PET and PET/CT have revolutionized the diagnosis, staging, and monitoring of treatment effect or recurrence for a wide range of cancers and shown promise for improving health outcomes for patients with cardiovascular and central nervous system diseases. However, this technology is challenged by insurance coverage policies that hinder patients' access to PET and discourage technologic innovation. Recently, the Medical Imaging & Technology Alliance (MITA), a Washington-based industry association, convened a workshop to consider new pathways for making decisions on Medicare coverage of new PET radiopharmaceuticals and imaging procedures that are currently subject to a national noncoverage decision, or "exclusionary rule." Stakeholders from the government, medical professional societies, academia, patient groups, and industry gathered to brainstorm alternatives to the national noncoverage decision and evaluate their potential to improve access and enhance innovation. Ultimately, MITA, on behalf of the PET community, expects to use the outcomes of the workshop to propose that the Centers for Medicare and Medicaid Services reconsider this current national noncoverage decision for PET and adopt a new framework for coverage.
[Show abstract][Hide abstract] ABSTRACT: The availability of (99m)Tc for single-photon imaging in diagnostic nuclear medicine is crucial, and current availability is based on the (99)Mo/(99m)Tc generator fabricated from fission-based molybdenum (F (99)Mo) produced using high enriched uranium (HEU) targets. Because of risks related to nuclear material proliferation, the use of HEU targets is being phased out and alternative strategies for production of both (99)Mo and (99m)Tc are being evaluated intensely. There are evidently no plans for replacement of the limited number of reactors that have primarily provided most of the (99)Mo. The uninterrupted, dependable availability of (99m)Tc is a crucial issue. For these reasons, new options being pursued include both reactor- and accelerator-based strategies to sustain the continued availability of (99m)Tc without the use of HEU. In this paper, the scientific and economic issues for transitioning from HEU to non-HEU are also discussed. In addition, the comparative advantages, disadvantages, technical challenges, present status, future prospects, security concerns, economic viability, and regulatory obstacles are reviewed. The international actions in progress toward evolving possible alternative strategies to produce (99)Mo or (99m)Tc are analyzed as well. The breadth of technologies and new strategies under development to provide (99)Mo and (99m)Tc reflects both the broad interest in and the importance of the pivotal role of (99m)Tc in diagnostic nuclear medicine.
Journal of Nuclear Medicine 12/2012; 54(2). DOI:10.2967/jnumed.112.110338 · 6.16 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The outcomes of a 2011 Medical Imaging & Technology Alliance (MITA) conference helped shape considerations about what might be the most appropriate pathways for the regulatory and payment considerations of new PET radiopharmaceuticals. As follow-up to that conference, MITA convened a second conference of stakeholders to advise payers on what might be acceptable endpoints for clinical trials to support the coverage of novel PET agents. The conference involved experts on imaging and clinical research, providers of PET services, as well as representatives of interested medical societies, the PET industry, and the regulatory and payer communities. The principal outcome of their deliberations was that it was unrealistic to expect trials of new PET radiopharmaceuticals to directly demonstrate a health benefit. Rather, intermediate outcomes, such as a positive change in patient management, would be more efficient and appropriate.
Journal of the American College of Radiology: JACR 07/2013; 54(9). DOI:10.1016/j.jacr.2013.04.010 · 2.84 Impact Factor
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