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Observational studies suggest improvements with frequent hemodialysis (HD), but its true efficacy and safety remain uncertain. The Frequent Hemodialysis Network Trials Group is conducting two multicenter randomized trials of 250 subjects each, comparing conventional three times weekly HD with (1) in-center daily HD and (2) home nocturnal HD. Daily HD will be delivered for 1.5-2.75 h, 6 days/week, with target eK(t)/V(n) > or = 0.9/session, whereas nocturnal HD will be delivered for > or = 6 h, 6 nights/week, with target stdK(t)/V of > or = 4.0/week. Subjects will be followed for 1 year. The composite of mortality with the 12-month change in (i) left ventricular mass index (LVMI) by magnetic resonance imaging, and (ii) SF-36 RAND Physical Health Composite (PHC) are specified as co-primary outcomes. The seven main secondary outcomes are between group comparisons of: change in LVMI, change in PHC, change in Beck Depression Inventory score, change in Trail Making Test B score, change in pre-HD serum albumin, change in pre-HD serum phosphorus, and rates of non-access hospitalization or death. Changes in blood pressure and erythropoiesis will also be assessed. Safety outcomes will focus on vascular access complications and burden of treatment. Data will be obtained on the cost of delivering frequent HD compared to conventional HD. Efforts will be made to reduce bias, including blinding assessment of subjective outcomes. Because no large-scale randomized trials of frequent HD have been previously conducted, the first year has been designated a Vanguard Phase, during which feasibility of randomization, ability to deliver the interventions, and adherence will be evaluated.

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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.

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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.

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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.

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BACKGROUND: Nontraumatic lower limb amputation is a serious complication of both diabetic neuropathy and peripheral vascular disease. Many people with end-stage renal disease (ESRD) suffer from advanced progression of these diseases. This study presents descriptive information on the rate of lower limb amputation among people with ESRD who are covered by the Medicare program. METHODS: Using hospital bill data for the years 1991 through 1994 from the Health Care Financing Administration's ESRD program management and medical information system (PMMIS), amputations were based on ICD9 coding. These hospitalizations were then linked back to the PMMIS enrollment database for calculation of rates. RESULTS: The rate of lower limb amputation increased during the four-year period from 4.8 per 100 person years in 1991 to 6.2 in 1994. Among persons whose renal failure was attributed to diabetic nephropathy, the rates in 1991 and 1994 were 11.8 and 13.8, respectively. The rate among diabetic persons with ESRD was 10 times as great as among the diabetic population at large. Two thirds died within two years following the first amputation. CONCLUSIONS: The ESRD population is at an extremely high risk of lower limb amputation. Coordinated programs to screen for high-risk feet and to provide regular foot care for those at high risk combined with guidelines for treatment and referral of ulceration are needed.

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At present, end-stage renal disease (ESRD) beneficiaries cannot enroll in health maintenance organizations (HMOs) or social health maintenance organizations (SHMOs), but HMO members who develop ESRD may remain enrolled, and the Health Care Financing Administration (HCFA) pays the HMO a state-specific, but otherwise unadjusted, capitation rate that is 95% of fee-for-service (FFS) costs. Thus, more than 6,000 ESRD beneficiaries were enrolled in HMOs in 1993, when Congress mandated an ESRD SHMO demonstration in which not only Medicare-covered services, but extra benefits were to be provided to Medicare beneficiaries, with the SHMO receiving a capitation rate based on 100% of FFS costs. The demonstration will test (1) the feasibility of year-round open enrollment of ESRD beneficiaries in HMOs; (2) a capitation system based on treatment status--dialysis, transplant, or functioning graft--and adjusted for age and whether diabetes was the cause of renal failure; (3) the effect of the additional benefits; and (4) whether managed care can improve ESRD quality outcomes. HCFA made demonstration awards in September 1996 to Kaiser-Permanente in Southern California; Health Options in Southern Florida; and Phoenix Healthcare in Central Tennessee. The sites are expected to have 1 year of planning and development before beginning the congressionally mandated 3 years of service delivery. There will be an independent evaluation.

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Significant improvements were made during the last two decades in the treatment of IDDM patients. To assess the risk of ESRD in a population that was exposed to these improvements, we determined the cumulative incidence of ESRD in a cohort of 142 white patients who were aged less than 21 years when they came to the Joslin Diabetes Center in 1959 with recently diagnosed IDDM. The first case of ESRD occurred after 13 years of IDDM, and a total of 25 cases have developed by 35 years' duration (cumulative incidence 21.3%). Median survival after the diagnosis of ESRD for the 16 patients who began dialysis was only 3.5 years. A strong predictor of the development of ESRD was the level of glycemic control during the first two decades of IDDM. ESRD developed in 36.3% of patients in the worst tertile for glycemic control but only in 14.4% and 9.2% of those in the middle and best tertiles. In comparison with two population based studies, the onset of ESRD in the Joslin Cohort was postponed by about five years. This advantage is more plausibly attributable to differences arising after the diagnosis of diabetes than to referral of less severe cases of IDDM to the Joslin Diabetes Center. What differences in diabetes care accounted for the postponement of ESRD cannot be discerned from comparisons among published studies, but likely candidates include Joslin's long-term advocacy of good glycemic control and the prompt implementation of new clinical interventions, such as antihypertensive treatment.

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BACKGROUND: There are wide disparities between blacks and whites in the use of many Medicare services. We studied the effects of race and income on mortality and use of services. METHODS: We linked 1990 census data on median income according to ZIP Code with 1993 Medicare administrative data for 26.3 million beneficiaries 65 years of age or older (24.2 million whites and 2.1 million blacks). We calculated age-adjusted mortality rates and age- and sex-adjusted rates of various diagnoses and procedures according to race and income and computed black:white ratios. The 1993 Medicare Current Beneficiary Survey was used to validate the results and determine rates of immunization against influenza. RESULTS: For mortality, the black:white ratios were 1.19 for men and 1.16 for women (P<0.001 for both). For hospital discharges, the ratio was 1.14 (P<0.001), and for visits to physicians for ambulatory care it was 0.89 (P<0.001). For every 100 women, there were 26.0 mammograms among whites and 17.1 mammograms among blacks. As compared with mammography rates in the respective most affluent group, rates in the least affluent group were 33 percent lower among whites and 22 percent lower among blacks. The black:white rate ratio was 2.45 for bilateral orchiectomy and 3.64 for amputations of all or part of the lower limb (P<0.001 for both). For every 1000 beneficiaries, there were 515 influenza immunizations among whites and 313 among blacks. As compared with immunization rates in the respective most affluent group, rates in the least affluent group were 26 percent lower among whites and 39 percent lower among blacks. Adjusting the mortality and utilization rates for differences in income generally reduced the racial differences, but the effect was relatively small. CONCLUSIONS: Race and income have substantial effects on mortality and use of services among Medicare beneficiaries. Providing health insurance is not enough to ensure that the program is used effectively and equitably by all beneficiaries.

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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.

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This report is a summary of the discussion on the United States Renal Data System and its data contents, as presented at the Symposium on World Renal Registries on December 10, 1993. The United States Rental Data System is a national database that collects and analyzes information on the incidence, prevalence, morbidity, and mortality, as well as the modalities of therapy of patients with end-stage renal disease (ESRD) in the United States. The database is funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Data on the patients are provided by the Health Care Financing Administration Medicare Program. The coordinating center for the database, operated through a contract mechanism, was formerly at the Urban Institute in Washington, DC, but is currently located at the University of Michigan, Ann Arbor, MI. The data system contains information on over 462,000 patients with more than 4 million dialysis records, 2.3 million inpatient records, 94,000 transplant reports, and more than 290,000 follow-up reports. The incidence rate of ESRD is approximately 180 per million population. However, the rate is higher in African-Americans (430) and Native Americans (281) than in whites (153) and Asian/Pacific Islanders (133). The gross mortality rate of the entire ESRD population is approximately 168 deaths per 1,000 patient-years at risk. The death rate is higher in diabetic than in nondiabetic ESRD patients. It is also higher in ESRD patients older than 65 years (357) than in patients in the 45- to 64-year-old age group (158) or those in the 20- to 44-year-old age group (62).

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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.

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The Health Care Financing Administration maintains a wide array of data systems that are essential to the functioning of the Medicare program. These data, collected and maintained for the purposes of ensuring entitlements and payment for services, also can be used to monitor programmatic changes and to define potential problem areas. The end-stage renal disease (ESRD) Program Management and Medical Information System (PMMIS) is a subset of the larger Medicare statistical system. It is a historic record of all Medicare ESRD beneficiaries dating back to 1978. Basic Medicare enrollment information on ESRD beneficiaries is enhanced with the addition of information on the cause of renal failure, type of dialysis therapy, transplantation history, and cause of death. The ESRD PMMIS has been put to a number of uses in the past decade or so, ranging from basic descriptive epidemiology to analyses of mortality rates to assessments of programmatic issues such as the composite rate and dialyzer reuse. Because of the limited clinical detail in the PMMIS, there are many specific questions that cannot be adequately addressed. With approval of the Food and Drug Administration and Medicare coverage of erythropoietin, a erythropoietin monitoring system was developed to assess utilization trends of this anemia control drug. Within a few months it became evident that dosing levels for erythropoietin were much lower than expected from the clinical trials. Following a change in the payment method from a fixed amount to one based on dose level, dosing has increased markedly. However, hematocrit levels still remain below optimal levels. This lack of hematocrit response has led the Health Care Financing Administration, in concert with the renal community, to target anemia control as a potential health care quality improvement project. This paper presents an example of the type of data presentation that can be derived from the current PMMIS. The Health Standards and Quality Bureau has made a commitment to a program of continuous quality improvement. Part of this process is the provision of descriptive data that can be the starting point for an iterative approach to quality improvement.

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The discovery of new drugs and their introduction into US markets will become an intense area of focus should health care reform result in Medicare insurance coverage for prescription drugs. Particular attention will be focused on high-cost drugs. Two high-cost drugs, cyclosporine and recombinant human erythropoietin (rHuEPO), introduced into the clinical management of patients with kidney disease during the past decade, provide some experience concerning the forces affecting the use of expensive drugs in a cost-conscious health care system. The decision to prescribe a drug will depend on provider's judgements of the drug's clinical benefits and costs compared with those of other possible therapies. It may also depend on payment policy. Both cyclosporine and rHuEPO were adopted rapidly and extensively by providers of end-stage renal disease care following US Food and Drug Administration approval, despite their high costs. Both drugs were remarkably effective, relatively safe, and able to be administered without great difficulty compared with the therapies they have replaced. There was no additional payment to hospitals for the initial use of cyclosporine, which was introduced in 1983 at the time when Medicare's prospective payment was established, since choice of immunosuppressive agent did not affect the fixed, per-admission payment determined by the diagnosis-related group for kidney transplantation. Medicare coverage for continuing outpatient use of cyclosporine was not initially provided, in contrast to rHuEPO, which was introduced in 1989 with Medicare outpatient coverage and payment of 80% of the allowed charge. Despite their high costs and different methods of insurance payment both drugs achieved a rather quick and high penetration rate into their respective populations.(ABSTRACT TRUNCATED AT 250 WORDS)

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Controversy exists as to whether provider organizational characteristics such as profit status and setting are associated with the content of medical care or efficiency with which care is rendered. Following FDA approval of human recombinant erythropoietin (EPO) for use in clinical practice, Medicare approved coverage for beneficiaries in its end stage renal disease program and established a fixed payment per dose. Because cost of EPO administration varied positively with dose, providers could realize larger profit with prescription of smaller doses. We used Medicare claims data to assess EPO use by renal dialysis providers one year after FDA approval (June 1990) as a function of provider ownership (for-profit, not-for-profit, government agency) and setting (hospital-based, free-standing). Mean dose of EPO was 236 units greater (P = 0.0001) for not-for-profit freestanding facilities, 593 units greater (P = 0.0001) for government facilities, and 555 units greater for not-for-profit hospitals (P = 0.0001) than among for-profit freestanding providers. With fixed payment per dose of EPO, for-profit, freestanding providers prescribed EPO more often and administered smaller doses than not-for-profit or government providers, behavior that is consistent with profit maximization.

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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.

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In a national longitudinal-cohort study of 59,462 end-stage renal disease (ESRD) patients, we examined dosing and effectiveness of erythropoietin (EPO) during the first year of its use in clinical practice (July 1989 through June 1990). In unadjusted and multivariate analyses of Medicare claims data, the mean dose of EPO prescribed was: relatively small and similar for initial and maintenance therapy, 2752 (95% confidence interval 2740 to 2764) and 2668 (95% confidence interval 2654 to 2682) units, respectively; lower when initial therapy was started later (591 units lower in September 1989 and 760 units lower in November 1989 vs. July 1989, P < 0.0001); lower by 135 units during initial therapy and by 116 units during maintenance therapy for females (who weigh less) compared to males (P < 0.001); and lower by 400 units for patients treated in for-profit versus not-for-profit centers. In multivariate analysis: hematocrit response was less and mean maintenance dose was 298 units and 621 units greater for patients whose ESRD was due to multiple myeloma and sickle cell disease, respectively, compared to those with hypertension-related ESRD (P < 0.01); and hematocrit response was logarithmically related to dose [hematocrit = 0.97 ln (dose), P < 0.0001]. Forty-four percent of patients had a hematocrit > or = 30 after four months of therapy. The percent of patients transfused during three month periods before and after therapy decreased from 20% to 5%, respectively (P < 0.0001).(ABSTRACT TRUNCATED AT 250 WORDS)

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OBJECTIVE: Examine access to recombinant human erythropoietin (rHuEPO) by dialysis-dependent end-stage renal disease (ESRD) patients during the first year after FDA approval for use in clinical practice and Medicare coverage. DESIGN: Longitudinal and cross-sectional claims data analyses. SETTING: All US providers of outpatient dialysis treatment. PATIENTS: 126,201 Medicare-entitled dialysis patients (approximately 93% of all US dialysis patients). OUTCOME MEASURES: Percentage of patients who received rHuEPO, odds of receiving rHuEPO according to patient characteristics, and cost of rHuEPO to Medicare. RESULTS: One year after FDA approval, 52% of all dialysis and 60% of in-center hemodialysis patients who regularly had Medicare-paid dialysis services received rHuEPO at a monthly cost to Medicare of $19 million (18% of Medicare ESRD outpatient expenditures and 6% of all ESRD program expenditures). Blacks were less likely than whites to receive rHuEPO (odds ratio, 0.88; 95% confidence interval, 0.86 to 0.91). Home peritoneal and hemodialysis patients were less likely than in-center hemodialysis patients to receive rHuEPO (odds ratios, 0.17 and 0.22, respectively; 95% confidence intervals, 0.16 to 0.17 and 0.20 to 0.24, respectively). Use of rHuEPO varied across geographic regions. The odds of receiving rHuEPO were lower for patients of male vs female sex, of ages 35 through 64 years vs less than 35 years and greater than 65 years, with a longer history of ESRD, with polycystic kidney disease vs other causes of ESRD, and receiving care in nonprofit vs for-profit facilities. First-month hematocrits were slightly higher (1.2 percentage points) for patients starting rHuEPO in the 12th month than in the first month after FDA approval. CONCLUSIONS: With prompt insurance coverage, the majority of Medicare-entitled dialysis patients received rHuEPO following widespread availability. Factors that may not be related to clinical need (race, setting of care, and geography) possibly influenced early patient access. More attention should be paid to monitoring the appropriate use of high-cost biotechnologic therapy.

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