BARIATRIC SURGERY. Please refer to the enrollee-specific benefit document to determine availability of benefits for these procedures.

Transcription

1 Protocol: SUR043 Effective Date: March 1, 2016 BARIATRIC SURGERY Table of Contents Page COMMERCIAL COVERAGE RATIONALE... 1 BENEFIT CONSIDERATIONS... 3 MEDICAID COVERAGE RATIONALE DESCRIPTION OF SERVICES CLINICAL EVIDENCE U.S.FOOD AND DRUG ADMINISTRATION (FDA) APPLICABLE CODES REFERENCES PROTOCOL HISTORY/REVISION INFORMATION INSTRUCTIONS FOR USE This protocol provides assistance in interpreting UnitedHealthcare benefit plans. When deciding coverage, the enrollee specific document must be referenced. The terms of an enrollee's document (e.g., Certificate of Coverage (COC) or Evidence of Coverage (EOC)) may differ greatly. In the event of a conflict, the enrollee's specific benefit document supersedes this protocol. All reviewers must first identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this Protocol. Other Protocols, Policies and Coverage Determination Guidelines may apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Protocols, Policies and Guidelines as necessary. This protocol is provided for informational purposes. It does not constitute medical advice. This policy does not govern Medicare Group Retiree members. UnitedHealthcare may also use tools developed by third parties, such as the MCG Care Guidelines, to assist us in administering health benefits. The MCG Care Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. COMMERCIAL COVERAGE RATIONALE Please refer to the enrollee-specific benefit document to determine availability of benefits for these procedures. The following bariatric surgical procedures are medically necessary in adults for the treatment of clinically severe obesity as defined by the National Heart Lung and Blood Institute (NHLBI): Gastric bypass (Roux-en-Y; gastrojejunal anastomosis) Adjustable gastric banding (laparoscopic adjustable silicone gastric banding) See FDA section/information Gastric sleeve procedure (also known as laparoscopic vertical gastrectomy or laparoscopic sleeve gastrectomy) Bariatric Surgery.doc Page 1 of 45

2 Vertical banded gastroplasty (gastric banding; gastric stapling) Biliopancreatic bypass (Scopinaro procedure) Biliopancreatic diversion with duodenal switch Bariatric surgery using one of the procedures identified above (primary, secondary or revisions), as a treatment for weight loss is medically necessary when all of the following criteria are met: Class III obesity, clinically severe [body mass index (BMI) > 40 kg/m2]; or Class II obesity (BMI kg/m2) in the presence of one or more of the following comorbidities: o Type 2 diabetes; or o Cardiovascular disease (e.g., stroke, myocardial infarction, poorly controlled hypertension (systolic blood pressure greater than 140 mm Hg or diastolic blood pressure 90 mm Hg or greater, despite pharmacotherapy); or o History of coronary artery disease with a surgical intervention such as cardiopulmonary bypass or percutaneous transluminal coronary angioplasty; or o Cardiopulmonary problems (e.g., documented obstructive sleep apnea (OSA) confirmed on polysomnography with an AHI or RDI of >= 30 (as defined by AASM Task Force Sleep1999;22:667-89);or o History of cardiomyopathy and The individual must also meet the following criteria: o Documentation of a motivated attempt of weight loss through a structured diet program, prior to bariatric surgery, which includes physician or other health care provider notes and/or diet or weight loss logs from a structured weight loss program for a minimum of 6 months. (NHLBI, 1998); and o Psychological evaluation to rule out major mental health disorders, which would contraindicate surgery and/or undermine patient compliance with post-operative follow-up care and nutrition guidelines. (NHLBI, 1998) The bariatric surgical procedures identified above are medically necessary in adolescents for the treatment of clinically severe obesity as defined by the National Heart Lung and Blood Institute (NHLBI) and who have: Archived greater than 95% of estimated adult height based on documented individual growth pattern; and A minimum Tanner stage of 4; and Met medical necessity criteria noted above for adults. (Note: See additional information in Description of Services section for growth and BMI charts) Bariatric surgical procedures in a person who has not attained an adult level of physical development and maturation are not medically necessary. Potential safety issues must be addressed in studies with sufficient sample size and adequate follow-up times necessary to demonstrate the impact of the surgery on physical, sexual and reproductive maturation and the long term improvement of co-morbidities in this age group. Bariatric surgery to treat gynecological abnormalities, osteoarthritis, gallstones, urinary stress incontinence, gastroesophageal reflux (including for Barrett s esophagus or gastroparesis) or other Bariatric Surgery.doc Page 2 of 45

3 obesity associated diseases that generally do not lead to life threatening consequences is not medically necessary. There is insufficient published clinical evidence to support bariatric surgery for the definitive treatment of gynecological abnormalities, osteoarthritis, gallstones, urinary stress incontinence or as treatment for gastroesophageal reflux and other obesity associated diseases. Bariatric surgery will frequently ameliorate symptoms of co-morbidities such as gastroesophageal reflux disease and obstructive sleep apnea. However, the primary purpose of bariatric in obese person s surgery is to achieve weight loss. Robotic assisted gastric bypass surgery is medically necessary as equivalent but not superior to other types of minimally invasive bariatric surgery. Surgical adjustment or alteration of a prior bariatric procedure is medically necessary for complications of the original surgery, such as stricture, obstruction, pouch dilatation, erosion, or band slippage when the complication causes abdominal pain, inability to eat or drink or causes vomiting of prescribed meals. The following procedures are not medically necessary for the treatment of obesity: Transoral endoscopic surgery Mini-gastric bypass (MGB) or Laparoscopic Mini-gastric bypass (LMGBP) Gastric electrical stimulation with an implantable gastric stimulator (IGS) VBLOC vagal blocking therapy Intragastric balloon Laparoscopic greater curvature plication, also known as total gastric vertical plication Further studies are needed to determine the safety and efficacy of these procedures as a treatment option for obesity. Gastrointestinal liners (EndoBarrier ) are investigational, not medically necessary as a treatment for obesity. Gastrointestinal liners have not received FDA approval. Their long-term efficacy has not been demonstrated. BENEFIT CONSIDERATIONS Many Evidence of Coverage (EOCs) explicitly exclude benefit coverage for bariatric surgery. Several states mandate coverage for bariatric surgery. Please refer to the enrollee-specific benefit document to determine availability of benefits for these procedures. As in all benefit adjudication, state legislated mandates must be followed. Therefore, the applicable state-specific requirements and the enrollee-specific benefit document must be reviewed to determine what benefits, if any, exist for bariatric surgery. Laparoscopic and "open" obesity surgeries are different and distinct procedures, from the standpoint of administering in network and out of network benefits. Similarly, biliopancreatic diversion with Bariatric Surgery.doc Page 3 of 45

4 duodenal switch is a unique procedure from the standpoint of administering in network and out of network benefits. Services associated with excluded services are also excluded. This includes services in the pre- and post-operative periods, including facility, anesthesia and ancillary services. Bariatric surgery will frequently ameliorate symptoms of co-morbidities such as diabetes, gastroesophageal reflux disease and obstructive sleep apnea. However, the purpose of bariatric surgery in obese persons is to achieve weight loss. Therefore, in benefit documents where bariatric surgery is excluded, coverage would not exist for bariatric surgery to treat co-morbidities caused or exacerbated by obesity. FEDERAL EMPLOYEE HEALTH BENEFIT PLAN COVERAGE RATIONALE Please refer to the current FEHBP benefit document to determine availability of benefits for these procedures. Gastric bypass (Roux-en-Y; gastrojejunal anastomosis), vertical banded gastroplasty (gastric banding; gastric stapling), adjustable gastric banding (laparoscopic adjustable silicone gastric banding), biliopancreatic bypass (Scopinaro procedure), biliopancreatic diversion with duodenal switch, and laparoscopic bariatric surgery are medically necessary in adults for the treatment of clinically severe obesity as defined by the National Heart Lung and Blood Institute (NHLBI) who have: A. A body mass index (BMI) of greater than 40 kg/m2; or B. A body mass greater than 35kg/m2 and significant co-morbidities such as: 1. cardiac disease, and/or 2. diabetes, and/or 3. hypertension; and/or 4. diseases of the endocrine system, e.g., Cushing's syndrome, hypothyroidism, and/or 5. disorders of the pituitary glands, and/or 6. disorders of the adrenal glands. C. Individuals must show documentation that medically supervised weight loss therapy for at least 3 months within the last 24 months have been ineffective. D. Individuals must be age 18 or over and have a psychological/psychiatric evaluation by a licensed practitioner, with a recommendation for gastric restrictive surgery. E. Covered services are also those rendered in the treatment of complications in connection with gastric restrictive surgery. Documentation Requirements: 1. History and physical, and 2. Risk factors including family history, and 3. Pulmonary evaluation and sleep study, if indicated, and 4. Documentation of medically supervised weight loss therapy (dietary, physical activity, behavior therapy, pharmacotherapy, combined therapy or other medically supervised therapy) at least 3 months in duration, and 5. Provision made for post-operative support management program. Bariatric Surgery.doc Page 4 of 45

5 Limitations of Coverage: No limit to number of surgeries. Tier 1 benefit only. Coverage for complications is specific per plan. Copays are specific per plan. MEDICARE COVERAGE RATIONALE Medicare covers certain surgical services for the treatment of obesity when criteria are met. Refer to the National Coverage Determinations (NCDs) for Bariatric Surgery for Treatment of Morbid Obesity (100.1); Surgery for Diabetes (100.14); Intestinal Bypass Surgery (100.8); Gastric Balloon for Treatment of Obesity (100.11); Treatment of Obesity (40.5) and Intensive Behavioral Therapy for Obestiy ( ). Accessed January Local Coverage Determinations (LCDs) for Nevada do exist. Refer to the LCDs for Laparoscopic Sleeve Gastrectomy for Severe Obesity (L34240). The National and Local Coverage Determinations are as follows: Bariatric Surgery for the Treatment of Morbid Obesity (NCD100.1) Nationally Covered Indications Effective for services performed on and after February 21, 2006, Open and laparoscopic Roux-en-Y gastric bypass (RYGBP), open and laparoscopic Biliopancreatic Diversion with Duodenal Switch (BPD/DS), or Gastric Reduction Deuodenal Swithch (BPD/GRDS), and laparoscopic adjustable gastric banding (LAGB) are covered for Medicare beneficiaries who have a body-mass index > 35, have at least one co-morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity. Effective for dates of service on and after February 21, 2006, these procedures are only covered when performed at facilities that are: (1) certified by the American College of Surgeons as a Level 1 Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006); or (2) certified by the American Society for Bariatric Surgery as a Bariatric Surgery Center of Excellence (program standards and requirements in effect on February 15, 2006). Effective for dates of service on and after September 24, 2013, facilities are no longer required to be certified. Effective for services performed on or after February 12, 2009, the Centers for Medicare & Medicaid Services (CMS) determined that Type 2 diabetes mellitus is a co-morbidity for purposes of this NCD. Nationally Non-Covered Indications Treatments for obesity alone remain non-covered. Supplemented fasting is not covered under the Medicare program as a general treatment for obesity (see section D below for discretionary local coverage) The following bariatric surgery procedures are non-covered for all Medicare beneficiaries: Open adjustable gastric banding; Open sleeve gastrectomy; Bariatric Surgery.doc Page 5 of 45

6 Laparoscopic sleeve gastrectomy (prior to June 27, 2012) Open and laparoscopic vertical banded gastroplasty Intestinal bypass surgery and, Gastric balloon for treatment of obesity. Other: Effective for services performed on and after June 27, 2012, Medicare Administrative Contractors (Noridian for the Nevada market) acting within their respective jurisdictions may determine coverage of stand-alone laparoscopic sleeve gastrectomy (LSG) for the treatment of co-morbid conditions related to obesity in Medicare beneficiaries only when all of the following conditions a. c. are satisfied: a. The beneficiary has a body-mass index (BMI) of 35 kg/m2, b. The beneficiary has at least one co-morbidity related to obesity, and c. The beneficiary has been previously unsuccessful with medical treatment for obesity. The determination of coverage for any bariatric surgery procedures that are not specifically identified in an NCD as covered or non-covered, for Medicare beneficiaries who have a body-mass index 35, have at least one co-morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity, is left to the local MACs. Where weight loss is necessary before surgery in order to ameliorate the complications posed by obesity when it coexists with pathological conditions such as cardiac and respiratory diseases, diabetes, or hypertension (and other more conservative techniques to achieve this end are not regarded as appropriate), supplemented fasting with adequate monitoring of the patient is eligible for coverage on a case-by-case basis or pursuant to a local coverage determination. The risks associated with the achievement of rapid weight loss must be carefully balanced against the risk posed by the condition requiring surgical treatment. Surgery for Diabetes (NCD ) Item/Service Description Medicare currently covers bariatric surgery for persons with type 2 diabetes mellitus (T2DM) and a body mass index (BMI) 35. Surgical procedures that are used in this context are discussed in section It was proposed that these same procedures may be beneficial for beneficiaries with T2DM who do not meet the criteria for treatment of morbid obesity. The Centers for Medicare & Medicaid Services (CMS) specifically evaluated the evidence associated with surgery among persons with T2DM to assess the effectiveness of such procedures in reducing the signs and symptoms of this disease in Medicare beneficiaries with a BMI < 35. Indications and Limitations of Coverage Nationally Covered Indications Effective for services performed on and after February 21, 2006, Open and laparoscopic Roux-en-Y gastric bypass (RYGBP), open and laparoscopic Biliopancreatic Diversion with Duodenal Switch (BPD/DS), and laparoscopic adjustable gastric banding (LAGB) are covered for Medicare beneficiaries who have a BMI 35, have at least one co-morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity. These procedures are only covered when performed at facilities that are: (1) certified by the American College of Surgeons as a Level 1 Bariatric Surgery.doc Page 6 of 45

7 Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006); or (2) certified by the American Society for Bariatric Surgery as a Bariatric Surgery Center of Excellence (program standards and requirements in effect on February 15, 2006). Nationally Non-Covered Indications Effective for services performed on and after February 12, 2009, open and laparoscopic RYGBP, open and laparoscopic BPD/DS, and LAGB are non-covered for Medicare beneficiaries who have a BMI < 35 and T2DM. Intestinal Bypass Surgery (NCD100.8) Indications and Limitations of Coverage The safety of intestinal bypass surgery for treatment of obesity has not been demonstrated. Severe adverse reactions such as steatorrhea, electrolyte depletion, liver failure, arthralgia, hypoplasia of bone marrow, and avitaminosis have sometimes occurred as a result of this procedure. It does not meet the reasonable and necessary provisions of 1862(a)(1) of the Act and is not a covered Medicare procedure. Gastric Balloon for Treatment of Obesity (NCD100.11), Item/Service Description The gastric balloon is a medical device developed for use as a temporary adjunct to diet and behavior modification to reduce the weight of patients who fail to lose weight with those measures alone. It is inserted into the stomach to reduce the capacity of the stomach and to affect early satiety. Indications and Limitations of Coverage The use of the gastric balloon is not covered under Medicare, since the long term safety and efficacy of the device in the treatment of obesity has not been established. Treatment of Obesity (NCD 40.5) Item/Service Description Obesity may be caused by medical conditions such as hypothyroidism, Cushing's disease, and hypothalamic lesions, or can aggravate a number of cardiac and respiratory diseases as well as diabetes and hypertension. Non-surgical services in connection with the treatment of obesity are covered when such services are an integral and necessary part of a course of treatment for one of these medical conditions. Certain designated surgical services for the treatment of obesity are covered for Medicare beneficiaries who have a BMI 35, have at least one co-morbidity related to obesity and have been previously unsuccessful with the medical treatment of obesity. In addition, supplemented fasting is a type of very low calorie weight reduction regimen used to achieve rapid weight loss. The reduced calorie intake is supplemented by a mixture of protein, carbohydrates, vitamins, and minerals. Serious questions exist about the safety of prolonged adherence for 2 months or more to a very low calorie weight reduction regimen as a general treatment for obesity, because of instances of cardiopathology and sudden death, as well as possible loss of body protein. Indications and Limitations of Coverage Nationally Covered Indications Bariatric Surgery.doc Page 7 of 45

8 Certain designated surgical services for the treatment of obesity are covered for Medicare beneficiaries who have a BMI 35, have at least one co-morbidity related to obesity and have been previously unsuccessful with the medical treatment of obesity. See Nationally Non-Covered Indications 1. Treatments for obesity alone remain non-covered. 2. Supplemented fasting is not covered under the Medicare program as a general treatment for obesity (see section D. below for discretionary local coverage). Other Where weight loss is necessary before surgery in order to ameliorate the complications posed by obesity when it coexists with pathological conditions such as cardiac and respiratory diseases, diabetes, or hypertension (and other more conservative techniques to achieve this end are not regarded as appropriate), supplemented fasting with adequate monitoring of the patient is eligible for coverage on a case-by-case basis or pursuant to a local coverage determination. The risks associated with the achievement of rapid weight loss must be carefully balanced against the risk posed by the condition requiring surgical treatment. Intensive Behavioral Therapy for Obesity (210.12) Indications and Limitations of Coverage Nationally Covered Indications Effective for claims with dates of service on or after November 29, 2011, CMS covers intensive behavioral therapy for obesity, defined as a body mass index (BMI) 30 kg/m2, for the prevention or early detection of illness or disability. Intensive behavioral therapy for obesity consists of the following: 1. 1.Screening for obesity in adults using measurement of BMI calculated by dividing weight in kilograms by the square of height in meters (expressed kg/m2); 2. Dietary (nutritional) assessment; and 3. Intensive behavioral counseling and behavioral therapy to promote sustained weight loss through high intensity interventions on diet and exercise. The intensive behavioral intervention for obesity should be consistent with the 5-A framework that has been highlighted by the USPSTF: 1. Assess: Ask about/assess behavioral health risk(s) and factors affecting choice of behavior change goals/methods. 2. Advise: Give clear, specific, and personalized behavior change advice, including information about personal health harms and benefits. 3. Agree: Collaboratively select appropriate treatment goals and methods based on the patient s interest in and willingness to change the behavior. 4. Assist: Using behavior change techniques (self-help and/or counseling), aid the patient in achieving agreed-upon goals by acquiring the skills, confidence, and social/environmental supports for behavior change, supplemented with adjunctive medical treatments when appropriate. Bariatric Surgery.doc Page 8 of 45

9 5. Arrange: Schedule follow-up contacts (in person or by telephone) to provide ongoing assistance/support and to adjust the treatment plan as needed, including referral to more intensive or specialized treatment. For Medicare beneficiaries with obesity, who are competent and alert at the time that counseling is provided and whose counseling is furnished by a qualified primary care physician or other primary care practitioner and in a primary care setting, CMS covers: One face-to-face visit every week for the first month; One face-to-face visit every other week for months 2-6; One face-to-face visit every month for months 7-12, if the beneficiary meets the 3kg weight loss requirement during the first six months as discussed below. At the six month visit, a reassessment of obesity and a determination of the amount of weight loss must be performed. To be eligible for additional face-to-face visits occurring once a month for an additional six months, beneficiaries must have achieved a reduction in weight of at least 3kg over the course of the first six months of intensive therapy. This determination must be documented in the physician office records for applicable beneficiaries consistent with usual practice. For beneficiaries who do not achieve a weight loss of at least 3kg during the first six months of intensive therapy, a reassessment of their readiness to change and BMI is appropriate after an additional six month period. For the purposes of this decision memorandum, a primary care setting is defined as one in which there is provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. Emergency departments, inpatient hospital settings, ambulatory surgical centers, independent diagnostic testing facilities, skilled nursing facilities, inpatient rehabilitation facilities and hospices are not considered primary care settings under this definition. For the purposes of this decision memorandum a primary care physician and primary care practitioner will be defined consistent with existing sections of the Social Security Act ( 1833(u)(6), 1833(x)(2)(A)(i)(I) and 1833(x)(2)(A)(i)(II)). 1833(u) (6) Physician Defined. For purposes of this paragraph, the term physician means a physician described in section 1861(r)(1) and the term primary care physician means a physician who is identified in the available data as a general practitioner, family practice practitioner, general internist, or obstetrician or gynecologist. 1833(x)(2)(A) Primary care practitioner The term primary care practitioner means an individual (i) who (I) is a physician (as described in section 1861(r)(1)) who has a primary specialty designation of family medicine, internal medicine, geriatric medicine, or pediatric medicine; or (II) is a nurse practitioner, clinical nurse specialist, or physician assistant (as those terms are defined in section 1861(aa)(5)) Bariatric Surgery.doc Page 9 of 45

10 Nationally Non-Covered Indications All other indications remain non-covered. Laparoscopic Sleeve Gastrectomy for Severe Obesity (LCD 34240) Coverage Indications, Limitations, and/or Medical Necessity The sleeve gastrectomy (SG) is a surgical procedure performed in either open or laparoscopic manner. The surgery involves excision of the lateral aspect of the stomach, leaving a much reduced, lessercurve based, tubular stomach. When performed laparoscopically, the term laparoscopic sleeve gastrectomy (LSG) is used. Presently, LSG is being used as a stand-alone approach to bariatric surgery. By reducing gastric capacity, there is both short and longer term weight loss. A stand-alone sleeve gastrectomy is sometimes referred to as an isolated sleeve gastrectomy. There are variations in the detail and technique for the sleeve gastrectomy procedure itself. LSG has been gaining popularity over the last few years with increased experience among surgeons and the procedure is taking its place among other bariatric surgical procedures for extreme obesity. Unlike some bariatric surgical procedures, this technique is irreversible. Obesity is recognized as an important risk factor for morbidity and mortality when associated with a number of chronic diseases such as heart disease and diabetes (Flegal, 2010). The Centers for Disease Control and Prevention (CDC) reported that obesity rates in the U.S. have increased dramatically over the last 30 years, and obesity is now epidemic in the United States (Kahn, 2009). For adults 60 years and older, the prevalence of obesity is about 37% among men and 34% among women (NHANES - National Health and Nutrition Examination Survey). Obesity may be further classified according to the National Institutes of Health (NIH): Class I Obesity = BMI kg/m² Class II Obesity = BMI kg/m² Class III (Extreme) Obesity = BMI 40.0 kg/m² CMS has recognized the importance of screening and treating obesity and recently provided Medicare coverage for intensive behavioral therapy for obesity. CMS also has allowed national coverage for some bariatric surgical procedures for Class II and Class III obesity: Open and laparoscopic Roux-en-Y gastric bypass (RYGBP); Laparoscopic adjustable gastric banding (LAGB); and Open and laparoscopic biliopancreatic diversion with duodenal switch (BPD/DS). Laparoscopic sleeve gastrectomy was specifically not approved under past NCDs. Recently, under a national coverage analysis (Decision Memo for Bariatric Surgery for the Treatment of Morbid OBESITY CAG-00250R2) CMS has made the decision for stand-alone LGS coverage to be at the discretion of the local Medicare contractor. Open sleeve gastrectomy is specifically not covered in the CMS NCD and as such remains non-covered. In the past, Noridian was concerned that there are no randomized controlled trials (RCTs) that evaluated adults 65 years. Subsequently, based on a valid reconsideration request, additional scientific literature was presently that showed several studies that supported the safety and efficacy of this procedure in the age 65 year old population when the same are carefully screened. Effective Bariatric Surgery.doc Page 10 of 45

11 January 01, 2015, Noridian will cover laparoscopic sleeve gastrectomy only when all of the following criteria are met: Patient has a Body Mass Index 35.0 kg/m² Patient has at least one CMS approved co-morbidity related to obesity and The beneficiary has been previously unsuccessful with medical treatments for obesity. The latter includes but is not limited to: active participation within the last 12 months prior to bariatric surgery in a weight-management program that is supervised by a physician or other health care professionals for a minimum of four consecutive months. The weight-management program must include monthly documentation of patient s weight and BMI, current dietary regimen and physical activity (e.g. exercise program). Physician-supervised programs consisting exclusively of pharmacological management are not sufficient to meet this requirement. A thorough multidisciplinary evaluation within the previous six months which includes ALL of the following: o an evaluation by a bariatric surgeon recommending surgical treatment, including a description of the proposed procedure(s) o a separate medical evaluation from a physician other than the requesting surgeon that includes both a recommendation for bariatric surgery as well as a medical clearance for surgery o clearance for bariatric surgery by a mental health provider including a statement regarding motivation and ability to follow post-surgical requirements o a nutritional evaluation by a physician or registered dietician LSG is furnished in a CMS approved bariatric facility for services performed prior to September 24, For Services performed on or after September 24, 2013 the requirement for the facility to be CMS certified no longer exists in accordance with Change request CR For Medicare and Medicaid Determinations Related to States Outside of Nevada: Please review Local Coverage Determinations that apply to other states outside of Nevada. Important Note: Please also review local carrier Web sites in addition to the Medicare Coverage database on the Centers for Medicare and Medicaid Services Website. MEDICAID COVERAGE RATIONALE Bariatric Surgery for Morbid Obesity Policy #6-07 Bariatric Surgery is a covered Nevada Medicaid benefit reserved for recipients with severe and resistant morbid obesity in whom efforts at medically supervised weight reduction therapy have failed and who are disabled from the complications of obesity. Morbid obesity is defined by Nevada Medicaid as those recipients whose Body Mass Index (BMI) is 35 or greater, and who have significant disabling comorbidity conditions which are the result of the obesity or are aggravated by the obesity. Bariatric Surgery.doc Page 11 of 45

12 Assessment of obesity includes BMI, waist circumference, and recipient risk factors, including family history. This benefit includes the initial work-up, the surgical procedure and routine post surgical follow-up care. The surgical procedure is indicated for recipients between the ages of 21 and 55 years with morbid obesity. (Potential candidates older than age 55 will be reviewed on a case by case basis.) Prior Authorization is required. Documentation supporting the reasonableness and necessity of bariatric surgery must be in the recipient s record and submitted with the prior authorization. Coverage is restricted to recipients with the following indicators: 1. BMI 35 or greater; and 2. Waist circumference of more than 40 inches in men, and more than 35 inches in women; and 3. Obesity related comorbidities that are disabling; and 4. Strong desire for substantial weight loss; and 5. Well informed and motivated; and 6. Commitment to a lifestyle change; and 7. Negative history of significant psychopathology that contraindicates this surgical procedure. Documentation supporting the reasonableness and necessity of the surgery must be in the medical record, and should include evidence of participation in a medically supervised weight loss program for a minimum of three months prior to the surgery. There must also be documentation of weight loss therapy participation including recipient efforts at dietary therapy, physical activity, behavior therapy, pharmacotherapy, combined therapy, or any other medically supervised therapy. No coverage will be provided for pregnant women, women less than six months postpartum, or women who plan to conceive in a time frame less than 18 to 24 months post gastric bypass surgery. DESCRIPTION OF SERVICES Obesity is a significant health concern due to its high prevalence and associated health risks. The number of obese adults is projected to reach 700 million by year The Centers for Disease Control and Prevention (CDC) estimate that 34% of adults in the United States, older than the age of 20 are obese (CDC, 2007). Health problems associated with obesity include hypertension, Type II diabetes, hyperlipidemia, atherosclerosis, heart disease, stroke, diseases of the gallbladder, osteoarthritis, and sleep apnea. In addition, certain cancers are more prevalent in obese individuals, including endometrial, ovarian, breast, prostate, colon cancer, renal cell carcinoma, and non-hodgkin's lymphoma. Obesity may account for 14% to 20% of all deaths from cancer in the United States (NHLBI, 1998; Kenchaiah et al., 2002; Calle et al., 2003). Obesity is second only to tobacco use as a modifiable risk factor in adult mortality. If current trends continue, within the next few years obesity will overtake tobacco use and become the number one modifiable risk factor in adult mortality. Obesity and overweight are defined clinically using the body mass index (BMI). Bariatric Surgery.doc Page 12 of 45

13 BMI is the most common measure used to measure relative weight in comparison in adults and children. The National Heart, Lung and Blood Institute (NHLBI) classify the ranges of BMI in adults as follows (NHLBI, 1998): Classification Underweight Normal weight Overweight Obesity (Class I) Obesity (Class II) Extreme Obesity (Class III) BMI < 18.5 kg/m kg/m kg/m kg/m kg/m2 40 kg/m Extreme obesity or Class III obesity as described in a 1998 NHLBI guideline was also addressed in previous consensus statements as morbid obesity. The term clinically severe obesity is preferred to the once commonly used term morbid obesity and is described in the NHLBI practical guide document of According to the NHLBI, Surgery is an option for well-informed and motivated patients who have clinically severe obesity (BMI 40) or a BMI 35 and serious comorbid conditions (NHLBI 2000). 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. First-line treatments for obesity include dietary therapy, physical activity, and behavior modification. Low-calorie diets, exercise programs, behavioral modification regimens and medical treatment have generally been unsuccessful in long-term weight management for obese individuals. Pharmacotherapy is an option for patients who do not respond to these measures but results in very modest reductions in weight. Obesity drugs currently on the market have provided weight loss of only about 3%-10% of a patient's total body weight and have been associated with undesirable adverse events. The failure rate of conservative nonsurgical treatment is estimated to be 95% (CDC, 2007). Therefore, this makes bariatric surgery an attractive treatment option. While in the past bariatric surgery was performed through long open incision approaches, most bariatric operations are now performed using laparoscopic techniques that employ smaller incisions to reduce tissue damage, lessen postoperative pain, and shorten the length of hospital stay (Lannoo and Dillemans, 2014). Today, the most commonly used bariatric technique is the Roux-en-Y gastric bypass (RYGB) and current use of the term "gastric bypass" typically refers to RYGB. Among bariatric procedures, gastric bypass is considered to be the gold standard. Four other main types of bariatric surgery are currently practiced: sleeve gastrectomy, vertical banded gastroplasty (VBG), adjustable silicone gastric banding (ASGB), and biliopancreatic diversion (BPD) with or without duodenal switch. All five procedures may be performed by open or laparoscopic technique. Bariatric Surgery.doc Page 13 of 45

14 Surgical treatment of obesity offers two main weight-loss approaches: restrictive and malabsorptive. Restrictive methods are intended to cause weight loss by restricting the amount of food that can be consumed by reducing the size of the stomach. Malabsorptive methods are intended to cause weight loss by limiting the amount of food that is absorbed from the intestines into the body. A procedure can have restrictive features, malabsorptive features, or both. The surgical approach can be open or laparoscopic. The clinical decision on which surgical procedure to use is made based on a medical assessment of the patient's unique situation. Gastrointestinal liners, such as the EndoBarrier system, utilize an endoscopically implanted sleeve into the stomach to reduce the stomach size. The sleeve is then removed after weight loss has been achieved. Laparoscopic greater curvature plication (LGCP), also known as total gastric vertical plication (TGVP), is a relatively new restrictive procedure that involves folding and suturing the stomach onto itself to decrease the size of the stomach. This procedure is a modification of the gastric sleeve which requires surgical resection of stomach. Bariatric surgery will frequently ameliorate symptoms of co-morbidities such as gastroesophageal reflux disease and obstructive sleep apnea. However, the primary purpose of bariatric surgery in obese persons is to achieve weight loss. According to the guidelines for bariatric surgery from the American Association of Clinical Endocrinologists (AACE), The Obesity Society (TOS), and the American Society for Metabolic and Bariatric Surgery (ASMBS), all patients seeking bariatric surgery should have a comprehensive preoperative evaluation. This assessment is to include an obesity-focused history, physical examination, and pertinent laboratory and diagnostic testing. A detailed weight history should be documented, including a description of the onset and duration of obesity, the severity, and recent trends in weight. Causative factors to note include a family history of obesity, use of weight-gaining medications, and dietary and physical activity patterns. A brief summary of personal weight loss attempts, commercial plans, and physician-supervised programs should be reviewed and documented, along with the greatest duration of weight loss and maintenance. This information is useful in substantiating that the patient has made reasonable attempts to control weight before considering obesity surgery. The guidelines state that preoperative weight loss should be considered for patients in whom reduced liver volume can improve the technical aspects of surgery (Mechanick, et al., 2013). CLINICAL EVIDENCE The criteria for patient selection for bariatric surgery are relatively uniform among clinical studies published in the peer-reviewed literature and broadly correspond to criteria recommended by the American Society for Bariatric Surgery (ASBS) and the Society of American Gastrointestinal Endoscopic Surgeons (SAGES). These criteria include (ASBS, 2005): BMI 35 to 40 with obesity-related co-morbid medical conditions BMI 40 without co-morbidity if the weight adversely affects the patient Demonstration that dietary attempts at weight control have been ineffective Bariatric Surgery.doc Page 14 of 45

15 Arterburn et al. (2015) evaluated the association between bariatric surgery and long-term survival in a retrospective cohort study of obese patients treated at the Veterans Administration (VA) health system. A cohort of surgical patients (n=2500; mean age, 52 years; mean body mass index [BMI] of 47), undergoing any bariatric surgery procedure, were compared with control patients (n=7462). At the end of 14 years, there were a total of 263 deaths in the surgical cohort group (n=2500) and 1277 deaths in the matched controls (n=7462). Based on Kaplan-Meier estimates, mortality rates were 2.4% at 1 year, 6.4% at 5 years, and 13.8% at 10 years for surgical cohort patients. In the matched controls, mortality rates were 1.7% at 1 year, 10.4% at 5 years, and 23.9% at 10 years. Bariatric surgery was associated with reduced mortality compared controls after 1 to 5 years (hazard ratio [HR], 0.45; 95% CI, 0.36 to 0.56) and after 5 years (HR, 0.47; 95%CI, 0.39 to 0.58). Across different subgroups based on diabetes diagnosis, sex, and period of surgery, there were no significant differences between surgery and survival at the mid- and long-term evaluations. Magallares et al. (2015) conducted a meta-analysis of 21 studies evaluating the mental and physical health-related quality of life (HR-QOL) measures with the Short Form-36 (SF-36) before and after bariatric surgery. Study authors reported that obese patients scored less in the mental health component of SF-36 prior to bariatric surgery (n=2680) compared with after surgery (n=2251). Similar results were observed in the physical health component of SF-36. Study authors concluded that obese patients experienced strong improvement in mental and physical QOL measures following surgery. Sjostrom et al. (2004) published a prospective controlled study of patients who had gastric surgery (average BMI of 41) and matched them with conventionally treated obese control subjects. Two treatment groups were identified: those who had surgery two years prior (4,047 patients) and those who had it 10 years prior (1,703). After two years, the weight had increased by 0.1% in the control group and decreased by 23.4% in the surgery group. After ten years, the weight in the control group had increased by 1.6% and had decreased in the surgical group by 16.1%. In addition to total weight loss, they measured laboratory values and lifestyle changes. The authors concluded that bariatric surgery appears to be a viable option for the treatment of severe obesity and resulted in long term weight loss, improved lifestyle and improvement in risk factors that were elevated at baseline. Obese individuals with metabolic syndrome (MS), a clustering of risk factors that include high levels of triglycerides and serum glucose, low level of high-density-lipoprotein cholesterol, high blood pressure and abdominal obesity, are at high risk of developing coronary heart disease and type 2 diabetes mellitus. A study by Lee et al. (2004) concluded that MS is prevalent in 52.2% of morbidly obese individuals and that significant weight reduction one year post surgery markedly improved all aspects of metabolic syndrome with a cure rate of 95.6%. They also note that obesity surgery performed by laparoscopic surgery is recommended for obese patients with MS. Buchwald et al. (2004) also found in their meta-analysis that a substantial majority of patients with type 2 diabetes mellitus, hyperlipidemia, hypertension and obstructive sleep apnea experienced complete resolution or improvement after bariatric surgery. Post-operative mortality was 0.1%-1.1% depending on the surgery type with lowest mortality in the restrictive techniques and highest for biliopancreatic diversion method. Dixon et al. (2008) conducted an unblinded randomized controlled trial to determine if surgically induced weight loss results in better glycemic control and less need for diabetes medications than Bariatric Surgery.doc Page 15 of 45

16 conventional approaches to weight loss and diabetes control. A total of 60 patients were randomized into the 2 groups; 30 receiving surgical treatment and 30 receiving conventional treatment. Remission of type 2 diabetes, at 2 year follow-up, was reduced 73% in the surgical group and 13% in the conventional therapy group. Christou el al. (2004) concluded that bariatric surgery not only decreased risk factors, but also decreased overall mortality. They performed a matched cohort study of 1,035 patients who had bariatric surgery with 5,746 obese patients who did not have surgery. Subjects with medical conditions other than morbid obesity were not included. The participants were followed for 5 years. The mortality rate in the treatment group was 0.68% compared with 6.17% of the controls which results in a reduction in the relative risk of death by 89%. Weight loss therapy is not appropriate for most pregnant or lactating women. Pregnancy after bariatric surgery was examined by Sheiner et al. (2004) who concluded that previous bariatric surgery had a high correlation with Cesarean delivery. There was no correlation with other indicators of adverse perinatal outcomes such as dystocia, Apgar scores, perinatal complications or perinatal mortality. Shen et al. (2004) studied the impact of patient follow-up on weight loss after bariatric surgery. They found that weight loss was correlated with the number of follow-up visits completed in the first year post surgery. They concluded that patient follow-up plays a significant role in the amount of weight loss after bariatric surgery and that patient motivation and surgeon commitment for long term followup is critical for successful weight loss after bariatric surgery. An analysis of outcome data for a subset of participants enrolled in the Swedish Obese Subjects (SOS) study found that obese individuals who received surgical treatment for their condition experienced significant weight loss and reductions in the incidence of cardiovascular risk factors, including diabetes, hypertriglyceridemia, and hyperuricemia, at both 2-year and 10-year follow-up, compared with contemporaneously matched controls who received nonsurgical treatment for their obesity. The SOS study enrolled 4047 obese individuals, defined as a body mass index (BMI) 34 for men and 38 for women, between the ages of 37 and 60 years who, according to personal preference and surgical eligibility, underwent bariatric surgery (n=2010) or nonsurgical treatment (n=2037) for their condition. Patients who preferred surgical treatment and met eligibility requirements for bariatric surgery underwent fixed or variable banding, vertical banded gastroplasty, or gastric bypass surgery. Nonsurgical treatment varied among centers. However, among enrolled patients, 10-year outcomes were available for 851 surgically treated patients who were contemporaneously matched with 852 control subjects and 2-year outcomes were available for 1845 surgically treated patients and 1660 controls. At 2-years of follow-up, a significant 23.4% weight reduction was observed among patients who were surgically treated compared with a 0.1% mean weight increase among patients in the control group. At 10-years of follow-up, patients who underwent bariatric surgery maintained a significantly greater percentage of weight loss compared with the control group (-16.1% versus +1.6%, respectively; P<0.001). Postoperative mortality among the 2010 patients who underwent surgery was 0.25% (Hayes, 2005). Fifteen years of follow-up by Sjostrom et al. (2007) showed that there were 129 deaths in the control group and 101 deaths in the surgery group. Bariatric Surgery.doc Page 16 of 45

17 Patients should have a clear understanding of expected benefits, risks, and long term consequences of surgical treatment as they require appropriate lifelong follow- up with nutritional counseling and biochemical surveillance. Care of the postoperative bariatric surgery patient is recommended for the lifetime of the patient with at least three follow-up visits with the bariatric surgery team within the first year. Laparoscopic adjustable gastric banding will require more frequent visits for band adjustment. Surgery should only be performed as part of a bariatric program intent on maintaining long-term follow-up as well as long-term evaluation. Greenberg et al. (2005) found a high incidence of depression, negative body image, eating disorders, and low quality of life (QoL) in patients with severe obesity. Although their investigation showed there are no predictive relationships between preoperative psychological evaluations and postoperative weight loss, they recommended that all bariatric surgery candidates be evaluated by a licensed mental health care provider experienced in the treatment of severely obese patients and working with a multidisciplinary team. In another study of clients followed for 1 year after weight loss surgery, perceived obesity-related health problems, motivation, and sense of coherence (SoC) predicted better weight loss. A history of sexual abuse correlated with poorer weight loss, whereas intrinsic motivational factors appeared to predict greater weight loss after surgery (Ray et al., 2003). Although research supports the association of psychological problems such as depression and personality disorder with less successful obesity surgery outcomes, rarely are the psychological problems cited as contraindications for surgery (Greenberg et al., 2005). Furthermore, the goal of psychological assessment should be the development of pre- and postsurgical treatment plans that address psychosocial barriers to postoperative success. Professional consensus is that bariatric surgery should be performed only in motivated, educated patients who have participated in a combined multidisciplinary assessment and only after behavior-based interventions have failed (Bachman et al., 2005). Absolute contraindications include patients with active substance abuse. A signed physician statement indicating that the patient is substance free is recommended. The following conditions should be considered relative contraindications to bariatric surgery: Major mental disorders, such as schizophrenia, uncontrolled depression, active suicidal ideation or personality disorders can interfere with the ability to comprehend informed consent for bariatric surgery and/or to comply with the recommended post-surgical follow-up. A variety of serious illnesses could be exacerbated by caloric restriction, including anorexia nervosa or bulimia nervosa. Gastric Bypass (Roux-en-Y; Gastrojejunal Anastomosis) The most commonly performed restrictive approach is the RYGB, which combines gastric restrictive and malabsorptive features. The Roux-en-Y bypass (RYGB) procedure involves restricting the size of the stomach by stapling shut 90% of the lower stomach. In addition, the proximal intestinal anatomy is rearranged, thereby bypassing the duodenum resulting in a malabsorptive effect. This can be an open or laparoscopic procedure. Long-limb Roux-en-Y gastric bypass (LLRGB) is similar to standard RYGB, except that the "Roux" limb (through which only food passes) is greater than 100 cm instead of the usual 45 to 100 cm. Consequently, the common limb (which empties both food and digestive fluids) is shorter, thereby Bariatric Surgery.doc Page 17 of 45

18 permitting less food absorption. Several authors assert that this procedure should be performed for patients with a BMI of greater than 50 instead of the RYGB. In retrospective cohort study, conducted over 18 years, by Adams et al. (2007), 9949 patients who had undergone gastric bypass surgery and 9628 severely obese persons who applied for driver's licenses were studied. From these subjects, 7925 surgical patients and 7925 severely obese control subjects were matched for age, sex, and body-mass index. The authors concluded that long-term total mortality after gastric bypass surgery, particularly deaths from diabetes, heart disease, and cancer, was significantly reduced. However, the rate of death from causes other than these diseases was higher in the surgery group than in the control group. Review of the data showed that a substantial number of severely obese persons have unrecognized presurgical mood disorders or post-traumatic stress disorder or have been victims of childhood sexual abuse. This is leading some bariatric surgery centers to recommend that all patients undergo psychological evaluation and, if necessary, treatment before surgery and psychologically related surveillance postoperatively. Despite an improved quality of life after gastric bypass surgery, certain unrecognized presurgical conditions may reappear after surgery. Therefore, further research is needed to explore the optimal approach to evaluating candidates for surgery, including the possible need for psychological evaluation and psychiatric treatment before surgery, and aggressive follow-up after surgery. Giordano (2015) conducted retrospective comparative study of consecutive super-obese patients. Patients either underwent laparoscopic Roux-en-Y gastric bypass procedure (n=102) or laparoscopic adjustable gastric banding (n=79). Early complications and weight loss outcomes were comparable between the two groups in the short term. However, weight loss and excess weight loss percent at 6 and 12 months of follow-up was significantly higher in patients who underwent Roux-en-Y surgery than gastric banding. Adverse events include gastrointestinal leak after RYGB and LLRGB. Some patients require reoperation to correct problems with the original surgery, including stenosis around the anastomosis site, causing post-prandial abdominal pain and vomiting. Other reasons for re-operation include gastrointestinal leak after RYGB (Kellum et al., 1998). Adjustable Silicone Gastric Banding (ASGB) The adjustable silicone gastric banding (ASGB) procedure involves placing an inflatable silicone band around the upper portion of the stomach. The silicone band contains a saline reservoir that can be filled or emptied under fluoroscopic guidance to change the caliber of the gastric opening. Laparoscopic or open techniques can complete the ASGB procedure. Adverse events include band leakage after ASGB. Other procedures that are used include the nonadjustable gastric banding (NAGB). This procedure was the precursor to the AGB and is similar to it. However, it differs in that the band diameter cannot be adjusted. Some surgeons still perform NAGB. Biliopancreatic Diversion with Duodenal Switch Biliopancreatic diversion (BPD) (also known as the Scopinaro procedure) is primarily malabsorptive but has a temporary restrictive component. As in RYGB, three "limbs" of intestine are created: one through which food passes, one that permits emptying of fluids (e.g., bile) from digestive organs, and a common limb through which both food and digestive fluids pass. This procedure involves removal of Bariatric Surgery.doc Page 18 of 45

19 the greater curvature of the stomach instead of the distal portion. The two limbs meet in a common channel measuring only 50 to 100 cm, thereby permitting relatively little absorption. Use of BPD/DS has been increasing steadily during the past five years. In addition, biliopancreatic diversion (BPD) with or without a duodenal switch has been done laparoscopically. In some morbidly obese patients, the risk of complications of operations that are both restrictive and malabsorptive is particularly high. These may include patients with "super" obesity (i.e., those with a BMI of 50 or higher) or certain types of heart disease. Due to these risks, some surgeons first perform only the restrictive portion of a more invasive operation. This restrictive portion is laparoscopic sleeve gastrectomy (also known as laparoscopic vertical gastrectomy) in which approximately 80% of the stomach is removed. Weight loss may be sufficient with this restrictive operation alone. If not, the patient may potentially undergo the second half of the operation that promotes reduced absorption of food (i.e., the sleeve gastrectomy is the restrictive component of a full operation called the biliopancreatic diversion with duodenal switch). The second operation may be performed 6-12 months after the first. Although 26 studies were published about gastric sleeve banding, 24 of these were case series, case reports and small reviews. None of the studies reported weight loss at three years or more after the operation, which is considered 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. Two controlled studies were reported with a total population of 83 patients that demonstrated weight loss and decreases in co-morbidities. However, the lack of randomization, blind evaluation and long term follow up limit the usefulness of the outcomes (ECRI, 2006). A single-center, nonblinded, randomized, controlled trial performed by Mingrone et al (2012), with 60 patients between the ages of 30 and 60 years with a body-mass index BMI of 35 or more, a history diabetes for at least 5 years, and a glycated hemoglobin level of 7.0% or more were randomly assigned to receive conventional medical therapy or undergo either gastric bypass or biliopancreatic diversion. The primary end point was the rate of diabetes remission at 2 years (defined as a fasting glucose level of <100 mg per deciliter [5.6 mmol per liter] and a glycated hemoglobin level of <6.5% in the absence of pharmacologic therapy). In severely obese patients with type 2 diabetes, bariatric surgery resulted in better glucose control than did medical therapy. Preoperative BMI and weight loss did not predict the improvement in hyperglycemia after these procedures. Vertical Gastrectomy (Sleeve Gastrectomy) ECRI published an emerging technology report on laparoscopic sleeve gastrectomy (LSG) which states that for patients with morbid obesity or obesity with serious comorbidity, the procedure may be performed to enable adequate weight loss and reduce comorbidities while potentially causing fewer adverse effects than bariatric surgeries that result in greater reduction of the stomach size and/or malabsorption. For patients with super obesity (BMI 50 kg/m2), LSG may provide a feasible and safe first step. Insufficient evidence was found to reach conclusions about the effectiveness of LSG compared to other bariatric procedures. No conclusions can be drawn regarding comparative safety because so few studies reported the same adverse events (ECRI, 2011). An assessment by the California Technology Assessment Forum (CTAF) (Walsh, 2010) concluded that sleeve gastrectomy does not meet CTAF technology assessment criteria for improvement in health outcomes for the treatment of obesity. The CTAF assessment reported that the results of multiple case Bariatric Surgery.doc Page 19 of 45

20 series and retrospective studies have suggested that sleeve gastrectomy as a primary procedure is associated with a significant reduction in excess weight loss. The CTAF assessment stated that, "[t]o date, long term outcomes from registry studies are relatively limited, but longer term follow-up will provide additional important information." A Cochrane Database Systematic Review by Colquitt et al. (2009) found that stand-alone sleeve gastrectomy appears to result in greater weight loss than adjustable gastric banding. The evidence suggests that weight loss following gastric bypass is similar to stand-alone sleeve gastrectomy and banded gastric bypass. Brethauer et al. (2009) performed a systematic review (n=36 studies) of the evidence on sleeve gastrectomy (SG). Studies included a single nonrandomized matched cohort analysis, RCTs (n=2 studies) and uncontrolled case series (n=33 studies). The mean BMI in all 36 studies was 51.2 kg/m2. The mean baseline BMI was 46.9 kg/m2 for the high-risk patients (range ) and 60.4 kg/m2 for the primary SG patients (range ). The follow-up period ranged from 3-60 months. The mean % of excess weight loss (EWL) after SG reported in 24 studies was 33 85%, with an overall mean %EWL of 55.4%. The mean postoperative BMI was reported in 26 studies and decreased from a baseline mean of 51.2 kg/m2 to 37.1 kg/m2 postoperatively. Improvement or remission of type 2 diabetes was found in more than 70% of patients. Significant improvements were also seen in hypertension and hyperlipidemia, as well as in sleep apnea and joint pain. The major postoperative complication rate ranged from 0%-23.8%. A randomized, nonblinded, single-center trial, Schauer et. al. (2012) evaluated the efficacy of intensive medical therapy alone versus medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy in 150 obese patients with uncontrolled type 2 diabetes. The mean age of the patients was 49±8 years, and 66% were women. The average glycated hemoglobin level was 9.2±1.5%. The primary end point was the proportion of patients with a glycated hemoglobin level of 6.0% or less 12 months after treatment. In obese patients with uncontrolled type 2 diabetes, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more patients than medical therapy alone. Further study will be necessary to assess the durability of these results. A prospective, randomized, double blind study by Karamanakos et al. (2008) evaluated 32 patients (16 LRYGBP; 16 LSG) to compare the effects of laparoscopic Roux-en-Y gastric bypass (LRYGBP) with LSG on body weight, appetite, fasting, and postprandial ghrelin and peptide-yy (PYY) levels. Patients were reevaluated on the 1st, 3rd, 6th, and 12th postoperative month. Blood samples were collected after an overnight fast and in 6 patients in each group after a standard 420 kcal mixed meal. Body weight and body mass index (BMI) decreased markedly (P<0.0001) and comparably after either procedure. After LRYGBP fasting ghrelin levels did not change significantly compared with baseline (P=0.19) and did not decrease significantly after the test meal. On the other hand, LSG was followed by a marked reduction in fasting ghrelin levels (P<0.0001) and a significant suppression after the meal. Fasting PYY levels increased after either surgical procedure (P < or = 0.001). Appetite decreased in both groups but to a greater extend after LSG. In addition, patients in the LRYGBP group had an increase in appetite after 12 months whereas the LSG group maintained a reduced appetite during the same timeframe. The authors concluded that LSG has better outcomes than LRYGBP with regard to appetite suppression and excess weight loss due to reduced ghrelin levels and increased PYY levels Bariatric Surgery.doc Page 20 of 45