The American Joint Replacement Registry - Joint Commission

The American
Joint Replacement
Registry

Introduction
Jean Range
Executive Director, Business Development
and
David Eickemeyer
Associate Director, Certification

Introduction
of AJRR
David G. Lewallen, MD
Mayo Clinic
Chairman, AJRR Board of Directors

Why a joint replacement registry?
The AJRR will provide comprehensive
orthopaedic knowledge by examining an array
of outcomes.
Registry information will enable patients and
their surgeons to make the best choices about
their total joint procedure, devices and
rehabilitation.
International registries have seen up to a 50%
reduction in revision rates after registry
initiation and identification of best practices.

AJRR Mission and Vision
Mission 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.
Vision A national total joint registry dedicated
to the improvement in arthroplasty patient care
by data driven modifications in the behavior of
collaborating providers, institutions,
manufacturers, payers, and patients.

Financing
AAOS
American Association of Hip and
Knee Surgeons (AAHKS)
The Hip Society
The Knee Society
Blue Cross and Blue Shield
United Healthcare
WellPoint
Orthopaedic Industry (via AdvaMed)

AJRR Board of Directors
The AJRR Board of Directors includes
representation from the entire
orthopaedic community including:
Orthopaedic surgeons
Orthopaedic industry
Private payers
Hospitals (in 2013)
Public

2012 AJRR Board of Directors
AAOS Representatives
Thomas C. Barber, MD, Kaiser
Permanente
William J. Maloney, MD, Stanford
Hospital
J. Wesley Mesko, MD, Michigan
Orthopaedic Center
E. Anthony Rankin, MD,
Providence Hospital
Specialty Society
Representatives
David G. Lewallen, MD, Mayo
Clinic, [The Hip Society] *
Kevin J. Bozic, MD, MBA, UCSF,
[AAHKS]
Terence J. Gioe, MD, University of
Minnesota, [The Knee Society]
Industry Representatives
Pamela L. Plouhar, PhD, DePuy
Orthopaedics Inc.
Eric Rugo, MBA, Stryker, Inc.
Payer Representatives
Catherine MacLean, MD, PhD
WellPoint Inc.
Steven H. Stern, MD
United Healthcare
Public Advisory Board
Representative
Patience White, MD, MA
Arthritis Foundation
Hospital Representative
To be appointed for 2013
Board of Directors
* AJRR Board Chairman

Public Advisory Board
Established to provide input to the AJRR
Board from a greater spectrum of patient
and public advisory groups
Current advisory members include:
Arthritis Foundation
Society for Women’s Health Research
AARP
Informed Medical Decisions Foundation
The Joint Commission
Patient Representatives

Overall goals and
Objectives of AJRR
Jeffrey P. Knezovich, CAE
Executive Director

AJRR Milestones
June, 2009
February, 2010
October, 2010
November,
2010
May, 2011
June, 2011
August, 2011
September,
2011 - present
Incorporated as a not-for-profit in Illinois
Approved AJRR Board members and bylaws
Started pilot program with 15 hospitals
Attained 501(c)(3) status as “supporting
organization” to AAOS
Business plan finalized, startup funding secured
Pilot study concluded with 8 institutions/11 hospitals
Selected final registry production software
Active recruitment of all hospitals conducting total
hip and knee replacements

AJRR Opportunities
WHERE CAN WE GO?
Approximately 4,200 orthopaedic hospital-based
programs.
We plan to double our hospital participation in each
of the next five years.
Goal: 90% of the programs sign-on by end of 2018.
WHAT WILL BE TRACKED?
An estimated 1 million arthroplasty procedures
annually.
Or, annually we could have data from over
900,000 procedures.
Demand is expected to increase by 2030 *
THA: 174% to 572,000
TKA: 673% to 3.48 million
* Kurtz et al, 2007

2012 Participation Update
Staff of 9 at AAOS Headquarters in
Rosemont, IL
All pilot sites continue to submit data
Over 30,000 procedures in database
400+ new sites have been contacted since
August, 2011
150+ hospitals/health systems are actively
engaged in the recruitment process
N = 64 Business Associate Agreements have
been signed
Representing 93 total hospitals

2012 Participation Update

Participating Hospitals
as of November 28, 2012
• Advocate Christ Medical Center
• Allegheny General Hospital
• Allen Health Systems
• Aurora Advanced Orthopaedics
• Ball Memorial Hospital
• Bayhealth Medical Center
• Benefis Hospital
• Blessing Health System
• Bronson Healthcare Group
• Cabell Huntington Hospital
• Carolinas HealthCare System
• Catholic Health System
• Central Peninsula General
Hospital
• Cleveland Clinic Foundation
• Conway Medical Center
• Denver Health and Hospital
Authority
• Fletcher Allen Healthcare
• Franciscan St. Francis Health
• Grant MedicalCenter
• HealthEast Care System
• Hospital of Central Connecticut
• Indiana Orthopaedic Hospital
• Inova Mt. Vernon Hospital
• Jordan Hospital
• Lakeland Regional Medical Center
• Lancaster General Hospital
• Maine Medical Center
• Massachusetts General Hospital
• Memorial Hermann Southwest
Hospital
• Memorial Medical Center –
Ludington, MI
• Memorial Medical Center –
Springfield, IL
• Mercy Health System
• Nix Health
• NorthBay Healthcare
• Northwestern Memorial Hospital
• NYU - Hospital for Joint Disease
• Ochsner Clinic Foundation
• OrthoCarolina Research Institute
• OSS Orthopaedic Hospital
• Orthopaedic Hospital of
Wisconsin
• Palmetto Health Richland
• Providence Health and Services
• Roper St. Francis Hospital
• Rush University Medical Center
• San Antonio Community Hospital
• Sanford Medical Center - Fargo
• Sanford USD Medical Center
• Scott & White Hospital - Temple
• Sharp Healthcare
• Sibley Memorial Hospital
• Southeast Georgia Health System
• Spencer Hospital
• St. Luke's Episcopal - Presbyterian
• St. Mary's Hospital and Regional
Medical Center
• St. Francis Hospital & Medical
Center (Connecticut Joint
Replacement Institute)
• Swedish Medical Center
• Thomas Jefferson University
Hospitals
• University of California, Los
Angeles Medical Center
• University of California,
San Francisco Medical Center
• Valley Medical Center
• Virginia Hospital Center
• Virginia Mason Medical Center
• Western Maryland Health System
• Winthrop University Hospital

2012 Participation Update
Targeting large hospital networks
Providence Health & Services, Aurora Advanced
Health Care, Ochsner Clinic Foundation, Carolinas
HealthCare System
Targeting major high volume medical centers
Rush University Medical Center, NYU Hospital for
Joint Disease, University of California-San Francisco
Medical Center, Cleveland Clinic, Massachusetts
General Hospital
Targeting institutional collaboratives such as
the High Value Healthcare Collaborative
(HVHC)
Dartmouth-Hitchcock Medical Center, Cleveland
Clinic, Mayo Clinic, Denver Health, and
Intermountain Healthcare

AJRR Collaboration
Collaborative Organizations
International Consortium of Orthopaedic Registries (ICOR)
International Societies of Arthroplasty Registries (ISAR)
AOA National Joint Replacement Registry (Australia)
Swedish Hip Arthroplasty Register/Knee Arthroplasty Register
Danish Hip Arthroplasty Register/Knee Arthroplasty Register
German Arthroplasty Register
California Joint Replacement Registry (CJRR)
AHRQ-funded Function and Outcomes Research for Comparative
Effectiveness in Total Joint Replacement (FORCE-TJR)
Other Hospital Based Registries

Strategic Alliances
Creating Alliances
The Joint Commission
American Board of Orthopaedic Surgeons (ABOS)
U.S. Food & Drug Administration (FDA)
Centers for Medicare & Medicaid Services (CMS)
Meaningful Use of the Medicare Incentive Program
Physician Quality and Reporting System (PQRS)
Pew Charitable Trusts
US Congress

AJRR Program Development
Program Development
Five Year Strategic Planning Document
Product Licensing
Maintenance of Certificate (MOC) Support
Report Writing
FDA Unique Device Identification
Product Surveillance

Review of AJRR Data
Procedures and
Acquisition
Randolph R. Meinzer
Director of Information Technology

AJRR Information Technology
Website - www.ajrr.net
The AJRR Website has additional
information on the data elements,
participation process and other helpful
content for your reference.

AJRR Level 1 Data Elements
LEVEL ONE
• Patient
– First Name
– Last Name
– Date of birth
– SSN
– Diagnosis (ICD-9 )
– Gender
– Ethnicity
• Hospital
– Name (NPI)
– Address
• Surgeon
– Name (NPI)
• Procedure
– Type (ICD-9/ICDP)
– Date of surgery
– Laterality
– Implants (Manufacturer,
Catalog Number and Lot
Number)
Required to track patients nationally
Electronic Data available????????

Hospital Pre-Work Packet
Hospital Information Why??? AJRR Creates an account for each hospital
Hospital Name
Hospital NPI
Street Address
City
State
Zip
Main Contact Last Name
Main Contact First Name
Main Contact Email
Main Contact Phone
Hospital Type (Research, University, Community,
Community Rural, Teaching)
Number of Beds
Physician Information Why??? Physician Identification and drop down menu
Orthopaedic
Surgeon
National
Provider
Identifier
(NPI)
Last
Name
First
Name
Middle
Initial
Orthopaedic
Surgeon
Practice Name
Street
Address City State Zip

AJRR Data Submission Methods
Preferred Method Data file upload to AJRR
One time report effort on the hospitals part
One time effort to refine data
Can be automated
Manual data entry through AJRR Secure web forms

AJRR Level 2 & 3 Data Overview
Available Q2, 2013
Level 2 data allows the AJRR to risk adjust hospital and
physician revision results
Level 2 data elements will include:
Procedure data
Approach, fixation, technique, OR time
Pre/Post-op care
DVT & infection prophylaxis, length of stay, disposition (PQRS
information), SCIP measures
Patient co-morbidity information
Obesity, CAD, diabetes, functional, cognitive, and nutritional
status
Complications
Neurovascular injury, PE, dislocation, MI, infection, fracture,
renal failure, death
Maintenance of Certification Data

AJRR Level 3 Data
Outcome instruments will include:
SF-36
SF-12 and EQ-5D
AJRR will store final scores and trend information on behalf of the
hospital / physician due to licensing constraints.
HOOS and KOOS
WOMAC
Oxford Hip and Knee Scores
Knee Society Knee Scoring System
Harris Hip Score
AAOS Hip and Knee Core Scale
AJRR will offer outcome scoring as a service to
the hospital or physician practice
AJRR Technology supports electronic patient
portals, computerized assessments and outcome
coordinator workflow management

Reporting
Publicly Available Annual Reports
Procedure frequency Nationally and by State/Region
Devices used with Device Specific Survivorship
Volume Effects: By Surgeon and Hospital “Type”
“Early Warning” surveillance of new technology
More specific or individualized data will be
available by subscription
Surgeons, Hospitals, Manufacturers, Payers,
Government Agencies
Frequency could be quarterly, monthly or as often as
needed

AJRR Dashboard Examples

Human Subjects Review
and Legal Agreements
Caryn D. Etkin, PhD, MPH
Director of Research

HIPAA/Common Rule Compliance
Collecting data primarily for quality
improvement/health care operations purposes
May use Protected Health Information (PHI) or
Limited Data Set (LDS) information for research
purposes
We won’t share PHI with any partners/hospitals
Business Associate/Data Use Agreement covers
transmission of PHI and LDS information from
sites to AJRR
AJRR acting as business associate of sites—
providing data aggregation and other quality
improvement functions/services for sites

HIPAA/Common Rule Compliance
For the collection of PHI for research
purposes, need waiver of authorization
Common Rule does not apply to AJRR—
NO federal funding/regulations/Federal Wide
Assurance, but sought waiver of consent anyway
Office for Human Research Protections
(OHRP) says that Common Rule does not
apply to sites that share data with external
researchers

HIPAA/Common Rule Compliance
Western IRB has granted waivers of HIPAA
authorization and Common Rule consent
to cover collection of data for research
purposes
Office for Civil Rights (OCR) and OHRP
both endorse central IRB waivers
Will use LDS info in accord with HIPAA
and agreements

Agreements
AJRR Board of Directors has approved
standard templates and non-negotiation
policy, with limited exceptions, for
Participation and BA/DU Agreements
Templates developed based on
documents used by other registries and
with input from pilot sites et al.
Will issue periodic updates/amendments
based on common concerns

Participation Agreement
Establishes rules for sharing data and
otherwise working together
Variations for hospital systems and use
of 3 rd party vendors for data submission
Participant’s Obligations
Submit accurate data through SSH File
Transfer Protocol or web-based portal
Subject to audit
Third-party vendor option

Participation Agreement
AJRR’s Obligations
Collect, analyze, report on data
Comply with HIPAA privacy and security
rules
Provision for fees—placeholder; no fees right
now, but will announce in 2013
Ownership of data
Sites own the data they submit
AJRR owns database; aggregate data; reports
Standard IP provisions
No return of data upon termination; but
protections live on

Participation Agreement
Indemnification/Limitation of Liability
Mutual with small variations
Will not require indemnification from state
institutions
Term
Through 12/31/12 with automatic renewals
Choice of Law/Governing Forum
Illinois
Intellectual Property
Clarified that Covered Entities are free to discuss
their reports as long as not false and misleading

Business Associate Agreement
Mostly standard
Reporting deadlines based on regulatory
maximums
Data use provisions included “just in case”
AJRR needs to collect or use Limited Data Set
information
“No Return” policy
Breach notification provision include cost
allocation language
Includes mutual indemnification
Relatively few comments, except on reporting
deadlines

Participation Fees
Jeffrey P. Knezovich, CAE
Executive Director

AJRR Staff Contact Information
Caryn Etkin, PhD, MPH, Director of Research
etkin@ajrr.net
Jeffrey Knezovich, CAE, Executive Director
knezovich@ajrr.net
Pamella Leiter, MSA, OTR/L, Director of Policy and Strategic Alliances
leiter@ajrr.net
Randy Meinzer, Director of Information Technology
meinzer@ajrr.net

Questions ????