ASMBS Update Fall 2011Robin Blackstone, MD, FACS, FASMBSPresident, ASMBS

Mechanism of Action of SurgerySafety and Efficacy of SurgeryAccess to CareMedicalization of Obesity

ASMBS Focus 2011/2012Building a Bridge to the future

Mechanism of Action of SurgerySafety and Efficacy of SurgeryAccess to CareMedicalization of Obesity

ASMBS Focus 2011/2012Building a Bridge to the future

Current Coverage Landscape Federal: Covered by Medicare States: covered as a standard benefit in 43/50 State employees

and 47/50 State Medicaid Plans Employer Coverage:

40% of plans <500 employees Small employers coverage is growing at 8% per year This is the group targeted by EHB 76% of plans with 20,000 or more employees

Mandated Coverage: New Hampshire, Indiana, Maryland Georgia and Virginia – employers have to be offered the ability to buy

coverage State Rule regarding medical necessity and HMO regulation also

require coverage: Michigan, New York, California

0%

10%

20%

30%

40%

50%

60%

70%

80%

2006

2007

2008

2009

2010

Between 2006 and 2010, bariatric surgery coverage expanded both among small as well as large employers.

Bariatric Surgery Coverage by Number of EmployeesMercer National Survey of Employer-sponsored Health Plans

Rapid Response Team of the Access Committee

Figure 3. Annual rate of bariatric surgery per 100,000 adults, 1990 to 2008. Data from1990 to 1997 was derived from Pope and colleagues7; data from 1998 to 2002 wasderived from Nguyen and colleagues Inpatient sample 2008 124,000 in-patient cases

Figure 2. Number of bariatric surgeons with membership in the American Society for Metabolic and Bariatric Surgery (ASMBS), 1998 to 2008.

Endoscopic Therapies and FDA: Read the report on the ASMBS website

Need to prepare surgeons to participate in endoscopic therapies and new devices and procedures

ASMBS Position Statements have clout – Clinical Issues CommitteeStacy Brethaur, Chair HCSC: BCBS of Illinois, Texas, New Mexico and Oklahoma ASMBS Position Statement on Preoperative weight loss

mailed to all medical directors in the United States Decision to Change Medical Policy for this requirement (last

week) Will not have an immediate effect on the Self Funded

employer plans but eventually medical policy should align it Data has a profound impact on medical policy

Patients should have access to obesity treatment through the essential health benefit

Recent all for Public Comment to HHS:Blackstone at HHS in Washington DCEvery major city surgeons and patients partnered to testify (Obesity Action Coalition)We have a presence on the hill every month visiting key people

ASMBS is the source of credible information on metabolic treatment of obesity Keavin Revis, Chair, Communication Committee

New and improved website Keith Kim, Chair Public Education Committee

Drive patients to our website for information and linkages to

Summary – Access to Care Continue effort to expand coverage to employers with 10-

499 employees through essential health benefit and expanded coverage among employers – John Morton, Chair Access to Care Committee

Prepare surgeons to participate in new technologies and procedures (Endoscopic training, central system for new procedures and technologies to be studied and approved through ASMBS) – Marc Bessler, EC; Bipan Chand, Chair Emerging Technology, Ninh Nguyen Sec/Treasurer

Continue to put out high impact position statements Stacy Brethaur, Chair Clinical Issues Committee

Continue to partner with Obesity Action Coalition, The Obesity Society and other colleagues to promote treatment across the continuum of care

Mechanism of Action of Surgery

Safety and Efficacy of Surgery

Access to Care

Medicalization of

Obesity

Bariatric Surgery 2011Bridge to the future

EPIGENETICS:Obesity, Diabetes and Kidney Disease

in Children

Increased Risk due to Fetal Exposure to

Diabetes

Prevention May be Possible During

Pregnancy

http://nihroadmap.nih.gov/EPIGENOMICS/images/epigeneticmechanisms.jpg 2005

Rapidly growing research field that investigates heritable alterations in gene expression

caused by mechanisms other than changes in DNA sequence.

Mechanism of Action of Surgery

Safety and Efficacy of Surgery

Access to Care

Medicalization of

Obesity

Bariatric Surgery 2011Bridge to the future

Mechanism of Action Mechanical

Calorie Restriction Malabsorption

Physiologic

Hormones from intestinal track

Hormones from Fat Cells Neuromodulation through

changes in signaling of vagus nerve

Weight Dependent effects only – Adjustable Gastric BandWeight Dependent and Weight Independent effects – Sleeve, Gastric Bypass and Switch

The Biology of Obesity and Mechanism of Action of Surgery

Key Theme of the ASMBS Annual Meeting in San Diego June 2012

Mechanism of Action of Surgery

Safety and Efficacy of Surgery

Access to Care

Medicalization of

Obesity

Bariatric Surgery 2011Bridge to the future

COE was Established for a Reason To improve quality and patient safety

It has contributed to a decrease in mortality (0.4 to 0.1%)

Established a culture of outcomes reporting in community hospitals/surgeons

Primary quality discriminator was facility volume of >125 cases

Very low volume programs dropped out of the market

Original 10 standards were interpreted by BSRC and “details” added over time – making it more “prescriptive” and more expensive for facilities to provide

Support from CMS in 2006 and other payers

ASMBS BSCOE ProgramProgram Participants

HospitalsFully Approved 458Provisionally Approved 143Provisional in Process 83 (52 new added through August 2011)

Total Participants 684

SurgeonsFully Approved 849Provisionally Approved 260Provisional in Process 147 (83 new added through August 2011)

Total Participants 1,256

50

As reported by personal communication with Gary Pratt

Drivers for Evolution of the ASMBS BSCOE Program Membership have questioned the volume requirement– they feel they

cannot impact this type of structural measure and it does not reflect the quality of work they are doing

Volumes are going down in some places making it difficult to continue to qualify for programs that have participated

The quality conversation has moved forward to use composite measures of quality for outcome discrimination

No quality improvement process in place within our structure at this time

Continue to have two quality programs in our field (ASMBS and ACS) Basis of some recommendations (based on surgeon best opinion)

may not contribute to quality and is expensive for programs to maintain. Need to clarify this within our requirements

Payer have compared their data to our programs and found that some of our programs have worse outcomes than other programs in their network but not in our program (BCBS Michigan and Leapfrog are no longer requiring the ASMBS BSCOE or ACS BSN designation)

ASMBS Quality and Standards Committee

Chair: Robin Blackstone, MD Co-Chair William Inabnit, MD Representing ASMBS

Chair of State and Local Chapters Committee Lloyd Stegeman, MD Chair of the Research Committee Ranjan Sudan, MD Chair of the Rural Subcommittee Wayne English, MD Chair of Bariatric Training Committee Samer Mattar, MD Chair of Insurance Committee Jaime Ponce Chair of Pediatric Committee Kirk Reichard Chair of Access to Care Committee John Morton President Elect of Integrated Health Karen Schulz, RN

Representing ACS Ninh Nguyen, MD and Matt Hutter, MD

Representing MBSC John Birkmeyer, MD, Justin Dimick, MD and Nancy Birkmeyer, MD

Representing the Bariatric Surgery Review Committee David Provost, MD

Representing BOLD Database Debbie Winegar, PhD

At large member: David Flum, MD At large member: Joe Nadglowski

Collaborations American College of Surgeons Michigan Bariatric Surgery Collaborative

GOAL is to find common ground and establish areas of collaboration

Areas that represent common ground between ASMBS and ACS Collaborative Design of the ASMBS Bariatric Quality

Improvement Program with joint implementation Database and Analyses of Data Facility Credentialing Advocacy

Meeting with David Hoyt in September, 2011 in ChicagoMeeting with ACS Regents on the Division of Research and Optimal Patient CareVote by the Board of Regents to support the collaboration of the two societies:October of 2011

To evolve the program…. Predictable Quality to allow programs to compare their

outcomes to their peers with quality data Over time would lead to using the composite risk adjusted

outcomes measures to qualify for the program Eventually public reporting would be possible

Process Improvement to Improve Patient Safety Key project for the future with a goal to decrease morbidity and

improve long term outcomes Improve access for patients to surgery in their local area

If access to care for obesity surgery/treatment improves then we need to be prepared with well trained surgeons in programs involved in continuous QI

Step 4: Facility/Surgeon Credentialing

ASMBS BSCOE/NBQI

P

ASMBS Bariatric Quality Improvement ProgramASMBS Bariatric Surgery Center of Excellence Program

An outcomes measure that allows us to Predict Quality

Step 1:Development of a Bariatric Surgery Composite Measure

Currents measures for assessing excellence with bariatric surgery

• Structural measures (e.g., volume)– Narrow in scope, proxy for true performance– Not always strongly related to outcomes

• Process measures – Important processes are controversial/unknown in

bariatric surgery• Outcomes measures (e.g., risk-adjusted morbidity)

– “Noisy” due to small sample sizes at some hospitals– Need detailed data for risk-adjustment

Composite Measure Allows outcomes from a variety of quality signals to be taken

into account Includes surgeon and facility volume All quality signals used are “risk adjusted” prior to

incorporation into the model Gives the most accurate prediction of future performance

available

Composite Measure Approach: Shrink to the mortality for volume group

0%

20%M

orta

lity

rate

(%)

Mortality rates forhigh-risk surgery 10%

Mor

talit

y ra

te (%

)

15%

5%

Observed mortality rates

Low volume

Medium volume

High volume

Mortality rates

Composite mortality

Preliminary findings

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

5.0

Hospital volume Serious complications Composite measure

3-star2-star1-star

Hospital rankings (2008-09)

Risk-adjusted serious complications

(2010)

3.3

2.72.4

3.4 3.43.0

3.2

4.0

4.6

Hospital volumeSerious

complicationsCompositemeasure

Odds Ratio (95% CI), 1-star vs. 3-star 0.85 (0.43-1.68) 1.56 (0.84-2.91) 1.99 (1.14 -3.47)

% VariationExplained 0% 28% 89%

Step 2: Establish a new quality matrix (currently in development) Mandatory

Has established the ASMBS National QI Database to enter all patients Participates in the ASMBS BSCOE NBQIP Has the ASMBS/ACS/SAGES Credentialing for surgeons doing bariatric surgery in place Has put in place a thromboprophylaxis protocol Has a transfer agreement to a tertiary center for rescue of complicated patients

Recommended Staff in service on recognizing signs and symptoms of complications Patients satisfaction surveys Other key process protocols (SCIP measures, MOC CME’s)

Best Practice Bariatric Service Line Medical Director Tertiary Care (Receives complex cases from smaller/rural programs through network of

agreements, revisions, sophisticated rescue techniques (24 hour ICU care) Sensitivity Training

Step 3: ASMBS National BSIP Database Select or develop further a database that allows us to have

increased functionality and be able to generate risk adjusted and reliability adjusted composite measures and areas to target improvement for continuous quality improvement

Provide monthly data abstracting to lower volume/rural programs through the society so that ongoing data validation can be performed and standardized (this option currently being explored) After each data entry is done (monthly) reports are immediately available to give feedback to the surgeons/program

Initial instruction on data entry and then annual data validation for larger programs

Step 3: Collaborative Quality Improvement

Basic idea: Physicians/hospitals collaborate with and learn from each other in improving outcomes

Robust data and feedback re process and outcomes

Empirical and non-empirical identification of best practices Leveraging “natural experiments” associated with variation in practice across

hospitals and physicians

Continuous development, implementation and testing of QI interventions Use the ASMBS State Chapters and ACS State Chapters to focus this

effort regionally and the annual meeting to focus nationally

Michigan Bariatric Surgery Collaborative

Example:

Variation in medical prophylaxisPreoperative Postoperative Post discharge NLMW LMW None 2,594

UF UF None 873UF None LMW 610UF LMW LMW 510None UF None 382None LMW None 223UF None None 221UF LMW None 175

Other Combinations 788

Preop prophylaxis vs. outcomes

Postop prophylaxis vs. outcomes

What MBSC did Developed prediction rule for stratifying baseline risk of VTE

by patient factors Statewide practice guidelines for prophylaxis according to

patient risk Based on both empirical analysis and group consensus

VTE Risk Predictor

Example:Risk Factor PointsSleeve 4Age 50 4BMI 50 3Female 0Smoker 2Total 14

MBSC Practice Guidelines

Trends in VTE Rates

QI intervention

Step 4: Joint (ASMBS/ACS/SAGES) credentialing guidelines for surgeons practicing bariatric surgery

Step 4: Facility/Surgeon Credentialing

ASMBS BSCOE/NBQI

P

ASMBS Bariatric Quality Improvement ProgramASMBS Bariatric Surgery Center of Excellence Program

Step 5: Align our goals with CMS, Leapfrog Group and major payors

Timeline: Public comment period December 15, 2011 Presentation of Composite Measure from BOLD data to EC January 2012

ASMBS NBQIP ASMBS BSCOE

ASMBS NBQIP : National Bariatric Quality Improvement Program

ASMBS BSCOE: Bariatric Surgery Center of Excellence

ASMBS NBQIP : National Bariatric Quality Improvement Program

ASMBS BSCOE: Bariatric Surgery Center of Excellence ACS BSN: American College of Surgery Bariatric Network

ASMBSACS NBQIP

ASMBS BSCOE

ACS BSN

ASMBSACS NBQIP

ASMBS BSCOE The most impactful quality and safety program on a nationwide

basis in bariatric surgery Established a culture of compliance with requirements to

implement structure and process and reporting of outcomes Poised to transform into a outcomes based and process

improvement program – based on composite measure (predictive) rather than volume (proxy)

Composite measure rich enough to give programs targets for improvement

Site inspections for data validation (RN team) Site inspections to improve process (surgeons/others

depending on need) All programs engage in process improvement at the first

National Quality Forum June 2012 at the ASMBS Annual Meeting

“Knowing is not enough, we must apply.Willing is not enough, we must do.”-Goethe

Thank you for your service to ASMBSRobin Blackstone, President

Mechanism of Action of Surgery

Safety and Efficacy of Surgery

Access to Care

Medicalization of

Obesity

Mentor Leadership