Stakeholder Meeting

1

• Stakeholder Meeting
• Monday, October 26, 2009
• Washington, DC

2
Welcome

• On behalf of the AJRR Project Team, I hope
• that todays meeting provides a forum for
• frank dialogue about the opportunities and
• challenges that await us. Active involvement
• and commitment is critical to the ongoing
• development and implementation of the
• American Joint Replacement Registry.

3
Mission Statement

• Foster a national center for data collection and
• research on total hip and knee replacement
• with far-reaching benefits to society including
• reduced morbidity and mortality, improved
• patient safety, improved quality of care and
• medical decision-making, reduced medical
• spending, and advances in orthopaedic science and
  
• bioengineering.

4
Vision

• An Independent National Total Joint Registry
  Dedicated to the Improvement in Arthroplasty
  Patient Care by Data Driven Modifications in the
  Behavior of Collaborating Providers,
  Institutions, Manufacturers, Payors, and Patients
  

5
Meeting Goals

• ENGAGE a Wide Range of Stakeholders
• REVIEW Work to Date
• ACHIEVE Consensus on Proposed Model and Direction
• IDENTIFY Barriers and Obstacles
• INVITE Formal Participation People/
• COMMIT to a Specific Project Timeline

6
AJRR Timeline 2010

• AJRR Board Appointed
• Workgroup responsibilities transition to AJRR
  Committee April 2010
• Develop and implement registry database system
• Test system 2nd Qtr 2010
• Process live data July 1, 2010
• 750 participants by year one
• Very Aggressive

7
Start-up Financing Commitments

• AAOS - 300,000
• AAHKS - 50,000
• Hip Society - 50,000
• Knee Society - 50,000
• WellPoint - 50,000
• AdvaMed members - 500,000
• 1,000,000

8
Recent Events

• 09/2008 Stakeholder meeting _at_ Brookings
  Institute, Washington, DC
• 02/2009 AAOS BOD appointed AJRR Project Team
• 02/2009 AAOS AJRR team meets with members of
  industry, receives assurances of conceptual
  support for the registry project

9
Recent Events

• 05/2009 AJRR Kick-off Meeting _at_ BOD meeting in
  NYC
• 06/2009 AJRR incorporation as NFP org
• 07/2009 Developed media campaign to generate
  support for AJRR
• 09/2009 - Formation of workgroups
• 10/2009 All Stakeholder Meeting in DC

10
Quality of Evidence for Guideline Recommendations
in CV disease
Source Robert Califf
11
Focus on Post-Approval Data

• Quality improvement
• Performance measurement
• Post-marketing surveillance
• Comparative effectiveness research

12
IOM Definition of CER

• The generation and synthesis of evidence that
• compares the benefits and harms of alternative
• methods to prevent, diagnose, treat, and monitor
  a
• clinical condition or to improve the delivery of
  care.
• The purpose of CER is to assist consumers,
• clinicians, purchasers, and policy makers to make
  
• informed decisions that will improve health care
  at
• both the individual and population levels.

13
IOM Recommendation 6

• The CER Program should fully involve all
• key stakeholders (consumers, patients,
• clinicians, providers, payers, policymakers)
• in key aspects of CER, including strategic
• planning, priority setting, research proposal
• development, peer review, and
• dissemination.

14
Total Hip and Knee Surgeries in the U.S.
1998-2006 (000s)

• Source Hospitalizations - National Hospital
  Discharge Survey 1998-2006. Data obtained from
  U.S. Department of Health
• and Human Services Centers for Disease Control
  and Prevention National Center for Health
  Statistics.

15
Incidence And Average Revision Charge In The U.S.
Source National Inpatient Sample, Healthcare
Cost and Utilization Project 1999-2007.
16
AJRR Consultants

• Robert Portman, JD providing guidance on
  governance, organizational, privacy, and
  protection issues
• Sean Tunis, MD leading the consensus building
  effort among key stakeholder groups
• William Yasnoff, MD, PhD lending expertise to
  the creation of the core data set and in
  addressing data collection barriers

17
Charter and Objectives
18
AJRR Project Charter

• Goals
• Collect Data
• Provide Reports
• Reduce Revision Rates
• Requirements
• Validated Protected Data
• Feedback Analysis Reports
• Patient Access to Their Own Data

19
AJRR Project Charter

• Challenges
• Make Data Submission Easy for Hospitals
• Match Revisions to Original Operation
• Ensure Financial Sustainability
• Estimated Costs
• Startup 781K (2009) 2,503K (2010)
• Ongoing 20 per Procedure

20
Governance Structure
21
AJRR Governance Structure

• Incorporated in Illinois in June 2009
• Will seek 501(c)(3) status as supporting
  organization
• Will not qualify as broadly-supported public
  charity or fee supported
• Can qualify as supporting organization of another
  (c)(3)i.e., AAOS
• Must be controlled by supported org.

22
AJRR Governance Structure

• Control Test
• There are several options, but the one that best
  fits the AJRR and that will give the IRS maximum
  comfort is for AAOS to appoint a majority of the
  board of directors.
• Proposed bylaws drafted to meet this test

23
AJRR Governance Structure

• Proposed Bylaws
• Composition of BOD
• 3 AAOS appointments
• 1 Hip Society
• 1 Knee Society
• 1 AAHKS
• 1 at-large orthopaedic surgeon

24
AJRR Governance Structure

• Proposed Bylaws
• Composition of BOD
• 2 Industry members
• 2 Payor members
• 1 hospital member
• 1 lay/public member

25
AJRR Governance Structure

• Proposed Bylaws
• Composition of BOD
• CEO/Medical Director (ex officio wov)
• Immediate Past President (ex officio wov)
• Board Observers FDA, AHRQ, CMS representatives

26
AJRR Governance Structure

• Proposed Bylaws
• All appointments subject to ratification by AAOS
  Board
• Removal by 2/3 vote of AAOS Board
• 3-year staggered terms option for 1 renewal term

27
AJRR Governance Structure

• Proposed Bylaws
• Officers
• Chair
• Vice Chair
• Secretary-Treasurer
• Chair/Vice Chair from ortho members
• Secretary-Treasurer non-ortho member

28
AJRR Governance Structure

• Proposed Bylaws
• Officers
• Chair1 two-year term
• Vice Chair1 two-year term and then succeeds to
  Chair per AJRR BOD
• Secretary-Treasurertwo-year term subject to 1
  renewal term chairs Finance/Audit Committee

29
AJRR Governance Structure

• Proposed Bylaws
• Committeesbroad representation
• Executive Committee
• Finance/Audit Committee
• Data Management
• Data Protection/Security
• Others TBD

30
AJRR Governance Structure

• Proposed Bylaws
• Committees
• Executive Committee
• Officers
• At-large member selected by AJRR BOD
• CEO/Medical Director (ex officio wov)

31
AJRR Governance Structure

• Proposed Bylaws
• Committees
• Executive Committee
• Acts for AJRR BOD in-between meetings
• Except for big issues like bylaws amendments
  dissolution appointment of officers/directors

32
AJRR Governance Structure

• Proposed Bylaws
• Committees
• Finance/Audit Committee
• Chaired by Secretary-Treasurer
• At least one financial expert

33
AJRR Governance Structure

• Proposed Bylaws
• Committees
• Data Management
• Data Collection
• Data Analysis
• Technology/Software

34
AJRR Governance Structure

• Proposed Bylaws
• Committees
• Data Protection/Security
• Confidentiality
• HIPAA compliance
• Protection from legal discovery
• Liability issues

35
AJRR Governance Structure

• Next Steps
• Initial BOD Approves Bylaws
• File Tax Exemption Application
• Constitute BOD
• Off and running!
• Develop/adopt policies and procedures (in
  progress)

36
AJRR Governance Structure

• Discussion

37
Stakeholder Responses
38
Afternoon Session
39
Welcome

• On behalf of the AJRR Project Team, I hope
• that todays meeting provides a forum for
• frank dialogue about the opportunities and
• challenges that await us. Active involvement
• and commitment is critical to the ongoing
• development and implementation of the
• American Joint Replacement Registry.

40
Mission Statement

• Foster a national center for data collection and
• research on total hip and knee replacement
• with far-reaching benefits to society including
• reduced morbidity and mortality, improved
• patient safety, improved quality of care and
• medical decision-making, reduced medical
• spending, and advances in orthopaedic science and
  
• bioengineering.

41
Vision

• An Independent National Total Joint Registry
  Dedicated to the Improvement in Arthroplasty
  Patient Care by Data Driven Modifications in the
  Behavior of Collaborating Providers,
  Institutions, Manufacturers, and Payors

42
Meeting Goals

• ENGAGE a Wide Range of Stakeholders
• REVIEW Work to Date
• ACHIEVE Consensus on Proposed Model and Direction
• IDENTIFY Barriers and Obstacles
• INVITE Formal Participation People/
• COMMIT to a Specific Project Timeline

43
AJRR Timeline 2010

• AJRR Board Appointed
• Workgroup responsibilities transition to AJRR
  Committee April 2010
• Develop and implement registry database system
• Test system 2nd Qtr 2010
• Process live data July 1, 2010
• 750 participants by year one
• Very Aggressive

44
Start-up Financing Commitments

• AAOS - 300,000
• AAHKS - 50,000
• Hip Society - 50,000
• Knee Society - 50,000
• WellPoint - 50,000
• AdvaMed members - 500,000
• 1,000,000

45
Workgroups
46
Workgroup Composition

• Currently populated by surgeons and AdvaMed
  representatives
• Membership will expand to include additional
  stakeholder representatives
• Governmental reps will be invited to sit-in

47
Workgroups

• Major areas of activity identified
• Opportunity to begin working with stakeholders to
  address organizational and operational issues
• Will serve as a bridge from the current project
  structure to the new Board of Directors

48
AJRR Workgroups and Chairs

• Steering John Callaghan, MD
• Governance and Management Daniel Berry, MD
• Regulatory/Legal/Privacy E. Anthony Rankin, MD
• Core Data William J. Maloney, MD

49
Workgroup Composition

• Currently populated by surgeons and AdvaMed
  representatives
• Membership will expand to include additional
  stakeholder representatives

50
Steering Workgroup

• John J. Callaghan, MD
• Chair
• Daniel J. Berry, MD
• Cheryl Blanchard, PhD
• Rhonda Fellows
• Peter Heeckt, MD, PhD
• William J. Maloney, MD

• E. Anthony Rankin, MD
• Karen L. Hackett, FACHE, CAE Staff Liaison
• Sean Tunis, MD, MSc Consultant
• Ex-officio
• David G. Lewallen, MD
• Richard J. Stewart

51
Steering Workgroup

• Oversee the development of the AJRR Business Plan
  and Budget
• Obtain AJRR financing
• Oversee relationships with stakeholders,
  specifically including the Federal Government
  (e.g., CMS, AHRQ, etc.)
• Oversee relationships with outside entities,
  including
• Congress
• Other registries, both international and domestic
• News media
• Monitor legislation impacting the AJRR
• Develop the surgeon support base for the registry

52
Steering Workgroup

• Met via teleconference 10/7
• Review draft changes
• Key issue discussed
• Adverse event reporting
• Surgeon buy-in and oversight
• Stakeholder buy-in

53
Steering Workgroup

• Discussion

54
Governance and Management Workgroup

• Daniel J. Berry, MD Chair
• Kevin J. Bozic, MD, MBA
• Robert Durgin
• Matthew Hull
• Joshua J. Jacobs, MD
• Michael L. Parks, MD

• Eric Rugo
• Richard N. Peterson - Staff Liaison
• Robert M. Portman Consultant
• Ex-officio
• David G. Lewallen, MD
• Richard J. Stewart

55
Governance and Management Workgroup

• Recommend AJRR Board representation and
  governance
• Propose AJRR bylaws
• Oversee corporate filings as appropriate (e.g.,
  Illinois annual reports. Internal Revenue
  applications, tax returns, etc.)
• Determine the staffing needs of the Registry and
  begin recruitment of necessary AJRR staff,
  assuming the AJRR Board and/or Chief Executive
  Officer are not in place
• Oversee the procurement of necessary operational
  services on behalf of AJRR
• Oversee the development of AJRR policies and
  procedures (e.g., conflict of interest, record
  retention/destruction, antitrust compliance,
  whistleblower, etc.)

56
Governance and Management Workgroup

• Discussions concerning the structure and function
  of the AJRR Board are ongoing
• Stakeholder perspectives vary and comments are
  being taken under advisement
• Other issues on the agenda include
• Incorporation as an Illinois not-for-profit
• Application for 501(c) (3) status
• Application for trademark protection

57
Governance and Management Workgroup

• Discussion

58
Regulatory/Legal/Privacy Workgroup

• E. Anthony Rankin, MD Chair
• Donald C. Fithian, MD
• Norman A. Johanson, MD
• Alicia Napoli
• David N. Royster
• Marlene K. Tandy, M.D., J.D.

• Jeanie Kennedy Staff Liaison
• Melissa Young, JD Staff Liaison
• Robert M. Portman Consultant
• Ex-officio
• David G. Lewallen, MD
• Richard J. Stewart

59
Regulatory/Legal/Privacy Workgroup

• Oversee compliance with regulatory requirements,
  including
• Medical Device Reporting requirements
• Adverse Event Reporting
• FDAs sentinel initiative
• Maximize protection from disclosure of registry
  data
• Research de-identification methodologies
• Ensure compliance with the legal aspects of
  privacy and confidentiality requirements
• Monitor regulatory proposals impacting the AJRR
• Unique Device Identification

60
Regulatory/Legal/Privacy Workgroup

• Currently drafting 2 memos 1 on Legal issues, 1
  on policy issues
• Privacy HIPAA compliance is likely the biggest
  issue
• Breach rules will apply
• Business Associate (BA) agreements for sites is
  necessary (covered under High Tech Act of 2009)
• Participation agreements needed
• Adverse Event (AE) Reporting AJRR not a
  manufacturer or user facility
• AJRR should define policies and procedures for AE
  reporting, access, etc.
• Other issues EHR, Sentinel Initiative, UDI

61
Regulatory/Legal/Privacy Workgroup

• Discussion

62
Core Data Workgroup
63
Core Data Workgroup

• William J. Maloney, MD Chair
• Thomas C. Barber, MD
• Doug Dennis, MD
• Leesa Galatz, MD
• William Jiranek, MD
• Mark A Kester, PhD
• Henrik Malchau, MD, PhD

• Pam Plouhar
• Jing Xie, PhD
• Katherine Sale Staff Liaison
• William Yasnoff, MD, PhD Consultant
• Ex-officio
• David G. Lewallen, MD
• Richard J. Stewart

64
Core Data Workgroup

• Draft Core Data items
• Work with hospitals and surgeon in determining
  Core Data collectability and sources refine Core
  Data items
• Determine timing of data submissions (e.g.,
  daily, monthly, etc.)
• Determine submission mode(s)
• Paper
• Fax
• Online
• Develop procedures on validating collected data
• Oversee technical data protection
• Oversee a pilot project on Core Data collection,
  submission validation
• Review, suggest incentives for hospital
  participation

65
Core Data Workgroup

• Three key areas
• Triggers for data entry
• Core Data set
• Mechanisms for data entry

66
Triggers for Data Entry

• Goal
• Tracks what goes in and what comes out
• Triggers
• ICD-9 procedure codes

67
Triggers for Data Entry
68
Core Data Elements

• Stratified Data Collection
• Level One Data
• Minimum data set to have a functioning registry
• Institutional responsibility

69
Core Data Elements

• Level One Data
• Patient
• Name
• Date of birth
• Social security number
• Diagnosis (ICD-9 codes)
• Sex

70
Core Data Elements

• Level One Data
• Surgeon
• Name
• Surgeon volume computed
• Hospital
• Name
• Address
• Hospital volume computed

71
Core Data Elements

• AJRR Unique Identifiers
• Patient
• Surgeon
• Hospital

72
Core Date Elements

• Why Unique Identifiers
• Allows index procedures to be linked to
  subsequent events
• Permits patients access to their own information
• Enables linkage to other data bases
• Helps to maintain confidentiality

73
Core Data Elements

• Level One Data
• Procedure
• Type (ICD-9 codes)
• Date of Surgery
• Age at surgery computed
• Laterality
• Implants

74
Survival Free of Cup Revision
Cup Type
HG-II
Implex Titanium
PFC
Primary
PSL
Revision
Reflection
Spherical
Trilogy
75
Australian Registry
76
Australian Registry
77
Link v. Oxford v. PCA
78
Core Data Elements

• Level Two Data
• Variables, if collected, would enhance the value
  of the data analysis
• Risk adjustment
• Depending on the data element, could be either an
  institutional or surgeon responsibility

79
Core Data Elements

• Level Two Data
• Patient
• BMI
• Co-morbidities
• CHF, COPD
• Process of Care
• Antibiotic prophylaxis

80
Core Data Elements

• Level Two Data
• The list of potential data elements is endless
• The Data Committee will need to balance the
  burden of data collection with the value any
  given element provides

81
Core Data Elements

• Level Three Data
• Clinical Outcome Tools
• WOMAC, SF-36
• Patient Satisfaction
• Depending on the tool, could be either a surgeon
  or patient Responsibility

82
Core Data Elements

• Level Four Data
• Radiographs
• Provide more in depth analysis of why and how
  implants/procedures fail

83
Core Data Elements

• Data Collection Strategy
• Start with level one data
• Define least burdensome approaches to data
  collection
• Expand hospital participation
• Add data elements incrementally

84
Mechanisms for Data Entry

• Web based
• High volume hospitals and hospitals with
  electronic medical record
• IT solution
• Create institutional registry with existing data
• Download to AJRR

85
Mechanisms for Data Entry

• Low volume hospitals or no electronic medical
  record
• Web based application to enter data on a case by
  case basis
• Complete level one data set
• Administrative claims form AJRR supplement
• Implant information, laterality

86
Core Data Elements

• Discussion

87
Implementation Challenges
88
Implementation Challenges

• Engagement and support from Critical Stakeholders
  influencing TJA outcome
• Recruiting Surgeons and Hospitals
• Make Data Submission Easy for Hospitals
• Incentivize submission as quality measure?
• Match Revisions to Original Operation
• Assure Appropriate Stakeholder Data
  Confidentiality
• Ensure Financial Sustainability

89
Implementation Challenges

• Hospital Buy-in
• Data Capture
• Reporting
• Back to institutions
• Vendors
• Physicians
• Flexibility is crucial

90
Implementation Challenges

• Hospital Buy-in
• Patient safety improvement through easier
  management of recalls
• Better information for contracting decision
  making
• Better information for marketing
• Improved ability to track and manage quality of
  care

91
Implementation

• Data Capture
• Flexibility Important
• Bar Code Scanning
• Capture rate
• Infrastructure
• Bar code location
• Paper capture for later data entry
• Decreased accuracy
• System integration with existing hospital systems
• Proven difficult in the past

92
Implementation

• Reporting
• To Institutions
• To Vendors
• To Physicians

93
Federal Stakeholder Responses
94
Funding
95
Registry Funding Models

• Hospital Fees
• Fee paid by hospital for each patient or annual
  fee for participation
• Most common model for private U.S. registries
• ICD Registry 3000 annual fee
• STS Registry 3750 annual fee
• NOPR 50 fee per patient

96
Registry Funding Models

• Government Funding
• In U.S., typically large multi-year grants from
  AHRQ or NIH.
• Primary funding source for international
  registries
• University of Rochester Muscular Dystrophy
  Registry has received a series of 4 year grants
  from NIAMS and NINDS

97
Registry Funding Models

• Manufacturer Grants
• Large, multi-year grants from industry beyond
  initial start-up phase
• Global Orthopaedic Registry (GLORY) received
  grants for 10 years, but funding ended and the
  registry is much smaller
• German Arthroplasty Register relied on grants for
  several years but had to seek other funding and
  reduce scope
• Manufacturer Fee per Implant
• Manufacturers pay per implant fee to the registry

98
Registry Funding Models

• Payer Add-on Fees
• Public and private health plans pay set per
  implant fee to the registry, on top of standard
  reimbursement
• Common among international public joint
  registries
• UK National Joint Registry 20.00 per implant in
  2009
• New Zealand National Joint Register 10 per
  implant

99
Wrap Up and Next Steps