SNM Board of Directors Arlington, VA April 28, 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 7:48am. Richard Noto, MD, SNM Secretary/Treasurer, confirmed a quorum was present. 2. Trends in Molecular Imaging Dr. Segall explained that there will be five industry partners providing an overview of the trends in molecular imaging, from their perspective. Once all industry partners have had the opportunity to present, there will be a panel discussion – which will include all industry representatives. a. Ward Digby – Siemens The following serves as a high level overview of the trends described by Ward Digby, PhD, Director, Molecular Imaging Biomarker Product Management at Siemens. i. Current Situation a. SPECT imaging is dropping a bit in terms of equipment volume (more so in the US than internationally) b. PET imaging is flat (no growth) ii. Health care reform has slowed down the purchase of equipment. Also the economic situation has further delayed the investment of new equipment. iii. Society was involved in assisting with reduced reimbursement – oddly enough if reimbursement is reduced, people use the equipment more in order to compensate for the decreasing reimbursement. This has led to impact on cardiology environment. iv. Future Outlook a. New tracer development will continue to increase in Europe. b. Launch of Amyvid and eventually other tracers for PET will help increase imaging in the United States c. New wave of interest from pharmaceutical companies – Siemens is unsure of how much of the interest is just using molecular imaging agents to learn something vs. a companion diagnostic role. v. Role of the SNM a. Reimbursement –If there is a way for society to work with self-referring specialists – rather than excluding them – that would be great. b. PET/MR – helping to explore other indications, identifying appropriate use and guidelines and working collaboratively with Alzheimer’s association on amyloid imaging. b. Roy Brown and Elaine Hayes – Covidien The following serves as a high level overview of the trends described by Roy Brown, MBA, Director, Strategic Alliances and Elaine Hayes, Vice-President & General Manager, Imaging Commercial Operations, Covidien. i. Current Situation - SPECT a. Myocardial perfusion 60% of volume b. Drivers i. Aging population ii. Large installed base of SPECT cameras, advances in camera technology iii. Established US Mo-99 supply iv. Diagnostic benefit of NM, cost effective c. Restraints i. Spending for imaging services ii. Longer term SPECT imaging 2% growth, growth in PET and new isotopes iii. Radiation reduction, thallium decline accelerate over next 2 years iv. Radiology/benefits managers and pre-authorization v. Reimbursement vi. Uncertainty in Mo-99 supply d. Tc-99m procedure volume has dipped since 2009-2010 but still dominates NM ii. SPECT favored a. SPECT procedure currently represent more than 88% of all nuclear medicine studies b. SPECT is still expected to represent 85% of the market in 2017 c. Price of PET cameras are significantly higher than SPECT cameras iii. Working hard to develop new Mo-99 capacity for long-term benefit iv. Role of SNM a. Government relations activities b. Coordination with the Council on Radionuclides and Radiopharmaceuticals on activities of mutual interest c. Supporting research initiatives with new PET agents d. Need to focus on nuclear medicines core products – SPECT e. Need to initiate comparative effectiveness studies that highlight SPECT products f. Assist in helping to educate Center for Medicare and Medicaid Services on the increasing costs of Mo-99/Tc-99m c. Piotr Maniawksi - Phillips Healthcare The following serves as a high level overview of the trends described by Piotr J. Maniawski, MSc, Director, Clinical Science - Nuclear Medicine, Phillips Healthcare. i. The number of Nuclear Medicine procedures are at best flat, the number of indications are not changing. ii. Possible that PET/MR is the opportunity for something new iii. Patient specific outcomes – need to identify how a specific patient gained from a specific procedure. iv. Phillips believes that it is essential to find a way (together) to perform research that validates role of NM studies v. Opportunity to expand education globally as markets are not uniform extending the SNM membership and inviting membership beyond the US vi. Extending concepts that have been successfully applied with gathering of evidence based data – NOPR type approaches beyond FDG PET. PET/MR may be candidate for lobbying with CMS to create a database. vii. Role of SNM a. Phillips and SNM share the same vision – believe that SNM, working with industry is the right mix of knowledge, talent and passion to make it happen. b. SNM needs to globalize its efforts (education, guidelines, etc.) c. Collaboration and Strategic Alliances – have engaged multiple alliances d. Evidence based approach e. Concentrated focused effort on relatively small number of projects (such as considering a strategic plan for PET/MR) and define a roadmap/blue print for the future. f. Show benefits of procedures that utilize radiation – need to shift focus from being defensive to educating on the benefits of imaging with radiation. d. Onikepe Adegbola – General Electric The following serves as a high level overview of the trends described by Onikepe Adegbola, MD, PhD, Chief Medical Officer, Molecular Imaging and Executive Medical Director of General Electric. i. Overall, there has been a downward trend in the nuclear medicine market ii. GE is invested in PET – yet reimbursement for PET is challenging iii. Opportunities 1. CZT – radiation dose reduction 2. Multi-tracer imaging 3. Health economic data/clinical evidence 4. Referring physician education 5. Emerging economies iv. Threats 1. Consolidation and merger of physician practices, hospital employment 2. Increasing imaging competition 3. Technetium supply 4. Radiation dose concerns 5. Economy and healthcare cuts. v. PET Market Drivers & Limiters 1. Large unmet need for diagnostic tools in neurology and oncology 2. Well established PET infrastructure in developed markets – emerging market investment in PET infrastructure 3. Public health focus on cost effectiveness 4. Personalized medicine drive in oncology 5. New Alzheimer’s therapeutics imminent 6. Alzheimer’s guidelines under review in US/EU, unclear role for PET (Strong MR push) 7. PET cost barriers and regulatory uncertainty in emerging markets reduces access vi. Role of SNM 1. Influence coding and reimbursement policy by working with other stakeholders – MITA, CMS, AA, health insurances plans 2. Regulatory hurdles impeding new tracers 3. Outreach and collaboration with other societies and specialty groups to develop guidelines and education for referring physicians 4. Education and training of NM manpower e. Colleen Glynn - Cardinal Health The following serves as a high level overview of the trends described by Colleen Glynn, CNMT, Sr. Director, Medical Specialty Solutions, Cardinal Health. i. Two integrated growth platforms 1. Core pharmacy (low energy) – SPECT 2. Manufacturing and Dispensing (high energy) – PET ii. Industry Perspective 1. Little being done to support MPI at a critical time 2. Broad spectrum of SNM activities, difficult to see progress 3. Lack of transparency in discussions w/ CMS and FDA 4. Exhibit Hall for annual meeting poorly attended iii. Rolf of SNM 1. Leadership on radiation exposure reduction (adult weight based protocol) 2. New products 3. Public outreach – for example, physicians should submit Nuclear Medicine information to Wikipedia to get out the correct information 4. Need to build bench strength (residents, PET certification for physicians) 3. Summary of Trends in Nuclear Medicine and Molecular Imaging Throughout this discussion, several common themes emerged. These items, as well as the specific focus areas are listed below (the order of listing does not indicate priority): a. Common Themes i. Volume and sales have decreased since 2007, and projections for growth in the US through 2017 are flat to minimal ii. The majority (85-87%) of procedures will continue to be based on Tc-99m and other single photon agents (SPECT and planar) iii. Emerging markets and the US market are at different time points in development. Education regarding the value of nuclear medicine/molecular imaging that is evidence based is very important iv. More outreach is needed to patients, referring physicians, payers and regulatory agencies. v. Continued emphasis on advocacy is important – CMS, FDA (and partnerships) vi. Health care reform is driving medicine that is evidence based and patient centered vii. New tracers and new technologies will drive growth viii. Quality is important to drive growth a. Training of professionals b. Quantification c. Standardization ix. Concerns about radiation safety should be addressed by dose optimization and education about the benefits of nuclear medicine/molecular imaging x. Collaboration and Strategic Partnerships are very important to achieving goals b. Focus i. ii. iii. iv. v. vi. vii. viii. Areas PET/MR PET/CT SPECT Tracer Development / New Products Reimbursement Evidence based medicine research International outreach Collaboration/Strategic Partnerships The SNM Board of Directors adjourned at 12:23pm for lunch. The SNM Board of Directors reconvened at 1:05pm. 4. Commencement a. Approval of Agenda and Standing Rules A motion was made to approve the SNM Board of Directors agenda for April 28, 2012. It was moved, seconded and unanimously voted to approve the SNM Board of Directors agenda for April 28, 2012. A motion was made to approve the standing rules. It was moved, seconded and unanimously voted to approve the standing rules. b. Approval of Meeting Minutes A motion was made to approve the February 21, 2012 minutes with changes. It was moved, seconded and unanimously voted to approve the February 21, 2012 minutes with changes. A motion was made to approve the March 20, 2012 minutes. It was moved, seconded and unanimously voted to approve the March 20, 2012 minutes. 5. Strategies to Address Common Themes Dr. Segall requested feedback from board members regarding the common themes presented by the industry representatives. The board agreed to focus on the following strategies: a. Education and outreach - Back to Basics b. Create small working group to develop a tactical plan on how we can improve quality as well as educate value of Tc-99m based nuclear medicine using innovative and traditional tools of education based on resources we already have. c. Continue discussion with industry at Molecular Imaging Industry Leaders Working Group (MIILWG) meeting at the SNM Annual Meeting. 6. Professional Standing of Nuclear Medicine Profession Henry Royal, MD, Executive Director of the American Board of Nuclear Medicine (ABNM), provided an overview of the current standing of the nuclear medicine profession. Currently the ACR and SNM are not working together, nor are the ABR and ABNM on training issues. Board members agreed that SNM should focus professional standards for quality and practice through guidelines. There have been some challenges in working with ACR regarding Training Task Force II. Board members agreed that SNM should stop reacting to standards released by ACR. The SNM should move forward in a politely assertive yet respectfully vocal manner with respect to best practices involving nuclear medicine and molecular imaging procedures and start marketing SNM’s guidelines as best practice for nuclear medicine and optimal patient care. It was agreed that SNM develop several statements on quality and publish them over the next several months. Dominique Delbeke, MD, PhD, Task Force II SNM Co-Chair will circulate a draft Joint Position Statement on Optimizing Training in Nuclear Medicine in the Era of Multimodality and Hybrid Imaging to the board for review. A second article, written by Richard Noto, MD, will be published and will highlight the need for appropriate training from a radiologist perspective. The Board will review the impact following the publication of these articles. 7. Global Outreach Fred Fahey, DSc., SNM President-Elect, explained that during the 2020 Task Force exercise, one of the working groups consistently identified the need to work more collaboratively with international organizations. Over the past several years, the SNM leadership has increased their efforts to partner with international organizations on guidelines and educational courses. In addition, the Center for Molecular Imaging Innovation and Translation (CMIIT) is working to develop a Global Pre-Clinical Training Curriculum. Board members agreed that international outreach and collaboration was essential to SNM and the future of the field, however, they noted that it was important to explain the need for international collaboration to the membership. 8. Adjournment A motion was made to adjourn the April 28, 2012 SNM Board of Directors meeting at 5:15pm. It was moved, seconded and unanimously voted to adjourn the April 28, 2012 SNM Board of Directors meeting at 5:15pm.