Note: Most Aetna HMO and QPOS plans exclude coverage of surgical operations, procedures or treatment of obesity unless approved by Aetna. Some Aetna plans entirely exclude coverage of surgical treatment of obesity. Please check benefit plan descriptions for details.

1. Roux-en-Y Gastric Bypass (RYGB), Laparoscopic Adjustable Silicone Gastric Banding (LASGB), Biliopancreatic Diversion (BPD) and Duodenal Switch (DS) Procedures:

   Aetna considers open or laparoscopic Roux-en-Y gastric bypass (RYGB), open or laparoscopic biliopancreatic diversion (BPD) with or without duodenal switch (DS), or laparoscopic adjustable silicone gastric banding (LASGB) medically necessary when the selection criteria listed below are met.

   Selection criteria:

   1. Presence of severe obesity that has persisted for at least the last 2 years, defined as any of the following:

      1. Body mass index (BMI)* exceeding 40; or

      2. BMI* greater than 35 in conjunction with any of the following severe co-morbidities:

         1. Coronary heart disease; or
         2. Type 2 diabetes mellitus; or
         3. Clinically significant obstructive sleep apnea (i.e., patient meets the criteria for treatment of obstructive sleep apnea set forth in Aetna CPB 004 - Obstructive Sleep Apnea); or

         4. Medically refractory hypertension (blood pressure greater than 140 mmHg systolic and/or 90 mmHg diastolic despite optimal medical management);

      and

   2. Member has completed growth (18 years of age or documentation of completion of bone growth); and
   3. Member has attempted weight loss in the past without successful long-term weight reduction; and

   4. Member must meet either criterion 1 (physician-supervised nutrition and exercise program) or criterion 2 (multidisciplinary surgical preparatory regimen):

      1. Physician-supervised nutrition and exercise program: Member has participated in physician-supervised nutrition and exercise program (including dietician consultation, low calorie diet, increased physical activity, and behavioral modification), documented in the medical record at each visit. This physician-supervised nutrition and exercise program must meet all of the following criteria:

         1. Nutrition and exercise program must be supervised and monitored by a physician working in cooperation with dieticians and/or nutritionists; and
         2. Nutrition and exercise program(s) must be for a cumulative total of 6 months or longer in duration and occur within 2 years prior to surgery, with participation in one program of at least three consecutive months. (Precertification may be made prior to completion of nutrition and exercise program as long as a cumulative of six months participation in nutrition and exercise program(s) will be completed prior to the date of surgery.); and

         3. Member's participation in a physician-supervised nutrition and exercise program must be documented in the medical record by an attending physician who supervised the member's participation. The nutrition and exercise program may be administered as part of the surgical preparative regimen, and participation in the nutrition and exercise program may be supervised by the surgeon who will perform the surgery or by some other physician. Note: A physician's summary letter is not sufficient documentation. Documentation should include medical records of physician's contemporaneous assessment of patient's progress throughout the course of the nutrition and exercise program. For members who participate in a physician-administered nutrition and exercise program (e.g., MediFast, OptiFast), program records documenting the member's participation and progress may substitute for physician medical records;

         or

      2. Multidisciplinary surgical preparatory regimen: Proximate to the time of surgery, member must participate in organized multidisciplinary surgical preparatory regimen of at least three months duration meeting all of the following criteria, in order to improve surgical outcomes, reduce the potential for surgical complications, and establish the member's ability to comply with post-operative medical care and dietary restrictions:

         1. Consultation with a dietician or nutritionist; and
         2. Reduced-calorie diet program supervised by dietician or nutritionist; and
         3. Exercise regimen (unless contraindicated) to improve pulmonary reserve prior to surgery, supervised by exercise therapist or other qualified professional; and
         4. Behavior modification program supervised by qualified professional; and

         5. Documentation in the medical record of the member's participation in the multidisciplinary surgical preparatory regimen at each visit. (A physician's summary letter, without evidence of contemporaneous oversight, is not sufficient documentation. Documentation should include medical records of the physician's initial assessment of the member, and the physician's assessment of the member's progress at the completion of the multidisciplinary surgical preparatory regimen.)

      and

   5. For members who have a history of severe psychiatric disturbance (schizophrenia, borderline personality disorder, suicidal ideation, severe depression) or who are currently under the care of a psychologist/psychiatrist or who are on psychotropic medications, pre-operative psychological clearance is necessary in order to exclude members who are unable to provide informed consent or who are unable to comply with the pre- and postoperative regimen. Note: The presence of depression due to obesity is not normally considered a contraindication to obesity surgery.

2. Vertical Banded Gastroplasty (VBG):

   Aetna considers open or laparoscopic vertical banded gastroplasty (VBG) medically necessary for members who meet the selection criteria for obesity surgery and who are at increased risk of adverse consequences of a RYGB due to the presence of any of the following comorbid medical conditions:

   1. Hepatic cirrhosis with elevated liver function tests; or
   2. Inflammatory bowel disease (Crohn's disease or ulcerative colitis); or
   3. Radiation enteritis; or
   4. Demonstrated complications from extensive adhesions involving the intestines from prior major abdominal surgery, multiple minor surgeries, or major trauma; or

   5. Poorly controlled systemic disease (American Society of Anesthesiology (ASA) Class IV) (see Appendix).

   Aetna considers VBG experimental and investigational when medical necessity criteria are not met.

3. Repeat Bariatric Surgery:

   Aetna considers medically necessary surgery to correct complications from bariatric surgery, such as obstruction or stricture.

   Aetna considers repeat bariatric surgery medically necessary for members whose initial bariatric surgery was medically necessary (i.e., who met medical necessity criteria for their initial bariatric surgery), and who meet either of the following medical necessity criteria:

   1. Conversion to a RYGB or BPD/DS may be considered medically necessary for members who have not had adequate success (defined as loss of more than 50 percent of excess body weight) two years following the primary bariatric surgery procedure and the member has been compliant with a prescribed nutrition and exercise program following the procedure; or

   2. Revision of a primary bariatric surgery procedure that has failed due to dilation of the gastric pouch is considered medically necessary if the primary procedure was successful in inducing weight loss prior to the pouch dilation, and the member has been compliant with a prescribed nutrition and exercise program following the procedure.

4. Experimental and Investigational Bariatric Surgical Procedures:

   Aetna considers each of the following procedures experimental and investigational because the peer reviewed medical literature shows them to be either unsafe or inadequately studied:

   • Loop gastric bypass
   • Gastroplasty, more commonly known as “stomach stapling” (see below for clarification from vertical band gastroplasty)
   • Sleeve gastrectomy
   • Mini gastric bypass
   • Silastic ring vertical gastric bypass (Fobi pouch)
   • Intragastric balloon
   • VBG, except in limited circumstances noted above.

   • LASGB, RYGB, and BPD/DS procedures not meeting the medical necessity criteria above.

Cholecystectomy:

As a high incidence of gallbladder disease (28%) has been documented after surgery for morbid obesity, Aetna considers routine cholecystectomy medically necessary when performed in concert with elective bariatric procedures.

Notes:

Calculation of BMI:

*BMI is calculated by dividing the patient's weight (in kilograms) by height (in meters) squared:

BMI = weight (kg) * [height (m)]2

Note: To convert pounds to kilograms, multiply pounds by 0.45. To convert inches to meters, multiply inches by 0.0254.

or

For a simple and rapid calculation of BMI, please click below and it will take you to the Obesity Education Initiative.

*BMI = weight (kg) * [height (m)]2

See also CPB 039 - Weight Reduction Medications and Programs.

These criteria were adapted from the NIH Consensus Conference on Surgical Treatment of Morbid Obesity (1998) which state that obesity surgery should be reserved only for patients who have first attempted medical therapy:  “Weight loss surgery should be reserved for patients in whom efforts at medical therapy have failed and who are suffering from the complications of extreme obesity.”

Rationale for Presurgical Preparatory Regimen:

The patient’s ability to lose weight prior to surgery makes surgical intervention easier and also provides an indication of the likelihood of compliance with the severe dietary restriction imposed on patients following surgery.

Given the importance of patient compliance on diet and self-care in improving patient outcomes after surgery, the patient’s refusal to even attempt to comply with a nutrition and exercise regimen prior to surgery portends poor compliance with nutritional and self-care requirements after surgery.  Therefore, the appropriateness of obesity surgery in noncompliant patients should be questioned.

The patient must be committed to the appropriate work-up for the procedure and for continuing long-term postoperative medical management, and must understand and be adequately prepared for the potential complications of the procedure.

There is rarely a good reason why obese patients (even super obese patients) cannot delay surgery in order to undergo behavior modification to improve their dietary and exercise habits in order to reduce surgical risks and improve surgical outcomes.  The patient may be able to lose significant weight prior to surgery in order to improve the outcome of surgery.

An individual’s understanding of the procedure and ability to comply with life-long follow-up and life-style changes (e.g., as exemplified by compliance with previous medical care) are necessary for the success of the procedure.

Obesity makes many types of surgery more technically difficult to perform and hazardous.  Weight loss prior to surgery makes the procedure easier to perform.  Weight reduction reduces the size of the liver, making surgical access to the stomach easier.  By contrast, the liver enlarges and becomes increasingly infiltrated with fat when weight is gained prior to surgery.  A fatty liver is heavy, brittle, and more likely to suffer injury during surgery.  Moreover, following surgery, patients have to follow a careful diet of nutritious, high-fiber foods in order to avoid nutritional deficiencies, dumping syndrome, and other complications.  The total weight loss from surgery can be enhanced if it is combined with a low-calorie diet.  For these reasons, it is therefore best for patients to develop good eating and exercise habits before they undergo surgery.

The preoperative surgical preparatory regimen should include cessation counseling for smokers.  The National Institutes of Health Consensus Statement (1998) states that all smokers should be encouraged to quit, regardless of weight.  Smoking cessation is especially important in obese persons, as obesity places them at increased risk for cardiovascular disease.  Severely obese persons are at increased risk of surgical complications.  Smoking cessation reduces the risk of pulmonary complications from surgery.

Ideally, the surgical center where surgery is to be performed should be accomplished in bariatric surgery with a demonstrated commitment to provide adequate facilities and equipment, as well as a properly trained and funded appropriate bariatric surgery support staff.  Minimal standards in these areas are set by the institution and maintained under the direction of a qualified surgeon who is in charge of an experienced and comprehensive bariatric surgery team.  This team should include experienced surgeons and physicians, skilled nurses, specialty-educated nutritionists, experienced anesthesiologists, and, as needed, cardiologists, pulmonologists, rehabilitation therapists, and psychiatric staff.  The American College of Surgeons (ACS) has stated that the surgeon performing the bariatric surgery be committed to the multidisciplinary management of the patient, both before and after surgery.  The ACS recommended:

They develop skills in patient education and selection and are committed to long-term patient management and follow-up.  There is active collaboration with multiple patient care disciplines including nutrition, anesthesiology, cardiology, pulmonary medicine, orthopedic surgery, diabetology, psychiatry, and rehabilitation medicine.  Appropriate technical skills in the performance of bariatric surgical procedures are acquired.

Although not a requirement for coverage, ideally, the bariatric surgeon should be board certified by the American Board of Surgery or in the process of certification within five years after completion of an accredited residency program in general or gastrointestinal surgery, and recertification has been obtained by the American Board of Surgery on an every 10-year basis, if applicable.  Appropriate qualifications for a bariatric surgeon include either fellowship training or extended mentoring by an experienced surgeon, preferably by members of international/national bariatric societies, in all aspects of bariatric surgery, advanced laparoscopic techniques, and additional training in re-operative techniques.

Body Mass Index as a Criterion for Candidacy for Obesity Surgery:

Surgery for severe obesity is usually considered an intervention of last resort with patients having attempted other forms of medical management (such as behavior change, increased physical activity and drug therapy) but without achieving permanent weight loss (Colquitt, et al., 2002; NIH, 1995).  Surgery is indicated for persons with severe obesity (body mass index (BMI) of 40 kg/m2 or more) or for persons with a BMI of 35 kg/m2 or more and serious co-morbidities such as diabetes, coronary heart disease, or obstructive sleep apnea.  Ideally patients selected for surgery should have no major perioperative risk factors, a stable personality, no eating disorders, and have lost some weight prior to surgery.  The patient's ability to lose weight prior to surgery makes surgical intervention easier and also provides an indication of the likelihood of compliance with the severe dietary restriction imposed on patients following surgery.

Rationale for Six-Month Nutrition and Exercise Program Prior to Surgery:

The NIH Consensus Conference on Surgical Treatment of Morbid Obesity (1998) states that obesity surgery should be reserved only for patients who have first attempted medical therapy: “Weight loss surgery should be reserved for patients in whom efforts at medical therapy have failed and who are suffering from the complications of extreme obesity.”

The NIH Consensus Conference states that the initial goal of medical therapy is a 10 percent reduction in weight, and that a reasonable duration for medical therapy is six months.  The Consensus Conference stated: “The initial goal of weight loss therapy is to reduce body weight by approximately 10 percent from baseline.  If this goal is achieved, further weight loss can be attempted, if indicated through further evaluation.  A reasonable time line for a 10 percent reduction in body weight is 6 months of therapy.”

The NIH Consensus Conference Statement (1998) explained "The rationale for this initial goal is that even moderate weight loss, i.e., 10 percent of initial body weight, can significantly decrease the severity of obesity-associated risk factors."  The NIH Consensus Conference (1998) states that the combination of a reduced calorie diet and increased physical activity can result in substantial improvements in blood pressure, glucose tolerance, lipid profile, and cardiorespiratory fitness.

The NIH Consensus Conference (1998) has stated that the patient should begin a nutrition and exercise program prior to surgery: “An integrated program must be in place to provide guidance on diet, physical activity, and behavioral and social support both prior to and after the surgery.”

The American Dietetic Association (1997), in their position statement obesity surgery, recommends dietetic counseling and behavioral modification commencing prior to, not after, surgery: “Careful dietetics evaluation is needed to determine if the patient will be able to comply with the postoperative diet.  A preoperative behavior change program with psychological evaluation should be required.”

Candidates for obesity surgery should begin a weight reduction diet prior to surgery.  The purpose of a preoperative nutrition program prior to obesity surgery are to test patient motivation, to reduce perioperative morbidity, to accustom patients to the restriction of food intake after surgery, and to increase total weight loss (van de Weijgert, et al.,1999; Jung & Cusciheri, 2000; Pekkarinen, et al., 1997; Martin, et al., 1995).  Even super obese patients (BMI > 50) may benefit from initiating a nutrition and exercise program prior to surgery.  Obesity itself increases the likelihood of pulmonary complications and wound infections (Choban, et al., 1995; Abdel-Moneim, 1985; Holley, et al., 1990; Myles, et al., 2002; Nair, et al., 2002; Bumgardner, et al., 1995; Perez, et al., 2001; Chang, et al., 2000; Printken, et al., 1975).  The higher the patient's BMI, the higher the surgical risk, and the highest risks occur among patients with a BMI over 50 (Gonzalez, et al., 2003; Oelschlager & Pellegrini, 2003).  Even relatively modest weight loss prior to surgery can result in substantial improvements in pulmonary function, blood glucose control, blood pressure, and other physiological parameters (Anderson, et al., 2000; Hakala, et al., 1995; Kansanen, et al., 1998; Pekkarinen, et al., 1998).  Factors such as blood glucose control, hypertension, etc., affect surgical risk.  Garza (2003) explained that the patient should lose weight prior to surgery to reduce surgical risks.   "The overall health of patients should be optimized prior to surgery to reduce the potential for complications.  Patients ought to be encouraged to lose as much weight as possible before surgery" (Garza, 2003).  Although the long-term effectiveness of weight reduction programs has been questioned, the Institute of Medicine (1995) has reported the substantial short-term effectiveness of certain organized physician-supervised weight reduction programs.

For maximal benefit, dieting should occur proximal to the time of surgery, and not in the remote past to reduce surgical risks and improve outcomes.  Even if the patient has not been able to keep weight off long-term with prior dieting, the patient may be able to lose significant weight short term prior to surgery in order to improve the outcome of surgery.

Given the importance of patient compliance in diet and self-care in improving patient outcomes after surgery, the appropriateness of obesity surgery in noncompliant patients should be questioned.  The American College of Surgeons has stated: “Not all persons who are obese or who consider themselves overweight are candidates for bariatric surgery.  These procedures are not for cosmesis but for prevention of the pathologic consequences of morbid obesity.  The patient must be committed to the appropriate work-up for the procedure and for continuing long-term postoperative medical management, and understand and be adequately prepared for the potential complications of the procedure.  Screening of the patients to ensure appropriate selection is a critical responsibility of the surgeon and the supporting health care team.”

Contraindications to Obesity Surgery:

Surgery for severe obesity is a major surgical intervention with a risk of significant early and late morbidity and of perioperative mortality (Colquitt, 2002; Oelschlager & Pellegrini, 2003).  Contraindications for these surgical procedures include perioperative risk of cardiac complications, poor myocardial reserve, significant chronic obstructive airways disease or respiratory dysfunction, non-compliance of medical treatment, psychological disorders of a significant degree that a psychologist/psychiatrist would have thought would be exacerbated or interfere with the long-term management of the patient after the operation, significant eating disorders, or severe hiatal hernia/gastroesophageal reflux.

Requirement that Obesity be Longstanding (Present for 2 or More Years):

Obesity surgery is not indicated for persons with transient increases in weight (Collazo-Clavell, 1999).  According to the Guidelines of the American Association of Clinical Endocrinologists and the American College of Endocrinology (1998), “Surgical treatment of obesity may be considered only in carefully selected patients [where] … obesity has been present for at least 5 years.”

Obesity Surgery in Children and Adolescents:

According to available guidelines, obesity surgery is indicated for persons age 18 and older (AACE, 1998).  Children and adolescents are rapidly growing, and are therefore especially susceptible to adverse long-term consequences of nutritional deficiencies from the reduced nutrient intake and malabsorption that is induced by obesity surgery.  It is not known whether the benefits of obesity surgery in children and adolescents outweigh the increased risks.

According to a panel of experts (Inge et al, 2004), bariatric surgery may be an appropriate treatment for severe obesity in adolescents who have completed bone growth.  According to the recommendations by the expert panel, potential candidates for bariatric surgery should be referred to centers with multi-disciplinary weight management teams that have expertise in meeting the unique needs of overweight adolescents.  Consideration for bariatric surgery is generally warranted only when adolescents have experienced failure of 6 months of organized weight loss attempts and have met certain criteria: severe obesity (a BMI of 40); have attained a majority of skeletal maturity (generally 13 years of age for girls and 15 years of age for boys); and have co-morbidities related to obesity that might be remedied with weight loss.  Surgery should only be performed at facilities that are equipped to collect long term data on clinical outcomes.  The panel recommended the Roux-en-Y gastric bypass method of surgery over the simpler, newer technique of implanting an adjustable gastric band since gastric bands are less effective and younger patients would probably need replacement as they age.

Requirement for Physician Supervision of Program Documented in Medical Record:

Aetna’s policy states that the patient should participate in a medically supervised nutrition and exercise program and/or a comprehensive multidisciplinary preoperative preparatory regimen, and that this participation be documented in the medical record.  As is true generally, physicians should document their assessment of the patient, what health interventions are prescribed, and their assessment of the patient’s progress.  There is established evidence that medical supervision of a nutrition and exercise program increases the likelihood of success (Blackburn, 1993).  The American Medical Association Council on Scientific Affairs recommends that “any person considering a weight loss program first consult a physician for a physical examination and an objective evaluation of the proposed weight loss program as it relates to the individual’s physical condition … Various health organizations recommend that physicians assess their patients for overweight and that patients receive appropriate counseling about safe weight management and the benefits of physical activity and a healthy diet [citing guidelines from the National Heart, Lung and Blood Institute, the AACE/ACE, the Institute of Medicine of the National Academy of Sciences, the U.S. Preventive Services Task Force, the American Obesity Association, the American Medical Association, and an expert committee of pediatric experts convened by the Health Resources and Services Administration]” (Lyznicki, et al., 2001).  “If treatment is indicated, physicians can help patients develop weight loss or management plans tailored to individual needs; this includes setting reasonable weight loss goals; selecting appropriate weight loss programs; referring patients to ancillary personnel when appropriate; and providing monitoring, support and encouragement” (Lyznicki, et al., 2001).

Requirement for Psychological Evaluation:

Candidates for obesity surgery who have a history of severe psychiatric disturbance (schizophrenia, borderline personality disorder, suicidal ideation, severe depression) or who are currently under the care of a psychologist/psychiatrist or who are on psychotropic medications should undergo a comprehensive evaluation by a licensed psychologist or psychiatrist to assess the patient’s suitability for surgery, the absence of significant psychopathology that can limit an individual’s understanding of the procedure or ability to comply with life-long follow-up (e.g., defined noncompliance with previous medical care, active substance abuse, schizophrenia, borderline personality disorder, uncontrolled depression).

Roux-en-Y Gastric Bypass (RYGB) and Vertical Banded Gastroplasty (VBG):

Surgery for obesity, termed bariatric surgery, includes gastric restrictive procedures and gastric bypass.  The gastric restrictive procedures include vertical banded gastroplasty accompanied by gastric banding which attempt to induce weight loss by creating an intake-limiting gastric pouch by segmenting the stomach along its vertical axis.  The process of digestion is more or less normal.  In the United States, the primary operative choice for severely obese patients has recently shifted from vertical banded gastroplasty (VBG) to the Roux-en-Y gastric bypass (RYGB) (Fisher and Schauer, 2002; Mason, et al., 1997).  Vertical banded gastroplasty (VBG), a purely restrictive procedure, has fallen into disfavor because of inadequate long-term weight loss.

Roux-en-Y gastric bypass (RYGB) combines restriction and malabsorption principles, and combines gastric segmentation along its vertical axis with a Roux-en-Y procedure, such that the food bypasses the duodenum and proximal small bowel.  Because the normal flow of food is disrupted, available literature indicates that there is a greater potential for metabolic complications compared to gastric restrictive surgeries, including iron deficiency anemia, vitamin B-12 deficiency and hypocalcemia, all of which can be corrected by oral supplementation.  Several studies have suggested that RYGB is a more effective weight loss procedure than VBG, offering the best combination of maximum weight control and minimum nutritional risk (Sugerman, et al., 1989; Howard, et al., 1995).  Pories, et al. (1995) reported 57.7%, 54.7%, and 49.2% excess weight loss with RYGB at 5, 10, and 14 years, respectively, in a large series with 95% follow-up.  Thus, the RYGB is "the current procedure of choice for patients requiring surgery for morbid obesity" (Barrow; 2002).  An assessment conducted by the French National Technology Assessment Agency (ANAES, 2001; Msika, 2003) found that surgical mortality for RYGB and VBG is about the same.  However, RYGB is associated with significantly more weight loss, and has become the procedure of choice for obesity surgery.

Gentileschi, et al. (2002) systematically reviewed the published literature on open and bariatric laparoscopic obesity surgery and concluded that the available evidence indicates that laparoscopic VBG and laparoscopic RYGB are as effective as their open counterparts.

An assessment of laparoscopic RYGB by the BlueCross BlueShield Association Technology Evaluation Center (BCBSA, 2005) stated that among available bariatric surgical procedures, RYGB appears to have the most favorable risk-to-benefit ratio, and that the overall risk-to-benefit ratio of laparoscopic RGBY is similar to that of open RGBY.  The assessment found that open and laparoscopic RYGB induces similar amounts of weight loss.  However, the assessment found that the profile of adverse events differs between the two approaches.  Laparoscopic RYGB is a less invasive approach that results in a shorter hospital stay and earlier return to usual activities.  The assessment found that the estimated mortality rate was low for both procedures, but somewhat lower for laparoscopic surgery than open surgery (0.3% versus 1.1%).  Laparoscopic RGBY had a higher rate of postoperative anastomotic leaks than open RGBY (3.7% versus 1.9%), and a somewhat higher rate of bleeding (4.1% versus 2.4%).  The report found, on the other hand, that open surgery had higher rates of cardiopulmonary complications (2.6% versus 1.0%) and wound infections (11.0% versus 4.7%).   Regarding long-term adverse events, the rates of reoperation (9.9%) and anastomotic problems (8.0%) may be higher for laparoscopic RGBY than for open RGBY (6.0% and 2.0% respectively), while the rate of incisional hernia is higher for open RGBY than laparoscopic RGBY (9.0% vs. 0%).

An assessment by the Institute for Clinical Systems Improvement (ICSI, 2005) found that large studies have shown that RYGB may result in weight loss of 60% to 70% of excess weight.  It also found that VBG shows substantial weight loss efficacy but less than that for RYGB.  In addition, VBG has a high rate of serious morbidity, including a reoperation rate of up to 30% from stoma obstruction and staple-line disruption.  Therefore, the evidence supports the overall superiority of RYGB over VBG in safety and efficacy for bariatric surgery. 

A decision memorandum from the Centers for Medicare and Medicaid Services (CMS, 2006) concluded that the evidence is sufficient that open and laparoscopic RYGBP is reasonable and necessary for Medicare beneficiaries who have a BMI greater than 35 and have at least one co-morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity.  The assessment concluded that the evidence is not adequate to conclude that open or laparoscopic vertical banded gastroplasty is reasonable and necessary and they are therefore non-covered for all Medicare beneficiaries. 

Biliopancreatic Diversion (BPD) (Jejunoilieal Bypass, Scorpinaro Procedure) and Duodenal Switch (DS) Procedures:

While appropriate surgical procedures for severe obesity primarily produce weight loss by restricting intake, intestinal bypass procedures produce weight loss by inducing a malabsorptive effect. Biliopancreatic bypass or diversion (BPD) (also called jejunoileal bypass or the Scopinaro procedure) consists of a subtotal gastrectomy and diversion of the biliopancreatic juices into the distal ileum by a long Roux-en-Y procedure; the result is a 200 cm long alimentary tract, a 300 to 400 cm biliary tract, and after these two tracts are joined at the distal anastomosis, there is a 50 cm common absorptive alimentary tract. The BPD was designed to address some of the drawbacks of the original intestinal bypass procedures, which resulted in unacceptable metabolic complications of diarrhea, hyperoxaluria, nephrolithiasis, cholelithiasis and liver failure.

The duodenal switch (DS) is a variant of the BPD procedure with a vertical subtotal gastrectomy and pylorus preservation, which eliminates the "dumping syndrome". The duodenum is divided just beyond the pylorus. The small bowel is then divided, and the end going to the cecum of the colon is connected to the short stump of the duodenum. This becomes the "enteral limb". The other end, leading from the gallbladder and pancreatic ducts, is connected onto the enteral limb at about 75-100 cm from the iliocecal valve. This limb is the "biliopancreatic limb". The last 75-100 cm then becomes the "common channel", measuring about 10% of the total small bowel length and is the only portion that can absorb fat. Some have advocated use of the DS procedure in the super-obese (i.e., persons with BMI greater than 50) because of the substantial weight loss induced by this procedure. Patients who have this operation must have lifelong medical follow-up, since the side effects can be subtle, and can appear months to years after the surgery.

A decision memorandum from the Centers for Medicare and Medicaid Services (CMS, 2006) concluded that open or laparoscopic BPD with or without DS are reasonable and necessary for Medicare beneficiaries.

Gastroplasty (“Stomach Stapling”):

Gastroplasty, more commonly known as "stomach stapling" and not to be confused with vertical banded gastroplasty (VBG), is a technically simple operation, accomplished by stapling the upper stomach to create a small pouch into which food flows after it is swallowed.  The outlet of this pouch is restricted by a band of synthetic mesh, which slows its emptying, so that the person having it feels full after only a few bites of food.  According to the available literature, patients who have this procedure seldom experience any satisfaction from eating, and tend to seek ways to get around the operation by eating more.  This causes vomiting, which can tear out the staple line and destroy the operation.  Overall, clinical studies have shown that about 40% of persons who have this operation do not achieve loss of more than half of their excess body weight.  In the long-term, five or more years after surgery, only about 30% of patients have maintained a successful weight loss.  Studies have reported that many patients must undergo another revisional operation to obtain the results they seek.

Sleeve Gastrectomy:

Sleeve gastrectomy is a 70 to 80 percent greater curvature gastrectomy (sleeve resection of the stomach) with continuity of the gastric lesser curve being maintained while simultaneously reducing stomach volume (CMS, 2005).  It is often the first step in a two-stage procedure when performing RYGB.  A decision memorandum from the Centers for Medicare and Medicaid Services (CMS) found that the data supporting open or laparoscopic sleeve gastrectomy are generally sparse and not adequate to draw conclusions. The CMS concluded, therefore, that these procedures are not reasonable and necessary for Medicare beneficiaries. A systematic evidence review prepared for Clinical Evidence concluded that the effectiveness of sleeve gastrectomy for morbid obesity is unknown (Arterburn, et al., 2007).

Loop Gastric Bypass:

Although the basic concept of gastric bypass remains intact, numerous variations are being performed at this time.  Recent data demonstrate that surgeons are moving from simple gastroplasty procedures, favoring the more complex gastric bypass procedures as the surgical treatment of choice for the severely obese patient.  The gastric bypass operation can be modified, to alter absorption of food, by moving the Roux-en-Y-connection distally down the jejunum, effectively shortening the bowel available for absorption of food.  The weight loss effect is then a combination of the very small stomach, which limits intake of food, with malabsorption of the nutrients, which are eaten, reducing caloric intake even further.  In a sense, this procedure combines the least desirable features of the gastric bypass with the most troublesome aspects of the biliopancreatic diversion.  Although patients can have increased frequency of bowel movements, increased fat in their stools, and impaired absorption of vitamins, recent studies have reported good results.  The loop gastric bypass developed years ago has generally been abandoned by most bariatric surgeons as unsafe.  Although easier to perform than the RYGB, it has been shown to create a severe hazard in the event of any leakage after surgery, and seriously increases the risk of ulcer forrmation, and irritation of the stomach pouch by bile.

Laparoscopic Adjustable Silicone Gastric Banding (LASGB):

Recent advances in laparoscopy have renewed the interest in gastric banding techniques for the control of severe obesity.  Laparoscopic adjustable silicone gastric banding (LASGB) has become an attractive method because it is minimally invasive and allows modulation of weight loss. Available brands of LASGB include the Lap-Band System (Allergan, Inc., Irvine, CA) and the Realize Adjustable Gastric Band (Ethicon Endo-Surgery, Cincinnati, OH). The claimed advantage of LASGB is the adjustability of the band, which can be inflated or deflated percutaneously according to weight loss without altering the anatomy of the stomach.  This method entails encircling the upper part of the stomach using bands made of synthetic materials, creating a small upper pouch that empties into the lower stomach through a narrow, non-stretchable stoma.  The reduced capacity of the pouch and the restriction caused by the band diminish caloric intake, depending on important technical details, thus producing weight loss comparable to vertical gastroplasties, without the possibility of staple-line disruption and lesser incidence of infectious complications.  However, distension of the pouch, slippage of the band and entrapment of the foreign material by the stomach have been described and are worrisome.

A decision memorandum from the Centers for Medicare and Medicaid Services (CMS, 2006) found that there was sufficient evidence to support LASGB as reasonable and necessary for Medicare beneficiaries with a BMI > 35 and comorbid medical conditions.  Sustained weight loss was well documented, ranging from an approximate mean of 30 to 50 percent excess weight loss in LASGB, compared to an approximate mean of 50 percent excess weight loss in RYGB.  The CMS decision memorandum found that short-and-long-term mortality associated with both LASGB and RYGB were low (less than 2%) in this younger age group.

Regarding performing adjustable gastric banding as an open procedure, the CMS decision memorandum (2006) concluded that the evidence is not adequate to conclude that open adjustable gastric banding is reasonable and necessary and therefore this procedure remains noncovered for Medicare beneficiaries.

Mini Gastric Bypass:

The "mini gastric bypass" has been promoted as a new surgical treatment for severe obesity.  It involves laparoscopic construction of a large and elongated gastric pouch and a loop gastric bypass with distal diversion (200 cm or up to half of the small bowel) to reduce food absorption. While the name mini gastric bypass implies "small" and "simple", this is a major surgical procedure.  The mini-gastric bypass uses a jejunal loop directly connected to a small gastric pouch, instead of a Roux-en-Y anastomosis.  In this way, the mini-gastric bypass is similar to the loop gastric bypass; the latter procedure that has been abandoned by bariatric surgeons because of its inherent risks.  Specifically, performing a loop, rather than a Roux-en-Y, anastomosis to a small gastric pouch in the stomach may permit reflux of bile and digestive juice into the esophagus where it can cause esophagitis and ulceration, and may thus increase the risk of esophageal cancer. The Roux-en-Y modification of the loop bypass was designed to divert bile downstream, several feet below the gastric pouch and esophagus to minimize the risk of reflux. The trend towards use of Roux-en-Y and away from loop gastric bypass was based on sound surgical experience of multiple surgeons with large series of patients.  The published evidence supporting the mini-gastric bypass comes from descriptive reports and case series; the potential biases inherent in reports of case series are well known in clinical epidemiology.  The evidence for the mini gastric bypass has come from a single investigator, thus raising questions about the generalization and validity of the reported findings.  The mini-gastric bypass has not been subjected to a prospective clinical outcome study in peer-reviewed publication.

Silastic Ring Vertical Gastric Bypass (Fobi Pouch):

The Fobi pouch, developed by California surgeon Mathias A.L. Fobi, is a modification of gastric bypass surgery.  The modifications to gastric bypass surgery are designed to prevent post-surgical enlargement of the gastric pouch and stoma.

In a traditional gastric bypass procedure, surgeons create a smaller stomach by stapling off a large section.  A problem with the traditional procedure is that the staples can break down, causing the stomach to regain its original shape -- and patients to start gaining weight again. Also, the stomach opening that leads into the intestines, which in surgery is made smaller to allow less food to pass through, often stretches as the years go by.  With the Fobi pouch, there is no use of staples; rather, the stomach is bisected and hand-sewn them to maintain the separation.  A synthetic band is placed around the stomach opening to keep it from stretching.

However, there is a paucity of direct comparative studies of the Fobi pouch to traditional gastric bypass surgery, causing colleagues to "question whether his technique is really an improvement on the traditional procedure" (Davis, 2000).  All of the published literature has been limited to descriptive articles, case series, and a prospective nonrandomized controlled study.  These studies were from a single group of investigators, raising questions about the generalization of the findings.

Intragastric Balloon:

The intragastric balloon (also known as the silicone intragastric balloon or SIB) has been developed as a temporary aid for obese patients who have had unsatisfactory results in their clinical treatment for obesity and super obese patients with higher surgical (Fernandes, et al., 2004).  Intragastric balloon is intended to reduce gastric capacity, causing satiety, making it easier for patients to take smaller amounts of food.  Randomized, controlled clinical studies, however, have found no increase in weight loss with the intragastric balloon plus dieting versus dieting alone (Rigaud, et al., 1995; Geliebter, et al., 1991; Mathus-Vliegen, et al., 1990; Lindor, et al., 1987).  One nonrandomized controlled clinical study that reported positive results reported that results were not maintained after gastric balloon removal (Ramhamadany, et al., 1989).  In addition, the intragastric balloon has been associated with potentially severe adverse effects, including gastric erosion, reflux, and obstruction.  An assessment of the intragastric balloon from the Canadian Coordinating Office for Health Technology Assessment (2006) concluded that “[m]ore data on the benefits, harms, and cost-effectiveness are required before the intragastric balloon can be compared with other short-term weight loss interventions, including low-calorie diets.”

Appendix

Table: American Society of Anesthesiologists Physical Status Classification

Source: Adapted from Miller RD, Principles and Practice of Anesthesia, 2nd ed., New York, NY: Churchill Livingstone; 1986.