Beyond "safe and effective": the role of the federal government in supporting and disseminating comparative-effectiveness research

Over the past century, medical advancements have resulted in tremendous health gains for Americans. Although the federal government has played a prominent role in ensuring that new treatments are safe and effective, questions about which medical treatments work best under which circumstances have largely remained unanswered. Thus, the federal government's recent major investments in comparative-effectiveness research have potential to play a significant role in helping both patients and health care providers navigate the vast array of available treatment options, as well as in improving the quality, efficiency, and delivery of health care system-wide. Yet, the controversial nature of the government's foray into comparative-effectiveness research also suggests that the path toward realizing these goals may be treacherous. This Article describes the rationales for federal support of comparative-effectiveness research and potential models for that involvement, analyzes the federal government's recent investments in the research, and concludes with predictions about the probable outcomes of these investments. While increased federal support for comparative-effectiveness research is unlikely to achieve all of the benefits anticipated by its supporters, it is a crucial step toward ensuring that Americans are able to take full advantage of the benefits of medical innovation     

Administrative "health courts" for medical injury claims: the federal constitutional issues

Our article analyzes whether the federal government may constitutionally supplant a traditional system of common-law trials before state judges and juries with new federal institutions designed by statute for compensating victims of medical injuries. Specifically, this article examines the federal constitutional issues raised by various proposals to replace traditional medical malpractice litigation in state courts with a federal system of administrative "health courts." In doing so, we address the following constitutional issues: 1. Is there federal authority to preempt state law (the commerce clause and spending clause issues)? 2. May jurisdiction be created in non-article 3 tribunals, and may claims be decided without trial by jury (the separation of powers and Seventh Amendment issues)? 3. Would pilot programs that require some claims to be pursued in a federal administrative forum while other claimants are left to pursue traditional state tort law remedies be constitutional (the equal protection issue)? The article concludes that a federal compensation system through administrative health courts should be constitutional provided the statute is appropriately drafted and that appropriate factual findings are made concerning the benefits to patients and the public as well as to doctors and their insurers.     

From shared cost to block funding and beyond: the politics of health insurance in Canada

This paper takes as its starting point recent major changes in arrangements between the federal and provincial government in Canada concerning the sharing of costs for health insurance programs. The switch from a shared cost (conditional grant) to a modified block funding system was motivated by federal desires to limit and make predictable their expenditures, by provincial desires to increase the flexibility of their allocation of funds and by a mutual desire to limit any growth of health care costs as a proportion of GNP. Concerns related directly to improving medical care delivery were insignificant The changes will effectively centralize responsibility for program financing and program delivery, thus providing a powerful incentive for provincial governments to apply very strong measures to control costs. For reasons largely external to the relationship between public sector insurers and the suppliers of medical services, these attempts are unlikely to be successful in the short run. The probable impact of this difficulty on government and members of the health care delivery system is assessed.     

Negotiating authority: a comparative study of reform in medical training regimes

Recently the medical profession has faced increased outside pressure to reform postgraduate medical training programs to better equip young doctors for changing health care needs and public expectations. In this article we explore the impact of reform on professional self-governance by conducting a comparative historical-institutional analysis of postgraduate medical training reform in the United Kingdom and the Netherlands. In both countries the medical training regime has shifted from professional self-regulation to coregulation. Yet there are notable differences in each country that cannot be explained solely by diverging institutional contexts. They also result from the strategic actions by the actors involved. Based on an assessment of the recent literature on institutional transformation, this article shows how strategic actions set negotiating authority processes into motion, producing new and sometimes surprising institutional arrangements that can have profound effects on the distribution and allocation of authority in the medical training regime. It stresses the need to study the interactions among political context, the properties of institutions, and negotiating authority processes, as they are crucially important to understanding institutional transformation.     

Medical liability and health care reform

We examine the impact of the Affordable Care Act (ACA) on medical liability and the controversy over whether federal medical reform including a damages cap could make a useful contribution to health care reform. By providing guaranteed access to health care insurance at community rates, the ACA could reduce the problem of under-compensation resulting from damages caps. However, it may also exacerbate the problem of under-claiming in the malpractice system, thereby reducing incentives to invest in loss prevention activities. Shifting losses from liability insurers to health insurers could further undermine the already weak deterrent effect of the medical liability system. Republicans in Congress and physician groups both pushed for the adoption of a federal damages cap as part of health care reform. Physician support for damages caps could be explained by concerns about the insurance cycle and the consequent instability of the market. Our own study presented here suggests that there is greater insurance market stability in states with caps on non-economic damages. Republicans in Congress argued that the enactment of damages caps would reduce aggregate health care costs. The Congressional Budget Office included savings from reduced health care utilization in its estimates of cost savings that would result from the enactment of a federal damages cap. But notwithstanding recent opinions offered by the CBO, it is not clear that caps will significantly reduce health care costs or that any savings will be passed on to consumers. The ACA included funding for state level demonstration projects for promising reforms such as offer and disclosure and health courts, but at this time the benefits of these reforms are also uncertain. There is a need for further studies on these issues.     

Embracing the new professionalism: self-regulation, mandatory reporting and their discontents

In response to perceived failures in medical self-regulation in Australia, first in two States (for doctors) and now under the National Registration and Accreditation Scheme (for all health practitioners), mandatory reporting of peer status or practice that poses risks to patients has been introduced. Yet now, in response to the lobbying of State and federal health ministers by the medical profession, mainly in relation to the impairment provisions, this is to be reviewed. This column argues that claims concerning the negative consequences for practitioners of mandatory reporting are illogical and lack supporting evidence. There is, however, evidence that the medical profession does not consistently act in accordance with its professed positions in the area of physician impairment and departure from accepted clinical standards. The call for a review of mandatory reporting reflects an outdated model of regulation that does not align with increasing calls for a "new professionalism". In its own interests, but primarily in the interests of patients, the medical profession should embrace new attitudes and practices that will at first appear to threaten the privilege of self-regulation, but on proper scrutiny will be seen as necessary to retain it.     

Bad medicine: prescription drugs, preemption, and the potential for a no-fault fix

For decades, federal regulation of pharmaceutical drugs and medical devices has worked hand in hand with state tort claims to protect the health and safety of the American public. Now, a new trend toward preemption endangers this scheme. In recent years, the Supreme Court has given increasing deference to agency assertions about their preemptive authority and has found preemption in an increasing number of cases. In the process, the Supreme Court has preempted claims for medical device injuries and left claims for pharmaceutical harms in a precarious position. The elimination of common law claims for drug and device harms will leave holes in the FDA's regulatory scheme, endangering the health and safety of Americans. It will also prevent ordinary Americans from seeking compensation for their injuries--even those injuries caused by manufacturer malfeasance. This Article proposes that Congress create a no-fault compensation scheme for drugs and medical devices to close these gaps. Such a scheme could be both practical and politically possible, satisfying manufacturers, tort reformers, patients, and plaintiffs' lawyers alike.     

Public Health Service--Health systems agency and state health planning and development agency reviews: certificate of need programs. Final regulation

These rules amend the Public Health Service regulations on health systems agency and State health planning and Development agency (State Agency) certificate of need reviews. These final regulations implement changes to Title XV of the Public Health Service Act made by the Health Planning and Resources Development Amendments of 1979 (Pub L. 96-79). Under the amended provisions of the Public Health Service Act, the planning agencies are required to review and determine the need for proposed capital expenditures, institutional health services and major medical equipment. These regulations set forth the minimum requirements for satisfactory certificate of need programs.     

Modernizing Medicaid eligibility criteria for children with significant disabilities: moving from a disabling to an enabling paradigm

Children with significant disabilities may qualify for Medicaid benefits, regardless of household income, if their state elects to offer the Tax Equity Fiscal Responsibility Act (TEFRA) option. However, a significant number of children with serious medical problems presently are being denied eligibility for, or terminated from, this Medicaid program. This Article describes the ways in which the existing health insurance system inadequately meets the needs of children with significant disabilities, recounts the history and development of the TEFRA Medicaid coverage option, and analyzes the eligibility criteria used by the various states. It proceeds to consider how disability should be legally defined in the health care context and proposes reforms to modernize the eligibility standards so that these benefits can be more effectively, efficiently, and fairly allocated. To accomplish this goal, the federal statute and regulation that define disability, as well as corresponding state laws, must be reformed so that the law can keep pace with advances in modern medical science, and people with disabilities are not, in effect, penalized for receiving currently accepted preventative care that maintains health but will never cure the underlying disease.     

The ghost that slayed the mandate

Virginia v. Sebelius is a federal lawsuit in which Virginia has challenged President Obama's signature legislative initiative of health care reform. Virginia has sought declaratory and injunctive relief to vindicate a state statute declaring that no Virginia resident shall be required to buy health insurance. To defend this state law from the preemptive effect of federal law, Virginia has contended that the federal legislation's individual mandate to buy health insurance is unconstitutional. Virginia's lawsuit has been one of the most closely followed and politically salient federal cases in recent times. Yet the very features of the case that have contributed to its political salience also require its dismissal for lack of statutory subject matter jurisdiction. The Supreme Court has placed limits on statutory subject matter jurisdiction over declaratory judgment actions in which a state seeks a declaration that a state statute is not preempted by federal law--precisely the relief sought in Virginia v. Sebelius. These statutory limits are a sea wall; they keep out, on statutory grounds, some suits that should otherwise be kept out on Article III grounds. The statutory and constitutional limits on federal jurisdiction over suits like Virginia v. Sebelius insulate federal courts from the strong political forces surrounding lawsuits that follow from state statutes designed to create federal jurisdiction over constitutional challenges by states to federal law. This Article identifies previously neglected jurisdictional limits, shows why they demand dismissal of Virginia v. Sebelius, and explains why it is appropriate for federal courts to be closed to suits of this type.     

Health systems agency and state health planning and development agency reviews; certificate of need programs--PHS

The Assistant Secretary for Health, with the approval of the Secretary of Health and Human Services, amends the regulations governing certificate of need reviews by State health planning and development agencies (State Agencies) and health systems agencies (HSAs). The amendments accomplish two tasks: (1) To implement amendments to the Public Health Service Act made by the Health Programs Extension Act of 1980 (Pub. L. 96-538) and the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35), and (2) to reduce Federal regulatory burdens. Under the provisions of Title XV of the Public Health Service Act, the planning agencies are required to administer certificate of need programs consistent with the Department's regulations, under which they review and determine the need for proposed capital expenditures, institutional health services and major medical equipment. These regulations change the requirements for satisfactory certificate of need programs.     

The Institutional Sources of State Success in Federalism Litigation before the Supreme Court

The Supreme Court's recent federalism decisions are the clearest example of the states' improving legal fortunes in litigation against the federal government. Reducing the dramatic shift in the Court's federalism jurisprudence to the attitudinal voting of individual justices ignores the influence on the Court's decision making from broader institutional developments in American politics and domestic policy. These developments include: (1) the diminishing effectiveness of the states' lobbying power in the federal policymaking arena; (2) the increasing effectiveness of litigation by states' attorneys general in the federal judicial arena; and (3) the convergence of these developments resulting in a pro-state Supreme Court agenda.     

Canada: study demonstrates positive effect of methadone treatment

A recent study on methadone maintenance treatment (MMT) in federal correctional institutions demonstrates that MMT has a positive impact on release outcome and on institutional behaviour. The study provides support for the need to expand access to MMT in prisons. Importantly, it concludes that the CSC may spend less money on offenders who are on MMT in the long term, saying that "the cost of the institutional MMT program may be offset by the cost savings of offenders successfully remaining in the community for a longer period of time than equivalent offenders not receiving MMT."     

Medical data breaches: Notification delayed is notification denied

The EU and the United States have implemented data breach notification rules that cover the health sectors. Nevertheless, data breach incidents involving medical data continue to rise, especially in the US and the UK. The HITECH Act, Pub. L. 111-5 Title XIII is the first federal health breach notification law in the US to be characterized by less government intrusions, while the revised EU Privacy Directive, 2009/136/EC calls for tougher privacy protection for data held by electronic communication providers. While the EU law sets a global de facto standard, the law remains toothless without strong enforcement mechanisms.     

Three meanings of capacity; or,why the federal government is most likely to lead on insurance access issues

This essay considers on what health policy issues the federal government is best able to lead. Positive leadership requires knowledge, power, and will. The federal government has different supplies of each for different aspects of quality of, cost of, and access to health care. Here I review technical capacity to attain desired ends, define the institutional strengths and weaknesses of the federal government, and outline current dynamics of the national political process. This analysis suggests both prospects for and some characteristics of successful policy. The federal government is more likely to lead on insurance than on other health policy issues because its supply of relevant knowledge and power is relatively high on insurance issues and the political barriers are lower than conventional wisdom suggests. But that leadership could take the form of either the expanding or contracting of access to insurance.     

Contesting anticompetitive actions taken in the name of the state: state action immunity and health care markets

The so-called state action doctrine is a judicially created formula for resolving conflicts between federal antitrust policy and state policies that seem to authorize conduct that antitrust law would prohibit. Against the background of recent commentaries by the federal antitrust agencies, this article reviews the doctrine and discusses its application in the health care sector, focusing on the ability of states to immunize anticompetitive actions by state licensing and regulatory boards, hospital medical staffs, and public hospitals, as well as anticompetitive mergers and agreements. Although states are free, as sovereign governments, to restrict competition, the state action doctrine requires that "the state itself" make the decision to do so. Partly on the basis of problems in the political environment, the article criticizes courts for using a mere "foreseeability" test to decide whether a state legislature sufficiently authorized competitors to act in contravention of clear federal policy: "Few things are more foreseeable than that a trade or profession empowered to regulate itself will produce anticompetitive regulations."     

农民健康权理论下我国农村合作医疗法律制度构建——以农民利益保障为研究视角

我国农村合作医疗是一项关系到8亿农民切身健康利益的重要制度，但在目前的实施过程中，仍存在医疗保障不到位、农民医疗利益被侵犯等各种问题，致使农民的生命健康权得不到应有的保障。鉴于此，以农民利益保障为研究视角，提出了我国农村合作医疗法律制度构建中的责任制度、资金制度、监管制度和纠纷解决制度以使我国农村合作医疗切实保障农民健康权的落实和农民利益的实现。     

Inching toward incrementalism: federalism, devolution, and health policy in the United States and the United Kingdom

In the United States, the recently enacted Patient Protection and Affordable Care Act of 2010 envisions a significant increase in federal oversight over the nation's health care system. At the same time, however, the legislation requires the states to play key roles in every aspect of the reform agenda (such as expanding Medicaid programs, creating insurance exchanges, and working with providers on delivery system reforms). The complicated intergovernmental partnerships that govern the nation's fragmented and decentralized system are likely to continue, albeit with greater federal oversight and control. But what about intergovernmental relations in the United Kingdom? What impact did the formal devolution of power in 1999 to Scotland, Wales, and Northern Ireland have on health policy in those nations, and in the United Kingdom more generally? Has devolution begun a political process in which health policy in the United Kingdom will, over time, become increasingly decentralized and fragmented, or will this "state of unions" retain its long-standing reputation as perhaps the most centralized of the European nations? In this article, we explore the federalist and intergovernmental implications of recent reforms in the United States and the United Kingdom, and we put forward the argument that political fragmentation (long-standing in the United States and just emerging in the United Kingdom) produces new intergovernmental partnerships that, in turn, produce incremental growth in overall government involvement in the health care arena. This is the impact of what can be called catalytic federalism.     

Medical Error and Patient Safety: Understanding Cultures in Conflict

Evidence documenting the high rate of medical errors to patients has taken a prominent place on the health care radar screen. The injuries and deaths associated with medical errors represent a major public health problem with significant economic costs and erosion of trust in the health care system. Between 44,000 and 98,000 deaths due to preventable medical errors are estimated to occur each year, making medical errors the eighth leading cause of death in the United States. However, the recent prominence of the issue of safety or error does not reflect a new phenomenon or sudden rift in the quality of health care (although it is a system fraying at the edges). Rather, the prominence of the issue reflects a radical change in the culture of health care, and in how relationships within the health care system are structured and perceived. In this paper, I discuss the multiple factors responsible for the change in the culture of health care. First, the culture has shifted from a clinician cantered system, in which decision making is one–sided, to a shared system of negotiated care between clinician and patient, and, often, between administrator or payer. Second, the nature of quality in health care has changed due to the geometric increase in the availability of technological and pharmaceutical enhancements to patient care. Third, the health care culture continues to rely on outdated models of conflict resolution. Finally, the regulatory structure of health system oversight was set in place when fee–for–service care governed physician–patient relationships and where few external technologies were available. In the current health care culture, that structure seems inadequate and diffuse, with multiple and overlapping federal and state regulatory structures that make implementation of patient safety systems difficult.     

Health systems agency and state health planning and development agency reviews; certificate of need programs--PHS. Notice of proposed rulemaking

The Assistant Secretary for Health, with the approval of the Secretary of Health and Human Services, proposes to amend the regulations governing certificates of need reviews by State health planning and development agencies (State Agencies) and health systems agencies (HSAs). The proposed amendments would accomplish two tasks: (1) Implement amendments to the Public Health Service Act made by the Health Programs Extension Act of 1980 (Pub. L. 96-538) and the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35) and (2) reduce Federal regulatory burdens. Under the provisions of Title XV of the Public Health Service Act, the planning agencies are required to administer certificate of need programs consistent with the Secretary's regulations, under which they review and determine the need for proposed capital expenditures, institutional health services and major medical equipment. These regulations set forth proposed changes to the requirements for satisfactory certificate of need programs. Interested persons are invited to submit written comments and recommendations concerning these proposed rules as well as suggestions for alternative methods of implementing any of the provisions of the amendments that affect the requirements for certificate of need programs.