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.

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