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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. © 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%. check details 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.The Food Safety and Inspection Service (FSIS) conducts microbiological baseline studies to determine national prevalence of select foodborne pathogens in federally inspected meat and poultry products and to obtain data for risk assessments. The FSIS conducted a baseline study from 1 June 2017 through 31 May 2018 to characterize and determine the prevalence of Salmonella and assess the occurrence of Shiga toxin-producing Escherichia coli (STEC) in a variety of raw pork products. In total, 4,014 samples from slaughter and processing establishments were analyzed for Salmonella; a subset of these samples (1,395) from slaughter establishments were also analyzed for STEC. Analyses determined that the national prevalence of Salmonella in raw pork products was highest in comminuted products (28.9%), followed by intact cuts (5.3%) and nonintact cuts (3.9%). Less than 1% of samples analyzed were positive for the top seven STEC. Our findings indicate there is a need for additional pathogen reduction strategies for raw pork products. Published 2020 by the International Association for Food Protection. Not subject to U.S. Copyright.ABSTRACT Mixed thermophilic and mesophilic commercial starter cultures (CSCs), particularly those including Streptococcus thermophilus as a primary milk acidifier, have been found to reduce growth and counteract in situ nisin A (NisA+) antilisterial effects by the novel, indigenous Lactococcus lactis subsp. cremoris M78 costarter in traditional Graviera thermized milk cheese curds. Therefore, this model challenge study evaluated growth and in situ NisA+ activity of strain M78 in coculture with S. thermophilus ST1 singly in sterilized raw milk (SRM). Strain ST1, derived from a CSC for cheese, was challenged at two inoculation levels (5 and 7 log CFU/mL) in SRM against 6 and 3 log CFU/mL of strain M78 and Listeria monocytogenes, respectively. Pure cultures of each strain and cocultures of strain ST1 with the CSC L. lactis LL2, in replacement of strain M78, served as controls. At the high (7-log) inoculation level, the rapid, competitive growth (>9.3 log CFU/mL) of S. thermophilus ST1 reduced growth of both L. lInternational Association for Food Protection.Process control validations require knowledge of the resistance of the pathogen(s) of concern to the target treatment, and, in some cases, the relative resistance of surrogate organisms. Selected strains of Escherichia coli O157H7 (five strains), Listeria monocytogenes (five strains), and Salmonella enterica (five strains) as well as Salmonella Enteritidis phage type (PT) 30 and nonpathogenic Enterococcus faecium NRRL B-2354 were inoculated separately (as individual strains) onto inshell pistachios. The thermal tolerance of each strain was compared via treatment of inoculated pistachios to hot oil (121°C) or hot water (80°C) for 1 min. Survivor curves in hot oil or hot water (0.5 to 6 min, n = 6 to 15) were determined for one or two of the most resistant strains of each pathogen, as well as E. faecium NRRL B-2354 and Salmonella Enteritidis PT 30, and the Weibull model was fit to the data. A pilot-scale air-impingement oven was used to compare the thermal tolerance of E. faecium NRRL B-2354 and Salmonella Enteritidis PT 30 on pistachios with or without a brining pretreatment and at either dry (no steam) or 30% humidity (v/v) oven conditions. No significant difference in the time to a 4-log reduction in hot oil or hot water was predicted for any of the strains evaluated, on the basis of the 95% confidence interval. In the pilot-scale oven, E. faecium NRRL B-2354 was more thermally resistant than Salmonella in a broad set of differing treatments, treatment times, and temperatures. Salmonella is a suitable target pathogen of concern in pistachios for thermal processes because no other pathogen tested was more thermally resistant under the conditions evaluated. E. faecium NRRL B-2354 was at least as thermally resistant as Salmonella under all conditions evaluated, making it a good potential surrogate for Salmonella on pistachios.Treatment of transplant-ineligible (TNE) newly diagnosed multiple myeloma (NDMM) requires a balance between disease control and maintaining quality of life (QoL). Patients value treatment-free remission periods in this incurable condition, as they are associated with better QoL. We set out to study clinical outcomes of consecutive TNE NDMM patients in routine care treated in Thames Valley Cancer Network between 2009 and 2017. The primary outcome was the evaluation of the treatment-free interval (TFI) after 1st and subsequent lines of therapy in the total cohort and in individual subgroups, according to age (≤75 vs. >75 years), and co-morbidities using Charlson Co-morbidity Index (CCI) mild 0-2 vs. moderate 3-4 vs. severe ≥5). Secondary outcomes include response rates, overall survival (OS) and progression-free survival (PFS) between subgroups according to age and according to co-morbidities. In a total cohort of 292 patients, median TFI (IQR) was longest after first-line therapy 6.9 months (1.4-16.9), reducing after second line therapy to 1.