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Other Key Issues

As the preeminent world organization for molecular imaging, SNM is a strong advocate for government policies that will ensure patients have access to some of the most sophisticated medical innovations. There are four important areas in which Congress has the power to make a difference in patient treatments and outcomes. Please let them know you care about these important issues.

  • Support the development of a reliable domestic supply of radioisotopes and the need for a thoughtful transition from HEU to LEU

    Jeffrey Norenberg, Pharm.D., discusses the fragility of the isotope supply.

    In order to ensure that patient needs are not compromised, a continuous reliable supply of medical radioisotopes is essential. Any change from highly enriched uranium (HEU) to low enriched uranium (LEU) must ensure that patient needs are not compromised. Currently, there are no facilities in the U.S. that are dedicated to manufacturing Mo-99 for Mo-99/Tc-99m generators. The United States must develop domestic capabilities to produce Mo-99, and not rely solely on foreign suppliers. Learn more »

    Issue

    In order to ensure that patient needs are not compromised, a continuous reliable supply of medical radioisotopes is essential. Any change from highly enriched uranium (HEU) to low enriched uranium (LEU) must ensure that patient needs are not compromised. Currently, there are no facilities in the U.S. that are dedicated to manufacturing Mo-99 for Mo-99/Tc-99m generators. The United States must develop domestic capabilities to produce Mo-99, and not rely solely on foreign suppliers.

    Background

    Over the past two years, SNM has become increasingly disturbed about supply interruptions of Mo-99 from foreign vendors and the lack of a reliable supplier of Mo-99 in the United States. As of February 2009, both the National Research Universal (NRU) and the High Flux Reactor (HFR) reactors are back online; however, this does not negate the need for a reliable domestic supply of medical radionuclides.

    Of those sources located within the U.S., SNM has identified two as being the most viable solutions to provide a domestic supply of medical radionuclides: the University of Missouri Research Reactor Center (MURR) in Columbia, Missouri, and in the longer-term, the Babcock & Wilcox (B&W)- Covidien collaboration.

    MURR could meet approximately 50% of the current market need for Mo-99, with little change to the current reactor. MURR is currently working on the design of a processing center that will be located adjacent to the reactor building. The new processing center would be solely owned by the University of Missouri, however a funding source has not yet been obtained. SNM recommends that the Department of Energy's (DOE) National Nuclear Security Administration (NNSA) fund the construction and development of the processing capability, especially since the major thrust of the NNSA is to demonstrate a high-level production path using LEU. Since the U.S. represents over one-half of the world's need for Mo-99, success at MURR and by Babcock & Wilcox (discussed below), would immediately reduce the amount of HEU that is now exported by the U.S. for Mo-99 production by 50%. This reduction would be a big step forward by the NNSA in achieving their goal.

    In February 2009, Babcock & Wilcox and Covidien jointly announced their intent to work on the development of an Aqueous Homogeneous Reactor (AHR). This proven type of reactor design would run on LEU and would therefore not require separate targets to be irradiated for Mo-99 production as is the case for conventional reactors. Their plans are to build several small units capable of supplying 50% of the U.S. need for Mo-99. Babcock & Wilcox is estimating that the facility can be operational within five years. SNM is not recommending government funding for this effort since it involves two corporations, and the funding for the development of this reactor and associated radiochemistry facility is already in place. What SNM is advocating, however, is government assistance in expediting the regulatory approval process, including the licensing process by the NRC and the FDA.

    Forcing a change from HEU to LEU must be done with adequate time made available for the research and development needed for the transition period. There also must be consideration of economic and environmental factors to prevent putting patients at risk because of delays in production of much needed radionuclides, such as Tc-99m which is made from Mo-99. Currently, no large-scale, commercial processes using LEU targets for medical isotopes have been developed, demonstrated, and implemented. In order to establish this process, there are two critical elements that must be accomplished. First, the technology must be proven to be robust and reliable, which requires a significant transition period to demonstrate its efficacy. Second, the system must be able to provide commercial quantities of Mo-99 (thousands of curies per week, every week). Otherwise patients—the ultimate consumers of Tc-99m—will be put at risk.

    The financial impact of forcing a change from HEU to LEU remains vague. Although it is technically feasible to produce Mo-99 from LEU, it would not be commercially viable without substantial federal subsidies. In addition to structural and technological changes that must be made, the new technology would require NRC approval and the actual production process would have to be approved by the FDA. Any new technology will not be considered complete until it receives approval from both the FDA and the NRC, which is expensive both in terms of time and the expected fees associated with the application process.

  • Maintain Funding for Nuclear Medicine Research at the U.S. Department of Energy

    Robert Atcher, Ph.D., M.B.A., describes the ability of molecular imaging procedures such as PET to determine early on whether treatments are working as intended.

    The funding for the basic research program at the U.S. Department of Energy (DOE) that leads to critical nuclear medicine procedures must be continued or future life-saving diagnostic and treatment procedures will be lost. DOE-supported nuclear medicine research is directed at the fundamental and technological aspects of biomedical imaging and radiotherapy that make technological breakthroughs possible. Continued DOE funding of new and innovative nuclear medicine research will provide the tools that investigators will use to expand our understanding of disease, and the diagnosis and treatment for those diseases. Learn more »

    Issue

    The funding for the basic research program at the U.S. Department of Energy (DOE) that leads to critical nuclear medicine procedures must be continued or future life-saving diagnostic and treatment procedures will be lost.

    Issue Background

    DOE-supported nuclear medicine research is directed at the fundamental and technological aspects of biomedical imaging and radiotherapy that make technological breakthroughs possible. Whereas support by the National Institutes of Health (NIH) is directed largely at specific diseases with clinical trials, the DOE directs hypothesis-driven, basic research into the chemistry and physics related to molecular and nuclear medicine. DOE's nuclear medicine research programs have been critical to the development of cutting-edge nuclear medicine imaging and therapy procedures, including positron emission tomography (PET). Nuclear medicine procedures like PET imaging are crucial for identifying the presence of cancer in the body and how the disease has progressed. Nuclear medicine research also has contributed extensively to the development of cardiac stress tests to analyze heart function, bone scans for orthopedic injuries, lung scans for blood clots, procedures to diagnose liver and gall bladder function abnormalities, and neurological disorders. Continued DOE funding of new and innovative nuclear medicine research will provide the tools that investigators will use to expand our understanding of disease, and the diagnosis and treatment for those diseases.

    In addition to the cutting-edge therapies and procedures that result from basic nuclear medicine research, many researchers have cut their teeth in the nuclear medicine field under the auspices of this program. Nuclear medicine basic research is multidisciplinary and exposes young researchers to the fields of physics, chemistry, and biology. At a time when the NIH has identified interdisciplinary research as a need in training and the execution of biomedical research, fewer young scientists are entering the field in basic research. The DOE program provides cross-disciplinary training that is critical to moving biomedical research forward.

    Current Environment

    After two years of not having funding for nuclear medicine research at the DOE, the fiscal year (FY) 2008 Energy and Water Appropriations bill restored $17.5 million to the program. Furthermore, on March 11, 2009, President Obama signed the FY 2009 omnibus appropriations bill into law, again allocating $17.5 million to nuclear medicine research. SNM continues to monitor the DOE Office of Science, which manages the research program, to make sure the funding is appropriately allocated to nuclear medicine.

  • Support the Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy (CARE) Act Bill

    Cindi Luckett-Gilbert, MHA, CNMT, PET, RT(N), advocates for passage of the CARE bill to protect patients.

    There is a need for consistent national education and credentialing standards for those professionals performing medical imaging and radiation therapy procedures. The quality and safety of medical imaging and therapeutic procedures are dependent upon the personnel performing them. Most Americans assume that the person performing their x-ray, nuclear medicine scan, or radiation therapy treatment has undergone formal training in the modality in which they are working; however, this is not always the case. Only 26 states have established standards for nuclear medicine technologists, only 32 states for radiation therapists, and only 38 states license or partially regulate radiologic technologists. Learn more »

    Issue

    There is a need for consistent national education and credentialing standards for those professionals performing medical imaging and radiation therapy procedures.

    Issue Background

    The quality and safety of medical imaging and therapeutic procedures are dependent upon the personnel performing them. Most Americans assume that the person performing their x-ray, nuclear medicine scan, or radiation therapy treatment has undergone formal training in the modality in which they are working; however, this is not always the case. Only 26 states have established standards for nuclear medicine technologists, only 32 states for radiation therapists, and only 38 states license or partially regulate radiologic technologists.

    The lack of federal standards allows inadequately trained personnel to perform medical imaging and therapeutic procedures in the United States every day. Poor quality images can lead to misdiagnosis, additional testing, delays in treatment and anxiety in patients, costing the U.S. health care system millions of dollars each year.

    The CARE bill would require those who perform medical imaging and radiation therapy procedures to meet minimum federal education and credentialing standards in order to participate in federal health programs administered by the Department of Health and Human Services, including the Medicare and Medicaid programs. Thus, medical imaging procedures, as well as radiation therapy treatments for patients covered under these programs, would need to be performed by personnel meeting these federal standards in order to be eligible for reimbursement.

    If enacted, the CARE bill will ensure quality in medical imaging and radiation therapy procedures, reduce healthcare costs by lowering the number of repeated procedures due to poor technique or improper positioning and improve the safety of patients undergoing medical imaging and radiation therapy procedures.

  • Stop Further Cuts to Medical Imaging Payments

    Michael Graham, M.D., Ph.D., explains the critical role PET scans can play in cancer management.

    Cuts to imaging payments by the Centers for Medicare and Medicaid Services (CMS) and Congress must be avoided in order to ensure patient access to the right procedure, for the right patient, at the right time.

    The Deficit Reduction Act (DRA) of 2005 and subsequent Medicare fee schedule changes have made deep cuts to Medicare payments for many imaging services. These cuts have limited physicians' ability to diagnose and treat diseases, by undervaluing the reimbursement for these procedures. Furthermore, proposals have been made for additional reductions to imaging payments that, if enacted, would further lower reimbursement for advanced diagnostic imaging services and could limit access to critical diagnoses and access to life-saving treatments for many patients. Learn more »

    Issue

    Cuts to imaging payments by the Centers for Medicare and Medicaid Services (CMS) and Congress must be avoided in order to ensure patient access to the right procedure, for the right patient, at the right time.

    The Deficit Reduction Act (DRA) of 2005 and subsequent Medicare fee schedule changes have made deep cuts to Medicare payments for many imaging services. These cuts have limited physicians' ability to diagnose and treat diseases, by undervaluing the reimbursement for these procedures. Furthermore, proposals have been made for additional reductions to imaging payments that, if enacted, would further lower reimbursement for advanced diagnostic imaging services and could limit access to critical diagnoses and access to life-saving treatments for many patients.

    Issue Background

    Over the past year, several reports, including two performed by the Government Accounting Office (GAO), have concluded that there has been a significant increase in the utilization of imaging services in the last decade. According to the GAO, this trend has led to an increase of almost 13% per year (from 2000 to 2006) in total Medicare expenditures for imaging services. SNM believes that the appropriate use of imaging services and technology is critical to patient care because it allows clinical professionals to better coordinate that care and have timely access to imaging findings, thereby permitting quicker diagnoses and implementation of treatment. This leads to greater overall Medicare savings and – more importantly – leads to better clinical outcomes. Moreover, newer diagnostic imaging studies are increasingly replacing more invasive procedures, which are no longer necessary, thus accounting for the increase in utilization, and at the same time saving downstream costs.

    Current and Proposed Imaging Payment Cuts

    Deficit Reduction Act of 2005
    The intent of the DRA was to reduce reimbursement for imaging services by approximately $8 billion over 10 years, starting in 2007. To accomplish this, Congress directed CMS to reduce the reimbursement rates for many types of imaging services performed in physician offices and independent imaging centers. Preliminary analysis from the GAO shows that spending for diagnostic services was reduced by 12.7 percent in 2007 after steadily rising by an average of 12.9 percent per year from 2000-2006. This change represents a complete reversal in the payment trends for imaging services, and calls into question the necessity for any new initiatives to further reduce spending for imaging services.

    Separate Payment Categories for Physician Services

    These proposed cuts would establish six separate reimbursement categories or "buckets" of physician services for Medicare payment, including a separate category for imaging services. The creation of separate categories will make it easier for Congress to target imaging services without affecting other physician services because it does nothing to address inappropriate utilization, which could be more effectively addressed by requiring physicians to adhere to evidence-based guidelines or appropriateness criteria. The policy also irrationally assumes that when a minimally invasive procedure replaces an invasive procedure, the value of the new service should go down and the value of the old service should go up. However, this is not necessarily the case. Additionally, across-the-board cuts to physician reimbursement would lead to a decrease in the use of clinically appropriate imaging services, which could result in potentially damaging clinical patient outcomes.

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