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Criteria #22 Gastric Bypass Surgery (Custom) - UDOH

Criteria #22 Gastric Bypass Surgery (Custom) - UDOH

2010 Procedures Adult Criteria Criteria #22 Gastric Bypass Surgery (Custom) - UDOH

2010 Procedures Adult Criteria Criteria #22 Gastric Bypass Surgery (Custom) - UDOH(1, 2*MDR, 3*MDR, 4*RIN, 5*RIN

, 6, 7, 8, 9, 10, 11, 12)

Created based on InterQual Subset: Version: InterQual® 2009

PATIENT: Name D.O.B. ID# GROUP# CPT/ICD9: Code Facility Service Date PROVIDER: Name ID# Phone# Signature Date

ICD-9-CM: 44.31, 44.38, 44.39, 44.68

INDICATIONS (choose one and see below)

100 Clinically severe Indication Not Listed (Provide clinical justification below)

(3*MDR, 13) 100 Clinically severe obesity [All] (14) 110 Obesity ≥ 3 yrs (15, 16) 120 BMI [One] (17) 121 BMI ≥ 35 and < 40 kg/m2 with comorbidity [One] (18) -1 Type 2 DM (19) -2 HTN (20) -3 CAD/CHF/dyslipidemia (21) -4 Obstructive (22, 23) -5 GERD (24) -6 Osteoarthritis (25) -7 Pseudotumor cerebri (26) 122 BMI ≥ 40 kg/m2 (27) 130 Continued obesity despite supervised diet program ≥ 6 mos [One] 131 ≥10% in the past 6 months (28) 140 Preoperative evaluation [All] (29) 141 Cardiac and pulmonary evaluation (30) 142 Dietary consultation (31) 143 Endocrinopathy excluded (32) 144 Active PUD excluded by testing [One] -1 EGD -2 UGI InterQual® criteria are intended solely for use as screening guidelines with respect to the medical appropriateness of healthcare services and not for final clinical or payment determination concerning the type or level of medical care provided, or proposed to be provided, to the patient. The Clinical Content is confidential and proprietary information and is being provided to you solely as it pertains to the information requested. Under copyright law, the Clinical Content may not be copied, distributed or otherwise reproduced except as permitted by and subject to license with McKesson Corporation and/or one of its subsidiaries. InterQual® copyright © 2010 McKesson Corporation and/or one of its subsidiaries. All Rights Reserved. Portions modified by Licensee have not been independently authenticated in whole or in part by McKesson. McKesson is not responsible for and hereby disclaims any liability related to any such modifications and their inclusion herein does not imply endorsement by McKesson of modifications. May contain CPT® codes. CPT only © 2009 American Medical Association. All Rights Reserved. Page 1 of 7 Licensed for use exclusively by Utah Department of Health. 2010 Procedures Adult Criteria Criteria #22 Gastric Bypass Surgery (Custom) - UDOH

(33, 34) -3 H. pylori negative (35) 145 Drug/alcohol screen [One] -1 No drug/alcohol abuse by Hx -2 Alcohol and drug free period for ≥ 1 yr (36, 37) 150 Procedure performed at bariatric surgery center (38, 39) 160 Patient understanding of surgical risk, post procedure compliance, and follow-up

Notes

(1) These criteria include the following procedures: Biliopancreatic Diversion with Laparoscopic Adjustable Gastric Banding (Lap Band) Roux-en-Y Gastric Bypass (RYGB) Weight Loss Surgery (2)-MDR: These criteria address weight loss surgery in adult patients. Although severe clinical obesity is a growing health concern in adolescents and children, few trials have studied long-term outcomes in this population and it is unclear whether data obtained from studies of adults undergoing bariatric surgery can be extrapolated to this younger age group. Requests for bariatric surgery in adolescents and children, therefore, require secondary medical review. (3)-MDR: UDOH requires that ALL approved Gastric Bypass Surgery cases receive secondary review approval from the appropriate committee (CHEC or UR) (4)-RIN: These criteria do not address revisional surgery, procedures of primarily historical interest (e.g., , horizontal gastric stapling), vertical banded gastroplasty (VBG), or new procedures not yet standard of care (e.g., sleeve , long limb gastric bypass, mini-gastric bypass, gastric balloon, transoral gastroplasty). (5)-RIN: Accompanying surgery: • Some patients with severe obesity have a ventral or umbilical . Repair at the time of weight reduction surgery is standard and does not require separate authorization. • for biliary colic or gallstones diagnosed preoperatively may be performed without separate authorization. • Gallstone formation is common following weight reduction surgery secondary to bile stasis. Ursodiol (Actigall) may be used postoperatively to reduce the formation of new gallstones (Miller et al., Ann Surg 2003; 238(5): 697-702). Prophylactic cholecystectomy (cholecystectomy performed on an asymptomatic patient) is, therefore, not warranted and requests for prophylactic cholecystectomy require separate authorization. • Although GERD is associated with severe obesity, weight loss surgery (by eliminating acid reflux even before the patient experiences weight loss) often eliminates this problem (Frezza et al., Surg Endosc 2002; 16(7): 1027-1031). Requests for simultaneous antireflux surgery, therefore, require separate authorization. (6)-DEF: Bariatric surgery is defined as gastrointestinal surgery for the treatment of clinically severe obesity and accompanying . The exact mechanism resulting in weight loss and resolution of comorbidities is unknown but is felt to be a combination of restriction of intake, increased satiety, malabsorption, changes in metabolism, and changes in GI hormonal pathways. (7) In patients with clinically severe obesity, even small reductions in weight can result in a health benefit (Klein, Surg Clin North Am 2001; 81(5): 1025-1038). Nonoperative treatment (e.g., diet, behavioral changes, drug therapy), however, has a high failure rate beyond one year (Kral, Int J Obes Relat Metab Disord 2001; 25 Suppl 1: S107-112). The inability to maintain weight loss is often a

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result of both biologic and psychological factors. Surgical therapy is the most effective approach for achieving long-term weight loss (Colquitt et al., Cochrane Database Syst Rev 2005; (4): CD003641). Intensive medical treatment compared at 2 years to gastric banding in one randomized, controlled trial showed significant improvement in weight loss and quality of life in the surgically treated group (O'Brien et al., Ann Intern Med 2006; 144(9): 625-633). Thirty-day mortality rates for bariatric procedures vary and range from 0.3% to 1.9% (Maggard et al., Ann Intern Med 2005; 142(7): 547-559; Flum and Dellinger, J Am Coll Surg 2004; 199(4): 543-551). Bariatric surgery has also been shown to be cost-effective when evaluating long-term treatment strategies and outcomes associated with reduction (Salem et al., J Am Coll Surg 2005; 200(2): 270-278; Sampalis et al., Obes Surg 2004; 14(7): 939-947; Clegg et al., Int J Obes Relat Metab Disord 2003; 27(10): 1167-1177). (8) The type of surgical procedure performed depends on the patient's BMI, their comorbidity profile, and surgeon preference. Malabsorptive procedures (e.g., biliopancreatic diversion) typically result in more weight loss than restrictive procedures (e.g., gastric banding, VBG) and should be used in very obese patients. RYGB, where a small gastric pouch is connected to a segment of , is the most commonly performed bariatric procedure in the U.S. and is a combination of a restrictive and malabsorptive procedure (Santry et al., JAMA 2005; 294(15): 1909-1917). Biliopancreatic diversion with duodenal switch, most commonly performed in Italy and Europe, shows impressive weight loss results (70% of EBW), especially in the super obese (Buchwald, Surg Obes Relat Dis 2005; 1(3): 371-381). This procedure involves the creation of a pouch of , typically larger than that seen with RYGB, and bypass of the proximal intestine to limit absorption (Ali et al., Surg Clin North Am 2005; 85(4): 835-852, vii). (9) Laparoscopic placement of an to restrict the size of the stomach is less invasive, is associated with decreased hospitals stays, and can be reversed if necessary. Long-term weight loss is less than for RYGB. Complications unique to this procedure include slippage of the band, erosion of the band into the stomach, band or port infection, and leaks around the balloon (Technology Evaluation Center, Technol Eval Cent Asses Program Exec Summ 2007; 21(13): 1-30; Chapman et al., Surgery 2004; 135(3): 326- 351). VBG has largely been replaced by other bariatric procedures, as less favorable outcomes (e.g., poor sustained weight loss) have been reported in the literature. The Bariatric Analysis and Reporting Outcomes System looks at percent of excess weight loss, comorbidities, and quality of life when evaluating success. Loss of 100% of excess body weight is not a realistic goal, as such weight loss is associated with a loss of lean body mass. (10) Nearly two-thirds of all bariatric procedures performed in the U.S. are performed laparoscopically. Bariatric surgery performed laparoscopically results in reduced wound-related complications (e.g., ventral ), increased mobility, shorter hospital stays, and shorter recovery times when compared to the open approach (Puzziferri et al., Ann Surg 2006; 243(2): 181-188; Buchwald, Surg Obes Relat Dis 2005; 1(3): 371-381; Jones et al., Surg Endosc 2004; 18(7): 1029-1037; Nguyen et al., Ann Surg 2001; 234(3): 279-289; discussion 289-291). (11) An open approach may be preferred for the super obese (BMI 50 kg/m2), in the presence of abdominal wall hernias, and when there are dense adhesions (Buchwald, Surg Obes Relat Dis 2005; 1(3): 371-381). (12) In patients over 60 years of age, whether weight reduction surgery improves long-term survival is debated. Quality of life may be improved, even if longevity is not, and may represent a sufficient reason for bariatric surgery in select patients. After careful analysis of data presented by professional societies and experts in the field, CMS reversed its previous decision and determined that RYGB, laparoscopic adjustable gastric banding, and biliopancreatic diversion with duodenal switch should be covered for patients 65 and older if performed by a credentialed surgeon at an accredited bariatric surgery center. A large, retrospective cohort study that looked at operative outcomes at 30 days, 90 days, and 1 year expressed concern for the safety of these procedures in the elderly (Flum et al., JAMA 2005; 294(15): 1903-1908). Others have reported mortality and morbidity rates in older patients as similar to those for younger patients. Even with a shift over recent years to higher-risk and older patients, there has not been an increase in hospital morbidity or mortality rates (Santry et al., JAMA 2005; 294(15): 1909-1917).

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(13)-DEF: Clinically severe obesity (formerly described as morbid obesity) is defined as > 100% of IBW, at least 100 lb above IBW, or a BMI > 35 2 kg/m . This definition includes women weighing greater than 240 lb and men weighing greater than 270 lb (Balsiger et al., Med Clin North Am 2000; 84(2): 477-489). (14) Although a 5-year time frame is recommended by the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE), surgery may be performed earlier in patients with associated comorbidities (Evans et al., Am J Surg 2002; 184(2): 97-102; AACE/ACE Obesity Task Force Endocrine Practice 1998; 4(5): 297-329). (15)-DEF: The most widely used indicator to measure obesity is the (BMI), calculated by dividing weight (lbs) by height (in) squared and multiplying by 703 or, alternatively, by dividing weight (kg) by height (m) squared (National Task Force on the Prevention 2 and Treatment of Obesity, Am Fam Physician 2002; 65(1): 81-88). There are four classes of obesity: Class I (30.0 to 34.9 kg/m ), 2 2 2 Class II (35.0 to 39.9 kg/m ), Class III (≥ 40 kg/m ), and Class IV (≥ 50 kg/m ) (Klein, Surg Clin North Am 2001; 81(5): 1025-1038; Kral, Surg Clin North Am 2001; 81(5): 1039-1061). (16) BMI is a safe, simple, and inexpensive method for gauging . Both the National Institutes of Health (NIH) and World Health Organization (WHO) have endorsed BMI as a measure of obesity (Kral, Surg Clin North Am 2001; 81(5): 1039-1061; NIH Consensus Development Conference Panel, Ann Intern Med 1991; 115(12): 956-961). (17) Obesity is associated with multiple complications and related comorbidities, and surgery has been shown to effectively result in significant, sustained weight loss, a reduction in mortality, and decreased development of new comorbid conditions (Buchwald et al., JAMA 2004; 292(14): 1724-1737; Christou et al., Ann Surg 2004; 240(3): 416-424). One recent study showed significantly improved 2 2 weight, health, and quality of life following surgery even in patients with a BMI between 30 kg/m and 35 kg/m who also had an accompanying comorbidity (O'Brien et al., Ann Intern Med 2006; 144(9): 625-633). (18) Obesity is strongly associated with the development of Type 2 DM. Approximately one third of the severely obese have Type 2 DM; 2 46% of patients with Type 2 DM have a BMI ≥ 30 kg/m (National Task Force on the Prevention and Treatment of Obesity, Arch Intern 2 Med 2000; 160(7): 898-904). With an associated BMI >35 kg/m , the risk of developing noninsulin-dependent DM is approximately 8 to 30 fold (National Task Force on the Prevention and Treatment of Obesity, Am Fam Physician 2002; 65(1): 81-88). DM resolves in more than 75% of patients after weight reduction; weight loss surgery should, therefore, be considered early in the management of obese, diabetic patients (Buchwald et al., JAMA 2004; 292(14): 1724-1737; Schauer et al., Ann Surg 2003; 238(4): 467-484; discussion 484-465; Sugerman et al., Ann Surg 2003; 237(6): 751-756; discussion 757-758). (19) The longer a person is obese, the more likely he or she is to develop HTN (Sugerman et al., Ann Surg 2003; 237(6): 751-756; discussion 757-758). The Swedish Obese Subjects study found no significant improvement in HTN after 8 years follow-up. They hypothesized that, although HTN is improved in the early postoperative period, blood pressure increases over time (Sjostrom et al., 2000; 36(1): 20-25). A more recent systematic review showed that HTN was resolved or improved by even small reductions in weight (Buchwald et al., JAMA 2004; 292(14): 1724-1737). (20) Elevated BMI is associated with an increased risk of CAD and heart failure in both men and women (Sjostrom et al., N Engl J Med 2004; 351(26): 2683-2693; Wilson et al., Arch Intern Med 2002; 162(16): 1867-1872; Kenchaiah et al., N Engl J Med 2002; 347(5): 305-313). Serum lipid levels improve in direct proportion to the amount of weight lost and revert to previous levels once the weight is put back on (Klein et al., Gastroenterology 2002; 123(3): 882-932). Reductions in cholesterol and lipid levels are more marked after malabsorptive, rather than restrictive, bariatric procedures (Buchwald et al., JAMA 2004; 292(14): 1724-1737). (21) Sleep apnea is a frequent condition of morbidly obese patients.Surgically-induced weight loss is associated with improved sleep quality, a decreased need for treatment with positive airway pressure, and less apneas or hypopneas per hour (Haines et al., Surgery 2007; 141(3): 354-358; Buchwald et al., JAMA 2004; 292(14): 1724-1737; Rasheid et al., Obes Surg 2003; 13(1): 58-61; Grunstein et al., Sleep 2007; 30(6): 703-710).

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(22)-DEF: Gastroesophageal reflux disease (GERD) is a condition where gastric contents reflux into the and produce chest pain, heartburn, or indigestion. (23) At 3 year follow-up, nearly 90% of patients with GERD in one study showed improved symptoms following laparoscopic gastric banding (Spivak et al., Am J Surg 2005; 189(1): 27-32). (24) Prevention and treatment of obesity can improve the pain, stiffness, and musculoskeletal function seen in patients with osteoarthritis. Pain in the hip, knee, and ankle joints, as well as neck and back pain, improved significantly in patients undergoing weight loss surgery compared with a control group at 2 year and 6 year follow-up (Peltonen et al., Pain 2003; 104(3): 549-557). (25) Pseudotumor cerebri (also called idiopathic intracranial hypertension) is associated with headache, blurred vision, and pulsatile tinnitus and may be secondary to a chronic increase in intra-abdominal pressure associated with central obesity. The condition in the obese resolves with weight loss (Friedman, Ophthalmol Clin North Am 2001; 14(1): 129-147, ix). Weight loss surgery may be a more appropriate treatment than CSF-peritoneal shunting, which addresses the symptom rather than the cause (Sugerman et al., Ann Surg 1999; 229(5): 634-640; discussion 640-632). (26) 2 A BMI of 40 kg/m , even in the absence of comorbidity (rare), qualifies for weight loss surgery (NIH Consensus Development 2 Conference Panel, Ann Intern Med 1991; 115(12): 956-961). Superobesity is defined as BMI ≥ 50 kg/m ; this subset of morbidly obese patients oftentimes requires special treatment and management. (27) Before surgery is considered, patients should undergo an adequate trial of nonoperative weight loss (Buchwald, Surg Obes Relat Dis 2005; 1(3): 371-381; NIH Consensus Development Conference Panel, Ann Intern Med 1991; 115(12): 956-961). A supervised diet should incorporate nutritional counseling, behavioral modification, and appropriate regular physical activity. The goal is weight loss of 0.5 kg/week and to reduce weight 5% to 10%. Although only a minority of patients will maintain weight loss, demonstration of previous serious dietary attempts is helpful in demonstrating patient motivation and provides information regarding eating habits and lifestyle. Pharmacologic therapy can be offered to obese patients but a trial of medication is not required prior to consideration of bariatric surgery. FDA-approved adjuvant drug therapy includes (a lipase inhibitor that prevents the absorption of dietary fat) and appetite suppressants (sibutramine, phentermine, diethylpropion); the choice of drug depends on side effects (Snow et al., Ann Intern Med 2005; 142(7): 525-531). A new formulation of low dose orlistat has recently been FDA-approved for over-the-counter use. (28) The benefits of bariatric surgery have been shown to outweigh the risk of surgery and the risk of remaining morbidly obese (Christou et al., Ann Surg 2004; 240(3): 416-424). However, this procedure is performed on a high-risk population due to significant medical comorbidities and can result in significant perioperative complications, including death. An extensive preoperative evaluation is essential in the work-up of the morbidly obese patient. The goals of screening are to identify comorbidities best managed before surgery (thus reducing perioperative morbidity and mortality) and to diagnose previously unrecognized comorbidities. Patient selection, along with pre- and postoperative education, may be of more importance than technical performance of the procedure in determining long-term success (National Task Force on the Prevention and Treatment of Obesity, Am Fam Physician 2002; 65(1): 81-88). Surgeons should screen patients carefully before operating. Concerns regarding noncompliance, psychiatric illness, substance abuse, complicated surgical history, or unreasonable expectations are red flags for potentially problematic patients (Puzziferri, Surg Clin North Am 2005; 85(4): 741-755, vi; Buchwald, Surg Obes Relat Dis 2005; 1(3): 371-381). (29) Patients should be routinely screened for cardiac and pulmonary disease. Preoperative evaluation may include CXR, ECG, pulmonary function testing, arterial blood gas analysis, sleep studies, and stress testing. Specialty consultation is appropriate for assisting in the interpretation of abnormal test results. (30) Patients must be informed that the success of weight loss surgery depends on postoperative modification of diet and that IBW is rarely achieved after surgery. Good education around eating habits is necessary to ensure weight loss surgery will not fail on both anatomic

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(e.g., rupture of suture line) and behavioral (e.g., previous eating habits) grounds. Development of severe , a potentially severe complication, is usually associated with noncompliance in taking multivitamin and iron supplements and missing scheduled follow-up visits (Albert et al., Clin Fam Pract 2002; 4(2): 447-463). (31) Endocrine causes of weight gain (e.g., hypothyroidism, Cushing's syndrome) account for a small proportion of obesity. Laboratory testing and imaging should be done based on clinical suspicion. These conditions must be excluded prior to surgical interventions for weight loss. (32) Because weight loss operations involve stapling or resection of the stomach, active PUD is an absolute contraindication to surgery; there is an increased chance of postoperative hemorrhage, anastomotic leaks, poor wound healing, and infection if PUD is present (Brolin, Surg Clin North Am 2001; 81(5): 1077-1095). (33) H. pylori is the predominant cause of peptic ulcers and is associated with the development of gastric cancer. Endoscopic biopsy-based methods of diagnosing H. pylori include rapid urease testing, histology, culture, and polymerase chain reaction testing. Nonendoscopic methods of testing include antibody testing, urea breath testing, and fecal antigen testing. Urea breath testing and fecal antigen testing are the most reliable for identifying H. pylori (Ikenberry et al., Gastrointest Endosc 2007; 66(6): 1071-1075). If an is being performed for other reasons, it is reasonable to perform a biopsy for H. pylori at the same time; however, it is not appropriate to perform endoscopy for the sole purpose of H. pylori testing (Chey and Wong, Am J Gastroenterol 2007; 102(8): 1808-1825). (34) Approximately 15% of patients evaluated for weight loss surgery test positive for H. pylori. These patients should be treated and surgery only performed once they test negative for H. pylori infection. (35) Screening for substance abuse is important because the medical complications of substance abuse, including , increase the risks of postoperative morbidity and mortality. Patients who have a history of substance abuse should demonstrate one year or more of continuous sobriety before weight loss surgery is considered. Smoking cessation should also be attempted. (36) Published data indicate that high volume bariatric programs and surgeon experience are more successful in achieving optimal outcomes when compared to lower volume centers (Nguyen et al., Ann Surg 2004; 240(4): 586-593; discussion 593-584; Flum and Dellinger, J Am Coll Surg 2004; 199(4): 543-551; Courcoulas et al., Surgery 2003; 134(4): 613-621; discussion 621-613; Liu et al., Am Surg 2003; 69(10): 823-828). The establishment of bariatric surgery centers ("Centers of Excellence") requires facilities to perform a predetermined number of cases, document surgical outcomes, and ensure that the delivered services were cost-effective and safe. The standards established for the American College of Surgeons (ACS) Bariatric Surgery Center Network delineate 4 levels for accreditation of inpatient facilities (Levels 1a, 1b, 2a, 2b), as well as one outpatient level. (37) Level 1 centers provide complete tertiary care and multispecialty services. They must have high-volume practices of 125 or more weight loss operations annually, with at least two credentialed bariatric surgeons each performing at minimum 50 bariatric procedures each year. Level 2 centers provide high quality care to a lower volume of patients having less severe obesity and comorbidities. At Level 2 centers, 25 or more weight loss operations are performed annually and the bariatric surgeon on staff performs at least 50 weight loss procedures over a 2 year period. Level 1a and 2a centers require the use of the ACS quality improvement program to collect and submit data, utilize trained surgical nurse reviewers to gather individual facility data, have access to national aggregate data and benchmark reports for outcome comparisons, and use best evidence guidelines and clinical pathways. Level 1b, 2b, and outpatient facilities only report outcomes to the ACS database for accreditation purposes but are not required to document quality improvement efforts. Outpatient centers provide the application and adjustment of laparoscopic bands only, with discharge in < 24 hours. These centers perform 50 or more procedures annually with at least 1 credentialed bariatric surgeon performing a minimum of 50 weight loss operations annually. (38)

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Bariatric surgery should be confined to weight loss programs designed to maintain long-term follow-up and outcomes evaluation (SAGES Guidelines, Surg Endosc 2001; 15(10): 1251-1252). The multidisciplinary approach includes medical management of comorbidities, specialized nursing care, dietary instruction, exercise training, and psychological expertise. (39) The patient must understand the seriousness of the surgery and possible complications. Although surgical mortality is very low, early complications such as infection, wound dehiscence, gastrointestinal leaks, PE, and thrombophlebitis occur in as many as 6% to 7% of patients. Anastomotic and staple-line leak causing and DVT with resultant PE remain the most serious complications following weight loss surgery (Livingston, Surg Clin North Am 2005; 85(4): 853-868, vii; Podnos et al., Arch Surg 2003; 138(9): 957- 961; Stocker, Endocrinol Metab Clin North Am 2003; 32(2): 437-457; Klein et al., Gastroenterology 2002; 123(3): 882-932). Late complications include , vomiting, marginal ulcer, small bowel obstruction, and metabolic sequelae (e.g., anemia, vitamin deficiencies) (Livingston, Surg Clin North Am 2005; 85(4): 853-868, vii; Podnos et al., Arch Surg 2003; 138(9): 957-961). The patient must be highly motivated and agree to the necessary postoperative requirements (e.g., diet, exercise, lifelong follow-up).

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