Bariatric Surgery Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 06|01|2023 POLICY LAST REVIEWED: 02|05|2025 OVERVIEW
Surgery for obesity, termed bariatric surgery, is a treatment for morbid obesity in patients who fail to lose weight with conservative measures. There are numerous different surgical techniques available. These different techniques have heterogenous mechanisms of action, with varying degrees of gastric restriction that creates a small gastric pouch, malabsorption of nutrients, and metabolic changes that result from gastric and intestinal surgery.
This policy only address services that are not covered for Medicare Advantage Plans and not medically necessary for Commercial Products.
For all other services, please refer to the Prior Authorization via Web-Based Tool for Procedures policy listed in the Related Policies section below. MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION Not applicable POLICY STATEMENT Medicare Advantage Plans The bariatric surgery procedures listed below are considered not covered as the evidence is insufficient to determine the effects of the technology on health outcomes:  Open adjustable gastric banding  Open sleeve gastrectomy  Open and laparoscopic vertical banding gastroplasty  Gastric balloon for treatment of obesity  Intestinal bypass Note: Blue Cross & Blue Shield of Rhode Island (BCBSRI) must follow Centers for Medicare and Medicaid Services (CMS) guidelines, such as national coverage determinations or local coverage determinations for all Medicare Advantage Plans policies. Therefore, Medicare Advantage Plans policies may differ from Commercial products. In some instances, benefits for Medicare Advantage Plans may be greater than what is allowed by CMS. Commercial Products The bariatric surgery procedures listed below are considered not medically necessary for the treatment of morbid obesity in adults who have failed weight loss by conservative measures as the evidence is insufficient to determine the effects of the technology on health outcomes:  Vertical-banded gastroplasty  Gastric bypass using a Billroth II type of anastomosis (mini-gastric bypass)  Biliopancreatic bypass without duodenal switch  Long-limb gastric bypass procedure (i.e., >150 cm)  Two-stage bariatric surgery procedures (e.g., sleeve gastrectomy as initial procedure followed by biliopancreatic diversion at a later time) Medical Coverage Policy | Bariatric Surgery

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 Laparoscopic gastric plication  Single anastomosis duodeno-ileal bypass with sleeve gastrectomy

The following endoscopic procedures are not medically necessary as a primary bariatric procedure or as a revision procedure (i.e., to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches), as the evidence is insufficient to determine the effects of the technology on health outcomes:  Insertion of the StomaphyX™ device  Endoscopic gastroplasty  Use of an endoscopically placed duodenojejunal sleeve  Intragastric balloons  Aspiration therapy device  Esophagogastroduodenoscopy - flexible, transoral, with volume adjustment of intragastric bariatric balloon

COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable surgery benefits/coverage or for applicable not medically necessary/not covered benefits/coverage.

BACKGROUND Bariatric surgery is performed to treat obesity and obesity-related comorbid conditions. The first treatment of class III obesity is dietary and lifestyle changes. Although this strategy may be effective in some patients, only a few individuals with class III obesity 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.

Intragastric balloon is unproven as a treatment for obesity. Further studies are needed to determine the safety and efficacy of intragastric balloon as a treatment option for obesity. Adverse effects associated with the intragastric balloon include gastric erosion, reflux, and obstruction (Fernandes, 2007). Currently, the available evidence in the published, peer-reviewed scientific literature is insufficient to establish the safety and efficacy of this procedure.

Vertical-banded gastroplasty was formerly one of the most common gastric restrictive procedures performed in the United States but has now been essentially replaced by other restrictive procedures due to high rates of revisions and reoperations. In this procedure, the stomach is segmented along its vertical axis. To create a durable reinforced and rate-limiting stoma at the distal end of the pouch, a plug of stomach is removed, and a propylene collar is placed through this hole and then stapled to itself. Because the normal flow of food is preserved, metabolic complications are uncommon. Complications include esophageal reflux, dilation, or obstruction of the stoma, with the latter two requiring reoperation. Dilation of the stoma is a common reason for weight regain. Vertical-banded gastroplasty may be performed using an open or laparoscopic approach.

Gastric Bypass Using a Billroth II Type of Anastomosis (mini-gastric bypass):
Recently, a variant of the gastric bypass, called the mini-gastric bypass, has been popularized. 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, similar to a Billroth II procedure. This unique aspect of this procedure is not based on its laparoscopic approach but rather the type of anastomosis used. It should also be noted that CPT code 43846 explicitly describes a Roux-en-Y gastroenterostomy, which is not used in the mini-gastric bypass.

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Biliopancreatic Bypass (BPB) Without Duodenal Switch (CPT code 43847- gastric restrictive procedure, with gastric bypass for morbid obesity; with small intestine reconstruction to limit absorption): Biliopancreatic bypass procedure (also known as the Scopinaro procedure) was developed and used extensively in Italy. It was designed to address some of the drawbacks of the original intestinal bypass procedures that have been abandoned due to unacceptable metabolic complications. Many of the complications were thought to be related to bacterial overgrowth and toxin production in the blind, bypassed segment. In contrast, BPB consists of a subtotal gastrectomy and diversion of the biliopancreatic juices into the distal ileum by a long Roux-en-Y procedure. The procedure consists of the following components:  A distal gastrectomy induces a temporary early satiety and/or the dumping syndrome in the ear1y postoperative period, both of which limit food intake.  A 200-cm long “alimentary tract” consists of 200 cm of ileum connecting the stomach to a common distal segment.  A 300- to 400-cm “biliary tract” connects the duodenum, jejunum, and remaining ileum to the common distal segment.  A 50- to 100-cm “common tract” is where food from the alimentary tract mixes with biliopancreatic juices from the biliary tract. Food digestion and absorption, particularly of fats and starches, are therefore limited to this small segment of bowel, i.e., creating a selective malabsorption. The length of the common segment will influence the degree of malabsorption. Because of the high incidence of cholelithiasis associated with the procedure, patients typically undergo an associated cholecystectomy.

Many potential metabolic complications are related to biliopancreatic bypass, including most prominently, iron deficiency anemia, protein malnutrition, hypocalcemia, and bone demineralization. Protein malnutrition may require treatment with total parenteral nutrition. In addition, there have been several case reports of liver failure resulting in death or liver transplant.

Single Anastomosis Duodenoileal Bypass with Sleeve Gastrectomy (SADI-S) (no specific CPT code): No controlled trials of single anastomosis duodenoileal bypass with SG, (SADI-S), were identified. Some case series have been published that report on weight loss and other clinical outcomes up to 5 years post-surgery. One of the larger series was published in 2015 and reported on 97 patients with obesity and type 2 diabetes mellitus (DM). The authors reported that control of DM, defined as HgA1c <6.0%, was achieved in between 70% and 84% of patients at the different time points. Remission rates were higher for patients on oral therapy than those on insulin, and were higher in patients with a shorter duration of DM.

Long-Limb Gastric Bypass (le, >150 cm) (Gastric restrictive procedure with gastric bypass for morbid obesity; with small intestine reconstruction to limit absorption): Recently, variations of gastric bypass procedures have been described, consisting primarily of long-limb Roux-en-Y procedures, which vary in the length of the alimentary and common limbs. For example, the stomach may be divided with a long segment of the jejunum (instead of ileum) anastomosed to the proximal gastric stump, creating the alimentary limb. The remaining pancreaticobiliary limb, consisting of stomach remnant, duodenum, and length of proximal jejunum, is then anastomosed to the ileum, creating a common limb of variable length in which the ingested food mixes with the pancreaticobiliary juices.

While the long alimentary limb permits absorption of most nutrients, the short common limb primarily limits absorption of fats. The stomach may be bypassed in a variety of ways, i.e., either by resection or stapling along the horizontal or vertical axis. Unlike the traditional gastric bypass, which is essentially a gastric restrictive procedure, these very long-limb Roux-en-Y gastric bypasses combine gastric restriction with some element of malabsorptive procedure, depending on the location of the anastomoses. Note that CPT code for gastric bypass (43846) explicitly describes a short limb (<150 cm Roux-en-Y gastroenterostomy, and thus would not apply to long-limb gastric bypass.

Two-Stage Procedure:

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The evidence on the comparative efficacy of different bariatric surgery approaches consists largely of low- quality evidence, with a lack of long-term, high-quality randomized controlled trials (RCTs). Compared with gastric bypass, the evidence is sufficient to conclude that laparoscopic adjustable gastric banding is associated with lower short-term complications and lower medium- to long-term weight loss. The evidence is also sufficient to conclude that sleeve gastrectomy has similar or lower short-term complications, with medium- to long-term weight loss that is somewhat less than for gastric bypass. The evidence on other types of bariatric surgery procedures is insufficient to form conclusions on the impact on health outcomes. For biliopancreatic bypass, the weight loss is similar or greater than gastric bypass but the complications rates, especially for nutritional complications, may also be higher. The evidence base for other types of procedures is insufficient to form conclusions.

Laparoscopic Gastric Plication (no specific CPT code): Laparoscopic gastric plication is a bariatric surgery procedure that involves laparoscopic placement of sutures over the greater curvature (laparoscopic greater curvature plication) or anterior gastric region (laparoscopic anterior curvature plication) to create a tube-like stomach. The procedure involves two main steps, mobilization of the greater curvature of the stomach and suture plication of the stomach for achieving gastric restriction, but specifics of the technique are not standardized.

Endoscopic Procedures: Endoscopic procedures (e.g., insertion of the StomaphyX™ device) as a primary bariatric procedure or as a revision procedure (i.e., to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches): Some of these procedures use devices that are also being evaluated for endoscopic treatment of gastroesophageal reflux (GERD) (policy No. 2.01.38). The published data concerning use of these devices for treatment of regained weight is quite limited. Published case series have reported results using a number of different devices and procedures (including sclerosing injections) as treatment for this condition. The largest series found involved 28 patients treated with a sclerosing agent (sodium morrhuate). Reported trials that used one of the suturing devices had fewer than 10 patients. For example, Herron et al. reported on a feasibility study in animals. Thompson et al. reported on a pilot study with changes in anastomotic diameter and weight loss in 8 patients who had weight regain and dilated gastrojejunal anastomoses after RYGB. No comparative trials were identified; comparative trials are important because of the known association between an intervention and short-term weight loss. The StomaphyX™ device, which has been used in this approach, was cleared by the U.S. Food and Drug Administration (FDA) through the 510(k) process. It was determined be equivalent to the EndoCinch™ system, which has 510(k) marketing clearance for endoscopic suturing for gastrointestinal tract surgery. In summary, the published scientific literature on use of these devices in patients who regain weight after bariatric surgery is very limited. No comparative studies were identified. These endoscopic procedures are considered investigational.

Esophagogastroduodenoscopy with Bariatric Surgery For Individuals with obesity undergoing bariatric surgery who receive esophagogastroduodenoscopy (EGD), the evidence includes systematic reviews of observational studies. Relevant outcomes are OS, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Current research has focused on pre-operative utility of EGD. The evidence evaluating the scope of EGD in both intraoperative and postoperative settings is lacking in comparison. Systematic reviews have found that only one-fifth of patients had findings from EGD that either altered their operative management or postponed their bariatric surgery. There is a need for direct comparative homogenous studies assessing whether EGD should be routine before bariatric surgery, and whether it is judicious to expose many patients to an invasive procedure that has potential risk and insufficient evidence of effectiveness. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Bariatric Surgery in Patients with a BMI less than 35 KG/M2:
Limited evidence is available on bariatric surgery in patients with a BMI of less than 35 kg/m2. Case series report a high rate of remission of diabetes in undergoing gastric bypass surgery, and this indication was judged to meet the TEC criteria in 2012. However, bariatric surgery for diabetes in patients with a BMI less than 35 is not currently considered standard of care and is not supported in current specialty society

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guidelines. For patients without diabetes, there is limited evidence on outcomes of surgery and no evidence that health outcomes are improved. As a result, bariatric surgery for patients with a BMI less than 35 is investigational.

The evidence on other types of bariatric surgery procedures is insufficient to form conclusions on the impact on health outcomes. For biliopancreatic bypass, the weight loss is similar or greater than gastric bypass but the complications rates, especially for nutritional complications, may also be higher. The evidence base for other types of procedures is insufficient to form conclusions.

For individuals who are preadolescent children with morbid obesity and receive bariatric surgery, the evidence includes no studies focused on this population. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment related mortality and morbidity. Several studies of bariatric surgery in adolescents also included some children younger than 12 years old, but findings were not reported separately for preadolescent children. Moreover, clinical practice guidelines have recommended that bariatric surgery not be performed in preadolescent children. The evidence is insufficient to determine the effects of the technology on health outcomes.

CODING Medicare Advantage Plans and Commercial Products The following CPT code(s) are not covered for Medicare Advantage Plans and not medically necessary for Commercial Products: 43290 Esophagogastroduodenoscopy, flexible, transoral; with deployment of intragastric bariatric balloon
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 0813T Esophagogastroduodenoscopy, flexible, transoral, with volume adjustment of intragastric
bariatric balloon (New code 1/01/2024)

There are no specific CPT code(s) for the not covered/not medically necessary indications listed in this policy. Claims should be filed using the unlisted CPT code(s):
43659 Unlisted laparoscopy procedure, stomach 43999 Unlisted procedure, stomach

The following HCPCS code(s) is not separately reimbursed: S2083 Adjustment of gastric band diameter via subcutaneous port by injection or aspiration of saline

RELATED POLICIES Non-Reimbursable Health Service Codes Prior Authorization via Web-Based Tool for Procedures Unlisted Procedures

PUBLISHED Provider Update, April 2025 Provider Update, June 2024 Provider Update, April 2023 Provider Update, May 2022 Provider Update, June 2021

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60. Salminen P, Helmiö M, Ovaska J, et al. Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss at 5 Years Among Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial. JAMA. Jan 16 2018; 319(3): 241-254. PMID 29340676
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79. Blue Cross Blue Shield Association Technology Evaluation Center (TEC). TEC Special Report: The relationship between weight loss and changes in morbidity following bariatric surgery for morbid obesity. TEC Assessments. 2003;Vol 18:Tab 18. Nov 5, 2024.
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97. Thompson CC, Abu Dayyeh BK, Kushner R, et al. Percutaneous Gastrostomy Device for the Treatment of Class II and Class III Obesity: Results of a Randomized Controlled Trial. Am J Gastroenterol. Mar 2017; 112(3): 447-457. PMID 27922026
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