Section 1115 of the Social Security Act is misconstrued as a mechanism to foster state flexibility, when in fact it is a narrow pilot program authority. HHS has exceeded the scope of this authority to approve harmful projects. Courts will not grant the agency broad deference when reviewing this abuse of authority.

During the past decade, Medicaid has experienced extraordinary growth, in both number of beneficiaries and total expenditures. Between 1988 and 1993, the number of Medicaid beneficiaries grew from 22 million to 32 million. While the number of Medicaid beneficiaries increased by 45 percent, expenditures increased by 145 percent, from 51 billion to 125 billion. Expressed in terms of its percentage of state budgets, Medicaid doubled from 10 percent to 20 percent over the same time period, to (...) the point that it is currently the second largest budget item for most states.Faced with unsustainable rates of program budget growth and serious concerns about the level of access and the continuity of care afforded by the Medicaid program, states have turned to managed care. Almost every state has introduced some form of managed care for a subset of their Medicaid beneficiary population. Twenty-three states have gone farther, and implemented, proposed, or are developing section 1115 waivers to overhaul their Medicaid programs. These waivers allow states to develop and introduce nonstandard approaches to benefits, eligibility, service delivery, and financing for the Medicaid beneficiary population. (shrink)

Inequality is the defining feature of our times. Many argue that it calls for a policy response, yet the most obvious policy responses require legislative action. And if inequality is the defining feature of our times, partisan acrimony and gridlock are the defining features of the legislature. That being so, it is worth considering what role administrative agencies, and administrative law, might play in ameliorating or exacerbating economic inequality. Here, I focus on American safety net programs, many of which are (...) joint operations between federal administrative agencies and state governments. In this context, a central mode of bureaucratic policy innovation comes in the form of administrative waivers, whereby a federal administrative agency waives some statutory requirement that is otherwise binding on state administrators. For example, the Centers for Medicare and Medicaid Services recently granted waivers to allow several states to impose various “personal responsibility” requirements on Medicaid beneficiaries. Faced with a choice between legislative inactivity and policy innovation through waivers, many scholars and policymakers of both parties have tended to favor waivers. The appeal of waivers as a path around legislative gridlock is compelling. However, I argue that this view has neglected the federal structure of American safety net programs, and does not account for the state politics of implementation. Moreover, scholars have not focused on the severe information problems that federal agencies face when issuing waivers; a permissive waiver regime exacerbates these problems. Focusing on Medicaid implementation, I highlight the risks of waivers for American safety net programs. Before concluding, I discuss possible reforms to administrative procedures, and offer a case study of litigation surrounding one recent waiver application. The case study illustrates many of the theoretical arguments, and further demonstrates the failure of judicial review; it indicates how review might be adjusted to promote more effective use of waivers and diminish their perils. (shrink)

In the face of escalating Medicaid costs and anticipated reductions in federal Medicaid spending, states are increasingly converting from fee-for-service to managed health care systems. The interrelated issues of enrollment and auto-assignment are fundamental to the overall success or failure of Medicaid managed care programs. The purpose of this article is to suggest how policy makers, consumer advocates, and providers should address these issues. My major premise is that implementation of managed care will proceed more smoothly if (...) states adopt enrollment strategies that promote voluntary selection of health plans by Medicaid consumers, minimize the likelihood of auto-assignment, and mitigate the negative consequences of mandatory assignment of consumers to managed care organizations.States seeking to implement Medicaid managed care must apply for a waiver from the secretary of the Department of Health and Human Services. Two different types of waivers are available to implement Medicaid managed care. (shrink)

We provide an overview of the characteristics of those who have gained insurance coverage due to the ACA as well as the characteristics of the remaining uninsured. We also describe the implications for the broader sharing of health care risks required under the law, and how they vary by individuals' health status. Finally, we assess the implications of state decisions to expand or not expand Medicaid eligibility under the law, how those decisions affect state finances, health care providers, residents, (...) and how the effects may vary for those states using waivers to expand eligibility using strategies designed to be more broadly politically acceptable. (shrink)

The United States Court of Appeals for the Third Circuit has followed the prevailing view in the federal courts by holding that state Medicaid funds must cover the same kinds of abortions as provided for under the 1994 Hyde Amendment. On July 25, 1995, the court held that a Pennsylvania law was preempted to the extent that it restricted Medicaid funding for abortions beyond the limits set by federal law ) by imposing additional procedures not prescribed by the (...) Hyde Amendment.Particularly, the court held that the Pennsylvania Abortion Control Acts ), whch requires victims of rape and incest to report the crime to law enforcement officials before Medicaid abortion funding is made available, exceeded the reporting requirements set by the Hyde Amendment, which provides a waiver for patients who are physically or mentally unable to comply with the reporting requirement. (shrink)

Abstract:This essay criticizes recent trends in disability policy as restrictive of individual liberty and informed by too narrow a definition of what constitutes human flourishing. I defend the value of intentional community settings as one legitimate residential option for people with intellectual and developmental disabilities. Recent federal regulations (HCBS Final Rule) define intentional communities or disability-specific housing as presumptively institutional in nature, misunderstanding the positive, noninstitutional features of intentional, integrated communities created by and for people with developmental disabilities. In addition, (...) current disability policy, despite its stated concern for the autonomy of people with intellectual and developmental disabilities, limits individual liberty by strictly defining the types of settings eligible for Medicaid waiver funding, expressly excluding agricultural communities, disability-specific residential settings, and intentional communities. A robust commitment to the autonomy of people receiving Medicaid waiver services would allow them to choose to direct their program dollars, recognizing that some individuals may choose a life in intentional community or with others facing similar challenges to themselves over an illusory “integration” into a wider society that remains too often unwelcoming and difficult to navigate. (shrink)

Early in 2018, the Trump administration's Centers for Medicare and Medicaid Services issued a guidance letter outlining a new and controversial kind of Medicaid waiver proposal. The administration invited states to propose waivers that would impose work (or other “community engagement”) requirements as a condition of eligibility for Medicaid. The Trump administration and state proponents of work requirements want to force able‐bodied Medicaid beneficiaries into the workplace. Critics allege that this is because they mistakenly believe (...) that low‐income individuals are not working because they're lazy or because aid programs provide them with a disincentive to work. Proponents respond that the requirements can lower the public programs' costs while helping its recipients. Medicaid data seems to show that the work‐requirement proposals are a solution in search of a real‐life problem. (shrink)

Presidential power has provoked increasingly vigorous debate since the turn of this century. In recent years, scholars and lawyers have been grappling with how Congress’s dictates may limit the president’s Commander-in-Chief power to detain enemy combatants at Guantanamo Bay, to fight wars abroad, and to conduct intelligence activities at home. But policymakers have not yet explored the many possibilities for invoking the president’s “Take Care” power to change health care policy.This article explores the scope and limits of President Barack Obama’s (...) ability to invoke his executive authority to reform health care. Specifically, it identifies ways the Obama Administration can use directives to: expand Medicaid and State Children’s Health Insurance Program coverage through section 1115 waivers; test quality initiatives through Medicare demonstration authority; expand health information technology; allow drug reimportation and experiment with contracting power under Medicare; enhance patient protections and private coverage requirements; lift coverage restrictions on Medicaid and SCHIP; and build on the health insurance program for federal employees. Consistent with the mission of the Legal Solutions in Health Reform project, this article does not endorse a particular policy. Instead of recommending “what,” it explains “how.”. (shrink)

State Medicaid programs have proposed closed formularies to limit spending on drugs. Closed formularies can be justified when they enable spending on other socially valuable aims. However, it is still necessary to justify guidelines informing formulary design, which can be done through a process of decision making that includes the public. This article examines criticisms that Medicaid closed formularies limit deliberation about decisions that affect drug access and unfairly disadvantage poor patients. Although unfairness to poor patients is a (...) risk, it is not a problem unique to Medicaid, since private insurance programs have also implemented closed formularies. (shrink)

Work requirements are the centerpiece of HHS's Trump Administration strategy to undo the ACA expansion for low income working age adults. This article examines the June 29, 2018 trial court opinion in Stewart v. Azar which held that HHS's approval of Kentucky's Section 1115 work demonstration was “arbitrary and capricious.” The purpose of Medicaid is to provide health coverage and HHS may not ignore the loss of coverage that will result from a work requirement.

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. (shrink)

Medicaid coverage matters for millions of low-income Americans, and especially for those with ongoing and serious health challenges. A source of comprehensive and affordable coverage, Medicaid has long been a cornerstone of federal and state efforts to improve access and health outcomes for very poor and medically vulnerable populations. The Affordable Care Act leveraged Medicaid's role in serving the poor to broaden the program's reach to millions of low-income uninsured adults, and positioned the program as a fundamental (...) component of the newly established continuum of public and private coverage. Looking ahead, if more states embrace the Medicaid expansion, there is the potential to build on this progress to significantly reduce the number of uninsured Americans. (shrink)

Informed consent is a vital part of ethical research. In emergency health care research environments such as ambulance services and emergency departments, it is sometimes necessary to conduct trial interventions or observations without patient consent. At times where treatment is time critical, it may be impossible or inappropriate to seek consent from next of kin. Emergency medicine is one of the few areas where the process of informed consent can be waived to allow research to proceed without patient consent. This (...) article will explore the ethics of informed consent in the prehospital emergency research context. This will include an overview of current Australian guidelines for ethical research, and recent changes in law internationally which have affected the conduct of international emergency health research. An overview of the ethical reasoning behind the waiver of informed consent in emergency research is presented, also addressing issues relating to emergency health research such as proxy consent, unconscious patients, and patient decision making capacity. The unusual circumstances encountered in the prehospital ambulance environment will also be discussed, including the dependent and coercive relationship between patients and ambulance professionals, and a lack of alternatives for care and transport for patients who refuse consent. The conflict arising from differences in medical culture and values between patients and health care professionals will also briefly be discussed. It will be argued that, while emergency care research should not require informed consent due to the restrictions of time and dependent nature of the relationship between patient and health professional, emergency health researchers still have a responsibility to consider the patients’ perspective when considering the ethical issues of an emergency research project, particularly in the prehospital environment. (shrink)

This commentary explores Medicaid's role for children with special health care needs today and considers how changes to Medicaid's federal financing structure under a per capita cap or block grant could affect coverage for these children.

Xenotransplantation is defined as “any procedure that involves the transplantation, implantation, or infusion into a human recipient of either live cells, tissues, or organs from a nonhuman animal source, or human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs.” Xenotransplantation has been viewed by desperate patients and their surgeons as a solution to the problem of the paucity of human organs available for transplantation. Foes of xenotransplantation argue that (...) the use of animal organs degrades the human race and should be avoided.In this paper, we briefly review the cultural context of xenotransplantation and explore the infectious disease risk of xenotransplantation. The United States Code of Federal Regulations requires life-long surveillance of a xenotransplantation recipient due to the largely unknown risk of novel infectious disease transmitted across species, known as xenogeneic infectious disease. We argue that despite being in the interest of protecting the public health, the imposition of lifelong surveillance requirements on xenotransplant recipients effectively abrogates the right to withdraw from a clinical trial after the transplantation has taken place. Moreover, we argue that a waiver of the right to withdraw should be made explicit in the interest of full disclosure, out of respect for the research subject’s right of self-determination. (shrink)

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 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. (shrink)

Neil Manson and Onora O’Neill have recently defended an original theory of informed consent in their book Rethinking Informed Consent in Bioethics (2007). The development of their ‘waiver’ model is premised on the failings of the theory of informed consent as disclosure, which is rejected on two counts: firstly, the disclosure model’s implicit reliance upon a ‘conduit-container’ model of communication means that the regulatory requirements of informed consent can rarely be achieved; secondly, the model’s purported ethical justification via a (...) principle of respect for patient autonomy is presented as being vacuous. Despite having laudable motivations for rethinking informed consent, I argue that their theory of informed consent as waiver can be criticised on similar grounds. In order to support this thesis I object that Manson and O’Neill’s developed theory of agential communication is too intricate to easily meet the demands of informed consent as waiver. Secondly, I show that the model appears to be implicitly reliant upon a principle of respect for patient autonomy. Hence, despite improving upon the doctrine of informed consent, the waiver model needs further elucidation in order to avoid the problems mounted against the disclosure model. (shrink)

Nowadays global inequalities in access to vaccines seem to be a growing problem. Intellectual Property Rights have been playing an important role both in causing and worsening them. Firstly,...

(1984). Discretionary waiver of juvenile court jurisdiction: An invitation to procedural arbitrariness. Criminal Justice Ethics: Vol. 3, No. 2, pp. 41-50.

In a familiar interpretation, the Non-Identity Problem claims that persons whose existence depends on a seemingly harmful action cannot in fact be harmed through such an action. It is often objected that the persons in question can nevertheless be wronged through a violation of their rights. However, this objection seems to fail because these persons would readily waive any violated right in order to come into existence. The present article will analyze this Waiver Counter Argument in detail and show (...) why it does not succeed. First, it is necessary to distinguish between a prospective and a retrospective waiver scenario. In the prospective scenario an imagined person must consider whether she wants to waive a right in order to come into existence. In the retrospective scenario a person is asked whether she would prefer a wronged existence to never having been born. In both scenarios the conditions of a legitimate waiver of rights are not met, but for different reasons. On this basis, an argument against NIP can be developed. (shrink)

Parental consent poses challenges to needed research with adolescents who identify as lesbian, gay, bisexual, transgender, queer and/or questioning (LGBTQ+) and are at heightened risk for negative health outcomes. Obtaining parental consent in studies focused on LGBTQ+ issues can prove arduous if adolescents have not yet disclosed their identity or have unsupportive guardians. Institutional Review Boards (IRBs) may be hesitant to grant waivers of parental consent, yet research suggests that studies requiring parental consent deter the participation of adolescents who identify (...) as LGBTQ+. In this article, ethical considerations regarding waivers of parental consent in the context of the American Psychological Association’s (APA) general ethical principles are reviewed and recommendations for psychological researchers seeking waivers of parental consent are offered. A vignette is used to demonstrate a question-and-answer guide to help determine if a waiver of parental consent is ethically justified. (shrink)

To be autonomous, a person must also have authentic moral values. She must act on her own values, not on values that were improperly pressed upon her. To respect a patient's autonomy, then, a caregiver must do more than carry out her requests. The caregiver must honor the patient's authentic requests. But how to do that?

The proposed national PrEP program would serve people who are uninsured as well as those enrolled in Medicaid. In this article, the authors propose a set of recommendations for the proposed program’s implementers as well as state Medicaid agencies and Medicaid managed care organizations to ensure PrEP access for people enrolled in Medicaid, addressing gaps without undermining the important role of the Medicaid program in covering and promoting PrEP.

Using data from the National Hospital Discharge Survey, this paper analyzes the effect of Medicaid eligibility expansions from 1985 to 1996 on the health insurance coverage of women giving birth. We find that the eligibility expansions reduced the proportion of pregnant women who were uninsured by approximately 10%, although the magnitude of this decrease is sensitive to specification. The decrease in the proportion of uninsured pregnant women came at the expense of a substantial reduction in private insurance coverage (crowd-out) (...) of at least 55%. Substantial crowd-out and the relatively small change in the proportion uninsured suggest that Medicaid eligibility expansions may have had small effects on infant and maternal health. (shrink)

Should Medicaid pay for supportive housing for homeless persons? After describing current limits on how states can use Medicaid funds to support housing, this article considers whether justice requires treating Medicaid recipients residing in nursing homes and Medicaid recipients needing supportive housing similarly.

This case is about a study of burn patients that included a request to the IRB for a waiver of consent for perianal specimen collection–a request which ultimately was not approved by a reviewing IR...

The U.S. Court of Appeals for the District of Columbia upheld, in Presbyterian Medical Center of the University of Pennsylvania Health System v. Shalala, 170 F.3d 1146, a federal district court ruling granting summary judgment to the Department of Health and Human Services in a case in which Presbyterian Medical Center challenged Medicare's requirement of contemporaneous documentation of $828,000 in graduate medical education expenses prior to increasing reimbursement amounts. DHHS Secretary Donna Shalala denied PMC's request for reimbursement for increased GME (...) costs. The appellants then brought suit in federal court challenging the legality of an interpretative rule that requires requested increases in reimbursement to be supported by contemporaneous documentation. PMC also alleged that an error was made in the administrative proceedings to prejudice its claims because Aetna, the hospital's fiscal intermediary, failed to provide the hospital with a written report explaining why it was denied the GME reimbursement. (shrink)

Research Ethics, Volume 18, Issue 2, Page 151-162, April 2022. In today’s online data-driven world, people constantly shed data and deposit digital footprints. When individuals access health services, governments and health providers collect and store large volumes of health information about people that can later be retrieved, linked and analysed for research purposes. This can lead to new discoveries in medicine and healthcare. In addition, when securely stored and de-identified, the privacy risks are minimal and manageable. In many jurisdictions, ethics (...) committees routinely waive the requirement for researchers to obtain consent from data subjects before using and linking these datasets in an effort to balance respect for individuals with research efficiency. In this paper, I explore the ethical justification for using routinely collected health data for research without consent. I conclude that, not only is this morally justified but also that data subjects have a moral obligation to contribute their data to such research, which would obviate the need for ethics committees to consider consent waivers. In justifying this argument, I look to the duty of easy rescue, distributive justice and draw analogies with vaccination ethics. (shrink)

Federal and state budgetary constraints continually challenge Medicaid. The effects of benefit cuts are common: long waiting lists for community‐based services, skeletonized drug formularies with unstable access to long‐term prescriptions, no psychiatric therapy for people immobilized by depression, and no more than fourteen days of acute hospitalization. Reimbursements may be so low that providers cannot hire qualified staff and must reduce services, close facilities, or refuse to take Medicaid altogether. Misguided efficiency policies may afflict some groups of patients (...) as well. Decisions to narrow access rights to publicly funded health care promote the perception that more broadly inclusive programs would be unwisely and unfairly generous. They also risk characterizing disability rights as “special,” confined to a narrow class of people who charitably ought not to be expected to provide for themselves. In contrast, on a philosophical view we have been exploring—one that addresses problems of justice under circumstances of injustice by pursuing rather than reducing inclusion—efforts like these are unjust. (shrink)