AJRR BOARD OF DIRECTORS MEETING MINUTES MARCH 10, 2014

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1 AJRR BOARD OF DIRECTORS MEETING MINUTES MARCH 10, 2014 Present: William J. Maloney, MD, Chairman Daniel J. Berry, MD, Vice Chairman Steven H. Stern, MD, MBA, Secretary-Treasurer Eric Rugo, MBA, Officer Director Terence J. Gioe, MD, Vice Chairman Robert L. Krebbs, Director Gregory B. Krivchenia, II, MD, Director Kristen Murtos, MBA, Director Colin Nelson, Director Pamela L. Plouhar, PhD, Director Scott M. Sporer, MD, Director Jeffrey P. Knezovich, CAE, Executive Director David G. Lewallen, MD, Medical Director Caryn Etkin, PhD, Director of Analytics Randolph Meinzer, Director of Information Technology Matthew Timmers, Program Advancement Associate # Richard Stewart, AAOS CFO # Robert Portman, JD, Counsel * *Via conference #partial attendance Excused: E. Anthony Rankin, MD, Director Bryan D. Springer, MD, Director 1.1 Call to Order: The scheduled meeting of the American Joint Replacement Registry Board of Directors was called to order at 8:15 am by Dr. Maloney. The Board members and staff were welcomed to New Orleans. Dr. Maloney expressed his appreciation to the Board for their willingness to arrive early to AAOS Annual Meeting to participate in our deliberations. He requested Mr. Knezovich complete any housekeeping items before considering the agenda. In accordance with AJRR procedures Dr. Maloney reminded each of the Board members of their obligations in order to serve on the Board of Directors (BOD) and requested if any member had any financial or conflict of interest disclosures that should be identified. No new disclosures were announced. 1.2 Introductions: Five new Board members were introduced and congratulated on their election to the Board of Directors. Dr. Maloney acknowledged Mr. Robert Krebbs, Dr. Gregory Krivchenia, Mr. Colin Nelson, Dr. Scott Sporer and Dr. Bryan Springer. 1.3.a Approval of Minutes: Dr. Stern requested a motion to approve the Minutes from BOD meeting on September 11, 2013.

2 A motion was made (Mr. Rugo), seconded (Ms. Murtos) and passed to approve the Minutes from the September 11, 2013 Board of Directors meeting held in Washington, DC. 1.3.b,c Receive the Minutes: Dr. Stern requested a motion to receive the Minutes from BOD Executive Committee meetings on August 8 and December 8, A motion was made (Mr. Rugo), seconded (Ms. Murtos) and passed to receive the Minutes from the August 8, and December 8, 2013 Executive Committee meetings held via conference call. 1.4.a Chairman s Report Annual AdvaMed CEO Conference Call: Dr. Maloney indicated the December 17, 2013 conference call went well. There was good discussion about the direction of the AJRR. During that meeting, Mr. Knezovich presented a slide deck with AJRR accomplishments and plans for growth. During the call the CEO s confirmed they would provide financial support through Follow-up correspondence was received detailing the granting process. 1.4.b Chairman s Report Registry Alliances: Dr. Maloney requested that Dr. Lewallen lead the discussion. The California Joint Replacement Registry (CJRR) received from the AJRR a Memorandum of Understanding (MOU) outlining the criteria for a grant funding. CJRR requested some restrictions on AJRR s recruitment efforts in California and AJRR will need to have Business Associate Agreements signed with those facilities wishing to contribute data to the AJRR. The Michigan Arthroplasty Registry Collaborative Quality Initiative (MARCQI) endorses the AJRR and recommends its hospitals participate in the national collaborative. FORCE-TJR is a national research effort that is collecting data. We have requested they develop correspondence encouraging their individual participants to develop a working relationship with the AJRR. The Virginia Joint Registry is seeking financial support. Dr. Lewallen suggested it might be advantageous for the AJRR to assume the central repository role in that state. AJRR could collect Virginia data and provide it to them for analysis and state reporting. It was confirmed that all negotiations follow the new due diligence requires recently adopted by the Executive Committee. 1.4.c Chairman s Report Centers for Medicare and Medicaid Services (CMS): Dr. Maloney reported that CMS officials requested a follow-up visit with AJRR leadership to discuss our vision for hospital incentives. Representing the AJRR at the January 10, 2014 meeting were Dr. Maloney, Mr. Rugo, Mr. Knezovich, Ms. Buckalew and Mr. Portman. CMS was represented by Dr. Kate Goodrich, Dr. Shari Ling and their senior staff. Not much headway was made on our primary concern of incentivizing hospitals. Rather discussion centered on the requirements pertaining to the Common Rule. Dr. Maloney encouraged ongoing dialog with CMS officials. Our DC staff should nurture a positive working relationship. 1.5.a Treasurer s Report - January 2014 Financial Statements: Dr. Stern, Secretary/Treasurer presented reports outlining the receipts and expenditures for the AJRR. He reported this was the first report of the fiscal year. The budget has been properly loaded and we will be watching everything closely. A motion was made (Gioe, MD), seconded (Krivchenia, MD) and approved to accepted the January 2014 Financial Statements Executive Director s Report Triennial Report: Mr. Knezovich presented the Board with a written report detailing the major activities of the staff since the September 2013 Board of Directors meeting.

3 Dr. Maloney suggested we talk about the staffing needs in Mr. Knezovich indicated he has had a self-imposed moratorium on hiring until the Avalere Health report was filed. In the report he outlined several new positions that cover marketing/ communications and business/finance positions. In 30 days Mr. Knezovich agreed to provide the board a hiring plan including revenue projections. A final policy pertaining to hiring will be adopted at the June Board of Directors meeting. Ms. Plouhar was concerned with the June date. She suggested open positions and an additional recruiter be hired as soon as possible. A motion was made (Plouhar, PhD), seconded (Gioe, MD) and passed to authorize the hiring of the marketing/communication and the additional recruiter positions. Mr. Portman was requested to report on the status of acquiring the Risk Calculator APP. He indicated it was still in legal negotiations with one institution. The institution has requested complete indemnification. Dr. Berry and Mr. Portman will convene a meeting tomorrow to work-out details. 1.6.a Executive Director s Report Commercial Lease: The Board was informed AJRR Counsel Portman has reviewed the Commercial Lease for the new office space and finds it in good order. He is not recommending any revisions. Occupancy is December 5, The base rent for the first year is $9, per month. A motion was made (Berry, MD), seconded (Dr. Stern) and passed that approves the Commercial Lease presented by Ortho Properties, LLC. 1.6.b Executive Director s Report AdvaMed Confirmation: The Board of Directors was apprised through formal communications with Jeffrey Binder, President and Chief Executive Officer, Biomet, Inc. and Chair of AdvaMed Orthopedic Sector that the organization will support the AJRR with $2.2 million in funding for c Executive Director s Report Government Relations: Mr. Knezovich presented a report on the ongoing legislative and regulatory advocacy activities being managed by Judi Buckalew, AJRR Government Relations Consultant. This is the first of many reports to follow. Mr. Knezovich stressed the importance of knowing the Board members relationship with any federal legislator. If you have an ongoing working relationship with an elected official, please provide this information to Judi or Jeff. 1.6.d Executive Director s Report Senator Richard Durbin (D-IL) Opportunity: The Board was apprised of meetings and requests made with Senator Durbin s staff. We are asking for language in the report that will accompany the FY 2015 Labor, Health and Human Services and Education Appropriation bill. The Committee notes that the requirements of the Federal Policy for the Protection of Human Subjects, otherwise known as the Common Rule for protecting identifiable patient information substantially overlap with the stricter, more comprehensive requirements of the regulations issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) for protecting individually identifiable health information (as defined by the HIPPA regulations). To avoid unnecessary duplication of effort, regulatory burden, and cost, the Committee encourages the Office of Human Research Protections in the Department of Health and Human Services to consider adopting an exception to the Common Rule for circumstances where individuals or entities subject to the Common Rule are collecting identifiable patient information, but are not engaged in direct human subjects intervention or interaction, and those individuals or entities are following all the applicable requirements of the HIPAA regulations with respect to protecting the privacy and security of such information.

4 1.6.e Executive Director s Report Commission Mr. Knezovich requested Dr. Lewallen take the lead on this report. It was confirmed that letters to the four partnering specialty societies had been sent and initial discussions with their leadership has been completed. The big issue is finding appointees to the Commission with limited or no conflicts. Again, that conflict is considered on an individual basis, not institutional. We have placed a March 31 deadline for the specialty societies to submit their nominees. 1.6.f Executive Director s Report Physician Quality Reporting System(PQRS) and Qualified Clinical Data Registry (QCDR) Self-nomination Dr. Etkin reviewed the requirements for self-nomination. She reported the AJRR has thus far met every deadline. The initial review indicated the four domains we submitted have been approved. They are now reviewing our measures. The next deadline, March 31, is for AJRR to report how we are going to document and process data related to the PQRS/QCDR process. A motion was made (Mr. Rugo), seconded (Stern, MD) to adopt to receive the Executive Director s Report. 1.7.a Medical Director s Report ISAR 3 rd Annual Meeting: Dr. Lewallen reported that the AJRR has been named a co-sponsor of the ISAR meeting to be held in Cambridge, MA on May 31 June 2, The preliminary program requires additional adjustment and should be published within the next two weeks. Over 100 abstracts have been submitted for consideration. Dr. Lewallen encouraged the entire Board to consider attending this very important meeting. Board members can register through the AJRR website. 1.7.b Medical Director s Report PCORI Grant: Dr. Lewallen reported that he and the staffs at Mayo and AJRR completed a Letter of Intent for significant funding from The Patient-Centered Outcomes Research Institute (PCORI). A coalition of national, state and institutional hip and knee registers will collaborate on the final grant request, should Mayo/AJRR be asked to submit a full application. (Footnote: Over 1700 Letters of Intent were received by the deadline). 2.1.a Analytics Director s Report Hospital Participation: Dr. Etkin reported that 263 hospitals had enrolled with more hospitals joining and submitting data each week. 2.1.b Analytics Director s Report Recruiting Process Metrics & Related Material Dr. Etkin explained that staff would need to spend substantial time on contracting issues with existing hospital participants for two reasons: 1) By September, 2014 all hospitals must have Business Associate Agreements compliant with the HIPAA Final Omnibus Rule that was released in AJRR has approximately 80 contracts that will need to be revised. 2) With the addition of participation fees, hospitals that enrolled prior to June 2013 (N=116) will need to have the Participation Agreements revised. Dr. Etkin said she assumes most of these hospitals will take the opportunity to negotiate new terms for the contracts, requiring a great deal of staff effort. Also, with the need to collaborate with private practice groups to obtain Level 2 and Level 3 data, Mr. Portman developed contracts to be used with these groups. Dr. Maloney stated these did not need full board approval and could be used at any time. 2.1.c Analytics Director s Report 2013 Annual Report: Dr. Etkin discussed the development of the 2013 Annual Report, which will be distributed to the public in conjunction with the AAHKS Annual Meeting. She provided details on two items relevant to the report,

5 including the selection of West Virginia Medical Institute (WVMI) to audit the 2013 data and the identification of an epidemiologist/ biostatistician to assist with analysis, Sylvia Furner, PhD, Associate Professor-Emerita at University of Illinois at Chicago. Additional items regarding the development of the report will be discussed during the New Orleans meeting with the three Data Committee workgroups (Data Analysis, Data Elements, and Research Projects). She referred Board members to the AJRR Annual Report Development Policy and Procedure document for further details. 2.1.d Analytics Director s Report Level 2 & 3 Pilot Program Report: Dr. Etkin provided an overview of the status of the pilot program. Fifteen hospitals agreed to participate, all in various stages of data submission. Dr. Etkin presented the various challenges faced by hospitals in submitting data and suggested the time frame for completion of the pilot program be lengthened by additional months to account for hospital issues and variability. 2.1.e Analytics Director s Report Intern Report Board members were referred to the book for details. 2.1.f Analytics Director s Report Data Management Committee: Dr. Etkin stated that Dr. Berry had selected three surgeons to serve as chairs of the Data Committee workgroups: Dr. Michael Dohm will oversee the Data Elements workgroup; Dr. Brian Hallstrom will oversee the Data Analysis workgroup and Board member Dr. Bryan Springer will oversee the Research Projects workgroup. As mentioned previously, the workgroup chairs will meet later in the week in New Orleans. 3.1.a Information Technology Report Registry Procedural Metrics 2013: Mr. Meinzer reported on the details of the 40,000 plus procedures submitted in calendar year 2013 and the cumulative 90,000 plus procedures submitted to the AJRR. A demonstration of the AJRR National electronic dashboards was presented to the BOD. Questions arose about AJRRs ability to track readmissions. There is a sense we need to utilize comparison data that will aid in identifying readmissions. Dr. Maloney appointed a workgroup of Directors Stern, Rugo and Krebbs; and staffed by Meinzer to develop strategies for collecting the necessary validating data. 3.1.b Information Technology Report Component Reference Database: Mr. Meinzer reported on the progress and efforts to define a component specification and acquire the associated component attributes in partnership with the AdvaMed Orthopaedic sector. AJRR s draft specification was delivered to AdvaMed earlier this year and is in review with the group. Dr. Plouhar informed the BOD that ICOR had recently issued a similar specification to the AdvaMed group for component attributes; she stated that the AdvaMed group wishes to conduct the effort to compile the information once and was assessing the respective specifications prior to beginning the work effort on the attribute details. 3.1.c Information Technology Report Level 1,2 & 3 Data System Initiatives: Mr. Meinzer reported that the Level 1, 2 & 3 pilot system was operational. He also explained that the pilot will be conducted using a separate system to isolate the AJRR Level 1 production registry system from any defects that may have been introduced while developing and adding software for the new Level 2 and 3 systems. These defects will be corrected prior to migrating the new functionality to the AJRR production registry system. Mr. Meinzer also recommended that AJRR extend the L2 &3 pilot duration until the data committee data elements workgroup completes a review of the Level 2 data elements to identify those that will be required versus optional.

6 Mr. Meinzer provided background information on the challenges of changing data element requirements and the effect and additional burden it places on existing registry participants and vendors that develop template reporting modules. Mr. Meinzer recommended that one year freeze on data element changes be implemented once the data element workgroup completes their analysis on the draft L2&3 specification and new Level 2 elements required to become a QCDR. The board agreed with Mr. Meinzer s recommendation. 4.1.Other Business: Dr. Maloney thanked Kristi Mitchell and Chris Boone of Avalere Health for their excellent report for proposed strategic initiatives and business planning for the AJRR. It was suggested a small workgroup from the executive committee convened to dissect the report. Mr. Knezovich will circulate the executive summary once it becomes available. Dr. Maloney appointed Directors Berry, Plouhar, Rugo, Krebbs, Murtos and Nelson to the workgroup. They should report back to the Executive Committee for their May 14, conference call. In addition, one firm recommendation was for the AJRR to hire a chief scientific officer to aid in the review of all the clinical data that AJRR has successfully collected. It was felt this is an important position to have on staff. At first, it could be a part-time position charging an hourly fixed fee. Dr. Maloney requested Director Plouhar, Medical Director Lewallen and Executive Director Knezovich develop a job description for this position. Adjournment: A motion was made (Krivchenia, MD) and seconded (Gioe, MD) to adjourn the AJRR Board of Directors meeting at 2:29 pm.

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