American Joint Replacement Registry

Board of Directors Conference Call

January 5, 2012

MINUTES

Members Present:

David G. Lewallen, MD, AJRR Chair & Hip Society Representative, Mayo Clinic

Kevin J. Bozic, MD, MBA, AAHKS Representative, UCSF

Robert E. Durgin, JD, Industry Representative, Biomet

Terence J. Gioe, MD, AAOS Representative, University of Minnesota & HEJR

William J. Maloney, MD, AJRR Vice Chair & AAOS Representative, Stanford Hospital & Clinics

J. Wesley Mesko, MD, AAOS Representative, Michigan Orthopaedic Center

E. Anthony Rankin, MD, AAOS Representative, Providence Hospital

Eric Rugo, Industry Representative, Stryker Orthopaedics

Steven H. Stern, MD, Payer Representative, United Healthcare

Patience H. White, MD, MA, Patient/Public Representative, Arthritis Foundation

Staff

Caryn D. Etkin, PhD, MPH, AJRR Director of Research

Randolph R. Meinzer, AJRR Director of Information Technology

Robert Portman, JD, General Counsel, Powers Pyles Sutter & Verville PC

Richard J. Stewart, AAOS COO/CFO

Members Absent:

Thomas C. Barber, MD, AAOS Representative, Kaiser Permanente

Catherine MacLean, MD, PhD, Payer Representative, WellPoint, Inc.

Call to order

The AJRR Board of Directors meeting was called to order by David G. Lewallen, MD, Chair at 6:01 p.m. CST. A quorum was established. Dr. Lewallen indicated that AJRR’s antitrust compliance and conflict of interest policies applied. No further conflicts were reported.

Dr. Lewallen welcomed the newest board member, Eric Rugo, Industry Representative from, Stryker Orthopaedics.

Financial Report

Dr. Stern reviewed the November, 2011 Financial Dashboard. He directed members to look at the operating expenses and noted that nothing had changed significantly.

Dr. Stern noted that AJRR has received $650,000 out of the $900,000 commitment from industry. In December, two companies’ donations were still outstanding. The smaller of the two companies did contribute and that amount will be reflected in the November statement. Dr. Stern is hopeful that over the next 45 days the remaining balance will be received.

Mr. Durgin expressed concerns about the budget performance against budget and milestones. Those concerns were addressed and Dr. Lewallen offered to work with Mr. Stewart on a presentation which could be provided explaining the AJRR budget and funding process.

Mr. Stewart acknowledged that there is a slight disconnect between industry, organizations and the industry staff assome organizations have hadstaff turnover. Mr. Stewart expects quicker funding turn-around in 2012, and also suggested we might send out preliminary funding requests asking for funding based on 2011 market share allowing industry to adjust accordingly. Mr. Rugo believed industry would be ok with that since market share does not change that much.

Dr. Lewallen confirmed that the AJRR has been building a reserve so funding would be available to bring new staff on board when needed. A better idea on the 2012 budget will be outlined by the next face-to-face meeting in March, including feedback from AdvaMed.

Dr. Lewallen also stated that AJRR has been very responsible with spending and offered to put together a document explaining in greater detail where the money is and where it will be going.

Action

Dr. Lewallen and Mr. Stewart to work together on a “budget explanation” presentation/talking points for future AdvaMed and other meetings.

Report on AdvaMed Presentation

Dr. Bozic updated all present on the AdvaMed orthopedic workgroup meeting he attended on December 15, 2011 regarding AJRR progress to date. He shared the budget and discussed where AJRR deviated from it in terms of progress. Dr. Bozic gave a revised estimate of where AJRR would be in a year from now. The funding request was kept consistent with 2010 because AJRR wants to build reserve funds for additional staff.

Mr. Durgin believed the presentation was well received. AdvaMed reaffirmed their commitment to the registry, but did have questions regarding 2012 budget performance against budget and milestones.

The initial meeting with the AdvaMed workgroup for 2012 was held on January 4th and will continue on a weekly basis.

AdvaMed requested that AJRR make funding decisions earlier this year, and Mr. Durgin felt we should set a goal to have this resolved.

Update on RemedyMD

Mr. Meinzer reported on RemedyMD’s progress. Multiple meetings were held over the past three weeks and Milestone data delivered the first test version on January 4th. Mr. Meinzer stated the database will be turned over to us this week. He further stated that we gave them the dashboards and they demonstrated how it will work. RemedyMD have designated 4 workgroups with the ultimate goal being to have the entire AJRR implementation by the end of January.

Dr. Lewallen feels we should begin to develop a level 3 outcome suite proposal before the Academy Meeting begins so we can inform interested parties that AJRR is currently working toward implementation and collection of Level 3 data in 2012.

Action

Dr. Bozic will send information on what’s being used in the California registry to Mr. Meinzer and the Board.

Update on Hospital Recruitment

Dr. Etkin provided an update on hospital recruitment. A number of agreements were signed in December bringing the number to 8 contracts and sites preparing their data for submission. 4 more conference calls are scheduled for January. She is waiting for contracts from 14 other hospitals with 70 others are in some process of discussion. Dr. Etkin stated that she is focusing efforts on larger systems and state registries as much as possible.

Mr. Meinzer added that Mooresville, IN sent all of their 2011 data. He stressed that many hospitals are in a “hold” mode working with their IT people or waiting for RemedyMD to be up and running. To date there are 11 active hospitals and data from Massachusetts General Hospital is forthcoming as well.

Dr. Bozic asked if RemedyMD was holding up the process, to which Mr. Meinzer replied no. Mr. Meinzer started that ¾ of the groups are working with their IT people. Mr. Meinzer feels that is the area AJRR needs to work on to make it simpler for IT to do batch data submission.

There was a brief discussion around whether state registries have the authority to disclose hospital data to another registry as a group or if we have to go to each hospital individually to get their approval. The question of duplicate records was also brought up.

Mr. Meinzer addressed the duplicate records question by stating that if AJRR has an agreement with a state registry which was previously an AJRR participant, the AJRR can turn off the individual hospital’s information feed and import only the information from the State registry.

Action

Dr. Etkin to get a summary of total numbers and total number of hospitals, create a map and incorporate that in to talks for AAOS.

Committee Structure and Activation of Committees

Dr. Lewallen provided an update on Committee Structure. Some committees have not been active and Dr. Lewallen feels the need to increase memberships in those groups. Dr. Lewallen asked everyone to look at the list and forward any recommendations on who should be on what committee to Dr. Etkin and copy him. Dr. Lewallen also thinks that the smaller groups need additional membership.

Dr. Maloney believes the data committee should have members of individual hospitals. Dr. Lewallen felt hospital representation should be on both committees preferably. Dr. Gioe offered suggestions of people who work with other large registries.

Dr. Lewallen approved the Board Minutes sent out earlier in the day.

Action

All are to look at the committee structure list and send Drs. Etkin and Lewallen suggestions before the next Executive Committee meeting.

Update on Marketing and Communications Materials

Dr. Etkin provided everyone an update on Marketing and Communications Materials which were reviewed by the Executive Committee on December 15th and altered per their instruction

Dr. Etkin reminded everyone that this is our “branding” and is not standalone.

Dr. White suggested that we show this to non-registry people and see how the message is received.

Dr. Maloney stated that the current AJRR website is in need of an update. Mr. Meinzer acknowledged and agreed. He has already set a meeting time early next with Ms. Venable to work on an update before annual meeting. We will continue to improve as we have time and hopefully this will be done by end Q1.

Action

Dr. Etkin will forward the marketing materials to Dr. White to share with the Public Advisory Board. Mr. Meinzer and Ms. Venable will update the AJRR website prior to the Annual Meeting

Patient Safety Act

Dr. Lewallen had a brief discussion on the Medical Device Patient Safety Act. Dr. Rankin will be attending the meeting next week with Mr. Portman and Ms. Kennedy of the AAOS Washington, DC office. Surgeon and academic input was invited. Dr. Lewallen felt this might be a good opportunity to see what is on tap with the bill.

Mr. Portman doesn’t see a direct role for registries. He felt it has a greater impact on companies that have clearance.

Dr. Lewallen believes it would be good to hear what has to be said and is an information gathering session.

Action

Mr. Portman and Dr. Rankin to report their comments from the meeting at the next Executive Committee session.

AAOS Annual Meeting

Dr. Lewallen discussed the AJRR Annual Meeting scheduled provided in the e-mail. The schedule includes registry related functions at the Annual Meeting along with AJRR meetings and scheduled functions. AJRR Board members are members of ISAR and as such can attend the ISAR meetings.

Action Items

Dr. Lewallen mentioned that there were no pressing points needing to be discussed, but that the item will be kept on the agenda for each call as a reminder and help the board not drop the ball on anything requiring attention.

Adjournment

Dr. Lewallen adjourned the meeting at 7:30pm CST.

Prepared By:Approved By:

Lore VenableSteven Stern, MD

AJRR Administrative AssistantAJRR Treasurer/Secretary

Date: ______Date:______