National Leadership Presentation - Texas Association for Bariatric

Future ASMBS Directions
John Morton, MD, MPH, FACS, FASMBS
Chair, ACS Cmte on Metabolic and
Bariatric Surgery
ASMBS President-Elect
ADVOCACY
•
•
•
•
•
•
MESSAGE
DATA
UNITY
COLLABORATION
PATIENCE
PERSISTENCE
• August 22, 2011
• CMS received an informal request for reconsideration
of the Bariatric Surgery for the Treatment of Morbid Obesity
NCD to review evidence for inclusion of sleeve gastrectomy
• September 30, 2011
CMS opens NCD reconsideration request to review the new
evidence for laparoscopic sleeve gastrectomy.
• March 29, 2012
• Proposal to cover LSG as part of an RCT
• June 29, 2012
• Reconsideration of LSG proposal due
• June 29, 2012
• Reconsideration of LSG proposal achieved
• July 2012
• ASMBS Response Letter to CMS
• October 1, 2012
• Non-coverage of Sleeve Removed
• November 12, 2012
• ASMBS Letter to LCDs
• Prior institution of coverage for the LSG via local MAC
• Assist in crafting Local Care Determination.
• February 7, 2013
• ASMBS Letter to LCDs without coverage or Age Restrictio
• Removal Preop Weight Loss Requirement
• May 20, 2013
• Removal of Final LCD with Age Restriction (Palmetto)
Grassroots: OAC
•
Dear CMS,
•
I am an obese patient who believes that obesity is a disease that needs to be
treated. I suffer from diabetes, high blood pressure, sleep apnea, high
cholesterol, joint disease, kidney disease, and/or liver disease. I need as many
options as possible to treat these obesity related diseases. I am appreciative
that CMS provides coverage for screening and treating obesity and recently
provided Medicare coverage for intensive behavioral therapy for obesity in
addition to covering gastric bypass and gastric banding. CMS should cover
sleeve gastrectomy as well just like other insurance providers. We need helpthe kind of life-saving treatment that laparoscopic sleeve gastrectomy can
provide. Please cover sleeve gastrectomy NOW. I want to be treated just like
everyone else and I want to have options that can better my health.
NATIONAL COMPARISIONS OF
BARIATRIC SURGERY SAFETY
AND EFFICACY: FINDINGS FROM
THE BOLD DATABASE 2007-2010
John M. Morton, MD, MPH1; Ninh Nguyen, MD2;
Bintu Sherif, MS3;
Deborah Winegar, PhD3; Jaime Ponce, MD4;
Robin Blackstone,MD5
Stanford University School of Medicine1; University of California,
Irvine2; American Society of Metabolic and Bariatric Surgery3; Dalton
Surgical Group4; Scottsdale Bariatric Center5
Results: Change in BMI
7.6
p<0.001
16.4
13.4
Results: Postoperative Safety Outcomes
N (%)
LAGB
LRYGB
LSG
P-value
30-Day Mortality
31 (0.03)
187 (0.14)
13 (0.08)
<.0001
30-Day Serious Complications
288 (0.25)
1729 (1.25)
155 (0.96)
<.0001
30-Day Readmission
1609 (1.37)
6409 (4.64)
581 (3.60)
<.0001
30-Day Reoperation
754 (0.64)
3801 (2.75)
274 (1.70)
<.0001
90-Day Mortality
41 (0.03)
241 (0.17)
17 (0.11)
<.0001
90-Day Serious Complications
330 (0.28)
1908 (1.38)
171 (1.06)
<.0001
90-Day Readmission
2098 (1.79)
8727 (6.31)
693 (4.29)
<.0001
90-Day Reoperation
1291 (1.10)
6356 (4.60)
355 (2.20)
<.0001
Conclusion
Laparoscopic sleeve gastrectomy
is positioned between the
laparoscopic gastric band and
gastric bypass for both safety
and efficacy
Sleeve Gastrectomy Coverage by
Medicare Administrative Contractors (MACs)
(as of Feb 1, 2013)
AK
WA
MT
ME
ND
MN
OR
ID
WI
SD
NY
MI
WY
RI
NE
NV
UT
IL
CO
CA
KS
NJ
OH
IN
DC
WV
KY
MO
OK
SC
MS
TX
VA
NC
AR
NM
DE
MD
TN
AZ
AL
GA
LA
HI
FL
States with CONFIRMED Sleeve Coverage from their MACs
States with DRAFT Local Coverage Decision (LCD) - MAC to decide within next 30-60 days
States with < 60 Age Restriction (Noridian: WA, OR, ID, AK, ND, SD, MT, WY, UT, AZ, MN (MAC A only))
States with < 64 Age Restriction (Palmetto GBA: SC, NC, VA, WV, CA, NV, HI)
Coverage current as of 2/1/13; coverage may have changed since this printing
CT
PA
IA
NH
VT
MA
ADVOCACY
•
•
•
•
•
•
MESSAGE- Safe & Effective
DATA-Value of Registry
UNITY-179/380 comments
COLLABORATION-Societies, Surgeons, OAC
PATIENCE-Timeline
PERSISTENCE-Remove Age/Wgt Loss
Restrictions, Retroactive, PreApproval, RVU,
Confirm LCDs
The Affordable Care Act and
Bariatric Surgery
• The ACA calls for both cost
reduction and quality
improvement.
• 10% of health costs are
obesity related/20% of
Medicare readmissions are
surgical
• Accountable Care
Organizations- HGA1C
METRIC
Look AHEAD (Action for Health in
Diabetes): Trial Halted Early
• Intensive lifestyle intervention resulted in1
– Average 8.6% weight loss
– Significant reduction of A1C
– Reduction in several CVD risk factors
• Benefits sustained at 4 years2
• However, trial halted after 11 years of
follow-up because there was no significant
difference in primary cardiovascular
outcome between weight loss, standard
care group
1, 2. Look AHEAD Research Group. Diabetes Care. 2007;30:1374-1383 and Arch Intern Med.
2010;170:1566–1575; http://www.nih.gov/news/health/oct2012/niddk-19.htm.
Diabetes is Cured?
• 3568 DM2 RYGB patients enjoyed
complete disease remission ranging from
82% to 98%
–
–
–
–
Pories et al. Ann Surg 1995
Schauer et al. Ann Surg 2000 and 2003
Sugerman et al. .Ann Surg 2003
Wittgrove et al. Obes Surg 2000
• Metanalysis of 136 studies/22,094 patients,
RYGB completely resolved DM 84%
Buchwald et al. Bariatric surgery: A systematic review
and meta-analysis. JAMA 2004; 292:1724-37
The Affordable Care Act and
Bariatric Surgery
• The Essential Health Benefit (EHB) is an
important centerpiece of the ACA with each
state required to provide a sample plan and
benefit package to be approved by HHS.
• The EHB is designed for those citizens
who do not have current coverage. Adverse
selection may occur when a single plan
exclusively offers a benefit.
Employer Coverage for Bariatric Surgery
2010 – ALL EMPLOYERS
AK
WA
MT
ME
ND
VT NH
MN
OR
ID
NY
WI
SD
MI
WY
RI
NE
NV
IL
CO
KS
CA
MO
NJ
OH
IN
WV
KY
OK
AR
NM
SC
MS
TX
AL
GA
LA
HI
FL
% Employer Coverage:
No Data
51 to 75%
0 to 25%
> 75%
DE
VA
NC
TN
AZ
CT
PA
IA
UT
MA
26 to 50%
Source: Mercer’s National Survey of Employer-Sponsored Health Plans 2010 – All Employers
MD
Is Bariatric Surgery Included in the State’s Qualified Health Plan?
Health Insurance Exchange (HIE) Coverage of Weight-Related Services
Affordable Care Act – Beginning January 2014
AK
WA
MT
ME
ND
MN
OR
ID
WI
SD
NY
MI
WY
RI
NE
UT
IL
CO
CA
KS
NJ
OH
IN
WV
KY
MO
OK
NC
AR
NM
HI
Does not cover bariatric surgery nor weight
loss programs
DC
SC
MS
TX
DE
VA
MD
TN
AZ
CT
PA
IA
NV
NH
VT
MA
AL
GA
LA
FL
Covers weight loss programs but does
not cover bariatric surgery
Covers bariatric surgery but does not
cover weight loss programs
Covers bariatric surgery and weight
loss programs
Source: Center for Consumer Information and Insurance Oversight
summary of EHB benchmark plans based on 2012 benefits – STOP Obesity
Alliance, Weight and the States Policy Research Bulletin, December 2012.
Obesity Action Coalition Spreadsheet, May 2013.
(States that have not selected an EHB benchmark plan defaulting to the
largest small-group employer plan in the state.)
Current as of 05-06-2013; Coverage may have changed since this printing
Who is Running the State Exchange?
Business Unit or
Department I
Obesity – Economic Burden
•National Expenditures for Obesity: 9.1%- $150B
4000
3500
Dollars
3000
2500
2000
$2,127
$2,358
20-24.9
25-29.9
$3,506
$2,873
$3,058
30-34.9
35-39.9
1500
1000
500
0
BMI
>40
Wee et.al., Am J Public Health 2005
Cost-Effectiveness
Qualified Health Plans - Bariatric Surgery To Date
State
Arkansas
California
Colorado
Connecticut
Florida
Georgia
Illinois
Indiana
Kentucky
Massachusetts
Maryland
Michigan
Minnesota
Missouri
North Carolina
New Jersey
New Mexico
Nevada
New York
Bariatric
Surgery an QIP's
EIX Type
EHB
ID'd
State
No
3
State
Yes
13
State
No
10
State
No
3
FFE
No
7
FFE
No
5
State
Yes
5
FFE
No
4
State
No
3
State
Yes
8
State
Yes
6
FFE
Yes
9
State
No
5
FFE
No
3
FFE
Yes
2
FFE
Yes
3
State
State
State
Yes
No
Yes
Ohio
FFE-MPM
No
Pennsylvania
FFE
No
Rhode Island
State
Yes
Texas
FFE
No
Virginia
FFE-MPM
No
Vermont
State
Yes
Washington
State
No
Wisconsin
FFE
Covidien | January No
Totals
27, 2014 |
2
4
17
9
8
1
10
7
2
7
10
166
Plans w/o Plans w/o
Plans w/ BS
BS
SBC
Benefits
Benefits Information
BS Access Restriction Noted
2
1
6
2
5
10
3
4
3
3
2
3
2
2
2
2
1
7
1
5
1
4
5
Once per lifetime
5
2
1
1
1
2
1
One new surgery per lifetime (Hayes Tech
2
Criteria)
4
3
2
12
3
8
6
8
2
1
1
6
2
1
47
7
25 6|
69
3
50
3 plans offer BS option as rider ($$$)
A Tale of Two States
ACA may not discriminate on
basis of health condition
Surgery: First Responder to Public
Health Epidemics
•
•
•
•
Cancer
Tuberculosis
Coronary Disease
Morbid Obesity
Most Populous States
(millions)
•
•
•
•
•
•
•
•
CA- 36
TX-23
NY-19
FL-18
OB-18
IL-12.8
PN-12.4
OH-11
Cause of death
RYGB vs. Car
drivers
p-value
All mortality
40% decrease
<0.001
CV disease
56% decrease
0.54
All cancers
60% decrease
<0.001
Diabetes
92% decrease
<0.005
Cost-Effectiveness
• Weiner JP, et al "Impact of
bariatric surgery on health care
costs, JAMA Surg 2013
• comparison cohort predicated
on ICD9 codes associated with
obesity, not actual weight
• Open procedures at 35% while
current rates are <10%.
dramatic reduction in follow-up
over the six years. Among the
29,820 study patients, the
follow-up at years 2 through 6
is 65, 43, 25, 15 and 7%
exacerbated for laparoscopic
gastric bypass at 1.9%
Increasing Acceptance and Access
•
•
•
•
•
•
Safety
Efficacy
Tertiary Prevention
Metabolic Disease
Family Disease
MOTIVATIONAL VIDEO
– DR NINH NGUYEN
Acceptance
• Develop coalitions for patient access –OAC, SQA,
ADA, AHA,AMA,TOS, TES, ACC- to illustrate
support for efforts to expand coverage for the
continuum of care surrounding obesity treatment
• Educate Primary Care about the scientific basis
for access to bariatric surgery- PCP Courses
• Create Private Payer Dialogue regarding Quality
• OBESITY SUMMIT
Tertiary Prevention
Prevention of disease progression and
attendant suffering after it is clinically
obvious and a diagnosis established.
Heart Disease and Obesity
• HD is leading cause of
death: >300,000
annually
• Primary modifiable
risk factors: Obesity
& Smoking (Lavie et al, J Am Coll
Cardiol, 2005)
• Smoking rates
declining, obesity
increasing (JAMA, 2003)
Cardiac Risk Factor Improvement
Morton SOARD 2007
LDL
Total Cholesterol
140
200
187
168
166
124
120
166
105
102
100
150
TC
Linear (TC)
100
88
80
LDL
Linear (LDL)
60
40
50
20
0
0
0
3 mos
6 mos
12 mos
0
3 mos
HDL
60
50
41
12 mos
TG
160
54
45
6 mos
141
140
45
116
120
40
92
100
HDL
Linear (HDL)
30
92
TG
Linear (TG)
80
60
20
40
10
20
0
0
0
3 mos
6 mos
12 mos
0
3 mos
6 mos
12 mos
Cardiac Risk Factor Improvement
Morton SOARD 2007
Homocysteine
12
11
10
9
8
7
6
5
4
3
2
1
0
10.1
9.4
C-Reactive Protein
9
8.4
HC
Linear (HC)
0
3 mos
6 mos
8.2
12 mos
Lipoprotein A
25
10
4.9
5
23
20
2.5
15
15
CRP
Linear (CRP)
12.9
10
10
1.4
LpoA
Linear (LpoA)
0
5
0
0
0
3 mos
6 mos
12 mos
3 mos
6 mos
12 mos
The Halo Effect of Gastric Bypass:
Weight Loss in Family Members
Morton JAMA Surgery 2011
Spread of Weight Loss
Spouse
Parents
Friends
150,000
annual
gastric
bypass
Children
ASMBS Comment to CMS
Two rounds of comments
Two phone meetings
3 letters
Accreditation
• Since the CMS NCD supporting accreditation:
– lives have been saved
– complications have been prevented
– readmissions have been averted
– cost has been lowered
– access has been broadened
• With accreditation, data collection will occur
and quality improvement efforts will be
enhanced.
GI Surgery
Cardiac Surgery
Vascular Surgery
Plastic Surgery
NO BARIATRIC SURGERY
Update
Time Line
• Standard will be release Jan 27th
• Program transitioning to new standard
• Application for new program
Contact
• Teresa Fraker, RN, Program administrator
• [email protected]
Risk-adjusted Data
Timeline for Risk-adjusted Data
• Beginning of 3rd quarter
• Given as rolling 12 months data on a quarterly
basis
Time Line
• Surgeon’s verification
Qualifications
• License to practice medicine
• Completion of US or Canada residency
• 60 hours of Obesity-related CME
• Certification examination
Bariatric Surgery Certification
• Certification of added qualification
• Non-ACGME certificate
• Based on high stake examination
• Certify by ABS
First National MBSAQIP
Quality Improvement Project:
Decreasing Readmissions through
Opportunities Provided (D.R.O.P )
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
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:
▪ ASBS/ Surgical Review Corporation.
▪ American College of Surgeons –
Bariatric Surgery Center Network.
57
These studies demonstrate that there are vulnerable patient
populations and potential additional costs associated with
surgery but suggest that surgical volume helps mitigate these
risks and costs," wrote Bruce M. Wolfe, M.D., of Oregon Health
& Sciences University in Portland and John M. Morton, M.D.,
M.P.H., of Stanford in an accompanying editorial.
"Bariatric surgery may be a potentially life-saving intervention in
the right
patients and in the right
surgeons' hands," they added. "The studies presented in
this issue indicate that experience and technique count."
BARIATRIC SURGERY:
AMERICAN SURGICAL
SUCCESS STORY
UHC data: In-Hospital Mortality
Bariatric Surgery In-hospital Mortality by Year 2002-2009
(N = 105,287)
4.5
4.0
4.0
Deaths per 1,000
3.5
3.0
2.6
2.3
2.5
2.0
1.6
1.5
1.5
1.0
0.8
1.0
0.6
0.5
0.0
2002
2003
2004
2005
2006
2007
2008
2009
Year
Nguyen et al. SOARD 2012
CMS NCD Effect
Flum 2011
Beyond Mortality
Four Guiding Principles of
Continuous Quality Improvement
Standards
• Individuali
zed by
patient
• Backed by
research
Right
Infrastructure
• Staffing
levels
• Specialists
• Equipment
• Checklists
Rigorous Data
Verification
• Clinical
• Backed by
research
• Postdischarge
tracking
• Continuously
updated
• External
peer-review
• Creates
public
assurance
Dashboard
x
Bariatric Surgery Volume & Re-operations
Surgery Type and Volume
Re-operations within 30 days
CY 2012
6%
CY 2011
5%
CY 2010
4%
CY 2009
3%
2%
CY 2008
1%
0
50
Bypass
Stomaphyx
100
Sleeve
VBLOC
150
200
250
SHC
0%
Band
CY
2008
CY
2009
National
CY
2010
CY
2011
CY
2012
Source: American College of Surgeons (ACS) Bariatric Surgery Center Network (BSCN) report
Slide Summary
 Total bariatric surgery cases increased from 120 in 2008 to 241 in 2012
 Re-operations decreased from 3.1% in 2009 to 0.8% in 2012
65 Goal: Re-operations to remain below BSCN national average
 Re-admissions decreased from 8.3% in 2008 to 2.1% in 2012 (see next slide)
We estimate that the cost to
Medicare of unplanned
rehospitalizations in 2004 was
$17.4 billion.
90% Unplanned Readmissions
22.4 % of Conditions at Index Discharge Surgical
Readmissions
Meta-Outcome
•
•
•
•
Patient Safety
Patient Satisfaction
Provider Satisfaction
Cost
Results: RNYGB Readmissions
Morton 2014
RNYGB readmission
p-value: <.0001
Causes for Readmissions
•
•
•
•
Dehydration
Nausea
Medication Side-Effects
Patient Expectations
• DVT 0.1%, SBO 0.2%, Leak: 0.4%, Bleed
1%, Readmissions 5-7%
Bariatric Surgery QI Plan 3:
8 to 2.5 %
69% Reduction
Actions Reducing Re-admissions
Goal: Reduce re-admissions for complications within 30
days to remain below national average.





Improved patient education/
discharge planning
Provided direct phone numbers
BMI Clinic RN calls each pt day s/p dc
Same day appointments now
available for concerns
Using Clinical Decision Unit
for 23 hour stays
% patients readmitted w/in 30 days
Evaluating the value of a combined
physician-dietician follow-up after
bariatric surgery
Binary categorical:
Fisher’s exact
95%
Preop
Patient Education Module
•
Postop Appointment Made
•
Postop Rx Given
•
Clinic Phone Numbers Given
•
Nutrition Review-Module
•
Nursing Review- Wound Care
• Pharmacist- Med Reconciliation
• High Risk Pt, Review w Family/PCP
• Modifiable Risk Factors- Wgt Gain>5%, HgA1c
Postop
Nurse Phone Call Made Day After DC (If
High Risk Patient, additional call made on
Friday of week of surgery)
1, 2 or 3 week post op appointment with
nutritional counseling
How Do We Do It?
• DC Checklist
– Phone Numbers, Medications, Appointment,
Diabetes/Nutrition Counseling
• Clinical Roadmap: Sample Guidelines, i.e.,
remove foley pod#1- there will be flexibility
here with the only expectation that
uncomplicated patients be dc’ed on pod 1
for band, pod 2 for stapled cases
Obesity Week 2013
Readmission Symposium
•
•
•
•
Chair, J Morton, Stanford
M Hutter, MGH, Why Readmissions Matter
Tony Petrick, Geisinger, ProvenCare
Stuart Verseman, Borges Hospital, MBSC
Experience
• Karen Schulz, CC, Nursing
• David Sarwer, UPenn, Psych
• Raul Rosenthal, CCF, Technical
Readmission Symposium
Audience Response
Decreasing Readmissions
through Opportunities
Provided (D.R.O.P )
Why do it?
• Specific complications (DVT/Leaks) rare.
• Readmissions are important to payors.
• Opportunity for improvement.
• Fulfills Quality Improvement project as in
MBSAQIP standards.
GOAL
• Reduce re-admissions within 30 days to
decrease by 20% nationally.
• Over 700 Hospitals
• @150,000 cases annually
• 7,500
6000 Readmissions
• 35K * 1500= 52.5 Million
Timeline
• Jan/Feb 2014
– MBSAQIP/BOLD Data regarding Readmissions
– Readmission Definition Harmonization
– Convene QI committee/vet module
• Mar/April 2014:Training/Modules/Videos
• May/June: Training/Sign Up Centers
• July 2014: Begin Study
• July 2015: Complete Study
Training/Followup
•
•
•
•
•
Webinars
Monthly Phone Calls
Online Video Modules/FAQs
Question Blog
Spring Event Miami June 19-22
– In Person Training
Conclusion
Utilizing national, clinically
derived data can drive quality
improvement
Who will rescue these patients?
ASMBS Leadership
We are here to serve our members
and patients
Thank You
[email protected]

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