SNM Board of Directors Arlington, VA April 29, 2012 DRAFT Members in Attendance: George Segall, MD; Fred Fahey, DSc; Gary Dillehay, MD, FACNM; Dominique Delbeke, MD, PhD; Richard Noto, MD; Ann Marie Alessi, BS, CNMT, NCT, RT(N); Brenda King, CNMT, FSNMTS; Carolyn Anderson, PhD; Peter Conti, MD, PhD; Bennett Greenspan, MD; Hossein Jadvar, MD, PhD, MPH, MBA; Tony Knight, MBA, CNMT, RT(N), NCT; Cindi Luckett-Gilbert, MHA, PET, CNMT, FSNMTS; Michael Middleton, MD; Jeff Norenberg, PharmD; Harvey Ziessman, MD; Virginia Pappas, CAE Members Not in Attendance: Munir Ghesani, MD; Peter Herscovitch, MD; Martin Sandler, MD SNM Staff in Attendance: Nikki Wenzel-Lamb, MBA; Jenny Mills, Sabrina Robinson, Judy Brazel, CMP; Joanna Spahr; Bob Milanchus; Rebecca Maxey; Sue Bunning; Bonnie Clarke; Marybeth Howlett; Pam Colman; Vince Pistilli; Christine Cachuela; Matt Dickens 1. Welcome and Call to Order George Segall, MD, SNM President, called the SNM Board of Directors meeting to order at 8:07am EST. Richard Noto, MD, SNM Secretary/Treasurer, confirmed a quorum was present. A motion was made to approve the SNM Board of Directors agenda for April 29, 2012. It was moved, seconded and unanimously voted to approve the SNM Board of Directors agenda for April 29, 2012. A motion was made to approve the standing rules. It was moved, seconded and unanimously voted to approve the standing rules. 2. Banner Issues and SNM Strategic Plan Dr. Segall explained that in 2010 the SNM approved a new strategic plan. In reviewing the strategic plan, the current goals were seen as “tactics” to achieve the banner issues. a. Value/Quality Dr. Segall reminded the board members that SNM has contracted with Avalere to develop a plan for SNM’s involvement in evidence-based medicine. Specifically, through surveying SNM’s existing involvement in the evidence-based medicine landscape, Avalere sought to: recognize, understand, and consider approaches to evidence development and quality improvement opportunities and frame key issues for SNM’s engagement in this area. . Through this assessment, several themes were identified: i. Lack of “good”, clinical evidence may be leading to decline in the value of the specialty ii. There is a need to promote standardization for high quality evidence iii. Developing partnerships early and often will support SNM’s credibility and impact iv. Quality is defined uniquely within the profession & used differently by stakeholders v. Appropriate training is required to ensure competency in reading molecular imaging and nuclear studies vi. There is a need to increase public awareness about the value of nuclear medicine & molecular imaging 1 vii. Diverse membership highlights an array of needs to support nuclear medicine and molecular imaging viii. An efficient, highly communicative, and appropriately aligned SNM organization model is necessary to mitigate challenges facing the field A tactical plan was also developed to address the themes mentioned above. Dr. Segall noted that SNM has been working with the Center for Medical Technology Policy (CMTP) and the University of Washington on a workshop: “Design of Comparative Effectiveness Research for Studies of Nuclear Medicine Imaging in Oncology: PET for Head and Neck Cancer.” The meeting will aim to produce a clearly defined framework for conducting studies that will improve the evidence available for clinical and health policy decision making. It was suggested that the outcome be published in the Journal of Nuclear Medicine following the meeting. In addition, through SNM’s work with Avalere, SNM now has developed a framework for developing appropriate, data-infused appropriate use criteria for beta amyloid imaging that is well understood by and applicable for SNM staff and members Board members requested feedback on how the SNM plans to handle the American College of Radiology’s new positions statement saying that they will not allow participating organizations to have overlapping guidelines. Dr. Segall explained that SNM will be collaborative with ACR when/if appropriate and individual representatives will continue to be involved. However, SNM will continue to retain their guidelines as we believe they best outline the procedures for optimal patient care. b. New Radiopharmaceuticals i. FLT Consortium Dr. Segall outlined the obstacles surrounding the introduction of new radiopharmaceuticals. Michael Graham, PhD, MD and others have developed a comprehensive proposal for the FLT Consortium in preparation for a meeting with the Federal Drug Administration (FDA) later this week. The 20‐page letter was submitted to FDA on February 20, 2012. The meeting is scheduled for Wednesday, May 2. Attendees will include Michael Graham, John Hoffman (via teleconference), Paula Jacobs, Gary Kelloff, Lalitha Shankar, Frank Lin, Craig Hill, Marlene Schultz‐Depalo, Virginia Pappas and SNM staff. If the FDA agrees with the approach, the complete plan to create the consortium will be reviewed and discussed by the board. ii. Gallium-68 Jeffrey Norenberg, PharmD, identified that Goal B, Strategy 4 suggests that SNM will create forums for commercial manufacturers to work together towards approval of new agents, such as Ga-68. Dr. Norenberg reviewed the proposed development plan for a gallium consortium. An immediate, achievable goal of the consortium would be to develop a template for a harmonized IND for 68Ga‐DOTATOC/TATE agent to facilitate independent submissions. Board members discussed other possible avenues to develop this molecular imaging agent, including an orphan drug status. The board agreed to continue the discussion over the next several weeks and to review a final plan in June. iii. FDA White Paper 2 Dr. Segall reviewed a paper entitled, “The Risk/Benefit Assessment and the Regulation of Molecular Imaging Agents” developed by Michael Graham, PhD, MD and Adrian Nunn, MD. The purpose of the paper is to provide an overview of the evidentiary framework that the Federal Drug Administration should consider when reviewing diagnostic imaging agents. Board members expressed concern that some information in the paper is dated and not relevant to current day practice. It was agreed that the paper should be revised to include the specific outcomes the SNM is seeking. Dr. Segall recommended convening an FDA Subcommittee, chaired by Henry VanBrocklin, PhD and Sally Schwarz, PharmD that will include several individuals from the SNM Board of Directors who have a direct interest (Dr. Anderson, Dr. Norenberg and Dr. Conti). The final white paper will be submitted to the board in June. c. Therapy Dr. Segall explained that Bayer approached SNM at the European Association of Nuclear Medicine (EANM) meeting and indicated that its GRID (GIST - Regorafenib in Progressive Disease) trial was completed and that the agent was fast tracked for approval and will most likely be approved by 2013. The board agreed that an strategic plan for therapy should be created to prepare members on how radiotherapy and this new therapy will be utilized. Specific attention will be paid to the technologists and what they will need as well. It was requested that the fishbone strategic plan be created prior to the June meeting. . d. New Technologies i. PET/MR Hossein Jadvar, MD, PhD, MPH, MBA, SNM board member and Correlative Imaging Council (CIC) Board member provided a brief overview of the PET/MR educational plan developed by the CIC. The plan suggests a series of case review courses, similar to the CT case reviews. In total, it is recommending that there be 1,500 cases over 5 years. The complete plan will be reviewed by the Education Committee during the Annual Meeting in June. Board members requested that SNM work with International Society for Magnetic Resonance in Medicine (ISMRM) to develop PET/MR education and develop a white paper on best practices. Ann Marie Alessi, BS, CNMT, NCT, RT(N), SNMTS President informed the board that the SNMTS had already partnered with the ISMRMT and was working on a white paper that would outline best practices for technologists working with PET/MR. In addition, the SNMTS and ISMRMT are collaborating on educational sessions at both meetings. ii. Optical Imaging Fred Fahey, DSc., SNM President-Elect, explained that SNM has becoming increasingly more engaged in the optical imaging space. The goal is to engage the optical imaging community and to make SNM their home for education, advocacy and resources. Dr. Fahey announced that he would be seeking the assistance of the Center for Molecular Imaging Innovation and Translation (CMIIT) to develop an optical imaging plan. A new task force will work between June and December to develop 3 a comprehensive plan. The plan will be reviewed by the Board during the MidWinter Meeting. Board members suggested that SNM form alliances with key optical imaging organizations. e. Dose Optimization Dr. Fahey informed the board that he has asked Adam Alessio, PhD, to co-chair the Dose Optimization Task Force. Over the past several weeks, a preliminary plan has been created which will focus on providing information and guidance regarding dose optimization to imaging professionals, referring physicians, and the public. SNM has already been involved with Image Gently and Image Wisely and the Go with the Guidelines campaign. SNM also collaborated on the Pediatric Radiopharmaceutical Administered Doses: 2010 North American Consensus Guidelines. Over the next several months, SNM will begin work with the Choosing Wisely Campaign. The Choosing Wisely campaign is designed to help physicians, patients and other health care stakeholders think and talk about overuse of health care resources in the United States. By identifying specific tests or procedures that physician specialty societies say are commonly used but not always necessary in their respective fields, the societies aim to stimulate discussion about the need – or lack thereof – for many frequently ordered tests or treatments, many of which are requested by patients. Over the next six months, SNM will begin the process of creating its list of “Five Things Physicians and Patients Should Question” and will provide specific, evidence-based recommendations physicians and patients should discuss to help make wise decisions about the most appropriate care based on their individual situation. Board members requested that the SNM become more involved with the Conference on Radiation Control Program Directors (CRCPD). Dr. Fahey and Cindi Luckett-Gilbert, MHA, CNMT, PET, FSNMTS, will be attending the meeting next week. The SNMTS will invite the CRCPD representative to attend the SNM meeting and provide an update during the National Council of Representatives meeting as well as the Radiopharmaceuticals and Government Relations Committees. f. Strategic Planning Grid Virginia Pappas, CAE, Chief Executive Officer, informed the board that the 2 nd quarter strategic plan measurement grid was included in the agenda. The grid is updated quarterly on the website and lists each department and which committees are responsible for managing each program. The SNM Board of Directors adjourned at 12:12pm for lunch. The SNM Board of Directors reconvened at 1:01pm. 3. SNM Proposed Name Change Dr. Fahey, Co-chair of the Name Change Task Force, provided an overview of the process and thanked Carolyn Anderson, PhD and Kathy Hunt, MS, CNMT for their work throughout the process. Virginia Pappas, CAE, SNM Chief Executive Officer explained that the official vote to change the SNM’s Articles of Incorporation will take place at the Plenary Session on Monday, June 11, 2012 during the SNM Annual Meeting in Miami, FL. The session is open to all attendees; however the voting members will be required to have a voting card in order to vote. For pre-registered voting members, the voting cards will be attached to the name badges that are mailed with attendee 4 registration packets prior to the meeting. Attendees who register after the registration deadline can pick up their voting card and badge at the registration desk onsite. Mrs. Pappas indicated that the society will offer legal assistance and guidance for the chapters to assist them with this process. Board members requested that several reminder notices be sent to the registrants to remind them to attend the plenary session and vote. a. Review of Proposed Logos Dr. Segall showed the board members several proposed logos, if the vote of the membership is positive. Ms. Alessi presented several additional options. Board members requested various changes to the logos. The logos will be revised to the specifications of the board and will be revisited on an upcoming conference call. b. Website Mrs. Pappas reminded the board that SNM purchased www.snmmi.org to use as the new domain name, if the board so chooses. c. Chapter Charter Mrs. Pappas explained that on a recent Committee on Chapters conference call, several Chapters asked if they could utilize “doing business as (DBA)” rather than undergoing the process of formally changing their name. In speaking with SNM’s legal counsel, it was determined that this is a feasible option, although not recommended as it may cause confusion amongst the chapters or organizations doing business with the chapters. A motion was made to allow SNM affiliated chapters to utilize “doing business as (DBA).” Chapters will be able to utilize to the “doing business as (DBA)” function for the foreseeable future. It was moved, seconded and unanimously voted to allow SNM affiliated chapters to utilize “doing business as (DBA).” Chapters will be able to utilize the “doing business as (DBA)” function for the foreseeable future. 4. President’s Report Dr. Segall presented his president’s report (appendix A). 5. President-Elect Dr. Fahey reminded the SNM Board of Directors that he was currently working on the SNM committee appointments. Dr. Fahey has spoken with all of the proposed committee chairs and they have agreed to serve. A motion was made to approve the committee chairs as listed in appendix B. It was moved, seconded and voted to approve the committee chairs as listed in appendix B. (2 abstentions) In addition, Dr. Segall explained that the General Program Chair is responsible for the oversight and coordination of the Mid-Winter Meeting, the Annual Meeting and other SNM meetings. The General Program Chair is nominated by the Executive Committee and approved by the Board of Directors for a three (3)-year term, serving as General Program Chairperson-elect one (1) year in advance of the commencement of his term as General Program Chairperson. A motion was made to approve Alan Packard, PhD as the General Program Chair-Elect (term starting June 2013). 5 It was moved, seconded and unanimously voted to approve Alan Packard, PhD as the General Program Chair-Elect (term starting June 2012). A motion was made to approve Satoshi Minoshima as the Scientific Program Committee ChairElect (term beginning June 2012). It was moved, seconded and unanimously voted to approve Satoshi Minoshima as the Scientific Program Committee Chair-Elect (term beginning June 2012). 6. Vice-President Elect Gary Dillehay, MD, SNM Vice-President Elect explained that the first year of the succession to the presidency has been a sort of “on the job training.” Dr. Dillehay has been involved in the PET PROS discussion, international education and Coding and Reimbursement. 7. Secretary/Treasurer Richard Noto, MD, SNM Secretary/Treasurer reported that the operating revenue is $3,347,943, $87,027 greater than budget, operating expense is $3,326,309, $42,139 greater than budget, and operating surplus is $21,634, $44,888 greater than budget through 3/31/2012. For the period ending March 31, 2012, SNM’s Capital Fund gains, net of expense, totaled $476,392 thus far in the fiscal year. In addition, Mrs. Pappas explained that the new Flexible Spending Account (FSA) plan will provide employees participating in the plan the option of utilizing a debit card to pay for qualified expenditures. Management will fund the FSA based on the election made by each employee. As employees use their debit card or as the vendor issues checks, the disbursements will occur within the new account. By having all FSA transactions occur within a separate bank account, management is able to better secure its banking activity. This arrangement prevents FSA transactions from occurring in the operating account without management’s advance approval. A motion was made to approve management’s recommendation to open a bank account for the new FSA with SNM’s CEO and CFO as signatories on the account. It was moved, seconded and unanimously voted to approve management’s recommendation to open a bank account for the new FSA with SNM’s CEO and CFO as signatories on the account. 8. SNMTS President Mrs. Alessi, presented the SNMTS President’s Report (appendix C). 9. Education and Research Foundation (ERF) Peter Conti, MD, PhD, ERF President, reported that the SNM and ERF created a Joint Task Force as a result of discussions at the SNM MWM. In addition, SNM and ERF worked to compromise on a proposal to make comparative effectiveness research a topic that would qualify for another MI Junior Medical Faculty Grant for $50,000. Thus, with this modification to the slate, the 2012 grants and awards slate for SNM has been affirmed by the ERF Board of Directors. Dr. Shaohui Zhang has received the 2012 Cassen Postdoctoral Fellowship. The Committee was very pleased to have four very compelling applications and commended our efforts to increase outreach this year. The Benedict Cassen Prize recipients for this year are Drs. Steve Larson and Abass Alavi. Drs. Larson and Alavi will be presenting the Cassen Lecture at the Plenary of the Annual Meeting and will be invited to attend the ERF Donor Luncheon at the meeting as well. 6 Dr. Conti reminded the board that the ERF developed a fund for special projects. The SNM submitted three projects for consideration. The ERF provided $5,000 in sponsorship to the Cardiovascular Molecular Imaging Symposium (CVMI). In addition, it was noted that the ERF Board of Directors has charged the Fundraising Committee with developing a fundraising plan for Amyloid Imaging. The ERF understands that this is a goal within the SNM Strategic Plan. The ERF also requested additional recognition at the Annual Meeting for being a donor. 10. Chief Executive Officer Mrs. Pappas presented the Chief Executive Officer (CEO) report (appendix D). 11. Adjournment A motion was made to adjourn the April 29, 2012 SNM Board of Directors meeting at 3:05pm. It was moved, seconded and unanimously voted to adjourn the April 29, 2012 SNM Board of Directors meeting at 3:05pm. 7