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1 MEDICAL POLICY Bariatric Surgery BCBSA Ref. Plicy: Effective Date: May 1, 2018 Last Revised: April Replaces: RELATED MEDICAL POLICIES: Vagal Nerve Blcking Therapy fr Treatment f Obesity Gastric Electrical Stimulatin Panniculectmy and Excisin f Redundant Skin Select a hyperlink belw t be directed t that sectin. POLICY CRITERIA DOCUMENTATION REQUIREMENTS CODING RELATED INFORMATION EVIDENCE REVIEW REFERENCES HISTORY Clicking this icn returns yu t the hyperlinks menu abve. Intrductin Bariatrics is the branch f medicine dealing with the causes and treatment f besity. Clinically severe besity (als knwn as mrbid besity) is when a persn is excessively verweight. Obesity itself is a health hazard as it impacts the heart, lungs, muscles, and bnes f the bdy. In additin, besity is a knwn risk factr t develp type 2 diabetes, heart disease and high bld pressure. Many individuals are able t lse weight by changing their diet and increasing their exercise. The challenge fr mst peple is keeping ff the weight they have lst. Fr sme peple surgery may be needed. Bariatric surgery is ften referred t as weight lss surgery r besity surgery. Surgical appraches t supprt lng-term weight lss have been develped ver the past 20 years. Fr sme individuals the surgery wrks very well, althugh even after surgery peple may need t significantly change their eating habits. Surgery is nt withut risk, hwever. There are several different types f weight lss surgery that are dne n the stmach, intestine r bth. They generally fall int tw main categries: surgeries that restrict the amunt f fd that may be eaten, and surgeries that restrict the bdy s ability t absrb calries and nutrients. Nt all plans cver besity surgery. When plans have a benefit fr besity surgery, then this plicy describes what infrmatin is needed by the health plan t determine if the surgery may be cvered. Nte: The Intrductin sectin is fr yur general knwledge and is nt t be taken as plicy cverage criteria. The rest f the plicy uses specific wrds and cncepts familiar t medical prfessinals. It is intended fr

2 prviders. A prvider can be a persn, such as a dctr, nurse, psychlgist, r dentist. A prvider als can be a place where medical care is given, like a hspital, clinic, r lab. This plicy infrms them abut when a service may be cvered. Plicy Cverage Criteria Indicatin Cntract limitatins Patient selectin criteria fr adults (Must meet all 3 criteria) Cverage Criteria Sme health plan cntracts d nt have benefits t cver surgical treatment f mrbid besity, cmplicatins, r after effects assciated with weight lss surgery. Refer t member cntract language fr benefit determinatin n weight lss surgery. Bariatric (weight lss) surgery in an adult may be cnsidered medically necessary when ALL f the fllwing criteria are met: A bdy mass index (BMI) greater than 40 kg/m 2 OR A BMI greater than 35 kg/m 2 with at least ONE f the fllwing cnditins: Established Crnary Heart Disease, such as: Histry f angina pectris (stable r unstable) Histry f angiplasty Histry f crnary artery surgery Histry f mycardial infarctin Other Athersclertic Disease, such as: Abdminal artic aneurysm Hypertensin that is uncntrlled r resistant t treatment (medically refractry) with a bld pressure (BP) greater than 140/90 despite ptimal medical management. Attempted medical management must have included at least 2 medicatins f different classes Peripheral arterial disease Symptmatic cartid artery disease Type 2 Diabetes uncntrlled by pharmactherapy Obstructive sleep apnea as dcumented by a sleep study Page 2 f 46

3 Indicatin Cverage Criteria (plysmngraphy) (see Related Plicies). AND Participatin in a physician administered weight reductin prgram lasting at least six cntinuus mnths within the tw year perid befre surgery is cnsidered. Evidence f active participatin dcumented in the medical recrd includes: Weight Current dietary prgram (MediFast, OptiFast) Physical activity (eg, exercise/wrk-ut prgram) OR Dcumentatin f participatin in a structured weight reductin prgram such as as Weight Watchers r Jenny Craig is an acceptable alternative if dne in cnjuctin with physician supervisin AND Psychlgical evaluatin and clearance by a licensed mental health prvider t rule ut psychlgical disrders, inability t prvide infrmed cnsent, r inability t cmply with pre- and pst-surgical requirements Nte: A physician s summary letter alne is nt sufficient dcumentatin. Patient selectin criteria fr adlescents less than 18 years f age Bariatric (weight lss) surgery in adlescents may be cnsidered medically necessary when ALL f the fllwing criteria are met: The health plan cntract allws bariatric surgery fr thse yunger than 18 years f age AND The adlescent meets the same patient selectin criteria as an adult AND The facility has experienced staff t supprt adlescents including psychscial and infrmed cnsent issues fr bariatric surgery Page 3 f 46

4 Indicatin Cvered bariatric (weight lss) surgeries Surgen and facility requirements Revisin bariatric surgery t crrect cmplicatins Cverage Criteria Refer t member cntract language fr benefit determinatin n treatment f besity fr adlescents. The fllwing bariatric (weight lss) surgery prcedures may be cnsidered medically necessary when criteria are met: Adjustable gastric banding laparscpic Bilipancreatic bypass (ie, the Scpinar prcedure) with dudenal switch pen r laparscpic Gastric bypass using a Rux-en-Y anastmsis pen r laparscpic Sleeve gastrectmy Bariatric (weight lss) surgery shuld be perfrmed: By a surgen with specialized training and experience in the bariatric surgery prcedure used AND In an institutin (facility r hspital) that includes a cmprehensive bariatric surgery prgram AND Any device used fr bariatric surgery must be FDA apprved fr that purpse and used accrding t the labeled indicatins Revisin bariatric (weight lss) surgery (such as replacement and/r remval f an adjustable gastric band, surgical repair r reversal, r cnversin t anther cvered bariatric surgical prcedure) may be cnsidered medically necessary t crrect cmplicatins frm the primary bariatric prcedure including, but nt limited t: Band ersin, slippage, leakage, herniatin r intractable nausea/vmiting that cannt be crrected with manipulatin r adjustment Hypglycemia r malnutritin related t nn-absrptin Obstructin Staple-line failure (eg, Gastrgastric fistula) Stricture Ulceratin Weight lss f 20% r mre belw ideal bdy weight Cverage fr bariatric surgery is available under the individual s Page 4 f 46

5 Indicatin Reperatin bariatric surgery fr inadequate weight lss Chlecystectmy Hiatal hernia repair Cverage Criteria current health benefit plan In the absence f a technical failure r majr cmplicatin, individuals with weight lss failure (nt described abve) must meet the initial medical necessity criteria fr bariatric surgery Rutine chlecystectmy (gallbladder remval) may be cnsidered medically necessary when perfrmed with bariatric surgery. Repair f a hiatal hernia during bariatric surgery may be cnsidered medically necessary fr a preperative diagnsis f hiatal hernia with clinical indicatins fr surgical repair. Rutine liver bipsy Bariatric surgery fr a BMI less than 35 kg/m 2 Bariatric surgery t treat cnditins ther than mrbid besity Nn-cvered bariatric surgeries/prcedures Repair f a hiatal hernia perfrmed at the time f bariatric surgery in the absence f preperative clinical indicatins fr surgical repairis cnsidered nt medically necessary Rutine liver bipsy during besity surgery is cnsidered nt medically necessary in the absence f preperative signs r symptms f liver disease.(eg, elevated liver enzymes, enlarged liver) Bariatric (weight lss) surgery is cnsidered nt medically necessary fr patients with a BMI less than 35 kg/m 2. Bariatric surgery is cnsidered investigatinal fr the treatment f any cnditin ther than mrbid besity, including, but nt limited t diabetes, gastresphageal reflux disease (GERD), r gastrparesis Vertical banded gastrplasty (stmach stapling) is cnsidered nt medically necessary as a treatment fr besity due t t many lng-term cmplicatins. The fllwing weight lss (bariatric) surgery prcedures are cnsidered investigatinal fr the treatment f mrbid besity: Bilipancreatic bypass withut dudenal switch Gastric bypass using a Billrth II type f anastmsis (minigastric bypass) Laparscpic gastric plicatin Page 5 f 46

6 Indicatin Cverage Criteria Lng-limb gastric bypass prcedure (ie, >150 cm) Single anastmsis dudenileal bypass with sleeve gastrectmy Tw-stage bariatric surgery prcedures (eg, sleeve gastrectmy as initial prcedure fllwed by bilipancreatic diversin at a later time) Vagus nerve blcking (eg, the VBLOC device r Maestr ) (See related medical plicy ) Endscpic prcedures as a primary bariatric prcedure r as a revisin prcedure including but nt limited t: Insertin f the StmaphyX device Insertin f a gastric balln (eg, Orbera ) Endscpic gastrplasty Use f an endscpically placed dudenal-jejunal sleeve Aspiratin therapy device (eg, AspireAssist ) Dcumentatin Requirements The medical recrds submitted fr review shuld dcument that medical necessity criteria are met. The recrd shuld include clinical dcumentatin f ALL THREE (3) criteria: 1. A bdy mass index (BMI) greater than 40 kg/m2, r BMI greater than 35 kg/m2 with at least ONE (1) f the fllwing cnditins: Established crnary heart disease Other athersclertic disease Type 2 diabetes uncntrlled by medicatins Obstructive sleep apnea as dcumented by a sleep study 2. Cmpletin f a physician administered weight-lss prgram that: Lasted fr at least six (6) mnths in a rw Tk place within tw (2) years befre the prpsed weight lss surgery Demnstrates in the medical recrd that the member actively tk part in the prgram, as well as include member s weight, the current dietary prgram (MediFast, OptiFast) and Page 6 f 46

7 Dcumentatin Requirements OR exercise/wrk-ut prgram. Dcuments participatin in a structured weight lss prgram such as Weight Watchers r Jenny Craig and that this prgram was supervised by the healthcare prvider 3. Psychlgical evaluatin and clearance by a licensed mental health prvider t rule ut psychlgical disrders, inability t prvide infrmed cnsent, r inability t cmply with presurgical and pstsurgical requirements. Nte: A letter by a healthcare prvider is nt enugh t meet these criteria. Cding Cde Descriptin CPT Laparscpy, surgical, gastric restrictive prcedure; with gastric bypass and Rux-en-Y gastrenterstmy (rux limb 150 cm r less) Laparscpy, surgical, gastric restrictive prcedure; with gastric bypass and small intestine recnstructin t limit absrptin Laparscpy, surgical, gastric restrictive prcedure; placement f adjustable gastric restrictive device (eg, gastric band and subcutaneus prt cmpnents) Laparscpy, surgical, gastric restrictive prcedure; revisin f adjustable gastric restrictive device cmpnent nly Laparscpy, surgical, gastric restrictive prcedure; remval f adjustable gastric restrictive device cmpnent nly Laparscpy, surgical, gastric restrictive prcedure; remval and replacement f adjustable gastric restrictive device cmpnent nly Laparscpy, surgical, gastric restrictive prcedure; remval f adjustable gastric restrictive device and subcutaneus prt cmpnents Laparscpy, surgical, gastric restrictive prcedure; lngitudinal gastrectmy (ie, sleeve gastrectmy) Gastric restrictive prcedure, withut gastric bypass, fr mrbid besity; vertical- Page 7 f 46

8 Cde Descriptin banded gastrplasty Gastric restrictive prcedure, withut gastric bypass, fr mrbid besity; ther than vertical-banded gastrplasty Gastric restrictive prcedure with partial gastrectmy, pylrus-preserving dudenilestmy and ileilestmy (50 t 100 cm cmmn channel) t limit absrptin (bilipancreatic diversin with dudenal switch) Gastric restrictive prcedure, with gastric bypass fr mrbid besity; with shrt limb (150 cm r less) Rux-en-Y gastrenterstmy Gastric restrictive prcedure, with gastric bypass fr mrbid besity; with small intestine recnstructin t limit absrptin Revisin, pen, f gastric restrictive prcedure fr mrbid besity, ther than adjustable gastric restrictive device (separate prcedure) Gastric restrictive prcedure, pen; revisin f subcutaneus prt cmpnent nly Gastric restrictive prcedure, pen; remval f subcutaneus prt cmpnent nly Gastric restrictive prcedure, pen; remval and replacement f subcutaneus prt cmpnent nly Nte: CPT cdes, descriptins and materials are cpyrighted by the American Medical Assciatin (AMA). HCPCS cdes, descriptins and materials are cpyrighted by Centers fr Medicare Services (CMS). Related Infrmatin Bdy Mass Index Calculatin Mrbid besity, als knwn as clinically severe besity, is measured using the bdy mass index (BMI). Severe besity is weight-based and is defined as a BMI greater than 40 kg/m 2 r a BMI greater than 35 kg/m 2 with besity-assciated health cnditins. BMI is calculated by dividing a patient s weight (in kilgrams) by height (in meters) squared. T cnvert punds t kilgrams, multiply punds by 0.45 T cnvert inches t meters, multiply inches by Click here fr BMI calculatin. Page 8 f 46

9 Evidence Review Descriptin Bariatric surgery is a treatment fr mrbid besity in patients wh fail t lse weight with cnservative measures. There are numerus surgical techniques available. While these techniques have different mechanisms f actin,the result is a smaller gastric puch that leads t restricted eating. Hwever, these surgeries may lead t malabsrptin f nutrients r eventually t metablic changes. Backgrund Bariatric surgery is perfrmed t treat mrbid (clinically severe) besity. Mrbid besity is defined as a bdy mass index (BMI) greater than 40 kg/m 2 r a BMI greater than 35 kg/m 2 with assciated cmplicatins including, but nt limited t, diabetes, hypertensin, r bstructive sleep apnea. Mrbid besity results in a very high risk fr weight-related cmplicatins, such as diabetes, hypertensin, bstructive sleep apnea, and varius types f cancers (fr men: cln, rectal, prstate; fr wmen: breast, uterine, varian), and a shrtened life span. A mrbidly bese man at age 20 can expect t live 13 fewer years than his cunterpart with a nrmal BMI, which equates t a 22% reductin in life expectancy. The first treatment f mrbid besity is dietary and lifestyle changes. Althugh this strategy may be effective in sme patients, nly a few mrbidly bese individuals can reduce and cntrl weight thrugh diet and exercise. Mst patients find it difficult t cmply with these lifestyle mdificatins n a lng-term basis. When cnservative measures fail, sme patients may cnsider surgical appraches. A 1991 Natinal Institutes f Health Cnsensus Cnference defined surgical candidates as thse patients with a BMI f greater than 40 kg/m 2, r greater than 35 kg/m 2 in cnjunctin with severe cmrbidities such as cardipulmnary cmplicatins r severe diabetes. 1 Reslutin (cure) r imprvement f type 2 diabetes (T2D) after bariatric surgery and bservatins that glycemic cntrl may imprve immediately after surgery, befre a significant amunt f weight is lst, have prmted interest in a surgical apprach t the treatment f T2D. Page 9 f 46

10 The varius surgical prcedures have different effects, and gastrintestinal rearrangement seems t cnfer additinal antidiabetic benefits independent f weight lss and calric restrictin. The precise mechanisms are nt clear, and multiple mechanisms may be invlved. Gastrintestinal peptides, eg, glucagn-like peptide-1 (1GLP-1), glucse-dependent insulintrpic peptide (GIP), and peptide YY (PYY), are secreted in respnse t cntact with unabsrbed nutrients and by vagally mediated parasympathetic neural mechanisms. GLP-1 is secreted by the L cells f the distal ileum in respnse t ingested nutrients and acts n pancreatic islets t augment glucse-dependent insulin secretin. It als slws gastric emptying, which delays digestin, blunts pstprandial glycemia, and acts n the central nervus system t induce satiety and decrease fd intake. Other effects may imprve insulin sensitivity. GIP acts n pancreatic beta cells t increase insulin secretin thrugh the same mechanisms as GLP-1, althugh it is less ptent. PYY is als secreted by the L cells f the distal intestine and increases satiety and delays gastric emptying. Types f Bariatric Surgery Prcedures The fllwing summarizes the mst cmmn types f bariatric surgery prcedures. Open Gastric Bypass The riginal gastric bypass surgeries were based n the bservatin that pstgastrectmy patients tended t lse weight. The current prcedure invlves bth a restrictive and a malabsrptive cmpnent, with hrizntal r vertical partitin f the stmach perfrmed in assciatin with a Rux-en-Y prcedure (ie, a gastrjejunal anastmsis). Thus, the flw f fd bypasses the dudenum and prximal small bwel. The prcedure may als be assciated with an unpleasant dumping syndrme, in which a large smtic lad delivered directly t the jejunum frm the stmach prduces abdminal pain and/r vmiting. The dumping syndrme may further reduce intake, particularly in sweets eaters. Surgical cmplicatins include leakage and perative margin ulceratin at the anastmtic site. Because the nrmal flw f fd is disrupted, there are mre metablic cmplicatins than with ther gastric restrictive prcedures, including irn deficiency anemia, vitamin B12 deficiency, and hypcalcemia, all f which can be crrected by ral supplementatin. Anther cncern is the ability t evaluate the blind bypassed prtin f the stmach. Gastric bypass may be perfrmed with either an pen r laparscpic technique. Page 10 f 46

11 Nte: In 2005, the CPT cde was revised t indicate that the shrt limb must be 150 cm r less, cmpared with the previus 100 cm. This change reflects the cmmn practice in which the alimentary (ie, jejunal limb) f a gastric bypass has been lengthened t 150 cm. This length als serves t distinguish a standard gastric bypass with a very lng, r very, very lng gastric bypass, as discussed further here. Laparscpic Gastric Bypass CPT cde was intrduced in 2005 and described the same prcedure as pen gastric bypass (CPT cde 43846), but perfrmed laparscpically. Adjustable Gastric Banding Adjustable gastric banding (CPT cde 43770) invlves placing a gastric band arund the exterir f the stmach. The band is attached t a reservir implanted subcutaneusly in the rectus sheath. Injecting the reservir with saline will alter the diameter f the gastric band; therefre, the rate-limiting stma in the stmach can be prgressively narrwed t induce greater weight lss, r expanded if cmplicatins develp. Because the stmach is nt entered, the surgery and any revisins, if necessary, are relatively simple. Cmplicatins include slippage f the external band r band ersin thrugh the gastric wall. Adjustable gastric banding has been widely used in Eurpe. Tw banding devices are apprved by the Fd and Drug Administratin (FDA) fr marketing in the United States. The first t receive FDA apprval was the LAP-BAND (riginal applicant, Allergan, BiEnterics, Carpinteria, CA; nw Apll Endsurgery, Austin, TX). The labeled indicatins fr this device are as fllws: "The LAP-BAND system is indicated fr use in weight reductin fr severely bese patients with a bdy mass index (BMI) f at least 40 r a BMI f at least 35 with ne r mre severe cmrbid cnditins, r thse wh are 100 lb r mre ver their estimated ideal weight accrding t the 1983 Metrplitan Life Insurance Tables (use the midpint fr medium frame). It is indicated fr use nly in severely bese adult patients wh have failed mre cnservative weight-reductin alternatives, such as supervised diet, exercise and behavir mdificatin prgrams. Patients wh elect t have this surgery must make the cmmitment t accept significant changes in their eating habits fr the rest f their lives." Page 11 f 46

12 In 2011, FDA-labelled indicatins fr the LAP-BAND were expanded t include patients with a BMI frm 30 t 34 kg/m 2 with at least 1 besity-related cmrbid cnditin. The secnd adjustable gastric banding device apprved by FDA thrugh the premarket apprval prcess is the REALIZE mdel (Ethicn End-Surgery, Cincinnati, OH). Labeled indicatins fr this device are: Th[e REALIZE] device is indicated fr weight reductin fr mrbidly bese patients and is indicated fr individuals with a Bdy Mass Index f at least 40 kg/m 2, r a BMI f at least 35 kg/m 2 with ne r mre cmrbid cnditins. The Band is indicated fr use nly in mrbidly bese adult patients wh have failed mre cnservative weight-reductin alternatives, such as supervised diet, exercise, and behavir mdificatin prgrams. Sleeve Gastrectmy A sleeve gastrectmy (CPT cde 43775) is an alternative apprach t gastrectmy that can be perfrmed n its wn r in cmbinatin with malabsrptive prcedures (mst cmmnly bilipancreatic diversin [BPD] with dudenal switch). In this prcedure, the greater curvature f the stmach is resected frm the angle f His t the distal antrum, resulting in a stmach remnant shaped like a tube r sleeve. The pylric sphincter is preserved, resulting in a mre physilgic transit f fd frm the stmach t the dudenum and aviding the dumping syndrme (verly rapid transprt f fd thrugh the stmach int intestines) seen with distal gastrectmy. This prcedure is relatively simple t perfrm and can be dne as an pen r laparscpic prcedure. Sme surgens have prpsed the sleeve gastrectmy as the first in a 2-stage prcedure fr very high risk patients. Weight lss fllwing sleeve gastrectmy may imprve a patient s verall medical status and, thus, reduce the risk f a subsequent mre extensive malabsrptive prcedure (eg, BPD). Bilipancreatic Bypass Diversin The BPD prcedure (als knwn as the Scpinar prcedure; CPT cde 43847) develped and used extensively in Italy, was designed t address drawbacks f the riginal intestinal bypass prcedures that have been abandned due t unacceptable metablic cmplicatins. Many cmplicatins were thught t be related t bacterial vergrwth and txin prductin in the blind, bypassed segment. In cntrast, BPD cnsists f a subttal gastrectmy and diversin f Page 12 f 46

13 the bilipancreatic juices int the distal ileum by a lng Rux-en-Y prcedure. The prcedure cnsists f the fllwing cmpnents: a. A distal gastrectmy induces a temprary early satiety and/r the dumping syndrme in the early pstperative perid, bth f which limit fd intake. b. A 200-cm lng alimentary tract cnsists f 200 cm f ileum cnnecting the stmach t a cmmn distal segment. c. A 300- t 400-cm biliary tract cnnects the dudenum, jejunum, and remaining ileum t the cmmn distal segment. d. A 50- t 100-cm cmmn tract is where fd frm the alimentary tract mixes with bilipancreatic juices frm the biliary tract. Fd digestin and absrptin, particularly f fats and starches, are therefre limited t this small segment f bwel, ie, creating selective malabsrptin. The length f the cmmn segment will influence the degree f malabsrptin. e. Because f the high incidence f chlelithiasis assciated with the prcedure, patients typically underg an assciated chlecystectmy. Many ptential metablic cmplicatins are related t BPD, including, mst prminently, irn deficiency anemia, prtein malnutritin, hypcalcemia, and bne demineralizatin. Prtein malnutritin may require treatment with ttal parenteral nutritin. In additin, several case reprts have nted liver failure resulting in death r liver transplant. BPD With Dudenal Switch CPT cde 43845, which specifically identifies the dudenal switch prcedure, was intrduced in The dudenal switch prcedure is a variant f the BPD previusly described. In this prcedure, instead f perfrming a distal gastrectmy, a sleeve gastrectmy is perfrmed alng the vertical axis f the stmach. This apprach preserves the pylrus and initial segment f the dudenum, which is then anastmsed t a segment f the ileum, similar t the BPD, t create the alimentary limb. Preservatin f the pylric sphincter is intended t amelirate the dumping syndrme and decrease the incidence f ulcers at the dudenileal anastmsis by prviding a mre physilgic transfer f stmach cntents t the dudenum. The sleeve gastrectmy als decreases the vlume f the stmach and decreases the parietal cell mass. Hwever, the basic Page 13 f 46

14 principle f the prcedure is similar t that f the BPD, ie, prducing selective malabsrptin by limiting the fd digestin and absrptin t a shrt cmmn ileal segment. Vertical-Banded Gastrplasty Vertical-banded gastrplasty (VBG; CPT cde 43842) was frmerly ne f the mst cmmn gastric restrictive prcedures perfrmed in the United States, but has nw been replaced by ther restrictive prcedures due t high rates f revisins and reperatins. In this prcedure, the stmach is segmented alng its vertical axis. In rder t create a durable reinfrced and rate-limiting stma at the distal end f the puch, a plug f the stmach is remved, and a prpylene cllar is placed thrugh this hle and then stapled t itself. Because the nrmal flw f fd is preserved, metablic cmplicatins are uncmmn. Cmplicatins include esphageal reflux, dilatin, r bstructin f the stma, with the latter 2 requiring reperatin. Dilatin f the stma is a cmmn reasn fr weight regain. VBG may be perfrmed using an pen r laparscpic apprach. Lng-Limb Gastric Bypass (ie, >150 cm) Variatins f gastric bypass prcedures have been described, cnsisting primarily f lng-limb Rux-en-Y prcedures (CPT cde 43847), which vary in the length f the alimentary and cmmn limbs. Fr example, the stmach may be divided with a lng segment f the jejunum (instead f ileum) anastmsed t the prximal gastric stump, creating the alimentary limb. The remaining pancreaticbiliary limb, cnsisting f stmach remnant, dudenum, and length f prximal jejunum, is then anastmsed t the ileum, creating a cmmn limb f variable length in which the ingested fd mixes with the pancreaticbiliary juices. While the lng alimentary limb permits absrptin f mst nutrients, the shrt cmmn limb primarily limits absrptin f fats. The stmach may be bypassed in a variety f ways (eg, resectin r stapling alng the hrizntal r vertical axis). Unlike the traditinal gastric bypass, which is a gastric restrictive prcedure, these very lng-limb Rux-en-Y gastric bypasses cmbine gastric restrictin with sme element f malabsrptive prcedure, depending n the lcatin f the anastmses. Nte that CPT cde fr gastric bypass (43846) explicitly describes a shrt limb (<150 cm) Rux-en-Y gastrenterstmy, and thus wuld nt apply t lng-limb gastric bypass. Page 14 f 46

15 Laparscpic Malabsrptive Prcedure CPT cde was intrduced in 2005 t specifically describe a laparscpic malabsrptive prcedure. Hwever, the cde des nt specifically describe any specific malabsrptive prcedure. Weight Lss Outcmes There is n unifrm standard fr reprting results f weight lss r fr describing a successful prcedure. Cmmn methds f reprting the amunt f bdy weight lss are percent f ideal bdy weight achieved r percent f excess bdy weight (EBW) lss, with the latter mst cmmnly reprted. EBW is defined as actual weight minus ideal weight and ideal weight is based n 1983 Metrplitan Life Insurance height-weight tables fr medium frame. These 2 reprting methds are generally preferred ver the abslute amunt f weight lss, because they reflect the ultimate gal f surgery: t reduce weight t a range that minimizes besity-related mrbidity. Obviusly, an increasing degree f besity will require a greater amunt f weight lss t achieve these target gals. There are different definitins f successful utcmes, but a successful prcedure is ften cnsidered ne in which at least 50% f EBW is lst, r when the patient returns t within 30% f ideal bdy weight. The results may als be expressed as the percentage f patients lsing at least 50% f EBW. Table 1 summarizes the variatins in reprting weight lss utcmes. Table 1. Weight Lss Outcmes Outcme Measure Definitin Clinical Significance Decrease in weight Abslute difference in weight pre- Unclear relatin t utcmes, and psttreatment especially in mrbidly bese Decrease in BMI Percent EBW lss Abslute difference in BMI pre- and psttreatment Amunt f weight lss divided by EBW May be clinically significant if change in BMI clearly leads t change in risk categry Has anchr t help frame clinical significance; unclear threshld fr clinical significance Percent patients lsing >50% f EBW Number patients lsing >50% EBW Additinal advantage f framing n Page 15 f 46

16 Outcme Measure Definitin Clinical Significance divided by ttal patients per patient basis. Threshld fr significance (>50%) arbitrary. Percent ideal bdy weight Final weight divided by ideal bdy weight Has anchr t help frame clinical significance; unclear threshld fr clinical significance BMI: bdy mass index; EBW: excess bdy weight. Durability f Weight Lss Weight change (ie, gain r lss) at yearly intervals is ften reprted. Weight lss at 1 year is cnsidered the minimum length f time fr evaluating these prcedures; weight lss at 3 t 5 years is cnsidered an intermediate time perid fr evaluating weight lss; and weight lss at 5 t 10 years r mre is cnsidered t represent lng-term weight lss fllwing bariatric surgery. Shrt-Term Cmplicatins (Operative and Periperative Cmplicatins <30 Days) In general, the incidence f perative and periperative cmplicatins is increased in bese patients, particularly in thrmbemblism and wund healing. Other periperative cmplicatins include anastmtic leaks, bleeding, bwel bstructin, and cardipulmnary cmplicatins (eg, pneumnia, mycardial infarctin). Reperatin Rate Reperatin may be required t either take dwn r revise the riginal prcedure. Reperatin may be particularly cmmn in VBG due t puch dilatin. Page 16 f 46

17 Lng-Term Cmplicatins (Metablic Adverse Events, Nutritinal Deficiencies) Metablic adverse events are f particular cncern in malabsrptive prcedures. Other lngterm cmplicatins include anastmtic ulcers, esphagitis, and prcedure-specific cmplicatins such as band ersin r migratin fr gastric-banding surgeries. Imprved Health Outcmes in Terms f Weight-Related Cmrbidities Aside frm psychscial cncerns, which may be cnsiderable, ne mtivatin fr bariatric surgery is t decrease the incidence f cmplicatins f besity, such as diabetes, cardivascular risk factrs (ie, increased chlesterl, hypertensin), bstructive sleep apnea, r arthritis. Unfrtunately, these final health utcmes are nt cnsistently reprted. Onging and Unpublished Clinical Trials Sme currently unpublished trials that might influence this review are listed in Table 2. Table 2. Summary f Key Trials NCT N. Trial Name Planned Cmpletin Enrllment Date Onging NCT Natinal Patient-Centered Clinical Research Netwrk 100,000 Jan 2018 (PCORnet) Bariatric Study NCT a NCT NCT a Weight Reductin by Aspiratin Therapy in Asian Patients with Mrbid Obesity Optimizatin and Fllw-Up f the Cnsecutive Use f Tw Intragastric Ballns in the Treatment f Obesity Pivtal Aspiratin Therapy with Adjusted Lifestyle Therapy Study 15 Dec Dec Jun 2019 Page 17 f 46

18 NCT N. Trial Name Planned Cmpletin Enrllment Date NCT Gastric Bypass Prcedure and AspireAssist Aspiratin Therapy 100 May 2020 System fr the Treatment f Mrbid Obesity, Observatinal Study ver 5 Years NCT NCT NCT Single Anastmsis Duden-Ileal Bypass with Sleeve Gastrectmy (SADI-S): a Prspective Chrt Study Laparscpic Rux-en-Y Gastric Bypass Versus Single Anastmsis Gastric Bypass (MGB vs LGBP) Laparscpic Single Anastmsis Dudenal-Jejunal Bypass with Sleeve Gastrectmy vs Laparscpic Dudenal Switch (DS vs SADI) 40 Jun Jun Apr 2026 NCT: natinal clinical trial. a Dentes industry-spnsred r cspnsred trial. Summary f Evidence Adults With Mrbid Obesity Fr individuals wh are adults with mrbid besity wh receive gastric bypass, the evidence includes randmized cntrlled trials (RCTs), bservatinal studies, and systematic reviews. Relevant utcmes are verall survival, change in disease status, functinal utcmes, health status measures, quality f life, and treatment-related mrtality and mrbidity. TEC Assessments and ther systematic reviews f RCTs and bservatinal studies fund that gastric bypass imprves health utcmes, including weight lss and remissin f type 2 diabetes (T2D). A TEC Assessment fund similar weight lss with pen and laparscpic gastric bypass. The evidence is sufficient t determine that the technlgy results in a meaningful imprvement in the net health utcme. Fr individuals wh are adults with mrbid besity wh receive laparscpic adjustable gastric banding (LAGB), the evidence includes RCTs, bservatinal studies, and systematic reviews. Relevant utcmes are verall survival, change in disease status, functinal utcmes, health status measures, quality f life, and treatment-related mrtality and mrbidity. Systematic reviews f RCTs and bservatinal studies have fund that LAGB is a reasnable alternative t gastric bypass. There is less weight lss with LAGB than with gastric bypass, but LAGB is less Page 18 f 46

19 invasive and is assciated with fewer serius adverse events. The evidence is sufficient t determine that the technlgy results in a meaningful imprvement in the net health utcme. Fr individuals wh are adults with mrbid besity wh receive sleeve gastrectmy (SG), the evidence includes RCTs, bservatinal studies (evaluating SG alne and cmparing SG with gastric bypass), as well as systematic reviews. Relevant utcmes are verall survival, change in disease status, functinal utcmes, health status measures, quality f life, and treatmentrelated mrtality and mrbidity. Systematic reviews f RCTs and bservatinal studies have fund that SG results in substantial weight lss and that this weight lss is durable fr at least 5 years. A meta-analysis fund that shrt-term weight lss was similar after SG cmpared with gastric bypass. Lng-term weight lss was greater after gastric bypass but SG is assciated with fewer AEs. The evidence is sufficient t determine that the technlgy results in a meaningful imprvement in the net health utcme. Fr individuals wh are adults with mrbid besity wh receive bilipancreatic diversin (BPD) with dudenal switch, the evidence includes nnrandmized cmparative studies, bservatinal studies and a systematic review. Relevant utcmes are verall survival, change in disease status, functinal utcmes, health status measures, quality f life, and treatment-related mrtality and mrbidity. Nn-randmized cmparative studies fund significantly higher weight lss after BPD with dudenal switch cmpared with gastric bypass at 1 year. A large case series fund sustained weight lss after 7 years. The evidence is sufficient t determine that the technlgy results in a meaningful imprvement in the net health utcme. Fr individuals wh are adults with mrbid besity wh receive BPD withut dudenal switch, the evidence includes bservatinal studies and systematic reviews. Relevant utcmes are verall survival, change in disease status, functinal utcmes, health status measures, quality f life, and treatment-related mrtality and mrbidity. A TEC Assessment reviewed the available bservatinal studies and cncluded that weight lss was similar after BPD withut dudenal switch r gastric bypass. Hwever, cncerns have been raised abut cmplicatins assciated with BPD withut dudenal switch, especially lng-term nutritinal and vitamin deficiencies. The evidence is insufficient t determine the effects f the technlgy n health utcmes. Fr individuals wh are adults with mrbid besity wh receive vertical-banded gastrplasty (VBG), the evidence includes bservatinal studies and systematic reviews. Relevant utcmes are verall survival, change in disease status, functinal utcmes, health status measures, quality f life, and treatment-related mrtality and mrbidity. A TEC Assessment identified 8 nnrandmized cmparative studies evaluating VBG and these studies fund that weight lss was significantly greater with pen gastric bypass. Mrever, VBG has relatively high rates f Page 19 f 46

20 cmplicatins, revisins, and reperatins. The evidence is insufficient t determine the effects f the technlgy n health utcmes. Fr individuals wh are adults with mrbid besity wh receive 2-stage bariatric surgery prcedures, the evidence includes a small RCT and bservatinal studies.. Relevant utcmes are verall survival, change in disease status, functinal utcmes, health status measures, quality f life, and treatment-related mrtality and mrbidity. There is a lack f evidence that 2- stage bariatric prcedures imprve utcmes cmpared with 1-stage prcedures. The small RCT cmpared IGB plus gastric bypass with the standard f care plus gastric bypass and did nt detect a difference in weight lss at 6 mnths pstsurgery. Case series have shwn relatively high cmplicatin rates in 2-stage prcedures, and patients are at risk f cmplicatins in bth stages. The evidence is insufficient t determine the effects f the technlgy n health utcmes. Fr individuals wh are adults with mrbid besity wh receive laparscpic gastric plicatin, the evidence includes 2 RCTS, bservatinal studies, and systematic reviews. Relevant utcmes are verall survival, change in disease status, functinal utcmes, health status measures, quality f life, and treatment-related mrtality and mrbidity. A 2014 systematic review identified nly a small nnrandmized cmparative study cmparing laparscpic gastric plicatin with SG.. Laparscpic gastric plicatin was mre effective than sham at 1-year fllwup and equally effective as SG at 2 year fllw-up. Additinal cmparative studies and especially RCTs with lnger fllw-up are needed t permit cnclusins abut the safety and efficacy f laparscpic gastric plicatin. The evidence is insufficient t determine the effects f the technlgy n health utcmes. Fr individuals wh are adults with mrbid besity wh receive single anastmsis dudenileal bypass with SG, the evidence includes bservatinal studies and systematic reviews. Relevant utcmes are verall survival, change in disease status, functinal utcmes, health status measures, quality f life, and treatment-related mrtality and mrbidity. N cntrlled trials were published evaluating single anastmsis dudenileal bypass with SG. There are a few case series, the largest f which had fewer than 100 patients. Cmparative studies and especially RCTs are needed t permit cnclusins abut the safety and efficacy f single anastmsis dudenileal bypass with SG. The evidence is insufficient t determine the effects f the technlgy n health utcmes. Fr individuals wh are adults with mrbid besity wh receive dudenjejunal sleeve, the evidence includes RCTs and systematic reviews. Relevant utcmes are verall survival, change in disease status, functinal utcmes, health status measures, quality f life, and treatment- Page 20 f 46

21 related mrtality and mrbidity. A systematic review f dudenjejunal sleeves included 5 RCTs and fund significantly greater shrt-term weight lss (12-24 weeks) with the sleeves cmpared with medical therapy. There was n significant difference in symptms assciated with diabetes. All RCTs were small and judged by systematic reviewers t be at high risk f bias. High-quality cmparative studies are needed t permit cnclusins n the safety and efficacy f the prcedure. The evidence is insufficient t determine the effects f the technlgy n health utcmes. Fr individuals wh are adults with mrbid besity wh receive intragastric balln (IGB) devices, the evidence includes RCTs, systematic reviews, and case series. Relevant utcmes are verall survival, change in disease status, functinal utcmes, health status measures, quality f life, and treatment-related mrtality and mrbidity. RCTs assessing the 2 IGB devices apprved by the Fd and Drug Administratin have fund significantly greater weight lss with IGB cmpared with sham treatment r lifestyle therapy alne after 6 mnths (maximum length f device use). Sme adverse events were reprted, mainly related t accmmdatin f the balln in the stmach; in a minrity f cases, these adverse events were severe. One RCT fllwed patients fr an additinal 6 mnths after IGB remval and fund sustained weight lss. There are limited data n the durability f weight lss in the lng term. Cmparative data are lacking. A large case series fund that patients gradually regained weight ver time. Mrever, it is unclear hw 6 mnths f IGB use wuld fit int a lng-term weight lss and maintenance interventin. The evidence is insufficient t determine the effects f the technlgy n health utcmes. Fr individuals wh are adults with mrbid besity wh receive an aspiratin therapy device, the evidence includes ne RCT and case series. Relevant utcmes are verall survival, change in disease status, functinal utcmes, health status measures, quality f life, and treatmentrelated mrtality and mrbidity. The RCT fund significantly greater weight lss with aspiratin therapy than lifestyle therapy at 1 year. One small case series reprted n 15 patients at 2 years. The ttal amunt f data n aspiratin therapy remains limited and additinal studies are needed befre cnclusins can be drawn abut the effects f treatment n weight lss, metablism and nutritin and lng-term durability f treatment. The evidence is insufficient t determine the effects f the technlgy n health utcmes. Page 21 f 46

22 Revisin Bariatric Surgery Fr individuals wh are adults with mrbid besity and failed bariatric surgery wh receive revisin bariatric surgery, the evidence includes case series and registry data. Relevant utcmes are verall survival, change in disease status, functinal utcmes, health status measures, quality f life, and treatment-related mrtality and mrbidity. Case series have shwn that patients receiving revisin bariatric surgery experienced satisfactry weight lss. Data frm a multinatinal bariatric surgery database has fund that crrective prcedures fllwing primary bariatric surgery are relatively uncmmn but generally safe and efficacius. The evidence is sufficient t determine that the technlgy results in a meaningful imprvement in the net health utcme. Adults With T2D Fr individuals wh are diabetic and nt mrbidly bese wh receive gastric bypass, sleeve gastrectmy, bilipancreatic diversin, r adjustable gastric banding, the evidence includes RCTs, nnrandmized cmparative studies, and case series. Relevant utcmes are verall survival, change in disease status, functinal utcmes, health status measures, quality f life, and treatment-related mrtality and mrbidity. Systematic reviews f RCTs and bservatinal studies have fund that certain types f bariatric surgery are mre efficacius than medical therapy as a treatment fr T2D in bese patients, including thse with a BMI between 30 and 34.9 kg/m 2. The greatest amunt f evidence is n gastric bypass. Systematic reviews have fund significantly greater remissin rates f diabetes, decrease in HbA1c levels, and decrease in BMI with bariatric surgery than with nnsurgical treatment. The efficacy f surgery is balanced against the shrt-term risks f the surgical prcedure. Mst RCTs in this ppulatin have 1 t 3 years f fllw-up; 1 RCT that included patients with BMI between 30 and 34.9 kg/m 2 had 5 year fllw-up data. The evidence is sufficient t determine that the technlgy results in a meaningful imprvement in the net health utcme. Nndiabetic and Nnbese Adults Fr individuals wh are nt diabetic and nt mrbidly bese wh receive any bariatric surgery prcedure, the evidence includes RCTs, nnrandmized cmparative studies, and case series. Relevant utcmes are verall survival, change in disease status, functinal utcmes, health Page 22 f 46

23 status measures, quality f life, and treatment-related mrtality and mrbidity. There is limited evidence fr bariatric surgery in patients wh are nt diabetic r mrbidly bese. A few small RCTs and case series have reprted lss f weight and imprvements in cmrbidities fr this ppulatin. Hwever, the evidence des nt permit cnclusins n the lng-term risk-benefit rati f bariatric surgery in this ppulatin. The evidence is insufficient t determine the effects f the technlgy n health utcmes. Hiatal Hernia Repair with Bariatric Surgery Fr individuals with mrbid besity and a preperative diagnsis f a hiatal hernia wh receive hiatal hernia repair with bariatric surgery, the evidence includes chrt studies and case series. Relevant utcmes are verall survival, change in disease status, functinal utcmes, health status measures, quality f life, and treatment-related mrtality and mrbidity. Results frm the chrt studies and case series have shwn that, when a preperative diagnsis f a hiatal hernia has been present, repairing the hiatal hernia during bariatric surgery resulted in fewer cmplicatins. Hwever, the results are limited t individuals with a preperative diagnsis. There was n evidence n the use f hiatal hernia repair when the hiatal hernia diagnsis is incidental. The evidence is sufficient t determine that the technlgy results in an imprvement in the net health utcme. Adlescent Children With Mrbid Obesity Gastric Bypass, LAGB, r SG Fr individuals wh are adlescent children with mrbid besity wh receive gastric bypass r LAGB, r SG, the evidence includes RCTs, bservatinal studies, and systematic reviews. Relevant utcmes are verall survival, change in disease status, functinal utcmes, health status measures, quality f life, and treatment-related mrtality and mrbidity. Systematic reviews f studies n bariatric surgery in adlescents, wh mainly received gastric bypass r LAGB, r SG fund significant weight lss and reductins in cmrbidity utcmes with bariatric surgery. Fr bariatric surgery in the adlescent ppulatin, althugh data are limited n sme prcedures, studies have generally reprted that weight lss and reductin in risk factrs fr adlescents is similar t that fr adults. Mst experts and clinical practice guidelines have recmmended that bariatric surgery in adlescents be reserved fr individuals with severe cmrbidities, r fr individuals with a BMI greater than 50 kg/m 2. In additin, greater cnsideratin shuld be Page 23 f 46

24 placed n the patient s develpmental stage, n the psychscial aspects f besity and surgery, and n ensuring that the patient can prvide fully infrmed cnsent. The evidence is sufficient t determine that the technlgy results in a meaningful imprvement in the net health utcme. Bariatric Surgery Other Than Gastric Bypass, LAGB, r SG Fr individuals wh are adlescent children with mrbid besity wh receive bariatric surgery ther than gastric bypass, r LAGB, r SG, the evidence includes systematic reviews and a chrt study. Relevant utcmes are verall survival, change in disease status, functinal utcmes, health status measures, quality f life, and treatment-related mrtality and mrbidity. Studies using bariatric surgery ther than gastric bypass, LAGB, r SG, have small sample sizes. Results frm a meta-analysis including patients using ther prcedures have shwn significant imprvements in BMI reductin, fasting bld insulin, and ttal chlesterl, althugh the estimates have wide cnfidence intervals, limiting interpretatin. The evidence is insufficient t determine the effects f the technlgy n health utcmes. Preadlescent Children With Mrbid Obesity Fr individuals wh are preadlescent children with mrbid besity wh receive bariatric surgery, the evidence includes n studies fcused n this ppulatin. Relevant utcmes are verall survival, change in disease status, functinal utcmes, health status measures, quality f life, and treatment-related mrtality and mrbidity. Several studies f bariatric surgery in adlescents have als included children yunger than 12 years ld, but findings were nt reprted separately fr preadlescent children. Mrever, clinical practice guidelines have recmmended against bariatric surgery fr preadlescent children. The evidence is insufficient t determine the effects f the technlgy n health utcmes. Clinical Input Frm Physician Specialty Scieties and Academic Medical Centers While the varius physician specialty scieties and academic medical centers may cllabrate with and make recmmendatins during this prcess, thrugh the prvisin f apprpriate Page 24 f 46

25 reviewers, input received des nt represent an endrsement r psitin statement by the physician specialty scieties r academic medical centers, unless therwise nted. In respnse t the requests, input was received frm 1 physician specialty sciety and 2 academic medical centers n the use f the REALIZE band while the plicy was under review in All 3 respnses supprted the use f the REALIZE band as a surgical ptin fr patients, as adpted int the plicy in In respnse t the requests, input was als received frm 2 academic medical centers n the use f the new endscpic placement f devices t remedy weight gain that ccurs after bariatric surgery while the plicy was under review in Input frm bth centers agreed that this apprach is cnsidered investigatinal, as adpted in the plicy in Practice Guidelines and Psitin Statements American Assciatin f Clinical Endcrinlgists et al In 2017, the American Assciatin f Clinical Endcrinlgists (AACE) and the American Cllege f Endcrinlgy (ACE) jintly published a cmprehensive diabetes type 2 management algrithm. 133 The dcument states: Bariatric surgery shuld be cnsidered fr adult patients with a BMI [bdy mass index] f 35 kg/m 2 r mre and cmrbidities, especially if therapeutic gals have nt been reached using ther mdalities. In 2016, AACE and ACE jintly published cmprehensive clinical practice guidelines n the medical care f patients with besity. 134 The guidelines addressed 9 brad clinical questins with 123 recmmendatins. The authrs nted that the 2013 guidelines specifically n bariatric surgery (see belw) were cnsidered adequate in the current frm. With regard t bariatric surgery fr these guidelines, the fllwing recmmendatins were added t thse in the 2013 guideline: Recmmendatin 35: Patients with besity (BMI 30 kg/m 2 ) and diabetes wh have failed t achieve targeted clinical utcmes fllwing treatment with lifestyle therapy and weightlss medicatins may be cnsidered fr bariatric surgery, preferably Rux-en-Y gastric bypass, sleeve gastrectmy, r bilipancreatic diversin. (Grade B; BEL1 [best evidence level], dwngraded due t evidence gaps) Page 25 f 46

26 Recmmendatin 121. Patients with a BMI f 35 kg/m 2 and 1 r mre severe besityrelated cmplicatins, including type 2 diabetes, hypertensin, bstructive sleep apnea, besity-hypventilatin syndrme, Pickwickian syndrme, nnalchlic fatty liver disease r nnalchlic steathepatitis, pseudtumr cerebri, gastresphageal reflux disease, asthma, venus stasis disease, severe urinary incntinence, debilitating arthritis, r cnsiderably impaired quality f life may als be cnsidered fr a bariatric surgery prcedure. Patients with BMI f 30 t 34.9 kg/m 2 with diabetes r metablic syndrme may als be cnsidered fr a bariatric prcedure, althugh current evidence is limited by the number f patients studied and lack f lng-term data demnstrating net benefit. BMI 35 kg/m 2 and therapeutic target f weight cntrl and imprved bichemical markers f CVD [cardivascular disease] risk (Grade A; BEL 1). BMI 30 kg/m 2 and therapeutic target f weight cntrl and imprved bichemical markers f CVD risk (Grade B; BEL 2). BMI 30 kg/m 2 and therapeutic target f glycemic cntrl in type 2 diabetes and imprved bichemical markers f CVD risk (Grade C; BEL 3). Recmmendatin 122. Independent f BMI criteria, there is insufficient evidence fr recmmending a bariatric surgical prcedure specifically fr glycemic cntrl alne, lipid lwering alne, r CVD risk reductin alne (Grade D). Recmmendatin 62: Rux-en-Y gastric bypass shuld be cnsidered as the bariatric surgery prcedure f chice fr patients with besity and mderate t severe gastresphageal reflux symptms, hiatal hernia, esphagitis, r Barrett s esphagus. (intermediate recmmendatin, intermediate evidence). Intragastric balln fr weight lss may increase gastresphageal reflux symptms and shuld nt be used fr weight lss in patients with established gastresphageal reflux (strng recmmendatin; strng evidence). Jint guidelines n supprt fr bariatric surgery patients were published by AACE, the Obesity Sciety, and American Sciety fr Metablic and Bariatric Surgery (ASMBS) in Recmmendatins n the fllwing questins are summarized belw. Which patients shuld be ffered bariatric surgery? Page 26 f 46