White Paper: Treating Clinical Obesity: When is Bariatric Surgery or Bariatric Surgery Revision Medically Necessary?

Transcription

1 White Paper: Treating Clinical Obesity: When is Bariatric Surgery or Bariatric Surgery Revision Medically Necessary? For Health Plans, Medical Management Organizations and TPAs Introduction More than one third of adults in the United States are obese. Obesity is the precursor for many other conditions and diseases that affect essentially every organ system. Being overweight or obese puts individuals at higher risk of morbidity from hypertension, dyslipidemia, type 2 diabetes, coronary heart disease, stroke, gallbladder disease, osteoarthritis, sleep apnea, and respiratory problems, as well as endometrial, breast, prostate, and colon cancers. Higher body weights are also associated with increases in all-cause mortality, and obese individuals may also suffer from social stigmatization and discrimination. Studies have shown that obesity-related diseases dramatically resolve or improve after bariatric surgery. The number of bariatric operations performed each year in the United States has been steadily increasing in recent years and continues to rise. This trend results from a handful of factors: the obesity epidemic, the recognition of obesity as a health hazard, the poor results with nonsurgical methods, the reproducible good results with surgical techniques, and the introduction of laparoscopic techniques. Approaches to Bariatric Surgery There are several different approaches to bariatric surgery. Restrictive procedures limit the amount of food intake by reducing the size of the stomach, while malabsorptive procedures limit the absorption of food in the intestinal tract by bypassing a portion of the small intestine to varying degrees. Some procedures combine restrictive and malabsorptive techniques. Bariatric surgery may result in hormonal or metabolic changes, as well as impact insulin resistance and diabetes, regardless of whether weight loss changes are occurring. Laparoscopic Adjustable Gastric Banding (LAGB) In LAGB, which is a restrictive procedure, an adjustable silicone band is laparoscopically placed around the upper part of the stomach to create a restrictive pouch. The band is connected to a subcutaneous port, through which saline can be injected or removed to tighten or loosen, respectively, the silicone band. Altering the amount of!uid in the band changes the band circumference and, thus, the outlet diameter. This procedure can be reversed if necessary. Vertical Sleeve Gastrectomy The number of bariatric operations performed each year in the United States has been steadily increasing in recent years and continues to rise. Vertical sleeve gastrectomy is a restrictive procedure, which involves stapling and dividing the stomach vertically and removing about 85% of it. The remaining stomach is shaped into a tube or sleeve, measuring from 1 to 5 ounces. This procedure can be performed as a "rst-stage operation prior to a gastric bypass or as a stand-alone procedure. AllMed Healthcare Management Inc. 1

2 Vertical Banded Gastroplasty This restrictive procedure involves creating a small (30 to 50 ml), vertically oriented pouch with a narrow gastric outlet. The pouch is created by stapling the front wall of the stomach to the back below the gastroesophageal junction. The distal end of the newly created pouch is constricted with either a 1 cm diameter polypropylene band or a 1 cm silastic ring. Gastric Bypass With Roux-en-Y Anastomosis (RYGB) RYGB, which is also known as proximal or short limb gastric bypass, can be an open or laparoscopic procedure. It involves both restrictive and malabsorptive components. A small gastric pouch is created from the upper part of the stomach by segmentation or resection to restrict the amount of food that can be ingested. The mid-portion of the jejunum is divided, and the cut end of the distal limb ( 150 cm) is attached to the gastric pouch outlet (Roux limb). The cut end of the proximal limb (the limb consisting of the duodenum and proximal jejunum) is attached to the side of the Roux limb (the limb connected to the pouch). This creates the Y con"guration of the small intestine, allowing food to bypass the duodenum and proximal jejunum, resulting in malabsorption. Biliopancreatic Diversion (Bypass) Procedure This procedure, which is also known as the Scopinaro procedure, also involves both restrictive and malabsorptive components. Subtotal (distal) gastrectomy creates a small gastric pouch at the top of the stomach to limit food intake. A long limb Roux-en-Y anastomosis (>150 cm) results in the biliopancreatic juices being diverted into the distal ileum, signi"cantly increasing malabsorption. The biliopancreatic diversion is designed to preferentially inhibit the absorption of fat, and is only partially reversible. Biliopancreatic Diversion (Bypass) With Duodenal Switch (BPD-DS) The BPD-DS is an adaptation of the standard biliopancreatic bypass. The restrictive component involves subtotal gastrectomy, resulting in a tube or sleeve-like stomach remnant that leaves the pyloric valve and the initial segment of duodenum intact. The long limb Roux-en-Y anastomosis (>150 cm) provides malabsorption in this variant as well, but the distal ileum is connected to the duodenal segment leading from the stomach sleeve, instead of the stomach pouch itself. Bariatric Surgery Revision Procedures Select patients who experience weight gain or inadequate weight loss following bariatric surgery may undergo revision procedures. Potential options for bariatric surgery revision include re-sleeve after sleeve gastrectomy, conversion to RYGB, and conversion to LAGB. In addition, patients who regain weight following RYBG may be candidates for StomaphyX revision, which is an endoscopic revision technique used to tighten a stretched gastric pouch using internal sutures or fasteners. Identifying Candidates for Bariatric Surgery and Revision The criteria for patient selection for bariatric surgery are relatively uniform among various authors and correspond to criteria recommended by the American Society for Metabolic and Bariatric Surgery (ASMBS) and the National Institutes of Health (NIH) National Heart, Lung, and Blood Institute (NHLBI). These criteria include: body mass index (BMI) 40 kg/ m2, or 35 kg/m2 with signi"cant high-risk comorbid disease (e.g., sleep apnea, type 2 diabetes); and documented failure of nonsurgical weight-loss programs, such as dieting, exercise, psychotherapy, and drug treatments. Additional ASMBS and NHLBI criteria for patients who are candidates for bariatric surgery include: acceptable operative risk; psychologically stable with realistic expectations; well-informed and motivated patient; supportive family/social environment; absence of uncontrolled psychotic or depressive disorder; and no active alcohol or substance abuse. 2

3 According to the NHLBI, weight loss therapy is not appropriate for most pregnant or lactating women, persons with uncontrolled psychiatric illness (such as major depression), and patients who have a variety of serious illnesses and for whom caloric restriction might exacerbate the illness. Patients with active substance abuse and those with a history of anorexia or bulimia should be referred for specialized care. When evaluating patients for bariatric surgery revision, a thorough nutritional and anatomic evaluation is needed to understand the causes of weight loss failure. It is also important to differentiate between patients who have not lost weight with bariatric surgery and patients who regained weight after signi"cant excess weight loss. In some cases, it may be useful to perform upper endoscopy and upper gastrointestinal contrast studies to evaluate anatomy and cause of weight gain after bariatric surgery Potential Complications of Bariatric Surgery and Revision A potential early complication of bariatric surgery is anastomotic stricture. As the anastomosis heals, it forms scar tissue, which contracts over time to create a stricture. The passage of food will usually keep it stretched open. If in!ammation and healing outpace stretching, scarring may make the opening so small that even liquids can no longer pass through. Most strictures result from ischemia at the anastomosis due to tension on the Roux limb, or are associated with a marginal ulcer. Longer-term complications can include marginal ulcers and nutritional de"ciencies. Marginal ulcers occur at the gastrojejunal anastomosis, usually on the jejunal side. Possible causes include: tension or ischemia on the anastomosis; foreign material (staples or nonabsorbable sutures); nonsteroidal anti-in!ammatory drug (NSAID) use; excessive acid exposure in the gastric pouch due to gastrogastric "stula; and smoking. Bypassing the stomach and duodenum can cause iron, vitamin B12, and other micronutrient de"ciencies. Calcium absorption in the duodenum and jejunum and vitamin D absorption in the jejunum and ileum can also become impaired. Potential risks of bariatric surgery revision include gastrointestinal leakage, higher conversion rate to open surgery, infection, longer hospital stays, and failure to resolve the original issue. Professional Society Guidelines and Recommendations The American Association of Clinical Endocrinologists (AACE) Task Force on Obesity reported that there is signi"cant clinical evidence to declare obesity as a disease state. Bariatric surgery is indicated for certain high-risk patients having clinically severe obesity. The comorbidities of severe obesity affect all the major organ systems of the body. The AACE Task Force states that surgically induced weight loss will substantially improve or reverse the vast majority of adverse effects from severe obesity. According to the American Diabetes Association (ADA), bariatric surgery may be considered for adults with BMI >35 kg/ m2 and type 2 diabetes, especially if the diabetes or associated comorbidities are difficult to control with lifestyle and pharmacologic therapy. For patients with type 2 diabetes who have undergone bariatric surgery, the ADA emphasizes the need for lifelong lifestyle support and annual medical monitoring, at a minimum. Although small trials have shown a glycemic bene"t of bariatric surgery in patients with type 2 diabetes and BMI 30 to 35 kg/m2, there is currently insuf- "cient evidence to generally recommend surgery in patients with BMI 35 kg/m2. Guidelines developed by the NIH state that gastrointestinal surgery (gastric restriction [vertical gastric banding] or gastric bypass [Roux-en Y]) can result in substantial weight loss, and therefore is an available weight loss option for well-informed and motivated patients with a BMI 40 kg/m2, or 35 kg/m2 with comorbid conditions and acceptable operative risks. The NIH guidelines also state that compared to other interventions available, surgery has produced the longest period of sustained weight loss. Determining Medical Necessity for Bariatric Surgery and Revision Insurance companies often base coverage decisions on criteria adapted from clinical guidelines developed by the NHLBI in These guidelines state that obesity surgery should be reserved only for carefully selected patients who have "rst attempted medical (nonsurgical) therapies and failed, and are suffering from the complications of extreme obesity. Most health plans do not cover endoscopic procedures such as StomaphyX revision surgery. 3

4 Sample Plan Language Bariatric surgery is considered medically necessary for treatment of clinical severe obesity for selected adults (18 years and older) who meet ALL of the following criteria: BMI 40 kg/m2, or BMI kg/m2 with medical comorbidities; Documentation of a motivated attempt of weight loss through a structured diet program prior to bariatric surgery, which includes physician or other healthcare provider notes and/or diet or weight loss logs from a structured weight loss program for a minimum of 6 months; and Psychological evaluation to rule out major mental health disorders that would contraindicate surgery and determine patient compliance with postoperative follow-up care and dietary guidelines. Repeat surgical procedures for revision or conversion to another surgical procedure for inadequate weight loss (i.e., unrelated to a surgical complication of a prior procedure) are considered medically necessary when all of the following criteria are met: The individual continues to meet ALL the medical necessity criteria for bariatric surgery; There is documentation of compliance with the previous prescribed postoperative dietary and exercise program; and Two years following the original surgery, weight loss <50% of preoperative excess body weight and weight remains at least 30% over ideal body weight (taken from standard tables for adult weight ranges). Independent medical reviews determine medical necessity based on medical policy and published clinical criteria. These high-quality, defensible determinations not only control overutilization of procedures and therapies, but also facilitate safe and effective treatment of patients. Medical necessity must be supported by thorough clinical documentation of BMI, motivated attempts at weight loss using a structured program, and any previous medical treatment. Effective care for patients who are clinically obese requires an in-depth understanding of continually evolving bariatric procedures and weight loss treatments. Independent reviews are designed to meet a variety of needs, including pre-authorizations, internal and external appeals, state and federal appeals, concurrent review of in-patient stay and provider quality of care, and fraud reviews. As an independent review organization (IRO), AllMed provides access to more than 400 peer review specialists covering more than 80 American Board of Medical Specialties (ABMS) specialties and subspecialties. These specialists are on the cutting edge of the latest medical research and standards of care. Working with an IRO like AllMed allows faster turnaround time for determinations and removes bias from the review process by eliminating con!icts of interest, which can relate to economics, lack of specialists to review cases, or having the same doctor who denied a case review an appeal. Conclusions The incidence of obesity continues to increase in the United States, along with other related health problems, placing an enormous strain on the healthcare system. Patients who do not lose weight with traditional weight management approaches may turn to bariatric surgery procedures, such as gastric bypass and LAGB. Although bariatric surgery can effectively treat obesity by helping patients achieve substantial, sustained weight loss, many health plans cover these procedures only when individuals meet very speci"c criteria and have well-documented failure of medical management. 4

5 Bibliography 1. American Diabetes Association. Obesity management for the treatment of type 2 diabetes. Diabetes Care. 2016;39:S47-S American Society for Metabolic and Bariatric Surgery. Rationale for the Surgical Treatment of Morbid Obesity Mechanick JI, et al. American Association of Clinical Endocrinologists position statement on obesity and obesity medicine. Endocr Pract. 2012;18: National Heart, Lung, and Blood Institute Obesity Education Initiative. The Practical Guide. Identi"cation, Evaluation, and Treatment of Overweight and Obesity in Adults. NIH Publication No October National Heart, Lung, and Blood Institute Obesity Education Initiative Expert Panel on the Identi"cation, Evaluation, and Treatment of Overweight and Obesity in Adults. Clinical Guidelines on the Identi"cation, Evaluation, and Treatment of Overweight and Obesity in Adults: The Evidence Report. NIH Publication No September Ogden CL, et al. Prevalence of obesity in the United States, NCHS Data Brief. No. 82. January Steinbrook R. Surgery for severe obesity. N Engl J Med. 2004;350: About AllMed AllMed Healthcare Management provides physician review outsourcing solutions to leading health plans, medical management organizations, TPAs and integrated health systems, nationwide. AllMed offers MedReview (SM), MedCert (SM), and Medical Director staffing services that cover initial pre-authorizations and both internal and external appeals, drawing on a panel of over 400 board-certi"ed specialists in all areas of medicine. Services are deployed through PeerPoint, AllMed s state-of-the-art medical review portal. For more information on how AllMed can help your organization improve the quality and integrity of healthcare, contact us today at info@allmedmd.com or visit us at 621 SW Alder St., Suite 740 Portland, OR