New Pathways to Medicare Coverage for Innovative PET Radiopharmaceuticals: Report of a Medical Imaging & Technology Alliance (MITA) Workshop
ABSTRACT 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.
- Nuclear Medicine Communications 09/2014; 35(12). DOI:10.1097/MNM.0000000000000205 · 1.37 Impact Factor
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ABSTRACT: The purpose of this study was to quantify the poorly understood radiation doses to murine bone marrow and blood from whole-body fluorine 18 ((18)F)-fluorodeoxyglucose (FDG) positron emission tomography (PET), by using specific biomarkers and comparing with whole body external low dose exposures. Groups of 3-5 mice were randomly assigned to 10 groups, each receiving either a different activity of (18)F-FDG: 0-37MBq or whole body irradiated with corresponding doses of 0-300mGy X-rays. Blood samples were collected at 24h and at 43h for reticulocyte micronucleus assays and QPCR analysis of gene expression in peripheral blood leukocytes. Blood and bone marrow dose estimates were calculated from injected activities of (18)F-FDG and were based on a recommended ICRP model. Doses to the bone marrow corresponding to 33.43mGy and above for internal (18)F-FDG exposure and to 25mGy and above for external X-ray exposure, showed significant increases in radiation-induced MN-RET formation relative to controls (P<0.05). Regression analysis showed that both types of exposure produced a linear response with linear regression analysis giving R(2) of 0.992 and 0.999 for respectively internal and external exposure. No significant difference between the two data sets was found with a P-value of 0.493. In vivo gene expression dose-responses at 24h for Bbc3 and Cdkn1 were similar for (18)F-FDG and X-ray exposures, with significant modifications occurring for doses over 300mGy for Bbc3 and at the lower dose of 150mGy for Cdkn1a. Both leucocyte gene expression and quantification of MN-RET are highly sensitive biomarkers for reliable estimation of the low doses delivered in vivo to, respectively, blood and bone marrow, following (18)F-FDG PET. Copyright © 2014 Elsevier B.V. All rights reserved.Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis 12/2014; 770. DOI:10.1016/j.mrfmmm.2014.09.002 · 4.44 Impact Factor
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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; DOI:10.2967/jnumed.112.110338 · 5.56 Impact Factor