Medical Director Responsibilities to the ESRD Network.

The 18 regional ESRD Networks are established in legislation and contract with the Centers for Medicare and Medicaid Services to improve the quality and safety of dialysis, maximize patient rehabilitation, encourage collaboration among and between providers toward common quality goals, and improve the reliability and the use of data in pursuit of quality improvement. The Networks are funded by a $0.50 per treatment fee deducted from the reimbursement to dialysis providers, and their deliverables are determined by a statement of work, which is updated in a new contract every 3 years. The Conditions for Coverage require dialysis providers to participate in Network activities, and failure to do so can be the basis for sanctions against the provider. However, the Networks attempt to foster a collegial relationship with dialysis facilities by offering tools, educational activities, and other resources to assist the facilities in meeting the evolving requirements by the Centers for Medicare and Medicaid Services on the basis of national aims and domains for quality improvement in health care that transcend the ESRD program. Because of his/her responsibility for implementing the quality assessment and performance improvement activities in the facility, the medical director has much to gain by actively participating in Network activities, especially those focused on quality, safety, patient grievance, patient engagement, and coordination of care. Membership on Network committees can also foster the professional growth of the medical director through participation in quality improvement activity development and implementation, authorship of articles in peer-reviewed journals, creation of educational tools and presentations, and application of Network-sponsored materials to improve patient outcomes, engagement, and satisfaction in the medical director's facility. The improvement of care of patients on dialysis will be beneficial to the facility in achieving its goals of quality, safety, and financial viability.

The medical directorship of renal dialysis facilities under the new Medicare conditions for coverage: challenges and opportunities.

The new Medicare conditions for coverage for providers of end-stage renal disease services provide both a challenge and an opportunity for medical directors. The conditions expect active clinical leadership in quality improvement and the performance of the facility staff and medical staff. These new rules define patient assessment and care planning processes that complement the quality assessment and performance improvement (QAPI) program. Infection control, patient safety and error reduction are given new emphasis. The interdisciplinary team (IDT) under the leadership of the medical director will advance the quality and safety of the patients under their care. Patients' rights and autonomy are stressed. The QAPI/IDT will monitor complaints, satisfaction surveys, and grievances to minimize involuntary discharge. The medical director will report the results of the QAPI program to the governing body. Medical directors will find that participation in renal network quality improvement programs and initiatives will enhance their facility's QAPI program.

How dialysis is paid for: what the dialysis medical director should know, and why.

While Medicare funds neither 100% of the patients, nor 100% of the costs incurred by dialysis patients, Medicare's policies dominate reimbursement. The medical director is well advised to understand these mechanisms and the processes leading to change. Medicare pays for dialysis according to laws and rules enacted by Congress. Congress is re-evaluating the funding of the end-stage renal disease program. The rules are changing. They are changing in a way designed to encourage better outcomes, and increased provider accountability. The new terms of art are "budget neutrality,""quality incentive payments," and "bundled composite rate." Providers will need to make choices that may impact the quality of care and the experience of the patient. It is up to the medical director to ensure that these choices result in benefit to their patients.

Finances of the independent dialysis facility.

Medicare pays 80% of the cost of dialysis treatment and associated medications. Congress directed the Centers for Medicare and Medicaid Services (CMS) to develop both a process of regular and more or less "automatic" updates of composite rate setting and "bundling" as much of the laboratory and ancillary medications as possible into the composite rate. In response to this mandate, CMS revised the wage indexing process, added an annual update, and removed the limits on the wage index range. CMS has moved the "margin" from medication acquisition and administration to an annually revised "drug add-on" to the composite rate and fixed reimbursement of separately billed medication (ancillary) to the average sales price +6%. CMS is funding a demonstration project on near 100% bundling to be completed by 2008 that will include metrics for automatically increasing the base composite rate.

Changes in Medicare reimbursement and patient-nephrologist visits, quality of care, and health-related quality of life.

BACKGROUND: Medicare's reimbursement system was changed in January 2004 to encourage more frequent visits between dialysis patients and nephrologists. We sought to determine the impact of this policy change on patient-nephrologist visits, quality of care, and health-related quality of life. METHODS: We examined visits and outcomes for 2,043 patients at 12 hemodialysis facilities in northeast Ohio for 12 months before and 7 months after the reimbursement change. For comparison of outcomes, we used linear, logistic, or negative binomial regression models (for continuous, binary, and rate outcomes, respectively) to assess the significance of changes across the 2 periods. RESULTS: For patients seen before and after the reimbursement change for at least 6 months, the number of visits per patient-month increased from 1.52 before to 3.14 after (P < 0.001). The percentage of patients with no nephrologist visits per patient-month decreased from 16.6% before to 4.6% after (P < 0.001). However, there were no clinically important changes in Kt/V, albumin level, hemoglobin level, phosphorus level, calcium level, hemodialysis catheter use, ultrafiltration volume, shortened or skipped treatments, hospital admissions, hospitalization days, or health-related quality of life, including patient satisfaction. CONCLUSION: Despite a marked increase in visits between patients and nephrologists, there was no clinically important impact on parameters related to quality of care or health-related quality of life. Additional work is needed to determine effective payment strategies to improve dialysis patient outcomes.

The effect of a change in epoetin alfa reimbursement policy on anemia outcomes in hemodialysis patients.

In 1997, the Health Care Financing Administration Hematocrit Measurement Audit (HMA) program initiated use of a 3-month rolling average hematocrit (Hct) level for reimbursement of epoetin claims in hemodialysis patients, with denial of payment when this value exceeded 36.5%. This study evaluated the impact of the HMA program on anemia-related outcomes in hemodialysis patients. An observational, retrospective study of 987 hemodialysis patients from 11 dialysis centers in the United States was performed, collecting data between October 1996 and December 1997. Centers were selected from a pool of nearly all facilities in the United States, which during May 1997 satisfied one of two criteria: greater than 75% of patients at the facility had mean Hct level of > or =33% (Group A) or fewer than 50% of patients at the facility had mean Hct level of > or =33% (Group B). Each facility maintained its own anemia management practices without specific anemia management interventions as part of this study. Hct level, hemoglobin (Hb) level, and epoetin dose were analyzed to compare the pre-HMA period (October 1996 to May 1997) to the HMA period (June to December 1997) and/or for each of the five quarters of the study period. The primary study endpoint was the percentage of patients with Hct levels of > or =33% during each study quarter. The mean Hct level at baseline was 34% in Group A and 33.4% in Group B (p = 0.01). Hct levels, which were increasing before implementation of the HMA program, decreased during the HMA period (p < 0.001 and p = 0.013 in Groups A and B, respectively). The percentage of patients in Groups A and B with mean quarterly Hct levels of > or =33% decreased during the last quarter of the HMA implementation period compared to the quarter immediately preceding the start of the HMA program (p < 0.001 for both comparisons). Changes in Hb levels were similar to those seen in Hct levels. The mean epoetin dose administered decreased from 13,090 U/week at the start of the study to 11,884 U/week immediately before the HMA program took effect (p < 0.05). The HMA program adversely affected anemia treatment outcomes, regardless of whether dialysis units before HMA implementation had <50% of patients with a Hct level of > or =33% or had >75% of patients with a Hct level of > or =33%. The decline in mean weekly dose of epoetin was likely a result of withholding doses out of concern among providers about risk of reimbursement denial.

Anemia management for hemodialysis patients: Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines and Dialysis Outcomes and Practice Patterns Study (DOPPS) findings.

BACKGROUND: After recombinant human erythropoietin was introduced into routine nephrologic practice, specific clinical guidelines were developed to optimize the quality of anemia management for patients with chronic kidney disease. METHODS: The Dialysis Outcomes and Practice Patterns Study (DOPPS), an international investigation providing patient- and facility-level data on hemodialysis practice, was developed to provide information on various aspects of current practices in hemodialysis management, including treatment of renal anemia. RESULTS: Hemoglobin concentration is strongly associated with both morbidity and mortality in hemodialysis patients. Although some improvements can be documented in anemia management practices in the years after the publication of international guidelines, wide variations in anemia management are still observed among countries. CONCLUSION: Many efforts are still needed to allow a greater proportion of patients to reach the recommended hemoglobin concentrations. Significantly improved outcomes may therefore be expected by a more widespread reaching of the recommended hemoglobin levels. The results of the DOPPS point to the difficulties in implementing clinical guidelines in the everyday management of individual patients. In specific circumstances, a well-designed observational study may offer credible information and serve as a basic instrument for monitoring the implementation of clinical guidelines in typical clinical practice.

Thrombotic events and markers of oxidation and inflammation in hemodialysis.

The goal of this study was to determine whether antioxidant therapy with vitamin E would alter the rate of vascular access complications or other macrovascular complications in hemodialysis (HD) patients. A secondary goal of the study was to explore the relationship between baseline pretreatment markers of oxidative stress (the advanced glycation end product pentosidine and basal levels of vitamin Ealpha and gamma) and the subsequent development of access failure. Thirty-five stable patients treated by HD were recruited for the study. Patients were provided with vitamin E (800 IU) or placebo capsules to be taken daily. Clinical variables, vascular access function (flow meter access flow measurements), and circulating blood markers were obtained initially and every 3 months throughout the study. Vitamin Ealpha levels rose in treated patients from 12.7 +/- 4.4 to 25.1 +/- 15.1 microg/mL at 3 months and 28.6 +/- 14.8 microg/mL at 6 months. Vitamin Egamma levels fell in treated patients from 3.9 +/- 1.7 to 2.3 +/- 1.5 microg/mL at 3 months and 1.7 microg/mL at 6 months. Patients who subsequently developed repeated thrombotic vascular access events were characterized by higher baseline pentosidine content of circulating proteins. Patients who developed a myocardial infarction had higher pentosidine, lower vitamin Ealpha, and much lower vitamin Egamma than patients who did not develop thrombotic events. These findings lead to the speculation that the anti-inflammatory effects of vitamin Egamma may play a more important role in thrombotic vascular events than the antioxidant effects of vitamin Ealpha. Additional studies of these interactions are in progress.

Hemoglobin variability in epoetin-treated hemodialysis patients.

BACKGROUND: Understanding the clinical variability of hemoglobin measurements in epoetin-treated hemodialysis patients is important, particularly when this therapy is aimed at maintaining patient hemoglobin levels within a narrow range, such as the 11 to 12 g/dL range recommended in National Kidney Foundation Kidney Dialysis Outcomes Quality Initiative (NKF-K/DOQI) guidelines. This study examines hemoglobin variability under conditions of standard clinical practice in epoetin-treated hemodialysis patients. METHODS: We studied 987 hemodialysis patients participating in an observational retrospective study that evaluated anemia management practices from October 1, 1996 to December 31, 1997 at 11 United States dialysis centers that were randomly selected from a pool of nearly all United States dialysis facilities. Each participating facility maintained its own anemia management protocols without specific anemia management recommendations or interventions made as part of this study. Hemoglobin variability was determined by calculating the 1-month and 2- to 6-month rolling average hemoglobin for each patient. The range of mean hemoglobin values that included the middle 50% (25th to 75th percentile), 80% (10th to 90th percentile), and 90% (5th to 95th percentile) of values were determined. The hemoglobin ranges that included 1 standard deviation (SD) (67%) of the study values and 2 SD (95%) of the study values for each time period were calculated. RESULTS: The mean hemoglobin was between 10.9 and 11.2 g/dL throughout the study. The hemoglobin range encompassing 50%, 80%, and 90% of values from a single month was 1.7, 3.3, and 4.4 g/dL, respectively. A progressive narrowing in the range of hemoglobin values encompassed by each percentile grouping (i.e., hemoglobin variability) was observed as longer rolling intervals were averaged. The hemoglobin range within the 25th to 75th percentile was 1.7 g/dL using single-month hemoglobin values and 1.1 g/dL using a 6-month rolling average. The range of hemoglobin values that encompassed 90% of patients was 4.4 g/dL using single-month values, 3.7 g/dL using 3-month rolling averages, and 3.2 g/dL using 6-month rolling averages. Fewer than 50% of patients had hemoglobin values within the 1.0 g/dL NKF-K/DOQI recommended range, even when a 6-month rolling average was applied. When hemoglobin values were measured for 1 month, 1 SD was 1.4 g/dL; for the 3-month rolling average, 1 SD was 1.1 g/dL; and for the 4-, 5-, and 6-month rolling averages, 1 SD was 1.0 g/dL. Greater hemoglobin variability correlated with higher mean corpuscular hemoglobin (P = 0.003) and serum ferritin (P = 0.047), and inversely correlated with age (P = 0.006) and serum albumin (P = 0.0001). CONCLUSION: Substantial variability occurs in hemoglobin values in epoetin-treated hemodialysis patients. The NKF-K/DOQI recommended hemoglobin range appears to be too narrow in clinical practice. Expanding the target range and use of rolling average hemoglobin intervals of 3 to 6 months as a clinical and quality assurance measure avoids clinical variability inherent with the use of isolated hemoglobin values or single-month hemoglobin averages.