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Medicare National Survey & Medicare National Survey & Certification ProgramCertification Program
forfor
Solid Organ Transplant ProgramsSolid Organ Transplant Programs
Advisory Committee on Organ Advisory Committee on Organ TransplantationTransplantation
March 12-13, 2014
Thomas E. Hamilton, DirectorThomas E. Hamilton, DirectorSurvey & Certification GroupSurvey & Certification Group
Centers for Medicare and Medicaid Certification Centers for Medicare and Medicaid Certification
Plan for the Discussion
1. CMS Regulation
2. Transplant Center Responses
Overview of CMS Approach
Outcomes Expectations
CMS National Coverage Decisions (NCDs) Heart – 1986 – if meeting Survival Minimum (1-Yr
73%, 2-Yr 65%) Liver – 1991 - if meeting Survival Minimum (1-Yr
77%, 2-Yr 60%) Lung – 1995 - if meeting Survival Minimum (1-Yr
69%, 2-Yr 62%)
CMS Requirements + Survey CMS Requirements + Survey FindingsFindings
Program Design + ManagementProgram Design + Management ABO VerificationABO Verification Multi-Disciplinary PlanningMulti-Disciplinary Planning Patient + Living Donor CarePatient + Living Donor Care Informed ConsentInformed Consent Patient SelectionPatient Selection Data Submission to OPTNData Submission to OPTN Quality Assessment + Performance Improvement (QAPI)Quality Assessment + Performance Improvement (QAPI)
Risk-Adjusted Outcomes Risk-Adjusted Outcomes (Graft + Patient (Graft + Patient Survival) Survival) Deficiency is Cited if:Deficiency is Cited if:
1.1. SMR: Observed/Expected Failures > 1.5 (One-Year SMR: Observed/Expected Failures > 1.5 (One-Year Post-Tx)Post-Tx)
2.2. P < .05 (one-sided value, same as OPTN)P < .05 (one-sided value, same as OPTN)3.3. Observed minus Expected > 3 Observed minus Expected > 3
CMS + OPTN Outcome Measures
CMS OPTNStatistical Measure for
Outcomes(Graft + Patient Survival)
If All 3 Below Apply:
1.SMR: Observed/Expected Failures > 1.5 (One-Year Post-Tx)2.P < .05 (one-sided value, same as OPTN)3.Observed minus Expected > 3
Statistical Measure for Outcomes
1.Probability is +75% that HR Exceeds 1.2 or 2.Probability is +10% that HR Exceeds 2.5 (small volume programs)
Condition-Level Deficiency is Cited if:
2 of the most recent 5 SRTR reports indicate that all 3 of the above thresholds are crossed (i.e., the most recent SRTR report plus 1 other report).
Identified for Review1 SRTR report indicates that the above applies
Plan for FY 2015-2016
Calculate Both Measures for Each Program Compare Effect of the 2 Measures Determine in FY2016 How to Best Restore
Alignment of Measures In the Meantime:
Review Results of OPTN’s Measure if a Program is Cited by CMS but not Flagged under the OPTN Measure
Include this review in Mitigating Factors Consideration
Public Policy Public Policy Challenge …Challenge …
1.1. How might CMS best back up OPTN?How might CMS best back up OPTN?
2.2. How might CMS reinforce the How might CMS reinforce the tradition of continuous quality tradition of continuous quality improvement of the transplant improvement of the transplant community?community?
Public Policy Public Policy Challenge …Challenge …
1.1. How might CMS best back up OPTN?How might CMS best back up OPTN?
2.2. How might CMS reinforce the tradition of How might CMS reinforce the tradition of continuous quality improvement of the continuous quality improvement of the transplant community?transplant community?
Require Internal Quality Improvement = Require Internal Quality Improvement = QAPIQAPI
Mitigating Factors ProcessMitigating Factors Process System Improvement AgreementsSystem Improvement Agreements
Patient & Graft SurvivalPatient & Graft Survival Single SRTR Rpt = Flag Single SRTR Rpt = Flag = 8-11% of = 8-11% of
ProgramsPrograms
Condition-LevelCondition-Level CitationCitation = 3 - 5% of = 3 - 5% of ProgramsPrograms 2 2 of 5 SRTR Rpts w/Statistically Significant of 5 SRTR Rpts w/Statistically Significant
OutcomesOutcomes (Most Recent + 1 Other of 5 SRTR Reports)(Most Recent + 1 Other of 5 SRTR Reports)
Mitigating Factors Mitigating Factors Process Process Up to 210 DaysUp to 210 DaysAllows for Allows for 33dd SRTR Rpt SRTR Rpt
Allows Time for Additional ImprovementsAllows Time for Additional Improvements SIASIA – if Progress + Hospital Commitment – if Progress + Hospital Commitment
Mitigating Factors ProvisionMitigating Factors Provision
CMS Regulations - Permit Consideration of CMS Regulations - Permit Consideration of “Mitigating Factors” “Mitigating Factors”
Main Types of Mitigating FactorsMain Types of Mitigating Factors Natural Disasters (e.g. Hurricane)Natural Disasters (e.g. Hurricane) Innovation (high HLA population, etc.)Innovation (high HLA population, etc.) ImprovementImprovement
Robust Program ImprovementRobust Program Improvement Evidence of Improved OutcomesEvidence of Improved Outcomes
Programs submit request for consideration Programs submit request for consideration to CMS Central Office (to ensure national to CMS Central Office (to ensure national consistency)consistency)
NewNew - Expanded MF Factors - Expanded MF Factors Regulation Regulation
42 CFR 488.61(f-h)42 CFR 488.61(f-h)
ecfr.gov (browse to Title 42, click on 482-699, ecfr.gov (browse to Title 42, click on 482-699, click on 488, click on 488.61)click on 488, click on 488.61)
Adds Explicit Recognition for Program Improvement as a Explicit Recognition for Program Improvement as a Mitigating FactorMitigating FactorInnovation as a FactorSystems Improvement Agreement Transparency
Favorable MF Decisions for Favorable MF Decisions for OutcomesOutcomes
Five Elements – All FulfilledFive Elements – All Fulfilled
1.1. Program ImprovementsProgram Improvements
2.2. SubstantialSubstantial
3.3. Address Root CausesAddress Root Causes
4.4. Implemented, Institutionalized, Sustainable Implemented, Institutionalized, Sustainable ((not just plansnot just plans))
5.5. EvidenceEvidence (Data) of Improved (Data) of Improved OutcomesOutcomes to to Support a Finding of Support a Finding of Present-Day CompliancePresent-Day Compliance
System Improvement Agreements (SIAs)
Key ElementsKey Elements of SIA of SIA1.1. Peer ReviewPeer Review: Onsite Peer Review with Topic Areas Specified : Onsite Peer Review with Topic Areas Specified
by CMSby CMS
2.2. Quality ConsultationQuality Consultation: Onsite Quality Consultant: Onsite Quality Consultant
3.3. QI InvestmentsQI Investments: Further Quality Improvement Efforts by : Further Quality Improvement Efforts by HospitalHospital
4.4. QAPI System ImprovementsQAPI System Improvements: including better use of SRTR : including better use of SRTR DataData
5.5. Waitlist AssistanceWaitlist Assistance: Assistance to People on Waitlist (if : Assistance to People on Waitlist (if Transferring) Transferring)
6.6. Reporting:Reporting: Regular Data & Program Reporting to CMS Regular Data & Program Reporting to CMS
7.7. AppealAppeal: Waiver of Appeal Rights: Waiver of Appeal Rights
8.8. After ActionAfter Action Report Report
Extension of Dates:Extension of Dates: CMS Extends the Effective CMS Extends the Effective Date of Medicare Termination during the SIADate of Medicare Termination during the SIA
Offered Only in Promising Circumstances, and if Offered Only in Promising Circumstances, and if Strong Institutional Support is Evident Strong Institutional Support is Evident
QAPI “Motto”QAPI “Motto”
If We Lose the Patient …If We Lose the Patient …
… …We Don’t Lose the We Don’t Lose the LessonLesson
Broad Challenges for Transplant Broad Challenges for Transplant
CentersCenters
17
Process Control with
Best Practice
Process Innovation
Process Improvement
QAPI
Five Medicare Five Medicare QAPI ThemesQAPI Themes andand
Examples of Transplant Center ActionsExamples of Transplant Center Actions
5
QAPI Theme:QAPI Theme: Five Major AspectsFive Major Aspects1.1. Design + ScopeDesign + Scope
2.2. Feedback, QI Systems, Feedback, QI Systems, Awareness Awareness
(a) Adverse Events(a) Adverse Events 1.1. Reported, Reported, 2.2. Tracked, Tracked, 3.3. Investigated Investigated 4.4. Analyzed + UsedAnalyzed + Used
(b) Quality Indicators(b) Quality Indicators 1.1. Problem Prone AreasProblem Prone Areas2.2. High Risk Areas High Risk Areas 3.3. TrackedTracked4.4. Used for Quality Used for Quality
ImprovementImprovement
3.3. Performance Performance Improvement ProcessesImprovement Processes
4.4. Systemic ImprovementSystemic Improvement
5.5. Governing Body + Governing Body + LeadershipLeadership
Adverse Events
1. Reported (e.g., incident
reporting systems)
Special Challenges
for Post-
Transplant Care
2. Tracked,
3. Investigated
4. Analyzed5. Used …“to effect
changes in the transplant center’s policies and practices to prevent repeat incidents (42 CFR 482.96(b)(2))
Turnaround Actions by Transplant Programs -
Examples
1. Challenge the Barrier of Beliefs
Case Example Case Example # 1# 1 - One-Year - One-Year PatientPatient Survival Survival
Adult Kidney ProgramAdult Kidney Program VANGVANG
Blinded by BeliefBlinded by Belief
Case Example #1 Case Example #1 continuedcontinued – Adult – Adult Kidney Kidney
Standardized Mortality Ratio (SMR)Standardized Mortality Ratio (SMR)
Blinded by Belief
Case Example # 2 – Liver Program Unacquainted with its Data
Case Example - Standardized Patient Mortality Ratio -
Adult Liver - 1/2006-12/2007 - (N=35)T fts
2.94
2.17
2.78
0.00
0.50
1.00
1.50
2.00
2.50
3.00
3.50
Non-ECD & non-DCD
DCD only ECD only
Turnaround Actions by Transplant Programs
1. Challenge the Barriers of Beliefs
2. Improve Root Cause Analyses and QAPI
High IQ but Low Quest Quotient
Case Example #3 – Root Cause Analysis Challenge
Case Study: ReportedInitial Analysis of Patient Deaths
5
2
1 1
0
1
2
3
4
5
6
Non-Compliance
Unknown Infection CardiacEvent
Nu
mb
er
of
Death
s
Case Example # 4 : Lung Program on Top of Its Data
Adult Lung Graft SMR - by SRTR Rpt Date C A C S a
67.7%
74.6%
81.7%
76.5%77.4%
60.0%
71.0%
78.8%79.0% 79.8%81.9%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
Jan-07 Jul-07 Jan-08 Jul-08 Jan-09 Jul-09 Jan-10 Jul-10 Jan-11 Jul-11
Graft ObservedSurvivalGraft ExpectedSurvival
InternalReview
ProgramChanges
Turnaround Actions by Transplant Programs
1. Challenge the Barriers of Beliefs 2. Improve Root Cause Analyses and QAPI
3. Improve Hospital Alignment Invest in Staff Electronic Health Records ICU Coordination & Training Specialize the Specialists
Example - Multi-Disciplinary Example - Multi-Disciplinary Teaming &Teaming &
Specializing the SpecialistsSpecializing the Specialists
A. Role of CardiologyA. Role of Cardiology Improved Cardiac Evaluation Pre-OpImproved Cardiac Evaluation Pre-Op Improved Pre-Op Intervention (e.g., Stents Improved Pre-Op Intervention (e.g., Stents
before Transplant rather than After)before Transplant rather than After) Dedicated SpecialistsDedicated Specialists
Research:Research: Cardiovascular events are the Cardiovascular events are the leading cause of deaths in patients with leading cause of deaths in patients with ESRD. ESRD.
Case Example # 5 – Impact of Cardiology Improvement – Pre + Post Tx
Patient Survival by SRTR Rpt Date - Adult Kidney Program - 2007-11
90.6%92.2%
88.9%87.3%
88.5%
90.2%
95.6%98.4%
100.0%
96.4%
96.7% 96.8%96.3%95.0%
0.800
0.850
0.900
0.950
1.000
1.050
Jan-07
May-07
Sep-07
Jan-08
May-08
Sep-08
Jan-09
May-09
Sep-09
Jan-10
May-10
Sep-10
Jan-11
May-11
Patient ObservedSurvival
Patient ExpectedSurvival
Case #5 - Patient Survival –Adult Kidney Program
Updated to 2012 1-Year Patient Survival
100.0%100.0%100.0%98.4%
96.4%96.4%
90.2%88.5%
87.3%88.9%
80%
85%
90%
95%
100%
Jul-12
Jan-12
Jul-11
Jan-11
Jul-10
Jan-10
Jul-09
Jan-09
Jul-08
Jan-08
Expected Patient Survival
Actual Patient Survival
Turnaround Actions by Transplant Programs
1. Challenge the Barriers of Beliefs 2. Improve Root Cause Analyses and QAPI3. Improve Hospital Alignment
4. Address Personnel Issues
Case Example # 6: Using SRTR Data to Improve the Program
Mortality Rate by Surgeon - Adult Kidney Program - Jan. 2010 SRTR Data C A S V
2.7%
7.3%
10.9%
4.6%
0.00%
2.00%
4.00%
6.00%
8.00%
10.00%
12.00%
30-DayMortality
90-DayMortality.
1-YrMortality
1-Yr GraftLoss
Doc X
Case Example # 6: Using SRTR Data to Improve the Program
Mortality Rate by Surgeon - Adult Kidney Program - Jan. 2010 SRTR Data C A S V
2.7%
7.3%
10.9%
4.6%
8.7%
4.9%
1.9%
4.9%
0.00%
2.00%
4.00%
6.00%
8.00%
10.00%
12.00%
30-DayMortality
90-DayMortality.
1-YrMortality
1-Yr GraftLoss
Doc X
Doc Y
Case Example # 6: Using SRTR Data to Improve
the Program Mortality Rate by Surgeon - Adult Kidney Program -
Jan. 2010 SRTR Data C A S V
2.7%
7.3%
10.9%
4.6%4.9%
1.9%
4.9%
8.7%
0.0%
0.9%
8.1%7.2%
0.00%
2.00%
4.00%
6.00%
8.00%
10.00%
12.00%
30-DayMortality
90-DayMortality.
1-YrMortality
1-Yr GraftLoss
Doc X
Doc Y
Doc Z
Outcome Trends for
Programs Completing SIAs and All Others
Comparison – Programs for Which:
1. Mitigating Factors (MF) was Approved without Need for System Improvement Agreement (SIA)
2. SIA was Completed Successfully (= 90% of SIAs)
3. Programs not Cited for Outcomes
Adult Kidney Actual 1-Yr Graft Survival (All Donors x MF Status, 6 Yrs)
86.0%
88.0%
90.0%
92.0%
94.0%
96.0%
98.0%
100.0%
2-1y pre 1-0y pre 0-1y post 1-2y post 2-3y post 3-4y post
Years before/after Survey Date (or 7/1/09 if non-MF)
MF-No SIA, 11
MF-SIA, 4
non-MF, 150
National Trends
Deceased Donor Volume Slowly Increasing Living Donor Volume Decreasing Acceptance of Risk is Increasing
Organs and Recipients
yet
Outcomes Continue to Improve
Deceased Adult Kidney Transplants CY2004-2013
12,570
13,313
14,27414,382
14,27814,394 14,409
14,786 14,754
15,005
10,486
11,102
11,90611,750 11,670 11,631
11,768
12,14011,991
12,268
9000
10000
11000
12000
13000
14000
15000
16000
CY2004 CY2005 CY2006 CY2007 CY2008 CY2009 CY2010 CY2011 CY2012 CY2013
Kidneys Recovered Kidneys Transplanted
Live Kidney Transplants 2004-2013
6,6476,573
6,436
6,0435,968
6,388
6,278
5,771
5,619
5,731
5200
5400
5600
5800
6000
6200
6400
6600
6800
CY2004 CY2005 CY2006 CY2007 CY2008 CY2009 CY2010 CY2011 CY2012 CY2013
Average Overall One-Year Kidney Risk Profile* by Flagging Status, 2001-2010
(Donor + Recipient Combined Effect)
* Relative to the average in 2007, overall risk due to the combination of recipient and donor-related factors for adult recipients of deceased donor kidney transplants
CMS Reg.
41