News | PET-MRI | May 23, 2019 Study Explores Magnetic Nanoparticles as Bimodal Imaging Agent for PET/MRI Researchers from Bourgogne University in Dijon, France, showed that use of superparamagnetic iron oxide nanoparticles (… read more Linking medical imaging to patient outcomes has long been a struggle for the medical community. But when Columbia University released results from a study showing increased utilization of advanced medical imaging improved life expectancy rates by a significant factor1, it appeared that the connection was clear.Less than a year later, however, Congress continues to target medical imaging as a means to cut healthcare costs, ignoring its positive impact on patient outcomes. This has left the medical community wondering if the government’s hard line on medical imaging contradicts its goal to promote comparative effectiveness research (CER), which will inevitably increase the use of medical imaging. Mandate for CEROne of the biggest factors changing the way medicine will be practiced in the United States is CER. It will be a key metric by which the government will establish reimbursement for different medical technologies and treatments.CER, as defined by the Institute of Medicine (IOM), is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care.Since the American Recovery and Reinvestment Act allocated $1.1 billion to the CER initiative, the Federal Coordinating Council for Comparative-Effectiveness Research has been tasked with outlining how to spend the budget. One of the first steps was for the council and IOM to release their recommendations on which diseases CER should start focusing. Top CER DiseasesCancer is the second leading cause of deaths in the United States and is one of the costliest diseases to treat. It is no surprise cancer fell under the six recommended primary CER topics, including screening technologies for colorectal and breast cancers, as well as the use of imaging technologies for diagnosing, staging and monitoring all cancers. Also on the top six list are neurological disorders. These involve diagnostic imaging used for diagnosing neurological conditions; for treating headaches, multiple sclerosis and epilepsy; and for the detection, treatment, and management of Alzheimer’s disease and other dementias.2Another top priority is researching cardiovascular and peripheral vascular disease as they relate to ischemic heart disease, heart failure and cardiac arrhythmias. Two topics focused on the treatment and management of peripheral vascular disorders. Since all of these diseases are largely diagnosed, treated and monitored using imaging studies, CER in all of these areas would increase the use of medical imaging. This is in direct conflict with Congress’ aim to cut healthcare costs by reducing the number of medical imaging exams, and poses an added challenge to those taxed with carrying out CER studies on major diseases. SNM Takes the LeadThe challenge now is to tie imaging to outcomes. Taking the lead on that is Michael M. Graham, Ph.D., M.D., president, Society of Nuclear Medicine (SNM), professor of radiology, director of nuclear medicine, department of radiology. He has established a task force to develop high-quality, comparative effectiveness PET imaging studies as part of the government directive to balance healthcare costs and effectiveness.Dr. Graham has stated that as president of SNM, his vision encompasses three main goals: first, to protect and expand appropriate reimbursement for nuclear medicine procedures; secondly, to provide essential education to members; and thirdly, to preserve and expand funding to support nuclear medicine research and development.Imaging Technology News (ITN) spoke with Dr. Graham about his approach to developing CER for comparative-effectiveness criteria for PET imaging. ITN: Does your initiative to develop high-quality, comparative-effectiveness PET imaging studies tie into these three goals?Dr. Graham: Yes. One of our concerns in PET imaging is that it is under utilized, and it is a very cost-effective procedure, in some settings decreasing unnecessary surgery or chemotherapy, which avoids expensive and ineffective treatment. ITN: How will comparative-effectiveness PET imaging studies balance healthcare costs and effectiveness?Dr. Graham: One of the problems with the way that CMS folks look at imaging is that it’s increasing more rapidly than the costs of medicine. [They] see it as getting out of control and as a major expense to rein in somehow. Their approach is to decrease reimbursement. This is alarming because on one side, they are decreasing the amount of inappropriate imaging that has been done, which is part of the problem with cost of medical imaging, but it is also making it more difficult to do imaging where it is appropriate.We need hard data brought to the argument, and this is where our literature is kind of weak. We are establishing guidelines for developing those studies. We submitted a proposal to the Agency for Healthcare Research and Quality (AHRQ) to fund a workshop to do just that, likely in July. We’ve put together a proposed agenda there, but haven’t confirmed it yet because we are waiting to hear if we will be funded by AHRQ. If we get funded, we’ll shift into high gear, and hope to have the meeting on the NIH (National Institute of Health) campus. We have also put together a smaller meeting on cost and comparative effectiveness…to help us put together the meeting for the summer. Other organizations interested in this area are RSNA (Radiological Society of North America) and ACR (American College of Radiology). Last May, the entire issue on JACR (the ACR journal) was on comparative effectiveness and cost effectiveness. Plus, RSNA [hosted] an exploratory workshop in February in the Chicago area on comparative effectiveness and cost effectiveness.ITN: Does comparative effectiveness tie into the appropriateness criteria that the ACR has been developing?Dr. Graham: Yes, it does because the whole point of cost effectiveness is that it is medical imaging in the appropriate clinical setting. It should be cost effective if it’s appropriate. That is part of the thinking that goes into identifying the appropriateness criteria, and I think going forward the connection between comparative effectiveness and appropriateness criteria will be more explicit. ITN: Has comparative effectiveness proven cost effective for nuclear medicine in the past?Dr. Graham: There is modest literature in nuclear medicine and probably the best has been in using PET imaging for staging of lung cancer. The case is made quite well that it really is cost effective. The problem is that it doesn’t seem to be widely accepted in the oncology community. It’s getting into NCCN (National Comprehensive Cancer Network) guidelines, but there’s an additional job that has to be done to educate the oncologists. This is a difficult task, and it’s one we’re approaching by collaborating with the large oncology societies like ASTRO (American Society for Therapeutic Radiology and Oncology) and ASCO (American Society of Clinical Oncology). We’re sharing speakers between the two organizations, so they can educate us in terms of the viewpoint of the oncologist, and we’re speaking at their meetings to teach them about the capabilities of the imaging approach. I think this is going to lead to more appropriate use of the methodology. The approach to medical care doesn’t change very rapidly, and it takes a long-term commitment to do this. There is a tendency to think that I’ve been using CT, and I don’t need a newer, more expensive test because the one I have is adequate. But does this make a difference in the survival or quality of life of a patient? If you avoid an operation, you avoid the morbidity as well as the expense associated with that. If it was going to be a futile operation, you have saved a great deal. But convincing the surgeons and oncologists of this is a long-term process. Even publishing an article in the New England Journal of Medicine doesn’t necessarily change their behavior. The question that hasn’t been adequately answered is: does this make a difference in the survival of the patient or the quality of life of the patient? We contend that it does. ITN: Do these studies influence CMS (Centers for Medicare and Medicaid Services) in its decision making?Dr. Graham: Yes, you have put your finger on a critical government organization. We need to convince CMS, and it is likely that good cost effectiveness data will convince CMS. But we also have to convince the referring physician. That is an essential educational effort that we have to do and, since the Society of Nuclear Medicine is an educational organization, that is what we are prepared to do, and that is what we are doing. ITN: What are the challenges of developing the criteria for comparative-effectiveness studies?Dr. Graham: The big challenge is relating the imaging study to the patient outcome. There are multiple levels of evaluating imaging studies — from accuracy at the low end to the effect on patient survival and quality of life at the other end. We can show that the PET study changes patient management 30 to 40 percent of the time. We would like to presume the change of management is in the right direction that results in a better outcome, but that has not been well established, and that is what we need to be able to show. The huge challenge in doing that rigorously is ideally you would have a control group. You would have a group of patients and a group of physicians who didn’t use PET in the management of disease, and then you would have another that did. The way things have developed, it’s very hard to do that. We’re having trouble convincing them to do it [because] you get into ethical questions in trying to run trials like that. It is a huge challenge, and one of the things I want to address at the workshop with health technology assessment experts, and bring people from CMS and the FDA (Food and Drug Administration) in to understand how we develop the data we need to establish the cost effectiveness of these procedures. Randomized clinical trials are really unlikely to be the way that we go. What we are trying to assess are the cost effectiveness of the studies for which CMS has already approved reimbursement. If we successfully show that and communicate that to the physicians, we will actually have a net decrease in the cost of healthcare.It’s possible that we will have an increase in the cost of medical imaging. This is an argument we must make very clearly to CMS; they shouldn’t just look at medical imaging in isolation, since the increasing costs of medical imaging are likely to be more than offset by the huge savings derived from avoiding many ineffective clinical treatments. ITN: Could you apply the patient-registry approach?Dr. Graham: Yes, with the patient registry approach there is huge power in going in that direction. I think that a large multi-site study with outcomes is the way to go. This may be a multimillion dollar project involving hundreds of institutions throughout the United States. We intend to do this and build on another major initiative within SNM — that’s our Clinical Trials Network. There we are building a network of sites to participate in clinical trials of PET imaging, and there are well over 200 sites that have already expressed interest in participating in that. I think these same sites would likely be interested in participating in a multi-site registry, if we can do it properly. These are two major issues I wanted to take on as president: clinical trials and cost effectiveness.ITN: How will clinical trials help to improve patient care?Dr. Graham: They will help us avoid ineffective imaging and weed out studies that are not particularly cost effective. We’ll be able to clearly identify areas where we can implement personalized medicine and identify if a treatment is or is not working very early in the course of the therapy. If it’s not working, you save the time and expense, and shift to a more effective treatment. There is a lot of potential for improving patient care, quality of life and outcome. ITN: As for cost effectiveness, how much will comparative-effectiveness for PET cut costs? Do you have a fiscal goal?Dr. Graham: There is not a fiscal goal, and it is going to vary significantly from procedure to procedure. Our initial estimates are in one particular setting, patients with liver metastases with recurrent colon cancer who are candidates for surgical excision of those metastases. In that setting, PET imaging identifies additional disease outside the liver in about one-third of the patients. Those patients don’t undergo surgery, but instead undergo chemotherapy because the surgery would not be effective in extending their lives and would cause a significant decrease in their quality of life. Some years ago, when I did a study at University of Washington, we calculated that it would be cost neutral if we identified one patient out of 17, and instead we were identifying about one in three. The amount of money you are going to save depends on the cost of the operation, but the average savings per patient is in the order of a few thousand dollars, and there is an increased quality of life. So it’s in the right direction for both measures in that you save money and you make the patient more comfortable. We can make a very strong argument that it’s cost effective.[As for developing comparative effectiveness criteria for PET studies,] we know where we’re going, but we don’t know how to get there, and that is why we are organizing these workshops. References:1. Lichtenberg, Ph.D., F. “The Quality of Medical Care, Behavioral Risk Factors, and Longevity Growth.” NBER Working Paper No. 15068. www.nber.org/papers/w15068. June 2009.2. Iglehart, John K. Prioritizing Comparative-Effectiveness Research — IOM Recommendations. NEJM.org. June 30, 2009. 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