The effects of frequent nocturnal home hemodialysis: the Frequent Hemodialysis Network Nocturnal Trial.

Prior small studies have shown multiple benefits of frequent nocturnal hemodialysis compared to conventional three times per week treatments. To study this further, we randomized 87 patients to three times per week conventional hemodialysis or to nocturnal hemodialysis six times per week, all with single-use high-flux dialyzers. The 45 patients in the frequent nocturnal arm had a 1.82-fold higher mean weekly stdKt/V(urea), a 1.74-fold higher average number of treatments per week, and a 2.45-fold higher average weekly treatment time than the 42 patients in the conventional arm. We did not find a significant effect of nocturnal hemodialysis for either of the two coprimary outcomes (death or left ventricular mass (measured by MRI) with a hazard ratio of 0.68, or of death or RAND Physical Health Composite with a hazard ratio of 0.91). Possible explanations for the left ventricular mass result include limited sample size and patient characteristics. Secondary outcomes included cognitive performance, self-reported depression, laboratory markers of nutrition, mineral metabolism and anemia, blood pressure and rates of hospitalization, and vascular access interventions. Patients in the nocturnal arm had improved control of hyperphosphatemia and hypertension, but no significant benefit among the other main secondary outcomes. There was a trend for increased vascular access events in the nocturnal arm. Thus, we were unable to demonstrate a definitive benefit of more frequent nocturnal hemodialysis for either coprimary outcome.

Mitral valve-tricuspid valve distance as a sonographic marker of trisomy 21.

OBJECTIVE: Pathologic studies suggest that a decreased mitral valve-tricuspid valve distance (MTD) is found in trisomy 21 fetuses without cardiac defects. We assessed the feasibility of using the MTD as a second-trimester sonographic marker for trisomy 21. METHODS: We performed a retrospective case-control study of all cases of trisomy 21 at our institution from 1998 to 2008. Cases without a prenatally identified cardiac defect and with adequate images from 15 to 26 weeks' gestation were assessed. The distance between the medial insertions of the mitral and tricuspid valves (i.e. the MTD) onto the ventricular septum was obtained. We also obtained the MTD from normal controls during the study period. Multiple linear regression analysis was used to assess the effects of gestational age and trisomy 21 on MTD. Gestational age-specific percentiles and multiples of the median were calculated, and curves were fitted using linear regression analysis. RESULTS: We identified 57 trisomy 21 fetuses with a measurable MTD and compared these with 634 control fetuses. Multiple linear regression analysis revealed a positive correlation between MTD and gestational age and a negative correlation between trisomy 21 and MTD. Using a cut-off of the 5(th) percentile, the MTD detected 70% of trisomy 21 cases with a 3.8% false-positive rate in the controls. CONCLUSIONS: The MTD increases with gestational age and is lower in fetuses with trisomy 21. Twenty (35%) of the 57 cases had no sonographic marker of trisomy 21 except an MTD below the 5(th) percentile for gestational age. The MTD was a useful independent marker for trisomy 21 in the second trimester.

End-stage renal disease in diabetic persons: is the pandemic subsiding?

Analysis of data compiled by the United States Renal Data System and the National Health Interview Survey as reported in the Centers for Disease Control and Prevention's Weekly Morbidity and Mortality Report indicates that between 1990 and 2002, there has been a sharp decline in incidence rate of the number of persons with diabetes who develop end-stage renal disease. Although it is comforting to practitioners to attribute this improvement to a widely advocated regimen of renoprotection, consisting of careful regulation of hypertensive blood pressure, improved glycemic control, and lifestyle modification, evidence for this causal relationship is appearing only now. There is need to clarify the source of this epidemiologic change that will lessen the projected burden on medical and socioeconomic resources in the immediate future.

Improved survival in HIV-infected African-Americans with ESRD.

AIMS: To determine if there has been improvement in survival of HIV-infected patients with end-stage renal failure subsequent to widespread use of highly active antiretroviral therapy. METHODS: The United States Renal Data System is a national data system funded by the National Institute of Diabetes and Digestive and Kidney Disease with the Centers for Medicare and Medicaid. Using the United States Renal Data System Standard Analysis Files, we analyzed all African-American end-stage renal failure patients in the United States from 1990-2001. We compared survival rates for patients with HIV disease, sickle cell anemia, diabetes, and all other diagnoses for the time periods 1990-1994 and 1995-2001. The main outcome measure was one- and five-year survival in each cohort. RESULTS: One-year survival of African-American patients with end-stage renal disease and HIV increased from 46.6% during 1990-1994 to 65.1% during 1995-2001 (odds ratio 2.139). One-year survival decreased in the sickle cell group (odds ratio 0.595) and decreased slightly in the diabetic group (odds ratio 0.927) and all others (odds ratio 0.941). Five-year survival in the HIV group increased from 13.3% in 1990-1995 to 30.4% in 1995-2001 (odds ratio 2.847). There was no corresponding increase in survival for the sickle cell group (odds ratio 0.987), the diabetic group (odds ratio 1.06), or all others (odds ratio 1.137). CONCLUSIONS: We conclude that survival in African-American end-stage renal disease patients and HIV infection has substantially improved subsequent to introduction of highly active antiretroviral therapy. Our data support aggressive multi-drug treatment of end-stage renal failure patients with HIV infection.

Diabetic end-stage renal disease among Native Americans.

OBJECTIVE: To examine why ESRD has become a major source of morbidity and mortality for Native Americans with diabetes mellitus. RESEARCH DESIGN AND METHODS: Using data from the Medicare ESRD Program, we examined incidence rates for ESRD among Native Americans for the years 1983-1987. RESULTS: During this period, the annual incidence of total ESRD in Native Americans increased by 18%, from 170.5/million to 200.1/million. The incidence of diabetic ESRD increased by 47%, from 80.6/million to 118.2/million. In 1987, the age-adjusted incidence rate of diabetic ESRD was 6.8 times higher in Native Americans than in whites. CONCLUSIONS: Recommendations for the prevention of diabetic ESRD include early identification of renal disease and improved control of hypertension and blood glucose. The magnitude of diabetic ESRD among Native Americans also underscores the need for primary prevention of non-insulin-dependent diabetes mellitus.

A quarter century of medicare expenditures for ESRD.

Medicare's end-stage renal disease (ESRD) program is unique in that it is the only example of an entitlement program based solely on the basis of a clinical condition. Medicare payments on behalf of ESRD beneficiaries is a combination of ESRD-specific payment policies such as those for dialysis, physician oversight, erythropoeitin, and immunosuppression and general Medicare payment policies such as hospital payments, nondialysis physician services, home health, and skilled nursing care. Over the 25-year history of the program, much of the ESRD-related care has been subject to cost controls more stringent than elsewhere in Medicare. Total payments for ESRD beneficiaries continue to consume an ever-increasing percentage of Medicare expenditures, largely because of ever-expanding patient treatment criteria. However, increases in per capita expenditures for ESRD beneficiaries have been far below that of Medicare in general.

Risk differential between Medicare beneficiaries enrolled and not enrolled in an HMO.

Medicare provides incentive reimbursements to health maintenance organizations (HMOs) which enroll Medicare beneficiaries on a risk option and provide care at a lower cost than expected. The incentive reimbursements are tied to an actuarial calculation of Medicare Adjusted Average Per Capita Cost (AAPCC). The AAPCC adjusts for a number of variables which affect Medicare reimbursements and for which data are available: place of residence, age, sex, welfare status, and institutional status of beneficiaries. These factors account for much of the expected difference in health care reimbursements. They do not, however, account for differences in health status. Because of this, AAPCC calculations of expected costs may be too high if a selected group of beneficiaries is healthier than average, or too low if the selected group has a poorer health status than average. This case study examines the utilization behavior and reimbursement experience of a group of Medicare beneficiaries prior to their joining an HMO (during an open enrollment period) under a risk-sharing option. Their use was compared with a comparable Medicare population (the comparison group) to determine if their usage rates were greater, equal, or less than average. Results show that beneficiaries who joined during open enrollment had a rate of hospital inpatient use over 50 percent below the comparison group and a reimbursement rate for inpatient services 47 percent below the comparison group. These beneficiaries' use of Part B services also appears to be lower than the comparison group. These results must be interpreted with care. The information came from a single case study. Specific aspects of the open enrollment process, described in the paper, further limit the general liability of the findings. Also, while some studies of the same subject support the results, many others do not.

Trends in Medicare reimbursement for end-stage renal disease: 1974-1979.

This article presents detailed analyses of the trends in Medicare expenditures for persons with end-stage renal disease. Program expenditures increased at an annual rate of 30.5 percent from 1974 to 1981. Three-fourths of this increase was a result of increases in enrollment. Per capita reimbursements for dialysis patients increased at a 5.2-percent annual rate and per capita reimbursements for transplant patients increased at a 10.5-percent annual rate. In 1979, per capital reimbursements for home dialysis patients were $5,000 less than for in-unit dialysis patients. Patient characteristics such as age, sex, race, and cause of renal failure were, for the most part, unrelated to the costs of dialysis and transplantation.

Prospective payment system and quality: early results and research strategy.

The implementation of the prospective payment system (PPS) in Medicare has raised concerns in both the public and private health sectors about the potential for compromised quality of care resulting from the financial incentives inherent in the system. As part of this concern, Congress has mandated annual reports from the Health Care Financing Administration (HCFA) on the impact of PPS, including the impact on Medicare beneficiaries. In order to meet this mandate, HCFA has initiated several studies concerning quality of care issues. Those activities and selected results from the 1985 PPS impact report are presented in this article.

Racial differences in access to kidney transplantation.

Previous work has documented large differences between black and white populations in overall kidney transplantation rates and in transplantation waiting times. This article examines access to transplantation using three measures: time from renal failure to transplant; time from renal failure to wait listing; and time from wait listing to transplantation. This study concludes the following First, no matter what measure of transplant access is used, black end stage renal disease (ESRD) beneficiaries fare worse than white, Asian-American, or Native American ESRD beneficiaries. Second, because the rate of renal failure exceeds the number of cadaver organs, access to kidney transplantation will deteriorate in future years for all races.

Racial and ethnic differences in hospitalization rates among aged Medicare beneficiaries, 1998.

Efforts to study racial variations in access to health care for minorities other than black persons have been hampered by a paucity of data. The Health Care Financing Administration (HCFA) has made efforts in the past few years to enhance the racial codes on the Medicare enrollment files to include Hispanic, Asian American, and Native American designations. This study examines hospitalization rates by these more detailed racial/ethnic groupings. The results show black, Hispanic, and Native American aged beneficiaries compared with white beneficiaries have higher hospitalization rates. Asian American beneficiaries have lower hospitalization rates. Rates of revascularization--coronary artery bypass graft (CABG) and percutaneous transluminal coronary angioplasty (PTCA)--are lower for black, Hispanic, and Native American beneficiaries compared with white beneficiaries, while rates for Asian Americans are similar to rates for white beneficiaries.

Pre-enrollment reimbursement patterns of Medicare beneficiaries enrolled in "at-risk" HMOs.

The Health Care Financing Administration (HCFA) has initiated several demonstration projects to encourage HMOs to participate in the Medicare program under a risk mechanism. These demonstrations are designed to test innovative marketing techniques, benefit packages, and reimbursement levels. HCFA's current method for prospective payments to HMOs is based on the Adjusted Average Per Capita Cost (AAPCC). An important issue in prospective reimbursement is the extent to which the AAPCC adequately reflects the risk factors which arise out of the selection process of Medicare beneficiaries into HMOs. This study examines the pre-enrollment reimbursement experience of Medicare beneficiaries who enrolled in the demonstration HMOs to determine whether or not a non-random selection process took place. The results of this study suggest that the AAPCC may not be an adequate mechanism for setting prospective reimbursement rates. The Marshfield results further suggest that the type of HMO may have an influence on the selection process among Medicare beneficiaries. If Medicare beneficiaries do not have to change providers to join an HMO, as in an IPA model or a staff model which includes most of the providers in an area, the selection process may be more likely to result in an unbiased risk group.

Using prior utilization to determine payments for Medicare enrollees in health maintenance organizations.

The Tax Equity and Fiscal Responsibility Act of 1982 is expected to make it more attractive for health maintenance organizations (HMO's) to participate in the Medicare program on an at-risk basis. Currently, payments to at-risk HMO's are based on a formula known as the adjusted average per capita cost (AAPCC). This article describes the current formula and discusses a modification, based on prior use of Medicare services, that endeavors to more accurately predict risk. Using statistical simulations, formulas incorporating prior use performed better for some types of biased groups than a formula similar to the one currently employed. Major concerns involve the ability to "game the system." The prior-use model is now being tested in an HMO demonstration. This article also outlines the limitations of a prior-use model and areas for future research.

The Medicare experience with end-stage renal disease: trends in incidence, prevalence, and survival.

This article presents a detailed account of the incidence, prevalence, and survival experience of people with end-stage renal disease (ESRD) covered by Medicare. The number of new entrants into the ESRD program has risen since its inception. This increase is greatest for people whose cause of renal failure is primary hypertensive disease or diabetic nephropathy. The program incidence rates for black people is 2.8 times that of white people. Incidence is highest for persons 65 to 69 years of age. Total patient survival is 44 percent 5 years after renal failure onset. Total Medicare enrollment for ESRD quadrupled between the years 1974 and 1981.

Trends in use, cost, and outcomes of human recombinant erythropoietin, 1989-98.

In this article the authors present descriptive data showing trends in human recombinant erythropoietin (EPO) doses, charges, and patient hematocrits from the fourth quarter of calendar year 1989 to the first quarter of 1998 for all recipients and recent data for patients treated by in-center hemodialysis. In 1997 nearly all in-center hemodialysis patients received EPO regularly at an average cost per recipient of $6,245 per year for total allowed charges of $842.2 million per year. The study shows that policy changes may have both anticipated and unanticipated effects on medical practice.

The first 3 years of Medicare prospective payment: an overview.

This article provides a synopsis of the available evidence on the impact of the Medicare prospective payment system (PPS) for hospitals over the first 3 years of its implementation. The impact of PPS on hospitals, Medicare beneficiaries, post-hospital care, other payers for inpatient hospital services, other health care providers, and Medicare program operations and expenditures is examined.

A review of the first year of Medicare coverage of erythropoietin.

Recombinant human erythropoietin (rHuEPO) is a new drug for treating anemia associated with end stage renal disease (ESRD). In a study of rHuEPO diffusion, costs, and effectiveness, we analyze ESRD program data and all claims submitted to Medicare for reimbursement of rHuEPO administered to ESRD dialysis patients. Access to rHuEPO was rapid and extensive during the first year of Medicare coverage. Dosing of rHuEPO and achieved hematocrit were lower than expected based on the results of clinical trials. rHuEPO cost Medicare $144 million in its first year. The analysis of insurance claims data allowed effective monitoring of access, costs, and effectiveness of this new biotechnology.

Cost issues in transplantation.

Major clinical progress has been made in recent years in solid organ transplantation. With the exception of kidney transplantation, very little reliable information is available concerning the costs of organ transplantation. This article addresses problems in assessing organ transplantation costs and makes recommendations about research approaches. It is suggested that the United Network for Organ Sharing waiting lists are good sources for developing transplant cost studies.