AJRR BOARD OF DIRECTORS MEETING MINUTES SEPTEMBER 11, 2013

Transcription

1 AJRR BOARD OF DIRECTORS MEETING MINUTES SEPTEMBER 11, 2013 Present: William J. Maloney, MD, Chairman Terence J. Gioe, MD, Vice Chairman Steven H. Stern, MD, MBA Secretary Treasurer Daniel J. Berry, MD, Director Kevin J. Bozic, MD, MBA, Director J. Wesley Mesko, MD, Director Kristen Murtos, MBA, Director Colin Nelson, Guest, Public Advisory Board Pamela G. Plouhar, PhD, Director E. Anthony Rankin, MD, Director Eric Rugo, MBA, Director Patience H. White, MD, MA, Director, Public Advisory Board Jeffrey P. Knezovich, CAE, Executive Director David G. Lewallen, MD, Medical Director Caryn Etkin, PhD, Director of Research Randolph Meinzer, Director of Information Technology, Security and Privacy Officer Richard Stewart, AAOS CFO Robert Portman, JD, Counsel Excused: Thomas C. Barber, MD, Director Catherine MacLean, MD, PhD, 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. 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. Dr. Berry disclosed his relationship with Mayo Clinic and that he has received royalties for contributing chapters to numerous scientific publications. Dr. Plouhar requested she receive the appropriate documents to file a formal conflict of interest statement. 1.2 Introductions: Three additional individuals participated in the meeting. Dr. Maloney welcomed Dr. Dan Berry to his first meeting as a director. Mr. Colin Nelson represented the Public Advisory Board. Mr. Richard Stewart attended to make a report pertaining to AJRR financial reporting.

2 1.3.a Approval of Minutes: Dr. Stern requested a motion to approve the Minutes from Board of Directors meeting on July 17, A motion was made (Mesko, MD), seconded (Rankin, MD) to approve the Minutes from the July 17, 2013 Board of Directors meeting held via conference call. 1.3.b Receive the Minutes: Dr. Stern requested a motion to receive the Minutes from Board of Directors Executive Committee meeting on June 13, A motion was made (Bozic, MD), seconded (Gioe, MD) to receive the Minutes from the June 13, 2013 Executive Committee meeting held via conference call. 1.4.a Chairman s Report Registry Alliances: Dr. Maloney requested that Dr. Lewallen lead the discussion. Reference was made to the exhibit in the Board materials. Four registries, including those in California, Virginia, Michigan and FORCE TJR have been contacted about establishing partnerships. Board members agreed financial support can be provided at the onset, but that funds will end after a period of time. Equally important, prior to agreeing to contractual terms, the AJRR will conduct proper due diligence (security issues, value proposition and corporate structure) that is necessary for creating a successful business relationship. A motion was made (Plouhar, PhD), seconded (Rankin, MD) to approve the release of the Letter of Agreement to the California Joint Replacement Registry. Authorization is afforded the AJRR Executive Committee to negotiation the terms for the remaining three registries. Dr. Maloney named a workgroup including Mr. Rugo and Mr. Knezovich to develop the value proposition for registries to join the AJRR alliance. 1.4.b Chairman s Report Legislative Day: Mr. Knezovich reviewed and reported on the outcome of the AJRR Legislative Day. Per the visitation schedule the AJRR met with representatives of the Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS). Both meetings were successful and will allow for additional follow up by staff. In the afternoon, the following Senate and Representative offices were visited: Senator Hatch (UT) Congressman Rogers (MI) Senator Boxer (CA) Congressman Walorski (IN) Senator Feinstein (CA) Congressman Schakowsky (IL) Senator Stabenow (MI) Senator Coats (IN) Mr. Knezovich requested that Board members who visited these offices provide him with details of the visit so the appropriate follow up correspondence can be prepared for distribution. The general opinion of the Board is that visits were well planned and accomplished the AJRR s goal to introduce our concerns affecting the growth of the AJRR and informing decision makers of

3 our willingness to be a valued resource for information. The consensus is for the Board is to hold a similar program next year. 1.4.c Chairman s Report AdvaMed 2014 Funding: The July 12, 2013 correspondence from Mr. Jeffrey R. Binder, Chair of the AdvaMed Orthopaedic Sector was presented to the Board. In the correspondence it was outlined that the AJRR can maintain its annual funding by achieving several initiatives: 1) Develop a value proposition to meet the varying needs of participating hospitals and a marketing strategy by Q to implement the value proposition in ) Establish new recruitment and hospital participation goals with AJRR performance criteria through the end of ) Develop a revised business plan by Q which includes alternate funding sources (e.g. grants, licenses, other stakeholder commitments, AJRR product sales). The Board will consider its options during the Board s discussion of the proposed 2014 budget. 1.5.a Treasurer s Report July 2013 Financial Statements: Dr. Stern, Secretary/Treasurer, presented reports outlining the annual receipts and expenditures for the AJRR. He reported that as of mid year the budget remained on target. He was pleased to report that each of the major funding companies had paid their 2013 commitment. The investments approved by the Board are secured in Certificate of Deposits. An attempt to ladder those funds is on going through the renewal process. A motion was made (Gioe, MD), seconded (Mesko, MD) and approved to accepted the July 2013 Financial Statements. 1.5.b Treasurer s Report Proposed 2014 Budget: Dr. Stern and Mr. Knezovich reviewed the AJRR proposed 2014 budget. The executive committee charged them with developing a budget not to exceed $2.4 million. With that consideration funding would be available for a business review, government relations programming, registry grants, new office space costs, and software needs. The proposed budget maintains the current level of staffing. The Board addressed the issues in the AdvaMed correspondence. Board exhibit 1.6.c contracts Avalere Health to complete a business review in accordance with AJRR specifications. Since the funding is available the board considered the contract. A motion was made (Bozic, MD), seconded (Gioe, MD) and approved the contract with Avalere Health LLC to conduct a business review. Concerns were expressed about the lack of funding for new personnel. Dr. Maloney indicated dollars were available for consultants. The AdvaMed correspondence strongly urged expansion of the recruitment efforts. A motion was made (Plouhar, PhD), seconded (Stern, MD) and approved to allow for up to 10% of the reserve funds (available funds, less 2014 Budget) to be allocated for new staff

4 positions. Mr. Knezovich will report to the Executive Committee on the appropriate staffing model. A motion was made (Stern, MD), seconded (Plouhar, PhD) and approved the 2014 budget with the necessary modification. It was noted that the business review charges will be reflected in the 2013 budget. It was suggested before a decision be made on retaining a government relations firm, that the AAOS Washington Office be requested to respond. Mr. Knezovich will facilitate. 1.5.c Treasurer s Report 2012 Tax Filing: It is the responsibility of the Board to understand all phases of financial management, including the preparation and filing of tax reports. Mr. Stewart presented the 2012 returns for discussion. A motion was made (Stern, MD), seconded (Rankin, MD) and approved to file the 2012 Internal Revenue Service documents as presented. 1.6.a Executive Director s Report Qualified Clinical Data Registry: Mr. Knezovich presented the AJRR response to CMS regarding the proposed regulations to establish Qualified Clinical Data Registries within the 2012 physician fee schedule. Staff prepared the document after consultation with AAOS Washington staff and AJRR leadership. On September 3, 2013 the AJRR Executive Committee approved the correspondence and moved that it be filed by the September 6 deadline. 1.6.b Executive Director s Report National Coalition of Registries: Mr. Portman, whose firm represents the Coalition, presented information regarding the group s activities. The Coalition currently represents 21 national registries. Most recently meetings were held with the Office of Civil Rights and Office of Human Research Protections. Mr. Knezovich represented the Coalition at that meeting seeking clarification of the Common Rule to clinical data registries. The Coalition will continue to monitor laws/rules coming out of Congress and the federal agencies. 1.6.c Executive Director s Report Avalere Health LLC: Per the discussion at the time of budget considerations, the Avalere Health scope of service and review plans were approved. 1.7.a Medical Director s Report Maintenance of Certification (MOC): Dr. Lewallen reported that the AJRR submitted a proposal to the American Board of Orthopaedic Surgery (ABOS) to develop software through the AJRR to satisfy the requirements for MOC Part IV. The ABOS should report back to AJRR later in September. 1.7.b Medical Director s Report International Society of Arthroplasty Registries (ISAR): Over the past several months the AJRR has been working with ISAR leaders to develop a program for their third annual meeting, to be held in Boston May 31 June 2, The AJRR is a sponsoring organization, meaning AJRR staff will assist with meeting planning and on site registration. Dr. Lewallen encouraged all Board members to register for this important meeting. 1.7.c Medical Director s Report Hospital Incentives:

5 Dr. Lewallen reported that AJRR staff has been examining strategies or ways to incentivize hospitals for their participation in the Registry. Refining approaches with multiple layers of management varies and it is imperative to address each layers concerns. It is anticipated that the Avalere business review document will highlight some successes, but undoubtedly bring to light difficulties in our inability to properly message AJRR goals. 2.1.a Information Technology Report Data Collection Metrics: Mr. Meinzer reported to the Board that the number of hospitals submitting data has increased significantly. As of the meeting 91 hospitals were submitting data on a regular basis. More importantly, with the addition of staff approximately 2300 new procedures are added to the system on a weekly basis. Mr. Meinzer continues to work with the manufacturers regarding obtaining their component catalogs. The Board members expressed a willingness to intervene if any one of the manufactures delayed in getting catalogs to the AJRR. 2.1.b Information Technology Report HIPAA Compliance Policies: Regulations set forth in the HIPAA Final Omnibus Rule require business associates to develop formal policies and procedures (P&P) focused on protection of electronic Protected Health Information. Twenty nine polies and procedures were drafted by AJRR staff and were presented to the Board for approval. A motion was made (Rugo), second (Rankin, MD) and approved policy that the AJRR will remain in compliance with all HIPAA regulations and that the required annual P&P review and staff training compliance will be presented annually to the AJRR Board of Directors. 2.1.c Information Technology Report Level 2 & 3 Update: Mr. Meinzer reported that AJRR and Remedy Informatics were nearing completion of the AJRR Level 2 and Level 3 development efforts. The current schedule for completion of the development effort, verification and validation testing is early October inclusive of two iterations of defect, correction and retest cycles. AJRR staff anticipates that a AJRR Level 2 and Level 3 data collection pilot program will be required will be required prior to a national launch of the new system.. The Level 2 Level 3 pilot is intended to identify the data collection method and solicit hospital participants feedback on the workflow and patient portal. AJRR staff is targeting Q4, 2013 for the pilot. National launch of the new AJRR production registry is expected Q A short video of the AJRR Level 2 & 3 system capabilities was presented by Mr. Meinzer. 3.1.a Research Report Hospital Participation Metrics: Dr. Etkin reported that as of September 1, 2013 N=123 institutions have signed agreements with AJRR, reflecting a total of N=188 hospitals. This is an increase of 50 hospitals since the March Board meeting. The AJRR business plan called for 180 hospitals be on board by year end. It is expected that 2013 enrollment will exceed this estimate by 20%.

6 3.1.b Research Report Recruiting Timelines): Chairman Maloney requested a report on the time required for AJRR to confirm hospital participation: Mean number of s per hospitals 35 Mean Number of individual contacts made within the institution 4.5 Mean number of months from initial contact to signing an agreement 8 Estimates legal cost for 11 hospitals requesting legal consult = $ c Research Report Annual Report Update: The Board of Directors was presented with an outline for the next public reporting cycle of AJRR 2012 data. There was much discuss as to whether or not the AJRR is prepared to publish a detailed report in advance of the November deadline. It was suggested that staff accumulate information that will update the last report and determine what other items can be included. It was stressed we need accurate and meaningful data to gain recognition from our international colleagues. We need to be careful on what we report. A motion was made (Mesko, MD), seconded (Rugo) to approve the release of a 2012 Progress Report. 3.1.d Research Report Intern Report: The Board of Directors is provided with information pertaining to the activities of last year s student intern program. Each year, AJRR sponsors a DePaul University Master of Public Health (MPH) student intern. Last year s intern Rylee Christensen developed web based content for the patient education portal of the AJRR website. 3.1.e Research Report Report of Data Committee: Committee Chair Dr. Berry reported on the organizational meeting of the Data Committee. Review of charges and activities dominated the discussions. Dr. Berry will develop a series of new charges to better reflect each of the work groups responsibilities. Also, industry will need to identify the individuals they would like to serve in the various positions open to them. 4.1 Other Business: No other business was identified Adjournment: A motion was made (Mesko, MD) and seconded (Gioe, MD) to adjourn the AJRR Board of Directors meeting at 2:19 pm. Respectively submitted, Steven H. Stern, MD Secretary/Treasurer