Medical Imaging Advocate Tackles Industry Challenges

Abstract

BI&T Tell me about the Medical Imaging and Technology Alliance.David Fisher The Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA), is the leading organization and collective voice of medical imaging equipment manufacturers, innovators, and product developers. It represents companies whose sales comprise more than 90 percent of the global market for medical imaging technology.The goals of MITA are to:BI&T Why did you take this job at MITA?David Fisher I've always enjoyed working on medical innovation issues generally and specifically on medical device issues. These are life-saving products that are constantly being improved to help physicians diagnose and treat patients. This makes it extremely easy to be enthusiastic about all of the projects we're working on.BI&T Can you give me a sense of how the medical imaging industry has grown?David Fisher Medical imaging has “grown” tremendously as an industry since the early era of X-rays. We are continuously innovating to produce new and improved technologies, like magnetometric resistivity (MMR) imaging and molecular breast imaging, that are nothing short of amazing—working modern-day miracles and helping to turn millions of patients into survivors.As a result of these new, innovative, and life-saving technologies, imaging utilization grew during the early part of the last decade. Yet, contrary to popular belief, the rate of growth for medical imaging has flattened since 2007, even though imaging technologies have become increasingly integral to standards of care for many medical procedures.Additionally, a May 2010 study by Dr. David Levin and his colleagues at the Thomas Jefferson University's Center for Research on Utilization of Imaging Services revealed imaging utilization rate increases as low as 0.7 percent.BI&T How has medical imaging changed the nature of healthcare?David Fisher Medical imaging has revolutionized healthcare delivery in America. It has dramatically changed how physicians measure, manage, diagnose, and treat disease.Recent technological advancements and innovations have made imaging faster, more precise, and less invasive, leading to broader use of medical imaging for more conditions and for more patients. As the technology has continued to evolve, it has enabled physicians to detect disease earlier, saving more lives.In light of the positive impact medical imaging has had on the practice of medicine, it is not surprising that the New England Journal of Medicine proclaimed medical imaging as one of the top “developments that changed the face of clinical medicine” during the last millennium. Medical imaging has undeniably revolutionized how most diseases are diagnosed and treated—sometimes even completely prevented.BI&T What's the biggest challenge facing the medical imaging industry?David Fisher We have two major challenges: reimbursement for imaging procedures and moving new products through the U.S. Food and Drug Administration (FDA) to market.Medical imaging has been subject to five separate cuts over the past five years, many of which are not yet even fully implemented. The result has been the closure of imaging centers, increased wait times for patients to get the scans they need, and difficulty in diagnosing patients early, when treatment is most effective. An analysis by The Moran Company found that the volume of advanced imaging services delivered to Medicare beneficiaries decreased in 2009 for the first time in 11 years. In the face of this downward trend in imaging use, Congress and government agencies have continued to propose further limiting the use of advanced imaging services through more cuts and restrictive policies such as prior authorization.MITA has been proactive in addressing the concerns that are driving policy makers to continue cutting imaging. These efforts include advocating for the use of appropriateness criteria to ensure that patients are receiving the right scan at the right time.MITA has also been heavily engaged in efforts to reform the FDA's 510(k) process for well over a year. Through an inclusive effort, manufacturers have been working with the FDA and the broader imaging community to identify and implement targeted and effective improvements to the 510(k) review process.We were concerned and disappointed by the Institute of Medicine's recent recommendation to completely abandon the current 510(k) device clearance process and design an entirely new regulatory framework. Not only do the recommendations come very late in the process, but they fall far outside of the current conversation. Yet, we're hopeful that the conclusions won't distract from the progress that's already been made and we remain committed to working with the FDA and Congress on reforms that will do more to promote innovation, enhance regulatory predictability, and protect public health.We are also heavily involved in the negotiations of the reauthorization of the user-fee legislation.BI&T There have been several stories over the past couple of years, notably from The New York Times, looking at the issue of radiation overexposure or overdoses. What's your assessment of the problem?David Fisher For technologies that are critical to saving lives and dollars, the benefits of medical imaging are too often overlooked and criticism is frequently overblown.Absent from the round-up of reporting regarding medical radiation are the comprehensive steps that medical imaging manufacturers have taken to reduce exposure and protect patients from overexposure to medical radiation due to human error. Imaging manufacturers have a long history of developing new technologies that reduce the amount of radiation required to create a clear image.Last year, MITA and its members released the Computed Tomography (CT) Dose Check Initiative, a commitment to include a new “dose notification” feature to reduce the dose levels associated with scans; a “dose alert” to prevent medical errors; and a new “dose recording” feature to help track dosing, and to develop reference dose levels to help providers understand how their facility compares to local and national standards. CT manufacturers have already begun shipping equipment with these new features.These innovative and life-saving technologies are allowing doctors to detect, diagnose and treat patients early, saving and improving millions of lives. In fact, a National Bureau of Economic Research study revealed that cancer-imaging innovation accounted for 40 percent of the reduction in U.S. cancer deaths between 1996 and 2006, making it likely the largest single contributor to decreased cancer mortality during this decade.It is unfortunate that some media coverage serves only to unnecessarily increase patient fears counter to sound science. In reality, the benefits of medical imaging far outweigh the risks, and they are the answer—not the problem.BI&T What's the solution to the problem?David Fisher In addition to the CT Dose Check Initiative I referenced, MITA continues to work with our member companies and the FDA to further enhance the safety of CT machines. MITA is a strong supporter of operator certification, facility accreditation, and physician appropriateness criteria, all of which have been shown to help facilitate safe and medically appropriate scans while preserving patient access to the right scan at the right time.BI&T In healthcare, there's a growing move toward interoperability of medical devices. How is that impacting the medical imaging industry?David Fisher Medical imaging has been a leader in the interoperability field. Back in the 1980s, MITA worked with the American College of Radiology (ACR) to develop the Digital Imaging and Communications in Medicine (DICOM) standard, which allows imaging equipment to communicate across vendors.BI&T What impact does the drive toward electronic health records have for your industry?David Fisher Our members believe that central to medicine is the ability of health information technology to connect healthcare systems together using appropriate standards so that data can flow and be understood between different systems.The DICOM standard allows digital imaging technologies to interact seamlessly. DICOM has evolved to support new imaging technologies and new storage paradigms, playing a key role in creating a fully digitized record that fits in the new virtual environment in medicine.Through the widespread availability, adoption, and use of the DICOM standard, providers have the ability right now to transmit, store, retrieve, and archive medical images and imaging information. Use of the DICOM standard for communication of imaging information is fundamental to achieving the goal of development and implementation of a nationwide health information technology infrastructure.BI&T What's the political environment as it relates to healthcare technology generally and medical imaging specifically?David Fisher Healthcare technology and medical imaging are all under threat in the challenging financial situation federal and state governments find themselves in. As governments become a larger part of the healthcare system, they will continue to focus heavily on payment. New technologies are always under threat in that type of environment.