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.