Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

JANET REHNQUIST 

INSPECTOR GENERAL 

JANUARY 2002 

OEI-01-99-00054 

Clinical Performance Measures 

for Dialysis Facilities 

Lessons Learned by the Major Dialysis Corporations 

and Implications for Medicare 

Supplemental Report # 2 
OFFICE OF INSPECTOR GENERAL 

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

protect the integrity of the Department of Health and Human Services programs as well as the 

health and welfare of beneficiaries served by them. This statutory mission is carried out through a 

nationwide program of audits, investigations, inspections, sanctions, and fraud alerts. The 

Inspector General informs the Secretary of program and management problems and recommends 

legislative, regulatory, and operational approaches to correct them. 

Office of Evaluation and Inspections 

The Office of Evaluation and Inspections (OEI) is one of several components of the Office of 

Inspector General. It conducts short-term management and program evaluations (called 

inspections) that focus on issues of concern to the Department, the Congress, and the public. The 

inspection reports provide findings and recommendations on the efficiency, vulnerability, and 

effectiveness of departmental programs. 

OEI's Boston office prepared this report under the direction of Mark R. Yessian Ph.D., Regional 

Inspector General and Joyce M. Greenleaf, M.B.A., Assistant Regional Inspector General. 

Principal OEI staff included: 

BOSTON HEADQUARTERS 

Aimee K. Golbitz, Lead Analyst Bambi D. Straw, Program Specialist 

Norman J. Han, Program Analyst 

To obtain copies of this report, please call the Boston Regional Office at 617-565-1050. 

Reports are also available on the World Wide Web at our home page address: 

http://oig.hhs.gov/oei/ 
EXECUTIVE SUMMARY 

PURPOSE 

To present lessons learned by the five largest dialysis corporations in using clinical 

performance measures to hold facilities accountable for the quality of care and to address 

the implications they have for the Centers for Medicare & Medicaid Services, formerly the 

Health Care Financing Administration. 

BACKGROUND 

In our June 2000 report, External Quality Review of Dialysis: A Call for Greater 

Accountability, we urged the Centers for Medicare & Medicaid Services (CMS) to use 

facility-specific clinical performance measures as a key part of its oversight of dialysis 

facilities. Clinical performance measures are quantitative indicators, typically expressed as 

a percentage, that reflect the quality of care patients received. CMS concurred with the 

directions we suggested and presented a detailed action plan to strengthen its use of 

clinical performance measures. Since then it has been active in carrying out this plan. 

In this follow-up inquiry, we examine the practices of the five largest dialysis corporations 

in using clinical performance measures to hold their own facilities accountable for the 

quality of care. We regard such an inquiry as important because: (1) these corporations 

account for about 70 percent of all dialysis patients in the United States, the vast majority 

of whom are Medicare beneficiaries, and represent over 2,000 facilities, (2) they have a 

substantial body of experience in using performance measures, and (3) they have gained 

know-how that can be helpful to CMS and others. 

This report is the second of two supplemental reports focusing on clinical performance 

measures for dialysis facilities. The main report is entitled, Building on the Experiences of 

the Dialysis Corporations. The first supplemental report, Practices of the Major Dialysis 

Corporations, describes the processes the corporations have to collect and use 

performance measures. All three reports are based on our review of corporate documents, 

interviews with corporate medical directors, and visits to a number of the corporations’ 

dialysis facilities. We sought to describe their processes and we did not evaluate the 

overall effectiveness of their systems. We did not audit or validate the performance data 

the corporations collect from their facilities. The corporations voluntarily participated in 

this review and the data presented was self-reported by the corporations. 

LESSONS LEARNED BY THE CORPORATIONS 

In our first report in this series, we described how the corporations collect, review, 

analyze, and disseminate facility-specific clinical performance measures. We found that 

each collects over a dozen measures and generates timely, facility-specific performance 

Dialysis: Lessons Learned and Implications for Medicare i OEI-01-99-00054 
reports. In this report, we present the lessons that the five major dialysis corporations told 

us that they have learned over the years in using these measures. The first two lessons 

address the foundation for accountability that must be established in order for the 

measures to have impact. The remaining lessons address the particulars of establishing 

and using the measures. 

Establishing a Foundation for Accountability 

T Look to medical directors to exert sustained leadership. 

T Secure the commitment of attending physicians. 

Implementing Clinical Performance Measures 

T Collect a broad set of measures. 

T Revisit the relevance of the measures regularly. 

T Establish minimum performance standards. 

T Develop performance goals. 

T Apply strict definitions to performance measures. 

T Check the accuracy of performance data regularly. 

T Minimize the data reporting burden. 

T Present performance data in ways that facilitate comparative assessment. 

T Provide timely feedback of performance data to facilities. 

T Stress quality improvement projects at the facility level. 

T Use performance data as a guide to possible performance problems, not as definitive 

indicators. 

T Intervene with facilities having performance problems in ways likely to motivate change. 

RECOMMENDATIONS 

CMS has played an important leadership role in developing national clinical performance 

measures to assess the quality of care of dialysis patients and, like the corporations, has 

Dialysis: Lessons Learned and Implications for Medicare ii OEI-01-99-00054 
its own system in place to collect facility-specific performance measures. The major

dialysis corporations also have been proceeding on a similar track and have gained

considerable know-how in how to make the most effective use of facility-specific

performance measures. The lessons that the corporations have learned in collecting and

using clinical performance measures reinforce the directions that CMS is taking to further

develop its system to collect and use facility-specific performance measures.

Below we draw on the lessons the corporations have learned that we conclude have

implications for CMS. Our intent is to help CMS further tap into the potential of

performance measures as a means of improving health care outcomes for dialysis patients.

Conditions for Coverage. CMS should revise the Conditions for Coverage, Medicare’s

regulations for dialysis facilities, so that they:

< Require facility medical directors to exert leadership in quality improvement.

< Require dialysis facilities to conduct their own quality improvement projects.

Attending Physicians. CMS should examine ways to foster the commitment of attending

physicians to performance measures. 

< Conduct educational forums that address the value of measurements to patient care. 

< Examine the possibility of physician-specific report cards.

< Focus greater attention on the responsibilities of attending physicians.

Intervention Strategies. CMS, with its oversight agents, the End-Stage Renal Disease

Networks and the State Survey Agencies, should develop more effective intervention

strategies for facilities experiencing performance problems. For this to happen, CMS

should:

< Foster greater collaboration between the Networks and the States that incorporates 

the respective strengths of the two. 

< Address the confidentiality and liability concerns that impede such integrated efforts. 

Dialysis Corporations. CMS should work with the corporations to share experiences 

and minimize burdens on dialysis facilities. At the core, the two have similar concerns 

about improving care. More sharing of experiences could be helpful to both parties, and, 

most importantly, to patients. 

COMMENTS 

We received written comments on the draft report from the CMS, the Forum of EndStage Renal Disease Networks, Renal Physicians Association, National Renal 

Administrators Association, and the five corporate dialysis providers that were the focus 

Dialysis: Lessons Learned and Implications for Medicare iii OEI-01-99-00054 
of our inquiry. Their comments were strongly supportive of the lessons we presented and 

of the thrust of the recommendations we made to CMS. We include the full text of the 

comments in appendix C. On the basis of the comments, we made a number of 

clarifications and technical changes. Among the respondents, our recommendations 

addressing medical director leadership and the commitment of attending physicians 

generated the most attention. Below, we briefly summarize the comments and our 

responses to them. 

Medical Director Leadership. CMS supported our recommendation that the Medicare 

Conditions for Coverage be revised to require medical directors to exert leadership in 

quality improvement. The dialysis corporations and the other commenters also 

underscored the importance of such leadership, but to varying degrees raised concerns 

about how it might be defined in the Medicare Conditions. They urged that leadership 

expectations be in accord with the real world in dialysis facilities. Their comments 

reinforce the importance of CMS clearly establishing the medical director’s authority and 

responsibility to provide leadership if it expects performance measures to be instrumental 

in improving care in dialysis facilities. At the same time, the comments suggest the value 

of collaboration between the corporations and CMS in further defining the leadership role 

of medical directors. 

CMS and other respondents supported our recommendation that medical directors be 

given authority to conduct or initiate peer review of attending physicians. But they were 

clearly wary of our recommendation that when patients are put at risk because of 

substandard medical care, the medical director should report the physician to an 

authoritative body, such as the facility’s governing board, the End-Stage Renal Disease 

Network, or the State medical board. We suggest that this is a vital patient protection 

responsibility that must be part of the purview of the medical director and that CMS 

should address it as part of its efforts to foster quality dialysis care. 

Securing the Commitment of Attending Physicians to Performance Measures. This 

is a vital matter having a significant bearing on the successful use of performance 

measures. CMS expressed its readiness to consider the measures we called for. Other 

respondents were supportive of convening educational forums. But some raised concerns 

with the use of physician-specific reports (which are already being used by at least one 

End-Stage Renal Disease Network and by two dialysis corporations) and with the 

establishment of more explicit Federal standards or requirements concerning the 

performance of attending physicians. We recognize that these are difficult issues, but 

suggest that they warrant careful examination as means of more fully engaging attending 

physicians in quality improvement efforts. 

Dialysis: Lessons Learned and Implications for Medicare iv OEI-01-99-00054 
TABLE OF CONTENTS 

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

INTRODUCTION .......................................................... 1

LESSONS LEARNED BY THE CORPORATIONS .............................. 5

Look to Medical Directors to Exert Sustained Leadership ....................... 6

Secure the Commitment of Attending Physicians .............................. 7

Collect a Broad Set of Measures .......................................... 8

Revisit the Relevance of the Measures Regularly .............................. 8

Establish Minimum Performance Standards .................................. 8

Develop Performance Goals .............................................. 8

Apply Strict Definitions to Performance Measures ............................. 9

Check the Accuracy of Performance Data Regularly ............................ 9

Minimize the Data Reporting Burden ....................................... 9

Present Performance Data in Ways That Facilitate Comparative Assessment ........ 10

Provide Timely Feedback of Performance Data to Dialysis Facilities ............... 10

Stress Quality Improvement Projects at the Facility Level ....................... 10

Use Performance Data as a Guide ........................................ 11

Intervene with Facilities ................................................ 11

RECOMMENDATIONS FOR CMS ........................................... 12

Revise the Conditions for Coverage ....................................... 13

Foster the Commitment of Attending Physicians .............................. 14

Develop More Effective Intervention Strategies .............................. 15

Work with the Dialysis Corporations ...................................... 16

COMMENTS ON THE DRAFT REPORTS .................................... 18

APPENDICES ............................................................ 21

Appendix A: Glossary ................................................. 21

Appendix B: Federal Sources of Performance Measures ........................ 22

Appendix C: Comments ................................................ 25

Appendix D: Endnotes ................................................. 54

Dialysis: Lessons Learned and Implications for Medicare v OEI-01-99-00054 
INTRODUCTION 

PURPOSE 

To present lessons learned by the five largest dialysis corporations in using clinical 

performance measures to hold facilities accountable for the quality of care and to address 

the implications they have for the Centers for Medicare & Medicaid Services, formerly the 

Health Care Financing Administration. 

BACKGROUND 

In 1972, Medicare began covering individuals with end-stage renal disease, or permanent 

kidney failure, making it the only entitlement criteria for Medicare based solely on a 

disease category. Patients receiving hemodialysis, the most common method of treatment, 

typically receive treatment in outpatient dialysis facilities three times a week.1 About 

3,500 dialysis facilities provide ongoing, life-sustaining dialysis treatments to about 

240,000 patients around the country.2 

Our Prior Inquiry 

In June 2000 we released a report examining the Centers for Medicare & Medicaid 

Services’ (CMS), formerly the Health Care Financing Administration, oversight of dialysis 

facilities as carried out by the End-Stage Renal Disease Networks and the State Survey 

Agencies (External Quality Review of Dialysis: A Call for Greater Accountability, OEI01-99-00050).3,4 In that report we gave attention to the fact that performance measures 

can be an important tool to encourage facilities to improve the quality of care and to help 

ensure that they meet minimum standards. But we also found that CMS rarely uses such 

measures to hold individual facilities accountable. 

In our recommendations, we urged CMS to collect and use facility-specific performance 

data as a key element of its external review system. Clinical performance measures are 

quantitative indicators, typically expressed as a percentage, that reflect the quality of care 

patients received. For example, the percentage of patients at a facility that achieved an 

adequate dose of dialysis as measured by a urea reduction ratio of $65 percent, is an 

indicator. (See appendix A for a glossary of terms.) 

We urged CMS to identify a new core set of performance measures to collect regularly on 

all patients from all facilities. We recommended that it make these measures available to: 

< facilities to support internal quality improvement activities, 

< Networks to support regional quality improvement activities and to identify 

outliers for further review, 

Dialysis: Lessons Learned and Implications for Medicare 1 OEI-01-99-00054 
< State survey agencies to help guide and inform the Medicare survey process, and 

< the public to foster public accountability. 

CMS’ Actions 

CMS concurred with the directions we set forth and presented a detailed action plan that 

incorporated numerous efforts it had underway and would be initiating. It is drafting new 

Conditions for Coverage, Medicare regulations, for dialysis facilities, which it expects to 

release in draft in the coming months. In doing so, it plans to consider our 

recommendations to strengthen the role of the medical director, to require facilities to 

electronically report on a core set of performance measures, and to require facilities to 

conduct their own quality improvement activities. 

CMS has also committed to strengthening its existing efforts to collect facility-specific 

data on all Medicare beneficiaries as soon as it is able to put into place its new information 

system, Vital Information System for Improvement of Outcomes in Nephrology.5 This 

new information system will allow facilities to electronically report data directly to CMS. 

The system will also help ensure accurate reporting through computer software that will 

contain automatic data edits that will notify the user when data that is illogical is entered. 

CMS has already implemented the Standard Information Management System for the EndStage Renal Disease Networks, which connects all the Networks together and directly 

with CMS. CMS is also revising three administrative data forms that it collects from 

facilities that contain data used to calculate performance measures. Eventually these 

forms will be submitted to CMS electronically by the facilities. 

Since 1995, CMS, via the End-Stage Renal Disease Networks, has distributed UnitSpecific Reports that provide comparative, facility-specific data, which includes mortality 

and hospitalization rates. Facility-specific urea reduction ratio and hematocrit levels were 

added to the reports after 1998. In January 2001, CMS publicly released comparative 

facility-specific reports that contained three performance measures: urea reduction ratio, 

hematocrit, and mortality. The reports are available on the Internet.6 In July 2001, CMS 

distributed to State survey agencies, facility-specific reports that also contain key 

performance measures. State survey agencies use these reports to assist in selecting 

facilities for review and to focus Medicare certification surveys. Currently the majority of 

the data in these reports comes from Medicare billing and administrative data and the data 

are over 2 years old. As the CMS implements its Vital Information System for 

Improvement of Outcomes in Nephrology it is expected that the data for these reports will 

be more timely (see appendix B for more detailed information about Federal sources of 

performance data). 

Finally, CMS revised its process to review and approve each of the Networks annual 

quality improvement projects. The new process is intended to reduce variation in the 

quality of projects and help Networks design more sophisticated projects. The new 

Dialysis: Lessons Learned and Implications for Medicare 2 OEI-01-99-00054 
process also gives Networks more guidance on what topic areas they should focus on for 

their quality improvement projects. 

Dialysis Corporations Use of Clinical Performance Measures 

In this follow-up inquiry we focus on the experiences of large, corporate dialysis providers 

in using clinical performance measures as a way of holding their own facilities accountable 

for the quality of care provided. This is a significant domain of external quality oversight 

that we did not address in our June 2000 report and that has been largely ignored in the 

public sphere. 

We regard it as important to learn more about the experiences of these providers for three 

major reasons. First, as the dialysis industry has consolidated in recent years, these 

corporations have become a major force in the dialysis field. The five largest 

corporations, which we focus on in this report, now account for about 70 percent of all 

dialysis patients in the United States, the vast majority of whom are Medicare 

beneficiaries.7 They account for over 2,000 of the nation’s 3,500 dialysis facilities.8 

Second, they have a substantial body of experience in using performance measures to 

monitor the quality of care at their own facilities. And, third, they have gained know-how 

that may be useful to Federal efforts. 

Methodology 

We limited our inquiry to the five largest providers: Fresenius Medical Care North 

America, Gambro Healthcare, Davita (formerly Total Renal Care), Renal Care Group, and 

Dialysis Clinic, Inc. In selecting the top five, we do not seek to imply that they are 

necessarily the best in using performance measures, nor to suggest that other corporations 

or independently owned facilities are not also experienced in using such measures. Each 

of the five corporations participated in our study voluntarily and made available to us 

information concerning its practices. The information we present is current as of June 

2001. The information contained in this report was self-reported by the dialysis 

corporations. 

At the outset, we considered including in our review measures that relate to clinical 

performance, patient satisfaction, and adverse events. Each is important to national policy 

and in each case the corporations have relevant experience. However, for this inquiry, we 

decided to limit our focus to clinical performance measures in order to allow for greater 

detail. Clinical performance measures are the measures that the corporations have the 

most experience with, receive most of their attention, and bear most immediately on CMS’ 

oversight. 

Our data-gathering methods included two focus groups with the medical directors of the 

five corporations, further interviews with each of the corporate medical directors and 

Dialysis: Lessons Learned and Implications for Medicare 3 OEI-01-99-00054 
other corporate officials, visits to several corporations’ dialysis facilities, and reviews of 

pertinent documents of the corporations. 

It is important to underscore that our inquiry is not an evaluation of the corporations’ 

practices. They have been carrying out these practices at their own initiative, not in 

response to any Federal requirements. We did not seek to assess how well they are using 

performance measures, nor did we obtain sufficient information to make such an 

assessment. We did not audit or validate the performance data the corporations collect 

from their facilities. We did seek to gain a clear understanding of their current practices. 

We also interviewed key stakeholders. The stakeholders included the Renal Physicians 

Association, the Forum of End-Stage Renal Disease Networks, and the National Renal 

Administrators Association. 

This Report and its Companion Report 

This report is the second of two supplemental reports that we are issuing based on the 

main report entitled, Clinical Performance Measures for Dialysis Facilities: Building on 

the Experiences of the Dialysis Corporations (OEI-01-99-00052). This supplemental 

report begins with two basic lessons associated with establishing a foundation for 

accountability within the dialysis facilities. It then to 12 lessons that concern the 

implementation of clinical performance measures. The report concludes with 

recommendations to CMS as it moves forward to strengthen its own facility-specific data 

collection. 

The first supplemental report, Clinical Performance Measures for Dialysis Facilities: 

Practices of the Major Dialysis Corporations (OEI-01-99-00053), describes the 

corporate practices concerning the use of facility-specific performance measures. We 

address specifics concerning data collection, validation, analysis, dissemination, and 

corporate practices for fostering improvements and intervening with poor performers. 

We conducted this study in accordance with the Quality Standards for Inspections issued 

by the President’s Council on Integrity and Efficiency. 

Dialysis: Lessons Learned and Implications for Medicare 4 OEI-01-99-00054 
LESSONS 

CORPORATIONS 

LEARNED BY THE 

Below we present key lessons the dialysis corporations told us they have learned in using 

clinical performance measures to hold facilities accountable for the care they provide. The 

first two address the foundation for accountability that must be established in order for the 

measures to have impact. The remaining lessons are more operational and cover the 

particulars of establishing and using clinical performance measures. 

Establishing a Foundation for Accountability 

Performance measures do not 

automatically contribute to improved 

dialysis care. For their potential to be 

realized, it is essential that they be used 

at the local level by individual dialysis 

facilities. The facilities’ governing 

boards, clinical and technical staff, and 

administrators must view the measures 

as helpful instruments to improve the 

overall processes of the facility. 

While it is important to gain the 

commitment of all those who are 

associated with the dialysis facilities, it 

is especially important to ensure that 

the two parties that have the most 

influence over the processes of dialysis 

treatment—the facility medical 

directors and the attending physicians 

—integrate the measures into their 

decision-making process (see text box). 

In the sections that follow, we 

elaborate on what the corporations 

have learned in this regard. 

The Role of the Facility Medical Directors and 

Attending Physicians 

Medical Directors. The Medicare Conditions for 

Coverage require each facility to have a physician 

who serves as a medical director who is responsible 

for “planning, organizing, conducting, and directing 

the professional [end-stage renal disease] services.” 

Corporations contract with local physicians to serve 

in this capacity. For facilities that are not part of a 

corporate chain, the facility owner and medical 

director can be the same person. In addition to their 

medical director duties, these physician directors 

have their own patients that can make up the 

majority of patients at a facility. It is not uncommon 

for a medical director to also be an attending 

physician at another facility regardless of the 

ownership. 

Attending Physicians. Dialysis facilities allow 

local physicians to send their patients to them for 

treatment. Attending physicians may send patients 

to several facilities that may be owned by several 

different corporations or entities. The physicians are 

not contractors or employees of the facility or the 

corporation, and their privileges can be revoked if 

they do not adhere to the facility’s policies. 

Dialysis: Lessons Learned and Implications for Medicare 5 OEI-01-99-00054 
Lesson 1. Look to medical directors to exert sustained leadership. 

The dialysis corporations underscore that if performance measurements are, in fact, to 

stimulate improved care, it is essential that facility medical directors provide leadership. 

They look to their medical directors to exert this leadership in two key ways. One is to 

lead by example. The medical directors must show that they are willing to use 

performance data to improve their own practices, for their own patients. Since the 

medical directors can account for a majority of a facility’s patients, such leadership by 

example is of no small consequence. 

The other dimension of medical director leadership is that of ensuring sustained attention 

in the facility to the improvement opportunities that performance measures can offer. The 

corporations have come to expect the medical directors to serve as the primary on-site 

agents to implement the corporate initiatives concerning the collection and use of 

measures, to help nurses and attending physicians recognize the value of using the 

measures, to determine how measures can foster continuous quality improvement efforts, 

and, where necessary, to intervene with individual physicians or nurses whose 

performance may be adversely effecting the facility’s overall performance. 

The medical directors’ contracts spell out their leadership responsibilities. These contracts 

include the responsibilities required by the Medicare regulations as well as any additional 

responsibilities required by the corporation.9 Among the contracts that we reviewed, we 

saw specifications that medical directors review their facilities’ performance measures 

monthly, attend regular training or meetings concerning quality improvement, and address 

attending physicians not performing adequately. Two of the corporations even include in 

their contracts a provision indicating that a portion of the medical director’s salary is 

contingent on how well their facilities fared on various performance measures. 

To further the leadership of their medical directors, the corporations also convene forums 

of various kinds at which medical directors receive training about the use of performance 

measures and the dynamics of quality improvement efforts. These sessions tend to focus 

on how such efforts can be instrumental in improving the processes of care. The 

corporations also conduct other kinds of outreach to help medical directors. For instance, 

one holds quarterly conference calls in which medical directors and other facility staff are 

encouraged to participate. The corporate leaders we met with believed that these efforts 

are helpful in engaging the medical directors. 

The corporate officials disagreed about how fully they are able to hold facility medical 

directors accountable for exerting leadership. Some stated that they had all the authority 

they needed through their contracts with facility medical directors. For them, it was 

simply having the will to enforce their contracts. Others drew attention to the limited 

leverage that the medical directors themselves have over the attending physicians who, 

unlike medical directors, do not have contractual obligations to the facility or the 

corporation and who often have patients at various facilities.10 The Medicare Conditions 

Dialysis: Lessons Learned and Implications for Medicare 6 OEI-01-99-00054 
for Coverage do not make explicit that medical directors have the authority to take action 

concerning patients attended to by other physicians.11 However, in CMS’ comments to 

this report it stated, “that medical director may take “independent action” (which can 

encompass a number of options) in the absence of explicit statutory or regulatory 

authority.”12 Moreover, in competitive marketplaces, medical directors and attending 

physicians, if unhappy with a facility, can encourage their patients to move with them to 

another dialysis facility. 

Lesson 2. Secure the commitment of attending physicians. 

For their own patients, the attending physicians determine the amount of dialysis, prescribe 

medications, and monitor the ongoing effects of dialysis treatment. In performing these 

roles, the attending physicians have a considerable influence on the quality of care 

provided at dialysis facilities and can influence how well particular facilities fare when 

performance measures are aggregated. 

Yet, corporate representatives indicate that these attending physicians, when they are not 

the medical director, are not necessarily drawn to facility-based performance measures. 

With their patients in a number of different facilities, they may find any one facility’s 

measurements to be of little consequence to their own clinical performance. And, finally, 

as busy professionals, they may find that they have little time to devote to improvement 

efforts, for which they receive no additional compensation. 

Still the corporations have devised ways to encourage attending physicians to participate 

in facility efforts to improve the quality of care being provided. One approach they use is 

to establish clear standards that attending physicians must meet in order to send their 

patients to the facility. Typically these standards are set forth in the facility bylaws. At 

least one of the corporations has reinforced its standards by requiring all attending 

physicians to sign an agreement stipulating their roles and responsibilities. Another 

approach is to provide opportunities for physicians to attend seminars or conferences 

addressing performance measures and/or quality improvement. Finally, to foster a 

stronger sense of individual physician accountability, two corporations provide physicianspecific performance reports so that physicians can see data that are more relevant to their 

own practice. 

Implementing Clinical Performance Measures 

The corporations have been collecting and using facility-specific performance measures for 

many years. They have gained a considerable appreciation for the complexities of the 

tasks involved. They have made and continue to make changes in their policies and 

procedures. We offer what they regard as major lessons learned. 

Dialysis: Lessons Learned and Implications for Medicare 7 OEI-01-99-00054 
Lesson 3. Collect a broad set of measures. 

Even with all the research on dialysis treatment in the last 25 years, there still is a lack of 

complete understanding of what affects mortality on dialysis patients. Dialysis treatment is 

a complex process. Treatment is also complicated by the fact that many patients suffer 

from other serious chronic conditions, such as hypertension and diabetes. Therefore, it is 

critical that facilities monitor many different measures in order to obtain a better picture of 

the care patients receive. 

Lesson 4. Revisit the relevance of the measures regularly. 

The measures the corporations collect have changed over time in order to keep pace with 

scientific advances. The corporations stated that if the measures were outdated (i.e., not 

clinically relevant), then physicians, nurses, and other renal professionals would be 

unwilling to invest their time in collecting and reviewing them. 

The vast majority of revisions have been adding new measures and refining definitions as 

opposed to eliminating measures. With new research coming out all the time and as 

researchers learn more about the process of dialysis treatment, new parameters are 

identified that influence mortality. In order to accomplish this task, the corporations rely 

on staff at the central level who monitor the latest research and can react quickly to revise 

the measures. 

Lesson 5. Establish minimum performance standards. 

Corporate officials emphasized that setting clear expectations for facility performance is 

key to ensuring a minimum level of care across all facilities. The corporations recognize 

that some variation will always exist in dialysis care. However, the corporate leaders 

agreed that there is a floor below which care is unacceptable. 

Minimum standards are often expressed as a percentage of patients meeting a certain 

target value rather than the average value for all patients at the facility for a given 

measure. Percentages more clearly indicate the number of patients not receiving adequate 

treatment. If 80 percent of patients are meeting the target value, then 20 percent of 

patients are not. The facility is then able to focus on that 20 percent. With averages it can 

be unclear how many patients are above and below the target and what the variance is 

among patients. 

Lesson 6. Develop performance goals. 

Corporate leaders emphasized the need for all facilities, even the top performers, to 

continually improve their performance. In order to prevent facilities from striving just to 

meet the minimum standards, three of the corporations have established goals for each 

performance measure. The goals are intended to be challenging enough to motivate all 

Dialysis: Lessons Learned and Implications for Medicare 8 OEI-01-99-00054 
facilities to improve. One corporate official stated that without goals, the minimums 

become the goals and the race to the bottom begins. 

Lesson 7. Apply strict definitions to performance measures. 

Standard definitions and processes need to be in place prior to collecting the data. Many 

of the clinical performance measures are collected as part of regular treatment, but they 

are not necessarily standardized. In order for the data to be used as part of an aggregate 

analysis, all the data need to be collected and analyzed in the same manner. For example, 

to obtain the urea reduction ratio a blood sample needs to be drawn from the patient. 

Depending on when and how the blood is drawn, the result will differ. In order to bring 

attention to this issue, one corporation requires all its staff members to wear a clip-on 

badge similar to an identification badge. The badge spells out the process for collecting 

blood samples for the urea reduction ratio. 

Other measures that corporate leaders have been especially careful to define the type of 

calculations to perform are hospitalization and mortality rates. For example, some 

corporations exclude patients with certain terminal diseases in calculating mortality rates 

and some do not. With hospitalization, some count the length of stay and some just count 

the number of times admitted. All the corporations indicated that it was important to 

make clear exactly what the measure represents so that all facilities can be collecting the 

same type of data. 

Lesson 8. Check the accuracy of performance data regularly. 

All the corporations indicated that this process is time consuming and often tedious. But 

without it, they were concerned that the integrity of the data could be compromised. 

Facilities first and foremost are in the business of providing patient care; they are not 

focused on statistics or data entry. Therefore, it is important to have a system in place to 

monitor the data. 

The review process serves two main functions: it helps ensure the accuracy of the data and 

it helps to foster the integrity of the entire performance measure program among 

physicians and facility staff. If care givers perceive that the data lacks integrity, they will 

likely ignore any reports generated from the data. 

Some of the corporations thought that, without review, some facilities might try to 

manipulate the data to make their performance appear to be better than it actually is. 

Other corporations disagreed. However, all the corporations agreed that a review process 

helps foster confidence in the data. 

Lesson 9. Minimize the data reporting burden. 

Staff time, as in any health care setting, is in short supply. Nurses and technicians are busy 

caring for patients and have little time left over for other activities, especially for 

Dialysis: Lessons Learned and Implications for Medicare 9 OEI-01-99-00054 
quality improvement activities that sometimes can be perceived as more paperwork. It is 

often the nurses and technicians who are left to deal with quality improvement tasks such 

as entering the data and submitting forms. To help reduce the workload, some of the 

corporations have integrated their electronic data systems for quality management with 

their data systems for patient management that nurses and doctors rely upon to provide 

day-to-day patient care. These types of integrated systems eliminate the need for double 

data entry. 

Lesson 10. Present the performance data in ways that facilitate comparative 

assessment. 

Corporate performance reports compare a facility to its own past performance and to its 

peers at the regional or national levels. Corporate officials told us that comparisons are a 

big motivator for improvement. They show at-a-glance where one facility stands among 

its peers. The facility can then begin to explore how the care they provide differs from 

their peers. 

Lesson 11. Provide timely feedback of performance data to dialysis facilities. 

If the data are 2 years old, or even a year old, physicians may tend to view them as 

something that shows a long-term trend that is irrelevant to the care they are providing 

today. According to corporate leaders, the more recent the data, the more likely 

physicians and staff will take them seriously as a reflection of the care they are providing 

now and if necessary make changes in their practices. 

They also believed that the performance measures can have greater impact if physicians 

are looking at them as part of their care-giving process, not as a task that they save until 

the end of the day after they have seen all their patients. Thus, the data need to be readily 

accessible through patient charts or on computer terminals within the facilities. 

Lesson 12. Stress quality improvement projects at the facility level. 

The corporations expect individual dialysis facilities to take the lead in conducting quality 

improvement projects. They look to the facilities to identify problems and to develop and 

implement their own quality improvement projects. Facilities are in the best position to 

identify areas in need of improvement. Furthermore, improvements can only occur if the 

individuals providing the care make changes in their processes. 

The corporations view themselves as assisting their facilities in improvement activities 

rather than conducting the projects themselves. Thus, they provide extensive training, 

technical assistance, and materials to help facilities conduct their own projects. On 

occasion, corporations will conduct corporate-wide projects, but most often the emphasis 

is placed on facility-based projects. 

Dialysis: Lessons Learned and Implications for Medicare 10 OEI-01-99-00054 
Lesson 13. Use performance data as a guide to possible performance problems, 

not as definitive indicators. 

Corporations use performance measures cautiously, as signals of possible problems. It is 

important that measures are used with other types of information. Prior to intervening, 

the corporations seek to verify the concern. They may examine the results of recent 

patient satisfaction surveys, complaints, results of any State surveys, adverse event 

reports, and the current demographics of the patient population. Some corporations wait 

until a definite pattern appears over several months before they will intervene. Corporate 

representatives emphasized that performance measures used in isolation can lead to false 

conclusions on both sides. A facility that fails to meet performance minimums may in fact 

be providing high quality care. Similarly, a facility exceeding performance goals may be 

providing inadequate care. 

One representative told us about a time that he called a facility medical director to express 

concern about the facility’s high mortality rate. It quickly became apparent the high 

mortality rate was explained by a patient population that included a large number of 

patients suffering from AIDs. The corporation did not adjust its data for AIDs and other 

terminal illnesses. The issue of patient comorbidity can be particularly complex as many 

measures are not adequately risk-adjusted. Another corporate official told us that he was 

surprised when he received a State survey report from one of his facilities that outlined 

several serious deficiencies. The facility was performing well on each of its performance 

measures. From these events and others, the corporations have learned not to rush to 

judgement based on the measures alone. 

Lesson 14. Intervene with facilities having performance problems in ways likely 

to motivate change. 

When the corporations have determined that a cause for concern exists at a facility, they 

will intervene using graded approaches. The corporations tend to begin their interventions 

with targeted training for the facility. Often facilities struggle because they simply do not 

know how to interpret their data and develop a corrective action plan. Often the training 

occurs on site so that the corporate officials can also review first-hand the practices of the 

facility. Many of the corporate officials believed that training would not only help the 

facility fix its current problem, but also help the facility address any problems in the future. 

If training fails, the next level of response is peer review. Corporate officials indicated to 

us that physicians and nurses are more receptive to advice from their regional peers than 

from a person in an executive position. According to the corporate representatives, these 

approaches are highly successful. It was rare that they had to resort to punitive actions 

such as firing facility staff, terminating contracts with facility medical directors, or 

revoking attending physician privileges. 

Dialysis: Lessons Learned and Implications for Medicare 11 OEI-01-99-00054 
RECOMMENDATIONS 

CMS has played an important leadership role in developing national clinical indicators to 

assess the quality of care of dialysis patients. Its efforts, through the Clinical Performance 

Measures Project, have drawn attention to the potential of clinical performance measures 

in the dialysis field. The data show that between 1994 and 1999 the percentage of patients 

with adequate dialysis treatment, defined as a urea reduction ratio $65 percent, has 

increased from 43 to 80 percent. The percentage of patients receiving adequate anemia 

management, defined as hemoglobin $ 11 gm/dL, has also increased from 43 to 68 percent 

between 1997 and 1999.13 CMS has also collected facility-specific data on performance 

measures mainly through billing and administrative forms and recently has taken steps to 

strengthen its systems to collect and disseminate facility-specific data (see appendix B and 

page 2). 

The major dialysis corporations, as we have shown, also have been active in using facilityspecific performance measures as tools of quality improvement. The lessons that they 

have learned in collecting and using clinical performance measures reinforce the directions 

that CMS is taking towards enhancing its current facility-specific reporting mechanisms. 

CMS is developing a new core data set, a mechanism to help ensure accurate reporting, a 

mechanism to provide ongoing evaluations of the measures, and a process to disseminate 

comparative data in a more timely fashion. 

In this final section, we draw on the lessons learned by the dialysis corporations to identify 

the implications that we conclude they have for CMS. As CMS seeks, in the years ahead, 

to further tap into the potential of performance measures as a means of improving health 

care outcomes for dialysis patients, it will need to address these recommendations. 

In presenting these recommendations, we offer two important caveats. One is that we do 

not intend to imply that the facilities that are part of the major dialysis corporations are the 

best or in any way deserve preferential treatment. As CMS continues to exert leadership 

in using clinical performance measures as tools for quality improvement, it must be 

attuned to their application in a full range of dialysis facilities, whether or not they are part 

of a corporate chain. Secondly, we recognize that performance measures are only part of 

the solution to improving care. The Medicare Payment Advisory Commission, and others, 

have noted that the current payment system for dialysis services is fragmented. This 

system inhibits the systematic, coordinated steps that dialysis facilities must take if they are 

to make effective use of performance measures to improve the quality of care. To 

continue to make substantial improvements, the fragmented nature of the payment system 

may need to be addressed so that it creates incentives to provide high quality care.14 

Dialysis: Lessons Learned and Implications for Medicare 12 OEI-01-99-00054 
Revise the Medicare Conditions for Coverage for dialysis facilities. 

CMS is now in the process of drafting revisions to the Medicare Conditions for Coverage, 

regulations that all dialysis facilities receiving Medicare payments must adhere to. In our 

June 2000 report, we emphasized that it was important to revise the Conditions so that 

they serve as a more effective foundation for accountability. We cited six specific changes 

that, at a minimum, should be part of the revision.15 Our review of the lessons learned by 

the dialysis corporations adds compelling support for two of the changes we called for. 

We address them below. 

Require facility medical directors to exert leadership in quality improvement. 

The corporations have learned that if performance measures are to be used effectively at 

the facility level, someone at the facility must take the lead to ensure that the nurses, 

attending physicians, and the technicians are all attuned to quality improvements. The 

medical director, who typically serves as a member of the facility’s governing body, is in 

the best position to fulfill this leadership role. Without medical directors being fully 

committed to and engaged with quality improvement activities, important opportunities 

for enhancing patient care are likely to be missed. 

Recognition of the significance of medical director leadership is not limited to the major 

dialysis corporations. The Renal Physicians Association has issued a position paper on the 

responsibilities of the medical director that calls for them to ensure that all attending 

physicians comply with Federal requirements.16 One of the End-Stage Renal Disease 

Networks, the TransPacific Renal Network, has adopted a set of standards for facility 

leadership that are modeled on those of the Joint Commission on Accreditation of 

Healthcare Organizations and cite the medical director as the final authority within the 

facility.17 And the Texas Department of Health, with input from the End-Stage Renal 

Disease Network’s medical board and the renal community, issued a set of standards that 

among other things calls for medical directors to attend monthly quality improvement 

meetings.18 

The current Medicare Conditions do not explicitly require the medical director to take the 

lead in quality improvement. It is time for them to catch up with developments such as 

those noted above and to state explicitly that the medical director must play a leadership 

role in using performance measurements to stimulate quality improvements. While the 

Conditions need not spell out that role in great detail, they should make it clear that the 

medical director is expected, on an ongoing basis, to lead quality improvement efforts. 

CMS should also address in the Conditions what medical directors are expected to do 

when a quality problem is attributable to an attending physician who is not performing 

adequately. CMS should make clear that medical directors have the authority to conduct 

and/or initiate peer review and to address performance problems through directed 

education efforts. And, for more serious situations where patients have been put at risk 

Dialysis: Lessons Learned and Implications for Medicare 13 OEI-01-99-00054 
because of poor care medical care, CMS should make clear the medical director’s 

responsibility to report the physician to an authoritative body, such as the facility’s 

governing board, End-Stage Renal Disease Network, and/or the State Medical Board. 

Require dialysis facilities to conduct their own quality improvement projects. 

To varying degrees, the corporations conduct regional or national quality improvement 

efforts. But each of them places the primary focus at the facility level. They look to their 

facilities to use performance measurement as a mechanism of constructive change. They 

look to the facilities to compare their performance scores over time and with other 

facilities and to ask: how can we do better? The main role for the regional or central 

corporate offices is to support such facility-based efforts. 

CMS can give added impetus to such facility-based efforts by enacting a Medicare 

requirement that facilities undertake quality improvement efforts.19 The requirement need 

not stipulate the type of efforts, but should call upon the facilities to draw on performance 

measures, as well as, other sources of information to improve the quality of care provided. 

This expectation should apply even for facilities that have comparatively high performance 

scores. All facilities, it seems reasonable to assume, can do better. 

Such a mandate need not preclude national or regional quality improvement projects but 

the corporate experience suggests that they should be of lesser significance than those that 

are facility-specific. It is essential here to recognize that improvement efforts are an addon to ongoing care responsibilities and that it can be difficult to garner sufficient attention 

to them. This is particularly true in the many facilities coping with staff shortages and high 

turnover rates. To the extent that CMS and/or the Networks call for facilities to 

participate in national or regional efforts, the facilities’ readiness and capability to generate 

their own intrinsic efforts may be lessened. This is an important policy consideration that 

warrants attention. 

Examine ways to foster the commitment of attending physicians to 

performance measures. 

This is a complicated issue, but our review of the corporate experiences suggests that 

without addressing it, the potential of performance measurement will not be fully tapped. 

Attending physicians are the ones who determine the course of treatment, prescribe 

medications, and monitor the overall health of the dialysis patient. For a facility to achieve 

sustained progress in its performance improvement efforts, these physicians must become 

active participants in such efforts. They must see themselves not just as a patient’s 

physician, but as a part of the facility’s team responsible for the patient’s care. And, just 

as the facility must be held accountable for the quality of the care provided, so too must 

the individual physician. 

Dialysis: Lessons Learned and Implications for Medicare 14 OEI-01-99-00054 
The key question is how can CMS best foster such accountability and commitment by the 

attending physician? Our review suggests three directions. One is for CMS and/or the 

Networks to provide educational forums for nephrologists that clearly convey the value of 

performance measures and their relevance to everyday care of the patient. Both CMS and 

the corporations have undertaken such efforts. Perhaps they could collaborate on what 

approaches work best and warrant more attention in the future. 

A second direction is to consider generating physician-specific report cards. One 

Network, as we noted in a prior report, has been doing this since 1997.20 Three times a 

year it generates a Physician Activity Sheet that compares the performance of individual 

physicians to their peers at the facility, State, and Network level and to clinical guidelines 

on several performance measures collected by the Network. Similarly, two of the dialysis 

corporations we contacted provide physician-specific report cards so that physicians can 

see how their performance compares with their peers. It strikes us that such efforts to 

drive down the data to the physician level can be an important way to draw attending 

physicians more fully into improvement efforts and to hold them more fully accountable 

for their performance. 

A third direction is for CMS to more fully address the expectations of attending physicians 

to contribute to and be responsive to quality improvement efforts and, more generally, to 

provide care to their patients. It could be instructive to review the extent and kind of 

expectations now set forth by facilities and what effects they seem to have concerning 

performance improvement. For example, several of the corporations provide standards 

that all attending physicians must meet in their facility bylaws. No such standards now 

exist at the Federal level. CMS may want to consider revising the Conditions for 

Coverage to require facilities to have a credentialing process in place for all attending 

physicians similar to the Medicare standards in place for hospitals.21 

Develop more effective intervention strategies for dialysis facilities. 

CMS relies on two separate organizations to oversee dialysis facilities: the End-Stage 

Renal Disease Networks and the State Survey Agencies. Each has its own expertise and 

authorities. The Networks have clinical expertise as they are comprised of local renal 

physicians and nurses, and the States have regulatory authority to enforce Medicare 

regulations. 

Networks, equipped with facility-specific data from CMS, can use the data to guide the 

types of regional quality improvement projects they conduct each year. They should also 

use the data to help focus training and technical assistance with the facilities in need of 

improvements. Similarly, Networks should use the data to identify the top performers in 

order to understand why they are successful and disseminate best practices. Finally, 

Networks can use the data to help conduct more targeted peer review and to identify 

facilities that need to develop formal plans for corrective actions. 

Dialysis: Lessons Learned and Implications for Medicare 15 OEI-01-99-00054 
States can use the facility-specific data they receive from CMS to help identify facilities to 

survey and to ask targeted questions once on site. We recognize that there is concern 

with the States taking the measures too literally and jumping to false conclusions. 

However, it seems reasonable that States should have performance data available to them, 

as one tool among many, that they can use to help inform the survey process.22 

Furthermore, CMS may want to consider expanding the enforcement options available for 

facilities that fail to comply with the Conditions for Coverage. Currently, CMS has very 

few options, short of terminating the facility from the Medicare program, to sanction 

dialysis facilities. CMS affords a wide range of enforcement options for other health care 

facilities. For example, under certain circumstances CMS can deny Medicare payments to 

all new admissions for nursing homes with deficiencies.23 CMS may want to consider a 

similar option for dialysis facilities. 

Even though both these entities complement one another and at times overlap, we found 

in our June 2000 report that the States and the Networks rarely communicate. This 

breakdown can lead to ineffective interventions.24 In order for the States and the 

Networks to be more effective in using performance measures and intervening based on 

them, CMS needs to find ways that they can work together in a coordinated fashion. 

One Network and State already collaborate extensively.25 However this model has not 

been replicated around the country. The two major barriers to greater collaboration are 

liability for Network staff and volunteer members when they conduct work outside their 

CMS contracts and privacy protection laws that prevent Networks from freely sharing 

data with other entities. CMS will need to address these issues first, in order for more 

collaboration to take place between the Networks and the States. 

Work with the corporations to share experiences and minimize burden 

on dialysis facilities. 

Traditionally, CMS and its agents, the States and the Networks, have not had much 

interaction with the dialysis corporations. Its focus has been on the licensed facilities, not 

the parent corporations. Yet, the parent corporations, like CMS, are also engaged in the 

external quality oversight of dialysis facilities. From different vantage points, the two have 

many of the same concerns. Our review suggests that it could be beneficial for both 

parties, and most importantly for the patients, for more collaboration and sharing to take 

place. 

CMS has taken some efforts to foster collaboration. At a recent CMS-sponsored 

conference for the End-Stage Renal Disease Networks, a presentation entitled 

“Accountability Panel: Corporate Dialysis QI [Quality Improvement] Representatives” 

was held that gave Network and corporate representatives the opportunity to discuss their 

activities.26 Out of this session several practical solutions arose to foster more 

Dialysis: Lessons Learned and Implications for Medicare 16 OEI-01-99-00054 
communication, such as sharing names of regional corporate contact persons and 

providing the corporations with a list of all Network quality improvement projects. CMS 

has also indicated that its new information system for dialysis facilities, the Vital 

Information System for Improvement of Outcomes in Nephrology, will contain software 

that will allow facilities to abstract data from their existing databases to submit to CMS. 

This is especially helpful for facilities owned by dialysis corporations that have their own 

data systems already in place to collect data. The new software will eliminate the need for 

these facilities to enter the data twice. In our interviews, corporate officials also indicated 

that they were open to the possibility of sharing facility-specific data with CMS. In 

addition, CMS has held several stakeholder meetings to solicit input from the larger renal 

community that included corporate representatives. 

We encourage CMS to continue to broaden its interactions with the dialysis corporations 

especially by encouraging more of the type of dialogue described above at the recent 

CMS-sponsored conference. It may want to consider sponsoring more meetings that 

include dialysis corporations, Network representatives, government officials, and State 

surveyors. The meetings could focus on practical solutions to foster greater collaboration 

among all these parties. Another concrete step that CMS should take is to share all its 

facility-specific data reports directly with the relevant corporations. 

Dialysis: Lessons Learned and Implications for Medicare 17 OEI-01-99-00054 
COMMENTS 

We received written comments on the draft report from CMS, Forum of End-Stage Renal 

Disease Networks (Forum), Renal Physicians Association, National Renal Administrators 

Association, and the five corporate dialysis providers that were the focus of our inquiry: 

Renal Care Group, Fresenius Medical Care, Davita, Gambro Healthcare, and Dialysis 

Clinic, Inc. Their comments were strongly supportive of the lessons we presented and of 

the thrust of the recommendations we made. We include the full text of the comments in 

appendix C. On the basis of the comments, we made a number of clarifications and 

technical changes. Below we summarize and respond to some of the points made 

concerning key issues in our reports. 

Medical Director Leadership 

CMS expressed support for our recommendation that the Medicare Conditions be revised 

to require facility medical directors to exert leadership in quality improvement. It 

indicated that it will consider how the Conditions might express such a requirement. 

Other respondents also expressed support, but some raised concerns about how leadership 

might be defined and how it might relate to real world situations. We recognize the 

dangers of defining leadership in too detailed a fashion. But our inquiry and the responses 

we received to the draft reports reinforce the importance of firmly establishing the medical 

director’s leadership responsibility and authority concerning quality improvement activities 

in a facility. CMS should seek feedback from key stakeholders on how this leadership role 

can best be expressed in the revised Medicare Conditions. 

CMS and others supported our recommendation that medical directors be given explicit 

authority to initiate or conduct peer review of attending physicians who are found to be 

performing inadequately and to address performance problems through directed education 

efforts. However, in the case of situations where patients have been put at risk because of 

poor medical care, CMS and others expressed reservations about our recommendation 

that CMS should make clear the medical director’s responsibility to report the physician to 

an authoritative body, such as the facility’s governing board, the End-Stage Renal Disease 

Network, and/or the State Medical Board. 

We are disappointed by the lack of support for this recommendation. We clarify here that 

we are referring to serious situations where the poor performance of a physician has 

clearly put a patient or patients at risk. Physicians, as part of their own State licensure, are 

already obligated to make such referrals to State medical boards. CMS, in its contract 

with the Networks, calls upon them to refer such cases to the Medicare Peer Review 

Organization, the State medical board, or the Office of Inspector General.27 It would 

seem to follow for CMS to reinforce this reporting responsibility for medical directors in 

its Medicare Conditions. 

Dialysis: Lessons Learned and Implications for Medicare 18 OEI-01-99-00054 
Quality Improvement Projects 

Our recommendation here drew attention to the value of facility-specific quality 

improvement projects, without necessarily precluding national or regional projects. The 

CMS indicated that it will consider including a requirement for such facility-specific 

projects in the revised Medicare Conditions. One of the corporate providers reinforced 

the point that sound quality improvement projects can be initiated centrally (by a 

corporation or by CMS) as well as by a facility itself. Another provider expressed concern 

that by adding quality improvement projects to a State survey agency’s checklist could 

undercut the intent by emphasizing process over results. It suggested that such projects 

only be required “as part of a corrective action plan relating to substandard clinical 

outcomes.” 

We recognize there is value in both centrally-driven and facility-driven quality 

improvement projects. We also recognize the danger that a Medicare requirement for 

facility specific projects (as exists for example for hospitals) could emphasize process at 

the expense of substance and could, if enforced too rigidly, be a burden for smaller 

facilities. We would urge that CMS reflect an awareness of these dangers in the 

Conditions and in its enforcement of them. However, we continue to believe that the 

quality improvement projects have relevance for all facilities, not just those showing 

substandard clinical outcomes. The latter approach would tend to characterize such 

projects as part of a compliance regime more than an improvement vehicle relevant to all 

facilities. 

Securing the Commitment of Attending Physicians to Performance Measures 

The importance of achieving the commitment of attending physicians and the difficulties 

experienced in obtaining it were recurrent themes that surfaced during our inquiry. We 

addressed the issue in our recommendations section by calling for CMS to pursue three 

directions. The first was to provide educational forums for nephrologists that convey the 

value of performance measures and their relevance to the everyday care of the patient. 

CMS and others who commented on this recommendation indicated support for such 

forums. 

The second direction we called for was to generate physician-specific report cards, as is 

already being done by at least one End-Stage Renal Disease Network and two of the 

dialysis corporations we reviewed. CMS indicated that its information system can not 

provide physician-specific data at this time, but that it will consider this recommendation 

as it further develops its system. Other respondents were more clearly concerned about 

this direction, noting concerns about methodological, legal, financial and other problems. 

We recognize the difficulties that can be associated with such reports cards. But there is 

real-world experience that can be drawn upon in developing and using them. And, within 

the context that measures are indicators, not outright indicators of good or bad 

performance, it would seem that physician-specific reports can play a valuable role in 

ensuring attending physicians become more fully engaged in improvement efforts. 

Dialysis: Lessons Learned and Implications for Medicare 19 OEI-01-99-00054 
Finally, the third direction we noted is the most sensitive of the three. Here we suggested 

not only a credentialing process for attending physicians but a consideration of more 

explicit standards for the care provided by attending physicians. With the Medicare 

payment to attending physicians, what standards of care are they expected to provide? 

CMS indicated it would consider our credentialing suggestion. Others expressed concern. 

Our aim here is to foster attention to the expectations that CMS ought to have of 

attending physicians and to how these expectations might be expressed and enforced. We 

believe this is an important area warranting further attention by CMS, the medical 

community, and others. 

Intervention Strategies 

CMS supported our recommendation that it examine ways in which the Networks and 

State survey agencies can work together more effectively in overseeing dialysis facilities. 

Others also expressed support. With respect to our suggestion that CMS consider 

expanding the enforcement options available to it, CMS noted it statutory limitations and 

that it is currently developing generic alternative sanctions for all types of providers. The 

need for having a broader array of sanction options is one that has come up previously in 

our review of the dialysis facilities and that we believe warrants further attention by CMS. 

Dialysis: Lessons Learned and Implications for Medicare 20 OEI-01-99-00054 




APPENDIX C 

Comments 

In this appendix, we present the full comments of all parties that responded to our draft 

report. In order, the comments are from the following parties: 

< Centers for Medicare & Medicaid 

< Davita 

< Dialysis Clinic Inc. 

< Fresenius Medical Care North America 

< Gambro Healthcare 

< Renal Care Group 

< Forum of the End-Stage Renal Disease Networks 

< Renal Physicians Association 

< National Renal Administrators Association 

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APPENDIX C 

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