Medical Policy: 02.01.56 

Original Effective Date: December 2015 

Reviewed: July 2020 

Revised: July 2020 

 

Notice:

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 Application:

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.

 

Description:

Bariatric is an internationally accepted term applied to patients who have a weight that far exceeds recommended guidelines and / or a body size that restricts their mobility, health, or access to available services. Multiple surgical and laparoscopic procedures are available for the treatment of obesity. The following miscellaneous bariatric procedures have been used to treat obesity.

 

The Intragastric balloon

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)

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

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

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.

 

Mini gastric bypass or Single-Anastomosis Gastric Bypass/stomach intestinal pylorus sparing surgery (SIPS)

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.

 

Long Limb Gastric Bypass

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

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

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.

 

  1. StomaphyX is a non-invasive procedure where the surgeon literally does an endoscopy where a scope is put in through your mouth and is fed down into the stomach pouch. No incisions are needed for this procedure as it goes directly into the mouth. Once the scope has been inserted, the surgeon will then suction out the stomach tissue into a small StomaphyX opening. This allows a fold of tissue to be created which is then secured with fasteners in the shape of an “H.” These small folds will eventually create a smaller stomach pouch about the same size as the one created during gastric bypass. The number of folds needed depends on the size of the stomach.
  2. Another non-invasive weight loss surgery is transoral ROSE. While this surgery is similar to StomaphyX, a surgeon will insert a similar tool to the endoscope that has four different channels into the mouth, down through the esophagus and into the stomach. He or she then puts specialized instruments through those four channels to sew the connection between the small intestine and stomach pouch together. In the transoral ROSE procedure, the surgeon sutures tissue to make several folds around the opening of the small intestine (the stoma) to decrease its diameter. Anchored sutures are then placed into the stomach pouch minimizing how much the stomach can actually hold.

 

Silastic ring vertical gastric bypass (Fobi pouch)

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.

 

Surgically-placed gastric tubes intended to drain a portion of the stomach contents ( e.g. the AspireAssist® device).

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.

 

Bariatric Arterial Embolization/Gastric Artery Embolization (e.g. Nanoblock procedure)

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.

 

Orally administered hydrogel capsules

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.

 

Practice Guidelines and Position Statements

American Society for Metabolic and Bariatric Surgery (ASMBS)

The ASMBS (2018) 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.

 

American Society for Metabolic and Bariatric Surgery (ASMBS, 2016):

 

According to the ASMBS, 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.

 

National Institute for Health (NICE)

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.

 

Regulatory Status

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.

 

Prior Approval:

Not applicable

 

Policy:

For information pertaining to gastric electrical stimulation, see policy 07.01.62 

For information pertaining to vagus nerve stimulation for obesity, see policy 07.01.60

 

Based upon our criteria and assessment of the peer-reviewed literature the following procedures are considered investigational:

  • Mini-gastric bypass (also called loop gastric by-pass)
  • Laparoscopic gastric plication, also known as laparoscopic greater curvature plication
  • Endoscopically placed duodenal-jejeunal sleeve
  • Sleeve gastrectomy as an open procedure
  • Adjustable banding as an open procedure
  • Intragastric balloon (e.g. ReShape® Integrated Dual Balloon System Obera device)
  • Intestinal bypass
  • Gastrointestinal liners including but not limited to Endobarrier, The ValenTx, and Gastric Vest System
  • Silastic Ring Vertical Gastric Bypass (Fobi pouch)
  • Long limb gastric bypass
  • Vertical banded gastroplasty
  • Transoral gastroplasty/Endoscopic grastroplasty (Also called: Natrual Orifice Transluminal Endoscopic Surgery (NOTES™) or TOGA) including but not limited to Restorative Obesity Surgery Endoluminal or ROSE procedure, endoscopic closure devices, StomaphyX, EndoCinch, OverStitch, Apollo, transoral outlet reduction
  • Surgically-placed gastric tubes intended to drain a portion of the stomach contents ( e.g. the AspireAssist® device)
  • Single anastomosis bypass with sleeve gastrectomy/stomach intestinal pylorus sparing surgery (SIPS)
  • Bariatric arterial embolization (BAE)
  • Hydrogel capsules (e.g. Gelesis100)
  • The Transpyloric Shuttle/TransPyloric Shuttle Delivery Device (TPS)

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.

  • 43659 Unlisted laprascopy procedure, stomach
  • 43842 Gastric restrictive procedure, without gastric bypass, for morbid obesity; vertical-banded gastroplasty
  • 43843 Gastric restrictive procedure, without gastric bypass, for morbid obesity; other than vertical-banded gastroplasty
  • 43999 Unlisted procedure, stomach
  • 44799 Unlisted procedure, small intestine

 

Selected References:

  • U.S. Food and Drug Administration (FDA). Orbera Intragastric Balloon System - P140008. Rockville, MD: FDA; August 6, 2015.
  • Lim RB. Bariatric operations for management of obesity: Indications and preoperative preparation.
  • UpToDate [online serial]. Waltham, MA: UpToDate; reviewed March 2015.
  • Mechanick JI, Youdim A, Jones DB, et al; American Association of Clinical Endocrinologists, Obesity Society, American Society for Metabolic & Bariatric Surgery. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient -- 2013 update: Cosponsored by American Association of Clinical Endocrinologists, the Obesity Society, and American Society for Metabolic & Bariatric Surgery. Endocr Pract. 2013;19(2):337-372.
  • SAGES Guidelines Committee. SAGES guideline for clinical application of laparoscopic bariatric surgery. Surg Endosc. 2008;22(10):2281-2300.
  • Parikh M, Chung M, Sheth S, et al. Randomized pilot trial of bariatric surgery versus intensive medical weight management on diabetes remission in type 2 diabetic patients who do NOT meet NIH criteria for surgery and the role of soluble RAGE as a novel biomarker of success. Ann Surg. 2014;260(4):617-622; discussion 622-624.
  • Georgiadou D, Sergentanis TN, Nixon A, et al. Efficacy and safety of laparoscopic mini gastric bypass. A systematic review. Surg Obes Relat Dis. 2014;10(5):984-991.
  • Eid GM, McCloskey CA, Eagleton JK, et al. StomaphyX vs a sham procedure for revisional surgery to reduce regained weight in Roux-en-Y gastric bypass patients : A randomized clinical trial. JAMA Surg. 2014;149(4):372-379.
  • Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014;129(25 Suppl 2):S102-S138.
  • Escalona A, Pimentel F, Sharp A, et al. Weight loss and metabolic improvement in morbidly obese subjects implanted for 1 year with an endoscopic duodenal-jejunal bypass liner. Ann Surg. 2012;255(6):1080-1085.
  • Adams TD, Davidson LE, Litwin SE, et al. Health benefits of gastric bypass surgery after 6 years. JAMA. 2012;308(11):1122-1131.
  • Schauer PR, Kashyap SR, Wolski K, et al. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012;366(17):1567-1576
  • U.S. National Institutes of Health (NIH). ClinicalTrials.Gov. Transoral Gastroplasty for the Treatment of Morbid Obesity (TOGA®). NCT00661245
  • Mingrone G, Panunzi S, Gaetano A, et. al. Bariatric Surgery versus Conventional Medical Therapy for Type 2 Diabetes. N Engl J Med 2012. March: 2012: 10.1056
  • ECRI. Laparoscopic sleeve gastrectomy for obesity. [Emerging Technology evidence report]. Plymouth Meeting (PA): ECRI Institute; 2011 Feb 28.
  • FDA News Release. FDA approves AspireAssist obesity device, June 14, 2016
  • Thompson CC, et al. Abstract #381. Presented at: Digestive Disease Week; May 21-24, 2016; San Diego.
  • Sullivan S, Stein R, Jonnalagadda S., et al. Aspiration therapy leads to weight loss in obese subjects: A pilot study. Gastroenterology 2016 145(6): 1245-1252
  • Ali MR, Moustarah F, Kim JJ, et al. American Society for Metabolic and Bariatric Surgery position statement on intragastric balloon therapy endorsed by the Society of American Gastrointestinal and Endoscopic Surgeons. Surg Obes Relat Dis. Mar-Apr 2016;12(3):462-467. PMID 27056407
  • Garvey WT, Mechanick JI, Brett EM, et al. American Association of Clinical Endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Executive summary. Endocr Pract. Jul 2016;22(7):842-884. PMID 27472012
  • Vilarrasa N, de Gordejuela AG, Casajoana A, et al. Endobarrier® in grade I obese patients with long-standing type 2 diabetes: role of gastrointestinal hormones in glucose metabolism. Obes Surg. 2016 Jul 28. [Epub ahead of print]
  • Rohde U, Hedbäck N, Gluud LL, et al. Effect of the EndoBarrier Gastrointestinal Liner on obesity and type 2 diabetes: a systematic review and meta-analysis. Diabetes Obes Metab. 2016 Mar;18(3):300-5.
  • Weiss CR, Gunn AJ, Kim CY, et al. Bariatric embolization of the gastric arteries for the treatment of obesity. J Vasc Interv Radiol. 2015 May; 26(5): 613–624.
  • ourcoulas A, Abu Dayyeh BK, Eaton L, et al. Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial. Int J Obes (Lond). Jan 24 2017. PMID 28017964
  • Kang, S.H., Lee, Y., Park, Y.S. et al. OBES SURG (2017) 27: 3314. 
  • ECRI Institute. Intragastric Balloons (Obalon, Orbera, and ReShape) for Treating Obesity. Plymouth Meeting (PA): ECRI Institute; 2017 Mar 01. (Emerging Technology Report).
  • Mahawar KK, Himpens J, Shikora SA, et al. The First Consensus Statement on One Anastomosis/Mini Gastric Bypass (OAGB/MGB) Using a Modified Delphi Approach. Obes Surg. 2018;28(2):303.
  • Hemsfield, S., Aronne, L., et. al. Clinical Perspectives on obesity treatment:Challenges, gaps, and promising opportunities. National Academy of Medicine. September 10, 2018. 
  • Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm - 2017 Executive Summary. Endocr Pract. Feb 2017;23(2):207-238. PMID 28095040
  • Carbajo MA, et al. Evaluation of weight loss indicators and laparoscopic one-anastomosis gastric bypass outcomes. Sci Rep 2018 Jan 31;8(1):1961.
  • Almalki OM, Lee WJ, Chen JC, et al. Revisional Gastric Bypass for Failed Restrictive Procedures: Comparison of Single-Anastomosis (Mini-) and Roux-en-Y Gastric Bypass. Obes Surg. 2018 Apr;28(4):970-975. PMID: 29101719
  • ECRI Institute. Ingestible Intragastric Balloons (Obalon, Orbera, and ReShape) for Treating Obesity. Plymouth Meeting (PA): ECRI Institute; 2020 April 15. (Custom Rapid Responses).
  • Itani MI, Farha J, Marrache MK, Fayad L, Badurdeen D, Kumbhari V. The Effects of Bariatric Surgery and Endoscopic Bariatric Therapies on GERD: An Update [published online ahead of print, 2020 Jan 20]. Curr Treat Options Gastroenterol. 2020;10.1007/s11938-020-00278-y. doi:10.1007/s11938-020-00278-y
  • Brooks M. Five deaths tied to intragastric balloons, FDA says. Medscape Pharmacists. August 10, 2017. 
  • National Institute for Health and Care Excellence (NICE). Interventional procedure guidance 569. Singleanastomosis duodeno-ileal bypass with sleeve gastrectomy for treating morbid obesity. Nov 2016.  
  • Robert M, Espalieu P, Pelascini E, Caiazzo R, Sterkers A, Khamphommala L, Poghosyan T, Chevallier JM, Malherbe V, Chouillard E, Reche F, Torcivia A0, Maucort-Boulch D, Bin-Dorel S, Langlois-Jacques C, Delaunay D, Pattou F, Disse E. Efficacy and safety of one anastomosis gastric bypass versus Rouxen-Y gastric bypass for obesity (YOMEGA): a multicentre, randomised, open-label, non-inferiority trial. Lancet. 2019 Mar 30;393(10178):1299-1309.
  • U. S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). TransPyloric Shuttle – P180024. April 23, 2019.

 

Policy History:

  • July 2020 - Annual Review, Policy Revised
  • July 2019 - Annual Review, Policy Revised
  • July 2018 - Annual Review, Policy Revised
  • July 2017 - Annual Review, Policy Revised
  • July 2016 - Interim Review, Policy Revised
  • December 2015 - New medical policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.