Clinically severe obesity is a result of persistent and uncontrollable weight gain that constitutes a present or potential threat to life. There are a variety of surgical procedures intended for the treatment of clinically severe obesity. This document addresses those procedures.

Medically Necessary: 

Gastric bypass and gastric restrictive procedures with a Roux-en-Y procedure up to 150 cm, laparoscopic adjustable gastric banding (for example, the Lap-Band^® System or the REALIZE^™ Adjustable Gastric Band), vertical banded gastroplasty, or biliopancreatic bypass with duodenal switch as a single surgery, is considered medically necessary for the treatment of clinically severe obesity for selected adults (18 years and older) who meet ALL the following criteria:

1. BMI of 40 or greater, or BMI of 35 or greater with co-morbid conditions including, but not limited to, life threatening cardio-pulmonary problems (severe sleep apnea, Pickwickian syndrome and obesity related cardiomyopathy), diabetes mellitus, cardiovascular disease or hypertension; AND
2. The patient must have actively participated in non-surgical methods of weight reduction; these efforts must be fully appraised by the physician requesting authorization for surgery; AND
3. The physician requesting authorization for the surgery must confirm the following:
   • The patient's psychiatric profile is such that the patient is able to understand, tolerate and comply with all phases of care and is committed to long-term follow-up requirements; and
   • The patient's post-operative expectations have been addressed; and
   • The patient has undergone a preoperative medical consultation and is felt to be an acceptable surgical candidate; and
   • The patient has undergone a preoperative mental health assessment and is felt to be an acceptable candidate; and
   • The patient has received a thorough explanation of the risks, benefits, and uncertainties of the procedure; and
   • The patient's treatment plan includes pre- and post-operative dietary evaluations and nutritional counseling; and
   • The patient's treatment plan includes counseling regarding exercise, psychological issues and the availability of supportive resources when needed. 

Surgical repair following gastric bypass and gastric restrictive procedures is considered medically necessary when there is documentation of a surgical complication related to the original surgery, such as a fistula, obstruction, erosion, disruption/leakage of a suture/staple line, band herniation, or pouch enlargement due to vomiting.  

Not Medically Necessary: 

Stretching of a stomach pouch formed by a previous gastric bypass/restrictive surgery, due to the patient overeating, does not constitute a surgical complication and the revision of this condition is considered not medically necessary. 

Investigational and Not Medically Necessary: 

Gastric bypass, using a Billroth II type of anastomosis (also known as a "mini gastric bypass") is considered investigational and not medically necessary as a treatment of clinically severe obesity. 

Malabsorptive procedures including, but not limited to, jejunoileal bypass, biliopancreatic bypass without duodenal switch, or very long limb (>150 cm) gastric bypass (other than the biliopancreatic bypass with duodenal switch) are considered investigational and not medically necessary as a treatment of clinically severe obesity.

Surgical repair or revision following a gastric bypass or gastric restrictive procedure is considered investigational and not medically necessary other than to treat surgical complications of the original surgery, as stated above.

All other surgical gastric bypass/restrictive procedures not listed above as medically necessary are considered investigational and not medically necessary including, but not limited to, minimally invasive endoluminal gastric restrictive surgical techniques, such as use of the EndoGastric StomaphyX^™ endoluminal fastener and delivery system and sleeve gastrectomy (by open or laparoscopic approach).

Further Consideration: 

A bariatric surgeon with experience in the pediatric population may request further consideration of a case of an individual under 18 years old with severe morbid obesity and unique circumstances by contacting a Medical Director.

At this time, there is sufficient evidence in the peer-reviewed medical literature to support the use of gastric bypass with a Roux-en-Y procedure up to 150 cm and/or vertical banded gastroplasty for the indication of clinically severe obesity. The evidence suggests that these procedures are beneficial for this indication in a selected group of individuals. The most compelling evidence for an improvement in comorbid conditions comes from the Swedish Obese Subjects (SOS) intervention trial that reported a large reduction in diabetes over a 5.5 year mean follow-up for the surgery group. While there is substantial evidence that these procedures can facilitate significant weight loss and improve co-morbidities in clinically severe obese individuals, perioperative mortality may occur in such individuals as well, occurring at a rate of approximately 1 in 200 procedures. In order to minimize potential morbidity and mortality, individuals who undergo such treatment should meet specific criteria prior to undergoing the procedure. The evidence supporting this conclusion includes properly randomized controlled trials.

There is also sufficient evidence to support the use of the biliopancreatic bypass with duodenal switch for individuals who have clinically severe obesity. Mortality is similar to the Roux-en-Y procedure, and the evidence suggests that up to 70% excess weight loss (EWL) can be maintained over long-term follow-up (up to 6 years post-surgery). The evidence supporting this conclusion includes multiple large case series. 

There is now sufficient U.S. data available supporting the safety and efficacy of laparoscopic adjustable gastric banding, using FDA-approved devices, such as the Lap-Band^® system or the REALIZE^™ Adjustable Gastric Band, for the treatment of clinically severe obesity. While EWL with a laparoscopic adjustable gastric banding procedure is more gradual than with other bariatric surgical procedures, studies with up to three years follow-up have shown that an EWL of 40% to 60% can be achieved. This is accompanied by improvements in quality of life scores. Recent improvements in the band design and use of the "pars flaccida" surgical approach have resulted in a lower complication rate. Both international and U.S. case studies have reported mortality rates for the laparoscopic gastric banding procedure that are lower than the mortality rates found for most other bariatric procedures, including the standard Roux-en-Y gastric bypass. The evidence supporting this conclusion includes large case studies, including a single-surgeon, single-institution non-randomized case series (Jan, 2005) that studied 219 patients undergoing laparoscopic gastric bypass and 154 patients undergoing laparoscopic gastric banding. On average, patients in the former group were observed to require 58 additional minutes of operating time, lost 15 cc more blood, and stayed 1.3 more days in the hospital, but after 12 months lost 64% vs. 36% of their excess weight, as compared with the laparoscopic banding group. By 36 months, excess weight loss was 60% vs. 57%, respectively, but by this time 20% of laparoscopic banding patients required reoperation vs. 10% in the gastric bypass group. In this study, degree of obesity did not seem to matter as much in those receiving laparoscopic banding, but in those receiving laparosopic bypass, excess weight loss during the first two years was less in those with higher BMI. The significant majority of individuals in this case series had BMI < 50.

Conversely, in another single-institution case series (Myers, 2006) reporting on 352 individuals, a retrospective review of 53 patients with initial BMI > 60 who underwent laparoscopic banding revealed that 28% of excess weight was lost by 12 months, and 35% by 18 months. Within this group, four patients had extended hospital stays, due to transient post-operative obstruction from edema. Other postoperative complications included one band removal for chronic obstruction, one band revision for slippage, and one nonfatal pulmonary embolism. The remaining group, with BMI < 60, demonstrated more rapid excess weight lost, averaging 36% at 12 months and 45% by 18 months. There was no statistically significant difference in postoperative complication rates in patients with preoperative BMI > 60 and those with preoperative BMI < 60. There is no prospective, randomized controlled data available with regard to studies directly comparing the Lap-Band^® system vs Roux-en-Y for individuals with BMI > 50. In summary, there is conflicting information, coming purely from case series data, as to the effectiveness of the Lap-Band^® system in patients with BMI > 50. However, based on national physician specialty society recommendations, and the views of a wide array of medical practitioners practicing in this clinical area, the use of the Lap-Band^® system for patients with initial BMI > 50 was felt to be in accordance with generally accepted standards of medical practice at this time.

There are relatively few randomized comparative studies evaluating the relative risk and benefit of each of the surgical options. Furthermore, long-term results (>6 years) are not abundant for any of the bariatric procedures. Thus, the quality of evidence to guide operative choice by surgeon and patient is fair at best, based primarily on single-institution case series. At this time, there is insufficient convincing evidence in the peer-reviewed medical literature, in terms of safety, to support the use of "mini gastric bypass," sleeve gastrectomy, and malabsorptive procedures, other than the biliopancreatic bypass with duodenal switch, in individuals with clinically severe obesity. Therefore, these procedures cannot be recommended for such individuals. The investigational status of these procedures is based on the judgment that there is insufficient evidence to demonstrate that the increased risks of these procedures, compared specifically to the gastric bypass with the Roux-en-Y procedure, are outweighed by a significantly greater reduction in obesity-related morbidities and excess weight loss. A new minimally invasive surgical technique is done endoscopically and is referred to as endoluminal gastric restrictive surgery or "natural orifice" transluminal endoscopic surgery (NOTES). This technique utilizes flexible endoscopy with a specialized device, the EndoGastric StomaphyX^™ device (EndoGastric Solutions^™ Inc., Redmond, WA). The StomaphyX device received U.S. Food and Drug Administration (FDA) clearance through the 510(k) approval process on March 9, 2007. This endoluminal fastener and delivery system is indicated for use in endoluminal trans-oral tissue approximation and ligation in the GI tract (FDA, 2007). Published evidence is currently insufficient to demonstrate the safety and efficacy of this surgical technique, as compared to conventional surgical treatment options (Swanstrom, 2005).

There is, at present, insufficient evidence to support the use of bariatric surgery for the pediatric and adolescent population. Several small case series have shown some promising results. However, in one case series of 33 patients, five individuals (15%) regained most or all of their weight five to ten years post-surgery. Concerns about possible nutritional deficiency in growing individuals also exist, and patient and procedure selection criteria are unclear. Further results are required before it is clearly known whether the benefits of surgery outweigh the risks in this population. However, in a small subset of adolescents with severe morbid obesity, the risks from comorbidities and complications are sufficiently high that bariatric surgery may be indicated. Consequently, special consideration for such surgery may be given for an adolescent with severe morbid obesity presenting with unique circumstances.

Gastric wrapping and the Garren Gastric Bubble represent obsolete techniques. The jejunoileal bypass has also been abandoned due to severe metabolic complications.

Surgery for clinically severe obesity (bariatric surgery) falls into two categories: gastric restrictive procedures and malabsorptive procedures. The first category, gastric restrictive procedures, includes procedures in which a small pouch is created in the stomach. Weight loss occurs as the individual feels fuller sooner, having eaten much less than usual. The second category, malabsorptive procedures, includes procedures that rearrange the connections between the stomach and intestines, causing the food to be poorly digested and incompletely absorbed. Weight loss is due to malabsorption without necessarily requiring dietary modification.

Surgery for the treatment of clinically severe obesity may be appropriate in a select group of individuals. According to the National Institutes of Health (NIH), weight loss surgery should be reserved for individuals suffering from the complications of extreme obesity, for whom the efforts of medical therapy have failed. Possible surgical candidates are those with severe obesity, defined as a body mass index (BMI*) of 40 or greater, or 35 or greater with other medical complications. Such complications include, but are not limited, to the following:

• Diabetes mellitus;
• Hypertension;
• Coronary artery disease;
• Obstructive sleep apnea;
• Pulmonary hypertension of obesity.

*BMI is calculated by dividing an individual's weight (in kilograms) by height (in meters) squared. To convert pounds to kilograms, multiply pounds by 0.45; to convert inches to meters, multiply inches by 0.0254.

According to the National Institutes of Health (NIH), an increase of 20 percent or more above an individual's ideal body weight is the point at which excess weight becomes a health risk. Today, nearly two-thirds of Americans are overweight or obese. Nearly 15 million of those are considered to have clinically severe obesity, in which there is higher risk of one or more obesity-related health conditions that result either in significant physical disability or even death. While medical complications of obesity may occur in moderately obese people, the frequency increases dramatically as weight increases.

The first line treatment of clinically severe obesity is dietary and lifestyle changes, including regular exercise. In order to lose weight, an individual must have a caloric deficit; calories out must be greater than calories in. This can be accomplished by decreasing the calories ingested with some form of dietary restriction and by increasing the calories expended through exercise. All available therapies (dietary, behavioral, pharmacologic, and surgical) help patients lose weight by changing the calories ingested, absorbed, or expended.

Surgery for clinically severe obesity is performed in a hospital setting. The number of days the individual is hospitalized is dependent on the type of surgery performed. When surgery is required for clinically severe obesity, the following are some of the more common procedures:

Gastric Restrictive Procedures

1.   Vertical Banded Gastroplasty

Vertical banded gastroplasty is a purely restrictive procedure. The stomach is divided vertically, and a band is stapled around the top portion of the stomach to decrease its size. Because the normal flow of food is preserved, metabolic complications are rare. Complications of this procedure include esophageal reflux, as well as either widening or blockage of the narrow portion of the stomach, which may require re-operation. Vertical banded gastroplasty may be performed using an open or laparoscopic approach. Many surgeons have abandoned this approach because of unsatisfactory long-term maintenance of weight loss.

2.   Adjustable Gastric Banding

Adjustable gastric banding is also a purely restrictive procedure. It involves placing a gastric band around the exterior of the stomach. A thin flexible tube attaches the band to a reservoir that is implanted subcutaneously in the rectus sheath so that the band can be adjusted without further surgery. The size of the stomach can be progressively reduced to induce greater weight loss, or expanded if complications, such as vomiting, develop. Because the stomach is never entered, the surgery and any revision, if necessary, are proposed to be safer than conventional surgical treatments. Additional proposed advantages include reversibility of the procedure and maintenance of gastrointestinal anatomic integrity. However, serious complications may include slippage of the external band or band erosion through the stomach wall. Furthermore, incorrect positioning of the band may result in vomiting, as well as ineffective weight loss. Recent improvements in surgical technique have decreased the incidence of such complications in some series, based on preliminary results, with erosions becoming rare and slippage (necessitating re-operation) occurring in about 2–5% of surgeries. Mortality is also generally less than other bariatric surgery procedures, amounting to about 1 in 1,000 to 1 in 2,000 procedures. The first device approved by the FDA, (in June, 2001) for marketing in the United States, is called the Lap-Band^® System (Inamed Health, formerly BioEnterics^®). On September 28, 2007 the REALIZE^™ Adjustable Gastric Band modified Model 2200-X with Velocity Injection Port (Ethicon Endo-Surgery, Inc., Cincinnati, OH) received 510(k) FDA clearance through the premarket approval process for the following indications, which are identical to the approved indications for the LapBand System:

For use in weight reduction for morbidly obese patients and is indicated for individuals with a Body Mass Index (BMI) of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with one or more co-morbid conditions. The Band is indicated for use only in morbidly obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs.  (FDA, 2007)

This FDA approval for the REALIZE device was based on a prospective, multi-center, single-arm trial conducted in the U.S., in which each subject served as his or her own control. Subjects were followed for three years post-implantation. A total of 405 subjects were screened for the study, and 276 were implanted with the device. Complete, 36-month follow-up data are available for 228 subjects. The remaining patients are categorized as discontinued. The mean percentage of estimated weight loss (%EWL) at three years post-implantation was 42.8% (one-sided t-test; p-value < 0.001). The %EWL increased between 4-6 weeks and 28 months and remained relatively stable between 28 months and 36 months. Starting at 8 months post-surgery, the %EWL target of 32.6% was already achieved, and this was maintained throughout the remainder of the study. Subjects who reached 36 months of follow-up lost, on average, 42.8% of their excess body weight. The results of the US clinical study demonstrated that:

The REALIZE^™ Band is effective in reducing excess weight in morbidly obese subjects.  At three years post implantation, the %EWL in the 228 subjects who completed the study was 42.8% with 77% of subjects having a %EWL of at least 25%...During the study, 266 (96.4%) of the subjects reported one or more adverse events. Specific adverse events associated with gastric banding reported during the course of the study included: 1 band erosion (0.4%), 7 port displacements (2.5%), 9 band slippages (3.3%), 10 pouch dilatations (3.6%), 9 esophageal dilatations (3.3%), 1 esophageal dysmotility (0.4%), 18 injection port site pain (6%), 1 band leak (0.4%), 12 port disconnections (4.3%), and 3 kinking of catheter (1.1%). Forty-three subjects (15.6%) required re-operations involving the Band including, 2 band replacements, 10 band revisions, 4 band explantations, 5 port replacements, and 22 port revisions. There was one death in the study. Causality was probably related to port replacement surgery.

Notably, FDA approval is contingent upon the results of a post-approval study to be conducted in the U.S. at up to twelve centers to evaluate the long-term safety and effectiveness of the REALIZE device. This device has been registered and marketed under the name Swedish Adjustable Gastric Band (SAGB) outside the U.S. since 1996.

3.   Gastric Bypass

The most commonly performed restrictive approach is the Roux-en-Y gastric bypass, which combines gastric restrictive and malabsorptive features. It involves a horizontal or vertical partitioning of the stomach, which results in a 90% restriction. It is followed by a Roux-en-Y procedure, in which the small intestine is reconfigured into a Y consisting of two limbs and a common channel. The proximal small bowel remains attached to the stomach and duodenum below the gastric division or partition. This limb is called the pancreatico-biliary conduit (or limb) and it drains bile, digestive enzymes, and gastric secretions. The other limb, sometimes called the Roux limb, is attached to and drains the small proximal gastric pouch, and so carries only food. The Y is created at the point where the pancreatico-biliary conduit and the Roux limb are connected. At this point, the digestive juices and food mix and go on together, passing through the remaining arm of the Y, known as the common channel. Gastric bypass not only prevents the ability to ingest larger volumes at any one meal, but also induces a "dumping syndrome" if the patient ingests too much food or a high-sugar liquid meal. This unpleasant "dumping syndrome" occurs when a large amount of partially digested food is delivered directly to part of the small intestine from the stomach and can cause nausea, weakness, sweating, faintness, abdominal pain and vomiting. The dumping syndrome may further reduce intake particularly among "sweet eaters." Surgical complications include leakage and stomal stricture. Since a major portion of digestion occurs in the stomach – specifically the process of breaking down food into nutrients – the amount of nutrients available for absorption is also reduced. As a result, this procedure requires that individuals take vitamin and mineral supplements. Gastric bypass may be performed using an open or laparoscopic approach.

4.   Mini Gastric Bypass

Recently a variant of the gastric bypass, called the "mini gastric bypass" has been popularized. Using a laparoscopic (periscope-type) approach, the stomach is divided, similar to a traditional gastric bypass, but instead of creating a Roux-en-Y connection, the jejunum is anastomosed directly to the stomach, similar to a Billroth II procedure to the stomach. The unique aspect of this procedure is not based on its laparoscopic approach, but rather the type of anastomosis used. While this surgical approach may result in shorter operating time, it creates the risk of biliary reflux gastritis, in which bile flows back into the stomach and causes irritation. That is one of the reasons that this procedure has been abandoned in favor of a Roux-en-Y gastric bypass.

5.     Sleeve Gastrectomy 

This alternative surgical approach to gastrectomy involves resection of the greater curvature of the stomach resulting in a stomach remnant shaped like a tube or "sleeve."  It can be performed by open or laparoscopic technique and can be done as a stand-alone procedure or as the first in a two-stage procedure subsequently followed by a malabsorptive procedure, such as biliopancreatic diversion with duodenal switch.  It has been proposed by some surgeons for very high risk patients where weight loss following sleeve gastrectomy may improve a patient's overall medical status and reduce risk for subsequent more extensive malabsorptive procedures.

Malabsorptive Procedures 

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

The biliopancreatic bypass (BPB) 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 bypassed segment of the intestine. In contrast, BPB consists of a subtotal gastrectomy and diversion of the biliopancreatic juices into the small intestine by a long Roux-en-Y procedure. This results in a 200 cm long alimentary tract and a 300 to 400 cm biliary tract. After these two tracts are joined at the distal anastomosis, there is only a 50 cm common absorptive alimentary tract. Because of the high incidence of gallstones associated with the procedure, patients typically have their gallbladders removed at the same time as the surgery. There are many potential complications related to biliopancreatic bypass, including iron deficiency anemia, protein malnutrition, hypocalcemia, and bone demineralization. Protein malnutrition may require treatment with total parental nutrition. In addition, there have been several case reports of liver failure resulting in death or requiring liver transplant.

2.   Biliopancreatic Bypass with Duodenal Switch

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, which is then anastomosed to a segment of the ileum to create the alimentary limb. Preservation of the pyloric sphincter is designed to be more physiologic. The sleeve gastrectomy decreases the volume of the stomach and also decreases the parietal cell mass, with the intent of decreasing the incidence of ulcers at the duodenoileal anastomosis. The basic principle of this procedure is similar to that of the biliopancreatic bypass, which promotes weight loss by producing selective malabsorption by limiting the food digestion and absorption to a short common ileal segment. The potential for metabolic complications still exist with this procedure; however, this potential is not as great as with BPB. Individuals undergoing the duodenal switch procedure require long-term medical follow-up and regular monitoring of fat soluble vitamins, vitamin B-12, iron and calcium. There is some disagreement among surgeons about how long to make the alimentary and common channels. In some series, the common channel was created to be 100 cm for all patients. In another series that obtained good results, the small bowel segments varied according to the original length of the bowel. In that series, the alimentary limb segment (excluding the common channel) is about 40% of the total length of the small bowel, with the common limb being about 10% of the length of the total original small bowel length in increments of 25 cm. The common limb, therefore, is usually 50 cm, 75 cm, or 100 cm long depending on the individual. The important consideration is to make the channels long enough to prevent malnutrition and short enough to result in effective EWL.

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

Recent variations of gastric bypass procedures have been described, primarily consisting of long limb Roux-en-Y procedures. The stomach may be bypassed in a variety of ways, i.e. either by resection or stapling along the horizontal or vertical axis. Unlike the traditional gastric bypass, which is essentially a gastric restrictive procedure, these very long limb Roux-en-Y gastric bypasses function essentially as a malabsorptive procedure, more similar in concept to the biliopancreatic bypass. In the biliopancreatic bypass, the ileum is used as the alimentary limb, while in long limb gastric bypass, the jejunum functions as the alimentary limb. 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.

Operator Dependence in the Safety and Efficacy of Bariatric Procedures

Furthermore, strong evidence from a number of reports and case series exists for "operator dependence" in determining the risks and benefits of any bariatric procedure. It is important that the surgeon be extensively trained in the respective procedure and that the initial surgeries are supervised by an experienced bariatric surgeon until the "learning curve" is passed.

Anastomosis: the connection of normally separate parts or spaces so that they intercommunicate; an anastomosis may develop naturally, or be artificially constructed during a surgical procedure

Body mass index (BMI): a key index for relating body weight to height; the BMI is a person's weight in kilograms (kg) divided by their height in meters (m) squared 

Duodenal: related to the duodenum, which is the first part of the small intestine

Fistula: an abnormal passageway in the body; a fistula may go from the body surface into a blind pouch or into an internal organ or between two internal organs

Gastric: having to do with the stomach

Gastric balloon (Gastric bubble): a device that is inserted into the stomach to reduce the stomach's capacity and produce early satiety; this device, now generally considered obsolete, was intended for temporary use as an adjunct to diet and behavior modification to assist patients with weight loss

Gastric banding: a surgical procedure used to help a person lose weight; a band is placed around the upper part of the stomach, creating a small pouch that can hold only a small amount of food; the narrowed opening between the stomach pouch and the rest of the stomach controls how quickly food passes from the pouch to the lower part of the stomach; the system helps the patient eat less by limiting the amount of food that can be eaten at one time and increasing the time it takes for food to be digested

Gastric bypass: a surgical procedure that reduces stomach capacity and diverts partially digested food from the duodenum to the jejunum (section of the small intestine extending from the duodenum)

Gastroplasty: a surgical procedure that decreases the size of the stomach

Jejunum: the portion of the small intestine that extends from the duodenum to the ileum

Obesity: the state of being well above one's normal weight because of an excessive accumulation of fat

Repair:  refers to a subsequent surgical procedure performed to correct an anatomic complication resulting from a prior gastric bypass or gastric restrictive procedure

Revision: refers to a surgical procedure performed either to anatomically reverse a prior bypass/restrictive procedure or to anatomically convert the patient's organs from a prior bypass/restrictive procedure to another  procedure, (e.g., from a prior vertical banded gastroplasty to a conventional Roux-en-Y bypass procedure)

Sleep apnea: temporary stoppage of breathing during sleep, often resulting in daytime sleepiness

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met: 

When services are Not Medically Necessary or Investigational and Not Medically Necessary:
For the procedure codes listed above, when criteria are not met, or when the code describes a procedure indicated in the Position Statement section as not medically necessary or investigational and not medically necessary. 

When services are Investigational and Not Medically Necessary:

When services are also Investigational and Not Medically Necessary:

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33. Dixon JB, O'Brien PE. Selecting the optimal patient for LAP-BAND placement. Am J Surg. 2002; 184(6 Suppl 2):S17-S20.
34. 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):316-323.
35. Dolan K, Hatzifotis M, Newbury L, Fielding G. A comparison of laparoscopic adjustable gastric banding and biliopancreatic diversion in superobesity. Obes Surg. 2004; 14(2):165-169.
36. Douketis JD, Feightner JW, Attia J, et al. Periodic health examination, 1999 update: Detection, prevention and treatment of obesity. CMAJ. 1999; 160(4):513-525.
37. Dukhno O, Ovnat A, Levy I. Our experience with 250 laparoscopic adjustable silicone gastric bandings. Surg Endosc. 2003; 17:601-602.
38. Eissa M, Gunner K. Evaluation and management of obesity in children and adolescents. Journal of Pediatric Health Care. 2004; 18(1):35-38.
39. Evans JD, Scott MH, Brown AS, et al. Laparoscopic adjustable gastric banding for the treatment of morbid obesity. The American Journal of Surgery. 2002; 184:97-102.
40. Fielding GA, Allen JW. A step-by-step guide to placement of the LAP-BAND adjustable gastric banding system. Am J Surg. 2002; 184(6 Suppl 2):S26-S30.
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50. Husemann B. Open-surgery management of morbid obesity: old experience-new techniques. Langenbecks Arch Surg. 2003; 388(6):385-391.
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59. Kothari SN, DeMaria EJ, et al. Lap-band failures: conversion to gastric bypass and their preliminary outcomes. Surgery. 2002; 131(6):625-629.
60. Langer FB Bohdjalian A, Felberbauer FX, et al.  Does gastric dilatation limit the success of sleeve gastrectomy as sole operation for morbid obesity?  Obes Surg. 2006; 16:166-171.
61. Lawson ML, Kirk S, Mitchell T, et al.  One-year outcomes of Roux-en-Y gastric bypass for morbidly obese adolescents:  a multicenter study from the Pediatric Bariatric Study Group.  J Pediatr Surg. 2006; 41(1):137-143.
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63. Marceau P, Hould FD, Simrad S, et al. Biliopancreatic diversion with duodenal switch. World J Surg. 1998; 22:947-954.
64. Mason EE, Tang S, Renquist KE, et al. A decade of change in obesity surgery. National Bariatric Surgery Registry Contributors. Obes Surg. 1997; 7:189-197.
65. McClean LD, Rhode BM, Nohr CW. Late outcome of isolated gastric bypass. Ann Surg. 2000; 231(4):524-528.
66. McClean LD, Rhode BM, Nohr CW. Long- or short-limb gastric bypass? J Gastrointest Surg. 2001; 5(5):525-530.
67. Meyer L, Rohr S, Becker J, et al. Retrospective study of laparascopic adjustable silicone gastric banding for the treatment of morbid obesity: results and complications in 127 patients. Diabetes Metab. 2004; 30(1):53-60.
68. Miller K, Hell E. Laparoscopic adjustable gastric banding: a prospective 4-year follow-up study. Obes Surg. 1999; 9(2):183-187.
69. Miller K, Hell E. Laparoscopic surgical concepts of morbid obesity. Langenbecks Arch Surg. 2003; 388(6):375-384.
70. Miller K, Pump A, Hell E. Vertical banded gastroplasty versus adjustable gastric banding: prospective long-term follow-up study. Surg Obes Relat Dis. 2007; 3(1):84-90.
71. Mittermair RP, Aigner F, Nehoda H. Results and complications after laparoscopic adjustable gastric banding in super-obese patients, using the Swedish band. Obes Surg. 2004; 14(10):1327-1330.
72. Mognol P, Chirurgie, Generale A. Laparoscopic gastric bypass versus laparoscopic adjustable gastric banding in the super-obese: a comparative study of 290 patients. Obes Surg. 2005; 15(1):76-81.
73. Mognol P, Chosidow D, Marmuse JP. Laparoscopic sleeve gastrectomy as an initial bariatric procedure for high risk patients: initial results in 10 patients.  Obes Surg. 2005; 15:1030-1033.
74. Mokdad AH, Ford ES, Bowman BA, et al. Prevalence of obesity, diabetes, and obesity-related health risk factors, 2001. JAMA. 2003; 289:76-79.
75. Montgomery KF, Watkins BM, Ahroni JH, et al. Outpatient laparoscopic adjustable gastric banding in super-obese patients. Obes Surg. 2007; 17(6):711-716.
76. Moon HS, Kim WW, Oh JH. Results of laparoscopic sleeve gastrectomy (LSG) at 1 year in morbidly obese Korean patients.  Obes Surg. 2005; 15:1469-1475.
77. Mortelé KJ, Pattijn P, Mollet P, et al. The Swedish laparoscopic adjustable gastric banding for morbid obesity Radiologic Findings in 218 Patients. AJR. 2001; 177:77-84.
78. Morino M, Toppino M, Bonnet G, et al. Laparoscopic adjustable silicone gastric banding versus vertical banded gastroplasty in morbidly obese patients: a prospective randomized controlled clinical trial. Morino Annal Surg. 2003; 238:835-842.
79. 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 (editorial). Gastrointest Endosc. 2007; 66(2): 246-247.
80. Murr MM, Balsiger BM, Kennedy FP, et al. Malabsorptive procedures for severe obesity. Comparison of pancreaticobiliary bypass and very long limb Roux-en-Y gastric bypass. J Gastrointest Surg. 1999; 3:607-612.
81. Myers JA, Sarker S, Shayani V.  Treatment of massive super-obesity with laparoscopic adjustable gastric banding.  Surg Obesity and Related Dis. 2006; 2:37-40.
82. Nguyen NT. A comparison study of laparoscopic versus open gastric bypass for morbid obesity. J Am Coll Surg. 2000; 191(2):149-155.
83. Nguyen NT, Rivers R, Wolfe BM. Factors associated with operative outcomes in laparoscopic gastric bypass. J Am Coll Surg. 2003; 197:548-557.
84. O'Brien PE, Dixon JB. Weight loss and early and late complications—the international experience. Am J Surg. 2002; 184(6 Suppl 2):S42-S45.
85. O'Brien PE, Dixon JB. Lap-Band®: outcomes and results. Journal of Laparoendoscopic & Advanced Surgical Techniques. 2003; 13:265-270.
86. O'Brien PE, Dixon JB. Laparoscopic adjustable gastric banding in the treatment of morbid obesity. Arch Surg. 2003; 138:376-382.
87. O'Brien PE, Dixon JB, et al. The laparoscopic adjustable gastric band (LAP-BAND): a prospective study of medium-term effects on weight, health and quality of life. Obes Surg. 2002; 12(5):652-660.
88. O'Brien PE, Dixon JB, Laurie C, Skinner S, et al. Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program.  Annals of Intern Med. 2006; 144(9):625-633.
89. Parikh MS, Laker S, Weiner H, et al.  Objective comparison of complications resulting from laparoscopic bariatric procedures.  Am Coll Surg. 2006; 202(2):252-261.
90. Parikh MS, Shen R, Weiner M, et al.  Laparoscopic bariatric surgery in super-obese patients (BMI > 50) is safe and effective:  a review of 332 patients.  Obes Surg. 2005; 15(6):858-863.
91. Parikh MS, Ayoung-Chee P, Romanos E, et al.  Comparison of rates of resolution of diabetes mellitus after gastric banding, gastric bypass, and biliopancreatic diversion.  J Am Coll Surg. 2007; 205(5):631-635.
92. Prachand VN, Davee RT, Alverdy JC. Duodenal switch provides superior weight loss in the superobese (BMI > or =50 kg/m2) compared with gastric bypass. Ann Surg. 2006; 244(4):611-619.
93. 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; 13:861-864.
94. Ren CJ. Controversies in bariatric surgery: evidence-based discussions on laparoscopic adjustable gastric banding. J Gastrointest Surg. 2004; 8(4):396-397.
95. Ren CJ, Horgan S, Ponce J. US experience with the LAP-BAND system. Am J Surg. 2002; 184(6 Suppl 2):S46-S50.
96. Ruben M, Spivak H. Prospective study of 250 patients undergoing laparoscopic gastric banding using the two-step technique: a technique to prevent postoperative slippage. Surg Endosc. 2003; 17:857-860.
97. Rubenstein RB. Laparoscopic adjustable gastric banding at a U.S. center with up to 3-year follow-up. Obes Surg. 2002; 12:380-384.
98. Schauer PR, Ikramuddin S, Gourash W. Outcomes after laparoscopic Roux-en-Y gastric bypass for morbid obesity. Ann Surg. 2000; 232:515-529.
99. Schauer PR, Burguera B, Ikramuddin S, et al. Effect of laparoscopic Roux-en Y gastric bypass on type 2 diabetes mellitus.  Ann Surg. 2003; 238(4):467-484.
100. Schauer P, Chand B, Brethauer S. New applications for endoscopy: the emerging field of endoluminal and transgastric bariatric surgery. Surg Endosc. 2007; 21(3):347-356.
101. Schirmer BD. Laparoscopic bariatric surgery. Surg Clin North Am. 2000; 80(4):1253-1267.
102. Schok M. Quality of life after laparoscopic adjustable gastric banding for severe obesity: postoperative and retrospective preoperative evaluations. Obes Surg. 2000; 10(6):502-508.
103. Scopinaro N, Adami GF, et al. Biliopancreatic diversion. World J Surg. 1998; 22(9):936-946.
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109. Skroubis G, Sakellaropoulas G, et al. Comparison of nutritional deficiencies after Roux-en-Y gastric bypass and after biliopancreatic diversion with Roux-en-Y gastric bypass. Obes Surg. 2002; 12(4):551-558.
110. Spivak H, Hewitt MF, Onn A, Half EE. Weight loss and improvement of obesity-related illness in 500 U.S. patients following laparoscopic adjustable gastric banding procedure. Am J Surg. 2005; 189(1):27-32.
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Government Agency, Medical Society, and Other Authoritative Publications:

1. American Gastroenterological Association.  American Gastroenterological Association medical position statement on obesity.  Gastroenterology.  2002; 123(3):879-881.
2. American Society for Metabolic and Bariatric Surgery (ASMBS). Position Statement on Sleeve Gastrectomy as a Bariatric Procedure.  Endorsed by ASMBS June 17, 2007. Available at: http://www.asbs.org/Newsite07/resources/sleeve_statement.pdf.  Accessed on January 28, 2009.
3. Baker S, Barlow S, Cochran W, et al. Overweight children and adolescents: a clinical report of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr. 2005; 40(5):533-543. Available at: http://www.guideline.gov/summary/summary.aspx?doc_id=7483&nbr=004429&string=obesity#s23.  Accessed on January 28, 2009.
4. Blue Cross Blue Shield Association. Newer techniques in bariatric surgery for morbid obesity. TEC Assessment, 2003; 18(10).
5. Blue Cross Blue Shield Association. Special report: the relationship between weight loss and changes in morbidity following bariatric surgery for morbid obesity. TEC Assessment, 2003; 18(9).
6. Blue Cross Blue Shield Association.  Surgery for Morbid Obesity: Laparoscopic Adjustable Gastric Banding, Biliopancreatic Diversion, and Long-limb Gastric Bypass.  TEC Assessment, 2005; 20(5).
7. Blue Cross Blue Shield Association.  Laparoscopic Gastric Bypass Surgery for Morbid Obesity.  TEC Assessment, 2006; 20(15).
8. Boudreau R, Hodgson A.  Laparoscopic adjustable gastric banding for weight loss in obese adults: clinical and economic review (Technology report number 90).  Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH); 2007.  Available at:  http://www.cadth.ca/media/pdf/L3009_LAGB_tr_e.pdf.  Accessed on January 14, 2008.
9. Buckwald H.  American Society for Bariatric Surgery (ASBS). Consensus Conference Panel Consensus Statement: Bariatric surgery for morbid obesity: health implications for patients, health professionals and third-party payers.  J Am Coll Surg. 2005; 200(4):593-604.
10. California Technology Assessment Forum (CTAF). Laparoscopic adjustable silicone gastric banding for morbid obesity. A Technology Assessment. San Francisco, CA: CTAF; February 28, 2007. Available at: http://ctaf.org/content/general/detail/685.  Accessed on January 28, 2009.
11. Centers for Medicare and Medicaid Services. National Coverage Determination: Bariatric Surgery for Treatment of Morbid Obesity. NCD #100.1. Effective date: Feb.21, 2006. Available at:https://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=160. Accessed on January 14, 2009.
12. Centers for Medicare and Medicaid Services. National Coverage Determination for Intestinal Bypass Surgery. NCD #100.8. Effective date not posted. Available at:  http://www.cms.hhs.gov. Accessed on January 14, 2009.
13. Centers for Medicare and Medicaid Services. National Coverage Determination for Treatment of Obesity.  NCD #40.5. Effective date: Feb. 21, 2006. Available at:  http://www.cms.hhs.gov. Accessed on January 14, 2009.
14. Centers for Medicare and Medicaid Services.  National Coverage Determination for Gastric Balloon for Treatment of Obesity.  NCD #100.11.  Effective date: Sept. 18, 1987.  Available at:  http://www.cms.hhs.gov.  Accessed on October 5, 2009.
15. Colquitt JL, Clegg AJ, Loveman E, Royle P, Sidhu MK. Surgery for morbid obesity. Cochrane Database Syst Rev. 2005; (4):CD003641. DOI: 10.1002/14651858.CD003641.pub2.
16. Fernandes MAP, Atallah ÁN, Soares B, et al. Intragastric balloon for obesity. Cochrane Database Syst Rev. 2007; (1):CD004931. DOI: 10.1002/14651858.CD004931.pub2.
17. Hayes, Inc. Hayes Health Technology Brief.  Bariatric Surgery for Pediatric Morbid Obesity. Lansdale, PA: Hayes, Inc; June 7, 2007. Search updated June 24, 2008.
18. Hayes, Inc. Hayes Medical Technology Directory.  Open Malabsorptive Bariatric Surgery: Roux-en-Y Gastric Bypass.  Lansdale, PA: Hayes, Inc; June 7, 2007.  Search updated June 12, 2008.
19. Hayes, Inc. Hayes Medical Technology Directory. Malabsorptive Bariatric Surgery: Open and Laparoscopic Biliopancreatic Diversion. Lansdale, PA: Hayes, Inc; June 7, 2007.  Search updated June 16, 2008.
20. Hayes, Inc. Hayes Medical Technology Directory.  Open Restrictive Bariatric Surgery: Gastroplasty and Gastric Banding. Lansdale, PA: Hayes, Inc; June 7, 2007.  Search updated June 6, 2008.
21. Hayes, Inc. Hayes Medical Technology Directory. Laparoscopic Bariatric surgery: Roux-en-Y Gastric Bypass, Vertical Banded Gastroplasty and Adjustable Gastric Banding. Lansdale, PA: Hayes, Inc; June 7, 2007.  Search updated June 17, 2008.
22. Hayes, Inc. Hayes Medical Technology Directory. Open Bariatric Surgery: Roux-en-Y Gastric Bypass, Vertical Banded Gastroplasty and Adjustable Gastric Banding. Lansdale, PA: Hayes, Inc; June 7, 2007.  Search updated June 17, 2008.
23. Hayes, Inc. Hayes Search and Summary. Laparoscopic Sleeve Gastrectomy for Super Obesity (BMI > 50) in Adults. June 27, 2008.
24. Institute for Clinical Systems Improvement (ICSI). Gastric restrictive surgery for clinically severe obesity in adults. Technology Assessment No. 14. Bloomington, MN: ICSI; May 2005.
25. International Pediatric Endosurgery Group (IPEG).  Guidelines for surgical treatment of clinically severely obese adolescents.  Updated: October 2003.  Available at:  http://www.ipeg.org/guidelines/morbidobesity.html.  Accessed on January 14, 2009.
26. National Institute of Health (NIH) National Heart Lung and Blood Institute (NHLBI). Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. The Evidence Report.  NIH Pub. No. 98-4083; 1998.  Updated Pub. No. 00-4084; 2000.  Available at: http://www.nhlbi.nih.gov/guidelines/obesity/ob_home.htm.  Accessed on January 14, 2009.
27. National Institute for Clinical Excellence (NICE). Obesity Guidance on the Prevention, Identification, Assessment and Management of Overweight and Obesity in Adults and Children.  Issued: December 2006.  Available at:  http://www.nice.org.uk/nicemedia/pdf/word/CG43NICEGuideline.doc.  Accessed on January 30, 2009.
28. National Institute for Health and Clinical Excellence (NICE). Obesity: The prevention, identification, assessment and management of overweight and obesity in adults and children. Clinical Guideline 43. London, UK: NICE; 2006.  
29. National Institute of Diabetes and digestive and Kidney Diseases (NIDDK).  Gastrointestinal Surgery for Severe Obesity.  NIH Publication No. 04-4006. December 2004.  Available at:  http://win.niddk.nih.gov/publications/PDFs/gasurg12.04bw.pdf.  Accessed on January 14, 2009.
30. Rogers BM.  Bariatric surgery for adolescents:  a view from the American Pediatric Surgical Association.  Pediatrics.  2004; 114:255-56.
31. Sauerland S, Angrisani L, Belachew M, et al.  Obesity surgery: evidence-based guidelines of the European Association for Endoscopic Surgery (EAES).  Surg Endosc. 2005; 19(2):200-221.
32. Shekelle PG, Morton SC, Maglione M, et al. Pharmacological and surgical Treatment of Obesity.  Summary, Evidence Report/Technology Assessment: Number 103.  AHRQ Publication No. 04-E028-1.  July 2004.  Agency for Healthcare Research and Quality, Rockville, MD.  Available at: http://www.ahrq.gov/  Accessed on January 14, 2009.
33. Snow V, Barry P, Fitterman N, et al.  Pharmacologic and surgical management of obesity in primary care: a clinical practice guideline from the American College of Physicians.  Ann Intern Med. 2005; 142(7):525-531.
34. Society of American Gastrointestinal Endoscopic Surgeons (SAGES).  Guidelines for the clinical application of laparoscopic bariatric surgery.  2003.  Updated: Surg Endosc. 2008; 22(10):2281-300. Available at: http://www.guideline.gov/summary/summary.aspx?doc_id=12384&nbr=006413&string=obesity#s23. Accessed on January 14, 2009.
35. Treadwell J, Sun F, Bruening W, et al. Bariatric surgery in pediatric patients. Health Technology Assessment. Prepared for the WSHA Health Technology Assessment Program by the ECRI Institute. Olympia, WA: Treadwell, WA State healthcare Authority, 2007.  Available at: http://www.hta.hca.wa.gov/documents/pbs_executive_summary.pdf.   Accessed on January 28, 2009.
36. University of Texas at Austin, School of Nursing, Family Nurse Practitioner Program. Evaluation and treatment of childhood obesity. Austin (TX): University of Texas at Austin, School of Nursing; 2004 May.  Available at: http://www.guideline.gov/summary/summary.aspx?doc_id=5431&nbr=003725&string=obesity#s23.  Accessed on January 28, 2009.
37. U.S. Department of Health and Human Services.  Agency for Healthcare Research and Quality (AHRQ). Evidence Report/Technology Assessment No. 103: Pharmacological and Surgical Treatment of Obesity.  AHRP Publication No. 04-E028-2. July 2004.  Available at: http://www.ahrq.gov/downloads/pub/evidence/pdf/obespharm/obespharm.pdf.  Accessed on January 14, 2009.
38. U.S. Food and Drug Administration 510(k) Premarket Notification Database.  REALIZE^™ Adjustable Gastric Band Model 2200-X. Summary of Safety and Effectiveness.  No. P070009. Rockville, MD: FDA. Sept. 28, 2007. Available at: http://www.fda.gov/cdrh/mda/docs/P070009.html. and http://www.fda.gov/cdrh/pdf7/p070009b.pdf.  Accessed on January 14, 2009.
39. U.S. Food and Drug Administration 510(k) Premarket Notification Database.  LapBand^® Adjustable Gastric Banding (LAGB^®) System. Summary of Safety and Effectiveness. No. P000008. Rockville, MD:FDA. June 5, 2001.  Available at: http://www.fda.gov/cdrh/pdf/P000008b.pdf.  Accessed on January 14, 2009.
40. Wittgrove AC.  Commentary: surgery for severely obese adolescents.  Further insight from the American Society for Bariatric Surgery.  Pediatrics.  2004; 114(1):253-254.

1. American College of Surgeons. Available at:  http://www.facs.org Accessed on January 14, 2009.
2. American Obesity Association. Available at:  http://www.obesity.org Accessed on January 14, 2009.
3. American Society for Bariatric Surgery. Available at:  http://asbs.org Accessed on January 14, 2009.
4. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH).  Longitudinal Assessment of Bariatric Surgery (LABS).  Available at:  www.niddklabs.org.  Accessed on January 14, 2009.

Adjustable Gastric Banding
Adjustable Silicone Gastric Banding
Bariatric Surgery
Biliopancreatic Bypass, with Duodenal Switch
Clinically Severe Obesity
Duodenal Switch Procedure
Gastric Banding
Gastric Bypass
Gastric Restrictive Procedures
Gastric Stapling
Jejunoileal Bypass
Lap-Band^®
Long Limb Gastric Bypass
Malabsorptive Procedures
Mini-Gastric Bypass
Morbid Obesity, Surgical Treatment of
REALIZE^™ Adjustable Gastric Band
Scopinaro Procedure
Sleeve Gastrectomy
Stomach Stapling
StomaphyX^™
Swedish Adjustable Gastric Band
Vertical Banded Gastroplasty

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Attachment

Surgery for Morbid Obesity
Physician Verification Form