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-DallasContributing Editor, JAMA

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

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

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

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

Evidence

• VA/DOD Obesity treatment CPG

• http://www.healthquality.va.gov/Obesity_Clinical_Practice_Guideline.asp

Recommendation Sources of Evidence QE Overall Quality R

1. Bariatric surgery (RYGB, AGB, & VBG) to promote substantial long-term (3 years) weight loss.

ECRI, 2005Maggard et al., 2005Shekelle et al., 2004

I Good A

2. Bariatric surgery (RYGB, AGB, & VBG) to improve or resolve comorbid conditions.

ECRI, 2005 I Fair* B

3. Bariatric surgery (RYGB, AGB, & VBG) to improve quality of life. ECRI, 2005Shekelle et al., 2004

I Fair* B

4. Long-limb RYGB to promote weight loss. ECRI, 2005 I Fair B

5. Mortality from bariatric surgery (all procedures). Shekelle et al., 2004ECRI, 2005

I Good A

6. Adverse events from bariatric surgery (all procedures). ** ECRI, 2005Shekelle et al., 2004

I Good A[SU1] 

7. RYGB promotes greater weight loss than VBG at three years. ECRI, 2005Shekelle et al., 2004

I Fair B

8. VBG promotes greater weight loss than ABG at one year. ECRI, 2005 I Fair B

9. Biliopancreatic Diversion and Duodenal Switch Procedures. ECRI, 2005Shekelle et al., 2004

II-2 Fair I

10. Bariatric surgery in those over 65 years of age. ECRI, 2005Shekelle et al., 2004

II-3 Fair I

11. Bariatric surgery for patients with BMI less than 40 kg/m2. Shekelle et al., 2004 I Poor I[SU2] 

12. Long-term (greater than 3 years) complications of bariatric surgery. Shekelle et al., 2004 II-1 Poor I

13. Preoperative weight loss. Expert Opinion III Poor I

14. Preoperative psychiatric assessment. Expert Opinion III Poor I

15. Bariatric surgery in patients with uncontrolled psychiatric disorders, substance abuse, severe cardiovascular disease, status post MI, wheelchair bound, or oxygen dependence.

Expert Opinion III Poor I

16. Bariatric surgery to improve long-term (greater than 5 years) survival. Christou et al., 2004Flum & Dellinger, 2004

II-2 Poor I

* 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)

Efficacy for Resolution of Diabetes

Vetter M L et al. Ann Intern Med 2009;150:94-103

©2009 by American College of Physicians

Why would insurance companies support COEs?

Insurance Company CEO Pay

Name Company 1-Year ($mil) 5-year ($mil)

Ronald A Williams Aetna 38.12 77.86

Joel F Gemunder Omnicare 12.55 67.01

H Edward Hanway Cigna 10.27 121.35

Stephen J Hemsley UnitedHealth Group 5.03 NA

Angela F Braly WellPoint 4.07 NA

Michael B McCallister Humana 2.39 56.91

Jay M Gellert Health Net 1.34 37.69

Source http://www.forbes.com/lists/2009/12/best-boss-09_CEO-Compensation-Health-Care-Equipment-Services_9Rank.html

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

What is the evidence that COEs are effective?

Conclusions do not follow data

Stats incorrect, erroneous conclusion based on p-value

Could we have concluded that the cost of care was greater in

COEs?

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