Associations between CMS's Clinical Performance Measures project benchmarks, profit structure, and mortality in dialysis units.

Prior studies observing greater mortality in for-profit dialysis units have not captured information about benchmarks of care. This study was undertaken to examine the association between profit status and mortality while achieving benchmarks. Utilizing data from the US Renal Data System and the Centers for Medicare & Medicaid Services' end-stage renal disease (ESRD) Clinical Performance Measures project, hemodialysis units were categorized as for-profit or not-for-profit. Associations with mortality at 1 year were estimated using Cox regression. Two thousand six hundred and eighty-five dialysis units (31,515 patients) were designated as for-profit and 1018 (15,085 patients) as not-for-profit. Patients in for-profit facilities were more likely to be older, black, female, diabetic, and have higher urea reduction ratio (URR), hematocrit, serum albumin, and transferrin saturation. Patients (19.4 and 18.6%) in for-profit and not-for-profit units died, respectively. In unadjusted analyses, profit status was not associated with mortality (hazard ratio (HR)=1.04, P=0.09). When added to models with profit status, the following resulted in a significant association between profit status (for-profit vs not-for-profit) and increasing mortality risk: URR, hematocrit, albumin, and ESRD Network. In adjusted models, patients in for-profit facilities had a greater death risk (HR 1.09, P=0.004). More patients in for-profit units met clinical benchmarks. Survival among patients in for-profit units was similar to not-for-profit units. This suggests that in the contemporary era, interventions in for-profit dialysis units have not impaired their ability to deliver performance benchmarks and do not affect survival.

The industrialization of clinical research.

Recent controversies over the protection of human subjects, payment of physicians for recruiting patients to clinical trials, Food and Drug Administration (FDA) removal of approved drugs from the market, and reporting of results of clinical trials have highlighted important facets of clinical research. Less visible has been the industrialization of clinical research, and especially of clinical trials, that is, its emergence as a "line of business" of substantial magnitude and rapid growth. The growth of drug-industry outsourcing of clinical trials and the concomitant rise of a contract research industry are described in this paper, which argues for greater transparency in the conduct of both publicly and privately sponsored clinical trials.

The political economy of nephrology.

An issue of Seminars devoted to "The Economics of Nephrology" requires consideration not only of the narrow economic issues affecting the specialty but also the public policies that establish its economic parameters. Some economic issues involve only the balancing of costs and revenues in a dialysis unit. Others turn on the ESRD policies of Medicare. Still others hinge on action by the US Congress and, by definition, are political in character. In nephrology, economics are intertwined with politics, hence the political economy of nephrology.

Are patients a scarce resource for academic clinical research?

Managed care has affected clinical research at academic medical centers (AMCs) in various ways. It has reduced revenues for both faculty practice plans and major teaching hospitals, thus constraining the internal funds available for the cross-subsidy of research. It has increased the amount of patient care required of academic clinicians to meet target incomes, thus reducing the time for research. Has managed care also reduced the availability of patients for academic clinical research, either indirectly by diverting patients to community hospitals or directly by constraining access to such research, including clinical trials? Consistent with other studies and based on extensive interviews at nine AMCs, this research found little evidence that patients were a scarce resource for academic clinical research.

Medicare's end-stage renal disease program: current status and future prospects.

The twenty-five years of the end-stage renal disease (ESRD) program have been characterized by remarkable clinical achievements, which have prolonged and improved the quality of life for thousands of patients. As the program enters the next millennium, it faces considerable challenges: As the number and acuity of patients increase, the availability of trained nephrologists will decrease, and total costs will continue to rise. Policymakers will need to work closely with the renal professional and patient communities to develop creative approaches to delivering and financing ESRD care that is of the highest quality, yet is affordable.

Measuring and improving the health status of end stage renal disease patients.

This highlight reports on recent efforts to develop and promote health status measurement instruments for use in dialysis units that treat end-stage renal disease (ESRD) patients, most of whom are covered for all medical services under Medicare. Readers interested in a more detailed discussion of instruments, including associated data collection and data processing aspects, should consult a recently published account, with its extensive references, of four instruments currently being used in dialysis units (Rettig et al., 1997). Those interested in early reports of the clinical utility of such instruments should consult the following references (Kurtin et al., 1992; Meyer et al., 1994; and DeOreo, 1997).

Medical innovation duels cost containment.

The nation's commitment to health cost control will potentially conflict with its deeper commitment to innovation in medical technology--drugs, medical devices, diagnostic and therapeutic procedures, and administrative infrastructure. Medical technology is implicated in increasing health care costs because, on a net basis, it increases the capabilities of medicine. Conceptual, methodological, institutional, and political factors limit the ability to address the potential conflict; these limits must be confronted and addressed if we are to formulate sound policy responses.

A proposal for guidelines for patient acceptance to and withdrawal from dialysis: a follow-up to the IOM report.

The Institute of Medicine Committee for the Study of the Medicare End Stage Renal Disease Program recommended that the nephrology community, patients, and families develop guidelines for decisions to accept patients to and withdraw them from dialysis. This article rebuts the arguments that have been voiced against such guidelines, presents arguments for them, and proposes a mechanism for their development should general agreement to draft such guidelines be reached.