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Department of Health and Human Services


OFFICE OF 

INSPECTOR GENERAL 

AVAILABILITY OF QUALITY OF 


CARE DATA IN THE MEDICARE 


END STAGE RENAL DISEASE 


PROGRAM


Daniel R. Levinson


Inspector General 


November 2006


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Office of Inspector General 
 http://oig.hhs.gov 

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, 

as amended, is to protect the integrity of the Department of Health and Human Services 

(HHS) programs, as well as the health and welfare of beneficiaries served by those 

programs. This statutory mission is carried out through a nationwide network of audits, 

investigations, and inspections conducted by the following operating components: 

Office of Audit Services 

The Office of Audit Services (OAS) provides all auditing services for HHS, either by 

conducting audits with its own audit resources or by overseeing audit work done by others. 

Audits examine the performance of HHS programs and/or its grantees and contractors 

in carrying out their respective responsibilities and are intended to provide independent 

assessments of HHS programs and operations. These assessments help reduce waste, 

abuse, and mismanagement and to promote economy and efficiency throughout HHS. 

Office of Evaluation and Inspections 

The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide 

HHS, Congress, and the public with timely, useful, and reliable information on 

significant issues. Specifically, these evaluations focus on preventing fraud, waste, or 

abuse and promoting economy, efficiency, and effectiveness in departmental programs. 

To promote impact, the reports also present practical recommendations for improving 

program operations. 

Office of Investigations 

The Office of Investigations (OI) conducts criminal, civil, and administrative 

investigations of allegations of wrongdoing in HHS programs or to HHS beneficiaries 

and of unjust enrichment by providers. The investigative efforts of OI lead to criminal 

convictions, administrative sanctions, or civil monetary penalties. 

Office of Counsel to the Inspector General 

The Office of Counsel to the Inspector General (OCIG) provides general legal services to 

OIG, rendering advice and opinions on HHS programs and operations and providing all 

legal support in OIG's internal operations. OCIG imposes program exclusions and civil 

monetary penalties on health care providers and litigates those actions within HHS. 

OCIG also represents OIG in the global settlement of cases arising under the Civil False 

Claims Act, develops and monitors corporate integrity agreements, develops compliance 

program guidances, renders advisory opinions on OIG sanctions to the health care 

community, and issues fraud alerts and other industry guidance. 
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Δ EXECUTIVE SUMMAR Y 

OBJECTIVE 

To assess the extent to which data are available to assist Networks in 

identifying End Stage Renal Disease facilities with quality improvement 

needs. 

BACKGROUND 

Patients with End Stage Renal Disease (ESRD) rely on dialysis 

treatment to compensate for kidney failure. In 2003, Medicare spent 

$18.1 billion on covered dialysis services for approximately 311,000 

dialysis patients. 

National aggregate data suggest that dialysis care has improved overall. 

However, questions remain about the quality of care provided at some 

ESRD facilities. According to the most recently available data (derived 

from 2002 claims data), about 270 ESRD facilities did not provide 

adequate dialysis care, as measured by the amount of waste removed 

from a patient’s blood during dialysis, for 20 percent or more of their 

patients. Nearly 1,700 ESRD facilities did not meet guidelines for 

anemia management for 20 percent or more of their patients. 

To help monitor and improve quality of care, the Centers for Medicare & 

Medicaid Services (CMS) oversees ESRD facilities through contracts 

with State survey and certification agencies and ESRD Networks 

(Networks). State survey and certification agencies survey ESRD 

facilities to ensure that ESRD facilities comply with current regulations. 

Networks are statutorily required to identify facilities in need of quality 

improvement and assist those facilities in developing plans to improve 

care. Network staff possess clinical expertise related to the care of 

ESRD patients, enabling them to both assess and assist facilities in the 

provision of dialysis. 

In June 2000, both the Office of Inspector General (OIG) and the 

Government Accountability Office (GAO) issued reports documenting 

problems with CMS oversight of ESRD facilities and presented their 

concerns at a hearing before the Senate Special Committee on Aging. 

OIG found that, while oversight using standardized performance 

measures encouraged improvements in quality of care, CMS did not use 

these measures to hold individual facilities accountable. GAO found 

that the oversight of ESRD facilities was limited. CMS concurred with 

the findings and recommendations made by these reports. To address 

some of the concerns raised by these reports, CMS stated that it was 

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EXE CUTIVE S U MMAR Y 

undertaking steps to begin collecting facility-specific data, including the 

collection of clinical measures through a project called the Core Data 

Set that would report accurate, meaningful, facility-specific 

performance measures. 

Given the previously identified problems with the oversight of quality of 

care in ESRD facilities and ongoing concerns related to quality of care, 

we assessed the extent to which data are available to help identify 

facilities with quality improvement needs, an important element of 

quality oversight. We limited our scope to data available to Networks 

because Networks are, legislatively and contractually, the primary 

entities responsible for oversight of quality improvement. 

To assess the extent to which data are available to assist Networks in 

identifying facilities with quality improvement needs, we based our 

analysis on three sources of information: (1) a review of data sources 

that measure the quality of care provided by ESRD facilities available to 

all Networks, (2) a review of documentation regarding how Networks 

use quality of care data to identify facilities with quality improvement 

needs, and (3) structured interviews with all Networks and CMS staff 

responsible for the oversight of quality improvement in ESRD facilities. 

In our review of data sources that CMS either provided to all Networks 

or required all Networks to use, we considered factors such as whether a 

Network could use the source of data to identify quality improvement 

needs for specific facilities, whether the data source provided 

comprehensive quality data, and whether the information in the data 

source was current. 

FINDINGS 

While multiple sources of data are available to Networks to assist 

them in identifying facilities with quality improvement needs, each 

source has limitations. Based on our analysis, the sources of data 

available to all Networks, individually and as a system, have limitations 

in assisting Networks to identify facilities with quality improvement 

needs. Among other responsibilities, the Social Security Act and the 

Networks’ current contracts with CMS require Networks to identify 

facilities in need of quality improvement and to assist those facilities in 

developing plans to improve care. Yet our review of available data 

sources reveals that Clinical Performance Measures data and Dialysis 

Facility Report data lack either the specificity or comprehensiveness 

necessary for Networks to use them to identify facilities that need 

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EXE CUTIVE S U MMAR Y

assistance. Fistula First provides current and facility-specific data, but 

only on a single clinical performance measure. Administrative data do 

not contain clinical performance measures. 

CMS has taken action towards providing a streamlined source of 

data that could assist Networks in identifying facilities with quality 

improvement needs; however, it has not yet been implemented. In 

2000, CMS stated that it was developing a Core Data Set project that 

would regularly collect facility-specific data on a comprehensive set of 

clinical performance measures. If implemented as described, the Core 

Data Set project could provide one national source of comprehensive 

facility-specific performance measures. However, CMS has faced 

technical and resource challenges and the implementation of the Core 

Data Set project is not complete. 

RECOMMENDATION 

This inspection found that while Networks have access to multiple 

sources of data about quality of care, each has limitations as a tool to 

assist Networks in identifying facilities with quality improvement 

needs. Limitations include lack of current, comprehensive, and facilityspecific performance data. Under the current system, Networks’ 

abilities to identify facilities in need of quality improvement may be 

impaired. CMS stated that it planned to provide a streamlined source 

of performance information through the Core Data Set project that 

would address these limitations. However, the Core Data Set project 

has been under development since 2000 and is not yet implemented. 

The consequences of the limitations in the current quality improvement 

data sources are twofold. First, Networks’ abilities to ensure that all 

patients in all facilities receive quality care may be hindered. To fulfill 

their legislative and contractual responsibility, Networks need current, 

facility-specific information about facility performance. Second, lack of 

facility-specific data negatively impacts CMS’s ability to implement a 

pay-for-performance system for ESRD. 

We recommend that CMS increase its efforts towards regularly 

collecting data from all patients and all facilities on all clinical 

performance measures identified by CMS to address quality of care 

issues in the ESRD program. 

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EXE CUTIVE S U MMAR Y

AGENCY COMMENTS 

CMS stated that it has made progress in collecting data to improve the 

quality of care in the ESRD program; however, opportunities for 

improvement still exist. CMS outlined the steps it has taken to improve 

quality of care for the ESRD program, including the development of 

clinical performance measures, definition of the Core Data Set, and 

proposed regulations that would require facilities to electronically 

submit all CPMs on all ESRD patients. CMS also stated that it recently 

renewed its commitment to developing a new information system called 

Consolidated Renal Operations in a Web-based Network (CROWN), 

which would consolidate existing data sources into one system. CMS 

expects CROWN to be completed in 2008. 

OFFICE OF INSPECTOR GENERAL RESPONSE 

We recognize that CMS has taken action towards providing a 

streamlined source of quality data that could assist Networks in 

identifying quality improvement needs. However, we found that 

current sources of data have limitations in assisting Networks in 

identifying facilities with quality improvement needs. We recommend 

that CMS continue to work towards providing Networks with facilityspecific data on all clinical performance measures. 

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Δ T ABLE OF CONTENTS 

EXECUTIVE SUMMARY .................................... i

INTR O D U C T I ON .......................................... 1

FINDI NGS ................................................ 9

Limitations in current sources of data exist ................. 9

CMS has initiated but not implemented streamlined data...... 13

RECOM M E NDATI O N ...................................... 16

 Agency Comments...................................... 17

Office of Inspector General Response....................... 17

APPENDI X ................................................ 19

 Agency Comments...................................... 19

ENDN OTE S ............................................... 23

ACKN O W LEDGMENTS .................................... 26
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Δ INTRODU C TION 

OBJECTIVE 

To assess the extent to which data are available to assist Networks in 

identifying End Stage Renal Disease facilities with quality improvement 

needs. 

BACKGROUND 

Patients with End Stage Renal Disease (ESRD) rely on dialysis 

treatment to compensate for kidney failure. In 2003, Medicare covered 

dialysis services for approximately 311,000 dialysis patients provided by 

approximately 4,500 Medicare approved ESRD facilities.1 Medicare 

spent $18.1 billion on ESRD patients in 2003.2 

National aggregate data suggest that dialysis care has improved 

overall.3 However, questions remain about the quality of care provided 

at some individual ESRD facilities. According to the most recently 

available data (derived from 2002 claims data), about 270 ESRD 

facilities did not provide adequate dialysis care, as measured by the 

amount of waste removed from a patient’s blood during dialysis, for 

20 percent or more of their patients. In addition, nearly 1,700 ESRD 

facilities did not meet the guidelines for anemia management for 

20 percent or more of their patients. 

CMS Oversight of the ESRD Program 

The Centers for Medicare & Medicaid Services (CMS) divides the 

responsibility for monitoring and improving the quality of care in the 

ESRD program between two offices within CMS. The Center for 

Medicaid and State Operations (CMSO) oversees the survey and 

certification of Medicare approved ESRD facilities by States. The Office 

of Clinical Standards and Quality (OCSQ) oversees the ESRD Network 

(Network) organizations, for which the goals are to develop and 

implement projects to improve quality of care within the ESRD 

program. 

State Survey and Certification 

CMS contracts with States to survey ESRD facilities to ensure that each 

facility complies with the ESRD regulations.4 ESRD regulations 

address patient care, as well as other conditions, such as the condition 

of the environment, water, and equipment. According to CMS staff, 

approximately one-third of ESRD facilities should be surveyed each 

year. 

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INTROD UCT ION

Networks 

CMS currently contracts with 18 regional Networks to oversee the 

quality of care in ESRD facilities. Established under section 

1881(c)(1)(A) of the Social Security Act, Networks are charged with 

improving the quality of ESRD facilities. Unlike State survey agencies 

that are responsible for regulatory enforcement, Network staff possess 

clinical expertise related to the care of ESRD patients, enabling them to 

both assess and assist facilities in the provision of dialysis. Network 

funding is approximately $25 million for 2006. 

Pursuant to the Social Security Act, Network responsibilities include, 

but are not limited to: 

o Developing criteria and standards relating to the quality and 

appropriateness of patient care, 

o Identifying facilities and providers that are not cooperating toward 

meeting Network goals, 

o Conducting onsite reviews of facilities and providers if necessary, 

and, 

o Collecting national ESRD data.5 

CMS further delineates Network responsibilities through the 2003-2006 

Network Statement of Work (SOW). Among other tasks, Networks are 

required under their contract to 

[assist] ESRD providers and facilities (either individually

or in groups) in developing and implementing facilityspecific quality improvement actions to improve their 

patient care processes and outcomes, upon request and/or 

upon identifying poor performance or a specific need.6 

Concerns Regarding the Oversight of ESRD Facilities 

The Office of Inspector General (OIG) and the Government 

Accountability Office (GAO) have previously found problems with CMS 

oversight of ESRD facilities. In June 2000, OIG and GAO issued 

reports7 documenting problems with CMS oversight of ESRD facilities 

and presented their concerns at a hearing before the Senate Special 

Committee on Aging. 

OIG found that while CMS oversight using standardized performance 

measures encouraged improvements in quality of care, CMS did not use 

these measures to hold individual facilities accountable. OIG also found 

that Medicare certification surveys played a limited role in ensuring 

that ESRD facilities met minimum standards. 

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INTROD UCT ION

GAO found that the oversight of ESRD facilities needed improvement. 

In particular, GAO found that CMS surveyed a limited number of 

facilities and that many facilities went years between surveys. In 

addition, GAO found that data used by CMS to target surveys were 

neither timely, nor necessarily reliable. 

CMS concurred with the findings and recommendations made in both of 

these reports. To address some of the concerns raised by these reports, 

CMS stated that it was undertaking steps to begin collecting facilityspecific data, including the collection of clinical measures through a 

Core Data Set project that would report accurate, meaningful facilityspecific performance measures. CMS also stated that it intended to 

collect these data on all ESRD patients regularly. 

In response to a request from the Senate Finance Committee, in 2003 

GAO conducted a follow-up study examining CMS oversight of ESRD 

facilities. GAO reported that problems with quality of care were 

prevalent at dialysis facilities, putting patients’ health at risk. GAO 

found that limitations in the ESRD survey process inadequately 

addressed or failed to detect quality problems. In response to this 

report, CMS stated that, among other improvements, it planned to 

provide “. . . one patient-centered data set that can be used for program 

oversight.”8 

ESRD Quality Initiative 

In 2004, as part of a larger departmental Quality Initiative intended to 

ensure quality health care for consumers, CMS developed an ESRD 

Quality Initiative with the objective of stimulating and supporting 

significant improvements in the quality of dialysis care.9 Among other 

activities, this initiative “aims to refine and standardize dialysis care 

measures, ESRD data definitions, and data transmission to support the 

need of Medicare’s ESRD program.”10 CMS is also currently 

experimenting with ways to link quality to payment. As part of the 

ESRD Quality Initiative, CMS is developing a demonstration project for 

bundled payment that has a pay-for-performance element. This 

demonstration project is supported by the Medicare Payment Advisory 

Commission,11 and is indicative of an overall effort by the Department 

of Health and Human Services (Department) to link performance and 

quality of care to reimbursement.12 

Use of Data in Oversight of the ESRD Program 

Several organizations have suggested that access to quality of care data 

is necessary to provide adequate oversight of the program. The 

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INTROD UCT ION 

Institute of Medicine and the Medicare Payment Advisory Commission 

have recognized the necessity of data to provide meaningful oversight.13 

These organizations recommended that providers be required to report 

performance measures to stimulate improvements in quality of care. 

Further, the Balanced Budget Act of 1997 required CMS to measure 

and report data about quality of care by the year 2000.14 In response, 

CMS began to develop the ESRD Clinical Performance Measures (CPM) 

and the Dialysis Facility Compare Web site, which publishes data from 

the Dialysis Facility Report (DFR) (described below). 

Currently, Networks have access to several data sources containing 

information about the ESRD program. 

ESRD Clinical Performance Measures Project 

The ESRD CPM project is a national effort led by CMS and the 

Networks to collect and report clinical performance data. Currently, 

13 clinical performance measures based on National Kidney Foundation 

clinical practice guidelines are reported as part of the CPM project. The 

National Kidney Foundation guidelines are commonly accepted 

standards on the quality of dialysis care. As such, CMS uses these 

measures as the key indicators of the quality of dialysis care. Each of 

the clinical performance measures addresses one of the following 

categories: adequacy of dialysis, anemia management, or vascular 

access. 

Performance data on each of these clinical performance measures is 

collected and reported in aggregate each year. The data are derived 

from a medical record review of a national random sample of ESRD 

patients, stratified by Network. 

Dialysis Facility Report 

Issued by CMS, the DFR is a report containing facility-specific 

information on dialysis services. In 1998, CMS hired a contractor to 

produce a report for each Medicare-certified ESRD facility. The report 

contains summary data on each facility’s dialysis patients for specific 

measures related to quality of care. The DFR data are derived from 

existing administrative and Medicare claims data. The DFR lists the 

State, Network, and national average for each performance measure for 

comparison. The DFR includes information on demographics, patient 

characteristics, adequacy of dialysis, anemia management, transplant 

rates, hospitalization rates, and mortality rates.15 The DFRs are issued 

annually. 

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INTROD UCT ION 

National Fistula First Initiative 

The National Fistula First Initiative (Fistula First) is a quality 

improvement project conducted by all Networks to promote the use of 

arteriovenous (AV) fistulas16 in all suitable dialysis patients. CMS, 

Networks, and other provider partners began to develop this project in 

July 2003. 

As part of Fistula First, facilities collect data elements related to 

vascular access and submit this information to the Networks monthly. 

The Fistula First data collection tool provided by CMS requests patient 

information about the type of access in use on the last day of the month. 

This information is aggregated into a monthly national report for 

comparison to regional and national averages. 

Administrative Data 

Networks also have access to administrative data. Networks report 

administrative information to CMS on an ongoing basis that includes 

patient demographics, enrollment, deaths, complaints, and grievances. 

Additional Process for Requesting Data 

Finally, CMS reports that they have developed a process through which 

Networks may request permission to collect additional data. According 

to the SOW, Networks are required to have any data collection effort 

that is not specifically required by the SOW approved by CMS. 

SCOPE AND METHODOLOGY 

Scope 

Given the previously identified problems with the oversight of quality of 

care in ESRD facilities and ongoing concerns related to quality of care, 

we assessed the extent to which data are available to help identify 

facilities with quality improvement needs, an important element of 

quality of care oversight. We limited our scope to data available to 

Networks because Networks are, legislatively and contractually, the 

primary entities responsible for oversight of quality improvement. 

Methodology 

To assess the extent to which data are available to help identify 

facilities with quality improvement needs, we based our analysis on 

three sources of information: (1) a review of data sources that measure 

the quality of care provided by ESRD facilities available to all 

Networks, (2) a review of documentation regarding how Networks use 

quality of care data to identify facilities with quality improvement 

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INTROD UCT ION 

needs, and (3) structured interviews with all Networks and CMS staff 

responsible for the oversight of quality improvement in ESRD facilities. 

Data Source Review 

To assess the extent to which data are available to help identify 

facilities with quality improvement needs, we reviewed sources of data 

that CMS either provided to all Networks or required all Networks to 

use. In reviewing these sources, we considered factors such as whether 

a Network could use the source of data to identify quality improvement 

needs for specific facilities, whether the data source provided 

comprehensive quality data, and whether the information in the data 

source was current. 

During our preliminary analysis, we identified the following four data 

sources that were available to all Networks: 

o 2004 ESRD Clinical Performance Measures Project, 

o 2004 Dialysis Facility Report, 

o Fistula First, and 

o Administrative data. 

To assess whether these four data sources assist Networks in 

identifying facilities with quality improvement needs, we reviewed the 

scope and methodology for reports or projects associated with each data 

source. We reviewed the type, age, and method of information collected. 

We also reviewed reports from these data sources (e.g., the 2004 CPM 

Annual Report and the 2004 DFR) to understand how CMS and 

Networks may be using these data sources to measure and identify 

quality of care needs in ESRD facilities. 

Documentation Review 

In addition to our review of the data sources available to Networks, we 

reviewed documentation provided by Networks and CMS to understand 

how potential problems with quality of care in ESRD facilities are 

identified. We also reviewed documents that provided information on 

the oversight of the ESRD program including relevant sections of the 

Social Security Act, current CMS regulations, and proposed CMS 

regulations for the ESRD program, which govern the survey and 

certification of the ESRD program. 

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INTROD UCT ION

From the Networks, we reviewed: 

o Any analysis that Networks had completed using quality of care 

data to identify possible dialysis facilities in need of review or 

training, 

o Documentation about the effectiveness of quality of care data, 

o Documentation regarding Network requests to collect data, and 

o Correspondence about any barriers to use of quality of care data. 

From CMS, we reviewed: 

o Current SOWs for Networks and CMS’s data contractors, 

o Evaluation criteria for the Networks, 

o Correspondence between CMS and the Networks about the 

collection and use of data, 

o Documentation regarding Network requests to collect data, and 

o All of the Networks’ quarterly reports for the first three quarters of 

calendar year 2005. 

Structured Interviews 

We conducted structured interviews with all Network and CMS staff 

responsible for the oversight of the quality of care provided in ESRD 

facilities to obtain information about how the various data sources are 

used to identify potential quality of care problems. 

We conducted structured interviews with executive-level 

representatives and/or their staff responsible for quality improvement 

and data-related activities from all 18 Networks. Our interviews were 

conducted between October 13 and November 10, 2005. We conducted 

one interview with all relevant parties at each Network. Because 

1 agency administers the contracts for 2 Networks, this resulted in 

17 interviews. 

During our structured interviews, we asked Networks how useful each 

of the data sources are in identifying needed improvements in quality of 

care in ESRD facilities. We also asked if Networks faced any barriers to 

using the data sources and inquired about the impact of those barriers. 

To ensure that we identified all sources of quality of care data, we 

inquired about any additional sources that Networks use to assist with 

their quality improvement activities. 

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INTROD UCT ION 

We also conducted structured interviews with CMS central office staff in 

November 2005. We spoke with staff responsible for the oversight of the 

ESRD program in OCSQ and CMSO to learn what quality of care data 

CMS provides to Networks, and to identify requirements regarding the 

use of quality of care data by Networks. We also asked for details on 

the sources of quality of care data CMS provides to all Networks and 

CMS’s future data collection plans for the ESRD program. 

We created a coding system to analyze our structured interviews. After 

creating the coding system, we analyzed the responses using both SAS® 

and Access®. In developing our findings, we used this analysis of 

interview data to supplement our review of the data sources and 

documentation. 

Standards 

This study was conducted in accordance with the “Quality Standards for 

Inspections” issued by the President’s Council on Integrity and 

Efficiency and the Executive Council on Integrity and Efficiency. 

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Δ FINDINGS

While multiple sources of data are available to 

Networks to assist them in identifying facilities 

with quality improvement needs, each source 

has limitations 

Among other responsibilities, the 

Social Security Act and the 

Networks’ current contract with 

CMS require Networks to identify 

facilities in need of quality 

improvement and to assist those facilities in developing plans to 

improve care. To identify these facilities, Networks need clinical 

performance data on each facility that would allow facilities to be 

assessed in a timely fashion. While Networks have access to a number 

of data sources related to the ESRD program, each of these sources has 

limitations as a tool to assist Networks in identifying facilities with 

quality improvement needs. Limitations of existing sources of data 

include lack of facility-specific data, lack of comprehensive clinical 

performance measures, and questionable timeliness. The multiple 

sources of data together compose a system of data about quality of care 

available to Networks. However, this system is fragmented, 

duplicative, and lacks comprehensive clinical performance measures. 

Clinical Performance Measures data do not enable Networks to identify 

facilities with quality improvement needs 

Our review of the CPM methodology revealed that the CPM project does 

not provide facility-specific clinical performance data. Rather, the CPM 

project collects aggregate performance data. The only way CPM data 

can be used to identify facilities with quality improvement needs is if 

facilities first identify their own performance problems by comparing 

their performance to the CPM data, and then self-report these problems 

to the Network. 

In addition to our review, Networks also report that CPM data cannot 

be used to identify facilities with quality improvement needs. 

Representatives from all 18 Networks reported that they cannot use 

CPM data to target individual facilities in need of quality improvement. 

As one Network representative noted, if 90 percent of facilities meet 

Network goals on a clinical performance measure and 10 percent do not, 

the Network has no way to use the CPM data to identify the 10 percent 

of facilities who need assistance. Other Network representatives 

observed that each facility may only have a few patients in the CPM 

sample, which is not enough for the data to be statistically valid at the 

facility level, so no conclusions can be drawn about a specific facility’s 

performance. 

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F I NDING S 

Staff at eight Networks reported that the lack of facility-specific 

performance information in the CPM data only allows for the 

identification of broad educational efforts. When these Networks have 

discovered a problem with a particular CPM, they have responded by 

educating the entire Network of facilities. While broad educational 

efforts may be beneficial, these efforts may also use resources that could 

have been more efficiently targeted at specific facilities with quality of 

care problems. 

Dialysis Facility Report data provides data on only 3 of the 13 clinical 

performance measures. In addition, most Networks report timeliness of the 

data is a limitation 

The DFR does contain some facility-specific data that may assist 

Networks in identifying facilities with quality improvement needs. The 

annual DFR contains facility-specific information about dialysis care, 

primarily derived from Medicare claims data. However, only 3 of the 

13 CPMs identified by CMS are covered by the DFR.17 Networks are 

not required to use DFR data under their SOW, as they are with other 

sources. The DFR is primarily intended to be used by State surveyors 

to target ESRD facilities that will be visited for recertification each 

year. 

The three CPMs reported in the 2004 DFR are derived from claims data 

that was between 8 and 20 months old at the time the Networks 

received it. For each of these three CPMs, the DFR reports one data 

point (an average or mode) derived from data from the previous 

calendar year. 

Despite finding some aspects of the DFR useful, representatives from 

14 of 18 Networks report that the age of the data is a limitation. Staff 

at one Network provided an example of how they tried to use the DFR 

data to identify and address quality improvement needs and had limited 

success. This Network developed a project to identify and assist 

facilities that did not meet the guideline for a particular DFR measure. 

The DFR data showed that 30 facilities in their Network were not 

performing adequately. However, when the Network began to assist 

these facilities, it discovered that nearly half of the facilities were, at 

that time of the intervention, meeting the identified goal. Further, the 

Network had no information on whether any facilities outside of the 

30 that were originally identified had developed a problem since the 

time period reflected by the data. 

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F I NDING S 

While some Networks attempted to use the DFR data to identify 

facilities with quality improvement needs, others reported that they 

only used it after a concern is identified through other means, citing 

timeliness as the reason. Nearly half of the Networks volunteered that 

they only review DFR data when addressing a previously identified 

concern about a facility, or only use it in conjunction with other 

information sources. All but one of these Networks indicated their 

limited usage is due to the age of the data. 

Six Networks also expressed concern about the accuracy of the DFR 

data. We did not review the accuracy of the data. We did ask the 

contractor who prepares the report about validation procedures for the 

DFR data. They reported that the data are not routinely validated, but 

facilities are allowed the opportunity to make corrections to their selfreported data prior to the reports being issued. A 2003 study compared 

DFR data to CPM data, a portion of which was validated against 

medical records.18 This study found that there was general agreement 

between clinical variables submitted on claims (used in the DFR) and in 

the CPM project. 

Fistula First data address only one clinical performance measure 

Our review of the Fistula First data collection tool revealed that Fistula 

First provides both facility-specific and current data related to the use 

of AV fistulas for hemodialysis access. Networks are evaluated on the 

performance of all facilities in their Network on vascular access 

measures. Our documentation review also identified examples of how 

Networks have successfully used this facility-specific information for 

quality of care oversight. Specifically, one Network uses the data to 

target facilities for site visits. In addition, several Networks use it to 

develop facility-specific quality improvement plans for vascular access. 

However, the Fistula First data provide information on only 1 CPM, 

related to vascular access, out of the 13 CPMs identified by CMS. These 

data do not provide information on other CPMs, such as those related to 

adequacy of dialysis or anemia management. 

Administrative data do not contain clinical performance measures 

Administrative data provide information on patient demographics, 

enrollment, and deaths. Administrative data also provide information 

on complaints or grievances, which can be used to identify instances of 

poor performance, although not systematically. Further, administrative 

data do not contain CPMs. For these reasons, Networks cannot rely 

upon these data to identify facilities with quality improvement needs. 

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F I NDING S 

CMS reports an additional process for collecting facility-specific data; 

however, this process is not designed to identify facilities with quality 

improvement needs 

CMS reported that they have developed a formal process through which 

Networks may request permission to collect additional data from 

facilities within their own Network. According to the SOW, Networks 

are required to have any data collection effort that is not specifically 

required by the contract approved by CMS. CMS established a data 

review committee to review such requests. 

However, this process is not intended to assist Networks in identifying 

facilities with quality improvement needs. According to CMS staff, 

CMS expects that a quality improvement need be identified before the 

data can be collected. Therefore, this process does not seem to be a 

viable option for Networks to use to identify facilities with quality 

improvement needs. 

Further, the process of Networks requesting additional facility-specific 

data is not routinely invoked. While the process of requesting data is 

available to all Networks, it requires a proactive effort to request it. 

Taken together, the sources of available data compose a system with 

limitations for identifying facilities with quality improvement needs 

All sources of data about quality of care together compose a system of 

data available to Networks. However, this system is fragmented, 

duplicative, and lacks comprehensive performance measures. 

The current system of data about quality of care is fragmented. We 

have identified at least five different sources of data about quality of 

care in this report. For Networks to try to use existing data 

systematically to identify facilities with quality improvement needs, 

they would need to extract different data elements from each of the five 

sources and assemble those data elements together to profile each 

facility in their Network. On average, each Network has approximately 

250 dialysis facilities. 

The current system of data also contains some information that is 

duplicative and inconsistently reported. For example, data about 

anemia management, a key measure of dialysis care, is currently being 

collected as part of two different projects: the CPM project and the 

DFR. Each project collects the data in different ways from potentially 

different populations covering different periods of time. The CPM 

project anemia management data are obtained from the medical records 

of sampled patients. The DFR data come from data reported on 

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F I NDING S 

Medicare claims. In addition, other duplicative data are reported using 

different measures. The 2004 DFR reported vascular access 

information, but not the same vascular access information reported in 

the CPM or Fistula First projects. 

Finally, the current system lacks comprehensive clinical performance 

measures on each facility. Even when viewed together as a system of 

data, currently available sources provide facility-specific information 

about only 4 of the 13 CPMs. 

CMS has taken action towards providing a 

streamlined source of quality data that could 

assist Networks in identifying facilities with 

quality improvement needs; however, it has not 

yet been implemented 

In 2000, CMS stated they were 

developing a Core Data Set project 

that would collect facility-specific 

data on a comprehensive set of 

clinical performance measures 

regularly. If implemented as 

described, the Core Data Set 

project could capture data currently collected from multiple sources in 

one national source of comprehensive facility-specific performance 

measures. However, CMS staff reported that technical and resource 

challenges have delayed implementation of the Core Data Set project, 

which is not complete. 

CMS initiated a Core Data Set project that could assist Networks in 

identifying facilities with quality improvement needs 

In response to the June 2000 OIG and GAO reports indicating flaws 

with the oversight of the ESRD program, CMS stated that it was 

developing the Core Data Set project. According to CMS’s comments 

published in each of these reports, the Core Data Set project would 

strive to “determine and report accurate, meaningful facility-specific 

performance measures [to] allow comparisons across dialysis centers 

and will ultimately increase facility accountability and patient choice.”19 

CMS also stated that they intended to collect these data on all ESRD 

patients regularly. Further, the Core Data Set SOW issued by CMS 

specified: 

that the Core Data Set will include data elements 

currently needed by the ESRD Networks under their 

contract with CMS to conduct quality improvement 

oversight activities and those data elements currently

needed (or collected) by CMS to conduct ESRD program

oversight activities.20 

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F I NDING S 

The Core Data Set project would include elements currently collected as 

part of other projects, such as the CPM, DFR, and Fistula First, as well 

as other measures.21 Rather than collect all of these data elements 

through separate projects, the Core Data Set project would consolidate 

and standardize these data into one project. 

While CMS has made progress, over the past 6 years the Core Data Set 

project has not been implemented 

CMS officials report that they have made progress towards 

implementing the Core Data Set project by identifying the data 

elements to be collected. In January 2000, CMS initiated a public 

process to identify the data elements of the Core Data Set. CMS 

finalized the list of desired data elements in 2005. 

CMS has also started establishing systems to collect the Core Data Set. 

According to CMS staff, the next phase of implementation of the project 

is electronic data collection. CMS is currently developing two different 

methods of electronic data collection. First, CMS is testing electronic 

downloads of quality improvement information with the Large Dialysis 

Organizations (LDO).22 Second, CMS is developing and distributing a 

software product that would enable electronic data collection for nonLDO facilities. 

CMS has continued to promote electronic data collection of quality 

improvement information by suggesting that it become mandatory. In 

the proposed regulations for ESRD facilities, CMS would require 

facilities to submit CPM data and future clinical performance standards 

electronically.23 The proposed regulations do not define how often these 

data would be collected; the regulations state that this information 

would be required to be submitted at intervals specified by the 

Secretary of the Department of Health and Human Services. 

In the meantime, CMS staff indicated that they have made recent 

progress by collecting facility-specific lab data. CMS staff report that 

Networks have access to at least 3 months of lab data from the 

preceding year from 70 percent of facilities, and that Networks are 

allowed to collect these same data from the remaining 30 percent of 

facilities. 

Despite progress, CMS staff responsible for the quality oversight of the 

ESRD program report that the Core Data Set project has not been 

implemented due to technical and resource challenges. Most of the 

technical challenges CMS staff report are associated with electronic 

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F I NDING S 

data collection and include: developing file specifications, standardizing 

definitions of data elements, and validation of Core Data Set elements. 

In a 2004 SOW for an electronic information system, CMS stated that 

“. . . there is an immediate need to develop a standard quality 

improvement data collection instrument and file format with standard 

definitions of the data elements to support quality improvement 

activities defined in the Network SOW.”24 However, CMS 

representatives reported during our interview that they do not have 

dedicated funding to implement the Core Data Set project. As such, 

CMS staff indicated that they are focusing on incremental changes to 

existing data systems in ways that would support the Core Data Set 

project. 

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Δ RECOMME NDA TION 

This study found that while Networks have access to multiple sources of 

data about quality of care, each has limitations as a tool to assist 

Networks in identifying facilities with quality improvement needs. 

Limitations include lack of facility-specific, comprehensive, and current 

clinical performance measures. Taken together, these sources compose 

a limited system of data about the quality of the ESRD program. 

Under the current system, Networks’ abilities to ensure that all 

patients in all facilities receive quality care may be impaired. While 

facilities may take the initiative to compare their own performance to 

national targets and self-report deficiencies, this is not required. To 

fulfill their legislatively mandated and contractual oversight 

responsibilities, Networks need facility-specific, comprehensive, and 

current clinical performance measures. 

In addition to implications for quality of care, limitations of the current 

system of data about the ESRD program may have implications for the 

movement in health care towards linking payment to quality. The 

Medicare Payment Advisory Commission has expressed an interest in a 

pay-for-performance system for ESRD facilities using quality 

improvement information. Also, the Department is currently 

developing a demonstration project that will include a pay-forperformance element. While CMS has not yet defined how they will 

implement a pay-for-performance system, it is reasonable to assume 

that such a system would require facility-specific, current information 

on a number of performance measures. 

Finally, the type of available data about the ESRD program are not only 

important for Networks but for other users as well, such as State 

surveyors, CMS staff who administer the ESRD payment, CMS staff 

who establish regulations, lawmakers, and the public. 

We recognize that CMS initiated a plan to provide a streamlined source 

of performance data through the Core Data Set project that could 

address the limitations of the current system. The Core Data Set 

project could provide facility-specific data on all of the clinical 

performance measures on all patients regularly to facilitate 

comparisons among facilities to increase facility accountability and 

patient choice. CMS has stated that it faces technical and resource 

challenges to collecting data for the Core Data Set. However, the Core 

Data Set project has been under development since 2000 and has not 

yet been implemented. 

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R E C O MMENDA T I ON 

We recommend that CMS increase its efforts towards regularly collecting 

data from all patients and all facilities on all clinical performance measures 

identified by CMS to address quality of care in the ESRD program. 

CMS could accomplish this through completing implementation of the 

Core Data Set project, or by some other means. This supports our 

earlier recommendation to CMS regarding development of facilityspecific quality improvement information. In our 2000 report entitled 

“External Quality Review of Dialysis Facilities: A Call for Greater 

Accountability” (OEI 01-99-00050), we recommended that CMS use 

facility-specific performance measures to encourage facilities to improve 

quality of care and to help ensure that facilities meet minimum 

standards.25 CMS concurred with this recommendation, stating that 

the Core Data Set project under development would accomplish this 

goal. 

AGENCY COMMENTS 

CMS stated that it has made progress in collecting data to improve the 

quality of care in the ESRD program; however, opportunities for 

improvement still exist. The complete text of CMS’s comments can be 

found in the appendix. 

CMS outlined a number of steps it has taken to improve quality of care 

for the Medicare program and ESRD. In particular, CMS noted that it 

developed CPMs in response to the Balanced Budget Act of 1997 

requirement that CMS measure and report the quality of renal dialysis 

services by January 1, 2000. CMS also noted that between 2003 and 

2005 it defined the Core Data Set, which created a data dictionary of 

data elements including clinical performance measures. In addition, 

CMS stated that it proposed regulations for ESRD facilities that would 

require facilities to electronically submit all CPMs on all ESRD 

patients. CMS expects to finalize these proposed regulations in 2007. 

CMS also stated that it recently renewed its commitment to developing 

a new information system called Consolidated Renal Operations in a 

Web-based Network (CROWN), which would consolidate existing data 

sources into one system. CMS expects CROWN to be completed by 

2008. 

OFFICE OF INSPECTOR GENERAL RESPONSE 

We recognize that CMS has taken action towards providing a 

streamlined source of quality data that could assist Networks in 

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R E C O MMENDA T I ON 

identifying quality improvement needs. However, we found that 

current sources of data have limitations in assisting Networks in 

identifying facilities with quality improvement needs. These limitations 

include lack of current, comprehensive, and facility-specific performance 

data. 

We recommend that CMS continue to work towards providing Networks 

with facility-specific data on all clinical performance measures. We 

encourage CMS to ensure that the Final Rule expected in 2007 in 

combination with the CROWN information system expected in 2008 will 

result in Networks being provided with facility-specific data on all 

clinical performance measures for all patients. 

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Δ APPENDIX 

AGENCY COMMENTS
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Δ ENDNOTE S 

1 “Summary Report of the End Stage Renal Disease (ESRD) Networks’ 

Annual Reports 2003.” Available online at 

http://www.cms.hhs.gov/ESRDNetworkOrganizations/Downloads/Networ 

kAnnualReport2003.pdf. Accessed January 6, 2006. 

2 “USRDS 2005 Annual Data Report.” Precis. Available online at 

http://www.usrds.org/2005/pdf/0B_precis_05.pdf. Accessed March 1, 

2006. 

3 “2004 Annual Report ESRD Clinical Performance Measures Project.” 

Centers for Medicare & Medicaid Services. December 2004. 

4 Current regulations governing the ESRD program are called the 

ESRD Conditions for Coverage, and can be found at 42 CFR 405 

Subpart U. 

5 Social Security Act § 1881(c)(2). 

6 2003-2006 ESRD Network SOW. Page 6. 

7 “External Quality Review of Dialysis Facilities: A Call for Greater 

Accountability” (OEI 01-99-00050) and “Oversight of Kidney Dialysis 

Facilities Needs Improvement” (GAO/HEHS-00-114). 

8 “Dialysis Facilities: Problems Remain in Ensuring Compliance with 

Medicare Quality Standards, (GAO-04-63),” Government Accountability 

Office. October 2003. Page 50. 

9 CMS description of “CMS Quality Initiatives.” Available online at 

http://www.cms.hhs.gov/QualityInitiativesGenInfo. Accessed January 27, 

2006. 

10 CMS Fact Sheet “End Stage Renal Disease Policy and Payment 

Initiatives.” August 1, 2005. Available online at 

http://new.cms.hhs.gov/apps/media/press/release.asp?Counter=1523. 

Accessed January 6, 2006. 

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11 “Report to the Congress: Medicare Payment Policy,” Medicare 

Payment Advisory Commission. March 2004. 

12 CMS Testimony before the Subcommittee on Health of the 

Committee of Ways and Means. March 15, 2000. Available online at 

http://www.hhs.gov/asl/testify/t050315a.html. Accessed March 22,2006. 

13 Institute of Medicine “Performance Measurement: Accelerating 

Improvement” 2006 and Medicare Payment Advisory Commission 

“Report to the Congress: Medicare Payment Policy.” March 2004. 

14 Balanced Budget Act of 1997, section 4558(b). 

15 As noted earlier, the CPM and DFR data come from different 

sources. Therefore, while the CPM and DFR may report on the same 

category (e.g., adequacy of dialysis or anemia management), the projects 

often do not use the same clinical measure to address that category. 

16 An AV fistula is the surgical connection of a vein and an artery to 

allow access to the vascular system, so blood can be removed and 

returned during hemodialysis. 

17 However, two of the three CPMs measure the same outcome. They 

are listed as separate CPMs because they refer to two separate types of 

dialysis patients, hemodialysis and peritoneal dialysis patients. 

18 Diane L. Frankenfield, et al., “Comparison of Urea Reduction Ratio 

and Hematocrit Data Reported in Different Data Systems: Results from 

the Centers for Medicare & Medicaid Services and The Renal Network 

Inc,” American Journal of Kidney Diseases 41 (February 2003) 2: 433­

441. Note: This article was written by CMS staff and other researchers. 

19 Agency Comments to OIG Report “External Quality Review of 

Dialysis Facilities: A Call For Greater Accountability” (OEI-01-00050), 

page 44 and “Oversight of Kidney Dialysis Facilities Needs 

Improvement” (GAO/HEHS-00-114). Page 33. 

20 “Frequently Asked Questions on the ESRD Core Data Set”, first 

page. Available online at 

http://www.simsproject.com/downloads/cds/WhatIsCoreDataSet.pdf. 

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Accessed January 3, 2006. Note: In addition to quality improvement 

information, the final Core Data Set measures include administrative 

information. 

21 In addition to quality improvement information, the final Core Data 

Set measures include administrative information. 

22 Large Dialysis Organizations are the four dialysis corporations that 

own or operate about two-thirds of Medicare-certified dialysis facilities. 

23 70 Fed. Reg 6254 (February 4, 2005). 

24 CMS CROWN Statement of Work for Computer Sciences 

Corporation, § (I)(A)(3). June 22, 2004. 

25 “External Quality Review of Dialysis Facilities: A Call For Greater 

Accountability” (OEI 01-99-00050). 

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Δ ACKNOWLEDGMENTS 

This report was prepared under the direction of Ann Maxwell, Regional 

Inspector General for Evaluation and Inspections in the Chicago 

regional office, and Thomas Komaniecki, Deputy Regional Inspector 

General. Other principal Office of Evaluation and Inspections staff who 

contributed include: 

Laura Torres Kordish, Project Leader 

Nicole Hrycyk, Program Analyst 

Natalie Coen, Program Analyst 

Janet Kilian, Program Analyst 

Doris Jackson, Program Specialist 

Tricia Davis, Director, Medicare Branch 

Barbara Tedesco, Mathematical Statistician 

Kevin Farber, Mathematical Statistician 

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