Research opportunities and ethical considerations for heart and lung xenotransplantation research: A report from the National Heart, Lung, and Blood Institute workshop.

Xenotransplantation offers the potential to meet the critical need for heart and lung transplantation presently constrained by the current human donor organ supply. Much was learned over the past decades regarding gene editing to prevent the immune activation and inflammation that cause early organ injury, and strategies for maintenance of immunosuppression to promote longer-term xenograft survival. However, many scientific questions remain regarding further requirements for genetic modification of donor organs, appropriate contexts for xenotransplantation research (including nonhuman primates, recently deceased humans, and living human recipients), and risk of xenozoonotic disease transmission. Related ethical questions include the appropriate selection of clinical trial participants, challenges with obtaining informed consent, animal rights and welfare considerations, and cost. Research involving recently deceased humans has also emerged as a potentially novel way to understand how xeno-organs will impact the human body. Clinical xenotransplantation and research involving decedents also raise ethical questions and will require consensus regarding regulatory oversight and protocol review. These considerations and the related opportunities for xenotransplantation research were discussed in a workshop sponsored by the National Heart, Lung, and Blood Institute, and are summarized in this meeting report.

Update on the ethical, legal and technical challenges of translating xenotransplantation.

This manuscript reports on a landmark symposium on the ethical, legal and technical challenges of xenotransplantation in the UK. King's College London, with endorsement from the British Transplantation Society (BTS), and the European Society of Organ Transplantation (ESOT), brought together a group of experts in xenotransplantation science, ethics and law to discuss the ethical, regulatory and technical challenges surrounding translating xenotransplantation into the clinical setting. The symposium was the first of its kind in the UK for 20 years. This paper summarises the content of the expert lectures showcasing the progress which has been made in xenotransplantation including-the history of xenotransplantation, advances in gene edited animals and progress towards clinical xenotransplantation. We then set out the ethical and legal issues still to be resolved. Finally, we report the themes of the roundtable discussion highlighting areas of consensus and controversy. While the detail of the legal discussion was directed towards the UK, the principles and summary reported here are intended to be applicable to any jurisdiction seeking to implement clinical xenotransplantation.

Understanding the Underlying Causes of Tensions That Arise in ICU Care for Older Patients.

AbstractObjective: We hypothesized that the reasons behind this tension are complex and can be understood better by applying social psychology theory.Design: A qualitative methodology was drawn on for data collection and thematic analysis, with focus group discussions adopted for interviews with patient families and ICU physicians. Additionally, we used a social psychology theory, the reasoned action approach (RAA) framework, to understand these tensions.Setting: Two 15-bedded ICUs of an academic university-affiliated teaching hospital in Singapore.Subjects: A total of 72 physicians and family members of older ICU patients (>70 years old).Measurements and Main Results: The primary analysis revealed five areas of tension around prognostication in the ICU. These dealt with issues of divergent views, different role expectations, conflicting emotional responses, and issues of communication and trust. Further analysis helped to identify underlying factors leading to tensions and behaviors. Differences in prognostication and in expectation of outcomes between clinicians and family members were the main cause of tensions. When the RAA framework was applied, these tensions could be predicted early on and understood more clearly.Conclusions: Tensions revolve around losing control of the patient's care, differences between hopeful expectations and clinical prognostication, perceived biases of physicians, and underlying mistrust between families and physicians.

The Impact of Firearm Legislation on Firearm Deaths, 1991-2017.

Firearm violence is a major public health concern in the USA with firearm suicide and homicide accounting for the majority of gun deaths. The present work seeks to explore the role of firearm legislation in reducing suicide and homicide rates. Using the State Firearm Law Database (www.statefirearmlaws.org), suicide and homicide rates were compared across the 50 US states from 1991 to 2017. A firearm regulations index was computed to represent the total number of state firearm laws. Generalized estimating equations were used to explore population-level increases or decreases in firearm regulations and their association with state suicide and homicide rates after controlling for several state-level covariates. Even after accounting for several key covariates (US region; time; gun ownership; percent of the state population that was White, Black, below the poverty line and 25 years or older with a bachelor's degree; incarceration rate, unemployment rate and divorce rate), we found that firearm laws significantly predicted state firearm suicide and homicide rates. States with greater numbers of laws had reduced suicide and homicide rates compared with those with fewer laws. The present findings point to the role of firearm legislation in curbing rates of gun violence across the USA.

The evolution of infant mortality and neighbourhood inequalities in four world cities: 1988-2016.

OBJECTIVES: To determine the level of neighbourhood inequalities in infant mortality (IM) rates in the urban core of four world cities and to examine the association between neighbourhood-level income and IM. We compare our findings with those published in 2004 to better understand how these city health systems have evolved. METHODS: We compare IM rates among and within the four cities using data from four periods: 1988-1992; 1993-1997; 2003-2008 and 2012-2016. Using a maximum-likelihood negative binomial regression model that controls for births, we predict the relationship between neighbourhood-level income and IM. RESULTS: IM rates have declined in all four cities. Neighbourhood-level income is statistically significant for New York and, for the two most recent periods, in Paris. In contrast, there is no significant relationship between neighbourhood income and IM in London or Tokyo. CONCLUSIONS: Despite programmes to reduce IM inequalities at national and local levels, these persist in New York. Until the early part of this century, none of the other cities experienced a relationship between neighbourhood income and IM, but growing income inequalities within Paris have changed this situation. POLICY IMPLICATIONS: Policy-makers in these cities should focus on better understanding the social and economic factors associated with neighbourhood inequalities in IM.

The Role of Formal Policy to Promote Informed Consent of Psychotropic Medications for Youth in Child Welfare Custody: A National Examination.

Active participation of youth and surrogate decision-makers in providing informed consent and assent for mental health treatment is critical. However, the procedural elements of an informed consent process, particularly for youth in child welfare custody, are not well defined. Given calls for psychotropic medication oversight for youth in child welfare custody, this study proposes a taxonomy for the procedural elements of informed consent policies based upon formal and informal child welfare policies and then examines whether enacted state formal policies across the United States endorsed these elements. A sequential multi-method study design included: (1) semi-structured interviews with key informants (n = 58) primarily from state child welfare agencies to identify a taxonomy of procedural elements for informed consent of psychotropic medications and then (2) a legislative review of the 50 states and D.C. to characterize whether formal policies endorsed each procedural element through February 2022. Key informants reported five procedural elements in policy, including how to: (1) gather social and medical history, (2) prescribe the medication, (3) authorize its use through consent and youth assent, (4) notify relevant stakeholders, and (5) routinely review the consenting decision. Twenty-three states endorsed relevant legislation; however, only two states specified all five procedural elements. Additionally, the content of a procedural element, when included, varied substantively across policies. Further research and expert consensus are needed to set best practices and guide policymakers in setting policies to advance transparency and accountability for informed consent of mental health treatment among youth in child welfare custody.

Medicaid Waivers and Tenancy Supports for Individuals Experiencing Homelessness: Implementation Challenges in Four States.

Policy Points Medicaid policymakers have a growing interest in addressing homelessness as a social determinant of health and driver of the potentially avoidable use of expensive medical services. Drawing on extensive document reviews and in-depth interviews in four early-adopter states, we examined the implementation of Medicaid's Section 1115 demonstration waivers to test strategies to finance tenancy support services for persons experiencing or at risk of homelessness. CONTEXT: The Affordable Care Act extended Medicaid eligibility to large numbers of individuals experiencing or at risk of homelessness. This legislative development and the growing recognition of homelessness as a significant social determinant of health have encouraged advocates and policymakers to seek new ways to use Medicaid to provide housing supports. METHODS: We conducted 28 semistructured interviews with 36 stakeholders in four states. The stakeholders were government administrators, health care providers, nonprofit housing staff, and consultants. We supplemented these interviews with extensive reviews of public documents, media accounts, think-tank reports, and published literature. We also conducted a systematic inductive qualitative analysis. FINDINGS: We identified seven challenges to the successful implementation of tenancy support demonstration projects: resolving the housing supply and NIMBY, removing silos between health care and homeless services providers, enrolling and retaining the target populations in Medicaid, contracting with and paying tenancy support providers, recruiting and retaining key workers, ensuring Medicaid's waiver durability, and reducing administrative crowd-out and waiver burden. CONCLUSIONS: Notwithstanding these challenges, three of the four states have made significant progress in launching their initiatives. At this point, the fourth state has delayed its start-up to consider alternatives to a Medicaid demonstration waiver to provide tenancy supports. The experience of the four states suggests lessons for Medicaid officials in other jurisdictions that are interested in pursuing tenancy support initiatives. Nevertheless, the limitations of tenancy support waiver programs suggest that federal policymakers should consider allowing states to more directly subsidize housing costs for those experiencing or at risk of homelessness as an optional Medicaid benefit.

Variation in end-of-life care and hospital palliative care among hospitals and local authorities: A preliminary contribution of big data.

BACKGROUND: Many studies explore the clinical and ethical dimensions of care at the end-of-life, but fewer use administrative data to examine individual and geographic differences, including the use of palliative care. AIM: Provide a population-based perspective on end-of-life and hospital palliative care among local authorities and hospitals in France. DESIGN: Retrospective cohort study of care received by 17,928 decedents 65 and over (last 6 months of life), using the French national health insurance database. RESULTS: 55.7% of decedents died in acute-care hospitals; 79% were hospitalized in them at least once; 11.7% were admitted at least once for hospital palliative care. Among 31 academic medical centers, intensive care unit admissions ranged from 12% to 67.4%; hospital palliative care admissions, from 2% to 30.6%. Across local authorities, for intensive care unit days and hospital palliative care admissions, the ratios between the values at the third and the first quartile were 2.4 and 1.5. The odds of admission for hospital palliative care or to an intensive care unit for more than 7 days were more than twice as high among people ⩽85 years (aOR = 2.11 (1.84-2.43) and aOR = 2.59 (2.12-3.17), respectively). The odds of admission for hospital palliative care were about 25% lower (p = 0.04) among decedents living in local authorities with the lowest levels of education than those with the highest levels. CONCLUSION: The variation we document in end-of-life and hospital palliative care across different categories of hospitals and 95 local authorities raises important questions as to what constitutes appropriate hospital use and intensity at the end-of-life.

Commentary: Global Comparisons of Physician Associations.

The authors reflect on their own work in relation to the articles in this special section on physician organizations, and they make four observations. First, association-government power relations shift after countries introduce universal health insurance, but they are by no means diminished. In France, Germany, and Japan, physicians' economic interests are explicitly considered against broader health system goals, such as providing affordable universal insurance. In low- and middle-income countries (LMICs), physician organizations do not share power in the same way. Second, in higher-income countries, fragmentation may occur along specialty or generalist lines, and some physicians are unionized. Generally speaking, physician influence over reimbursement policy is reduced because of organizational fragmentation. Third, associations develop as legitimate voices for physicians, but their relationship to other professions differs in higher-income countries. Associations in LMICs form coalitions with other health professionals. Finally, although German state physician associations have a key implementation role, in most countries, state and federal policy roles seem relatively defined. Global comparison of the LMICs and other countries suggests power, unity, legitimacy, and federal roles are tied closely to the stage of health system development.

Unsanitized and Unfair: How COVID-19 Bailout Funds Refuel Inequity in the US Health Care System.

CONTEXT: The CARES Act of 2020 allocated provider relief funds to hospitals and other providers. We investigate whether these funds were distributed in a way that responded fairly to COVID-19-related medical and financial need. The US health care system is bifurcated into the "haves" and "have nots." The health care safety net hospitals, which were already financially weak, cared for the bulk of COVID-19 cases. In contrast, the "have" hospitals suffered financially because their most profitable procedures are elective and were postponed during the COVID-19 outbreak. METHODS: To obtain relief fund data for each hospital in the United States, we started with data from the HHS website. We use the RAND Hospital Data tool to analyze how fund distributions are associated with hospital characteristics. FINDINGS: Our analysis reveals that the "have" hospitals with the most days of cash on hand received more funding per bed than hospitals with fewer than 50 days of cash on hand (the "have nots"). CONCLUSIONS: Despite extreme racial inequities, which COVID-19 exposed early in the pandemic, the federal government rewards those hospitals that cater to the most privileged in the United States, leaving hospitals that predominantly serve low-income people of color with less.

Alcohol Consumption by Older New York City Residents: The Need for New Policies to Address Misuse.

AIMS: The aim of this study is to assess risk factors for alcohol misuse among older New York City residents and examine the effect of local public health efforts to address alcohol misuse. METHODS: The Community Health Survey, a cross-sectional telephone survey of 8500 randomly selected adult New Yorkers, records the frequency of alcohol use. We examine these results among 65 and older subjects by sociodemographic status using logistic regression modeling and compare trends in smoking and alcohol consumption between 2002 and 2016. RESULTS: Those with unhealthy drinking habits, combining binge drinking and excessive consumption, constituted 5.7% of 65 plus population and were more likely to be White, US born, healthy, better educated and wealthier. The percentage of older smokers in New York City has decreased while unhealthy drinking is nearly flat since 2002. CONCLUSIONS: Our findings reinforce the importance of screening geriatric populations for alcohol use disorders and support the development of new public health efforts to address alcohol misuse if the city is to achieve results similar to those obtained in decreasing tobacco consumption.

The Administrative Presidency, Waivers, and the Affordable Care Act.

Within the American system of shared power among institutions, the executive branch has played an increasingly prominent policy role relative to Congress. The vast administrative discretion wielded by the executive branch has elevated the power of the president. Republican and Democratic presidents alike have employed an arsenal of administrative tools to pursue their policy goals: high-level appointments, administrative rule making, executive orders, proclamations, memoranda, guidance documents, directives, dear colleague letters, signing statements, reorganizations, funding decisions, and more. Presidents Obama and Trump employed most of these tools in an effort to shape the implementation and outcomes of the Affordable Care Act (ACA) during its first decade. This article focuses on the Obama and Trump administrations' use of comprehensive waivers to shape ACA implementation. The Obama administration had mixed success using waivers to convince Republican states to expand Medicaid. Compared to Obama, the Trump administration has found it harder to accomplish its policy goals through waivers, but if the courts support the Trump administration's work requirement and 1332 waiver initiatives, it would enable the president to use waivers to achieve an ever broader set of goals, including program retrenchment.

Putting The Pieces Together Again: American States and the End of the ACA's Shared Responsibility Payment.

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.

Infant Mortality in Moscow: the Perils of Progress in Russia's World City.

This paper examines changes in infant mortality (IM) in Moscow, Russia's largest and most affluent city. Along with some remarkable improvements in Moscow's health system over the period between 2000 and 2014, the overall IM rate for Moscow's residents decreased substantially between 2000 and 2014. There remains, however, substantial intra-city variation across Moscow's 125 neighborhoods. Our regression models suggest that in higher-income neighborhoods measured by percent of population with rental income as a primary source, the IM rate is significantly lower than in lower-income neighborhoods measured by percent of population with transfer income as primary source (housing and utility subsidies and payments to working and low-income mothers, single mothers and foster parents). We also find that the density of physicians in a neighborhood is negatively correlated with the IM rate, but the effect is small. The density of nurses and hospital beds has no effect. We conclude that overall progress on health outcomes and measures of access does not, in itself, solve the challenge of intra-urban inequalities.

Undermining the ACA through the executive branch and federalism: what the Trump administration's approach to health reform means for older Americans.

The ACA has survived multiple existential threats in the legislative and judicial branches, including dozens of congressional attempts at repeal and two major Supreme Court cases. Even as it seems that the ACA is here to stay, what the law accomplishes is far from settled. The Trump administration is using executive powers to weaken the law, in many cases using the same powers that President Obama used to strengthen the effects of the reform. States have responded by seeking flexibility to pursue reforms, such as work requirements, that could not pass Congress and that were not allowed by the Obama administration. There is no indication that the ACA is imploding as President Trump has predicted and seems to desire, although these changes have a real and substantial impact on the lives of many Americans, including the near-elderly in unique ways.

A series of unfortunate events: implications of Republican efforts to repeal and replace the Affordable Care Act For older adults.

This paper discusses Republican efforts to repeal the 2010 Patient Protection and Affordable Care Act (ACA) over President Trump's first year in office (2017) and their impact on near-elderly Americans (50-64 years old). We describe how the ACA's provisions for strengthening health care coverage were particularly advantageous for near-elderly Americans: The law shored up employer-sponsored health care, expanded Medicaid, and-most important-created conditions for a strong individual health insurance market. We then describe Republican efforts to undermine the ACA in the years immediately following its passage, followed by detailed discussion of Republican proposals to repeal and replace the ACA during 2017. We conclude by discussing factors informing the fate of Republican legislation in this area, the potential consequences of the legislation that ultimately passed, and the prospects for future attempts to repeal and replace the ACA through the legislative process.

The state of aging policy and politics in the Trump era.

The surprise election of President Donald J. Trump to the presidency of the United States marks a singular turning point in the American republic-not only because of his idiosyncratic approach to the office, but also because the Republican Party now holds the presidency and both houses of Congress, presenting a historic opportunity for change. The role of older Americans has been critical in both shaping and reacting to this political moment. Their political orientations and behaviors have shaped it through their electoral support for Republican candidates, but they also stand as highly invested stakeholders in the policy decisions made by the very officials they elected and as beneficiaries of the programs that Republicans have targeted. This article draws on the content of this issue to explore the ways in which Trump administration policies are likely to significantly undermine the social safety net for near-elderly and older Americans with respect to long-term care, housing, health care, and retirement. It also draws on issue content to speculate on the ways that these policy changes might shape politics and political behavior. We conclude that the response of older voters in the 2018 midterm elections to efforts by the Trump administration and its Republican allies in Congress to draw back on the federal government's commitment to programs and policies affecting them will shape the direction of aging policy and politics in the years to come.

Medicare and Amyloid PET Imaging: The Battle Over Evidence.

We examine a recent dispute regarding the Centers for Medicare and Medicaid Services' (CMS) refusal to unconditionally pay for amyloid positron emission tomography (PET) imaging for Medicare beneficiaries being assessed for Alzheimer's disease. CMS will only pay for amyloid PET imaging when patients are enrolled in clinical trials that meet certain criteria. The dispute reflects CMS's willingness in certain circumstances to require effectiveness evidence that differs from the Food and Drug Administration's standard for pre-market approval of a medical intervention and reveals how stakeholders with differing perspectives about evidentiary standards have played a role in attempting to shape the Medicare program's coverage policies.