Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

THE ESRD BENEFICIARY 

GRIEVANCE PROCESS 

Daniel R. Levinson 

Inspector General 

December 2013 

OEI-01-11-00550 
 

 

EXECUTIVE SUMMARY: THE ESRD BENEFICIARY GRIEVANCE PROCESS 

OEI-01-11-00550 

WHY WE DID THIS STUDY 

Over 5,000 dialysis facilities provide life-sustaining treatment to more than 

340,000 End-Stage Renal Disease (ESRD) Medicare beneficiaries. Medicare regulations 

require that dialysis facilities implement a process for beneficiaries to file grievances 

without reprisal or denial of services. Beneficiaries also have the option of filing 

grievances with ESRD Network Organizations, which are Medicare contractors that 

oversee dialysis facilities. Previous Office of Inspector General work found that the 

ESRD beneficiary grievance process was unreliable in identifying and resolving 

quality-of-care concerns. 

HOW WE DID THIS STUDY 

We sent a questionnaire to a random sample of 150 dialysis facilities and had an 

80-percent response rate. We sent a questionnaire to 17 of the 18 ESRD networks and 

had a 100-percent response rate. (We conducted a site visit to the 18th network, during 

which we pretested the questionnaire.) We also made site visits to 13 facilities and 

3 networks in 5 States, where we conducted structured interviews with staff and reviewed 

documentation, including the facility grievance logs. 

WHAT WE FOUND 

Dialysis facilities have latitude in what they record as a grievance, and two-thirds of 

facilities recorded five or fewer grievances in 2011. The most common grievances 

recorded concerned the comfort or appearance of the physical environment and 

interactions with staff. Anonymous grievance processes can be difficult to implement, 

and fear of reprisal may be difficult for facilities to measure. The Centers for Medicare 

& Medicaid Services (CMS) has begun to require that facilities use a standardized 

satisfaction survey that does not assess patient fear of reprisal for filing a grievance. 

ESRD networks’ involvement with beneficiary grievances are constrained by limited data 

and reporting. They analyze grievances for trends, but the database they use is of limited 

utility. CMS is unable to readily provide network-specific grievance and complaint data. 

WHAT WE RECOMMEND 

We recommend that CMS (1) define “grievance” for facilities, (2) require that facilities 

report grievances regularly to their respective networks, (3) provide guidance to facilities 

on what constitutes a robust process for anonymous grievances, (4) work with the 

Agency for Healthcare Research and Quality to add a question to the standardized 

satisfaction survey to assess ESRD beneficiaries’ fear of reprisal, and (5) provide 

networks with better technical support for their grievance database. CMS concurred with 

three of our five recommendations. 
TABLE OF CONTENTS 

Objective......................................................................................................1 

Background..................................................................................................1 

Methodology................................................................................................5 

Findings........................................................................................................8 

Two-thirds of facilities recorded five or fewer grievances in
 

2011 ..................................................................................................8 

Anonymous grievance processes can be difficult to implement, 

and fear of reprisal may be difficult for facilities to measure ........12 

ESRD networks’ involvement with beneficiary grievances is 

constrained by limited data and reporting ......................................13 

Conclusion and Recommendations ............................................................15 

Agency Comments and Office of Inspector General Response .................17 

Appendixes ................................................................................................19 

A: Nonrespondent Analysis ..........................................................19 

B: Point Estimates and Confidence Intervals Based on the 

Facility Questionnaire....................................................................20 

C: Agency Comments ...................................................................21 

Acknowledgments......................................................................................25 
 

 

 

 

 

OBJECTIVE 

To describe the grievance processes that dialysis facilities and End Stage 

Renal Disease (ESRD) Network Organizations have in place for 

beneficiaries. 

BACKGROUND 

ESRD, characterized by a permanent loss of kidney function, entitles 

individuals to Medicare coverage based solely on the presence of a 

specific medical diagnosis.1 Most patients with ESRD rely on lengthy, 

uncomfortable dialysis treatment several times a week to compensate for 

kidney failure. Medicare pays for treatment for eligible Americans 

diagnosed with ESRD.2 In 2009, Medicare spent $9.2 billion on dialysis 

services for 340,000 ESRD beneficiaries.3 

Effective oversight of dialysis facilities, including robust processes for 

handling beneficiary grievances, is necessary to protect the vulnerable 

ESRD beneficiary population. The Centers for Medicare & Medicaid 

Services (CMS) divides oversight between State Agencies (SAs) and 

ESRD Network Organizations (networks). SAs, networks, and dialysis 

facilities all can handle beneficiary grievances; the grievance processes of 

networks and facilities are the subject of this report. 

Dialysis 

Treatment options for ESRD include dialysis or kidney transplantation. 

The most common treatment is hemodialysis, 4 in which a machine 

functions as an artificial kidney and pumps blood from the patient and 

removes toxins and excess fluid as it flows through a filter called a 

dialyzer. The cleansed blood is returned to the patient’s body through a 

vein. Peritoneal dialysis is a less common method, which drains toxins 

and excess fluid through the abdominal cavity using the patient’s natural 

peritoneal membrane as a filter. 

More than 5,500 facilities provide dialysis to ESRD Medicare 

beneficiaries. The majority of facilities are freestanding (90 percent), as 

opposed to hospital-based units. Most facilities are for-profit (82 percent) 

1

 Medicare also covers patients with amyotropic lateral sclerosis. 2

 Social Security Act (SSA), § 1881(a).
 3

 Medicare Payment Advisory Commission (MedPAC), Report to the Congress:
 

Medicare Payment Policy, ch. 6, March 2011.
 4

 Government Accountability Office, End-Stage Renal Disease: CMS Should Monitor 

Access to and Quality of Dialysis Care Promptly after Implementation of New Bundled
 

Payment System, GAO-10-295, March 2010. 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 1 
 

 

 

 

 

 

 

 

and operated by a chain organization (80 percent).5 Almost two-thirds of 

facilities are operated by just two chain organizations.6 

Oversight of Dialysis Facilities 

ESRD Networks. CMS contracts with 18 ESRD Network Organizations 

(networks) to evaluate and resolve beneficiary grievances, identify 

facilities not providing appropriate medical care, and measure and 

improve the quality of care through quality improvement projects.7 Each 

network covers a specific geographic region.8 On average, networks 

oversee 322 facilities in their regions. The largest network has 

590 facilities in its region, and the smallest has 170. Each network’s staff 

includes clinical personnel and a medical review board with dialysis 

provider and beneficiary representation.9 CMS withholds 50 cents per 

patient per dialysis treatment from facilities to fund the networks. 

Funding for networks in 2010 was about $28 million.10 

Consumer Assessment of Healthcare Providers and Systems Survey. As of 

2012, as part of CMS’s quality incentive program (QIP) for dialysis 

facilities, facilities must use the Consumer Assessment of Healthcare 

Providers and Systems (CAHPS) survey to measure patient satisfaction.11 

Monitoring patient satisfaction can identify concerns about the care 

provided. The Agency for Healthcare Research and Quality (AHRQ), 

which developed CAHPS, recommends that a third party administer the 

survey.12 Under the QIP, facilities failing to meet certain quality-of-care 

performance standards had their Medicare payments reduced between 

0.5 and 2 percent.13 In December 2011, CMS announced that 30 percent 

5

 MedPAC, Report to the Congress: Medicare Payment Policy, ch. 6, March 2011. 6

 Ibid. Fresenius Medical Care North America and DaVita together own 60 percent of all
 

dialysis facilities and 70 percent of freestanding dialysis facilities.
 7

 SSA, § 1881(c) and 42 CFR § 405.2112. 

8

 The statute at SSA, § 1881(c) requires the establishment of only 17 networks, but CMS
 

ultimately established 18. See CMS, Medicare ESRD Network Organizations Manual. 

Pub. 100-14, ch. 1, § 20. 

9 SSA, § 1881(c)(1), 42 CFR § 405.2113, and CMS, Medicare ESRD Network 

Organizations Manual. Pub. 100-14, ch. 2, §§ 40 and 60. 10 CMS, ESRD Network Organization Program 2010 Summary Annual Report, p. 6.
 11 76 Fed. Reg. 70228, 70269–70270 (Nov. 10, 2011). 12 AHRQ, Fielding the CAHPS In-Center Hemodialysis Survey, May, 2009. 13 P.L. 100-275 § 153(c), which added subsection (h) to SSA, § 1881. 42 CFR § 

413.177; 76 Fed. Reg. 628 (Jan. 5, 2011). The regulations set forth the QIP incentive 

program in general terms; the specifics can be found in the Federal Register entry. CMS 

determines the payment reduction on the basis of calculated facility performance scores. 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 2 
 

 

 

 

 

 

 

of dialysis facilities would have their payments reduced in 2012 based on 

their QIP scores.14 

Medicare Conditions for Coverage for Dialysis Facilities. Facilities must 

meet 16 Conditions for Coverage (CfCs) to participate in the Medicare 

program. 

15 The CfCs address topics such as patient rights, safety, and 

quality assessment and performance improvement. 

16 Each CfC includes 

standards that facilities must meet. For example, under the CfC for 

infection control is a requirement that facilities monitor staff members and 

ensure that they comply with aseptic techniques. SAs oversee the CfCs 

through onsite certification surveys of facilities. 

Beneficiary Grievances 

Beneficiaries can file grievances with their respective facilities, networks, 

or SAs. CMS has declined to define what constitutes a grievance at the 

facility level.17 Facilities may instead define the term for themselves. This 

contrasts with other parts of Medicare, such as Medicare Advantage (MA), 

for which CMS defines a grievance as “any complaint or dispute... 

expressing dissatisfaction with any aspect of an MA organization’s or 

provider’s operations, activities, or behavior, regardless of whether 

remedial action is requested.”18 

Facility Processes for Handling Grievances 

Facilities must implement an internal grievance procedure for 

beneficiaries to file oral or written grievances without reprisal or denial of 

services.19 Beneficiaries may file internal grievances personally, 

anonymously, or through a representative of the patient’s choosing.20 

Furthermore, the CfCs state that beneficiaries have the right to privacy and 

confidentiality in all aspects of treatment.21 Facilities must prominently 

display a copy of patients’ rights, including the right to file a grievance, 

where it can be easily seen and read by patients.22 

14 CMS could not calculate performance scores for 625 facilities because they did not 

meet the minimum threshold for cases. Their payments were not reduced. CMS, CMS 

Announces First Results for Program to Improve Care for Dialysis Patients, December 

15, 2011. Accessed at http://www.cms.gov on December 15, 2011. 15 42 CFR pt. 494. 

16 CMS first issued CfCs for ESRD dialysis facilities in 1976, revising them in 2008. See 

73 Fed. Reg. 20370 (April 15, 2008).
 17 73 Fed. Reg. at 20392 (April 15, 2008). 

18 42 CFR § 422.561.
 19 42 CFR § 494.180(e). 

20 42 CFR § 494.70(a)(17). 

21 42 CFR § 494.70(a)(3).
 22 42 CFR § 494.70(c). 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 3 
 

 

 

 

 

Facilities must inform beneficiaries of both the facility-level internal 

grievance process and the network- and SA-level grievance options.23 

Facilities must also measure, analyze, and track patient satisfaction and 

grievances as part of the CfC for quality assessment and performance 

improvement (QAPI).24 Facilities typically track grievances in a written or 

electronic log. 

ESRD Network Processes for Handling Grievances 

Beneficiaries can also file grievances with their respective networks.25 

Beneficiaries do not need to first file grievances with their facilities before 

contacting the networks; however, CMS instructs networks to encourage 

beneficiaries to use the facility-level grievance process before contacting 

the network. 26 Some beneficiaries may find it difficult to approach facility 

staff and reach resolution at the facility level. 

Networks must keep confidential the grievant’s identity unless given 

specific permission.27 When networks receive grievances, they gather 

information via telephone, letter, email, and onsite reviews. Networks can 

make referrals to Quality Improvement Organizations, Managed Care 

Organizations, or other such entities if the networks identify concerns 

those entities could more appropriately handle.28 Networks immediately 

refer allegations to SAs and CMS when they involve a potential lifethreatening situation.29 

If networks determine that an instance or pattern of care exists that has 

affected or might affect the health or well-being of one or more 

beneficiaries, networks can require facilities to develop and implement 

improvement plans. Networks monitor how facilities implement plans and 

expect facilities to complete the plans within 1 to 3 months. If networks 

determine that facilities failed to correct the problem, networks may 

request a revised improvement plan, refer the grievance to SAs, or 

recommend sanctions to CMS regional offices.30 

23 42 CFR § 494.70(a)(14)–(17). 

24 42 CFR § 494.110(a)(2)(viii). 

25 CMS, Medicare ESRD Network Organizations Manual, ch. 7, § 130. Beneficiaries can 

also file a complaint with the network. The network complaint process is less formal 

than the network grievance process. The beneficiary decides whether to use the network 

complaint or grievance process. In this report, we use the term “grievance” to refer to
 

both grievances and complaints at the network level.
 26 CMS, Medicare ESRD Network Organizations Manual, ch. 7, § 130.2. 27 Ibid., ch. 7, § 130.4.
 28 Ibid., ch. 7, § 130.6.
 29 Ibid., ch. 7, § 130.9.
 30 Ibid., ch. 7, § 150. 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 4 
 

 

 

 

Networks must track and process all grievances in an electronic database.31 

Networks have recently switched to a new database as part of a larger data 

system migration to the Consolidated Renal Operations in a Web-enabled 

Network (CROWNWeb). Facilities use CROWNWeb to submit clinical 

quality measures to the networks. The database that networks use to track 

grievances is called the Network Contact Utility. This database also 

includes information on other types of requests made to networks, such as 

facilities asking for help with noncompliant patients or beneficiaries 

asking for information about their dialysis care. 

Previous Work 

In 2000, the Office of Inspector General (OIG) found major shortcomings 

in the oversight of dialysis facilities.32 Oversight focused on overall 

quality improvement rather than enforcing minimum requirements that 

protect beneficiaries from harm, and it lacked coordination and 

accountability on the part of the networks, SAs, and facilities. The report 

also found that the ESRD beneficiary grievance process was unreliable in 

identifying and resolving quality-of-care concerns. OIG recommended 

that CMS hold facilities more fully accountable for the quality of care they 

provide and hold the networks and SAs more fully accountable for their 

performance in overseeing the quality of care provided by facilities. CMS 

generally agreed with OIG’s recommendations and specifically stated that 

it would strengthen procedures for anonymous grievances to avoid the 

possibility of retaliation against patients. 

METHODOLOGY 

Scope 

This inspection is national in scope. It examined network and facility 

grievance data for 2011. 

Data Sources and Collection 

Questionnaire for networks. We surveyed 17 of the 18 networks using an 

online questionnaire. (We pretested the questionnaire during a site visit to 

the 18th network.) The questionnaire asked about challenges that networks 

face in investigating grievances, how they use grievance data to identify 

quality improvement opportunities, and how they share facility-specific 

data with SAs and CMS. We conducted the survey from 

June–September 2012, and had a 100-percent response rate. 

31 Ibid., ch. 7, § 130.
 32 OIG, External Quality Review of Dialysis Facilities: A Call for Greater 

Accountability, OEI-01-99-00050, June 2000. 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 5 
 

 

Questionnaire for dialysis facilities. We surveyed a simple random sample 

of 150 facilities (of the 5,571 facilities operating in 2011) using an online 

questionnaire. The questionnaire covered facility grievance procedures, 

the number of grievances that facilities received, how facilities use 

grievances as part of their overall QAPI efforts, and whether facilities 

would record hypothetical concerns as formal grievances. As part of the 

questionnaire, we asked facilities to provide us with copies of the survey 

instrument they used in 2011 to measure patient satisfaction. We 

conducted the survey from July–October 2012. Two facilities we 

attempted to contact had closed. We received responses from 

120 facilities, an 80-percent response rate. Because of this response rate, 

our results apply to an estimated 4,457 of the 5,571 facilities in our 

sampling frame. See Appendix A for an analysis of nonrespondents and 

Appendix B for confidence intervals and point estimates for key data 

points from the facility questionnaire. 

Site visits to dialysis facilities and networks. We conducted site visits at a 

purposive sample of 3 networks in 3 States and 13 facilities in 5 States. 

We selected the networks on the basis of geographic diversity and size of 

patient population, and we selected the facilities on the basis of their 

proximity to the networks, as well as ownership status and QIP results. At 

the networks and facilities, we conducted structured interviews with staff 

members and reviewed policies and procedures, including those for how 

staff members investigate beneficiary grievances. We conducted the site 

visits from June–August 2012. 

Dialysis facility grievance logs. While onsite, we obtained the 

2011 grievance logs from the 13 facilities we visited. The logs contained a 

total of 103 grievances. 

Analysis 

Questionnaires and site visits. We performed qualitative data analysis on 

responses from the interviews and questionnaires. For example, we 

reviewed the responses for common themes. We also analyzed network 

and facility questionnaire responses by performing frequency counts of 

responses. 

Dialysis facility grievance logs. We abstracted and categorized the nature 

of each grievance and the facility’s response to it, and performed 

frequency counts of those categories. 

Limitations 

We did not independently verify the data that facilities and networks 

reported to us in their questionnaires. We also could not confirm whether 

facilities recorded all 2011 grievances in their logs; we could analyze only 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 6 
 

 

the grievances that were in the logs. The conclusions we drew from our 

site visits are limited to the facilities and networks we visited. 

Standards 

This study was conducted in accordance with the Quality Standards for 

Inspection and Evaluation issued by the Council of the Inspectors General 

on Integrity and Efficiency. 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 7 
 

 

FINDINGS 

Two-thirds of facilities recorded five or fewer 

grievances in 2011 

Facilities recorded 25,032 beneficiary grievances in 2011. However, 

28 percent of facilities recorded no grievances, and 38 percent recorded 

between one and five grievances. Because CMS does not define what a 

grievance is, facilities have latitude in defining what they record as a 

grievance; this may explain the variation across facilities in the number of 

reported grievances. The low number recorded in any one facility makes 

it difficult for a facility to analyze grievances for patterns. 

CMS requires facilities to prominently display a copy of patients’ rights, 

including the right to file a grievance, where it can be easily seen and read 

by patients.33 On our site visits, we generally observed these postings in 

facilities’ waiting areas. Furthermore, we obtained documentation from 

the facilities we visited detailing the information given to patients 

regarding facility grievance procedures. Facilities typically gave this 

information to patients when they began treatment. 

The most common grievances that facilities recorded 

concerned the comfort or appearance of the physical 

environment and interactions with staff 

About one in four grievances that facilities reported in response to our 

questionnaire concerned the comfort or appearance of the physical 

environment (see Table 1). Because dialysis patients spend so much time 

at facilities receiving treatment (typically three treatments per week lasting 

3 to 4 hours each), the environment and comfort are of obvious 

importance to them. Examples of such grievances included the facility’s 

temperature (most often, too cold), working order of televisions, and 

condition of dialysis treatment chairs. 

Facility staff also can be the subject of grievances (17 percent of recorded 

grievances). Patients frequently interact with technicians, nurses, 

physicians, and social workers during treatment. These grievances might 

involve a patient reporting that he or she had been treated rudely or 

unfairly by staff. For example, in one facility a patient complained that 

the receptionist was rude, and the patient left without receiving treatment. 

The facility resolved the grievance by counseling that staff member on 

how to be more sensitive to patients’ needs. 

33 42 CFR § 494.70(c). 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 8 
 

 

Another type of recorded grievances concerned quality of care. Examples 

of these grievances included instances of patients losing either too much 

or too little fluid during treatment.34 In response to these grievances, 

facility staff and the patient’s physician would monitor the patient during 

treatment, and make adjustments as necessary. 

Table 1: Nature of Grievances Recorded by Facilities in 2011 

Nature of Grievance Percentage of 

Recorded Grievances 

Physical Environment 26% 

Staff Interactions 17% 

Scheduling 11% 

Quality of Care 10% 

Staff Competence 5% 

Patient-to-Patient Conflicts 3% 

Other 22% 

Facility Could Not Categorize 6% 

Total 100% 

Source: OIG analysis of data from facility questionnaires, 2012. 

Facilities have latitude in what they decide to record as a 

grievance 

Although there is no expectation for any volume of grievances, the limited 

number that are recorded may result from the latitude that facilities have in 

determining what they record in their grievance logs. Because facility 

staff determine for themselves what to record as a grievance, it is possible 

that some concerns could be omitted from grievance records. 

We asked facilities to provide their definitions of a grievance, and those 

definitions ranged from the very broad “any problem a patient has” to the 

more narrowly defined “a request for an investigation of a complaint about 

a possible risk to the health, safety, or well-being of a patient”; or “a 

situation where the patient is unnecessarily at high risk.” Many facilities 

did not offer a definition beyond that of having a process to resolve 

grievances; some merely defined grievance as a “patient complaint,” and 

others defined it as a problem that cannot be resolved quickly. 

Our questionnaire provided facilities with potential concerns and asked 

whether the facilities would record them as grievances if they were to 

receive those concerns from beneficiaries. Most facilities recorded many 

of the concerns—particularly quality-of-care-related concerns—as formal 

34 Dialysis removes harmful waste, extra salt, and water from blood. 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 9 
 

 

grievances. However, 20 percent of facilities reported that they would not 

record at least one of the following quality-of-care-related concerns: a 

technician is not properly cleaning dialysis machines between shifts; a 

nurse is being rough when connecting the patient to the dialyzer; a nurse is 

not changing gloves before connecting the patient to the dialysis machine. 

This last concern could be a violation of the CfC on infection control, but 

because the facility would choose not to record it as a beneficiary 

grievance, State surveyors may not be aware of the potential violation 

unless a patient contacted them or the network directly. See Table 2 for 

concerns that facilities would and would not record as grievances. 

At the 13 facilities we visited, staff told us that they generally record 

grievances only when they cannot resolve the concern immediately. In 

four of those facilities, staff told us that beneficiaries can request that their 

grievances be recorded regardless of subject or severity, which can lead to 

the elevation of seemingly minor problems. 

Table 2 – Concerns That Facilities Would and Would Not Record As 

Grievances 

Concern 

Percentage of 

Facilities That Would 

Not Record Concern 

as a Grievance 

Percentage of 

Facilities That 

Would Record 

Concern as a 

Grievance 

Technician is not properly cleaning 

dialysis machines between shifts 13% 87% 

Nurse is rough when connecting the 

patient to the dialyzer 12% 88% 

Nurse does not change gloves 

before connecting the patient to the 

dialysis machine 

12% 88% 

Staff make the patient feel 

unwelcome 15% 85% 

Facility is too cold 24% 76% 

Patient demands to move to another 

dialysis chair because the patient 

next to him/her makes him/her feel 

uncomfortable 

23% 77% 

Patient submits written request to fix 

the television 28% 72% 

Source: OIG analysis of data from facility questionnaires, 2012. 

However, in some cases, grievances are not recorded at all. For example, 

at one facility we visited, a beneficiary complained over several months 

both about quality-of-care-related issues and his comfort during treatment. 

The facility did not record these as grievances. These unrecorded 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 10 
 

grievances could present a missed opportunity to analyze trends and 

identify opportunities to improve quality. 

Facilities generally resolve grievances directly with the staff 

involved, rather than through systemic improvements 

Facilities have a number of tools available to resolve grievances. In their 

survey responses, facilities told us that these tools include staff training, 

implementing quality improvement plans, disciplining employees, and 

contacting their respective networks. 

However, when we examined grievance logs in the facilities we visited, 

we observed that most grievances are resolved by talking to the 

beneficiaries and specific staff directly involved in the incident. On only a 

few occasions—when grievances addressed broad quality-of-care issues— 

did facilities hold training sessions for all staff. For example, one such 

grievance concerned a patient who experienced painful cannulation 

(insertion of a needle into the venous access point). As a result, the 

facility trained its nursing staff on communicating with patients during 

difficult interactions (the log did not note whether the facility also trained 

staff on cannulating). Another grievance concerned one patient who felt 

that some staff members were not proficient in using his dialysis machine. 

The facility held an in-service training on proper use of the machine. 

Facility staff typically tried to resolve common grievances about the 

physical environment, such as temperature or broken equipment, 

immediately, for example by adjusting the thermostat or calling in the 

appropriate repair people. 

Furthermore, facilities’ analysis of grievances rarely results in systemic 

improvements. About half the facilities that we visited hold monthly 

meetings focused on facilitywide quality and performance improvement. 

During these meetings, facility staff might discuss trends gleaned from 

grievances; however, staff told us that their grievance volume is so low 

that they almost never have any grievances to discuss. For grievances that 

staff do not record, such as issues with televisions or temperature, staff do 

not conduct any formal trend analysis. Instead, the facility’s point person 

for resolving grievances tries to informally track and identify patterns. 

All but 3 percent of facilities reported that they analyze grievances to 

identify trends, but they are unable to see an actual trend because of the 

low number of cases. Of the facilities that do analyze for trends, almost 

all look for trends related to the physical environment, specific employees, 

quality of care, facility procedures, and activities of specific patients, but 

they were able to identify trends in fewer than a third of these areas, as 

Table 3 shows. 

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The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 12 

Table 3: Grievances That Facilities Analyzed for Trends 

Nature of Grievance 

Percentage of 

Facilities That 

Analyze for Trends 

Percentage of 

Facilities That 

Identified Trends 

Physical environment or appearance 98% 30% 

Specific employee 97% 26% 

Quality of care 97% 19% 

Facility procedures 96% 20% 

Specific patient 94% 27% 

Source: OIG analysis of data from facility questionnaires, 2012. 

Anonymous grievance processes can be difficult to 

implement, and fear of reprisal may be difficult for 

facilities to measure 

Almost all facilities reported that they offer methods for beneficiaries to 

submit grievances anonymously. Anonymous processes at facilities we 

visited included submission by telephone, to corporate headquarters or to a 

third party, and to suggestion boxes. However, 5 of the 13 facilities we 

visited did not offer anonymity. At these facilities, staff told us that, 

although they keep confidential the identity of patients who submit 

grievances, the patients must give their names. 

Anonymous grievances can be difficult for facilities to address. For 

example, if a grievance concerns a particular staff interaction, it may be 

difficult to obtain details about the incident when staff do not know which 

patient was involved. One staff person told us that “an adequate 

resolution is usually dependent on identifying the complainant.” Ensuring 

anonymity is also difficult because, as facility staff told us, even when 

patients submit grievances anonymously, staff can often deduce the 

patients’ identities because of the nature of the grievances. 

On the other hand, it is important that patients who file grievances feel 

safe from reprisals, as OIG and patient advocates have documented.35 

Staff at one network told us that they sometimes must stop a grievance 

investigation when the patient’s anonymity becomes threatened, and 13 of 

the 18 networks said in response to our questionnaire that when they are 

resolving grievances, it is a challenge to assure patients that they will not 

face reprisals for complaining. 

35 OIG, External Quality Review of Dialysis Facilities: A Call for Greater 

Accountability, OEI-01-99-00050, June 2000. 
 

 

Two-thirds of the patient satisfaction surveys that facilities submitted to us 

include a question to measure fear of reprisals; such questions show 

facilities’ awareness that fear of reprisal may exist. Facilities can use 

these data to assess how well they create an environment in which patients 

feel comfortable raising questions or grievances about their care. 

These patient satisfaction surveys were developed by the facilities. 

However, as part of its QIP, CMS mandated that facilities administer the 

CAHPS survey to measure patient satisfaction. CAHPS includes 

questions that address patient satisfaction with common concerns, such as 

facility cleanliness, insertion of needles with as little pain as possible, and 

the timeliness of starting treatment. However, CAHPS does not include a 

question to measure a patient’s fear of reprisal for lodging a grievance. 

Because of the time and expense involved, it is unlikely that facilities will 

administer both the CAHPS survey and a survey of their own. As a result, 

facilities may discontinue conducting their own surveys, and the chance to 

learn about fear of reprisal among patients will be limited. 

ESRD networks’ involvement with beneficiary

grievances is constrained by limited data and 

reporting 

Although the networks serve as an external option for resolving 

beneficiary grievances with dialysis care, that role is constrained by 

limited data and reporting on grievances. In addition to investigating 

grievances, networks also collect data and provide technical assistance to 

providers and beneficiaries.36 We found that communication between 

networks and facilities primarily concerned these latter areas, not 

grievances. Networks communicated with facilities primarily through 

email reminders promoting network initiatives, such as flu vaccination, 

and through other educational materials. Most networks reported that they 

visited at least one facility in 2011, most often to provide training rather 

than to assist in resolving a grievance. Similarly, facilities reported that 

networks rarely visit them, and when networks do go onsite at a facility it 

is for reasons such as providing training, not to resolve grievances. 

All networks analyze grievances for trends, but the database 

they use is of limited utility 

Networks analyze grievances for trends at individual facilities and within 

chain organizations, as well as to identify opportunities to improve quality 

networkwide. All 18 networks run reports from the CMS-developed 

Network Contact Utility database to analyze grievances for trends. All but 

36 SSA, § 1881(c)(2) and 42 CFR § 405.2112. The Network areas are determined by 

number and concentration of beneficiaries. 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 13 
 

two networks reported that they had developed their own programs (e.g., 

using Excel or SAS) to conduct additional analysis. Most networks 

worked to identify systemic concerns at individual facilities and 

opportunities for networkwide projects to improve quality. 

The networks we visited raised concerns about the usefulness of the 

Contact Utility database for analyzing grievance data. One network 

reported that its understanding and use of the Contact Utility database is 

limited because the database lacks a data dictionary or user manual. 

Another network that we visited duplicated all the data from the database 

into its own system to more accurately and specifically categorize 

grievances. In doing so, this network identified a lack of historical data as 

a problem; because the database retains only 18 months of data, its value 

is limited. Furthermore, the broad categories in the database make it 

difficult to compare grievance trends across networks, as networks can 

interpret category labels differently. 

Facilities rarely contact networks for assistance with 

grievances 

Facilities rarely contact the network for assistance in dealing with 

grievances. Only 1 of the 13 facilities we visited had contacted its 

network for such help. Sixty-one percent of dialysis facilities responding 

to our survey said that they do not report to their respective networks the 

number and types of grievances they receive. Of the facilities that did, 

most did so only upon the network’s request or on an as-needed basis, 

rather than on a regular basis. Only eight networks reported in our survey 

that they conducted an onsite investigation of a facility. 

Facilities that we visited generally contacted their respective networks for 

assistance with difficult patients rather than for help with the grievance 

process. Recently, facilities have been contacting networks for assistance 

with the transition to CMS’s CROWNWeb data system. Many of the 

facilities we visited voiced frustration with the transition and have often 

contacted their networks for help in using the new system. 

CMS is unable to readily provide network-specific grievance 

data 

We asked CMS to provide us with information on network-specific data 

on grievances for 2011, including the nature of grievances and their 

disposition. After 8 months, CMS was able to provide only high-level 

summary data, apparently because of the networks’ inability to extract the 

data from the Contact Utility database. This raises questions about CMS’s 

ability to effectively oversee the networks’ role in investigating 

grievances. 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 14 
 

CONCLUSION AND RECOMMENDATIONS 

Medicare regulations require dialysis facilities to measure, analyze, and 

track beneficiary grievances. When promulgating its ESRD regulations, 

CMS declined to define “grievance” on the grounds that the term was 

“commonly understood.”37 However, we found that facilities define 

grievances differently and as a result, they vary in how they measure and 

track them. Some facilities are likely not recording important, quality-ofcare-related grievances, such as a nurse not changing gloves before 

connecting a patient to the dialysis machine, and other facilities are 

recording trivial grievances, such as televisions with poor reception. 

This variation, coupled with facilities’ not routinely reporting their 

grievance data to networks, means that networks do not get an accurate, 

complete picture of the grievances occurring in their respective regions. 

Furthermore, limitations with networks’ own data make it difficult for 

them to conduct their own analyses of grievance data. 

Therefore, we recommend that CMS: 

Define “grievance” for facilities 

CMS could offer a strict definition of a grievance. Alternatively, it could 

define a grievance in terms of what facilities would be required to record 

in their logs. For example, CMS could require facilities to record only 

those grievances related to quality of care or staff interactions, rather than 

grievances related to temperature or broken television sets. CMS could 

work with the networks to create a definition. 

Provide guidance to facilities on what constitutes a robust 

process for anonymous grievances 

CMS, either directly or via the networks, could provide facilities with 

guidance that explains the difference between a confidential process and 

an anonymous process. Networks could also offer facilities guidance on 

effective strategies for investigating a grievance when the beneficiary 

chooses to remain anonymous. 

Require facilities to report grievances regularly to their 

respective networks 

CMS already requires facilities to regularly report certain clinical data to 

their respective networks. As part of this reporting, CMS could require 

facilities to periodically provide a summary of grievances. For example, 

facilities could send quarterly reports to their networks with the number 

and nature of any grievances the facilities recorded. CMS, together with 

37 73 Fed. Reg. at 20392 (April 15, 2008). 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 15 
 

the networks, could define which types of grievances facilities could 

report, omitting grievances concerning broken television sets and focusing 

on more serious concerns related to quality of care and staff interactions. 

Such regular reporting would give networks more data with which to 

analyze trends, and thus give them a better sense of the types of grievances 

that beneficiaries in their regions are raising with facilities. 

Work with AHRQ to add a question to CAHPS to assess 

beneficiaries’ fear of reprisal 

Once facilities transition to the CAHPS survey, it is unlikely that they will 

also conduct their own surveys. As a result, far fewer facilities will 

capture data from beneficiaries regarding fear of reprisal. CMS could 

work with AHRQ on adding a small number of questions designed to elicit 

this information. CMS would then be able to better measure the extent to 

which ESRD beneficiaries throughout the country fear reprisal for voicing 

grievances about their care. 

Provide networks with better technical support for the Contact 

Utility database 

CMS could provide networks with a data dictionary and user manual 

detailing the elements of the database. It could also standardize for 

networks the definitions for types of grievances; such standardization is 

essential for cross-network analysis. Furthermore, CMS could add 

additional standard reports and more historical data to the database so that 

networks would not need to create their own duplicative tools for data 

analysis. 

We understand that the entire network data system is in a state of 

transition as CMS implements the new CROWNWeb system. Better 

support to networks will ease this transition and allow networks to best use 

grievance data to identify concerns in their regions. 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 16 
 

AGENCY RESPONSE AND OFFICE OF INSPECTOR GENERAL 

RESPONSE 

CMS concurred with our first, second, and fifth recommendations. 

Regarding the first recommendation, CMS no longer distinguishes 

between grievances and complaints at the network level, and will consider 

proposing to define “grievance” in the ESRD CfCs during the next 

rulemaking cycle. 

In concurring with our second recommendation, CMS references its 

addition of a requirement in 2008, in response to an earlier OIG report 

(2000), that facilities inform beneficiaries of the right to file grievances 

personally, anonymously, or through a representative of the beneficiary's 

choosing. CMS noted that the networks are responsible for ensuring that 

facilities are aware of this requirement, and for informing beneficiaries of 

their right to decide whether to begin the grievance process at the facility 

or network level. CMS stated that it is working with beneficiaries, 

families, and other stakeholders to get direct input on making the 

grievance system more robust. However, our report shows that some 

facilities either do not have an anonymous process in place, or that they do 

not understand what an anonymous process is. CMS notes that networks 

must inform beneficiaries of their right to file a grievance either at their 

facility or their network, although CMS’s guidance to networks 

encourages beneficiaries to use the facility-level grievance process before 

contacting the network. This policy reinforces how important it is that 

facilities have a robust process for anonymous grievances. 

Regarding our fifth recommendation, CMS held training sessions with the 

networks to assist them in learning the Contact Utility database, and 

included a copy of the technical manual. 

CMS did not concur with our third and fourth recommendations. 

Regarding the third recommendation, the agency agreed that although 

such data may be useful, safeguards exist to ensure that grievances are 

resolved. For example, the CfCs require that facilities have grievance 

policies and procedures in place, as well as include beneficiary satisfaction 

and grievances as part of their QAPI activities; that networks inform 

beneficiaries of the network's role in receiving, reporting, resolving, and 

tracking patient grievances; and that State surveyors assess the QAPI 

program and grievance component during their onsite inspections of 

facilities. 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 17 
 

Additionally, CMS stated that the recommendation did not take into 

account its costs and that further assessment of need and a benefit analysis 

would have to be performed. However, our recommendation is meant to 

enhance the networks’ statutory responsibility to monitor facilities by 

providing another indicator the networks can use to identify poor 

performers. With respect to the benefit analysis, we invite CMS to 

conduct such an analysis, including its assumptions of the costs and 

benefits of requiring reporting of such data. 

Regarding our fourth recommendation, CMS stated that it needs to 

consider additional costs for revising the survey, as well as the change in 

burden for the beneficiaries because of the increased number of survey 

questions. CMS is also concerned whether an ESRD beneficiary would 

honestly answer a question about fear of reprisal. The ESRD Network 

Coordinating Center is exploring ways to obtain information on patient 

satisfaction with grievance resolution, and CMS plans to conduct a small 

number of interviews with beneficiaries and will look into this issue. 

OIG questions CMS’s assumption that beneficiaries would not honestly 

answer a question about fear of reprisal on an anonymous survey 

administered by a third party. That assumption calls into question whether 

beneficiaries would answer any of the questions honestly. Furthermore, if 

beneficiaries are in fact too fearful to honestly answer such a question 

from a third party, it underscores the importance of measuring and 

addressing that fear. 

For the full text of CMS’s comments, see Appendix C. 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 18 
 

APPENDIX A 

Nonrespondent Analysis 

Our findings are based on estimates made solely from data collected from 

sample respondents, and we did not statistically adjust our results because 

of any assumptions about how the nonrespondents may have answered our 

questions. Consequently, our results pertain to approximately 80 percent 

of the population of all dialysis facilities. We performed a nonresponse 

analysis to see if these results for 80 percent of the population might 

substantially differ from those of the entire population. We compared 

whether the respondents and nonrespondents differ in certain 

characteristics and examined whether the time of response affected the 

results. 

Comparisons of Respondents and Nonrespondents 

The characteristics we had available for both respondents and 

nonrespondents were facility type (chain or nonchain) and nonprofit status 

(for-profit or nonprofit). We estimated the proportion of respondents and 

nonrespondents with these characteristics and performed Wald Chi-Square 

tests of significance. We found no statistically significant differences at 

the 95-percent confidence level between the respondents and 

nonrespondents for either of these facility characteristics. 

Analysis of Late Respondents 

Survey researchers have found some evidence that—in general—late 

respondents may provide answers more similar to those that 

nonrespondents would have provided than to those provided by early 

respondents. We categorized the respondents as either “early” or “late” by 

whether they responded to the questionnaire within three written attempts 

(“early”) or only after we contacted them by telephone (“late”). We then 

compared estimates of early and late respondents on key survey questions, 

i.e., questions as to whether facilities recorded grievances, analyzed 

grievances for trends, or had a method for patients to complain 

anonymously. We found no statistically significant differences at the 

95-percent confidence level between estimates by early and late 

respondents. 

Although we found no statistically significant differences on the basis of 

this analysis, we cannot conclude that no differences exist. The magnitude 

of any potential differences is a product of both the nonresponse rate and 

the extent to which nonrespondents actually would have answered the 

questions differently from respondents. However, our results based only 

on responding facilities may reasonably be expected not to differ 

substantially from those based on all facilities in the sample. 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 19 
 

 

APPENDIX B 

Point Estimates and Confidence Intervals Based on the Facility 

Questionnaire 

We calculated confidence intervals for key data points in the facility 

questionnaire. The sample size, point estimates, and 95-percent confidence 

intervals are given for each of the following: 

Data Element Description Sample Size Point Estimate 95-Percent Confidence Interval 

Number of Grievances Recorded 120 25,032 18,370–31,695 

Percentage of Facilities That Recorded No Grievances 120 28% 20%–36% 

Percentage of Facilities That Recorded 1–5 Grievances 120 38% 30%–47% 

Grievances Related to Physical Environment 120 26% 15%–37% 

Grievances Related to Staff Interactions 120 17% 11%–23% 

Grievances Related to Scheduling 120 11% 8%–13% 

Grievances Related to Quality of Care 120 10% 6%–14% 

Grievances Related to Staff Competence 120 5% 3%–7% 

Grievances Related to Patient-to-Patient Conflicts 120 3% 1%–5% 

Facility Would Record as a Grievance That Technician Is Not 

Cleaning Machine 120 87% 79%–92% 

Facility Would Record as a Grievance That Nurse Is Rough 

When Connecting Patient to Machine 120 88% 81%–93% 

Facility Would Record as a Grievance That Nurse Did Not 

Change Gloves 120 88% 81%–93% 

Facility Would Record as a Grievance That Staff Makes 

Patient Feel Unwelcome 120 85% 77%–90% 

Facility Would Record as a Grievance That Temperature Is 

Too Cold 120 76% 67%–83% 

Facility Would Record as a Grievance Patient Request To 

Move Chairs 120 77% 68%–83% 

Facility Would Record as a Grievance Patient Written Request 

To Fix TV 120 72% 64%–80% 

Facilities That Analyze Grievances for Trends 120 97% 93%–99% 

Facilities That Analyze for Trends About Physical Environment 117 98% 93%–100% 

Facilities That Analyze for Trends About Specific Employees 117 97% 91%–99% 

Facilities That Analyze for Trends About Quality of Care 117 97% 91%–99% 

Facilities That Analyze for Trends About Procedures 117 96% 90%–98%

 Facilities That Analyze for Trends About Specific Patients 117 94% 88%–97% 

Facility Identified Trends About Physical Environment 117 30% 22%–38% 

Facility Identified Trends About Specific Employees 117 26% 18%–34% 

Facility Identified Trends About Quality of Care 117 19% 13%–27% 

Facility Identified Trends About Procedures 117 20% 13%–28% 

Facility Identified Trends About Specific Patients 117 27% 19%–35% 

Source: OIG analysis of facility questionnaire data, 2012. 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 20 
APPENDIXC 

Agency Comments 

*'fP."lC~.~ 

( ~ ,~,. DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 

Administrator 

Washington, DC 20201 

DATE: OCT 3 0 2013 

TO: Daniel R. Levinson 

Inspe~tor General 

FROM: Mar~nTavenner 

Adminl'stratO. 

SUBJECT: Office of Inspector General (OIG) Draft Report: The ESRD Beneficiary 

Grievance Process (OEI-0 I -I I -00550) 

Thank you for the opportunity to review and comment on the above subject OIG draft report. 

The Centers for Medicare & Medicaid Services (CMS) appreciates the recommendations for 

improving the End Stage Renal Disease (ESRD) Beneficiary grievance process and views this 

report as a means to reassess progress, and to highlight recent changes we have implemented to 

improve the ESRD Network grievance process and to improve dialysis care. OIG's objective for 

this study was to describe the grievance processes that dialysis facilities and ESRD Network 

Organizations have in place for beneficiaries. 

The investigation and resolution ofgrievances is an opportunity to focus on meeting the needs of 

ESRD patients and to create change by listening to, and learning from, the patient's perspective. 

In January 2013, CMS implemented a redesigned ESRD Network Statement of Work (SOW) to 

improve alignment with the Department of Health and Human Services National Quality 

Strategy and the three aims of better health, better care, and lower costs. The new approach 

facilitates a heightened focus on patient and family centered concerns and aims to promote better 

access to care. 

The OIG recommendations and CMS responses to those recommendations are provided below. 

OIG Recommendation 

The OIG recommends that CMS define "grievances" for facilities. 

CMS Response 

The CMS concurs with the recommendation. CMS was already in the process of implementing a 

standard definition prior to this review. The ESRD Network is responsible for using 

standardized procedures to collect data and address grievances to promote consistency. The 

Networks now adhere to the definition of grievances and the grievance resolution processes 

described in the revised Chapter 9, "Grievances and Patient-Appropriate Access to Care," of the 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 21 
 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 22 
 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 23 
 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 24 
 

ACKNOWLEDGMENTS 

This report was prepared under the direction of Joyce M. Greenleaf, 

Regional Inspector General for Evaluation and Inspections in the Boston 

regional office; Russell Hereford, Deputy Regional Inspector General; and 

Kenneth Price, Deputy Regional Inspector General. 

Ivan Troy served as team leader for this study. Other Office of Evaluation 

and Inspections staff from the Boston regional office who conducted the 

study include Elizabeth Havener and Kimberly Yates. Central office staff 

who provided support include Althea Hosein, Kevin Farber, Meghan 

Kearns, and Christine Moritz. 

The ESRD Beneficiary Grievance Process (OEI-01-11-00550) 25 
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 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 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. These evaluations focus on preventing fraud, waste, or abuse and promoting 

economy, efficiency, and effectiveness of departmental programs. To promote impact, OEI 

reports also present practical recommendations for improving program operations. 

Office of Investigations 

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

of fraud and misconduct related to HHS programs, operations, and beneficiaries. With 

investigators working in all 50 States and the District of Columbia, OI utilizes its resources 

by actively coordinating with the Department of Justice and other Federal, State, and local 

law enforcement authorities. The investigative efforts of OI often lead to criminal 

convictions, administrative sanctions, and/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 for OIG’s internal operations. OCIG represents OIG in all civil and 

administrative fraud and abuse cases involving HHS programs, including False Claims Act, 

program exclusion, and civil monetary penalty cases. In connection with these cases, OCIG 

also negotiates and monitors corporate integrity agreements. OCIG renders advisory 

opinions, issues compliance program guidance, publishes fraud alerts, and provides other 

guidance to the health care industry concerning the anti-kickback statute and other OIG 

enforcement authorities.