Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Bariatric Surgery

Policy #:11.03.02r

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

COMMERCIAL

ADULT CRITERIA

Medically Necessary

Bariatric surgery for morbid obesity is considered medically necessary and, therefore, covered for individuals who are 18 years of age or older when all of the following criteria are met:
  • The individual has either of the following:
    • A BMI greater than or equal to 40
    • A BMI between 35 and 40 in conjunction with one or more comorbidities related to obesity (e.g., refractory hypertension, coronary artery disease, type 2 diabetes mellitus, clinically significant obstructive sleep apnea, pseudotumor cerebri, severe nonalcoholic steatohepatitis [NASH])
  • The individual has a documented failed history of medical weight loss.
  • The individual is not currently pregnant and/or breast feeding and has agreed to avoid pregnancy for at least one year postoperatively.
  • The individual has participated in preoperative surgical care, directed and provided by the member's physician or through a multidisciplinary surgical preparatory regimen, including all of the following components:
    • A thorough medical history and physical examination
    • Consultation and instruction by a professional provider on low-calorie diets and an exercise program based on the individual's capability
    • An evaluation by a licensed mental health professional provider that specifically evaluates all of the following: any mental health or substance abuse conditions; the emotional readiness and ability of the individual to make and sustain lifestyle changes; and the adequacy of the individual's support system
  • The individual is scheduled for one of the following operations:
    • Vertical-banded gastroplasty, laparoscopic (CPT code 43659) or open (CPT code 43842)
    • Adjustable gastric banding, laparoscopic (CPT code 43770) or open (CPT code 43843)
    • Sleeve gastrectomy, laparoscopic (CPT code 43775) or open (CPT code 43843)
    • Roux-en-Y gastric bypass with long limb (distal) (greater than 150 cm) (laparoscopic [CPT code 43645] or open [CPT code 43847])
    • Roux-en-Y gastric bypass with short limb (proximal) (150 cm or less) (laparoscopic [CPT code 43644] or open [CPT code 43846])
    • Biliopancreatic diversion, laparoscopic (CPT code 43645) or open (CPT code 43847)
    • Biliopancreatic bypass with duodenal switch (CPT code 43845)

Sleeve Gastrectomy as Part of a Two-Staged Procedure

Sleeve gastrectomy performed as part of a two-staged procedure is considered one surgery for the purposes of the Company's bariatric surgery benefit.

As a risk reduction strategy for individuals who are morbidly obese, sleeve gastrectomy (laparoscopic [CPT code 43775] or open [CPT code 43843]) as part of two-stage procedure is considered medically necessary and, therefore, covered for individuals who are 18 years of age or older when all of the following criteria are met:
  • The individual has a BMI greater than or equal to 50.
  • It is anticipated that the individual will achieve weight loss and a decrease in comorbidities as a result of the first-stage procedure (sleeve gastrectomy) that allows for the performance of a second-stage bariatric surgery procedure (e.g., duodenal switch, Roux-en-Y).
  • The planned second-stage bariatric surgery procedure (e.g., duodenal switch, Roux-en-Y) is to occur within 24 months following the first-stage sleeve gastrectomy procedure.
  • The individual has a documented failed history of medical weight loss.
  • The individual is not currently pregnant and/or breast feeding and has agreed to avoid pregnancy for at least one year postoperatively.
  • The individual has participated in preoperative surgical care, directed and provided by the member's physician or through a multidisciplinary surgical preparatory regimen, including all of the following components:
    • A thorough medical history and physical examination
    • Consultation and instruction by a professional provider on low-calorie diets and an exercise program based on the individual's capability
    • An evaluation by a licensed mental health professional provider that specifically evaluates all of the following: any mental health or substance abuse conditions; the emotional readiness and ability of the individual to make and sustain lifestyle changes; and the adequacy of the individual's support system

Experimental/Investigational

Bariatric surgery for adult individuals who do not meet the medical necessity criteria above, including bariatric surgery for individuals with a BMI less than 50 undergoing sleeve gastrectomy as part of a two-staged procedure for individuals or for individuals with a BMI less than 35, is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

The following procedures are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of these procedures cannot be established by review of the available published peer-reviewed literature:
  • Gastric balloon (CPT code 43999)
  • Malabsorption (regulatory metabolic) surgeries (e.g., jejunoileal bypass, jejunocolic bypass), laparoscopic (CPT code 44238) or open (CPT code 44799)
  • Mini-gastric bypass, laparoscopic (CPT code 43659) or open (CPT code 43999)


ADOLESCENT CRITERIA

Medically Necessary

Bariatric surgery for morbid obesity is considered medically necessary and, therefore, covered for individuals who are younger than 18 years of age when all of the following criteria are met:
  • The individual has any of the following:
    • A BMI greater than or equal to 50
    • A BMI between 40 and 50 in conjunction with one or more less serious comorbidities (e.g., hypertension, insulin resistance, glucose intolerance, dyslipidemia, clinically significant obstructive sleep apnea)
    • A BMI between 35 and 40 in conjunction with one or more major obesity-related comorbidities (e.g., type 2 diabetes mellitus, moderate to severe obstructive sleep apnea [apnea-hypopnea index > 15])
  • The individual has a documented failed history of medical weight loss.
  • The individual is not currently pregnant and/or breast feeding and has agreed to avoid pregnancy for at least one year postoperatively.
  • The individual has participated in preoperative surgical care, directed and provided by the member's physician or through a multidisciplinary surgical preparatory regimen, including all of the following components:
    • A thorough medical history and physical examination
    • Consultation and instruction by a professional provider on low-calorie diets and an exercise program based on the individual's capability
    • An evaluation by a licensed mental health professional provider specializing in pediatric care that specifically evaluates all of the following: any mental health or substance abuse conditions; the emotional readiness and ability of the individual to make and sustain lifestyle changes; and the adequacy of the individual's support system
  • The individual has attained or nearly attained physiologic maturity as defined by one of the following:
    • Tanner Stage IV (skeletal and sexual maturation is almost complete [Refer to Attachment B for the Tanner Staging System criteria.])
    • Ninety-five percent of adult height based on estimates from radiologic bone age
  • The individual is scheduled for one of the following operations:
    • Roux-en-Y gastric bypass with short limb (proximal) (150 cm or less) (laparoscopic [CPT code 43644] or open [CPT code 43846])
    • Roux-en-Y gastric bypass with long limb (distal) (greater than 150 cm) (laparoscopic [CPT code 43645] or open [CPT code 43847])
    • Sleeve gastrectomy, laparoscopic (CPT code 43775) or open (CPT code 43843)

Experimental/Investigational

Bariatric surgery for adolescent individuals who do not meet the medical necessity criteria outlined above is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

MEDICARE ADVANTAGE

MEDICALLY NECESSARY

The Company's Medicare Advantage members are covered according to the following Medicare criteria.

Bariatric surgery procedures are considered medically necessary and, therefore, covered when all of the following criteria are met:
  • The individual has a BMI greater than 35 in conjunction with one or more comorbidities related to obesity (e.g., refractory hypertension, coronary artery disease, type 2 diabetes mellitus, clinically significant obstructive sleep apnea). (Refer to the Coding Table for a list of diagnosis codes that represent BMI ranges greater than 35.)
  • The individual has a documented failed history of medical weight loss.
  • The individual is scheduled for one of the following operations:
    • Adjustable gastric banding (laparoscopic only [CPT code 43770])
    • Roux-en-Y gastric bypass with short limb (proximal) (150 cm or less) (laparoscopic [CPT code 43644] or open [CPT code 43846])
    • Roux-en-Y gastric bypass with long limb (distal) (greater than 150 cm) (laparoscopic [CPT code 43645] or open [CPT code 43847])
    • Sleeve gastrectomy (laparoscopic only [CPT code 43775] as part of a stand-alone procedure)
    • Biliopancreatic bypass with duodenal switch (CPT code 43845)

NON-COVERED

For the surgical intervention of morbid obesity or morbid obesity and type 2 diabetes mellitus in Medicare Advantage members, all other bariatric procedures other than those outlined above as medically necessary are considered not medically necessary because they are not covered by Medicare. These include, but are not limited to, the following procedures:
  • Sleeve gastrectomy as an open (CPT code 43843) stand-alone procedure or as part of a two-stage procedure: laparoscopic (CPT code 43775) or open (CPT code 43843)
  • Adjustable gastric banding as an open (CPT code 43843) procedure
  • Vertical-banded gastroplasty: laparoscopic (CPT code 43659) or open (CPT code 43842) procedure
  • Gastric balloon (CPT code 43999)

Additionally, bariatric surgery is considered not medically necessary and therefore, not covered for individuals with any of the following absolute contraindications as defined by Medicare:
  • Prohibitive perioperative risk of cardiac complications due to cardiac ischemia or myocardial dysfunction
  • Severe chronic obstructive airway disease or respiratory dysfunction
  • Failure to cease tobacco use
  • Psychological/psychiatric condition
    • Schizophrenia, borderline personality disorder, suicidal ideation, severe or recurrent depression, or bipolar affective disorders with difficult-to-control manifestations (e.g., history of recurrent lapses in control or recurrent failure to comply with management regimen)
    • Intellectual disability that prevents personally provided informed consent or the ability to understand and comply with a reasonable pre- and post-operative regimen
    • Any other psychological/psychiatric disorder that, in the opinion of a psychologist/psychiatrist, imparts a significant risk of psychological/psychiatric decompensation or interference with long-term postoperative management
  • History of significant eating disorders, including anorexia nervosa, bulimia, and pica (i.e., ingesting sand, clay, or other abnormal substances)
  • Hepatic disease with prior documented inflammation, portal hypertension, or ascites (i.e., fluid accumulation in the peritoneal cavity)
  • Severe hiatal hernia/gastroesophageal reflux (for purely restrictive procedures such as laparoscopic adjustable gastric banding)
  • Autoimmune and rheumatological disorders (including inflammatory bowel diseases and vasculitides) that will be exacerbated by the presence of intra-abdominal foreign bodies (for the laparoscopic adjustable gastric banding procedure)

Note: A history or presence of mild, uncomplicated, and adequately treated depression due to obesity is not normally considered an absolute contraindication to bariatric surgery.

In accordance with Medicare, repeat bariatric surgery is generally not covered for Medicare Advantage members.

COMMERCIAL AND MEDICARE ADVANTAGE

CONCURRENT CHOLECYSTECTOMY

Cholecystectomy performed in conjunction with bariatric surgery is considered medically necessary and, therefore, covered when the individual has any of the following:
  • Signs and/or symptoms of gallbladder disease
  • Finding of a grossly diseased gallbladder at the time of bariatric surgery
  • A history of metabolic derangements that will result in symptomatic gallbladder disease following bariatric procedures

COMPLICATIONS

Complications of a bariatric surgery procedure may include those associated with any major surgery such as bleeding or infection, but may also include those specific to the bariatric procedure itself or the method (e.g., laparoscopic, open) used. Complications associated with bariatric surgery (including those resulting from a technical failure) usually occur during the 30-day period following the operation. The most common complications include, but are not limited to:
  • Band erosion
  • Band slippage
  • Internal hernia requiring further surgery
  • Leaks from or dehiscence of anastomoses or staple lines
  • Separation of stapled/sutured areas
  • Wound separations
  • Strictures
  • Ulcers
  • Nutritional deficiencies

SECOND BARIATRIC SURGICAL PROCEDURES

If it is NOT specifically excluded under the terms of the member's benefit contract, the following are considered medically necessary for members who met medical necessity criteria for their initial bariatric surgery:
  • Conversion (e.g., to a Roux-en-Y gastric bypass or vertical gastrectomy) for members who have not had adequate success (defined as loss of more than 50 percent of excess body weight) two years following the primary bariatric surgery procedure and who have been compliant with a prescribed nutrition and exercise program following the initial procedure (documented in the letter of medical necessity). In addition, the member must have been examined by a licensed mental health professional provider that specifically evaluates all of the following: any mental health or substance abuse conditions; the emotional readiness and ability of the individual to make and sustain lifestyle changes; and the adequacy of the individual's support system.
  • Revision of a primary bariatric surgery procedure that has failed due to dilation of the gastric pouch where the primary procedure was successful in inducing weight loss prior to the pouch dilation, and the member has been compliant with a prescribed nutrition and exercise program following the initial procedure (documented in the letter of medical necessity)
  • Replacement of an adjustable band due to complications (e.g., port leakage, slippage) that cannot be corrected with band manipulation or adjustments
  • The second stage of a covered two-stage procedure (sleeve gastrectomy and duodenal switch; sleeve gastrectomy and gastric bypass)

For information on benefit limitations, please refer to the Guidelines section of this policy.

PLACE OF SERVICE

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

At the time of precertification of the services listed below, the surgeon must submit a letter of medical necessity (LOMN), attesting that the member has been compliant with a prescribed nutrition and exercise program following the initial procedure.

Services for which the LOMN is required:
  1. Conversion (e.g., to a Roux-en-Y gastric bypass or vertical gastrectomy) for members who have not had adequate success (defined as loss of more than 50 percent of excess body weight) two years following the initial bariatric surgery procedure.
  2. Revision of a primary bariatric surgery procedure that has failed due to dilation of the gastric pouch where the primary procedure was successful in inducing weight loss prior to the pouch dilation.

Guidelines

Refer to the Coding Table for a list of diagnosis codes that represent a BMI of 35 or greater.

Inadequate weight loss or regain of weight is most commonly associated with an individual's noncompliance with postoperative nutrition and exercise recommendations. Individuals who experience inadequate weight loss or weight gain should be evaluated for technical failure of the surgical procedure. Contrast upper gastrointestinal examination is appropriate to ensure the integrity of the gastric reconstruction. Once technical failure of the operation has been excluded, individuals should be referred for dietary counseling.

Note: Surgical intervention in the treatment of obesity is an adjunct to an overall dietary plan and will not result in adequate weight loss in the absence of a conscious effort at dietary control.

CLINICAL TRIALS

Services that are considered experimental/investigational are non-covered services. However, routine services associated with some experimental/investigational services may be covered when they are performed in a qualified clinical trial. For more information, refer to the Company policy on qualifying clinical trials.

There currently exist several clinical trials for laparoscopic adjustable gastric banding in adolescents. These include, but may not be limited to, the following:
  • NCT01619488: Laparoscopic Adjustable Gastric Banding in Adolescents; DuPont Hospital for Children/Nemours Children’s Clinic; Wilmington, Delaware
  • NCT01409928: A Study of the Laparoscopically Placed Adjustable Gastric Band for the Management of Obesity in Adolescent Patients; Children’s Medical Center Dallas; Dallas, Texas
  • NCT01882049: Use of Adjustable Gastric Band in Adolescents; University of Minnesota; Minneapolis, Minnesota
  • NCT01045499: Laparoscopic Adjustable Gastric Banding (LAGB) as a Treatment for Morbid Obesity in Adolescents; Morgan Stanley Children’s Hospital of NY Presbyterian; New York, New York

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, bariatric surgery is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met. However, services that are identified in this policy as experimental/investigational or not medically necessary are not eligible for coverage or reimbursement by the Company.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

SECOND BARIATRIC SURGICAL PROCEDURES

Member benefit contracts may limit bariatric surgery to one surgical procedure per lifetime.

A prior bariatric surgery can be counted towards the lifetime limit under the following circumstances:
  • Fully insured groups: the member is employed by the same employer and the same Carrier provides coverage (e.g., the member was employed by Employer ‘A’ at the time of the first surgery, which was covered by the Company. At the time of the request for the second surgery, the member is still employed by ‘A’ and the Company is still the Carrier). Please note that if the employer group changes Carriers, any surgery performed while the employed was covered by the earlier Carrier will not be counted toward the lifetime limit.
  • Self-insured groups: the member is covered under the same group Health Plan (i.e. employer), but the employer changes claims administrators (e.g., the member was employed by Employer ‘A’ at the time of the first surgery and the Claims Administrator was not the Company. At the time of the request for the second surgery, the member is still employed by ‘A,’ but the Company is now the Claims Administrator).
  • The employer changes its funding status (e.g., the member was employed by Employer ‘A,’ which was fully insured at the time of the first surgery. At the time of the request for the second surgery, the member is still employed by ‘A,’ but ‘A’ has changed its funding status to self-insured).
  • The member changes products (i.e., the member was employed by Employer ‘A’ and enrolled in a Company HMO program at the time of the first surgery. At the time of the request for the second surgery, the member is still employed by ‘A,’ but is now enrolled in a Company PPO program).

Any new or different obesity surgery, revisions, repeat, or reversal of any previous surgery may not be covered even if the new or different procedure intended to treat obesity is medically necessary.

The limitation of coverage for a repeat, reversal, or revision of a previous obesity surgery does not apply when the initial procedure results in technical failure or when the proposed procedure is required to treat complications of the initial procedure, which if left untreated, would result in endangering the health of the individual.

Weight gain or weight plateau resulting from failure to follow the regimen of diet and exercise recommended after the first bariatric surgery would be excluded from coverage for a repeat, reversal, or revision of a previous obesity surgery because the second procedure is not being performed to treat a complication or technical failure of the initial procedure.

MEDICARE

This policy is consistent with Medicare's coverage criteria for Medicare Advantage members. The Company's payment methodology may differ from Medicare.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The Lap-Band® adjustable gastric banding system (BioEnterics Corporation, Carpinteria, CA) received FDA approval on June 5, 2001. The REALIZE™Adjustable Gastric Band (Ethicon Endo-Surgery, Inc., Cincinnati, OH) received FDA approval on September 28, 2007. Supplemental approvals for Lap-Band® adjustable gastric banding system and REALIZE™ Adjustable Gastric Band have since been issued by the FDA. Adjustable gastric banding systems are not indicated for individuals who are younger than 18 years of age.

The Cook Gastric Sizing Balloon Catheter (Cook Incorporated, Bloomington, IN) received FDA approval on July 11, 2003, for use in gastric and bariatric surgical procedures to size the gastric pouch and drain gastric fluid.

BILLING GUIDELINES

Psychiatric evaluations performed prior to bariatric surgery are covered under the member's medical benefit. Reimbursement for the evaluation is in accordance with the performing professional provider's contract.

Description

MORBID OBESITY

Obesity is an increase in body weight beyond the limitation of skeletal and physical requirements caused by an excessive accumulation of fat in the body. Morbid obesity, also referred to as clinically severe obesity, refers to an individual with a body mass index (BMI) of 40 or greater, such as an individual who is 100 pounds over ideal weight.

Morbid obesity is also categorized based on BMI with terms such as super-obese (BMI greater than 50) and super-super obese (BMI greater than 60). BMI is a measurement of excess adipose tissue in the body according to height and weight that is used to quantify body fat.

The immediate cause of obesity is a caloric intake that is persistently higher than caloric output. Obesity may also be caused by illnesses such as hypothyroidism, Cushing's disease, and hypothalamic lesions.

Morbid obesity has been associated with cardiac disease, type 2 diabetes mellitus (type 2 DM), obstructive sleep apnea (OSA), and various cancers. The initial treatment for morbid obesity is usually medical management using conservative measures. Medical management to induce weight loss includes caloric restriction, increased physical activity, US Food and Drug Administration (FDA)--approved weight-loss agents, and behavioral modification.

Another method used for weight loss is supplemented fasting, which combines a low-calorie intake with a supplemented mixture of protein, carbohydrates, vitamins, and minerals. However, prolonged adherence to this diet (2 months or more) has resulted in undesirable results such as loss of body protein, cardiopathology, or, in some cases, sudden death. Therefore, supplemental fasting is not a standard treatment for morbid obesity.

When attempts to induce weight loss through the medical management methods described above have failed, bariatric surgery is often considered as an intervention to treat morbid obesity. Current surgical procedures used for weight loss in morbidly obese individuals have been noted to reduce medication use and, in some cases, eliminate type 2 DM altogether in morbidly obese individuals. The same procedures have been proposed to treat type 2 DM in individuals who are not morbidly obese. However, the available published peer-reviewed literature is insufficient to conclude that these procedures improve health outcomes in individuals who are not morbidly obese (i.e., those with BMI of less than 35). Refer to Attachment A in this policy for BMI charts.

Bariatric surgical procedures reduce caloric intake by modifying the anatomy of the gastrointestinal tract. These procedures are classified as follows:
  • Restrictive procedures
  • Gastric restriction combined with a diversionary procedure
  • Diversionary malabsorptive procedures (regulatory metabolic)

Restrictive procedures, such as adjustable gastric banding and vertical banded gastroplasty, cause weight loss by limiting the capacity of the stomach for food and by slowing the flow of ingested nutrients. Diversionary (alone or combined with a restrictive procedure) and malabsorptive procedures bypass or resect the stomach and also bypass long segments of the small intestine in order to reduce the area of mucosa available for nutrient absorption.

With restrictive procedures, expected weight loss is approximately 50 percent of an individual's pre-surgery body weight. Diversionary procedures provide for a weight loss of as much as 60 to 70 percent of body weight. In general, weight loss with malabsorptive procedures tends to be greater than weight loss with solely restrictive procedures. Studies show that individuals reach their maximum expected weight loss within 2 years of the procedure. Within this 2-year time frame, a normal stretching of the gastric pouch occurs; therefore, unless the individual continues with dietary restrictions and exercise, weight loss will plateau, or the individual may regain weight. A dedicated and experienced team is needed to assess, educate, and manage the individual before and after surgery. Studies have shown that bariatric surgery performed at hospitals with more than 100 cases performed annually is associated with fewer complications and a greater degree of success.

BARIATRIC SURGERY PROCEDURES

The following sections describe bariatric surgery procedures. Many procedures are performed by either a laparoscopic or an open technique.

VERTICAL BANDED GASTROPLASTY (VBG) (RESTRICTIVE) (LAPAROSCOPIC [CPT code 43659], OPEN [CPT code 43842])
VBG limits dietary intake by stapling along the vertical axis to incapacitate part of the stomach. Food empties slowly into the bottom portion of the stomach through a rate-limiting stoma, which is created by a band placed through the stomach wall. VBG was a common surgical procedure in the late 1980s and early 1990s, but because stoma dilation often causes weight regain, VBG has been largely replaced by adjustable band procedures.

Peer-Reviewed Literature

In a randomized controlled trial, Werling et al. (2013) evaluated the long-term results associated with Roux-en-Y gastric bypass (RYGB) and VBG. Of the initial 82 study participants, ultimately 80% (n=66) were randomized to RYGB or VBG and followed for up to 6 years. Outcome measurements included BMI, body composition, eating habits, and gastrointestinal hormones. Frequency of reoperation was also assessed up to 10 years following surgery. Intent-to-treat analyses demonstrated a statistically significantly greater weight loss after RYGB compared with VBG at 6-year follow-up (p = 0.036). RYGB caused a larger loss of fat mass and better preservation of lean tissue as well. Approximately 89% of individuals who initially had VBG had undergone, or were scheduled for, conversion to RYGB at last follow-up. The authors concluded that RYGB was superior to FBG with respect to weight loss, body composition, and dietary composition.

ROUX-EN-Y GASTRIC BYPASS WITH SHORT LIMB (COMBINATION RESTRICTIVE AND MALABSORPTION) (LAPAROSCOPIC [CPT code 43644], OPEN [CPT code 43846])
RYGB with short limb (combination restrictive and malabsorption), also referred to as the traditional gastric bypass, combines a partition of the stomach with a Roux-en-Y tract less than 150 cm, causing the flow of food to bypass the duodenum and proximal small bowel and to be delivered directly to the jejunum, creating a gastroenterostomy.

ROUX-EN-Y GASTRIC BYPASS WITH LONG LIMB (COMBINATION RESTRICTIVE AND MALABSORPTION) (LAPAROSCOPIC [CPT code 43645], OPEN [CPT code 43847])
RYGB with long limb (combination restrictive and malabsorption) consists primarily of long-limb RYGB procedures, which vary in the length of the alimentary and common limbs. The stomach may be bypassed in a variety of ways, involving either resection or stapling along the horizontal or vertical axis. An example of this is to divide the stomach with a long segment of the jejunum (instead of ileum) anastomosed to the proximal gastric stump, creating the alimentary limb. The remaining pancreaticobiliary limb (consisting of stomach remnant), duodenum, and length of proximal jejunum are then anastomosed to the ileum, creating a common limb varying in length, where the ingested food mixes with the pancreaticobiliary juices. The long alimentary limb permits absorption of most nutrients. The short common limb primarily limits fat absorption.

Peer-Reviewed Literature

In a controlled study, Karlsen et al. (2013) evaluated health-related quality of life (HRQL) after RYGB compared to intensive lifestyle intervention (ILI). A total of 139 morbidly obese individuals chose treatment with RYGB (n=76) or ILI (n=63). ILI comprised four stays, each lasting 7 weeks, at a specialized rehabilitation center over the course of 1 year. The daily schedule was divided between physical activity, psychosocially oriented interventions, and motivational approaches. No special diet or weight-loss medications were prescribed. Outcome measurements included HRQL questionnaires before treatment and at 1-year follow-up. BMI, mental health, and emotional health outcomes were all statistically significantly better for individuals undergoing RYGB compared to ILI. The authors concluded that morbidly obese individuals may benefit from both ILI and RYGB, though individuals undergoing RYGB may have better outcomes.

In a multi-center randomized controlled trial, Ikramuddin et al. (2013) evaluated the safety and effectiveness of RYGB compared to lifestyle and intensive medical management to achieve control of obesity-related comorbid factors. One-hundred twenty individuals with type 2 DM and a BMI between 30 and 39.9 were randomized into an RYGB or medical management (MM) group and were followed for 12 months. MM included medications for hyperglycemia, hypertension, and dyslipidemia. Successful outcomes were defined as hemoglobin A1c (HbA1c) levels of less than 7%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mmHg. After 12-month follow-up, 49% of participants (n=28) in the RYGB group and 19% of participants (n=11) in the MM group achieved successful outcomes. Participants in the RYGB group required 3.0 fewer medications and lost 26.1% of their initial body weight compared to only 7.9% of those in the MM group. Regression analyses indicated that the achieved successful outcomes were primarily attributable to weight loss. There were 22 serious adverse events in the RYGB, including 1 cardiovascular event. There were 15 serious adverse events in the MM group. The authors concluded that in mild to moderately obese individuals with type 2 DM, adding RYGB surgery to lifestyle and MM was associated with a greater likelihood to lose weight and control obesity-related comorbid factors.

ADJUSTABLE GASTRIC BANDING (AGB) (RESTRICTIVE) (LAPAROSCOPIC [CPT code 43770], OPEN [CPT code 43843])
AGB was designed to mimic the vertical banded gastroplasty but is a less invasive procedure. Adjustable banding allows the size of the gastric pouch to be altered with the positioning of the band. This adjustable, inflatable band is placed around the exterior of the stomach to narrow the upper stomach and create a small gastric pouch with a rate-limiting stoma. The band has a balloon that is adjusted by injecting or removing saline from an access port, which is placed under the skin in the abdomen. The band is either initially empty or only partially inflated, allowing the individual to get acquainted with the band while healing from the surgery. A band adjustment is usually made 4 to 6 weeks after surgery, depending on the amount of weight that is lost, the amount of food the individual is able to comfortably consume, the amount of exercise in which the individual is participating, and how much fluid was initially placed in the band. Adjustments are done either in the hospital or in a doctor's office. Use of X-ray equipment (fluoroscopy) may be needed to guide the needle into the access port and/or to evaluate the pouch size and the stoma size. Subsequent adjustments may be made based on the needs of the individual. AGB devices are not FDA-approved for individuals under 18 years of age.

Peer-Reviewed Literature

In a randomized controlled trial, Dixon et al. (2008) evaluated the safety and effectiveness of laparoscopic AGB (LAGB) compared to conventional therapy in controlling type 2 DM. Sixty individuals with recently diagnosed (< 2 years) type 2 DM and a BMI between 30 and 40 were enrolled. Of the 60 individuals enrolled, 92% (n=55) completed 2-year follow-up. Outcome measurements included remission of type 2 DM (fasting glucose < 126 mg/dL and HbA1c < 6.2% while taking no glycemic therapy) and weight loss. Remission of type 2 DM was achieved by 73% of the LAGB group (n=22) and 13% of the conventional therapy group (n=4), representing a statistically significant difference. Surgical and conventional therapy groups had a statistically significant reduction of 20.7% and 1.7% of mean weight, respectively, at 2-year follow-up (p < 0.001). There were no serious complications in either group. The authors concluded that individuals undergoing LAGB were more likely to achieve type 2 DM remission through greater weight loss. The study is limited in its relatively small sample size and mid-term follow-up.

In a prospective, randomized controlled trial, Nguyen et al. (2009) compared the outcomes of laparoscopic RYGB and LAGB for the treatment of morbid obesity. Two-hundred fifty individuals with a BMI between 35 and 60 were randomized to RYGB or LAGB. Ultimately, 111 individuals underwent RYGB and 86 individuals underwent LAGB. Outcome measurements included weight loss, changes in QOL, length of hospital stay, and reoperation rates. Treatment failure was defined as less than 20 percent of excess weight loss (EWL) or conversion to another bariatric operation for failure of weight loss. The mean BMI was statistically significantly higher in the RYGB group (p < 0.01), while the mean age was higher in the LAGB group (p < 0.01). Compared with LAGB, operative blood loss was higher and the mean operative time and length of stay were longer in the RYGB group. The 30-day complication rate was higher after RYGB (21.6% vs. 7.0%). However, there were no life-threatening conditions. The percent EWL at 4-year follow-up was higher in the RYGB group (68% vs. 45%, p < 0.05). Treatment failure occurred in 16.7% of individuals undergoing LAGB and in 0% of those undergoing RYGB. The authors concluded that LAGB and RYGB are both safe and effective approaches for the treatment of morbid obesity. RYGB resulted in better weight loss at mid- and long-term follow-up, though may be associated with more perioperative and late complications.

In a multi-center, prospective open-label study, Shayani et al. (2012) reported on the 2-year results of the LAP-BAND AP® trial. Five-hundred seventeen morbidly obese individuals at 50 clinical centers were followed for 2 years after undergoing LAGB. The mean age was 42.5 years and the mean BMI was 44.0. Outcome measurements included percent weight loss and BMI. At 2-year follow-up the mean BMI change was -8.5 and the mean percent weight loss was -19.3%. Obesity-related comorbid conditions were remitted or improved in the majority of study participants at 2 years, including type 2 DM (96), hypertension (91%), gastroesophageal reflux disease (91%), hyperlipidemia (77%), obstructive sleep apnea (86), depression (75%), and osteoarthritis (93%). LAGB was relatively well-tolerated, with 19.1% and 6.0% of individuals reporting device-related adverse events or serious device-related adverse events, respectively. The authors concluded that LAGB was a safe and effective procedure, with clinically meaningful improvements in quality of life (QOL) and obesity-related comorbidities. The study is limited in its lack of a comparative control group.

In a prospective longitudinal cohort study, O'Brien et al. (2013) evaluated the long-term outcomes associated with LAGB. A total of 3227 individuals, with a mean age of 47 years and a mean BMI of 43.8, were treated with LAGB. Follow-up was intact for 81% of study participants overall and 78% for those beyond 10 years. There was no perioperative mortality for the primary placement or any revisional procedures. Study participants demonstrated a mean of 47.1% EWL at 15 years and 62% EWL at 16 years. There was a mean of 47% EWL for all individuals who were followed for at least 10 years. Revisional procedures were performed for proximal enlargement (26%), port and tubing problems (21%), and erosion (3.4%). The need for revision has decreased as the technique evolved, with a 40% revision rate for proximal gastric enlargements in the first 10 years. The revision rate decreased to 6.4% in the last 5 years. The authors concluded that LAGB demonstrates a durable weight loss that is maintained to 15 years. The study is limited in its lack of a comparative control group.

SLEEVE GASTRECTOMY (LAPAROSCOPIC [CPT code 43775], OPEN [CPT code 43843])
Sleeve gastrectomy is a surgical weight-loss procedure in which the stomach is reduced to about 35 percent of its original size by surgical removal of a large portion of the stomach, following the major curve. The open edges are then attached together (often with surgical staples) to form a sleeve or tube with a banana shape. The procedure permanently reduces the size of the stomach. The sleeve gastrectomy was originally developed as the first stage in a two-stage procedure in high-risk individuals with a BMI of more than 60; however, it was later proposed as a stand-alone procedure.

In 2009, the American Society for Metabolic and Bariatric Surgery (ASMBS) issued their Position Statement on Sleeve Gastrectomy as a Bariatric Procedure, stating that the concept of staged bariatric surgery using lower-risk procedures as initial treatment appears to have value as a risk-reduction strategy for high-risk patients, and that, because a significant proportion of individuals have demonstrated durable weight loss after sleeve gastrectomy and might not require conversion to another procedure, it is justifiable to recommend sleeve gastrectomy as an ASMBS-approved bariatric procedure. In 2011, the ASMBS noted that sleeve gastrectomy was considered an acceptable option both as a primary bariatric procedure (stand-alone) and as a first-stage procedure in high-risk individuals as part of a planned 2-stage procedure.

Peer-Reviewed Literature

In a randomized controlled trial, Kehagias et al. (2011) evaluated the safety and effectiveness of LSG compared to gold standard laparoscopic RYGB for the management of obesity in individuals with a BMI less than 50. Sixty study participants were randomized to RYGB or LSG and were monitored for 3 years postoperatively. Outcome measurements included percent EWL, early and late complications, improvement of obesity-related comorbidities, and nutritional deficiencies. There was no statistically significant difference in early and late morbidity in either group and there were no mortalities. Weight loss was statistically significantly better after LSG in the first year of follow-up. At 3-year follow-up, percent EWL reached 62% after RYGB and 68% after LSG, though this did not represent a statistically significantly difference (p = 0.13). There was no statistically significant difference in the overall improvement of comorbidities, and nutritional deficiencies occurred at the same rate in both groups, with the exception of vitamin B12 deficiency, which was more common after RYGB. The authors concluded that both LSG and RYGB were safe and effective in the reduction of comorbidities, while LSG is associated with fewer postoperative metabolic deficiencies. The study is limited in its relatively small sample size and mid-term follow-up period.

In a double-blind randomized controlled trial, Lee et al. (2011) evaluated the safety and effectiveness of LSG compared to gold standard RYGB in moderately obese individuals. Sixty study participants with poorly controlled type 2 DM after conventional treatment of at least 6 months and a BMI between 25 and 35 were randomized into two groups. The primary outcome measurements was remission of type 2 DM, defined as fasting glucose < 126 mg/dL and HbA1c < 6.5% without glycemic therapy. Secondary outcome measurements included weight and metabolic syndrome. At 12-month follow-up, remission of type 2 DM was achieved by 93% (n=28) in the RYGB group and 47% (n=14) of the LSG group, representing a statistically significant difference (p = 0.02). Participants enrolled in the RYGB group lost more weight, achieved a lower waist circumference, and had lower glucose, HbA1c, and blood lipid levels compared to LSG. No serious complications occurred in either group. The authors concluded that individuals undergoing RYGB were more likely to achieve remission of type 2 DM compared to individuals undergoing LSG. The study is limited in its relatively small sample size and short-term follow-up period.

TWO-STAGE PROCEDURE(S) (COMBINATION RESTRICTIVE AND MALABSORPTION) (LAPAROSCOPIC [CPT code 43775], OPEN [CPT code 43843])
Two-stage procedure(s) have been proposed for extremely overweight individuals who are super or super-super obese, with a BMI of 50 to 60 or greater. The theory behind two-stage procedures is that by first performing a procedure such as a laparoscopic sleeve gastrectomy in high-risk, morbidly obese individuals, followed by a second procedure such as a gastric bypass or a biliopancreatic diversion/duodenal switch, complications and mortality can be reduced as a result of the significant weight loss resulting from the earlier procedure.

As a risk-reduction strategy/tool, the two-stage procedure(s) have been shown to be effective in very carefully selected individuals who require short-term weight loss and minimization or reduction of obesity-related comorbidities before undergoing a more complex bariatric procedure.

Peer-Reviewed Literature

In a retrospective study, Cottam et al. (2006) evaluated the safety and effectiveness of LSG as an initial weight-loss procedure for high-risk individuals with morbid obesity. A total of 126 participants underwent LSG, with a mean BMI of 65.3 [range of 45 to 91]. The mean number of co-morbid conditions was 9.3 with a median of 10 [range of 3 to 17]. The incidence of major complications was 13%, with a mean of 46% EWL. Of the initial participants, 36 individuals with a mean post-LSG BMI of 49.1 (38% EWL) had a second-stage RYGB. The mean number of co-morbidities in this post-LSG group was 6.4 (reduced from 9). The mean time interval between the first and second stages was 12.6, with an incidence of major complications of 8%. The mean BMI after the second-stage RYGB was 39 (reduced from 49.1), representing a statistically significant reduction (p < 0.05). The mean number of co-morbidities was reduced to 2. The authors concluded that two-stage LSG followed by RYGB was a safe and effective approach for high-risk individuals with morbid obesity. The study is limited in its retrospective study design and lack of a comparative control group.

In a retrospective study, Alexandrou et al. (2012) evaluated the long-term results of LSG as an initial weight loss procedure in super-morbid obese individuals. Forty-one individuals with a mean BMI of 59.5 underwent LSG. Of these, 29.3% (n=12) achieved a BMI of less than 35 with only LSG and lost 78.7% EWL. The remaining 28 individuals lost 48.1% EWL and achieved a mean BMI of 44.2, requiring a second-stage laparoscopic RYGB. Of these 28 individuals, 10 underwent the second-stage procedure. The mean BMI after second-stage RYGB was 33.6. The authors concluded that two-stage LSG followed by RYGB was an effective treatment plan for individuals with super-morbid obesity. The study is limited in its relatively small sample size, retrospective study design, and lack of a comparative control group.

BILIOPANCREATIC DIVERSION (BPD) (COMBINATION RESTRICTIVE AND MALABSORPTION) (LAPAROSCOPIC [CPT code 43645], OPEN [CPT code 43847])
BPD is also known as the Scopinaro procedure, consisting of a subtotal gastrectomy and diversion of the biliopancreatic juices into the distal ileum by a long Roux-en-Y procedure. The degree of malabsorption depends on the length of the common tract. Due to the high incidence of cholelithiasis (stone formation in the gallbladder) that results from BPD, cholecystectomy is commonly performed with this procedure. BPD consists of the following components:
  • Distal gastrectomy to limit food intake by inducing a temporary early satiety and/or dumping syndrome in the early postoperative period
  • 200 cm alimentary tract made from the ileum to connect the stomach to a common distal segment
  • 300 to 400 cm biliary tract connecting the duodenum, jejunum, and remaining ileum to the common distal segment
  • 50 to 100 cm common tract where food (from the alimentary tract) mixes with biliopancreatic juices (from the biliary tract)

Peer-Reviewed Literature

In a retrospective study, Scopinaro et al. (1996) evaluated the safety and effectiveness of 1968 obese individuals who underwent BPD since 1976. The last consecutive 1217 individuals underwent BPD with a 200-cm alimentary limb, a 50-cm common limb, and a gastric volume varying between 200 and 500 mL. Mean excess weight was 117% and mean age was 37. Individuals were followed for up to 115 months. Outcome measurements included mean percent EWL and complication rates. Mean percent initial EWL at 8 years was 77%. Specific late complications included protein malnutrition (7%), anemia (less than 5%), and stomal ulcer (2.8%). Surgical revision by common limb elongation or by restoration was performed in 1.7% of individuals. The authors concluded that BPD was a safe and effective procedure, but may be dangerous if performed incorrectly. The study is limited in its lack of a comparative control group, retrospective study design, and heterogeneous study population and treatment.

BILIOPANCREATIC BYPASS WITH DUODENAL SWITCH (COMBINATION RESTRICTIVE AND MALABSORPTION [CPT code 43845])
A biliopancreatic bypass with duodenal switch is a variant of the BPD procedure. It involves a partial gastrectomy, in which the pylorus and initial segment of the duodenum are preserved and anastomosed to a segment of the ileum to create the alimentary limb. The goal of this procedure is to limit food digestion and absorption to a shorter, common ileal segment.

Peer-Reviewed Literature

In a randomized controlled trial, Hedberg and Sundom (2012) evaluated the safety and effectiveness RYGB compared to BPD and duodenal switch (BPD/DS), a modification of the Scopinaro BPD procedure. Forty-seven individuals with a mean BMI of 54.5 were randomized to RYGB (n=23) or BPD/DS (n=24). Outcome measurements included BMI and glycated hemoglobin levels. BPD/DS resulted in a statistically significantly greater weight loss than RYGB (-23.2 vs. -16.2 or 80% vs. 51% EWL, p < 0.001). BPD/DS also yielded lower glucose and glycated hemoglobin levels at 3-year follow-up. While more study participants listed troublesome diarrhea and malodorous flatus after BPD/DS, no statistically significant difference was seen. The authors concluded that BPD/DS produced superior weight results and lower glycated hemoglobin levels compared with RYGB in individuals with a BMI greater than 48. The study is limited in its relatively small sample size and lack of long-term follow-up.

In a retrospective study, Pata et al. (2013) evaluated the safety and effectiveness of BPD/DS. A total of 874 individuals with a mean preoperative BMI of 52 underwent the DS procedure. Comorbidities present included hypertension (57%), hypercholesterolemia (87%), hypertriglyceridemia (53%), type 2 DM (35%), and OSA (9%). The mean follow-up was 11.9 years. The median BMI decreased to 33.9 after 1 year following the BPD/DS procedure, 31.1 after 2 to 5 years, 30.9 after 5 to 10 years, and 31.2 after 10 to 15 years. Sixty-seven percent of diabetic individuals were able to stop insulin and 97% were able to stop oral hypoglycemic medications within a year. Blood pressure, triglyceride, and cholesterol levels became normal in greater than 96% of individuals within a year. OSA was resolved within 8 months in all cases. There was no long-term mortality. The authors concluded that BPD/DS was a viable bariatric procedure with excellent long-term outcomes in terms of weight loss, improvement of obesity-related diseases and QOL. The study is limited in its lack of a comparative control group.

ENDOSCOPIC GASTRIC BALLOON (CPT code 43999)
Endoscopic gastric balloon (e.g., Cook gastric sizing balloon catheter) is the implantation or insertion of an inflatable device into the stomach, which is used as a temporary adjunct to diet and behavior modification for individuals who fail to lose weight with conservative measures alone. The balloon is endoscopically inserted into the stomach to reduce its capacity and induce early satiety. The available published peer-reviewed literature is insufficient to establish the safety and/or effectiveness of the endoscopic gastric balloon.

JEJUNOILEAL BYPASS (INTESTINAL BYPASS) (MALABSORPTION) (LAPAROSCOPIC [CPT code 44238], OPEN [CPT code 44799])
Jejunoileal bypass (intestinal bypass) (malabsorption) affects digestion by interrupting the absorption of food, which is accomplished by bypassing a portion of the bowel. Because food is unable to pass through the entire bowel, calories and nutrients are only partially absorbed, resulting in the reduction of body weight. Malabsorption surgeries (e.g., jejunoileal bypass, jejunocolic bypass) are associated with complications such as steatorrhea, electrolyte depletion, liver failure, arthralgia, hypoplasia of bone marrow, avitaminosis, and death. The available published peer-reviewed literature is insufficient to establish the safety and/or effectiveness of jejunoileal bypass for the treatment of obesity.

MINI-GASTRIC BYPASS (LAPAROSCOPIC [CPT code 43659], OPEN [CPT code 43999])
Mini-gastric bypass is similar to the traditional gastric bypass in that a small gastric pouch is created (much lower) in the abdomen. Instead of creating a Roux-en-Y tract to divert biliary juices away from the stomach, the jejunum is anastomosed directly to the stomach, creating a gastrojejunostomy. Because this loop anastomosis can potentially cause biliary reflux gastritis, the Roux-en-Y procedure is typically preferred over the mini-gastric bypass. Research has not demonstrated the safety and/or efficacy of the mini-gastric bypass. The available published peer-reviewed literature is insufficient to establish the safety and/or effectiveness of jejunoileal bypass for the treatment of obesity.

ADOLESCENT CONSIDERATION

The 1998 National Institutes of Health (NIH) Consensus Panel stated that bariatric surgery is an acceptable alternative to achieve sustained weight loss in adults but did not address its use in the adolescent population. However, published literature by Inge et al. (2004) addressed morbid obesity in adolescents and provided guidelines for selecting individuals for bariatric surgery. According to Inge et al. (2004), the optimal timing of bariatric surgery for adolescents depends on variable components, such as skeletal development, psychosocial maturation, decisional capacity, and the support systems available to them.

Girls usually attain skeletal maturity at 13 years of age or older, and boys attain skeletal maturity at 15 years of age or older. These ages represent conservative estimates of skeletal maturity because overweight children often experience an early onset of puberty. Morbidly obese children are likely to achieve skeletal maturity (i.e., adult stature) earlier in adolescence, compared with age-matched, non-overweight children. When there is uncertainty regarding whether skeletal maturity has been attained, bone age can be objectively assessed with radiographs of the hand and wrist. If 95 percent or greater of adult stature (as confirmed by radiography) has been attained, there is little concern that a bariatric procedure may significantly impair linear growth. It is unknown if bariatric surgery may affect bone mineral density adversely and increase the risk of brittle bone fractures later in life. Additionally, several case reports suggest that adolescents may be disproportionately likely to develop thiamine deficiency. Nutritional complications of weight loss surgery are particularly important considerations for adolescents because of their long life expectancy and reproductive capacity.

Additionally, although these severely obese adolescents may be physiologically mature, psychological readiness for a bariatric surgery must be evaluated on an individual basis. An assessment of the individual's family environment with respect to postoperative-regimen adherence is also an important part of the evaluation. Compliance with medication, treatment protocols, and follow-up may be more problematic in adolescents.

In 2008, the Endocrine Society published clinical practice guidelines for the prevention and treatment of obesity in an adolescent population. The guidelines provided recommendations for bariatric surgery in adolescents with a BMI above 50 or above 40 with significant, severe comorbidities who have attained at least a Tanner IV pubertal development and final or near-final adult height. Psychological evaluation confirming stability and competence of the family unit and access to an experienced surgeon in a medical center employing a team capable of long-term follow-up was recommended as well. Bariatric surgery was not recommended for preadolescent children, pregnant or breast-feeding adolescents, or for those planning to become pregnant within 2 years of surgery.

In 2012, the American Society for Metabolic and Bariatric Surgery (ASMBS) released best practice guidelines for the treatment of obese adolescents. The ASMBS highlighted several co-morbid factors related to obesity in adolescents including type 2 DM, OSA, nonalcoholic steatohepatitis (NASH), and pseudotumor cerebri. Because all adolescent boys and girls younger than 18 years of age with a BMI of 35 are considered to be greater than the 99th BMI percentile, the ASMBS indicated that BMI thresholds used for adult selection were appropriate in adolescents. It was recommended that bariatric surgery be considered for adolescents with a BMI between 35 and 40 with major co-morbidities (e.g. type 2 DM, moderate to severe OSA [based on an apnea-hypopnea index > 15], pseudotumor cerebri, or severe NASH). Bariatric surgery should also be considered for adolescents with a BMI greater than 40 and other less serious co-morbidities (e.g. hypertension, insulin resistance, glucose intolerance, substantially impaired QOL, and clinically significant OSA). The ASMBS noted that the current evidence was not sufficiently robust to allow precise discrimination or recommendations for specific bariatric procedures. However, the ASMBS did recognize that substantial efforts should be made to achieve long-term follow-up to limit the associated risks of micronutrient and vitamin deficiencies. It was noted that in the United States, the use of AGB was considered off-label in the adolescent population. The number of sleeve gastrectomies being performed in the adolescent population has increased due to the low short-term complication rates reported in the adult population and the decreased risk of associated nutritional deficiencies.

Peer-Reviewed Literature

In a review of bariatric surgery in obese adolescents, Keidar et al. (2011) indicated that the literature was still lacking. The majority of the peer-reviewed literature consists of retrospective case series which demonstrate relative safety along with significant weight loss. In addition, the vast majority of obesity-related comorbidities were resolved following the procedure. The authors caution that precise patient selection criteria, choice of the procedure, and the extent of the multidisciplinary preoperative and postoperative care are yet to be defined.

In a retrospective cross-sectional study, Kelleher et al. (2013) determined the current rate of inpatient bariatric surgical procedures among adolescents and analyzed the national trends from 2000 to 2009. The primary outcome measurement was the national population based bariatric procedure rate. Secondary outcome measurements included trends in procedure rates and complication rates. The inpatient bariatric procedure rate increased from 0.8 per 100,000 individuals in 2000 to 2.3 per 100,000 in 2003. Since 2003, however, the rate has only increased to 2.4 per 100,000 individuals in 2009. The use of LAGB approached one-third (32.1%) of all procedures by 2009. The prevalence of comorbidities statistically significantly increased from 49.3% in 2003 to 58.6% in 2009 (p = 0.002). The complication rate remained low. The authors concluded that despite the worsening childhood obesity epidemic, the rate of inpatient bariatric procedures among adolescents has plateaued since 2003. The predominant procedure types include RYGB and LAGB. The study did not attempt to compare the safety and effectiveness between procedure types.

In a systematic review, Black et al. (2013) evaluated the current state of the peer-reviewed literature on the safety and effectiveness of bariatric surgery in obese adolescents. Outcome measurements included change in BMI 1-year post-surgery, complication rates, comorbidity resolution, and HRQL. In total, 637 individuals from 23 studies were included. There were statistically significant decreases in BMI at 1-year follow-up, though complications were inconsistently reported. There was some evidence of comorbidity resolution and improvements in HRQL. The authors concluded that bariatric surgery led to significant short-term weight loss in obese adolescents. However, the risk of complications is not well-defined and long-term, prospectively designed studies were needed to firmly establish the harms and benefits of bariatric surgery in an adolescent population. The study is limited in its heterogeneity and lack of comparisons between the various bariatric procedures.

SUMMARY

Morbid obesity remains a concern in both the adult and adolescent populations. There currently exists a large body of literature on bariatric surgery, but few are high-quality randomized controlled trials. The available peer-reviewed literature primarily consists of non-randomized comparative studies and case series which support the conclusion that compared to nonsurgical treatments, bariatric surgery results in greater weight loss and improvements in obesity related comorbidities. RYGB remains the gold standard to which other procedures should be compared, though there exists evidence that sleeve gastrectomy, BPD, and LAGB improve obesity related outcomes.

There remain concerns about the long-term outcomes associated with LAGB, which include band erosion and device slippage. Sakran et al. (2013) indicated that one of the most serious adverse events associated with LAGB is a staple line leak, which requires revision surgery or conversion. However, there exist prospective, randomized controlled trials which indicate that LAGB is associated with successful outcomes and resolution of obesity-related comorbidities. In addition, there exist prospective longitudinal cohort studies that demonstrate a durable weight loss that may be maintained up to 15 years.

Based on clinical input, the available peer-reviewed literature, and guidance from relevant medical societies, bariatric surgery for the treatment of morbid obesity may be appropriate in a select population of individuals with morbid obesity who have a documented failed history of medical weight loss and have participated in a comprehensive preoperative surgical preparatory regimen.

BARIATRIC SURGERY IN INDIVIDUALS WITH A BMI LESS THAN 35

There is limited evidence available on bariatric surgery in individuals with a BMI of less than 35. There exist case series which report a high rate of remission of diabetes in individuals undergoing gastric bypass surgery. A systematic review by Maggard-Gibbons et al. (2013) evaluated the relative benefits and risks associated with surgical and nonsurgical therapies for treating diabetes or impaired glucose tolerance in individuals with a BMI of 30 to 35. The authors noted that bariatric surgery is associated with more short-term weight loss (up to 2 years) and better intermediate glucose outcomes than nonsurgical therapy in individuals with diabetes and a BMI of 30 to 35. The authors concluded that because the data on the long-term benefits and risks of bariatric procedures in this population are unknown, the evidence is insufficient to reach conclusions as the appropriate use of these procedures in individuals with a BMI less than 35.

Bariatric surgery for diabetes in individuals with a BMI less than 35 is not currently considered standard of care and is not supported in current specialty society guidelines. For individuals without diabetes, there is limited evidence on the outcomes of surgery or that health outcomes are improved. As a result, bariatric surgery for individuals with a BMI less than 35 is investigational.

BARIATRIC SURGERY IN ADOLESCENT INDIVIDUALS

There is currently a paucity of data comparing the safety and effectiveness of the various bariatric procedures among adolescents. Long-term outcomes are not yet available. Although the current evidence base is not sufficient to determine which weight loss procedures are optimal for adolescents, it is widely accepted that RYGB has been effective in treating the medical consequences of morbid obesity in adolescents. Additionally, sleeve gastrectomy is increasingly performed in the adolescent population, with successful short- and mid-term results. In the United States, adjustable gastric banding has also become available to adolescents through research studies. However, gastric banding is currently not FDA approved for use in individuals younger than 18 years of age and there is a lack of high-quality evidence (e.g., randomized controlled trials with appropriate comparative controls) supporting its use in an adolescent population. Therefore, its off-label use in adolescents remains experimental/investigational.

Additionally, the appropriate time to intervene with surgical treatment for morbidly obese adolescents is controversial and often depends on the severity of the obesity related comorbidities. The available published peer-reviewed literature strongly recommends that all adolescents who undergo bariatric surgery be monitored throughout their lives in order to attain an optimal weight loss and maintain that weight to improve their overall health status. This is particularly important because there is inadequate data to conclude what impact the surgical treatment of obesity in adolescents will have on either primary or secondary outcomes such as growth and development, familial relationships, and psychological health.
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Centers for Medicare & Medicaid Services (CMS). Bariatric Surgery: Medicare Approved Surgeries. [CMS Web site]. 5/21/2012. Available at:http://www.cms.gov/Medicare/Medicare-General-Information/MedicareApprovedFacilitie/Bariatric-Surgery.html. Accessed September 2, 2014.

Centers for Medicare & Medicaid Services (CMS). Bariatric surgery for treatment of morbid obesity 100.1. [CMS Web site]. 12/17/2013. Available at:http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=57&ncdver=5&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Pennsylvania&KeyWord=bariatric+surgery&KeyWordLookUp=Title&KeyWordSearchType=And&list_type=ncd&bc=gAAAABAAAAAAAA%3d%3d&. Accessed September 2, 2014.

Centers for Medicare & Medicaid Services (CMS). CMS Manual System. CAG-00250R3: Proposed Decision Memo for Bariatric surgery for the treatment of morbid obesity- Facility Certification Requirement. [CMS Web site]. 06/27/13. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=57&ncdver=4&bc=AgAAgAAAAAAAAA%3d%3d&. Accessed September 2, 2014.

Centers for Medicare & Medicaid Services (CMS). CMS Manual System. Transmittal 150. 01/29/13. [CMS Web site].

Centers for Medicare & Medicaid Services (CMS). CMS Manual System. CAG-00250R: Bariatric surgery for the treatment of morbid obesity. [CMS Web site]. 04/28/06. Available at: http://www.cms.hhs.gov/transmittals/downloads/R54NCD.pdf. Accessed September 2, 2014.

Centers for Medicare & Medicaid Services (CMS). Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). 06/27/12. Available at: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=258&fromdb=true. Accessed September 2, 2014.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 100.14:Surgery for the diabetes. [CMS Web site].04/2009.
https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=326&ncdver=1&bc=AgAAgAAAAAAA&. Accessed September 2, 2014.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 100.11: Gastric balloon for treatment of obesity (100.11) [CMS Web site]. 09/18/87. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=111&ncdver=1&bc=AgAAgAAAAAAA&. Accessed September 2, 2014.

Chen B, Kiriakopoulos A, Tsakayannis D, et al. Reinforcement does not necessarily reduce the rate of staple line leaks after sleeve gastrectomy. A review of the literature and clinical experiences. Obes Surg. 2009;19(2):166-72.

Chiu S, Birch DW, Shi X, et al. Effect of sleeve gastrectomy on gastroesophageal reflux disease: a systematic review. Surg Obes Relat Dis. 2010;7(4):510-5.

Chouillard EK, Karaa A, Elkhoury M, et al. Laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy for morbid obesity: case-control study. Surg Obes Relat Dis. 2011;7(4):500-5.

Clinical Issues Committee of American Society for Metabolic and Bariatric Surgery. Sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis. 2007;3(6):573-6.

Colquitt JL, Picot J, Loveman E, Clegg AJ. Surgery for obesity. Cochrane Database Syst Rev. 2009;(2):CD003641.

Company Benefit Contracts.

Cottam D, Qureshi FG, Mattar SG, et al. Laparoscopic sleeve gastrectomy as an initial weight-loss procedure for high-risk patients with morbid obesity. Surg Endosc. 2006;20(6):859-63.

Crookes PF. Surgical treatment of morbid obesity. Annu Rev Med. 2006;57:243-64.

Dapri G, Vaz C, Cadiere GB, Himpens J. A prospective randomized study comparing two different techniques for laparoscopic sleeve gastrectomy. Obes Surg. 2007;17(11):1435-41.

DeMaria EJ. Bariatric surgery for morbid obesity. N Engl J Med. 2007;356(21):2176-83.

D’Hondt M, Vanneste S, Pottel H, et al. Laparoscopic sleeve gastrectomy as a single-stage procedure for the treatment of morbid obesity and the resulting quality of life, resolution of comorbidities, food tolerance, and 6-year weight loss. Surg Endosc. 2011;25(8):2498-504.

Dixon JB, O'Brien PE, Playfair J, et al. Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. JAMA 2008; 299(3):316-23.

Farrell TM, Haggerty SP, Overby DW, et al. Clinical application of laparoscopic bariatric surgery: an evidence-based review. Surg Endosc. 2009;23(5):930-49.

Felberbauer FX, Langer F, Shakeri-Manesch S, et al. Laparoscopic sleeve gastrectomy as an isolated bariatric procedure: intermediateterm results from a large series in three Austrian centers. Obes Surg. 2008;18:814-8.

Frezza EE, Reddy S, Gee LL, Wachtel MS. Complications after sleeve gastrectomy for morbid obesity. Obes Surg. 2009;19:684-7.

Fuller W, Rasmussen JJ, Ghosh J, Ali MR.Is routine cholecystectomy indicated for asymptomatic cholelithiasis in patients undergoing gastric bypass? Obes Surg. 2007 Jun;17(6):747-51.

Gagner M, Deitel M, Kalberer TL, et al. The Second International Consensus Summit for Sleeve Gastrectomy, March 19-21, 2009. Surg Obes Relat Dis. 2009;5(4):476-85.

Gagner M, Gumbs AA. Gastric banding: conversion to sleeve, bypass, or DS. Surg Endosc. 2007;21:1931-35.

Gagner M, Gumbs AA, Milone L, et al. Laparoscopic sleeve gastrectomy for the super-super-obese (body mass index _60 kg/m(2)). Surg Today 2008;38:399-403.

Guh D, Zhang Wei, Bansback N, et al. The incidence of co-morbidies related to obesity and overweight: a systematic review and meta-analysis. BMC Public Health. 2009;9:88. Also available on the BMC Web site at: http://www.biomedcentral.com/1471-2458/9/88. Accessed September 2, 2014.

Hakeam HA, O’Regan PJ, Salem AM, et al. Inhibition of C-reactive protein in morbidly obese patients after laparoscopic sleeve gastrectomy. Obes Surg. 2008;19:456-60.

Hamoui N, Anthone GJ, Kaufman HS, Crookes PF. Sleeve gastrectomy in the high-risk patient. Obes Surg. 2006;16(11):1445-9.

Harper J, Madan AK, Ternovits CA, Tichansky DS. What happens to patients who do not follow-up after bariatric surgery? Am Surg. 2007;73(2):181-4.

Hedberg J, Sundom M. Superior weight loss and lower HbA1c 3 years after duodenal switch compared with Roux-en-Y gastric bypass -- a randomized controlled trial. Surg Obes
Relat Dis. 2012;8(3):338-43.

Helmio M, Victorzon M, Ovaska J, et al. SLEEVEPASS: a randomized prospective multicenter study comparing laparoscopic sleeve gastrectomy and gastric bypass in the treatment of morbid obesity: preliminary results. Surg Endosc. 2012;26(9):2521-6.

Himpens J, Dapri G, Cadiere GB. A prospective randomized study between laparoscopic gastric banding and laparoscopic isolated sleeve gastrectomy: results after 1 and 3 years. Obes Surg. 2006;16(11):1450-6.

Himpens J, Dobbeleir J, Peeters G. Long-term results of laparoscopic sleeve gastrectomy for obesity. Ann Surg. 2010;252(2):319-24.

Inge TH, Krebs NF, Garcia VF, et al. Bariatric surgery for severely overweight adolescents: concerns and recommendations. Pediatrics. 2004;114(1):217-23.

Institute for Clinical Systems Improvement. Prevention and Management of Obesity (Mature Adolescents and Adults). 2009. Available at: https://www.icsi.org/_asset/5qw5rd/ObesityAdutsSoC.pdf. Accessed September 2, 2014.

Ikramuddin S, Korner J, Lee WJ, et al. Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia: the Diabetes Surgery Study randomized clinical trial. JAMA. 2013;309(21):2240-9.

Kadera BE, Lum K, Grant J, et al. Remission of type 2 diabetes after Roux-en-y gastric bypass is associated with greater weight loss. Surg Obes Relat Dis. 2009;5(3):305-9.

Kakoulidis TP, Karringer A, Gloaguen T et al. Initial results with sleeve gastrectomy for patients with class I obesity (BMI 30-35 kg/m2). Surg Obes Relat Dis 2009; 5(4):425-8

Karamanakos SN, Vagenas K, Kalfarentzos F, Alexandrides TK. Weight loss, appetite suppression, and changes in fasting and postprandial ghrelin and peptide-YY levels after Roux-en-Y gastric bypass and sleeve gastrectomy: a prospective, double blind study. Ann Surg. 2008;247(3):401-7.

Karlsen TI, Lund RS, Roislien J, et al. Health related quality of life after gastric bypass or intensive lifestyle intervention: a controlled clinical study. Health Qual Life Outcomes. 2013;13(11):11-17.

Kasalicky M, Michalsky D, Housova J, et al. Laparoscopic sleeve gastrectomy without an over-sewing of the staple line. Obes Surg. 2008;18:1257-62.

Kefly AS, Barlow SB, Rao G, Inge TH, Hayrnan LL, et al. Severe Obesity in Children and Adolescents: Identification, Associated Health Risks, and Treatment Approaches: A Scientific Statement From the American Heart Association. Circulation. 2013 128:00-00.

Kehagias I, Karamanakos SN, Argentou M, et al. Randomized clinical trial of laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy for the management of patients with BMI < 50 kg/m2. Obes Surg. 2011;21(11):1650-6.

Keidar A, Hect L, Weiss R. Bariatric surgery in obese adolescents. Curr Opin Clin Nutr Metab Care. 2011;14(3):286-90.

Kelleher DC, Merrill CT, Cottrell LT, Nadler EP, Burd RS. Recent national trends in the use of adolescent inpatient bariatric surgery: 2000 through 2009. JAMA Pediatr. 2013;167(2):126-32.
Lakdawala MA, Bhasker A, Mulchandani D, et al. Comparison between the results of laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass in the Indian population: a retrospective 1 year study. Obes Surg. 2010;20(1):1-6.

Lee WJ, Chong K, Ser KH, et al. Gastric bypass vs sleeve gastrectomy for type 2 diabetes mellitus: a randomized controlled trial. Arch Surg. 2011;146(2):143-8.

Lee WJ, Wang W, Lee YC, et al. Effect of laparoscopic mini-gastric bypass for type 2 diabetes mellitus: comparison of BMI>35 and <35 kg/m2. J. Gastrointest. Surg. 2008; 12(5):945-52.

Leyba JL, Aulestia SN, Liopis SN. Laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy for the treatment of morbid obesity. A prospective study of 117 patients. Obes Surg. 2011; 21(2):212-6.

Levitsky LL, Misra M, Boepple PA, Hoppin AG. Adolescent obesity and bariatric surgery. Curr Opin Endocrinol Diabetes Obes. 2009;16(1):37-44.

Livingston EH. Complications of Bariatric Surgery. Surg Clin North Am. 2005;85(4):853-68.

Lynn CH, Miller JL. Bariatric surgery for obese adolescents: should surgery be used to treat the childhood obesity epidemic? Pediatr Health. 2009;3(1):33-40.

Maggard-Gibbons M, Maglione M, Livhits M, Ewing B et al. Bariatric surgery for weight loss and glycemic control in nonmorbidly obese adults with diabetes: A systemic review. JAMA2013; 309(21):2250-2260.

Mechanick JI, Kushner RF, Sugerman HJ, et al. American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery medical guidelines for clinical practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient. Obesity (Silver Spring). 2009;17:Suppl 1:S1-70.

Mechanick JI, Youdim A, Jones DB, Garvey WT et al. Clinical Practice Guidelines for the Perioperative Nutritional, Metabolic, and Nonsurgical Support of the Bariatric Surgery Patient —2013 Update : Cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery. AACE/TOS/ASMBS Bariatric Surgery Clinical Practice Guidelines, Endocr Pract. 2013;19(No. 2) Available at: https://www.aace.com/files/publish-ahead-of-print-final-version.pdf. Accessed September 2, 2014.

Medscape Diabetes and Endocrinology. Calculating BMI for Children and Teens: Downloadable Tools. [Medscape Web site]. 4/29/11. Available at: http://www.medscape.org/viewarticle/741573. Accessed September 2, 2014.

Michalsky M, Reichard K, Inge T, Pratt J. et al. Update ASMBS pediatric committee best practice guidelines. Surgery for Obesity and Related Diseases 8(2012) 1-7. Also available at: http://s3.amazonaws.com/publicASMBS/GuidelinesStatements/Guidelines/ASMBS%20Pediatric%20Committee%20Best%20Practice%20Guidelines%20Sep%202011.pdf. Accessed September 2, 2014.

Milone L, Strong V, Gagner M. Laparoscopic sleeve gastrectomy is superior to endoscopic intragastric balloon as a first stage procedure for super-obese patient (BMI > or =50). Obes Surg. 2005;15(5):612-17.

Mingrone G, Panunzi S, De Gaetano A et al. Bariatric surgery versus conventional medical therapy for type 2 diabetes. N. Engl. J. Med. 2012; 366(17):1577-85.

Mognol P, Chosidow D, Marmuse JP. Laparoscopic conversion of laparoscopic gastric banding to Roux-en-Y gastric bypass: a review of 70 patients. Obes Surg. 2004;14(10):1349-53.

Morton JM. Weight gain after bariatric surgery as a result of large gastric stoma: endotherapy with sodium morrhuate to induce stomal stenosis may prevent the need for surgical revision. Gastrointest. Endosc. 2007; 66(2):246-7.

Moszkowicz D, Arienzo R, Khettab I, Rahmi G, Zinzindohoue F, Berger A, Chevallier JM. Sleeve gastrectomy severe complications: is it always a reasonable surgical option? Obes Surg. 2013;23(5):676-86.

Mount Sinai Program for Surgical Weight Loss, The. The Sleeve Gastrectomy, or 2-Stage Procedure. [Surgically Slim Web site]. 03/01/06. Available at: http://surgicallyslim.com/sleeve.htm. Accessed September 2, 2014.

Mui WL, Ng EK, Tsung BY, et al. Laparoscopic sleeve gastrectomy in ethnic obese Chinese. Obes Surg. 2008;18:1571-4.

National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI). The Practice Guide - Identification, Evaluation, and Treatment of Overweight and Obesity in Adults (NIH publication no. 00-4084). [NHLBI Web site]. 10/01/00. Available at: http://www.nhlbi.nih.gov/guidelines/obesity/prctgd_c.pdf. Accessed September 2, 2014.

Nguyen NT, Hohmann S, Slone J, Varela E, Smith BR, Hoyt D. Improved Bariatric Surgery Outcomes for Medicare Beneficiaries After Implementation of the Medicare National Coverage Determination. Arch Surg. 2010;145(1):72-78.

Nguyen NT, Slone Ja, Nguyen XM, et al. A prospective randomized trial of laparoscopic gastric bypass versus laparoscopic adjustable gastric banding for the treatment of morbid obesity: outcomes, quality of life, and costs. Ann Surg. 2009;250(4):631-41.

Nguyen NT, Longoria M, Gelfand DV, et al. Staged laparoscopic Roux-en-Y: a novel two-stage bariatric operation as an alternative in the super-obese with massively enlarged liver. Obes Surg. 2005;15(7):1077-81.

Nguyen NT, Paya M, Stevens CM, et al. The relationship between hospital volume and outcome in bariatric surgery at academic medical centers. Ann Surg. 2004;240(4):586-93.

Nguyen NT, Rivers R, Wolfe BM. Factors associated with operative outcomes in laparoscopic gastric bypass. J Am Coll Surg. 2003;197(4):548-55.

O’Brien PE, Sawyer SM, Laurie C, et al. Laparoscopic adjustable gastric banding in severely obese adolescents: a randomized trial. JAMA. 2010;303(6):519-26.

O'Brien PE, MacDonald L, Anderson M, et al. Long-term outcomes after bariatric surgery: fifteen-year follow-up of adjustable gastric banding and a systematic review of the bariatric surgical literature. Ann Surg. 2013;257(1):87-94.

Ou Yang O, Loi K, Liew V, et al. Staged laparoscopic sleeve gastrectomy followed by Roux-en-Y gastric bypass for morbidly obese patients: a risk reduction strategy. Obes Surg. 2008;18:1575-80.

Parikh M, Gagner M, Heacock L, et al. Laparoscopic sleeve gastrectomy: does bougie size affect mean %EWL? Short-term outcomes. Surg Obes Relat Dis. 2008;4:528-33.

Pata G, Crea N, Di Betta E, Bruni O, Vassallo C, Mittempergher F. Biliopancreatic diversion with transient gastroplasty and duodenal switch: long-term results of a multicentric study. Surgery. 2013;153(3):413-22.

Peterli R, Wolnerhanssen B, Peters T, et al. Improvement in glucose metabolism after bariatric surgery: comparison of laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy: a prospective randomized trial. Ann Surg. 2009;250(2):234-41.

Prachand VN, DaVee RT, Alverdy JC. Duodenal switch provides superior weight loss in the super-obese (BMI > or =50 kg/m2) compared with gastric bypass. Ann Surg.2006;244(4):611-19.

Quesada BM, Roff HE, Kohan G, et al. Laparoscopic sleeve gastrectomy as an alternative to gastric bypass in patients with multiple intraabdominal adhesions. Obes Surg. 2008;18:566-8.

Ramon JM, Salvans S, Crous X, et al. Effect of Roux-en-Y gastric bypass vs sleeve gastrectomy on glucose and gut hormones: a prospective randomised trial. J Gastrointest Surg. 2012;16(6):1116-22.

Regan JP, Inabnet WB, Gagner M, Pomp A. Early experience with two-stage laparoscopic Roux-en-Y gastric bypass as an alternative in the super-obese patient. Obes Surg. 2003;13(6):861-4.

Rodgers BM. Bariatric surgery for adolescents: a view from the American Pediatric Surgical Association. Pediatrics.2004;114;255-6.

Rubin M, Yehoshua RT, Stein M, et al. Laparoscopic sleeve gastrectomy with minimal morbidity early results in 120 morbidly obese patients. Obes Surg. 2008;4:33-8.

Sakorafas GH, Milingos D, Peros G. Asymptomatic cholelithiasis: is cholecystectomy really needed? A critical reappraisal 15 years after the introduction of laparoscopic cholecystectomy. Dig Dis Sci. 2007;52(5):1313-25..

Sakran N, Goiten D, Raziel A, et al. Gastric leaks after sleeve gastrectomy: a multicenter experience with 2,834 patients. Surg Endosc. 2013;27(1):240-5.

Saltzman E, Anderson W, Apovian CM, et al. Criteria for patient selection and multidisciplinary evaluation and treatment of the weight loss surgery patient. Obes Res. 2005;13(2):234-243.

Sánchez-Santos R, Masdevall C, Baltasar A, 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.

Scopinaro N, Gianetta E, Adami GF, et al. Biliopancreatic diversion for obesity at eighteen years. Surgery. 1996;119:261-8.

Schauer PR, Kashyap SR, Wolski K et al. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N. Engl. J. Med. 2012; 366(17):1567-76.

Shayani V, Voellinger D, Liu C, et al. Safety and efficacy of the LAP-Band AP adjustable gastric band in the treatment of obesity: results at 2 years. Postgrad Med. 2012;124(4):181-8.

Shekelle PG, Morton SC, Maglione M, et al. Pharmacological and Surgical Treatment of Obesity. Summary Report/Technology Assessment: Number 103. Agency for Healthcare Research and Quality (AHRQ) Publication Number 04-E028-1. [AHRQ Web site]. 07/01/04. Available at: http://www.ahrq.gov/clinic/epcsums/obesphsum.htm. Accessed September 2, 2014.

Silecchia G, Boru C, Pecchia A, et al. Effectiveness of laparoscopic sleeve gastrectomy (first stage of biliopancreatic diversion with duodenal switch) on co-morbidities in super-obese high-risk patients. Obes Surg. 2006;16:1138-44.

Silecchia G, Rizzello M, Casella G, et al. Two-stage laparoscopic biliopancreatic diversion with duodenal switch as treatment of high-risk super-obese patients: analysis of complications. Surg. Endosc. 2009; 23(5):1032-7.

Sjostrom L, Narbro K, Sjostrom CD, et al. Effects of bariatric surgery on mortality in Swedish obese subjects. N. Engl. J. Med. 2007; 357(8):741-52.

Skrekas G, Lapatsanis D, Stafyla V, Papalambros A. One year after laparoscopic “tight” sleeve gastrectomy: technique and outcome. Obes Surg. 2008;18:810-13.

Snyder B, Scarborough T, Yu S, et al. Failure of adjustable gastric banding: starting BMI of 46 kg/m2 is a fulcrum of success and failure. Surg Obes Relat Dis. 2009;5(3):310-6.

Society of American Gastrointestinal and Endoscopic Surgeons. Guidelines for Clinical Application of Laparoscopic Bariatric Surgery. [ SAGES Web site]. March 2008. Available at:http://www.sages.org/publications/guidelines/guidelines-for-clinical-application-of-laparoscopic-bariatric-surgery/. Accessed September 2, 2014.

Takata MC, Campos GM, Ciovica R, et al. Laparoscopic bariatric surgery improves candidacy in morbidly obese patients awaiting transplantation. Surg Obes Relat Dis. 2008;4:159-65.

Tarantino I, Warschkow R, Steffen T, Bisang P, et al. Is routine cholecystectomy justified in severely obese patients undergoing a laparoscopic Roux-en-Y gastric bypass procedure? A comparative cohort study. Obes Surg. 2011 Dec;21(12):1870-8. doi: 10.1007/s11695-011-0495-x.

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Tucker ON, Szomstein S, Rosenthal RJ. Indications for sleeve gastrectomy as a primary procedure for weight loss in the morbidly obese. J Gastrointest Surg. 2008;12(4):662-7.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

FOR ALL LINES OF BUSINESS, PLEASE REFER TO THE POLICY SECTION FOR COVERAGE CRITERIA

43644, 43645, 43659, 43770, 43775, 43842, 43843, 43845, 43846, 43847, 43999, 44238, 44799

THE FOLLOWING PROCEDURE CODES REPRESENT REVISIONS TO BARIATRIC SURGERY PROCEDURES OR REMOVAL/REPLACEMENT OF BARIATRIC SURGERY COMPONENTS
43659, 43771, 43772, 43773, 43774, 43848, 43886, 43887, 43888



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

See Attachment C


HCPCS Level II Code Number(s)



S2083 Adjustment of gastric band diameter via subcutaneous port by injection or aspiration of saline



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Bariatric Surgery
Description: Body Mass Index (BMI) Charts

Attachment B: Bariatric Surgery
Description: Tanner Staging System Criteria for Adolescents

Attachment C: Bariatric Surgery
Description: ICD-10-CM codes




Policy History

Revision from 11.03.02r
12/19/2018This policy has been reissued in accordance with the Company's annual review process.
10/01/2018This policy was identified for the ICD-10 code update, effective 10/01/2018.

The following ICD-10 codes have been deleted from this policy: T81.4XXA, T81.4XXD, T81.4XXS

The following ICD-10 codes have been added to this policy: T81.40XA, T81.40XD, T81.40XS, T81.41XA, T81.41XD, T81.41XS, T81.42XA, T81.42XD, T81.42XS, T81.43XA, T81.43XD, T81.43XS, T81.44XA, T81.44XD, T81.44XS,T81.49XA, T81.49XD, T81.49XS


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 10/01/2018
Version Issued Date: 11/09/2018
Version Reissued Date: 12/19/2018

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Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.