بررسی سود و زیان اصلاحات نظارتی : چه سوالاتی باید پرسیده شود ؟

In 1984, Portney argued that “[w]e should scrutinize proposed reforms of the rulemaking process every bit as carefully as the regulations that process produces.” In the 23 years since then, the regulatory process on the federal level has been continuously reformed by statute, by executive order, and by directives from the OMB. Despite the extensive debate on the need for these reforms, there has been very little analysis of the reforms themselves. This paper updates Portney's work on analyzing cost–benefit analysis and expands it to evaluate reforms of the regulatory process. I use as my primary example the recent peer-review guidelines issued by OMB. I argue that we may have reached a point of diminishing returns in regulatory reforms, that the peer-review guidelines likely have costs that exceed their benefits, and that further regulatory reforms merit closer evaluation.

The revolution in managed care has not only drastically altered the practice of medicine but has raised a whole new set of ethical dilemmas for physicians. In the past, many ethical issues seemed to cross all boundaries of medicine. With the advent of managed care, however, the ethical issues facing the primary care physician may be much different than those facing the specialist. For example, in the past cardiologists were accused of financial conflict of interest when they “selfreferred” patients for a series of tests they performed, such as stress testing, echocardiography, catheterization, and angioplasty. The dynamics of the emerging health care system, especially capitation, however, has shifted the financial conflict of interest back to the primary care physician, who may profit or at least please his employer by restricting tests performed by specialists. It is in the setting of dramatic changes in health care such as these that the American College of Cardiology (ACC) has organized this Bethesda Conference to review the ethical dilemmas facing today’s cardiovascular specialists. This conference is divided into three task forces. Task Force 1 discusses current external influences on the practice of cardiology. Task Force 2 discusses ethical dilemmas surrounding end of life decisions. Finally, Task Force 3 discusses clinical trial monitoring and ethical issues associated with the explosion of scientific knowledge in molecular biology and genetics. Like its predecessor, this conference on ethics cannot hope to address all of the current ethical issues facing cardiovascular specialists. The focus on selected topics, however, will provide valuable information to the reader in important areas. This is the second Bethesda Conference on Ethics conducted by the American College of Cardiology. The first was held on October 5 to 6, 1989 and was subsequently published in the Journal of the American College of Cardiology (1). It is interesting to compare these two as a marker of changing times. First of all, it is important to recognize that the major goal of both conferences is to stimulate an increased interest and focus on ethical issues in cardiovascular practice. In and of itself, we hope that this heightened awareness will sensitize the “ethical” physician to act appropriately. We assume that physicians in general want to uphold the ideals of our profession. By understanding the issues, we are in a better position to act. The first ethics conference focused on three major issues: 1) the relation of cardiovascular specialists to patients, other physicians and physician-owned organizations; 2) perspectives

c Cardiovascular physicians have an ethical obligation to provide high quality end of life care. c As society seeks to constrain costs of medical care, the expenditure of resources in end of life situations becomes a particularly inviting target for cost savings and intensifies the ethical issues surrounding the care of this vulnerable subset of patients. c Although mortality, morbidity, and cost do increase with age in the application of complex medical technology, age, per se, is a poor predictor of medical outcomes. Such applications properly selected, in elderly patients, are associated with favorable, beneficial outcomes, often in circumstances in which alternative management strategies are not available or are not effective. c Palliative care should provide relief of suffering and preserve the dignity of patients who have end-stage heart disease. c Palliative care is valuable to patients and should be a priority for resource allocation in health care systems. c The knowledge and skills to provide good palliative care should be included in undergraduate, graduate, and postgraduate medical education. c We encourage research in methods of provision of care at the end of life. c The physician should provide competent palliative care regardless of financial considerations. c Treatment that is expected to provide little sustained benefit or has proven useless in achieving its desired effect, should be discontinued in favor of palliative care, despite pressures to pursue such futile treatment. c Patients have the right to forgo life-sustaining treatment— a right grounded in the ethical principle of respect for patient autonomy and protected by the legal doctrine of informed consent.