Although the ESRD population is less than 1% of the entire U.S. population it continues to increase at a rate of 5% per year impacting all races, age groups, and socioeconomic standings. Because the ESRD Network organizations cover all 50 states plus Puerto Rico, Commonwealth of the Northern Mariana Islands, Guam, and the U.S. Virgin Islands, much variation is seen in both the overall population and the ESRD population.

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There were 242 transplant centers within the United States in 2000.

According to the annual facility surveys conducted by the Networks, 14,143 kidney transplants were performed within the United States during 2000. Due to decreases in the availability of cadaveric donors, the percent of living and living unrelated donor transplants have increased in recent years and in 2000 represented 37% of all transplants performed. A large number of patients are on waiting lists for kidney transplants (currently over 51,000). As some patients may be placed on more than one waiting list, there is no number available for the total number of patients awaiting transplant.

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While in-center hemodialysis is the predominate modality choice, changes are occurring in peritoneal dialysis. The number of patients undergoing continuous cycling peritoneal dialysis in a self-care setting rose 5% between 1999 and 2000, however the number of continuous ambulatory peritoneal dialysis patients has decreased by 6%.

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In 2000 a majority of the ESRD patients were over the age of 60. The pediatric population remained relatively small with less than one percent of the ESRD population under 20 years old. These prevalence distributions have remained the same over the past three years.

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While the majority of ESRD patients are White, the number of Blacks and Native Americans with ESRD is disproportionately high compared to the U.S. population. While Black Americans comprise 13% of the population they make up 37% of the total ESRD population. Network 6 (GA, NC, SC) has a large population of Blacks and Network 15 (AZ, CO, NV, NM, UT, WY) is home to a large number of Native Americans.

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The leading cause of renal failure in the United States is diabetes. Given the diverse patient populations seen within each geographic region it is surprising that there is little variation between the Network populations with respect to the diagnosis of their prevalent populations. All Networks reported diabetes as the primary cause of renal failure in 2000 but Network 15, at 51%, had the highest percentage of patients with this primary diagnosis. Network 6 had a higher percentage of patients with hypertension, 32%.

The percentage of patients with a primary diagnosis of diabetes has increased from 39% in 1999 to 41% in 2000. While diabetes is the most common cause of ESRD it is prominently the cause of ESRD in women while hypertension is the most common cause of ESRD in men.

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Type of Grievances

Examples of Grievances

Networks are authorized to propose (to CMS) sanction recommendations against facilities who are out of compliance and to make recommendations for additional facilities in the service area, as they are necessary for each particular Network. During 2000, no sanction recommendations were made to CMS. There were several incidents noted that required Network scrutiny:

• In one Network, twenty-one (21) facilities, 7% of the provider community, were placed on an improvement track during 2000. One of the 21 units had problems with both Hemodialysis adequacy and anemia management, and another facility had problems in Hemodialysis adequacy and mortality. Eighteen (18) of the facilities were to be released from monitoring pending data from the fourth quarter of 2000 (to be available in early 2001). Site visits were conducted to three (3) of the 21 facilities.
  
  
• Another Network participated with a state survey agency on two visits in which patient safety was identified as a concern. The result of the investigation was CMS’ termination of both provider numbers. Under CMS direction, the Network provided the patients with the names of alternative facilities in the immediate area and provided telephone support to patients and families as they transferred to other ESRD facilities.
  
  
• In 2000, a Network Medical Review Board again recommended closure of a facility that had been surveyed in 1999 and was recommended for facility closure and Medicare decertification. The Network apprised CMS of the unheeded recommendation and alerted CMS regarding the serious quality of care issues citing the absence of Medicare survey performance and reporting to CMS by the State Agency. Through the courts, the state appointed a temporary manager to ensure the safety of the patients, either through transfer or change in the delivery of care. At last report, meaningful improvements in care had occurred that involved the replacement of the medical director and staff, the director of nurses and other key staff.

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Several Networks made recommendations in their Annual Reports. These included:

• The availability of additional stations has been slower than the increased volume of new ESRD patients. Several facilities have opened in recent years but a shortage of trained dialysis staff continues to prevent outpatient dialysis stations from being fully utilized. In Year 2000, the “special purpose unit” status was granted to relieve the problem of new ESRD patients remaining in the hospital for unnecessary extended periods of time. This was a helpful but short-term solution which needs to be reviewed for an appropriate long-term solution.
  
  
• Medicare assessment of the costs to operate dialysis centers should include regional adjustments for staff wages and local and state regulations, which affect operational costs. The increased number of challenging patients requires unique staff communications and interpersonal skills. Consideration of special dialysis units with additional reimbursement, to help accommodate these patients, might reduce the number of patients being discharged from dialysis units.
  
  
• There is an increase in the number of medically stable patients that require a course of short-term dialysis (non-chronic) in out-patient programs, usually requiring less that 3 months of dialysis. It is recommended that CMS develop billing codes for this patient population and consideration be given to future policy issues that will evolve as these non-chronic patients increase in number.
  
  
• There is a need in the ESRD system to address the treatment of patients who have not been accepted by an outpatient treatment facility. The practice of discharging patients that pose a behavioral risk in the outpatient dialysis care setting is steadily increasing. At present, the ESRD system is not prepared to handle patients with mental illness or the dangerous situation that the patients create. It is recommended that CMS study the issues to identify a solution that will provide quality, alternative care for the patient that is not appropriate for the outpatient setting. This review should include representative from the ESRD and mental health communities. Solutions may include changes to Medicare billing policies for hospitals; designation of and increased compensation for units staffed to handle challenging patients; and other creative responses to this complex situation.
  
  
• Dialysis companies continue to place new facilities in previously under-served areas. The greatest need is a payment exception policy for displaced patients who require treatment at acute care hospitals. Such a policy would guarantee reimbursement for regular treatments, ending the current policy of conditioning services on proof of immediate severity.
  
  
• The overall availability of dialysis and transplant services is satisfactory but inquiries continue to be received concerning:
  • Provision of dialysis services in Skilled Nursing/Long-Term Care and other non-ESRD certified health care facilities
  • Alternative treatment settings and /or reimbursement formula for abusive/violent patients whose access to care is constrained under the current system
  • Access to care/services for undocumented immigrants whose Medi-Cal eligibility is limited to “emergency services.

Formerly known as the National ESRD Core Indicators Project, the collection and reporting of these data provides the foundation for many of the Network quality improvement activities. It provides important feedback on outcome measures at both the national and Network levels.

Selected findings from the 2000 ESRD Clinical Performance Measures Project are highlighted below. Important improvements in adequate therapy and anemia management have been realized since the onset of this project. It is important to note that although the project year is 2000, the data are from 1999. When years are noted in the information below, it refers to the year the data came from, not the project year.

• Adequacy of Dialysis: Hemodialysis
  • Mean URRs have increased each year that the project has been conducted, from 62.7% in 1993 to 69.9% in 1999.
  • The proportion of patients with mean URRs > 65 has also increased steadily from 43% in 1993 to 80% in 1999.
    
  • 84% of patients had a mean delivered Kt/V > 1.2 in 1999, representing a 13.5% increase from 74% in 1996 when Kt/V was introduced in the project.
  • In 1999, the percent of patients with Kt/V > 1.2 continued to vary by Network, ranging from 78% to 93%. However, the range is narrowing as variation decreases. In 1996 when Kt/V was first reported in this project, the range among Networks was 61% to 85%.
• Adequacy of Dialysis: Peritoneal Dialysis
  • Adequacy of dialysis was assessed during the study period (October 1999-March 2000) for an estimated 85% of patients. This is a dramatic increase from 66% in 1995 when a peritoneal dialysis cohort was first added to the project.
  • 68% of CAPD patients had both a mean weekly Kt/V > 2.0 and creatinine clearance > 60 L/wk/1.73m2.
  • 66% of cycler patients (no daytime dwell) had a mean Kt/V > 2.2 and a mean weekly creatinine clearance of > 66 L/wk/1.73m2.
  • 65% of cycler patients (with daytime dwell) had a mean Kt/V > 2.1 and a mean weekly creatinine clearance of > 63 L/wk/1.73m2.
  • The proportion of CAPD patients meeting K-DOQI recommended levels for adequacy increased from 27% in 1995-96 to 65% in 1999-00. Similarly, the proportion of cycler patients with adequate therapy increased from 28% in 1995-96 to 60% in 1999-00.
• Anemia Management: Hemodialysis
  • In 1999, the proportion of patients with a hemoglobin > 11 was 68%, compared to 59% in 1998.
  • The mean hemoglobin increased from 11.1 gm/dL in 1998 to 11.4 gm/dL in 1999.
  • The percent of patients with mean hemoglobin > 11 gm/dL varied by Network and ranged from 57% to 74% with a national average of 68%.
• Anemia Management: Peritoneal Dialysis
  • The mean hemoglobin in 1999-2000 was 11.6 gm/dL.
  • 69% of patients had a mean hemoglobin of > 11 gm/dL, compared to 61% in the 1998-1999 study period.
• Serum Albumin: Hemodialysis
  • The percent of patients with adequate mean serum albumin values > 3.2 (BCP) or 3.5 (BCG) in 1999 was 80%, compared to 77% in 1993.
  • The percent of patients with optimal mean serum albumin values > 3.7 (BCP) or 4.0 (BCG) in 1999 was 32%, compared to 27% in 1993.
  • Mean serum albumin value in 1999 with bromcresol green (BCG) laboratory method was 3.8 gm/dL, unchanged from 1997 and 1998.
  • Mean serum albumin value in 1999 with bromcresol purple (BCP) laboratory method was 3.5 gm/dL, compared to 3.6 gm/dL in 1997 and 1998.
• Serum Albumin: Peritoneal Dialysis
  • The mean serum albumin value for 1999 was 3.5 gm/dL (BCG) and 3.3 gm/dL (BCP), unchanged from 1997 and 1998.
  • The percent of patients with adequate mean serum albumin > 3.2 (BCP) and 3.5 (BCG) was 56%.