1. The Case Against Bariatric Surgery Centers of Excellence Edward H. Livingston, MD, FACS, AGAF Professor and Chairman, Division of Gastrointestinal Surgery University of Texas Southwestern School of Medicine-Dallas Contributing Editor, JAMA

2. History Highly publicized bad outcomes Insurers pulled out of the market CMS MCAC 2004 ASMBS asks for CMS NCD 2005 –Offer COE requirement that they would administer through SRC

3. Were COEs necessary? Bariatric surgery mortality and morbidity steadily decreasing Associated with greater acceptance for these operations and referral of lower risk candidates There was no outcomes crises requiring regulation of bariatric surgery

4. Argument: Insurers will not cover bariatric surgery True but not because of bad outcomes Bad outcomes occurred but current COEs do not address these matters Reticence to cover bariatric results from inadequate data to support the use of bariatric surgery

5. Bariatric Surgery Evidence Cause weight loss: Level 1 Cause complications: Level 1 Improve comorbidities: Level 2 and below The greatest risk to bariatrics is the low quality of evidence to support its use. Few ongoing studies will overcome this limitation

6. Evidence VA/DOD Obesity treatment CPG http://www.healthquality.va.gov/Obesity_Cl inical_Practice_Guideline.asp

7. RecommendationSources of EvidenceQEOverall QualityR 1.Bariatric surgery (RYGB, AGB, & VBG) to promote substantial long- term (3 years) weight loss. ECRI, 2005 Maggard et al., 2005 Shekelle et al., 2004 IGoodA 2.Bariatric surgery (RYGB, AGB, & VBG) to improve or resolve comorbid conditions. ECRI, 2005IFair*B 3.Bariatric surgery (RYGB, AGB, & VBG) to improve quality of life.ECRI, 2005 Shekelle et al., 2004 IFair*B 4.Long-limb RYGB to promote weight loss.ECRI, 2005IFairB 5.Mortality from bariatric surgery (all procedures).Shekelle et al., 2004 ECRI, 2005 IGoodA 6.Adverse events from bariatric surgery (all procedures). **ECRI, 2005 Shekelle et al., 2004 IGoodA [SU1] [SU1] 7.RYGB promotes greater weight loss than VBG at three years.ECRI, 2005 Shekelle et al., 2004 IFairB 8.VBG promotes greater weight loss than ABG at one year.ECRI, 2005IFairB 9.Biliopancreatic Diversion and Duodenal Switch Procedures.ECRI, 2005 Shekelle et al., 2004 II-2FairI 10.Bariatric surgery in those over 65 years of age.ECRI, 2005 Shekelle et al., 2004 II-3FairI 11.Bariatric surgery for patients with BMI less than 40 kg/m 2.Shekelle et al., 2004IPoorI [SU2] [SU2] 12.Long-term (greater than 3 years) complications of bariatric surgery.Shekelle et al., 2004II-1PoorI 13.Preoperative weight loss.Expert OpinionIIIPoorI 14.Preoperative psychiatric assessment.Expert OpinionIIIPoorI 15.Bariatric surgery in patients with uncontrolled psychiatric disorders, substance abuse, severe cardiovascular disease, status post MI, wheelchair bound, or oxygen dependence. Expert OpinionIIIPoorI 16.Bariatric surgery to improve long-term (greater than 5 years) survival.Christou et al., 2004 Flum & Dellinger, 2004 II-2PoorI * Evidence quality was rated as fair, because few studies reported these outcomes consistently, and few studies were designed to examine the impact of surgery on these outcomes. **Adverse Events and need for reoperation. QE = Quality of Evidence; R = Recommendation (see Appendix A) [

8. Efficacy for Resolution of Diabetes Vetter M L et al. Ann Intern Med 2009;150:94-103 ©2009 by American College of Physicians

9. Why would insurance companies support COEs?

10. Insurance Company CEO Pay NameCompany1-Year ($mil)5-year ($mil) Ronald A WilliamsAetna38.1277.86 Joel F GemunderOmnicare12.5567.01 H Edward HanwayCigna10.27121.35 Stephen J HemsleyUnitedHealth Group5.03NA Angela F BralyWellPoint4.07NA Michael B McCallisterHumana2.3956.91 Jay M GellertHealth Net1.3437.69 Source http://www.forbes.com/lists/2009/12/best-boss-09_CEO-Compensation-Health-Care-Equipment-Services_9Rank.html

11. Why would insurance companies support COEs? Quality? Cost? How can they best limit bariatric surgery? –Not cover it at all Works for some but they are selling insurance products in a competitive market –Make it difficult to attain Arbitrary requirements (pre op weight loss) –Get surgeon buy in to make it difficult COE

12. What is the evidence that COEs are effective?

13. Conclusions do not follow data Stats incorrect, erroneous conclusion based on p-value

16. Could we have concluded that the cost of care was greater in COEs?

19. Conclusion COEs were not necessary COE standards are not evidence based COEs are very expensive COEs are harming general surgery practice COE outcomes are no better than non COEs