only be used with special arrangements for clinical governance, consent and audit or research.
In March 2007, the FDA granted 510(k) pre-marketing clearance to the StomaphyX (EndoGastric Solutions, Inc.), an endoluminal fastener and delivery system used to tighten esophageal tissue.
On July 28, 2015, the Food and Drug administration (FDA) approved the ReShape Integrated Dual Balloon System (ReShape Medical Inc., San Clemente, CA) to treat obesity without the need for invasive surgery.
On June 14, 2016, the FDA approved the AspireAssist device to assist in weight loss in patients aged 22 and older who are obese, with a BMI of 35 to 55, and who have failed to achieve and maintain weight loss through non-surgical weight-loss therapy.
On April 2019 FDA approved the TransPyloric Shuttle non-surgical device intended for treating obesity, now cleared as a weight loss solution for adults with obesity and a body mass index of 30 to 40 kg/m2.
See related medical policies
The following surgical or minimally invasive procedures are considered investigational as a treatment of morbid obesity including but not limited to the following due to insufficient evidence demonstrating an impact on improved net health outcomes:
The following which is orally administered Hydrogel capsules (e.g., Gelesis100) for the treatment of morbid obesity is considered investigational, because the evidence is insufficient to determine the effects of the technology on net health outcomes.
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.
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