BCBS PPO of IL Policy

[mcmurraydragon 0]

Title:

Surgery for Morbid Obesity

Number:

SUR716.003

Effective Date:

07-01-2007

Legislation:

ILLINOIS: None

NEW Mexico: None

OKLAHOMA: None

TEXAS: None

FEDERAL (applies to all Plans):

Contract:

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

Coverage:

The following criteria and guidelines have been developed to judge eligibility for coverage of bariatric surgery for the treatment of morbid obesity.

To be considered eligible for benefit coverage of bariatric surgery for treatment of morbid obesity, the following three criteria must be met:

• A diagnosis of Morbid Obesity, defined as:
  1. Body Mass Index (BMI) of greater than or equal to 40 kg/meter squared; OR
     
  2. BMI greater than or equal to 35kg/meters squared with at least two (2) of the following co-morbid conditions which have not responded to maximum medical management and which are generally expected to be reversed or improved by bariatric treatment:
     • Hypertension,
       
     • Dyslipidemia,
       
     • Diabetes Mellitus,
       
     • Coronary heart disease, and/or
       
     • sleep apnea.

[Note: A BMI formula can be found in the description section of this policy.]

AND

• At least a five-year history of Morbid Obesity supported by medical record documentation.

AND

• It is expected that appropriate non-surgical treatment should have been attempted prior to surgical treatment of obesity

Non-surgical treatment of morbid obesity appropriateness criteria:

• Medical record documentation of active participation in a clinically-supervised, non-surgical program of weight reduction for at least 6 months, occurring within the twenty-four (24) months prior to the proposed surgery and preferably unaffiliated with the bariatric surgery program. [NOTE: The initial BMI at the beginning of a weight reduction program will be the “qualifying” BMI used to meet the BMI criteria for the definition of morbid obesity used in this policy.]
  
• A program will be considered appropriate if it includes the following components:
  1. Nutritional therapy, which may include medical nutrition therapy such as a very low calorie diet such as MediFast or Optifast OR a recognized commercial diet-based weight loss program such as Weight Watchers, Jenny Craig, etc.
     
  2. Behavior modification or behavioral health interventions.
     
  3. Counseling and instruction on exercise and increased physical activity.
     
  4. Pharmacologic therapy (as appropriate).
     
  5. Ongoing support for lifestyle changes to make and maintain appropriate choices that will reduce health risk factors and improve overall health.

Surgical Program for the treatment of morbid obesity documentation requirements:

• Documentation that growth is completed. [Generally, growth is considered completed by 18 years of age or with documentation of completed bone growth.]
  
• Evaluation by a licensed professional counselor, psychologist or psychiatrist, should be completed within the 12 months preceding the request for surgery. This evaluation should document:
  1. The absence of significant psychopathology that would hinder the ability of an individual to understand the procedure and comply with medical/surgical recommendations.
     
  2. Any psychological co-morbidities that are contributing to weight mismanagement or a diagnosed eating disorder.
     
  3. Patient’s willingness to comply with preoperative and postoperative treatment plans.

Significant relative contraindications for surgical treatment of obesity include:

• Mental handicaps that render a patient unable to understand the rules of eating and exercise and therefore make them unable to participate effectively in the post-operative treatment program. [An example is a patient with malignant hyperphagia (Prader-Willi syndrome), which combines mental retardation with an uncontrollable desire for food.]
  
• Portal hypertension, which is an excessive hazard when laparoscopic gastric surgery is performed.
  
• Age greater than 65 because for these patients the weight loss is less effective, the duration of benefits is shorter and the risks of the procedures are greater.

GASTRIC RESTRICTIVE PROCEDURES

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

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

Gastric bypass using a Billroth II type of anastomosis, popularized as the mini gastric bypass is considered experimental, investigational and unproven as a treatment of morbid obesity.

Adjustable gastric banding (adjustable Lap-Band®) performed laparoscopically or open and consisting of an external adjustable band placed high around the stomach creating a small pouch and a small stoma, may be eligible for coverage as a surgical treatment option for patients with morbid obesity who meet the eligibility criteria for surgery, including lack of response to the required conservative measures listed above.

Sleeve gastrectomy, when done as the sole procedure, is considered experimental, investigational and unproven as a treatment for morbid obesity.

MALABSORPTIVE PROCEDURES

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

• Biliopancreatic bypass (i.e., the Scopinaro procedure),
  
• Biliopancreatic bypass with duodenal switch, or
  
• Long limb gastric bypass procedures (i.e. >150cm)

Repeat of a Covered Bariatric Surgery

Repeat of a covered bariatric surgery may be eligible for coverage only when ALL of the following criteria are met:

• For the original procedure, patient met all the screening criteria, including BMI requirements
  
• The patient has been compliant with a prescribed nutrition and exercise program following the original surgery
  
• Significant complications or technical failure (i.e., break down of gastric pouch, slippage, breakage or erosion of gastric band, bowel obstruction etc.) of the bariatric surgery has occurred that required take down or revision of the original procedure that could only be addressed surgically
  
• Patient is requesting reinstitution of an acceptable bariatric surgical modality.

A Roux-en-Y procedure following vertical banded gastroplasty or laparoscopic adjustable banded gastroplasty is not eligible for coverage for patients who have been substantially noncompliant with a prescribed nutrition and exercise program following the original procedure.

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

Coverage is allowed for gallbladder removal at the time of a covered gastric bypass surgical procedure, either for documented gallbladder disease or for prophylaxis.

Note: Refer to Medical Policy SUR709.031 named Gastric Electrical Stimulation for coverage when used to treat morbid obesity.

Codes:

CPT Codes:HCPCS Codes:00797, 43633, 43644, 43842, 43843, 43846, 43848

New Codes Effective 1/2006: 43770, 43771, 43772, 43773, 43774, 43886, 43887, 43888

, 43645, 43845, 43847

New Codes Effective 7/2006: 0155T, 01556T, 0157T, 0158T

, 43999

S2083

Deleted Codes Effective 1/2006: S2082

ICD-9 Diagnosis Codes:ICD-9 Procedure Codes:278.01

44.31, 44.69

Description:

Morbid obesity is defined as an increase in weight over the optimal weight which results in significant complications and a shortened life span. For example, morbid obesity has a significant impact on:

• cardiac risk factors,
  
• incidence of diabetes,
  
• arthritis of the hips, spine or knees,
  
• obstructive sleep apnea, and
  
• various types of cancers (for men colon, rectum, and prostate; for women, breast, uterus, and ovaries).

The treatment of morbid obesity should be dietary and life style changes. Although this strategy may be effective in some patients, frequently the weight loss is not durable with only 5% to 10% of patients maintaining the weight loss for more than a few years. When conservative measures fail, some patients may consider surgical approaches. A 1991 National Institutes of Health (NIH) Consensus Conference identified surgery as an option in those patients with a body mass index (BMI)* of greater than 40 kg/m-2, or greater than 35 kg/m-2 in conjunction with severe comorbidities such as cardiopulmonary complications or severe diabetes. Super obesity has been described as a BMI greater than 50 kg/m-2.

Surgery for morbid obesity (termed bariatric surgery) falls into two general categories;

• Gastric restrictive procedures that create a small gastric pouch resulting in weight loss by producing early satiety and thus decreasing dietary intake; and
  
• Malabsorptive procedures, which produce weight loss due to malabsorption without necessarily requiring dietary modification.

The following summarizes the different restrictive and malabsorptive procedures:

GASTRIC RESTRICTIVE PROCEDURES

Vertical Banded Gastroplasty :

This is probably the most common kind of gastric restrictive procedure performed in this country. The stomach is segmented along its vertical axis to create a durable reinforced and rate-limiting stoma at the distal end of the pouch. A plug of stomach is then removed and a propylene collar is placed through this hole and then stapled to itself. Because the normal flow of food is preserved, metabolic complications are rare. Complications include esophageal reflux, dilation or obstruction of the stoma, with the latter two requiring reoperation. Dilation of the stoma is a common reason for weight regain. Vertical banded gastroplasty may be performed using an open or laparoscopic approach.

Adjustable Gastric Banding (gastric restrictive procedure without gastric bypass, for morbid obesity; other than vertical-banded gastroplasty):

Adjustable gastric banding involves placing a gastric band around the exterior of the stomach. The band is attached to a reservoir that is implanted subcutaneously in the rectus sheath. Injecting the reservoir with saline will alter the diameter of the inner lining of the gastric band and the stoma in the stomach can be progressively narrowed to induce greater weight loss, or expanded if complications develop. Because the stomach is not entered, the surgery and any revisions (if necessary) are relatively simple. There is absence of a major incision. Complications have included port displacement (7%), pouch dilatation (<1%), gastric prolapse (2%), or band erosion (<1%) through the gastric wall. Although adjustable gastric banding has been widely used in Europe, there is currently one device approved by the U.S. Food and Drug Administration (FDA) for marketing in the United States (Lap-Band Adjustable Gastric Banding System manufactured by BioEnterics Corp., Carpenteria, CA) June 5, 2001. These procedures are performed laparoscopically or open.

Gastric Bypass (Gastric restrictive procedure, with gastric bypass for morbid obesity; with short limb (up to and including 150 cm) Roux-en-Y gastroenterostomy):

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

Mini Gastric Bypass:

Recently a variant of the gastric bypass called the mini-gastric bypass has been popularized. Using a laparoscopic approach the stomach is segmented (similar to a traditional gastric bypass) but instead of creating a Roux-en-Y anastomosis the jejunum is anastomosed directly to the stomach (similar to a Billroth II procedure). The type of anastomosis used makes this procedure unique. It should also be noted that CPT code 43846 does not accurately describe the mini-gastric bypass. This CPT code explicitly describes a Roux-en-Y gastroenterostomy (which is not used in the mini-gastric bypass).

Sleeve Gastrectomy:

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

MALABSORPTIVE PROCEDURES

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 blind, bypassed segment. In contrast, BPB consists of a subtotal gastrectomy and diversion of the biliopancreatic juices into the distal ileum by a long Roux-en-Y procedure. The procedure consists of the following components:

• A distal gastrectomy functions to induce a temporary early satiety and/or the dumping syndrome in the early postoperative period, both of which limit food intake.
  
• A 200-cm long alimentary tract consists of 200 cm of ileum connecting the stomach to a common distal segment.
  
• A 300- to 400-cm biliary tract, which connects the duodenum, jejunum, and remaining ileum to the common distal segment.
  
• A 50- to 100-cm common tract where food from the alimentary tract mixes with biliopancreatic juices from the biliary tract. Food digestion and absorption, particularly of fats and starches, are therefore limited to this small segment of bowel, i.e., creating a selective malabsorption. The length of the common segment will influence the degree of malabsorption.
  
• Because of the high incidence of cholelithiasis associated with the procedure, patients typically undergo an associated cholecystectomy.

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

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. This is then anastomosed to a segment of the ileum (similar to the above procedure) to create the alimentary segment. Preservation of the pyloric sphincter is designed to be more physiologic. The sleeve gastrectomy decreases the volume of the stomach and also decreases the parietal cell mass with the intent of decreasing the incidence of ulcers at the duodenoileal anastomosis. However, the basic principle of the procedure is similar to that of the biliopancreatic bypass; i.e., producing selective malabsorption by limiting the food digestion and absorption to a short common ileal segment.

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

Recently variations of gastric bypass procedures have been described that consist primarily of long limb Roux-en-Y procedures. For example, the stomach may be divided with a long segment of the jejunum (instead of ileum) anastomosed to the proximal gastric stump to create the alimentary limb. The remaining pancreaticobiliary limb (consisting of stomach remnant, duodenum, and length of proximal jejunum) is then anastomosed to the ileum creating a common limb of variable length in which the ingested food mixes with the pancreaticobiliary juices. The stomach may be bypassed in a variety of ways, i.e., either by resection or stapling along the horizontal or vertical axis. Unlike the traditional gastric bypass (essentially a gastric restrictive procedure) these very long limb Roux-en-Y gastric bypasses function as a malabsorptive procedure more similar in concept to the biliopancreatic bypass. The long limb gastric bypass is designed to reduce the incidence of metabolic complications but the potential complications are similar to those of the biliopancreatic bypass. Note prior to 1-1-2005 that CPT code (43846) for gastric bypass explicitly describes a short limb (<100 cm) Roux-en-Y gastroenterostomy and thus would not apply to long limb gastric bypass. As of 1-1-2005 the description of CPT code 43846 has been revised to describe a short limb (150cm or less) Roux-en-Y gastroenterostomy.

Body Weights in Pounds According to Height and Body Mass Index

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

Weight in Pounds

x 703

Height in inches x Height in inches

Body Mass Index can also be calculated using kilograms and meters (or centimeters).

Weight in Kilograms

x 703

Height in meters x Height in meters

Weight in Kilograms

x 10,000

Height in centimeters x Height in centimeters

To convert pounds to kilograms, multiply pounds by 0.45.

To convert inches to centimeters, multiply inches by 2.54.

To convert feet to meters, multiple feet by 0.30.

Rationale:

Medical Treatment

A reasonable time line of 6 months of weight reduction therapy has been established based on National Institute of Health’s Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. The guidelines state that weight loss at the rate of 1 to 2 lbs. per week commonly occurs for up to six months. After six months weight loss usually declines and weight plateaus.

Bariatric Surgery

Outcomes of bariatric surgeries are notoriously difficult to evaluate due in part to the constantly evolving nature of the surgery. Small modifications are commonly made to decrease the incidence of postoperative and long-term complications. In addition, there have been no controlled studies (with one exception discussed below) that have directly measured the weight loss and complications associated with the different surgical approaches, especially comparing gastric restrictive procedures with malabsorptive procedures. Case series from individual institutions or individual surgeons with varying lengths of follow-up dominate the literature. The outcomes for specific surgeries may differ widely among institutions or surgeons, perhaps due to small variations in surgical technique, intensity of follow-up, or patient selection criteria. However, during the 1970s and 1980s both vertical banded gastroplasty (VBG) and gastric bypass became widely accepted types of bariatric surgery. These two procedures were the focus of the 1991 NIH Consensus Development Conference on gastrointestinal surgery for severe obesity, which also noted that limited data were available regarding biliopancreatic bypass. Therefore, vertical banded gastroplasty and gastric bypass are considered the gold standards for the purpose of this discussion. The results of these procedures will be compared to the newer procedures not addressed by the 1991 conference; i.e., gastric banding and biliopancreatic bypass with or without duodenal switch.

The following outcomes are considered relevant for bariatric surgery:

Weight loss

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

Durability of weight loss

Weight change (i.e., gain or loss) at yearly intervals is often reported. The weight loss with gastric restrictive procedures is thought to be less durable compared to malabsorptive procedures, due to the dilation of the gastric pouch.

Operative and peri-operative complications

There is an increased incidence of operative and peri-operative complications in obese patients in general, particularly the incidence of thromboembolism and wound healing.

Reoperation Rate

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

Metabolic Side Effects

Metabolic side effects are of particular concern in malabsorptive procedures.

Final health outcomes in terms of complications of obesity

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

• diabetes,
  
• cardiovascular risk factors (i.e., increased cholesterol, hypertension),
  
• obstructive sleep apnea, or
  
• arthritis.

Unfortunately, these final health outcomes are not consistently reported.

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

Vertical Banded Gastroplasty

As a representative example of a large case series with long-term follow-up, MacLean and colleagues reported on 201 patients who underwent vertical banded gastroplasty and who were followed for a minimum of 2 years. Staple line perforation occurred in 48% of patients and 36% underwent reoperation either to repair the perforation or to repair a stenosis at the rate-limiting orifice. However, the more than 50% of patients who maintained an intact staple line had durable weight loss of 75% to 100% of excess weight. The procedure was less successful in the super obese, defined as a BMI of >50 kg/m-2, in whom only 85 achieved an excellent result. These results suggest that failures of vertical banded gastroplasty are primarily technical in nature. Based on these results the authors have altered their surgical technique by reinforcing the staple lines to reduce the incidence of perforation. It is this type of small change in surgical technique that can markedly affect results among different surgeons. In a 1987 case series of 305 patients undergoing vertical banded gastroplasty, there was a mean weight loss of 60% of excess weight at 2-year follow-up. In contrast to MacLean's report, there was only a 1.3% incidence of staple line disruption. Significant decreases in cardiovascular risk factors, incidence of diabetes and sleep apnea have also been reported. For example, Melissas and colleagues evaluated obesity's co-morbid conditions in 62 patients who had undergone a vertical banded gastroplasty. All patients were followed up for 12 to 48 months, with 84% of patients losing at least 50% of their excess weight. Of the 218 weight-related pathologic conditions existing before the operation, 83% were either cured or improved.

Gastric Bypass with Short Limb (<150 cm)

Griffen summarized the experience of over 10,000 gastric bypass operations from a number of bariatric surgeons. It was estimated that 85% of patients reduced their weight to at least 50% above the ideal weight. In about 5,000 patients who were followed up for 10 years, 80% were able to maintain this result. Pories and colleagues reported on 608 patients who underwent a gastric bypass procedure and were followed up for 1 to 14 years. One of the unique features of this report is that only 3% of patients were lost to follow-up. The average weight loss was 75% of excess weight at one year, declining to 50% by the eighth year. The authors observed an immediate drop in both blood glucose and exogenous insulin requirements after surgery. Long-term observation of 298 patients with preoperative diabetes or impaired glucose intolerance revealed that 91% had normal values for blood glucose and hemoglobin A1-C after surgery. The incidence of hypertension declined from 58% before surgery to 14% after gastric bypass.

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

In the one controlled trial reported, Sugarman and colleagues randomized 40 patients to receive either a vertical banded gastroplasty or a gastric bypass procedure. After 9 months the gastric bypass patients had significantly greater weight loss that persisted in a 3-year follow-up. The gastric bypass patients lost approximately 64% of excess weight, whereas the gastroplasty patients lost only 37% of excess weight. In this study technical differences could not explain the discrepancy, since small intact gastric pouches were seen in patients who experienced unsuccessful vertical banded gastroplasty procedures. The authors hypothesized that the unpleasant dumping syndrome, seen most frequently in sweets eaters, may have been responsible for the increased success of the gastric bypass procedure. A nonrandomized study of 200 patients reported that gastric bypass and vertical banded gastroplasty may be equally effective in achieving 40% excess weight loss. However gastric bypass patients may achieve 50% to 60% of excess weight loss. Metabolic abnormalities are seen more frequently in gastric bypass patients compared to those receiving a vertical banded gastroplasty. Anemia, iron deficiency, Vitamin B 12 deficiency, and red blood cell folate deficiency are commonly seen abnormalities. Marginal ulcerations are also seen in gastric bypass patients, particularly in those whose gastric pouches are too large and include acid-secreting parietal cells. There is currently no data in the published medical literature regarding a gastric bypass using a Billroth II anastomosis (the mini gastric bypass). While this surgical approach may result in decreased surgical time, the anastomosis creates the risk of biliary reflux gastritis. This is one of the reasons that this anastomosis has been abandoned, in general, in favor of a Roux-en-Y anastomosis that diverts the biliary juices away from the stomach.

Gastric Banding

Gastric banding (using an external adjustable band placed around the stomach) has been extensively used in Europe. The procedure is designed to mimic the vertical banded gastroplasty, but is an easier, reversible, and more flexible surgery. Similar to all gastric surgeries, the literature is dominated by large case series from individual surgeons who report varying results. Gastric banding surgery is still an evolving procedure with band migration being addressed by altering the position of the band and band erosion addressed by stabilizing the placement of the band. Therefore, it is very difficult to compare one series to another. For example, in this country Doherty and colleagues reported on an initial experience with adjustable gastric banding in 40 patients. The authors reported an unacceptable reoperation rate of 80%, due primarily to technical problems with the subcutaneously implanted reservoir. While those with an intact gastric band achieved 41% excess weight loss, the authors concluded that revisions to the surgical procedure and improvements in the device itself must be implemented. In a subsequent study the authors reported several surgical modifications (including location of the gastric band) and modifications in the device itself. Also, the surgery was performed laparoscopically. Seven of the 22 patients (33%) required reoperation, a considerable improvement. In contrast to this American experience, as a representative example, Miller and Hell report a reoperation rate of only 7% in a case series of 158 patients. Median BMI decreased from 44 kg/m-2 preoperatively to 28 kg/m-2 after 36 months. Suter and colleagues compared vertical banded gastroplasty with laparoscopic gastric banding in consecutive case series. They reported that laparoscopic gastric banding was associated with a significant decrease in postoperative morbidity, due primarily to a decrease in thromboembolism and wound infections. After 2 years of follow-up there was no significant difference in weight loss between the 2 groups.

Recent improvements in surgical technique appear to have reduced the incidence of prolapse/slippage and pouch dilatation. Although complete follow-up of the multicenter clinical trial is not yet available, it appears the combination of the revised surgical technique (including placement and strict attention to securing the gastric band) and close patient follow-up with frequent band adjustment, performed in a comprehensive bariatric program setting, may be an effective treatment alternative for some individuals with morbid obesity.

Biliopancreatic Bypass

Scopinaro (who developed the procedure) reports the largest experience with biliopancreatic bypass. In 1996, Scopinaro summarized his experience with 1,217 patients. The author reported that during the first 3 to 4 months after the surgery patients had decreased appetites related to the dumping syndrome. These symptoms regressed with time to the point that the majority of patients could resume eating large meals. Most patients were eating more than they did before the operation. With follow-up of up to 9 years, the authors reported a durable excess weight loss of 75%, suggesting that weight loss is greater with this procedure compared to gastric restrictive procedures. In addition, the vast majority of patients reported disappearance and/or improvement of such complications as obstructive sleep apnea, hypertension, hypercholesteremia, and diabetes. The authors considered protein malnutrition the most serious metabolic complication (occurring in almost 12% of patients and responsible for 3 deaths). This complication may require inpatient treatment with total parenteral nutrition. To address the issue of protein malnutrition, 4% of patients underwent reoperation to either elongate the common limb (thus increasing protein absorption) or had the operation reversed (restoring normal intestinal continuity). The authors also found that protein malnutrition was strongly related to ethnicity and presumably eating habits with an increased incidence among those from southern Italy where the diet contains more starch and carbohydrates than the north. Peripheral neuropathy may occur in the early postoperative period due to excessive food limitation but may be effectively treated with large doses of thiamine. Bone demineralization, due to decreased Calcium absorption, was seen in about 33% of patients during the first four postoperative years. All patients were encouraged to maintain an oral Calcium intake of 2 gr. daily with monthly Vitamin D supplementation.

Totte and colleagues in Belgium reported their experience with biliopancreatic bypass in 180 patients. Prior to surgery the mean BMI was 48.8 kg/m-2 and dropped to 28.8 kg/m-2 at 36 months, corresponding to about 70% of excess weight loss. Six patients (3.3%) experienced serious perioperative complications including acute dilatation of the stomach, diffuse peritonitis, and acute pancreatitis. Late complications included incisional hernia in 17%, anastomotic ulcers in 10%, and severe protein malnutrition requiring total parenteral nutrition in 1.1% of the patients. Obesity-related complications (such as diabetes, hypertension, or arthritis) were resolved or improved in all patients. Nanni and colleagues reported on a case series of 59 patients. Weight loss was similar to Totte and colleagues with 78% of excess weight loss after 2 years. Protein deficiency was noted in 2 (3.4%) patients.

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

Gastric Bypass with Long Limb (>150 cm)

Long limb gastric bypass is designed primarily to be a malabsorptive procedure, differing in the lengths of the various limbs and the fact that the jejunum is used for the alimentary limb compared to the ileum in biliopancreatic bypass. In addition, as described by Murr, the common segment is increased from 50 to 100 cm allowing for greater food absorption. These modifications have been developed in an effort to decrease the metabolic side effects associated with biliopancreatic bypass. However, there has been limited reported experience. Murr reported on 26 patients who underwent a very long limb Roux-en-Y gastric bypass. In comparison to a case series of 11 patients who underwent biliopancreatic bypass the authors reported similar weight loss but decreased metabolic or nutritional abnormalities. This was attributed in part to the increased length of the common segment (100 cm) compared to 50 cm used in biliopancreatic bypass. Sugarman also attributes increasing the length of the common segment to decreasing metabolic morbidities.

Biliopancreatic Bypass with Duodenal Switch

The largest case series of the above procedure is reported by Marceau, who reported on 465 patients who underwent the duodenal switch procedure compared to 252 who underwent the biliopancreatic bypass. It should be noted that in addition to the preservation of the duodenum, the common segment was elongated to 100 cm. The authors noted similar weight loss in the 2 groups. In the duodenal switch group, there was a lower incidence of metabolic abnormalities (such as protein malnutrition) which prompted reversal of the procedure in 1.7% of those undergoing biliopancreatic bypass vs. only 0.1% after the duodenal switch procedure. However, it is not known whether this outcome is attributed to the lengthening of the common segment vs. retention of the pylorus. Hess reported on a case series of 440 patients with variable lengths of the common channel. The percentage excess weight loss varied between 60% and 90% depending on the length of the common segment and alimentary limb. There were 2 late deaths, 1 due to septic shock secondary to an infected panniculus and 1 related to liver failure. A total of 10 patients underwent revision to lengthen the common segment secondary to low protein or excessive diarrhea. Seven patients underwent shortening of the common segment due to inadequate weight loss. Baltasar and colleagues reported on a case series of 60 patients undergoing the duodenal switch procedure with a common segment length of 75 cm. One patient succumbed to liver failure and another due to malnutrition. The authors questioned the safety of the procedure.

Sleeve Gastrectomy

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

As a stand-alone procedure, there is limited data to evaluate outcomes and/or compare efficacy to other procedures. A small number of clinical series have been published which report on outcomes after sleeve gastrectomy alone. Moon et al reported on a series of 60 patients who had undergone sleeve gastrectomy and who had at least one year of follow-up. These authors reported that the percentage of estimated weight loss at 12 months was 83%. Diabetes resolved in 100% of patients in this series and hypertension resolved in 93% In a smaller series of 23 patients, Langer et al (20) reported a % EWL of 56% at one year.

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

Summary:

As noted in the Policy section, this policy suggests that malabsorptive procedures for treatment of morbid obesity remain investigational. This interpretation of the term investigational may be questioned by those who would point out the procedure, particularly the Scopinaro procedure, has been performed for some 20 years with results of large case series reported in the peer-reviewed literature. The percent of excess weight loss for malabsorptive procedures, typically at or above 70%, may be higher than that reported with gastric restrictive procedures (reported at around 60%) but higher among those patients who maintain intact stomas. However, one of the criteria used to define the term investigational is whether the malabsorptive procedures are at least as good as the alternatives; i.e., gastric restrictive procedures. This involves a judgment as to whether the acknowledged increased metabolic risks associated with malabsorptive procedures are more than outweighed by an increased benefit associated with potentially greater weight loss. While most of the studies of bariatric surgeries report results in terms of weight loss, the degree of weight loss is essentially an intermediate outcome. The underlying medical rationale for the surgery (the basis for its coverage eligibility) is not the degree of weight loss but the decreased risk of the morbid complications of obesity, i.e., a decreasing incidence of diabetes and cardiac risk factors, among others. While the psychosocial benefits of achieving normal weight may be compelling they are not necessarily equivalent to the medical benefit. As noted by Brolin, a substantial number of morbidly obese patients experience marked improvement of medical problems with a relatively modest amount of weight loss. For example, in his case series of 130 patients undergoing bariatric surgery, over 90% experienced resolution or improvement in associated symptoms even though only 41% of patients lost weight to within 50% of their ideal weight. Ideally, one would like to compare the incidence of morbidities in gastric restrictive vs. malabsorptive procedures. However, there is no report of a head-to-head comparison among similar patients. It is difficult to compare results between case series due to variations in surgical procedures and different outcome measurements. In addition, the literature focuses on the degree of weight loss and not the incidence of obesity-related morbidities. However, it appears that the reduction in incidence of diabetes and cardiovascular risk factors is excellent with either a gastric restrictive or malabsorptive procedure. Therefore, this policy regarding the investigational status of malabsorptive procedures is based on the judgment that there is not sufficient evidence to demonstrate that the increased risks of malabsorptive procedures compared to restrictive procedures is outweighed by a significantly greater reduction in obesity-related morbidities.

In the future, further modifications of malabsorptive procedures, including further experience with long limb gastric bypasses and refinement of surgical technique may be associated with a declining risk of metabolic complications. However, gastric restrictive surgeries are also evolving at the same time, with techniques focused on fortifying the stoma such that durable weight loss can be maintained.

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

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

Pricing:

Note: Code 43633 has been incorrectly used to bill for obesity surgery

[mcmurraydragon 0]

I have BCBS PPO of IL. They cover RNY and Lapband after a 6 mth supervised program. I am in Florida and my company/Union made an agreement with them to make sure this provision was in our agreement. Some companies dont do this and some do. Just have to check into it. BCBS of IL told me to go to www.BCBSIL.comMedPolicy and look up Morbid Obesity and you can type in your policy Number and see exactly what the cover and what is required.

[Perky66 1]

Is there any way around the 6 month waiting period???