Subject:
Surgery for Morbid Obesity
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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As indicated by its name, morbid obesity is defined as an increase in weight over 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, obstructive sleep apnea, and various types of cancers (for men: colon, rectum, and prostate; for women: breast, uterus, and ovaries). The first treatment of morbid obesity is obviously dietary and life style changes. Although this strategy may be effective in some patients, frequently the weight loss is not durable with only 5%-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 defined surgical candidates as those patients with a body mass index (BMI) of greater than 40 kg/m2, or greater than 35 kg/m2 in conjunction with severe comorbidities such as cardiopulmonary complications or severe diabetes. Super obesity has been described as a BMI greater than 50 kg/m2.
Surgery for morbid obesity, termed bariatric surgery, falls into two general categories; (1) gastric restrictive procedures that create a small gastric pouch, resulting in weight loss by producing early satiety and thus decreasing dietary intake; and (2) malabsorptive procedures, which produce weight loss due to malabsorption without necessarily requiring dietary modification. The following summarizes the different restrictive and malabsorptive procedures.
Gastric Restrictive Procedures
1. 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 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.
The restrictive component of a standard gastric bypass with Roux-en-Y anastomosis usually consists of a horizontal or vertical partitioning of the stomach to create a small stomach pouch and this is commonly done by stapling. Vertical banded gastroplasty is sometimes performed as a technical variation for this restrictive component.
2. Adjustable Gastric Banding
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 gastric band; therefore the rate limiting 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. Complications include slippage of the external band or band erosion through the gastric wall. Adjustable gastric banding has been widely used in Europe. Currently, the Lap-Band Adjustable Gastric Banding System made by BioEnterics Corporation is the only approved device by the U.S. Food and Drug Administration (FDA) for marketing in the United States. [Please refer to specific benefit coverage under the Federal Employees Health Benefits Program (FEHBP).]
3. Gastric Bypass with Short-Limb (150 cm or less) Roux-en-Y Anastomosis
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). Thus 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, including 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.
The restrictive component of a standard gastric bypass with Roux-en-Y anastomosis usually consists of a horizontal or vertical partitioning of the stomach to create a small stomach pouch and this is commonly done by stapling. Vertical banded gastroplasty is sometimes performed as a technical variation for this restrictive component.
4. 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. This unique aspect of this procedure is not based on its laparoscopic approach but rather the type of anastomosis used.
5. Sleeve Gastrectomy
A sleeve gastrectomy has been proposed to be an alternative approach 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 the stomach into the 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 procedure as the first in a 2-stage procedure for very high-risk patients including those who are “super” obese (BMI>50). 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
There are multiple variants of malabsorptive procedures, which differ in the lengths of the alimentary limb, the biliopancreatic limb, and the common limb, where the alimentary and biliopancreatic limbs are anastomosed. The degree of malabsorption is related to the length of the alimentary and common limbs. For example, a shorter alimentary limb (i.e., the greater the amount of intestine that is excluded from the nutrient flow) will be associated with malabsorption of a variety of nutrients, while a short common limb (i.e., the biliopancreatic juices are allowed to mix with nutrients for only a short segment) will primarily limit absorption of fat.
1. Biliopancreatic Bypass 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. 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.
B. A 200-cm long "alimentary tract" consists of 200 cm of ileum connecting the stomach to a common distal segment.
C. A 300- to 400-cm "biliary tract," which connects the duodenum, jejunum, and remaining ileum to the common distal segment.
D. 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.
E. 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 death or 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, 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.
3. Long Limb Gastric Bypass (i.e., >150 cm)
Recently, variations of gastric bypass procedures have been described, consisting 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, creating 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, 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. The long limb gastric bypass is designed to reduce the incidence of metabolic complications, but the potential complications are similar to those of the short limb gastric bypass. If the proximal biliopancreatic limb is bypassed more than 150 cm., then the metabolic complications are similar to those of the biliopancreatic diversion.
Policy:
[INFORMATIONAL NOTE: When significant weight loss is achieved such as is typically the case after bariatric procedures for morbid obesity, it is not uncommon for the patients to be left with a significant amount of redundant skin (e.g., in the abdomen, breasts, thighs and arms). Procedures to remove the redundant skin are typically considered to be cosmetic. The eligibility of procedures and/or services related to, or resulting from, a prior surgical procedure for morbid obesity is determined by the patient’s specific contract benefits.
When the patient’s contract does not specifically exclude such procedures and/or services, they are subject to review for medical necessity. Medical policies pertaining to the covered person’s condition should be consulted, as applicable (e.g., Policy #025 on Abdominoplasty, Policy #028 on Reduction Mammaplasty, and Policy #001 on Cosmetic Procedures including excision of excessive skin and subcutaneous tissue and suction assisted lipectomy, under the Surgery Section). The approval of a bariatric procedure for medical necessity should not be interpreted to be an automatic approval for procedures that address the sequelae of significant weight loss, nor should it create the expectation that such procedures will be approved.]
I. Contract exclusions and/or limitations for surgery for morbid obesity (bariatric surgery) will determine the available benefit.
[INFORMATIONAL NOTE: Some contracts specifically exclude surgery for morbid obesity (bariatric surgery). Please refer to the group’s or individual member’s contract benefit language to determine benefit availability.]
II. If NOT specifically excluded by contract, one of the following: adjustable Gastric banding (using the Lap-Band Adjustable Gastric Banding System by BioEnterics Corporation), vertical-banded gastroplasty (using either an open or a laparoscopic approach), gastric bypass with short-limb (i.e., 150 cm or less) Roux-en-Y anastomosis and the biliopancreatic conduit is also 150 cm or less (using either an open or a laparoscopic approach), or biliopancreatic bypass with duodenal switch (using either an open or a laparoscopic approach) is considered medically necessary when all of the following lettered criteria are met:
[Please refer to specific benefit coverage for adjustable gastric banding under the Federal Employees Health Benefits Program (FEHBP).]
Note: The restrictive component of a standard gastric bypass with Roux-en-Y anastomosis usually consists of a horizontal or vertical partitioning of the stomach to create a small stomach pouch and this is commonly done by stapling. Vertical banded gastroplasty is sometimes performed as a technical variation for this restrictive component.]
A. The member is at least 18 years of age and/or has reached full skeletal growth. Bariatric surgery is considered NOT medically necessary for members under 18 years of age unless the member has already achieved full skeletal growth and has a life threatening co-morbidity (i.e., pseudotumor cerebri, severe sleep apnea, uncontrollable hypertension, incapacitating musculoskeletal disease, etc.).
[INFORMATIONAL NOTE: According to published medical literature, bone age can be objectively assessed with radiographs of the hand and wrist.]
B. The member has morbid obesity for at least 5 years. Morbid obesity is defined as either:
1. A body mass index (BMI) greater than 40 kg/m2; or
2. A BMI greater than 35 kg/m2 with associated life-threatening or disabling co-morbidities including, but not limited to, coronary heart disease, diabetes, hypertension, or obstructive sleep apnea. Other co-morbid conditions to be considered are: hyperlipidemia, severe GERD, non-alcoholic fatty liver (NASH), osteoarthritis, depression, etc.
[INFORMATIONAL NOTE: BMI is calculated by dividing a patient’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 .0254]
C. The member has a BMI that does not exceed 60 (i.e., the member is not super-super obese). Bariatric surgery for members whose BMI exceed 60 is considered investigational since it has not been proven to result in improved health outcomes in this specific subset of individuals.
[INFORMATIONAL NOTE: A number of bariatric studies including The Bariatric Work Group recommendations (Division of Healthcare Quality and Oversight - New Jersey Department of Health and Human Services, October 2005) report higher mortality and morbidity rates in patients with a BMI >60.]
D. There is formal documentation from the treating physician that the member has tried a supervised conservative weight loss program for at least 6 months but has failed to achieve or maintain long-term weight reduction. It should include lifestyle modifications (restricted calorie diet and regular exercise) and behavioral therapy (self-monitoring of food intake, avoidance of triggers to eating, social and family support, cognitive restructuring). Supervised programs may be provided by the patient's physician, a PCP or registered dietitian.
[INFORMATIONAL NOTE: Programs supervised by a registered dietitian may not be a covered service under a member's contract.]
E. The member has undergone a thorough preoperative assessment including psychological evaluation and clearance. ( Please note that psychological testing is NOT included in this requirement.)
F. The member has enrolled in a multidisciplinary integrated program to provide guidance on diet, physical activity, and behavioral and social support prior to and after the surgery.
[INFORMATIONAL NOTE: It should be noted that all bariatric surgeries require a high degree of patient compliance. For gastric restrictive procedures the weight loss is primarily due to reduced caloric intake, and thus the patient must be committed to eating small meals, reinforced by early satiety. For example, gastric restrictive surgery will not be successful in patients who consume high volumes of calorie rich liquids. In addition, patients must adhere to a balanced diet, including proper micronutrient supplementation, to avoid metabolic complications. (Micronutrients are defined as vitamins, minerals, and trace elements.)
The high potential for metabolic complications requires life-long follow-up. Therefore, patient selection is a critical process, often requiring psychiatric evaluation and a multidisciplinary team approach.]
III. Mini-gastric bypass, biliopancreatic bypass (i.e., the Scopinaro procedure), and long limb gastric bypass procedure (i.e., >150 cm) are considered investigational as treatments for morbid obesity. There is insufficient evidence to demonstrate that the overall benefits from these malabsorptive procedures significantly outweigh the increased risk for morbidities that are associated with these procedures.
IV. In addition, open or laparoscopic sleeve gastrectomy is considered investigational either as a sole procedure or as one step in a staged procedure.
[INFORMATIONAL NOTE: There is limited data published in the medical literature to evaluate outcomes of sleeve gastrectomy as a stand-alone procedure and to compare its efficacy with other procedures. Furthermore, the published data on outcomes following completion of both stages of a 2-stage operation are limited to case reports and case series with very small number of patients. According to the ECRI Health Technology Assessment Information Service Custom Hotline Response on Laparoscopic Sleeve Gastrectomy for Morbid Obesity (last updated 01/22/2007), “None of the studies reported weight loss at three years or more after the operation, which we consider the most important outcome measure for these studies to report. Earlier follow-up periods may not provide data indicative of the eventual results of the surgery and do not provide sufficient time to assess the possible long-term complications of this surgery”.]
V. Repeat bariatric surgery or any subsequent modification should be handled on an individual case basis and reviewed by the medical director. Supporting documentation should at least include a clear explanation of the clinical cir****tances as to why the procedure failed, the member’s BMI, and the results of any diagnostic tests or studies performed.
A distinction between clinical failure and technical failure must be established. A clinical failure is defined as weight regain, inspite of an intact, functional operation. In these instances, a psychological profile must be obtained and approval based on the probability of acceptable member compliance. If the psychological profile indicates that the member is not likely to comply with the postoperative requirements (e.g., diet, physical activity, etc.), repeat bariatric surgery or any subsequent modification of the original bariatric surgery is not considered medically necessary. A technical failure is defined as a breakdown of the operation itself (i.e., staple line disruption, fistula formation, dilatation of the pouch, marginal ulceration, band slippage, etc.). In these instances, psychological re-assessment of the patient is not mandatory.
[INFORMATIONAL NOTE: Band adjustment is a regular part of follow-up for adjustable gastric banding. All adjustments done within 90 days from band implantation are considered part of the global surgical service. Any subsequent adjustment beyond this period is eligible for separate reimbursement if the band implantation was deemed medically necessary.]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what cir****tances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Surgery for Morbid Obesity
Adjustable Gastric Banding
Banding, Gastric
Bariatric Surgery
Biliopancreatic Bypass Procedure
Biliopancreatic Diversion
Bypass, Biliopancreatic
Bypass, Gastric
Duodenal Switch, Biliopancreatic Bypass with
Gastrectomy, Sleeve
Gastric Banding
Gastric Bypass
Gastric Restrictive Surgery
Gastroplasty
Lap-Band Adjustable Gastric Banding System
Laparoscopic Adjustable Gastric Banding
Laparoscopic Gastric Bypass
Laparoscopic Mini-Gastric Bypass
Laparoscopic Sleeve Gastrectomy
Long Limb Gastric Bypass
Malabsorptive Procedures
Morbid Obesity, Surgery for
Mini-Gastric Bypass
Obesity, Morbid, Surgery for
Scopinaro Procedure
Sleeve Gastrectomy
Vertical Banded Procedures
References:
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61. Barlow SE. Bariatric surgery in adolescents: for treatment failures or health care system failures. Pediatrics. 2004 Jul;114(1):252-3.
62. Haynes B. Creation of a bariatric surgery program for adolescents at a major teaching hospital. Pediatr Nur. 2005;31(1):21-3.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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