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Participants allocated less funding beyond benefit coverage, such as spending on healthy communities. Participants perceived the deliberative process as fair and informative, and they supported using it in the policy-making process. CONCLUSION The choices of participants from low-income, medically underserved communities reflect a unique set of priorities and suggest that the engagement of low-income communities more deeply in Medicaid policy making might result in different prioritization decisions. Copyright © 2020 by Duke University Press.CONTEXT Overtreatment is costly, but is it fraud? In a growing number of False Claims Act cases, the Department of Justice has sought and received multimillion dollar settlements from providers accused of billing Medicare for unnecessary care. This article evaluates the use of the False Claims Act as a tool for reducing overuse. METHODS The author reviewed (1) recent cases where litigants sparred over the applicability of the False Claims Act to overtreatment, and (2) criticisms of the expanding use of the False Claims Act in health care. FINDINGS Some judges have dismissed suits on the grounds that expert testimony regarding the necessity of treatment is insufficient for concluding Medicare claims were false or fraudulent. Other judges have let cases proceed, especially in instances where clinicians appear to have overstated the severity of patients' illnesses to justify treatment. Cases that lead to changes in medical practice may result in substantial savings to the Medicare program. CONCLUSIONS Courts have struggled with how to apply the False Claims Act to overtreatment. False Claims Act cases that address unnecessary care are potentially less problematic than other types of cases that address technical violations with few implications for costs or quality. Copyright © 2020 by Duke University Press.The Tax Cuts and Jobs Act (TCJA) eliminated the ACA's "shared responsibility payment," which penalized those who failed to comply with the requirement to purchase health insurance. In this article the authors explain efforts in several states to respond to this change by adopting individual health insurance mandates at the state level. Although there are good reasons to think that states may be reluctant to consider establishing their own mandates, New Jersey, the District of Columbia, and Vermont quickly joined Massachusetts in establishing such measures in 2018. In 2019 California and Rhode Island enacted state-level mandates. Four other states-Maryland, Connecticut, Hawaii, and Washington-formally considered mandates but have not enacted them. The authors compare the policy debates among these states and one other state, New York, which has not seen a legislative proposal for a mandate despite its strong support for the ACA. Their analysis explores the dynamics within the US federal system when a key component of a complex and politically salient national initiative is eliminated and states are left with many policy, political, and administrative questions of what to do next. Copyright © 2020 by Duke University Press.Various grading systems are currently used for chimeric antigen receptor (CAR) T-cell-related toxicity, cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS). We compared the recently proposed American Society for Transplantation and Cellular Therapy (ASTCT) grading system to other grading scores in 2 populations of adults patients (n = 53) with B-cell acute lymphoblastic leukemia (B-ALL) treated with 1928z CAR T-cells (clinicaltrials.gov #NCT01044069), and patients (n = 49) with diffuse large B-cell lymphoma (DLBCL) treated with axicabtagene-ciloleucel (axi-cel) or tisagenlecleucel after US Food and Drug Administration approval. According to ASTCT grading, 82% of patients had CRS, 87% in the B-ALL and 77% in the DLBCL groups (axi-cel 86%, tisagenlecleucel 54%), whereas 50% of patients experienced ICANS, 55% in the B-ALL and 45% in the DLBCL groups (axi-cel 55%, tisagenlecleucel 15%). All grading systems agreed on CRS and ICANS diagnosis in 99% and 91% of cases, respectively. However, when analyzed grade by grade, only 25% and 54% of patients had the same grade in each system for CRS and ICANS, respectively, as different systems score symptoms differently (upgrading or downgrading their severity), leading to inconsistent final grades. Investigation of possible management implications in DLBCL patients showed that different recommendations on tocilizumab and steroids across current guidelines potentially result in either overtreating or delaying treatment. Moreover, because these guidelines are based on single products and different grading systems, they cannot be universally applied. To avoid discrepancies in assessing and managing toxicities of different products, we propose that unified grading be used across clinical trials and in practice and that paired management guidelines with product-specific indications be developed. CUDC-101 in vitro © 2020 by The American Society of Hematology.The fetal-to-adult hemoglobin switch has been a focus of a long-standing effort to potentially treat sickle cell disease and β thalassemia by induction of fetal hemoglobin. In a continuation of this effort, we designed specific transcriptional activator-like effectors (TALEs) to target both the Gγ and Aγ-globin promoters. We fused the TALEs to a LIM domain binding protein (Ldb1) dimerization domain, followed by a T2A green fluorescent protein (GFP) cassette, which were assembled into a lentiviral vector. To prevent deletions caused by the repeats of TALEs during the lentivirus packing process, we changed the TALE encoding DNA by codon optimization. Intriguingly, 5 of 14 TALEs showed forced reactivation of fetal-globin expression in human umbilical cord blood-derived erythroid progenitor (HUDEP-2) cells, with a significant increase in the γ-globin mRNA level by more than 70-fold. We also observed a more than 50% reduction of β-globin mRNA. High-performance liquid chromatography analysis revealed more than 30% fetal globin in TALE-induced cells compared with the control of 2%. Among several promoters studied, the β-globin gene promoter with the locus control region (LCR) enhancer showed the highest TALE expression during CD34 erythroid differentiation. At day 19 of differentiation, 2 TALEs increased fetal-globin expression more than 40-fold in the mRNA level and up to 70% of the total globin protein. These TALEs have potential for clinical translation. © 2020 by The American Society of Hematology.
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