Approval Criteria Checklist for Obesity Surgery* A reference guide of standard obesity surgery coverage criteria to assist you in selecting a benefit design plan that will meet your company’s needs Candidate Qualifications for Surgery Super Obese BMI ≥50 Extreme Obesity / Class III Obesity BMI ≥40 Obese/Class II Obesity BMI ≥35 – 39.9 with serious, co-morbid, medical conditions Hypertension Type II Diabetes Mellitus Dyslipidemia Musculoskeletal, neurological or body size problems precluding or severely impairing quality of life (employment, family function or ambulation) Life-threatening Cardiopulmonary Problems (sleep apnea, obesity-hypoventilations syndrome or obesity-related cardiomyopathy) Coronary Artery Disease Obesity-Related Cardiomyopathy Suggested Additional Candidate Qualifications for Surgery Documentation that other methods of weight loss have been tried unsuccessfully (e.g., changes in eating, behavior, increased physical activity and/or drug therapy) Documentation that performing daily routine activities (e.g., work-related & family functions) are not possible & quality of life is seriously impaired due to severity of obesity Documentation of a formal psychological evaluation demonstrating the patient is a sound candidate for bariatric surgery & is able to adhere to post surgical behavior management requirements Documentation of 3 continuous months of compliance with medically supervised, nonsurgical weight reduction methods by PCP or bariatric surgeon Documentation of a Pre-Surgery Evaluation: evaluations may vary based on patient needs & surgeon preference but should at least include the following: Medical (including clearance from primary care physician) Surgery (by bariatric surgeon) Cardiology (in selected patients to uncover potential heart disease & to determine treatment as necessary) Pulmonary (including a pulmonary function test & when indicated, a sleep apnea test) Psychological or psychiatric Endocrinology Nutrition Documentation of participation in a comprehensive Weight Management Program: Must attend & comply with all outlined activities & visits as established by the bariatric program. The Weight Management Program should Include, at Pre & Post Surgery, these components: ____ Nutrition Education ____ Personalized Exercise Program ____ Psychological Evaluation ____ Support Groups ____ Appropriate Diet Supplementation ____ Surgery Education ____ Surgeon & RN Visits ____ Comprehensive Lab Work-ups ____ Bariatric Program Coordinator ____ Behavior Management Program ____ Family & Social Support System DSL# 10-0179 ©2010 All rights reserved EREM027 *Compiled from multiple sources. See Reference List. Approval Criteria Checklist for Obesity Surgery* A reference guide of standard obesity surgery coverage criteria to assist you in selecting a benefit design plan that will meet your company’s needs Surgical Procedures Open or Laparoscopic Roux-en-Y (gastric bypass) STANDARD PROCEDURES LAGB (Laparoscopic Adjustable Gastric Band) VBG (Vertical Banded Gastroplasty) BPD (Biliopancreatic Diversion) LSG (Laparoscopic Sleeve Gastrectomy) INVESTIGATIONAL PROCEDURES Mini Gastric Bypass Gastric Balloon Provider Qualifications Recognized COE (Center of Excellence/Center of Distinction) facility and/or surgeon practice by either the Surgical Review Corporation (SRC), the American College of Surgeons (ACS), Medicare & Medicaid Services (CMS) or a Health Plan, such as Aetna, BCBS, CIGNA, UnitedHealthcare. Rural Area Exception – See “Clarification Points” Section Benefit Design Options Limit coverage to Centers of Excellence facilities & surgeons as defined by CMS (Medicare & Medicaid Services) the SRC, the ACS or health plan Provide different patient co-insurance levels based on selecting COE facility or nonCOE facility Consider employment tenure for bariatric surgery benefit to be accessed Tie surgical benefit & COE program requirements in with company sponsored wellness or obesity management programs Provide a Post-Surgery Incentive Strategy Some examples include: Set up criteria for post-surgery maintenance & program adherence. With achievement of “x number” of met criteria patient/employee may qualify for paid or partially paid postbariatric plastic surgery. Set up criteria for post surgery maintenance & program adherence. With achievement of “x number” of met criteria patient/employee may receive reimbursement dollars back into their HSA account. DSL# 10-0179 ©2010 All rights reserved EREM027 *Compiled from multiple sources. See Reference List. Approval Criteria Checklist for Obesity Surgery* A reference guide of standard obesity surgery coverage criteria to assist you in selecting a benefit design plan that will meet your company’s needs Clarification Points Other areas of discussion related to benefits design are listed below. However, there is not sufficient clinical documentation to make a recommendation. For each topic, a reference is included to assist with decision-making. Repeat Surgery To include revisions, repeat surgeries and conversion surgeries https://secure.preferredone.com/Shared/MedicalPolicy/MC_H003.pdf California Association of Health Plans Consensus Statement; or National Health Plan Medical Policies (cited below) A. Conversion to another surgical procedure – including all of the following 1-3: 1. Failure to respond to initial gastric bypass 2. Original surgery was at least 2 years prior to repeat procedure 3. Documentation that patient has been enrolled in & compliant with the previous postoperative program B. Revision of obesity surgery due to documented surgical complication from the primary procedure that has not responded to medical treatment – including, but not limited to, one of the following: 1. Obstruction 2. Stricture 3. Dilatation of gastric pouch (only if procedure was successful in inducing weight loss prior to pouch dilatation) 4. Stoma dilation or stenosis 5. Stoma ulcer 6. Malnutrition C. Take down (reversal) of obesity surgery (only if documented complication present) Note: All requests for repeat obesity surgery for staple line breakdown must be referred for physician review. Rural Area COE Exception It has been suggested that in rural areas where the volume requirements cannot be made that the facility must be COE provisional status level with the SRC or Level II status with the ACS. http://bbthor.bcbsnd.com/Bulletins/Blue_Cross_Blue_Shield_ND_Medical_Policy/Bariatric_Surgery.htm DSL# 10-0179 ©2010 All rights reserved EREM027 *Compiled from multiple sources. See Reference List. Approval Criteria Checklist for Obesity Surgery* A reference guide of standard obesity surgery coverage criteria to assist you in selecting a benefit design plan that will meet your company’s needs Clarification Points COE REQUIREMENTS COE standard requirements vary among credentialing bodies but all address: Surgical Volume & Training: Usually a minimum of 125 surgeries per year/facility Surgeon performed at least 125 total bariatric cases lifetime with at least 50 cases performed in the preceding 12-month period Processes in place for additional training & training of new surgeons brought into practice Medical Director: Physician Medical Director for bariatric surgery who participates in the relevant decision-making administrative meetings of the institution Trained Bariatric Staff & Program Extenders: Utilization of a designated nurse or physician extender who are dedicated to serving bariatric surgical patients & who are involved in the continuing education & care of bariatric patients Organized & supervised support groups for all patients who have undergone bariatric surgery at the institution Program dedicated to a long-term patient follow-up goal of at least 75% at five years for bariatric procedures with a monitoring & tracking system for outcomes Equipment: For the care of bariatric surgical patients including furniture, wheel chairs, operating room tables, beds, radiologic capabilities, surgical instruments & other facilities suitable for morbidly obese patients Care Pathways: Facilitate the standardization of perioperative care for the relevant procedure Data Collection: Collect & report outcomes for surgeon & facility DSL# 10-0179 ©2010 All rights reserved EREM027 *Compiled from multiple sources. See Reference List. Approval Criteria Checklist for Obesity Surgery* A reference guide of standard obesity surgery coverage criteria to assist you in selecting a benefit design plan that will meet your company’s needs References 1 Does Preoperative Weight Loss Predict Success with Laparoscopic Roux-en-Y Gastric Bypass. Bariatric Times, April 2007 2 Oregon Health Resources Commission MedTAP Report June 2007 3 Sjostrom L, et.al. Effects of Bariatric Surgery on Mortality in Swedish Obese Subjects. NEJM 357 (8) August 23, 2007 4 Adams TD, et al. Long Term Mortality after Gastric Bypass Surgery. NEJM 357 (8) August 23, 2007 5 Bray GA. The Missing Link – Lose Weight, Live Longer. NEJM 357 (8) August 23, 2007 6 http://www.lapsurgery.com/BARIATRIC%20SURGERY/ASBS.htm 7 CMS National Coverage Decision: http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=160 [online] 8 CMS Centers of Excellence List: www.cms.hhs.gov/center/coverage.asp [online] 9 National Institute of Health Consensus Statement on Bariatric Surgery: http:// consensus.nih.gov/1991/1991GISurgeryObesity084PDF.pdf [online] 10 http://www.anthem.com/medicalguidelines/va/f5/s10/t2/pw_037637.pdf [online] 11 https://www.unitedhealthcareonline.com/b2c/cmaIndexResult.do? channelId=016228193392b010VgnVCM100000c520720a____&htmlFilePath=/ccmcontent/ ProviderII/UHC/enUS/Assets/ProviderStaticFiles/ProviderStaticFilesHtml/MedicalPolicies/ Bariatric_Surgery.htm [online] 12 http://www.humana.com/providers/tools/provider_tools/clinical_healthcare.asp [online] 13 http://www.cigna.com/customer_care/healthcare_professional/coverage_positions/medical/ mm_0051_coveragepositioncriteria_bariatric_surgery.pdf [online] 14 http://www.aetna.com/cpb/medical/data/100_199/0157.html [online] 15 Bradley DW; Sharma C, Bal K. Centers of Excellence in Bariatric Surgery: Design, Implementation and One-Year Outcomes. Surgery for Obesity and Related Diseases, 2 (2006) 513-517 16 California Association of Health Plans: The Consensus Guidelines on Bariatric Surgery: CAHP Obesity Initiative Workgroup. June 2006 17 http://bbthor.bcbsnd.com/Bulletins/Blue_Cross_Blue_Shield_ND_Medical_Policy/ Bariatric_Surgery.htm [online] 18 https://secure.preferredone.com/Shared/MedicalPolicy/MC_H003.pdf [online] 19 https://secure.preferredone.com/Shared/MedicalPolicy/MC_H003.pdf [online] DSL# 10-0179 ©2010 All rights reserved EREM027 *Compiled from multiple sources. See Reference List.