This book explores the making of health care rationing decisions through the analysis of three alternative decision makers: patients paying out of pocket; officials setting limits on treatments and coverage; and physicians at the bedside. Hall develops this analysis along three dimensions: political economics, ethics, and law. The economic dimension addresses the practical feasibility of each method. The ethical dimension discusses the moral aspects of these methods, while the legal dimension traces the most recent developments in jurisprudence and health law.

The importance of preserving trust in physicians and in medical institutions has received widespread attention in recent years. Primarily, this is due to the threats to trust posed by managed care, but there is a general and growing recognition that trust deserves more attention than it traditionally has received in all aspects of medical ethics, law, and public policy. Trust has both intrinsic and instrumental value. Trust is intrinsically important because it is a core characteristic that affects the emotional and (...) interpersonal aspects of the physician/patient relationship. As an instrumental value, trust is widely believed to be essential for effective therapeutic encounters. It has been hypothesized or shown to affect a host of important behaviors and attitudes relating to care, including seeking care, disclosing private information, complying with treatment, and being satisfied with care. Moreover, trust may be a mediator of measurable clinical outcomes and a key factor in the mind–body interactions that underlie placebo/nocebo effects and the effectiveness of alternative medicine. It is no surprise, then, that preserving, justifying, and enhancing trust is the fundamental goal of much of medical ethics, and is a prominent objective in healthcare law and public policy. Discussions of trust and related concepts were commonplace in professionally based medical ethics prior to the 1970s. a 1 2. (shrink)

Changes in healthcare financing increasingly rely upon patient cost-sharing to control escalating healthcare expenditures. These changes raise new challenges for physicians that are different from those that arose either under managed care or traditional indemnity insurance. Historically, there have been two distinct bases for arguing that physicians should not consider costs in their clinical decisions—an “aspirational ethic” that exhorts physicians to treat all patients the same regardless of their ability to pay, and an “agency ethic” that calls on physicians to (...) be trustworthy advisors to their patients. In the setting of greater patient cost-sharing, physicians' aspiration and agency roles increasingly conflict. Satisfactorily navigating the new terrain of consumer-driven healthcare requires physicians to consider these two roles and how they can best be reconciled so as to maximize quality of care while respecting the heterogeneity of patients' financial resources and willingness to pay. (shrink)

On September 8, 2015, the Department of Health and Human Services issued a Notice of Proposed Rule Making to revise the Federal Policy for the Protection of Human Subjects, widely known as the “Common Rule.” The NPRM proposes several changes to the current system, including a dramatic shift in the approach to secondary research using biospecimens and data. Under the current rules, it is relatively easy to use biospecimens and data for secondary research. This approach systematically facilitates secondary research with (...) biospecimens and data, maximizing the capacity for substantial public benefit. However, it has been criticized as insufficiently protective of the privacy and autonomy interests of biospecimen and data sources. Thus, the NPRM proposes a more restrictive regime, although more so for biospecimens than data. Both the status quo and the NPRM's proposal are critically flawed. (shrink)

Both the USA and Europe limit access to care by undocumented immigrants. In the debate over what level of access to confer to IMs, there are various public policy rationales operating either explicitly, or below the surface, ranging from minimalist humanitarianism to full cosmopolitan equality, with several intermediate positions between these two poles. This article informs the international debate by providing a conceptual mapping of these underlying policy rationales. Each position is based on different lines of reasoning or bodies of (...) evidence, and each leads to somewhat different conclusions about the extent to which IMs should have access to different types of health care. It is unlikely that broad consensus will be achieved in this ongoing debate. However, by articulating the ethical, legal, pragmatic and conceptual reasons to support or oppose various positions, we hope to help determine where in the landscape of reasoned argument various positions lie, and how each position might be best supported or refuted. In particular, we see in this debate an illustration of Michael Walzer’s classic analysis of competing spheres of justice. Various positions depend to a considerable extent on whether their advocates approach this issue from the health policy sphere rather than the sphere of immigration policy, or whether they attempt to blend the two spheres. (shrink)

Centralized, democratic rules are often asserted as a superior basis for rationing than individualized physician discretion. This article counters this prevailing wisdom by exploring the deficiencies of rule-based rationing. Rules are too imprecise to accurately reflect all the nuances of physical and mental impairment and the complexity of medical science, particularly considering the widely varying personal values that different patients attach to medical risk and benefit. Rule-based rationing also suffers from the biasing effects of interest group pressure on political processes (...) and the tendency to absolve physicians from any moral responsibility for the rationing decisions they implement. Internalizing cost constraints is a more socially and professionally acceptable means of rationing and, in any event, it is inevitable since even a preponderance of rule-based rationing will leave considerable areas of discretion for physician judgment in the implementation and interpretation of the rules. As a consequence, despite the flaws of bedside rationing, it is foolhardy to dispense with it entirely in favor of an exclusively rule-based system. Keywords: Bedside rationing, cost-constraints, rule-based rationing CiteULike Connotea Del.icio.us What's this? (shrink)

Many proposals to reform health care finance and delivery require individuals or private employers to pay for private health insurance. Senators Ron Wyden and Robert Bennett’s Healthy Americans Act, for instance, would require every adult person who is not covered by a public program to purchase health insurance. Similarly, President Obama’s campaign proposal requires that parents arrange for coverage of their minor children and that all but small employers pay a tax if they do not provide their workers health insurance.This (...) paper addresses the constitutionality of such proposals. Compulsory health insurance might raise constitutional concerns because there is no existing social legislation that serves as a perfect legal analogy to an individual mandate for private health insurance. Insurance mandates are familiar in other contexts, such as automobile liability, but they present an easier case for constitutionality because they are a condition of exercising a privilege, such as driving a car. (shrink)

Health insurance mandates have been a component of many recent health care reform proposals. Because a federal requirement that individuals transfer money to a private party is unprecedented, a number of legal issues must be examined. This paper analyzes whether Congress can legislate a health insurance mandate and the potential legal challenges that might arise, given such a mandate. The analysis of legal challenges to health insurance mandates applies to federal individual mandates, but can also apply to a federal mandate (...) requiring employers to purchase health insurance for their employees. There are no constitutional barriers for Congress to legislate a health insurance mandate as long as the mandate is properly designed and executed, as discussed below. This paper also considers the likelihood of any change in the current judicial approach to these legal questions. (shrink)

Strategies for disclosing investigators' financial interests to potential research participants have been adopted by many research institutions. However, little is known about how decisions are made regarding disclosures of financial interests to potential research participants, including what is disclosed and the rationale for making these determinations. We sought to understand the attitudes, beliefs, and practices of institutional review board chairs, conflict of interest committee chairs, and investigators regarding disclosure of financial interests to potential research participants. Several themes emerged, including general (...) attitudes toward conflicts of interest, circumstances in which financial interests should be disclosed, rationales and benefits of disclosure, what should be disclosed, negative effects of and barriers to disclosure, and timing and presentation of disclosure. Respondents cited several rationales for disclosure, including enabling informed decision making, promoting trust in researchers and research institutions, and reducing legal liability. There was general agreement that disclosure should happen early in the consent process. Respondents disagreed about whether to disclose the amounts of particular financial interests. Clarifying the goals of disclosure and understanding how potential research participants use the information will be critical in efforts to ensure the integrity of clinical research and to protect the rights and interests of participants. (shrink)

Investigator and institutional financial conflicts of interest have raised concerns about both the integrity of clinical research and protecting the rights and welfare of research participants. In response, professional groups and governmental bodies have issued guidance for managing conflicts of interest to minimize their potential untoward effects. Although a variety of approaches have been offered, a common protection is to disclose financial interests in research to potential research participants as part of the recruitment and informed consent process. This approach reinforces (...) a basic norm of candor, ideally allowing potential research participants to evaluate whether financial interests should affect their decision to participate in research. Disclosure to potential research participants is viewed as an alternative to having regulators or research institutions limit or prohibit all financial interests in research, assuming that not all such interests are unacceptable. (shrink)

Since 1991, over half the states have enacted laws that restrict or prohibit insurers’ use of genetic information in pricing, issuing, or structuring health insurance. Wisconsin was the first state to do so, in 1991, followed by Ohio in 1993, California and Colorado in 1994, and then several more states a year in each of the next five years. Similar legislation has been pending in Congress for several years. Also, a 1996 federal law known as the Health Insurance Portability and (...) Accountability Act prohibits group health insurers from applying “preexisting condition” exclusions to genetic conditions that are indicated solely by genetic tests and not by any actual symptoms. (shrink)

The overriding goal of health reform is to provide every American affordable access to adequate health care. Yet in every national effort to date, the focal means to this end has always been health insurance. Massachusetts is congratulated for having achieved nearly universal insurance coverage, and congressional Democrats are aiming for the same. But what if they don't succeed? Even in Massachusetts, 167,000 residents remain uninsured. Is it still possible to provide adequate access to medical care for those without insurance? (...) If so, shouldn't we reframe social goals to achieve universal access through any means possible, whether or not insurance is involved? (shrink)

It was a happy surprise when, overcoming partisan divisions and interest‐group lobbying, Congress enacted the No Surprises Act, which bans unfair out‐of‐network “balance billing.” Although this is only a modest legislative victory, key efforts by the health policy community made a real difference in a time of legislative gridlock.

Health care reform is being assaulted from all sides. In January, the House of Representatives voted to repeal The Patient Protection and Affordable Care Act (the "Affordable Care Act"). For now, that effort will not succeed, owing to Democratic control of the Senate and the presidential veto. But conservative lawmakers in the House threaten to withhold key funding for implementation, and we can expect ongoing efforts to enact various partial amendments.Meanwhile, a core component of the reform law is running the (...) gauntlet of constitutional challenges in dozens of courts.1 So far, two federal district judges—in Richmond, Virginia, and Pensacola, Florida—have declared the individual mandate unconstitutional, as .. (shrink)

Not since the civil rights era has enacted national legislation been fought so fiercely as the Patient Protection and Affordable Care Act. Political, ideological, and social forces have mobilized to undermine the ACA at numerous fronts, including the Supreme Court, Congress, state governments, and the court of public opinion. The ACA has survived a constitutional challenge, a presidential re‐election, numerous repeal votes in the House, and avowedly obstreperous state regulators. But it has not yet run the full gauntlet of lethal (...) strategies. The latest line of attack is a collection of orchestrated lawsuits seeking to keep the federal exchange from paying any premium tax subsidies.What if the challengers eventually prevail? What would happen then? (shrink)

Since 1991, over half the states have enacted laws that restrict or prohibit insurers’ use of genetic information in pricing, issuing, or structuring health insurance. Wisconsin was the first state to do so, in 1991, followed by Ohio in 1993, California and Colorado in 1994, and then several more states a year in each of the next five years. Similar legislation has been pending in Congress for several years. Also, a 1996 federal law known as the Health Insurance Portability and (...) Accountability Act prohibits group health insurers from applying “preexisting condition” exclusions to genetic conditions that are indicated solely by genetic tests and not by any actual symptoms. (shrink)

Opponents of the Affordable Care Act have attempted to topple it in court by challenging the legality of two of its three legs. Three years ago, in NFIB v. Sibelius, Chief Justice Roberts narrowly upheld the constitutionality of the individual mandate, in a 5-to-4 decision that characterized the mandate as an optional tax rather than as a regulatory command. This year, on June 25, the health policy community exhaled a giant sigh of relief when the Supreme Court upheld the subsidy (...) leg of the ACA structure. In King v. Burwell, Justice Roberts again wrote the majority opinion, ruling as a matter of statutory interpretation that subsidies for insurance premiums are available not just through state-based exchanges but also through the federal exchange. (shrink)

This article reviews the primary avenues of judicial challenge to the ACA, focusing on those that have reached, or have the potential to reach, the Supreme Court. The review demonstrates how deep-seated public policy opposition can be expressed through litigation.

The new millennium is still very young, so it is too early to declare National Federation of Independent Business v. Sebelius1 the health law “case of the century,” but that title would not be hyperbolic. Never before have we seen a case of such monumental importance for how health care is financed and delivered in the United States. At the Supreme Court, no decision has been more closely watched and more anxiously awaited since Bush v. Gore in 2000. In the (...) balance was the fate of President Obama's signature piece of domestic legislation, one that affects nearly every aspect of the largest segment of our economy, and so is perhaps the most important piece of social legislation since the New Deal. To no one's surprise, the decision was announced at the very end of the Court's term and was split five to four.What was very surprising, however, was the Court's embrace of the tax power defense of the individual mandate. And what was outright shocking was a seven‐to‐two majority in favor of finding the Medicaid expansion unconstitutional unless states are allowed to opt out of the expansion.The case holds great significance not only for the fate of the Patient Protection and Affordable Care Act—and, thus, for the nation's health care public policy—but also for constitutional doctrine that applies much more broadly than in the health care arena. (shrink)

“Unconscionable.” “Outrageous.” “Indefensible.” These are just some of the tamer descriptions for the billing practices of most hospitals, and also many physicians, that have recently come to the public's attention. Earlier this year, Time magazine published an extraordinary 24,000‐word exposé—the longest article it has ever published—detailing how even charitable hospitals routinely price‐gouge their patients.1 With characteristic flare for telling details, journalist Steven Brill documented ten‐fold markups of charges over costs at some prominent hospitals for common services like X rays and (...) lab tests, and one‐hundred‐fold mark‐ups on mundane supplies such as gauze pads and generic aspirin. Just as the buzz from Brill's article was abating, the Centers for Medicare & Medicaid Services released a comprehensive data set in May that galvanized local and national media across the country. This news tsunami caught hospital managers flat‐footed and tongue‐tied. Typical responses conceded that hospitals’ pricing practices are based neither on actual cost structures nor rational marketplace dynamics. Instead, hospitals attempted to deflect blame by noting that hardly anyone actually pays list prices, and they characterized their indefensible pricing as a symptom of a broken system that is beyond them to fix. There are two glaring faults in these standard defenses. (shrink)

As politicians revisit the merits of health insurance reform and courts deliberate its constitutionality, government regulators are busily working on the wonky details of implementation. The Affordable Care Act leaves vast swaths of regulation for various agencies to prescribe, most notably the Department of Health and Human Services. Infamously (or perhaps apocryphally, since I'm certainly not going to bother counting), the statute contains more than a thousand commands to the effect of, "the Secretary shall decide." This massive delegation of authority (...) is unavoidable in any attempt to comprehensively reform, yet preserve, our Byzantine health insurance system.Throughout this regulatory nativity, the government .. (shrink)