Report Template Update  = 04-30-05_rev.12  
Department of Health and Human Services

OFFICE OF 

INSPECTOR GENERAL 

A Q
VAILABILITY OF  UALITY OF 

C D M
ARE  ATA IN THE  EDICARE 

E S R D
ND  TAGE  ENAL  ISEASE 

P
ROGRAM

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.  Report Template Update  = 04-30-05_rev.12 
  E X E C U T I V E   S U M M A R 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 patients 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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E X E C U T I V E   S U M M A R 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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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 facility-
specific 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 CMSs 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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E X E C U T I V E   S U M M A R 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 facility-
specific data on all clinical performance measures. 
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  T A B L E   O F   C O N T E N T S  

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

I N T RO DUC T IO N  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   1

F I N D IN G S  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   9

Limitationsin current sourcesof data exist  . . . . . . . . . . . . . . . . .   9

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

R E C O MMEN D A T ION  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  16

  AgencyComments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  17

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

APPENDIX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  19

  AgencyComments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  19

E N D NO T ES  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  23

A C K NO WL E D G M E N T S  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  26
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  I N T R O D U C T I O N  

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 patients 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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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 facility-
specific 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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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 facility-
specific data, including the collection of clinical measures through a 
Core Data Set project that would report accurate, meaningful facility-
specific 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 Medicares 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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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 facilitys 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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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.  
SCOPEAND 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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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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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 CMSs 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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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 
CMSs 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 Presidents Council on Integrity and 
Efficiency and the Executive Council on Integrity and Efficiency. 
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  F I N D I N G S

While multiple sources of data are available to  Among other responsibilities, the 
Networks to assist them in identifying facilities  Social Security Act and the 
with quality improvement needs, each source  Networks current contract with 
CMS require Networks to identify 
has limitations  
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 facilitys 
performance. 
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F I N D I N G 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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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 self-
reported 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 N D I N G
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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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FFFF IIII NNNN DDDD IIII NNNN GGGG SSSS  
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  In 2000, CMS stated they were 
streamlined source of quality data that could  developing a Core Data Set project 
that would collect facility-specific 
assist Networks in identifying facilities with 
data on a comprehensive set of 
quality improvement needs; however, it has not 
clinical performance measures 
yet been implemented 
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 CMSs 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 N D I N G
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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 non-
LDO 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 N D I N G 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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  R E C O M M E N D A T I O N  

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-for
performance 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 M M E N D A T I O N  
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 facility-
specific 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 CMSs 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 M M E N D A T I O N  
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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 A P P E N D I X  
AGENCY COMMENTS
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A P P E N D I X  
 
 
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A P P E N D I X  
 
 
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A P P E N D I X  
 
 
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  E N D N O T E 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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  A C K N O W L E D G M E N T S  

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 
  OEI-05-05-00300  AVAILABILITY OF QUALITY OF CARE DATA IN THE MEDICARE ESRD PROGRAM  26