BlueCross and BlueShield of Montana Medical Policy/Codes
Bariatric Surgery
Chapter: Surgery: Procedures
Current Effective Date: November 26, 2013
Original Effective Date: November 01, 2001
Publish Date: August 26, 2013
Revised Dates: June 21, 2012; November 06, 2012; August 15, 2013
Description

Surgery for morbid obesity, termed bariatric surgery, falls into two general categories: 1) gastric-restrictive procedures that create a small gastric pouch, resulting in weight loss by producing early satiety and thus decreasing dietary intake; and 2) malabsorptive procedures, which produce weight loss due to malabsorption by altering the normal transit of ingested food through the intestinal tract.  Some bariatric procedures may include both a restrictive and a malabsorptive component.

Bariatric surgery is performed for the treatment of 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 hypertension, dyslipidemia, diabetes, coronary artery disease, obstructive sleep apnea or osteoarthritis.  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, rectum, and prostate; for women: breast, uterus, and ovaries), and a shortened life span. A morbidly obese man at age 20 can expect to live 13 years less than his counterpart with a normal BMI, which equates to a 22% reduction in life expectancy.

MEDICAL MANAGEMENT OF MORBID OBESITY

The Society of Gastrointestinal and Endoscopic Surgeons (SAGES) states the treatment of morbid obesity should be dietary, exercise, and behavior modification with possible prescription medications under the management of a physician.  Although this strategy may be effective in some patients, frequently the weight loss is not durable with only 5% to 10% of patients maintaining the weight loss for more than a few years.  When conservative measures fail, some patients may consider surgical approaches.  The1998 National Institutes of Health (NIH) Clinical Guidelines and the 1991 NIH Consensus Conference identified surgery as an option in those patients with a BMI of greater than 40 kg/m2, or greater than 35 kg/m2 in conjunction with severe comorbidities related to obesity such as cardiopulmonary complications or severe diabetes.  Super obesity has been described as a BMI greater than 50 kg/m2.

SURGICAL MANAGEMENT FOR MORBID OBESITY

The following summarizes different restrictive and malabsorptive procedures:

GASTRIC RESTRICTIVE PROCEDURES

1.  Vertical-Banded Gastroplasty (VBG) 

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 then 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 rare.  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.

2.  Adjustable Gastric Banding (AGB) or (LAGB®)

Adjustable gastric banding involves placing a gastric band around the exterior of the stomach. The band is attached to a reservoir that is implanted subcutaneously in the rectus sheath.  Injecting the reservoir with saline will alter the diameter of the inner lining of the gastric band and the stoma in the stomach can be progressively narrowed to induce greater weight loss, or expanded if complications develop.  Because the stomach is not entered, the surgery and any revisions (if necessary) are relatively simple.  There is absence of a major incision. Complications have included port displacement (7%), pouch dilatation (<1%), gastric prolapse (2%), or band erosion (<1%) through the gastric wall.   These procedures are performed laparoscopically or open.   Although adjustable gastric banding has been widely used in Europe, there are currently two devices approved by the U.S. Food and Drug Administration (FDA) for marketing in the United States: the LAP-BAND® (LAGB®) approved in 2001 and the REALIZE™ device approved in 2007.  

3.  Open Gastric Bypass with Roux-en-Y short-limb (<150cm) (GBY or RYGB)

The original gastric bypass surgeries were based on the observation that post-gastrectomy patients tended to lose weight.  The current procedure involves a horizontal or vertical partition of the stomach in association with a Roux-en-Y procedure (i.e., a gastrojejunal anastomosis).  The flow of food bypasses the duodenum and proximal small bowel.  The procedure may also be associated with an unpleasant dumping syndrome in which a large osmotic load delivered directly to the jejunum from the stomach produces abdominal pain and/or vomiting.  The dumping syndrome may further reduce intake, particularly in sweets eaters.  Operative complications include leakage and marginal ulceration at the anastomotic site.  Because the normal flow of food is disrupted there are more metabolic complications compared to other gastric restrictive procedures.  These complications include iron deficiency anemia, vitamin B-12 deficiency, and hypocalcemia (all of which can be corrected by oral supplementation).  Another concern is the ability to evaluate the blind bypassed portion of the stomach.

4.  Laparoscopic Gastric Bypass (LAGB)

Introduced in 2005, LAGB is the laparoscopic version of the open gastric bypass described above.

5.  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).  The type of anastomosis used makes this procedure unique. 

6.  Sleeve Gastrectomy (SG)

A ‘sleeve’ gastrectomy is an alternative approach to gastrectomy that can be performed on its own, or in combination with malabsorptive procedures (most commonly biliopancreatic diversion with duodenal switch).  In this procedure, the greater curvature of the stomach is resected from the angle of His to the distal antrum, resulting in a stomach remnant shaped like a tube or ‘sleeve’.  The pyloric sphincter is preserved, resulting in a more physiologic transit of food from the stomach to the duodenum, and avoiding the ‘dumping syndrome’ (overly rapid transport of food through stomach into intestines) that is seen with distal gastrectomy.  The sleeve gastrectomy procedure is relatively simple to perform, and can be done by the open or laparoscopic technique. Some surgeons have proposed this as the first in a two-stage procedure for very high-risk patients.  Weight loss following sleeve gastrectomy may improve a patient’s overall medical status, and thus reduce the risk of a subsequent more extensive malabsorptive procedure, such as biliopancreatic diversion.

7.  Endoluminal (also called endosurgical, endoscopic, or natural orifice) bariatric procedures

With these procedures access to the relevant anatomical structures is gained through the mouth without skin incisions.  Primary and revision bariatric procedures are being developed to reduce the risks associated with open and laparoscopic interventions.  Examples of endoluminal bariatric procedures studies include gastroplasty using a transoral endoscopically guided stapler and placement of devices such as a duodenal-jejunal sleeve and gastric balloon.

MALABSORPTIVE PROCEDURES

The multiple variants of malabsorptive procedures differ in the lengths of the alimentary limb, the biliopancreatic limb, and the common limb, in which the alimentary and biliopancreatic limbs are anastomosed.  These procedures also may include an element of a restrictive surgery based on the size of the stomach pouch.  The degree of malabsorption is related to the length of the alimentary and common limbs.  For example, a shorter alimentary limb (i.e., the greater the amount of intestine that is excluded from the nutrient flow) will be associated with malabsorption of a variety of nutrients, while a short common limb (i.e., the biliopancreatic juices are allowed to mix with nutrients for only a short segment) will primarily limit absorption of fat.

1.  Biliopancreatic Bypass Diversion Procedure (also known as the Scopinaro procedure) (BPD)

The biliopancreatic bypass procedure, developed and used extensively in Italy, 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, BPD 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 functions to induce a temporary early satiety and/or the dumping syndrome in the early 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 300-400 cm biliary tract, which connects the duodenum, jejunum, and remaining ileum to the common distal segment.
  • A 50-100 cm common tract 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.

There are many potential metabolic complications 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 liver transplant or death.

2.  Biliopancreatic Bypass Diversion with Duodenal Switch (BPD/DS)

The duodenal switch procedure is essentially a variant of the biliopancreatic bypass described above.  However, instead of performing a distal gastrectomy, a sleeve gastrectomy is performed along the vertical axis of the stomach preserving the pylorus and initial segment of the duodenum.  This is then anastomosed to a segment of the ileum to create the alimentary segment.  Preservation of the pyloric sphincter is designed to be more physiologic.  The sleeve gastrectomy decreases the volume of the stomach and decreases the parietal cell mass with the intent of decreasing the incidence of ulcers at the duodeno-ileal anastomosis.  However, the basic principle of the procedure is similar to that of the biliopancreatic bypass, i.e., producing selective malabsorption by limiting the food digestion and absorption to a short common ileal segment.

3. Gastric Bypass with Long-Limb (i.e., > 150cm)

Recently variations of gastric bypass procedures have been described that consist primarily of long limb Roux-en-Y procedures.  For example, the stomach may be divided with a long segment of the jejunum (instead of ileum) anastomosed to the proximal gastric stump to create 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.  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 (essentially a gastric restrictive procedure), these very long limb Roux-en-Y gastric bypasses function as a malabsorptive procedure, more similar in concept to the biliopancreatic bypass.  The long limb gastric bypass is designed to reduce the incidence of metabolic complications but the potential complications are similar to those of the biliopancreatic bypass. 

4.  Laparoscopic Malabsorptive Procedure

This describes any of the malabsorptive/restrictive procedures done by laparoscopy.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions.  Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage

NOTE:   Check member’s contract for benefit coverage for bariatric surgery. 

PATIENT SELECTION CRITERIA FOR COVERAGE

For a member to be considered eligible for benefit coverage of bariatric surgery to treat morbid obesity, the member must meet the following two criteria:

1.  Diagnosis of morbid obesity, defined as a:

  • Body mass index (BMI) equal to or greater than 40 kg/meter² (* see guidelines below for  BMI calculation); OR
  • BMI equal to or greater than 35kg/meters² with at least two (2) of  the following comorbid conditions related to obesity that have not responded to maximum medical management and that are generally expected to be reversed or improved by bariatric treatment:
    • Hypertension, OR
    • Dyslipidemia, OR
    • Diabetes mellitus, OR
    • Coronary heart disease, OR
    • Sleep apnea, OR
    • Osteoarthritis; AND

2.  Documentation from the requesting surgical program that:

  • Growth is completed (generally, growth is considered completed by 18 years of age); AND
  • Documentation from the surgeon attesting that the patient has been educated in and understands the post-operative regimen, which should include ALL of the following components:
  1. Nutrition program, which may include a very low calorie diet or a recognized commercial diet-based weight loss program; AND
  2. Behavior modification or behavioral health interventions; AND
  3. Counseling and instruction on exercise and increased physical activity; AND
  4. Ongoing support for lifestyle changes to make and maintain appropriate choices that will reduce health risk factors and improve overall health; AND
  • Patient has completed an evaluation by a licensed professional counselor, psychologist or psychiatrist within the 12 months preceding the request for surgery.  This evaluation should document:
  1. The absence of significant psychopathology that would hinder the ability of an individual to understand the procedure and comply with medical/surgical recommendations, AND
  2. The absence of any psychological comorbidity that could contribute to weight mismanagement or a diagnosed eating disorder, AND
  3. The patient’s willingness to comply with preoperative and postoperative treatment plans.

Contraindications for surgical treatment of obesity include:

  • Patients with mental handicaps that render a patient unable to understand the rules of eating and exercise and therefore make them unable to participate effectively in the post-operative treatment program (e.g., a patient with malignant hyperphagia [Prader-Willi syndrome], which combines mental retardation with an uncontrollable desire for food).
  • Patients with portal hypertension, an excessive hazard with laparoscopic gastric surgery.
  • Women who are pregnant or lactating.
  • Patients with serious medical illness in whom caloric restriction could exacerbate the illness.

* Guidelines on how to calculate BMI:

Body Mass Index (BMI) can be calculated using pounds and inches with this equation:

BMI = [Weight (lbs) ÷ Height (in2)] x 703

Body Mass Index can also be calculated using kilograms and meters:

BMI = Weight (Kg) ÷ Height (m2)

To convert pounds to kilograms, multiply pounds by 0.45.

To convert inches to centimeters, multiply inches by 2.54.

To convert feet to meters multiple feet by 0.30.

COVERAGE STATEMENTS FOR SPECIFIC BARIATRIC SURGICAL PROCEDURES (Gastric Restrictive and Gastric Malabsorptive)

NOTE: For a member to be eligible for benefit coverage of any one of these procedures the member must meet the Patient Selection Criteria described above AND the member’s contract or certificate of coverage must allow coverage of bariatric surgery.

  • Gastric bypass using a Roux-en-Y anastomosis (up to and including 150cm) may be considered medically necessary as an open or laparoscopic surgical treatment option for morbid obesity that has not responded to the required conservative measures. 

NOTE:  This policy does not address Roux-en-Y gastric bypass performed primarily for the treatment of gastric reflux even though this condition may improve following a Roux-en-Y performed for the treatment of morbid obesity.

  • Adjustable gastric banding (open or laparoscopic), consisting of an external adjustable band placed high around the stomach creating a small pouch and a small stoma, may be considered medically necessary as a surgical treatment option for patients with morbid obesity who meet the eligibility criteria for surgery, including lack of response to the required conservative measures. 

NOTE:  If the original adjustable gastric banding procedure was a covered benefit, it is not necessary to request documentation for refill and maintenance procedures.

  • Sleeve gastrectomy (open or laparoscopic) may be considered medically necessary as a surgical treatment option for patients with morbid obesity who meet the eligibility criteria for surgery, including lack of response to the required conservative measures.
  • Biliopancreatic bypass (Scopinaro procedure) WITH duodenal switch (open or laparoscopic) may be considered medically necessary as a surgical treatment option for morbidly obese patients with BMI of 50 kg/m² or greater who meet the other eligibility criteria for surgery, including lack of response to the required conservative measures.

The following procedures are considered not medically necessary as a treatment of morbid obesity:

  • Vertical banded gastroplasty is no longer a standard of care.
  • Biliopancreatic bypass with duodenal switch is considered not medically necessary as a treatment for patients with a BMI less than 50kg/m².

The following procedures are considered experimental, investigational and unproven as a treatment of morbid obesity:

  • Biliopancreatic bypass without duodenal switch,
  • Long limb gastric bypass procedures (e.g., >150cm),
  • Gastric bypass using a Billroth II type of anastomosis, popularized as the “mini gastric bypass.”
  • Endoluminal procedures including but not limited to:
    • Natural Orifice Transluminal Endoscopic Surgery (NOTES™); and/or
    • Transoral gastroplasty (TOGA).

The following procedures are considered experimental, investigational and unproven to treat weight gain after bariatric surgery:

  • Endoscopic procedures (e.g., insertion of the StomaphyX™ device) including but not limited to sclerotherapy of the stoma, or
  • Transoral ROSE procedure (Restorative Obesity Surgery).

MISCELLANEOUS PROCEDURE COVERAGE STATEMENTS

  • Bariatric surgery in treatment of Type-2 diabetes mellitus:  Bariatric surgery is considered experimental, investigational and unproven as a cure for type-2 diabetes mellitus.
  • Repeat/Revision of bariatric surgery:  may be considered medically necessary (when specifically included as a benefit or covered service in the member’s benefit plan, summary plan description or contract) only when ALL of the following criteria are met:
    • Original surgery was considered a covered benefit of the member’s current plan, AND the repeat/revision of bariatric surgery is a covered benefit of the member’s current plan; AND
    • For the original procedure, patient met all the screening criteria, including BMI requirements, AND
    • The patient has been compliant with a prescribed nutrition and exercise program following the original surgery, AND
    • Significant complications or technical failure (e.g., break down of gastric pouch, slippage, breakage or erosion of gastric band, bowel obstruction, staple line failure, etc.) of the bariatric surgery has occurred that requires take down or revision of the original procedure that could only be addressed surgically, AND
    • Patient is requesting reinstitution of an acceptable bariatric surgical modality.
  • New bariatric surgery following a previous different bariatric procedure:  A Roux-en-Y procedure following a previously approved vertical banded gastroplasty or laparoscopic adjustable banded gastroplasty is not eligible for coverage for patients who have been substantially noncompliant with a prescribed nutrition and exercise program following the original procedure.
  • Incidental procedures during a bariatric surgery:  Coverage is allowed for gallbladder removal at the time of a covered gastric bypass surgical procedure, either for documented gallbladder disease or for prophylaxis.

Rationale

The 1998 National Institutes of Health (NIH) Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults state, “Weight loss surgery is one option for weight reduction in a limited number of patients with clinically severe obesity, i.e., BMI >40 or >35 with comorbid conditions…  Surgery should be reserved for patients in whom efforts at medical therapy have failed and who are suffering from the complications of extreme obesity.”

Medical Treatment

The NIH Guidelines give recommendations for weight loss at the rate of 1 to 2 lb. per week, which occurs up to six months.  After six months, weight loss declines and then weight plateaus. Patients should participate in a medically supervised nutrition and exercise program and/or comprehensive multidisciplinary preoperative preparatory regimen, which should include:  a diet with lower calories and low fat with increased physical activities, behavioral therapy, possible pharmacotherapy, discussion on smoking cessation, and progress should be documented in the medical record.  The goal of medical therapy is a 10% reduction in weight from baseline, and the reasonable duration is six months. 

Bariatric Surgery

Outcomes of bariatric surgeries are notoriously difficult to evaluate in part due to the constantly evolving nature of the surgery.  Small modifications are commonly made to decrease the incidence of postoperative and long-term complications.  In addition, few controlled studies have directly measured the weight loss and complications associated with the different surgical approaches, especially comparing gastric restrictive procedures with malabsorptive procedures.  Case series from individual institutions or individual surgeons with varying lengths of follow-up dominate the literature.  The outcomes for specific surgeries may differ widely among institutions or surgeons, perhaps due to small variations in surgical technique, intensity of follow-up, or patient selection criteria.  However, during the 1970s and 1980s both vertical banded gastroplasty (VBG) and gastric bypass became widely accepted types of bariatric surgery. These two procedures were the focus of the 1991 NIH Consensus Development Conference on Gastrointestinal Surgery for Severe Obesity, which also noted that limited data were available regarding biliopancreatic bypass. 

A 2003 Blue Cross Blue Shield Association (BCBSA) Technology (TEC) Assessment  summarized studies comparing open gastric bypass and vertical-banded gastroplasty.  These comparisons demonstrated that open gastric bypass resulted in a greater amount of weight loss than vertical-banded gastroplasty, with no definite differences in complication rates.  Therefore, gastric bypass is considered the gold standard for the purpose of this discussion, and this is supported by the increasing acceptance of gastric bypass by the surgical community, representing greater than 80% of all bariatric surgery procedures performed in 2002.  Therefore, the results of open gastric bypass will be compared to the newer procedures not addressed by the 1991 NIH conference; i.e., gastric banding and biliopancreatic bypass with or without duodenal switch.  The following outcomes are considered relevant for bariatric surgery:

Relevant Outcomes to Consider for Bariatric Surgery:

1.  Weight loss

There is no uniform standard for reporting results of weight loss and no uniform standard for describing a successful procedure.  Weight loss is an intermediate outcome and the objective of all weight management tactics is to improve the health status of the obese individual.  Common methods of reporting the amount of weight loss are percent of ideal body weight achieved or percent of excess body weight (EBW), with the latter most commonly reported.  These two methods are generally preferred over the absolute amount of weight loss since they reflect the ultimate goal of surgery; to reduce weight into a range that minimizes obesity-related morbidity.  Obviously, an increasing degree of obesity will require a greater amount of weight loss to achieve these target goals.  There are different definitions of successful outcomes, but a successful procedure is often considered one in which at least 50% of EBW, or when the patient returns to within 30% of ideal body weight.

2.  Durability of weight loss

Weight change (i.e., gain or loss) at yearly intervals is often reported.  Weight loss at one year is considered the minimum length of time for evaluating these procedures; weight loss at 3–5 years is considered an intermediate time period for evaluating weight loss; and weight loss at 5–10 years or more is considered to represent long-term weight loss following bariatric surgery.

3.  Short-term complications - Operative and perioperative complications that occur within 30 days

There is an increased incidence of operative and peri-operative complications in obese patients in general, particularly the incidence of thromboembolism, wound healing, anastomotic leaks, bleeding, obstruction, and cardiopulmonary complications such as pneumonia or myocardial infarction.

4.  Reoperation Rate

Reoperation may be required to either “take down” or revise the original procedure.  Reoperation may be particularly common in vertical banded gastroplasty due to pouch dilation.

5.  Long-term complications 

Metabolic side effects are of particular concern in malabsorptive procedures.  Other long-term complications include anastomotic ulcers, esophagitis, and procedure-specific complications such as band erosion or migration for gastric banding operations.

6.  Improved health outcomes in terms of weight-related comorbidities

Aside from psychosocial concerns, which may be considerable, one of the motivations for bariatric surgery is to decrease the incidence of complications of obesity, such as:

  • Diabetes; or
  • Cardiovascular risk factors (e.g., increased cholesterol, hypertension, etc.); or
  • Obstructive sleep apnea; or 
  • Arthritis.

Unfortunately, these final health outcomes are not consistently reported.

SUMMARY OF LITERATURE ON BARIATRIC SURGERY

The following discussion provides a representative summary of the literature on bariatric surgery, focusing on malabsorptive procedures compared to gastric restrictive procedures.

Vertical Banded Gastroplasty (VBG)

Numerous clinical series report substantial amounts of weight loss following vertical-banded gastroplasty.  In 1990, MacLean and colleagues reported on 201 patients who underwent vertical banded gastroplasty who were followed for a minimum of two years.  Staple line perforation occurred in 48% of patients and 36% underwent reoperation either to repair the perforation or to repair a stenosis at the rate-limiting orifice.  However, more than 50% of patients who maintained an intact staple line had durable weight loss of 75% to 100% of excess weight.

Staple line perforation occurred in 48% of patients, and 36% underwent reoperation either to repair the perforation or to repair a stenosis at the rate-limiting orifice. 

In another case series in 1987 by Wilbanks et al. of 305 patients undergoing vertical-banded gastroplasty, there was a mean weight loss of 60% of excess weight at 2-year follow-up.  In contrast to MacLean’s report, there was only a 1.3% incidence of staple line disruption. Significant decreases in cardiovascular risk factors and incidence of diabetes and sleep apnea were also reported in this trial and other case series by Brolin, Kolanowski, and Melissas et al.  For example, Melissas and colleagues evaluated obesity’s comorbid conditions in 62 patients who had undergone a vertical-banded gastroplasty.  All patients were followed up for 12 to 48 months, with 84% of patients losing at least 50% of their excess weight.  Of the 218 weight-related pathologic conditions existing before the operation, 83% were either cured or improved.

A smaller body of literature compares outcomes between vertical-banded gastroplasty and open gastric bypass.  The most rigorous of these comparative trials, the Adelaide Study in 1990, randomized 310 morbidly obese patients to gastric bypass, vertical-banded gastroplasty, or horizontal gastroplasty.  The percent of patients with greater than 50% EWL at three years’ follow-up was 67% for gastric bypass, 48% for vertical-banded gastroplasty, and 17% for horizontal gastroplasty (p<0.001).  There were no demonstrable differences in adverse events among groups.  A second, smaller randomized controlled trial (RCT) in 1987 by Sugerman and colleagues randomized 40 patients to receive either a vertical-banded gastroplasty or a gastric bypass procedure.  After nine months, the gastric bypass patients had significantly greater weight loss that persisted at three-year follow-up.  The gastric bypass patients lost approximately 64% of excess weight, whereas the gastroplasty patients lost only 37% of excess weight.

A number of other nonrandomized, comparative studies of open gastric bypass versus vertical-banded gastroplasty were included in the 2003 TEC Assessment (n=8 studies, 3,470 patients). All eight of these studies reported greater amounts of weight loss with open gastric bypass.  These studies reported a 44%–70% improvement in total weight loss, a 28%–43% improvement in the percent excess weight loss, and 19%–36% more patients with >50% excess weight loss for patients undergoing gastric bypass compared with vertical-banded gastroplasty.  Comparison of adverse events was more difficult, as the data in these studies did not allow rigorous comparison of adverse events.  Nevertheless, the data suggested that the mortality rate for both operations was low overall.  Serious perioperative adverse events were also infrequently reported, but were possibly somewhat higher for gastric bypass.  Long-term adverse events were inconsistently reported, although it appeared that revision rates were higher for vertical-banded gastroplasty.

Adjustable Gastric Banding (AGB)

Adjustable gastric banding (using an external adjustable band placed around the stomach) has been used extensively in Europe and one such device, the Lap-Band, received approval in 2001 from the U.S. Food and Drug Administration (FDA) in this country.  The procedure is designed to mimic the vertical banded gastroplasty, but is an easier, reversible, and more flexible surgery.  Similar to all gastric surgeries, the literature is dominated by large case series from individual surgeons who report varying results.

The data presented as part of the FDA-approval process for the Lap-Band is summarized in their package insert, and represents one of the most rigorously performed clinical series of this procedure in the United States.  In a group of 299 patients, the mean excess weight loss was 36.2% at 3 years.  This figure contrasts with a 40%–60% excess weight loss reported in other series of VBG and 50% for gastric bypass.  One of the challenges of VBG is dilation of the pouch, which may prompt surgical revision.  The Lap-Band procedure is intended to address this complication, as any pouch dilation can be altered by adjustment of the inflatable band.  The incidence of adjustment of the band or how this maneuver affected weight loss is not provided in the package insert.  For example, although a 24% incidence of band slippage or pouch dilation was reported, it was not reported whether this complication was resolved with adjustment of the gastric band.  There was a 9% incidence of surgical revision procedures and an additional 24% of patients had their entire Lap-Band systems explanted, most commonly due to band slippage or pouch dilation, but also due to erosion, infection, or gastrointestinal disorders.

The 2006 Blue Cross Blue Shield Association (BCBSA) Technical Evaluation Center (TEC) Assessment updated the evidence on laparoscopic adjustable gastric banding (LAGB), and compared outcomes to those of gastric bypass.  This Assessment concluded that for patients considering bariatric surgery, there is sufficient evidence to allow an informed choice to be made between gastric bypass and LAGB.  An informed patient may reasonably choose either open gastric bypass (GBY) or laparoscopic gastric bypass (LAGB) as the preferred procedure. Preoperative counseling should include education on the comparative risks and benefits (such as extent of weight loss, frequency and timing of potential complications) of the two procedures in order to allow the optimal choice to be made based on preferences and shared decision making.

Weight loss outcomes from the studies reviewed in the Assessment confirm the conclusions of previous TEC Assessments that weight loss at one year is less for LAGB compared with GBY. The percentage of excess weight lost (EWL) at one year is in the range of approximately 40%, compared to 60% or higher for GBY.  At time points longer than one year, some of the comparative studies report the difference in weight loss between LAGB and GBY lessens, but others do not. 

These studies also confirm that short-term (perioperative) complications are very low with LAGB, and lower than with either open or laparoscopic GBY.  Death is extremely rare, and serious perioperative complications probably occur at rates of less than 1%.

In comparing LAGB with GBY, there is a tradeoff in terms of risks and benefits.  LAGB offers a less-invasive procedure that is associated with fewer procedural complications, a decreased hospital stay, and earlier return to usual activities.  However, the benefits, as defined by the amount of weight loss, will also be less for LAGB.  The patterns of long-term complications also differ between the two procedures.  For LAGB, longer-term adverse events related to the presence of a foreign body in the abdomen will occur, and will result in re operations and removal of the band in a minority of patients.  Patients who have their bands removed can later be offered an alternative bariatric surgery procedure, such as gastric bypass.

Gastric Bypass with Short Limb (<150 cm)(Roux-en-Y)

While vertical banded gastroplasty was perhaps the dominant bariatric surgery in the 1980s, it has been surpassed in this country by the gastric bypass procedure, based on a variety of studies that report improved weight loss with the gastric bypass procedure.   This body of literature has been instrumental in establishing that gastric bypass should be the reference procedure to which other procedures are compared.  Practice patterns in the United States have adopted this approach, with gastric bypass now composing the vast majority of all bariatric procedures performed.

In 1987, Griffen summarized the experience of over 10,000 gastric bypass operations from a number of bariatric surgeons.  It was estimated that 85% of patients reduced their weight to at least 50% above the ideal weight.  In about 5,000 patients who were followed up for 10 years, 80% were able to maintain this result.  In 1995, Pories and colleagues reported on 608 patients who underwent a gastric bypass procedure and were followed up for one to 14 years.  One of the unique features of this report is that only 3% of patients were lost to follow-up.  The average weight loss was 75% of excess weight at one year, declining to 50% by the eighth year.  The authors observed an immediate drop in both blood glucose and exogenous insulin requirements after surgery.  Long-term observation of 298 patients with preoperative diabetes or impaired glucose intolerance revealed that 91% had normal values for blood glucose and hemoglobin A1-C after surgery.  The incidence of hypertension declined from 58% before surgery to 14% after gastric bypass.

In 1987, Flickinger and colleagues reported on the incidence of diabetes and hypertension in a case series of 397 patients.  Prior to surgery, 22% had diabetes mellitus and 13% had impaired glucose intolerance.  After surgery, all but one of the patients remained euglycemic.  A total of 57% of patients were hypertensive before surgery compared to only 18% after surgery.  Similarly, in 1995, Pories and colleagues reported that of 163 obese patients with diabetes or impaired glucose tolerances; only 5% remained with inadequate control after gastric bypass surgery and associated weight loss.  In 1998, Cowan et. al. reported that gastric bypass surgery and weight loss are associated with improvements in the lipid profile.

As discussed previously, comparative trials summarized in the 2003 TEC Assessment consistently report favorable outcomes for open gastric bypass when compared with vertical-banded gastroplasty, including two randomized, controlled trials. Some nonrandomized trials that compare open gastric bypass with procedures other than vertical-banded gastroplasty were also summarized in the 2003 TEC Assessment.  While there are fewer trials for these other procedures, comparisons of open gastric bypass to gastric banding, horizontal gastroplasty, and silastic ring gastroplasty all reported that weight loss was superior with open gastric bypass.

Metabolic abnormalities are seen more frequently in gastric bypass patients compared to those receiving a vertical banded gastroplasty.  Anemia, iron deficiency, vitamin B 12 deficiency, and red blood cell folate deficiency are commonly seen abnormalities.  Marginal ulcerations are also seen in gastric bypass patients, particularly in those whose gastric pouches are too large and include acid-secreting parietal cells.

A 2005 TEC Assessment focused on the issue of laparoscopic gastric bypass, which intends to reproduce the open procedure via minimally invasive techniques.  This is a technically complex operation that requires a dedicated team and a relatively high degree of skill and experience in laparoscopic surgery.  This Assessment reviewed seven comparative trials of open gastric bypass and laparoscopic gastric bypass, including three randomized, controlled trials. In addition, 18 large clinical series of laparoscopic gastric bypass were included in the review.

The 2005 TEC Assessment on laparoscopic gastric bypass concludes that weight loss at one-year is similar between laparoscopic and open gastric bypass approaches.  Weight loss at longer follow-up periods has been less well reported, but appears to be similar as well.  While comparisons of complication rates are less certain, certain patterns are evident and relatively consistent across the data examined.  The profile of adverse events differs between the two approaches, with each having its advantages and disadvantages.  Laparoscopic gastric bypass offers a less-invasive procedure that is associated with decreased hospital stay and earlier return to usual activities.  The mortality may be lower with the laparoscopic approach, although both procedures have mortality rates less than 1%.  Postoperative wound infections and incisional hernias are also less common with laparoscopic gastric bypass.  On the other hand, anastomotic problems, gastrointestinal bleeding, and bowel obstruction appear to be higher with the laparoscopic approach, but not markedly higher. Given these data, it is not possible to say that one procedure is superior to the other, and overall the benefit/risk ratio for these two approaches appears to be more similar than different.

The mini-gastric bypass has been primarily advocated by one surgeon.  In 2001, Rutledge published his experience with 1,274 patients who underwent the mini-gastric bypass procedure.  The mean operating time was 36 minutes, and the mean hospital stay was 1.5 days.  Mean excess weight loss was 51% at 6 months, 68% at 12 months, and 77% at two-years.  The overall complication rate reported was 5.2%.  While this surgical approach may result in decreased surgical time, the anastomosis creates the risk of biliary reflux gastritis, one of the reasons that this anastomosis has been abandoned, in general, in favor of a Roux-en-Y anastomosis that diverts the biliary juices away from the stomach.

Sleeve Gastrectomy

Sleeve gastrectomy may be performed as a stand-alone procedure, or in combination with a malabsorptive procedure, such as the biliopancreatic diversion with duodenal switch.  It has also been proposed as the first step in a two-stage procedure, with gastric bypass or biliopancreatic diversion as the second stage.

As a stand-alone procedure, there is limited data to evaluate outcomes and/or compare efficacy to other procedures.  A small number of clinical series have been published which report on outcomes after sleeve gastrectomy alone.  In 2005, Moon et al. reported on a series of 60 patients who had undergone sleeve gastrectomy and who had at least one year of follow-up.  These authors reported an 83% EWL at 12 months.  Diabetes resolved in 100% of patients in this series, and hypertension resolved in 93%.  In a smaller series of 23 patients in 2006, Langer et al. reported a 56% EWL at one-year.

A small number of clinical series report on sleeve gastrectomy as the initial procedure of a two-stage operation.  This approach has been generally attempted in patients with “super” obesity (BMI >50), in whom a more complex initial operation may be associated with higher risk.  Weight loss following sleeve gastrectomy may reduce the risk of these patients undergoing a more complex malabsorptive procedure in the future.  The available series to date report only on very small numbers of patients, e.g. in 2003 Regan et al. (n=7) and in 2005 Mognol et al. (n=10). The published data on outcomes following completion of both stages of a two stage operation are limited to case reports and case series with very small numbers of patients.    

Biliopancreatic Bypass

Numerous clinical series of biliopancreatic bypass have been published, but, as with other procedures, high-quality trials that directly compare outcomes of this procedure with gastric bypass are lacking.  The largest experience with biliopancreatic bypass is reported by Scopinaro, who developed the procedure. 

In 1996, Scopinaro summarized his experience with 1,217 patients.  With follow-up of up to nine years, the authors reported a durable excess weight loss of 75%, suggesting that weight loss is greater with this procedure compared to gastric restrictive procedures.  In addition, the vast majority of patients reported disappearance and/or improvement of such complications as obstructive sleep apnea, hypertension, hypercholesteremia, and diabetes.  The authors considered protein malnutrition the most serious metabolic complication (occurring in almost 12% of patients and responsible for three deaths).  This complication may require inpatient treatment with total parenteral nutrition.  To address the issue of protein malnutrition, 4% of patients underwent reoperation to either elongate the common limb (thus increasing protein absorption) or had the operation reversed (restoring normal intestinal continuity).  The authors also found that protein malnutrition was strongly related to ethnicity, and presumably eating habits of the patients, with an increased incidence among those from southern Italy where the diet contains more starch and carbohydrates than the north.  Peripheral neuropathy may occur in the early postoperative period due to excessive food limitation but may be effectively treated with large doses of thiamine.  Bone demineralization, due to decreased calcium absorption, was seen in about 33% of patients during the first four postoperative years.  All patients were encouraged to maintain an oral calcium intake of 2 g/day, with monthly vitamin D supplementation.

The available evidence was reviewed in the 2005 TEC Assessment, and outcomes of biliopancreatic bypass, with or without duodenal switch, were compared with those of gastric bypass.  One comparative trial and seven single-arm series suggested that weight loss outcomes at one-year are in the same range as for gastric bypass.  While these data are not sufficient to distinguish small differences in weight loss between the two procedures, these data do not support the hypothesis that biliopancreatic bypass results in greater weight loss than open gastric bypass.

Complication rates are poorly reported in these trials.  The data suggest that mortality is low (approximately 1%) and in the same range as for open gastric bypass.  However, rates of other complications, especially long-term complications, cannot be determined from these data. Limited data suggest that long-term nutritional and vitamin deficiencies occur at a high rate following biliopancreatic bypass.  In 2004, Slater et al. focused specifically on vitamin and calcium deficiencies following biliopancreatic bypass.  These authors reported high rates of vitamin and calcium abnormalities in their population over a 4-year period.  By year 4, approximately half (48%) of the patients were found to have low calcium and 63% had low levels of vitamin D.  Other fat-soluble vitamins showed similar patterns of abnormalities.  Low vitamin A was found in 69% of patients at 4 years, low vitamin K in 68%, and low zinc in 50%.  In 2004, Dolan et al. reported similar data in a study that compared several technical variations of biliopancreatic bypass.  These authors reported low calcium levels in 12%–34% of patients, low vitamin D in 22.2%–70.6%, low vitamin A in 53%–67%, and low vitamin K in 44%–59%.  In addition, this study reported high rates of iron deficiency (11%–47%) and anemia (11%–40%). The rates of nutritional deficiencies and the consequences of these deficiencies require further investigation.

The bulk of the experience with biliopancreatic bypass appears to be in Europe, particularly Italy. There are no case series reported in this country.  According to Murr and colleagues (1999), biliopancreatic bypass has not been widely accepted in this country due to unacceptable serious long-term morbidities.  For example, biliopancreatic bypass has largely been abandoned at the Mayo clinic due to the occurrence of steatorrhea, diarrhea, foul-smelling stools, severe bone pain, and the need for a life-long commitment to supplemental vitamins and minerals.   In addition, there have been scattered case reports of liver damage, resulting either in liver transplant or death.  In addition, Murr hypothesizes that the incidence of protein malnutrition may be higher in this country compared to Scopinaro's Italian series since the North American diet has a higher percentage of fat and lesser amounts of carbohydrates. 

Biliopancreatic Bypass with Duodenal Switch

Biliopancreatic diversion may be performed with or without the duodenal switch procedure. In the duodenal switch procedure, sleeve gastrectomy is performed, preserving the pyloric sphincter. Preservation of the pyloric sphincter is intended to ameliorate the dumping syndrome and decrease the incidence of ulcers at the duodenoileal anastomosis by providing a more physiologic transfer of stomach contents to the duodenum.

The largest case series of this procedure is reported in 1998 by Marceau et al. , who reported on 465 patients who underwent the duodenal switch procedure compared to 252 who underwent the biliopancreatic bypass.  It should be noted that in addition to the preservation of the duodenum, the common segment was elongated to 100 cm.  The authors noted similar weight loss in the two groups.  In the duodenal switch group, there was a lower incidence of metabolic abnormalities (such as protein malnutrition) which prompted reversal of the procedure in 1.7% of those undergoing biliopancreatic bypass vs. only 0.1% after the duodenal switch procedure.  However, it is not known whether this outcome is attributed to the lengthening of the common segment vs. retention of the pylorus.  In 1998, Hess reported on a case series of 440 patients with variable lengths of the common channel.  The percentage excess weight loss varied between 60% and 90% depending on the length of the common segment and alimentary limb.  There were two late deaths, one due to septic shock secondary to an infected panniculus and one related to liver failure.  A total of ten patients underwent revision to lengthen the common segment secondary to low protein or excessive diarrhea.  Seven patients underwent shortening of the common segment due to inadequate weight loss.  In 1997, Baltasar and colleagues reported on a case series of 60 patients undergoing the duodenal switch procedure with a common segment length of 75 cm.  One patient succumbed to liver failure and another due to malnutrition.  The authors questioned the safety of the procedure.

The malabsorptive component of biliopancreatic bypass with duodenal switch is essentially identical to biliopancreatic bypass alone; therefore, the incidence of metabolic and nutritional deficiencies between the procedures is likely to be very similar.

Gastric Bypass with Long Limb (>150 cm)

The degree of malabsorption associated with long-limb gastric bypass will vary with the length of the alimentary and biliary limbs.  These modifications have been developed in an effort to decrease the metabolic side effects associated with biliopancreatic bypass.  However, there has been limited published evidence on outcomes from this procedure, and a large amount of variability in the technical aspects of the procedure among the published literature.  In 1999,   Murr reported on 26 patients who underwent a very long limb Roux-en-Y gastric bypass.  In comparison to a case series of 11 patients who underwent biliopancreatic bypass the authors reported similar weight loss but decreased metabolic or nutritional abnormalities.  This was attributed in part to the increased length of the common segment (100 cm) compared to 50 cm used in biliopancreatic bypass.  In 1997, Sugerman also attributed increasing the length of the common segment to decreasing metabolic morbidities.

The 2005 TEC Assessment  reviewed studies that compared outcomes of standard or ”short” limb gastric bypass with outcomes of “long” limb gastric bypass. Two or more different lengths of the Roux limb were compared in six comparative studies.  However, although the categorization of patients into “standard” versus “long-limb” is based on the length of the Roux (alimentary) limb, there is not a definite cut-off for long versus standard limbs. In these studies, there was variability in the lengths of the Roux limbs for both the standard gastric bypass and for the long-limb groups.

The majority of comparisons of weight loss do not reveal significant differences between short and long limb gastric bypass. The strongest evidence in this category is from two randomized, controlled trials (Choban and Flancbaum 2002 and Inabnet 2005).  In both of these trials, there were no significant differences in weight loss between groups.  In 2002, Brolin et al. compared three limb lengths, with the longest limb (distal gastric bypass) group having a significantly larger decrease in BMI at one-year, while the other two groups had similar decrease in BMI.  In 2001, MacLean et al. examined morbidly obese and super obese patients separately, and reported a significant difference in favor of the long-limb gastric bypass group.  However, this analysis compared the final BMI of the two groups, and did not report the actual change in BMI or the initial BMI for each group.

Adverse events were poorly reported by these studies, with only three reporting data on adverse events.  In 1997, Mason et al. reported the percent of patients with “major post-op complications,” which was 2.3% for standard gastric bypass and 1.2% for long-limb gastric bypass.  There was no further breakdown of the types of major complications recorded, and no statistical testing for this outcome.  In the remaining two studies, the rates of short-term adverse events reported by Inabnet et al. in 2005 were higher for standard gastric bypass, while the rates reported by Brolin et al. in 2002 were higher for the long-limb gastric bypass.  Data on long-term complications were scant, and did not reveal any apparent differences between short- and long-limb procedures.

Endoscopic Procedures for Weight Gain After Bariatric Surgery

Many patients regain weight over time following bariatric surgery.  Reasons for this include issues with compliance with post-operative instructions, as well as technical or structural issues.  It has been suggested that dilation of the gastrojejunostomy anastomosis or stoma may play a role in the loss of the sensation of satiety or the ability to feel full after eating.  The gastric pouch may also dilate along with an enlargement of the gastrojejunostomy stoma.  Various sclerotherapy agents may be used including but not limited to sodium morrhuate.

Removal of the Gallbladder at the time of an Approved Gastric Bypass Surgical Procedure

Gallstones are more common in the obese population and may be formed during rapid weight loss.  After a Roux-en-Y gastric bypass surgery, 40% of patients form stones in the post-operative period.  Because of the high incidence of gallbladder disease even with negative pre-operative findings in morbidly obese patients and the lack of significant morbidity with cholecystectomy, routine cholecystectomy at the time of weight loss surgery is justified.

Endoscopic Procedures for Weight Gain After Bariatric Surgery

Enlarged gastric stoma and/or enlarged gastric pouches may be associated with weight regain after bariatric surgery.  It is not known if endoscopic procedures (e.g., sclerotherapy) are effective in the treatment of these abnormalities. The StomaphyX™ device, which has been used in this approach, was cleared by the 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 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.  Published data concerning the use of devices or procedures including sclerotherapy is limited to small case series.  Randomized controlled studies are necessary to validate the use of these treatments. 

Summary:

Gastric bypass, performed by either the open or laparoscopic approach, improves health outcomes of morbidly obese patients by leading to substantial weight loss with relatively low rates of adverse events.  The degree of weight loss following gastric bypass is associated with improvement in weight-related morbidities for these patients.  Gastric bypass accounts for over 80% of bariatric operations performed in the United States, and is considered the reference standard to which other procedures should be compared.  There is sufficient evidence for patients considering bariatric surgery to make an informed choice between gastric bypass and adjustable gastric banding.  An informed patient may choose either approach as the preferred procedure based on assessment of comparative risks and benefits.

As noted in the coverage section, some bariatric procedures for treatment of morbid obesity remain investigational.  This interpretation of the term investigational may be questioned by those who would point out some procedures, for example, biliopancreatic bypass, have been performed for some 20 years with results of large case series reported in the peer-reviewed literature.  However, one criterion used to define the term investigational in the Introduction to the Medical Policy Reference Manual is whether the malabsorptive procedures are at least as good as the alternatives.

For biliopancreatic diversion, the comparison involves a judgment as to whether the increased metabolic risks are more than outweighed by an increased benefit associated with potentially greater weight loss.  Some experts contend that the percent of excess weight loss following biliopancreatic bypass is at or above 70%, higher than that reported with gastric restrictive procedures.  However, the recent 2005 TEC Assessment, which included comparative studies and the largest clinical series, did not find that the evidence was sufficient to conclude that weight loss following biliopancreatic bypass was greater than for gastric bypass.   In addition, the TEC Assessment found that rates of nutritional and metabolic complications appear to be very high following biliopancreatic bypass.

The duodenal switch procedure is often performed in conjunction with biliopancreatic diversion. This modification of biliopancreatic bypass affects the gastric restrictive portion of the surgery but not the malabsorptive component.  The evidence is not sufficient to determine whether this modification leads to important differences in health outcomes.  Limited evidence suggests that weight loss is similar between the procedures.  The metabolic and nutritional deficiencies reported following biliopancreatic diversion are expected to be the same whether or not the duodenal switch is included in the procedure.

To achieve optimal outcomes following bariatric surgery, similar to those reported in the literature from large bariatric surgery centers, certain conditions should be met.  Careful patient selection and thorough pre-operative screening are essential.  Surgeons need to be adequately trained in the particular techniques and should perform a high volume of these procedures.  The institution should provide a full range of ancillary services, such as nursing and psychological support, and should provide for life-long follow-up after surgery.  These conditions are best attainable as part of a dedicated, comprehensive bariatric surgery program that focuses on multidisciplinary care of the bariatric surgery patient.

It should be noted that all bariatric surgeries require a high degree of patient compliance.  For gastric-restrictive procedures, weight loss is primarily due to reduced caloric intake, and thus the patient must be committed to eating small meals, reinforced by early satiety.  For example, gastric restrictive surgery will not be successful in patients who consume high volumes of calorie-rich liquids.  In patients undergoing biliopancreatic bypass, reduced intake may not be as much of an issue, but patients must adhere to a balanced diet to avoid metabolic complications. In addition, the high potential for metabolic complications requires life-long follow-up. Therefore patient selection is a critical process, often requiring psychiatric evaluation and a multidisciplinary team approach.  Given these factors, bariatric surgery should be approached very cautiously in adolescents.

Recommendations from the National Institutes of Health stress the importance of a multidisciplinary approach to bariatric surgery patients, including such ancillary services as nutritional and psychological support.   It is also recommended that bariatric surgery programs provide lifelong follow-up for treated patients.  However, no regulatory mechanisms ensure that these resources are present in all programs.

High-volume bariatric programs are likely to be more successful in achieving optimal outcomes. Accumulating evidence supports a correlation between increasing volume and positive outcomes for bariatric surgery.  Nguyen et al.  compared outcomes of low- and high-volume academic medical centers.  The authors reported that higher-volume hospitals (more than 100 cases/year) had lower rates of mortality (0.3% vs. 1.2%, p<0.01) and overall complication rates (10.2% vs. 14.5%, p<0.01), when compared with lower volume hospitals.   Liu et al. examined complication rates from bariatric surgery in California, classifying programs as very low (<50 cases/year), low (50–99 cases/year), or high (>200 cases/year) volume.  After adjusting for differences in case-mix, patients at very low-volume hospitals were 2.72 times more likely to experience perioperative complications, and patients at low-volume hospitals were 2.7 times more likely to experience complications, compared with high-volume hospitals.  Courcoulas et al. examined mortality and complications in Pennsylvania bariatric surgery programs by individual surgeon and hospital volume.  This study reported that low-volume surgeons had higher rates of adverse events (28% vs. 5%, p<0.05), and a trend toward higher mortality (5% vs. 0.3%, p=0.06), when compared to high-volume surgeons.

Some states and health systems have instituted internal regulations to address these programmatic concerns.  Blue Cross and Blue Shield Association (BCBSA) has an ongoing initiative that attempts to identify high performing bariatric surgery centers that meet programmatic requirements and, ultimately, that achieve pre-specified outcomes (BCBSA Bariatric Surgery Workgroup).  This initiative identifies numerous indicators including institutional factors, characteristics of individual surgeons, the availability of ancillary services, patient selection procedures, and follow-up plans.  It also outlines data collection and management procedures that can be used in the future to track patient outcomes, such as mortality, complications, and re-admission rates.

This policy does not apply to patients under the age of 18 years.  There is limited long-term follow-up information for bariatric surgery in these patients and a need for clinical trials.  Studies are needed to assess the relative benefits and harms of bariatric surgery for these individuals.  In particular, the impact on growth and development needs further study.  Of note, the FDA premarket approval (PMA) for the LAP-BAND system indicates that it is for use only in severely obese adult patients.  (The clinical study submitted to the FDA for LAP-BAND approval involved adults ages 18–55 years.)

2009 Update

1.  Adjustable Gastric Banding with BMI>50kg/m2

One area of focus was use of adjustable gastric banding in those with a BMI>50 kg/m2.  Overall, the data concerning this use of gastric banding are quite limited, in that they are focused on reporting duration of surgery, complications, and percentage of EWL.  While weight loss is important, data about impact on comorbid conditions such as diabetes, hypertension, and obstructive sleep apnea are of equal importance.  Comparative data, but not from a randomized trial, were reported by Bowne in 2006.  Using a prospectively maintained database, the authors identified patients who underwent operative treatment for morbid obesity between February 2001 and June 2004.  The study group included super morbidly obese patients (BMI>50) who received LAGB or LRYGB.  Among 106 patients with super morbid obesity, 60 (57%) and 46 (43%) underwent LAGB and LRYGB, respectively.  The overall median follow-up was 16.2 months (range, 1–40 months).  Compared with LRYGB, patients who underwent LAGB experienced a greater incidence of late complications and re operations.  Likewise, patients who underwent LRYGB had a greater resolution of concomitant diabetes mellitus and sleep apnea compared with the LAGB group.  The EWL was 52% in the LRYGB group compared to 31% in the LAGB group.  Other studies identified by Parikh et al., Myers et al., Montgomery et al., and Mongol et al. did not report on the impact of the surgery on comorbid conditions and/or did not provide comparative data with other techniques.  For example, in 2005, Parikh reported a retrospective comparative review of super-obese patients (BMI greater than 50) who underwent LAGB, LRYGB, or biliopancreatic diversion.  At one year, EWL was 35% for LAGB and 58% for LRYGB.  This study also noted that LAGB had the shorter operative times and lowest morbidity; however, it did not report outcomes on comorbid disease.  Because of the limited data, concerns exist that the LAGB will not produce sufficient long-term weight loss to impact important comorbid conditions such as diabetes, hypertension, and sleep apnea.  

2.  Endoscopic Procedures For Weight Gain After Bariatric Surgery

Another area of focus for this update was to review endoscopic procedures for patients who gain weight after bariatric surgery.  There are a number of reasons why patients who are treated with accepted forms of bariatric surgery may not lose weight or may regain weight that is initially lost. These reasons include issues of adherence (compliance) as well as technical (structural) issues. Some patients who regain weight after bariatric surgery, e.g., after RYGB, are found to have enlarged gastric stoma and/or enlarged gastric pouches.  Correction of these abnormalities has been reported to again result in successful weight loss.  However, in 2007 Morton et al. questioned whether the association with enlarged stoma is as important as it is for enlarged pouches.  While these abnormalities can be revised using standard operative approaches, novel endoscopic procedures are being publicized as an option for these patients.  Some of these procedures use devices that are also being evaluated for endoscopic treatment of gastroesophageal reflux.  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 is by Catalano et al. in 2007; it involved 28 patients treated with a sclerosing agent (sodium morrhuate).  Reported trials that used one of the suturing devices had fewer than ten patients.  For example, Herron reported on a feasibility study in animals.  Thompson reported on a pilot study with changes in anastomotic diameter and weight loss in eight 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.  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.  This evidence does not prompt reconsideration of the coverage statement.

3.  Adjustable Gastric Banding

Recently another adjustable gastric banding device has been approved by the FDA through the PMA process.  The REALIZE device was approved in September 2007.  The results of a multicenter study with three-year follow-up that enrolled 276 adults submitted to the FDA show outcomes with this device that are similar (weight loss, reoperation, complications) to other studies reviewed in this policy for adjustable gastric banding.  Thus, this device is another option that can be used in adjustable gastric banding.

4.  Mini-gastric Bypass

Although largely abandoned because of concerns about biliary regurgitation with bile gastritis and esophagitis, the mini-gastric bypass procedure continues to have its proponents, mainly outside the United States.  In 2005, Lee et al. reported on an RCT which compared mini-gastric bypass with LRYGB in 80 patients randomized to 40 patients in each group.  At two-years, the EWL was not significantly different (64% vs. 60%, respectively).  The rate of major early postoperative complications was 5% in the LRYGP group and none in the mini-gastric bypass group, but the incidence of marginal ulcer was 5% in the mini-gastric bypass group and 3% in the LRYGP group.  A number of case series with short outcomes are reported in the recent literature. Wang and colleagues report results in 423 patients.  Mean preoperative BMI was 44.2 and decreased to 29.2 and 28.4 at one and two year follow-up.  Mean EWL at one and two years was 69% and 72%, respectively.  Seven major and 18 minor complications occurred.  Marginal ulcers were noted in 34 patients and anemia in 41 during follow-up.  Chakhtoura et al. and Noun et al. (two case series) had 100 or more patients but report only six-month or one-year outcomes.  Johnson and colleagues identified 32 mini-gastric bypass patients who require or required surgical revision after the procedure.  Complications requiring surgery included gastrojejunostomy leak, bile reflux, intractable marginal ulcer, malabsorption/malnutrition, and weight gain.  Twenty-one patients underwent conversion to RYGB, and five more have planned revisions in the future.  The authors propose a national registry to record complications and revisions performed after non-traditional bariatric procedures.  This evidence does not prompt reconsideration of the coverage statement.

5.  Biliopancreatic Diversion (BPD) and Biliopancreatic Diversion with Duodenal Switch (BPD/DS)

Literature search since the last policy update identified three comparative studies of biliopancreatic diversion as follows.

Skroubis et al. randomized 130 patients with a BMI of 35–50 to either RYGB or BD (without duodenal switch) using a variant of BPD that included Roux-en-Y gastrectomy in place of sleeve gastrectomy.  All patients were followed for at least two years.  Weight loss outcomes were superior for the BD group at every time period examined up to two years.  The EWL at one year was 73.7% for RYGB and 83.1% for BD (p=0.0001); at three years, the EWL was 72.6% for RYGB and 83.1% for BD (p=0.00003).  There were more early complications in the RYGB group, but this difference did not reach statistical significance (six complications vs. one, p=0.12).   Late complications also did not differ significantly between the RYGB and BD groups (16 complications vs. 22, p=0.46).

Prachand et al. published the largest comparative series of 350 super-obese patients with BMI >50 who underwent either RYGB (n=152) or Scopinaro BD combined with the DeMeester duodenal switch (DS-BPD) (n=198).  In this retrospective study, the surgeon and/or patient made the decision for surgery.  The DS-BPD patients differed from RYGB patients on weight and BMI; mean weight in pounds was 368.2 +/- 52.3 (range, 267.4–596.5) in DS-BPD patients vs. 346.3 +/- 55.2 (range, 239.8–504.9) in the RYGB group and mean BMI was 58.8 +/- 6.7 (range, 50–96) in DS-BPD patients vs. 56.4 +/- 6.8 (range, 49.5–84.2) in the RYGB group.  At one year, data were reported for 143 DS-BPD patients and 81 RYGB patients.  The EWL was greater for BPD versus RYGB (64.1% vs. 55.9%, p<0.01), and the reduction in BMI was also greater for BPD versus RYGB (23.6 vs. 19.4, p<0.001).  Complications and data on resolution of comorbidities were not reported in this study.  Strain et al. published a smaller comparative study of 72 patients who underwent either RYGB (n=50) or BPD (n=22).  Choice of surgery was per surgeon and/or patient and the patient populations differed in age and time since surgery. Weight loss at one year was greater for BPD, with a reduction in BMI of 23.3 for BPD compared to 16.5 for RYGB (p<0.001).

Marceau and colleagues conducted a retrospective study comparing results of BPD with distal gastrectomy (DG, Scopinaro method) vs. BPD with duodenal switch (DS) at ten years after surgery.  Between 1984 and 1990, 248 patients underwent BPD-DG and, between 1992 and 1997, 438 had BPD with DS. The BPD-DS patients were significantly more obese preoperatively than the BPD-DG patients (49.5 +/- 9.6 vs. 46.4 +/- 8.7).  At 10 years, EWL in the BPD-DG group (n=140) was 60.2 +/- 20.7 kg vs. 69.6 +/- 21 kg in the BPD-DS group (n=251) (p=.001). Ten percent more patients in the BPD-DS group than in the BPD-DG group had lost >50% of the initial excess weight.  During 10-year follow-up, 46 of 248 BPD-DG patients required revision surgery versus six of 431 BPD-DS patients.  Most revisions after BPD-DG were for malnutrition and diarrhea and consisted of lengthening the common channel. Information regarding side effects was collected in questionnaires; 90 of 178 BPD-DG and 44 of 185 BPD-DS responders reported vomiting during the last month, and diarrhea was reported by 14% of BPD-DG versus 20% of BPD-DS responders.  Heartburn was reported more frequently by BPD-DS patients (67 of 185 vs. 32 of 178) and was manageable without revision.  One ulcer was documented by gastroscopy and cured with medical treatment.  Long-term complications (fractures, urolithiasis) and rates of reoperation for obstruction were not significantly different between groups.  At ten years, albumin levels were comparable; however, the common channel had been lengthened in 20% of BPD-DG patients for hypoalbuminemia.  Mortality at ten years was 4.8% in the BPD-DG group and 8.4% in the BPD-DS group, although the difference was mainly attributed to causes unrelated to operative technique (trauma and suicide).

Parikh and colleagues compared three types of bariatric surgery for outcomes on resolution of diabetes: LAGB, n=218; RYGB, n=53; and BPD (with or without DS), n=11.  Outcomes with and without DS were not reported separately.  Patient preference played a large part in choice of surgery type.  Data on the 282 diabetic patients came from a registry of 1,293 patients collected from July 2001 through December 2004 at a U.S. center.  Diabetes diagnosis was based on requirement for diabetes medication or diagnosis of glucose intolerance by the primary physician. Resolution was defined as discontinuation of oral hypoglycemic agents or insulin. Preoperative BMIs were LAGB, 49.8 +/- 11; RYGB, 46.1 +/- 9.6; and BPD with or without DS, 46 +/- 10.6.  The EWL at one year was 43% for LAGB (87% follow-up), 66% for RYGB (72% follow-up), and 68% for BPD with or without DS (55% follow-up).  At three years, the EWL was 45% (65% follow-up), 66% (65% follow-up), and 82% (56% follow-up).  At one year, 39% of LAGB patients, 22% of RYGB patients, and 11% of BPD patients required oral hypoglycemics, and at two years 34%, 13%, and 13%, respectively, did.  At one year, 14% of LAGB patients, 7% of RYGB patients, and 11% of BPD patients required insulin, and at two years, 18%, 13%, and 13%, respectively, did.  A subgroup analysis revealed that LAGB patients who still required medications at two years had longer duration of diabetes before surgery and a lower EWL.

One single-arm case series provided further evidence on long-term outcomes from BPD.  In this study, 343 consecutive patients who underwent the Larrad variation of BPD were followed for up to 10 years (n=65).  (The Larrad 50-50 BPD consists of lengthening the alimentary channel preserving most of the jejunum-ileum, by creating a short biliopancreatic limb (50 cm) and maintaining 50 cm of common limb.)  Weight loss was maintained for up to 10 years, with a 77.8% EWL reported at 10 years.  Diarrhea was reported in 10.8% of patients, with severe diarrhea in 2.5%.  Anemia or iron deficiency was experienced by 30% of patients, and vitamin D deficiency was experienced by 30% of patients.

Marceau et al. reported their 15-year experience with DS in 1,423 patients from 1992–2005. Follow-up evaluation was available for 97% of patients.  Survival rate was 92%.  After a mean of 7 years (2–15), 92% of patients with an initial BMI < 50 obtained BMI <35, and 83% of patients with BMI >50 achieved a BMI <40.  Diabetes medication was discontinued in 92% and decreased in others.  The use of continuous positive airway pressure was discontinued in 92% of patients and the prevalence of cardiac risk index >5 was decreased by 86%.  Operative mortality was 1%; the revision rate was 0.7%, and the reversal rate was 0.2%.  Revision for failure to lose sufficient weight was needed in only 1.5%.  Severe anemia, vitamin deficiency, or bone damage were preventable or easily treated and without documented permanent damage.

Farrell et al. summarized data on BPD with or without DS, RYGB (proximal), and adjustable gastric band (AGB) and report that at mean of one year follow-up, EWL for BPD with or without DS (outcomes with and without DS not reported separately) was 72% (four studies, aggregate n=896), 67% for RYGB (seven studies, n=1,627), and 42% for AGB (11 studies, n=4,456).  At mean follow-up of five years, EWL for BPD with or without DS was 73% (three studies, aggregate n=174), 58% for RYGB (three studies, n=176), and 55% for AGB (five studies, n=640).  The authors note, “Given the marked paucity of prospectively collected comparative data among the different bariatric operations, it remains impossible to make definitive recommendations for one procedure over another.”

In summary, the comparative studies provide evidence that weight loss at one year following BPD is superior to RYGB.  The difference in EWL at one year is approximately 10% in favor of BPD.  Evidence of long-term weight loss is limited, and comparisons between techniques are more difficult.  Long-term nutritional complications such as protein, iron, or vitamin D deficiency are common after malabsorptive procedures, and careful monitoring and compliance with dietary advice and supplementation are required.  The impact of these and other long-term nutritional/metabolic complications of BPD cannot be determined from the current evidence. Some studies combine data for BPD with and without DS so that the outcomes of one or the other technique cannot be directly compared.  The more recent literature describes BPD with DS. Though RCTs with mid- to long-term outcomes are lacking, BD with DS appears to produce weight loss at least comparable to that with RYGB.  Thus, the coverage statement is revised related to BPD with DS.

6.  Limb-Length

Interest in improving weight loss outcomes, increasing control of comorbidities, and minimizing complications, particularly long-term nutritional deficiencies, has resulted in continuous evolution of bariatric surgical procedures including modification of limb lengths.  Two comparative studies that evaluated long-limb gastric bypass were identified.  Christou et al. reported the results of a study comparing long-term weight loss between short-limb (standard) and long-limb gastric bypass.  This retrospective study obtained data on 228 of 272 (83.8%) consecutive patients undergoing one of the two procedures at one institution.  Short-limb gastric bypass was performed on 140 patients (61%), and 69 (39%) underwent long-limb bypass; the mean follow-up for all patients was 11.4 years.  The decision on which operation to perform was made according to time, as this institution used the short-limb bypass until 1993 and then switched to the long-limb bypass afterward.   The results of this study showed no difference between groups in weight loss or percent of patients categorized as ‘failures’. 

In a study by Pinheiro et al., 105 patients with BMI of 50 or greater who were diabetic or had insulin resistance were randomly assigned to RYGB with a biliary limb of 50 cm and a Roux limb of 150 cm (group 1, n=57) or RYGB with a biliary limb of 100 cm and a Roux limb of 250 cm (group 2, n=48).  Comorbidities were considered controlled if patients required no medications and had normal blood test results during follow-up and improved if they required less medication or had improved blood test results.  Mean follow-up was 48 months (range, six–56 months).  Preoperatively, 55 patients in group one had a mean fasting glucose of 154 mg/dL and a mean hemoglobin A1c of 7.7%; 34 used oral hypoglycemic drugs, 11 used oral drugs and insulin, and ten used only insulin.  In group two, 45 patients had a mean fasting glucose of 174 mg/dL and a mean hemoglobin A1c of 8.3%; 23 used only oral agents, 14 used oral agents and insulin, and eight used only insulin.  In group one, 32 of 55 (58%) patients achieved control of diabetes (mean fasting glucose 104 mg/dL), 22 improved (mean fasting glucose 118 mg/dL), and one had no response.  In group two, 42 of 45 (93%) patients achieved control, one improved, and two had no improvement (p<.05).  Control was achieved within one to 12 weeks in both groups. With respect to lipid disorders (present in 52 of the 57 group one patients and in 41 of the 48 group two patients), 30 (57%) in group one and 29 (70%) in group two improved (p<.05).  Rates of improvement in hypertension, sleep apnea, and gastroesophageal reflux disease were not significantly different between groups.  Excess weight loss was faster in group two, but not significantly different at 48 months.  The authors cite total and subgroup sample size as limitations of their study and note that larger studies are needed to better assess the differences between the techniques.

One case series was identified in recent literature.  Hamoui et al. divided their series of 1,001 patients with mean BMI of 52 +/- 9 who underwent BBP with DS into two groups according to the ratio of the biliopancreatic limb length to the total small bowel length: a biliopancreatic limb length 45% or less of the small bowel length versus a biliopancreatic limb length more than 45% of the small bowel length.  They compared nutritional parameters and EWL at one, two, and three years follow-up.  In patients with a BMI of 60 or less, EWL was not clinically significant at any time point.  For patients with BMI greater than 60, the EWL was 56.8% in patients with a biliopancreatic limb length 45% or less of the small bowel length versus 61.4% in those with a biliopancreatic limb length more than 45% of the small bowel length (p=.07).  At two years, the EWL was 62.2% versus 77.5% (p=.04), and at three years, it was 59.8% versus 77.5% (p=.05).

This evidence does not prompt reconsideration of the coverage statement, which remains unchanged.

7.  Sleeve Gastrectomy

Two trials and a large number of reports of case series were identified in the literature search, most from centers outside the United States.  Sleeve gastrectomy as a stand-alone procedure dominates the recent literature.  Himpens et al. reported on a randomized study comparing LAGB and laparoscopic isolated sleeve gastrectomy (SG).  Eighty subjects received surgery over a period of one year.  Median BMI was 37 (range, 30–47) in the LAGB group versus 39 in the SG group.  Outcomes of weight loss, feeling of hunger, sweet eating, gastroesophageal reflux disease, complications, and re-operations were recorded at one and three years’ follow-up.  Median decrease in BMI in the GB group was 15.5 (range, five–39) after one year and 18 (range, 0–39) at three years after LAGB.  One year after SG, decrease in BMI was 25 (range, 0–45) after one year and 27.5 (range, 0–48) after three years.  Median EWL in the LAGB group was 41.4% after one year and 48% at three years.  Median EWL after SG was 58% and 66% at one and three years, respectively.  More patients having SG than LAGB reported loss of craving for sweets, but the differences were not significant; gastroesophageal reflux disease appeared de novo in more SG than LAGB patients at one year, and the relationship reversed at three years; between group differences were not significant at either time point.  Two SG patients required reoperation for complications.  Late complications requiring reoperation after LAGB included pouch dilations treated by band removal (n=2) or conversion to RYGB (n=1), one gastric erosion treated by conversion to RYGB, and three disconnections of the system were reconnected.  Four patients had re operations for inefficacy; two GB patients underwent conversion to RYGB, and two SG patients had conversion to duodenal switch.  The authors note that the number of re operations was significant in both groups and that the severity of complications was greater in the SG group. Karamanakos and colleagues carried out a double-blind study to compare outcomes of LRYGB and laparoscopic SG (LSG) on body weight, appetite, and fasting and postprandial ghrelin and peptide-YY (PYY) levels at 1one, three, six and 12 months after surgery. Thirty-two patients were randomized, half to each procedure.  Decrease in body weight and BMI was marked and comparable in each group.  Excess weight loss was greater after LSG at six months (55.5% vs. 50.2%, p=0.04) and 12 months (69.7% vs. 60.5%, p=0.05).  Fasting PYY levels increased after both surgical procedures.  Appetite decreased in both groups but was greater after LSG.

Case series with at least 100 subjects and at least one-year follow-up are summarized here.  All report on LSG as a stand-alone procedure.  Lee et al. report on a comparison of outcomes of four different laparoscopic bariatric procedures, RYGB (303 patients), adjustable gastric band (AGB, 271 patients), vertical banded gastrectomy also known as sleeve gastrectomy) (VG, 216 patients), Hess’ BPD and DS (56 patients) performed between November 2002 and August 2005.  Choice of operation was based on a combination of insurance coverage, patient preference, and physician recommendations. Preoperative and one-year outcomes are shown below.

VG

AGB

RYGB

BPD-DS

 

n=216

n=271

n=303

n=56

Preop BMI

49+/-11

42+/-5 

46+/-6 

47+/-6 

1-yr BMI 

37+/-9 

32+/-5 

28+/-5 

27+/-4 

1-yr EWL,%

59+/-17 

47+/-20 

75+/-16 

79+/-12 

BMI at 2 years (from graph) 

27.7 

31.4 

27.8 

25.1 

Complication rates are as follows: 

 

 

 

 

Nonoperative readmissions %

5 (2.3) 

4 (1.5) 

12 (4.0) 

4 (7.1) 

Reoperations (%)

6 (2.8) 

13 (4.8) 

26 (8.6) 

18 (32.1)

Deaths (%) 

0 (0)

0 (0)

0 (0)

0 (0)

Major complications (%) 

10 (4.6)

13 (4.8) 

32 (10.6) 

22 (39.3)

Total complications (%) 

6 (7.4) 

18 (6.6) 

69 (22.8) 

27 (48.2) 

The authors conclude that while long-term efficacy of sleeve gastrectomy is not clear, the data is promising.  Nocca and colleagues report EWL, mortality, and morbidity for 163 patients who underwent LSG.  The EWL was 48.97% at six months, 59.45% at one year (120 patients), 62.02% at 18 months, and 61.52% at two years (98 patients).  No statistical difference was noticed in EWL between obese and extremely obese patients.  There was no operative mortality. Perioperative complications occurred in 12 cases (7.4%).  The reoperation rate was 4.90%, and the postoperative morbidity was 6.74% due to six gastric fistulas (3.66%), in which four patients (2.44%) had a previous LAGB.  Long-term morbidity was caused by esophageal reflux symptoms (11.80%).  The authors noted that LSG may be proposed for volume-eater patients; however, weight regained, quality of life, and obesity-related morbidities need to be evaluated in longer-term studies.  Fuks et al. reviewed experience with 135 patients who had stand-alone LSG. Mean preoperative BMI was 48.8 (range, 37–72) and decreased to 39.8 at six months (p < .001).  Average excess body weight loss was 38.6% and 49.4% at six months and one year, respectively.  There was no mortality, and the major complication rate, corresponding to gastric fistula in every case, was 5.1% (n = 7). 

Hamoui et al. reported on 118 high-risk patients undergoing sleeve gastrectomy by the open approach.  There was one perioperative death (0.85%) and 18 postoperative complications (15.3%).  Median EWL was 49.4% at 12 months and 47.3% at 24 months.  Cottam et al. 2006 reported on 126 high-risk patients (ASA class III or IV) who underwent LSG as the first stage of a two-stage operation.  There was one death that occurred after the immediate postoperative period (0.8%), and major postoperative complications occurred in 16 patients (13%).  Mean EWL at one year was 46%; 36 patients proceeded to the second stage operation, LRYGP, after a mean interval of 12.6 months. 

Two papers report on complications of sleeve gastrectomy.  Lalor et al. retrospectively reviewed data from 164 patients who underwent LSG as a primary or revision bariatric surgery.  The major complication rate was 2.9% in the 148 patients who had LSG as a primary procedure. Complications were one leak and one case of hemorrhage requiring reoperation, one postoperative abscess, one sleeve stricture requiring endoscopic dilation, and late choledochololithiasis and bile duct stricture requiring a Whipple procedure.  Of the 16 patients undergoing revision surgery, one developed a leak and an abscess requiring reoperation, one case was aborted, and two were converted to an open procedure due to dense adhesions.  No patient in either group died.  Frezza and colleagues reported their patients’ complications after LSG and compared them to 17 other published series.  The mean complication rate for the 17 articles was 4.5%, the most common being reoperation, which occurred after 3.6% of procedures.

The additional evidence on sleeve gastrectomy indicates that this procedure is associated with early mortality of <1% and a risk of postoperative complications in the range of 13%–15%.  The RCT suggests that weight loss at one year may be greater than for LAGB, while the case series report weight loss at one year that may be less than that reported for RYGP.  This new evidence does not prompt reconsideration of the coverage statement, which remains unchanged.

8.  Bariatric Surgery For Children and Adolescents

Published data on pediatric and adolescent patients undergoing bariatric procedures are limited. Treadwell and colleagues conducted a systematic review and meta-analysis of the published evidence.  They included in their analysis English language articles on currently performed procedures when data were separated by procedure and there was a minimum one-year follow-up for weight and BMI.  Studies must have reported outcome data for three or more patients aged 21 years or younger, representing at least 50% of pediatric patients enrolled at that center.  Nineteen studies reported on from 11 to 68 patients who were 21 years or younger.  Eight studies of LAGB reported data on 352 patients (mean BMI 45.8, median age range, 15.6–20 years); six studies on RYGB included 131 patients (mean BMI 51.8, median age range 16–17.6 years); five studies of other procedures included 158 patients (mean BMI 48.8, median age range 15.7–21 years).  Meta-analyses of BMI at longest follow-up indicated sustained and clinically significant reductions for both LAGB and RYGB.  Comorbidity resolution was sparsely reported, but surgery appeared to resolve some medical conditions including diabetes and hypertension; two studies of LAGB showed large rates of diabetes resolution but low patient enrollment and only one study of RYGB reporting relevant data.  No in-hospital or postoperative death was reported in any LAGB study.  The most frequently reported complications for LAGB were band slippage and micronutrient deficiency with sporadic cases of band erosion, port/tube dysfunction, hiatal hernia, wound infection, and pouch dilation.  More severe complications were reported for RYGB such as pulmonary embolism, shock, intestinal obstruction, postoperative bleeding, staple line leak, and severe malnutrition.  No in-hospital death was reported; however, one patient died nine months after the study with severe Clostridium difficile colitis; three more died of causes that were not likely to have been directly related to the bariatric surgeries.  No LAGB studies reported data on the impact of surgery on growth and development.  One study of RYGB reported pre- and postoperative heights and concluded that there was no evidence of growth retardation at an average follow-up of six years but it could not be determined from the data whether expected growth was achieved.  Nadler et al. report on 73 patients aged 13 to 17 years who have undergone LAGB since 2001 at the authors’ institution.  Mean preoperative BMI was 48.  The EWL at six months, one year, and two years postoperatively was 35% +/- 16%, 57% +/- 23%, and 61% +/- 27%, respectively.  Six patients developed band slippage, and three developed symptomatic hiatal hernias.  Nutritional complications included asymptomatic iron deficiency in 13 patients, asymptomatic vitamin D deficiency in four patients, and mild subjective hair loss in 14.  In the 21 patients who entered the authors’ FDA-approved study and had reached one-year follow-up, 51 comorbid conditions were identified, 35 of which completely resolved, nine improved, five were unchanged, and two were aggravated after one year.  (The FDA approval of the LapBand device is unchanged as of this writing. This new evidence does not prompt reconsideration of the coverage statement, which remains unchanged.

9.  Bariatric Surgery for Treatment of Type-2 Diabetes

Current indications for bariatric surgery view poorly or uncontrolled diabetes mellitus as a comorbidity whose presence supports the medical necessity of surgery for patients with BMI of 35 to 40.  There also is growing interest in gastrointestinal surgery to treat patients with type-2 diabetes with a BMI in this range whose disease is under control and in patients with lower BMI. Dixon et al. performed an RCT designed to determine if surgically induced weight loss results in better glycemic control and less need for diabetes medication than conventional approaches to weight loss and diabetes control in patients with BMI of >30 and <40.  (Results were not reported separately for patients with BMI < or >35.)  Sixty patients were enrolled and 30 were randomized to LAGB and 30 to conventional diabetes care.  Fifty-five completed the two-year follow-up.  Remission of diabetes was achieved by 22 (73%) in the LAGB group and four (13%) in the control group.  The surgical group lost 62.5% of excess weight (using BMI of 25 as ideal weight) versus a loss of 4.3% of excess weight in the conventional group.  Mean hemoglobin A1C was <6.2% at baseline in two surgically and four conventionally treated patients versus 24 and six patients, respectively, at two years.  At baseline, two surgically treated and four conventionally treated patients were using no pharmacotherapy versus 26 and eight, respectively, at two years.  One surgical patient developed a wound infection, two developed gastric pouch enlargement and had laparoscopic revision to remove and replace the band.

The remaining evidence consists of small case series and case reports with short follow-up from non-U.S. centers employing procedures considered investigational in this policy.  Lee et al. retrospectively identified 44 patients with type-2 diabetes and BMI <35, 114 patients with BMI between 35 and 45, and 43 patients with BMI >45 in a large series (820) of patients who underwent laparoscopic mini-gastric bypass.  One year after surgery, fasting plasma glucose levels returned to normal in 89.5% of patients with BMI <35 and in 98% of those with BMI >35. The treatment goal of hemoglobin A1C <7%, LDL<150 mg/dl, and triglyceride <150 mg/dl was met in 76.5% of patients with BMI <35 and in 92.4% of those with BMI >35.  DePaula et al. report on 39 patients with BMI <35 who underwent one of two laparoscopic procedures comprising different combinations of ileal interposition into the proximal jejunum via a sleeve or diverted sleeve gastrectomy.  Mean BMI was 30.1 (range, 23.4–34.9).  All had type-2 diabetes for at least three years (mean duration, 9.3 years, range 3–22 years) and evidence of stable treatment with oral hypoglycemic agents or insulin for at least 12 months. Mean follow-up was seven months (range, 4–16 months).  Mean postoperative BMI was 24.9 (range, 18.9–31.7). Adequate glycemic control was achieved for 86.9% of patients, and 13.1% had important improvement.  Four major complications occurred within 30 days of surgery, and mortality was 2.6%.  Scopinaro reported outcomes at mean follow-up of 13 years (range, 10–18 yrs.) on seven patients with BMI < 35 who underwent BPD.  In all patients, serum glucose levels were normalized at one, two, and three years. In five patients, a slight increase above 123 mg/dl was observed at or around five years.  The values were maintained at all subsequent times with no one value higher than 160 mg being recorded.  The other two patients had full resolution of diabetes at all follow-up times.  Serum cholesterol and triglyceride values fell to normal one year after BPD and remained within the normal range.  Blood pressure normalized in six cases and improved in one.  No patient had excessive weight loss at any postoperative time.  Kakoulidis and colleagues investigated the role of sleeve gastrectomy for patients with BMI 30–35.  Fifteen of the 79 patients in the study had type 2 diabetes.  At a follow-up of six months or more, diabetes was resolved in two patients and improved in one.  Ramos et al. reported preliminary results for 20 patients with BMI <30 who underwent duodenal-jejunal exclusion for treatment of type-2 diabetes.  Outcomes measured preoperatively and at three and six months were BMI and fasting glycemia, glycosylated hemoglobin, and C-peptide levels. BMI decreased to the third month and stabilized between three and six months.  Fasting glycemia was reduced by 43.8% (mean preoperative value, 171.3 [127–242], 107.1 [82–145] at three months, and 96.3 [78–118]) at six months, and hemoglobin A1C was lowered by 22.8% up to the sixth month (mean preoperative level, 8.8% [7.5–10.2], 7.8% [6.7–9.6] at three months, and 6.8% [5.8–7.9] at six months).  C-peptide levels decreased 25% between the third and sixth months (p<0.001).  Two (20%) patients remained on oral medication after the sixth month.  Longer follow-up of a larger number of patients is required before conclusions can be drawn regarding a potential role for this procedure.  Clinical trials are underway in South America.

The data are insufficient to allow conclusions regarding the efficacy of expanding the surgical approach in the treatment or cure of type-2 diabetes.

July 2010 Update

A search of peer-reviewed literature was performed through May 2010 which focused on sleeve gastrectomy. 

Sleeve Gastrectomy (SG)

Brethauer and colleagues reviewed 36 studies (n=2,570) for a systematic review of SG as staged and primary procedure, the largest number (16) coming from European centers.  Two RCTs, one nonrandomized matched cohort analysis, and 33 case series were examined.  Thirteen studies (n=821) reported on high-risk patients having a staged approach and 24 studies (n=1,749) on SG as primary procedure.  Mean percentage of excess weight loss (%EWL) was reported in 24 studies (n=1662) and was 55.4% overall (range, 33%-85%).  Mean postoperative BMI was reported in 26 studies (n=1940) and decreased from a baseline mean of 51.2 to 37.1.  Other studies reported weight loss in terms of BMI decrease, percentage of BMI lost, or percentage of total weight lost, and all had significant reductions from baseline.  Follow-up periods were 3-60 months.  Ten studies included detailed postoperative comorbidity data (n=754); more than 70% of patients had improvement or remission of type 2 diabetes, and significant reductions were seen in hypertension and hyperlipidemia, sleep apnea, and joint pain.  The rate of major postoperative complications ranged from 0% to 23.8% for all studies and 0% to 15.3% in studies with >100 patients.  Leaks (2.2%), bleeding episodes requiring reoperation (1.2%), and postoperative strictures requiring endoscopic or surgical intervention (0.6%) were reported in the 33 studies reporting detailed complication data (n=2,570).  All extracted studies reported mortality data with five deaths within 30 days of surgery (overall mortality rate 0.19%, two in the high-risk/staged group and three in the primary procedure group).  The authors comment that long-term follow-up is limited.

Recent additional case series report similar outcomes with at least two-year outcomes include the following.  Sanchez-Sanchos et al. report on short and mid-term outcomes for 540 patients recorded in a National Registry in Spain.  Mean follow-up was 16.5 +/- 10.6 months.  Mean percent excess BMI loss (EBL) at three months was 38.8 +/- 22, 55.6 +/- 8 at six months, 68.1 +/- 28 at 12 months, and 72.4 +/- 31 at 24 months.  Percentage of excess weight lost was superior in patients with lower initial BMI and lower age.  The morbidity rate was 5.2% and mortality rate 0.36%.  Diabetes was remitted in 61% of patients and hypertension improved in 63.2%.  Eighteen patients had a second-stage surgery.  Complications presented more frequently in super-obese patients (OR, 2.8), male (OR, 2.98), and patients >55 years old (OR, 2.8).  Staple line reinforcement was related to a lower complication rate (3.7% vs 8.8%).  The authors noted that staple line reinforcement and a thinner bougie are recommended to improve outcome.

Arias and others report mid-term outcomes of 130 SG. Mean BMI decreased to 36.9, 32.8, 29.5, 28, and 27.1 at 3, 6, 12 18, and 24 months, respectively. Percent of excess weight loss (%EWL) was 33.1, 50.8, 62.2, 64.4, and 67.9 at 3, 6, 12, 18, and 24 months, respectively. 

Technology Assessments, Guidelines and Position Statements

In November 2009, the American Society for Metabolic and Bariatric Surgery (ASMBS) updated its position on sleeve gastrectomy to state that it has accepted sleeve gastrectomy as an approved bariatric surgical procedure primarily because of its potential value as a first-stage operation for high-risk patients. They site the need for long-term data to confirm the effectiveness of the procedure as a stand-alone intervention.

Summary

The bulk of the published evidence on sleeve gastrectomy reports only short- and mid-term outcomes as interest has shifted to sleeve gastrectomy as a stand alone procedure.  Evidence of longer term outcomes and complication rates is limited to small series of patients, some of whom had staged procedures.  Short to mid-term outcomes and complication rates of sleeve gastrectomy appear to be similar to those of other restrictive and malabsorptive procedures.  The ASMBS notes in a November 2009 updated position statement on sleeve gastrectomy that “Unanswered questions remain regarding how often patients will ultimately require conversion after SG to another procedure….”  The report notes its potential value as a first-stage operation for high-risk patients and cites the need for long-term data to confirm the effectiveness of the procedure as a stand-alone intervention.  The policy statement on SG is changed to medically necessary.

2010 Re-Review

A search of peer-reviewed literature was performed through July 2010 which focused on vertical banded gastroplasty, revision procedures, endoluminal techniques as primary or revision procedures, and the efficacy of adjustable lap-banding with respect to resolution of comorbidities in patients with BMI >50.

Vertical Banded Gastroplasty (VBG)

Fisher and Schauer report the primary operative choice for morbidly obese patients has shifted from VBG to the RYGBP, due to inadequate long-term weight loss.  Mongol et al. states VBG was the restrictive procedure of choice for many years due to a high rate of long-term failure.  He reviewed the data on patients undergoing conversion of failed VBG to RYGBP.  SAGES stated that only 7% of bariatric procedures in 2002 were VBG. 

Revision Procedures

A number of studies have evaluated the efficacy of revision procedures after failed bariatric surgery and reported satisfactory weight loss and resolution of comorbidities with somewhat higher complication rates than for primary surgery. 

Mognol et al. reported on conversion of AGB to RYBBP in 70 patients.  Indications for conversion were insufficient weight loss or weight regain after band deflation for gastric pouch dilatation in 34 patients (49%), inadequate weight loss in 17 patients (25%), symptomatic proximal gastric pouch dilatation in 15 patients (20%), intragastric band migration in three patients (5%), and psychological band intolerance in one patient.  Median excess body weight loss was 70%.  Sixty percent of patients achieved a BMI of <33 with mean follow-up 18 months. The early complication rate was 14.3% (10/70).  Late major complications occurred in six patients (8.6%). 

Brolin and Cody, reporting on a series of 151 revision surgeries, observed that “Weight loss after revision of pure restrictive operations is significantly better than after revision of operations with malabsorptive components.  Improvement of comorbidities in the great majority of patients justifies revision of all types of bariatric operations for unsatisfactory weight loss.”  

Beuter et al. reported that of 172 patients who underwent adjustable gastric band placement between May 1997 and June 2006, 41 had one or more revision procedures.  There were no deaths following the re-operations.  Band replacement (n = 18), band repositioning (n = 7), conversion to SG (SG, n = 2) and RYGBP (RYGBP, n = 2) or band removal without any further substitution (n = 12) were performed as first reoperation.  Seven patients had a second reoperation.  Median follow-up since reoperation was 56 months (range 7-113).  Excess weight loss (EBWL%) of patients was 59.4% after RYGBP (n = 5), 45.1% after re-banding (n = 18), and 33.4% after SG (n = 2).  Comorbidities were further reduced or even resolved after reoperation. 

Endoluminal/Endoscopic Procedures

Evidence of efficacy of endoluminal primary or revision bariatric procedures is very limited, consisting only of reports of a small number of case series, most from non-United States centers and with 20 or fewer subjects.  The FDA has not cleared the gastric balloon for marketing in the United States.  A survey of members of the ASMBS’ bariatric surgeons have different risk tolerance and weight loss expectations for primary and revisional endoscopic procedures.  They were “willing to accept less weight loss and more risk for revisional endoluminal procedures than for primary endoluminal procedures.”  Durability of the procedures was a concern, and most surgeons were unwilling to consider the procedures until their efficacy has been proven

Use of adjustable banding for BMI >50

Updated information on selection of candidates for adjustable gastric banding, particularly with respect to the relationship between preoperative BMI and postoperative resolution of comorbidities, was also sought for this update.  As noted in previous updates, comparative studies consistently demonstrate that patients who undergo adjustable gastric banding experience slower and smaller weight loss than those having gastric bypass or malabsorptive procedures. 

Brancatisano and colleagues identified 682 patients with type-2 diabetes, impaired glucose tolerance, and metabolic syndrome and at least six-month follow-up in their database of patients who received the Swedish Adjustable Band. They report that remission of type-2 diabetes was dependent on both the magnitude of excess weight loss (P= .008) and the duration of existing diabetes.

Kadera et al. tested the hypothesis that RYGB improves type-2 diabetes by way of metabolic changes, before significant weight loss occurs.  Of 1546 patients with at least 12 months follow-up, 71 had type-2 diabetes and were taking insulin.  Patients who achieved remission, defined as a cessation of diabetic medications and a hemoglobin A1C level of <7%, were compared with those who did not achieve remission.  All 71 patients achieved a reduction in the dose of and/or number of medications at 30 months, and 35 (49%) demonstrated remission.  By multivariate analysis, the significant factors associated with remission were preoperative insulin dose and percent of excess weight loss.  The % EWL was greater in the remission group as early as three months after surgery (P = .04) and at 6, 12, 18 and 24 months.

Citing a number of studies, Snyder et al. states that “it has become clear through most physicians’ clinical experience that those with a greater starting body mass index do not lose as much excess weight as those with a lower starting BMI”.  To determine at what point the BMI is too great for effective weight loss, they collected weight loss data for 430 patients who had had an adjustable gastric band placed and stratified the % EWL within one year for patients with a BMI of 30-59, for BMI groups of 30-39, 30-49, and 50-59 and compared it with the average % EWL over time. Patients with a BMI <46 had a 50% EWL at one year while those with a BMI >46 had a 33% EWL.  The % EWL was significantly different between groups at all measured intervals (P<.0001).  The authors conclude that “a BMI of 46 kg/m² identifies those at high risk of failure to lose a significant percentage of excess weight after adjustable banding and who require closer follow-up” and that “patients should be advised that their weight loss might be suboptimal at one year”.  

Buchwald et al. conducted a systematic review that included 621 studies with 888 treatment arms and 135,246 patients; 103 treatment arms with 3188 patients reported on resolution of diabetes.  Nineteen studies with 43 treatment arms and 11,175 patients reported both weight loss and diabetes resolution separately for 4,070 diabetic patients.  Percent of excess weight loss was greatest for patients who had BPD/DS, followed by GB, gastroplasty, and least for LB.  Overall, 78.1% of diabetic patients had complete resolution and 86.6% had improvement or resolution.  Diabetes resolution by procedure was as follows: biliopancreatic diversion/duodenal switch (95.1% resolved), gastric bypass (80.3%), gastroplasty (79.7%), and laparoscopic adjustable gastric banding (56.7% resolved).  With few exceptions, studies of adjustable gastric banding include patients with preoperative mean BMIs <45 and only a very few include patients with BMIs >50.  Few papers report detailed outcomes on resolution of comorbidities in patients with BMIs >50 who received adjustable gastric bands, sample sizes are very small, resolution in comorbidity is not defined, or reduction and resolution may be combined in outcome measures. 

Angrisani et al. performed a retrospective analysis of the multicenter Italian experience in patients with BMI over 50 who had adjustable gastric banding over a four-year period.  Of 1,797 having the procedure, 239 had BMI >50 (mean 54.6).  Mean % EWL was 34.1 (198 of 198 patients available for follow-up) at 12 months.  Of the 12 patients who were diagnosed with diabetes preoperatively, one achieved resolution (fasting glycemia <110 mg/dl and HbA1C <6% without medication) at one year. 

Tice et al. compared outcomes of LAGB and RYGB in a systematic review.  In five of the 14 included studies, BMI was 50 or more, comparative data on comorbidities was reported in one.  In that study, (reviewed in the 2008 update [42]) 100% of patients in the RYGB group achieved resolution of diabetes vs. 40% of those in the LAGB group.  Resolution of hypertension was reported in 63% of RYGB and 27% of LAGB patients.  The EWL was 52% in the RYGB group compared to 31% in the LAGB group.

In another study reviewed in the previous update, Prarikh et al. compared resolution of diabetes after gastric banding (LAGB), gastric bypass (RYGB), and biliopancreatic diversion (BPD/DS) in 282 patients.  Preoperative BMIs were 47.2 in the LAGB group (n=218), 47.2 in the BPD/DS group (n=11).  Percent excess weight loss at two years was 50% in the LAGB group (68% of patients evaluated), 68% in the RYGB group (56% of patients evaluated) and 77% in the BPD/DS group (64% of patients evaluated).  Preoperatively, oral hypoglycemics were used by 83% of the Lap-Band, 87% of the RYGB, and 82% of the BPD/DS patients and insulin was required by 18%, 28%, and 18% respectively.  At two-year follow-up, 34% of the LAGB group, 13% of the RYGB group and 13% of the BPD/DS group required oral hypoglycemics and 18%, 13%, and 13% respectively required insulin.

Technology Assessments, Guidelines and Position Statements

In January 2009, the ASMBS Emerging Technologies and Clinical Issues Committee issued a Position Statement on Emerging Endosurgical Interventions for Treatment of Obesity.  The committee stated that “use of novel technologies should be limited to clinical trials done in accordance with ethical guidelines of the ASMBS and designed to evaluate the risk and efficacy of the intervention.”  It calls for trials to generate data for risk-benefit analysis, assessments of disability, durability, and resource utilization and notes that dramatic reduction in risk may allow for acceptance of interventions which do not provide durable benefits comparable to currently accepted bariatric procedures.

Summary

Vertical band gastroplasty is no longer the standard of care and the coverage statement is changed to not medically necessary.

There is insufficient evidence for endoluminal bariatric procedures (primary or revision) to draw conclusions regarding the safety and efficacy of these techniques and devices and they are considered experimental, investigational and unproven.

2011 Update

Patient Selection Criteria for Coverage

A requirement that a candidate for bariatric surgery complete a formal, medically supervised weight loss programs of specified duration has been a fixture of HCSC bariatric surgery medical policy for some time. The rationale for this requirement was founded on review and interpretation of available evidence in the scientific medical literature, primarily national consensus guidelines. However, HCSC has decided to modify this requirement based on a current review of the bariatric surgery scientific literature related to required pre-surgery weight loss programs, and including consideration of input from bariatric surgeons and their professional societies. The HCSC policy will no longer require documentation that a morbidly obese member must have completed a pre-surgery weight loss program of specified duration as one of the criteria for benefit coverage of bariatric surgery. This change does not mean, however, that HCSC no longer believes that successful bariatric surgery requires multi-disciplinary support from the member's bariatric surgery program and a life-long commitment to life-style changes.

Coding

Disclaimer for coding information on Medical Policies          

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy.  They may not be all-inclusive.           

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers.  Only the written coverage position in a medical policy should be used for such determinations.           

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

43.7, 43.89, 44.31, 44.68, 44.69, 44.95-44.98, 278.01

ICD-10 Codes

E66.01

Procedural Codes: 00797, 43236, 43633, 43644, 43645, 43770, 43771, 43772, 43773, 43774, 43775, 43842, 43843, 43845, 43846, 43847, 43848, 43886, 43887, 43888, 43999, S2083
References
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  51. Prachand, V.N., DaVee, R.T., et al. Duodenal switch provides superior weight loss in the super-obese (BMI≥50 kg/m²) compared with gastric bypass. Ann Surg (2006) 244:611-19.
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  85. Marceau, P., Biron, S., et al. Duodenal switch improved standard biliopancreatic diversion: a retrospective study. Surg Obes Relat Dis (2009)5(1):43-7.
  86. Ramos, A.C., Galvão, Neto, et al. Laparoscopic duodenal-jejunal exclusion in the treatment of type 2 diabetes mellitus in patients with BMI<30 kg/m2 (LBMI). Obes Surg (2009)19:307-12.
  87. Sánchez-Santos, R., Masdevall, C., et al. Short- and mid-term outcomes of sleeve gastrectomy for morbid obesity: the experience of the Spanish National Registry. Obes Surg (2009) 19(9):1203-10.
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History
June 2012 Policy updated with literature search, reference numbers 100-107 added, policy statement on sleeve gastrectomy changed to medically necessary.
November 2012 Policy updated with literature review, references 5-8, 13,14,18-20,30,31,38-49,50,53-56,61,62,64-66,69-75,78,79,83,85-88,93-101,105,106,108 deleted, references 1-3, 6-15, 51-53, 62, 63, 66, 69 added. Vertical banded gastroplasty removed from list of medically necessary procedures; two-stage procedures added as investigational; policy statement added regarding bariatric surgery in adolescents as medically necessary with special considerations towards psychosocial and informed consent issues.
August 2013 Policy formatting and language revised.  Title changed from "Morbid Obesity: Surgical Management" to "Bariatric Surgery".  Policy statement revised and more restrictive.
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Bariatric Surgery