The Affordable Care Act and the Medicare program: the engines of true health reform.

The Patient Protection and Affordable Care Act and its amendments by the Health Care and Education Reconciliation Act of 2010 constitute landmark legislation known as the Affordable Care Act (ACA). The ACA has made many changes in the Medicare program as part of comprehensive health reform for the U.S. health care sector. Title III of the ACA pertains to improving the efficiency and quality of health care. Title VI calls for greater program integrity for all federally funded health insurance programs. Collectively, the changes in Medicare in these two titles address the three major problems that the Medicare program has faced since its inception: cost and volume inflation, quality assurance, and fraud and abuse. These changes, if successfully implemented, will have a dramatic impact on the reform of the American health care sector. The policy-making process in the Medicare program is exemplary of the process of "muddling through," as described by the Yale economist Charles E. Lindblom. Nevertheless, these changes may also prepare the Medicare program to be transformed, through several incremental changes in upcoming years, into a single payer system.

Foundation for a natural right to health care.

Discussions concerning whether there is a natural right to health care may occur in various forms, resulting in policy recommendations for how to implement any such right in a given society. But health care policies may be judged by international standards including the United Nations' Universal Declaration of Human Rights (UDHR). The rights enumerated in the UDHR are grounded in traditions of moral theory, a philosophical analysis of which is necessary in order to adjudicate the value of specific policies designed to enshrine rights such as a right to health care. We begin with an overview of the drafting of the UDHR and highlight the primary influence of natural law theory in validating the rights contained therein. We then provide an explication of natural law theory by reference to the writings of Thomas Aquinas, as well as elucidate the complementary "capabilities approach" of Martha Nussbaum. We conclude that a right to health care ought to be guaranteed by the state.

Comparative effectiveness research under the Patient Protection and Affordable Care Act: can new bottles accommodate old wine?

The Patient Protection and Affordable Care Act (PPACA), as amended by the Health Care and Education Reconciliation Act of 2010, initiated comprehensive health reform for the healthcare sector of the United States. PPACA includes strategies to make the American healthcare sector more efficient and effective. PPACA's comparative effectiveness research initiative and the establishment of the Patient-Centered Outcomes Research Institute are major strategies in this regard. PPACA's comparative effectiveness research initiative is one in a long line of federal initiatives to address the rising costs of healthcare as well as to obtain better value for healthcare expenditures. The key question is whether the governance and design features of the institute that will oversee the initiative will enable it to succeed where other federal efforts have faltered. This Article analyzes the federal government's quest to ensure value for money expended in publically funded healthcare programs and the health sector generally. This Article will also analyze what factors contribute to the possible success or failure of the comparative effectiveness research initiative. Success can be defined as the use of the findings of comparative effectiveness to make medical practice less costly, more efficient and effective, and ultimately, to bend the cost curve.

Realization of the international human right to health in an economically integrated North America.

With the North American Free Trade Agreement (NAFTA), the health care sectors of the United States, Canada, and Mexico are becoming more economically integrated. NAFTA poses major challenges to the realization of the international human right. These include: (1) Cross Border Trade in Medical Products, (2) Cross Border Trade in Medical Services, and the attendant investment protections, (3) Portability and Comparability of Health Insurance Coverage, and (4) Protection of Public Health Insurance Programs. The United States, Mexico, and Canada all provide public health insurance programs either to the entire population as in Canada or to vulnerable groups as in the United States. In none of these countries have private, for-profit providers and insurers been able to provide universal and affordable health coverage and care in a truly free market. Private insurers and for-profit providers should not profit from the care of the healthy and wealthy in ways that compromise the public programs that serve the poor and seriously ill. Nor should they be allowed to use NAFTA processes to compromise public programs. Policy makers must consider implications of NAFTA and move toward assuring access to affordable health care for all people on the North American continent.

The corporate transformation of medical specialty care: the exemplary case of neonatology.

The key to wealth in health care is the physician, who certifies to third-party payers that health care items and services are necessary for patient care. To compete more effectively for this wealth, physician specialists are organizing their practices into for-profit corporations and employing other physicians. Focusing on neonatology, this article describes the prevailing business model of these for-profit medical groups as controlling employed physicians through restrictive employment contract provisions, e.g., non-compete and mandatory arbitration clauses. With this business model and because of deficiencies in current law, for-profit medical groups eliminate competition from other physician specialists to the detriment of patients and consumers.

Patient-directed medicine labeling: text differences between the United States and Spain.

As part of a larger project to examine the complexities of patient adherence to medical directions, the current study compares written information given with prescribed medicines to patients in the United States (US) and Spain suffering from two chronic diseases. First, the legal context of the voluntary nature of the provision of such information in the US, and the mandatory nature of provision in Spain, was explored. Then, 30 drugs in common use in both countries, 19 for cardiovascular disease and 11 for endocrine disorders, were identified and the texts of the corresponding patient-directed written information were included in an electronic corpus and analysed. Ten rhetorical features common to both the US and Spanish texts were identified. Differences were found in the placement of two of the features in relation to the complete text: information on 'side effects' and concerning 'the need to seek medical advice' appeared more frequently throughout the US texts than in the Spanish texts. Detailed lexical analysis showed more technical vocabulary in use in the Spanish texts.

A randomized trial of two quality improvement strategies implemented in a statewide public community-based, long-term care program.

BACKGROUND: It has not been demonstrated that the implementation of computerized quality improvement strategies can improve client-centered outcomes in public community based, long-term care (CBLTC) programs. OBJECTIVES: To test and evaluate 2 innovative computer-assisted, client-centered quality improvement strategies for public community-based, long-term care. The first strategy, the Normative Treatment Planning (NTP) program, assesses needs, prescribes services, and evaluates outcomes. The second strategy, the Client Feedback System (CFS) program, provides service vendors with feedback on client perceptions of services. RESEARCH DESIGN: A 2 x 2 factorial design with the 2 strategies using cluster randomization. SUBJECTS: A total of 2222 clients (86% of eligible program clients) enrolled in Indiana's state case management program and/or the Medicaid home and community-based services waiver program for the aged and disabled as of January 1, 1995. MEASURES: Outcomes of needs met and client satisfaction were measured through telephone surveys every 6 months for 2 years. RESULTS: A total of 1006 participants (45%) completed the 2-year evaluation study. For the group using only the NTP program, perception of needs met and client satisfaction were significantly better than the control group over the 2 years. During this period, the group using only the CFS program had significantly better client satisfaction than the control group. However, the effect sizes of the significant differences were small, and no statistically significant effects were found for the group using both programs. CONCLUSIONS: Client-centered quality improvement strategies can be implemented to enable public CBLTC programs to meet client needs better and increase client satisfaction.

Pharmaceutical research involving the homeless.

Discussions of research involving vulnerable populations have left the homeless comparatively ignored. Participation by these subjects in drug studies has the potential to be upsetting, inconvenient, or unpleasant. Participation occasionally produces injury, health emergencies, and chronic health problems. Nonetheless, no ethical justification exists for the categorical exclusion of homeless persons from research. The appropriate framework for informed consent for these subjects of pharmaceutical research is not a single event of oral or written consent, but a multi-staged arrangement of disclosure, dialogue, and permission-giving. Payments and other rewards in biomedical research raise issues of whether it is ethical to offer inducements to the homeless in exchange for participation in drug studies. Such inducements can influence desperate persons who are seriously lacking in resources. The key is to strike a balance between a rate of payment high enough that it does not exploit subjects by underpayment and low enough that it does not create an irresistible inducement. This proposal does not underestimate the risks of research, which are often overestimated and need to be appraised in light of the relevant empirical literature.