Evidence for Accreditation in Bariatric Surgery Hospitals John Morton, MD, MPH, FASMBS, FACS Chief, Bariatric and Minimally Invasive Surgery Stanford School of Medicine President,American Society for Metabolic & Bariatric Surgery Co-Chair, Committee on Metabolic and Bariatric Surgery, American College of Surgeons 2015 Annual NSQIP & MBSAQIP Meeting
Disclosures I have no relevant disclosures to Data Registry or Accreditation Process
Increased Need, Utilization and Safety of Bariatric Surgery 18 million patients qualify for bariatric surgery 1998-2008: Bariatric Procedures have increased nearly 10- fold with a corresponding decline in mortality (Nguyen JACS 2011) D e a t h s p e r 1, 0 0 0 4.5 4.0 3.5 3.0 2.5 2.0 1.5 1.0 0.5 0.0 4.0 Bariatric Surgery In-hospital Mortality by Year 2002-2009 (N = 105,287) 2.6 2.3 1.6 2002 2003 2004 2005 2006 2007 2008 2009 Year 1.5 1.0 0.8 0.6
ASMBS Bariatric Surgery Numbers Estimation 2011 2012 2013 2014 Total 158,000 173,000 179,000 193,000 RNY 36.7% 37.5% 34.2% 26.8% Band 35.4% 20.2% 14% 9.5% Sleeve 17.8% 33% 42.1% 51.7% BPD/DS 0.9% 1% 1% 0.4% Revisions 6% 6% 6% 11.5% Other 3.2% 2.3% 2.7% 0.1% Over-all increase of 22% 3 years Sleeve most common RevIsions increasing
Evidence Evaluating Framework Civil- Preponderance of the Evidence Cost Budget Neutrality Statute Gut What s best for the patient? Mother If your mom needed surgery, where would you send her?
Low Volume Hosp, Older Patient: 9% 30-day & 21% 1-Year mortality
Accreditation in Bariatric Surgery CMS National Coverage Determination February, 2006 CMS will approve and reimburse procedures at a program accredited by one of the two programs: 729 Hospitals ASBS/ Surgical Review Corporation. American College of Surgeons Bariatric Surgery Center Network. 7
What s Happened Since Accreditation Implemented?
Summary of Accreditation Literature PRO (8) (1) Morton, Ann Surg 2014 (2) Telem, SOARD 2014 (3) Nguyen, Surg Endo 2013 (4) Kwon, SOARD 2012 (5) Nguyen, JACS 2012 (6) Flum, Ann Surg 2011 (7) Nguyen, Arch Surg 2010 (8) Kohn, JACS 2010 CON (3) (1) Livingston, Arch Surg 2009 (2)Birkmeyer, JAMA 2010 (3) Dimick, JAMA 2013
Summary Support Data For Accreditation Flum et al. Ann Surg 2011: pre vs. post NCD. Nguyen et al. J Am Coll Surg 2012: UHC 2007-2009, 71 COEs (31,479) vs. 43 non-coes (3,805) Better outcome at accredited centers may be related to higher volume Jafari et al. Surg Endosc 2013: NIS 2006-2010. High volume (>50 stapling cases), COEs vs. non-coes. Accreditation status independent of volume
2012: COE vs non-coe UHC 2007-2009 71 COEs (31,479) vs. 43 non-coes (3,805) Nguyen et al. JACS 2012
0.6 In-hospital mortality, 2007-2009 In-hospital mortality (%) 0.5 0.4 0.3 0.2 0.1 0.06 0.21* 0.04 0.48* 0 Observed Mortality Risk-adjusted Accredited Non accredited *p<0.05, binomial regression
2011: Before vs After CMS Decision Nationwide Medicare data, 17,127 before vs 29,903 post 90-day mortality 1.5% pre vs 0.7% post (p<0.01) Decreased risk of death, complications & readmission Flum et al. Ann Surg 2011
Data Against Accreditation Livingston. Arch Surg 2009: 2005 NIS, 24 COEs (5,420) vs. 229 non-coes (19,363) Birkmeyer. JAMA 2010: 8 non-coes vs. 17 COEs, no sig diff in rates of serious complications COE definition: registry, volume, QI Dimick. JAMA 2013: 12 state database, outcomes before vs. after NCD for Medicare & non-medicare (control)
Pre vs. Post NCD: Serious Complications Differences in Differences Analysis Mortality? Failure to Rescue? Sentinel Events Dimick et al. JAMA 2013
Private Insurers Blue Cross Centers of Distinction Aetna Institutes of Quality United/Optum Centers of Excellence Cigna Bariatric Centers of Excellence
Does hospital accreditation impact bariatric surgery safety? John Morton 1, MD, MPH, FACS, FASMBS Trit Garg 1, BA Ninh T. Nguyen 2, MD, FACS, FASMBS 1 Stanford University 2 University of California, Irvine 134 th Annual Meeting of the American Surgical Association
Study Aim To determine if hospital accreditation for bariatric surgery improves outcomes?
Methods Data Source: Nationwide Inpatient Sample, the largest allpayer non-federal database in the United States Time-Frame: 2010-2011 Definitions: LRYGB (44.38), LAGB (44.95), and LSG (43.82, 43.89, and 44.68), with a confirmatory d(x) code for morbid obesity (278). Transfers, Age<18, Cancer Dx Excluded HVHs defined as 125 cases Accredited Centers Identified By Hospital Name/AHA Number and Cross-Referenced to ACS BSCN/ ASMBS SRC Relevant ICD9 diagnoses or procedure codes were used for identifying complications or failure to rescue (FTR) events as defined by the Agency for Healthcare Research and Quality (AHRQ) Patient Safety Indicators (PSI).
Results: Hospital Characteristics Unaccredited Accredited P value Hospitals, No. (%) 66 (45.5) 79 (54.5) Mean volume 279 265 0.909 High Volume Center, % 52.8 80.8 <0.0001 Teaching hospital, % 66.2 58.1 <0.0001
Results: Patient Characteristics Unaccredited Accredited P value Patients, No. (%) 12,366 (17.0) 60,249 (83.0) Procedure, % <0.0001 LRYGB 69.5 60.3 LAGB 15.6 25.7 LSG 14.8 14.0 Age, years 44.7 44.6 0.522 Age, >65 3.33 4.92 <0.0001 Female, % 78.8 78.3 0.186 Race - Caucasian 68.6 63.5 <0.0001
Results: Patient Characteristics Unaccredited Accredited P value Patients, No. (%) 12,366 (17.0) 60,249 (83.0) Insurance <0.0001 Private 70.3 68.8 Medicare 8.75 13.5 Medicaid 6.67 11.6 Self-pay 10.1 2.57 Other 4.20 3.59 Charlson comorbidity, % <0.0001 0 48.7 47.1 1 39.6 37.6 2 10.5 12.3 >=3 1.22 3.02
Results: Hospital Length of Stay Unaccredited Accredited P value Length of Stay (days) <0.0001 Mean 2.25 ± 11.0 1.99 ± 4.90 Median 2.00 2.00
Results: In-Hospital Outcomes Unaccredited Accredited P value Total charges (mean), $ Any complication, % 51,189 42,212 <0.0001 12.3 11.3 0.001 Mortality, % 0.13 0.07 0.019 FTR, % 0.97 0.55 0.046 Abbreviations: FTR, failure to rescue
Results: Postoperative Complications Unaccredited Accredited P value Blood transfusion 2.04 1.07 <0.0001 Abscess 0.51 0.21 <0.0001 Pulmonary embolism 0.08 0.04 0.087 Pneumonia 0.16 0.29 0.010 Other pulmonary 1.41 1.15 0.015 Wound 0.55 0.25 <0.0001 Spleen 0.29 0.06 <0.0001 Deep venous thrombosis 1.43 2.12 <0.0001 Genitourinary 1.11 1.08 0.755 Cardiac arrhythmia 2.91 3.79 <0.0001 Myocardial infarction 0.04 0.07 0.307 Stroke 0.00 0.02 0.146 GI leak 1.85 1.47 0.002 Re-operation 0.40 0.29 0.043 Other 6.47 4.73 <0.0001
Results: Logistic Regression In- Hospital Complication O.R. 95% CI P value Unaccredited 1.09 1.03-1.16 0.005 High volume center 0.82 0.77-0.86 <0.0001 Teaching hospital 1.32 1.26-1.39 <0.0001 Age >=50 1.59 1.52-1.67 <0.0001 Male 1.25 1.18-1.32 <0.0001 White 1.02 0.97-1.07 0.459 Private insurance 0.91 0.85-0.97 0.004 Medicare insurance 1.69 1.56-1.83 <0.0001 Charlson comorbidity 0 (reference) - 1 1.03 0.98-1.09 0.286 2 1.50 1.40-1.61 <0.0001 >=3 2.68 2.40-2.99 <0.0001
Results: Logistic Regression In- Hospital Mortality O.R. 95% CI P value Unaccredited 2.26 1.24-4.10 0.007 High volume center 0.82 0.44-1.52 0.524 Teaching hospital 1.58 0.86-2.89 0.140 Age >=50 0.61 0.33-1.11 0.106 Male 1.35 0.75-2.42 0.322 White 1.07 0.62-1.85 0.808 Private insurance 0.22 0.11-0.43 <0.0001 Medicare insurance 1.46 0.74-2.87 0.271 Charlson comorbidity 0 (reference) - 1 0.86 0.44-1.67 0.648 2 1.63 0.75-3.52 0.217 >=3 7.50 3.36-16.7 <0.0001
Summary In this study, utilizing population-based data incorporating all bariatric surgeries, accredited centers have: Decreased mortality (0.07 vs. 0.13%) Improved Failure to Rescue Rates (0.55 vs. 0.97%) Lessened Overall complications (11.3 vs. 12.3%) Lowered Resource Utilization (42,212 vs. 51,189)
Mechanisms for Improved Outcomes at Accredited Centers Experience in Recognition Multi-Disciplinary Team Resources Risk Assessment Established Processes-VTE, SSI Technical-Leaks, Splenectomy, Reoperation
Sun setting Quality? Surgical Evolution 1913- American College of Surgeons 1922- Committee on Fractures 1933- Commission on Cancer 1951- JCAHO 1964- Society for Thoracic Surgeons 1991-NSQIP 2006-Bariatric Surgery Center of Excellence
Implications for Accreditation Competing Hospital Resources Data collection through registry with risk-adjusted reports & implement best practices through multidisciplinary team Can t Manage What You Don t Measure Accreditation Focuses Attention
Serious Morbidity for morbidly obese patients undergoing other laparoscopic general surgery operations at AC vs. NAC 30 25 Accredited Nonaccredited Serious Morbidity (%) 20 15 10 * * 5 0 5.5 10.3 5.9 13.6 18.3 19.5 Antireflux Procedures Cholecystectomy Colectomy P<0.05 * Odds-ratio: 2.03; adjusted p-value: 0.0001 Odds-ratio: 2.36; Odds-ratio: 1.11; Courtesy N Nguyen MD
Accreditation Improves Access for Medicare beneficiaries Nguyen et al. Arch Surg 2010: 29% reduction within 2 quarters after NCD but returned to baseline within 1 year and exceeded baseline after 2 years. Flum et al. Ann Surg 2011: 17.8 procedure/100,000 pre NCD to 23.8 post NCD. Dimick et al. JAMA 2013: 249 Medicare pts./mo. pre NCD vs. 352 pts./mo. post NCD
ACS Quality Family (Years of Existence@2014) (1) (23) (8) (5) (81)
NEXT STEPS SURGEON ACCESS FOLLOW-UP QUALITY IMPROVEMENT
First National MBSAQIP Quality Improvement Project: Decreasing Readmissions through Opportunities Provided (D.R.O.P ) % patients readmitted w/in 30 days 8 to 2.5 % 69% Reduction
Evidence Evaluating Framework Civil- Preponderance of the Evidence Cost Budget Neutrality Statute Gut What s best for the patient? Mother If your mom needed surgery, where would you send her?
Conclusion With accreditation, improved outcomes exist for bariatric surgery patients and allows for data collection with enhanced quality improvement efforts
The ASMBS Textbook ESSENTIALS OF OBESITY MANAGEMENT APP
ASMBS 25 TaskForces/Committees 10 Taskforces Obesity Summit, Tipping Point (Motivational Video, Patient Portal, Obesity Week Oscars), Foundation Essentials of Bariatric Surgery, Bariatric Certification, China Compensation, Numbers, Revision, DROP 15 Committees Access to Care, Clinical Issues, Public Education, Communications Emerging Technology and Procedures, Insurance, Patient Safety, Bariatric Surgery Training Research, Program, State Chapters, Integrated Health Military Task Force, International Development, Pediatric Surgery
Ethnic minority Non-white Dimick JAMA 2013 12 States Database Nicholas JAMA 2013 8 States Database Medicare (pre vs. post NCD) 27.1% - 25.2% 27.5% - 25.9% -1.9-1.6 Non-Medicare (pre vs post NCD) 25.7% - 28.3% 26.2% - 29.1% +2.6 +2.9 Conclusion Rates of demographics were similar before and after NCD No Minority Access Issue A policy intended to improve pt. safety associated w/ unintended consequence of reduced use of BS by minority
Demographics Before NCD After NCD Mean no. institutions 60 45 Total No. of cases 3,196 3,068 Female gender (%) 2,638 (82.5) 2,500 (81.5) Age (%) <30 years 31-50 years 51-64 years >65 years Race (%) Caucasians African American Hispanic Nguyen et al. Arch Surg 2010 429 (13.4) 1,649 (51.6) 879 (27.5) 239 (7.5)* 2,161 (67.6)* 623 (19.5) 199 (6.2)* 418 (13.6) 1,531 (49.9) 826 (26.9) 293 (9.6) 1,942 (62.3) 643 (21.0) 255 (8.3)