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1.
Milbank Q ; 2024 Jul 05.
Artigo em Inglês | MEDLINE | ID: mdl-38966909

RESUMO

Policy Points The adoption of Medicaid institutions for mental disease (IMD) exclusion waivers increases the likelihood of substance abuse treatment facilities offering mental health and substance abuse treatment for co-occurring disorders, especially in residential facilities. There are differential responses to IMD waivers based on facility ownership. For-profit substance abuse treatment facilities are responsive to the adoption of IMD substance use disorder waivers, whereas private not-for-profit and public entities are not. The response of for-profit facilities suggests that integration of substance abuse and mental health treatment for individuals in residential facilities may be cost-effective. CONTEXT: Access to integrated care for those with co-occurring mental health (MH) and substance use disorders (SUDs) has been limited because of an exclusion in Medicaid on paying for SUD care for those in institutions for mental disease (IMDs). Starting in 2015, the federal government encouraged states to pursue waivers of this exclusion, and by the end of 2020, 28 states had done so. It is unclear what impact these waivers have had on the availability of care for co-occurring disorders and the characteristics of any facilities that expanded care because of them. METHODS: Using data from the National Survey of Substance Abuse Treatment Services, we estimate a two-stage residual inclusion model including time- and state-fixed effects to examine the effect of state IMD SUD waivers on the percentage of facilities offering co-occurring MH and SUD treatment, overall and for residential facilities specifically. Separate analyses are conducted by facility ownership type. FINDINGS: Results show that the adoption of an IMD SUD waiver is associated with 1.068 greater odds of that state having facilities offering co-occurring MH and substance abuse (SA) treatment a year or more later. The adoption of a waiver increases the odds of a state's residential treatment facility offering co-occurring MH and SA treatment by 1.129 a year or more later. Additionally, the results suggest 1.163 higher odds of offering co-occurring MH/SA treatment in private for-profit SA facilities in states that adopt an IMD SUD waiver while suggesting no significant impact on offered services by private not-for-profit or public facilities. CONCLUSIONS: Our study findings suggest that Medicaid IMD waivers are at least somewhat effective at impacting the population targeted by the policy. Importantly, we find that there are differential responses to these IMD waivers based on facility ownership, providing new evidence for the literature on the role of ownership in the provision of health care.

2.
Clin Trials ; : 17407745241259360, 2024 Jun 25.
Artigo em Inglês | MEDLINE | ID: mdl-38916109

RESUMO

There is growing interest in using embedded research methods, particularly pragmatic clinical trials, to address well-known evidentiary shortcomings afflicting the health care system. Reviews of pragmatic clinical trials published between 2014 and 2019 found that 8.8% were conducted with waivers of informed consent; furthermore, the number of trials where consent is not obtained is increasing with time. From a regulatory perspective, waivers of informed consent are permissible when certain conditions are met, including that the study involves no more than minimal risk, that it could not practicably be carried out without a waiver, and that waiving consent does not violate participants' rights and welfare. Nevertheless, when research is conducted with a waiver of consent, several ethical challenges arise. We must consider how to: address empirical evidence showing that patients and members of the public generally prefer prospective consent, demonstrate respect for persons using tools other than consent, promote public trust and investigator integrity, and ensure an adequate level of participant protections. In this article, we use examples drawn from real pragmatic clinical trials to argue that prospective consultation with representatives of the target study population can address, or at least mitigate, many of the ethical challenges posed by waivers of informed consent. We also consider what consultation might involve to illustrate its feasibility and address potential objections.

3.
BMC Public Health ; 24(1): 2104, 2024 Aug 05.
Artigo em Inglês | MEDLINE | ID: mdl-39103811

RESUMO

The Medicaid Aging Waiver program (MAW) subsidizes the cost of long-term care (LTC) at home or in communities to satisfy older people's increasing desire to age in place. The MAW program might be health improving for older people by allowing them to age at home. However, less quality and quantity of home-based care comparing to nursing home care could offset some of the potential benefits. I use policy expenditure across states over time linked with detailed health information from the Health and Retirement Study (HRS) to identify the associated effects of MAWs on health outcomes of older adults who are at risk of needing LTC and who are resources constrained to be potentially eligible for Medicaid. Overall, the findings suggest that the MAW program is beneficial to health: a $1,000 increase in MAW spending for each older person results is associated with a 1.4 percent improvement in self-reported health status, a 1.5 percent reduction in functional mobility limitations, a 1.6 percent decrease in Instrumental Activities of Daily Living (IADL) limitations, and a 1.7 percent improvement in negative psychological feelings. For older people who are most likely not eligible for MAWs, such as those who are wealthy or in good health and do not require LTC, these health-improving effects have not been observed.


Assuntos
Vida Independente , Assistência de Longa Duração , Medicaid , Humanos , Estados Unidos , Idoso , Masculino , Feminino , Assistência de Longa Duração/economia , Idoso de 80 Anos ou mais , Nível de Saúde , Serviços de Assistência Domiciliar/economia , Atividades Cotidianas
4.
J Health Polit Policy Law ; 49(2): 269-288, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-37801019

RESUMO

Section 1332 of the Affordable Care Act (ACA) provides states unprecedented flexibility to alter federal health policy. The authors analyze state waiver activity from 2019 to 2023, applying a comparative approach to understand waivers proposed by Georgia, Colorado, Washington, Oregon, and Nevada. Much of the waiver activity during this period focused on reinsurance programs. During the Trump administration, the most innovative waiver application was from Georgia, which sought to restructure and decentralize its individual market, moving away from the framework established by the ACA. While the Biden administration suspended Georgia's efforts, Democratic-led states have focused implementing waiver programs supporting and expanding on the ACA. This has included adopting public-option insurance plans offered by private insurers and expanding eligibility for qualified health plans for previously ineligible groups. The authors' analysis offers insights into contemporary health politics, policy durability, and the role of the administrative presidency.


Assuntos
Medicaid , Patient Protection and Affordable Care Act , Estados Unidos , Humanos , Política de Saúde , Oregon , Definição da Elegibilidade
5.
Adm Policy Ment Health ; 51(1): 85-102, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37976019

RESUMO

Eleven states offer 1915(c) Home and Community Based Services (HCBS) Medicaid waivers to organize and fund programs that provide in-home and community support services to address the unique needs of children and youth with complex mental health concerns and their families. However, as the COVID-19 pandemic-imposed restrictions on community movement and school engagement were enacted, these children and youth lost in-person access to needed supports through school-based programs and professional community providers. The well documented mental health impacts of the pandemic on children and youth necessitates understanding how behavioral health programs and policies were adapted to the constraints of pandemic life for this uniquely at-risk population. This study examines and characterizes trends in modifications made to these programs. Appendix K applications amending HCBS waiver programs targeting children with serious emotional disturbances (SED) were collected from the Center for Medicaid & Medicare Services (CMS) website. In total, 33 applications from 10 states were included in the study. Utilizing a policy mapping approach, applications were coded by hand comparing text from elements in the applications across all 10 states. A summary of program changes reported in applications was created and changes were tracked over the course of the federal public health emergency. States modified programs by adding services for waiver participants, changing the service settings allowed, removing service limit restrictions, and offering electronic/remote service delivery. All states also issued measures to either expand or retain their provider workforce, adding family members as providers, modifying experience requirements, and offering financial incentives via increased payment rates or retainer payments. Modifications to mental health assessment processes ranged from changing the evaluation tools or documentation requirements, extending deadlines, and allowing for remote evaluations. Service plan development processes were adapted by allowing virtual service plan development meetings, allowing participants or representatives to electronically sign plans of care, and permitting verbal consent to begin receiving services. Documenting programmatic adjustments provides a context for further research to understand the experiences of youth, families, and providers in navigating these changes and the relative success or failures of these policies.


Assuntos
COVID-19 , Serviços de Assistência Domiciliar , Idoso , Criança , Adolescente , Humanos , Estados Unidos , Saúde Mental , Serviços de Saúde Comunitária , Pandemias , Medicare , Medicaid
6.
Dev World Bioeth ; 23(1): 59-66, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-35307947

RESUMO

What has the past reaction to the COVID-19 pandemic taught us? We have seen that many low and middle-income countries (LMICs) still lack access to vaccines, and it seems little progress has been made in the last few months and year. This article discusses whether the current strategies, most notably, vaccine donations by the international community and the COVID-19 global access facility COVAX, offer meaningful solutions to tackle the problem. At the centre of our analysis, we compare the concepts of "donations" and "charity" with "vaccine equity" and the "empowerment" of poorer countries. We suggest that the achievement of fair global vaccine production requires that our global approach is supportive of the idea of empowerment. We, therefore, need structural reforms, which would most importantly include capacity building, to positively impact this goal and to take the interests of the global poor seriously.


Assuntos
COVID-19 , Vacinas , Humanos , Países em Desenvolvimento , COVID-19/prevenção & controle , Pandemias/prevenção & controle , Saúde Global
7.
BMC Med Ethics ; 23(1): 98, 2022 09 24.
Artigo em Inglês | MEDLINE | ID: mdl-36153500

RESUMO

BACKGROUND: The South African legal framework requires mandatory parental/legal guardian consent for all research with children. Ethics guidelines provide some reprieve by allowing RECs to grant waivers of parental or guardianship consent in certain defined circumstances. In the first instance, consent may be provided by a proxy when parents or guardians are unavailable, for example with orphaned children. In the second instance, guidelines permit adolescent self-consent when the nature of the study justifies this approach, for example, research on sensitive issues like sexual behaviour or substance use. DISCUSSION: South African guidelines set several conditions that must be met for waivers to be granted. These norms overlap with those in international guidelines. However, the ethical norms, especially related to self-consent are sometimes vague. This article critically evaluates the consent norms in the national ethics guidelines and makes recommendations for reform to ethics guidelines in a way that recognises the value of child participation in research, their evolving decision-making capacity and their best interests. CONCLUSION: Recommendations are made to harmonise ethics guidelines and law in a way that promotes child participation in research, to ensure additional protections for adolescents when self-consent is allowed, and to withdraw procedural requirements for the community endorsement of self-consent strategies.


Assuntos
Tutores Legais , Consentimento dos Pais , Adolescente , Criança , Humanos , Consentimento Livre e Esclarecido , Princípios Morais , Pais , África do Sul
8.
J Emerg Med ; 63(3): 420-425, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-36241474

RESUMO

BACKGROUND: As a result of the Coronavirus disease 2019 (COVID-19) pandemic, health plans were required to implement, or voluntarily implemented, patient cost-share waivers for COVID-19-related emergency care. The impact of the cost waivers on patients for emergency physician services has not been previously reported. OBJECTIVE: To measure the impact of COVID-19 cost-sharing waivers on patients for emergency physician services. METHODS: A multicenter retrospective review of emergency physician commercial claims was conducted to determine the impact of the patient cost share waivers on COVID-19-related emergency physician services. Seventy-seven emergency departments (EDs) representing about a quarter of all EDs in California were included in the study. Emergency physician claims during a 9-month prepandemic period in 2019 were compared with claims during a 9-month pandemic period in 2020 to determine if there were any changes in the patient cost share between the two study periods and between COVID vs. non-COVID-related care. RESULTS: The average patient cost share was $19 for COVID-19-related emergency physician professional care and $52 for visits unrelated to COVID-19. Compared with non-COVID-19 care visits, the patient cost share was 63% less for COVID-19-related care. There was a small increase (< $2) in the patient cost share for non-COVID-19 emergency professional care during the pandemic compared with the prepandemic period. CONCLUSION: Payment policies implemented by California health plans were effective at reducing the patient cost share for patients that required COVID-19-related emergency physician care.


Assuntos
COVID-19 , Médicos , Humanos , Pandemias , Serviço Hospitalar de Emergência , Estudos Retrospectivos
9.
J Health Polit Policy Law ; 47(3): 293-318, 2022 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-34847221

RESUMO

CONTEXT: States have experimented with the income eligibility threshold between Medicaid coverage and access to subsidized Marketplace plans in an effort to increase coverage for low-income adults while meeting other state priorities, particularly a balanced budget. In 2014, Wisconsin opted against adopting an ACA Medicaid expansion, instead setting the Medicaid eligibility threshold at 100% of the poverty level-a state-funded partial expansion. Childless adults gained new eligibility, while parents and caregivers with incomes between 101-200% of poverty lost existing eligibility. METHODS: We used Wisconsin's all-payer claims database to assess health insurance gains, losses, and transitions among low-income adults affected by this partial expansion. FINDINGS: We found that less than one third of adults who lost Medicaid eligibility definitely took up commercial coverage, and many returned to Medicaid. Among those newly eligible for Medicaid, there was little evidence of crowd-out. Both groups experienced limited continuity of coverage. Overall, new Medicaid enrollment of childless adults was offset by coverage losses among parents and caregivers, rendering Wisconsin's overall coverage gains similar to nonexpansion states. CONCLUSIONS: Wisconsin's experience demonstrates the difficulty in relying on the Marketplace to cover the near poor and suggests that full Medicaid expansion more effectively increases coverage.


Assuntos
Cobertura do Seguro , Medicaid , Adulto , Acessibilidade aos Serviços de Saúde , Humanos , Seguro Saúde , Patient Protection and Affordable Care Act , Estados Unidos , Wisconsin
10.
J Health Polit Policy Law ; 47(4): 497-518, 2022 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-35044466

RESUMO

CONTEXT: In 2015, the Centers for Medicare and Medicaid Services (CMS) urged state Medicaid programs to use 1115 waiver demonstrations to expand substance use treatment benefits. We analyzed four critical points in states' decision-making processes before expanding benefits. METHODS: We conducted qualitative cross-case comparison of three states that were early adopters of the 1115 waiver request. We conducted 44 interviews with key informants from CMS, Medicaid, and other state agencies, providers, and managed care organizations. FINDINGS: Policy makers expanded substance use treatment in response to "fragmented" care systems and unsustainable funding streams. Medicaid staff had mixed preferences for implementing new benefits via 1115 waivers or state plan amendments. The 1115 waiver process enabled states to provide coverage for residential benefits, but state plan amendments made other services permanent parts of the benefit. Medicaid agencies relied on interorganizational networks to identify evidence-based practices. Medicaid staff secured legislative support for reform by focusing on program integrity concerns and downstream effects of substance use rather than Medicaid beneficiaries' needs. CONCLUSIONS: Decision-making processes were influenced by Medicaid agency characteristics and interorganizational partnerships, not federal executive branch influence. Lessons from early-adopter states provide a road map for other state Medicaid agencies considering similar reform.


Assuntos
Medicaid , Transtornos Relacionados ao Uso de Substâncias , Idoso , Órgãos Governamentais , Humanos , Medicare , Governo Estadual , Estados Unidos
11.
Milbank Q ; 99(3): 648-692, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33904611

RESUMO

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.


Assuntos
Pessoas Mal Alojadas , Medicaid/legislação & jurisprudência , Definição da Elegibilidade , Humanos , Entrevistas como Assunto , Determinantes Sociais da Saúde , Estados Unidos
12.
Crit Rev Toxicol ; 51(7): 600-621, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34756157

RESUMO

Traditionally, human health risk assessment focuses on defining the hazard through mammalian toxicity studies followed by exposure estimation. We have explored ways of predicting exposure based primarily on the use scenario and comparing the exposure to reference dose values derived by various regulatory agencies (US EPA, JMPR, and EU Commission) in order to identify mammalian toxicity studies that are relevant to human health risk assessment. Human dietary exposure was based on existing residue data for substances with comparable use on the same or similar crops. Human occupational exposures were based on the use scenarios and application methods. To provide a point of comparison for the exposure predictions, data were collated for acute, chronic and occupational reference dose values derived by various regulatory agencies (US EPA, JMPR, and EU Commission). The exposure predictions and range of hazard endpoints were compared using the ILSI HESI Risk21 risk matrix plots in order to visualise and contextualise the level of potential concern for the exposure prediction. In addition, an approach is proposed to categorise the likelihood of acceptability of risk based on where the exposure sits relative to the distribution of reference dose values. The approaches proposed in this study allow for exposure prediction based on the Good Agricultural Practice (GAP) in conjunction with the use of existing hazard data for crop protection products in order to make an initial determination on acceptability of risk and to identify key studies that are required for human health risk assessment and also opportunities for study waivers.


Assuntos
Proteção de Cultivos , Exposição Ocupacional , Animais , Humanos , Medição de Risco
13.
J Health Polit Policy Law ; 46(2): 357-374, 2021 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-32955558

RESUMO

The Trump administration's Healthy Adult Opportunity waiver follows a long history of Republican attempts to retrench the Medicaid program through block grants and to markedly reduce federal spending while providing states with substantially greater flexibility over program structure. Previous block grant proposals were promulgated during the presidential administrations of Ronald Reagan and George W. Bush and majorities in Congress led by House Speaker Newt Gingrich and House Budget Committee Chair and then Speaker Paul Ryan. Most recently, Medicaid block grants featured prominently in Republican efforts to repeal and replace the Affordable Care Act. This essay traces the history of Republican Medicaid block grant proposals, culminating in the Trump administration's Healthy Adult Opportunity initiative. It concludes that the Trump administration's attempt to convert Medicaid into a block grant program through the waiver process is illegal and, if implemented, would leave thousands of people without necessary medical care. This fact, combined with failed legislative efforts to block grant Medicaid during the last forty years, highlights the substantial roadblocks to radically restructuring a popular program that helps millions of Americans.


Assuntos
Governo Federal , Financiamento Governamental/economia , Medicaid/economia , Política , Financiamento Governamental/história , História do Século XX , História do Século XXI , Medicaid/história , Governo Estadual , Estados Unidos
14.
Clin Trials ; 17(3): 253-263, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32367741

RESUMO

BACKGROUND: Novel rationales for randomizing clusters rather than individuals appear to be emerging from the push for more pragmatic trials, for example, to facilitate trial recruitment, reduce the costs of research, and improve external validity. Such rationales may be driven by a mistaken perception that choosing cluster randomization lessens the need for informed consent. We reviewed a random sample of published cluster randomized trials involving only individual-level health care interventions to determine (a) the prevalence of reporting a rationale for the choice of cluster randomization; (b) the types of explicit, or if absent, apparent rationales for the use of cluster randomization; (c) the prevalence of reporting patient informed consent for study interventions; and (d) the types of justifications provided for waivers of consent. We considered cluster randomized trials for evaluating exclusively the individual-level health care interventions to focus on clinical trials where individual randomization is only theoretically possible and where there is a general expectation of informed consent. METHODS: A random sample of 40 cluster randomized trials were identified by implementing a validated electronic search filter in two electronic databases (Ovid MEDLINE and Embase), with two reviewers independently extracting information from each trial. Inclusion criteria were the following: primary report of a cluster randomized trial, evaluating exclusively an individual-level health care intervention, published between 2007 and 2016, and conducted in Canada, the United States, European Union, Australia, or low- and middle-income country settings. RESULTS: Twenty-five trials (62.5%, 95% confidence interval = 47.5%-77.5%) reported an explicit rationale for the use of cluster randomization. The most commonly reported rationales were those with logistical or administrative convenience (15 trials, 60%) and those that need to avoid contamination (13 trials, 52%); five trials (20%) were cited rationales related to the push for more pragmatic trials. Twenty-one trials (52.5%, 95% confidence interval = 37%-68%) reported written informed consent for the intervention, two (5%) reported verbal consent, and eight (20%) reported waivers of consent, while in nine trials (22.5%) consent was unclear or not mentioned. Reported justifications for waivers of consent included that study interventions were already used in clinical practice, patients were not randomized individually, and the need to facilitate the pragmatic nature of the trial. Only one trial reported an explicit and appropriate justification for waiver of consent based on minimum criteria in international research ethics guidelines, namely, infeasibility and minimal risk. CONCLUSION: Rationales for adopting cluster over individual randomization and for adopting consent waivers are emerging, related to the need to facilitate pragmatic trials. Greater attention to clear reporting of study design rationales, informed consent procedures, as well as justification for waivers is needed to ensure that such trials meet appropriate ethical standards.


Assuntos
Consentimento Livre e Esclarecido/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Projetos de Pesquisa , Austrália , Canadá , Análise por Conglomerados , Ética em Pesquisa , Europa (Continente) , Humanos , Consentimento Livre e Esclarecido/estatística & dados numéricos , Ensaios Clínicos Pragmáticos como Assunto/ética , Prevalência , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Estados Unidos
15.
J Community Health ; 45(1): 148-153, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31446543

RESUMO

To examine school factors associated with philosophical exemption rates among kindergarteners in Michigan from 2014, before Michigan's implementation of administrative rule 325.176 (12), to 2015, after the rule change revising the process for receiving nonmedical exemptions from school entry vaccines. The study explored the extent to which the factors-school type, geographical location, and socioeconomics-were associated with philosophical exemptions among kindergarteners before and after the rule change, using negative binomial regression and Spearman's Rho correlation. Philosophical exemptions decreased from 2014 to 2015 for all school types but remained highest among rural private schools. Urban private schools had the second highest exemptions with rates 2.22 times higher than those of urban public schools. Exemption rates among rural charter schools were double those of urban public schools, while rural public schools' rates were 1.22 times higher than those of urban public schools. Free and reduced school lunch eligibility had a strong inverse association with philosophical exemptions for both 2014 and 2015, with higher philosophical exemptions being associated with higher socioeconomic schools. Philosophical exemption rates decreased in the wake of the rule change; however, high philosophical exemptions, post rule change, were still associated with private schools, rural locations, and high socioeconomic status schools.


Assuntos
Recusa de Vacinação/legislação & jurisprudência , Recusa de Vacinação/estatística & dados numéricos , Vacinação/legislação & jurisprudência , Vacinação/estatística & dados numéricos , Criança , Humanos , Michigan , Instituições Acadêmicas , Fatores Socioeconômicos
16.
BMC Med Ethics ; 21(1): 23, 2020 03 20.
Artigo em Inglês | MEDLINE | ID: mdl-32197602

RESUMO

BACKGROUND: Several jurisdictions, including Singapore, Australia, New Zealand and most recently Ireland, have a public interest or public good criterion for granting waivers of consent in biomedical research using secondary health data or tissue. However, the concept of the public interest is not well defined in this context, which creates difficulties for institutions, institutional review boards (IRBs) and regulators trying to implement the criterion. MAIN TEXT: This paper clarifies how the public interest criterion can be defensibly deployed. We first explain the ethical basis for requiring waivers to only be granted to studies meeting the public interest criterion, then explore how further criteria may be set to determine the extent to which a given study can legitimately claim to be in the public interest. We propose an approach that does not attempt to measure magnitude of benefit directly, but rather takes into account metrics that are more straightforward to apply. To ensure consistent and justifiable interpretation, research institutions and IRBs should also incorporate procedural features such as transparency and public engagement in determining which studies satisfy the public interest requirement. CONCLUSION: The requirement of public interest for consent waivers in secondary biomedical research should be guided by well-defined criteria for systematic evaluation. Such a criteria and its application need to be periodically subject to intra-committee and intra-institution review, reflection, deliberation and amendment.


Assuntos
Comitês de Ética em Pesquisa , Consentimento Livre e Esclarecido , Austrália , Análise de Dados , Humanos , Nova Zelândia , Singapura
17.
J Health Polit Policy Law ; 45(4): 633-646, 2020 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-32186339

RESUMO

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.


Assuntos
Medicaid/organização & administração , Patient Protection and Affordable Care Act/organização & administração , Política , Governo Federal , Política de Saúde/legislação & jurisprudência , Governo Estadual , Estados Unidos
18.
J Aging Soc Policy ; 32(4-5): 343-349, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32475257

RESUMO

Medicaid provides essential coverage for health care and long-term services and supports (LTSS) to low-income older adults and disabled individuals but eligibility is complicated and restrictive. In light of the current public health emergency, states have been given new authority to streamline and increase the flexibility of Medicaid LTSS eligibility, helping them enroll eligible individuals and ensure that current beneficiaries are not inadvertently disenrolled. Though state budgets are under increased pressure during the economic crisis created by the coronavirus, we caution states against cutting Medicaid LTSS eligibility or services to balance their budgets. These services are critical to an especially vulnerable population during a global pandemic.


Assuntos
Infecções por Coronavirus/epidemiologia , Definição da Elegibilidade/organização & administração , Assistência de Longa Duração/organização & administração , Medicaid/organização & administração , Pneumonia Viral/epidemiologia , Idoso , Betacoronavirus , Orçamentos , COVID-19 , Gastos em Saúde , Serviços de Assistência Domiciliar/organização & administração , Humanos , Assistência de Longa Duração/economia , Medicaid/economia , Pandemias , SARS-CoV-2 , Estados Unidos
19.
J Health Polit Policy Law ; 42(6): 1039-1064, 2017 12.
Artigo em Inglês | MEDLINE | ID: mdl-28801463

RESUMO

Since the Supreme Court decided that the Affordable Care Act's (ACA) Medicaid expansion is optional for the states, several have obtained federal approval to use Section 1115 waivers to expand Medicaid while changing its coverage and benefits design. There has long been concern that policy making for Medicaid populations may lack meaningful engagement with low-income constituents, and therefore the ACA established a new process under which the public can submit comments on pending Medicaid waiver applications. We analyzed 291 comment letters submitted to federal regulators pertaining to Medicaid Section 1115 waiver applications in the first five states to seek such waivers: Arkansas, Indiana, Iowa, Michigan, and Pennsylvania. We found that individual citizens, including those who identified as Medicaid-eligible, submitted a sizable majority of the comment letters. Comment letters tended to mention controversial provisions of the waivers and reflected the competing political rhetoric of "personal responsibility" versus "vulnerable populations." Despite the fact that the federal government seemed likely to approve the waiver applications, we found robust public engagement, reflecting the salience of the issue of Medicaid expansion under the ACA. Our findings are consistent with the argument that Medicaid is a program of growing centrality in US health politics.


Assuntos
Participação da Comunidade , Política de Saúde , Medicaid/organização & administração , Formulação de Políticas , Pobreza , Defesa do Consumidor/psicologia , Governo Federal , Pessoal de Saúde/psicologia , Humanos , Medicaid/legislação & jurisprudência , Patient Protection and Affordable Care Act/legislação & jurisprudência , Política , Governo Estadual , Estados Unidos
20.
J Health Polit Policy Law ; 42(2): 247-284, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28007801

RESUMO

Seven states have used Section 1115 waivers to expand Medicaid as part of the Affordable Care Act (ACA). While each state pursued a unique plan, there are similarities in the types of changes each state desired to make. Equally important to how a state modified their Medicaid programs is how a state talked about Medicaid and reform. We investigate whether the rhetoric that emerged in waiver states is unique, analyze whether the rhetoric is associated with particular waiver reforms, and consider the implications of our findings for the future of Medicaid policy making. We find that proponents in waiver states have convinced a conservative legislature that their reform is sufficiently innovative that they are not doing a Medicaid expansion, and not building on the traditional Medicaid program. Particularly striking is that none of these reforms are entirely new to the Medicaid program. While not new, the way in which waiver states have been allowed to implement many of the reforms is new and has become stricter. We find an emerging consensus utilized by conservative policy makers in framing the Medicaid expansion. Expansion efforts by conservative policy makers in other states have subsequently pushed this framing far to the right.


Assuntos
Medicaid , Patient Protection and Affordable Care Act , Governo Estadual , Pessoal Administrativo , Humanos , Formulação de Políticas , Estados Unidos
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